When the Food & Drug Administration last November ordered the Mountain View, Calif.-based firm 23andMe to stop marketing its health-related genetic test kit to consumers, the ensuing debate took on a "rage against the machine" tenor. Entrepreneurs, patients' rights advocates and genetics geeks across the country argued that the plodding, risk-averse regulators of the FDA had neither the right nor the expertise to insert themselves between people wishing to own whatever mysteries their genes contained, and a company that promised to deliver such information.
Now, however, a pair of respected experts in the dual fields of genetics and bioethics has weighed in — on the side of the FDA.
"The FDA was right to issue a warning to 23andMe," write Boston University bioethicist George Annas and Northwestern University's Dr. Sherman Elias, a professor emeritus of obstetrics and clinical genetics. Writing in the New England Journal of Medicine, Annas and Elias argue that in the rapidly evolving field of clinical and consumer genomics, firms' peddling of genetic information that is unexplained, incomplete and potentially wrong can endanger patients.
Given the relatively rudimentary state of the testing offered by 23andMe — and of scientists' understanding of the genetics of most disease risk — a thorough family history is probably at least as telling for most individuals who are now denied the services of 23andMe, the two wrote. The FDA thus is denying consumers nothing that they can't already get, they added, and is merely insisting that the services being offered by companies like 23andMe are reliable, accurate and work as promised to inform its customers.
"That is traditional consumer protection, and what the public expects from the FDA," they wrote.
Annas and Elias also recast this debate as a David-and-Goliath story in which the FDA is on the side of consumers against potential predators — not necessarily the genetics-services companies themselves, but perhaps insurance companies or data-marketing firms that might misuse an individual's genetic information. Commercial considerations, they wrote, must not get out ahead of the making of laws, institutions and clinical practices designed to protect the privacy of this most private information — an individual's genetic profile.
Finally, they wrote, the societal debate over a person's right to refuse to know some genetic information has been engaged. But it is far from concluded, and until it has come to some firm conclusions, firms who offer consumers the raw outline of their genomes may be giving them information they would have chosen not to have.
Racing along behind direct-to-consumer companies like 23andMe (and threatening to overtake them) are whole-genome sequencing companies, which soon will be able to provide quickly and at relatively low cost a far more comprehensive analysis of a person's genetic profile. That, wrote Annas and Elias, makes a pause in genetic-test marketing all the more timely.
The FDA's imposition of a moratorium on 23andMe's marketing "provides the opportunity for serious dialogue that could be a basis for setting standards not just for 23andMe, but for the entire industry," wrote Elias and Annas. That could mean setting norms and standards for the whole-genome sequencing companies as well, which will raise all the same questions — in spades — before long, they added.
[For the Record, 5:48 p.m. PDT, March 12: This story has been changed to clarify that the FDA's order to cease marketing genetic test services applied only to those that offered consumers health information. 23andMe was not ordered to stop selling its Personal Genome Service, which includes ancestry information, and continues to sell access to raw health data without interpretation.]