aTypical Joe: a gay New Yorker living in the rural South

Thursday, September 29, 2005

Susan Wood, the FDA & political cronyism

Susan Wood, the one-time director of the Office of Women’s Health who resigned over the Plan B “morning after” pill last month was on Nightline the other night.

She says science at the FDA is overruled by politics.

Seems so. 

KOPPEL: Do you remember what the vote was?

WOOD: It was 23 to 4 I believe in favor and unanimous that it was safe for women to use over the counter.

KOPPEL: And within the FDA?

WOOD: Within the FDA, you know FDA does overturn its advisory committees on occasion and usually when they do so it’s for good reason. In this case the FDA staff at every level within the agency, multiple levels, agreed that it should be approved for over the counter status, agreed that it was appropriate for women to have access in a timely manner so it would actually work more effectively.

A couple weeks ago Wood was replaced by a male veterinarian. Three days later, after “active and largely negative comment on the Internet and elsewhere,” a spokeswoman for the agency said the vet “had never been appointed acting director.”

I can only wonder if the guy wasn’t another victim of Mike Brown.

Mike Allen was on Fresh Air yesterday, discussing his Time magazine article, How Many Brown’s Are Out There? The FDA figured prominently in the story:

Internal e-mail messages obtained by TIME show that scientists’ drug-safety decisions at the Food and Drug Administration (FDA) are being second-guessed by a 33-year-old doctor turned stock picker. At the Office of Management and Budget, an ex-lobbyist with minimal purchasing experience oversaw $300 billion in spending, until his arrest last week. At the Department of Homeland Security, an agency the Administration initially resisted, a well-connected White House aide with minimal experience is poised to take over what many consider the single most crucial post in ensuring that terrorists do not enter the country again. And who is acting as watchdog at every federal agency? A corps of inspectors general who may be increasingly chosen more for their political credentials than their investigative ones.

Nowhere in the federal bureaucracy is it more important to insulate government experts from the influences of politics and special interests than at the Food and Drug Administration, the agency charged with assuring the safety of everything from new vaccines and dietary supplements to animal feed and hair dye. That is why many within the department, as well as in the broader scientific community, were startled when, in July, Scott Gottlieb was named deputy commissioner for medical and scientific affairs, one of three deputies in the agency’s second-ranked post at FDA.

His official FDA biography notes that Gottlieb, 33, who got his medical degree at Mount Sinai School of Medicine, did a previous stint providing policy advice at the agency, as well as at the Centers for Medicare and Medicaid Services, and was a fellow at the American Enterprise Institute, a conservative think tank. What the bio omits is that his most recent job was as editor of a popular Wall Street newsletter, the Forbes/Gottlieb Medical Technology Investor, in which he offered such tips as “Three Biotech Stocks to Buy Now.” In declaring Gottlieb a “noted authority” who had written more than 300 policy and medical articles, the biography neglects the fact that many of those articles criticized the FDA for being too slow to approve new drugs and too quick to issue warning letters when it suspects ones already on the market might be unsafe.

Susan Wood says she’s surprised by the attention she got. Coming as it did during Katrina, it got less attention than it otherwise would have.

Wood says she feels deeply about the issue and will be speaking out. She should be heard.