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The FDA's Attack on 23andMe

{The following guest post is from Shayne Wissler, author of REASON and LIBERTY: The Foundations of Civilization and former Lions of Liberty Podcast guest. Be sure to check out his blog, For Individual Rights, for his thought-provoking philosophical perspective on the ideas of liberty.}

by Shayne Wissler

Today, the FDA sent this enforcement letter to genetic testing company, 23andMe.In this blog post I am going to clear up some common misconceptions.

This action will hurt 23andMe.

Not necessarily.The action will not necessarily hurt 23andMe the company, but it will certainly stifle innovation, in two ways: 1) New companies will not be given the nearly 8 year head start 23andMe had in working virtually free from FDA interference. On the contrary, any new "little guy" competitors to 23andMe that spring up can expect immediate FDA interference, which will prevent us from ever seeing most of them; businessmen will send the capital elsewhere. 2) Money and attention that would have been spent on R&D will instead be spent on clearing bureaucratic hurdles. New ideas within the company will be judged not according to their effectiveness in principle, but on their economic viability in the new bureaucratic setting.What doesn't kill 23andMe will make it relatively stronger by killing competition, but R&D will slow. This is how companies go from being path-breaking innovators to being stodgy. Such consequences are not the inevitable result of brilliant success on a free market -- it's what happens in America's corporatist regime.

This action is reasonable.  23andMe has already been involved in misdiagnoses, which are damaging to customers. We need some guarantee of product effectiveness.

It is interesting how people use facts to further ideas they already agree with.Surely, every competent adult is already aware of the fact that medical misdiagnoses happen all the time by our system of government approved doctors, and at a far greater rate per patient than 23andMe has. (I haven't fact-checked this but I'll eat my proverbial hat if my guess is wrong.) So, to be consistent, should the person making such statements really be clamoring for free market medicine, in order to stem the tide of medical unreliability?But even more importantly, why would anyone think that bureaucrats from the FDA are even qualified to be assessing a company working at the bleeding edge of technological innovation? If you were a qualified scientist with a desire to help humanity, would you rather work for a bureaucratic agency trying to stop people from innovating, or would you rather work for a company striving to create historically novel forms of medical technology? The answer is obvious. Qualified scientists with creative motivations will have already been hired by 23andMe, and probably with far better compensation than the FDA doles out.The problem of misdiagnoses is real, and the way you do deal with it is to double-check. 23andMe provides a very valuable "heads up" regarding something that very likely could be a problem; once you get their information you can pursue additional sources of information.

But people are stupid and easily scammed. We need the FDA to make sure that companies like 23andMe don't hurt people.

Consider this equivalent argument: People are stupid and routinely abuse their children. Therefore we need police cameras installed in everyone's home to make sure the stupid people aren't abusing their children.This shameful "guilty and punishable unless constantly proven innocent" policy is called prior restraint, and is a moral abomination that no principled, humane person can condone.There are already laws on the books against fraud. If 23andMe is ever suspected of fraud, then the proper procedure is for a prosecutor to bring evidence before a judge, not to dole out punishment (in the form of restraint) because stupid people who are incapable of imagining how to create a proper system of law happen to be capable of imagining that 23andMe might be abusing its customers.

This article was originally published at For Individual Rights.

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