In its 2013 letter shutting down 23andMe’s Personal Genome Service, the Food and Drug Administration (FDA) dreamed up some entirely hypothetical problems, but cited not a single example of customer confusion or dissatisfaction with the California-based genotype screening company. At the time, 23andMe had developed an excellent, transparent, and still improving online consumer interface that enabled users to obtain and understand the significance of their genetic test results. Customers were linked to the scientific studies on which 23andMe’s interpretations of their data were based. The company was helping its customers learn how to understand and use genetic information.
Before the FDA’s ban, the company ranked its results using a star system. Well-established research, in which at least two big studies found an association between a customer’s genetic variants and a health risk, got four stars. Very preliminary studies got one star. As more scientific research came in, 23andMe would update each customer’s health risks.
In my case, 23andMe reported that I had genetic variants that increased my risk for atrial fibrillation, venous thromboembolism, and age-related macular degeneration. On the other hand, based on the genes that were tested, it informed me that my risk for gout, Alzheimer’s disease, melanoma, and rheumatoid arthritis were lower than average.
The old 23andMe provided me with results related to more than 125 different health risks associated with my genetic variants. In addition, the company reported my results for more than 60 different traits that I might have inherited, and it told me how I might respond to nearly 30 different pharmaceuticals. Now the FDA merely allows 23andMe to tell me less useful information, such as the fact that I carry more Neanderthal genetic variants than 85 percent of its other customers.
In all, the company is now legally permitted to provide me with just seven “Wellness Reports,” which tell me, among other things, that I am probably not lactose intolerant, I don’t flush when I drink liquor, I am not likely to be a sprinter, I probably have no back hair, and my second toe is probably longer than my big toe. Thanks for nothing, FDA.