Yesterday NRO posted a beside-the-point editorial by Henry Miller who once again recycled his assertion that all the FDA needs is a strong commander who will kick the asses of drug reviewers who fail to approve new medicines as fast as possible.
http://article.nationalreview.com/?q=YWU5M2MzY2JhODM4M2QyZDljODJiOWMxZTcxMzNjY2Y=
His attacks have no substance and are actually recycled from news articles written by journalists like Alicia Mundy — who is also a fellow at the Soros funded New America Foundation — and ad homimen attacks from people like Donald Kennedy, the last FDA Commissioner to smoke. Miller dredges up the media invented charge that Gottlieb’s appointment is unusual because he had no medical experience. Miller knows better: Gottlieb still sees patients and has been doing so for years. And Miller’s attacks on Andy von Eschenbach and Janet Woodcock are purely second hand.
Has Henry never heard of surrogate endpoints and biomarkers. And does he really believe that the FDA is fully responsible for the decline in new drug approvals? How about poorly validated targets? How about the fact that companies often withdraw drugs after Phase III? He tosses out a laundry list of FDA problems and ignores the efforts of the three people he attacked to undo them with better science and better oversight. To simply say that only leadership matters is to ignore the fact that scientific change is an important tool for forcing change at the FDA and moving the agency away from being risk averse. Had he had read the Critical Path opportunities list? Does he really think that outdate methods of drug evaluation don’t need to be changed? Is anything going on inside Miler’s mind in this regard beyond chatty assaults?
