As I posted previously, the Federal Drug Agency stepped their boot on the throat of 23andMe which is a popular medical and genealogical genetic testing company. The general reaction has not been kind to the FDA. Good!
From the Washington Post, "The FDA should leave 23andMe alone":
The point is a general one: Having more information about your health status is never dangerous by itself. It only becomes dangerous if patients use it to make dangerous medical decisions. But most dangerous medical decisions can't be made unilaterally; they generally require the assistance of licensed medical professionals who will do their own assessment of the situation before performing procedures that could harm patients.
More to the point, patients have a right to make dumb decisions if they want to. We don't ban patients from reading medical textbooks or WebMD, even though doing so undoubtedly leads to some harmful self-diagnoses. In a free society, patients have a right to accurate information about their health, even if medical professionals and regulators fear patients will misuse it. That includes information about our genetic code.
Berin Szoka of TechFreedom "FDA Just Banned 23andMe's DNA Testing Kits, and Users Are Fighting Back"
23andMe is simply doing what the Internet does best: forcing old dogs to learn new tricks. That's what the fight between Uber and taxicab commissions is about. Same for AirBnB and hotel regulators. The only profession slower to change how they do things than doctors is bureaucrats. So the FDA's reaction is understandable -- but misguided.
23andMe issued this statement, "An Update Regarding The FDA’s Letter to 23andMe"
This is new territory for both for 23andMe and the FDA. This makes the regulatory process with the FDA important because the work we are doing with the agency will help lay the groundwork for what other companies in this new industry do in the future. It will also provide important reassurance to the public that the process and science behind the service meet the rigorous standards required by those entrusted with the public’s safety.
Nick Gillespie at the DailyBeast, "No DNA Testing For You, Thanks to the FDA"
The FDA is seriously claiming that you might learn you have a possibility of developing breast cancer and then insist on having the potentially cancerous body part lopped off. And that you'll be able to find a doctor or hospital or taxidermist who will do any or all of that without doing further tests and followups. They don’t provide a single instance of this happening nor do they specify any possible medical world in which this might happen, but that’s enough to shut down 23andMe for the foreseeable future.
Razib Khan at Slate, "The FDA's Battle With 23andMe Won't Mean Anything in the Long Run"
You can frame this as an “old economy” vs. “new economy” clash. Medical testing firms are well-established sectors of the American economy, and they expect relatively tight regulatory oversight because of the nature of what they are selling. Tech companies, in contrast, are governed with a looser hand, and they sink or swim without much oversight in their first years. Based out of Silicon Valley (not to mention co-founded by Anne Wojcicki, the reportedly estranged wife of Google’s Sergey Brin), 23andMe has the blood of a tech company coursing through its veins, but it’s entering a domain which has traditionally been governed by numerous regulations.
Ronald Bailey on the Reason.com blog, "FDA Shuts Down 23andMe: Outrageously Banning Consumer Access to Personal Genome Information"
What the test results would actually lead patients to do is to get another test and to talk with their physicians. The FDA also cites the genotype results that indicate the sensitivity of patients to the blood-thinning medication warfarin. Again, such results would be used by patients to talk with their doctors about their treatment regimens should the time come that they need to take the drug. In fact, in 2010 the FDA actually updated its rules to recommend genetic testing to set the proper warfarin dosages for patients.
It is notable that the FDA cites not one example of a patient being harmed through the use of 23andMe's genotype screening test.
Bloomberg interviewed 23andMe co-founded Anne Wojcicki here.