What's 23andMe Really Selling? (Cuz the Feds Are Asking.)
A congressional committee is looking closely at direct-to-consumer genetic tests of the sort that purportedly tell you your predisposition to various diseases and likely responses to drugs—and which you may have seen advertised on the sides of blimps and such. Indeed, 23andMe, which is partly owned by Google and markets its services via dirigible (among other platforms) is one of the three California personal-genomics firms now under federal scrutiny. (The others are Pathway Genomics and Navigenetics, Inc.)
Yesterday, Rep. Henry Waxman sent letters (download here) to the three firms on behalf of the House Committee on Energy and Commerce. The move was prompted by news reports that Pathway plans to sell its kits—previously unavailable from retail stores—at Walgreen's, the nation's largest drugstore chain. The companies have about two weeks to produce, among other things, the following:
All documents relating to the ability of your genetic testing products to accurately
identify consumer risk, including:
a. internal and external communications regarding the accuracy of your testing;
b. documents describing how your analysis of individual test results controls for
scientific factors such as age, race, gender, and geographic location;
c. third party communications validating the association between the scientific data
your company uses for analyzing test results and the consumer's risk for each
condition, disease, drug response, or adverse reaction as identified by the results
of an individual test; and
d. documents relating to proficiency testing conducted by your clinical laboratories.
Sounds like the feds are finally catching on to the sorts of concerns MoJo contributor and medical writer Shannon Brownlee covered in our November/December 2009 issue. (See "Google's Guinea Pigs.") The gist was that most of these kits should be labeled with that timeless disclaimer "For Novelty Use Only" given how little they actually tell us about our health. Truly useful genetic associations with disease, as opposed to navel-gazing fodder, require that you conduct serious, clinically controlled testing of hundreds of thousands of people. Brownlee writes:
Knowing how genes affect people's response to medicines could help drugmakers determine proper dosages. And tailoring products to patients with specific gene profiles may allow Big Pharma to revive once marginal drugs, extend patents, and reduce side effects—and thus lawsuits. Doctors can already use genes to determine, for example, which of their breast cancer patients will most likely benefit from the drug Herceptin.
But there's a rub: It will be years, even decades, before this new research produces many tangible benefits. For the time being, SNPs [the DNA fragments most companies use as the basis for their testing] won't tell you much. My 23andMe profile suggests I'm prone to having underweight babies. (My boy was nine pounds, six ounces.) I should have an average number of freckles. (I'm covered.) Blue eyes. (Bzzzt! Green.) Poor performance on nonverbal tests of intelligence. (I aced my SATs.) If science can't get the trivial stuff right, why should I worry when a company says I have an elevated risk for heart disease or macular degeneration? My profile also says my SNPs should make me sensitive to the anti-clotting drug warfarin. What it can't tell me is how my doctor is supposed to use this information. Should she not prescribe it, and leave me vulnerable to blood clots? Or give me a low, perhaps ineffective dose? The drug susceptibility info these companies provide is the roughest sort of guide.
In fact, for 23andMe, the tests themselves are a loss leader. Despite touchy-feely marketing that uses terms like "empowered" and "live strong," the real business model isn't about telling you your predisposition to Crohn's disease and such. As Brownlee puts it: