Class Action Law Suit Filed Against 23andMe

Original post on Forbes by Dan Munro, 12/2/13

That didn’t take long. Quite literally about 5 days from the date of the FDA’s warning letter to 23andMe (11/22) and the filing of a class action law suit in the Southern District Court of California (11/27).

While the merits of the legal case are best suited for legal interpretation and debate, the damage to the marketing of general purpose Personal Genome Services (by 23andMe or any other company) could be significant. As stated in the filing:

“NATURE OF THE ACTION”

1. This proposed class action alleges that 23andMe, Inc. (“Defendant”) falsely and misleadingly advertises their Saliva Collection Kit/Personal Genome Service (“PGS”) as providing “health reports on 240+ conditions and traits”, “drug response”, “carrier status”, among other things, when there is no analytical or clinical validation for the PGS for its advertised uses.

2. In addition, Defendant uses the information it collects from the DNA tests consumers pay to take to generate databases and statistical information that it then markets to other sources and the scientific community in general, even though the test results are meaningless.

3. Despite Defendant’s failure to receive marketing authorization or approval from the Food and Drug Administration (“FDA”), Defendant has slowly increased its list of indications for the PGS, and initiated new marketing campaigns, including television advertisements in violation of the Federal Food, Drug and Cosmetic Act (“FDC Act”).

It’s that second bullet point that’s at the very heart of the FDA filing and subsequent debate. Are the test results “meaningless?” Absent the scientific rigor of an FDA process – how do we as consumers know?

In light of all the recent publicity, several stories have also surfaced that call into question that exact point.

“The point is that if I cannot trust 23andMe to tell me much of value about my risk factor for Celiac, or my ability to digest dairy products or coffee, or to get my son’s results right, can I trust it for anything? What should I do if it tells me that I am at higher risk of developing Alzheimer’s or lung cancer? The answer is … not lose any sleep about it.” Bernard Munos – Forbes Contributor – 11/29/2013 (23andMe: A Fumbling Gene In It’s Corporate DNA)

“I sent a support request to 23andMe including my research and conclusions (this would be called a “bug report” in software engineering). After a few days of waiting, 23andMe confirmed the bug and apologized. So the bug was not inside of me, but in the algorithm. An algorithm can be fixed easily, unlike my genetic code.” Lukas F. Hartmann – 11/26/2013 (Why 23andMe Might Have The FDA Worried: It Wrongly Told Me I Might Die Young)

The controversy extends further back too. This was filed in April of 2011:

My suggestion is that unless you have a specific reason behind your motivation, don’t bother with genetic testing services, especially if you’re not of European ancestry and you’re under the age of 30. I can see how it may be useful as a preemptive measure for people with a family history of a debilitating disease, or for people who are seeking out long-lost relatives. But for the rest of us, the money is probably better spent towards a gym membership, more fruits and vegetables and health/life insurance. And not having to worry for the rest of your life about something that may or may not happen to you? That’s priceless. Elly Hart – Night Editor, Allure Media (Why 23andMe Genetic Testing Is A Waste of Time and Money)

Ms. Hart also points out a legal dilemma that has yet to be tested. The Genetic Information Nondiscrimination Act (GINA – 2008 here) specifically prohibits the use of genetic information in health insurance and employment. GINA has no such applicability to Disability or Life Insurance as noted by this repetitive 23andMe disclaimer: “GINA does not cover life or disability insurance providers” (8 occurrences here).

All of which is why the FDA was correct in issuing their warning. It’s one thing to believe in the false hopes and misleading promises of dietary supplements. It’s something else entirely when an email arrives warning you of a serious health condition or genetic risk lurking in your DNA. For anything beyond ancestral curiosity, personal genetic data definitely needs the full rigor of scientific review and accuracy.

Click here to see the original article on Forbes.com