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The FDA’s Genetic Paternalism
Stifling research, costing Americans more, and sending them into the black market — some likely consequences of overregulation


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DTC companies also use their technology to conduct research on non-customer subjects. Just this month, several researchers affiliated with 23andMe, along with some other academics, presented evidence that humanity’s roots may reside in southern Africa, not the eastern part of the continent, as previously thought.

Unfortunately, the FDA seems intent on denying the contributions of DTC companies to research. Jeffrey Shuren, head of the FDA division that handles “medical devices,” was asked in congressional testimony last summer whether “these companies have researchers that are adding to the information that will help us [learn] more about propensity to disease and how to make medicine more personal.”

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“From the information we know,” Shuren replied, “they’re not doing their own research on the genetic profiles, but they’re interpreting the studies that have been performed by others.” This wasn’t just ignorance on his part. Recently, a video surfaced on the website FDABlog; it was footage from two days before the testimony, depicting none other than Jeffrey Shuren sitting on a panel, listening to a presentation by a 23andMe representative about her company’s research projects, including one on Parkinson’s disease.

Incredibly, the FDA has stood by Shuren’s remarks. In an official statement provided to National Review, spokeswoman Erica Jefferson writes, “At that time we were not aware of any of the more than a dozen DTC genetic tests making medical claims that were based on results of a company’s own research. Instead, the companies relied on published research in the literature.” Note the incongruity between Shuren’s answer during his testimony and the FDA’s defense of it: Shuren said that DTC companies weren’t doing research “on the genetic profiles”; the defense claims that companies weren’t relying on their own research for the “medical claims” they made to customers.

Two final points. First, the FDA cannot hope to control DNA testing. All testing requires is for a saliva sample to travel by mail in one direction, and for the data to come back via the Internet. Once someone has the data, he can send them for medical analysis to whomever he pleases, with or without a doctor’s permission. As John Derbyshire has noted, if the FDA forbids this to take place within the U.S., companies will move overseas. Then, Americans can simply send their saliva (and money) abroad to companies that don’t mind flouting American law. Perversely but unsurprisingly, by overregulating the American market, the FDA could push Americans into the black market.

Second, while specialized “genetic counselors” could be of some value, it’s wrong to assume that all medical doctors, among their many duties, manage to keep up-to-date with cutting-edge genetic research about minor disease risks. One can learn about basic findings in this field by studying the fundamentals of genetics, following science news, and reading the executive summaries of the important studies, but even this requires a significant investment of time. “Someone who regularly reads this blog . . . knows much more about genomics than 99 percent of medical doctors,” Khan noted recently on Gene Expression.

“They’re just getting rent,” Khan says. “I understand the need for a certain degree of paternalism in medicine. . . . But frankly, these doctors don’t know enough to be paternalistic in this area. And they need to step off.”

— Robert VerBruggen is an associate editor of National Review.



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