Calls to repeal D2C diagnostics laws in some US states
In the wake of the Theranos scandal, doctors have spoken out against the raft of diagnostics startups competing to deliver the end user more and more data about themselves. Speaking to Mashable,  Bob Wachter, Professor and Interim Chair of the Department of Medicine at the University of California said "There are a lot of companies, including Theranos, that have an interest in making you believe that more data will magically make you healthier, it won’t, at least not in the short-term", and indeed may actually harm patients by giving them unnecessary anxiety about their possible disorders; far from empowering patients, too much data may overwhelm them into self-diagnosis. Diagnostics startups, in particular Theranos, have gone one step further and urged lawmakers to enact legislation that allows patients to circumvent healthcare professionals in receiving diagnostic tests; some are now calling for the repeal of laws that allow Theranos to work directly with the consumer, until they produce "extraordinary - or at least very good -evidence". 

Imagine walking into your local pharmacy and ordering one of hundreds of blood tests from a menu, no doctor’s note required. You will receive the results in a matter of hours and decide for yourself how to interpret and act on them.

That may seem far off, but it’s slowly becoming a reality due to a much-hyped Silicon Valley biotech startup called Theranos, which features Silicon Valley's only female billionaire as its CEO and a star-studded board of directors that haven't stopped the company from being mired in scandal.

The company’s rise to prominence and a multi-billion dollar valuation was fueled by the promise of its fast and inexpensive finger-prick blood testing technology.

Theranos isn’t just defending its approach – it is lobbying state lawmakers to pass favorable legislation. On April 6, a law that Theranos co-authored went into effect in Arizona. The law, called Laboratory Testing Without Order, opened up the floodgates for residents to request a blood test without their doctor’s permission.

Theranos is notoriously secretive about its technology, but the company has been very clear about its commitment to lobbying. The company has recruited advisors and staff-members from the Washington D.C. elite. Its original board included three former cabinet secretaries and two former senators.

“We would like to see that model [the Arizona bill] replicated in states across the country,” a Theranos spokeswoman told me this week. “We believe this law can and should serve as a model for the nation for direct testing.”

But trouble was brewing from the beginning. From the outset, the company declined to backup its claims with peer-reviewed research.

After years of positive press, the Wall Street Journal published a scathing report that raised doubts about the effectiveness of its technology and methods.

In the ensuing fallout, Theranos had to regroup and change its business model. The company subsequently scaled back the use of its finger-pricking technique, which uses a drop of blood from a finger instead of blood drawn from a vein, for all but one of 200 tests it offers.

The scandal took another twist when the U.S. Food and Drug Administation published inspection reports from a recent visit to Theranos’ lab, which argued that the company failed to show adequate evidence that its technology lived up to the claims.

Theranos then announced that it would restructure its unusual board, which contained a who’s-who of the military industrial complex including former secretaries of state Henry A. Kissinger and George P. Shultz.

In the face of mounting criticism, Theranos’ CEO and Stanford University dropout Elizabeth Holmes, now a billionaire at the age of 31, has held the line on her vision of making health data more available to patients – calling it, a “basic human right.” That means giving patients direct access to lab tests.

But what if more testing without nuanced interpretation is actually harmful to patients? Beyond the efficacy of its products, doctors and medical experts are increasingly questioning Holmes’ vision of cheap and ubiquitous lab tests.

‘A Model for the Nation’

Theranos argues that this approach will help patients detect diseases earlier and get the treatment they need. But this defies conventional wisdom that tests should only be ordered by a health professional when there is a specific question to be addressed that might result in a useful intervention.

“There are a lot of companies, including Theranos, that have an interest in making you believe that more data will magically make you healthier,” said Bob Wachter, Professor and Interim Chair of the Department of Medicine at the University of California, San Francisco. “It won’t, at least not in the short-term.”

According to Wachter, it’s not surprising that Theranos is pushing to make it easier for people to order their own blood tests. After all, the company would make money every time a consumer walks into a pharmacy and order one of its tests.

High-profile doctors like Wachter recently rallied around this issue in April, when Dallas Maverick’s owner Mark Cuban suggested on Twitter that anyone who can afford it should get quarterly blood tests. Cuban echoed Holmes’ views by describing it as a “big failing of medicine” that most people wait until they’re sick to get their blood tested.

In the long-term, some of this data from patient-ordered tests might turn out to be useful. But for now, Wachter explained, it will cause a “tremendous amount of uncertainty” for patients.

That’s because erroneous results do occur that may indicate a patient doesn’t have a disease when they actually do (false negative), or that a patient does have a disease when they’re perfectly fine (false positive).

The more tests that a patient orders, the more likely it is that they will receive a seemingly abnormal result. That leads to a higher probability of further tests and even unnecessary treatment. And treatment carries side effects.

“The story we’re hearing from companies like Theranos is that more information in the hands of patients will be good and empowering,” said Patti Zettler, an associate professor of law at Georgia State University. “But will patients try to diagnose themselves, or misunderstand the results?”

‘Why Should We Trust Them?’

Theranos has yet to publish peer-reviewed studies to back up its claims, which is adding further fuel to its critics’ case. A company spokesperson told me that it is working on getting its data published in a peer-reviewed journal to backup its claims, “but those things don’t happen overnight.”

Legal experts say that evidence could not come quickly enough, especially given that some patients are able to order their own blood work.

“Anything new really needs some evidence before it should it believed - and extraordinary claims require extraordinary - or at least very good – evidence,” said Hank Greely, the Director, Center for Law and the Biosciences at Stanford University. “Theranos has so far just said ‘trust us.’ Why should we just trust them?”

Greely went as far as to suggest that the Arizona legislature reconsider the bill. In general, he said, test results should go through a “licensed and knowledgeable health professional” on their way to a patient. Theranos said that it’s a patient’s prerogative to contact a doctor to talk through the results. But it recently release a service called MD Connect, which helps people connect with primary care physicians.

But some doctors are more sympathetic to Theranos’ mission. They believe that it’s inevitable that patients will own their health data, whether it’s X-rays, genetic information or chemistry tests.

“We are entering into an era where many people, if not all people, will want to see their own data,” said Robert C. Green, an associate professor of medicine at Brigham and Women’s Hospital and Harvard Medical School.

Green argues that resources need to be made available for patients who have to ask questions about their results. He admits that there is still some opportunity for misunderstanding, but stressed that it shouldn’t halt progress in its tracks. “We need to find some way to cope with that.”

Others see a middle ground where patients can order some, but not all tests, on their own.