Pharma’s Cutting Edge

Below read my (unpublished) response to the editorial by the NEJM’s Dr. Jerry Avorn. Funny how my recent non-controversial letter on the FDA was accepted for publication, whereas two critical letters were not.

Dr. Avorn proposes that public funds be used to study medications to liberate us from “the industry-driven approach to defining the nation’s drug-research agenda.” He cites Pfizer’s development of a fixed combination of torcetrapib-atorvastatin as the archetype of this ostensibly flawed approach. However, publicly funded clinical trials would not alleviate these concerns. A fixed combination tablet cannot be ‘unfixed’ to allow for alternative therapy combinations. Furthermore, there is no regulatory or legal mechanism that provides for publicly funded clinical trials of an experimental therapy without the manufacturer’s cooperation. The market-driven pharmaceutical industry is best equipped to research and develop experimental therapies. Pharmaceutical manufacturers will formulate and study new therapies in ways that they believe will maximize their investment returns. Potential consumers of new medicines that are not satisfied with how new drugs have been formulated or studied will not buy them, and the desired investment returns will not materialize—a self-correcting mechanism. The U.S. government will exert substantial influence over this market mechanism as it collectively becomes the world’s largest drug consumer next year.