A reader writes:
I’m a physician, and I wanted to encourage this to become an ongoing thread, as it’s a fascinating and important topic. Two clarifications, however: first, Bailey claims that the FDA recommends genetic testing prior to warfarin administration. This is incorrect. The FDA neither recommends nor recommends against genetic testing because it is not clear that it is necessary or cost-effective, according to multiple studies. What the FDA does support, in its 2010 statement, is the use of genetic information in dosing if it happens to be available. This is an important difference.
Second, Tabarrok claims that this is a First Amendment issue. This seems clearly wrong, as medical and scientific accuracy determines much of what drug and device manufacturers can and cannot say about their products. Likewise, it’s obvious that physicians have no First Amendment protection for giving out false medical advice in an established doctor-patient relationship.
Another:
Sure, in this country we protect speech. We do, however, restrict the rights of companies to profit from disseminating damaging misinformation. This issue here is not the safety of the testing service, rather the problem is the harm done to vulnerable consumers through the dissemination of misinformation. Here’s a 2010 report issued by the Government Accountability Office addressing this concern. The video [seen above] highlights the harm that can be done if personalized genetic information is sold and interpreted to consumers and by amateurs.
Another reader is bummed about the FDA’s move:
I had my genome sequenced four years ago through 23andme. The health reports I received indicated that I have the markers for six times greater than average chance of developing macular degeneration (a debilitating eye disease). Since I have a spot in the center of my vision left over from a meningioma brain tumor the size of a tennis ball (also indicated in my health report) I thought it wise to see my doctor. I might have been so inclined without the report since my grandmother went blind from the disease and my mother is coping with it now, but the report reinforced my concern and I got checked out. Fortunately there were no signs of the disease, but the fact that that the FDA is coming down hard on 23andme (and none of the other sequencing companies) seems ridiculous. They’re providing information, not a diagnosis. Had I not already had my tumor removed I would have been far better prepared to take the symptoms seriously were they to occur today. I have nothing but good to say about 23andme.
Shaheen Pasha also praises the service:
When my results came back, my ancestry composition turned out to be fascinating. But my medical report was even more compelling. My health traits report indicated an elevated risk for autoimmune disorders, including Hashimoto’s disease. That hit home for me. After a 6-year struggle with multiple doctors to figure out what was wrong with me, I received my official diagnosis of Hashimoto’s in August, just weeks before I received my 23andMe results back. Perhaps if I had had a report indicating the possibility of such an illness in my genetic code, I could have been spared the headache of dealing for years with skeptical doctors who thought my ailments were all in my head.
More Dish on the topic here. Update from a reader:
Seems pretty clear from this letter that although the FDA spent a lot of time trying to work with 23andMe (14 meetings, hundreds of emails, etc), 23andMe chose to disregard their multiple warnings.
The Dish 