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November 15, 2005

Kook Right Politics Trump Science Again

I admit I was a bit taken aback when I heard that Kansas can now teach intelligent design in public schools. As some of you know, I grew up in Kansas and I didn't let the Kook Right get to me, so don't y'all fret now about kids coming out of Kansas ignorant. As we all know, most of the kids that get out of Kansas are smart, and the ones that stay are ignorant. The very few exceptions I've seen are those frightened few, huddled together for emotional and intellectual support in Lawrence, KS and at Kirby's Beer Store in Wichita.

But today, I see another example of the Kook Right squashing science. Only this one is much more disturbing, as it has the potential to really harm some people rather than just contribute humorous talking points to bloggers and late-night comics. The Government Accountability Office (GAO) has just released a report showing that the FDA did not follow it's usual procedures in rejected an application to make the Plan B Contraceptive available over-the-counter.

The report outlines four areas that were inwhich the handling was "unusual."

-- The heads of the FDA offices that reviewed Barr's application --
Dr. Florence Houn, whose office deals with reproductive drugs, and Dr.
Jonca Bull, responsible for over-the-counter medicines -- refused to
sign the agency's decision because they disagreed with it. Dr. John
Jenkins, director of the Office of New Drugs, also disagreed and did
not sign the decision.

-- High-level management was more involved in the decision than is
usually the case for over-the-counter approvals, the GAO said.

-- Investigators cited the conflicting accounts among midlevel and
senior managers over whether the decision to reject the request was
made before scientific evaluations had been completed.

-- The rationale for shielding younger adolescents "was novel and did
not follow FDA's traditional practices," the report said. In the past,
the agency had not made such distinctions about age when it came to
contraceptive use.

Now, we already knew that, 67 medications were approved for sale without a prescription since 1994 and that Plan B was is the only drug rejected by the FDA when the advisory committee approved it.

The most telling part of this whole thing is of course, the timing of the tacit "rejection" and the completion of the study. It's a litte confusing, but pay attention and read what Think Progress says:

FDA officials, including the Director and Deputy Director of the
Office of New Drugs and the Directors of the Offices of Drug Evaluation
III and V, told us that they were told by high-level management that the
Plan B OTC switch application would be denied months before staff had
completed their reviews of the application. The Director and Deputy
Director of the Office of New Drugs told us that they were told by the
Acting Deputy Commissioner for Operations43 and the Acting Director of
CDER, after the Plan B public meeting in December 2003, that the
decision on the Plan B application would be not-approvable. They
informed us that they were also told that the direction for this
decision came from the Office of the Commissioner. Both office reviews
were not completed until April 2004.

Plan B is a drug that prevents pregnancies after unprotected sex. It doesn't cause abortions. It is effective before fertilization and most effective within 24 hours after sex. So, as you can see, The Kook Right Overloads waved their Magic Kook Right Wands and now women who could have easily prevented their pregnancies now will have to deal with unwanted pregnancies.