IS THIS THE GAME WE WANT TO PLAY?
On Monday, the FDA celebrated the start of the holiday season by sending a letter to 23andMe, informing the direct-to-consumer personal genomics service that they must cease and desist offering their signature test. The proximal cause of this action, as described by the FDA and not disputed by the company, was that 23andMe had ceased to participate in a process of establishing their PGx test as “validated for its intended uses.” They had, the FDA suggested, dropped the ball – well, not just dropped the ball, but kicked it out of bounds, an old soccer trick for delay of game, which Mya Thomae and Dylan Reinhardt suggest might have been exactly what the company had in mind, playing for time while they attempted to accumulate better data than what-all they have right now.
The FDA move prompted a vast twitterlanche of commentary, ranging from indignant outrage to smug satisfaction (Dietrich Stephan, founder of the erstwhile DTC competitor Navigenics, said, “Engaging the FDA as a partner to bring the most robust and safe new type of test to market is diagnostics 101”). Genetic counselors might be suspected of indulging in a bit of schadenfreude, since the relationship between 23andMe and the GC community has inclined in the direction of mutually suspicious, if not downright frosty. The company, which advocates for access to one’s DNA information with almost a religious fervor, sees GC’s as gatekeepers, as a self-anointed coterie of priestesses guarding the oracle at Delphi. Genetic counselors, for their part, tend to perceive the very existence of 23andMe as an affront, as though the possibility that a subset of people might benefit from genetic testing without access to counseling was insult and injury — an existential threat.
To be fair, nobody reacts well to the suggestion that their chosen profession is a cabal that threatens the freedom and well-being of fellow citizens – not even investment bankers, and at least they get to soothe their wounded souls with lots of material goods. But pettiness is unbecoming and unproductive, and we would all do well to remember that a groundbreaking organization like 23andme is a part of the energy and excitement of the field – an expression of an explorer’s mentality that draws people to the potential of genetics in 2013. That’s not only fun and sort of cool but also incredibly powerful because it attracts the kind of intelligence and curiosity that makes big new ideas possible (David Dobbs does a thoughtful and balanced job making the case for 23andMe in this piece for the New Yorker).
So minus any animus toward 23andMe, was this a reasonable move by the FDA? There are two main questions that have been raised: 1. can they regulate? and 2. should they regulate? (a third question, HOW DARE THEY?, has also gotten a lot of play but I am going to ignore that one because, c’mon guys get over yourselves this isn’t ONE STEP FROM TOTALITARIANISM). The first one takes up the issue of whether or not a personal genomics test falls under the FDA jurisdiction. I am going to say yes, but will not rehash those arguments here, since they have been more ably covered elsewhere – I particularly recommend this piece by Hank Greely at the Stanford Law School Center for Law and the Biosciences blog.
So, should they regulate? The rationale for regulatory action in the letter to 23andMe is a risk of harm to customers, including the possibility that a customer might alter his medication without medical advice or misunderstand her risk for breast cancer and have an unnecessary prophylactic mastectomy. While theoretically true, it seems wildly unlikely that very many people would insist on a mastectomy without getting more information than mail-order genetic results – and those cases might be more indicative of out-of-control anxiety issues and irresponsible medical practice than the power of a PGx report. More commonly, misunderstanding the limits of the test in terms of risk reduction might empower a customer to skip out on appropriate preventative measures. Either way, this is nothing new — a rehash of concerns genetic counselors have had about DTC testing since its inception. In practice, perhaps the best summary of the clinical impact to date comes from Anders Nordgren, who called it “Neither as harmful as feared by critics nor as empowering as promised by providers.” Having spent hours poking through the generally well-written and thorough 23andMe reports, and spoken to some of their customers, I would suggest that misunderstanding the results that come from 23andMe could pose some risk — real risk, to be sure, but limited risk.
However, it is possible to envision a scenario where a genetic testing sold DTC did pose a significant danger to consumers, with inaccurate results, irresponsible advice, tests used to market scam treatments or preventatives. None of this is farfetched, and some of it has already been documented. For this reason alone, the possibility of FDA action is an important deterrent. A company like 23andMe, which makes real efforts to be thoughtful and responsible, will ultimately benefit from the restraint on less scrupulous entities. And of course, it is possible that 23andMe would have been less thoughtful and less responsible if they had not been motivated by the threat of FDA action. So arguments against regulation in general based on the fact that 23andMe is well-intentioned are misguided.
But despite a bias in favor of showing some muscle, I have questions about how much time and energy the FDA should spend cracking down on the likes of 23andMe. Is it, I wonder, the best use of resources? For one thing, attempts to stop the free flow of information in 2013 are fingers in the dike. Razib Khan at Slate expands on this argument, suggesting that companies pushed by the FDA could simply move offshore, away from any regulation.
And more importantly from my point of view, the emphasis on negative action diverts us from the possibility of doing something positive. Rather than keeping consumers away from tests we think are insufficiently documented, how about providing a resource to the general public that endorses tests that are ready for prime time? After all, a few bold individuals may be excited at the prospect of downloading Promethease to query their own exome data but most people would rather not, thank you very much. Most people would be happy to have some guidance. They can get that guidance from the company, but even the classy companies have a vested interest in hyping the significance of their results – that’s what they’re selling, right? There is an opportunity here for the government and the genetics community to create a trusted source of information that is neutral, unbiased and supports a best-case scenario use of genetic testing by those eager to take the plunge. Hell, you could imagine tying in such a resource to something like ClinVar or GenVar, so that early adapters could contribute to publically accessible databases rather than giving it to 23andMe to sell.
After years of running up and down the pitch, the FDA has demonstrated that it knows how to blow the whistle – that’s good. I’m pretty sure 23andMe will be back – and that’s good too. But if we really want something great to come out of this discussion, let’s stop doing color commentary on the FDA action, and imagine what it could be like if we changed the game.
10 responses to “THE FDA CALLS A PENALTY ON 23andMe”
Laura, your commentary is always so well researched, articulate and entertaining. Thank you.
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Hi Laura, In my free online ‘MOOC’ course Useful Genetics (available through Coursera) I’m doing my best to educate the general public about genetics, with particular emphasis on personal genomics. It’s a particularly appropriate course for people who want to understand what can and can’t be learned about health and ancestry from currently available tests.
Rosie, thanks for the response! Looked at your syllabus and the class looks great. Education is definitely a huge part of the answer, to the extent that there is an answer. Would love to hear your suggestions for how to spread genetic literacy, especially for this sort of information which in its nature needs constant updating.
Laura, Thank you for your clear presentation of the issues surrounding this very interesting situation. I’d like to hear more about your ideas for ways to offer the general public access to sufficient knowledge and understanding of this information. With the great wealth of genetics knowledge available to consumer fingertips, guidance is crucial. While genetic counselors are the most obvious navigators of this information, I’m curious what other options could be developed, and what ideas have been proposed.
Hi Linda. Thanks for the comment and the compliment. I have this notion of a sort of “Good Housekeeping Seal of Approval” approach — labs or companies could apply to some sort of standing panel, which would approve the validity and use (including how it is presented/advertised) for a given test. No requirements that they do so — but hopefully the endorsement would mean something to the public, and perhaps the lack of it would deter people. Alternatively, there’s the Dr. Spock model — a resource for lay people that would cover various crises in which the might find themselves. Given it’s no longer 1960, it would have to be online and not in print! I don’t know — just ideas. But worth discussing, I think. Any inspirations?
Laura- I like the “seal of approval” idea. Interested to hear if you think our professional organizations (National Society of Genetic Counselors and Canadian Association of Genetic Counsellors) would be an appropriate body to take on this type of task?
I think your Seal of Approval idea is very interesting, and I can definitely see how it could be effective! I wonder what it would take for something like this to be created? Would this be a project of the FDA, or from within the scientific community?
I also agree with you on the public resource idea. I think public education and access to clear, competent information is so critical. Especially since many people constantly seek medical advice from the internet – a clear, informational guide would be a great resource, especially if maintained by an accredited genetics organization or something (I’m not really sure WHO this would be, but it would be a great idea).
Thank you for sharing your thoughts!
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