Do Genetic Tests Need Doctors? FDA Defends Its Challenge to 23andMe

A 23andMe DNA collection kit Photograph by Monica Almeida/The New York Times via Redux

Alberto Gutierrez doesn’t want to look like the bad guy who’s getting between you and your DNA. That’s not why he sent a warning letter to 23andMe, telling the company to immediately stop marketing its $99 genetic test to the masses. “We don’t have an issue with people getting their own DNA data,” says Gutierrez, who heads the Center for Devices and Radiological Health at the U.S. Food and Drug Administration. “We just have concerns with how it’s being interpreted.”

Those concerns have been mounting for four years, he says, and have taken on a new urgency as Google-backed 23andMe accelerates its mass-market push with national ads and a media campaign. To Gutierrez, mainstream marketing increases the risk that less sophisticated consumers might cut off their breasts or stop taking a life-saving drug after reading an analysis of their spit.

“If you scare somebody into believing they’re high risk, they could take actions that hurt their health,” says Gutierrez. Not only is the data on some genetic links inconclusive, he adds, it’s well-chronicled that patients can push their doctors into authorizing unnecessary procedures. “Doctors do a lot of double mastectomies because of fear.”

While Gutierrez has a point, critics argue that singling out 23andMe is naive in a world where people buy pregnancy and HIV tests at the drugstore and can wade through a river of medical data online. “It’s a 20th-century response to 21st-century health care,” says Peter Huber, a senior fellow at the Manhattan Institute. It’s vilifying a startup for giving people a partial picture that its work could help complete, he says, and it seemingly ignores the role of doctors in authorizing—or rejecting—the treatments people can receive.

More important, the FDA is targeting a startup that already takes steps to accurately present results. Gutierrez hasn’t taken the 23andMe test. If he had, he would see that it offers a simple promise on the health front: clarity on your genetic makeup, linked to peer-reviewed research on correlated health risks or benefits.

Gutierrez seems to take particular issue with studies on the effectiveness of the blood thinner warfarin, noting they differ regarding African Americans—a difference reflected in the results. The 23andMe report is an information tool that reinforces what your family history probably suggests and is updated as new research comes in and ranks recommendations by the strength of that research. The company also makes you pause to read the limitations and impact of your results in order to “unlock” genes associated with breast cancer, Alzheimer’s, or Parkinson’s. Gutierrez cites the devastating impact of discovering you carry the gene for Huntington’s, a complex test not offered by 23andMe.

So far, 23andMe has issued a contrite statement reinforcing the importance of its relationship with the FDA. The company has until Dec. 13 to make a formal response. Whether Gutierrez’s warning is well founded, 23andMe Chairwoman Anne Wojcicki and her team know it can have devastating consequences.

In May 2010, a similar FDA warning prompted Walgreens to drop plans to sell an over-the-counter genetic test from Pathway Genomics. The San Diego company still exists, but now a physician needs to register and order the test for you. “They shifted their model,” Gutierrez says, while “23andMe has had the entire playing field largely to itself.”

Does that mean he would like 23andMe to make people go through their doctors, too? Maybe. Some results might be best filtered through genetic counseling, Gutierrez suggests, or the company could have an outside party interpret some analysis. In other cases, he says, it might be better to acknowledge the uncertainty of the science by making no mention of a genetic correlation at all. “For many of the tests, we don’t think the business model has to change,” he says.

And yet Gutierrez agrees that the marriage of genetic data and technology has the power to transform health care. “People have every right to get their data,” he says. “We want to make sure they can trust what they’re being told about it, too.”

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