Matthew Holt

State regulators challenge the rights to your DNA

It is something of a surprise that it popped up this way, but the establishment
challenge to Health 2.0 was going to start somewhere. And it appears to have started with two big states, New York & California ordering 13 companies to stop Gene Testing.

Karen Nickel, from the California Department of Public Health, argues that these companies are operating without a clinical laboratory license in California. The genetic tests have not been validated for clinical utility and accuracy.”

But as those companies are outsourcing the testing anyway, that argument barely holds water. Here’s what Navigenics CEO Mari Baker said Navigenics uses a doctor to transit orders and review results, and it relies on a state-certified lab testing company to do the gene tests.”

So what this really is about, of course, is who has the right to order a test? Is it you or do you have to go through a doctor? Or put another way, is it your DNA or is it the state’s?

Of course, with
the ability of Health 2.0, a direct-to-consumer service can help you
order a lab test and explain it to you. So why do you need a doctor if
you don’t want to use one?

The same thing
is more or less true with prescription medications. The argument in
that case is that only a doctor can manage your prescription regimen,
but countless studies show that’s a total lie — in practice doctors
barely manage their patients’ medication regimen. If they did we
wouldn’t have the crisis of polypharmacy complications that costs
hundreds of thousands of lives and billions of dollars.

So this is a
case where the regulations are running way behind the technology, and
the trade protection organizations of health care providers are, I’m
sure, whispering in the ear of the regulators.

Oh, and then there’s this…

California
said its investigation followed a number of consumer complaints. "The
consumers were unhappy about the accuracy [of the tests] and thought
they cost too much," a spokeswoman for the department said

The
genetic firms should be damn concerned if their tests aren’t accurate,
and someone in regulatory terms should be checking on who’s doing it.

But
what business is it of the state how much they charge? And if pricing
is the issue of the state, how about they start with Exxon-Mobil!

And
think about one more thing. I had a complete set of lab tests the other
day. The cash price was over $400. For a similar set of tests in New
Zealand a few years back I paid less than one-third that amount — a much
bigger difference than the cost of a FedEx to New Zealand! So if I’m
checking my own data, why do I need an American doctor or an American
lab company.

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11 replies »

  1. I understand the legitimate concerns about shysters conducting tests without proper certification. I hope the non-CLIA certified people do get run out. The sticking point is requiring a doctor’s order to run the test. Doctors don’t know and don’t want to know the latest in SNP risk correlations. It’s not their job and they don’t want it to be. In addition, there’s significant non-disease related information to be gained from SNPs, such as ancestry, and it’s just kinda absurd to make doctors the gatekeepers of that information.

  2. if the condition and test you are interested in obtaining has been confirmed by metanalysis and published in a disease specialty or genetic specialty peer review journal(it is a rapidly moving globally produced information product)by all means it is a free country….if you can afford these tests….they are likely marked up by a factor of 5-35 times production costs…..as is still done in your local hospital who stands to loose alot if you can prevent conditions….
    FTC is after the bad apples…you can help drive a consumer market where we can stop at a kiosk next to the phone kiosk in the mall….

  3. Hate to rain on the paranoia parade, but these tests are considered laboratory tests, and lab tests are tightly controlled by innumerable regulations, both federal and state. (I am speaking as a former hospital laboratory medical director). Just because the actual test is outsourced does not relieve the ordering company from responsibility for the accuracy and precision of the tests, and both the state and the feds will likely want to verify that, especially with this new category of tests. I foresee this happening in many other states. I would WANT it to happen in this case, as otherwise the field would be wide open for all number of profiteering shysters with inaccurate methodology and results.

  4. Matthew,
    Thanks for calling me wrong based on a fragment of my argument out-of-context.
    FDA is just the biggest fish illustrating how regulation distorts market, how much it can cost, how it can slow down innovation or undermine its economics. Plenty other players in policy arena are capable of huge influence.
    I am puzzled why you would ignore states given their huge role in regulating actual profession definitions, licensure, standards of practice, pharmacy, prescribing, public health programs, Medicaid, managed care and so on. If you need a history lesson, look at how prescribing over the Internet got banned in nineties. I personally know a doctor who got caught in some weird sting across state lines without even knowing of violating other state’s laws. He lost his license and ended his career.
    If anything, states are the ones to watch. They are closer to real people than Feds and have every incentive to create political issues. Too many legislators just do not have enough to do. The lady who represents my district in California Assembly introduced a bill to jail parents for spanking their kids!
    I find it interesting, if not a little hypocritical, that you keep talking about the need for regulating insurance markets, while ignoring any suggestion that it is only fair to put these “Health 2.0” services under the same risk vs. benefit scrutiny as the rest of the market.

  5. Matthew,
    Just to clarify, I do not feel a doc should be present to review tests (did I write that?), nor am I against genetic testing. What I am against are tests that are equivocal in nature, add little to management strategies, or cause further testing or needless costs. This is not about restricting who makes the money or doctor fees, I really could care less about that (maybe others dont), but about adding a layer of confusion to an already vexing array of available testing (total body CT scanning screens another good example). If there is a good genetic test that allows people to make decisions and the results are meaningful, fire away. However, most I have seen dont fit that description.
    Anyway, I think we agree in spirit.
    brad

  6. In response to your comments…
    Brad. You essentially say people shouldn’t be able to see test results without a doctor present. Maybe you’re right. Maybe people shouldn’t have access to their test results. Funnily enough Group Health of Puget Sound which has spent more time and effort looking into online distribution of lab tests has found that they should be released to patients at the same time as they’re released to physicians. So that’s already happening. But you think they’re wrong! The answer with poor tools is to make them better, which is what Grop Health did. The way you do that is to release them, not hide them.
    JD. I agree (as usual!)
    Dmitriy. My surprise is not that there’s a challenge. I agree with you about that. My only surprise is that it’s a state, rather than either a mainstream consumer campaign, a lawsuit or Federal agency, as the source of the challenge. But, as is rather frequent, your analysis of health care is incorrect. Most process innovations are brought into health care without any FDA approval. Check out the history of surgery if you doubt me. It’s new products (drugs & devices) that need clinical trials in current regulations. New ways of delivering the same test results that are already being done do not require FDA approval, so your analysis is wrong. As David says in the comment below, this is all about innovation vs establishment. It doesn’t mean that the innovators are right or necessarily will win every time. It does mean, it’s not covered by legislation requiring clinical trials, and it also means that it’s similar to any other innovation.
    David. You’re right, but of course the underlying problem is the incentive structure in health care–we should be at a place where the rewards for providing cost-effective care are return to the innovators. But as that’s not often the case, we end up with these fights.
    Greg. You’re completely right. The gene tests in question are less immediate than typical lab tests. Even less reason, therefore, to limit access to them.

  7. Gene Testing helps one to understand their genetic blueprint. Genes create the blueprints for the production of proteins within the cell. A protein is a molecule that makes a cell behave in a certain way. It does so by interacting with other proteins in a complex series of steps.
    The goal of gene testing is to look for patterns of normal and abnormal gene expression which could suggest that certain proteins might or might not be produced within a cell. However, just because a gene is present, it does not mean that an associated protein has been produced.
    Protein testing goes one step further by testing to see if the relevant protein actually has been produced. But again, even protein testing cannot tell us if a protein is functional or how it will interact with other proteins.
    Gene and protein testing examines a single process or a relatively small number of processes. The aim is to tell if there is a theoretical predisposition, nothing more.
    In regards to laboratory testing, there is poor agreement between the results from local laboratory-based testing and those of central testing by experienced investigators. There has been poor concordance between community and central laboratory testing.

  8. Matthew: Right on the mark, my friend. I think that the regulatory backlash against Health 2.0 may actually have started when CVS/MinuteClinic and nurse practitioners were opposed by a group from organized medicine in Massachusetts last year. They argued that NPs are unsupervised and not competent to care for simple medical problems, neither of which is true. The argument crashed against the rocks of reality, when the state medical society’s own data revealed that over half of the primary care medical practices in the state were closed to new patients, and waiting times for a new appointment were in excess of 6 weeks. No reasonable person can justify protection of a health care system that is so consumer-unfriendly, nor hold off forever market forces that bring responsible innovations that lower price, increase convenience, and make access less of a hassle. I think we’ll see the same debate about laboratory testing take place in many states over the next year.

  9. Wake up and smell Reality 2.0, my friends!
    If Matthew paid attention to the real world, it would not be “a surprise that it popped up this way”
    Any substantive change in the way healthcare is practiced is subject to whoopload of regulation and litigation. Here is the problem with being revolutionary and pushing the envelope in healthcare. The benefits are never proven early on and any new ideas have to be weighted against the risk (as in “Do No Harm”). Does not matter whether risk is real or perceived. Advocacy groups have a way of turning perceived problems into very real ones.
    Think as if introduction of a “Health 2.0” intervention is treated as a clinical trial for a drug. You could pour a BILLION down the hole before you know it is lost. With economics like that (in virtually every segment of the genuine healthcare innovation market!) you have to ask how much of this stuff has any chance of really sticking. Lots of entrepreneurs and VCs stand to lose their shirts – BIG TIME.
    This is not “innovators vs. establishment”. If we applied the same adoption & approval standards to drug trials that would be a very interesting and scary world to live in. This unpleasant reality undermines most of the benefits of “Web 2.0” in healthcare.
    More in my recent piece: The State of eHealth: Napster or iTunes? Harley or Segway?

  10. Brad, what is it that you disagree with? It sounds like you disagree with doing genetic testing at all, regardless of whether a physician is required as a middle-man, or at least, you appear to believe this for some large subset of genetic tests. So we can look at some of our genes but not others, and you want laws to decide this?
    Paternalism is sometimes called for, but is this really a case? What harm has been done to people who have ordered these tests? Not hypothetical harm, real harm.
    And in any case, if physicians were required to “interpret” genetic tests, Matthew makes a good case that this may add costs far more than it adds meaningful guidance, given the track record of physicians in managing care thus far.

  11. Several reasons why genetic tests are different than drug prescriptions:
    1) Their interpretation, with few exceptions, is difficult. Many “positives” may indicate increased risk (2x or 3x normal with a baseline disease prevalence of 1/1000 lets say)–what do you tell the patient AFTER they get it. Im a doc and would throw my hands up to my own mother with the results of many of these tests.
    2) Given nebulous findings, do you prescribe interventions which at this time may have risk > benefit given uncertainty of outcome.
    3) Unwarranted anxiety due to positive finding of uncertain clinical significance.
    I could give more, but you get the idea. Some genetic tests have utility, but many that are marketed now are simply not ready for prime time.
    Sorry, I really disagree on this one. I absolutely feel these tests should not be unleashed on the public. I should ad that I am unabashedly for health care transparency, P4P, value based purchasing, etc., and am not concerned about empowering patients…only with sensible tools.

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