x-posted at
Kautilyan
Recently I posted on the Rovian tactics that have been used at the FDA to stifle unwanted scientific findings regarding anti-deppressant use. The Wall Street Journal now reports that there has also been politicization regarding emergency contraceptive use. This latter example of FDA shenaningans ought to be receiving much more coverage than it has. This account was buried on page B4 of the Journal and as far as I am aware has not been brought up as a new source of embarassment for the Administration. This issue ought to be exploited by the Kerry campaign as a major issue to rally women voters. Aside from politics the misuse of science for political gain should be considered beyond the pale.
Here is an excerpt from the Journal:
The leader of drug reviewers at the Food and Drug Administration told his superiors that the agency was subjecting an application for emergency contraception to harsher scrutiny than other drugs.
The views of the director of the Office of New Drugs, John K. Jenkins, were revealed in internal documents written in April and May. That is when the agency weighed making the drug, known as Plan B, available without a prescription.
Memos reviewed by The Wall Street Journal paint a vivid picture of the face-off between lower ranking medical reviewers and top officials, including then-Commissioner Mark McClellan. Dr. McClellan's involvement in the debate wasn't previously known. At a meeting in February, Dr. McClellan and other top officials disagreed with a proposed approval, and said they were considering an age restriction. Dr. McClellan is now the administrator for the Centers for Medicare and Medicaid Services. An FDA spokesman said it was "not unusual" for the commissioner to be briefed on "contentious issues."
In my last post I speculated that the politicization of the FDA may tarnish the reputation of Mark McClellan, a highly respected economist and MD, who is one of only a few Bush policy advisors who had a decent chance of leaving Washington with a modicum of respectability.
Here is the nitty gritty of the debate which makes clear that it is conservative politics and not science which as at issue:
The agency overruled the advice of its panel of outside experts, which by a vote of 23-4 recommended that the drug be sold over the counter.
With input from at least four reviewers, Dr. Jenkins wrote that Plan B met the crucial criteria for an over-the-counter drug, namely that it could be used safely and effectively without the supervision of a doctor. But in meetings as early as February, top FDA officials, including Steve Galson, the head of the Center for Drug Evaluation, said that concerns over how young women would use the drug made approval problematic. In a memo, Dr. Galson wrote that the FDA "lacked the relevant data on over the counter use of the product by young adolescents" because Barr Pharmaceuticals Inc. only included 29 women age 14-16 out of a total of 585 in its study of the drug.
Several conservative groups and members of Congress made adolescent use of Plan B the main thrust of their lobbying to oppose wide availability for the drug.
Dr. Jenkins and his staff didn't agree that younger women posed any special risks. The data in Barr's application was "fully consistent with the Agency's usual standards for meeting the criteria" required for a drug to be sold over the counter. He said that the FDA has never considered the use of birth-control pills among younger women a problem, and such pills contain the same ingredients as Plan B. "I am not aware of any compelling scientific reason" to think that emergency contraception would be any different in younger women, he wrote.
(Emphasis Added)