Thursday, May 25, 2006

Crazy Stuff at the FDA

The LA Times has the story:
The last two appointees to head the FDA were closely involved in decisions to overrule the agency's medical reviewers and block the "morning-after" birth control pill from being sold without a prescription, according to court transcripts to be released today.

Last year, Lester M. Crawford personally took the decision away from his top subordinates, according to depositions of two senior Food and Drug Administration officials. And at an earlier stage in the process, his immediate predecessor as FDA commissioner, Mark B. McClellan, raised objections that formed the basis for overruling medical reviewers.

The transcripts provide the most detailed look yet at an internal review that some critics say has been tainted by politics. The dispute over the drug, marketed as Plan B, has pitted Christian conservatives against liberal women's groups and raised concerns in academic circles that the FDA had compromised its scientific principles. FDA's Role in Blocking 'Morning-After' Pill Cited

You wonder what the basis for these decisions is. Your scientific staff and your ethicists and everybody say, ok, it's good to go, and then the top guy says no.*

I can imagine the reasoning behind the opposition to abortion, and I can see why the nuts want to teach abstinence-only in the schools, and I can see why they're afraid to include sexual orientation in sex-ed classes -- I think the reasoning is flawed, but at least I can figure out how they got to their conclusions.

But this. The Plan B, "morning after" pill. What's the deal there?

OK, here's a clue:
... Wendy Wright, senior policy director for Concerned Women for America, a conservative public policy group, said the FDA had no authority to promulgate such an age restriction and no way to enforce it.

The involvement of the two commissioners "brought some basic common sense to the decision-making," said Wright, whose group opposes over-the-counter status for the drug.

"What this is really all about is the abortion lobby has been losing on the issue of abortion, and they are now diverting attention to something they can win on — the 'morning-after' pill," she said.

What? They just want to win something? Isn't the abortion issue supposed to be about murdering babies? Plan B doesn't do that.
Available only by prescription, Plan B is a high dose of a common contraceptive that, if taken within 72 hours of unprotected sex, works primarily by preventing a woman's ovary from releasing an egg. It also may prevent fertilization of an egg or prevent a fertilized egg from implanting in the uterus. The FDA does not consider Plan B to be an abortion drug, Woodcock and Galson testified.

No egg, no fertilization, no baby, no murder.

Ah, here you go:
... [former FDA Commissioner Mark B.] McClellan raised specific objections about whether the youngest teenage girls could safely use the drug, noting that its manufacturer, Barr Laboratories, had enrolled few young teens in its studies.

Woodcock, the mother of two teenage daughters, testified that McClellan's argument had struck her as reasonable: The easy availability of a "morning-after" pill might prompt some young teens to engage in risky sexual behavior.

Can you believe that the nuts at Concerned Women for America -- who lend active support to the anti-MCPS groups in our school controversy -- want to interfere in the decision-making of thousands of women, women who may have been raped or may have made a terrible mistake that it's not to late to recover from, so that teenage girls don't get the idea that they can have sex?

These people are insane. Stop them.

* In these two sentences I am having fun with uncomfortable agreement of verbs with their subjects.


Blogger Dana Beyer, M.D. said...


I'm responding here because I don't recall the thread for which you posted the question about herd immunity.

It varies with each virus and bacterium. For instance, 95% coverage is required for measles, which is why you get outbreaks even today in religious communities Rubella and smallpox required only 85%.

HPV is highly contagious, being spread by touch. When we speak of STDs we are usually refering to penetration of one sort or the other, but HPV spreads easily with touch. That stands in sharp contrast with HIV, for instance.

May 25, 2006 9:31 PM  
Blogger andrear said...

I didn't even tell my kids about sex- like the mom of two in the article- because we know knowledge promotes sexual activity- I know that even letting them know about sex would make them do it. My parents never told me and I still don't know what sex is(does it have something to do with why I gave birth to two children?).

May 26, 2006 3:01 PM  

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