By Gordon Hull
A couple of weeks ago, in a post on Theranos, which has been developing a new - and very fast and cheap - technique for blood-testing, I mentioned the woes of 23andMe.com, a site which originally offered direct to consumer genetic testing, before the FDA shut it down for any medical claims (the FDA letter is here). As 23andMe put it (in a pre-shutdown version of its website), customers might “gain insight into your traits, from baldness to muscle performance. Discover risk factors for 97 diseases. Know your predicted response to drugs, from blood thinners to coffee. And uncover your ancestral origin.” That sort of claim, and its dubious scientific basis, was the basis of the FDA’s shutdown order, which also expressed concern about false positives and the difficulty in understanding negative results in isolation. In this, the FDA was echoing concerns of bioethicists, who have generally been alarmed about the spread of genetic testing outside of a clinical context. As a 2011 piece summarized the concerns, the lack of regulatory oversight of these practices, which trade upon the public’s fear of cancer and limited understanding of genetics, creates potential problems with inappropriate referrals, misinterpretation of results, excessive anxiety about positives, false reassurances about negatives, and even the confusion between diagnostic genetic variants and surrogate genetic markers (which account for very little risk).
It’s unclear whether these worries are overblown, but the experience of DTC advertising of pharmaceuticals (which is allowed in very few places outside the U.S.) isn’t encouraging. For example, one recent study of the DTC marketing of erectile dysfunction drugs indicated that the industry routinely violated its own ethical standards. An assessment of all the television, print, and web materials provided for the drugs found that none of them advised patients of nondrug, nonsurgical options for treatment; few provided information on the relation between ED an underlying diseases; ED drugs are presented as first-line treatments, despite significant known risks (not all of which were routinely disclosed); and what information was there tended to require a higher level of literacy than the average consumer possesses.
It’s seemed to me for a while that, whatever else is going on, DTC marketing for pharmaceuticals and now genetic testing needs to be read as part of an overall effort to teach consumers to treat their health and interactions with medicine on a neoliberal consumer model: health is something in which one invests, and for which one needs to know the various risks in order to make appropriate actuarial decisions; those decisions then can both involve literal consumer choices, and be viewed as consumer choices.
What wasn’t, perhaps, as apparent until yesterday was the extent to which companies like 23andMe are also data brokers – and they have a lot of potentially interesting data at their disposal which they can leverage into their business model. Hence, 23andMe just announced a deal with Genentech for up to $60 million – and claims that it has nine more such deals with big pharmaceutical and biotech companies inked and on the way. One interesting part of the deal is that its initial motivation is Parkinson’s Disease research; cooperating with advocacy groups, 23andMe has an exceptionally large number of PD patients in its databases, and those patients have viewed the company as partners in their efforts to understand and treat the disease. In addition to the importance and value of big data as a business model, then, the deal illustrates the emergence of newer, advocacy-group based approaches to medicine. As Nikolas Rose notes, the PD community has been leaders in this approach, which involves creating activist communities of those who push for (and raise funds for) research into the disease, and then mounting aggressive public relations and awareness campaigns (often with celebrity endorsements, as in the case of longtime Parkinson’s patient Michael J. Fox) to keep the disease in the public view. In any case, 23andMe had presented itself as developing the data resources to discover genetic underpinnings of diseases. Now it has monetized those resources.
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