Afternoon session at Duke

Joe Smith (West Wireless Health Institute) gave a spirited and delightful post lunch presentation on the risk aversion of the FDA and how it is a threat to innovation. In particular, he noted that a current point of discussion at the FDA involves data delivery assurance over wireless networks and how regulatory unwillingness to accept any level of perceivable risk trumps an overwhelming benefit that can accrue from accepting some risk. Joe also called attention to the lack of caution with respect to the lack of regulation of tobacco, which has quite a few risk issues. Paraphrasing his point, individual choice is the standard for tobacco use, but we must be protected from the low possibility of data loss over a wireless connection, when the benefit is substantial (see Joe's article in IEEE Spectrum http://spectrum.ieee.org/health1011). What's wrong with this picture?

I’m reminded of the discussion of this aspect of human nature from the evolutionary biology perspective in How Risky is It? by David Ropeik. The argument is that we are wired, by the process of natural selection, to over react to the possibility of risk. The cited example is that of two early humans walking through the savannah and hearing a rustling sound in the grass. One thinks it might be a lion, and flees. The other, more rational one, thinks the odds are that the sound is not from a lion, does not flee and is eaten. Moral: only the over reacting early man lives to pass on his genes. So here we are.