On the side of less regulation is Alex Tabarrok in “Our DNA, Our Selves”:
At the same time that the NSA is secretly and illegally obtaining information about Americans the FDA is making it illegal for Americans to obtain information about themselves.
In a warning letter the FDA has told Anne Wojcicki, The Most Daring CEO In America, that she “must immediately discontinue” selling 23andMe’s Personal Genome Service . . .
I am not offended by all regulation of genetic tests. Indeed, genetic tests are already regulated. . . . the Clinical Laboratory Improvement Amendments (CLIA) . . . requires all labs, including the labs used by 23andMe, to be inspected for quality control, record keeping and the qualifications of their personnel. . . .
What the FDA wants to do is categorically different. The FDA wants to regulate genetic tests as a high-risk medical device . . . the FDA wants to judge . . . the clinical validity, whether particular identified alleles are causal for conditions or disease. The latter requirement is the death-knell for the products because of the expense and time it takes to prove specific genes are causal for diseases. Moreover, it means that firms like 23andMe will not be able to tell consumers about their own DNA but instead will only be allowed to offer a peek at the sections of code that the FDA has deemed it ok for consumers to see. . . .
From another section of my blogroll comes a pro-regulation argument from Kaiser Fung, “For a change, the FDA earned my trust”:
For a change, the FDA is doing something right for consumers, without waiting 10 or 15 years. . . . These tests have never been tested clinically and the company never applied for approval from the FDA. Given that it is not that hard to conduct proper testing of this product, especially if it is looking for diseases that have clear genetic markers, one suspects that the makers know that the tests would not pass rigorous testing.
There may be a day in which such tests are possible but the day hasn’t arrived yet. I also think the chance that most diseases can be turned into equations that say if you have gene X, then you will develop disease Y is overly reductive.
So what? Why should we care? Kaiser continues:
One of the lesser studied effects of screening tests is the psychological impact of false results. If you tested positive for say breast cancer, and even if the biopsy showed the result was a false positive, there is always lagging doubt – every next time you feel something, part of your brain will make you worry. Then, there are those who take a better-safe-than-sorry attitude and elect to do procedures regardless – and some of these procedures have harmful side effects, which are frequently not properly explained.
Much of the discussion at both blogs was interesting. A particularly instructive bit came from a commenter who wrote: “As someone with a Master’s degree in Human Genetics, I chose to have this testing to enhance my knowledge of my own genome, fully mindful of the limitations. I learned that I am likely sensitive to Warfarin, a potentially serious health risk when you are unaware of your sensitivity. Now, I already knew I had a family history of this, but prior to taking this test, it never would have occured to me to mention it to a doctor. . . .” This comment was interesting to me because it suggests that there is a special symbolic value of genetics, even beyond the (considerable) information supplied. We have a well-informed person who already knew she had a family history of a potentially serious health risk but, before the genetic test, it “never would have occurred” to her to mention to a doctor.
This story suggests to me that one of the things people value about the genetic profile is its scientific framing. I’m getting this story from a non-random N=1, and a self-report at that, so of course it’s not strong evidence for anything, but it’s interesting to me partly because it fits into some other issues regarding the communication of statistical information. In particular, Kaiser has written frequently on Lance Armstrong and other dopers, and one of his continuing themes is that people interpret blood tests as being more definitive than they actually are. According to Kaiser, a negative drug test on an athlete does not supply much information, but a positive drug test actually is pretty definitive—but this asymmetry is not always so clearly portrayed in the news media.
In the comments, Kaiser also writes that “23andme should market the genealogical component as a separate product.” So maybe he and Alex aren’t so far apart on the merits of the case, they just have different views on what should be the default position.
P.S. Alex points to this discussion from Lior Pachter on the statistics of the genotyping.