23andMe Genetic Testing Kits Under Fire: FDA Compliance and ‘Designer Babies’
There’s been a lot of buzz lately over 23andMe’s genetic testing products and services. The company has ongoing issues with the Food and Drug Administration (FDA), which requires paperwork and data they say 23andMe hasn’t provided. A class-action lawsuit is in the works. But the second issue is creating most of the buzz outside of genealogy circles: the idea that 23andMe’s genetic tests could be used to create “designer babies.”
So why does the FDA, a U.S. regulatory agency, care about genetic genealogy kits? Because they’re marketed as more than that. 23andMe describes their kits as tools for helping users make more informed decisions about their personal health. (See the letter sent by the FDA for more details.)
Bottom line? “FDA is concerned about the public health consequences of inaccurate results from the PGS [Personal Genome Service] device; the main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work….Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device.” (emphasis added)
A news reporter describes his experience with 23andMe as very much about health information, not just ancestry: “I apparently have a higher risk of thromboembolism, Alzheimer’s, age-related macular degeneration, type 1 diabetes, melanoma, rheumatoid arthritis, restless leg syndrome, esophageal squamous cell carcinoma, and a number of other conditions I’d never even heard of,” he writes. He adds that the 23andMe site “provides recommendations for lifestyle adjustments and links to medical websites all in the interest of giving me, and others, a chance to review built-in genetic health risks.”
FYI, 23andMe immediately responded to the FDA’s letter with a public statement. “We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”
Many genealogists are wondering what happens next for current 23andMe customers and the products under fire. Legal Genealogist Judy G. Russell’s blog offers suggestions for customers and an interesting legal perspective. The most recent development is a class action law suit that has been filed against 23andMe (read about it on Forbes).
But a bigger story has been unfolding, too: the idea that 23andMe’s genetic testing could be used to select (or de-select) genes in unborn babies. Wired recently reported that “23andMe has developed a system for helping prospective parents choose the traits of their offspring, from disease risk to hair color. Put another way, it’s a designer baby-making system.”
The story explores existing technologies for pre-selecting genes for babies. Wired quotes 23andMe as saying they have no current plans for using their data this way because there’s no existing demand for it. The issue raises strong feelings on many sides of the question. The idea that future generations could sidestep serious genetic medical conditions appeals to many. But a lot of other ethical and social questions come up.
These stories remind me that genealogy–gene-ealogy–is about so much more than the past! It’s also about what we do with our lives now and the fate of future generations.
What do you think? Join the discussion by leaving your comments.