Personal Genetics Firms must Show Their Work to Avoid Breeding Trouble

January 16, 2014

The more we learn about human genomics and the effects of an individual’s DNA on their future health, the more possibilities “personalized medicine” seems to have as the future in modern diagnostic and treatment procedures. However, it sometimes also appears that for every advance in medical technology that could increase the efficacy of personalized medicine, there is a legal hindrance to the use of said advances.
Personal genetics firms are one such medical advance. These firms typically charge customers to send in a sample of easily obtainable genetic material, such as that found in saliva. The firm then evaluates the DNA found in the sample to determine whether the customer appears likely to develop certain conditions or diseases. Recently, two genetic testing companies have come under fire in courts. 23andMe as well as GeneLink have been brought into court under false advertising claims within the past year.
23andMe—which encouraged customers to use its services in order to “‘[l]earn hundreds of things about [their] health. . . .  so [they] can take an active role in managing it[]’”—was named as the defendant in a class action suit in November of 2013, with the plaintiff class alleging that the firm had falsely advertised the accuracy and helpfulness of its services. This claim was partially based on warnings to cease operations that the firm had recently received from the FDA because the firm had thus far failed to show any proof of the accuracy of the tests through clinical research or other analysis. “And . . . if the company cannot satisfy the FDA, the court [is allowed to] impose an injunction against 23andMe continuing to make its claims for (or to provide) the PGS test.”
Similarly, GeneLink has settled a suit brought against it by the FTC for “making unsubstantiated health claims.” The claims in the case against GeneLink differed from those made by 23andMe because GeneLink not only promised to detect potential health concerns—it also provided a selection of “custom-blended supplements [which were said to] help compensate for aging or mitigate health issues such as heart disease and arthritis” to its customers based on their test results. GeneLink’s settlement agreement includes a pledge not to make any more claims regarding the efficacy of its supplements “unless such claims are supported by two double-blind, randomized control trials—the gold standard of medicine.”

The role of law . . . is to prevent technologies which are still being developed from harming any individuals or industries in the time between their creation and that at which they become reliable.

The role of law in these situations has been well exemplified in these two cases. Its purpose is to prevent technologies which are still being developed from harming any individuals or industries in the time between their creation and that at which they become reliable. Unsubstantiated claims by personal genetics firms could lead consumers to panic unnecessarily or make changes to their daily lives—such as taking dietary supplements—which are not needed. Or patients could go many steps further, choosing to undergo surgical procedures or refuse certain medications because of a test which has not been proven to work.
This is not to say that personal genetics needs to go the way of the moa. 23andMe continues to sell their tests; however they have dropped their claims about health benefits and now market the tests according to the information that genetic testing can provide on an individual’s ancestry and related traits. And if GeneLink uses the agreement it reached as part of its settlement to actually provide a basis to its lofty claims, it and other personal genetics firms may be back stronger than ever in the near future. It is important in the meantime simply to make sure that people are “able to trust products and claims,” which is much more likely if the claims made in personalized medicine do not “[get] ahead of the science[.]”