The California stem cell agency is continuing to bask in the light of several recent pieces in the mainstream media that portray CIRM in a generally favorable light.
"Prominent researchers continue to flock to California. Confidence in the endeavor is so high that grants and gifts from private sources to California researchers have totaled more than $200 million so far. The feeble lawsuit challenging the program's legality should be history before June. And regulations are in place to govern the state agency in charge of distributing the $3 billion in grants, the first of which should be awarded in a matter of weeks.
"Given the nature of scientific research, it will take well over a decade to fully evaluate the state's stem-cell experiment. But it's already clear that, thanks to California voters, the United States is poised to become a world leader in one of the most promising areas of medical research today. That was not the case before Proposition 71 was passed in November 2004."
One CIRM staffer, who pointed with some pride to the editorial, noted that the agency's situation is a far cry from last year at this time. And he is right.
The Washington Post today caught up with some of the doings at the California stem cell agency, reporting that private, "almost unprecedented contributions" have saved the day at CIRM.
The story by Sonya Geis said the loans have also helped fuel other giving for embryonic stem cell research in California, echoing a point made in the San Diego Union-Tribune series, "The Stem Cell Wars."
"Private money is also building new stem cell labs on university campuses across the state. Los Angeles philanthropist Eli Broad gave $25 million to the University of Southern California for a stem cell institute, sound-technology pioneer Ray Dolby gave $16 million to the University of California at San Francisco, and local donors are contributing to a $75 million expansion at the University of California at Davis.
"'I was amazed by the number of wealthy Californians who have stepped up and decided to support a public agency,' said Owen Witte, director of the new Institute for Stem Cell Biology and Medicine at the University of California at Los Angeles. 'I've never heard of anything like this.'"
California's stem cell effort, still yet to dispense a single research dollar, has served as lever globally to boost funding for the field in locations ranging from New Jersey to Australia.
That's one of the conclusions of the third article in a three-part series in the San Diego Union-Tribune called "The Stem Cell Race."
"While San Diego's large stem cell research community has been waiting to tap the state funding, the Harvard University area – supported largely by philanthropists – has become the U.S. science cluster best known internationally for embryonic stem cell research.
"Also pushing ahead have been the governments of Singapore, China, Japan and several European nations, which have supported their embryonic stem cell scientists with money and favorable policies.
"'Proposition 71 is supposed to help the economy by creating jobs first, then new tools and treatments, but until it really gets moving it's just an old Jag in the garage," said Tom Okarma, chief executive of Geron, a Menlo Park stem cell research company."
"New York Gov.-elect Eliot Spitzer plans to push a $1 billion 10-year stem cell initiative that mirror's California's. On Friday, New Jersey's legislature approved borrowing $270 million to fund stem cell research. And Connecticut has floated a $100 million 10-year initiative. Part of the states' impetus was the fear of losing top researchers to California and abroad."
"Scientists and government officials from 15 nations have visited the stem cell institute over the past year, said Zach Hall, the institute's president. Delegations from India, Israel, the United Kingdom and China were eager to forge relationships and take home ideas and the possibility of collaborations."
Nonetheless, Somers reported that 30 "notable" scientists have come to California in the last two years because of the state effort. An informational graphic with the story showed that private and federal funds totalling $234 million have poured into the state, boosting research efforts. And she noted that CIRM now has $181 million in hand, ready to dispense on research.
"'With these loans California's funding is now six times the nation's funding through the (National Institutes of Health) and California is squarely in the global leadership of this breakthrough field of medical research,' said Robert Klein, chairman of the California Institute for Regenerative Medicine."
In Singapore, embryonic stem cell research is spelled Biopolis. It is a simple way of saying, We focus intensely on people and laboratories, fast action and strong collaboration.
On Monday, reporter Terri Somers of the San Diego Union-Tribune examined Singapore's embryonic stem cell effort in the second of her three-part series, "The Stem Cell Race."
"When she needs a new supply of embryonic stem cells, she phones in an order and walks across the campus of the science center her government has built to pick them up. Although her work is highly regulated, authorities have made obtaining human embryonic stem cells only slightly more difficult than snagging a box of pens from a supply cabinet."
"On what used to be grassland, a seven-building cluster of modern, glass-walled structures sprouted in 18 months. Enclosed glass walkways shelter workers from the unrelenting heat and downpours of the tropics, giving the complex the look of giant Habitrail for humans.
"Two more buildings opened in November, creating more space for the nine research institutes and consortiums that fill Biopolis, along with several research and development outposts of biotechnology and pharmaceutical companies.
"There's a storage facility for tens of thousands of mice for use in experiments, a tissue bank and a bioprocessing facility that is making the culture medium in which stem cells will be grown. Eventually it will produce millions of stem cells.
"The government accommodates the workers' long hours with a child-care center, supermarket, hair salon, dry cleaners, bars and even a 7-Eleven convenience store.
"On a typical workday, members of this multinational scientific community can be seen outside enjoying the cooling mist of a fountain, the shade of lush foliage or the convenience of a cafe, as they share ideas over lunch or lattes. They seem oblivious to the Miami-in-August temperatures and humidity."
The Singapore effort has paid off by attracting a host of first-rate scientists as well. Somers reviews the cast that now stars in the Biopolis "theater," ranging from UC San Diego's former medical school dean, Edward Holmes, and his wife, Judith Swain, a cellular cardiologist, to Neal Copeland and Nancy Jenkins, top ESC researchers from the NIH.
"The advisory board to Singapore's Biomedical Research Council reads like a who's who of medical research, including David Baltimore of Caltech and La Jolla-based scientists John Reed of the Burnham Institute for Medical Research, Sydney Brenner of the Salk Institute for Biological Studies and Richard Lerner of The Scripps Research Institute."
Both Reed and Baltimore also serve as directors of CIRM.
"Yeo called his friend Stuart Weissman, a pioneer in embryonic stem cell research at Stanford, seeking advice on what type of work could be done at Biopolis that would complement efforts in the United States.
"Yeo (then) set about trying to lure – he would say borrow – top researchers to Singapore. Governments jilted by researchers who have found his offers too good to refuse refer to him as a 'serial kidnapper.'"
The San Diego Union-Tribune Sunday began a three-part series on embryonic stem cell research globally, reporting that the United States is "getting a taste of being the underdog."
Reporter Terri Somers, who has followed the industry and the California stem cell agency from San Diego's biotech hotbed, also wrote a Sunday piece looking that the business side of the research.
Both Sunday articles are as comprehensive on their subjects as one is likely to see in the mainstream media. Included is a downloadable world map with country-by-country snapshots.
Here are some excerpts from the front page series called "The Stem Cell Race:"
"'For the first time, we have a lot of competition ... . I don't think we've had as much concern for another country besting us in science since the race to the moon,' said Dr. Evan Snyder, who runs the embryonic stem cell research program at the Burnham Institute in La Jolla.
"It is a competition with crucial consequences for San Diego County and California, home to leading stem cell researchers and 50 percent of the world's biotechnology research."
"China reportedly is doubling its investment in stem cell research. But an air of mystery and skepticism surrounds China's work, because the country's regulatory guidelines differ from those in the West and because research from Chinese scientists has not been widely published.
"The United Kingdom already has invested about $198 million in stem cell research at 90 laboratories, of which 11 are licensed to conduct human embryonic stem cell research.
"Singapore, with just 4 million citizens, is investing $25 million to $29 million annually in research, excluding overhead costs and infrastructure.
"That investment may seem wimpy compared with the $609 million the United States government spent on stem cell research last year. But because of federal funding restrictions on human embryonic stem cell research, only $20 million to $40 million a year – about 6 percent at best – has been directed to that field.
"Money is not the sole catalyst of success. Scientists say supportive government policies that free them to concentrate on their work, national commitment and contagious scientific enthusiasm are just as important.
"The United States, long the world leader in biomedical research and commercialization, is getting a taste of being the underdog."
"Worldwide, only about a dozen companies are building a business based on human embryonic stem cells, and only three of those are publicly traded: Geron in Menlo Park, Advanced Cell Technology in Alameda and Stem Cell Sciences in Edinburgh, Scotland.
"Executives at several of the companies say the key to tapping funds at such an early stage is either finding someone with deep pockets and a personal passion for curing disease or possessing a unique technology to address a potentially huge market.
"Given the current business climate and the political and moral debate surrounding human embryonic stem cells in the United States, people in the business don't expect more competition to pop up soon."
The Greenlining Institute, a longtime activist community group in California, has come up with a series of recommendations on stem cell research in California, including suggestions that biotech companies receiving state grants set goals for directing some of the money to minority and women-owned businesses.
The proposals stem from a Greenlining conference earlier this year on stem cell issues. They have been compiled in a report, called "Fair Cures," prepared by Joe Araya Tayag, health program manager for Greenlining. The group has been around for decades and has litigated and agitated successfully on a wide range of issues involving minorities. The organization's name stems from its position opposed to the practice of redlining.
Currently CIRM is preparing a proposal to fund $47.5 million million in lab facilities. The grants are expected to be awarded in June. The agency has generally indicated support for diversity efforts, but it is not clear how that might be reflected in its grants for labs.
"...(R)esearchers and firms that obtain patents on health care technology, such as stem cell advancements, have virtually no incentive or authorization to ensure fair access to innovations in medical treatment. Without an adjustment in patent law, the cost of patent licenses in the stem cell industry will impact costs of any potential products. Because researchers have to recoup the costs of licenses, prices are driven up, with the greatest burden ultimately falling on disadvantaged communities of color. The CIRM currently includes provisions for affordability in their intellectual property policies that may be used as models for future state-funded research programs."
There it was – in the 4th paragraph of the press release – a CIRM scholar produces a newsworthy finding as the result of "some of the first research funded by the California stem cell agency," according to one reporter.
Rebecca Vesely of the Contra Costa Times highlighted the CIRM connection in her story about the research at UC San Francisco that suggests "stem cells in the brain have a surprising capacity to repair damaged tissue." She said that researchers indicated that "the findings could help in the quest for treatments of brain trauma such as stroke."
"Kuo is one of 16 UCSF CIRM Stem Cell Scholars – up and coming young scientists funded by the California Institute for Regeneration (sic) Medicine, established by California voters in 2004 to allocate $3 billion over 10 years to support stem cell research."
"Kuo said he received a $45,000 stipend, plus funds for medical benefits and a $10,000 allowance for research costs.
"'It allows trainees independence,' he said. 'It's given me incredible freedom to do my research.'"
Obviously the research is of considerable interest, but what adds to it is the CIRM-funding connection. One of the abiding concerns at the agency is producing results that fulfill the promise of Prop. 71. This is the first such event the agency can point to, albeit only as a modest funding effort.
A three-day series dubbed the "Stem Cell Race" begins Sunday in the San Diego Union-Tribune. Written by Terri Somers, the lengthy effort will cover the issue from Singapore to California.
Sunday will examine which country is leading the stem cell race. Monday will attempt to answer the question: "Why is Singapore spending millions in research?" And Tuesday addresses the issue of whether California can lead the U.S. in stem cell research.
Items of some interest involving California stem cell matters.
Inside a Grant Review Session – Longtime patient advocate Don Reed, on his blog stemcellbattles.com, has a heartfelt look inside a session that reviewed grant applications for spinal research. Reed sits on the review committee. Reed also writes in opposition to more public disclosure in the CIRM grant process.
Whither Donley? -- Beth Donley, the longtime counsel for WARF, has resurfaced in a stem cell start-up. Donley, who served notice last spring that California would have to pay its stem cell dues to WARF, is the CEO of Stemina Biomarker Discovery Inc., which aims to use stem cells to develop tests for diseases. Reporter David Wahlberg of the Wisconsin State Journal has more here.
A couple of California novelists have dipped into politics and stem cells and come up with a thriller involving the death of a hard-nosed female state legislator.
The authors are Jonathan and Faye Kellerman. Their book, "Capital Crimes," consists of two novellas. Here are a couple of commentaries on the effort. First from Bookgasm and then Amazon(Publishers Weekly).
"The first, longest and best of the two procedurals is the inappropriately titled 'My Sister’s Keeper,' in which a feisty, dedicated female California state rep is found dead in her office, practically decapitated by a shotgun blast. The detectives who investigate wonder if her politics — whether public (she was a proponent of stem-cell research) or private (she was a lesbian) – have anything to do with the young woman’s demise. Following a trail whose clues include an STD and more than one right-wing nutjob, they have their answer. And then, just when we think it’s all said and done, the Kellermans throw in an extra delicious twist."
"The second collaboration by bestsellers Jonathan and Faye Kellerman (after Double Homicide) offers two thin novellas that dedicated fans will most appreciate. In the first, My Sister's Keeper, Faye Kellerman's LAPD detective Peter Decker makes an extended cameo role in an inquiry into the murder of an activist lesbian California state representative, Davida Grayson. Grayson, who was the focus of threats from politicians and members of the radical right opposed to her support for stem-cell research, is found shot to death in her Berkeley office; an uninspired pair of local police find that the dead woman's personal relationships, rather than her politics, may have motivated the killer."
Only hours after we wrote that the impending departure of Zach Hall would make it more difficult to hire senior management at the California stem cell agency, CIRM said it has filled a key position involving its grant efforts to build scientific facilities.
Rick Keller, currently assistant vice chancellor for capital resource management at the University of California, Davis, will become CIRM's senior officer for scientific and medical research facilities as of Jan. 2. Keller has held his position at Davis for 19 years.
Keller has worked with the California legislature and the California State Department of Finance. He also was chairman of Mercy Healthcare, a subsidiary of Catholic Healthcare West, one of the nation's largest nonprofit hospital systems.
CIRM President Zach Hall said, "His experience with more than $2 billion in complex building projects will be enormously helpful to us, as we move forward with our shared and major facilities grants."
One year ago this month the situation at the California stem cell agency was likened to the war in Iraq by a Nobel Prize winning scientist from Stanford.
Today the situation is much improved. So what better time for CIRM's president, Zach Hall, to announce that he is leaving.
Which is what he did last week. The move prompted comments that clashes with CIRM Chairman Robert Klein may have been involved, but Hall is 69 and has made it clear from the start that he did not want to hold the post over a long period of time.
Hall and Klein have butted heads. Klein told reporter Terri Somers of the San Diego Union-Tribune, "We mentally challenged each other to excel." But Hall also said said his plan to leave within six months is almost entirely personal. His wife retired earlier this year. They have a place in Wyoming. They love the outdoors. He doesn't need the money. And who needs the aggravation and long hours that came with the president's job.
Hall's work has set the stage for approval of the first round of research grants. And he oversaw preparation of the agency's now approved plan for giving away $3 billion for embryonic stem cell research. It is a far cry from last December when New York Times reporter Andrew Pollack quoted Paul Berg, the Stanford Nobel laureate, as likening the situation at CIRM to the Iraq war.
"We won the war and didn't know what to do afterward," Berg said.
"Major training, research and joint research facilities grants will have been awarded.
"Major polices on IP, medical and ethical standards, and grant administration will be in place.
"A realistic scientific strategic plan will be in place that emphasizes science rather than hype.
"The role of the president and chief executive of CIRM will have been defined by Zach's commitment and high standards in a way that minimizes the possibility of excessive meddling by the ICOC chairman in the day-to-day operation of the institute.
"In sum, he'll have done a heck of lot to get the fledgling state agency off the ground and functioning in a productive way. Not at all a bad time to pass the torch to a younger leader."
"I was surprised when he took the longer-term job in the first place, so I am not really surprised now. His can't be an easy job."
CIRM seemed to have difficulty in finding a president back in 2005 which is one reason that Hall agreed to serve longer as president. Now the agency has the task of starting a new search, although it presumably could go back to the list it had worked on then. The job is likely to seem less risky, but the agency has structural problems involving the president's job that cannot be changed short of another vote of the people. Those involve overlapping responsibilities with the chairman.
Klein, however, indicated to reporter Somers that he may be leaving in 2008, setting the stage for a different sort of relationship between a new president and new chairman. Somers wrote that Klein, who works without a salary, said "he planned to stay probably another year so he could contribute his real estate and facilities expertise when the institute is expected to award large grants for the construction of new research facilities."
The Oversight Committee took no action last week on setting up a search for a new president since the matter was not placed on the agenda in advance as required by state law. The next meeting of the group is not scheduled until February, but presumably the old presidential search subcommittee could reconvene quickly. It also seems reasonable to assume that some work is already underway to prepare for a new search, either on Klein's part or other folks at the agency.
Hall's departure overshadowed the announcement of the resignation of Mary Maxon, deputy vice chair of the agency. She has been instrumental in putting together CIRM's proposals on the critical intellectual property policies. Maxon has been with CIRM since the beginning. She noted arduous nature of work at CIRM. "It's been like three jobs in one," she told Somers.
Hall's announcement does raise the level of uncertainty at the tiny agency (roughly 20 staffers) at a time when stability seemed to be increasing. It is likely to make it more difficult to recruit other top level people, such as the chief legal officer and senior facilities officer, which are among four positions that agency hopes to fill soon.
Hall brought a steady hand, good humor, common sense and good science to a young and struggling organization in its formative years. All qualities whose absence can be sorely missed.
(Here are links to other stories on Hall: Rebecca Vesely, Oakland Tribune; Mary Engel, Los Angeles Times; Carl Hall, San Francisco Chronicle, and The Associated Press.
Like the the spawn of Godzilla, there is no getting rid of Hopalong and its hardy crew of two(your humble correspondent and his magnificent wife). We arrived about noon on Sunday in Mazatlan following three nights at sea. We nearly killed each other on 2.75 occasions. But we have learned once again lessons of the sea.
First, take a day sail – following an extended layoff from the sea -- before you set out on a three-day passage, no matter how many sea miles you have under your personal flotation device. A boat that hasn't been sailed for months needs to be rechecked better than we did. So does the crew. Then you don't have to wrestle with lines and knots while hanging from from a precarious perch that might pitch you into the plunging seas many miles from shore.
After a long layoff, be prepared for equipment to fail. A leak popped up from our rudder post when we were about 100 miles out. Crawling under the cockpit sole with two 1/2-inch wrenches to attack the steering quadrant took care of that.
Then there are the problems that you can't fix, such as the ones with the Alpha autopilot, which became crankier than the crew and yawed unmercifully. Sleep was nearly impossible as the boat rolled in response. That was unfixable because Alpha refuses to disclose the secrets of its autopilot, which cannot be opened without actually breaking something (as in cracking open a part) on the $3,000 device.
Now for good news: We successfully performed the most important task of a sailor -- listening to Mother Nature. She tells you when to sail and when not to. Our passage took us three days. Another sailboat of the same size left the same port we did, but seven days earlier and just arrived here a few hours before us. The difference is that the other boat was so beaten up by nasty waves in the Sea of Cortez that they had to put into shelter on two different occasions and wait until the sea had settled down.
What does this have to with the California stem cell agency, the subject of this blog? Really nothing. But we can tell the folks at CIRM that timing and patience are important ingredients in success. Luck too. Stay tuned for hot stuff on stem cell affairs – as soon as I catch up on all the events that occurred while we were at sea.
The California Stem Cell Report will be in the middle of the Sea of Cortez for about the next week, making it impossible to file reports. We will be on a passage from the Guaymas area to Mazatlan, both of which are on the mainland of the west coast of Mexico.
By popular demand (at least one or two requests), we are providing a few more details of the cruising life, as it is known. This passage will involve at least four nights at sea, perhaps more. The entire crew of our vessel, Hopalong, consists of two persons. We stand watches 24 hours a day while we are at sea. This is required by maritime law as well as by common sense. There are other vessels out there. Some of them are not lighted at night. Others, including large commercial ships, simply set their autopilots and proceed without keeping what is known a proper watch. So we must stay out of their way.
Our watch schedule consists of three hours on, three off during the dark hours. That means one person tries to sleep while the other keeps an eye out. During daylight, we keep a six-on, six-off schedule, but this time of year does not provide 12 hours of daylight. We also have an autopilot that takes care of the actual steering for us. Hand steering becomes tedious at the very least and sometimes arduous under rough conditions, although we hand steered for 2,000 miles one year when our autopilot was down. Those were not consecutive miles but parcelled out over a period of months. I once made a passage from Hawaii to San Francisco, which involved hand-steering nearly the entire distance on a Santa Cruz 40 called Gandy Dancer. However, we had a crew of six, which made life much easier.
During a week when the California stem cell agency might think it should be receiving some kudos, it has taken a couple of stiff shots in the media.
On Thursday CIRM's Oversight Committee is expected to approve its strategic plan for spending $3 billion on embryonic stem cell research. It is a remarkable document, the result of many months of work and involving ideas and suggestions from hundreds of persons, including the top scientists in the field and patient groups. The plan is a key bench mark in the life of an extraordinary agency that is unlike any other state department in the United States. In addition, CIRM represents the single largest source of embryonic stem cell funding in the world.
"Californians were promised wonder cures if they passed Proposition 71 to fund stem-cell research in 2004. Turns out they have bought a $3 billion jug of snake oil."
"Activist complaints about the private sector's focus on adult and umbilical-cord stem cells have driven the state to spend $3 billion on embryonic stem-cell research — something the market won't touch, even though you can find plenty of liberal venture capitalists out there willing to pay for political campaigns with celebrity endorsers.
"The only thing this amounts to is a boondoggle for voters — fool's gold the private sector had already panned for and rejected, having found the truth out first."
The emphasis on the results of adult stem cell research echoes the party line from the foes of ESC research. The newspaper also quotes the LA Times piece earlier this week. That article has been widely cited online around the country by ESC opponents. The business newspaper piece is also surfacing rapidly on anti-ESC web sites.
"...(I)t remains baffling why the institute can't be completely transparent and publicly reveal the financial interests of its grant reviewers. Scientists regularly disclose such conflicts when presenting papers at conferences. They should do so when making recommendations on grants that involve millions -- and potentially, billions -- of taxpayer dollars.
"The institute has made some good progress this year, including adoption of a strategic plan that sets realistic goals and lowers the inflated expectations of the Proposition 71 "countdown for cures" campaign. If institute leaders could take another step and come clean about internal conflicts, they could go a long way toward securing the trust they have risked squandering the last two years."
The California stem cell agency is not the only group with good financial news this fall. The Foundation for Taxpayer and Consumer Rights has come up with a $100,000 grant to continue its work attempting to influence CIRM.
John M. Simpson, stem cell project director for the FTCR, said today that it has received the cash from the Nathan Cummings Foundation for 2007. The money will go to FTCR's Stem Cell Oversight and Accountability Project, which was also funded by Cummings this year.
"We've tried to be constructive critics of the California Institute For Regenerative Medicine as this important groundbreaking state agency got off the ground, holding its staff members and overseers to the highest level of transparency and accountability. With $6 billion of taxpayers' money at stake and with the agency's built-in, but legal conflicts of interest, we're gratified to be able to continue our work in behalf of all Californians to ensure they benefit from the research they are funding."
The Cummings Foundation has a $500 million endowment that originated with Nathan Cummings, the late founder of the Sara Lee Corp. It has a wide range of activities including "humane health care."
"Nothing will ever be accomplished if all possible objections must first be overcome."
The latest move to ensure the affordability of stem cell cures developed by California-financed research faces opposition from both the California biomedical industry and one of the chief advocates for widespread access.
John M. Simpson, stem cell project director for the Foundation for Taxpaper and Consumers Rights, said the proposed policy to be considered this Thursday by the CIRM Oversight Committee falls "far short of ensuring that all Californians will have affordable access to the therapies, drugs and cures that their tax dollars fund."
"California’s attempt to lower drug prices, by threatening drug manufacturers with prior authorization requirements, will likely face legal challenge in federal or state court. Absent a successful legal challenge, the threat of prior authorization requirements may force most drug manufacturers to the negotiating table."
"The proposed for-profit (intellectual property) policies -- like the non-profit polices -- fall far short of ensuring that all Californians will have affordable access to the therapies, drugs and cures that their tax dollars fund.
"There is an appropriate formula for a payback to the state if taxpayer dollars fund discoveries that produce a revenue stream. The plan appears to strike a reasonable balance between capping the payback so companies know their potential liability and provisions that increase the state's share if there is a true 'blockbuster' discovery. The provision that Californians get preference in the event of a limited supply is only fair since we are funding the research.
"But there must be a provision to preclude the possibility of egregious profiteering. If prices are unreasonable, the state through the attorney general must have the right to intervene -- 'march in' -- and remedy the situation. There must be a reasonable relationship between the public money invested and the price that is charged.
"What must be be prevented is the Genentech situation. The National Cancer Institute provided $44.6 million to develop the cancer drug Avastin, yet Genentech set the price at $100,000 a year.
"Another troubling aspects about the for-profit policy is that it provides that there will be a discount on therapies purchased in California with public funds without spelling out the mechanism for reaching the discount. The devil will certainly be in the details.
"We see that in the non-profit regulations. The original policy called for selling drugs and therapies at the federal Medicaid price. Under incessant battering from the so-called California Healthcare Institute – actually nothing but a shill for the biomedical industry -- the regulation before the ICOC Thursday has been watered down to cover only drugs and only through the California Discount Prescription Drug Plan. It doesn't cover all purchases made by publicly funded health plans. They pledge to amend the regulation to include therapies when a mechanism is worked out, but with CHI in the picture I am frankly worried."
"As a consequence of expenditure of the 'first dollar' of CIRM funding, the for-profit awardee organization agrees to provide a plan to provide access at the time of commercialization to resultant therapies for uninsured California residents.
"In addition, the awardees will provide the therapies at a discount price to residents whose therapies are purchased in California by public funds. For drugs generated as a consequence of CIRM funding, awardees agree to provide drugs at prices negotiated pursuant to the California Discount Prescription Drug Program (commencing with California Health and Safety Code section 130500, et seq.) to eligible Californians under that program. Awardees also agree to provide discount pricing for therapies in addition to drugs that result from CIRM funding.
"In the unfortunate event of limited availability of therapeutic products resulting from CIRM funding, awardees agree to give preference to Californian residents unless prohibited by law and whenever feasible. If an awardee is unable to grant preference to Californian residents, the awardee agrees to submit a statement of justification to CIRM."
"According to the author, this bill is needed because Californians, especially those with no drug coverage, continue to pay some of the highest costs in the world for prescription drugs. The author states that this bill uses the state's purchasing and negotiating power to help Californians cope with the rising cost of prescription drugs by creating a drug discount card program for state residents. According to the author, despite the skyrocketing cost of drugs, to date the state has done little, compared to other states, to help residents afford their medication."
Both industry and health advocate groups opposed some facets of the legislation for different reasons. You can read a discussion of those concerns in a Senate staff analysis.
Here is a piece by Health Access California on the new law.
How Funny is ESC Research?
This you have to see.
The performance audit requested by former Sen. Deborah Ortiz is already having an impact on the the California stem cell agency.
On Monday, CIRM's Governance Subcommittee approved a number of changes in its policies that seemed to be needed as a result of the state auditor's work. The full audit is not expected to be officially released until March.
The changes deal with contracting, travel and other policies.
"We decided to address issues raised in (the audit) process to date, rather than wait for the final report. Our objective is to run a tight ship. If we can eliminate ambiguities, we'd prefer to do so sooner, not later. The problems are relatively minor, evidence of an agency that is young and new to the detailed requirements of travel and contracts applied to established government entities. Better to uphold the highest possible performance standards now, before signficant resources are placed in our trust. We want to be a model agency."
We can also say that it is good PR as well as good management to take care of this kind of stuff before it winds up as a bone of contention in a critical audit.
CIRM is heavily dependent on outside contractors because of its small staff. These changes seem appropriate but still allow considerable leeway in letting contracts without bids. While the bidding process does not guarantee good value, negotiated contracts can also lead to abuses. How all this shakes out will depend on the skills of CIRM staffers in dealing with outside contractors, which can be a real art.
Here are links to the proposed new policies which were approved unanimously and sent along to the Oversight Committee for action later this week. Travel.
The California legislature reconvenes Monday in Sacramento minus its chief advocate for embryonic stem cell research.
Her absence will not well serve the California stem cell agency, although its chairman, Robert Klein, probably has a different view. He labelled her an "ongoing threat" in a harshly worded screed earlier this year.
While it is impossible to fully determine the roots of his animosity, Klein and the agency are losing a valuable asset with the departure of former Sen. Deborah Ortiz, D-Sacramento.
She was the one of the earliest and strongest advocates for stem cell research in California and played a key role in the conceptualizing Prop. 71. Following its passage, she understood some of its failings and began to work to correct them. But Klein did not welcome the attention and stiffed the Senate Health Committee, which Ortiz chaired, during a session examining the research agency.
It is natural to bridle at one's critics. And sometimes their motives are mixed. But in the case of Ortiz, she was a friendly critic, one who supported CIRM but also understood its imperfections and the political risks that they continue to pose.
Having powerful friends in politics and government is important for any state agency. Otherwise a department can become fair game for the genuinely malicious. A friend such as Ortiz can provide important guidance to governmental novices as they attempt to navigate the tricky byways of the Capitol. But most importantly a powerful legislator can deflect truly harmful fire by taking an agency under wing.
Perhaps one of the best known examples of a friendly critic was Harry Truman when he was a U.S. senator in the early 1940s. His committee of one exposed examples of poor military training, waste and fraud. Folks in the Roosevelt administration did not care for this. But ultimately Truman earned appreciation from within the administration. He was a Democrat and a friendly critic. Problems with the war effort? Well, the Roosevelt administration could say, "Harry's on top of it." Harry took the wind out of the sails of many of those who could have played hob with FDR's plans.
The Los Angeles Times, California's largest newspaper with nearly one million circulation, Sunday published an overview of the state's stem cell agency, headlined "Reality Check for Stem Cell Optimism."
Written by Mary Engel, the story spoke of the "long and slow scientific journey" facing CIRM.
"Even with the $150-million state loan approved recently to kick-start work stalled by legal challenges, there are no breakthroughs in sight. Gone are the allusions to healing such afflictions as spinal cord injuries and Parkinson's and Alzheimer's diseases that dominated the 2004 campaign for Proposition 71. In fact, scientists say, there is no guarantee of cures — certainly not any time soon — from the measure that was optimistically titled the California Stem Cell Research and Cures Act."
Engel's piece included a host of interviews with a variety of folks interested in the agency. She also had an interesting quote from Sen. Deborah Ortiz, D-Sacramento, concerning some of the hype involved in the campaign for Prop. 71. It reflected one of the realities of political life – one sometimes not fully understood by those who criticize the overblown rhetoric of the campaign.
"'A campaign requires a message to be driven home,' (Ortiz) said. 'You can't raise those hopes and then say, 'Oh by the way, it may take us 10 or 15 years.' That's just the nature of campaigns.'"
Certain news media tend to set the agenda in news coverage throughout the nation. One of those is The Associated Press, whose news service goes into virtually every newspaper, radio and television station in the country.
Not only are its stories read by millions, but perhaps more importantly they are read by editors – gatekeepers -- who make judgments about what is fit to print. Those editors look to The AP for guidance about what is important, what is not and what to think about subjects they are not familiar with.
Now comes an update on the California stem cell agency by AP reporter Paul Elias, who has covered CIRM since its inception. The story, which is also likely to be circulated overseas, sounds a bit of a cautionary note in advance of next week's meeting of the CIRM Oversight Committee.
"Our aspirational goal is to cure disease. But you can't snap your fingers and have that done."
"...(M)uch of the money (the agency) doles out in 2007 will finally go to senior scientists eager to push stem cell research out of the lab and into patients.
"But don't expect those promised cures anytime soon. The research is in such a nascent stage that even fundamental questions such as what defines a human embryonic stem cell remain unanswered."