The Wild, Wild East of DTC Genomics and the Need for Meaningful Self-Regulation

SalesmanEarlier this month CNN reported on the launch of a new program by the Chongqing Children’s Palace (CCP), in Chongqing, China, “that uses DNA testing to identify genetic gifts and predict the future.” In a story seemingly more appropriate for the Onion than for CNN, the article reports that Chinese scientists at the CCP are using the test, which is developed by the Shanghai Biochip Corporation, to “isolate eleven different genes” that will provide “information about a child’s IQ, emotional control, focus, memory, athletic ability and more.”

Shockingly, the CNN story expresses only the barest skepticism about the scientific claims made by CCP. Thankfully, Daniel MacArthur of Genetic Future, stepped in to provide a dose of clarity:

A quick note for any Chinese parents considering having this test performed on their children: you’re wasting your money (and we’re not talking small change – the test costs US$880).

The genetic variants that are currently known to affect traits such as athletic performance and height explain only a tiny fraction of the variation in these traits, so predictions made from genetic tests are extremely weak. In fact, for a trait such as height, parents can make substantially better predictions simply by measuring their own height than they can using the best that modern genetics has to offer…

…this is a scam, pure and simple, preying on parents’ willingness to believe in the power of science and to pay through the nose for anything they think might give their child an extra edge.

Although disappointing, the outlandish scientific claims made by CCP are unfortunately far from unique. Atlas Sports Genetics, which sells a $149 test that promises to predict a child’s natural athletic strengths, has been criticized for using genetic testing “to sell new versions of snake oil.” A Swiss-based DNA dating website, GenePartner, claims to measure the “genetic compatibility between two individuals and make[] an accurate prediction of the strength of their basis for a long-lasting and fulfilling romantic relationship” which, if true, would offer many a $99 insurance policy against vastly greater sums paid to divorce attorneys later in life.

Nobody should be surprised at the desire of companies to profit from consumer misconceptions about the predictive power of genetics. But these genetic snake oil salesmen present a risk to the mainstream DTC genomics industry, as well as to unwitting consumers, which each new charlatan increasing the likelihood of a legislative or regulatory response. A response which may or may not distinguish between those genetic or genomic services that offer scientifically supported information and those that do not.

Self-regulation of the DTC genomics industry has often been proposed, both here and elsewhere (pdf), as a more appropriate form of regulation than direct governmental oversight. Robust self-regulation would serve several important goals, including (1) discouraging consumers from purchasing products not adequately supported by scientific evidence, (2) providing regulators such as the Federal Trade Commission (FTC) with a standard against which to evaluate (and sanction) false or misleading DTC tests or services, and (3) ensuring that inevitable governmental regulation is not overly restrictive. While key players in the DTC genomics industry appear to favor this approach, the most frequently cited example of such self-regulation, a proposal from members of the Personalized Medicine Coalition addressing the scientific validity of genetic services available directly to consumers (pdf), remains a work in progress.

Last week, new NIH director Francis Collins announced that his chief of staff will be Kathy Hudson, currently the director of the Genetics & Public Policy Center (GPPC) at Johns Hopkins University. Hudson has consistently presented the case for expanded governmental oversight and regulation of genetic and genomic testing and services (pdf), including most recently in the journal Public Health Genomics where she co-authored a paper outlining a blueprint for a mandatory genetic test registry. Hudson’s removal to NIH, where she will be much better positioned to execute that blueprint, is a further reminder to the DTC industry that the time to demonstrate meaningful and effective self-regulation may be running short.