The FDA’s Genetic Paternalism - Stifling research, costing Americans more, and sending them into...

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

Ever wonder why your hair is the color it is, where your remote ancestors resided, or whether you carry genes for diseases that could affect you or your children?

As of today, it’s not possible to know all of that with certainty — not even close. But you can get a few answers by sending a saliva sample to a private company and paying it to analyze your DNA. Even better, as new research becomes available, you can check it against your personal data; some companies even provide subscription services that do the legwork for you. It is a true scientific revolution — the collected data inform people about their history, help doctors and patients make medical decisions, and enable researchers (with permission from their subjects) to make headway in the nature–nurture debate. As prices fall — already, Google-backed 23andMe, one of the leading companies, provides its service for a mere $200 plus $5 a month — progress will only accelerate.

And so, naturally, the Food and Drug Administration is preparing to step in with heavy regulations. The “test kits” — spit receptacles, more or less — that these companies send to their customers apparently qualify as “medical devices,” and thus place the process in the FDA’s jurisdiction. The FDA already regulates the labs that do the actual testing, but now it is considering — with input from a recent advisory panel and urging from the American Medical Association — additional limits on any information containing “medical claims.” Most troubling, it may require prescriptions for many DNA tests, or mandate that consumers pay physicians or “genetic counselors” to explain their results to them.

It is easy to oversell DNA testing, especially when it comes to medical benefits, and some companies fail to resist the temptation. In the interest of preventing fraud, the FDA might reasonably place limits on the claims that these companies make. But there is no reason to insist that a government-approved doctor stand between Americans and their DNA.

WHAT DNA CAN’T TELL YOU
Anyone considering direct-to-consumer (DTC) testing for medical reasons should know the technology’s limits. “For maybe 10 percent of people, the medical information is very actionable, very predictive,” says Razib Khan, who writes about genetics for the Discover magazine blog Gene Expression, and who has been genotyped by 23andMe. Jon Entine, a fellow at the American Enterprise Institute, for example, discovered he had a mutation that raises the risk of breast cancer — information that is quite important, given that his daughter might have inherited the gene. But for most people — except those who don’t have access to their family’s medical history (adoptees, for instance) — a genetic test is unlikely to contain much unexpected medical information.

After all, the results won’t tell you whether you’ll get leukemia; they’ll tell you whether you’re at an elevated risk for leukemia, which you already know if leukemia runs in your family. And the numbers can be misleading. Khan notes that if you’re 50 percent more likely than the average person to get a certain disease, that may not be cause for concern: You could have gone from a 1 in 500 chance to a 1 in 333 chance. “You need a fine-grained understanding of probability to get the most juice from it,” he says, “and there’s not much juice there to begin with.”

DTC companies usually provide some kind of disclaimer to this effect, but some ad copy can leave the opposite impression. Iceland’s deCODEme, for example, says that “your genes are a road-map to better health” and that you can “discover your genetic risk for 47 diseases and traits ranging from Heart Attack and Diabetes to Alcohol Flush Reaction and Testicular Cancer.” These kinds of borderline-untrue statements — genes can be part of a roadmap to better health; you can see data on the genetic risk factors that happen to have been discovered already — are par for the course in advertising, but they could easily be misinterpreted by uninformed shoppers.

To his credit, Kári Stefánsson, the CEO of deCODE Genetics, didn’t defend the “road-map” line when I asked about it — in fact, he seemed surprised. “I think that is both cheesy and somewhat incorrect. I don’t know who came up with that, but whoever it is, is going to be duly punished,” he said. “I think it’s safe to say we’ll probably be removing that statement and putting up something that at least sounds better.”

The FDA should require DTC companies to post clear disclaimers on their websites, and possibly it should develop criteria as to how DTC companies interpret DNA data for consumers. Many companies, including 23andMe and deCODEme, even support some additional regulations. “I think it’s going to be advantageous for those of us who market these tests that they are regulated,” Stefánsson says. 23andMe is “moving forward to establish the process for FDA authorization of our entire genetic testing platform,” including the information it provides, according to the company’s general counsel, Ashley Gould.

A few overzealous ads, however, are not a reason to force all consumers to seek the government’s permission before sending their own DNA to a private company for testing.

Another common worry is that people may react improperly to the information they’re given. In fact, this just doesn’t seem to be happening: A recent study found that, overwhelmingly, people don’t change their lifestyles in response to their DNA results. And even if people did change their behavior, the odds are pretty good that it would be for the better: A few people might do irrational things like take up smoking on the assumption that they’d die from something else anyway, but most would probably just eat healthier, start a vitamin regimen targeted toward their biggest risks, and exercise more.

WHAT DNA CAN ACCOMPLISH
All of that said, DTC companies allow individuals to track their genealogy, provide information that may in the future become medically relevant, and give researchers a massive collection of data to work with. The FDA needs to preserve Americans’ direct access to these services.

To be clear, the FDA does not claim an authority to regulate DTC testing that’s done for strictly genealogical reasons. However, many companies’ standard services include both medical and genealogical results, and the more thorough tests that are the wave of the future — those that catalogue massive numbers of genetic variations, and those that sequence the entire genome — could fall under the forthcoming regulations.

How much does genetic testing tell a person about his ancestry? Quite a lot, actually. It turns out — contrary to the deafening chorus of “Race is nothing but a social construct” coming out of the academy — that as groups of people evolved in different regions of the globe, they developed distinctive genetic patterns. Now that researchers have figured out which genetic patterns correspond to which ancestries, DTC companies can ascertain, with a high degree of accuracy, where a customer’s bloodlines come from. Certainly, some people find this kind of information more fascinating than others do — but there’s no government interest whatsoever in making such knowledge harder to access, even if it’s packaged with medically relevant facts.

Further, while the medical aspect of DTC testing is of limited value now, that may change soon. Many diseases result from complex interactions between genes and environment, and as geneticists develop more sophisticated tools, they may unravel those interactions — making genetic information that much more valuable.

And it turns out that DTC testing itself is a significant boost to this research; some companies offer their customers the chance to participate in studies. By giving scientists access to their genomes, and by answering survey questions, customers can advance the state of knowledge about genes, disease, and behavior. Thanks to this sense of volunteerism, researchers can access DNA from all over the world without having to collect it themselves. “For our Sarcoma Community,” notes 23andMe’s Gould, “we were able to assemble more than 500 participants in only six months, which would be expensive and nearly impossible to do in traditional research models due to the extremely rare nature of sarcomas.”

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.”

“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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