Protecting Consumers From Their Own Genetic Data Will Come at a Cost

7/28/10

Last week’s U.S. House Energy and Commerce Committee hearing into the direct-to-consumer (DTC) genetic testing industry was a vicious affair, with more than a whiff of the show trial about it. Representatives from testing companies 23andMe, Navigenics and Pathway Genomics faced a barrage of questions about the accuracy and utility of their tests, made all the worse by the fact that most of the Committee’s members seemed unable to distinguish between the more responsible companies in the field and the scammers and bottom-feeders. (Lawyer Dan Vorhaus has a thorough summary of the hearing here.)

And the news for direct-to-consumer companies just kept getting grimmer: the star attraction of the hearing was a new report from a sting operation by the US Government Accountability Office, which detailed the results of anonymous purchases of kits from four DTC testing companies as well as assessments of marketing from 11 other companies approached by the GAO “both by phone and in person” without purchasing kits. While all the companies are listed as anonymous numbers in the report, the first four were revealed in the hearing as the four most prominent personal genomics companies: 23andMe, deCODEme, Pathway Genomics, and Navigenics. The remaining 11, which appear to mostly occupy a far less reputable corner of the industry, currently remain nameless.

The report details a litany of complaints—ranging from the flimsy to the serious—about the marketing, reporting and scientific basis for the companies’ operations. More damagingly, it also includes covertly taped conversations between GAO employees and several DTC companies, now published by the GAO on YouTube. In the tapes, a representative from one company (apparently Navigenics) offers terrible advice to a customer about the implications of breast cancer risk predictions, and a call center operator from another company (apparently Pathway Genomics) enthusiastically promotes non-consensual DNA testing for a customer’s fiance. The remaining companies on the tape, who offer a variety of scientifically bizarre claims to the undercover GAO operatives, aren’t members of the first four (reputable) testing companies, but rather of the still-anonymous 11.

There’s no denying it: the tapes are pure gold for the critics of the DTC testing industry. In the first and third clips, a couple of poorly-trained call center operators at otherwise reputable companies nonchalantly produce stakes that will now be driven into the heart of the DTC genetics industry, over and over again. The remaining three clips appear to depict scam operations—nothing like the products offered by 23andMe, deCODEme, Pathway or Navigenics—that will nonetheless be effectively conflated in the public mind with DTC genetic testing as a whole.

A one-sided attack

The report itself includes some nonsensical complaints. For instance, the fact that “one donor who had a pacemaker implanted 13 years ago to treat an irregular heartbeat was told that he was at decreased risk for developing such a condition.” The tests are clearly labelled as providing a probabilistic risk prediction, not a diagnosis. The GAO criticism is like claiming that the link between smoking and lung cancer is spurious because one individual with lung cancer never smoked.

Others criticisms are more justified. For instance, the differences in the risk predictions offered by different companies to the same individual is a problem that has been raised periodically since the industry’s inception. There’s a clear need for industry-wide standards for marker inclusion and background risk figures. This isn’t disputed by the companies themselves, who in fact have been pleading for the FDA and the NIH to provide official guidelines in these areas; nonetheless, the companies deserve a substantial share of the blame for not resolving these issues earlier.

But overall, the document is obscenely one-sided. It conflates responsible companies offering scientifically valid products with small-time con artists. It ignores … Next Page »

Daniel MacArthur is a researcher at the Wellcome Trust Sanger Institute in Cambridge, UK, and blogs at Genetic Future (http://scienceblogs.com/geneticfuture/) and Genomes Unzipped (http://www.genomesunzipped.org/). Follow @

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