23andMe and the FDA clearance

By Razib Khan | July 31, 2012 1:18 am

As they say, read all about it. I’m rather ambivalent. 23andMe has a business rationale to go in this direction, so I don’t begrudge them their decision. The problem, at least from a legal perspective, is that they’re providing medical advice at least implicitly. And I think this medical direction is really where the big money is in any case. There’s no angle standing on principle.

But, I still believe that on a deep level regulatory agencies don’t “get it.” Our own genotype and genome is going to be a cheap commodity in the next few years. Services like Promethease will proliferate to provide people open source information. Is openSNP going to the FDA anytime soon? The main reason that firms like 23andMe will go through regulatory hurdles is that they are, or aim to be, legitimate public entities. In other words this is an artifact of our institutions. Mind you, 23andMe et al. will probably always have slicker user interfaces, and there’s some value in that. But that doesn’t entail FDA oversight, does it?

The shift toward automation and computation are real ones, and I have a difficult time how seeing regulation developed in the 20th century is going to be relevant. There is a doctor shortage in this country. The number of graduates from medical schools is not keeping up with population growth, or a shift toward a population which consumes more health care. For regulatory reasons professionals like nurses can’t provide all the services that a full M.D. can, and I see no expectation that the medical professionals of the USA will welcome more competitors. So technology is the way to go in increasing productivity. If doctors don’t go into general practice because there’s no money in that, perhaps there’ll be an app for that?

I’m not imagining some magic bull algorithm. Rather, I’m assuming that the quantified self and more powerful artificial diagnostics will be able to take care a lot of the “low hanging fruit.” Personal genomics is part of this, though obviously not the totality of it.

  • Rhwawn

    From their announcement:

    > We are confident that our initial application to the FDA is complete and comprehensive. Being the first in the industry to announce we are actively working toward FDA clearance of our direct-to-consumer service demonstrates our commitment to make personal genetics an integral part of routine healthcare without sacrificing people’s right to access information about themselves. Our goal is to remain the world’s trusted source of genetic information — not just for people with a doctor’s order, but for everyone regardless of why or how they choose to learn about their DNA. DNA is fascinating, but it’s even more fascinating when it’s about you.

    And the frontrunner in industry X begins to raise barriers to competition by working with regulators… This is not something to celebrate.

    (As Peter Thiel said, Paypal’s so valuable because with all the post-9/11 regulation, it’d be next to impossible to start another one.)

  • Stephen

    The only clean approach is that the people who get/sell the data and the people who advise about its meaning should be separately licensed, if licensed at all, and separately priced. Because I buy SNP chip results from one firm should not obligate me to buy that firm’s advice. The reason for this is simple conflict of interest, in that the data seller makes an implicit statement about the data’s importance. It’s not in their interest to be clear about how few SNPs are truly useful. The buyer is already free to take the data to any interpreter, including those with purely educational, not financial, motives, of course. Yet the FDA needs to avoid sanctioning any particular, implicit medical importance attached to the sale of raw data.

  • John

    I wouldn’t underestimate the need for slicker interfaces. What we have now is not up to the task, and would certainly lighten the burden in terms of educating general public/physicians methinks.

  • https://plus.google.com/109962494182694679780/posts Razib Khan

    #3, i’m not. my point is that better app design doesn’t require FDA approval. that will come if there is money in the area (or, if nerds take sufficient interest re: open source).

  • Stephen

    So long as personal genomics interfaces are primitive, the FDA won’t worry that any implicit medical advice is unwarranted. But making a “slicker app” is not intellectually neutral — it carries with it a claim that the data are meaningful to people without the background to understand the primitive version. For genes of drastic effect there’s little difficulty. But relative risk estimates are fraught with (and cannot be separated from) interpretive vagaries. There will always be a category of scores which are only global probabilities and aren’t strong data about individuals. The specific way a “slicker app” presents these carries a value judgment that the FDA might deem an aspect of doctor-patient relations.

  • http://www.earthlab.net Brandon Keim

    It’s easy to see genomic data regulation in romantic narrative terms — The plucky little guys who want to be free! The big, bad institutions who want to control them! — and it’s also a trap. Interpreting genomic information in a medically useful way is very, very complicated. It’s easy to do badly — and people may make life-altering decisions based on bad information.

    Gene-testing companies already have a track record of offering tests unsupported by unsupported by clinical evidence, such as CYP450 testing to determine antidepressant dosage. A let-the-market-regulate-itself, buyer-beware approach isn’t any more desirable than it would be for new drugs.


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About Razib Khan

I have degrees in biology and biochemistry, a passion for genetics, history, and philosophy, and shrimp is my favorite food. In relation to nationality I'm a American Northwesterner, in politics I'm a reactionary, and as for religion I have none (I'm an atheist). If you want to know more, see the links at http://www.razib.com


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