I have just completed a paper that represents “first thoughts” arising from a project on medical innovations that I am doing with Katherine Stebbins McCaffrey and Srikant Datar. This paper draws on a case history of HIV/AIDS that Katherine has been working on, my reading of medical history and my prior work on “multi-player” innovation.
Although it is not a “policy” paper it concludes thus:
In medicine too, we should expect that an FDA that made safety its primary focus would reduce the incidence of dangerous drugs or devices brought to market. Meanwhile, scaling back the regulation of efficacy promises two important benefits. Sharply reducing the costs of regulatory compliance should foster some of the hectic, frugal innovation that we find in so many other fields. And, replacing centrally supervised randomized trials with more pluralistic evaluations (by medical associations, insurers and other third-party payers, and on-line communities of consumers) should improve the matching of treatments and patients. True, useless treatments might increase with more innovations coming to market. But, as is the case outside medicine, widespread sharing of diverse experiences of actual use, might also yield more knowledge of what works best and under what circumstances. We could sip a little more of the holy grail of personalized medicine on the cheap, simply by allowing more ad-hoc user experimentation.
We certainly should not suppress science, disdain bio-tech and Big Pharma, or replace trained physicians with Maoist barefoot doctors, but we could be less credulous about imminent research breakthroughs and offer more scope for nurse practitioners and even completely un-credentialed outsiders to innovate. Placing ever-larger bets on exclusive innovation is a poor remedy for its debilities. Harnessing the enterprise and ingenuity of the many and for the many should be the way ahead.
Download the paper here