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Editorial: FDA is right to pull plug on 23andMe genetic tests

Quackery or something promising in the health field?

An intriguing California business, 23andMe, named after the 23 pairs of chromosomes that humans have, has been selling $99 genetic testing kits since 2007 directly to consumers. It claims to provide customers with “health reports on 240+ conditions and traits.”

These reports offer people information like “your DNA puts you at higher risk” for carrying or contracting various diseases or conditions such as diabetes, heart disease, breast cancer, arthritis, and for sensitivity to certain medicines, such as coumadin.

The U.S. Food and Drug Administration for the last five years rightly has been pushing the company to provide studies on the accuracy of its DNA test results and to back up its health claims. To no avail.

Finally, after the company embarked on a major advertising campaign with the goal of reaching 1 million customers by year’s end, the FDA pulled the plug in a harsh Nov. 22 letter, telling 23andMe to “immediately discontinue marketing” the tests. The FDA action is warranted.

We should all be concerned about false positive results or false negative results and claims that certain markers can predict disease. Because 23andMe’s tests might be used to make medical decisions, the FDA must insist on accuracy. The company must prove that the tests work and stop inflating claims about what the tests show.

Scott Diehl, director of the Center for Pharmacogenomics and Complex Disease Research at the Rutgers School of Dental Medicine, told the online publication Medical XPress that using results from one or two genetic markers to inform people they have an increased risk for getting a disease is useless, like “predicting whether your car will break down during a long journey after you’ve only checked whether a couple of lug nuts on one of the wheels are sufficiently tight.”

Hank Greely at Stanford’s Center for Law and the Biosciences supports the FDA crackdown on 23andMe: “Because tests of unknown accuracy are no better than no tests at all, I applaud the FDA for taking seriously its mandate to protect public health.”

23andMe’s genetic testing method, Greely writes, “never was very good at providing useful genetic information” and already is obsolete.

The future, it seems, lies with so-called “next generation” sequencing. For example, the FDA approved San Diego-based Illumina’s sequencing device for genetic testing of cystic fibrosis three days before its letter to 23andMe. That, Greely believes, is the future.

The FDA kerfuffle misses what 23andMe really is about. While the company markets its genetic tests as a way for individuals to take charge of their health, it’s really a way to create a giant genetic database that 23andMe can sell to drug companies and researchers to develop cures that can be patented: a biobank.

Fast Company magazine’s November issue points out that “if 23andMe amasses 75,000 Crohn’s disease patients, or diabetes patients, or heart disease patients, there are giant ways to monetize that data as new treatment options emerge.” That is the real issue.

“Why should 23andMe have my health information so they can sell it?” a genetics counselor asked in the Fast Company piece. That is the right question. The issue of the National Security Agency’s warrantless surveillance of Americans’ phone records has become an important national issue. But private companies collecting our genetic data to sell or give to pharmaceutical companies and researchers has not yet become a major issue. It should be.