Yesterday I saw the news break about the noted DNA testing company 23andMe. I first read about it in a Gizmodo article posted by Thomas MacEntee. 23andMe has long been in negotiations with the Food and Drug Administration about the health aspects of its testing. Yesterday, the FDA ordered 23andMe to stop selling their testing kits.
The story is picking up steam, even appearing on today’s Good Morning America. The crux of the issue is regulation of the part of the testing dealing with health issues, not the genealogical side. The concern is purported to be about the quality of the testing for medical conditions, and whether this will cause problems for people in their medical treatment.
Now, I completely understand the concern. People need to educate themselves. But, quite frankly, anyone who goes and has a double-mastectomy based on $99 take-at-home test without consulting with their physician has serious problems (not to mention the problems of a surgeon who would conduct such a procedure without doing additional testing!).
Slate had a good article about the situation yesterday, The FDA’s Battle with 23andMe Won’t Matter in the Long Run by Razib Khan. He states:
“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.”
He goes on to comment:
“This brings us to the fact that 23andMe is just part of a broader movement toward the democratization of health information. This incident highlights the tension between the paternalistic medical establishment that arose to deal with the dangers of 19th-century quack medicine, and a ‘techno-populist’ element of American society pioneering personal health assessment and decision-making by leveraging new information technologies. Caught between them is the general public, which trusts institutions but is obviously intrigued by the offerings of consumer medicine, as judged by units sold of 23andMe’s kits.”
I agree with what Khan has to say. This is clearly a conflict of “old” vs. “new.” An additional problem is the power and influence of the established medical testing firms who resent upstarts moving past them (and cutting into their profits).
Judy G. Russell, The Legal Genealogist, weighted in on the matter today in Fooling with FDAI must say I completely agree with her conclusions. First off, the FDA will not shut down 23andMe. They are trying to force them into addressing these problems, which the company has been dragging its feet on for more than a year. And second, the FDA is not going to get involved in genetic testing for genealogy purposes. It is the other side of 23andMe’s business that is causing the problem.
In the meantime, if you are a 23andMe customer, do as Judy suggests. Download your data using all methods possible, to guard against any access issues, just in case this becomes a messier issue. Then we will all need to sit back and see what happens next.