No doubt anybody reading this is aware of the announcement yesterday that Pathway Genomics plans to sell their direct-to-consumer genetic health/ancestry test in Walgreen's pharmacies across the U.S. Well, that was yesterday. Today I opened the newspaperto find that they are canceling that plan, at least for now, because of objections from the FDA.
The Genomics Law Report has had several detailed blog posts in the last couple of days that cover all sorts of angles on this, and it's excellent commentary, as always.
I find this development ridiculous. I think the news media has overlooked the fact that this test was already available for purchase over the internet with apparent tacit acceptance from the FDA, and that similar tests from 23andMe and Navigenics, among others, have been available for years. That's right, since 2007! In addition, the Pathway test from Walgreen's delivers its results on the internet regardless of how you bought the kit in the first place, in much the same way 23andMe and Navigenics are doing already.
It's probably true that this move would have made this kind of test available to some people who might not have known about it before. But it was already widely available using the same internet storefront technology that Amazon.com and others use ubiquitously. Does the FDA worry that people who shop at Walgreen's are somehow less able to deal with these results than people who shop on the internet? Or are they worried that they have fiddled around on what to do about direct-to-consumer genetics tests and this announcement was obvious evidence of that?
What is this, the suede denim secret police, with all the liberal/fascist illogic that implies? Personally, I would like to see some leadership from Francis Collins, and his ultimate boss, Barack Obama, on this. Both are supposed proponents of freedom of information and openness in research and government. If they, and the leadership of the department of Health and Human Services, don't provide some guidance on this I'll consider it a real failure
It's true that these tests are starting to provide medical information and clearly should be regulated in some way to keep out the scam artists and charlatans. But I have a real suspicion of any argument that keeps people from knowing something about their own body and genetic makeup, especially when it seems to be done in a haphazard and ad-hoc manner.
