Genetic paternalism & the F.D.A.

By Razib Khan | March 24, 2011 2:54 am

It’s been over a week since I’ve addressed the “F.D.A. D.T.C.” controversy. I plan on getting back to the issue in more detail later, but right now I thought I’d point you to Robert Verbruggen’s article in National Review. It’s titled ‘The FDA’s Genetic Paternalism’. Robert contacted me for my take on the issue, and you get a few choice quotes from yours truly. It being National Review you can guess the general tenor of the objections from that quarter. Over the past few weeks tracking inbound links and Twitter mentions it does look as if the coming possible restrictions on direct-to-consumer personal genomics have triggered more suspicion and opposition from the political Right. Even with that said, my friends Michelle and Zack, who I think are accurately characterized as on the political Left, also both expressed great reservations about the thrust of Jeffrey Shuren’s comments. Nor do I think that the Genomes Unzipped crowd are all Right-libertarians. Even those who assert the need for regulation and some intermediation between genomic results and the patient/consumer are unhappy with the way the government and some pro-regulation activists have been approaching the matter.

Overall I’d say there are two broad political-philosophical tracks by which you can approach the issue of regulation of genomic results. The first is one of rights. That is, you have a right to your genomic information. This is a clean and simple intuition, though the reality is that “fundamental rights” are often contested and constrained. So let us contest for our right! The second avenue is one of consequentialism. What are the consequences of D.T.C. personal genomics? I think in my writing on this topic you can infer that I believe a relatively loose regulatory regime for D.T.C. personal genomics at this stage of the industry is justified. This may make some readers nervous, as they believe that loose regulation in other domains has wrought havoc on our society. But to my mind most of the negative consequences of D.T.C. personal genomics being unfettered from specialist interpretation seem rather overwrought in the broader context of other public health issues. There is far more low hanging fruit in terms of efficacy upon which the fiat power of government could be brought to bear, but many of those actions are blocked by the nature of interest group politics. D.T.C. personal genomics as an actionable complement to personal health is not “prime time” yet in any case, and the instinct to restrict & regulate at this stage seems like the precautionary principle gone wild. Yes, 23andMe is not too big to fail, like Goldman Sachs or AIG, but it is small enough that the government can make it fail. In which case the American consumer has been protected from the malevolent intentions of Sergey Brin’s wife, and can look forward to the blossoming of Asian genomics firms which step in to fill the breach.

I can accept that the public in some cases needs to be “protected from itself.” But let us set the bar high.

CATEGORIZED UNDER: Genetics, Genomics, Personal Genomics

Comments (9)

  1. Sandgroper

    (Transferred from Around the Web): “Apparently in your world Jeffrey Shuren is sort of like Hitler.”

    No, that is an absurd statement.

    But if I were an American I would want to know what motive he has, and how he and the FDA can get away with it.

  2. I suspect many on those on the left who object do so because some of the move to regulate — and particularly to make doctors gatekeepers — can look like a money grab, as well as an incursion on personal freedom. Something for everyone (to object to).

  3. jytdog

    I came across your inflamed post from March 9th and the more I read the more disappointed I became, especially when I read your comment “following twitter, it seems there may be a distinction between raw sequence and interpretation. it may be the latter where there are “gatekeepers.” probably for reasons of liability, public safety, etc. (ergo, FDA). i see the logic, but from a perspective of utility i don’t think that the regs will improve human well being. though that’s probably not the implicit rationale behind “interested parties.””

    The distinction there is ABSOLUTELY CRUCIAL. There is a huge difference between providing your raw genomic information, and providing diagnostic interpretation.

    The AMA letter clearly stated that it was directed to ” direct to consumer (DTC) genetic tests that make medical claims” and it is “the making of medical claims” that puts certain offerings of DTC genetic testing squarely in the FDA’s domain; uninterpreted DTC genetic test results – the raw sequence – are NOT in the FDA’s domain under current regulations. Medical claims are. And I have not heard the FDA claim that they would even try to regulate uninterpreted DTC genetic test results. Have you? (not a rhetorical question)

    I found your sloppy, over-emotional post — and the unthinking overreactions by commentors, to be deeply disheartening. How can people claim to be super-smart and bellow about their right to their own information and to be better informed than 99% of MDs (sheesh there is some unsubstantiated overstatement) — how can these people lack the basic common sense, much less decency, to read carefully and think through the actual regulatory issues, before starting to self-righteously holler about being stepped on? Shame on all of you who did that.

    Razib – please post an “oops I over-reacted” with respect to this entire over-heated mess that you have poured oil onto. That would show some integrity and thoughtfulness, which we need more of. We do not need more emotional over-reactions to regulatory issues. The dietary supplement people are doing just fine with that.

  4. Razib – please post an “oops I over-reacted” with respect to this entire over-heated mess that you have poured oil onto. That would show some integrity and thoughtfulness, which we need more of. We do not need more emotional over-reactions to regulatory issues. The dietary supplement people are doing just fine with that.

    are you a patronizing asshole, or do you just play one on the internet? i might take you more seriously if you told me who you were on your high fucking horse. all i know is that you’re IP originates from cornell medical school (at least previously MD associated commenters had the decency to admit conflict of interest re: AMA).

  5. jytdog

    i am not a doctor. ad hominem tactics are more smoke than substance and if you want to go that way, have at it. i will just be gone.

    to the substance of things — when you write hysterically in your lede “In the very near future you may be forced to go through a “professional” to get access to your genetic information.” — you are missing the point completely of the FDA’s and AMA’s concerns.

    When you write “Someone reading this blog will have to pay, either out of pocket, or through insurance, someone else for access to their own information. ” you are just spreading inflammatory nonsense and getting people worked up over nothing.

    The FDA and AMA have concerns (and as you admit, potentially legit) about medical claims that are sold to patients; they have nothing to say – that i have seen – about just sequence data.

    Again — if you see anything in what the FDA is producing that is directed to shutting down access to your genome, I would be interested to see that! I say there is NOTHING and you are just flaming this issue out of ignorance or just to get people riled and get more page views. But substance? I see none. Too bad!

  6. i will just be gone.


    yes, there is some ambiguity regarding sequencing (see mary carmichael et al.’s discussion on this), probably because the authorities in question aren’t totally sure of the distinction between illumina and 23andme. this has been covered. i’m not interested in talking to you, you’re a patronizing asshole. begone! (not a request, BEGONE! your amusement value is expired)

  7. jytdog

    If you are talking about this interview: ….

    If you read it while keeping the distinction between “providing sequence information” and “providing medical information” very clear in your mind, the 2 FDA reps are 100% consistent — over and over they say that their concern is with companies making medical claims. The letter they sent to Ilumina was about Illumina selling chips to companies that use them in the process of providing medical information, when the chips are labelled “for research use only.” That is indeed a problem.

    Please maintain the distinction between “providing medical information” and “providing sequence information” — it will keep a lot of the fog out of the conversation. We need clarity in the conversation around health care!

    We have enough people in the country angry about phantoms in the health care arena (“Death panels”) without smart people adding to the noise.

  8. asdf

    the 2 FDA reps are 100% consistent

    Did we read the same interview? Alberto Gutierrez and Elizabeth Mansfield come across as complete drooling idiots, stumbling over themselves.

    Mansfield says that “agency wide, the FDA doesn’t look at costs”.

    Gutierrez trips over himself, saying at first that the regulations are clearly stated and on the other hand — and much more revealingly — that they would be *difficult for someone to follow*.

    We have enough people in the country angry about phantoms in the health care arena

    Absolutely. What you don’t get is that Shuren, Mansfield, and Gutierrez are the ones spreading fear and hate, with anecdotal tales of possible future repercussions should the unwashed masses be allowed direct access to their genome.

    This is the same thing we see at the airports. Always another terrorist act to justify increased government power, to justify the TSA’s security theater. The FDA is safety theater. It is not about real safety, it’s about the appearance of safety. The risk of injury from having my own personal genome from 23andMe is about as remote as the risk of me taking over the airplane with nailclippers, but the bureaucratic mindset is ban and restrict “just to be safe”. Well, screw that, and screw you if you think you can fight people who really care about this!

    While we’re at it, let’s dispense with this distinction between sequencing and interpretation. You do understand that for many variants — probably most — that sequencing *is* interpretation? Given a dictionary such as SNPedia, you can run a lookup table over a genome sequence to find out what most variants do. Not much of an interpretation layer there.

    Oh, but you say, they’re not talking about banning that. Yet.

    Wow. Fantastic. We should all bow down to the great god Shuren. He is only trying to gain powerover the ENTIRE HUMAN GENOME. We should be glad that he has allowed this one backdoor out!

    Leave aside the fact that an attack on the revenue of 23andMe and Illumina is by default a ban on direct personal access to genome sequences. Just focus on Shuren’s great gift to all Americans.

    Now he has truly protected the public by attacking any kind of user-friendly interpretation or frontend for raw genome sequence.

    Great job. Golf clap. That really showed ’em. “Smart regulation can increase innovation”. And increase profits for his “traditional manufacturers”.

    What if only PhDs in Electrical Engineering and Computer Science could get access to personal computers when they first came out? Or if Mac OS was banned because it made computers too user friendly? Cuz that’s what we’re talking about here, jytdog.


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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


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