Let the buyer beware of commercial genetic tests
Published 6:11 pm, Thursday, December 5, 2013
Sixty years ago James Watson, Francis Crick and colleagues ushered in the modern science of genetics. Ever since, people have been trying to learn about genes - especially their own. Thus the rise of "commercial genomics," wherein companies, for a fee, test human saliva and provide a report on your genetic makeup and what that might mean for your health. But the most prominent of these companies, 23andMe, recently was ordered by the Food and Drug Administration to stop offering such testing, and customers filed a $5 million class-action suit against the company late last month in federal court in San Diego.
The FDA regulates devices used to diagnose, prevent or cure. 23andMe offers "health reports on 254 diseases and conditions." The company seeks to "revolutionize medical care" and claims they "save lives." This spurred the FDA to have long discussions with 23andMe; but the company stopped responding- while increasing its aggressive marketing. The FDA's order thus drips with anger - Forbes called it "brutally scathing" in a post titled "23 and Stupid."
Giving people tools to manage their health is a good idea - but only solid tools. The testing that 23andMe sells may not qualify, with potentially high rates of false or misleading results. But more important, even where accurate, the meaning of the test results is highly speculative. The same samples sent to different companies have yielded widely varying interpretations; even geneticists often cannot say with much confidence what such tests imply.
The broad results offered by 23andMe present what has been termed "a genetic tower of Babel." Even where there are well-established links, such as BRCA genes and cancer, there is much uncertainty about what actions to take, as Angelina Jolie's case highlighted. Things get even fuzzier outside of such cases. The anxiety that can result from being told one's risk is "heightened" for something scary can result in bad treatment decisions.
I've conducted an informal survey of doctors and genetic counselors about these tests, and the feedback is not encouraging. Terms like "garbage in, garbage out" recur, with shrugs and frustration at valuable clinical time lost. Patients with test results ask for - or demand - procedures such as MRI scans, which do have risks. It recalls the craze a decade ago for useless full-body scans, detested by most physicians.
There are other concerns. Scientific American calls the privacy implications of 23andMe "terrifying." Customers grant the company use of their "data" in research - and marketing. That could include anybody willing to pay them. Recall the questionable "privacy" policies of Google and Facebook?
The FDA's move has predictably spurred charges of "paternalism" and meddling in a right to know about our bodies. But regulators seek to protect citizens from false advertising and medical quackery all the time. The FDA's action regarding 23andMe fits squarely into that established role.
The "medical" advice one might garner from commercial genetic testing is most always the same as that best offered without such testing - stay fit, eat healthy foods, don't smoke, don't drink too much alcohol, get enough sleep, manage stress, and so forth. Money spent on genetic testing would, in the vast majority of cases, be better used for running shoes, gym memberships, maybe even broccoli. As for commercial testing - as the old saying goes, let the buyer beware.