DTC, FDA, regulation, etc.

Gene ExpressionBy Razib KhanMar 13, 2011 1:41 AM


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It's been a few days since my post on the FDA DTC hearings was linked around the blogosphere, and generated some incredibly well informed discussion. There are plenty of reactions, but there are two which I want to point to specifically. First, Mary Carmichael at Wild Type, who takes a stance more in keeping with my own. And second, Mike the Mad Biologist, who tends to be more sympathetic to the idea that regulation of DTC medical results are necessary. Over the past few days I've received some feedback from medical professionals too expressing worry about total laissez-faire. In regards to Mike's post, I will admit that I am not totally disinclined toward paternalism. I'm not a libertarian, though my sympathies in that direction are often clear. When it comes to major public health issues the wisdom gained by the professionals through experience and the scientific method needs to be determinative in terms of public policy. But I simply do not see the misinformation inadvertently fostered by DTC personal genomics as in the same kind of category as anti-vaccination paranoia or the results from HIV tests. The medical inferences one makes are generally weak to non-existent in effect and relevance. Second, the arguments for paternalism strike me as very weak in the context of other issues in the broader society. We live in a world of fad diets, agricultural subsidies, and esoteric supplements. Mike wonders about the concern about "freedom" when it comes to one's own genome in light of major violations of civil liberty in our time, but I wonder about the focus on the down sides of DTC personal genomics when there are much bigger health issues looming on the horizon. DTC personal genomics is powerful primarily in the domain of ancestry. The medical relevance is marginal (right now). Second, there is the bigger issue of health care and medicine in our society. There are background assumptions at work in my argument which I didn't flesh out. Individuals vary in knowledge and intelligence. My friends who are doctors admit privately that treatment varies a great deal based on how much the patient is willing to, or capable of, being a partner in treatment and diagnosis. The current crop of DTC personal genomics users are generally well educated and motivated. The later crops are going to be barely able to multiply. That's a problem. How to distinguish the two? Those of us who aren't stupid, and know as much, or more, in particular details as medical doctors or genetic counselors are a small minority, but we're obviously loud, motivated, and are willing to become well mobilized. A quick "genetic competency test" perhaps could serve as a filter, dividing the unwashed from the enlightened. And yet something else looming in the background right now is the way medicine is practiced in the world today is changing, and has to change. I accept the proposition that from Galen to the 20th century medical doctors generally caused more harm than benefit (much of it due to the fact that they spread disease amongst their patients). Modern medicine is exceptional in that it actually works on a biophysical level. But a lot of the "low hanging fruit" has been picked, and due to the nature of medical research much of the "cutting edge consensus" is wrong. Medicine, like many fields, has been subject to information overload, and I'm skeptical of the ability of any human to keep up. The practice of medicine needs to be augmented by computational analytic tools, as well as a deeper understanding of the natural distortions which occur because of the nature of funding and the institutional framework of biomedical research in the United States, which exhibits an unfortunate trend toward careerism. Add on top of it the political, legal, and ethical variables, and medicine is a tangle which is far more than just applied human biology. Licensing regimes, and the shift of physicians from being shamans and therapists, and surgeons from being butchers, is a product of a particular time and place, to protect patients from frauds as well as safeguard the legitimacy of a nascent profession. In the current discussion about DTC personal genomics the idea of 'genetic counselors' has cropped up repeatedly, which makes sense. The treatment of an individual needs to be chopped up into appropriate specialties, already evident in the need for highly specific medical subfields. The professional system which produces M.D.'s will probably have to change to adapt to the times, as motivated patients will (like me) will have access to enough real-time information to understand that doctors are not omniscient, and need a great deal of complementation to maximize the fruit of the most up-to-date research. Are we going to force the software engineers who write the complementary diagnostic AIs to get an M.D.? Concretely, I'd say the marginal return on public health of a more competent and intelligent doctor is going to decrease because of the "cloud" nature of information which you'll have access to, especially with the rise of movements such as quantified self. Over the long term what we really need to increase human well being are materials scientists and entrepeneurs who produce innovation which drives economic growth, not more encyclopedic physicians, clever quantitative financial engineers, and eloquent lawyers. So there you go, from narrow specific focus to the big picture. I know that many technologists and scientists who have had the same visceral reaction have some of the same implicit presuppositions about the nature of progress and the way to maximize human well being. Some have characterized my previous post a call to "war." But my impulse was driven by the perception that this is just one battle in the never ending struggle to keep the Malthusian world at bay through gains in economic productivity and efficiency.

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