It's All About Control

I can't think of any justification for the FDA's shutdown of 23andme's genetic testing service except one of pure control.  It is yet another case where you and I are not smart enough or sophisticated enough to be trusted with information about our own bodies.  Because we might use the information in some way with which Maya Shankar might not agree.

Let me be clear, I am not offended by all regulation of genetic tests. Indeed, genetic tests are already regulated. To be precise, the labs that perform genetic tests are regulated by the Clinical Laboratory Improvement Amendments (CLIA) as overseen by the CMS (here is an excellent primer). The CLIA requires all labs, including the labs used by 23andMe, to be inspected for quality control, record keeping and the qualifications of their personnel. The goal is to ensure that the tests are accurate, reliable, timely, confidential and not risky to patients. I am not offended when the goal of regulation is to help consumers buy the product that they have contracted to buy.

What the FDA wants to do is categorically different. The FDA wants to regulate genetic tests as a high-riskmedical device that cannot be sold until and unless the FDA permits it be sold.

Moreover, the FDA wants to judge not the analytic validity of the tests, whether the tests accurately read the genetic code as the firms promise (already regulated under the CLIA) but the clinical validity, whether particular identified alleles are causal for conditions or disease. The latter requirement is the death-knell for the products because of the expense and time it takes to prove specific genes are causal for diseases. Moreover, it means that firms like 23andMe will not be able to tell consumers about their own DNA but instead will only be allowed to offer a peek at the sections of code that the FDA has deemed it ok for consumers to see.

Alternatively, firms may be allowed to sequence a consumer’s genetic code and even report it to them but they will not be allowed to tell consumers what the letters mean. Here is why I think the FDA’s actions are unconstitutional. Reading an individual’s code is safe and effective. Interpreting the code and communicating opinions about it may or may not be safe–just like all communication–but it falls squarely under the First Amendment.

I know that libertarians want to kill the FDA altogether.  That is never going to happen.  But what might be more realistic is to shift their governing law from validating that medical treatments are safe and effective to just safe.

Brad Warbiany has more, including real life examples of how 23andme's service has been useful to his family.

  • MingoV

    The FDA, in the early 1990s, carefully scrutinized the lab tests,
    calculated risks, and patient counseling related to chromosomal defects in fetuses. The FDA considered calling that system a high-risk medical device. Fortunately, reason won out and the FDA backed off.

    The FDA considers the computer software for blood banks to be a high risk medical device. The software is nothing more than a customized database. This is a weird situation because the FDA has no jurisdiction over hospital or laboratory information systems. The FDA claimed that blood bank software was integral to blood bank tests (such as blood typing) and therefore fell under its domain. But, the earlier paper record system was not regulated by the FDA, it was regulated by CLIA. Go figure.

  • Brad Warbiany

    Thanks for the mention.

    I should point out that the genetic tests that we found valuable with my son were doctor-ordered tests. Any potential benefits from 23andme have yet to be revealed, as we haven't yet gotten our results back (and are unsure whether this FDA letter will keep us from ever getting them).

  • NL7

    Some people argue the future of medicine is in genetic testing and tailored treatments and drugs. People and diseases are more different than is readily obvious, with countless variations in reaction to treatment and huge numbers of varieties of diseases previously considered single pathologies. Genomic testing is likely to be a big part of future medical treatment as computing power increases and large volumes of ACGTs are easily calculated and analyzed.

    So if the FDA isn't careful, a big part of medical treatment could slip past them and go unregulated.

    Plus technocrats have the undying fear that somebody somewhere hasn't made sufficient notifications.

  • rxc

    I wonder how much of this control by the FDA is intended to slow down public demands for more medical services/care that could impact the public treasury under Obamacare. If you don't know all the different potential threats to your health, then you can't worry about them and lobby your congress-critter for research/treatment.

    It is an interesting contrast to the way that this sort of info is pushed on the public to support changes to individual behavior - i.e., "if you have certain genetic traits, you may be at higher risk of cancer/heart disease/diabetes, and we[the govt/insurance companies] need to help you to change your behavior and prevent those bad health outcomes." It is as if the public health professionals are the only entities who should know about this stuff, and only inasmuch as it applies in the aggregate. No individual should be allowed to know whether they, individually, has the traits. This gives the public health "experts" the ability to try to change the behavior of the entire populace, in the name of saving the most vulnerable.

    It really is all about control.

  • irandom419

    Oh great, they had to rerun my sample since they couldn't find DNA the first time through and now the FDA will be delaying it even further.