November 26, 2013
FDA Moves To Shut Down 23andme Genetic Testing Service

The US Food and Drug Administration has told 23andme to stop selling personal genetic testing kits directly to consumers. Alex Tabarrok, an economist who has done work in medical policy, takes up the issue in an excellent post hitting many relevant notes.

At the same time that the NSA is secretly and illegally obtaining information about Americans the FDA is making it illegal for Americans to obtain information about themselves.

Knowledge about ourselves is dangerous. The FDA fears we might make bad medical decisions with this knowledge. Yes, sure. But America is (or at least is supposed to be) a free society. That is one of the risks of a free society.

One of the FDA's fears: women will get double masectomies based on genetic testing results. Well, women might also get double masectomies based on hearing Angelina Jolie describing why she decided to do the same. People will respond to information they hear in all sorts of ways. They'll go on diets, ask their doctors for specific drugs, ask for more medical tests. Hey, people do things. Their doctors are free to try to persuade them away from their ideas or even refuse to carry out a treatment.

But this is not only a question of individual freedom. Direct-To-Consumer (DTC) genetic testing promises a very large utilitarian benefit even to people who do not get tested. Alex gets to the absolute crux of the matter of why you should care deeply about this outrage: FDA obstacles in the way of the masses getting themselves genetically tested will greatly slow the rate of progress in figuring out what the genetic variants mean.

The FDA also has the relationship between testing and clinical validity ass-backward. The FDA wants to say no to testing until clinical validity is established but we are never going to discover clinical validity until we have mass testing.

We can speed up the rate of advance of genetic testing by getting ourselves genetically tested and then volunteering to medical researchers both medical information and our testing results. 23andme has already published research papers made possible by its customers.

Doctors and regulatory agencies used to be priesthoods who controlled our access to medical information about ourselves. There was a time when doctors would even withhold diagnoses for fatal diseases. We've come a long way toward openness and greater self knowledge. The FDA is fighting to maintain the ancien regime where they exercised much greater control over what we can know about ourselves. They can deny us a faster rate of medical research advance if they get away with it.

Share |      Randall Parker, 2013 November 26 08:22 PM 


Comments
Jamie said at November 29, 2013 10:59 AM:

I generally agree that this sucks.

The problem, though, seems to be that 23andme took a "fuck you" attitude towards the FDA. They repeatedly didn't respond. Say what you will about how things shouldn't be this way, but in the world we live in, ignoring governments who ask questions is a suboptimal survival strategy.

I hope this doesn't cause an overreaction, and that the next entrepreneur isn't so dumb.

Nick G said at November 29, 2013 12:53 PM:

Randall,

I generally agree with you - this is an outrage: the risks of customer exploitation, or customer mis-use, are small compared to the benefits. This is the FDA protecting the medical community from competition.

OTOH, I agree with Jamie, though for a different reason: I've looked at 23andme's website, and got a very uncomfortable feeling that they weren't doing a very good job of educating consumers or really clarifying the meaning of the data they provide.

philw1776 said at November 29, 2013 6:25 PM:

The US is no longer a free society in the sense you describe. Way, way too much government regulation of behavior that unchecked, only harms the individual.

spindizzy said at November 29, 2013 6:36 PM:

I am probably missing the point but, as I understand it, 23andme operates entirely by mail anyway. The company can more-or-less continue business as usual by relocating outside the US.

placebo said at November 30, 2013 11:48 AM:

Spindizzy - my thoughts exactly.

Engineer-Poet said at December 1, 2013 2:47 PM:

It would seriously crimp their style if the mail-order kits were intercepted by the USPS or customs due to FDA prohibitions.

spindizzy said at December 2, 2013 5:14 AM:

On the assumption that the sample kits don't contain much more than a plastic receptacle and an instruction book, could there be a legal basis to impound such mail?

It seems like action of this sort would at least be a major step up from the FDA's current stance.

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