Why The Debate Over Personal Genomics Is a False One
I appeared on KQED's Forum show this morning to discuss this whole Walgreen's/Pathway Genomics fallout. Here's a link to the show: And here are some quick thoughts:
The controversy seems to have stirred the FDA to assert its authority - and that of physicians - over any and all medical metrics. As readers of The Decision Tree know, I have little patience for the argument that we need doctors as gatekeepers of our genetic information. This isn't a drug, and this isn't a device - it's information about ourselves, as ordinary as our hair color or our waist size or our blood pressure - all things that we can measure and consider without a doctor's permission.
I'm amazed, in many ways, that this discussion continues to be perpetuated in terms of "can people handle the truth?" - because that line of argument is flawed in so many ways. I'll offer a few: 1) People are more capable of handling genetic information (and other health information) than they're given credit for. 2) Most doctors aren't experts in genetics anyways. 3) If you wait for doctors to give us this information, we'll be waiting for something like 17 years. 4) This is our information, about us, and we own it as much as we own our thoughts and our values. 5) We may want to ask doctors or genetic counselors about what our DNA means - I'm not saying it's easy to understand - but that's entirely our choice.
I'm sincerely fearful that, now with Congress deciding it wants to inspect this stuff, that the FDA will feel obligated to regulate and shut us off from what is rightfully ours. To me, getting access to this information is a civil rights issue. It's our data.
Some in the government see things clearly here. Donald Berwick, President Obama's nominee to run CMS - the agency that oversees Medicare and Medicaid - has defended the rights of patients to own their information. The FDA is now run by the well-regarded Peggy Hamburg, who I have only heard great things about; in a brief conversation with her last year, I was struck by her fair-mindedness and belief in the ideals of transparency and greater consumer empowerment. My hope is that she sees the light here. She's written about how the FDA is a public-health agency, particularly in terms of "risk communication"; well, one of the reasons we communicate risks is to allow people to take responsibility and act in ways to minimize our risks. It's the basis of preventive health. That's precisely the potential of personal genomics, and to squash that would have a net effect of undermining the public's health.
The FDA doesn't have to use regulation like a hammer to squash innovation and the opportunity for people to use genetics to take control of their health. They can help foster innovation and issue some basic guidelines that recognizes information is a powerful tool, and one that rejects intermediation and paternalism.
I'm crossing my fingers.