Mark McClellan--former CEA member, former FDA head, now head of CMS--was one of the very, very few people who looked like they might get out of the Bush administration with their reputation intact. But now Kautilyan directs us to a Wall Street Journal story saying that this is not so: that McClellan has been corrupted into making FDA decisions that are inconsistent with its scientific and medical regulatory mission:
Posted by DeLong at June 20, 2004 12:28 PM | TrackBack | | Other weblogs commenting on this postKautilyan: Recently I posted on the Rovian tactics that have been used at the FDA to stifle unwanted scientific findings regarding anti-depressant 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 embarrassment 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."...
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.
For what it's worth my wife left her doctor's office with an unsolicited prescription for emergency contraception. "If you need it, you've got it." Doc said that in that office it's now standard policy: everyone (female) who is sexually active is offered a prescription, by default. Hope that's true elsewhere.
Posted by: CD318 on June 20, 2004 01:09 PMSo are people opposed to selling a drug that could greatly reduce the number of abortions really "anti-abortion"? No they are "pro-life". Maybe pro-life means believing that people who have sex outside of marriage should be punished by having the responsibility of raising unwanted children.
Pro-life == anti-sex
Could people in favor of marketing this drug be "anti-abortion"?
Posted by: bakho on June 20, 2004 07:29 PMbakho, that's the inherent contradiction in their argument, and it's one you'll never hear them acknowledge. "If we deny $34M to UNFPA, they can't talk about family planning which includes abortion." Never mind that because family planning also includes contraception and monogamy, those two items also suffer by the denial.
Posted by: Linkmeister on June 20, 2004 10:19 PMActually, their arguments are consistent. They believe that God punishes people who sin and sinners deserving of punishment should not be absolved of that punishment. They believe that God punishes people who have pre-marital sex by forcing them to bear unwanted children. Abortion and yes, even birth control is therefore an immoral attempt to weasel out of God's punishment. Similarly, people who commit murder deserve God's punishment, the death penalty.
Pro-life is a marketing term attached to these beliefs to try to broaden their acceptance.
A rational argument would be: "Abortion is a problem. What can we do to reduce or eliminate abortions?" However, this argument is not even being heard. This argument is rarely used by the most vocal opponents of abortions. Instead, they argue, "Abortion is a sin. We must pass a law against it." Of course, making abortion illegal would have the same effect as making alcohol illegal. If abortion were illegal tomorrow, an underground trade in abortion pills would boom overnight. The birth rate would climb rapidly and place a large demand on insurance costs and already overburdened government health programs. The health and financial costs from the misuse and side effects of those drugs would be enormous.
Abortion foes cannot see this outcome because they are blinded by the rosy scenario of sinful harlots by the millions, delivering healthy white babies for adoption by loving, infertile, Christian couples.
Of course, the rosy scenario has as much relation to reality as the cakewalk in Iraq. If they pray hard enough, God might will it to happen.
Oh come now. The neocons will all come out with their reputations still in tact. Their supporters will continue to support them and will find an excuse as to why whatever they did didn't work the way it was "supposed" to. Look at Reagon and supply side economics which has been shown not to have worked, even the Gipper himself had to backtrack and increase taxes during his terms in office. He by the way is still looked at as the great tax cutter. He also seems to have deluded the religous right who seem to think that he was god's gift to religion when the man was a divorcee and rarely participated in religous services.
Posted by: Karl on June 21, 2004 09:55 AMThe most baffling element is what McClellan must be thinking about his next career move after government. If I saw him at a conference I'm afraid I would laugh in his face.
He has apparently presided over an unprecedented politicization of the Agency and that within the agency, his name is met by groans or laughter or a hesitant sigh of relief that he took some of his crazies to CMS with him. Unfortunately, from this Plan B incident, it appears that the spirits of AEI, Cato, Heritage, right wing hill staffers, and the Federalist Society remain.
Then again, 47% of the people in this country don't believe in evolution (and most vote for GWB) -- so one might argue that this is the type of scientific agency these people want.
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