Von Eschenbach steps down at NCI

Instead of running both organizations, Dr. Andrew von Eschenbach will temporarily give up his post at the National Cancer Institute to take the top spot at the Food and Drug Administration. He released the news late Friday in emails to staff at both organizations.

While this eliminates the blatant conflict of interest (the NCI investigates new drugs; the FDA approves them), it will not put to rest consumer fears about the changes he has in mind for the agency. At NCI, von Eschenbach was a forceful advocate for more rapid approvals of new drugs based on inconclusive markers of their efficacy.

In his new job, he has a similar-minded deputy in Dr. Scott Gottlieb, the 33-year-old physician/writer who has come under media scrutiny in the past week for his ties to a newsletter that touts biotech and pharma stocks based on informed speculation about ongoing clinical trials. (The Securities and Exchange Commission is investigating similar activities by physicians involved in the clinical trials, which if leaked to investors amounts to illegal insider trading. It remains to be seen how rigorously the SEC will pursue these allegations.)

Dr. Von Eschenbach takes over a deeply troubled agency. The FDA has come under intense scrutiny in the past year for failing to protect the public from unsafe drugs like Vioxx and failing to warn the public about the use of antidepressants in children. It has allowed religious zealots inside the Bush administration to bully its scientists on issues like Plan B (the morning after birth control pill). Safety officers like Dr. David Graham have had to rely on whistleblower protection laws to get their views out to the public.

Responding to those concerns, Congress is moving to limit the agency's ability to appoint scientists with conflicts of interest to its advisory committees. The Institute of Medicine -- part of the National Academies of Science -- has undertaken a thorough review of the agency's safety record. A number of Republicans have joined with Democrats to call for revamping the agency by separating its safety division from the new drug approvals division.

These appointments reveal a Bush administration that is openly contemptuous of these concerns. They also suggest the pharmaceutical industry and its allies in the agency, on Capitol Hill and in the administration may be gearing up under the rubric of "speeding innovative new drugs to market" for another assault on the FDA's mandate to protect the public from unsafe and ineffective drugs, medical devices, food and dietary supplements.

It's too easy to say, as New York Times columnist Paul Krugman has, that these appointments are part and parcel of the administration's penchant for appointing incompetent cronies to top jobs. Drs. von Eschenbach and Gottlieb are smart men with not very secret agendas. It will be very interesting to follow the changes they make at the FDA. Time Magazine reported last week that Dr. Gottlieb has already begun questioning some of the drug application rejections made by FDA staff.

It this is a harbinger of things to come, the FDA may soon rival FEMA in its ability to serve the needs of the American public.

Posted by gooznews at October 1, 2005 12:46 PM