Friday, May 07, 2004

Plan B Is The New Ecstasy

Experts say Plan B should be sold over-the-counter (OTC), but the White House, via the FDA, doesn't agree.

Barr Labs' application to sell Plan B OTC was rejected by the FDA because of concerns about whether young girls would be able to use it safely.

The vote for selling Plan B OTC, from the panel of independent experts assembled by the FDA, was 23 to 4 in favor of making Plan B available OTC. The panel concluded that:

1. Plan B was effective.

2. Women could be trusted to use it correctly without a doctor.

The second conclusion is particularly important, because, when deciding whether to allow Plan B to be sold OTC, the FDA wants to make sure that women can do three things without a doctor's help:

a. Diagnose the problem themselves.

The problem for which Plan B is used: having unprotected sex (birth control method malfunctioned; no birth control was used; forced intercourse) and not wishing to become pregnant. The requirement for diagnosing this problem: being able to walk and chew gum at the same time.

b. Can be trusted to treat the problem effectively.

The effective treatment for unprotected sex/no pregnancy desired: use of emergency contraception (in this case, Plan B). The requirement for trust, according to the FDA and Concerned Women for America (see below): not being a woman.

c. Can understand the drug's label.

For Plan B, the instructions for use are: take one pill now, and another pill 12 hours later.

(And, just in case you're wondering: there are no contraindications to using Plan B, except already being pregnant and an allergy to any of the pill's components. Even if you're pregnant and use Plan B, it won't harm the fetus. Also, the most common side effect is nausea.)

To recap, in order to use Plan B safely you have to be able to figure out (all by your own little pretty self) that you had unprotected sex and don't want to become pregnant, that you need to use Plan B, and that you should take two pills, 12 hours apart. In my professional opinion, if you're able to walk in a straight line, you're able to use Plan B.

Unfortunately, it is now clear to me that my professional opinion, and my clinical experience are worthless. Why? Because neither has enabled me to figure out this one most basic of scientific truths--women are blathering idiots:

According to Wendy Wright, senior policy director at Concerned Women for America, a conservative women's organization, said that the agency had ignored political pressure and made its decision based on science.

"The F.D.A. is right to be cautious about having a potent drug that can be harmful to women sitting next to candy bars and toothpaste," Ms. Wright said. Broad availability of Plan B would allow people to slip the medicine to women without their knowledge, Ms. Wright said. (emphasis added)

I want you to read this again, and think about it for a moment:

Broad availability of Plan B would allow people to slip the medicine to women without their knowledge, Ms. Wright said.

So, the science the FDA based its decision on is women's inability to detect when people slip them medicines.

Ms. Wright's comments must be, without a doubt, among the most insulting words ever uttered towards women ! (I have to ask, who are these people who routinely slip FDA-approved drugs to them--clerks, pharmacists, store cleaning crew, doctors, naughty neighbors?)

I must admit that this relentless and pervasive insistence on treating women like incompetent buffoons, incapable of making even the smallest decisions, is discouraging. So, I will let the experts' expert have the last word:

James Trussell, director of the office of population research at Princeton University and a member of the advisory board, said that the agency never raised the issue of label comprehension among young teenagers when it approved other products to be sold over the counter. "The White House has now taken over the F.D.A.," Mr. Trussell said.

UPDATE: Part II, and Part III, Part IV.

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