House panel probes drug distributors and DEA amid national opioid crisis

Drugmakers and distributors face barrage of lawsuits over opioid epidemic

The companies that manufacture and distribute highly addictive painkillers are facing a barrage of lawsuits for the toll their product has taken on communities across the country as the worst drug epidemic in U.S. history continues to escalate. Within the past year, at least 25 states, cities and counties have filed civil cases against manufacturers, distributors and large drugstore chains that make up the $13 billion-a-year opioid industry. In the past few weeks alone, the attorneys general for Ohio and Missouri, along with the district attorneys for three counties in Tennessee, filed suits against the industry — and the attorney general for Oklahoma filed suit on Friday. The strategy echoes the effort against major tobacco companies in the 1990s and is born of similar frustration over rising death rates and the increasing costs of addressing the continuing public health crisis. After years of government and pharmaceutical firms failing to control the problem, some lawyers say the suits have the potential to force the industry to curb practices that contribute to it. “If they’re not going to do it voluntarily, we’re going to drag them to the table and make them,” said Ohio Attorney General Mike DeWine, who sued five drug manufacturers for the costs of the opioid epidemic. Dozens of other state, county and city governments and local law enforcement agencies are considering legal action. Some states are interviewing law firms. Delaware is among a handful of states that are even issuing “requests for proposals” from law firms. In addition, more than half the country’s state attorneys general — Republicans and Democrats — have banded together to investigate the industry. Two congressional panels also are examining the industry — the Senate Homeland Security and Governmental Affairs Committee and the House Energy and Commerce Committee. The Justice Department’s inspector general is investigating why the Drug Enforcement Administration slowed enforcement efforts against drug distribution companies. Representatives of the companies deny wrongdoing and vow to vigorously defend themselves. They said they have taken steps to prevent the diversion of their drugs to the black market. Stemming the epidemic, they said, will take a coordinated effort by doctors, the industry, and federal and local government agencies. “As we look to prevent abuse and misuse in the future, it will require a forward-looking, systemic approach that calls on greater coordination and collaboration between health-care, law enforcement, and state and federal regulatory authorities,” said the Healthcare Distribution Alliance, which represents companies that distribute drugs. But in a blow to the industry, the D.C. Court of Appeals on Friday rejected arguments from a drug distributor, Masters Pharmaceutical, that would have undermined the DEA’s ability to hold companies responsible for pain pills that are diverted to the black market. The lawsuits come as states and communities grapple with the economic impact of a prescription drug epidemic that has resulted in nearly 180,000 overdose deaths between 2000 and 2015 — more than three times the number of Americans who died during the Vietnam War. The epidemic has led to thousands more deaths from overdoses of heroin and fentanyl, which are becoming easier and cheaper to obtain than prescription drugs. But winning the lawsuits will not be easy, according to Richard C. Ausness, a professor at the University of Kentucky College of Law who studies product liability litigation. He said it is more likely that the companies will settle rather than try to defend themselves against dozens, perhaps hundreds, of lawsuits. “I think what’s going on, and this is what happened in the tobacco litigation, is that the plaintiffs never actually won a case,” Ausness said. “What they did is they drove up the cost of litigation so much that the defendants finally settled.” Manufacturers, distributors and pharmacy chains are expected to argue that they cannot be held responsible for what happens to pain pills once they travel down the supply chain. “They ship a drug that’s approved by the FDA [Food and Drug Administration], and then a bunch of bad actors intervene — pill mills, doctors who overprescribe and the addicts themselves,” Ausness said. “It’s a pretty strong argument.” The suits are reminiscent of the tobacco cases filed two decades ago. In the 1990s, 46 attorneys general eventually combined their resources to sue the tobacco companies. In 1998, the industry settled those suits, agreeing to pay more than $200 billion. “These pharmaceutical companies should be scared as hell,” said Richard Fields, an attorney who has filed suit on behalf of the Cherokee Nation in Oklahoma. The suit alleges that the nation’s top six drug distributors and pharmacy chains flooded the state with hundreds of millions of pain pills, decimating the Cherokee Nation’s 14 counties. During a meeting of the Democratic Attorneys General Association in May in Portland, Ore., industry officials said they were not to blame for the epidemic. Instead, they said during a panel discussion that they were part of the solution and had put programs in place to prevent the illegal use of pain pills. Grant Woods, a former Arizona attorney general who was the first Republican to sue the tobacco companies, said he was appalled by what he heard. As the officials finished their presentations, Woods stood from his seat in the crowded sixth-floor ballroom of The Nines resort hotel and told them they all deserved to be sued. Woods has joined forces with another veteran of the tobacco lawsuits, Mike Moore, who served as the attorney general for Mississippi and filed the first of the tobacco suits. The two attorneys, along with other high-profile lawyers, are now working for Ohio and Mississippi on their opioid cases, and they are signing up other states to sue the companies. Woods said the similarities between the opioid and tobacco suits are striking. “They are big companies that knew their product was doing harm,” he said. “Instead of helping to solve the problem, they promoted the irresponsible use of their product to improve their bottom line.” At the same time, prescription narcotics, when used appropriately, can eliminate pain without deadly health consequences — a claim cigarette manufacturers could not make. The suits target some of the biggest names in the business, including McKesson, Johnson & Johnson and CVS. Some of the suits allege that the companies fraudulently marketed opioids to the public. Others claim that the companies failed to report suspiciously large orders of prescription pain pills placed by distributors and pharmacies. McKesson, the largest drug distribution company in the country, said in a statement: “While McKesson doesn’t manufacture, prescribe, or dispense opioids, we have taken steps to play a leadership role in combatting this epidemic in close partnership with doctors, pharmacists, the DEA and other organizations across the supply chain.” Johnson & Johnson’s pharmaceutical unit, Janssen Pharmaceutical, issued a statement saying the company is “continuing to work with stakeholders to support” the “safe and appropriate use” of opioids. CVS said it has “stringent” procedures to keep prescription pain pills out of the hands of drug addicts and dealers. “CVS Health is committed to the highest standards of ethics and business practices, including complying with all federal and state laws governing the dispensing of controlled substance prescriptions, and is dedicated to reducing prescription drug abuse and diversion,” the company said in a statement. As the epidemic spreads, more states are declaring states of emergency and filing lawsuits. In New York, eight counties have filed suits. Salvatore Badala, who filed a suit on behalf of Nassau County on June 12, said his client needs financial help. “It’s getting worse every day,” he said. In Missouri, Attorney General Josh Hawley filed suit June 22 against three manufacturers of opioids. In 2015, 500 people died from opioid-related overdoses, not counting heroin, and there were 30,000 opioid-related emergency room visits that same year, a 200 percent increase over the previous decade. In West Virginia, seven counties filed suit in March. “It’s outrageous,” said Paul Farrell Jr., who filed the suits. He and other attorneys say they expect industry lawyers to delay the cases. “They can drag it on for a very long time,” said J. Gerard Stranch IV, a lawyer who is part of the Tennessee suit. “But there will come a day when they have to stand up in front of a jury and explain themselves. And that day of reckoning is coming.”

A mega-case puts opioids on trial

Nearly 19,000 people lost their lives to opioid overdoses in 2014, a quadrupling of these deaths in just 15 years. The devastation wrought by the prescription opioid crisis, and the subsequent related epidemic of addiction to chemically similar heroin, is spreading anguish across America. Government’s response so far consists mainly of damage control — more drug treatment, distributing overdose antidotes to first responders. Fundamental change might be on the way, however, depending on what happens during the coming weeks in an unlikely locale: the Hinds County courthouse in Jackson, Miss. A state judge there will decide whether Mississippi Attorney General Jim Hood — aided by a phalanx of private plaintiffs’ attorneys — can proceed with a suit against opioid manufacturers in which the companies stand accused of promoting the drugs by allegedly systematically understating their health risks and exaggerating their benefits, violating state law. The potential exists for a mega-case like the one that ultimately brought Big Tobacco to heel. At a minimum, pretrial discovery might force drug companies to do something they have heretofore fiercely resisted: produce their internal records, including any that show discrepancies between what they told doctors, regulators and the public about opioids, and what they knew or suspected privately. To be sure, state attorneys general and trial lawyers, the former notoriously motivated by political ambition, the latter by whopping contingency fees, are not optimal redeemers of the public interest, in the health-care context or any other. For reasons of accountability, efficiency and consistency, elected officials, acting with or through independent, expert regulatory bodies, should be the first choice for that job, not state courts. Yet the opioid epidemic is a crisis in large part because the responsible institutions failed; indeed, they fell under the influence of the very interest groups — especially the drugmakers — they were supposed to regulate. Eyeing billions in profits, opioid companies bombarded the marketplace’s gatekeepers — medical societies, academics, state legislatures, Congress and, crucially, the Food and Drug Administration — with a consistent, seductive message: Chronic pain affects tens of millions of adults and is woefully undertreated; and it can be safely and effectively eased, on a continuous basis, with opioids, contrary to long-standing medical wisdom. To read the allegations in the 250-page Mississippi lawsuit is to marvel at the sophistication of a marketing campaign that recast a handful of debatable scientific studies as pro-opioid conventional wisdom, then fed it to everyone from selected opinion leaders in the medical elite to small-town family practitioners. Audaciously, drugmakers — or ostensibly objective “pain management” experts and organizations funded by industry — labeled patient behaviors suggestive of opioid addiction, such as hoarding medication or doctor-shopping, as “pseudoaddiction,” and then instructed doctors that it was indicative of pain that should be treated with more opioids, the suit alleges. The FDA went along. Among its many opioid approvals, it greenlighted OxyContin for chronic pain, based in part on the manufacturer’s claim that it was less addictive because a dose lasts 12 hours. As the Mississippi lawsuit argues, and investigative journalists have documented, that claim proved dangerously invalid for many patients. Over the past decade, the opioid makers and their allies spent more than $880 million to lobby against tougher regulations, state and federal, according to a recent report by the Associated Press and the Center for Public Integrity. Groups favoring regulation, by contrast, spent $4 million. The industry’s money supported 7,100 candidates for state-level offices and funded an average of 1,350 lobbyists nationwide. They also have excellent lawyers that have urged the Mississippi court to dismiss the attorney general’s lawsuit in deference to the FDA’s “primary jurisdiction” over drug regulation. The seasoned, expert regulators in Washington are in the best position to decide these technical matters and are already conducting an evidence-based review, the industry lawyers note. (This year a new FDA commissioner, chastened by congressional criticism of the agency’s record on opioids, promised to “fundamentally re-examine the risk-benefit paradigm for opioids.”) Given the past coziness between the drug industry and government, the companies’ contention is both predictable, and convenient. There is legal precedent for it, though. A California state judge threw out a lawsuit against the opioid makers last year on the grounds that it would have usurped the FDA. On Sept. 29, however, plaintiffs got a boost when a federal judge in Chicago rejected the “primary jurisdiction” argument and allowed that city to go ahead with a similar case. The conflicting rulings in California and Chicago make the Mississippi case a tie-breaker of sorts, which could spawn many new lawsuits if it goes against the opioid makers. At stake is whether they may continue being held accountable primarily by institutions where their clout is well established — or whether, for the first time, they will have to answer charges before impartial judges, as well as juries drawn from the very communities their products have ravaged. _Read more fromCharles Lane’s archive, follow him on Twitter or subscribe to his updates on Facebook._ **Read more on this topic:** The Post’s View: The CDC’s promising plan to curb America’s opioid dependence Alison Block: A doctor’s dilemma: Do I prescribe opioids? The Post’s View: Maryland takes one step forward and one step back against opioids The Post’s View: Lawmakers are finally sobering up to the reality of opioid addiction

House panel recommends cutting funding for Planned Parenthood, reigniting old debate

A House panel formed by Republicans to investigate the procurement of human fetal tissue for medical research has recommended stripping federal funds from Planned Parenthood, heralding a new congressional assault on the nation’s largest provider of abortions and women’s health care. The GOP majority on the Select Investigative Panel included the recommendation in the 471-page final report, which was issued Tuesday on the dissolution of the panel. It was formed in 2015 after antiabortion activists recorded a series of undercover videos that they said documented abuses by abortion providers and intermediaries that provide fetal tissue to researchers. Over strong objections from Democrats, medical groups and abortion rights supporters, Republicans issued subpoenas to dozens of clinics, procurement firms and research institutions. Their final report suggests that some clinics and firms are illegally profiting from fetal-tissue transactions and that their business arrangements could create an incentive to perform more abortions. While GOP panel members denied targeting Planned Parenthood as they conducted their investigation, the report closely scrutinizes several of the organization’s affiliates, accusing them of “careless management” and “a general disinterest in clinical integrity.” “My hope is that this is going to provide the information that is necessary for action to be taken,” Rep. Marsha Blackburn (R-Tenn.), the panel’s chairwoman, said in an interview Wednesday. “This will be a Congress and an administration that will be known for standing for the women, for the protection of unborn children, and the protection of life.” The panel’s Democrats preemptively blasted the findings in a 114-page report of their own, released in December, that challenged the Republicans’ key claims. They criticized the GOP members’ “McCarthy-era tactics,” accused them of relying on “unsourced, unverified documents” and argued that there is “no legitimate basis” to strip federal funding for Planned Parenthood’s medical services. “Republicans spent nearly $1.6 million taxpayer dollars chasing inflammatory lies being peddled by antiabortion extremists,” said Rep. Jan Schakowsky (D-Ill.), the panel’s top Democrat, who said the body “leaves behind a legacy of lies, intimidation and procedural misconduct.” The panel has been sharply partisan from the outset: It was created on a party-line vote after some Republicans threatened a government shutdown unless Planned Parenthood was stripped of federal funding. Republicans have styled it as the “Select Panel on Infant Lives,” while some Democrats preferred to call it the “Select Panel to Attack Women’s Health.” One GOP recommendation is to ban federal funding for research on fetal tissue obtained through elective abortions while providing for the donation of miscarried fetuses for research through existing organ-donation programs. Another would have Congress direct the National Institutes of Health to develop new guidelines for the use of human fetal tissue. Other recommendations include having Congress “take appropriate measures” to ensure that the Justice Department prosecute violations of the federal ban on profiting from the sale of fetal tissue and beefing up protections for “born-alive” infants. But the most politically charged implications of the report are certain to surround Planned Parenthood, whose affiliates performed 324,000 abortions in 2014 among more than 9 million other discrete medical services. The group reported receiving $553 million in government funding that year, about half of its total revenue. Congress has barred federal funding for abortions since 1976, but health providers that offer abortions are eligible for Medicaid reimbursements and federal family-planning grants for other services. But antiabortion lawmakers have long challenged the notion of abortion providers getting federal funding of any sort. “What we just want to do is just put that clear line there,” Blackburn said. “It is as simple as that: To be sure that [federal funds] are not going into abortion services.” Roughly 40 percent of Planned Parenthood’s funding could be at risk with a Republican Congress willing to pass defunding legislation and an incoming Republican president willing to sign it. The panel’s report stands to give antiabortion lawmakers a rallying point as they push to include that measure in a legislative package aimed at repealing President Obama’s health-care reform law that is expected to pass this year. A Planned Parenthood executive on Wednesday called the GOP report “nothing more than a partisan attack on Planned Parenthood and women’s access to safe and legal abortion” and noted that investigations in 13 states and by several other congressional committees found no wrongdoing. “Planned Parenthood has never profited while facilitating its patients’ choice to donate fetal tissue for use in important medical research,” said Dana Singiser, the organization’s vice president for public policy and government affairs, who noted that only about 1 percent of its health centers offer the option to donate. Congress is not the only entity that Planned Parenthood and other organizations targeted by the panel have to be concerned about. Panel Republicans issued 15 referrals to federal and state law enforcement authorities over potential criminal violations, and Blackburn said she expects that the administration of President-elect Donald Trump will closely examine those. But it remains unclear how aggressive Trump will be regarding Planned Parenthood, an organization he has praised in the past, and whether he will push to defund it as part of his larger health-care plans. A bill repealing the Affordable Care Act that was vetoed by President Obama early last year included a provision targeting Planned Parenthood. Vice President-elect Mike Pence did not mention defunding the group when he went to Capitol Hill on Wednesday to discuss the GOP’s health-care plans, according to several lawmakers. But Blackburn, a member of Trump’s transition team, said she was confident he would sign defunding legislation. “I truly think that Donald Trump is going to continue to speak on behalf of life and stand for life,” she said.

The Benghazi investigation is over, but another House GOP probe soldiers on

The House select committee investigating the 2012 deaths of four Americans in Benghazi, Libya, wrapped up this week after more than two years of investigation and more than $7 million in taxpayer dollars spent — ending, as it began, awash in partisan sniping. Meanwhile, another special House panel that has become enveloped in similar political warfare quietly continues its work. This panel — called the Select Investigative Panel on Infant Lives —established last year to probe allegations made in undercover videos produced by antiabortion activists is halfway through its year-long mandate to investigate and report on links between abortion providers and medical researchers. Like the Benghazi committee, the select panel began life with a sharply partisan House vote, and relations between the Republican majority and Democratic minority on the panel have since steadily eroded, with Democrats casting the investigation as a “witch hunt” and pushing repeatedly to end it. The Republicans have been undaunted, holding two public hearings that have aimed to cast doubt on the ethics and necessity of fetal tissue research, as well as the legality of the commerce in fetal tissue between abortion clinics, medical researchers and the “procurement entities” standing between them. They have also issued dozens of subpoenas to those parties in an effort to document whether the tissue trade has resulted in illegal profits and a tacit incentive to perform more abortions. “Evidence uncovered through our investigation provides a view of abortion clinics willing to sell baby body parts to make more money,” Rep. Marsha Blackburn (R-Tenn.), the panel’s chairwoman, said in a statement. “It shows clinics and middlemen willing to exploit young women because they now see their babies as a profit center. We’ve even learned of a public university embarking on an aggressive campaign to expand abortions by receiving fetal tissue from and sharing staff with a for-profit late term abortion clinic in New Mexico. These disturbing findings are exactly why this investigation is warranted and we will continue to follow the facts in order to complete our report to Congress by the end of the year.” Last week, panel Republicans accused the University of New Mexico and an Albuquerque abortion clinic of possibly violating state and federal law, delivering a referral for criminal investigation to New Mexico’s attorney general. Blackburn, in a statement, cited evidence that “personnel within UNM’s hospital and medical school have aggressively engaged in expanding abortion in New Mexico through the offices, personnel, and resources of UNM.” A spokesman for the university’s Health Sciences Center told the Albuquerque Journal last week that researchers paid no money for fetal tissue and that Blackburn had misread New Mexico law. “We categorically deny the chair’s assertions in every respect,” the spokesman, Billy Sparks, said. The UNM referral came after the panel last month sharpened its focus on StemExpress, a California firm that procures research specimens, accusing it in a letter to federal regulators of engaging in contractual relationships with abortion clinics “under which both sides make a profit from the baby body parts inside the young woman’s womb.” Democrats — both those on the panel and in the House at large — have pushed back on virtually all the Republican claims and have called for the panel’s shutdown. They have accused their GOP colleagues of engaging in “McCarthyism” rooted in philosophical opposition to abortion and of seeking to intimate law-abiding researchers. The evidence that panel Republicans have presented, the Democrats say, do not support claims of wrongdoing. “The Republicans should take the lesson learned from their long, costly and partisan Benghazi investigation,” said Rep. Jan Schakowsky (Ill.), the panel’s ranking Democrat. “Instead, they continue to follow their same partisan playbook at great cost to American taxpayers and the truth.” She added that “three other House Republican-led committees and thirteen states investigated [the activists’ videos] and found no wrongdoing. It is time for Republicans to stop spending taxpayer dollars on politically purposed witch hunts. Enough is enough.” In terms of its scope, the select panel’s charge is broad — it is authorized to look at a range of practices and policies regarding fetal tissue procurement, including those of abortion providers and whether federal resources are indirectly supporting abortion clinics through the tissue trade. But in terms of the resources, the probe is considerably smaller than the investigation by the Benghazi committee. According to congressional staff records maintained by Legistorm, this panel employs 10 staff members compared with the 28 employed by the Benghazi panel. The panel is set to expire with the current Congress, and Blackburn said earlier this year that she anticipates issuing a final report before year’s end. There is a caveat: If Republicans maintain control of the House in November, they could vote to continue the panel into 2017 — much as the Benghazi panel was extended. Earlier this month, the infant-lives panel’s expenditures rose to $790,000 after Republicans on the House Administration Committee quietly moved to authorize an additional $490,000 in spending beyond the $300,000 earmarked for the panel last year. Democrats on that committee have objected to the new funding, calling the panel “nothing more than a political weapon targeting women, doctors and valuable research” in a June 16 letter to Administration Committee Chairman Rep. Candice Miller (R-Mich.). “We should not reward this catastrophe with more taxpayers dollars,” they wrote. In a statement, Miller defended the additional funds, saying it was well within the scope of her committee’s powers to “ensure House committee panels have the resources they, both majority and minority, need to conduct their oversight and to address important issues that were not anticipated at the time of the original committee funding hearings.” The funding is split between Democrats and Republicans, with the majority receiving two-thirds to the minority’s one-third. Aides from both parties expect more funding will be necessary before the panel wraps up its work, but it is not expected to rise to the $7 million spent by the Benghazi panel. But the work appears destined to remain mired in partisan warfare — demonstrated in the dueling names that Republicans and Democrats are using to describe the panel. The GOP calls it a panel to “protect infant lives”; for Democrats, it is intended to “attack women’s health.” Together with the Benghazi panel, this select panel’s legacy might well be to mark the increasing politicization and polarization of congressional investigations — a point made this week by the Benghazi panel’s chairman, Rep. Trey Gowdy (R-S.C.). “Congress does a lousy job of conducting apolitical nonpartisan investigations, and the American people deserve better,” Gowdy said Tuesday in an MSNBC interview.

FDA nominee says nation’s opioid crisis is as serious as Ebola, Zika threats

Scott Gottlieb, the physician and entrepreneur who is President Trump's nominee to head the Food and Drug Administration, told senators Wednesday that the nation's opioid crisis is a “public health emergency on the order of Ebola and Zika” and requires dramatic action by the agency and the rest of government. During his confirmation hearing before the Health, Education, Labor and Pensions Committee, Gottlieb described the FDA as “complicit, even if unwittingly,” in helping to fuel the opioid epidemic. Officials, he said, “didn't fully recognize the scope of the emerging problem” several years ago and needed a new strategy to combat the issues involved. Developing that strategy, he added, would be his “highest and most immediate priority” and would involve taking a hard look at the FDA's framework for approving painkillers and pressing for greater availability of nonaddictive painkillers. Gottlieb, a high-ranking FDA official during the George W. Bush administration, was welcomed warmly by Republicans, who praised his experience in industry, medicine and the government. With strong support from Chairman Lamar Alexander (R-Tenn.), his confirmation seems all but assured. The committee vote is at least two weeks away because of an upcoming congressional recess. The nominee took some flak from Democrats, who worried that his long-standing financial ties to the pharmaceutical industry would impair his ability to regulate it. Sen. Patty Murray (D-Wash), the panel's ranking minority member, said she remained uneasy about Gottlieb's “unprecedented entanglements” with the industry, despite his agreement to recuse himself for a year from any decisions involving more than 20 companies with which he has had financial relationships since leaving the government in 2007. “I do struggle to see how this means your views are not shaped by your investments,” she said, adding that she's also concerned President Trump, who has described the FDA drug-approval process as “slow and burdensome,” might pressure him to lower safety and efficacy standards to speed products to market. But the 44-year-old Gottlieb, who worked for New Enterprise Associates, one of the world's largest venture capital firms, pledged to be an “impartial and passionate advocate for public health” and said that there is “one standard for safety and effectiveness, and no commissioner can change that.” During the hearing, he was questioned on a variety of issues, including vaccine safety. Trump has repeatedly suggested that there is a link between vaccines and autism — a widely discredited theory. Gottlieb said the purported vaccines-autism link has been “one of the most exhaustively studied questions” in scientific history. Now, he said, “We need to come to the point where we can accept no for an answer and come to the conclusion that there is no causal link between vaccination and autism.” His comments on opioids came a day after two Democratic senators whose states have been ravaged by prescription painkillers — Edward J. Markey of Massachusetts and Sherrod Brown of Ohio — came out in opposition to his nomination. Both argued that Gottlieb's record, as well as his extensive writings on FDA issues, suggested that he didn't support using the necessary tools to fight the epidemic. In particular, they criticized a 2012 article in which he questioned the Drug Enforcement Administration's efforts to police opioids. He wrote that the DEA's approach was “burdening a lot of innocent patients” and suggested that some of its responsibilities be turned over to the Department of Health and Human Services. During the hearing, Sen. Tim Kaine (D-Va.) urged Gottlieb to aggressively scrutinize pain management in general and to seek additional help from Congress if needed. Late last month, Trump appointed a high-profile commission, chaired by New Jersey Gov. Chris Christie (R), to combat the crisis. Gottlieb was not immediately named as a member, and it's not clear whether he will join if confirmed as FDA commissioner by the Senate. Gottlieb said he would take an “all-of-the-above approach” in trying to find solutions to the opioid problem but also added that the issue has become too big for the FDA to solve on its own. “This is a staggering human tragedy that is going to require dramatic action on the part of the agency,” he said. He acknowledged that the agency's response had been “too incremental” over the years, though he said he wasn't criticizing his predecessors. Much of the hearing — and most of the Democratic senators' questions — focused on Gottlieb's business connections to the drug industry. After serving as deputy FDA commissioner, he worked for numerous companies and investment firms in a variety of roles, including as a consultant, paid speaker, investor and adviser. Gottlieb said he would take additional steps to ensure that neither he nor the agency is compromised by his prior relationships with industry. He already has stepped down from various boards and sold his interests in several health-care companies, he said in an ethics agreement he recently filed with federal officials.

Patrick J. Kennedy calls America’s opioid crisis the ‘biggest public health epidemic of our time’

Former congressman Patrick J. Kennedy, who has struggled with drug addiction and alcoholism, says the country is in “deep, deep denial” about the opioid crisis. “If this were an infectious disease, we’d be throwing hundreds of billions of dollars at it right now,” Kennedy told The Washington Post in a live interview on Tuesday. Kennedy, the author of “A Common Struggle: A Personal Journey Through the Past and Future of Mental Illness and Addiction,” and a member on the White House Commission on Combating Drug Addiction and the Opioid Crisis, said he does not support the use of block grants, which are part of the Republican spending package, to help states fund addiction treatment and mental health programs for low-income individuals. “They’re using grants as a way of really doing what they don’t want to vote on doing, and that’s sharply cutting the amount of money that goes to treatment. So, they say they’re giving the same amount but they’re letting states to do the dirty work,” Kennedy told the Washington Post’s Mary Jordan. “People with addiction and mental illness are the most unpopular of all constituencies so they’re the easiest people to drop by the wayside.” Kennedy also drew a connection between overdoses and suicides, saying that “we have no clue what the true suicide rate” is in the United States. “You cannot divorce the suicide rate from the opiate overdose rate,” he said. Kennedy offered his perspective during a Washington Post Live program on America’s opioid crisis featuring doctors, health care experts and elected officials.   Sen. Ed Markey (D-Mass.), said opioid-related deaths in Massachusetts are “three times worse than the national rate,” noting that about 2,000 people in his state died as a result of addiction in 2016. Massachusetts, he said, “has been a predictor of this catastrophe spreading inextricably, inevitably, across the country.” Rep. Greg Walden (R-Ore.), the chairman of the House Energy and Commerce Committee, represents a rural district in Eastern Oregon, where he said he has seen many families and communities affected by the crisis. He attributes a lot of Oregon’s addiction problems to the over prescribing of opioids to relieve pain. “We’re also seeing a dramatic increase in 65 and older that are being treated as inpatients in hospitals because of this addiction,” Walden said. “It’s affecting every age group.” And Rep. Diana DeGette (D-Colo.) said her state is facing similar challenges. “What all three of us have recognized, is this really does seem to have exploded on the scene,” she said. “We’ve heard stories about addiction for some years and cautions about overuse of opioids. But these stories are just exploding.”   Dr. Andrew Kolodny, Co-Director of Opioid Policy Research at The Heller School for Social Policy and Management at Brandeis University, said the opioid addiction epidemic was misrepresented from the start as a problem that only affects “so-called drug abusers.” “Opioids are not safe and effective treatments for the vast majority of people suffering with chronic pain,” he said, adding: “It’s not an abuse crisis. It’s an addiction epidemic.” Dr. Leana Wen, Health Commissioner of Baltimore City, agreed that this crisis is different from other public health crises, particularly due to “huge stigma around treatment.” “We don’t say to someone with diabetes, ‘well why are you still on insulin, why can’t you get off your insulin and isn’t lifestyle changes, shouldn’t that be enough?’” she said in an interview with the Post’s Lenny Bernstein. “And yet we make those assumptions about people with the disease of addiction all the time.” Anne Pritchett, Vice President of Research and Policy at PhRMA, the association that represents large pharmaceutical manufacturers, said many factors contribute to the nationwide crisis, notably the over prescription of opioids. “There are enough prescription opioids being prescribed so that every person in America has a 30-day supply,” Pritchett said, according to research from the U.S. Centers for Disease Control and Prevention. “So, clearly we have a problem.” Post health and medicine reporter, Lenny Bernstein, asked Pritchett about the case of West Virginia — a state that was flooded with 780 million opioids over a five-year period. “Everyone in the supply chain has a role and a responsibility to behave ethically and legally and to ensure that only as much medication as needed is being provided,” Pritchett acknowledged. “Clearly there is a disconnect in the supply chain.”

Embattled DEA chief to resign following ‘sex parties’ scandal

The head of the Drug Enforcement Administration is stepping down in mid-May, following revelations about “sex parties” involving prostitutes overseas and other misconduct among its agents. Michele Leonhart, who has served at the helm of the DEA since 2007, has come under heavy criticism on Capitol Hill since an inspector general’s report last month documented a series of episodes in which agents hired prostitutes. Agents were also found to have had sex parties with some women hired by Colombian drug cartels. Attorney General Eric H. Holder Jr. announced Leonhart’s pending departure in a statement Tuesday in which he noted she was the first woman at the agency to reach the rank of special agent in charge. “She was a trailblazer for equality,” he said. Holder made no mention of the recent DEA controversies and said Leonhart had informed him she would be retiring. “Over the past decade, under her leadership, there have been innumerable instances of the DEA dismantling the most violent and most significant drug trafficking organizations and holding accountable the largest drug kingpins around the world,” he said. The White House and Congress had signaled their frustrations with the DEA in recent weeks. Speaking before the announcement that Leonhart would be stepping down, White House press secretary Josh Earnest said the administration continued to “have concerns” about issues cited in the inspector general’s report. The White House had repeatedly declined opportunities to express confidence in Leonhart. “The president, as you know, maintains a very high standard for anybody who serves in his administration, particularly when it comes to law enforcement officials,” Earnest said Tuesday. “And the IG report raised serious concerns about that conduct.” Leonhart testified before the House Oversight and Government Reform Committee last Wednesday, telling lawmakers that the “activity” described in the inspector general’s report “has not and will not be tolerated.” Afterward, however, the panel announced it had lost confidence in her ability to lead the agency. On Tuesday, leaders of the committee called her departure appropriate in light of the controversy. “With the opportunity now for fresh leadership, we are hopeful that the DEA can restore itself to an agency of distinction and excellence,” said Chairman Jason Chaffetz (R-Utah) and ranking Democrat Elijah E. Cummings (Md.). The Justice Department inspector general’s report focused on cases from 2009 to 2012 but also cited complaints dating to 2005. At last week’s hearing, the committee released a summary of a separate report prepared by the DEA’s Office of Professional Responsibility that found agents were having sex parties with prostitutes paid for by Colombian drug cartels as early as 2001. The report described “literally dozens” of such parties at residences paid for with U.S. government funds, Cummings said. The reports by the inspector general and DEA show that the agents who attended the parties received suspensions of two to 10 days, a penalty that Chaffetz said reflected an “unacceptable” lack of accountability. Mark Berman contributed to this report.

The Washington Post to explore nation’s opioid crisis during event featuring U.S. Surgeon General Vivek Murthy

Deaths due to prescription opioids and heroin use are at a record high. As the epidemic worsens, efforts to curb its rise have emerged from government agencies, community initiatives and the private sector. On Wednesday May 4, The Washington Post will host Coffee@WaPo: Addiction in America, featuring conversations with leaders and influencers in government, health care and advocacy examining the causes of the opioid epidemic, who it affects and possible solutions. U.S. Surgeon General Vivek Murthy; Director of National Drug Control Policy Michael Botticelli; Mayor of Ithaca Svante L. Myrick; Jason Snyder, Policy and Communications Director of the Pennsylvania Department of Drug and Alcohol Programs; Anne McDonald Pritchett, vice president of policy and research at PhRMA; and John Rosenthal, Co-founder of Police Assisted Addiction and Recovery Initiative, will take part in the discussions led by moderators including Washington Post Live Editor Lois Romano and National Reporter Kimberly Kindy.  Coffee@WaPo: Addiction in America is sponsored by Cigna with support fro m the American Society of Addiction Medicine.

Senator calls for investigation into alleged FDA ‘pay to play’ meetings with drug firms

Sen. Joe Manchin III is calling for an investigation of “pay to play” allegations regarding a scientific panel that shaped the Food and Drug Administration’s thinking on painkillers and that, according to the organizer’s e-mails, was funded by major pharmaceutical companies that put up as much $25,000 to attend a meeting. In a letter to FDA Commissioner Margaret Hamburg, Manchin requested that the agency turn over to his office a long list of documents, including the names of all the companies that paid to attend the panel’s meetings, how much they paid, and e-mails between the organizers and agency officials. Manchin (D-W.Va.) has been pressing the agency to put stricter limits on hydrocodone — one of the key ingredients in Vicodin and Lortab — because of their addictive power and widespread availability. Pharmacy companies and others have resisted the effort, saying in part that more restrictions could unfairly put the drugs out of reach for patients who need them. “It is a shame that some of these companies were able to influence the FDA’s decision with a $25,000 contribution, while West Virginian families are destroyed by the addiction these pills cause,” Manchin said in a statement. He said he is “calling for a full investigation to see how far this goes. If these allegations are true, they explain why it has taken the FDA almost a year to reach a decision to reschedule hydrocodone.” In calling for the investigation, Manchin cited a Washington Post report this week that drug companies paid as much as $25,000 to attend meetings of the scientific panel, according to e-mails among organizers. The meetings were arranged by two academics and were attended by FDA officials overseeing painkillers. They amounted to what one agency officials described as “an essential collaborative effort.” FDA officials said they were “unaware of any improprieties” associated with the meetings of the group. An FDA spokesman declined to comment on Manchin’s request. Related story: Drug firms paid to attend meetings of advisory panel

In the GOP House, Infant Lives probe accelerates while Zika funding request stalls

The special House committee formed by Republicans last year to probe threats to “infant lives” held its second hearing Wednesday, training its focus on whether abortion clinics have illegally profited from the sale of fetal tissue for medical research.  GOP leaders, including House Speaker Paul D. Ryan of Wisconsin, say they are open to providing more funding for the Zika response once the Obama administration answers questions about its request. But their cautious approach in responding to the virus, now strongly linked to infant microcephaly, stands in contrast to the aggressive probe now being waged into fetal tissue procurement and research practices by the Select Investigative Panel on Infant Lives. That disconnect has fueled Democratic attacks on both the funding impasse and the highly polarized fetal tissue investigation. “If you were just an outsider in the world, listening to the news about Zika, you would assume that a select committee on infant lives would be talking about this horrific impact to infant lives around the globe and potentially here in our country,” said Sen. Patty Murray (D-Wash.), the top Democrat on both the Health, Education, Labor and Pensions Committee and on the Appropriations subcommittee handling health-related matters. Zika has figured only tangentially in the House panel’s investigation. Wednesday’s hearing focused on whether abortion clinics and “procurement entities” — middle men who gather and prepare specimens for researchers — have illegally profited from fetal tissue transactions. The panel’s chairwoman, Rep. Marsha Blackburn (R-Tenn.), unveiled documents that she said constituted evidence that one procurement firm, StemExpress, had advertised its services as offering financial benefits to clinics. The evidence included marketing materials for a StemExpress partnership program that “fiscally rewards clinics for contributing to the advancement of life-saving research” and, in another case, specifically mentions “Financial Profits.”  Blackburn said there is no evidence that the abortion clinics who do business with these procurement firms incur any costs needing to be reimbursed, thus any payments between the two would constitute illegal profits. Panel Republicans invited a trio of former federal prosecutors to Wednesday’s hearing to testify that the StemExpress documents constitute probable cause of a criminal offense — one, they said, that the Justice Department should vigorously investigate. “It strikes me as odd that there would not be an aggressive and meaningful investigation into the allegation that human baby body parts are being sold for profit,” said Kenneth Sukhia, a former U.S. attorney in Florida. There is no public indication that the Justice Department has investigated or is investigating StemExpress or the abortion clinics that facilitate fetal tissue donations, including those affiliated with Planned Parenthood. Law enforcement investigations in 12 states have not resulted in any charges for those entities. Democrats and StemExpress itself — whose name was redacted from the documents but responded publicly with a lengthy statement and letter to the panel — sharply challenged the Republicans’ claims. StemExpress accused the panel of sourcing some of the documents not from the 900 pages of materials it provided in response to a committee request but from “unauthenticated, stolen documents” obtained by David Daleiden, the anti-abortion activist who produced the undercover videos that sparked the panel’s creation. The marketing materials mentioning financial “benefits” and “profits,” StemExpress said, referenced its work with adult blood and tissue, which it said constitutes the “overwhelming majority” of its work and all of its profit. In the statement, StemExpress mentioned Zika as the type of research supported by the fetal tissue it procures. “Many researchers throughout the medical community have shared with StemExpress that their institutions are waiting for the Select Panel to complete its investigation before going forward with additional fetal tissue research specific to the Zika virus and potential treatments,” the firm said.   At Wednesday’s hearing, Rep. Jackie Speier (D-Calif.) asked why the Zika threat wasn’t getting more attention from the panel given its moniker: “Considering Zika-affected infants suffer from brain damage, severe seizures and other medical problems, why aren’t we talking about protecting those infant lives?”  “All of us want to see progress made in curing diseases, and all of us want to push forward when it comes to precision medicine and addressing outbreaks such as Zika,” she said. “I don’t see that there is a cause-and-effect or a relationship or a contradiction between that. What we are charged with doing is figuring out if there is a violation, if there is a profit, and that’s what we’re going to continue to do.” Blackburn noted the administration’s redirection of Ebola response funding to the Zika threat — a maneuver which has been the centerpiece of the House Republican response to the White House request for emergency funds. There has been movement in the Senate on providing emergency Zika funds. The Republican chairman of the Senate Appropriations Committee, Thad Cochran of Mississippi, said at a Thursday committee meeting that he expected supplemental funds for Zika to be attached to a spending bill on the Senate floor “in the near future.” But House GOP appropriators have maintained that, with the redirected Ebola funding, the Zika response can wait until the congressional spending process culminates in the fall. Ryan (R-Wis.), who has backed those appropriators, said Thursday that Zika is an issue “we take extremely seriously” and did not rule out an emergency funding measure. But he said the Obama administration has yet to provide “followup answers to the questions that we’ve had about what is needed, where it’s needed, and what pipeline we need to put the money through.” “We see our job as being good stewards of the taxpayer dollars as making sure that we have answers to our questions about how we fund these things,” he said. Matt Dennis, a spokesman for the Democrats on the House Appropriations Committee, said the administration “has been extremely forthcoming and answered every question asked of them, repeatedly, but Congress continues to hem and haw over accounting while the virus spreads.” “We need vaccines, diagnostics, and mosquito control now — not when the majority gets around to it,” he said.

Senate clears way for confirmation of new FDA commissioner

Lawmakers on Monday cleared the way for the confirmation of Robert Califf as the new commissioner of the Food and Drug Administration, despite ongoing objections from senators who have criticized his ties to the pharmaceutical industry. The Senate overwhelmingly backed a procedural motion to prevent any legislator from blocking a vote on Califf’s nomination and to limit debate on the decision to 30 hours. A final vote could come as early as Tuesday. In recent months, several senators have held up the confirmation of the longtime cardiologist and Duke University researcher. Democratic presidential candidate Sen. Bernie Sanders (Vt.) has argued that Califf’s background — pharmaceutical companies funded many of the research studies he oversaw at Duke — would prevent him from standing up to drug companies and looking out for ordinary consumers. Sen. Lisa Murkowski (R-Alaska) briefly held up Califf’s nomination because she wanted the FDA to put in place labeling requirements for genetically engineered salmon. But perhaps the most severe criticism has come from Sen. Edward J. Markey (D-Mass.) and Sen. Joe Manchin III (D-W.Va.), who sought to block Califf’s confirmation vote because of their frustration with what they see as the FDA’s lax approach to opioid painkillers amid an epidemic of prescription-drug abuse. “Right now, FDA is part of the opioid problem, when America is counting on it to be part of the solution,” Markey said at a news conference with Manchin. The pair criticized the FDA’s recent vow to overhaul its opioid protocols — the agency promised to strengthen follow-up studies on painkiller use and convene outside expert panels before considering new opioids without “abuse-deterrent” properties — as hollow and unlikely to slow the addiction crisis. “The FDA, now more than ever, needs a champion who’s committed to changing the way the agency approaches opiates,” Manchin said. Despite their opposition, Manchin and Markey acknowledged that they faced an uphill battle in blocking Califf, who last month sailed through an initial vote by a Senate health committee and has wide support on Capitol Hill. In addition to Markey and Manchin, senators who voted against the measure were Kelly Ayotte (R-N.H.), Richard Blumenthal (D-Conn.), Bill Nelson (D-Fla.) and Rob Portman (R-Ohio).

Senate panel investigates drug companies’ ties to pain groups

As the Senate Finance Committee launched an investigation Tuesday into the relationship between makers of narcotic painkillers and the groups that champion them, a leading advocacy organization said it was dissolving “due to irreparable economic circumstances.” The American Pain Foundation, which described itself as the nation’s largest organization focused on patients’ pain, was the subject of a December investigation by ProPublica in The Washington Post that detailed its close ties to drugmakers. The group received 90 percent of its $5 million in funding in 2010 from the drug and medical-device industry, ProPublica found, and its guides for patients, journalists and policymakers had played down the risks associated with opioid painkillers while exaggerating the benefits from the drugs. It is unclear whether the group’s announcement Tuesday evening — that it would “cease to exist, effective immediately” — was related to letters senators Max Baucus (D-Mont.), the finance panel chairman, and Charles Grassley (R-Iowa) sent earlier in the day to the foundation, drug companies and others. In the letters, the senators cited an “an epidemic of accidental deaths and addiction resulting from the increased sale and use of powerful narcotic painkillers.” That class of drugs includes popular brand names like Oxycontin, Vicodin and Opana. Growing evidence, they wrote, suggests that drug companies “may be responsible, at least in part, for this epidemic by promoting misleading information about the drugs’ safety and effectiveness.” The American Pain Foundation’s Web site carried a statement Tuesday night saying its board voted May 3 to dissolve the group because it couldn’t stay “operational.” The foundation did not respond to requests for comment Tuesday. The senators are targeting a who’s who of the pain industry, seeking extensive records and correspondence documenting the links, financial and otherwise, between them and the makers of the top-prescribed painkillers. The senators’ letters also cite reporting by the Milwaukee Journal Sentinel and MedPage Today that found the companies’ close ties extended to physician societies and academic research groups. The letters went to three pharmaceutical companies — Purdue Pharma, Endo Pharmaceuticals and Johnson & Johnson — as well as to five groups that support pain patients, doctors or research: the American Pain Foundation, the American Academy of Pain Medicine, the American Pain Society, the Wisconsin Pain and Policy Studies Group, and the Center for Practical Bioethics. The Federation of State Medical Boards, the trade group for agencies that license doctors, received a letter, as did the Joint Commission, an independent nonprofit group that accredits hospitals nationwide and made pain management a national priority in 2001. The senators requested information on payments since 1997 to 10 groups and eight people, including two doctors featured in ProPublica’s December report. They asked about any influence the companies had on a 2004 guide for doctors about pain that was distributed by the Federation of State Medical Boards, on guidelines by the American Pain Society and on the American Pain Foundation’s Military/Veterans Pain Initiative. Patients in serious pain need access to opioids, the senators wrote, but drugmakers and health-care groups “must distribute accurate information about these drugs in order to prevent improper use and diversion to drug abusers.” Concerns about the overuse and abuse of painkillers have intensified in recent years. As sales of the powerful drugs have boomed — rising 300 percent since 1999 — so, too, have overdose deaths. Opioids were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined, according to the U.S. Centers for Disease Control and Prevention. Pain doctors and patient groups say that while overdoses are a legitimate concern, only a small percentage of deaths involves patients who get them from their doctors. Most involve illicitly obtained drugs, statistics show. The groups also say that patients have a low risk if they do not have addictive personalities and that any restrictions should not punish patients who suffer from serious pain.

What the doctor ordered

WITH THE publication Thursday of a comprehensive 428-page report on drug and alcohol misuse, Surgeon General Vivek H. Murthy has added his voice to those calling for a more vigorous, better informed approach to addiction in the United States. Dr. Murthy emphasizes the need for a public-health-based approach to the problem, one that offers sufferers less moralizing and more medically based treatment options; fortunately, that seems already to be the emerging consensus, one of the few things Republicans and Democrats agree on. Backed by the authority of Dr. Murthy’s office, the document is likely to become a standard reference; a 1964 report on smoking and health by an earlier surgeon general, Dr. Luther Terry, became a cultural milestone. As the report makes clear, the growth in the United States’ drug problem comes from opioids, fed both by misuse and diversion of legal, prescribed drugs and by heroin. In fact, the report’s statistics on alcohol, cocaine and hallucinogen consumption show no significant change between 2002 and 2014. Meanwhile, deaths from prescription-opioid and heroin overdoses have surged. The report also documents a measurable recent uptick in marijuana use, probably linked to its recent legalization in several states. The surgeon general identifies several non-trivial public health risks of rising marijuana usage; advocates of legalization may find themselves challenged to explain, better than they have so far, how those risks can be mitigated. But the opioid crisis is the greater danger by far. President-elect Donald Trump lamented it time and again as he toured the Rust Belt and Appalachian regions where the ravages of these drugs are particularly severe. In a speech on the subject last month, he demagogically linked drug addiction to the “sanctuary cities” movement, claiming participating towns “refuse to turn over illegal immigrant drug traffickers for deportation.” Much of what he proposed, however, was at least plausible, indeed mainstream, including alternatives to jail for users and greater access to treatment. He advocated tighter regulation of prescription opioid production in the United States, as well as less regulation of medications designed to treat addiction. He called for a crackdown on shipments of synthetic opioids through the U.S. postal system from China. Keeping his promise to repeal Obamacare, however, would mean nullifying a law that dramatically expanded access to drug and alcohol treatment, and provided funding, through Medicaid, for low-income people. This potential contradiction is just one of many reasons to be concerned about the GOP’s plans for health care in the Trump years. **Read more on this topic:** The Post’s View: Locating blame in the opioid epidemic Charles Lane: A mega-case puts opioids on trial The Post’s View: The FDA sets a new course to save lives from opioid addiction Alison Block: A doctor’s dilemma: Do I prescribe opioids? The Post’s View: Lawmakers are finally sobering up to the reality of opioid addiction

Locating blame in the opioid epidemic

DESTRUCTIVE AND persistent, the epidemic of opioid addiction is also deeply ironic: Unlike previous drug scourges in U.S. history, this one spread via perfectly legal channels. Millions of people were introduced to addictive pain-killing medications by doctors’ prescriptions, filled at pharmacies, ultimately supplied by pharmaceutical manufacturers. All of this went on in one of the most heavily regulated sectors of the U.S. economy — health care — which is supervised by a veritable army of officials working for dozens of agencies, state and federal. Understandably, Americans want to know how the corporate, governmental and medical establishment could have presided over the growth of a public health crisis that caused 18,893 overdose deaths related to prescription pain relievers in 2014, plus 10,574 from a follow-on heroin epidemic, according to the Centers for Disease Control and Prevention. Some of the answers — or, at least, more good questions — emerged from a recent series of articles in The Post about the interaction between two little-known but crucial players in the pharmaceutical business: wholesalers that link factory to pharmacy, and the Drug Enforcement Administration, which is responsible for ensuring that legally produced narcotics aren’t diverted for improper or illegal use. The key finding of the articles by Lenny Bernstein, Scott Higham and David S. Fallis is that DEA career personnel responded to the rise in opioid abuse after the turn of the 21st century by pursuing aggressive civil enforcement against wholesalers suspected of pumping drugs into corrupt “pill mills” around the country. These efforts were important because they enabled DEA officials to stop abusive practices through administrative orders, backed by financial penalties, without mounting full-blown criminal prosecutions. Yet the DEA officials told The Post they eventually ran into resistance from higher-level Justice Department officials who were being heavily lobbied by the wholesalers, which include some of the biggest corporations in the United States. The number of civil case filings against wholesalers plunged from 131 in fiscal 2011 to 40 in fiscal 2014 before rebounding to 64 in fiscal 2016. Whether this decline is due to regulatory capture of the DEA by the industry, as the DEA’s in-house critics allege, better conduct by industry, as industry says, or a combination of the two is a matter Congress should investigate. Sens. Ron Wyden (D-Ore.) and Patrick J. Leahy (D-Vt.) sent Attorney General Loretta E. Lynch a letter asking her for a detailed response to the evidence in the Post stories — something neither Justice nor the DEA was willing to provide when our reporters asked. Congress too may have some explaining to do; this year it enacted, and President Obama signed, a law that makes it more difficult for the DEA to initiate civil enforcement actions against wholesalers, by raising the legal standard for doing so — all in the name of better “cooperation” between industry and government and patient “access” to necessary medicines. Given the way addictive prescription drugs flooded into the market even during the days when wholesalers were complaining that the DEA was overly adversarial toward them, we’re skeptical that what’s called for is a friendlier industry-government relationship. To the contrary. **Read more:** Charles Lane: A mega-case puts opioids on trial The Post’s View: Lawmakers are finally sobering up to the reality of opioid addiction Charles Lane: The opioid epidemic: For whites only? The Post’s View: The FDA sets a new course to save lives from opioid addiction Alison Block: A doctor’s dilemma: Do I prescribe opioids?

Transcript: Addiction in America

Joining me on stage, and pardon me just a moment while I adjust this, first off, we have Congresswoman Diana DeGette of Colorado.  She is a senior Democrat on the House Energy and Commerce Committee.  She’s the ranking Democrat on the Oversight Investigation Subcommittee.  She co-authored the 20th Century Cures Act, which put a billion dollars of new federal funds into the opioid epidemic to combat it.  She’s also the chief deputy whip of the Democratic House Democratic Caucus.  Thank you very much, Congresswoman. Senator Ed Markey is here of Massachusetts, Democrat and member of the Senate Commerce Committee, which has broad jurisdiction over private industry, including the pharmaceutical industry.  He’s done numerous investigations and authored numerous pieces of legislation to address this crisis.  He’s going to talk quite a bit about that.  And last but not least, Chairman Greg Walden is with us today of Oregon, Republican of Oregon.  He has drawn attention to the opioid epidemic as its effected his district in rural Eastern Oregon.  He also plays a key role in overseeing the health sector of our economy.  He played a key role in drafting the American Healthcare Act, which is now going through the Congressional process, and we’re going to give you an opportunity to talk about that legislation and the oversight that you’ve done on your committee.  Thank you very much for being here. Let me start with Senator Markey.  This is a question I’m going to throw to everybody on the panel today.  But tell me how you first experienced this crisis as a crisis?  When did you understand that this is something that needed your attention and what did you see in your state that compelled you to act? Markey:           It was Taunton, Massachusetts; it was Martin Luther King Day, January 15, 2014.  I was standing in the back of the room getting ready to give my speech and I said to the police chief and the mayor, Mayor Hoye in Taunton, “What’s the biggest issue?”  And he said, “Well, we’ve lost seven people to overdoses in just the last couple of weeks.”  And then I said to the chief, I said, “Well, what’s the issue?”  And he said, “Well, they’re now lacing the heroin with fentanyl.”  Then he explained to me about fentanyl.  And I brought back Gil Kerlikowske, the drug czar for the United States the next month into Taunton. And the numbers are huge.  In Massachusetts in 2016, we lost 2,000 people to overdose deaths, opioid-related death.  We’re only two percent of America’s population.  If the whole country was dying at our rate, that would be 100,000 people in a year.  That would be two Vietnam Wars every single year.  Of those who died, the 2,000, 70 percent had fentanyl in their system.  That would be 1,400 people in Massachusetts last year.  You extrapolate that out for the whole country, that would be 70,000 people dying from fentanyl-related overdoses in one year.  That is now something that is going to hit the rest of the country, slowly but surely. Massachusetts is the preview of coming attractions.  Only 33,000 people died from opioid overdoses in the whole country last year.  We’re three times worse than the national rate.  But unless we put in place the prevention and treatment programs, we are going to see this epidemic just explode even further.  And from that moment in Taunton when the police chief and the mayor told me about fentanyl, it has been just a predictor of this catastrophe spreading inexorably, inevitably across the country. DeBonis:         And what year was that, Senator? Markey:           January of 2014.  So it was ‘14, ‘15, ‘16; we’re now halfway through 2017 and the numbers have skyrocketed since 2014 in Massachusetts as they have across the whole country.   DeBonis:         Chairman Walden, let me ask you.  You represent Eastern Oregon.  It’s a rural community, largely rural, some of the most beautiful country in America.  But what’s happening there?  What have you seen and what was the moment when you realized there was something that needed to be done? Walden:           Right.  I’ve done a series of roundtables a couple of years ago, and I always remember just a couple examples.  There was a woman in Hermiston, Oregon, rural Eastern Oregon, who talked about her addiction to opioids.  She’s now a treatment counselor.  But trying to get off of it was almost impossible.  She wanted to get onto Suboxone I think that helps you get off of it.  There was no physician in the immediate area that could help her, so she would commute five and a half hours each way into Washington State where she could get treatment and finally get off. Then down in Southern Oregon in Medford, I did a roundtable, law enforcement, addictions specialists, hospital people, and family.  And this fellow that was sitting in the back, he wasn’t actually part of the roundtable, but I called on him and said, what brings you here?  He said, “My son.  My son was an athlete in high school and got injured and got prescribed opioids to deal with the pain and tragically got hooked.  And he went to the cheaper, more potent version of that; you would know it as heroin.”  And he said, “He succumbed to that.  My sister was a nurse, same sort of scenario.  She got hooked on it.  She would write her own prescriptions, forging the doctor’s prescription pad, got caught, moved on somewhere else, took it up again.  The addiction overwhelmed her and she too had died.” And then you begin to talk to everybody else in your communities, how they’re affected.  And this addiction explosion has been going on now in Oregon, we’re ninth in the country, fourth among women, but we predate that with the other scourge, which was methamphetamine and the cooking and all that.  Oregon really led in this.  We did work here in Washington on it like we’re doing on opioids to get the precursor chemicals out.  That still remains a big issue in Eastern Oregon. One of the leaders in trying to push back on this, Dr. Chuck Hoffman, is a friend of mine.  He was quoted recently in a news series about how he was trained as a physician to prescribe opioids to relieve pain.  They were never really trained in alternative pain relief practices.  And now it’s just write the pills.  And so he’s trying as a physician leading an effort to turn this around.  We’re also seeing a dramatic increase by the way in 65 and older that are being treated as inpatients in hospitals because of this addiction; so it’s affecting every age group.  DeBonis:         Congresswoman, let me ask you this.  You represent a different kind of district.  You represent a good part of Denver and its suburbs.  It’s an urban and suburban district.  So much of the reporting on this is talked about this as a rural phenomenon in communities like in Eastern Oregon.  Is that the whole picture or is that not the whole picture? DeGette:         Oh, no.  I mean this opioid problem, it pervades—I think people focus on rural areas because they expect that drug and addiction issues will be urban issues, so they’re shocked when it’s in rural Oregon.  But I remember you were asking my colleagues when did this hit home.  A couple of years ago, I was at the Booklover’s Ball, which is the annual fundraiser for the Denver Public Library.  And I was sitting next to the Denver public librarian, and I said, “What are the issues you’re facing here at the Denver Public Library?”  And I thought she would say something like cybersecurity or access to books.  She said, “You know, we have people overdosing in the library every day and we need to get our librarians naloxone so that they can give it to people who have overdosed.”  At the Denver Public Library.  And now there was just a story the other day in the Denver Post that they finally did get the librarians naloxone.  But they actually had a guy die in the main library last year.  They’ve had a number of overdoses and the librarians just open up their desks and run over.  I mean imagine that. And I think what all three of us have recognized is this really does seem to have exploded on the scene.  We’ve heard stories about addiction for some years and cautions about overuse of opioids.  But these stories are just exploding.  And in our committee, the Oversight and Investigation Subcommittee of Energy and Commerce, we did a whole series of hearings about a year or two ago on opioids, and it was amazing how many misconceptions there were about the extent and the nature of the problem, and how much confusion there was about what you do about it.  And so it’s not always that you have hearings that really educate the members of Congress, but I think we all learned a lot about what we need to be doing.  And of course, that was part of what informed the CARA Bill last summer that we passed, and then the funding that you mentioned that Fred Upton and I put in our 21st Century Cures Bill. DeBonis:         Yeah, let’s talk about Cures briefly.  That was a really remarkable bill not only for what was in it, but the fact that it came together at all at a time when the parties weren’t last year and still aren’t working together on a whole lot in a productive manner.  But this is one area where Republicans and Democrats came together.  You worked with Fred Upton, Chairman Walden’s predecessor in Energy and Commerce to make this happen.  Talk specifically about the addiction part of that bill and how that got brought into this bill that was also about so much more, including pharmaceutical development and things like that. DeGette:         Well, I mean this was a bill that we worked on for about three years, and it wasn’t just me and Fred.  It was also Greg and it was Ed and his Democratic and Republican colleagues in the Senate.  So it was really an effort to focus on primarily research at the NIH and the FDA, but as the bill moved into its final stages, we realized that there were some funding issues in the healthcare space where we could really get bipartisan bicameral consensus. And as I said, we had passed that CARA Bill the year before.  It had a lot of really good administrative programs for opioid prevention and treatment, but it had no money.  And that was one of the biggest criticizes everybody had at that time.  And so when we did the Cures Bill, we were able to then say let’s really put some oomph here.  Let’s put a billion dollars in grants for state governments. DeBonis:         Mr. Chairman, let me ask you this.  Pardon me for putting it in these terms, but it can be difficult for Republicans, especially House Republicans to spend money on anything sometimes.  But this issue was one where there was a wide agreement that something had to be done.  Talk about what the feeling has been among your Republican colleagues in trying to come together and address this. Walden:           Yeah, I would suggest too that in 21st Century Cures, we did mandatory spending for NIH because we believe in medical research, and really the big increases in NIH’s budget go clear back to the days of Newt Gingrich, who believed in investing in medical research.  And doubling the NIH budget, we did that, then there was kind of a pause.  Now we’re trying to ramp it back in a bigger direction.  And clearly Diana’s work and Fred’s and others, Tim Murphy and others really passionate about this; these issues don’t pick parties when they show up on your doorstep.  And I think they help bring us all together in common cause. The billion dollars, in my state we just got $65 million in grants out of that.  So in pretty short order I would argue that money not only got in there but now is getting out onto the ground into the field, hopefully into the hands of those professionals in our communities who know best what to do with it to address this issue.  So I think there are really good mechanical pieces to Diana’s point.  In terms of changing how many people a physician could treat with Suboxone, my friend from Hermiston who had to go out of state to get treatment, now they can treat more people.  You don’t have to fully fulfill the prescription; that gets excess pills out of the market, hopefully. These are all things we learned, I learned in the roundtables that I did back home, and they gave the money in there.  And in the AHCA, we put another $15 billion toward this, addiction and other things, but it’s certainly in there.  It’s not always about the money, it’s about changing behaviors and finding best practices.  I think that was part of the debate I heard at least was better understanding the physician prescribing community about what they should do, what they shouldn’t do.  It kind of goes back to an original study that said there’s no addictive nature to this, so feel free.  If you go back, the foundation for where we are today was built I think on a false premise that it was okay, that these pills wouldn’t be addictive.  Now we know 90 days is danger zone, so we need to do this education.  Markey:           Well, I’m working with Marco Rubio on a bill to give customs and border patrol the technologies they need in order to detect fentanyl and other substances at our border so that before it comes in from Mexico or from China, they’re able to do that.  I actually said to Mitch McConnell two years ago that Lexington, Kentucky, Lexington, Massachusetts, it doesn’t make any difference.  We need a surgeon general’s report on addiction.  What I suggested to him was the smoking report, the surgeon general’s report in 1964 was a seminal moment.  We, that is Mitch, you and I, we should ask the surgeon general to do it.  And he completed it in one year, which laid out now the parameters of the problem and what needs to be done.  To that extent, there is a lot of bipartisanship.  I was able to pass legislation with Rand Paul on Suboxone, on medication assisted therapy, so that became a part of the law as well. On the other hand, we’re having a big battle right now about funding in the Affordable Care Act and whether or not the slashing of that funding is going to have a profound effect upon the ability for people to gain access to the treatment which they need.  The Centers for American Progress have concluded that $91 billion under the Affordable Care Act would have been spent on substance use disorders over the next ten years.  And that money will not be there if the Affordable Care Act is repealed. And so we’re going to have a huge debate over whether or not this funding is going to be there because honestly, a vision without funding is a hallucination.  You’ve got to have the funding there in order to provide these programs, and this debate is now really escalating in the Senate because we, the Democrats, are saying that this opioid epidemic, the substance use disorder epidemic is something that is going to get seriously shortchanged if the proposal as it is currently constructed becomes the law in our country. DeBonis:         Let me talk to Chairman Walden.  As Chairman of the Energy and Commerce Committee, you know more than anybody else in the Capital about what’s in the American Healthcare Act, which is the Republican healthcare bill that’s now moving through the process.  Certainly, that is not a bipartisan effort, as we all know.  This is the Republican response to the Affordable Care Act.  You’ve heard folks like Senator Markey and even some people in your own party on the Senate side talk about the potentially difficult effects this bill could have on addiction treatment.  Just give us some facts as you see them of what this bill would do and what’s in that bill to help folks who are suffering from addiction. Walden:           Yeah, thank you.  First of all, you have to bifurcate it because what we do know is the individual insurance market has a lot of problems on the exchanges.  And so you have a group of people who we want to make sure have insurance or access to choices in affordable insurance, and right now state after state, county after county, we’re seeing more and more limited choices.  Some counties may have no choice.  So if you’re in need of treatment and you can’t get insurance, you have really no options, or very few options. So we’re trying to fix that insurance market.  This is difficult work to do.  It’s difficult in the House, it’s difficult in the Senate because we’re all—we share a common goal of trying to make coverage available, make it affordable.  On the other hand, on the Medicaid side, we believe that there’s enough headroom in there, in the about $90 billion that’s there that we put in under a provision to allow increased deductibility of health insurance costs.  It was really just to move about $90 billion to make it more flexible for the Senate to make some changes. We put specifically $15 billion in for addiction treatment and some other related causes in addition to the flexibility of the Patient State and Stability Fund, which gives states great flexibility to use the money either to bolster their insurance markets and/or use it for other purposes, which could be addiction.  So I think there’s a lot there.  And it’s not always about the money.  And remember, early on I said that in my state we’re seeing an enormous percentage uptick in people that are 65 and older; most likely they’re on Medicare, not Medicaid.  That’s a problem area as well that needs help.  So I mean what we have to do is get to the root cause.  You have to get the prescription issues, you have to get to the treatment issues.  I understand.  But we think there’s room there to do that. DeBonis:         Congresswoman DeGette, I imagine you might have a differing perspective. DeGette:         I agree.  Money’s not always the panacea, but the problem is that if people don’t have insurance to pay for their treatment, then they can’t get the treatment no matter what funds you set up or whatever else.  And according to the nonpartisan Congressional Budget Office, under the House proposal, 23 million people will lose their insurance even after all these funds were added at the 11th hour on the floor.  And so when you have 23 million people who are either on the Medicaid expansion or are going to lose their insurance because their premium support is reduced or whatever it is, if they can’t get access to mental health treatment programs because they don’t have insurance, then it doesn’t do any good.  And that’s why many, many commentators in the mental health space say that the AHCA would be very, very—it would be a huge backwards step for opioid treatment because people just simply wouldn’t be able to get access to those programs. And frankly, as much as I love my former Energy and Commerce colleague Ed Markey, I don’t ever legislate in the hopes that the Senate—to say, “Well, okay, this is a problem with this bill but I know it will be fixed over in the Senate.”  I think we should get it right the first time.  And I’m really concerned right now, frankly, that maybe Ed could talk about this, that Mitch McConnell saying he’s going to bring up some bill.  Not only have the Democrats not seen it, most of the Republicans haven’t seen it either.  We have no idea what that bill is going to do in terms of access to Medicaid in the states or to premium support or anything else. Markey:           And Diana is right.  The only thing more secret than this Republican healthcare bill in the Senate are Donald Trump’s tax returns.  We have no idea what’s in it, the public has no idea what’s in it.  It’s being put together in secret.  We know it could have a profound impact on substance use disorder, treatment.  And so the consequences for public health in our country are profound.  And right now, this is a process that has not allowed for any public input, any Democratic bipartisan input.  Just the opposite of the way in which the Cures Act and CARA were put together. DeBonis:         Let me ask Chairman Walden to jump back in here.  You’ve got Republican colleagues in the Senate, people like Rob Portman, Shelly Morcapito, who have been very outspoken on the effect of this crisis on their states.  Are you confident that they’re not going to vote for a bill that they think is going to harm their constituents in this way? Walden:           Well, first of all, I’m not going to speak for any senator, let alone Senator Portman.  They can speak for themselves how they’re going to vote or anything else.  I do know they care deeply about these issues.  I do know that throughout the discussions in the House, I made a couple of presentations at the Senate Republican Conference.  So none of this was a secret within our world in terms of moving things back and forth.  I mean the legislative process is built upon give and take between the House and the Senate and understanding and flexibility.  I’m sure that’s how we got to 21st Century Cures, it’s how we got to CARA.  It’s how we get to major legislation.  There’s always give and take between the Senate and there’s communication between the Senate.  Reconciliation traditionally is a pretty partisan process by both sides, used by both sides. As you know, when the Affordable Care Act was first fully implemented, the final bill, we weren’t allowed a single amendment on the House floor because it couldn’t be changed because in my friend’s state, Senator Kennedy passed away and was replaced by Scott Brown.  They couldn’t allow a single word to be changed, so we had no amendment capability, and then they chased it with reconciliation to try and clear up the mess.  And that’s the law we have today. And it’s crashing around the country when it comes to the individual insurance markets.  You’ve got five states that may be down to one or no options, multiple counties, premiums have not gone down $2,500, they’ve gone up.  And the CBO scores has consistently been wrong based on the principle they put on, or the power they put on the individual mandate that is going to force people to buy insurance.  They’ve been off two to one in their estimates in 2016, and their estimates in 2017, I mean they get it wrong.  They’ve got a tough job, but their numbers are off.  We’re trying to rescue that market so people have access to affordable insurance. And by the way, if you’re not in that subsidized pool, I remember the woman the other day, $600 a month in premium, $16,000 in deductible.  That’s hardly insurance.  You’ve got a whole group of people out there that are suffering today, and we’re trying to fix that market so it’ll work in the future and people can get access to coverage. DeBonis:         I’ll just say obviously there’s a partisan divide on this bill that we’re not going to overcome today on this stage.  I did want to in our last few minutes here ask about another part of this.  We’ve talked about this from the industry perspective, the public health perspective, the oversight perspective.  This is also a criminal issue that people are breaking the law here.  Senator Markey, you talked about fentanyl and the very serious problem that that very potent opioid has created.  We have a proposal on the table now from Senator Grassley and Senator Feinstein, a bipartisan proposal to give the federal prosecutors, the Justice Department, more powers to take action in that regard.  Have you had the chance to look at that legislation?  Is that something that you’re able to support or is there another way to go about it? Markey:           Well, look, we have to crack down on the really bad actors, that is these drug cartels coming in from Mexico, what China is doing.  We have to elevate this importation of fentanyl up to the same level as nuclear nonproliferation and copyright protection in our discussions with the Chinese.  That’s the level, that’s the terrorist threat on the streets of America.  There’s no two ways about it; that’s how the American people see it. But let’s be honest, we owe an apology to an entire generation of African American young men who we incarcerated as part of the crack cocaine epidemic in the 1990s.  So let’s not think again that we can incarcerate our way out of this problem.  We can only provide treatment to get out of this problem.  And while there might be some targeted law enforcement measures that we can all come together to support, the overriding issue is providing the funding, the access to treatment and prevention for families in our country. DeBonis:         Mr. Chairman, what are you hearing from the law enforcement in your district and what other tools do you think they need? Walden:           Yeah, there are some communication issues that we need to carefully think through between the law enforcement and the prescribing community.  How do you manage patient privacy in that realm?  When the law enforcement pick somebody up, what are they on, how do you treat them?  There are some communication issues there.  And I think it really gets back to who is issuing the prescription in the first place, and are they getting the proper consultation and best practices?  Because that’s where it starts; we have this other issue, and I concur, we have to deal with in terms of treatment for people who are hooked. But if we’re now making some progress, instead of issuing a 90-day prescription, it’s 21, there’s fewer pills out there.  And we’re investigating, ONI is investigating, or will, the fentanyl issue.  We’re investigating the issue in West Virginia.  How does a community with a few hundred people have a hundred million pills going into it?  I mean we’re doing a lot of that sort of work as well.  I commend the Chinese for the steps they have taken, but obviously there’s more to take to reduce access to fentanyl.  And let’s look at the postal service.  Most of this stuff is coming in through the U.S. Postal Service because they don’t have the tools to adequately screen it out.  So we’ve got some of this on our own hands here that we have to do more work on, and we’re going to be investigating all of those through the Oversight and Investigation Subcommittee. DeBonis:         Congresswoman, I’m going to give you the last word. DeGette:         I’ll just end on a collegial note here, is that what both my colleagues said is really true.  We need so much more coordination, understanding of the problem, coordination with the whole system.  The prescription system, the law enforcement system.  We didn’t have that before.  We also need to have a medical understanding of those these opioids work and what the best treatment is.  In Colorado, we have a consortium that has formed.  I just met with them the other day.  And they’re looking at this holistic approach. How do we work on controlling how these opioids are prescribed?  How do we prevent people and educate doctors and patients?  And then how do we work at it from the law enforcement perspective?  And then how do we help people who have become addicted?  I think more and more people realize that holistic approach is really the approach that’s going to work.  And in Congress, what we need to figure out is both how to get the funding for that and also how to get the programs that work. Walden:           I want to end— DeBonis:         Real quick. Walden:           I think it’s really important.  We also should not overreact.  These drugs are very important in pain management when administered appropriately.  And so we have to understand there are a lot of people managing pain effectively with opiates.  We have to make sure that we don’t overreact and hurt them along the way by accident.  So it’s a balance. DeBonis:         Thank you very much Congresswoman Diana DeGette, Senator Ed Markey and Chairman Greg Walden.  And thank you all.  We’ll have more panels for you very shortly.  They’ll be in very good hands with my colleague Lenny Bernstein.  Thank you very much.  An Epidemic in America: Cause and Effect:  Dr. Kolodny was sounding the alarms about irresponsible opioid prescribing before most of us were listening.  Dr. Wen has taken steps in Baltimore that many cities have yet to take in combating this crisis.  So we’re very fortunate to have them here.  Andrew, it seems that when we throw the full weight of our public health resources at other epidemics, HIV, drunk driving, car accidents, that we much more quickly were able to bend the curve on fatalities.  Here we are 17 years into the opioid crisis.  If the latest data is correct, the numbers are just continuing to escalate, and escalate rather sharply.  What’s different here?  Why haven’t we been able to solve this? Kolodny:         That’s a good question.  I think one of the main reasons that we have failed to respond appropriately to the opioid crisis is that it was misframed, and intentionally so.  Certainly by 2000, 2001, there were reports coming from Appalachia and New England about Oxycontin overdoses and addiction, and it was clear we were having a problem with opioids.  From the beginning of the crisis, the way the issue was framed, particularly by pain organizations that were getting funding from opioid manufacturers, the way the issue was framed for policy makers was as if all of the bad things that we’re hearing about, all of the opioid harms policymakers were told, were limited to so-called drug abusers and that millions of patients were being helped by the increase in prescribing. And so policymakers were told that your challenge is to try and do something about this drug abuse problem without making the chronic pain problems worse.  Millions of Americans are suffering from chronic pain, and if you were to promote any kind of intervention that would result in reduced prescribing, you’ll be punishing the pain patients for the bad behavior of the drug abusers.  You’ve got to balance these two competing problems.  And the reality is that we don’t have these two distinct groups, and opioids are not safe and effective treatments for the vast majority of people suffering with chronic pain.  Millions of patients with pain have become opioid addicted.  Thousands of patients have lost their lives. So the opioid crisis is not an issue of drug abuse.  It’s not an abuse crisis.  If you frame it that way, it suggests that the problem is people behaving badly, taking dangerous drugs because it feels good, and they’re accidently killing themselves.  And that maybe the intervention is to make the pills hard to crush so people can’t abuse them.  It’s not an abuse crisis.  It’s an addiction epidemic.  The reason we have historically high levels of overdose deaths, the reason we’re seeing heroin and fentanyl flood into non-urban areas, the reason we’re seeing a soaring increase in infants born opioid-dependent, children winding up in the foster care system, outbreaks of injection-related infectious diseases is because we’ve had this very sharp increase in the prevalence, the number of Americans suffering from opioid addiction.  And if we’re going to bring the epidemic under control, we have to stop creating new cases of addiction through more cautious prescribing, and we have to see that the millions who are addicted have access to effective treatment. Bernstein:        But Andrew, just very briefly, you and I have both spoken to dozens and dozens of people, many of them older folks who swear they couldn’t get through the day without their opioids.  It might be a small dose.  They may never have increased that dosage over the years, but they say, “Look, I’m in this wheelchair if I don’t have opioids.” Kolodny:         Well, there are about 10 to 12 million Americans who have been put on long-term opioids and certainly when you write a story about opioids, you’ll sometimes see in the comments section people writing in saying, “I’m not an addict and you’re punishing me.  You’re calling me an addict.  I shouldn’t lose access.”  You’ve got many of these people who may truly believe the opioids are helping them, but if they’re on daily long-term opioids, they’re probably not being helped.  What they may experience as relief when they take an opioid is probably relief of withdrawal pain rather than relief of an underlying pain problem.  If you’re taking opioids every day around the clock like an extended-release opioid, Oxycontin you take in the morning and at night, and if you’re doing that for months and years, it’s unlikely that you’re still getting pain relief from the drug.  If you’re on opioids chronically in order to get pain relief, you’ll need higher and higher doses.  And as the doses get higher, we see that people’s functioning begins to decline.  And we know that opioids can even make pain worse.  It’s a phenomenon called hyperalgesia. I wouldn’t say that we should never give opioids to people with chronic pain, but the way in which they might be effective for people who suffer from chronic pain is if they’re used intermittently on a really bad day.  Around the clock opioids are not helping these patients, and millions of Americans are now stuck on opioids.  I think we should really be thinking of that population as victims of our era of aggressive prescribing.  We need a compassionate response for those folks.  We don’t want their primary care docs to just fire them.  For some of those patients, we’d probably see them turn to heroin if they can’t get opioids anywhere. Bernstein:        Understood.  Leana, the truth is that we know what works in the battle against opioid addiction.  The science is there.  The policy is there.  Could you tell us what works and why we still have an epidemic if we know those things? Wen:                That’s right.  This is why all of our discussions today are so frustrating.  There are a lot of diseases out there for which we don’t have a cure, we don’t have a treatment, we don’t have prevention, and we really struggle with those and we need more research.  And yes, we need more research when it comes to opioids as well, but we actually know what works. And to your question earlier, Lenny, about why has this been so different from any other public health crisis, there’s one word.  Stigma.  There are myths and misconceptions around the disease of addiction that’s very different from other illnesses.  I hear for example in Baltimore, you had mentioned that we’ve been putting out our antidote medication, Narcan or Naloxone.  I wrote a blanket prescription for this medication to every single one of our 620,000 residents because everyone should be able to save a life.  And yet I hear people all the time say, “Well, why give this medication to people?  Isn’t that just going to make them use more drugs?”  Would you ever say to someone who is dying from a peanut allergy, “I’m sorry, I’m not going to give you an Epi-pen because it might make you eat more peanuts next time?”  But we don’t hear that. Naloxone works.  It’s immediately lifesaving.  It’s non-addictive.  It’s safe.  And we have to save someone’s life today to get them into treatment tomorrow.  So that’s one thing that works, and yet we don’t have nearly enough of it because of stigma.  There’s also huge stigma around treatment.  We don’t say to someone with diabetes, “Well, why are you still on insulin?  Why can’t you get off of your insulin and isn’t lifestyle changes, shouldn’t that be enough?”  And yet we make those assumptions about people with the disease of addiction all the time.  And we— Bernstein:        In regard to Suboxone and methadone? Wen:                That’s right.  When actually the science is clear that medication-assisted treatment with methadone, buprenorphine, combined with psycho-social counseling are what works for the treatment of addiction.  And for so long, we have treated addiction as a moral failing, as a crime.  I go back to what I think are Senator Markey’s excellent points about a whole generation of people who we have to apologize to.  In Baltimore City, I’ve had our residents at community forums come up to me and say, “I don’t understand why suddenly the opioid epidemic is a public health crisis.  Why is it an emergency when it’s been a state of emergency my entire life?”  Because it was poor minorities in inner cities who had this illness, and therefore it was seen as a choice and a moral failing.  Therefore, if you end up in jail or dead, it’s your fault.  I’m glad that we’re now seeing it as a disease.  But then we need to treat it as any other disease and devote the resources that are necessary to fight it. Bernstein:        And very quickly, what percentage of the people who need it get treatment? Wen:                The Surgeon General’s report said that it’s about one in ten people.  One in ten people with the disease of addiction are able to get the help that they need.  Now, what other disease would we find that to be acceptable?  Would we find it acceptable if only one in ten people with cancer can get chemotherapy? Bernstein:        One of the things that has changed in the last few years is that prescription opioids, the rate of overdose and addiction from those is going up much more slowly, but we have this explosive fentanyl/heroin crisis.  Does that change the epidemic for us and what do we do about that? Kolodny:         I think it’s important to understand the trends and to interpret the data appropriately.  What we’ve seen over the past couple of years has been a leveling off and maybe even a slight decline in overdose deaths involving prescription opioids.  But starting in 2011, we’ve seen a soaring increase in overdose deaths involving heroin.  And I think that many are misinterpreting that data.  What they’re thinking is that we’ve seen this leveling in prescription opioids while heroin has gone up, so that means that the drug users are all switching from the pills to heroin and that the painkiller problem has turned into a heroin problem. That’s not really correct.  It’s half correct in that the vast majority of people who started using heroin post-1995 were first addicted to prescription opioids.  So the switching part is correct, but the switching didn’t begin in 2011.  From the beginning of the prescription opioid crisis, young people who are becoming opioid addicted were switching to heroin.  A young person who becomes opioid addicted through use of prescription opioids and the addiction begins from either recreational use or medical use or sometimes a combination, brief medical exposure followed by recreational use. The young people are becoming opioid addicted.  Once addicted, they have a hard time maintaining their supply visiting doctors.  And it isn’t that doctors and dentists don’t like to give young people lots of pills; unfortunately, we’re too comfortable doing that.  But doctors don’t like to give healthy looking 25-year-olds a large quantity on a monthly basis.  So young people who are becoming opioid addicted, to maintain their supply—and once addicted, you have to maintain your supply.  You’re not using because it’s fun; you’re using because you have to keep using to avoid feeling awful. Once addicted and they have to maintain their supply, they wind up on the black market.  The pills are very expensive on the black market.  If they’re in a region of the country where heroin is available, they switch because it’s cheaper.  And what’s happened steadily, not starting in 2011 but steadily from the beginning of the prescription opioid crisis, is we’ve seen heroin flood into more regions of the country where it wasn’t previously available to meet the demand for it by these young people who are opioid addicted. What starts happening in 2011 is that the heroin supply becomes more dangerous; increasingly it has fentanyl in it, or increasingly it’s fentanyl being sold as heroin.  So we’ve seen this sharp increase in deaths among young heroin users, but not a sudden switching.  But what’s also very important to understand with regard to the prescription opioid overdoses is that we really have two populations that have become opioid addicted over the past 20 years; the younger group that I just described, but an older group as well, people in their 40s up through their 80s. The older group is developing their opioid addiction almost entirely through medical treatment.  The older group, when they become addicted, is generally not turning to the black market.  When they become addicted, they generally don’t have a hard time finding doctors who will maintain them on a large quantity of opioids on a monthly basis.  And up until pretty recently, we were seeing far more overdose deaths in the older group that gets pills more easily from doctors than we were seeing in the younger group that’s been switching to heroin. Fentanyl is now causing that younger group to catch up, but in 2015, the last year for which we have the national data, it was about equal in terms of the number of prescription opioid overdoses to the heroin overdoses.  I think next year we will see more deaths in the younger heroin using group because of fentanyl. Bernstein:        Okay.  Hang onto that thought because I want to get back to it.  Baltimore has had a heroin problem for decades. Wen:                That’s right. Bernstein:        What are you seeing out there? Wen:                It’s getting worse.  So we have had the crack epidemic, heroin epidemic; we also have prescription pills.  That’s a big issue in our city as well.  And also fentanyl.  I mean we’re hearing a lot about fentanyl today, but fentanyl is many times stronger than heroin.  And it’s now being mixed in with heroin and people who are using it don’t know it.  So if they’re using what they think is their usual amount and now there’s fentanyl in it, they’re overdosing and they’re dying. The number of people in our city overdosing from fentanyl has increased by 35 times in the last three years.  Not 35 percent; 35 times in the last three years.  No doubt it’s a public health emergency.  But as with all public health emergencies, it’s complicated and there are at least two components.  There’s the supply issue and there’s a demand issue.  We heard about the supply issue and the need for law enforcement.  Sure, that’s one issue.  But then we’re going to continue to have a problem unless we can address demand.  Unless we can get people who have addictions into treatment, whether they’re addicted to heroin or prescription pills, they need treatment.  And unless we can address that, we’re still going to see this crisis escalate.  And now because of how deadly this drug is, it’s only going to get worse. So what we’ve done in the city is first, we’ve gotten Narcan or naloxone into the hands of every individual as much as we can.  In the last two years, actually, we’ve gotten this drug not only into the hands of first responders like paramedics and police officers, we’ve gotten it into the hands of everyday people.  And every day people have saved the lives of over 950 of their fellow residents in the last two years; 950.  Now, we do have a problem where we’re now being priced out of the ability to save lives.  We simply don’t have the money to purchase enough Narcan; so that’s a problem. Bernstein:        Is that why Baltimore is running low on Narcan because you simply are running out of money to buy it? Wen:                That’s correct.  We don’t have a shortage of Narcan in the sense that there’s plenty of this medication out there.  But we don’t have enough resources to be able to purchase it for everyone who needs it.  So we’ve got to ration this lifesaving medication.  And then we’ve also been trying to increase treatment, but we also don’t have enough resources to do so. Bernstein:        Is that because some people need four, five, six shots of Narcan when they take fentanyl? Wen:                There are multiple reasons.  One is that fentanyl is such a strong drug that you do need multiple doses of Narcan.  But the other reason is we have reduced the regulatory barriers so that everyone can carry it.  Well, now everyone wants to carry it.  People are calling the Health Department every day saying, “I’m a faith leader.  I run a neighborhood association.  People are overdosing outside my door every day.  I want to have this medication here.”  We don’t have nearly enough to supply everyone in our city who can save a life to be able to do so. Bernstein:        I want to get back to a point you made and maybe I’ll start with Leana on this one, though.  You’re both physicians.  I thought back in 2015 towards the end of the year when the CDC put out the guidelines for physicians and then that was soon followed by work by the AMA, one of the more conservative physician’s organizations.  They started to get the message out to doctors, you don’t need to give 30 pills when someone has a tooth pulled.  You don’t need to prescribe 60 when someone has a very minor surgical procedure. It seems to be universally agreed that physicians are going to have to step up in some regard and take responsibility for this epidemic.  Are they changing their philosophies?  Everybody in this room has a friend who went home with a bottle of Vicodin, 30 or 40 for a procedure that really didn’t call for it. Wen:                From my standpoint, the medical profession is changing, but slowly; but in the right direction.  When I was going through medical training, I didn’t really learn about how addictive opioids were.  We had big pharma around all the time, really misleading people about how important it is to address pain.  Yes, it’s important to address pain, but becoming pain free actually shouldn’t be our goal.  If you fall down and you sprain your ankle or you bruise your knee, I don’t know that you need to take opioids to take away that pain.  Maybe living with the pain is okay. But we didn’t really learn about that, and now we are.  We are learning about it, but physicians too are very frustrated because we went into medicine to take away people’s suffering.  We don’t have a lot of tools when it comes to pain control.  We’re not really taught about physical therapy, we’re not really taught about alternatives to opioids.  That’s something that we have to work on.  The guidelines are helpful and physicians at least in my city are beginning to use the guidelines and hold onto these guidelines to do better by their patients. But I would say one more thing, which is that we continue to be frustrated every day in our practice.  I’m an emergency physician, and in the ER, I have patients coming in who know that they need treatment.  They will tell me they need treatment.  Every nurse, every social worker, every physician that sees them know that they need treatment.  They may even have overdosed multiple times, and now they’re seeking treatment.  But I tell them, “I’m sorry, the next available treatment slot is in three weeks, or two months.”  Again, what other disease would we find that to be acceptable?  Do we ever say to someone, “Sorry you’ve had a heart attack.  If you’re not dead in three months, come back and maybe we can get you to see someone then”? Bernstein:        Is that an insurance reimbursement issue? Wen:                It’s a capacity issue.  It’s a reimbursement issue.  It’s also something that will only be worsened if we are to repeal the ACA, but a whole different story.  There’s a lot more that needs to be done, but we physicians should be seen as partners in this process.  We should push physicians, but physicians are trying to do the right thing as well. Bernstein:        Andrew, are doctors getting the message? Kolodny:         I’m not so sure.  The increase in opioid prescribing that would ultimately lead to this epidemic, it starts in 1996.  From 1996 until around 2012, opioid prescribing was still increasing.  The medical community was responding to a multifaceted campaign that misinformed us, led us to believe that the risk of addiction was very low and the compassionate way to treat just about any complaint of pain was with an opioid prescription.  So prescribing starts going up in ‘96.  Since 2012, it’s plateaued and come down a little bit.  But it really hasn’t come down very far.  We are still massively overprescribing opioids in the United States.  We want doctors to be able to weigh risks versus benefits better when prescribing opioids, but they’re not doing that very well. And I think one of the problems has really been the Food and Drug Administration.  I think that unfortunately, the Food and Drug Administration is not properly enforcing the Food, Drug and Cosmetic Act.  Had it been properly enforcing that law back in ‘96 when Oxycontin hit the market, the FDA would have told Purdue, “Great.  You have extended release oxycodone, you can market that drug for use in hospices.  You can send your sales reps to the palliative care doctors, to the hospices.  But we’re not going to let you promote oxycontin for back pain.  We’re not going to let you do this in primary care and family practice because the risks of using opioids for back pain outweigh the benefits.” And so if they had properly enforced the law, they would have done that, and I don’t think we’d have an epidemic today.  By 2001, 2002, it was very clear the prescribing had taken off at a rate far beyond what could be clinically needed.  FDA is beginning to hear from members of Congress whose constituents are overdosing.  They’re holding meetings and they’re saying, “Should we be changing the way in which we allow these drugs to be marketed?  Should we be changing the way in which we’re approving these drugs?” And they asked that at a meeting in 2002, and unfortunately the experts they called in to advise them were the same docs who were leading the campaign to increase prescribing.  And FDA decided not to make any changes, and in fact they went in the opposite direction.  Other pharmaceutical companies saw how well this was working for Purdue; they wanted their extended release opioids on the market as well.  And FDA actually made it easier for new opioids to hit the market. So despite the fact that we had a clear problem, we’ve seen a steady stream of new opioid approvals.  Each time a new opioid hits the market, the company that brings that opioid to market has to recoup the investment, a considerable investment.  The way they do that is with a campaign to increase prescribing.  So at a time when the CDC and health officials across the country are urging the medical community to prescribe more cautiously, you’ve got new products hitting the market with campaigns to increase prescribing. Bernstein:        Didn’t they just ask one company to take an opioid off the market because it’s being so widely abused? Kolodny:         Yes.  The FDA just asked Endo Pharmaceuticals to remove Opana from the market.  And hopefully this could signal that FDA is beginning to change its opioid policies.  It’s unclear whether or not that decision was based on a change at FDA or might have had something to do with a battle between FDA and Endo over whether or not Opana should have been labeled abuse deterrent.  It’s hard to say.  There is quite a bit FDA could do, and if they start taking the proper steps, it would be very helpful. Bernstein:        We have about five minutes so I’m just going to give you each about half of that.  You’re the drug czars, and I don’t mean ONDCP.  I mean you’ve got all the power in the world to change this epidemic.  Leana, what would you do?  What’s your list of policies? Wen:                It sounds amazing, first of all.  I have to get used to this.  First, I would ensure that there is treatment on demand.  Not treatment in three months, but treatment at the time that people need and the right treatment.  We shouldn’t be telling people there’s only one thing available.  You get methadone or you get counseling.  We should give people the medication, the counseling, the services that they need.  So first of all, ensuring treatment on demand. Second, I would support those on the front lines with the resources that they need.  We in Baltimore City, we work very closely with law enforcement, the district attorney’s office, with our nonprofit partners.  We know what we need in the city.  We have made requests of our state and federal partners and as long as we are able to get the resources, we know what works best in our community.  So support those on the front lines with getting the treatment that we need.  The third is I would change the culture; something that might take a little bit longer.  But we need to change the culture by asking the difficult questions, including why is it that we have this mentality of a pill for every pain?  How can we change prescribing practices, advertising practices, approval, but also the culture, the mentality that patients have too, that we all have for a pill for every pain? And we need to ask the question too, what pain is it that we’re treating?  Because we’re not just treating physical pain; we’re also treating deep trauma, deep disparities, mental health issues that may need to be addressed in another way.  So there needs to be a systemic and holistic approach that can only come from us asking the hard questions and taking the difficult approach.  When we see that this is a solvable problem, we know what works, we just need the resources to get there. Bernstein:        And that was less than two and a half minutes, so I’m going to ask you a really quick yes or no question before Andrew gives us his list.  Safe injection sites?  They’re against the federal law right now, but yay or nay here in the United States? Wen:                I would do it. Bernstein:        Would you tell people what a safe injection site is? Wen:                Sure.  Safe injection site is a facility where people can come in and be monitored while they are using drugs.  So they’ll have a nurse who can take their blood pressure, their oxygen saturation and et cetera while they are using drugs.  This is a harm reduction approach, similar it’s an extension of needle exchange, which we’ve had in Baltimore for over 20 years. Bernstein:        There’s on in Vancouver that has never lost anyone to an overdose. Wen:                That’s right.  And there is evidence saying that it is one approach to be taken to reduce the number of overdose deaths.  Since there is evidence for it and because it is a harm reduction public health approach, it’s something that we would explore in Baltimore City if it were legal because we don’t really want to go to jail and don’t want all of our federal funding to be pulled in order for us to do this. Bernstein:        So that’s a yay. Kolodny:         I’ll answer the safe injection and then— Bernstein:        And then tell us how you would— Kolodny:         I don’t know that it will really help or hurt.  Where it makes sense to have safe injection facilities is where you have—in urban areas where there are homeless or people who are injecting drugs, and they can go in and inject someplace where they can be monitored. Bernstein:        Like Baltimore. Kolodny:         Yeah.  But our opioid addiction epidemic is disproportionately suburban and rural.  We just saw a big fight in Ithaca, New York, over whether or not there should be a safe injection facility there.  In suburban or rural areas, I think it’s very unlikely people are going to commute into town to inject in a facility.  I think if they built it, nobody would come.  And you have many areas where there are waiting lists for addiction treatment, waiting lists to get buprenorphine, which can effectively treat opioid addiction and save lives.  And you’ve got these debates over whether or not to have a safe injection facility.  So I think it’s a bit of a red herring.  I think there are interventions that would be much more effective. Bernstein:        You’re the drug czar for 82 seconds.  Tell us what you’re going to do. Kolodny:         There are many different policies, and I heard an economist talk about the problem recently, and he said, “There’s no magic bullet.  We need magic buckshot.”  So what I’ll just mention in my few seconds is the big picture strategies for controlling the problem.  This is an addiction epidemic and the way that we respond to this disease epidemic is similar to the way you respond to other disease epidemics.  You have to prevent people from getting the disease and you have to see that the people who are suffering from the disease have access to effective treatment. To prevent opioid addiction, that really boils down to much more cautious prescribing so that we don’t directly addict patients or indirectly cause addiction by stocking everybody’s home with a highly addictive drug.  There’s quite a bit that could be done on a state level and a federal level to produce more cautious prescribing.  And for the millions who are addicted, you have to see that they have access to effective treatment. And when I say effective treatment, I’m not talking about counseling or rehabs or detoxes or even the Vivitrol injection, which I think is really only appropriate for a small subset of people who are opioid addicted.  I’m talking about buprenorphine treatment and methadone maintenance.  We have to see that it’s much easier to access buprenorphine than it is to access pills, heroin or fentanyl or we’re not going to be able to reduce overdose deaths.  Bernstein:        Thank you so much.  We really appreciate it.  That’s about all the time we have.  Dr. Leana Wen, Dr. Andrew Kolodny, thank you so much for joining us.  We look forward to speaking with you more in the future.     M:                    We now want to introduce our sponsor segment and bring to the stage Joe Berger, vice president and general manager for Health and Consumer Solutions at Battelle, and Dr. Wilson Compton, deputy director of the National Institute on Drug Abuse. Berger:            So, we’ve heard a lot of statistics this morning about the opioid problem, and I live in Ohio, and we have the unfortunate honor of leading the nation in this problem.  In fact, I was driving to the airport yesterday, and heard the most recent statistics on central Ohio, which is mostly urban and suburban.  And that the opioid deaths are on track to go from 350 last year to 500 this year, so we continue to be faced with this problem.  And, so, now the question is what can we do about it? So, today I’m joined by Dr. Wilson Compton, deputy director of the National Institute on Drug Abuse, to discuss evidence-based treatment strategies to reduce the number of people developing addiction problems, and to treat those who become addicted.  So, Dr. Compton, thanks very much for joining me. Compton:        I’m glad to be here today. Berger:            So, let’s start.  What are some of the biggest areas of progress we’ve made in stemming the tide of opioid addiction?  We obviously are making some progress, but we still have a long way to go. Compton:        Well, I think you’ve just reminded us that even as we are making progress in a few areas, the number of deaths overall continues to increase, and that has every public health official and every policy maker concerned.  So, how can we do a better job of addressing this public health crisis?  We do see some improvements in two areas I want to highlight for you.  One, and we heard this from some of the earlier speakers, that the overall number of prescriptions written for opioids has begun to decline.  It leveled off starting in about 2012, and we’ve seen a reduction in the physician’s willingness, and overall over-prescribing of these medications. That’s a little bit of a hopeful sign, but we need to do a better job, not just level off, but actually decrease the number of prescriptions significantly.  The second hopeful sign is, we’ve actually seen a terrific improvement in the recreational or illicit use of these medications by teenagers. About 10 or 15 years ago, we saw that about 10% of 12th graders were using a prescription opioid, or misusing it, for its intoxicating properties. They wanted to get high and they were using these medications recreationally.  That number has dropped to under 4%, so that’s a terrific improvement, and this is the future of the field.  These are the people who will go on to misuse during their early 20s and really develop the serious problems that end up with the addictions and deaths that we’re seeing now.  So, I think that’s very hopeful. Berger:            I’d love to dig into that more, but let’s talk about—we’ve heard this morning about medication-assisted treatment a lot, so I’d like you to talk a little bit about what that is, maybe for our audience who aren’t as familiar with it as soon. Compton:        I think it’s a great question.  You know, what is medication-assisted treatment? Well, basically, what that means is that means using a prescription medication to combat the disease of addiction.  We’re very lucky in this field of opioid use disorder, opioid addiction that we have three FDA-approved medications.  We’ve had methadone for about 50 years in our country, to treat people who are addicted to opioids.  We added buprenorphine just a few years ago, and we’ve had naltrexone, both in its oral form for a number of years, and then more recently we had a long-acting version of naltrexone.  That’s a blocking agent. So, these come in two different classes.  Buprenorphine and methadone are both medications that substitute for opioids and allow people, when doses properly, to enter recovery, to get back their functioning and save their lives.  Naltrexone has sort of the opposite effect; it blocks how opioids work in our brains, and so it’s a blocking agent, and now this new formulation can last as long as a month with a single injection. Berger:            And are you seeing—so, are there trends?  Are some of these becoming more popular?  Are some of them being used less? What’s happening in that area with these three different treatments? Compton:        Of course, we’d like to see these medications be available to every patient that needs them, everywhere in the country, on demand.  That’s actually our goal, and that’s the goal of all the public health system, is to increase the availability so that if you or a loved one has a problem with addiction, and you go to your physician, or you show up at an emergency room, they can get you treatment on demand.  Unfortunately, that is not the case.  We have seen increases in both methadone availability—these have to be in specialized methadone treatment programs. We see the increased in buprenorphine prescribing, because we have a greater number of prescribers, and due to changes in the rules that our colleagues at SAMHSA implemented, we see an improvement in the number of people that clinicians can treat with buprenorphine.  We also see increases in the availability of the long-acting naltrexone injection.  But despite those improvements, there are tremendous barriers in many parts of our country, and a lack of educated clinicians to take care of patients that need this care. Berger:            So, what’s keeping—what are some of the policy issues, what’s keeping us from getting it more broadly available to patients who do need it? Compton:        I think we’ve heard this theme already this morning, that the fundamental issue is the stigma around addiction; that we’ve spent way too long thinking of addiction as purely a moral failing and a decision-making.  So, you’re making bad choices; just quit doing that, is sort of the message people get.  If it were that simple, all of my patients and others who have addiction would have quit long ago.  They suffer tremendous harms, and yet, because of the compulsive behavioral origins of this condition, they keep engaging in the behavior.  That’s why we need effective medications that can combat it, and I think forums like this, that help educate the public and others about the medical nature of this disease can really make a big difference. Berger:            So, we both live in the research world.  So, let’s talk a little bit about some of the research you think that needs to be done in this area, and maybe talk a little bit about some of the research that you’re doing at NIDA these days, to help us understand the problem better, and help us address the problem. Compton:        Well, of course, I’m very proud of the work we’re conducting at the National Institutes of Health, and particularly at the National Institute on Drug Abuse, to try to address this public health crisis.  I sort of put the research in two main buckets; one is we have treatments that have effects.  We have treatments that are useful.  We have prevention approaches that can provide communities and families the tools they need to raise healthy children and keep them from moving into the addiction sphere. So, why aren’t we implementing these widely and universally?  That’s sort of a key research question. What can we do to improve the access and availability of the current treatments?  Now, as much as I like our current treatments, and I’m thrilled that we have multiple approaches to prevent and treat these diseases, they are not as effective or as good as I would like.  I would like something that was perfectly effective.  I’d like something as good as ampicillin for an ear infection, where you go to the doctor, you have a sore ear, you get the medication, and you’re better. That’s not the case with our addiction treatments.  They work; they help people, but they only help a minority of the people that start them.  People stop their treatment; this is a long-term condition, and yet people often don’t take their medications as long as they need to, to benefit from it.  So, these are some of the issues where I think research can provide tools that can be the solutions to these long-term problems, if we invest in research successfully. Berger:            And, so we’ve talked a little bit this morning about how this really is a rural—a bigger rural problem than maybe an urban problem.  So, what are some of the ways that maybe we can help that rural community access some of these treatments more effectively?  It’s probably—we’ve heard it’s much easier, maybe, to put this in an urban setting, but what about the rural settings? Compton:        It’s not just limited to addiction.  We struggle to get healthcare to rural populations across a range of issues.  If you need a cardiologist, and you live outside a major urban area, it’s really difficult to access that care.  We have addiction specialists in many locations, we have family doctors in more locations, but there are some parts of the country that don’t even have access to general medicine, or family medicine.  So, what can we do to use telehealth?  What can we use to use part-time practices that may come into these locations? What can we do to get nurse practitioners, physician assistants, other forms of care that are a part of helping people enter recovery, in all the regions that need them? Can we use the internet to provide care long distance?  Some of that has been shown to be possible, but how can we do that on a more widespread basis? Research can help with that, as can the new funding that we’ve seen with the 21st Century Cures Act, and other novel ideas that the states and local areas are coming up with. Berger:            So, you got a little bit ahead of me there.  So, what public health policies that have been implemented, at either federal or state or community levels, even, do you see having a positive impact, other than maybe the Cures Act? Compton:        Well, there are multiple policies and practices that need to be implemented.  What can we do to change the availability of medication-assisted treatment, for example?  Some states still have regulations that require to fail non-medication treatment before you can even start medications.  That seems counterintuitive.  As a physician, I want my patients to have access to the effective medications, when they have the problem, and not have to fail some other ineffective approach before they can take what might help them. That’s just one example of policies that can change.  When it comes to the provision of naloxone, we heard Dr. Wen [ph] describe how she’s written a prescription so that everyone in the city of Baltimore can gain access to this life-saving medication.  There are certain states and locations that have done that in other parts of the country, as well, but that’s not universal.  So, what can we do to make sure that this immediate, life-saving, non-addictive medication is universally and easily accessible when people have an overdose.  In those libraries we’ve been hearing about, which is really a remarkable story, or in other places where people may experience this death.  Compton:        Thanks very much.   Bernstein:        Welcome back again.  Today, in this segment, we have Anne Pritchett, she is the vice president for research and policy at PhRMA, the association that represents large pharmaceutical manufacturers, and we are going to talk about their role in the epidemic, and what might be done about it.  And I think I’m supposed to remind you that if you would like to tweet us questions, we can take them off of here and ask. So, let’s start with the premise that this country has more opioids than it may need for legitimate pain control.  Why is that?  What is the manufacturing company’s role in that?  And why are we seeing that, and its contribution to this epidemic? Pritchett:         Well, I would say CDC is actually said that there are enough prescription opioids being prescribed so that every person in America has a 30-day supply.  So, clearly we have a problem.  In terms of what the sources are of the problem, there are a number of different factors that have contributed to the situation we’re in now.  There are inappropriate opportunities to identify inappropriate prescribing.  There have been lack of clinical guidelines to inform physicians prescribing, and we’ve seen major changes in that space over the past couple of years, particularly with CDC releasing guidelines on the treatment of chronic pain, but clearly more needs to be done. There is insufficient use of prescription drug monitoring programs.  These are state-run databases that allow you to identify potential doctor shoppers, as well as identify potential inappropriate prescribing behavior, and yet, only 22 of 49 states require that physicians access those databases.  So, we need to do more in terms of using the resources we have.  We have seen that the DEA this past year reduced the quota, which in essence was taking away a supposed cushion in terms of opioids. We have a disconnect, though, in that DEA has said there was a cushion, and they’ve reduced the amount of—they’ve lowered the quotas for manufacturers, but at the same time, we have a GAO report saying that when you look at drug shortages, the vast majority are for pain medications.  So, clearly we have a disconnect and this is a very complex issue, as we heard from the prior speakers, that we really need to get our hands around collectively.  And I think we’ve seen tremendous progress from the administration where we have the FDA announcing the new FDA commissioner saying that they’re going to review what their role is, in terms of the crisis; that we have NIH, as you may have heard from Wilson on the previous panel, that NIH and NIDA are looking to develop a public/private partnership with the industry so that we can develop non-opioid analgesics. So, that would be alternatives that aren’t addictive to opioids, so that we can further the science and technology to allow us to develop abuse deterrent formulations, and that we can explore other ways that we can appropriately treat pain. Bernstein:        Before we get to those, when we read or unfortunately some of us see on the ground, and others experience, that 780 million opioids are sent into West Virginia over a five-year span, certainly the distributors who are bringing those there know that that is occurring.  The retailers who are selling them in drug stores know that that is occurring.  Don’t the manufacturers know as well?  Shouldn’t they intervene? Pritchett:         I think that everyone in the supply chain has a role and a responsibility to behave ethically and legally and to ensure that only as much medication as needed is being provided, and I think clearly there is a disconnect in the supply chain, that that’s not currently occurring. Bernstein:        And what can we do about this? Is it DEA’s responsibility?  Under the law, everyone in the supply chain is supposed to raise red flags. Pritchett:         I think there’s a collective responsibility.  I do know—I don’t engage directly on a lot of the supply chain issues, but what we have heard, and what I’ve read from different entities is that one of the challenges is that there is a lack of clarity from DEA on what is a suspicious order; what each person—what each actor in the supply chain’s role is, and that I think there does need to be more coordination between DEA and the FDA, in terms of approval of products, setting quotas, and engaging in those areas. But I think there is a collective responsibility, and I wish I had the silver bullet answer to that.  But I think events like this that are brining attention to these issues, and that we have an administration that has stated that they are very focused on this; we have a Congress that over the past couple of years has really come to the recognition that prescription drug abuse and addiction are bipartisan issues, not political issues, and that we really need to address them holistically.  I think that’s what we need, is all events like this to bring stakeholders together in ongoing dialogue about our collective roles, and how we collectively identify the appropriate solutions. Bernstein:        So, in what fashion are the manufacturers engaging with the government? Pritchett:         So, I would say that a number of our companies have been engaging with NIH in the discussion about public/private partnerships, in terms of developing medication alternatives, furthering abuse deterrent formulations that we have been actively engaged with the federal government in terms of supporting the efforts of the FDA to look at things, like should there be mandatory prescribed—should there be mandatory education for prescribers, for pain and addiction? And I would say that’s something we feel very strongly about.  We know it’s not popular among some provider groups, but the FDA requires as a risk mitigation strategy for the approval of long-acting and extended release opioids, that companies fund continuing medical education to provide training for providers on how to appropriately prescribe opioids, yet what we’ve seen from the FDA is that, unfortunately, only about—they weren’t able to meet their goal of 80,000 prescribers taking that training over a two-year period. So, for us, we think it is critically important that there be a focus on, unfortunately, while no likes mandates, the reality is prescribers need better education about the treatment of pain, and about addiction.  Studies have found that medical schools only spend a handful of hours on how to treat pain, as well as how to treat addiction.  That’s a huge gap in our system.  And our view is very strongly that you should only—that physicians need the education need to determine when it’s appropriate to prescribe an opioid, when it isn’t, and that when they are prescribing one, they are relying on clinical guidelines to inform at what dosage and for how long, and whether there are alternatives. And I would say, one of the other areas where we’ve been engaged in is educating—I would say one of the challenges in this area is that a lot of people think—they have this misconception that because it’s a prescription medicine, it’s somehow safer than something like heroin, which is not accurate.  So, we all need to do a collectively better job of educating the public about the dangers in this space, and we need to discourage people from sharing their medications.  It’s very disturbing when the national household survey on drug use and health find that’s of about half of those that use opioids non-medically, they obtain them from a family member or friend. So, we are engaged in efforts to educate that patients should take their medications as directed; if they have questions, they need to have that discussion with their provider, and that they need to safely secure their medicines, and appropriately dispose of their medicines.  And certainly, sharing medications is not appropriate. Bernstein:        Okay, so let’s talk about the medications themselves, those pills.  Abuse deterrent pills, or other forms.  It’s been tried; it hasn’t been hugely successful.  Is it possible?  Can you make the medications unusable by abusers? Pritchett:         So, I would say before I came to PhRMA, I spent almost eight years in the White House drug policy office, more on the illegal drug side.  And what we found is that kind of those that want to do ill will are always kind of one step ahead of the game, and you know, I do want to correct something.  A lot of people think that if it’s an abuse deterrent formulation, that means it can’t be abused at all.  That’s not accurate. It means that there is less potential for abuse, and there are a variety of forms of abuse deterrents, and the FDA recognizes that the science and technology continues to evolve in this space.  And that’s one of the reasons why the FDA requires post-approval research on these medications, so that we’re continuing to collect real world evidence to assess how well these medications are working, and their level of abuse deterrents.  And that’s one of the areas that the NIH public/private partnership is intended to focus on, is how do we develop better abuse deterrent technologies?  Are there opportunities in terms of developing non-opioid analgesics?  What can we learn about biomarkers so that we can more appropriately target medications, because pain is not one size fits all; addiction isn’t one size fits all.  There’s a lot more that needs to be done.  But abuse deterrent formulations, we believe, are one part of the toolkit. Bernstein:        So, they should be in the toolkit; they are partly successful, even though, as you said, the folks who are going to abuse always seem to find some way into them.  Now, maybe you could tell folks two things: what a non-opioid analgesic is, and I don’t want to load you up, but the possibility for using opioids that kill pain but don’t provide the euphoric effect. Pritchett:         So, I’ll just give you a sense of kind of what’s in the pipeline.  So, there are about 40 abuse deterrent formulations in the pipeline right now, about 40 different medications to treat addiction, and that includes a number of those are opioid reversal agents, which we know is an area where people are looking for convenient delivery forms, given the number of first responders is greatly expanding in that area.  And then, one of the areas is non-opioid analgesics.  And in essence, this is looking at alternative medications where they don’t have the potential for addiction, and there are about 30 medications in that space in development. And I would say that one of the biggest challenges in all of these areas is that when you look at the opioids that are on the market, about 96% of those are generic, and none of those generics have an abuse deterrent formulation.  So, only about 2% of the market is abuse deterrent formulations, and then the other 2% is branded opioids. Bernstein:        Sorry, why wouldn’t generics have an abuse deterrent formulation? Pritchett:         Well, the FDA just recently finalized their guidance in that area, so we are hopeful that there will be generics entering the market in that space.  I would say one of the challenges is there is a lot of scientific and regulatory uncertainty as you’re developing abuse deterrent formulations.  The FDA doesn’t kind of have a, you know, black and white of here’s the criteria you have to meet to be approved as having—being an abuse deterrent formulation, so that’s one of the challenges. But we also have a disconnect in terms of when you look at the commercial coverage policies for these products.  So, what you generally see is that the generics that—you generally see that abuse deterrent formulations are, you know, tier three, tier four.  So, in other words, you’re failing first on everything else, and there’s not kind of a calculation that, from the insurer perspective, that we need to be considering the potential for abuse, and prioritizing that. The FDA has said that it’s a key priority for them to approve abuse deterrent formulations, yet we have a disconnect when it comes to coverage in payment policies of the value of these medicines.  And again, they’re only one tool in the toolkit, but an important one. Bernstein:        But I want to make sure I understand.  96% of the drugs—the opioids that folks take routinely, daily, legally, do not have any kind of abuse deterrent. Pritchett:         Correct, and they’re generic. Bernstein:        So, if someone—if a kid takes one out of medicine cabinet, there’s nothing there that would keep him from crushing it and snorting it, or cooking it up and injecting it? Pritchett:         Correct, and that’s one reason why we think it’s so important to increase our prescriber education, and we support mandatory education on a continuing basis, because we’re developing new abuse deterrent formulations.  As I mentioned, we’re going to have new, non-opioid analgesics coming onto the market, but prescribers need to know what the new developments are in terms of what medicines are coming, what the risks and benefits of new medications are.  They also need to know what the current learnings are about the treatment of pain, the potential for addiction. I would say we’ve seen over the past couple of years, you know, just recently, the American college of physicians altered its guidance—clinical guidelines regarding the appropriate treatment of lower pain.  And we had CDC release the guidelines on how do you treat chronic pain.  And so, given we have these changes on an ongoing basis, we need to ensure that prescribers are up to date, as well.  And that’s critically important, but I would say, again, educating the public, as someone who has had loved ones affected by substance abuse issues, you know, when I’m meeting with a doctor, I’m meeting with a doctor on behalf of one of my family members, I’m perfectly comfortable saying, “You know, is there a potential for—is there an alternative?  What’s the most appropriate treatment?” And I think we need to educate patients and caregivers, that they need to be asking those questions of prescribers, that we need to empower them to be aware that medicines need to be taken appropriately, that if they have questions, they need to be asking their prescriber so that they are being appropriately treated. Bernstein:        And if you’re not able to ask the question yourself, perhaps your loved one can ask them for you. Pritchett:         Yes.  Well, and as one of those who’s in that generation where, increasingly, you’re taking care of your parents, you know, the roles kind of shift a little bit, and so it is important, given that we are seeing a higher prevalence of addiction among actually—so, we have two issues.  It’s non-medical use of opioids, and then it’s the issue of those that are being treated for chronic pain or other conditions, who become addicted.  And I would say, one of the changes I’ve seen over time is that we used to, as a society, simply focus on that non-medical use, and now there’s increased focus on how do we prevent addiction among those that may be taking a number of medications including pain medications, over a long period of time. Bernstein:        So, I think of a non-opioid analgesic as ibuprofen, or acetaminophen.  Now, clearly, that’s not going to work for post-surgical pain, or the pain of cancer late-stage, near end of life pain.  So, what are we talking about?  What’s in development? Pritchett:         So, we’ve got about 40 different medications in development at various stages, that hold promise, but I would say that when we are talking about, let’s say, breakthrough cancer pain, late-stage, having seen my grandmother suffer from cancer late-stage, and fentanyl was the only thing that helped her manage that breakthrough cancer pain.  And I was note, as we’ve heard from the other panelists, fentanyl is something that’s being implicated in exacerbating the current crisis.  And I would note that Judge Louis Freeh, former FBI director, recently came out with a report that was bringing attention to the threat of counterfeit fentanyls. The DEA has said that hundreds of thousands of counterfeit fentanyl pills are being manufactured in China, and coming to the U.S. through Mexico and Canada.  So, this is greatly exacerbating the opioid epidemic, and as we heard from one of the prior panelists, fentanyl is exponentially more powerful than morphine.  And so, we have this challenge of needing to address the need to ensure legitimate—that patients with legitimate medical needs have access to the medicines they need, including fentanyl, but we need to increase our law enforcement efforts, including considering whether we need to increase penalties for those that are involved in criminal organizations that are bringing counterfeit fentanyl into the U.S. And as we’ve heard some horror stories of an elephant tranquilizer being mixed with other illicit substances, so there’s a lot of progress that needs to be made, and we really need to take a holistic approach, but we need to ensure that where opioids are appropriate, that physicians have the clinical guidelines to inform their prescribing, and to be clear, opioids are a critical medication and when used appropriately, can be incredibly beneficial to patients.  But we do need to balance that with identifying alternatives, including non-medication alternatives, other therapies that are appropriate. Bernstein:        Okay, we’re getting close to the end so I want to ask you two more questions.  We’re getting a number of questions here on Twitter about cannabis, and whether PhRMA might go into that area.  I think the point is to try to get me to say cannabinoid in front of all these people.  So, if I got that right, is PhRMA willing to go in that direction? Pritchett:         So, as you know, there are some medical cannabinoid products available.  We’ve looked at the pipeline, and I think there—it’s a—I want to say it’s a half-dozen products that are in the pipeline, that are in that space.  So, there are companies that are exploring medication uses under— Bernstein:        And it has both practical potential, and affordability?  Or is it too early? Pritchett:         I think that I am not in a position to comment on that; that we need the science to tell us what the—whether and what the potential is. Bernstein:        Okay.  Great.  I did this in the last session, and so for the next minute and 44 seconds, you’re the drug czar, and you are— Pritchett:         Having worked in the drug czar’s office— Bernstein:        That’s right.  What’s your list?  What’s your list of—we’re giving you all the power you need to solve the opioid epidemic. Pritchett:         Right, so, for me, this is a multi-faceted problem, and there’s not a one size fits all solution.  But among—of my top five on the list, it’s that we need to improve education for prescribers.  That means mandated education; that means on an ongoing basis.  As part of that, continuing to educate the public to increase their awareness of opioids and when they’re appropriate and when they’re not.  That, too, we need to mandate the use of prescription drug monitoring programs, because what we have found, studies show that when prescribers are using prescription drug monitoring programs, it does affect their prescribing.  And that many of them say that it has reduced the potential for misuse and abuse. Bernstein:        Even if they don’t catch doctor shoppers, it affects the way they do their jobs? Pritchett:         It affects the way they do their jobs, and so I think we need to look at the prescriber patterns, and we need to look at the flags for potential doctor shoppers.  And I would say, in the PDMP space, one of the things that we’ve heard from physicians is that you have to go through ten screens to get to the information you need; we need to make that easier.  We need to increase law enforcement capabilities and capacity to crack down on rogue pill mills, and illicit websites that are illegally provided controlled substances in the U.S.  And we need, as we heard earlier, to increase treatment capacity, and I would say one of the big positives is that while I heard a lot that there’s still a lot of stigma, having worked in this area for the majority of my career, I think we’ve made a lot of progress in reducing stigma, in that we are all here having this conversation today.     Kennedy:        Well, my late grandmother on my mom’s side died at the age of 61 and wasn’t found for a week.  Like most people with alcoholism, she pushed away my mother, my aunt, her husband, and she was alone.  And that same disease that she had passed itself to my mother, who had very debilitating both depression and alcoholism, which I grew up with and my dad, of course, had all of these luminaries of the day come over to our house; people who were household names.  And my mom would shuffle through the house clearly incapacitated from her illness and no one would look up and no one would look at her and no one would say anything to her. So as a young boy, I got the very clear message that these were not things that we should talk about and I, like everyone else, was hoping and praying that my mom would go back into a room and lock the door so that she could spare us the embarrassment of being out amongst everyone in our house.  I had friends come over to the house to play with me when I was little and I was terrified my mom would come to the door if my friend’s mom would ring the doorbell.  And no one talked about it.  Now, my dad, as everyone knows, had a number of traumatic events that happened in his life.  We didn’t know what trauma was back then until 9-11, this idea of post-traumatic stress was not something in our nomenclature.  But my dad, if you wanted to find anyone who qualified for suffering from post-traumatic stress, my dad would be the guy. He would be like a perfect portrait of someone suffering from post-traumatic stress and he suffered from— Jordan:            From the assassinations of his two brothers, do you mean?  I have to see my primary care physician and pulmonologist all the time.  But somehow, my insurers were paying for my inpatient at Mayo Clinic but weren’t paying for any follow-up.  And these insurance companies know better but they don’t do it and then they complain to people like me who are trying to enforce the Parity Law.  That, “Well, there’s all these fly-by-night rehabs down in Florida that aren’t giving evidence-based treatments.  And I’m like, “You got me.  I’m with you.  I’m not trying to protect them.”  In fact, I’d like to shut those places down because there’s 90% relapse rate for people coming out of those places.  There’s no outcomes-based metrics and insurance companies still have to pay for that.  That’s not what we want.  We want chronic care, continuity of care, recovery living.  And insurance companies aren’t paying for that now. Jordan:            So we’re going to go back to that super important— Kennedy:        I jumped right into my policy speech.  [LAUGHTER] Jordan:            No, but this is important— Kennedy:        I’m trying to get away from having to talk about— Jordan:            It’s an important issue.  First of all, thank you for sharing your story.  I think that we’ve heard this morning about stigma and that this still exists and somehow, if it’s in your mind, like it’s not in your body.  And so do you feel like there is some movement forward on that as—  Jordan:            Let’s talk about what to do.  What needs to be done? Kennedy:        Well, it needs to be understood it’s the whole person.  We need to align financial incentives.  The bottom line in all of us is that we need to align financial incentives to encourage prevention, which is the best treatment of all, to encourage chronic care management, and integration of the whole person, i.e., mental health and addiction needs to be treated along with all other physical health conditions.  So that’s got to be our concept and we have to understand that social determinants make a big deal.  Like, if you grow up in a family like Kaiser showed, where your mother or father was alcoholic, in jail, lived in poverty, subject to violence, and witnessed violence.  You check those bars off your trajectory in terms of vulnerability and risk goes through the roof.  So it’s not like we have to spend a lot of money on everybody.  We’ve got to spend the right amount of money on those with the highest risk. Jordan:            And spend it on prevention and chronic care.  So now, you’re at the White House.  You had your first meeting and who showed up to that meeting? Kennedy:        So first of all, the commission is really impressive.  Governor Christie, if anybody saw his video that went viral during the presidential about talking about addiction, everybody knows Governor Christie gets it.  Okay, he gets it and we have Governor Cooper, a Democrat.  We have Bertha Madras.  I won’t tell her party affiliation but she works at Harvard out of McLean Hospital.  You guess what her party affiliation.  I’m obviously, a Democrat and then you’ve Baker from Massachusetts, who is not like considered a real hardcore Trump supporter, right?  So the irony is you’ve got a commission that I think is very legitimate. Jordan:            But does Trump himself care?  He’s talked about this throughout the campaign.  He said, “This was, high, high, high, on this issue.”  And now, we’re going to have to talk about what money is he putting up and especially with what’s going on in healthcare right now and perhaps slashing of Medicaid.  Is the White House really ready to address that?  Because you’re one of the few people in there talking to him. Kennedy:        Well, obviously, Medicaid—as I said in my opening statement at the commission was the elephant in the room.  And that was because without continuity of care—block grants, I don’t want block grants.  Block grants only pay for non-evidence based treatment.  You don’t fight cancer with block grants. Jordan:            And is block grants what’s going on in the secret GOP negotiations? Kennedy:        They’re using block grants as a way of really doing what they don’t want to vote on doing and that’s sharply cutting the amount of money that goes to treatment.  So they say they’re giving the same amount, but they’re letting states to do the dirty work.  Because states’ budgets are going to crowd out the funding and the money is going to be fungible so they’ll use those dollars to fund other things because people with addiction and mental illness are the most unpopular of all constituencies so they’re the easiest people to drop by the wayside.  But I think here’s the big thing for the president is if he’s going to ask for an 18% cut for corporate taxes, I propose that the White House make an objective for our country, at a minimum, to reduce suicide rates and overdose rates by an equal percentage for the American people.  Because if we don’t put our mind to something, we’re never going to start bending the curve and applying ourselves to the goal at hand. So I think when you see the suicide rates and overdose so high and all of the scientists will tell you, “We can reduce those.  We can reduce those quite dramatically.  We know what to do to reduce those.”  But if we’re not making it a goal of this country to reduce those, we’re never going to get to where we need to go.  So I would say make the reduction in suicide and overdose the same as you make corporate taxes, the reduction in corporate taxes.  And two, if we’re going to repatriate hundreds of billions of dollars of overseas corporate taxes and this is the biggest public health crisis of our times and it affects one in four Americans; why not say that we’re going to spend one in four dollars in repatriated money and put it into this, the biggest public health epidemic of our time and let’s build the infrastructure because you’re hearing from everyone that we don’t have the workforce out there.  We don’t have the availability out there.  We don’t have the telemedicine out there.  Let’s build that out and with that—  Kennedy:        Yes. Jordan:            And you are with Chris Christie and Donald Trump’s brother had problems with this.  So this is— Kennedy:        That’s what I’m saying.  This doesn’t know any partisan boundaries, okay? Jordan:            Okay, and people are talking.  It’s money that we have to watch where if some of these programs are gutted, someone this morning said that $91 billion—  The enormity of this crisis as it relates to a number of different budgets, but what CBO and JO have not done is they’ve not quantified across many budgets what this epidemic is doing in terms of its cost to society.  If you took the true, honest, zero-based budgeting on the true costs, I think you could justify to Republicans that it’s smart to have an entitlement where you can track efficacy and quality.  Republicans should be about outcomes-based metrics.  We ought to be about ensuring that we get our quote-unquote “money’s worth” and we’re not paying for what works today and we should pair up with Republicans and say, “Listen, you want to get accountability.  We want to get more people covered.  Let’s get together on this.” Jordan:            So, so far, Republicans and Democrats are certainly talking about this.  They’re certainly saying, on both sides, this is a massive issue.  They’re like this when it comes to how much money to spend on it, right?  At least through the federal government.  Where in your discussions is there kind of hope that they’re something in agreement?  Is it finally to get rid of the stigma?  I noticed that people keep calling it a brain disease.  And your hashtag is, right?  Tell them what it is. Kennedy:         #ForBrainHealth. Jordan:            And stop talking about it like it’s some moral problem, as somebody earlier today said, right?  Where are you seeing agreement?  Where are you seeing the road forward? Kennedy:         Yeah, but when you’re active in your illness, you do a lot immoral things and that’s why people are looked down upon and that’s why those of us who have been blessed to be in recovery talk about this as a three-fold illness, a physical allergy, a mental obsession, and a spiritual malady.  Because if we’re acting against and hurting other people, we’re hurting our own chances of living in recovery because we all are subject guilt.  We all have consciences and I think we that we need to have the active participation of the medical community.  I was just with Reverend and Kay Warren.  Fantastic people, purpose-driven life.  They lost their son to these illnesses and most churches have no way of talking about these things.  I was asked by my Catholic church, St. Thomas in Brigantine to speak about these issues. I was denied communion by my bishop in Rhode Island for not having the right kind of set of Catholic checklists.  And yet now, I’m getting messages from the bishop that I’m doing great work and that my parish priest thinks I’m great and I’m there on Sundays.  I don’t know what the point is but I just had to say that.  [LAUGHTER] Jordan:            But I think one point there is that times are changing.  Everyone is touched by this and people are getting it more and at least that is a step forward. Kennedy:        I just get approached everywhere.  I often say when I came back from rehab after crashing my car in the capital and everybody knew I was addict-alcoholic, no one else in Congress knows who we are.  But because I was in the newspapers all the time—so when I got to the floor, you would be amazed at how many of my colleagues grabbed me to pull me off the floor of the House to tell me their own stories because they didn’t know amongst all of my other colleagues which one of us was in recovery or struggling with a mental illness or addiction.  And so it was a real eye-opener for me that in this room, there’s a number of us who have been suffering.  There’s a number of us who have already gotten our 12-step meeting in for the day and there’s many of us who also understand, as I do, that it took both medication-assisted treatment and 12-step recovery for me to have the longest period of stability and sobriety in my life.  So it’s not as if it’s one or the other.  But the whole advocacy community is at each other’s throats because the 12-step folks think the MAT is an abomination.  All of the scientists say, “Yeah, but all of the evidence says that MAT, medication-assisted treatment is what is called for with this opiate crisis and we have a scant application of MAT across the country and two-thirds of the rehabilitation centers don’t even practice MAT and yet we’re paying for them.”  Jordan:            I’ve got to ask you because your father devoted his whole life practically to healthcare and when we see what’s going on now, what do you think he would think about the GOP plan and ripping up Obamacare now and then we’re going to talk about what that means for addiction. Kennedy:        Well, my dad just believed—he watched my brother Teddy in the early ‘70s get treated for cancer and he was standing in the same children’s ward as all of these other parents who were hoping their own kids could get the treatment, who had to discontinue the treatment because they didn’t have the financial wherewithal.  And I found out later on in my life how many families came up to me and said, “Your father paid for all of our kids’ treatment”—after my brother was released.  Because it was something that he couldn’t abide by the fact that he simply because he had the money, could pay to save his son’s life but the other parents could not save their children’s lives.  He just said, “There’s something morally wrong about that.”  And so this wasn’t a policy.  This was a principle and I think he would just say, “How can we?”  And we could go all into the economics that it doesn’t actually make sense to cut people off because we know they come back through the doors sicker and more costly and we all end up paying for it as a surcharge on our insurance, for those of us who are fortunate enough to have private insurance. But it’s an inefficient way to treat people through these ERs.  The better way is to cover them and do the prevention that I spoke about earlier.  But taking all that aside, it’s just about treating others as you would want your own loved one to be treated. Jordan:            And then when it comes to addiction, since you know what you’ve been through and how hard it is, what does a good prevention program look like? Kennedy:        Wilson Compton could tell you, there’s terrific resiliency, coping mechanism, problem-solving skills that can be brought into education.  Keep in mind, we focus on numeracy and literacy with our children, but we do not focus on emotional strength, resiliency, problem-solving skills.  The very things that they’re going to need in order to be successful.  So our education system really isn’t purely designed to produce the most effective and capable students.  So I would say that we have to do social and emotional learning.  It’s got to be in every class in America.  And this isn’t soft science.  There’s a lot of data out there showing it reduces the dropout.  It actually improves scores in some of the worst, most violent sections of neighborhoods in this country where they’ve tested mindfulness and other things, coping mechanisms.  They find that kids’ scores go up dramatically because their amygdalas are not firing because they’re fight or flight mode, which is what’s going on in the brain if they come to school and there are gunshots and their mother and father is incapacitated from drugs, alcohol, or in jail. These kids have a lot that they’re bringing to school.  We need to help prepare them and— Jordan:            I’m looking at a few questions on Twitter.  A lot of questions on Twitter, but several of them about marijuana.  What do you think about marijuana?  As places around the country now are legalizing it. Kennedy:        I just don’t want it targeting kids and when you look at the products that are being produced by the new big tobacco, it’s gummy bears with—red, white, and blue gummy bears.  It’s like elixirs.  I don’t know if you guys know what elixirs are. Jordan:            gummy bears with marijuana in them? Kennedy:        Yeah, THC.  I’m not talking about the smoked kind.  That’s benign.  I’m talking about the kind you put in your e-cigarette.  We all see folks with their e-cigarettes around here.  A dab of this high THC concentrate, but it’s mostly the edibles.  Yeah, there’s all kinds of them. Jordan:            And you think they’re more addictive? Kennedy:        Well, first of all, I think we already have seen the dramatic increase in use amongst teenagers.  At the same time that the use of tobacco is going down, thanks to great public health efforts.  Imagine in this country, we’ve done all this work reducing tobacco use—bless you.  [LAUGHTER] Now, we’re like, “Ah, this is no problem.”  And again, it’s the targeting of kids.  So I think we should have an impartial panel of medical experts just reviewing the products that are being sold out there and putting a stop to those products that clearly have a higher penetration amongst kids.  We should all be in agreement that kids should not be using this stuff because it affects their developing brains, because it puts them at risk for all kinds of other addictions, including opiate addiction, and it affects their mental health dramatically. And if more people use—I know there’s a certain percentage that have a predisposition to having a mental illness for addiction.  Guess what?  That percentage goes up if the larger population of those using goes up.  So we just have to be very conscious as a nation what we’re walking into as a nation with the quote-unquote “legalization”.  But I think it’s the commercialization is the problem and there’s no way public health is going to be able to keep pace dollar-for-dollar with the enormity of the budgets that the big marijuana corporate folks are going to have to market this stuff in all kinds of ways that I think is going to jeopardize all our best prevention efforts.  There’s one thing we can do, but we’ve got big marijuana just flooding with different ads that it’s medical and all the rest.  If it’s medical, then let it go through the usual medical process.  Don’t be selling something out of your basement and, “Oh, it’s medical.” Don’t know what’s in it, no way of telling you how it might be spiked.  Don’t have any sense of whether it gives you the relief that it’s supposed to give you, but it’s medical. Jordan:            How many kids—you have four kids now? Kennedy:        Four kids. Jordan:            Four kids and three under the age of four or something?  You have a lot of little ones, right?  [LAUGHTER] Kennedy:        Yes. Jordan:            So thinking about these little— Kennedy:        That’s why I’m fixated on gummy bears. Jordan:            Yeah, okay. Kennedy:        [LAUGHTER] And I’m not kidding.  Kids pick this stuff up and put it in their mouths and it’s happening.  The poison control— Jordan:            But as we look to all our kids and it’s tough now.  It seems to be it’s tougher now be to a kid than it ever was.  There’s more stuff on the market.  There’s more everything.  What would you do to fix one thing across the country to make it better and easier for kids today when it comes to addiction? Kennedy:        Well, I think look the whole family.  If your parents are in crisis, your kids are going to be in crisis.  We can’t think of this as separate issues.  My first bill signed into law was called the Foundations for Learning Act.  It never got voted on in subcommittee, full committee, or even on the floor of the House, but somehow, it because of federal law.  It had nothing to do with the fact that my dad was chairman of the Conference Committee on Education.  [LAUGHTER] So he airdropped it in and basically, it said that if parents need support, support the parents because you’re going to end up helping the kid dramatically if the parent can get the support they need.  If the parent is a wreck, I don’t care what you do for the kid, the kid is going to have a tough time.  And we have to understand with this opiate crisis—the last thing I’ll say is there is a secondary effect of this opiate crisis and that’s all the kids now who have grown up with these family members who have suffered and died as a result of this crisis.  And let me finally say—suicide has not been talked about much at this forum but you cannot divorce the suicide rate from the opiate overdose rate and both of them are way underreported because a quarter of all coroners in this country are elected and there’s no standardization for medical examiners, if you can believe it in this country.  So everything you saw—if it weren’t Carrie Fisher, we would have thought she died of sleep apnea.  She had the extraordinary circumstance of being an uber, uber-celebrity, so we found out everything else that was going on. We have no clue what the true suicide rate, overdose rate is here in this country.  And not to be too startling, but as I said from the beginning, we’re in denial in this country if we think we can micromanage this a little bit over here and we put a little block grant for opiates over here.  God bless Senator Portman for pushing for that.  But this is along the margins.  We are moving chairs on the Titanic is our current approach to this issue.  We need to fundamentally come to a different approach for how to deal with mental illness and addiction and stress management and mental health in this country.  Unless we celebrate it, support it, through the whole healthcare system, encourage it, pay for it, reimburse for it, all of these other costs, you’re going to be playing Whack-a-Mole.  Diabetes is going to go up.  Cardiovascular disease is going up.  All of this hypertension is going to go up.  Suicide is going to continue to go up.  We have to make this a national priority if we expect to do anything to help change the nature of this illness and actually make a dent in the future suicide and overdose rates. [APPLAUSE]

How drugs intended for patients ended up in the hands of illegal users: ‘No one was doing their job’

For 10 years, the government waged a behind-the-scenes war against pharmaceutical companies that hardly anyone knows: wholesale distributors of prescription narcotics that ship drugs from manufacturers to consumers. The Drug Enforcement Administration targeted these middlemen for a simple reason. If the agency could force the companies to police their own drug shipments, it could keep millions of pills out of the hands of abusers and dealers. That would be much more effective than fighting “diversion” of legal painkillers at each drugstore and pain clinic. Many companies held back drugs and alerted the DEA to signs of illegal activity, as required by law. But others did not. Collectively, 13 companies identified by The Washington Post knew or should have known that hundreds of millions of pills were ending up on the black market, according to court records, DEA documents and legal settlements in administrative cases, many of which are being reported here for the first time. Even when they were alerted to suspicious pain clinics or pharmacies by the DEA and their own employees, some distributors ignored the warnings and continued to send drugs. “Through the whole supply chain, I would venture to say no one was doing their job,” said Joseph T. Rannazzisi, former head of the DEA’s Office of Diversion Control, who led the effort against distributors from 2005 until shortly before his retirement in 2015. “And because no one was doing their job, it just perpetuated the problem. Corporate America let their profits get in the way of public health.” A review of the DEA’s campaign against distributors reveals the extent of the companies’ role in the diversion of opioids. It shows how drugs intended for millions of legitimate pain patients ended up feeding illegal users’ appetites for prescription narcotics. And it helps explain why there has been little progress in the U.S. opioid epidemic, despite the efforts of public-health and enforcement agencies to stop it. At the peak of the crisis, the DEA retreated from the battle. A Post investigation published Saturday revealed that beginning in 2013, some officials at DEA headquarters began to block and delay enforcement actions against wholesale drug distributors and others, frustrating investigators in the field. Several former DEA officials told The Post that the shift in approach undercut the cases against some of these distributors, who were ignoring signs that their customers were ordering suspicious quantities of narcotics. “We could not get these cases through headquarters,” said Frank Younker, a DEA supervisor in the Cincinnati field office who retired in 2014 after a 30-year career. “We were trying to shut off the flow, and we just couldn’t do it.” The 13 companies include Fortune 25 giants McKesson, Cardinal Health and AmerisourceBergen, which together control about 85 percent of all pharmaceutical distribution in the United States. They also include regional wholesalers such as Miami-Luken and KeySource Medical, both based in Ohio, as well as Walgreens, the nation’s largest retail drugstore chain. Many of the distributors are tiny operations with just a few employees. It is not clear how many other cases exist. Because the DEA handles its enforcement actions administratively, few details surface unless the agency or the company discloses them, or if one side appeals in civil court. The DEA declined to disclose how many enforcement actions it has brought against distributors, requiring a Freedom of Information Act request that The Post filed in April. The request is pending. The DEA also would not make any officials available to discuss this article, but it provided a statement from acting administrator Chuck Rosenberg defending the agency’s enforcement actions. “We now have good folks in place and are moving in the right direction,” he said. Some of the 13 companies have fought the DEA’s enforcement efforts in court and in hearings before the agency’s administrative law judges. Except in two pending cases, all have lost or settled. Using its civil authority, the DEA stopped the flow of narcotics from some company warehouses, and U.S. attorneys levied fines totaling more than $286 million. Most of the 13 **** wholesalers involved in these cases declined to be interviewed. In court filings and congressional testimony, they said they have developed large and sophisticated systems to help prevent drug diversion. They have complained that it is difficult to police the activities of far-flung drug dispensers and have noted that drugs could not be sold to illegal users without prescriptions written by corrupt doctors. They also criticized the DEA’s past approach to the problem as punitive and its rules as vague and confusing. But the problem is clearly ongoing. Prescription narcotics cause more overdose deaths every year than any street drug, including heroin. The painkiller epidemic has taken 165,000 lives since the turn of the century, with the number of deaths soaring from 3,785 in 2000 to 14,838 in 2014. Opioid overdoses, mainly from prescription drugs, are also the leading cause of the recent unexpected rise in the mortality rate of middle-aged white Americans, particularly women in rural areas, after decades of steady decline. But it is impossible to estimate how much of the opioid supply is siphoned away to illicit use. “No one knows, because it’s impossible to track what happens to an individual prescription once it leaves the pharmacist,” said Susan Awad, director of advocacy and government relations for the American Society of Addiction Medicine. One of the first wholesalers targeted by the DEA under its “Distributor Initiative” was Southwood Pharmaceuticals, a small company based in Lake Forest, Calif., that sent controlled substances to Internet pharmacies. Because these online businesses typically allowed people to obtain drugs without being seen by a doctor, they were ripe for abuse. In 2005, for example, Southwood supplied one Florida online drugstore, Medipharm-Rx, with 8.6 million doses of hydrocodone — the opioid found in Vicodin and Lortab, according to the DEA. But Southwood failed to file a single suspicious order report, even after the DEA warned the company in July 2006 about the growth in the volume of its shipments. The DEA had seen the trend in its own monitoring of drug-sales data. “Even after being advised by agency officials that its internet pharmacy customers were likely engaged in illegal activity, [Southwood] failed miserably to conduct adequate due diligence,” Michele Leonhart, then the DEA’s deputy administrator, wrote in a 2007 decision to revoke the company’s license to distribute narcotics. “The direct and foreseeable consequence of the manner in which [Southwood] conducted its due diligence program was the likely diversion of millions of dosage units of hydrocodone,” Leonhart wrote, adding that the company had reason to know that the 44 million doses of hydrocodone it distributed were probably being diverted. That amount would provide a 30-day supply of narcotics for everyone in the city of Dallas, according to Express Scripts, a pharmacy benefit management company. Southwood got out of the business of selling controlled substances and six years later lost its pharmacy license in California. The company’s president, John Sempre, ****recently told The Post that ****the company did not understand at first that it was supplying Internet pharmacies. He said it is very difficult for companies to monitor the sales of faraway retailers. “If companies like McKesson can’t control it, what does that tell you?” Sempre asked. **** In 2008, McKesson, the nation’s largest drug distributor, settled a case that accused three of its U.S. warehouses of failing to report hundreds of suspicious orders from Internet pharmacies. “As a result, millions of doses of controlled substances were diverted from legitimate channels of distribution,” the Justice Department said in a news release. The company paid a $13 million fine to U.S. attorney’s offices in Florida, Maryland, Colorado, Texas, Utah and California. “By failing to report suspicious orders for controlled substances that it received from rogue Internet pharmacies, the McKesson Corporation fueled the explosive prescription drug abuse problem we have in this country,” Leonhart, then the acting DEA administrator, said in a statement at the time. Seven years later, after being caught up in a second diversion case, McKesson agreed to pay a $150 million fine and accepted license suspensions at four warehouses, according to a company filing with the Securities and Exchange Commission. No other details of that case have become public, and both the company and the DEA declined to discuss it. A McKesson spokeswoman said in a statement to The Post, “We welcome the ongoing dialogue with the DEA aimed at developing effective controlled substances monitoring programs and successfully mitigating prescription drug abuse and diversion.” AmerisourceBergen, another member of the so-called Big Three distributors, lost its license to send controlled substances from an Orlando warehouse on April 24, 2007, amid allegations that it was not controlling shipments of hydrocodone to Internet pharmacies. The facility was back in business by August of that year and did not pay a fine, according to a company spokeswoman. Few details of the case have surfaced. Cardinal, the third member of the Big Three, paid a $34 million fine in 2008 after seven of its warehouses across the country filled thousands of suspicious orders from Internet pharmacies without reporting them, despite an earlier warning from the DEA, according to a Justice Department news release. On Oct. 5, 2010, when Cardinal investigator Vincent Moellering visited Gulf Coast Medical Pharmacy , a drugstore in Fort Myers, Fla., he found evidence of diversion everywhere, records show, including suspicious customers who came in groups to fill their prescriptions. The pharmacy’s owner told Moellering that he could sell even more narcotics if Cardinal would supply them, according to Moellering’s report, which the DEA introduced in a court proceeding. Moellering labeled the drugstore “high risk” and wrote: “I am not convinced that the owner is being forthright pertaining to his customers’ origin or residence. I have requested permission to contact DEA to resolve this issue.” But Cardinal didn’t notify the agency or cut off Gulf Coast’s drug supply, the DEA contends. Instead, the shipments kept going out. In 2011 alone, Cardinal sent more than 2 million doses of oxycodone to Gulf Coast. Cardinal typically shipped 65,000 doses of the opioid annually to comparable pharmacies, the DEA said. Even as Cardinal was increasing its shipments to Gulf Coast, another wholesale drug distributor, H.D. Smith, was cutting off its supply of painkillers to the pharmacy. Smith took action after one of its compliance officers visited Gulf Coast and found “impaired and lethargic” customers “with glassy eyes” in November 2010, a few weeks after Moellering’s visit, court records show. The Smith inspector learned that the pharmacy filled 300 prescriptions a day, nearly half for controlled substances. Smith considered anything over 20 percent to be a red flag. Gulf Coast owner Jeffrey R. Green and manager Karen S. Hebble sometimes waited after hours to sell narcotics, even without a pharmacist present, court records show. Drug dealers said they brought groups of fake patients — known in the trade as “spuds” or “skidoodies” — to Gulf Coast to fill bogus prescriptions obtained from cooperating prescribers, court records state. They always paid cash. One drug dealer would call ahead to make sure Gulf Coast had enough pills for his fake customers. Cardinal only stopped shipments to Gulf Coast in October 2011, shortly before the DEA demanded information from the distributor. The next month, Gulf Coast surrendered its license. Green and Hebble were ultimately convicted in federal court of conspiracy and money-laundering charges. Cardinal contended that volume of drug sales alone is not an accurate measure of lack of compliance. The company noted that Gulf Coast served a hospital complex and hundreds of physicians. In 2012, Cardinal settled the administrative case, but no fine has been levied. Negotiations are ongoing, according to a federal prosecutor and the company. In a statement to The Post, Brett Ludwig, Cardinal’s vice president of public relations, said the company deploys “advanced analytics, technology, and teams of anti-diversion specialists and investigators who are embedded in our supply chain. This ensures that we are as effective and efficient as possible in constantly monitoring, identifying, and eliminating any outside criminal activity.” At Walgreens, an employee at one of the 13 warehouses the drugstore chain operated in the United States grew suspicious of the large orders being sent to some of its pharmacies, court records show. Kristine Atwell, who managed distribution of controlled substances for the company’s warehouse in Jupiter, Fla., sent an email on Jan. 10, 2011, to corporate headquarters urging that some of the stores be required to justify their large quantity of orders. “I ran a query to see how many bottles we have sent to store #3836 and we have shipped them 3271 bottles between 12/1/10 and 1/10/11,” Atwell wrote. [A bottle sent by a wholesaler generally contains 100 doses.] “I don’t know how they can even house this many bottle[s] to be honest. How do we go about checking the validity of these orders?” Walgreens never checked, the DEA said. Between April 2010 and February 2012, the Jupiter distribution center sent 13.7 million oxycodone doses to six Florida stores, records show — many times the norm, the DEA said. In March 2011, the situation became so alarming at two Walgreens drugstores in the small town of Oviedo, Fla., that Police Chief Jeffrey Chudnow wrote to the company’s top executives, Alan G. McNally, who was chairman; and Gregory D. Wasson, then the president and chief executive. Chudnow asked that they prohibit Walgreens pharmacists from filling orders where the quantities of narcotics were split over two prescriptions. “These types of prescriptions overtly denote misuse and possible street sales of these drugs,” Chudnow wrote. He said he never heard back from the executives. In 2012, the DEA launched a six-month investigation of Walgreens’s Jupiter facility. The probe found that Walgreens failed to maintain an effective system for detecting suspicious orders or reporting them to the DEA. Even when suspicious orders were identified, the warehouse often shipped the drugs anyway, without making inquiries, the DEA said in court papers. A company spokesman said Walgreens would have no comment on the case. Walgreens settled with the DEA in 2013, agreeing to pay an $80 million fine — a record for a diversion case at the time. The company acknowledged that its “suspicious order reporting for distribution to certain pharmacies did not meet the standards identified by DEA.” In 2013, DEA officials at the agency’s headquarters began requiring a higher burden of proof before investigators in the field could take enforcement action. One case that was underway became entangled in that shift, according to interviews and records. Beginning in 2011, the DEA had repeatedly warned Miami-Luken, an Ohio-based distributor, about suspicious sales of opioids, according to Jim Geldhof, then the agency’s program manager in Detroit. “We went to management of the company and told them they have to look at their sales. They are pretty extraordinary,” said Geldhof, who retired in January after more than four decades with the agency. “We spoke to them on multiple occasions, and we were pretty much ignored.” Yet investigators couldn’t persuade lawyers at DEA headquarters to allow them to take action. Geldhof said orders to show cause that he requested in 2013 were not issued until November 2015. “It sat there for two years. I don’t know why there was a delay,” Geldhof said. “We went back and forth. The ball was always moving. We had all of this going on, overdose deaths, what part of this are we not getting them to understand. We said, ‘You tell us what you want and we’ll give it to you.’ ” Inside Miami-Luken headquarters, employees had also seen troubling signs. Two of them sent word up the chain. A pharmaceutical buyer and a customer-service representative were concerned about large oxycodone orders by a southern Ohio pain clinic. The warnings reached senior company officials, including then-chief executive Anthony Rattini. But little changed. Cindy Willet, the senior pharmaceutical buyer, told investigators in 2015 that she eventually “stopped talking to [Rattini] about her concerns because he wasn’t doing anything about it. It was as if it was falling on deaf ears. Tony never stopped an order.” Last year, a federal grand jury indicted the Temponerases and a pharmacist on charges that they conspired to illegally sell medication, alleging that at least eight people had died of overdoses connected to the drugs. Three of those people died while the clinic was receiving drugs from Miami-Luken between November 2008 and August 2010, according to the indictment and DEA records. It is unclear whether Margy Temponeras also purchased drugs from other distributors, or whether any of those who died consumed drugs distributed by Miami-Luken. The Temponerases are scheduled to stand trial early next year. Their attorneys declined to comment. An attorney for the pharmacist, Raymond Fankell, who is also scheduled to stand trial next year, said Fankell’s involvement was limited to helping Margy Temponeras set up the dispensary in her office and to filling her prescriptions at his drugstore. During one of their interviews with Rattini, DEA investigators asked how the company documented suspicious orders. Rattini pointed to his compliance officer, who put a finger to his head. “It’s all just up here,” he said. The company said in court filings that it has purchased software to better identify suspicious orders and added staff to its compliance efforts. Its chairman, Joseph Mastandrea, intends to testify that he removed Rattini from his role supervising compliance “as DEA’s inquiries increased” and that he “realized that Mr. Rattini was not fulfilling the company’s DEA compliance obligations,” according to court filings. Rattini did not return calls seeking comment. The chairman “will accept responsibility for the company’s past failings,” the court documents state. **Unnatural causes: Sick and dying in small-town America** This story is part of a series exploring the rise in death rates among middle- aged white women and the forces driving it. Read previous stories from this series here.

Drug industry hired dozens of officials from the DEA as the agency tried to curb opioid abuse

Pharmaceutical companies that manufacture or distribute highly addictive pain pills have hired dozens of officials from the top levels of the Drug Enforcement Administration during the past decade, according to a Washington Post investigation. The hires came after the DEA launched an aggressive campaign to curb a rising opioid epidemic that has resulted in thousands of overdose deaths each year. In 2005, the DEA began to crack down on companies that were distributing inordinate numbers of pills such as oxycodone to pain-management clinics and pharmacies around the country. Since then, the pharmaceutical companies and law firms that represent them have hired at least 42 officials from the DEA — 31 of them directly from the division responsible for regulating the industry, according to work histories compiled by The Post and interviews with current and former agency officials. The number of hires has prompted some current and former government officials to ask whether the companies raided the division to hire away DEA officials who were architects of the agency’s enforcement campaign or were most responsible for enforcing the laws the firms were accused of violating. “The number of employees recruited from that division points to a deliberate strategy by the pharmaceutical industry to hire people who are the biggest headaches for them,” said John Carnevale, former director of planning for the White House’s Office of National Drug Control Policy, who now runs a consulting firm. “These people understand how DEA operates, the culture around diversion and DEA’s goals, and they can advise their clients how to stay within the guidelines.” The DEA’s Diversion Control Division, tasked with preventing prescription drugs from reaching the black market, wields enormous power within the pharmaceutical world. The small division, with about 300 employees at its Arlington, Va., headquarters, can suspend or revoke the licenses of doctors, pharmacies and pharmaceutical companies that fail to comply with federal law. From 2000 to 2015, nearly 180,000 people died of overdoses from prescription painkillers in what public health authorities have called an epidemic. States including Massachusetts, and most recently Virginia, have declared public health emergencies as the number of deaths has escalated. It is not unusual for corporations to hire federal employees directly away from the government. Their expertise and inside knowledge can be invaluable, but there are laws and regulations to slow the “revolving door” in Washington and prevent potential conflicts of interest. The restrictions include a lifetime ban on participating “personally and substantially” on a “particular matter” that the official had handled while working for the federal government. There also is a two-year ban on switching sides on a wider array of matters that were in the employee’s official purview. State bar associations impose additional post-employment restrictions for government lawyers. An industry spokesman said former DEA diversion officials are hired for their expertise. “Our industry is highly specialized, and the function of drug diversion experts even more so,” said John M. Gray, president and chief executive of the Healthcare Distribution Alliance, which represents drug distributors. “As such, for these individuals who want to continue to grow in their areas of expertise, it is logical for them to pursue government and industry roles that are closely aligned with their professional experience.” While The Post did not find evidence that the officials violated conflict-of-interest regulations, the number of hires from one key division shows how an industry can potentially blunt a government agency’s aggressive attempts at enforcement. The DEA diversion officials who have gone to the industry since 2005 include two executive assistants who managed day-to-day operations; the deputy director of the division; the deputy chief of operations; two chiefs of policy; a deputy chief of policy; the chief of investigations; and two associate chief counsels in charge of legal affairs and enforcement actions against pharmaceutical companies. “It’s obvious that they targeted the office,” said Joseph T. Rannazzisi, who ran the diversion division for a decade before he was removed from his position and retired in 2015. “If you want to understand how we were doing our investigations, the best way to do it is to take our people who are doing the investigations and put them in place in your company. It’s not difficult to understand why you would take these guys. They know the law.” Most of the DEA officials went to work for the pharmaceutical industry and law firms within weeks of leaving the agency. Among the 31 DEA diversion employees, 22 began their new jobs within weeks of leaving the DEA, according to work histories the officials posted on LinkedIn, as well as news releases and biographies published by the companies and law firms that hired them. The Post found that several high-ranking DEA supervisors from outside the diversion division also took top jobs with industry: four special agents in charge and three assistant special agents in charge of field operations in some of the nation’s largest cities, including New York, Washington and Atlanta. In responses to questions from The Post, the DEA said in a statement that former employees must follow the law and ethics regulations in taking jobs in the private sector. “Many who serve in government possess expert knowledge in a wide variety of fields. It is not uncommon for former government officials to use or rely on such expertise when they transfer to the private sector following their public sector service,” DEA spokesman Rusty Payne said in the statement. “Employees who leave DEA and other government agencies for private sector work are expected to abide by the applicable laws and ethics rules that govern their private sector activities.” At least five of the 31 DEA employees were hired by McKesson — the nation’s largest drug distributor and fifth-largest corporation. McKesson has been the subject of two publicly disclosed DEA enforcement actions, which resulted in $163 million in fines after allegations that the firm failed to report hundreds of suspicious orders for millions of pain pills from Internet pharmacies and others. “McKesson has put significant resources towards building a best-in-class controlled substance monitoring program to help identify suspicious orders and prevent prescription drug diversion in the supply chain,” the company said in a statement. “It is only natural that this team is comprised of a broad range of experts, including individuals who have spent time at DEA, as they bring deep knowledge of effective strategies to prevent diversion. Our team is deeply passionate about curbing the opioid epidemic in our country.” The Post contacted a dozen former DEA officials who went to work for the drug industry, but few agreed to be interviewed. Those who did said they followed federal ethics guidelines designed to prevent potential conflicts of interest for officials who switch from government to the industries they once regulated. “I don’t feel like I took off the white hat and put the black hat on,” said Larry P. Cote, who left as the associate chief counsel for the DEA’s diversion division in May 2012 to become a partner at the law firm Quarles & Brady. “That’s really not what’s going on. It’s trying to get the best people in place to make sure that companies are staying compliant. And frankly, that benefits the DEA as much as it benefits the companies.” At Quarles & Brady, Cote serves as co-director of the firm’s DEA Compliance and Litigation Practice Group and provides legal advice to some of the nation’s largest pharmaceutical companies. Cote said he obtained an ethics opinion from the DEA that advised him on which cases he could and could not handle in the private sector. Ethics experts said revolving-door issues have been a long-standing concern across the government, with some of the most notable cases coming from the Defense Department. President-elect Donald Trump recently criticized the revolving door at the Pentagon, saying high-ranking officials “should never be allowed to go work” for companies in the defense industry. The ethics experts said the number of officials switching sides at the DEA raises serious questions about whether the ability of the diversion division to carry out its mission has been compromised by the pharmaceutical industry. “The findings that so many DEA officials have switched from their roles preventing, detecting and investigating illegal drug use to working for those involved in the supply chain is disturbing,” said Scott H. Amey, general counsel for the Project on Government Oversight, a watchdog group in Washington. “It’s also another reminder of how well the revolving door is greased and how the revolving door can negatively impact government operations. It’s not a surprise that DEA isn’t as vigilant as it once was when so many ex-feds are working for the companies that they once investigated.” *** In 2004, DEA officials became alarmed by the increasing number of overdose deaths. The following year, the agency’s diversion division launched an initiative designed to hold distributors of narcotics accountable for the hundreds of millions of pills that were being diverted to the black market. The DEA pursued cases against some of the largest opioid distributors in the country, including McKesson, Cardinal Health and AmerisourceBergen, as well as CVS and Walgreens, which distribute opioids to their own pharmacies. In general, the companies did not admit wrongdoing and said they were taking steps to address illegal diversion. In 2008, McKesson settled one of those cases, paying a $13 million fine without admitting liability. That same year, the DEA filed a case against Cardinal. That company also settled, paying a $34 million fine. Cardinal promised to improve monitoring of its drug shipments. The DEA’s initiative was sharply curtailed in the face of pressure from the pharmaceutical industry beginning in 2013, according to a Post investigation published in October. In fiscal 2011, civil case filings against distributors, manufacturers, pharmacies and doctors had reached 131. By 2014, they had fallen to 40. The slowdown came after DEA lawyers began to require a higher standard of proof before cases could move forward. Supervisors in the field said they were frustrated that their cases were being stalled at DEA headquarters. Top DEA and Justice Department officials have declined to discuss the reasons behind the slowdown. Government ethics experts said regulators often join the industries they oversee, lured by substantially higher salaries. “That high rate of turnover makes you really wonder whether those officials were acting in the interests of the DEA rather than the companies they were regulating,” said Craig Holman, an expert on revolving-door issues for Public Citizen, a government watchdog group in Washington. “Just by seeing your colleagues going that way, that tells you that you can shape your future employment prospects if you behave accordingly.” Once senior employees leave for jobs in the industry, they are in positions to help pharmaceutical companies comply with the complex laws and regulations that govern controlled substances. But ethics experts said they also can exploit weaknesses they are aware of within the DEA. One of the key players in the DEA’s diversion initiative went to work for a law firm that represents the companies he used to regulate. D. Linden Barber, who served as associate chief counsel from 2006 to 2010, guided cases against some of the largest pharmaceutical companies in the country. In 2008, Barber’s office filed its first diversion case against Cardinal, accusing it of failing to properly monitor shipments of painkillers. Barber conducted extensive meetings with DEA attorneys assigned to the case and was deeply involved in crafting a “memorandum of agreement” to settle the allegations against Cardinal, according to a DEA document. The case resulted in the $34 million settlement with Cardinal. In September 2011, Barber, who had been serving as the DEA’s regional diversion counsel in the Midwest, left for the law firm Quarles & Brady. His colleague, Larry Cote, had taken over as associate chief counsel at DEA headquarters. The next month, the DEA served warrants seeking records from Cardinal as part of a second case against the company. Quarles & Brady’s clients include Cardinal. Seven months later, in May 2012, Cote, who helped to coordinate the second Cardinal case while at the DEA, joined Barber at Quarles & Brady, becoming the co-director of compliance and litigation. Cote had appeared in court on behalf of the DEA in the case against Cardinal three months earlier, records show. Barber said he sought advice from Roberto D. DiBella, the DEA’s ethics lawyer, before and after leaving the agency. Barber declined to say whether he asked DiBella for advice about representing Cardinal, but he said his representation of his clients complied with ethics laws. “The rules governing my work as an attorney make it inappropriate for me to discuss work I did for DEA and any other clients,” he said in a statement to The Post. “However, the records of DEA will show that I followed the rules. I never worked on a matter for DEA and then worked on the same matter for the other party. I am proud of the work I did for DEA and of the work I do in private practice for clients who want to work with DEA to stop the abuse of prescription drugs.” The DEA provided The Post with a copy of DiBella’s ethics opinion. It shows that Barber asked for guidance on his representation of Cardinal. DiBella told him that he was banned for life from representing Cardinal on any issues connected to the 2008 memorandum of agreement (MOA). “Your representation of Cardinal to address an alleged violation of the MOA would on its face appear that you switched sides on a matter that you participated in as a DEA employee,” DiBella wrote. DiBella did not respond to interview requests. The DEA said the ethics opinion was reviewed by DiBella’s supervisor to double-check the advice Barber was given. Cote said he, too, asked DiBella for an ethics opinion before leaving the agency in 2012. “I provided him with a fairly comprehensive list of the cases that I worked on,” he said in a recent interview. The DEA provided a copy of the opinion to The Post. It noted that Cote had participated “personally and substantially” in specific matters relating to at least 10 companies while he was at the DEA. It said he was banned for life from communicating with or appearing before the DEA or any other federal agency on behalf of those companies on the specific matters he handled. The companies include some of the largest drug distributors and retailers in the nation, including McKesson, AmerisourceBergen, CVS, Walgreens, Rite Aid and Walmart. Cote said he has followed the opinion, which also singled out his work for the DEA on the Cardinal case. “I did not and really have not represented Cardinal since I left DEA,” Cote said. “Our firm does do work for Cardinal, but I’ve been really walled off from it because some of these matters are still pending and I just didn’t want to go there.” Josephine Peterson contributed to this report. She is attached to The Post’s investigative unit through a program at American University.

In first hearing, GOP panel casts doubt on fetal tissue research

Republicans on the special House panel investigating fetal tissue procurement and research practices aggressively questioned the morality and necessity of that research in the panel’s first hearing Wednesday, while Democrats sought to portray the probe as a politically motivated witchhunt. The Select Investigative Panel, created by Republican leaders last year following the release of undercover videos produced by anti-abortion activists, gaveled to order in an underground Capitol hearing room while, just across the street, the Supreme Court heard arguments in the most closely watched abortion case in 24 years.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Wednesday’s hearing was set to explore the ethical implications of using fetal tissue in biomedical research but before the panel heard from six expert witnesses — four selected by Republicans and two by Democrats– members clashed over the series of document requests Republicans made to more than 30 entities. Those requests, made by subpoena in some cases, include demands for names of researchers, technicians and medical personnel involved in fetal tissue handling. [ _Dozens of groups targeted as House fetal tissue probe accelerates_ ]    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Rep. Jan Schakowsky (D-Ill.), the panel’s ranking Democrat, said the decision by chairwoman Marsha Blackburn (R-Tenn.) to subpoena the names was an “abuse of her position” that is “frankly reminiscent of Sen. Joe McCarthy’s abusive tactics.” She noted the November shooting at a Colorado Planned Parenthood clinic, where the gunman used the phrase “no more baby parts” to explain his actions after killing three. “Linking individual’s names to an investigation that the Republicans describe as examining the ‘harvesting of baby body parts’ and the ‘horrific practices’ of abortion providers puts people in danger,” she said. “Our words and our actions matter.” Blackburn replied that the panel is “entitled to the information,” and a Democratic motion to quash the three subpoenas issued thus far was defeated on a party-line vote. The panel emerged from the controversy created last year by undercover videos taken of Planned Parenthood officials talking about the use of fetal tissue, which anti-abortion activists alleged the officials were illegally attempting to sell. Conservative House members nearly ground the 2015 budget process to a halt – in the process ousting then-Speaker John Boehner (R-Ohio) – over their demands that federal funding be stripped from the group because it performs some abortions. Several state investigations have found no wrongdoing by Planned Parenthood, and the House panel has not yet sought documents or testimony from the organization. However, the panel’s brief has greatly expanded: Blackburn’s own statements Wednesday, as well as the testimony of the four GOP-invited witnesses, appeared to be the beginnings of a case for broad new restrictions on the research use of aborted fetuses. “There should be no doubt that the use of cadaveric fetal organs and tissue for research and clinical applications raises serious moral and ethical concerns, concerns that are heightened when the organs and tissue are obtained as the result of elective abortion,” read the prepared testimony of one witness, Paige Comstock Cunningham of Trinity International University.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Another witness, Patrick Lee of the Franciscan University of Steubenville, testified that not only is it “unjust for the government to fund or encourage elective abortions” and to allow the use of fetal tissue resulting from those abortions, but that women who have abortions should have no option to donate their fetus: “Women who choose to have direct abortions by that act forfeit the moral standing needed for being a proxy decision-maker in regard to the disposition of their baby’s remains.”    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Blackburn said in a Feb. 10 interview that the panel would take a broad look at the state of medical research, the practices of fetal tissue procurement, and the ethical dimensions at their intersection. “It’s time for us to sit down and look at the changes and what has happened with research and see what a way forward ought to be,” she said. “When you go back and you look at the history of it, you realize, yeah, it’s been a while since we have looked at this.” The effort could inject bioethics into politics e to a degree not seen in more than a decade, after President George W. Bush strictly limited federal funding for embryonic stem-cell research — a decision which emerged as a significant issue during his 2004 re-election campaign. Blackburn suggested in the interview that recent medical advances are mostly due to research involving adult stem cells and that the panel’s review might conclude that the use of fresh fetal tissue is not scientifically necessary. Several of the Republican-invited witnesses on Wednesday cast doubt on the necessity of fetal tissue research. G. Kevin Donovan of the Georgetown University School of Medicine, for instance, said that tissue might be harvested from spontaneous miscarriages, thus avoiding the moral implications of using aborted fetuses. Kathleen M. Schmainda of the Medical College of Wisconsin said the research potential of fetal tissue experiments was “largely overexaggerated,” noting that only 0.25 percent of the National Institutes of Health research budget funded fetal-tissue experiments. “This is not going to change the direction of science,” she said. Donovan told the panel that “not all scientific experimentation has been praiseworthy” and mentioned the medical experimentation of Nazi doctor Josef Mengele and the Tuskegee syphilis experiments. “No one would want to associate our current scientific studies involving the human fetus with such egregious breaches of research ethics,” he said. Donovan was later pressed by Rep. Diana DeGette (D-Colo.) on whether he considered contemporary fetal tissue research to be morally equivalent to those infamous experiments. “I think that we need to be very careful so that we don’t do that,” Donovan replied. “Do you think that they are equal, yes or no?” DeGette asked. “Maybe,” Donovan said. The witnesses invited by Democrats refuted the idea that fetal tissue is either unnecessary or ethically problematic. That position also won support in a Tuesday letter to the panel from the American Academy of Pediatrics, which wrote that it “strongly supports continued federal funding for fetal tissue research” based on “the substantial historical and future potential benefit on child health.” Lawrence S.B. Goldstein of the University of California San Diego, who testified on behalf of the American Society for Cell Biology and the International Society for Stem Cell Research, prepared this testimony: “My message is simple: fetal tissue and cells that would otherwise be discarded play a vital role in modern cutting edge medical research. These fetal tissues and cells cannot be replaced by embryonic stem cells, reprogrammed stem cells, or adult stem cells.”    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Goldstein cited ongoing research into potential therapies for Alzheimer’s disease and spinal cord injuries, as well as efforts to grow new kidneys: “We need all different types of cells to do research, because we don’t know what is best.” While much of the hearing focused on the larger implications of that research, some Republicans concentrated on the particular practices of those handling that tissue — previewing what is likely to be an ongoing line of GOP inquiry. Republicans highlighted several documents they obtained through their investigation, including an April 2014 email between undisclosed parties discussing a researcher’s need for a “first trimester human embryo, preferably around 8 weeks, and up to 10 weeks gestation.” Rep. Diane Black (R-Tenn.) suggested the email was evidence “there effectively is an Amazon.com for human parts, including entire babies.” “This is not dignity,” she said. “This is not respect for human life.” One of the Democratic witnesses, R. Alta Charo, a bioethics professor at the University of Wisconsin at Madison, said the language in the email was the “same kind of clinical, dispassionate language” typically used in medical research on human tissue. The timing of Wednesday’s hearing also emerged as a partisan issue. Not only did it coincide with the closely watched Supreme Court argument, but it also conflicted with a House hearing on the government’s response to the Zika virus. Top government officials from the Centers for Disease Control and Prevention, the National Institutes of Health and the Department of Health and Human Services testified. The Select Panel’s Democrats asked Blackburn last month to reschedule the fetal tissue hearing so they could attend the hearing on Zika, which has been linked to infant microcephaly, a devastating birth defect. In a letter to Blackburn, Rep. Jan Schakowsky (D-Ill.), the Select Panel’s top Democrat, noted the Republican practice of referring to the committee as the “Select Panel on Infant Lives.” “Given the disproportionate and devastating impact of the virus on women and infants, having our members fully engaged and participating in congressional work on Zika should be a shared interest for all of us,” Schakowsky wrote. “Indeed, it would be unfortunate if members of the Select Panel were unable to attend a hearing on a matter with such clear, negative impact on infants.” The hearing was not rescheduled. Schakowsky asked Goldstein on Wednesday if new restrictions on fetal tissue research would delay a vaccine or cure for  Zika or  microcephaly. Goldstein said any crackdown on the research would “absolutely delay” efforts to address Zika. “If you want to understand the Zika virus, the most efficient place to start is with the fetal tissue that is infected,” he said. “I think you have to go to the source if you want to understand what’s going wrong.”

White House opioid commission to Trump: ‘Declare a national emergency’ on drug overdoses

“With approximately 142 Americans dying every day,” the report notes, “America is enduring a death toll equal to September 11th every three weeks.” The commission, led by New Jersey Gov. Chris Christie, states that the goals of such a declaration would be to “force Congress to focus on funding” and to “awaken every American to this simple fact: if this scourge has not found you or your family yet, without bold action by everyone, it soon will.”  Prescription overdose deaths began to rise in the mid-2000, following aggressive marketing and widespread prescribing of the drugs starting in the late 1990s. In response, state and federal authorities began cracking down on prescription opiate availability, introducing “abuse-deterrent” formulations, tighter prescribing guidelines and operations targeting “pill mills” that made the drugs widely available.  In his inaugural address, President Trump cited “drugs that have stolen too many lives and robbed our country of so much unrealized potential,” vowing that “this American carnage stops right here and stops right now.” Trump established the opioid commission to study the issue in March, with a mandate to “study ways to combat and treat the scourge of drug abuse, addiction, and the opioid crisis.” In addition to declaring a national emergency, the commission's first report includes a number of recommendations that public health experts and drug policy reformers have been advocating for years. They include:  “The interim report is mostly appropriately focused around dealing with the opioid crisis as the health issue that it is,” said Grant W. Smith of the Drug Policy Alliance, a group that advocates for a more public health-centered approach to drug issues. “It offers a sharp contrast to the overall approach that the Trump administration has been taking to escalate the war on drugs.”  The commission's report repeatedly addresses the president directly and encourages him to use his bully pulpit to raise awareness of the issue. “Our country needs you, Mr. President,” it concludes. “We know you care deeply about this issue. We also know that you will use the authority of your office to deal with our nation’s problems.”

181 Democrats join call to end House fetal-tissue probe

All but a handful of House Democrats are calling on Speaker Paul D. Ryan to disband the special committee established last year to probe connections between abortion providers and medical researchers, accusing the panel of “continued abuses which jeopardize the integrity of the House and the safety of Americans.”  The new letter, signed by 181 of 188 House Democrats, raises the protests to a new level, asking Ryan (R-Wis.) for a written response to their accusations of harassment, intimidation and McCarthyism on the part of the panel’s Republican members and staff. “Speaker Ryan is the speaker of the whole House,” said Rep. Diana DeGette (D-Colo.), a Select Panel member. “It’s job of the speaker to maintain some level of decorum in the House, and if the speaker finds out that a select committee that has been appointed by his predecessor and supported by him is on a partisan witchhunt, he needs to stop it.” DeGette and Rep. Louise Slaughter (D-N.Y.), who are co-chairs of the Congressional Pro-Choice Caucus, gathered support for the letter, along with Rep. Jan Schakowsky (D-Ill.), the ranking Democrat on Select Panel. In his nearly six months as speaker, Ryan has quietly expressed support for the panel and its chairwoman, Rep. Marsha Blackburn (R-Tenn.), as it has issued subpoenas to abortion providers, research institutions and other entities involved in fetal-tissue procurement. A spokeswoman for Ryan responded to a previous call for the panel’s demise with a brief statement of support: “Speaker Ryan supports the Select Committee’s continued efforts to protect infant lives.” AshLee Strong, the spokeswoman, said Tuesday her previous comment applied to the new letter as well. DeGette said she tried to raise the matter directly with Ryan at a charity event both attended last week: “He said, ‘Now is not the time to talk about this.'” The letter is asking Ryan for a written response by June 6, and DeGette said she is seeking a meeting with Ryan about the panel. Earlier this month, House Minority Leader Nancy Pelosi (D-Calif.) said the panel was “engaged in abuses that have not been seen on Capitol Hill since the days of Joseph McCarthy,” referencing the disgraced former senator who waged a scorched-earth search for communists in the federal government. The panel’s requests for names of researchers and other personnel, Pelosi and other Democrats say, amounts to a similar effort at political intimidation. “To this day, the Panel still lacks credible evidence to support its case that any federal laws were broken,” the new letter reads. “Yet the Chair and majority staff continue to harass individuals, researchers, clinics, and health care facilities, issuing a total of 35 subpoenas so far, often without reaching out to the subject of the subpoena to ask for voluntary compliance first or without giving subjects sufficient time to comply. Congress simply has no business ‘prosecuting’ these unfounded allegations.” The panel issued subpoenas this month targeting LeRoy Carhart, a late-term abortion specialist who has long been been a target of antiabortion activists, Carhart’s clinic in Germantown, Md., and various entities involved in the response to the 2013 death of a 29-year-old woman at the clinic. Three Maryland state agencies found no wrongdoing in the incident.  Responding to a previous call for the panel’s disbanding, Blackburn spokesman Mike Reynard said the panel is focused on determining whether human fetal tissue is being sold on contravention of federal law: “While the majority members of the Panel are busy pursuing those records, all that can be heard from the Democrats is the same old tired rhetoric designed to distract from getting to the truth.” DeGette said the panel’s conduct has become a “public safety issue,” citing the November shooting at a Planned Parenthood clinic in Colorado, which left three dead and nine injured at the hands of a mentally ill man who made reference to “baby parts” in interviews with authorities. “Despite this horrific event, the same inflammatory language has been used repeatedly during Panel hearings, in communications with the press, and in other documents,” the letter reads, before imploring Ryan to step in: “The onus is on you to put an end to this witch hunt. You cannot continue to turn a blind eye to the serious risks presented by the Panel and still claim to fulfill your responsibilities as Speaker.”

House passes opioid bills, setting up negotiations with the Senate

The House on Friday passed legislation to combat heroin and painkiller abuse, setting up potentially tense negotiations with the Senate on an issue lawmakers are eager to show voters they can address ahead of November’s election. The country’s worsening opioid abuse crisis captured the attention of politicians across the political spectrum this year, kicking into high-gear a congressional effort to tackle the epidemic through grants to local governments focused on improving education, treatment and recovery programs aimed at helping addicts and preventing those at risk from becoming addicts. The stakes have been particularly high for a handful of vulnerable Republicans facing difficult reelection battles in places like Ohio, New Hampshire, New York and Illinois where the opioid crisis is particularly acute. There have been tensions between some House and Senate Republicans over how each chamber has been addressing the issue. Sen. Rob Portman (R-Ohio), co-author of the opioid bill the Senate passed two months ago, has been particularly critical about the House approach, which took longer and was more wide-ranging than the Senate bill. The legislative package the House passed on Friday was comprised of 18 bills. “While I remain concerned that the House approach is not truly comprehensive I am hopeful we can resolve our differences rather quickly,” Portman said in a statement Friday. Senators and advocates have expressed concerns that the grant rules in the House’s package will not guarantee that state and local governments address all aspects of the opioid crisis. But the House maintains that their broader slate of bills, pulled together through a bipartisan task force jointly led by Rep. Frank Guinta (R-N.H.), who also faces an uphill reelection battle, was the better approach. “This unique problem requires a comprehensive coalition, and a multipronged solution,” said Rep. Hal Rogers (R-Ky.), who has campaigned for opioid legislation for several years. “There is no silver bullet.” Each of the bills in the House package passed with bipartisan support, and members supported the final package on a near unanimous 400 to 5 vote. With such overwhelming support, the chances of striking a compromise are high. But the opioid debate is unlikely to end once lawmakers produce a mutually agreeable bill. Neither the House nor the Senate bill provides additional funding to address the crisis through the new grant programs they would create. Democrats, including President Obama, insist that without extra funding, the measures are insufficient. Democrats are already taking that complaint to the campaign trail.

GOP congresswoman meets with Trump as fetal tissue investigation moves to a close

President-elect Donald Trump met Tuesday with the chairwoman of a controversial congressional committee that has spent a year probing links between abortion providers and medical investigators and is expected to issue a report in the coming weeks that could call for new curbs on research using fetal tissue.  Blackburn said in a statement released by her office Monday that she expected “to discuss a broad range of policy issues, the transition, and to continue helping him choose the best people for his administration” during her visit with Trump. “It was an honor to be a surrogate for Mr. Trump during his hard-fought campaign and to subsequently be asked to serve on the Executive Committee for his Transition Team,” she said. After the morning meeting, Blackburn told reporters she “had a great visit.” Not mentioned was the Select Panel, whose authority will expire when the Congress adjourns next month and thus must finish its work as soon as next week. The panel has held two public hearings and has issued subpoenas to numerous organizations, ranging from abortion providers to research institutions to “procurement entities” that arrange transfers of fetal tissue. The panel’s Republicans have aggressively questioned whether groups are illegally profiting from transactions involving tissue from aborted fetuses and whether the research involving that tissue should be considered “mainstream” science. The minority Democrats, meanwhile, have cast the investigation as an ideological “witch hunt” aimed at undermining legal abortion providers and intimidating researchers who are pursuing life-saving medical cures. “You have these precious children that are aborted and then these parts are being sold,” Blackburn told The Washington Post in February as the panel started its work. “People want to give this a good and thorough look.” In the hearings, subpoenas and referrals to outside authorities, panel Republicans have indicated they are interested in at least two particular areas. One is the relationship between researchers at the University of New Mexico and an Albuquerque abortion provider, Southwest Women’s Options — that matter was referred to New Mexico’s attorney general for criminal prosecution for alleged violations of the state’s anatomical gift act. Both the university and the clinic have denied any wrongdoing. An interim report from panel Republicans identified four other universities with relationships with abortion providers.   In September, the panel voted on party lines to recommend contempt charges for StemExpress and its chief executive, Cate Dyer, for not complying with a panel subpoena. That measure has not advanced to the House floor. But the election of Trump, along with GOP congressional majorities, has transformed the ability of Republicans to act on the Select Panel’s recommendations. The panel’s jurisdiction does not allow it to directly write legislation, but it can make suggestions to other standing House committees on changes to federal laws and regulations. One key provision it might propose altering is a federal law making it “unlawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration” — in other words, selling fetal tissue for profit. But the law makes exceptions for “reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage,” and the panel could recommend tightening or eliminating those exceptions. The panel could also suggest an expansion of the Hyde Amendment, the provision banning taxpayer funding for abortions that has been attached to government spending bills since 1976, to prohibit federal funding for research involving the aborted fetal remains. Federal regulations on research ethics oversight and patient consent could also be questioned. Democrats, meanwhile, are preparing their own report, documenting the benefits of medical research involving fetal tissue and the alleged abuses of panel Republicans. Rep. Jan Schakowsky (D-Ill.), the panel’s top Democrat, said last week the public could be surprised by the scope of the recommendations made by Select Panel Republicans. “It is the law of the land that abortion is legal, and they treat everyone who’s engaged in really positive activities like Planned Parenthood, like scientists, as criminals,” she said. “We’re going to push back as hard as we can in the House. We do hopefully have somewhat of a firewall in the Senate. We’ll see. And do everything we can to mobilize outside forces who support our positions to call on their legislators, call on their senators, call on the president not to set this country back.”

Number of U.S. railroad workers testing positive for drug use skyrockets

Early this year, a railroad worker who had just been briefed on his duties for the day was discovered in a restroom, dead from an overdose of illegal prescription drugs. In the months that followed, tests conducted after three railroad accidents resulted in six employees testing positive for drugs. Testing in 2016 has shown that nearly 8 percent of workers involved in rail accidents were positive for drug use, including marijuana, cocaine, ecstasy, benzodiazepine, OxyContin and morphine, according to internal federal documents obtained by The Washington Post. The number of post-accident drug-positives was the highest since the Federal Railroad Administration (FRA) began keeping records in 1987 and three times greater than it was 10 years ago. Overall, the number of railway workers — including engineers, train crew and dispatchers — who tested positive for drug use in random tests soared 43 percent last year, the documents show. The number rose to 256 last year from 2014. After rail accidents in 2014, no one tested positive for drugs, and just two people did last year. With more than three months left in this year, 16 rail workers have shown positive in post-accident tests. Railroads transported 565 million passengers and 14.2 million carloads of freight last year. Their workers rank among the most heavily drug-tested employees in the country, faced with drug screening before they are hired, random on-the-job testing and another round of testing every time they make a significant mistake. But after several years in which heroin and illegal opioid use has increased in the general population, there is hard evidence that the use of those and other drugs may be on the rise in the railroad industry. Faced with the initial positive test results, federal regulators began sounding an alarm this spring. This month, the heads of all of the nation’s freight and passenger rail lines were summoned to Washington for a closed-door session to deal with a crisis that federal officials fear has put workers and train travelers at risk. Officials from the FRA, National Transportation Safety Board and the Office of National Drug Control Policy spelled out their concerns and asked the railroads to help them address the growing problem. This week they had a similar private session with railroad unions. “We’ve discussed in depth the kind of data that we are seeing, the uptick in positive post-accident tests, the significant rise in positives in our random testing pool,” FRA Administrator Sarah E. Feinberg said in remarks prepared for the Railroad Safety Advisory Committee on Thursday. “We are seeing a trend going in the wrong direction, and we must address it immediately.” The popularity of illegal prescription drugs and heroin has increased dramatically in recent years, with some analysts suggesting that efforts to crack down on illegal prescriptions have encouraged addicts to use heroin instead. A record 28,647 people died from heroin and prescription opioid use in 2014, according to the Centers for Disease Control and Prevention, and opioids caused more than 6 in 10 overdose fatalities. The CDC said deaths by powerful synthetic opioids such as fentanyl rose by more than 80 percent. Overall, 47,055 people died from drug overdoses in 2014, the CDC said. Despite drug testing protocols, transportation workers are as susceptible to trends as the rest of society. The U.S. Department of Transportation drug-tests about 7 million people who hold commercial driver’s licenses, as well as railroad and transit workers, and the U.S. Coast Guard. In the past five years, the DOT tests have shown sharp increases in use of amphetamines and natural opiates. Among the railroad workers subject to random testing, however, the approximately 50,000 tests each year had shown no appreciable increase since 2009. Then they shot up by 43 percent last year. What’s more, the number of railroad workers found to be positive for drugs in the aftermath of rail accidents jumped dramatically this year. “We know that the country is struggling with an opioid epidemic — and there is no reason why our industry would be immune from an epidemic affecting the entire country,” Feinberg said. “Workers who are struggling with addiction need, and deserve, our help. Workers who are intoxicated on the job are a danger to themselves, other workers, passengers, and anyone else who may cross paths with a train.” Among the estimated 25,000 railroad workers who repair train engines and rail cars, FRA testing found that alcohol use was five times higher than among railway workers who performed other tasks. Railroad drug testing is limited to about 120,000 workers who are considered “safety sensitive” — those whose performance puts lives at risk. The train-repair workers and about 70 percent of the 37,000 workers who maintain track beds and railroad right-of-ways are not required to undergo the same drug testing. Alarmed by the overall increase in drug use, Feinberg in May finalized a new rule that would require “maintenance of way workers,” as the track workers are known, to undergo the same random drug testing as other workers. The railroads, however, are resisting the proposed rule, which is scheduled to take effect April 1. They have petitioned to delay the testing for an additional 14 months, contending it will require “training supervisors on the signs and symptoms” of drug use. The Association of American Railroads (AAR), which joined regional railroads, railroad construction and transit firms in petitioning for the extension, said the freight railroads it represents would meet the April 1 deadline for testing maintenance workers it employs. “This is an issue that is evident throughout today’s society that requires attention, and the freight rail industry is ready to work with the FRA to further enhance the safety of the nation’s rail network,” AAR spokesman Ed Greenberg said. “Freight railroads not only comply with federally mandated drug and alcohol testing regulations, but go beyond those measures with stringent railroad-specific programs,” Greenberg said. “That said, the freight rail industry recognizes the seriousness of this situation and will work together with the FRA to make the rail system even safer, including supporting the expansion of testing to include items such as synthetic opioids.” Officials said Feinberg views any delay in implementing the rule as unacceptable. The FRA and the railroads it regulates have been in the forefront of drug testing since 1987, when an Amtrak train collided with three Conrail freight locomotives linked together just north of Baltimore. The engineer and 15 others on the Amtrak train were killed; 174 other people on the trains were injured. Investigators determined that the engineer of the Conrail train and his brakeman had shared a marijuana joint as they made their way from the rail yard. The engineer, Ricky Lynn Gates, was convicted on state and federal charges and served four years in prison. In 1993, he told the Baltimore Sun that smoking marijuana was the cause of the crash and that it was not the first time he had done it on the job. The FRA moved quickly in the aftermath of the crash to implement a drug-testing program for railroad workers. Less than four years later, Congress took the next step, requiring drug testing for “safety sensitive” workers in all industries regulated by the U.S. Department of Transportation.

Democrats walk out before House fetal tissue panel approves contempt measure

Republican members of a special House committee investigating fetal-tissue transactions voted Wednesday to hold a biotechnology firm in contempt of Congress, moments after Democrats walked out of the Capitol Hill meeting in protest. The Select Investigative Panel, created by the House GOP to examine links between abortion providers and medical researchers, subpoenaed California-based StemExpress earlier this year seeking a variety of records. While the firm provided much of the information the panel sought, Republicans say it did not cooperate completely, withholding employee names as well as banking and accounting statements. The panel’s chairman said Wednesday that the records are crucial to determining whether StemExpress is illegally profiting from the fetal tissue trade. The company has said it loses money on those transactions. “The panel is entitled to this information so we can answer the question. … Did companies improperly profit?” said Rep. Marsha Blackburn (R-Tenn.). “A subpoena is not a suggestion. It is a lawful order, and a subpoena is to be complied with.” Democrats, who opposed the panel’s creation and have called for its shuttering, renewed their objections to the Republican inquiry at the Wednesday meeting. They raised several procedural and substantive objections to the contempt-of-Congress resolution and ultimately walked out of the meeting before the final vote after an unsuccessful attempt to adjourn the meeting. “This whole process is illegitimate, and we are not willing to participate in it,” Rep. Jan Schakowsky (D-Ill.), the panel’s top Democrat, told reporters afterward. Another panel member, Rep. Diana DeGette (D-Colo.), called the proceeding a “kangaroo court.” The next steps for the contempt resolution are unclear. The full House would have to approve the measure before it is referred to the Justice Department for prosecution. After the vote Wednesday, Blackburn said that “we will leave that for leadership to decide.” Democrats said that because the panel is officially an Energy and Commerce subcommittee, the full committee would need to approve the contempt measure before it moves to the House floor. The House last passed a contempt-of-Congress resolution in 2014, after former Internal Revenue Service official Lois Lerner declined to testify before a House committee. Republicans said that StemExpress’s unwillingness to share the records they sought suggested possible wrongdoing: “There is obviously something that is being hidden here,” said Rep. Diane Black (R-Tenn.). “What payment have they received that they don’t want us to see?” added Rep. Sean Duffy (R-Wis.). But StemExpress said that they have cooperated with the probe and have been willing to cooperate further. “This is a disappointing outcome after spending over a year providing accounting documents and offering to testify — an offer they never took us up on,” the company said in a statement Wednesday. “The claim that we did not provide bank records is simply not true. StemExpress continues to be devoted to the acceleration of cures and prevention of serious medical conditions.”

Senators ask for DEA data in wake of Washington Post investigation

Two senators asked Attorney General Loretta E. Lynch Wednesday to explain a sharp drop in the number of enforcement actions against large pharmaceutical distributors and others by the Drug Enforcement Administration. Sen. Patrick J. Leahy (D-Vt.) and Sen. Ron Wyden (D-Ore.) requested a wide variety of information about cases brought by DEA’s Diversion Control Division in the wake of a Washington Post investigation published over the weekend. The DEA division enforces laws written to prevent the diversion of opioid painkillers to the black market, where they can fall into the hands of substance abusers and drug dealers. The senators’ four-page letter asks Lynch to explain why the office has filed few administrative charges in recent years, whether a law approved by Congress earlier this year has hamstrung the diversion division and what standard the DEA uses before deciding to take an enforcement action. The senators also asked for more information about a 2015 settlement with pharmaceutical giant McKesson that has remained largely confidential aside from the company’s disclosure in federal filings that it would pay a $150 million fine for its actions. And the lawmakers asked why no fine has been levied against Cardinal Health, another major distributor, despite a settlement in a diversion case against the company in 2012. The senators singled out a drop in cases from 131 in 2011 to 40 in 2014. “This startling decrease in enforcement activity occurred just as our nation began to confront the scope of the opioid epidemic — and just as the over-prescription of powerful opioid painkillers was recognized as a major driver of the crisis,” Leahy and Wyden wrote. About 165,000 people have died of painkiller overdoses between 2000 and 2014. Leahy is the ranking Democrat of the Senate Judiciary Committee, which oversees criminal justice and drug enforcement policy. Wyden is the ranking Democrat of the Senate Finance Committee, which oversees the Medicare and Medicaid programs. By 2020, Leahy and Wyden wrote, public and private spending on substance abuse treatment is expected to reach $42.1 billion, and Medicare and Medicaid will account for a third of that spending. Justice Department spokesman Peter Carr said, “We will review the letter.” The Post reported Sunday that, beginning in 2013, DEA lawyers started to delay and block enforcement efforts against large opioid distributors and others, requiring investigators in the field to meet a much higher burden of proof before they could take action. The slowdown came despite the continued high death toll from overdoses of prescription narcotics that has plagued the country for years. Five former DEA supervisors told The Post that they were alarmed and frustrated by the sharp drop in enforcement actions. The supervisors’ concerns were echoed in reports filed by the DEA’s chief administrative law judge that were obtained by The Post under the Freedom of Information Act. Investigators said they unsuccessfully confronted Clifford Lee Reeves II, the attorney in charge of the DEA unit that approves administrative cases against people and companies suspected of diverting painkillers to the black market. “It was like he was on their side, not ours,” said Jim Geldhof, the diversion program manager in the Detroit field office when Reeves took over in late 2012. “I don’t know what his motive was, but we had people dying. You’d think he’d be more aggressive. We were in the throes of a major pill epidemic.” The former head of the diversion office, Joseph T. Rannazzisi, said he was summoned to an unusual meeting in 2012 with then-Deputy Attorney General James M. Cole. Rannazzisi said the meeting came during an investigation of Cardinal Health and CVS Health, and he said he was and chastised “for going after industry.” Cole told The Post he was trying to ensure that Rannazzisi was getting all of the facts from the companies. Rannazzisi was replaced in 2015 and retired from DEA later that year. After stories appeared in The Post, acting DEA Administrator Chuck Rosenberg sent an agency-wide message. “Recent articles in The Washington Post criticized our historical management of administrative diversion cases,” the message read. “Are there things we need to fix? You bet. We can — and should — learn from fair and thoughtful criticism. Such criticism can be painful, but we ignore it at our peril. . . . “What we simply cannot do is impugn the integrity and motives of those people with whom we argue or disagree. The personalization of professional disagreements is unfair and corrosive. I was appalled that some people thought it ok to attack the integrity and motives of their former colleagues.” ****

‘We can do more,’ FDA says in announcing overhaul of approach to opioid painkillers

The Food and Drug Administration, which has been criticized as too willing to approve addictive narcotic painkillers and too slow to fight their abuse and overuse, said Thursday that it will overhaul policies addressing the powerful class of drugs. The announcement comes amid an epidemic of prescription drug and heroin overdoses, which now kill more Americans each year than automobile accidents. The problem has become a key issue in the presidential campaign and among lawmakers on Capitol Hill, where at least one U.S. senator -- Edward Markey of Massachusetts -- has vowed to block the confirmation of President Obama's nominee to lead the FDA until the agency takes greater action. "We're not doing this directly because of Sen. Markey," Robert Califf, the currently stalled nominee, told reporters in a call. But, he added, "It's fair to say we heard what Congress had to say. ... They are reflecting the concerns of the American people." Califf said the changes followed an assessment in which agency officials agreed that "we can do more" to combat the public health crises stemming from opioid and heroin abuse. The FDA plans to convene an outside advisory committee to seek advice before approving any new opioid medication that does not have "abuse-deterrent" properties. It also will convene a separate pediatric advisory committee to examine any proposed labeling changes that relate to children; last year, the FDA approved the use of OxyContin in children as young as 11 without seeking such input. Officials said they will strengthen follow-up studies to provide more insight about the safety and effectiveness of opioids' long-term use and, in an effort to curb over-prescribing, will aim to increase the number of doctors who receive training about them. In addition, the agency will encourage development of more painkillers that are difficult to crush, break or dissolve -- common tactics for people trying to ingest large amounts quickly by snorting or injecting a drug. And it will try to widen access to treatments such as naloxone, a drug that can quickly counteract the effects of heroin or opioid overdose. Andrew Kolodny, director of Physicians for Responsible Opioid Prescribing and a frequent critic of the FDA's response to the opioid epidemic, doubts the agency's proposed changes will have much impact. "I think the key driver behind FDA’s announcement is public relations," Kolodny said in an email. "They’ve been getting beat up for their opioid decisions -- with good reason." Kolodny said the agency should hold advisory meetings for all opioid-related decisions, not just for new drugs that lack abuse-deterrent properties. While glad the agency plans to strengthen warning labels on immediate-release opioids, he said he doubts its moves will be specific and aggressive enough to meaningfully alter prescribing habits. But if the FDA truly changes its risk-benefit analysis when considering the powerful painkillers, that could prove significant, he said. "But that's a big if." In a statement Thursday, Markey called the agency's proposed changes "a good start," but said it needed to go further and hold public advisory committee hearings around any kind of opioid approval decision. Until the agency commits to doing that, he said, "I will continue my hold on Dr. Califf's nomination." *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico The Centers for Disease Control and Prevention reported recently that the 28,647 deaths from prescription opioids and heroin in 2014 were a record. The agency said that more than six in 10 drug overdose deaths were caused by opioids that year. West Virginia, New Mexico, New Hampshire, Kentucky and Ohio had the highest rates of drug overdose deaths per 100,000 people in 2014. North Dakota, New Hampshire, Maine, New Mexico and Alabama saw the largest increases in their death rates. In recent years, government officials at the federal, state and local levels have devoted new resources to cracking down on illegal drug trafficking and, more broadly, to distributing naloxone. The Obama administration announced new "public health-public safety partnerships" in areas plagued by drug overdoses, moved to increase access to treatment and took steps to better train doctors who prescribe prescription painkillers. This week, the White House proposed more than $1 billion in new spending for an array of federal and state programs to offer expanded access to treatment for the millions of Americans hooked on opioid painkillers and heroin. The FDA itself has been faulted. Its approval last year of OxyContin -- an extended-release form of the painkiller oxycodone -- for certain pediatric use was welcomed by some pediatricians and pain specialists but provoked anger on social media and among some lawmakers. Though the agency restricted the drug to children 11 and older who need “daily, round-the-clock, long-term” relief from pain that can’t be treated adequately with other medications, critics accused it of acting irresponsibly. Sen. Joe Manchin III (D-W.Va.), whose state has been especially hard hit by the epidemic of prescription drug and heroin abuse, wrote a scathing letter telling the FDA it “should be absolutely ashamed of itself for this reckless act.” Like Markey, Manchin has threatened to hold up Califf's nomination.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Democratic presidential candidate Hillary Clinton called the decision "absolutely incomprehensible." The FDA, in its defense, said the drug's approval wasn’t intended to expand the use opioids in children but to instead give doctors better guidelines about how to use OxyContin safely in pediatric patients. Doctors can already prescribe medications any way they see fit, and many physicians have long given potent painkillers “off label” to children suffering from cancer, major surgeries or other trauma, the agency said. _This post has been updated._    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico READ MORE: Deaths from opioid overdoses set a record in 2014    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico CDC urge doctors to curb opioid prescriptions: “The risks are addiction and death, and the benefits are unproven.”    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Three senators now holding up FDA nominee — for three different reasons    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico

Senator to investigate opioid makers’ role in drug crisis

Sen. Claire McCaskill of Missouri demanded information Tuesday from five top opioid manufacturers, saying she would investigate their alleged role in the drug epidemic responsible for more than 200,000 overdose deaths since 2000.

Opioid distributors sued by West Virginia counties hit by drug crisis

A new legal front is opening in the war against the nation’s opioid crisis as attorneys begin to pursue major corporations that distribute prescription painkillers. They are seeking billions of dollars in reimbursements for the devastation the drugs have caused in communities across the country. Attorneys in West Virginia, which has the highest opioid overdose rate in the nation, filed lawsuits in federal court Thursday on behalf of two counties and targeting some of the nation’s largest drug distribution companies. A dozen attorneys general in hard-hit states are considering similar suits against many of the same companies. “The purpose of these lawsuits is to make the economic cost of willfully violating the law so significant that we force the wholesalers to abide by the law,” said Paul Farrell Jr., who filed the lawsuits in West Virginia and plans to file lawsuits on behalf of five other counties in the state next week. The suits are among the first of their kind in the country. They accuse the companies of creating a hazard to public health and safety by shipping inordinate quantities of opioids into the state in violation of a West Virginia law. The law was originally designed to permit the demolition of run-down buildings that posed a public nuisance and threatened the safety of a community. The lawsuits name McKesson Corp., Cardinal Health and AmerisourceBergen — which distribute 85 percent of the nation’s drugs. Also named are Walgreens, CVS and others. “The unlawful conduct by the defendant wholesale distributors is purposeful and intentional,” the suit says. John Parker, a spokesman for the Healthcare Distribution Alliance, a trade association that represents the drug distributors, said in a statement that “prescription drug abuse is a complex problem and each component of the supply chain shares the responsibility for controlling the availability of opioid pain medications.” “This epidemic must be addressed through a multifaceted, collaborative approach that includes the doctors who write the prescriptions, the pharmacists who dispense the drugs, the distributors who deliver the medicines, the manufacturers who make and promote the products, and the federal and state regulators who license and regulate these entities and determine supply.” A spokeswoman for AmerisourceBergen said in a statement that the company “has been and remains committed to the safe and appropriate delivery of controlled substances.” The lawsuits come as counties and states grapple with the economic impact of a prescription-opioid epidemic that has resulted in nearly 180,000 overdose deaths since 2000 and led to tens of thousands more deaths from overdoses of heroin and fentanyl as the crisis has evolved. The epidemic has taken a financial toll on hospital emergency rooms, jails and law enforcement agencies. It has also undermined the stability of families in the hardest-hit communities. The death toll from overdoses of prescription painkillers has more than tripled in the past decade, according to the Centers for Disease Control and Prevention. Nearly 40 people die each day in the United States from overdoses of drugs, such as oxycodone and hydrocodone. The West Virginia attorney general’s office recently settled lawsuits filed against opioid distributors for violating the state’s consumer protection laws. Cardinal Health agreed to pay $20 million and AmerisourceBergen $16 million. Both companies denied wrongdoing. A dozen attorneys general in states stricken by the epidemic are considering filing lawsuits against the distribution companies, according to attorneys Serena Hallowell and Michael P. Canty, a former federal prosecutor who handled prescription diversion cases for the Justice Department. They said the attorneys general are planning to seek damages from the distributors for the economic impact the drugs have had on their states. Under federal law, drug distribution companies are required to report suspicious orders of narcotics to the Drug Enforcement Administration, including orders of unusually large size, orders that deviate from a normal pattern and orders of unusual frequency. Companies that fail to report such orders can face fines, and their DEA registrations can be revoked. The Washington Post reported in October that at least 13 of the companies knew or should have known that hundreds of millions of pills were ending up on the black market. But the companies ignored warnings and continued to send the drugs, sometimes after being alerted by the DEA or their own employees. Several of the drug distribution companies and pharmacies have already paid civil fines to settle cases brought by the federal government alleging that they violated the nation’s drug laws. Those companies include McKesson, the fifth largest corporation in the United States, Cardinal Health, Walgreens and CVS. Some of the companies also had portions of their operations suspended. “The epidemic still rages because the fines and suspensions imposed by the DEA do not change the conduct of the wholesale distribution industry,” the lawsuits filed in West Virginia say. “They pay fines as a cost of doing business in an industry which generates billions of dollars in annual revenue.” Between 2007 and 2012, drug distribution companies shipped 780 million doses of opioids to West Virginia, and 1,728 overdose deaths occurred, according to an investigation by the Charleston Gazette-Mail. Cabell County, in the heart of the state, was flooded with nearly 40 million tablets of painkillers in that time. With a population of 96,000, that’s more than 400 pills for every adult and child. Farrell said the counties he represents want the distribution companies to pay for the treatment of addicts, programs to educate young people before they become addicted and law enforcement task forces to combat the continuing epidemic. He said damages could amount to “billions of dollars.” Counties across the state have been ravaged by the crisis. “The impact is beyond words,” said W. Kent Carper, president of the Kanawha County Commission in West Virginia, one of the counties that is suing the drug distributors. He said the distributors sent 66 million doses of oxycodone and hydrocodone into Kanawha County, population 190,000. Addiction and deaths have cost his taxpayers millions of dollars in lost wages and productivity, along with increased spending for police, hospitals and jails, he said. Distributors should be held accountable for the damage their drugs have done, Carper said. “They have no plausible reason for doing what they’re doing,” Carper said. “They did it for one reason: greed. People should go to jail.”

May 4 Coffee@WaPo: A policy conversation about addiction in America

Deaths due to prescription opioids and heroin use are at a record high. As the epidemic continues to worsen, efforts to curb its rise have emerged from government agencies, community initiatives and the private sector. In his final State of the Union address, President Obama urged lawmakers to battle drug abuse as a bipartisan priority. The Food and Drug Administration announced new “black box” cautions about the risk of addiction, overdose and death for short-acting opioid pain medications. In Congress, House Republican leaders plan to hold a vote next month on the issue. It has also been a focus of the presidential race as candidates offer specific proposals to tackle an epidemic that doesn’t discriminate by socio-economic status.        -David Cordani, President and CEO, Cigna   -Michael Botticelli, Director of National Drug Control Policy, The White House      -U.S. Surgeon General Vivek Murthy    Vice Admiral Vivek H. Murthy was confirmed on December 15, 2014, as the 19th United States Surgeon General. As “America’s Doctor,” Dr. Murthy is responsible for communicating the best available scientific information to the public regarding ways to improve personal and public health. He also oversees the operations of the U.S. Public Health Service Commissioned Corps, comprised of approximately 6,700 uniformed health officers who serve in nearly 800 locations around the world. He received his Bachelor’s degree from Harvard and his M.D. and M.B.A. degrees from Yale. He completed his residency training at Brigham and Women’s Hospital and Harvard Medical School where he later joined the faculty as an internal medicine physician and instructor.  Michael Botticelli was sworn in as director of National Drug Control Policy at the White House on Feb. 11, 2015, after being unanimously confirmed by the United States Senate. He joined the White House Office of National Drug Control Policy as deputy director in November 2012 and later served as acting director. Botticelli leads the Obama Administration’s drug policy efforts. In response to the national opioid epidemic, he has coordinated actions across the Federal government aimed to reduce prescription drug abuse, heroin use and related overdoses. Botticelli has been in long-term recovery from a substance use disorder for more than 26 years. He previously served as director of the Bureau of Substance Abuse Services at the Massachusetts Department of Public Health.  Svante L. Myrick was sworn into office in January 2012 and became, at 24, the City of Ithaca’s youngest mayor and first mayor of color. Svante was first elected to the city’s Common Council at the age of 20 while still a junior at Cornell University.    John Rosenthal is the president of Meredith Management. He is a real estate developer and manager in Massachusetts, and is also developing the Fenway Center mixed-use project on land and air rights over the MassTurnpike next to Fenway Park. In 1987, Rosenthal started The Friends of Boston’s Homeless. In partnership with the City of Boston, The Friends serves 800 people every night and helps transition more than 400 formerly homeless men and women in Boston beyond shelter with housing and full-time jobs each year. In June 2015, Rosenthal and Gloucester Police Chief Leonard Campanello co-founded the Police Assisted Addiction and Recovery Initiative to support the innovative Gloucester Police Angel program and help other police departments around the state and country address the deadly epidemic and desease of opioid addiction. Within seven months of it’s founding the Gloucester Angel Program placed over 400 people into treatment.  Gary Mendell is the founder and chief executive of Shatterproof. Mendell founded Shatterproof to spare others the tragedy his family suffered with the death of his son Brian, who lost his battle with addiction in 2011. Mendell is the founder and former chief executive of HEI Hotels and Resort and the former president of Starwood Lodging Trust. Mendell is also a member of the Clinton Health Matters Initiative, President Obama’s Better Building Challenge, the Collaborative for Effective Prescription Opioid Policies and Drugs Over Dinner.  Deborah Simpson Taylor received her training in the field of psychiatric nursing and has worked in the addiction field since 1972. In 1989 she joined Vanguard Services Unlimited as executive director and later became president and chief executive. In 2010, she started at Phoenix House Mid-Atlantic as senior vice president and regional director when Vanguard finalized their affiliation with Phoenix House, the largest national not-for-profit substance abuse treatment organization.  Rear Adm. Anne Schuchat has been principal deputy director for the Centers for Disease Control and Prevention since September 2015. Schuchat began her public health career in 1988 when she came to the CDC as an epidemic intelligence service officer. She was director of CDC’s National Center for Immunization and Respiratory Diseases from 2006 to 2015. Other CDC leadership posts she’s held include acting director of the National Center for Infectious Diseases and the Center for Global Health, chief of the respiratory diseases branch and chief health officer for CDC’s 2009 H1N1 pandemic influenza response. Schuchat also served as CDC’s interim deputy director for science and program in early 2009. She was promoted to rear admiral in the United States Public Health Service in 2006 and earned a second star in 2010.  Anne McDonald Pritchett is the vice president of policy and research at the Pharmaceutical Research and Manufacturers of America. Her primary focus is overseeing the development of legislative and policy analysis and research studies on a range of issues impacting biopharmaceutical companies. Previously, she served as deputy vice president of strategic planning for PhRMA. Prior to joining PhRMA, she served in the White House Drug Policy Office for almost 8 years focusing on policy development and analysis. She’s also held positions as the director of government affairs and public relations for a small medical association as well as senior positions with several contract research firms providing communications, policy analysis, and research and evaluation support to a range of federal agencies from the U.S. Department of Justice to the Centers for Disease Control and Prevention and several Institutes of the National Institutes of Health.  Timothy Wynn is a veterans treatment court graduate from Philadelphia. He is a combat Marine who honorably served during the invasion of Iraq. Following a stop-loss he returned home, and within 72 hours was arrested. Wynn was struggling to cope with undiagnosed mental health issues which were exacerbated by substance abuse. Wynn’s intervention came after his seventh arrest when he was given the chance to participate in the Philadelphia Veterans Treatment Court. Today, he is a certified peer specialist and volunteers as a mentor to other veterans in the veterans treatment court program. As a mentor, Wynn says he sees veterans struggling with addiction to opiates every week.  David Cordani became president and chief executive officer of Cigna in 2009. Previously, Cordani was with Coopers & Lybrand. He actively works with March of Dimes, the Juvenile Diabetes Research Foundation and the Achilles International Freedom Team of Wounded Veterans. Cordani is a charter board member of ChildObesity180, and was named to the General Mills Board of Directors in 2014 and to the U.S.-India Business Council Board of Directors in 2015.   Rear Adm. Susan J. Blumenthal is a currently a senior fellow in health policy at New America, a senior medical advisor at amfAR and a clinical professor of psychiatry at Georgetown and Tufts University Schools of Medicine. Blumenthal was U.S. assistant surgeon general, the first deputy assistant secretary for women’s health and senior global health advisor in the U.S. Department of Health and Human Services, where her focus was driving health issues like mental illness and women’s health to the forefront of the U.S. health care agenda. Earlier in her career, Blumenthal served as chief of the behavioral medicine and basic prevention research branch as well as head of the suicide research unit at the National Institutes of Health. She has also been a health columnist, host and medical director of a television series on health.

DOJ announces charges against 400 people for $1.3 billion in health-care fraud

More than 400 people across the country have been charged with participating in health care fraud scams totaling about $1.3 billion in false billings, including for the prescription and distribution of opioids. In what federal officials Thursday called the “largest ever health care fraud enforcement action” by the Medicare Fraud Strike Force, 412 individuals, including 115 doctors, nurses and other licensed medical professionals, were arrested in a nationwide operation that involved more than 1,000 law enforcement agents in at least 30 states.  Sessions said the operation began with tips from people in the affected communities and from “very sophisticated computer programs that identify outliers.” The investigation particularly focused on medical professionals who were involved in the unlawful distribution of opioids and other prescription narcotics, officials said. The abuse of pharmaceutical opioids is widely blamed for a medical crisis involving tens of thousands of overdoses on heroin and fentanyl. “Last year, an estimated 59,000 people died from a drug overdose…opioids play an enormous role in that total number,” said Chuck Rosenberg, acting administrator of the Drug Enforcement Administration. “This is an epidemic.” Approximately 91 Americans die every day of an opioid related overdose, according to the Centers for Disease Control and Prevention. Among the 412 defendants, 120 were charged with opioid-related crimes. Six of the doctors were charged with operating a scheme in Michigan to prescribe unnecessary opioids, some of which were then sold on the street. The doctors allegedly billed Medicare for $164 million in fraudulent claims, according to federal officials. A clinic in Houston allegedly gave out prescriptions for cash. Officials said one doctor at the clinic provided 12,000 opioid prescriptions for over two million illegal painkiller doses. And a rehab facility for drug addicts in Palm Beach, Fla., that is alleged to have recruited addicts with gift cards, drugs and visits to strip clubs, billed the government for over $58 million in false treatments and tests. “Narcotics officers have arrested schoolteachers, doctors, nurses and fellow law enforcement personnel,” said acting FBI Director Andrew McCabe. “Many who succumb to the lure of the opioid high are kids…In some cases, we had addicts packed into standing-room only waiting rooms, waiting for those prescriptions.” McCabe said that some doctors wrote out more prescriptions for controlled substances in one month than entire hospitals were writing.   “Health care fraud is a reprehensible crime,” said Health and Human Services Inspector General Daniel Levinson. “It not only represents a theft from taxpayers who fund these vital programs, but impacts the millions of Americans who rely on Medicare and Medicaid.”

House set to pass legislation aimed at heroin and painkiller abuse

The House this week is set to pass legislation to combat heroin and painkiller abuse, a top priority for lawmakers this election year, but tricky negotiations with the Senate lie ahead. The package of House bills being considered enjoy bipartisan support and should pass by a strong margin. While Democrats are pushing for additional funding for programs aimed at preventing and treating opioid addiction, they mostly support the policy proposals being moved by Republican leaders. “The good news is, [Democrats] have worked with their Republican colleagues, and their Republican colleagues have worked with them,” said House Minority Whip Steny Hoyer (D-Md.), though he added that without more resources, the anti-opioid effort may amount to little more than “empty rhetoric” and political posturing. The package of more than a dozen bills, which will be rolled into one package upon passage, would reduce opioid prescriptions; enhance treatment for vulnerable groups, such as veterans and babies born to drug-addicted mothers; strengthen protections for those intervening to prevent drug overdoses; and provide more tools to combat drug trafficking. The House approach is more wide-ranging than legislation the Senate passed on an overwhelming 94 to 1 vote two months ago. For instance, the House legislation focuses more on drug trafficking than the Senate bill. It would give states and local governments wider latitude with how they use federal grants — though advocates for opioid legislation worry this could compromise efforts to fund specific programs, particularly those aimed at recovery efforts. These differences could complicate efforts to quickly reach a House-Senate deal before the congressional schedule becomes extremely light as lawmakers spend more time at home campaigning ahead of the November elections. Senators have voiced their frustrations with the pace of the House’s consideration of opiod bills. The nation’s drug abuse crisis has grown deadly enough to command the attention presidential candidates, and many members of Congress see addressing it as vital to their re-election efforts. That is especially true for Republican senators like Ohio’s Rob Portman, who co-wrote the Senate opioid bill, and New Hampshire’s Kelly Ayotte, one of its chief advocates — both represent states where the rate of deaths from overdoses has skyrocketed. Portman expressed frustration that the House didn’t quickly take up the Senate bill as House leaders instead opted to allow their members to highlight their own proposals. The House relied on a bipartisan group to sift through and endorse a slate of bills on painkiller abuse and related drug trafficking issues, while members of the House Judiciary Committee voted to restructure the grant programs. Senators have not condemned the House’s approach as unworkable. But they continue to fret about how long the process will take, with only a few weeks of congressional working days left before members depart for the final push to the election. Even if Congress clears opioid legislation in the coming weeks, it is unlikely to quell the political debate over whether Washington could do more to combat the crisis. Funding remains the crux of the divide between the two parties. The House bills on offer do not allow for a vote on any additional funding to support programs, despite an effort from Rep. Joe Courtney (D-Conn.) and over fifty other House Democrats, who sent a letter to House Speaker Paul D. Ryan (R-Wisc.) last week urging him to allow a vote on an additional $600 million for the opioid crisis.

Three senators now holding up FDA nominee — for three different reasons

Two additional senators have announced plans to stall the confirmation of a new Food and Drug Administration commissioner, with one citing the nominee's relationship to the pharmaceutical industry and the other saying the agency needs to reform the way it approves powerful opioid painkillers at the heart of a national epidemic of overdoses. Vermont senator and Democratic presidential candidate Bernie Sanders said Tuesday that he would place a hold on the confirmation of former Duke University researcher and cardiologist Robert Califf, President Obama's nominee to head the FDA. His reason: Califf's "close ties to the pharmaceutical industry and lack of commitment to lowering prices." Sanders becomes the third senator standing in Califf's way. On Monday, Sen. Edward J. Markey (D-Mass.) said he had placed a hold on the confirmation until the agency agrees to several measures related to the use of opioid painkillers such as oxycodone and hydrocodone. Markey wants the FDA to rescind its recent approval of OxyContin for children as young as 11, to make abuse and dependence issues a factor in which opioids are considered "safe" and to automatically convene advisory committees for recommendations on future opioid-related decisions. "Expert after expert has warned about the real world dangers of abuse of and dependence on these new supercharged opioid painkillers, but the FDA has willfully blinded itself to the warning signs," Markey said in a statement Monday. "The FDA needs to commit to shift the way it approaches and evaluates addiction before I can support Dr. Califf's nomination. Until it does, we will continue to see this tsunami of opioid overdoses engulf family after family." The Centers for Disease Control and Prevention said recently that nearly 30,000 Americans died from heroin and prescription opioid overdoses in 2014, the highest annual number on record. More than six in 10 drug overdose deaths were caused by opioids that year as the prescription drug epidemic worsened and the pace of heroin fatalities surged, the CDC said. _[Why the FDA approved OxyContin for kids as young as 11]_    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Officials at the FDA, where Califf currently serves as a deputy commissioner, had no immediate comment to either lawmakers' announcements. But during a confirmation hearing late last year, Califf did address the issue of industry funding of his research at Duke. "I think if you look at my record, I've never been a proponent of lowering standards. If anything I've argued for raising them," he told lawmakers. "I think I've been staunch in that regard." Sanders remains unswayed, saying in in a new statement that "we need a leader at the FDA who is prepared to stand up to the drug companies. Dr. Califf's extensive ties to the pharmaceutical industry give me no reason to believe that he would make the FDA work for ordinary Americans."    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico _[FDA nominee faces questions about drug industry ties]_    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Earlier this month, a Senate health committee voted unanimously to advance the nomination to the full Senate. Just before that vote, Sen. Lisa Murkowski (R-Alaska) told her colleagues that she intended to hold up Califf's nomination until the FDA agrees to mandatory labeling requirements for genetically engineered salmon.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico The AquaAdvantage salmon, produced by Massachusetts-based AquaBounty and approved by the agency in November, is an Atlantic salmon that contains a growth hormone from a Chinook salmon and has been given a gene from the ocean pout, an eel-like fish. The result is a fish engineered to grow twice as fast as its natural counterpart. It is the first genetically altered animal approved for human consumption and was the subject of long-running fights involving food-safety activists, environmental groups and the salmon fishing industry. Murkowski helped insert language late last year in a massive federal spending bill, directing the FDA to prevent the product from reaching the market until regulators finalize labeling guidelines. She said this month that "voluntarily labeling is not adequate. I’m going to be pushing for further conversations with Dr. Califf on this." Generally, though, Califf enjoys broad support on Capitol Hill. Should the senators who have held up a vote on his confirmation lift their opposition, he is expected to be confirmed for the FDA post. **READ MORE:**    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico The FDA just approved the nation’s first genetically engineered animal: A salmon that grows twice as fast    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Prescription drug prices jumped more than 10 percent in 2015, analysis finds    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico ‘It’s the Wild West out there.’ E-cigarette advertising reaches 70 percent of middle and high schoolers, CDC says.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico How cancer will affect Americans in 2016 — in seven charts    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico _For more health news, you can sign up for our weekly newsletterhere _.__    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico

Heroin deaths surpass gun homicides for the first time, CDC data shows

Opioid deaths continued to surge in 2015, surpassing 30,000 for the first time in recent history, according to CDC data released Thursday. That marks an increase of nearly 5,000 deaths from 2014. Deaths involving powerful synthetic opiates, like fentanyl, rose by nearly 75 percent from 2014 to 2015.  Heroin deaths spiked too, rising by more than 2,000 cases. For the first time since at least the late 1990s, there were more deaths due to heroin than to traditional opioid painkillers, like hydrocodone and oxycodone. "The epidemic of deaths involving opioids continues to worsen," said CDC Director Tom Frieden in a statement. "Prescription opioid misuse and use of heroin and illicitly manufactured fentanyl are intertwined and deeply troubling problems."  In a grim milestone, more people died from heroin-related causes than from gun homicides in 2015. As recently as 2007, gun homicides outnumbered heroin deaths by more than 5 to 1.    "The prescription opioid and heroin epidemic continues to devastate communities and families across the country—in large part because too many people still do not get effective substance use disorder treatment,” said Michael Botticelli, Director of National Drug Control Policy, in a statement. "That is why the President has called since February for $1 billion in new funding to expand access to treatment."  Drug policy reformers say the criminalization of illicit and off-label drug use is a barrier to reversing the growing epidemic. “Criminalization drives people to the margins and dissuades them from getting help,” said Grant Smith, deputy director of national affairs at the Drug Policy Alliance. “It drives a wedge between people who need help and the services they need. Because of criminalization and stigma, people hide their addictions from others.”

U.S. senator calls for investigation of DEA enforcement slowdown amid opioid crisis

A U.S. senator on Monday called for an investigation into why the Drug Enforcement Administration slowed enforcement efforts against pharmaceutical companies accused of violating laws designed to prevent pain pills from reaching the black market. Sen. Claire McCaskill (Mo.), the ranking Democrat on the Senate Homeland Security and Governmental Affairs Committee, in a letter asked the Justice Department’s inspector general to investigate. She said she had “serious concerns” about reports of an enforcement slowdown as the opioid epidemic escalated nationwide. “This a matter of life and death and I want to know whether or not we could have done more,” McCaskill said in a statement. A spokesman for Inspector General Michael E. Horowitz declined to comment. A DEA spokesman said the agency would review the senator’s request. McCaskill cited recent reports by The Washington Post that the agency had delayed and blocked enforcement efforts against several large opioid distributors and required field investigators to meet a higher burden of proof before they could take action. Five former supervisors from the DEA’s Diversion Control Division, which regulates the pharmaceutical industry, told The Post in on-the-record interviews that they had become frustrated by the slowdown as overdose deaths soared, particularly in the nation’s rural communities. Their concerns were documented by the DEA’s chief administrative law judge, who said in his quarterly reports to agency supervisors that the number of enforcement actions being approved at headquarters was “stunningly low for a national program.” The Post also reported that enforcement efforts had been questioned by high-ranking Justice Department officials and that key architects of the DEA’s campaign against opioid distributors had been hired away by the pharmaceutical industry. McCaskill noted that 183,000 people have died from overdoses of prescription narcotics between 1999 and 2015, with more than 15,000 in 2015 alone. She said her home state ranked first among Midwestern states in the number of prescription painkillers being sold. The senator said that the DEA had reached financial settlements in several cases against the nation’s largest distributors of narcotic painkillers. But she questioned whether those penalties were sufficient to curb the continuing epidemic and hold the companies accountable. The DEA’s efforts have been “too little, too late,” she said in the letter requesting the investigation. In October, nine other U.S. senators demanded that the DEA explain why it has slowed enforcement efforts against the pharmaceutical industry. In letters to the agency, those senators said their questions have been “ignored” by the agency or that the answers they received “were totally inadequate.”

More senators ask for DEA data on issues raised by Washington Post opioid probe

Seven more senators demanded information Friday about a steep decline in enforcement actions by the Drug Enforcement Administration against large wholesale companies that distribute opioid painkillers. Six Democrats and one independent expressed “serious concern” that “over the last few years, the [DEA] has scaled back its enforcement efforts” against distributors who violate laws designed to prevent painkillers from falling into the hands of illicit drug users. In a four-page letter to Attorney General Loretta E. Lynch and DEA acting Administrator Chuck Rosenberg, the senators cited the findings of a Washington Post investigation published last weekend. “The allegations in the Washington Post article are especially troubling given the opioid-abuse epidemic that is claiming nearly 30,000 lives in the United States annually,” they wrote. The letter was signed by Democratic Sens. Edward J. Markey (Mass.), Richard J. Durbin (Ill.), Joe Manchin III (W.Va.), Amy Klobuchar (Minn.), Tammy Baldwin (Wis.), Richard Blumenthal (Conn.) and independent Bernie Sanders (Vt.). On Wednesday, Sens. Patrick J. Leahy (D-Vt.) and Ron Wyden (D-Ore.) sent a similar request to Lynch. A Justice Department spokesman said the department would review the letter. The DEA did not immediately respond to an email requesting comment. The Post reported Sunday that beginning in 2013, DEA lawyers started to delay and block enforcement efforts against large opioid distributors and others, requiring investigators in the field to meet a much higher burden of proof before they could take action. About 165,000 people died of overdoses caused by prescription narcotics between 2000 and 2014, and tens of thousands more succumbed to overdoses of heroin and fentanyl, according to the Centers for Disease Control and Prevention. Five former supervisors from the DEA’s Diversion Control Division told The Post that they were frustrated by the sharp drop in enforcement actions. The supervisors’ concerns were echoed in reports filed by the DEA’s chief administrative law judge. Investigators said they unsuccessfully confronted Clifford Lee Reeves II, the attorney in charge of the DEA unit that approves administrative cases against people and companies suspected of diverting painkillers to the black market. On Friday, the senators asked whether actions against painkiller distributors and others had indeed dropped from 131 in 2011 to 40 in 2014 — the Justice Department figures cited by The Post — and if so, why. They requested an explanation for the higher standard imposed on investigators in the field and sought information about whether companies had turned to then-Deputy Attorney General James M. Cole for relief from DEA efforts.

Higher-ed associations join to protest House fetal tissue subpoenas

Three umbrella groups representing U.S. institutions of higher education have joined in objecting to a special House panel’s requests for documents pertaining to fetal tissue procurement and research, heightening a conflict over the privacy and safety of personnel involved in those activities. The Association of American Medical Colleges, the American Association of Universities and the Association of Public and Land-Grant Universities indicated “significant concerns” in a joint letter sent Thursday to the leaders of the Select Investigative Panel, a day after its chairwoman, Rep. Marsha Blackburn (R-Tenn.), issued 12 new subpoenas seeking unredacted records.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico “These requests appear to go beyond the Panel’s stated scope of ‘relevant matters with respect to fetal tissue procurement,'” the letter reads. “Initial requests sent to our member institutions failed to articulate why information that identified individuals was being requested and how the Panel intended to use this information. … Many scientists and physicians are deeply concerned for their safety and that of their patients, colleagues, and students in light of inflammatory statements and reports surrounding fetal tissue donation. We are troubled that this information is being sought without any rules or process in place to govern how the Panel will use and protect personally identifiable and other sensitive information.” The panel was established last fall by House Republicans after undercover videos filmed by anti-abortion activists sparked a conservative firestorm over the use of aborted fetuses in medical research and, in particular, the role of Planned Parenthood in facilitating that research. It has since embarked on a broad review of fetal-tissue research, including a public hearing on March 2 that featured several Republican-invited witnesses who cast doubt on its morality and efficacy. The panel has issued document requests to more than 40 groups and individuals, and it has now issued 15 subpoenas. Among those subpoenaed Wednesday were four unnamed “individuals with relationships” with the University of New Mexico, which itself was subpoenaed in February. Also subpoenaed Wednesday were StemExpress, a firm that provides scientific research specimens; BioMed IRB, which provides ethical reviews to researchers; and Ganogen, a research firm that has attempted to grow human fetal kidneys in nonhuman hosts, including rats. Planned Parenthood has not been subpoenaed, though the subpoena issued Wednesday to BioMed IRB seeks documents related to several Planned Parenthood affiliates in California. As the panel enters the fifth month of a one-year investigative mandate, questions of privacy and security have mounted from the panel’s Democratic minority and from many of the entities Republicans are seeking information from. Democrats have been quick to cite November’s shooting at a Planned Parenthood clinic in Colorado, after which the assailant is alleged to have said “No more baby parts.” The panel’s top Democrat, Rep. Jan Schakowsky (D-Ill.), said in a statement Wednesday that Blackburn is pursuing “baseless, inflammatory claims generated by anti-abortion extremists” in issuing the subpoenas: “Chair Blackburn has refused to explain why she needs a database of names. It is time for this witch hunt to come to an end.” Mike Reynard, a spokesman for Blackburn, said Republicans have no interest in publicizing the names and noted that the subpoenas and other documents the panel has released have contained no identifying information. But he said the documents that have been provided to the panel have been rife with redactions that have made it impossible for investigators to understanding the transactions under review. “It is important to the chairman to be responsible with the use of these names, but it impossible for the panel to do a complete investigation without knowledge of the individuals involved in the practices we are investigating,” he said. Panel investigators have attempted to reach accommodations with some of the entities being probed that would provide additional privacy safeguards, Reynard said, but those offers have been rejected. The higher-education groups insist the stakes in the privacy battle are high. “Whatever the intention of the panel, these subpoenas are seen by many as an attempt to intimidate people involved with fetal tissue research,” Peter McPherson, president of the Association of Public and Land-Grant Universities, said in a statement. “The release of names with their institutional connections could well lead to individuals being targeted for harassment or worse. The rhetoric around fetal tissue research already inflames an issue that generates both passionate support and opposition. Of course, Congress has an important oversight role, but we see no legitimate public purpose for collecting vast lists of individuals involved with this research.”

The CIA should cooperate with the Senate on the torture report

AT THE heart of the dispute between the Senate Select Committee on Intelligence and the Central Intelligence Agency is a document known as the CIA’s internal review.  This is a summary and analysis of a dark chapter in the CIA’s history: the use of torture in the interrogation of suspected terrorists after the Sept. 11 attacks. The internal review was undertaken when Leon Panetta was director of the agency and is drawn largely on some 6.2 million pages of CIA documents that the Senate panel was permitted to examine during a five-year investigation. The Senate panel is putting the finishing touches on a 6,300-page report on the CIA’s use of torture — waterboarding and other techniques — in the interrogations. While reviewing the CIA documents, Senate staffers found a draft of the internal review but have not said exactly how they got it. Committee chairwoman Dianne Feinstein (D-Calif.) says the internal review is important because it contradicts CIA statements and it documents agency wrongdoing. John Brennan, the CIA director, maintains that the internal review should never have been seen by the committee because it is “sensitive, deliberative, pre-decisional” material protected by executive privilege. A public breach has emerged between the CIA and Ms. Feinstein, normally a strong defender of the agency, over whether and, if so, how it attempted to interfere with the Senate probe by penetrating computers used in the investigation. Mr. Brennan denies trying to thwart the Senate. Not all details of this episode are known, but some preliminary conclusions are possible. In principle, Mr. Brennan is right to argue that certain documents are legitimately excluded from disclosure to Congress. But the internal review is in Senate hands, so it seems rather futile for the CIA to insist that the cork be put back in the bottle. The Senate is perfectly capable of handling classified material. In the interest of airing the whole story of the interrogations, the CIA ought to quickly work out an accommodation with the Senate that will permit use of the internal review in the Senate’s report. It should not be shunted off to some vault. Sharp, penetrating intelligence is crucial to the United States. Tens of thousands of people labor each day at the CIA, National Security Agency and elsewhere to protect the country’s interests. They are not some kind of whipping boy for Congress or the public. What the CIA did after Sept. 11, 2001, was part of a covert action program authorized by the president; when the full report comes out, we hope for a debate that goes beyond just the CIA. It should be about decisions made by President George W. Bush. To maintain the essential confidence of the American people, intelligence agencies, like all in government, must at times admit mistakes and face accountability. Denial and obfuscation only erode that confidence. The Senate has a legitimate function in oversight. Let’s get on with publishing the torture report, the internal review and the CIA’s comments — and then focus on how to improve democracy, counterterrorism, intelligence collection and protecting the nation. **Read more on this issue from Opinions:** Eugene Robinson: The CIA is out of line Dana Milbank: Allegations of CIA spying on the Senate deserve investigation The Post’s View: Declassify the Senate report on CIA interrogation methods Ann Telnaes: Senator Dianne Feinstein’s double standard ****

Special House committee will investigate Planned Parenthood, abortion issues

House Republicans voted Wednesday to create a special committee to investigate a wide range of practices related to abortions and fetal tissue procurement in the latest and perhaps most lasting consequence of an activist campaign targeting Planned Parenthood. The new 13-member select Energy and Commerce subcommittee would continue the work of three House panels that have investigated Planned Parenthood since July, when antiabortion activists first released undercover videos depicting some of the group’s executives discussing its handling of tissue harvested from aborted fetuses for research. But the committee of eight Republicans and five Democrats would have a broad charge to investigate abortion practices and new resources to do so, including the power to subpoena documents and testimony. “The intent is to bring all of the work . . . under one panel,” Rep. Marsha Blackburn (R-Tenn.) said Tuesday. “The thought is that this will be a more expedient way to handle this, a more efficient way, and allow us to determine if there was any law broken and if there is any need for further investigation.” The 242-to-184 vote was almost entirely along party lines. Two Democrats, Daniel Lipinski of Illinois and Collin C. Peterson of Minnesota, and one Republican, David Jolly of Florida, broke ranks. The activist group that produced the videos, the Center for Medical Progress, and a wide range of conservative political voices say the clips provide evidence of wrongdoing, including breaches of federal law governing fetal tissue transactions. Planned Parenthood has strongly denied breaking any laws and decried the appointment of the special committee as a ploy. “It’s become very obvious that this is all part of a political agenda to make abortion illegal in this country,” Dawn Laguens, Planned Parenthood’s executive vice president, said in a statement. “Despite the clear political agenda behind these investigations, we continue to cooperate fully with all of them.” The special committee is the second that Republicans have appointed since seizing control of the House in 2011. A select committee was appointed last year to investigate the 2012 attacks on American diplomats in Benghazi, Libya, and it continues its work amid increasingly loud protests from Democrats who say the investigation has been overly politicized. Those outcries have reached a fever pitch in the past week, since House Majority Leader Kevin McCarthy (R-Calif.) made comments in a Fox News Channel interview suggesting that the panel had been appointed to undermine Hillary Rodham Clinton’s presidential campaign. Democrats have seized on McCarthy’s comments to paint both special committees as political witch hunts. Democrats also have pointed to comments made by Rep. Jason Chaffetz (R-Utah), chairman of the Oversight and Government Reform Committee, who was asked during a CNN interview last week whether Planned Parenthood had broken any laws. “No, I’m not suggesting that they broke the law,” said Chaffetz, who presided over a five-hour hearing last week that featured testimony from Planned Parenthood chief executive Cecile Richards. Committee Democrats sent Chaffetz a stern letter Tuesday, complaining that the majority had allowed David Daleiden, the mastermind behind the videos, to stonewall the committee, while Richards appeared in person to answer questions at a hearing and her group has handed over 20,000 documents. “Continuing to shield Mr. Daleiden and his organization from accountability creates the unfortunate impression that the Committee is more interested in attacking Planned Parenthood than in an even-handed investigation of potential violations of the law,” said the letter, signed by 17 members. Rep. Xavier Becerra (D-Calif.), chairman of the House Democratic Caucus, compared the Republican committees to the early 1950s investigations of alleged communist infiltration. “We may be going back to some of those bad old days,” he said in an interview. “No one is saying don’t do investigative hearings, but do them when there’s a basis for them,” Becerra said. “I defy anyone to explain what the basis for the Planned Parenthood assault is. What’s the basis for a congressional investigation when even [Chaffetz] says he is not suggesting there was any violation of law?” The words “Planned Parenthood” do not appear in the resolution establishing the special committee. Its jurisdiction is considerably broader, encompassing “medical procedures and business practices used by entities involved in fetal tissue procurement” and “any other relevant matters with respect to fetal tissue procurement.” It also permits the committee to probe the subject of federal funding for abortion providers generally, the practices of providers who perform abortions in the second and third trimesters, and “medical procedures for the care of a child born alive as a result of an attempted abortion.” The committee is also empowered to recommend changes in laws or regulations based on its findings. “This is not simply an investigation of Planned Parenthood,” Blackburn said. “This will be a broad-based, information-gathering, fact-finding mission to answer questions about how we treat and protect life in this country.”

FDA head Margaret Hamburg to resign in March; Ostroff to be acting chief

Margaret A. Hamburg, who as commissioner of the Food and Drug Administration for nearly six years oversaw far-reaching new initiatives on food safety and tobacco regulation and a wave of new drug approvals, plans to resign in March. “The honest truth is that I had never expected to stay this long,” Hamburg said in an interview Thursday. “But the place got under my skin. It’s an extraordinary agency with amazing people and a unique and essential mission.” Stephen Ostroff, the FDA’s chief scientist and a former official at the Centers for Disease Control and Prevention, will become the agency’s acting commissioner. Other top officials recently hired by Hamburg could potentially be nominated to succeed her, including Robert Califf, a well-known cardiologist and Duke University researcher who later this month will begin serving as deputy commissioner for medical products and tobacco. Hamburg, 59, is among the longest-serving FDA commissioners in recent decades. A Harvard Medical School graduate and the daughter of physicians, she served as New York City’s health commissioner during the 1990s. “There are few harder jobs in this town,” former FDA commissioner David Kessler said. “She’s pushed the ball uphill in a host of areas. . . . She’s been an excellent steward.” But, like many of her predecessors, Hamburg also wound up embroiled in controversies, including ones over the sale of the morning-after pill to younger teenagers; a meningitis outbreak caused by unsanitary practices at a Massachusetts “compounding” pharmacy; and the agency’s approval of painkillers at the heart of the nation’s prescription drug epidemic. “I’m pleased to see her go,” said Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing and the head of an addiction treatment center in New York. Kolodny, who has often clashed with the FDA, said, “Her administration consistently put the interests of the drug companies ahead of public health.” The reach of the sprawling agency, which regulates products accounting for about 20 cents of every dollar spent by American consumers, expanded during Hamburg’s tenure. In 2009, Congress gave the FDA authority to regulate the tobacco industry. That effort has unfolded slowly, but the agency has begun putting in place new rules and has said it intends to regulate the booming market in electronic cigarettes. In 2010, lawmakers directed the FDA to undertake the first major overhaul of the nation’s food-safety system in generations. To do so, Hamburg has had to balance a wide spectrum of interests, from small apple farmers to massive produce companies. Hamburg also has overseen efforts to implement calorie-count labels on restaurant menus and the phaseout of harmful trans-fats. On the international front, she has dealt with the safety of drugs made in India and food imported from China. Perhaps most significantly, the FDA in recent years has streamlined drug approvals. Last year alone, the agency approved 51 new drugs and biologics, many of them designated as “breakthrough” therapies for cancer and other conditions. “When I came on board, FDA had been through a number of significant crises,” Hamburg said. “There was low morale and a sense that the agency really needed rejuvenation and redirection.” In the years before she arrived, for example, the agency had failed to warn of the potential dangers of the anti-inflammatory drug Vioxx. And in 2005, the agency’s head, Lester Crawford, who had hidden ownership of stock in companies the agency was regulating, abruptly resigned. Marion Nestle, a prominent nutrition expert and a public health professor at New York University who pushed hard for new food-safety measures, said Hamburg “managed to keep the agency funded, avoided scandals, and got [food safety], menu labels and food labels going. . . . Mostly, she kept Congress and the White House from tearing the agency apart.” Hamburg said Thursday that no single factor triggered her departure, but she endured public battles and private frustrations during her years in the job. In 2011, Kathleen Sebelius, then the secretary of health and human services, overruled the FDA and said the controversial contraceptive Plan B could not be sold over the counter to young teenagers. The Obama administration later allowed sales to women of all ages. Hamburg encountered tough questions on Capitol Hill in 2012 after an unprecedented outbreak of fungal meningitis killed dozens of people who had received unsterile injections made at a compounding pharmacy in New England. Hamburg said at the time that the FDA needed broader authority over such operations. The agency also faced criticism for monitoring the e-mails of some of its scientists who had expressed concerns that the FDA was approving medical devices they believed exposed patients to unacceptable risks. The Pharmaceutical Research and Manufacturers of America, a top industry group, praised Hamburg for her “thoughtful regulation” and “strong leadership,” but others have said the agency is too close to the drug industry. “Too often, the FDA has succumbed to industry and political pressures, implementing policies and taking actions that tilt too far toward the bottom-line interests of pharmaceutical and medical device companies,” Michael Carome, director of the health research group at Public Citizen, a nonprofit consumer advocacy organization, said in a statement. Hamburg on Thursday recalled an old joke that the FDA has only two speeds of approving drugs: too fast or two slow. “My goal has always been to try to make sure that patients and consumers have products they need as rapidly as we can responsibly move them through the process, while always adhering to our standards for safety and efficacy,” she said. Behind the scenes, Hamburg and other FDA officials often expressed frustration at the slow pace at which the Obama administration reviewed and revised proposed regulations on food safety, menu labels and tobacco products. Her departure comes as lawmakers are working on bipartisan legislation aimed at streamlining the approval of drugs and devices even further, fueling concerns among some groups that safety could be sacrificed. Hamburg has made it clear to numerous friends and colleagues that she has been weighing whether to leave for some time. “She just told me that it had been very intense and all-consuming and that she was ready to leave,” said one senior administration official, who spoke on the condition of anonymity because he wasn’t authorized to discuss personnel matters. Hamburg said Thursday she hasn’t spent much time pondering what lies ahead. “This is an intense, 24/7 job, where it’s very hard to step back and reflect on what it is that I might want to do next,” she said. “I just want to take a little time to reflect. And relax.”

It’s time to shut down the special panel on fetal tissue research

ANY DOUBT about the kind of investigation into fetal tissue research that would be conducted by a special House panel was erased at its first hearing, when one of the witnesses called by Republicans drew comparisons between this life-saving medical work and the experiments of Nazi war criminal Josef Mengele. And the panel has gone downhill since. The committee has issued indiscriminate subpoenas, intimidated witnesses and relied on misleading information. It is abusing power at taxpayer expense, and Democrats are right to demand its shutdown. In a letter this week to House Speaker Paul D. Ryan (R-Wis.), 181 of the 188 House Democrats called for disbanding the select investigative panel, characterizing it as a “witch hunt.” The committee was created last year by former speaker John A. Boehner (R-Ohio) to probe connections between abortion providers and medical researchers in the wake of the furor caused by sting videos purporting to show Planned Parenthood involved in the illegal sale of fetal tissue. As we now know, those videos are bunk, neither accurate nor reliable. Previous investigations by three House committees found no wrongdoing. Twelve states that launched investigations into Planned Parenthood found nothing; another eight determined there was no credible evidence even to warrant investigation. The only wrongdoing, according to a Texas grand jury that was under orders to investigate Planned Parenthood, was committed by the antiabortion activists who filmed the misleading videos. None of those facts seems to matter to Republicans who see the committee as an opportunity to score political points with their antiabortion base. Their heavy-handed tactics in service of this grotesque theater are disturbing. Rep. Marsha Blackburn (R-Tenn.), the committee chair, despite amassing 19,000 pages of documents claims noncompliance and has unilaterally issued dozens of subpoenas, often without reaching out to subjects to ask for voluntary compliance. Her demand for names of individuals who work in labs and clinics without providing a justification and without assurances of privacy is troubling and irresponsible. According to Democrats, one of the individuals targeted by the investigation already has received graphic death threats after being identified in the videos. There is no legitimate reason for this inquiry. Individuals and organizations are being unfairly targeted and placed at risk. Mr. Ryan, who took office with talk of wanting to change how the House does business, should put an end to these sordid proceedings. **Read more on this topic:** Dana Milbank: Republicans finish discrediting their Planned Parenthood investigation The Post’s View: The Planned Parenthood witch hunt The Post’s View: Planned Parenthood has been absolved. The GOP should give up its crusade.

Sessions won’t testify at congressional budget hearings but at Senate intelligence hearing instead

Attorney General Jeff Sessions, who had agreed to testify this week before the Senate and House appropriations subcommittees about the Justice Department budget, wrote the chairmen of the committees Saturday and said he was sending his deputy to testify instead. Sessions was scheduled to testify before Congress on Tuesday for the first time since he was confirmed as attorney general in February. In light of former FBI director James B. Comey’s testimony last week, Sessions was expected to get many questions from lawmakers about his contacts with Russian officials during the 2016 election campaign. Sessions wrote to the two chairmen that he would testify before the Senate Intelligence Committee on Tuesday instead. A Justice Department official said that committee hearing probably will be closed to the public. In early March, The Washington Post reported that Sessions twice met with Russian Ambassador Sergey Kislyak during the campaign and did not disclose that to the Senate Judiciary Committee during his confirmation hearing in January. The next day, Sessions recused himself from the Russia investigation and said it would be overseen by his deputy attorney general, who last month appointed a special counsel to handle the probe. Sessions also was expected to get questions about his involvement in the firing of Comey and the news that he offered his resignation to President Trump at one point recently. “I previously accepted an invitation to testify on behalf of the Department of Justice before the House and Senate Appropriations Subcommittees about the department’s FY18 budget, which funds the department’s efforts in several important areas such as combating the opioid crisis and violent crime,” Sessions wrote to Sen. Richard C. Shelby (R-Ala.), chairman of the Appropriations subcommittee on commerce, justice, science and related agencies, and Rep. John Abney Culberson (R-Tex.), chairman of the House Appropriations subcommittee on commerce, justice, science and related agencies. “In light of reports regarding Mr. Comey’s recent testimony before the Senate Select Committee on Intelligence, it is important that I have an opportunity to address these matters in the appropriate forum,” Sessions wrote. “The Senate Intelligence Committee is the most appropriate forum for such matters, as it has been conducting an investigation and has access to relevant, classified information.” Comey testified Thursday that the bureau had information about Sessions — before he recused himself from overseeing the investigation into Russian meddling in the 2016 election — that would have made it “problematic” for him to be involved in the probe. Sessions wrote the chairmen that Deputy Attorney General Rod J. Rosenstein will take his place before both the House and Senate subcommittees to testify about the Justice Department’s budget. Sessions said he was “pleased to accept” the invitation to appear before members of the Senate Select Committee on Tuesday. Spokesmen for the chairman and ranking minority member of the committee could not be reached to confirm whether the hearing will be open or closed to the public.

Fast and Furious scandal: House panel votes to hold Eric Holder in contempt

A congressional committee voted Wednesday to recommend that Attorney General Eric H. Holder Jr. be held in contempt after the Obama administration, citing executive privilege for the first time, refused to turn over documents pertaining to a botched gun-trafficking operation. The party-line vote at a marathon session of the House Oversight and Government Reform Committee intensified a feud between the Obama administration and Republican lawmakers and dealt an embarrassing blow to the nation’s highest-ranking law enforcement official. House leaders said they will schedule a vote of the entire chamber on the matter next week unless the attorney general turns over certain documents on Operation Fast and Furious. If the full House votes to find Holder in contempt, the U.S. attorney for the District of Columbia — who is employed by the Justice Department — will have to decide whether to criminally prosecute him. In a statement, Holder called the vote “an election year tactic” and blasted it as “an extraordinary, unprecedented and entirely unnecessary action, intended to provoke an avoidable conflict between Congress and the Executive Branch.” Speaking Thursday from Copenhagen, Denmark, where he is attending meetings with European Union officials, Holder said the administration had given the House Oversight and Government Reform Committee a proposal to negotiate an end to the conflict. “I think the possibility still exists that it can happen in that way,” Holder said, according to the Associated Press. “The proposal that we have made is still there. The House, I think, the House leadership, has to consider now what they will do, so we’ll see how it works out.” The vote against Holder marks only the third time in 30 years that a congressional panel has held an attorney general in contempt. At Wednesday’s often-heated hearing, Republicans railed against the former judge and U.S. attorney, accusing him of repeatedly stonewalling them in their investigation. Democrats blasted the GOP for allowing the dispute to devolve into personal attacks against Holder. At its core, the conflict centers on a particular set of documents that the oversight committee’s chairman, Rep. Darrell Issa (R-Calif.), subpoenaed from the Justice Department in October for the investigation he launched into Operation Fast and Furious in the spring of last year. The operation, named after the popular movie series, was run out of the Phoenix division of the Bureau of Alcohol, Tobacco, Firearms and Explosives between 2009 and 2011, with the legal backing of the U.S. attorney in Phoenix. As part of the operation, ATF agents purposefully did not interdict more than 2,000 weapons they suspected of being purchased at Arizona gun shops by illegal buyers known as “straw purchasers”; agents hoped to later track them to a Mexican drug cartel. ATF lost track of most of the firearms, some of which have been found at crime scenes in Mexico and the United States. Two of the guns connected to the operation were found at a scene in the Arizona desert where a Border Patrol agent, Brian Terry, was killed in December 2010. While lawmakers have already conducted an investigation of the operation, they are seeking to determine who in the Justice Department knew about the tactics used in Fast and Furious and when. They are also trying to find out whether any officials tried to cover up their knowledge of the tactics once Congress began investigating. Last year, a Justice Department official told lawmakers in a letter that ATF had not ever “sanctioned” or otherwise knowingly allowed the sale of assault weapons to a straw purchaser who then transported them into Mexico. Ten months later, the Justice Department withdrew the letter, acknowledging the botched operation. That episode has heightened suspicions among Republican lawmakers, who have demanded that the department hand over the records of any deliberations it had about Fast and Furious after the Feb. 4, 2011, letter. Justice officials have insisted that no senior officials in the department knew of the controversial tactics, which were approved by ATF’s Phoenix division. They also have said they have worked hard to cooperate with requests from Issa’s committee. Over the past year, Justice officials have turned over 7,600 documents relating to the operation, as well as documents relating to another operation involving “gun-walking,” as the tactic is known, in the George W. Bush administration. Holder has testified to congressional committees about Fast and Furious nine times over the past 14 months. But Issa and his investigators said the Justice Department was not fully cooperating with their request, arguing that the records turned over were only a sliver of the 80,000 documents that Justice has given to the department’s inspector general, who is also investigating the gun operation at Holder’s request. In recent weeks, Issa has narrowed his request to documents relating to “internal deliberations” over the operation. Justice officials have insisted that they do not have to hand over those files based on long-standing executive branch policy. They have also said that many of the documents delivered to the inspector general pertain to ongoing criminal investigations and legally cannot be released to Congress. In a bid to head off a contempt vote, Holder met with Issa and several other lawmakers Tuesday evening. The attorney general agreed to turn over documents that Justice officials think would answer Issa’s questions if the committee would consider the subpoena issues related to Fast and Furious to be “resolved.” He told reporters afterward that the set of documents “pretty clearly demonstrates that there was no intention to mislead, to deceive.” Issa declined the offer, however, saying he would not make such a determination until he saw the documents. On Wednesday morning, just minutes before the scheduled hearing, committee staff members said they were informed by the Justice Department that Obama was invoking executive privilege to withhold the contested documents. After a six-hour hearing, the panel voted 23 to 17 to hold the attorney general in contempt. “Fast and Furious was a reckless operation that led to the death of an American border agent, and the American people deserve to know the facts to ensure that nothing like this ever happens again,” House Speaker John A. Boehner (R-Ohio) and Majority Leader Eric Cantor (R-Va.) said in a statement after the vote. House Democrats quickly denounced their plans to bring a vote to the floor next week. “If Mr. Boehner takes this to the House, he will be seen as one of the most extreme speakers that ever took charge of the House,” the oversight committee’s ranking Democrat, Elijah E. Cummings (Md.), told reporters. He noted that in the Clinton administration, then-Speaker Newt Gingrich (R-Ga.) declined to bring to the House floor a vote on contempt charges against Attorney General Janet Reno. “Instead of going after guns, the Republican majority is going after the attorney general of the United States,” Rep. Carolyn B. Maloney (D-N.Y.) told reporters. “This is a political witch hunt during the witch hunt season, and the witch hunt season will probably not end until Election Day.”

How sensationalism compounds the opioid crisis

As Republicans debate alternatives to the Affordable Care Act, support for addiction treatment has been notably absent from their policy prescriptions.  While less passionate about the issue, Donald Trump launched his presidency with a pledge to stop the “American carnage” caused by rising drug use and overdose deaths. At first glance, these descriptions of the damage wrought by the opioid epidemic appear compassionate. When viewed in light of the devastating cuts to Medicaid services for mental health and addictive disorders proposed in the Senate’s Better Care Reconciliation Act, they appear contradictory and even hypocritical. In reality, these narratives are not antidotes to the policy problem, but a piece of it. Since the nation’s first opiate epidemic peaked in the mid-1890s, stories designed to create a visceral emotional response have generated attention, but ultimately undermined effective solutions. In calling attention to the problem of addiction, these sensational stories reinforced stereotypes that people who used substances, regardless of their backgrounds, were subhuman, unworthy and probably incurable. As an unintended consequence, support for treatment was often short-lived. From the asylums of the late 1800s to the federal narcotics penitentiaries of the mid-1900s to the nationwide treatment system of today, treatment advocates dwelled on the negative consequences of substance use in an attempt to evoke pity, fear or alarm that would inspire immediate public support. Now, even the most sympathetic Republican proposals for more generous treatment funds extend a crisis-driven mentality that has been part of the larger problem in treating drug addiction since the 19th century. This approach has caused support for treatment to evaporate almost as quickly as it materializes and has thwarted every attempt to build a sustainable treatment infrastructure. By preserving an outdated and counterproductive view of addiction, GOP policymakers’ sensationalism inhibits their ability to solve the crisis they love to lament. Sensationalism as a literary form debuted in the 1860s and 1870s. Exposing the details of lurid private acts — sex, violence, drug use — the form soon infected other genres: Newspaper publishers justified its use by arguing that manufactured shock and outrage raised awareness about important social problems. They sensationalized one of the most pressing problems of the age — drug addiction. Then as now, panicked coverage raised public awareness about the previously submerged problem. The medicinal use of opiates took off in the 1800s, becoming an epidemic after midcentury and peaking in the mid-1890s. Muckraking journalists played a key role in exposing the source of the epidemic: the doctors who endorsed opium and morphine, and the drug companies who peddled patent medicines with undisclosed narcotic ingredients. The stories also entailed breaching the privacy of the main drug abusers, “neurasthenic” upper-class white women who nursed their habits in secret. Sensational portraits in everything from novels to medical literature painted the addict as a pathetic domestic figure who was flirting with death. The novelist Wilkie Collins depicted this figure drinking laudanum to welcome “the blessing of oblivion,” while neurologist George M. Beard deemed her destined to be “weeded out” as “the tendency for debility leads to its own elimination.” For a time, designated asylums offered treatment to address the growing addiction problem. But the sympathy elicited by the sensational coverage quickly dwindled when treatment providers’ promises to permanently transform patients failed to materialize. At the height of the 19th-century opiate epidemic, treatment was already on the decline; only 30 of the first 50 organizations founded to treat addiction remained open in 1893. Public perceptions about asylums’ incorrigible upscale client population contributed to their downfall. The public began to view treatment as a luxury of idle, ill-behaved wealthy people who offered little social value to the wider community. Treatment virtually disappeared as the stigma associated with it increased. Patients’ demand for private residential treatment dropped, and the limited funding for publicly supported asylums dried up. The situation worsened in the early decades of the 20th century as the demographics of drug use shifted from middle- and upper-class women to lower-class urban males. For this new population, heroin and morphine use was “recreational,” and reformers began to reframe drug use as a symptom of lawlessness rather than nervousness. The press cast people who used drugs as villains rather than victims. Anti-drug policies hardened in response. But sensational tropes continued to shape conversations about treatment, even as treatment took more limited and punitive forms. In 1928, William Randolph Hearst helped journalist Winifred Black publish “Dope: The Story of the Living Dead,” a book intended to drum up support for two centralized federal penitentiaries designed to corral and treat people with narcotic addiction. The campaign was successful. The facilities became the therapeutic concession to a federal drug policy that was otherwise committed to punishing users of illicit narcotics. By the 1950s, writers presented the high relapse rates — as high as 90 percent in some accounts — of the residents discharged from the federal penitentiaries as a sensational failure of treatment. The stories of relapse once again supported the notion that the available forms of treatment were a poor public investment and addiction to hard drugs a hopeless cause. Ironically, when former penitentiary residents challenged this treatment system by creating their own alternative treatment model, their protests reinforced negative stereotypes about people who used substances by recounting “hitting bottom” with their addictive behaviors and their close brushes with death. One influential group of “ex-addict” reformers organized a response to rising heroin use in the 1960s by contesting the effectiveness of existing treatment institutions, not the perception that their addictions had stripped them of their humanity.  Today, the sensationalist narrative remains, and so does the crisis-driven mentality it promotes.  Although support for addiction treatment has ebbed and flowed for more than a century, the stigma against people who use drugs has been a historical constant. Today’s sensationalistic coverage of addiction — gruesome scenes of parents overdosing in front of children, babies born with neonatal abstinence syndrome, families fracturing as drugs enter their homes and communities, or drug-dependent women being driven into prostitution — exploit the private suffering of an already vulnerable population and contribute to stigma rather than countering it. Stigma, in turn, contributes to apathy, and time-limited funding disappears when the public no longer feels a sense of urgency. Future attempts to build a sustainable treatment infrastructure will be undermined as long as treatment advocates continue to depict people who struggle with addiction as already dead.

Opioid abusers play no part in opioid abuse?

The Oct. 31 editorial “Locating blame in the opioid epidemic” pointed the finger of blame for opioid abuse at Congress, medical providers, drug companies, government regulators, pharmacies and wholesalers, virtually every entity in the supply chain. But it conveniently omitted the final and most important link in this chain: the individual who elects to abuse prescription opioids. By ignoring individuals’ responsibility for their health, the editorial perpetuated the victimization syndrome that permeates much of our society. Until personal responsibility is acknowledged, problems such as drug abuse, parental failure, educational underachievement and crime will continue, despite well-intentioned but misconceived government programs. ****Robert Glenn** , Ashburn** **The overwrought editorial on** the Justice Department’s cooling of the Drug Enforcement Administration’s prohibitionist jets was dangerously misleading. What the editorial and like-minded medical Carrie Nations failed to admit is that vital pain-relieving opioids are being lumped in the same category as street heroin, and DEA enforcement zealotry is driving the turn to heroin, a far worse alternative. People will use and abuse pain pills. The answer to the so-called epidemic is to educate people, not throttle their access to palliatives. The prohibitionist tendencies of The Post’s editorial page, which for years has railed against the decriminalization of marijuana, come forward again. ****Brian Petty** , Washington**

House Republicans playing deadly politics with painkillers — so say some Senate Republicans

It was one day after House Majority Leader Kevin McCarthy’s announcement last week that the House would not consider the Senate bill to combat heroin and opioid abuse, a major issue on the 2016 campaign trail. House GOP leaders quickly passed the mic to one of their most vulnerable incumbents, Rep. Bob Dold of Illinois. The Republican lawmaker made the first GOP weekly radio address on opioid abuse since Rep. Paul D. Ryan (R-Wis.) became speaker.  Dold isn’t on any of the committees with jurisdiction over treatment, education, prevention or law enforcement efforts related to opioid abuse. It’s not even clear that Dold’s bill to improve and better regulate the distribution of such drugs, named after a constituent who died of an overdose, will be in the mix of measures that McCarthy (R-Calif.) said would be considered this month, with a goal of reaching the House floor by May. GOP leaders seem to believe that giving Dold airtime on the issue — which has been a focus of the presidential campaign and may bleed into House and Senate contests — is smart politics. Yet some champions of painkiller legislation, including vulnerable Senate Republicans, beg to differ. They fear the House may be foot-dragging on bipartisan Senate legislation in order to let members take a turn in the spotlight on a widely popular issue. But in the process, they worry, the House’s decision to start from scratch instead of picking up the popular Senate bill may upset a near-perfect opportunity to get something done. For example, Sen. Rob Portman (R-Ohio) — also one of the most vulnerable members of his party this election cycle, and from one of the states hardest hit by drug-overdose deaths — is watching the calendar, and his frustration with the House is bubbling over. There are only a few months this year to pass meaningful legislation before Congress effectively disbands for the election season. And it took years to craft and pass the Senate bill on opioid and heroin abuse that Portman co-authored with Sen. Sheldon Whitehouse (D-R.I.). It survived a floor test last month not only mostly intact but with an almost unheard-of endorsement from the usually fractious body, passing by a vote of 94 to 1. Portman and his colleagues point to the bipartisan support as the best argument for capitalizing on the moment for Congress to address the national opioid epidemic. But Portman questions whether House members speaking of urgency in their public comments are really committed to putting politics aside and getting a bill done. Every extra moment they deliberate, Portman argues, they potentially waste time. “The House must act, and they must act soon,” Portman said on the Senate floor last week, the same day McCarthy announced the House would go its own way on the issue. “I am not going to be patient on this. This is urgent, and people’s lives are at stake. . . . We need to take advantage of this opportunity that the Senate has given us by this huge vote.” House GOP leaders said they plan to act quickly. “It is not about politics, it is personal,” Ryan said on Wednesday. He added there is common ground between what the House is pursuing and the Senate legislation as well as with President Obama’s opioid initiatives. “We can get this done and we can win this battle and that is why we here in the House are bringing our ideas to the table too, going through the committee process to meet with the Senate so that we can make sure that we actually advance a solution to this problem,” Ryan said. Rep. F. James Sensenbrenner Jr. (R-Wis.) introduced companion legislation to Portman’s bill, but there are a host of other House measures on offer — to change approaches to treatment, to alter the attitude toward prescribing opioid painkillers, and to address illegal trafficking in addictive and illicit drugs, particularly synthetics. The measures all have bipartisan support. But some members worry that with so many options on the table, the debate could start to lose focus, as members scramble to promote individual bills and local politics could take precedence. A bill from Rep. Larry Bucshon (R-Ind.) that would aim to improve treatment of opioid addiction is one that made leadership’s shortlist. He’s a surgeon from a state that has seen one of the sharpest recent rises in the drug-overdose death rate, according to data from the Centers for Disease Control and Prevention, and he sits on the House Energy and Commerce health subcommittee that is likely to field opioid legislation. Though Bucshon said he couldn’t care less whether he gets personal credit for his efforts, he worries the temptation to seize the spotlight may grip others and delay progress. “Could there be pitfalls where for political reasons, people are bantering around and worried about who’s getting credit, and it stops it up? I’m a little worried about that because it’s a front-page issue and everybody’s talking about it,” Bucshon said, declining to name parties or names of who might pose a problem. “It doesn’t do us any good to be working on legislation that’s ultimately not going to end up on the president’s desk,” he added. Bucshon isn’t particularly vulnerable in 2016, and neither is Rep. Charlie Dent (R-Pa.), who authored one of the synthetic-drug bills on McCarthy’s list that is now getting rolled into the House’s opioid strategy.  There are some House Republicans voicing complaints about the Senate legislation. Rep. Susan Brooks (R-Ind.), who said the opioid crisis had become “very personal” after her years working in the legal system and witnessing the worsening crisis in Indiana, authored a bill setting up a federal task force to come up with best practices for reducing opioid prescriptions. She said the Senate bill is flawed because it relies too much on grant programs and is difficult to find a way to pay for, while the House, she expected, would produce something with fewer grant-based initiatives. “There are certainly a lot of ways to tackle the problem without adding a lot of new grant programs,” Brooks said. That criticism might not sit so well with senators such as Portman and Kelly Ayotte (R-N.H.), who not only helped design those grant programs but also bucked their party to support $600 million in emergency spending to fund them.

Longtime Virginia prosecutor to seek lieutenant governor job

After 27 years in the Justice Department, a Virginia prosecutor who targeted doctors who overprescribed pain pills is now hoping to tackle the state’s opioid crisis from a new angle: as lieutenant governor. Gene Rossi aspires to join a Democratic administration trying to cope with the problem through a combination of harsh prosecution and holistic treatment. He left his job as a prosecutor in July and said he intends to make a formal announcement this month about his plan to seek office. Rossi, 60, started his federal career in criminal tax enforcement and spent recent years training young assistant U.S. attorneys in Alexandria’s Eastern District federal court. He’s gone to trial more than 100 times. But he’s best known for Operation Cotton Candy, a multiyear opioid investigation that has led to 235 convictions. Among the most prominent ensnared was William Hurwitz, a McLean pain doctor who saw three patients die of overdoses from his prescriptions. He was initially sentenced in 2005 to 25 years in prison, but his conviction was overturned, and after retrial, his term was cut in 2007 to less than five years. “An increasing body of respectable medical literature and expertise supports those types of high-dosage, opioid medications,” Judge Leonie M. Brinkema said at the time. She took the side of ****drug policy reform advocates **** who argued that prosecuting doctors makes it harder to help people who need relief. “I think the aggressive prosecution can really undermine legitimate prescription to people who are in pain,” said Grant Smith, deputy director of national affairs at the Drug Policy Alliance. Law enforcement, he said, should not have “carte blanche permission to investigate and prosecute physicians and decide how much pain medication is too much pain medication.” Rossi counters that the FBI and Justice Department used extraordinary discretion in targeting certain doctors. “When a doctor runs a pill mill, he’s a drug dealer,” Rossi said. When Rossi tells doctors at Justice Department presentations how much Hurwitz was prescribing, he said, they have no sympathy, and they don’t fear for their own practices. Likewise, Rossi has no qualms asking for long sentences for drug dealers he deems motivated by “pure, unadulterated greed.” In his last trial for the Justice Department in June, he helped persuade a jury to convict a woman of helping her husband sell opioids; she could go to prison for two decades. But Rossi said his thinking has evolved on people who sell drugs to finance their own addiction. “Twenty years ago, I didn’t blink an eye when someone was sentenced to 10 or 20 years,” he said. “Now I think: Is our society better off?” He works on the Eastern District’s drug court, which offers an alternative to traditional probation for nonviolent offenders. “I’ve watched Gene in particular come to understand . . . that these people aren’t moral degenerates, they don’t have weak backbones; they’re suffering from a disease,” said David Mercer, himself an alcoholic and a community representative on the court. Whenever someone graduated from the 18-month program, he said, Rossi insisted on bringing balloons. Lawyers say Rossi is a respected prosecutor with a reputation for fairness. Originally from Connecticut, he lives in Alexandria with his wife, Diane. The couple have three children: a son in his teens and a son and daughter in their 20s. Rossi coaches youth basketball and is on the board of Friends of Guest House, a nonprofit that helps women who were incarcerated reenter society. Rossi said that if elected, he would focus on sentencing reform and ways to help former prisoners succeed, in addition to seeking ways to combat drug addiction. “It’s hard for me to imagine the U.S. attorney’s office without Gene there,” said Geremy Kamens, the lead public defender in the Eastern District. “He always fought hard, but what mattered most to him was that justice was done. If that meant an acquittal, Gene was fine with that.” Defense attorneys and former prosecutors who trained under Rossi say he is particularly conscientious about turning in all available evidence to the opposition. “He was very committed to being fair to those he was prosecuting. I wish that was an attribute shared across the DOJ,” said Justin Gelfand, who trained with Rossi before becoming a defense attorney. Rossi said he is close to declaring his campaign for lieutenant governor. But he faces an uphill battle in the Democratic primary against Justin Fairfax, who came close to being the party’s 2013 nominee for attorney general, and potentially state Del. Eileen Filler-Corn (Fairfax). Relentlessly energetic and schooled in wooing juries, he for the first time is trying to win over a general public. Rossi argues that his many years of public service — he actually trained Fairfax during the former federal prosecutor’s two years in the Eastern District — make a compelling case.

FDA seeks removal of opioid painkiller from the market

The Food and Drug Administration on Thursday asked a drug company to remove its opioid pain medication from the market, the first time the agency has made such a request because of the public health consequences of abuse. The agency concluded after an extensive review of Endo Pharmaceuticals’ Opana ER that the “benefits of the drug may no longer outweigh its risks.” The company reformulated the drug in 2012 to make it more difficult to snort, but the FDA said that move actually led to more injections — and a major HIV outbreak. FDA Commissioner Scott Gottlieb, who has pledged to take “more forceful” steps to curb the nation’s opioid epidemic, said the agency’s action reflects its increased focus on the risks posed by the illicit use of opioids. The FDA “is looking broadly at the whole policy framework” used for the painkillers, he said Thursday. The medication was approved in 2006 for moderate to severe pain when a round-the-clock painkiller is needed. During the drug’s reformulation, Endo introduced a coating designed to deter people from crushing and snorting the medication. But the FDA declined to give it an “abuse deterrent” label, saying the data didn’t support such a designation. The FDA said Thursday that subsequent data showed a “significant shift” in the route of abuse “from nasal to injection” after the reformulation. Increased needle-sharing of the drug has since been linked to serious blood disorder cases in Tennessee in 2012 and a 2015 outbreak of HIV and hepatitis C in Indiana, officials said. In March, an FDA advisory committee voted, in an 18-to-8 decision, that the benefits of the reformulated Opana ER no longer outweighed the risks it posed. “The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak,” Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, said in a statement Thursday. “When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market.” If the company declines to remove the product, the FDA will take steps to formally require its removal by withdrawing agency approval. In a statement, the company said it was reviewing the FDA’s request but that it “remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients.” Michael Botticelli, director of the Office of National Drug Control Policy for nearly three years under President Barack Obama, said the FDA action is “a real encouraging step. It sounds as if the FDA is using expanded criteria in the way they look at opioids.” The agency has been criticized in the past for examining the safety and effectiveness of individual opioid painkillers without considering the wider effects each could have on the nation’s epidemic. “This falls in line, I think, with their recently released guidance on how they were going to think of drugs and drug approval,” Botticelli said. From 2000 to 2015, nearly 180,000 Americans died of overdoses of prescription opioids, and tens of thousands more have succumbed to heroin and fentanyl overdoses as the crisis has evolved. Opana ER brought in $158 million in sales last year for Endo, a 10 percent drop from 2015 because of generic competition, according to FiercePharma, a trade site. The company, which is based in Dublin and has its U.S. headquarters in Malvern, Pa., recently announced two rounds of job cuts.

Katrina vanden Heuvel: The CIA should be looking over its shoulder

For the Central Intelligence Agency’s covert warriors, disdain for the law comes with their mandate. From its drone attacks to its destabilization efforts, the CIA is tasked with operating, as former vice president Dick Cheney put it, “ in the shadows,” trampling international law. The CIA, shielded by secrecy, armored by its national security mandate, pursues its mission with far too little accountability. The agency’s warriors operate on the president’s writ, but presidents generally seek deniability. After Sept. 11, the agency was given a virtually limitless charter to do things that presidents would rather not know about. Congress set up intelligence committees to provide oversight of the agency, but senators, while generally happy to get a peek behind the curtain of secrecy, know better than to probe too far. The peril is apparent. The covert warriors who trample laws abroad in the name of national security are likely to scorn legal limits at home. That is what is at stake in the deepening scandal of the CIA’s subversion of the Senate intelligence committee’s investigation of its shameful and unlawful program of torture during the Bush administration. Amid the charges and countercharges, the truth is clear. The CIA ran these barbarous programs for several years. An agency report later concluded that torture was ineffective. The agency not only suppressed that conclusion; its leaders lied to the Congress about it, while its agents destroyed tapes of the torture sessions. Faced with a serious Senate investigation, the CIA withheld documents and wasted years demanding that outside contractors read and reread an astonishing 6.2 million documents before providing some of them to professional Senate staffers with appropriate security clearances. When the Senate staffers finally produced a 6,000-page report that allegedly documented the program’s brutality as well as its ineffectiveness, the CIA blocked its publication, dissenting from its conclusion. When it was discovered that the Senate staffers had possession of the CIA’s own internal review that reaffirms the report’s conclusions, the agency didn’t go after those who lied to the Congress, it went after the Senate staffers, snooping on their computerized work product and threatening them with investigation and prosecution. The wanton obstruction finally outraged Senate intelligence committee Chairman Dianne Feinstein, who has been a staunch defender of the agency and its covert programs. On matters of national security, like Hillary Clinton, Feinstein would rather be tough than smart. That the CIA’s actions have now outraged even Feinstein reveals that the CIA’s misbehavior has triggered a full-scale constitutional crisis. Through all this, President Obama has been absent without leave. Upon taking office, the president chose to “look forward and not backwards” and declined to prosecute or even fully investigate the perpetrators of the torture operations, arguing that he didn’t want CIA employees “to suddenly feel like they’ve got to spend all their time looking over their shoulders.” Obama not only didn’t dismiss those involved, he named some to higher positions, from CIA Director John Brennan on down. Feinstein is clearly dismayed that the CIA’s acting general counsel, involved with threatening Senate staffers, was previously the chief lawyer for the CIA unit that managed the torture program. The president says he wants the Senate report published but refuses to overrule the agency’s refusal to allow declassification. Brennan defends the CIA’s Senate committee abuses, but the president says he continues to have faith in him. This showdown can’t be ignored. At stake is whether the CIA is accountable to the Congress and the law. At stake is also whether the secret activities of the national security state can in fact overrule the laws of the republic. It is long past time for the president to assert authority over his own administration. Brennan astonishingly claims the CIA has done nothing wrong. But he correctly says the president “can ask me to stay or to go.” Obama should take him up on the latter option while ordering declassification of the Senate report. Beyond that, the Justice Department should be ordered to initiate an investigation of the CIA’s subversion of a legitimate Senate investigation. The perpetrators should be prosecuted and dismissed. And the Senate should bestir itself to assert its constitutional prerogatives. It is long past time for an independent, bipartisan special committee — modeled on the Church Committee that investigated intelligence agency lawlessness in the 1970s — to be chartered to provide a comprehensive investigation of the activities of the intelligence agencies after Sept. 11, revealing the abuses, reviewing the claimed authority and strengthening the legal limits on the secret state. Obama is wrong: We do want the CIA “looking over its shoulder” at the laws of the republic. If the scandals of torture, drones murdering innocents from the sky, kidnapping and rendition, innocents held without charges and without review for years, National Security Agency spying on U.S. citizens and more do not trigger a reassertion of law, then the national security state will grow ever more scornful of the Constitution it is supposed to defend. _Read more fromKatrina vanden Heuvel’s archive or follow her on Twitter._ **Read more on this topic:** Eugene Robinson: The CIA is out of line Dana Milbank: Allegations of CIA spying on the Senate deserve investigation Ruth Marcus: The CIA is its own worst enemy The Post’s View: The CIA should cooperate with the Senate on torture report

In meeting with DEA, NFL says it has a ‘compliance plan’ for prescription drug handling

NFL representatives met with the Drug Enforcement Administration in the District in March and assured officials that a “compliance plan” for handling prescription drugs had been put into effect for all 32 of the league’s teams. The meeting at DEA headquarters, which was revealed by a DEA official in a letter to House lawmakers, came two weeks after the congressmen had asked the agency about its investigation into the NFL’s drug practices. The DEA recently had investigated allegations that teams flouted federal laws that govern the transporting, handling and disbursement of controlled substances. “Currently, DEA is unaware of any new evidence that the NFL member teams travel with controlled substance across state lines,” the DEA official wrote to four Democratic members of the House Energy and Commerce Committee in a letter dated May 24. “And additionally, as of the fall 2015, DEA was advised that NFL team physicians no longer store inventory of controlled substances at NFL facilities.” The lawmakers sent questions in March to the NFL and the DEA after revelations and allegations included in a federal lawsuit charged NFL teams with improperly administering pain medication to players and violating the Controlled Substances Act. While the bulk of the lawsuit was dismissed last month, a handful of claims survived. The NFL responded to the letter in April, saying its teams had begun to change their protocols in 2011 after being warned by the DEA and that it felt its teams now were in compliance with federal laws. “The NFL and DEA responses to our letters raise more questions about the troubling allegations that teams may have been overusing medications to alleviate or mask pain, including both controlled substances and the drug Toradol,” Rep. Frank Pallone Jr. (N.J.), the top-ranking Democrat on the committee, said in a statement to The Washington Post. “While it’s encouraging that our inquiry may have sparked the DEA to meet with the NFL about its compliance plans, it’s clear that much more needs to be done to ensure that teams are prioritizing the health and safety of their players, and that they are informed about the risks and side effects of any drugs they are given.” A spokesman for the panel’s Democrats said they were reviewing the NFL and DEA responses before determining any future steps. An NFL representative confirmed the March meeting between the league and the DEA. The DEA’s reply to lawmakers, signed by Matthew Strait, the agency’s head of congressional affairs, did not respond point by point to the questions posed by the House members. The DEA made no mention, for example, of the federal investigation into the league’s drug practices or surprise inspections that occurred in 2014, both points of interest posed in the lawmakers’ letter. The DEA letter noted a meeting held in 2011, in which the agency’s former head of diversion control made a presentation to team medical personnel at the NFL combine. The Post reported in April that the meeting was a contentious one at which many team doctors and trainers learned for the first time that they might be violating the Controlled Substances Act by traveling with prescription pain medications, distributing them at road games or allowing non-physicians to dispense drugs. It wasn’t until 2015, though, that the league instituted a league-wide protocol that utilized local physicians to administer prescription medication to traveling teams. In its April letter to the lawmakers, the NFL assured the committee members that its teams were in full compliance with federal laws concerning controlled substances. Whatever the House committee members choose to do next — if anything — the NFL has provided plenty of background material. One document, previously unreported, is titled “NFL Prescription Drug Advisory Committee Major Findings and Recommendations,” an internal summary document from 2014 that noted “substantial variation exists in reported prescribing behaviors” among its teams. It said drugs were administered and dispensed by people other than physicians and non-players also were being prescribed controlled substances. It also found that “a correlation between prescribing behaviors and injuries could not be determined.”

Ohio is right to sue opioid manufacturers

OHIO ATTORNEY GENERAL Mike DeWine filed a lawsuit against five leading opioid painkiller manufacturers May 31, accusing them of misleadingly minimizing the real addiction risks associated with the powerful pills, thus triggering the nationwide epidemic of opioid addiction and death. Mr. DeWine brought his case in an Ohio state court, choosing as his venue the courthouse in Chillicothe, a small city whose struggle with the addiction crisis was the subject of a heartbreaking report by The Post’s Joel Achenbach. This suit joins similar efforts against the drug companies filed by jurisdictions as different as Everett, Wash., which has charged Purdue Pharma with failing to blow the whistle on massive diversion of its product to that city’s black market, and the Cherokee Nation, which is suing pharmacy chains and their wholesale suppliers on similar allegations. We hasten to add that all of the companies accused, Purdue Pharma included, deny any wrongdoing, and argue that they work hard to comply with federal regulations and prevent the improper use of their products. It is also true that, even though the opioid lawsuits are often compared to the litigation that ultimately held Big Tobacco accountable, prescription opioids have legitimate health uses, unlike cigarettes. The fact remains, however, that more than 183,000 people have died in the United States from overdoses related to prescription opioids between 1999 and 2015, according to the federal Centers for Disease Control and Prevention. Such deaths were rare prior to the 1990s, when prescription opioids became commonly prescribed for non-cancer pain — at the urging of the pharmaceutical industry’s marketing teams. Mr. DeWine’s lawsuit and others like it might not be equivalent to the tobacco lawsuits, legally or morally, but they express widespread and understandable public feeling. They amount to a cri de coeur in the courtroom. Whether these uphill legal battles actually succeed or not, we hope litigation pressures everyone in the prescription opioid supply chain to reveal more clearly what they knew, and when they knew it, about the addictive properties of these products and their mass diversion into dubious “pill mills.” Perhaps the states won’t achieve a settlement on the scale of the $206 billion tobacco case, but there’s an opportunity to make industry pay more of the costs of addiction prevention and treatment, which are imposing tremendous hardship on local governments across the country. Alas, any accountability imposed through litigation is necessarily retrospective — which means unsatisfactory. We have an opioid crisis in large part because gatekeepers at every level — from the Food and Drug Administration to the medical profession — either could not or would not prevent it. These institutions have awakened to the mistakes they made in the past, and have set about correcting them, in some cases as zealously as they once promoted opioids. Resort to the state courts, in that sense, represents not even a second-best solution to the opioid crisis, or even a third-best. Perhaps, though, by administering justice, however rough or limited, the suits can reinforce the bitter lessons of this avoidable crisis, thus helping assure it is never repeated. **Read more on this topic:** Charles Lane: Who is to blame for the opioid epidemic? The Post’s View: To solve an opioid ‘state of emergency,’ Maryland starts very small Corey Stewart and Frank Wagner: GOP hopefuls for Va. governor debate Metro, the opioid epidemic, Confederate statues The Post’s View: In Maryland, a measure to ease the opioid epidemic Charles Lane: A mega-case puts opioids on trial

Nominee to head FDA joined effort to get a drug company more fentanyl

In December 2006, Scott Gottlieb did something unusual for a deputy commissioner of the Food and Drug Administration: He joined other FDA officials who tried to help a pharmaceutical company secure more fentanyl for a powerful painkiller product. The company, Cephalon, was running short of the opioid it put in a lollipop designed for the intense pain of some cancer patients, according to interviews and documents obtained by The Washington Post. But Cephalon was also under investigation at the time for illegally pushing doctors to prescribe the drug for other uses, from headaches to back pain. Gottlieb is the Trump administration’s nominee to head the FDA. While his exact role in the episode is in dispute, his critics contend that his participation demonstrates the kind of friendly relationship with the pharmaceutical industry that they fear he will create at the FDA if he is confirmed. “When the prescription opioid epidemic was exploding, it appears Dr. Gottlieb advocated to put even more addictive fentanyl onto the market when it wasn’t appropriate or necessary,” said Sen. Edward J. Markey (D-Mass.), who has previously criticized Gottlieb’s ties to the drug industry. “We cannot have a leader at the FDA who has aided and abetted the prescription drug and heroin epidemic by pushing more addictive, deadly opioids onto the American public.” Markey’s office has asked the Drug Enforcement Administration for documents related to the episode, in which Cephalon’s request was ultimately rejected. Gottlieb declined to comment, citing the long-standing tradition of staying silent before a Senate committee vote on his nomination, which is scheduled for Wednesday. But Sheldon Bradshaw, a former FDA attorney, said Gottlieb’s role was minimal — confined to a meeting of FDA and DEA officials on Dec. 8, 2006, and only because protocol called for a deputy commissioner to be present given the participation of similarly high-level DEA representatives. In any event, Bradshaw added, Gottlieb’s responsibility was to help the FDA protect legitimate pain patients from possible shortages of critical analgesics. “The FDA isn’t there to shill on behalf of Cephalon. They’re there to inform the DEA what the medical needs are,” he said. The FDA itself had opened an investigation of Cephalon, but it is unclear whether Gottlieb or the other officials were aware of it at the time they met with the DEA. The month before the meeting, reports of a probe by the Connecticut attorney general had surfaced in the Wall Street Journal. Gottlieb has said he will recuse himself from agency decisions for a year involving more than 20 companies he has worked for, invested in or had some other kind of financial relationship with, according to his federal ethics filings. That includes two big pharmaceutical firms, GlaxoSmithKline and Bristol-Myers Squibb. He also has said he would resign as a member of Glaxo’s product investment board. There is no evidence in Gottlieb’s financial disclosure statements that he has accepted any payments from Cephalon, which was acquired in 2011 by Teva Pharmaceuticals. The company did not respond to requests for comment. In a document submitted to a Senate committee as part of the confirmation process and obtained by The Post, Gottlieb wrote that “none of my actions were undertaken on behalf of, or intended to benefit, a particular person or company. Rather, my role was to represent the agency’s public health positions.” Gottlieb called publicly in 2012 for the DEA to relinquish its control over the manufacture of drugs that contain controlled substances and transfer that authority to the Department of Health and Human Services. Cephalon pleaded guilty in 2008 to illegally promoting the fentanyl lollipops — marketed under the name Actiq — and two other drugs, and paid a $425 million fine. The Justice Department said the company instructed its large sales force to focus on physicians other than oncologists and to promote Actiq for a wide variety of pain despite the restrictions imposed by the FDA. According to court papers in a related case, just 1 percent of the prescriptions filled for Actiq in the first six months of 2006 were written by cancer doctors. The company’s revenue from the drug soared in just a few years. “Whoever is in charge of the FDA must put the people’s safety over drug company profits,” said Sen. Sherrod Brown (D-Ohio), who has joined Markey in criticizing Gottlieb. Since long before the opioid crisis mushroomed into the epidemic it is now, the FDA and the DEA have fought over whether the public needs more narcotics. (The fentanyl responsible for a surge in overdose deaths in the past few years is almost entirely a synthetic black-market version, not the drug produced for medical use.) The DEA controls the annual “quota” of drugs containing controlled substances that are produced in the United States each year, and it assigns each manufacturer a certain portion of that allotment. The 2006 fight between the two agencies over a possible shortage festered for months. Cephalon told FDA that it was running low on fentanyl because it was trying to produce its own branded Actiq as well as supplying two generic companies with versions of the lollipop, according to a letter from Steven Galson, then director of FDA’s Center for Drug Evaluation and Research, which monitors the U.S. drug supply. And the company had to destroy a sizable quantity of the painkiller because of a manufacturing problem, it said. The FDA agreed. “This will result in a shortage which is anticipated to last approximately 10 weeks,” Galson wrote in a letter to a DEA official obtained by The Post. The DEA was not convinced. The agency also met with Cephalon and said the public faced no shortage of the painkiller, because Cephalon had enough on hand and the two generic companies had more, according to a letter from then-Deputy Administrator Michele Leonhart to the FDA. It warned the FDA not to declare a shortage of Actiq or to suggest the use of another Cephalon fentanyl product, Fentora. The episode was curious for another reason. The meeting came little more than three weeks before the start of 2007, when Cephalon would gain access to its full fentanyl quota for the next calendar year. Leonhart said she had difficulty understanding why Cephalon needed more fentanyl with so little time remaining until 2007. “We find no basis to conclude that Cephalon must be given additional quota to use over the remaining 18 days of 2006,” she wrote. Alice Crites contributed to this report.

House Ethics Committee investigating Rep. Michael Grimm

The House Ethics Committee announced Monday that it has formally opened an investigation into Rep. Michael Grimm (R-N.Y.), but will defer to the ongoing Justice Department probe of the Staten Island Republican’s fund-raising activities. The committee, voting unanimously this month, said it would investigate allegations that in his first congressional bid in 2010, Grimm broke campaign finance laws by using a system of straw donors and promised an Israeli national help in obtaining a green card in exchange for helping solicit donations from a large New York synagogue. Federal prosecutors have charged Ofer Biton, the former Grimm fundraiser, with violating immigration laws, but are also probing whether he helped Grimm exceed campaign donation limits and allowed foreign nationals to donate to his campaign. Additionally, investigators are examining whether Grimm, a former undercover FBI agent who retired in 2006, went into business with a restaurateur with ties to organized crime. The Office of Congressional Ethics, the quasi-independent investigators who conduct preliminary reviews, advised the full ethics committee to dismiss the matter because it “could not establish with a sufficient certainty that a violation occurred” when Grimm served in Congress, the ethics committee wrote Monday.      The committee rejected that proposal based on precedent in which lawmakers have been rebuked for inappropriate actions in pursuit of their first term in Congress. “The committee unanimously voted to continue to assert jurisdiction over matters relating to a successful campaign for election to the House,” wrote Reps. Jo Bonner (R-Ala.) and Linda Sanchez (D-Calif.), the chairman and ranking member, respectively, of the evenly divided 10-member committee. The panel’s announcement that it will defer to the Justice Department falls in line with other recent investigations, including most recently its probe of former representative  Jesse Jackson Jr. (D-Ill.) and his efforts to secure the appointment to the Senate seat that was vacated when then-Sen. Barack Obama won the presidency four years ago. The ethics panel started a probe but stood down as the U.S. attorney’s office in Chicago led an investigation into the matter. Jackson announced his resignation from office Wednesday amid ongoing inquiries into that matter and a related investigation of alleged misuse of campaign funds. Though Democrats hoped to raise doubts about Grimm by highlighting the ongoing investigations, he won reelection this month just days after his district was ravaged by the affects of Hurricane Sandy. Grimm quickly emerged as a visible and frequent spokesperson for his displaced constituents on national television shows and toured storm damage alongside more popular federal and New York-area political figures. **Update, 1:20 p.m.:** Grimm’s legal team welcomed the decision as a next step in their defense: “Today’s announcement by the House Ethics Committee comes as no surprise.  We appreciate the Committee’s decision to defer consideration of this matter while we continue to work with the Department of Justice to favorably resolve the false allegations against Congressman Grimm,” William McGinley, a lawyer with Patton Boggs representing Grimm, said in a statement. “Any fair and objective review of all of the facts in this matter will conclude that Congressman Grimm engaged in no wrongdoing.  We are confident that the Department of Justice and the Ethics Committee will reach that result.” _Share your thoughts in the comments section below._ **Read more atPostPolitics**

The Washington Post examines addiction in America

As the country grapples with the opioid epidemic, The Washington Post hosts ‘Addiction in America,’ bringing together policymakers, researchers and health care experts to examine the roots of the country’s opioid crisis and discuss solutions for combating addiction in America. They will discuss the role of doctors in managing patients’ pain and helping to fight the epidemic and describe what’s being done to reduce the abuse of opioids as recreational drugs and address questions like: How might Congress and the Trump Administration take action? Will new recommendations for prescription drug practices be adopted and will they be effective? What measures might be used to prevent addiction and what new treatments could curb addiction rates?   The Washington Post’s “Addiction in America” is presented by Battelle with support from Georgetown University McDonough School of Business.

Lawmakers wrestle with who is responsible for Flint water crisis

A key congressional committee on Wednesday launched its investigation into the Flint, Mich., water crisis with its Republican chairman issuing subpoenas to force depositions from two officials, while Democrats complained the state’s governor has not been called to testify for political reasons. House Oversight and Government Reform Chairman Jason Chaffetz (R-Utah) accused the two officials of not being cooperative and was particularly critical of Flint emergency manager Darnell Earley, whose lawyer declined to accept an earlier subpoena seeking his testimony before the panel. “We’re calling on the U.S. marshals to hunt him down and give him that subpoena,” he said at a hearing, sparking a round of applause. Participation before the oversight committee “is not optional,” he noted, adding that when people are invited, “you show up.” A subpoena is also being issued for Susan Hedman, the EPA’s former region 5 administrator, which oversees Flint. She has been criticized for trying to keep the contamination crisis under wraps – criticism Chaffetz appeared to echo by reading from several emails between EPA and state officials. Democrats on the committee accused Republicans of playing politics with a public health catastrophe, by refusing to compel similar testimony from Michigan Gov. Rick Snyder (R) and officials he tapped to run Flint. “We are missing the most critical witness of all,” said the committee’s ranking Democrat, Rep. Elijah Cummings (Md.), referring to Snyder and presenting Chaffetz with a letter from committee Democrats demanding he organize another hearing featuring the governor and former Flint emergency managers. “If we act selectively for political reasons then we become a part of the problem.” Congress is investigating the Flint water contamination crisis in the wake of a national outcry over revelations that lead in drinking water hit extremely high levels after the city switched its water source in April 2014 from Detroit’s water system to the local Flint River. The river water proved highly corrosive to the city’s lead pipes, leading to health problems in the city, especially among children.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico [ _Flint mayor calls for the rapid replacement of city’s lead service lines_ ]    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Chaffetz said he planned to scrutinize officials at every level and did not rule out calling Snyder to testify. “I’m disappointed in the response at the local level, at the state level and at the federal level,” he said. “This is a failing at every level.” The subpoenas require Hedman and Earley to give depositions to the committee this month, and Chaffetz suggested more hearings would follow.  The committee is expecting the EPA to produce more of Hedman’s communications and documents by the end of the week. [ _Flint’s water crisis reveals government failures at every level_ ]    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Earley’s lawyer objected to the idea his client, who oversaw the water-system change as Flint’s former emergency manager, was holding out on the committee. “We aren’t running from anybody and we’re not hiding anything,” A. Scott Bolden said in an interview. The subpoena to compel Earley to appear before the committee on Wednesday at 9 a.m. was delivered Tuesday at 6 p.m., a “completely unreasonable” turnaround, he argued, given that Earley is in Michigan. Bolden said the threat to send out U.S. marshals is overblown because he has already told the committee, in writing, that he would accept service of the next subpoena and his client would willingly testify. “He wants to tell his story, he wants to set the record straight,” Bolden said, arguing that Earley, perhaps better than anyone, could enlighten the committee about the chronology of which people and agencies at various levels of government made decisions about Flint’s water. Who bears primary responsibility for the crisis was the key question and point of contention throughout Wednesday’s four hour-long hearing. Republicans, led by Chaffetz, were clearly laying the blame at the EPA’s doorstep. “We’ve had something festering at the EPA for a long period of time, and often when there’s smoke, there’s a bigger fire,” Chaffetz said. He cited a series of emails showing Miguel del Toral, the program manager in the EPA region that oversaw Flint, had alerted other EPA officials to unsafe levels of lead in drinking water and that Flint had not been taking steps to control corrosion of its pipes. The emails also indicated that Hedman, later, had urged Flint’s mayor to discount such warnings, because the report was still only in the draft stage. “It’s important for the EPA to tell the public that they’re poisoning their kids if they drink the water,” Chaffetz said. “Why didn’t they do it? They sat on it for almost a year.” Democrats said they supported Chaffetz’s decision to hold the EPA to task, but warned that responsibility for the crisis should lie primarily with the state government. “When we talk about failure of government at every level, let’s just be clear about one point, one very important point: every decision that was made for the city of Flint was made by a state-appointed emergency manager,” said Rep. Dan Kildee (D-Mich.), a native of Flint who testified before the committee Wednesday. “There’s an effort to create false equivalency of responsibility,” he added. Kildee argued that the committee should push Michigan to “make it right for the people of Flint” – not simply by assigning blame, but by ensuring there are resources to fix the city’s water infrastructure and provide care for the children who were poisoned by the lead. Senators are currently wrestling with an amendment that would provide $600 million in emergency spending to Flint, $400 million of which would only be made available if Michigan matches the money dollar for dollar. Michigan’s U.S. senators, Democrats Debbie Stabenow and Gary Peters, filed the amendment to an energy bill currently being considered on the Senate floor, but Republicans are insisting that any additional spending be offset. Kildee argued Wednesday that Michigan should be shouldering the cost of remedying the situation. “We need the pipes fixed in Flint. In fact, the governor should write a check tomorrow for the $60 million that the mayor has asked for… he’s sitting on a billion-dollar surplus,” Kildee argued. In addition, he said the Michigan government should pay for early childhood education, good nutrition and any other developmental assistance necessary to help children affected by contaminated drinking water. Other lawmakers suggested Congress should find money to help families beyond Flint, noting that other cities have grappled with water contamination crises. “We should set aside a fund or whatever, because we should make certain these kids are being taken care of,” said Rep. John Mica (R-Fla.), recalling the discovery of lead in Washington, D.C.’s water supply a decade ago. The initial decision to change Flint’s water source was done to save money while the city was facing an economic troubles. Experts testifying before the committee said the city could have avoided the crisis by adding phosphates to the water supply when they switched water sources, as legally required. This would have cost $80 to $100 a day, they said. “In general, corrosion control, for every dollar you spend on it, you save $10,” said Marc Edwards, a municipal water expert and professor of civil engineering at Virginia Tech. “But in Flint’s situation, every dollar you spend on it, you would have saved $1,000.” These numbers struck a chord with lawmakers. “For that much money, we poisoned the kids in Flint, didn’t we,” Mica said. State officials testifying before the committee admitted more should have been done. “It’s highly unusual across this country to go from one water source to another. And so the rigor should have been more when the water source changed,” said Keith Creagh, the director of Michigan’s Department of Environmental Quality, agreeing with lawmakers that that the crisis could have been avoided. “We were minimalistic and legalistic in our behavior,” Creagh said. Creagh added that he could not guarantee at this time the water in Flint was safe to drink.

Trump picks Indiana Health Commissioner for surgeon general

President Trump on Thursday nominated Indiana Health Commissioner Jerome M. Adams to become the next U.S. surgeon general, a move that would place Adams in the symbolically important post while the president’s bid to replace the Affordable Care Act tops his agenda. Adams would succeed Vivek H. Murthy, who was appointed during the Obama administration and was fired in April. If confirmed by the Senate, which is controlled by Republicans, Adams would become another prominent health official from Vice President Pence’s home state to take a high-profile post in the Trump administration. Seema Verma, a former health policy consultant who crafted Indiana’s unusual Medicaid expansion rules, now heads the federal Centers for Medicaid and Medicare Services. An anesthesiologist, Adams may be best known in recent years for responding to an HIV outbreak soon after he took his post in late 2014. The outbreak left 181 people infected in a sparsely populated rural Indiana county. _ _ The outbreak in Scott County was traced largely to needle-sharing among people who were illegally injecting the prescription opioid Opana. Adams and Pence came to see the value of needle exchange programs in fighting the outbreak, despite a state ban on the practice. The governor declared a public health emergency in March 2015 and dropped the prohibition temporarily. The ban was later ended, and other Indiana counties have adopted needle exchanges. Adams tweeted Thursday that he was “truly honored” to be nominated for the post. A spokesman for the U.S. Department of Health and Human Services said Adams would not be speaking to the media before his confirmation hearing. The American Public Health Association said in a statement that Adams “has worked on the front lines of public health in Indiana, and his status as a working physician will serve him well in leading our nation’s health promotion and disease prevention efforts.” Sometimes known as the “nation’s doctor,” the surgeon general has little power beyond the ability to call attention to serious public health problems and offer information and policy suggestions. He or she oversees the U.S. Public Health Service Commissioned Corps, more than 6,600 uniformed public health- care personnel who work in various parts of the federal government. Some surgeons general, like C. Everett Koop, who rallied the country against smoking and AIDS in the 1980s, became influential. Murthy produced a landmark report on drug and alcohol addiction in November that placed it alongside other public health crises of the past 50 years. Adams would serve a four-year term if confirmed. As part of efforts to repeal the Affordable Care Act, Trump and the GOP are seeking to reverse the expansion of Medicaid, which Indiana adopted before the passage of the ACA and later continued after the passage of the law. The expansion extended coverage to many of the people in Scott County who otherwise would not have had it, according to a study published in July, 2016 in the New England Journal of Medicine. Adams also worked to tamp down panic in the United States over the Ebola outbreak in West Africa, which Trump stoked with inaccurate tweets and demands to halt flights from the affected region to this country. Rear Admiral Sylvia Trent-Adams has been holding the surgeon general’s post on an interim basis since Murthy’s departure.

House panel rejects White House claim of immunity from subpoena

A House panel on Friday officially rejected the Obama administration’s claim that White House political adviser David Simas is immune from a congressional subpoena, setting up a potential contempt battle.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday The Republican-led House Oversight and Government Reform Committee voted along party lines to approve a resolution saying that the White House has “denied committee members and the American people an opportunity to hear from the head of an office that has — under several previous administrations — misused government resources for political purposes.” Rep. Elijah Cummings (Md.), the ranking Democrat on the panel, agreed that the White House does not have absolute immunity from congressional subpoenas, but he said that “this is the worst possible case with which to try our position.” Democrats said Republicans lack justification for the Simas subpoena, noting that they have offered no evidence of potential wrongdoing. He and other Democrats on the panel said GOP lawmakers are trying to launch a “fishing expedition” to find potentially damaging information. Committee chairman Darrell Issa (R-Calif.) said the committee has a responsibility to examine the White House political affairs office, but he acknowledged that the panel has no evidence of wrongdoing. “We are accusing neither the president nor this four-person office of any wrongdoing,” he said. Republicans noted that White House political offices have a history of Hatch Act violations during previous administrations. They also pointed out that one of President Obama’s past Cabinet members, former Health and Human Services secretary Kathleen Sebelius, was found to have run afoul of the federal statute, which governs the political activities of federal employees and officials. The Sebelius incident occurred at a time when the White House political office was inactive. Obama closed the office in 2011 and reopened it in January 2014. U.S. Special Counsel Carolyn Lerner said in a letter to Cummings on Thursday that the Obama White House’s political office appears to be complying with Hatch Act restrictions “[t]o the extent that OPSO’s activities are limited to those described in the White House correspondence [with the oversight committee].”    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday Lerner also said that her office “has not received any allegations that Assistant to the President David Simas or anyone in OPSO has violated the Hatch Act.” Issa on Thursday offered the White House a chance to make Simas available for deposition rather than having him appear publicly before the committee.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday Cummings recommended that Issa continue negotiating with the White House to obtain information from the political office rather than pressing forward with the subpoena.

Senate probe creates tension with CIA, agents

For a government worker, nothing concentrates the mind quicker — or makes you at first angry and later perhaps more cautious — than the prospect that you might go to jail for doing your job. It’s a reminder from the conflict between the Senate Select Committee on Intelligence and the CIA over the panel’s more-than 6,300-page report on the CIA’s coercive interrogations during the administration of President George W. Bush. They included waterboarding and other torture-like methods. From 2008 through 2012, CIA officers and contractors faced a criminal investigation by a Justice Department special prosecutor for their roles in what now is considered torturous interrogations, as well as the 2005 destruction of 92 video recordings of some of those activities. The interrogation methods were approved by Bush and his Justice Department attorneys in 2002, 2003 and 2004. CIA attorneys did not object when told that the tapes were being destroyed, because they had been initiated to make certain that the DOJ’s rules were followed and there were operational reports covering what they showed. In November 2010, special prosecutor John H. Durham decided there would be no prosecution for the tape shredding. In June 2011, Durham concluded that most torture and interrogation allegations should not be prosecuted, but he continued looking at two cases in which CIA prisoners died in custody. In August 2012, the DOJ said no charges would be brought in those cases. For CIA officers who faced years of investigation, it was a repeat of past instances when a new administration took issue with previous directives and sought to punish agency personnel rather than the former top officials who had approved those activities. Today, Senate intelligence panel staff members as well as CIA officers and perhaps contractors could be potential subjects of a preliminary DOJ criminal inquiry into the handling of the so-called “Panetta Review,” a set of controversial classified documents that fell into the hands of Senate investigators working on the panel’s probe. Under a 2009 arrangement with the panel, the CIA agreed to provide detailed operational cables, internal e-mails and messages relative to the interrogations. They went into an electronic database for Senate staffers situated in a rented, secure office outside agency headquarters. The CIA also set up secure computers for Senate staffers in that office that could download documents the agency fed into the database. The Senate computers were walled off from the CIA system and available only to Senate investigators. Former CIA director Leon Panetta and other past and present CIA officials say there was no Panetta Review. Instead, starting in 2009, an administrative record was to be made of documents as batches were fed into the committee’s database. Each was to list the documents transferred along with a short factual summary written by a CIA employee or contractor. In some cases, however, a mid-level supervisor added some analysis such as what the committee might conclude based on those facts — such as the use of techniques not approved by the DOJ. Those summaries were never approved or read at higher agency levels. According to the CIA, this cataloging ended in late 2010 after CIA attorneys discussed with Durham, the special prosecutor, that creating more documents could complicate his probe. Documents were made available to the committee database through mid-2012, but no more entries were added to what became known as the Panetta Review. The previously written listed documents and summaries were put in binders and stored away. What’s left are questions and frustrations. As committee Chairman Diane Feinstein (D-Calif.) put it on March 11 in a Senate floor speech, the CIA’s own Internal Panetta Review “corroborates critical information in the committee’s 6,300-page study that the CIA’s official response [provided in June 2013] either objects to, denies, minimizes, or ignores.” That’s being investigated by the DOJ, the CIA’s inspector general and more recently the Senate’s sergeant at arms. Feinstein on March 11 said, “At some point in 2010, committee staff searching the documents that had been made available found draft versions of what is now called the ‘Internal Panetta Review.’ ” In other words, someone sent the documents to the committee database. Feinstein added: “We have no way to determine who made the Internal Panetta Review documents available to the committee. Further, we don’t know whether the documents were provided intentionally by the CIA, unintentionally by the CIA, or intentionally by a whistleblower.” The CIA first heard about the documents when the committee in January 2013 requested the final version of what it referred to as the Panetta Review. CIA officials then realized that the committee already must have some of the documents. Feinstein said in her March speech that she requested in December 2013 “that the CIA provide a final and complete version of the Internal Panetta Review to the committee, as opposed to the partial document the committee currently possesses.” The CIA inspector general had begun an investigation because apparently an unauthorized disclosure had taken place. The CIA formally turned down the committee request, claiming the documents were internal papers. The CIA in early January searched for the Panetta Review documents not only in the database provided to the committee but also the committee’s walled-off computers in the secure facility. CIA Director John Brennan on Jan. 15 told Feinstein about the search, saying it followed an allegation that a committee staffer had hacked into the CIA system to get the documents. Feinstein was angry at the CIA search. Early in 2010 the agency was caught having twice removed hundreds of documents from the database. The CIA denied it, but the issue went to the White House, where the matter was settled and the CIA apologized. The CIA’s inspector general is looking within the agency into how the committee obtained the documents . So is the Senate’s sergeant at arms. The DOJ has been asked to look into the matter. The CIA also has sent a crimes report to the DOJ based on committee staffers copying their version of the documents and taking it to Capitol Hill. The DOJ is not expected to act on that crimes report. Probably not until at least the committee’s executive summary — now about 500 pages — is declassified by the White House and released. CIA officers and contractors go through another round of investigations for what happened a decade ago. If more accountability is required, start with Bush and his vice president, Dick Cheney. Meanwhile, the committee and the CIA continue to do business — but with a new level of tension.

House panel finds no intelligence failure in Benghazi attacks

An investigation by the Republican-led House Intelligence Committee has concluded that the CIA and U.S. military responded appropriately to the attacks on U.S. facilities in Benghazi, Libya, in 2012, dismissing allegations that the Obama administration blocked rescue attempts during the assault or sought to mislead the public afterward. After a two-year probe that involved the review of thousands of pages of classified documents, the panel determined that the attack could not be blamed on an intelligence failure, and that CIA security operatives “ably and bravely assisted” State Department officials who were overwhelmed at a nearby but separate diplomatic compound. The committee also found “no evidence that there was either a stand down order or a denial of available air support,” rejecting claims that have fed persistent conspiracy theories that the U.S. military was prevented from rescuing U.S. personnel from a night-time assault that killed U.S. Ambassador Christopher Stevens and three other Americans. The House panel faulted preliminary assessments by the CIA and other agencies on what had caused the attacks and motivated militants, leading to erroneous public assertions by then-U.S. Ambassador to the United Nations Susan Rice that the assault had erupted from a spontaneous protest. The White House effort to assemble her talking points was deemed “flawed.” But overall, the panel’s findings were broadly consistent with the Obama administration’s version of events. Previous investigations have reached similar conclusions, but the House committee’s report may be seen as more credible by critics of the administration’s handling of Benghazi because the panel is controlled by Republicans. “We concluded that all the CIA officers in Benghazi were heroes,” the ranking Republican of the committee, Rep. Mike Rogers (Mich.) and ranking Democrat Rep. C.A. Dutch Ruppersberger (Md.), said in a jointly issued statement. “Their actions saved lives.” Rep. Adam B. Schiff (D-Calif.), a member of the committee, expressed “hope that this report will put to rest many of the questions that have been asked and answered yet again” about the Benghazi attacks. The investigation involved a review of thousands of pages of intelligence assessments and internal administration e-mails, as well as interviews with senior intelligence officials, security personnel and eyewitnesses to the attacks. Earlier this year, the United States captured one of the militants accused of orchestrating the attacks in a raid in Libya. Ahmed Abu Khatalla now faces trial in the United States. In addition to Stevens, foreign service officer Sean Smith and CIA security contractors Tyrone S. Woods and Glen Doherty were killed. The committee concluded that there was no intelligence failure prior to the attacks, and that militants with links to al-Qaeda were involved. But more than two years later, it said, “the intelligence was and remains conflicting about the identities, affiliations, and motivations of the attackers.”

The days of freely prescribed painkillers are ending. Here’s what’s next.

For more than a decade, doctors, dentists and nurse practitioners liberally prescribed opioid painkillers even as evidence mounted that people were becoming addicted and overdosing on the powerful and addictive pain medications. Now, in the face of a prescription drug overdose epidemic that killed more than 14,000 people in 2014, a handful of states are insisting that health professionals do a little research before they write prescriptions for such highly addictive drugs as Percocet, Vicodin and OxyContin. “We in the health-care profession had a lot of years to police ourselves and clean this up, and we didn’t do it,” Greg Jones, an addiction specialist, says in an online training course he gives fellow doctors in his home state of Kentucky. “So the public got fed up with people dying from prescription-drug abuse and they got together and they passed some laws and put some rules in place.” By tapping into a database of prescriptions for opioid painkillers and other federally controlled substances, physicians in Kentucky can check patients’ use of opioids and of combinations of potentially harmful drugs, such as sedatives and muscle relaxants, to determine whether they are at risk of addiction or overdose death. Prescribers also can determine whether patients are “doctor shopping” — receiving painkillers or other controlled substances from several sources at once. Such patients are at high risk for addiction and overdose and may be selling drugs illicitly. In 2012, Kentucky became the first state to require doctors and other prescribers to search patients’ prescription-drug histories on an electronic database called a prescription drug monitoring program (PDMP) before prescribing opioid painkillers, sedatives and other addictive drugs. Sixteen states — including, as of last month, Maryland — have enacted similar laws, and national experts, including the Centers for Disease Control and Prevention and the White House Office of National Drug Control Policy, are encouraging others to do the same. The American Medical Association supports physician use of drug-tracking systems to identify potential addiction and the diversion of drugs into the black market. But some state medical societies have argued against mandatory measures that they say interfere with the practice of medicine. Patients’ privacy and need to ease pain, they say, could be jeopardized by requiring physicians to investigate potential abuse of pain medications. Despite such objections, more states are imposing the requirements. “Comprehensive mandates are the single most effective thing states have done to curb opioid prescribing, and it seems to have an almost instantaneous effect,” said John Eadie who has evaluated state programs at Brandeis University’s Prescription Drug Monitoring Program Center of Excellence in Massachusetts. In states where physicians are required to use monitoring systems, overall opioid prescribing has plummeted, as have drug-related hospitalizations and overdose deaths, Eadie said. States also are seeing a rise in addiction treatment as more doctors refer patients to treatment after discovering they are taking painkillers from multiple sources and are probably addicted to them. In Kentucky, hydrocodone (Vicodin) prescribing dropped 13 percent, oxycodone (Percocet) dropped 12 percent, oxymorphone (Opana) dropped 36 percent and tramadol (Ultram) dropped 12 percent between 2012 and 2013, the first year the law was implemented, according to an analysis by the University of Kentucky’s College of Pharmacy. Since the law was passed, overdose hospitalizations declined 26 percent, and prescription opioid deaths dropped 25 percent, the first reduction in nearly a decade, according to a March 2016 report by Shatterproof, a national advocacy organization that promotes prevention and treatment of drug addiction. In another effort to stem overprescribing of opioid painkillers, the CDC in March issued national opioid prescribing guidelines. The guidelines are not compulsory, but CDC recommendations are influential. Along with patient education, the testing of urine samples to detect drug abuse and the use of opioids formulated to deter abuse, the federal agency recommended that prescribers check prescription databases to reduce the risk of overdose and addiction. Monitoring systems for prescription drugs have existed since the 1930s, and every state except Missouri has some type of system. But the rules governing who has access, how quickly pharmacies must enter dispensing data and which medications are included vary widely from state to state. In Kentucky, doctors and some patients complained about the requirement when it was adopted, said Van Ingram, Kentucky’s director of drug control policy. But these days, he said, he mostly hears doctors saying, “Wow, I treated that patient for 20 years and had no idea he had a drug problem.” Before Kentucky physicians were required to check the database, patients commonly visited multiple doctors to get prescriptions for opioid painkillers, the sedative Xanax and the muscle relaxant Soma, according to David Hopkins, director of the database. “The cocktail” of these three drugs, as it’s known in Kentucky, produces a high that is similar to heroin and just as deadly. It has become much less prevalent since the law was enacted. The number of people receiving the components of the cocktail has dropped 30 percent since the law took effect, Hopkins said, and the number of doctor shoppers has dropped 52 percent. Kentucky’s rules, which were developed by the state Board of Medical Licensure, allow doctors to have a delegate review patients’ drug profiles. Doctors typically ask their assistants to run prescription-drug histories on all the patients they will see the next day and add the information to their electronic medical records, said Michael Rodman, director of Kentucky’s licensure board for physicians. If a potential problem is detected, prescribers can query the database to determine how other physicians in the state are addressing the pain needs of similar patients and they can discuss an individual patient’s drug history with another prescriber, something that was forbidden under previous state privacy laws. To increase the effectiveness of drug monitoring programs, Kentucky and other states use reciprocal agreements to allow interstate sharing of drug dispensing information for pharmacists, law enforcement and physicians in nearby states. Kentucky has agreements with at least 12 other states. New Jersey Gov. Chris Christie, a Republican, announced in April that New York had joined his state in sharing PDMP information, along with Connecticut, Delaware, Minnesota, Rhode Island, South Carolina and Virginia. As for what happens when physicians discover people who are obtaining drugs from multiple doctors, Rodman said, they often dismiss the patients and no longer treat them. But Jones, who heads the Kentucky Physicians Health Foundation, which supports doctors with substance use disorders, tells doctors not to do that to patients. “Maybe you don’t keep prescribing them 90 OxyContins with five refills,” he said, “but don’t throw them out. If you do, you’re missing an important opportunity to save a life.” ** — Stateline ** **Read more:** Deaths from opioid overdoses set a record in 2014 CDC urge doctors to curb opioid prescriptions: “The benefits are unproven.”

Trump ignores his own commission’s advice on opioids

CREDIT PRESIDENT TRUMP with appropriate timing. On the day that updated government statistics confirmed that deaths from opioid overdoses continued to set records in 2016, he convened a meeting on the issue at his New Jersey vacation spot. Whatever welcome sense of urgency might have been demonstrated by that decision, though, was quickly undercut by what the president said during the public portion of the gathering. After an appropriate nod to prevention, which is indeed a potentially efficient means of stemming the epidemic, Mr. Trump launched an extended attack on his predecessor’s record, accusing President Barack Obama’s administration of having reduced drug prosecutions and failing to achieve longer sentences in those drug-related cases it won. Not only did this inject a discordantly partisan note into a subject that had heretofore brought Democrats and Republicans together, but also it was of dubious logic. For much if not most of the Obama presidency, users obtained opioids through _legal_ channels — starting with doctor prescriptions. At least Mr. Obama’s administration sought to clamp down on that through tightened national prescribing guidelines late in his term. Mr. Trump’s promise to deal with the opioid epidemic as a “battle,” in which “strong law enforcement is absolutely vital,” has its place. There must be greater interdiction of deadly fentanyl that comes from foreign suppliers, mainly in China. His own commission on the opioid crisis made that point — but otherwise did not emphasize law enforcement in its July 31 interim report . To the contrary, the commission’s recommendations centered on non-repressive approaches. These include increasing addicted patients’ access to inpatient treatment and medications, enhanced monitoring of opioid prescribing and improved training for health-care providers. Mr. Trump’s comments gave short shrift to the non-punitive side of the ledger. Accompanying the president, Health and Human Services Secretary Tom Price indicated that the administration would not be adopting the commission’s headline recommendation, either: to declare the opioid epidemic a national emergency. So much for what the panel called its “most urgent” advice. To be sure, declaring a national emergency might have a mostly symbolic impact. But it could open some new federal funds for states and permit federal agencies to take otherwise-prohibited steps such as letting Medicaid reimburse for drug treatment in large-scale inpatient facilities. And there is symbolism in rejecting the suggestion, too, in the context of a presidential statement that brushed aside all but one of the panel’s ideas. What it symbolizes is that Mr. Trump may not fully appreciate the work needed to address what has become one of the worst drug-related scourges in U.S. history. **Read more on this topic:** The Post’s View: The FDA takes a stand against an opioid that fueled an epidemic Robert Gebelhoff: An obvious way to fight the opioid epidemic — and make doctors’ lives easier The Post’s View: Ohio is right to sue opioid manufacturers Charles Lane: Who is to blame for the opioid epidemic? The Post’s View: How to reverse a catastrophe

DEA agents had the fun, now boss pays the price

The DEA agents had all the fun, now their boss is paying the price. They partied with prostitutes and took expensive gifts, but it is the Drug Enforcement Administration chief whose head could roll, while some agents got off lightly. A strong bipartisan majority of the House Oversight and Government Reform Committee has taken the unusual step of issuing a statement of “no confidence” in DEA Administrator Michele Leonhart. President Obama nominated her for the job in 2010. Her answers at Tuesday’s long and testy hearing before the Oversight Committee seriously disappointed its members. The next day they released a statement saying that “Leonhart has been woefully unable to change or positively influence the pervasive ‘good old boy’ culture that exists throughout the agency. From her testimony, it is clear that she lacks the authority and will to make the tough decisions required to hold those accountable who compromise national security and bring disgrace to their position. Ms. Leonhart has lost the confidence of this Committee to initiate the necessary reforms to restore the reputation of a vital agency.” White House press secretary Josh Earnest declined to say whether Obama has confidence in Leonhart, which probably means her days are short. “We do have concerns about what’s been reported by the Office of the Inspector General,” Earnest said. “We do have high expectations for those who serve this government and serve the American people.” Here is some of what agents did according to DEA information provided by the Judiciary Committee: • A DEA agent in Bogota, Colombia, a frequent patron of prostitutes, assaulted one in July 2009, leaving her bloody. A case was opened in 2010, and he was suspended for 14 days in 2012. • In February 2010, a DEA employee solicited sex from an undercover police officer in the District. Three years later, he was suspended for eight days. • DEA agents engaged in sex parties over several years with prostitutes provided by drug cartels, according to the committee. Among those who did not resign, punishments ranged from a letter of caution to a 10-day suspension. The gifts included Rolex and Corum watches and Mont Blanc wallets and pens, according to a Judiciary Committee aide. Three agents allegedly were given money, expensive gifts and weapons from members of drug cartels, the Justice Department inspector general reported. An Oversight Committee summary of a DEA report, prepared by the Democratic staff, says one gift to an agent was an AK-47 assault rifle. All of this sounds like bribery, though the reports do not use that word. The lack of authority cited by the Oversight Committee holds ramifications that go beyond the DEA. For a Congress that seems increasingly uncomfortable with the sometimes lengthy due process that must be followed to fire federal employees, the light punishments for DEA agents and Leonhart’s inability to discipline them is reason for Congress to act. “I can’t fire,” Leonhart said. “I can’t recommend a penalty. . . . I don’t have the authority to intervene in the disciplinary process.” To some extent, the members of Congress seemed to hold her responsible for not exercising authority that Congress has not given her. Don’t be surprised if Congress moves to make it easier to fire not just DEA employees but also other federal employees, as it did last year with Department of Veterans Affairs Senior Executive Service members. Read more in the Federal Diary.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico

Justice Department reaches first settlement with opioid manufacturer

The Justice Department and Mallinckrodt Pharmaceuticals reached a $35 million settlement Tuesday to resolve allegations that the company failed to report signs that large quantities of its highly addictive oxycodone pills were diverted to the black market in Florida, where they helped stoke the opioid epidemic. The agreement is the first with a major manufacturer of the opioids that have sparked a crisis of overdoses and addictions across the country. The Justice Department said the deal establishes “groundbreaking” new standards that require the company to track its drugs as they flow through the supply chain to consumers in an effort to control the epidemic. The company had argued that once it passed the drugs to wholesale distributors, it was not responsible for illegal diversion of the painkillers as they were sent to retailers and then pain patients. “The Department of Justice has the responsibility to ensure that our drug laws are being enforced and to protect the American people,” Attorney General Jeff Sessions said in a statement. “Part of that mission is holding drug manufacturers accountable for their actions. Mallinckrodt’s actions and omissions formed a link in the chain of supply that resulted in millions of oxycodone pills being sold on the street.” The Washington Post reported a tentative settlement between the two sides in April, highlighting the frustration of investigators with the Drug Enforcement Administration who had spent six years trying to hold Mallinckrodt responsible for its role in the epidemic. At one point, the government calculated that it could have assessed the company $2.3 billion in fines for nearly 44,000 violations of the federal Controlled Substances Act, according to confidential government documents obtained by The Post. The settlement and the relatively small fine reflected the government’s difficult legal challenge in proving that Mallinckrodt — or any drug manufacturer — knew its product was being sold and used illegally by people far down the supply chain. ****Between 2008 and 2012, about 500 million of Mallinckrodt’s pills ended up in Florida, 66 percent of all oxycodone sold in the state, The Post reported. Nearly 180,000 people died of overdoses of prescription painkillers between 2000 and 2015, and the abuse of pharmaceutical opioids is widely blamed for a crisis that now involves many thousands of overdoses on heroin and fentanyl. The civil settlement, which includes U.S. attorney’s offices in Michigan and New York, also holds Mallinckrodt responsible for record-keeping violations at its manufacturing plant in Hobart, N.Y. The agreement covers alleged violations during the years 2008 to 2011. In a statement, Mallinckrodt, one of the largest manufacturers of generic oxycodone, denied wrongdoing and said that it had previously set aside enough money to cover the cost of the settlement. The company is based in Britain. “While Mallinckrodt disagreed with the U.S. government’s allegations, we chose to resolve the legacy matter in order to eliminate the uncertainty, distraction and expense of litigation and to allow the company to focus on meeting the important needs of its patients and customers,” Michael-Bryant Hicks, the company’s general counsel, said in the release. Joseph T. Rannazzisi, who supervised DEA efforts to control diversion of opioids for a decade before he retired in 2015, said Tuesday that multimillion-dollar fines have not deterred large pharmaceutical corporations accused of failing to report suspicious orders of pain pills to the DEA. “These fines mean nothing to Fortune 500 companies,” he said. “Large corporations see these fines as the cost of doing business. Unless there are meaningful sanctions brought against these companies, they will continue to violate the law.” The government has reached nearly a dozen such settlements with wholesale distributors of opioids, including one that brought a record $150 million fine against McKesson Corp. Other large settlements have been reached with major retail drug chains.

The nation’s opioid crisis garners attention at party conventions

The nation’s epidemic of opioid abuse, which has killed thousands of people over the past decade through powerful prescription painkillers and heroin, has taken on a prominent role at the Democratic National Convention — a sign of the issue’s growing importance in both parties. On Monday night, a woman whose daughter has struggled with addiction gave a prime-time speech, followed by the former governor of New Hampshire, where more than 400 people died of drug overdoses last year. Then, on Tuesday afternoon, people packed into a Quaker conference center in Philadelphia to hear delegates, elected officials and others talk about recovering from substance abuse and what needs to be done to combat it. A similar forum was held at the Republican National Convention in Cleveland last week. Both conventions featured a recovery and wellness room for those suffering from addiction. The focus on opiate addiction comes after a year in which the opiate epidemic drove a sustained conversation on the presidential campaign trail, particularly in New Hampshire, where voters told wrenching stories of how drug abuse upended lives and candidates told starkly personal stories about how addiction affected their families. It also comes as addiction has moved into the political sphere, after years when advocates felt little was being done. The White House has, for the past few years, held summits on opiate addiction, and Congress last month passed a comprehensive bill backed by Republicans and Democrats to fight opioid abuse; President Obama signed it this week. The issue has become a bipartisan one, with many on both sides agreeing that the focus must be on treating people with addiction, not on putting them in prison. However, several Republican presidential contenders last year stopped short of advocating that approach to other drug laws, most notably those involving marijuana and cocaine, which disproportionately affect African Americans. Opiate abuse predominately affects whites. Last year, Democratic nominee Hillary Clinton went to a roundtable discussion at a New Hampshire manufacturing facility, where Pamela Livengood told Clinton that she had to take care of her grandson because of drug abuse. Livengood stood on the stage in Philadelphia on Monday night and told her story. “For my 50th birthday, I got a 2-year-old,” the Keene, N.H., woman said, recounting how her daughter could no longer care for her son because she was addicted to drugs. The boy is now living with his grandfather, she said. “My story isn’t unique,” Livengood said. “This epidemic has devastated communities all over the country. It doesn’t discriminate against age, race, gender or income. It affects all of us. But sometimes it feels like folks in Washington don’t hear these stories.” Drug overdoses are now the leading cause of injury-related death in the United States, according to the Centers for Disease Control and Prevention. Heroin-related deaths have more than tripled since 2010, and, in 2014, more than 14,000 people died of overdoses involving prescription painkillers, the CDC said. “Our policymakers have to understand that this is a situation and issue you can win on,” Boston Mayor Marty Walsh, a recovering alcoholic, said at Tuesday’s forum. “I don’t mean to turn to politics, but families don’t know where to turn.” Andrew Kolodny, the chief medical officer at Phoenix House, a national chain of rehab facilities, said it is remarkable that people are talking about opiate addiction at national political conventions, because it was swept under the rug until recently. “It does seem like policymakers have recognized that we’re in the midst of the worst addiction epidemics in our nation’s history,” he said. Clinton, who made drug addiction part of her stump speech in the primaries, released a $10 billion plan last year to fight drug addiction. It includes widening access to treatment and recovery programs through a federal-state spending package and broadening access to Naloxone, a drug that can reverse the effects of an opiate overdose. Republican presidential nominee Donald Trump has said that his plan to build a wall on the U.S.-Mexico border will keep out drugs, something that people who study drug trafficking said will not stop the flow of heroin. Trump has not offered any specifics on how he will fight drug abuse beyond that. Drug abuse has become a factor in some Senate races, including in Ohio, where incumbent Sen. Rob Portman (R) and his challenger, former governor Ted Strickland (D), are accusing each other of exploiting the epidemic for political gain. Portman held two drug-related events during the Republican National Convention and spoke on a panel discussion about abuse at the convention. Both Ohio and Pennsylvania have been decimated by the opiate epidemic. More than 2,500 died of drug overdoses in Ohio in 2014, and nearly 2,500 succumbed in Pennsylvania. Philadelphia is a hotbed of drug abuse, with dealers selling some of the nation’s purest heroin. The city serves as a hub for heroin distribution in southern New Jersey and the Philadelphia suburbs. “We have the largest-scale open-air heroin market probably on the East Coast,” said Patrick J. Trainor, a spokesman with the Drug Enforcement Administration in Philadelphia. It is about eight miles north of Wells Fargo Arena, where the convention is taking place. “The politicians, when they talk about it, it’s a start,” Trainor said of drug abuse. “It’s definitely a start, and we’re really, really pleased with that.” Carol McDaid, who is in recovery, said she first tried to bring forums and a recovery room to the party conventions in 2008. “Honestly, we were told by some of the folks we contacted, ‘Our delegates really don’t have these problems.’ It just kind of stood you back on your heels,” she said. This year, delegates who are also addicts decided to talk about their struggles and recovery. Ramon Ryan, a Democratic delegate from Tennessee, said he wondered whether he would be able to attend a recovery meeting while at the convention. “I heard not only are there recovery meetings, there’s this amazing caucus,” he said. “We are having a public conversation about this issue.”

Inside the pill mill

_James Hill is a former senior editor for The Washington Post News Media Services._ As its name implies, “American Pain” makes for some painful — yet fascinating — reading. Painful because the creation of a drug-pushing empire disguised as a prescription painkiller operation should never have been allowed to happen. Painful because people with licenses to practice medicine answered ads on Craigslist and became part of the charade. Painful because pharmaceutical companies kept pushing to expand the number of opiates allowed to be prescribed. And painful because the Drug Enforcement Administration kept allowing that supply to grow, even as the toll from opiate abuse became not only common knowledge but a national disgrace. John Temple’s thoroughly reported examination of how twin brothers with a love for anabolic steroids stumbled into a gold mine selling Oxycodone and other opiates is a story of both American entrepreneurship run amok and the difficulties of shutting down a rogue operation even when it has become clear that someone is breaking the law. Temple, a professor of journalism at West Virginia University, focuses on the George twins, Jeff and Chris, and their friend Derik Nolan. Together, exploiting loopholes amid a lax regulatory environment, the three started what became a multimillion-dollar industry in South Florida pushing medications prescribed by doctors who worked at pain clinics. The bulk of the empire-building fell to Chris George and Nolan, who was brought on to provide some muscle around the office but ended up being a version of chief operating officer of the enterprise. What an empire it was. Originally named the South Florida Pain Clinic, and advertising on billboards, in free weeklies and on the Internet, what morphed into American Pain lured thousands of “zombies,” mostly from Kentucky, West Virginia and Tennessee, down the interstates or by cheap flights (one was nicknamed the Oxy Express) to get a fix. It also created a thriving copycat industry. As Temple notes, by November 2009, there were 115 pain clinics in Broward County alone. A more astonishing number: “By the height of the state’s pill mill rush, Florida doctors were purchasing nine times more Oxycodone than doctors in other states. That’s nine times more than the other forty-nine states _combined_.” As newspapers and a local television reporter began to investigate, it became clear that these pill mills were in jeopardy. The feds swept in, and many of the pushers, including the George twins and Nolan, were given long prison sentences. In Appalachia, Oxycodone is no longer the heroin du jour. Rather, heroin itself has become the drug of choice. “American Pain” offers a window into America’s drug-addiction epidemic. It’s a painful sight, but sometimes seeing the ugly is preferable to burying our heads in the sand. By John Temple Lyons. 299 pp. $26.95

Here’s how the White House plans to address rural America’s struggle with heroin

The White House will announce Friday that President Obama is appointing Agriculture Secretary Tom Vilsack, his Cabinet’s longest-serving member, to lead a new interagency effort focused on addressing rural America’s struggle with heroin and opioid abuse as well as other pressing problems. The decision to centralize federal decision-making on drug abuse as well as other major problems in rural areas — rising suicide rates, declining physical and mental health, and increased financial stress — comes as addiction to heroin and other opiates has become a crisis in many areas. In an interview Thursday, White House Chief of Staff Denis McDonough said the work Vilsack has done since 2011 chairing the White House Rural Council, a group focused on these areas, has given him “firsthand experience” seeing how substance abuse and poverty have continued to keep Americans in some parts of the country from making headway. “The whole point is to have the secretary of agriculture look across the [federal government] to see what unique capabilities agencies have to invest in blowing through these obstacles to opportunity in rural communities.” The Rural Council encompasses 15 departments and multiple agencies, including Health and Human Services, Veterans Affairs and the Office of National Drug Policy, among others. Heroin and prescription opioid drug overdoses kill about 30,000 people a year — heroin-related death rates increased 28 percent from 2013 to 2014 alone — and state, local and federal law enforcement officials have begun to rethink how best to treat addicts who often have trouble getting treatment. And as opioid addiction has emerged as a more pressing political issue — with presidential candidates from both parties addressing the concerns of voters in Iowa and New Hampshire, the two states that will cast votes on the parties’ 2016 nominees next month — both GOP and Democratic lawmakers have shown a willingness to expand federal support for tackling it. The budget agreement struck last month provided the administration with more than $400 million to address the epidemic, an increase of more than $100 million from the previous year. It also cut language barring the use of federal funds for needle-exchange programs, a move that many public health advocates had sought. Vilsack will unveil the new initiative during a town hall discussion on Friday at Ohio State Universirty in Columbus, where he will be discussing the expansion of the administration’s rural-development efforts in 11 counties experiencing persistent poverty in the part of Appalachia that extends into southern Ohio. In an interview Thursday, Vilsack said that while any long-term solution to the problem will have to be pursued by the next president, the current administration could help develop a comprehensive strategy and elevate the issue in the American consciousness. Obama held a forum on the subject in October in Charleston, W.Va., a state where more than one-third of the overall injury deaths stem from drug overdoses. “For me, as presidential candidates talk about this, the importance to me is to bring this issue out of the shadows,” Vilsack said, noting that the “rugged” image of independence often prized in rural America “really makes it hard for people to seek help.” Vilsack, whose adoptive mother struggled with addictions to alcohol and prescription medication, said he was optimistic that there could be bipartisan support because it affects so many families. Matt Chase, executive director of the National Association of Counties, said in an interview that the new initiative is “very timely and much-needed federal attention.” He described the increase in drug and alcohol abuse in rural areas as “symptoms” of an economy where there is more automation and a lower need for workers. “To me, it really boils down to the lack of economic opportunity in so many of these areas,” he said, adding that although the administration has looked at the issue in the past, Vilsack’s appointment shows “more presidential focus.” In many cases, state and local groups are banding together to try to combat rising overdoses. The National Association of Counties and several other state and local government groups announced Thursday that they have successfully negotiated with drug companies to purchase Narcan nasal spray, which can counteract the effects of an overdose, at a 40 percent discount. Mark Publicker, past president of the Northern New England Society of Addiction Medicine, said that while he was “utterly pessimistic” that a government task force could have a major impact on the problem, he had been encouraged by some of the efforts the administration had been taking to address the fact that the rural poor are “most stricken by the epidemic and have the least access to treatment.” “There’s value in identifying the fact that we’re dealing with a multidimensional, complex problem that deserves more than the simple answers that are being floated,” said Publicker, who treats addiction patients in rural Maine.

The Planned Parenthood witch hunt

TWELVE STATES that undertook investigations of Planned Parenthood found no wrongdoing. An additional eight states refused even to investigate, citing lack of credible evidence. A grand jury in Texas and a federal judge in California exonerated the organization after each conducted extensive reviews. Three congressional committees failed to turn up any improprieties. In short, the hidden-camera videos purporting to show illegal selling of fetal tissue show no such thing. Despite all that, a Republican-led House panel is undeterred in conducting its own investigation, or, more accurately, witch hunt. Even more troubling than the considerable time and money that will be wasted is the potential damage to health care and medical research. The coyly named Select Investigative Panel on Infant Lives has made sweeping requests (including three subpoenas) for documents and information from more than 30 agencies and organizations that provide abortions or are involved in fetal tissue research. Of particular concern is the panel’s demand for the names of doctors, medical students and researchers involved in performing abortions or conducting research with fetal tissue. Democrats on the panel decried the creation of such a database, which — without rules to protect it from public disclosure — risks individual privacy and safety without legitimate reason. How is the name of a graduate student who five years ago was an intern at a lab relevant to anything? Rep. Marsha Blackburn (R-Tenn.), chair of the House panel, has defended the investigation as necessary because of lingering questions raised by secretly recorded videos of Planned Parenthood personnel released last year by the equally misnamed Center for Medical Progress. Those videos, supposedly showing Planned Parenthood illegally selling aborted fetal organs for profit, have been discredited. A grand jury empaneled in Houston to investigate Planned Parenthood ended up indicting the activists who produced the videos and, after reviewing the evidence for two months, cleared Planned Parenthood of any wrongdoing. U.S. District Court Judge William H. Orrick reached the same conclusion, granting a preliminary injunction prohibiting release of illegally obtained recordings and materials in a decision that laid bare the fraud against Planned Parenthood. Also noted by the judge was the alarming increase in incidents of harassment and violence directed against abortion providers since the videos were released last July. Among them: four incidents of arson and the attack on a Colorado clinic by a gunman in which three people were killed. Federal law permits medical use of fetal tissue. The handful of Planned Parenthood clinics in which patients are able to donate fetal tissue adhered to the law that allows reasonable payment for costs associated with donations, but they have stopped accepting any reimbursement because of the controversy. Congress, with approval from both sides of the aisle, legalized fetal tissue research in 1993 because of the potential for scientific advances in treating and curing illnesses. Congress has the prerogative to change that law, if it wants to undermine the kind of medical research that has led to breakthroughs such as the polio vaccine. But it has no call to engage in a reckless investigation with the potential to cause a great deal of harm. **Read more on this topic:** The Post’s View: Planned Parenthood has been absolved. The GOP should give up its crusade. Dana Milbank: The GOP still has nothing to show for its anti-Planned Parenthood campaign Cecile Richards: Planned Parenthood president: These extremist videos are nothing short of an attack on women George F. Will: Planned Parenthood and the barbarity of America Kathleen Parker: Premature finger-pointing after the Planned Parenthood shooting

Oversight has no Trump-related probes planned

Despite pleas from Democrats, the House Oversight and Government Reform Committee agenda for the next two years includes no planned inquiries into the Trump organization’s global entanglements and the potential for conflicts of interset. Instead, the 43 items listed in a proposed agenda for the GOP-led panel includes a look at District of Columbia spending, cyber security policy at federal agencies and reform at the Office of Government Ethics, which had previously been critical of Trump’s failure to divest himself of potential conflicts. The committee’s chair, Rep. Jason Chaffetz (R-Utah), said the panel considered investigative priorities from Democrats and adopted many of them. Democrats proposed several Trump-related investigations in different formats, they said. But so far, they said Chaffetz has expressed more interest in non-Trump inquiries, including a recent letter to the FBI asking for more detail about Hillary Clinton’s email operations. Another asked about the conduct of the director of the Office of Government Ethics, who was critical of Trump’s decision not to divest his personal holdings. “There is great irony here,” said ranking Democrat Rep. Elijah Cummings (D-Md.). “The very first letter to come out of our Committee regarding the Trump Administration’s conflicts of interest was the Chairman’s letter attacking the head of the Office of Government ethics for raising concerns about the presiden’t refusal to divest.” The partisan differences over the agenda of the Oversight Committee — the House’s main investigative body — are expected to emerge publicly Tuesday at a hearing to discuss priorities in the 115th Congress. In the agenda distributed Monday, Republicans proposed investigations into health care and entitlement programs, federal grantmaking and the operation of the Washington Metropolitan Area Transit Authority. Democrats are expected to reiterate their interest in three areas related to the Trump administration they proposed to Republicans on Monday. First, they suggested the committee probe foreign funds or other benefits received by any businesses owned by the president to protect against violations of the “Emoluments Clause” of the U.S. Constitution, which forbids presidents from obtaining any benefit from foreign government entities without the consent of Congress. Second, Democrats asked that the panel examine reports of funding or other benefits received by the president and his businesses from Russian individuals or entities. The proposal, provided to the Post by the committee’s Democratic staff, specifically calls for review of “communications between Russian officials or entities and the President’s advisors and associates,” including contacts with Trump’s national security adviser, Michael Flynn. Finally, the Democrats want the panel to review the president’s “apparent breach of his company’s lease with the General Services Administration” for the Trump Hotel in the Old Post Office Building. The lease prohibits elected officials from being a party to the transaction. Last week, Cummings reminded his colleagues that he often joined with Republicans to investigate the Obama administration, signing 740 letters with Republicans to pursue such probes. “We conducted bipartisan investigation of the Secret Service, law enforcement agencies, monitoring the cell phyones of American citizens, sexual misconduct at the National Park Service, and leadership problems at the Chemical Safety Board.” “I know Republicans are not going to investigate President Trump with the same urgency that they investigated President Obama and Secretary Clinto for the past eight years. But our oversight cannot be non-existent.” Chaffetz said in a statement provided to The Post that his team has listened to Democrats’ concerns and adopted many of them. “We exercised a high level of flexibility when incorporating the priorities of members on both sides of the aisle into our oversight plan. Over the last two years we’ve earned a reputation of working with democrats and will continue to do so moving forward.” That’s not Cumming’s view. “Unfortunately, I have been extremely saddened by what we have seen since the election,’ he said.

Rep. Dan Burton, who transformed House panel into a feared committee, to retire

From the investigations of the Clinton White House to the more than 1,000 subpoenas he issued almost single-handedly, Rep. Dan Burton (R-Ind.) cut an investigative path along Pennsylvania Avenue unlike that of almost any other committee chairman of the past 50 years. Through a force of will that some called reckless, Burton’s tenure as chairman of the House Oversight and Government Reform Committee in the late 1990s made him one of the most polarizing lawmakers to wield a gavel in the modern era. Burton, who announced Tuesday his plans to retire at the end of 2012, once shot watermelons in his backyard to examine bullet angles related to the suicide of a top White House aide. His staff subpoenaed the wrong man and released false tapes of an imprisoned former confidant of the Clinton family. “The Burton investigation is going to be remembered as a case study in how not to do a congressional investigation and as a prime example of investigation as farce,” Norman Ornstein, a congressional scholar at the American Enterprise Institute, said in 1998. Burton, 73, rose from humble beginnings in a household with an abusive father to serve 30 years in the House. “To go from humble beginnings to meeting with presidents, kings, princes and some of the world’s most powerful leaders, it has been an experience that I cherish. I consider myself to be the luckiest man on the face of the Earth,” he said Tuesday. Regardless of one’s take on his investigations, Burton’s impact is lasting. He helped transform the somewhat sleepy oversight panel into one of the most feared committees on Capitol Hill, particularly when the chairman hails from the opposing party of the president. Rep. Henry A. Waxman (D-Calif.), who bristled under Burton’s chairmanship for six years, used his two years with the gavel to pummel the Bush White House’s use of security contractors in Iraq and its ties to failed energy concern Enron. Now, Rep. Darrell Issa (R-Calif.) is trying to forge a similar role as investigative thorn in the side to the Obama White House, with the oversight committee digging into the Justice Department’s controversial “Fast and Furious” criminal gun program. Through his staff alumni, Burton’s impact will be felt for years to come. His chief investigator at the time, Barbara Comstock, is now a rising Republican star in Virginia’s House of Delegates, representing Northern Virginia, and is a potential congressional candidate in the future. Reps. Robert J. Dold (R-Ill.) and Tim Griffin (R-Ark.), both members of the rabble-rousing group of 89 Republican freshmen who took office last year, cut their teeth investigating the Clintons in the 1990s. Perhaps no other Burton staffer summed up the tumult of the committee at that time better than David Bossie, who is now the president of Citizens United, the conservative group that served as lead protagonist in the landmark 2010 Supreme Court ruling that opened a new pathway for hundreds of millions of dollars in special-interest money to make its way into elections. By 1998, Bossie was the lead investigator into several threads of Clinton-related probes, including Webb Hubbell, the Arkansan who was partner in a Little Rock law firm with Hillary Rodham Clinton before Bill Clinton won the presidency. Hubbell, who became associate attorney general, ended up in prison for defrauding the law firm. Bossie got hold of tapes of Hubbell’s jailhouse conversations, editing 150 hours of conversations down to one hour — creating a damning impression that was later revealed to be at odds with the entire talks. After Burton put up some resistance, then-Speaker Newt Gingrich (R-Ga.) demanded Bossie’s resignation. Gingrich told a closed-door meeting of Republicans that the investigation had become “a circus” and told Burton, “I’m embarrassed for you.” Gingrich, who promoted Burton to the chairmanship, remains close to the retiring lawmaker and has campaigned with Burton in Florida this week in advance of Tuesday’s presidential primary election in the Sunshine State. Burton is just one of four lawmakers who served with Gingrich in the House and are still in office to endorse his candidacy. Burton’s most lasting legislative accomplishments were his hawkish views on Cuba, expressed in his co-authoring of the Helms-Burton Act, which imposed stricter sanctions on the Castro regime. Democrats, however, recall Burton almost entirely for his furious pursuit of the Clintons, something that led them to produce a minority report that accused Burton of running a partisan investigation with little regard for the truth. “The investigation may be historic, but for all the wrong reasons,” the Democrats, led by Waxman, wrote of Burton.

Cardinal Health fined $44 million for opioid reporting violations

One of the nation’s largest drug distributors has agreed to pay $44 million in fines to resolve allegations that it failed to alert the Drug Enforcement Administration to suspicious orders of powerful narcotics by pharmacies in Florida, Maryland and New York. The agreement on monetary penalties comes more than four years after the DEA reached an administrative settlement with the mammoth drug wholesaler Cardinal Health over alleged misconduct at its Lakeland, Fla., drug distribution warehouse. Officials have said that the company and the Justice Department have been negotiating the fine since the May 2012 settlement was reached. “These agreements allow us to move forward and continue to focus on working with all participants addressing the epidemic of prescription drug abuse,” Craig Morford, Cardinal’s chief legal and compliance officer, said in a Dec. 23 news release. Under federal law, narcotics distributors must alert the DEA when they see evidence of suspicious orders by their customers, which include retail drugstores, hospitals, nursing homes and other places where opioids are dispensed. The system is designed to combat diversion of legal narcotics from those places to the black market. Under the settlement, Cardinal acknowledged that between 2009 and 2012 it did not comply with some of those reporting requirements in Florida and Maryland. A subsidiary of the company acknowledged the same violations between 2011 and 2012 in New York City. The deal also resolves an investigation in Washington state into whether Cardinal kept adequate records on painkillers there. The company did not admit to those allegations but agreed to settle them anyway. In 2008, Cardinal paid a $34 million penalty to settle similar allegations at seven warehouses around the United States. Under the 2012 administrative settlement, Cardinal’s DEA license to distribute narcotics from the Lakeland warehouse was suspended for two years. More than 16,000 people died of overdoses of prescription opioids, including methadone, in 2015, and more than 180,000 have perished since 2000. Cardinal, one of the three major drug distributors in the United States, is ranked 21st on the Fortune 500 list of top U.S. companies, with more than $102 billion in annual revenue last year. Publicly disclosed fines against distributors for similar violations have been as high as $150 million. In October, The Washington Post reported that beginning in 2013, the DEA significantly slowed enforcement actions against major distributors despite the growing opioid epidemic and the surge in overdose deaths. ****

Amtrak, airline and package delivery company employees got rich as DEA informants

The Drug Enforcement Administration paid confidential informants millions of dollars without appropriate oversight and used sources in ways that might run afoul of the Constitution, the Justice Department inspector general found. Those findings were part of a withering 65-page report released Thursday that outlined serious missteps in the DEA’s use of confidential informants and that recommended the agency tighten its policies and procedures. Deficient oversight led to instances of fraud and abuse, Inspector General Michael E. Horowitz found. In one, according to the report, the DEA paid more than $469,000 over a five-year period to a source who had previously been deactivated for lying in trials and depositions. In another, the DEA paid an Amtrak employee hundreds of thousands of dollars “for information that was available at no cost to the government,” the inspector general found. The DEA wrote in its official response to the report that it had already made many improvements in agents’ use of confidential informants and would work to make even more. A DEA spokesman did not immediately return a phone message seeking comment. Amtrak said in a statement that employees are forbidden from sharing information for personal gain, and DEA “violated federal regulations by selectively approaching and paying Amtrak employees for information that the DEA would have received for free.” It also said Amtrak was working “to apply what we have learned from this incident and further strengthen our procedures.” Using confidential informants to uncover illegal drug activity is a critical part of DEA agents’ work. According to the report, the agency had more than 18,000 active informants between October 2010 and September 2015, and more than 9,000 of those received about $237 million in payments. The sources ranged from criminals providing information on their associates to airline, train and parcel-service employees providing tips on suspected drug traffickers’ movements. The work, for all involved, can be lucrative. The inspector general found one airline employee who received more than $600,000 in less than four years, and a parcel employee who received more than $1 million in five years. The inspector general found, though, that more money did not always come with more oversight. The DEA’s Intelligence Division, for example, paid $25 million to eight sources over a five-year period and “did not independently validate the credibility of these sources, or the accuracy of the information they provide,” according to the inspector general. The Intelligence Division, according to the report, generally relied on “DEA field offices’ risk assessments and determinations that confidential sources are reliable.” The inspector general found that sources who had been deactivated, sometimes because of unsatisfactory behavior, continued to take DEA money. According to the report, the agency paid about $9.4 million to more than 800 previously deactivated sources between fiscal 2011 and 2015. The reasons for the deactivations were not always clear, but the inspector general found two examples that “raise serious questions of propriety.” In one, according to the inspector general’s report, the DEA paid more than $962,000 to the Amtrak employee who was the subject of an inspector general investigation. More than $44,000 of that money came after the source was deactivated, according to the inspector general’s report. In the other instance, the DEA, with the Justice Department’s approval, reactivated a source who had been shut down for lying in trials and depositions. Over the next five years, the inspector general found, 13 DEA field offices paid the source more than $400,000. The source then lied again, this time to a prosecutor during an investigation, and was deactivated a second time. But, according to the inspector general’s report, the DEA kept paying the source, who would eventually make more than $469,000. The inspector general also criticized how the DEA used transportation and parcel service employees in ways that pushed the boundaries of agency guidelines and the Constitution. Instead of using employees as tipsters, DEA agents would request sources search proprietary databases, transfer packages to the DEA, or turn over suspicious travel itineraries. In some cases, according to the inspector general, agents would ask for passenger manifests almost daily. Aside from Amtrak, no company or airline is named in the report. From fiscal 2011 to fiscal 2015, the DEA used at least 33 Amtrak employees and eight TSA employees as sources, paying the Amtrak employees over $1.5 million and the TSA employees over $94,000, according to the report. The use of TSA was particularly troublesome, as TSA screeners “are obligated to report to law enforcement suspected criminal activity that they observe in the course of their duties,” the inspector general found. And the amount of money at stake and hands-on guidance that DEA agents offered raised other questions of impropriety. “Together, these factors call into question whether the source is truly providing information independently or is acting as DEA’s agent, the latter of which could have implications relating to compliance with the Fourth Amendment’s protections against unreasonable searches and seizures,” the inspector general wrote.

Did the House weaken the Senate’s drug abuse bill? Rob Portman thinks so

Advocates of legislation to combat painkiller and heroin abuse are balking at changes House Republicans have made to a Senate-passed bill, arguing the revisions would compromise drug addiction prevention and recovery programs. The House Judiciary Committee on Wednesday is scheduled to begin considering legislation to address the opioid crisis, a major priority for members in both chambers this election year. But there have been simmering tensions between House Republicans and the senators who led the effort to get an opioid bill through the upper chamber over how quickly the House is moving and the specifics of the legislation being proposed. “Some of the most important ideas are missing from the House Judiciary Committee’s alternative,” Sen. Rob Portman (R-Ohio), who co-authored the Senate’s opioid bill, said on Tuesday. The Senate passed the legislation last month 94-1, and Portman called it “comprehensive. No other bill comes close.” Portman faces a tough reelection race this year, and he is heavily promoting the opioid bill as part of his campaign. House leaders have dismissed the concerns, arguing that many of the worries expressed by Portman and advocacy groups are addressed either by expanded grant programs elsewhere in the legislation or under bills being examined by several committees. “You’ll see streamlining a number of grants,” House Majority Leader Kevin McCarthy (R-Calif.) said on Tuesday, adding that the overall House bill would be “a real improvement” over the Senate’s legislation. At issue are how grants for treatment, prevention and recovery programs should be distributed. The House bill seeks to reduce the number of grant programs while giving states and localities more freedom in how they use the federal funds. But advocates of the Senate approach said they are concerned this will deemphasize programs they think are important but are not specifically addressed under the House approach such as youth-focused education campaigns, recovery support centers and programs to collect unused painkillers. Consolidating programs under one funding umbrella “risks imbalance, as many states and localities seeking funding may only prioritize one or two of these activities,” Harm Reduction Coalition Policy Director Daniel Raymond wrote in a letter to House Judiciary Committee leaders on Monday, one of several advocates to pen alarmed notes to lawmakers. But House leaders insist their final product will be better than the Senate bill, noting that their bill also puts more money toward the crisis — the House bill authorizes $103 million for programs, compared with the $77 million in the Senate bill. McCarthy said this week that he planned to put a package of bills on the floor the week of May 9, and that he is already discussing with Senate Majority Leader Mitch McConnell (R-Ky.) ways to quickly settle differences and send a final product to the president’s desk. Part of the process, McCarthy stressed, is allowing individual committees to address the parts of opioid legislation that relate to their jurisdiction. For now, advocates are focusing on initiatives absent from the House legislation that they argue would help improve recovery efforts, especially those that target young people. “Prevention, treatment and enforcement cannot solve the opiate problem without recovery supports,” Patty McCarthy Metcalf, executive director of Faces & Voices of Recovery, another advocacy organization, said in a statement on Monday.

Hogan proposing independent redistricting, tougher opiod laws

Gov. Larry Hogan (R) on Tuesday proposed creating a nonpartisan redistricting panel to draw Maryland’s legislative and congressional districts, a change that would strip that power from the legislature and the governor’s office. Hogan also proposed legislation to help the state crack down on a growing epidemic of opiod addiction by changing the state’s gang laws to be more like federal racketeering statutes and by eventually requiring doctors and pharmacists to use the state’s prescription-monitoring database to ensure they are not over-prescribing narcotics. The redistricting proposal — which will be formally introduced in the legislature Wednesday — would require an amendment to the state constitution. The change would have to be approved both by the Democratic-majority legislature and by voters. Democratic legislative leaders have vowed to resist such redistricting changes, saying they prefer to wait for national redistricting reform that would also affect states where Republicans control the legislatures. Hogan has criticized state lawmakers and his Democratic predecessor, Martin O’Malley, for creating what experts agree are some of the nation’s most gerrymandered districts. All but one of Maryland’s eight members of the House of Representatives are Democrats, in part because of the way the districts are drawn. “For too long, fair elections and a healthy, strong, and competitive two-party system have been nearly impossible in our state,” Hogan said in a news release Tuesday. Independent redistricting commissions are used in six Western states, including Arizona, whose system was upheld by the U.S. Supreme Court last year. ****The option was recommended by a commission Hogan appointed to study the issue. Similarly, the governor’s legislative proposals to combat opioid addiction follow recommendations from a task force led by Lt. Gov. Boyd Rutherford (R). Hogan’s office said his legislation would aid criminal prosecutions and the pursuit of civil penalties against drug traffickers by aligning Maryland’s gang law more closely with federal organized crime sanctions designed to crack down on mobsters. The report on the task force recommendations said that “when parts of the organization are taken down piecemeal, as under the current statutory scheme, the leaders that are still in place can recruit replacements and keep the organization running and the drugs and violence flowing.” The governor also proposed changing the state’s voluntary prescription monitoring program to phase in mandatory registration by doctors who prescribe painkillers and other addictive drugs. Carin C. Miller, co-founder of Maryland Heroin Awareness Advocates, said she supports efforts to bolster the monitoring program. But she said legislation to crack down on drug rings shouldn’t treat drug traffickers the same as small-time dealers, many of whom are trying to support their own habits. “One needs prison, and the other one needs treatment,” said Miller, whose husband and son have struggled with addiction. Hogan spokesman Matt Clark said the proposed legislation — which also will be introduced Wednesday — should not lead to the prosecution of low-level drug dealers but would allow the state to move more strongly against drug dealers who belong to criminal gangs or organizations. Clark said Hogan also is focusing on recommendations by the task force that addressed treatment or other preventative efforts but do not require legislation. For example, Clark said, the state has started a public-service announcement campaign and has trained workers at local health departments and detention centers to administer drugs such as naloxone, which can reverse the effects of an overdose. Also on Tuesday, the legislature’s fiscal analysts briefed lawmakers on the $42.3 billion budget that Hogan proposed last week, highlighting several issues that could become flash points during the General Assembly’s 2016 session. Warren G. Deschenaux, executive director of the Department of Legislative Services, said the biggest policy decisions facing the legislature will center around tax relief for businesses and how much money the state should set aside as reserve funds. Hogan’s budget would provide modest reductions in taxes and fees for working families, seniors and selected small businesses, while increasing the state’s rainy day fund to more than $1.1 billion. “I think we need to be cautious about some of the corporate income-tax proposals,” said Del. Maggie L. McIntosh (D-Baltimore), chairman of the House Appropriations Committee, referring to a recommendation from a panel appointed by Democratic leaders. Discussing retirees who may be well-off, she questioned “giving tax credits to . . . Marylanders who have the highest amount of discretionary money already.” McIntosh said she supports the governor’s plan to ramp up tax credits for the working poor and wants to expand the benefit even further. Hogan’s proposal would increase the credits by $79 a year, on average. Among other potential sticking points, Deschenaux noted that Hogan’s plan calls for $5 million in tax credits for donations to public or private schools, an idea Democrats roundly rejected last year. Deschenaux pointed out that the governor’s budget would reduce education aid for Baltimore by $24 million because of declining enrollment and increased wealth in the city, while boosting funding for rural counties such as Carroll, Garrett and Kent, which also have shrinking student populations. He also noted that Hogan’s capital budget provides no room for initiatives that originate in the legislature. Traditionally, he said, governors have left about $15 million in capital funding to the General Assembly’s discretion. He also noted that Hogan’s budget would provide $25 million more than required under Maryland law for the state employees’ pension fund, which saw its annual contributions slashed under the previous administration. Additionally, Deschenaux said Hogan’s budget lacks operational funds for a regional hospital project in Prince George’s County. The governor’s fiscal plan also calls for outsourcing more than 100 jobs at state-run hospitals to the private sector, particularly in food service and housekeeping. Fenit Nirappil contributed to this report.

GOP ideology is curtailing vital medical research

IT WAS clear from its start that the aim of the House’s perversely named Select Investigative Panel on Infant Lives was to put a stop to fetal-tissue research. Unfortunately, it appears the Republican-led panel may be succeeding. This is not because it has found any evidence — or even hint — of wrongdoing, but because its harassment and intimidation of doctors and researchers are having a chilling effect on their lifesaving medical work. The panel was created after undercover videos purported to show that Planned Parenthood profited from the illegal sale of fetal tissue recovered from abortions. The allegations, the work of antiabortion activists, have been thoroughly discredited. Previous investigations by three House committee s found no misconduct, and 20 states conducted investigations that found nothing amiss or determined there was no credible evidence even to warrant investigation. None of that deterred Republicans on a witch hunt. Under the chairmanship of Rep. Marsha Blackburn (R-Tenn.), the panel has churned out subpoenas, intimidated witnesses, used inflammatory rhetoric and been reckless with information about individuals, which has resulted in concerns for their security. Its most recent outrage was voting to recommend criminal contempt charges against a small biotech company and its owner for allegedly failing to produce accounting documents and other information sought by the panel. Never mind that the company had been trying to cooperate, supplying more than 1,700 documents and offering individuals to testify. Democrats called the effort to seek contempt charges illegitimate and walked out of the proceedings. According to Rep. Jan Schakowsky (D-Ill.), ranking minority-party member, the fear being sowed by the Republican majority is affecting critical medical research. Universities and researchers have reported difficulty in obtaining fetal tissue. One tissue procurement company is no longer doing business, due in part to the costs of having to answer congressional inquiries. Promising studies and critical trials, for conditions such as multiple sclerosis and Alzheimer’s disease, have been halted or delayed due to the reduced availability of fetal tissue for research. Also at risk is research to deal with the Zika virus because, according to a leading association of research scientists, the use of donated fetal tissue has provided the best understanding of how that virus behaves in the body. So much for the ridiculous contention of Republicans that fetal-tissue research is “outdated” and “not mainstream science.” It is time to let the doctors and scientists do their lifesaving work unimpeded by shortsighted political ideology. **Read more here:** The Post’s View: The Planned Parenthood witch hunt The Post’s View: It’s time to shut down the special panel on fetal tissue research The Post’s View: Defunding fetal tissue research would be a mistake

Veteran federal prosecutor joins 2017 race for Virginia lieutenant governor

RICHMOND — Democrat Gene Rossi, a veteran federal prosecutor best known for targeting doctors who overprescribe pain pills, jumped into the 2017 race for lieutenant governor on Thursday. “I will be a strong voice for justice,” Rossi said in a statement. “I’m passionate about how our state government can better serve its citizens in many areas. I have seen firsthand what works — and what doesn’t. Above all, we must be fair, firm, and compassionate in our approaches to the opioid crisis, criminal justice, voting rights restoration, healthcare, and education.” Rossi spent 27 years with the Justice Department, going to trial more than 110 times. He is best known for Operation Cotton Candy, a multiyear opioid investigation that led to 235 convictions. One of his most prominent targets was William Hurwitz, a McLean pain doctor who saw three patients die of overdoses from his prescriptions. Rossi discussed his planned run with The Washington Post when he left Justice in July, but he officially launched his bid Thursday. Rossi is vying to succeed Lt. Gov. Ralph Northam (D), who is running for governor in 2017. He faces competition for the Democratic nomination from another former federal prosecutor, Justin Fairfax, whom Rossi trained in the Eastern District. State Del. Eileen Filler-Corn (D-Fairfax) also has been exploring a run. Republican contenders include Del. Glenn R. Davis Jr. (Virginia Beach), state Sen. Bryce E. Reeves (Spotsylvania) and state Sen. Jill Holtzman Vogel (Fauquier). Virginia’s lieutenant governorship is a part-time office charged with presiding over the state Senate and breaking tied votes. The Senate has been closely divided between Republicans and Democrats in recent years, resulting in more ties for the lieutenant governor to break and giving the position a higher profile.

‘Chasing the Dragon’: FBI film aims to reach kids before drug addiction does

The faces on the screen are a cross-section of suburban America. One is an eagle scout. Another is a cheerleader. There’s a mother of an infant child and a corporate account executive clearing six figures a year. All abused prescription painkillers, a common trait that has them appearing in a new documentary, “Chasing the Dragon,” produced at the behest of FBI director James Comey. The searing film featuring testimony from overdose survivors is part of a revamped effort by the FBI and the Drug Enforcement Administration to address a health crisis that they say has quietly destroyed countless lives and kills tens of thousands of people each year. Comey, who took a personal interest in the film’s development, is scheduled to meet with educators and administrators from school districts in the Washington region Thursday to talk about an increasingly dangerous trend among youths: the abuse of prescription opiates such as Vicodin, OxyContin and Percocet. Even more worrisome, FBI officials said, is the concern that the addiction that begins with pills from household medicine cabinets often leads teens to the heroin syringe. “This epidemic does not discriminate,” Comey said in a statement to The Washington Post. “All across this country, it is taking good people from good homes and leading them down a trail that often ends in pain and sadness.” The topic of drug abuse has become an element of both Republican and Democratic presidential campaigns, with candidates describing heroin addictions as a health crisis. New Jersey Gov. Chris Christie has spoken at length about addiction as a disease and called for reforming aspects of how the justice system treats drug abusers. “We need to start treating people in this country, not jailing them,” Christie said in November while campaigning in New Hampshire. The new film begins with a stark observation: FBI and DEA research shows that about 46,000 people die from drug abuse annually in the U.S., more than the combined number of Americans who are killed in car accidents and because of gun violence. Half of those deaths are related to opiate drug abuse, according to federal data cited in the film. The cause for alarm at the FBI is the rocketing number of deaths from heroin, which often is a cheaper alternative on the black market to brand-name prescription drugs. In 2014, heroin overdose deaths peaked at 10,000. “The numbers are appalling and shocking — tens of thousands of Americans will die this year from drug-related deaths and more than half of these deaths are from heroin and prescription opioid overdoses,” said Acting DEA Administrator Chuck Rosenberg. “You will see in ‘Chasing the Dragon’ opioid abusers that have traveled a remarkably dangerous and self-destructive path. I hope this will be a wakeup call for folks. Please pay close attention to this horrific epidemic. Help reverse it. Save a life. Save a friend. Save a loved one.” Part of the deadly surge can be attributed to an effort by pharmaceutical companies to tamp down on the abuse of prescription painkillers. In 2010, the FDA approved a new formulation for OxyContin designed to turn the powerful synthetic drug into a gel when mixed in a syringe. But the medical breakthrough came with what federal officials say is a perverse side effect: in the past decade alone, the number of new heroin users has doubled. The documentary’s title comes from a slang term for heroin use, and it is how one drug abuser describes his addiction on camera. “You’re constantly seeking that first high,” he said. “What’s going to happen if you catch it?” The FBI and DEA plan to distribute 10,000 copies of the new video to all of its 56 field offices for nationwide classroom educational use. The video was specially produced with teenagers in mind and includes tearful interviews with recovering addicts who started using in high school; rather than pushing the sobering data to parents, the FBI hopes to make a personal connection with the kids. “This film may be difficult to watch, but we hope it educates our students and young adults about the tragic consequences that come with abusing these drugs and that it will cause people to think twice before becoming its next victim,” Comey said. One of those victims was Cierra Marie Vallejo, who was an AP student at Woodbridge High School when she dropped out, turned to exotic dancing to feed her habit and served time behind bars before overdosing on Feb. 18, 2013. She was 22. The story of Cierra’s life, told with raw honesty by her mother, Patricia Vallejo, serves as one of the cautionary tales of the FBI documentary. Shane Dana, a special agent with a health care fraud unit based out of the Washington field office who investigated Cierra’s death, said that her case shows that addiction can “happen to anyone.” Cierra was once a competitive cheerleader, her mother said in an interview. “She was the one they threw into the rafters,” Vallejo said. Petite, with silky dark hair, Cierra also served as a church volunteer, one time appearing at mass in her cheer outfit complete with makeup and glitter. “She was just a ball of sunshine,” Vallejo said. “Just angelic. And you can’t look at her and not think the world of her.” Cierra’s sudden downward spiral came in high school and stunned everyone who knew her. “It’s something I think about everyday to this day: where did it go wrong? What happened,” Vallejo said. “I cannot tell you and that’s something I’ll never know.” Her first hint perhaps came when Vallejo saw her daughter’s mood rise and fall at the slightest irritation. “You just think it’s normal -- it’s hormones, it’s growing up,” Vallejo said. “She would just lie and manipulate and twist and turn.” Then came the felony conspiracy conviction after she went to local pharmacies to fill fake prescriptions on a physician’s pad one of her friends stole. The signs of her addiction soon became more obvious, including discarded needles strewn about her bedroom. “She’d say, ‘Those aren’t mine,’ and I’d believe her,” Vallejo said. “She was petrified of needles. That’s how powerful — these things make you do things you’d never do.” Dana, who said he has interviewed about 200 people addicted to opiates, said that Vallejo’s experience “is not uncommon. ... These are typical stories.” Frustrated and afraid, Vallejo ultimately called her daughter’s probation officer and arranged for Cierra to be taken to jail. “She was telling me, ‘How could you put me here?’” Vallejo said, recalling a video-call she had with her daughter at the Prince William County jail. “I told her, ‘You put yourself there, your choices, what you’re doing put you there. If I can get more time out of you by putting you in jail, that’s my job as your mother.’” Cierra participated in a rehab program and was released after serving seven months, on Feb. 12, 2013. “She was happy and clearheaded,” Vallejo said. On the night she died, Cierra left the house to fetch Marlboro menthol cigarettes from a nearby gas station. When the trip took longer than expected, Vallejo thought nothing about it, she said. Cierra came through the door, kissed her mother on the cheek, grabbed a banana and headed up the steps to her bedroom, while Vallejo cooked her daughter’s favorite meal, Swiss steaks. At one point Vallejo heard a thud, but she said she thought it had been Cierra’s brother practicing skateboard tricks upstairs. When she finished preparing dinner, Vallejo hollered for the kids to come down, but Cierra didn’t appear. Vallejo climbed the 17 steps toward her daughter’s bedroom door and found her on the floor, her arm splayed beside her limp body and her eyes wide open. “I pushed on her chest and heard that last breath,” Vallejo says during the FBI documentary. Cierra had been home from jail for six days. She was buried a week later. Dana helped trace the drug that killed Cierra to a Prince William man who had been selling prescription painkillers he’d obtained through Medicaid; he had been dealing heroin on the side. He was convicted and is serving a 76-month prison sentence. A Wisconsin native, Dana had served as a National Guard infantry officer before joining the FBI. He now examines the drug trade as a battlefield creeping into high school classrooms. “I ask people: ‘How’d you get addicted?’” Dana said. “The stories that I would hear were typically very similar.” Dana said that teens start by popping painkillers — little pills the size and shape of a Tic Tac — before developing a tolerance that requires a more powerful dose, leading many to heroin. Dana has seen the devastating results of that transition too many times. So Dana and his squad decided to lead the production of “Chasing the Dragon” with the intention of providing an insider’s view of the opioid epidemic. Many of those interviewed in the film are addicts that Dana helped arrest. As his personal reminder of heroin’s toll, Dana carries a photograph of Cierra with him. “I keep it in my wallet and have shown it to many people when I get into discussions about the realities of opiate addiction,” Dana said. “It is helpful to remind people that the statistics have a face.” Vallejo said that she is glad that Cierra’s story might help prevent another teen from straying down her path. Vallejo said that she wishes her daughter were still alive but believes her addiction was a force even more powerful than a mother’s love. “I sleep soundly at night,” Vallejo said. But “everyday it’s a struggle to get up and get out of bed. Everyday it’s hard to smile, to laugh. ... It never goes away. It will never go away.”

Holder calls deaths from heroin overdoses an ‘urgent and growing public health crisis’

The Obama administration called attention on Monday to the nationwide surge in heroin abuse, with Attorney General Eric H. Holder Jr. saying a spike in overdoses from the deadly drug constitutes “an urgent and growing public health crisis.” In a video message posted on the Justice Department’s Web site, Holder said the government is targeting violent traffickers who bring heroin into the United States while urging emergency personnel to carry an anti-overdose drug. “Confronting this crisis will require a combination of enforcement and treatment. The Justice Department is committed to both,” said Holder, who noted that the Drug Enforcement Administration has opened more than 4,500 heroin-related investigations since 2011. The message marked the first major public foray by the nation’s top law enforcement officer into a debate over heroin that has escalated since the recent death of actor Philip Seymour Hoffman from heroin and other drugs. Heroin use rose 79 percent nationwide between 2007 and 2012, federal data show, and Holder said heroin-related deaths are up 400 percent in areas such as Cleveland. In response, he said, the government is “doing more than ever to keep illicit drugs off the streets” through a DEA strategy aimed at reducing the supply of heroin “at all levels of the supply chain.” At the same time, Holder added, officials are partnering with police, doctors and others to increase prevention and treatment programs for heroin and prescription opioids such as OxyContin. Prescription drug abuse kills far more people each year than heroin, federal statistics show. “It’s clear that opiate addiction is an urgent — and growing — public health crisis,” Holder said. At times, the government has been slow to confront the problem. Gil Kerlikowske, who runs the Office of National Drug Control Policy as President Obama’s “drug czar,” recently said that he should have done more to raise awareness of heroin during much of the administration’s first term but that heroin is now a much bigger priority. Top drug policy officials in the Obama and George W. Bush administrations have said that for a long time they rarely discussed repeated warnings from inside the government that the crackdown on prescription drug abuse could help fuel a new heroin epidemic. Many prescription drug abusers have switched to cheaper heroin, since prescription pills and heroin provide a comparable, euphoric high. Experts say the government’s actions in arresting doctors and shuttering “pill mills” contributed to the shift. In the past few years, law enforcement has been aggressive in combating heroin. Federal data show that heroin trafficking cases rose 52 percent between 2008 and 2012. Federal officials say Mexican heroin production has increased, and traffickers are targeting areas of the United States hard hit by prescription drugs with a much cheaper product. States are also increasingly confronting the spread of heroin use, usually by trying to prevent deaths. In recent years, 17 states and the District of Columbia have passed “good Samaritan” laws, offering some measure of immunity to those who seek medical help for an overdose victim. Nearly 20 states and the District are also taking steps to allow more medical professionals to carry and administer naloxone, the drug Holder highlighted Monday, which reverses the effects of overdoses. Even as his department has cracked down on heroin, Holder’s personal efforts to use the power of his office to raise awareness have been sporadic, a review of his speeches and public statements shows. The attorney general speaks often, in deeply personal terms, about how he witnessed the impact of drugs as a father and former prosecutor and D.C. Superior Court judge. In 2009, soon after taking office, Holder said at a congressional hearing that he recognized heroin as an emerging problem. In recent years, however, Holder’s drug-related efforts have focused more on matters such as reducing mandatory minimum prison terms for some low-level, nonviolent drug offenders and crafting a federal approach to state laws legalizing marijuana. Speaking at a 2012 congressional hearing focusing on prescription drugs, the attorney general cited a variety of illicit substances. “People, when they hear drugs, they think of crack. They think about cocaine, methamphetamine,” he said. He did not mention heroin. John Carnevale, who worked for four drug czars in Republican and Democratic administrations, praised Holder’s remarks on Monday, especially his focus on public health and treatment along with enforcement. “What the attorney general is saying makes perfect sense,” Carnevale said. But Theodore Cicero, an expert on addiction at Washington University in St. Louis, said the comments should have come much earlier. “Calling attention to heroin is a good thing, but there was a lot of dodging it for some time,” he said. “It’s too bad it took something like Philip Seymour Hoffman to have the country wake up.” A Justice Department official said Holder was reacting more to the broader national discussion about heroin than to the actor’s death and wanted to invoke that to highlight the department’s actions to combat it. “The attorney general wanted to have a voice in what has become a rising debate around the uptick in heroin-related deaths,” said the official, who spoke on the condition of anonymity to discuss internal deliberations.

Officials’ defenses of NSA phone program may be unraveling

From the moment the government’s massive database of citizens’ call records was exposed this year, U.S. officials have clung to two main lines of defense: The secret surveillance program was constitutional and critical to keeping the nation safe. But six months into the controversy triggered by former NSA contractor Edward Snowden, the viability of those claims is no longer clear. In a three-day span, those rationales were upended by a federal judge who declared that the program was probably unconstitutional and the release of a report by a White House panel utterly unconvinced that stockpiling such data had played any meaningful role in preventing terrorist attacks. Either of those developments would have been enough to ratchet up the pressure on President Obama, who must decide whether to stand behind the sweeping collection or dismantle it and risk blame if there is a terrorist attack. Beyond that dilemma for the president, the decision by U.S. District Judge Richard J. Leon and the recommendations from the review panel shifted the footing of almost every major player in the surveillance debate. NSA officials, who rarely miss a chance to cite Snowden’s status as a fugitive from the law, now stand accused of presiding over a program whose capabilities were deemed by the judge to be “Orwellian" and likely illegal. Snowden’s defenders, on the other hand, have new ammunition to argue that he is more whistleblower than traitor. Similarly, U.S. officials who have dismissed NSA critics as naive about the true nature of the terrorist threat now face the findings of a panel handpicked by Obama and with access to classified files. Among its members were former deputy CIA director Michael J. Morrell and former White House counterterrorism adviser Richard A. Clarke, both of whom spent years immersed in intelligence reports on al-Qaeda. A day after the panel’s report was made public, U.S. officials said its findings had stunned senior officials at the White House as well as at U.S. intelligence services, prompting a scramble to assess the potential effect of its proposals as well as to calculate its political fallout. The president is “faced with a program that has intelligence value but also has political liabilities,” said Mark M. Lowenthal, a former senior CIA official. “Now that he has a set of recommendations from a panel he appointed, if he doesn’t follow them people are going to say, ‘are they just for show?’ Or if he does follow them, he scales back a program that he supported.” Members of the panel met with Obama on Wednesday and said he was receptive to the group’s findings. “Obama didn’t say, we accept this on the spot,” Clarke said in an interview. “But we didn’t get a lot of negative feedback. They’re going to talk to the agencies and see what the agencies’ objections are and then make their decisions.” White House officials declined to comment on specific recommendations Thursday, but press secretary Jay Carney signaled that the administration remains reluctant to dismantle the data-collection program. “The program is an important tool in our efforts to combat threats against the United States and the American people,” Carney said. Several current and former U.S. officials sought to downplay the impact of the court case and the review panel, saying that their influence is likely to be offset by the work of an internal White House group made up of national security officials who are regular consumers of NSA intercepts and may be more cautious about curtailing the agency’s capabilities. The controversial program to amass the call records of millions of Americans also continues to have influential supporters on Capitol Hill, including Sen. Dianne Feinstein (D-Calif.), chairman of the Senate Intelligence Committee. “It’s just an advisory report,” said former acting CIA director John E. McLaughlin. Obama “can take credit for having turned some smart people loose to independently look at this issue. And he can say at the end of the day, . . . ‘I’m the president. I’m responsible for the security of this country. Here’s where I come out.’ ” However, the developments this week were a reminder that the outcome may be beyond Obama’s control. Leon’s ruling set in motion a legal battle that may culminate in a ruling by the Supreme Court. The panel’s findings gave new momentum to lawmakers who have introduced legislation that would bring an end to the NSA’s bulk collection of phone records. As part of their initial research, members of the review panel spent a day at NSA headquarters in Fort Meade, Md. But officials said that neither the NSA chief, Gen. Keith B. Alexander, nor Director of National Intelligence James R. Clapper was given a copy of the report in advance or a chance to comment on its findings. A DNI spokesman declined to comment, but officials said U.S. intelligence officials would evaluate the panel’s proposals and prepare material for the White House on the potential effects of implementing its recommendations. That effort will likely focus on the panel’s push for new legislation that “terminates the storage of bulk telephony metadata by the government,” requiring those records to be held by phone and Internet companies, and searched only when the government has a court order. Technology leaders met with Obama at the White House on Tuesday. Although industry reaction to the review board’s report has been muted, officials see it as largely in line with their goals. The proposal to no longer allow the NSA to store domestic records, one of the panel’s 46 recommendations, would end an arrangement that has enabled the agency to stockpile call “metadata”: billions of records on virtually every phone customer in the United States, including records of the numbers dialed and durations of calls, but not their contents. The NSA is allowed to retain those records for five years, and officials have repeatedly described the program as a critical safeguard against terror plots, allowing the NSA and FBI to establish links between terrorism suspects overseas and potential accomplices in the United States. In congressional testimony, Alexander has credited the program with helping to detect dozens of plots both in the United States and overseas. The developments this week cut deeply into the credibility of those claims. Leon’s opinion said that the government had failed to “cite a single instance in which analysis of the NSA’s bulk metadata collection actually stopped an imminent attack.” The review panel said the program “was not essential to preventing attacks and could readily have been obtained in a timely manner using conventional [court] orders.” Craig Timberg and Cecilia Kang contributed to this report.

Native American kids need more protection, advisory panel tells Holder in new report

A panel of Indian-country experts will recommend to Attorney General Eric H. Holder Jr. on Tuesday that tribes be allowed to criminally prosecute non-Indians who sexually or physically abuse Native American children on tribal land, saying that juveniles on reservations are living with “dire” levels of violence and poverty. The recommendation addresses a loophole in a law passed by Congress last year. The measure allowed the nation’s 566 federally recognized tribes for the first time to prosecute non-Indians who commit certain crimes of domestic violence against Native Americans in Indian country. But the law, opposed by most Republican lawmakers, does not allow non-Indians to be prosecuted by tribes for abusing Indian children on a reservation. Closing that loophole is one of 31 wide-ranging recommendations made by the Attorney General’s Advisory Committee on American Indian and Alaska Native Children Exposed to Violence in a 120-page report obtained by The Washington Post. The committee, which conducted four public hearings this year — in North Dakota, Arizona, Florida and Alaska — is releasing the report Tuesday morning. “I felt profound sadness for what so many of these children have gone through,” said former U.S. senator Byron L. Dorgan (D-N.D.), who co-chaired the 13-member committee with Iroquois singer and child advocate Joanne Shenandoah. More than 600 people participated in the hearings, including more than 70 experts and representatives from over 60 tribes and 15 states. “American Indian and Alaska Native children represent the future and they face unprecedented challenges, including an unacceptable level of exposure to violence, which we know can have lasting and traumatic effects on body and mind,” Holder said in a statement provided to The Post. “We must understand these impacts well so we can pursue policies that bring meaningful change.” The panel highlights “vastly under-resourced programs” for American Indian and Alaska Native children and recommends significantly increasing funding. The report says these children experience post-traumatic stress disorder at the same rate as veterans returning from Iraq and Afghanistan and triple the rate of the general population. “Day in and day out . . . American Indian and Alaska Native children suffer exposure to violence at rates higher than any other race in the United States,” the report says. The result is “increased rates of altered neurological development, poor physical and mental health, poor school performance, substance abuse, and overrepresentation in the juvenile justice system,” the report concluded. Dorgan said that along with giving tribes more criminal jurisdiction over their children, the U.S. government’s responsibility to Indian nations requires the provision of basic governmental services on reservations. Funding for reservations, however, is in the discretionary portion of the federal budget, he said. “This should be mandatory funding,” Dorgan said. “If you have a treaty and laws, how do you describe it as discretionary funding?” The Interior Department, through the Bureau of Indian Affairs, provides funding for tribal court systems. But, according to the report, the funding “is far too low” and should be brought into line with spending levels in the rest of the country. The Justice Department has been an important source of funding for tribal justice programs since the late 1990s. But the money has been consistently decreasing in recent years, especially the one grant program that has offered the most help to children exposed to violence. Justice Department funding for that grant dropped from $25 million in fiscal 2010 to $5 million in 2014. The panel recommended that all grant-based and competitive Indian-country criminal-justice funding end and be replaced with a permanent funding system. The panel said the Department of Housing and Urban Development should build facilities for children exposed to violence and places for youth activities. Children on reservations grow up in “Third World conditions” in housing mostly built by HUD decades ago, Dorgan said. “It’s unbelievable,” he said. The panel also recommended that the Obama administration establish by May a permanent, fully staffed Native American Affairs Office in the White House with a senior official devoted to the issues faced by American Indian and Alaska Native children.

The GOP’s Russia investigation is a joke — and Americans know it

Among Republicans, partisanship prevails — only 21 percent favor a congressional investigation.  As Trump critics argued at the time, the Senate Intelligence Committee is not set up to do this work. Events proved them correct. (“Part of the reason why the committee has not acted more swiftly is because of its current structure. The Senate Intelligence Committee is typically an oversight panel, not an investigative one. It is set up more to review than to actively probe.”) One suspects that this is precisely why the investigation was shoved into its jurisdiction. At any rate, neither the House nor the Senate panel provides reassurance that a legitimate, nonpartisan and thorough investigation can be undertaken. We have argued that at the very least, a select committee with proper staff and funding is required. Given how badly Republicans are dragging their feet and the lengths to which the House Intelligence Committee chairman went to assist the White House in distracting the public, there is reason to doubt that any congressional arrangement will inspire confidence. The argument for a truly independent commission or a special prosecutor gets stronger with each passing day. As with the ethics scandals, any legitimate investigation of the Russia scandal is hampered by Republicans’ utter lack of seriousness and their determination to play defense for the White House. When meddling by a foreign government is at issue, you’d think that Republicans would take their oaths of office seriously. Alas, no. Russian efforts to hobble Hillary Clinton and the possible secret collusion by the Trump team (in addition to Trump’s open reliance on WikiLeaks material and Russian propaganda) have not sufficiently impressed GOP lawmakers. In demonstrating their small-minded partisanship, they are making Democrats’ 2018 argument for them, namely that the GOP is not performing its constitutionally mandated role.

DEA agents helped hire prostitute for Secret Service agent, report says

A Drug Enforcement Administration agent helped hire a prostitute for a supervisory special agent of the Secret Service during a presidential visit to Colombia last year, according to a Justice Department report. The sexual encounter, which started with a massage, took place at a second DEA agent’s Colombian residence, the report said. News of a prostitution scandal involving Secret Service personnel first surfaced in April, when the agency recalled several agents from the South American country. The inspector general revealed the involvement of DEA agents in a one-page summary of findings to the Senate Homeland Security and Governmental Affairs committee on Dec. 20. NBC published the report online Thursday. Investigators determined that the drug agents tried to hide their involvement in the scandal by denying knowledge of the sexual encounter and deleting data from their government-issued BlackBerry phones during a Justice Department probe. The agents later confessed to wiping data from their BlackBerry devices and admitted they had hired prostitutes for themselves and used their DEA smartphones to arrange the encounters, according to the report. In its letter to the Senate committee, the inspector general noted that the State Department “prohibits solicitation of prostitutes by U.S. government personnel assigned to a foreign mission ‘irrespective of whether prostitution is legal in the host country.'” _**For more federal news from The Washington Post, visitThe Federal Eye, The Fed Page,and _**PostPolitics.**_**_ _ **Follow Josh Hicks onTwitter or subscribe his Facebook page.**_

Md. opioid task force releases final recommendations

A Maryland task force on Tuesday released its final recommendations on how to address the growing scourge of opioid addiction and deaths in the state, calling for expanded access to treatment and increased efforts to disrupt drug trafficking. The work group issued 33 proposals, including calls for more emphasis on overdose prevention, a pilot recovery unit for inmates addicted to drugs and mandatory tracking of prescription data to help identify people who may be abusing powerful pain medications. Gov. Larry Hogan (R), whose cousin died of a heroin overdose, created the 11-member task force this year. On Tuesday, he said in a statement that he would take action after reviewing the recommendations. Opioid-related deaths have skyrocketed in recent years, fueled by addictions to powerful pain medications and a growing use of heroin. Lt. Gov. Boyd Rutherford (R), who leads the task force, said in a statement Tuesday that heroin and opioid abuse is “an issue that transcends race, socio-economic status, age, and any other demographic.” Nationwide, the rate of heroin deaths has nearly quadrupled since 2000, according to the federal Centers for Disease Control and Prevention. In Maryland, 578 people died of heroin overdoses last year, a 25 percent increase from 2013 and more than twice the number who died from using it in 2010. A recent poll by The Washington Post and the University of Maryland found that nearly 3 in 10 Marylanders have a close friend or family member who is addicted to opioids. In August, Rutherford announced an initial round of actions, based on earlier recommendations from the work group. The plans involved spending $2 million on initiatives to increase access to treatment on the Eastern Shore, expand training in how to administer drugs that reverse the effects of overdoses, boosting law enforcement efforts to disrupt dealers and launching a public- awareness campaign about the dangers of addiction. The task force’s final recommendations called for stricter laws against organized drug trafficking and a criminal penalty for heroin distribution that results in an overdose. It also proposed creating a heroin-investigation unit within Maryland State Police that would coordinate with local law enforcement in gathering intelligence and halting illegal distribution operations. Additionally, the work group said that more doctors should be allowed to prescribe buprenorphine, a drug that produces low levels of opioid-like euphoria to suppress withdrawal and help addicts quit. About 800 Maryland doctors are authorized to offer it, but few are active prescribers, according to the report. “Opioid addicted individuals who cannot access a provider may seek diverted buprenorphine in an attempt to self-treat,” the task force said. “Scarcity creates an incentive for prescribers to run cash-only practices, denying access to those with private insurance and Medicaid.” The final recommendations come less than three weeks after Johns Hopkins University released a report calling for stricter guidelines for prescribing and dispensing opioids, saying doctors often give the medications “in quantities and for conditions that are excessive, and in many cases, beyond the evidence base.” In the poll by The Post and U-Md., 52 percent of Marylanders who know an addict said the state spends too little on treatment, compared with 38 percent of those who do not know one. Only 8 percent of respondents said fighting addiction should be the state’s top priority, compared with 37 percent for education, 20 percent for the economy and 13 percent for taxes.

Trump’s hypocrisy on the opioid epidemic sees bipartisan outrage — and rightfully so

Trump’s crocodile tears about opioid abuse and professed concern for rural Americans who are in the throes of the drug epidemic mean nothing if he is unwilling to put resources into the ONDCP. Democrats were furious. The Democratic National Committee put out a statement: Coming the day after passage of the GOP health-care plan that provides huge tax relief for the very rich, the decision to virtually obliterate the ONDCP highlights the administration’s misplaced priorities. Republicans were unhappy as well. Sen. Rob Portman (R-Ohio), who co-authored the Comprehensive Addiction and Recovery Act, released a statement:  This issue reflects a more fundamental problem. While the president is insistent on a huge tax cut for the rich, increases in defense spending and no reform of our entitlement programs, worthwhile functions such as this are going to be slashed or eliminated. If permitted, it will amount to a huge transfer of wealth and abandonment of much of the safety net. The populist hero is turning out to be the enemy of the most vulnerable members of our society. The administration insists the budget process is by no means complete. Nevertheless, the administration’s thoughtlessness and lack of concern for the health and well-being of the American people remain some of its rotten, defining features.

Finding of possible conflicts in Md. medical pot program sparks call for legislation

A prominent Maryland lawmaker on Monday renewed calls for the legislature to reconvene to overhaul the state’s troubled medical marijuana program in light of a Washington Post report that several independent experts hired to score prospective businesses had ties to applicants for licenses to enter the cannabis industry. Del. Cheryl D. Glenn (D-Baltimore City), chair of the legislature’s Black Caucus, who has sought more minority inclusion in the program, again asked for a special session to pass legislation halting the licensing of growers and processors expected in August. House Speaker Michael E. Busch (D-Anne Arundel) and Senate President Thomas V. Mike Miller Jr. (D-Calvert) have previously rejected Glenn’s call for a special session, instead offering to support an emergency bill when the legislature reconvenes in January. They appeared similarly unmoved Monday by her latest request. Maryland’s medical marijuana program has been embroiled in controversies and lawsuits over how regulators chose companies to grow, process and sell the drug. The Post reported Sunday that at least three evaluators hired to review business applications had ties to the companies, including one whose husband was listed as general manager for an applicant. The cannabis commission says it is investigating these potential conflicts. Industry advocates have defended the licensing process. But Glenn says the Post report calls into question whether Maryland selected the best companies after an objective review. Legislation to authorize more licenses for minority-owned companies collapsed in the final moments of the session that ended in April, and Glenn has pushed for a special session to finish that effort. “In order for the state of Maryland to have a clean medical cannabis program devoid of any corruption or collusion or anything, we should just restart the whole process with a new commission, with a new system of evaluation where nothing should be secretive,” Glenn said. Busch’s chief of staff, Alexandra Hughes, said it’s not possible to have a special session before commissioners award licenses in August because the speaker is recovering from a liver transplant and there are too many other logistical challenges. “The speaker, and Senate president, too, have a lot of concerns about the way this program has been administered, but we are at a point right now where it can’t happen in August,” Hughes said. A spokesman for Miller declined to comment. Gov. Larry Hogan (R) overhauled the cannabis commission in August, replacing 10 of 16 members. His office did not respond to requests for comment on the potential conflicts of interest. The commission last year gave preliminary approval to 15 growers, 15 processors and 102 sellers. But most of those licenses await final approval, with the exception of a grower in Anne Arundel County and a dispensary in Frederick County that are authorized to begin work. No company has been approved to start processing marijuana into medical products. Several businesses denied licenses have filed lawsuits challenging the process of selecting growers, posing another hurdle for the program. A Baltimore judge in May ordered state regulators to temporarily stop issuing new marijuana cultivation licenses while a lawsuit alleging that regulators failed to consider racial diversity was still pending. The Maryland Court of Appeals overturned his order and on Friday issued a ruling allowing certain pre-licensed marijuana growers to intervene in the suit. Patrick Jameson, the commission’s executive director, confirmed his agency thinks that it again can issue licenses in light of the high court’s decision.

Former Trump campaign consultant warns president’s surrogates away from House Intel probe

A former consultant to the Trump campaign is warning other surrogates away from talking to the House Intelligence Committee behind closed doors as it probes Russian influence in the 2016 elections, and is demanding that the panel publicize the transcript of his own testimony after one member suggested that he might have lied under oath. Michael Caputo’s complaint stems from an interview that committee Democrat Rep. Jackie Speier (Calif.) gave to CNN on Tuesday, in which she suggested that Caputo “may have actually lied” during the briefing. It’s not the first time that Caputo and Speier have locked horns as the House Intelligence Committee probes evidence of links between the Trump team and Russian officials. Speier has referred to Caputo in an open hearing in March as “Putin’s image consultant,” referring to the years Caputo spent in Russia during the 1990s and 2000s working for the U.S. government and then as an employee of oil and energy company Gazprom’s media arm, a conglomerate controlled by the Russian state. Caputo has denied the characterization. This latest spat, however, could have implications for the investigation if Caputo’s warnings are heeded by other Trump surrogates who have yet to be interviewed by the panel. “I caution everyone against participating in closed hearings into this matter, because it’s starting to feel like a rigged game,” Caputo said in an interview Wednesday. Caputo, who left the Trump campaign in June 2016, has denied allegations that there were contacts between the campaign and Russian officials. He says he left the Friday interview with House Intelligence Committee lawmakers “with a positive impression” that the panel was being “fair and thorough” in how they were doing their work. But he has taken particular umbrage at Speier’s comments, made even though Speier acknowledged during the interview that she had not actually been present during Caputo’s testimony. In a July 19 letter to Rep. K. Michael Conaway (R-Tex.), who is running the committee’s Russia probe, and panel ranking member Rep. Adam B. Schiff (D-Calif.), Caputo’s lawyer Dennis C. Vacco argued that “for raw partisan political gain and without any regard to the work of HPSCI, Rep. Speier again made irresponsible and un-vetted allegations against Mr. Caputo in public that are likely to unfairly tarnish Mr. Caputo’s reputation.” They requested the committee release the transcript publicly to set the record straight. “Rep. Speier’s careless remarks make full transparency absolutely necessary,” Caputo said during an interview, charging that her comments displayed “typical smear-first, ask-questions-later tactics.” A spokeswoman for Speier declined to comment for this article. Spokesmen for Conaway and Schiff did not immediately return a request for comment on whether they think Caputo’s warning would upset their investigation, or whether they were concerned about him lying to the committee. Caputo stressed that his ire is primarily directed toward the House Intelligence Committee, noting that he has “yet to see this kind of scurrilous activity at the Senate,” and was thus “not ready to make this kind of judgment on the Senate.” The Senate Intelligence Committee panel has requested documents from him, Caputo said, adding that he looks “forward to being responsive to their inquiry.” Caputo added that he has not yet been contacted by special counsel Robert S. Mueller III’s team.

House fetal tissue panel seeks to hold Calif. firm in contempt of Congress

A special House committee investigating links between abortion providers and medical researchers announced Monday it will seek to hold in contempt of Congress a company that procures fetal tissue specimens. Should the Select Investigative Panel proceed at a scheduled Wednesday meeting, it would be the first congressional contempt proceeding pursued since the House voted to sanction former Internal Revenue Service official Lois Lerner in 2014. The panel, created by House Republicans last year after a series of undercover videos alleged criminal wrongdoing in the transfer of fetal tissue from abortion providers to researchers, has probed whether the company in question, California-based StemExpress, has illegally profited from those transfers.    The committee is also set to vote on releasing a transcript of a deposition it conducted with an official at the University of New Mexico School of Medicine. The panel had investigated links between that institution and an Albuquerque abortion provider. Representatives for StemExpress and Dyer could not be immediately reached Monday. But the panel’s top Democrat criticized the Republican chairman, Rep. Marsha Blackburn of Tennessee, for having “manufactured a controversy over information that she does not need.” “Her threat to punish a small biotech company and its owner is particularly outrageous given the company’s compliance with her unilateral subpoena demands,” said Rep. Jan Schakowsky of Illinois, who noted that StemExpress has produced roughly 1,700 pages of documents and offered to testify about its business practices. “The McCarthyesque threat that StemExpress ‘name names’ of all employees or face congressional contempt is disgraceful. We will fight this continued abuse of congressional authority every step of the way.” Should the House find StemExpress or Dyer in contempt, it is unclear whether any sanctions would result. The GOP report anticipates referring the matter to the Justice Department, but prosecutors have not pursued charges against the two executive branch officials found in contempt during the Obama administration, Lerner and former attorney general Eric H. Holder Jr.

Roger Clemens’s defense wants to force lawmaker to take stand at perjury trial

Jurors in the perjury trial of Roger Clemens have endured six weeks of testimony from more than 30 witnesses, including former major league baseball players, a steroid dealer and even a housekeeper. But as the trial enters its final stages, they have not heard from a critical set of witnesses who were present at the scene of the alleged crime, an ornate congressional hearing room where the legendary pitcher is accused of having committed perjury. In a twist that could occur only in Washington, Clemens’s alleged victims — the lawmakers themselves — elected not to testify. That might change as early as Monday, when U.S. District Judge Reggie B. Walton hears arguments from Clemens’s attorneys, who are seeking to force Rep. Darrell Issa (R-Calif.) to take the witness stand. Known on Capitol Hill for wielding his own subpoena power, Issa is fighting a subpoena from Clemens’s attorneys, who say that their client has a right to confront his accuser. House lawyers say Issa is too busy to appear in court and is shielded from doing so by a relatively obscure provision of the Constitution. Legal experts are split in their opinions on how Walton might rule, but they mostly agree that the showdown highlights a central absurdity of the trial: Lawmakers sought the Justice Department investigation into Clemens’s testimony but won’t appear in court. “Here you have federal prosecutors going out on a limb to help these guys, members of Congress,” said Roscoe Howard, a former U.S. attorney for the District. “It seems inherently unfair when lawmakers refer someone for prosecution and then don’t show up at a public trial to give their perspective or even tell why this case is as important as they say it is.” Clemens, baseball’s most decorated pitcher, is charged with lying to the House Committee on Oversight and Government Reform in 2008, when he denied that he ever took performance-enhancing drugs. The hearing was nationally televised and dramatic: Clemens sat at the same witness table as his chief accuser, his former strength coach. Under intense questioning from lawmakers that lasted more than four hours, the strength coach, Brian McNamee, alleged that he had injected the seven-time Cy Young Award winner with steroids or human growth hormone in 1998, 2000 and 2001. Just as assertively, Clemens denied the accusations, saying he had never taken any such substances. Within days of the proceeding, the committee’s top Democrat and Republican sent a letter to then-Attorney General Michael B. Mukasey asking federal authorities to investigate whether Clemens “committed perjury and made knowingly false statements during” the hearing and to House investigators. Federal agents quickly launched an investigation, and a grand jury in the District’s federal court indicted the right-handed pitcher in 2010 on charges of perjury, false statements and obstruction of Congress . The trial has been plodding along since April 16 — two jurors have been dismissed for sleeping — and prosecutors rested their case Tuesday. The defense, which is expected to include testimony from McNamee’s estranged wife and Clemens’s wife, could wrap up by Friday. To make their case, prosecutors must prove that Clemens lied and that those false statements were “material,” or important, to Congress’s work. But lawmakers on the committee have not testified to help prosecutors prove that element of the alleged offense. Rep. Henry A. Waxman (D-Calif.), then-chairman of the committee, refused to comment on why he did not take the stand, citing a judicial “gag” order. Issa, the current chairman, also declined to comment. It is not known whether prosecutors asked Waxman or other members to testify, but the lawmakers have done so in the past. Two members of Congress — Lee H. Hamilton (D-Ind.) and Henry J. Hyde (R-Ill.) — willingly testified in John Poindexter’s Iran-contra case in 1990 — one for the prosecution, the other for the defense. Hamilton could not remember whether he was subpoenaed but said in an interview, “I felt it was my obligation to testify.” Instead of making a legislator available to prosecutors and defense attorneys in the Clemens trial, the committee designated a former top staffer — Phil Barnett — to take the witness stand. Over 11 often-grueling hours on the witness stand, Barnett said the committee sought Clemens’s testimony because lawmakers wanted to gauge the accuracy of a 2007 report that found rampant steroid use in major league baseball. The former pitcher appeared voluntarily before the committee. The report, by former senator George J. Mitchell (D-Maine), relied on McNamee’s accusations about Clemens and other ballplayers. When the report was made public and Clemens vehemently denied the allegations, committee members wanted to see whether they could trust the report’s conclusions and would need to take further action to reduce the use of performance-enhancing drugs in baseball, Barnett testified. But not all members of Congress felt that way. At least one congressman called the hearing a “show trial,” and the Republican minority staff issued a lengthy and highly critical report about the allegations contained in the Mitchell report. And then there is Issa, who ascended to chairman in 2011 after Republicans took control of the House. The California congressman had seemed perturbed that the committee was holding the hearing, saying it appeared too focused on alleged steroid use by an individual player. “We’re not prosecutors, and we’re not supposed to worry about a former pusher and a former [alleged] user,” he said. “We’re supposed to be dealing with a whole industry that had a problem.” He also described the hearings as a witch hunt. “We don’t really have a mandate to be looking at this,” he told New York’s Daily News. “To me, it smacks of the McCarthy era.” He later told the same newspaper that “this was all about entrapping Roger Clemens.” For obvious reasons, Clemens’s attorneys would like to have Issa repeat those comments to the jury and allow the defense to attack the “materiality” of the charges. If the committee’s chairman thought the hearing was a farce, they argue, how can jurors convict someone of lying during the proceedings? So they subpoenaed Issa. In lengthy legal filings, House lawyers argued that Issa is too busy to testify and is protected by the Constitution’s “Speech or Debate” clause, which they wrote “bars compelled testimony about legislative acts.” Clemens’s legal team, led by attorneys Rusty Hardin and Michael Attanasio, argued that Clemens’s right to a fair trial trumps any such protections for lawmakers, especially when the testimony would allow them to undercut a key element of the case. Issa, who attended part of the House investigators’ deposition of Clemens, is “well positioned to opine about the legislative purpose of the questions to Mr. Clemens and the materiality of his answers to those questions,” the pitcher’s attorneys wrote. “And Chairman Issa’s numerous comments to the media leave no doubt that his testimony will be” helpful to Clemens’s defense. Legal experts say Walton could rule either way but is more likely to side with House lawyers. Ruling in favor of Clemens would probably spark an emergency appeal that could further delay the trial. Such a ruling might also lead to other members of Congress being subpoenaed to offer their opinions — a kind of arms race of dueling lawmakers. “It could get messy,” said Stanley Brand, a D.C.-based litigator who is considered an expert on the Speech or Debate clause and who represented Major League Baseball during congressional hearings in 2005. However, Brand said, Hardin has an excellent argument, especially because this case is not a typical one involving a lawmaker seeking protection from investigators. “When Congress is the one pushing the button and the government is prosecuting you for not showing up or for lying, then it could be argued that members of Congress have waived all of their objections and privileges,” Brand said.

Business digest: GM’s Barra draws pointed questions from Senate panel

Federal authorities on Thursday charged FedEx with assisting illegal pharmacies by knowingly delivering painkillers and dangerous drugs to customers without prescriptions. The indictment, filed in federal court in San Francisco, alleges that FedEx conspired with two related online pharmacies for 10 years, ending in 2010. The Justice Department wants FedEx to forfeit $820 million the department says the company earned by assisting the illicit pharmacies. The Memphis-based delivery company is accused of shipping the powerful sleep aid Ambien, anti-anxiety medications Valium and Xanax, and other drugs to customers who had no legitimate medical need and lacked valid prescriptions. FedEx insists it did nothing wrong. The company says it handles 10 million packages a day and shouldn’t be in charge of “assuming criminal responsibility” for every delivery. “We will plead not guilty. We will defend against this attack on the integrity and good name of FedEx and its employees,” company spokesman Patrick Fitzgerald said in a statement. The Justice Department alleges that federal officials have been telling FedEx since 2004 it was shipping dangerous drugs without prescriptions. The indictment also alleges that FedEx couriers in Kentucky, Tennessee and Virginia warned executives about suspicious drug deliveries. **— Associated Press** Lawmakers grilled General Motors chief executive Mary Barra on Thursday about the role of her company’s legal department in GM’s failure to respond to a deadly ignition switch defect for more than a decade. An internal GM investigation made public last month found that some GM officials knew about the ignition switch problem for years before it was publicly divulged, but the probe found no wrongdoing by the company’s top executives. Barra, who took over as chief executive at the start of this year, has said she has fired 15 employees, including some company attorneys, in connection with the safety scandal. Testifying Thursday before a Senate subcommittee, Barra defended the company’s general counsel, Michael Millikin, against calls from several senators that he too should be dismissed. In his own testimony, Millikin told the Senate panel that his subordinates had not informed him about possible punitive damages the company could face as a result of the ignition switch problem. In a particularly tense exchange with Barra, Sen. Claire McCaskill (D-Mo.), the head of the subcommittee, demanded to know why Millikin had been allowed to keep his job, calling his lack of knowledge about the issue “either gross negligence or gross incompetence.” Barra rose to Millikin’s defense. “He is the person I need on this team. He had a system in place. Unfortunately, in this instance it wasn’t brought to his attention,” she said. **— Rebecca Robbins** Two influential members of Congress demanded Thursday to know why the Department of Homeland Security recently awarded a contract worth up to $190 million to USIS, a company facing a Justice Department lawsuit that accuses it of defrauding the government. In a letter to DHS, Rep. Elijah E. Cummings (D-Md.) and Sen. Tom Coburn (R-Okla.) said they wanted to know why the department awarded the company the contract despite the lawsuit and requested a briefing from Secretary Jeh Johnson. “The purpose of our inquiry is to determine whether the Department considered this billion-dollar fraud suit against USIS before awarding the company a new government contract worth hundreds of millions of dollars,” Cummings said in a statement. “If not, we want to know why not, and whether legislative reforms may be necessary.” USIS has long performed much of the work on background checks used by the federal government in granting security clearances. The suit, which was initially brought by a whistleblower and later joined by the Justice Department, alleges that USIS “dumped,” or submitted incomplete background checks, in 665,000 cases in order to hit revenue targets. In a statement, USIS said that it was awarded the DHS contract “after a rigorous two-year competition.” The company also said the division that won the contract “is not involved in the background investigation business and has not been linked in any way to the ongoing government investigation.” The contract, awarded July 1, involves field support services related to DHS’s immigration system. DHS did not immediately respond to a request for comment. **— Christian Davenport** **— From news services**

Bipartisan House statement expresses lost confidence in DEA chief

The powerful House Oversight and Government Reform Committee has lost confidence in Drug Enforcement Administration chief Michele Leonhart, according to a statement from a majority of the panel Wednesday. “After over a decade of serving in top leadership positions at DEA, Administrator Leonhart has been woefully unable to change or positively influence the pervasive ‘good old boy’ culture that exists throughout the agency,” the message said. The statement, signed by 13 Democrats and nine Republicans, came less than three weeks after a Justice Department inspector general review revealed that DEA agents had “sex parties” with prostitutes hired by drug cartels.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico _[The agents, some of whom had top-secret security clearances, received suspensions of two to 10 days]_    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Leonhart, who has led the DEA since 2007, testified before the oversight committee Wednesday that she regards the findings as “significantly troubling” and does “not take them lightly.” However, she said civil service protections limit what she can do about the issue. “I do not have the authority to simply terminate employees at will,” she said in her written testimony. “This is not because I am being overly cautious, but because federal employees have certain constitutional due-process rights.”    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Leonhart noted that the DEA has so far addressed the alleged misconduct by amending its personnel manual and issuing an agency-wide memo to clarify appropriate conduct. But her remarks did little to quell the concerns of most committee members. “From her testimony, it is clear that she lacks the authority and will to make the tough decisions required to hold those accountable who compromise national security and bring disgrace to their position,” the statement said. Rep. Jason Chaffetz (R-Utah), who heads the oversight panel, said late Tuesday that President Obama should fire Leonhart if she does not resign her position, according to an Associated Press report.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico

Michele Leonhart’s exemplary record at the Drug Enforcement Agency

The May 30 In the Loop column, “An off-the-radar White House lunch — until a tweet spilled the beans,” quoted Rep. Jared Polis (D-Colo.) as saying on the House floor that Michele Leonhart, the administrator of the Drug Enforcement Administration, is a “terrible” agency head. It also highlighted how Rep. Frank Wolf (R-Va.) rose to Ms. Leonhart’s defense and commended her for 30 years of service to the agency. As the administrator of the DEA from 1976 to 1981, under Presidents Ford, Carter and Reagan, I am very familiar with the position and Ms. Leonhart; I swore her in as a special agent. Ms. Leonhart was selected as the “outstanding agent” in her 1980 class. I have watched her rise in the ranks since, and she has excelled at every assignment. Under her leadership, the Colombian cartels have been disbanded, the biggest and most dangerous drug traffickers have been captured, prescription drug abuse has been confronted, cocaine availability has been curtailed and working relationships with state, local and foreign law enforcement have never been better. Mr. Polis’s personal attack on Ms. Leonhart has nothing to do with her stewardship of the DEA. It probably has everything to do with her dedication to support science and the documented dangers and consequences of marijuana, which follows her duty as administrator to follow the law. Mr. Polis was out of line. The House deserves better. So does the public, and so does Ms. Leonhart. ****Peter Bensinger,** Chicago**

House Intelligence Committee likely to issue subpoena for Flynn, top Democrat says

The House Intelligence Committee will likely issue subpoenas as soon as this week for information from former national security adviser Lt. Gen. Michael Flynn and his companies, according to the panel’s top Democrat, after Flynn failed to voluntarily provide documents they had requested for their probe into alleged Russian meddling in the 2016 elections. Rep. Adam B. Schiff (Calif.), the ranking Democrat on the committee, said the panel “would explore whatever compulsory process that we would need to use,” to compel information from Flynn, including subpoenas, and, if those are rejected, the option of citing Flynn for contempt. He made those comments during a breakfast with reporters sponsored by the Christian Science Monitor. The Senate Intelligence Committee has been grappling with such options this week, after Flynn’s lawyers informed that panel that he would not comply with a subpoena for documents relating to his contacts with Russian officials between June 16, 2015, and Jan. 20, arguing that Flynn had a Fifth Amendment right against self-incrimination. The Senate panel responded to that letter Tuesday by issuing two new subpoenas for information from Flynn’s companies, arguing, as vice chairman Sen. Mark R. Warner (D-Va.) put it, “a business does not have the right to take the Fifth.”

Is DEA a bad guy in opioid addiction fight?

Chuck Rosenberg, acting administrator of the Drug Enforcement Administration (DEA), had a fairly easy time at Wednesday’s Senate Judiciary Committee hearing, where his efforts to change the opaque culture of the agency won praise. Then it was Sen. Richard J. Durbin’s time to ask questions. The Illinois Democrat wasted little time with niceties. He wanted to know if DEA is one of the bad guys in the fight against opioid addiction. “Who is responsible when it comes to decisions made that have created this and made it worse?” he asked. The DEA, according to Durbin. He quoted Rosenberg’s testimony about DEA’s enforcement activities against “the violent cartels and drug trafficking gangs responsible for feeding the heroin and prescription drug epidemic in our communities.” But that strategy has “one key element missing and it is an element that you have responsibility for,” he told Rosenberg. “That is the overproduction of opioids by the pharmaceutical industry.” The numbers are staggering. In 2014 alone, the industry put 14 billion opioid pills on the market with DEA approval, “enough for every adult in America to have a one-month prescription,” Durbin said. More than 28,000 people overdosed and died from prescription opioid and heroin, an illegal opioid, that year. Many heroin addicts started with prescription opioids. DEA sets annual production quotas for opioids, which is a class of pain relievers. Between 1993 and 2015, oxycodone production jumped from 3.5 tons to 150 tons, according to Durbin. During that same period, he said the production of hydrocodone increased 12-fold, hydromorphone 23-fold and fentanyl, the drug that killed Prince, 25-fold. “You’ve said all the right things, after the fact,” Durbin told Rosenberg. “What your agency has failed to concede is that they have been the gatekeepers who have opened the gate wide. . . . Do you accept responsibility as an agency for being part of the problem?” “I think we’re part of the problem,” Rosenberg said, with the directness that characterized much of his testimony. But he pushed back when Durbin said the DEA “has decided to flood America with opioid pills, far beyond any medical purpose. Why?” Rosenberg said the agency is trying to meet legitimate industry needs that are fueled by physician requests. Durbin wouldn’t back down, saying the 14 billion pills went beyond pain management: “We are feeding the beast we are trying to kill.” There’s lots of blame to go around, but DEA decides “to red light or green light production. Look at what’s happened…it starts with your decision.” Does some of the fault rest with DEA, “yes it does,” Rosenberg acknowledged. “Can we do better? We will.”  Opioid death stats demonstrate the ravages of the epidemic. About 47,000 people died from overdoses in 2014, Rosenberg said. That’s 129 every day. About 61 percent were due to prescription opioid and heroin. At the same time the DEA authorizes the production of the drugs, it also tries to take them back. It sponsors a National Drug Take Back Initiative that Rosenberg said collected 1.6 million pounds of unwanted medication during take-back events in September and April. “The illicit drug market is constantly evolving,” he said. “We are increasingly encountering counterfeit prescription drugs laced with fentanyl and fentanyl derivatives, as well as heroin laced with fentanyl.” The number of fentanyl evidence items jumped 1,392 percent in two years, according to Rosenberg, from 934 in 2013 to 13,002 in 2015. “The trafficking of this drug, which is significantly more potent than street-level heroin, presents a significant risk of overdose to users,” Rosenberg said, “and to the law enforcement personnel who may come into contact with the substance during the course of their work.” Durbin said he recognizes the appropriate role opioids play in relief and the need for medicine makers to turn a profit. But, “we need drug companies,” he added, “who, for years, pedaled these dangerous drugs, misrepresenting their benefits and under-representing their risks, to step up.  We need doctors – who have been prescribing these addictive pain medications in ever-greater quantities year after year – to step up. “And we need the DEA – which is responsible for determining how many of these opioid pills are allowed to flood the U.S. market every year – to step up.”

Searching for naloxone to cure a heroin overdose? The FDA wants an app for that.

The winning scientists received $500,000. Now, the federal Food and Drug Administration is tackling a more deadly foe — the nationwide opioid crisis — and it’s calling on a different band of heroes for help. The dilemma is this: Despite the FDA’s desperate efforts to fast-track the approval of an easily administered, lifesaving form of an opioid overdose antidote called naloxone, the drug still requires a prescription in some states. Without immediate access in the critical moments of an overdose, as a person’s breathing grows more shallow and level of consciousness fades, the antidote is useless. Some states have tried to eliminate this barrier by making naloxone — and a nasal-spray version of the antidote sold under the brand name Narcan — more readily available to first responders, community organizations and even the friends and family members of opioid users, and some states have made the antidote available without a prescription — all in an effort to create a grass-roots web of people willing and able to help. Now, the FDA wants to take that concept one step further — by building an app. It will be like Yelp, but for the nearest naloxone instead of takeout Chinese.   The ideas will then be independently refined and resubmitted with a prototype video and conceptual description by Nov. 7. A panel of judges from the FDA, National Institute on Drug Abuse (NIDA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) will review the submissions. The highest-scoring proposal will be awarded $40,000.   This time last year, the only way naloxone could be administered legally was by injection. The FDA fast-tracked the review of a nasal spray form of the antidote, called Narcan, which first responders were more easily able to deliver as opioid overdoses rapidly rose across the country. It was approved in November.   “You can actually resurrect someone,” Skolnick said. About 28,000 people died in 2014 from opioid overdoses, both from prescription opioids like oxycodone, hydrocodone and morphine, and illicit ones like heroin and fentanyl. Since 1999, overdose deaths have more than tripled.  It’s primarily used as a large-animal tranquilizer. It’s strong enough to knock out an elephant. Disturbingly, the potency of heroin laced with fentanyl or carfentanil means that the usual doses of naloxone aren’t always effective on overdose patients, forcing first responders to administer multiple doses of the antidote to get the same results and depleting supplies along the way.  Ultimately, he said, these are small hurdles compared to size of the opioid problem nationwide. “There’s not a minute to waste,” Lurie told the Times.