Tuesday, August 02, 2005

FDA gets serious about not doing its job

I'm so relieved. The US Food and Drug Adminstration, the folks that brought us Vioxx, Celebrex and many other boons to mankind (Viagra?) has announced personnel changes "designed to create an even more efficient and compact central organization." Even more efficient? Wow. If it gets much more efficient we won't need it at all.

So what's up?
"With this senior team of experienced public health professionals, FDA is well positioned to continue to improve our science," said [FDA Administrator Lester] Crawford. "We are now ensuring that we get safe and effective products to patients, who need them, that we communicate clearly with patients and physicians so they have the best information available to make well informed decisions about their health, and that we continue to take new steps through our Critical Path initiative to take advantage of changes in medical science and healthcare delivery to move our healthcare system from one focused on treatment to also addressing chronic needs and healthcare prevention through more personalized approached to medical care."
Good. We need good science and good objective scientists. No more of this Big Pharma brown nosing. So let's get to it. Who is the new guy in charge of science?
Scott Gottlieb, MD, a former FDA and Centers for Medicare and Medicaid Services senior official, is returning as FDA's new Deputy Commissioner for Medical and Scientific Affairs. In this position, Dr. Gottlieb will coordinate medical and scientific affairs for the Office of the Commissioner serving as senior policy advisor to the Commissioner in these areas. Dr. Gottlieb is a practicing physician who most recently worked as a Resident Fellow at the American Enterprise Institute (AEI), a prominent Washington, DC-based think tank and also spent time as an American medical correspondent for the British Medical Journal.
I have to say that even for someone as jaded as I am, parading as a credential for a regulatory agency a Resident Fellow at the American Enterprise Institute (AEI), "a prominent Washington, DC-based think tank," is a bit much. AEI is prominent, all right. It is more than prominent. It is notorious. If you go to their website you can read a book review (and press release for) such volumes as, Regulation and the Natural Progress of Opulence by Sam Petlzman (an AEI member of their Council of Academic Advisers), or an essay, "Why Do We Regulate Banks?" (Answer: we shouldn't).

Here's how AEI describes itself:
The American Enterprise Institute for Public Policy Research is dedicated to preserving and strengthening the foundations of freedom--limited government, private enterprise, vital cultural and political institutions, and a strong foreign policy and national defense--through scholarly research, open debate, and publications.
AEI scholarship and scholars are doggedly right-wing, pro-business and anti-regulation.

Just the right background for the person in charge of "science" for the nation's key regulatory agency on food and drugs.