Thursday, August 02, 2007

Evaluating The Program Designed To Prevent Pregnancies Among Accutane Users

Last year the FDA decreed that reproductive age women, in consultation with their physicians, are incapable of using Accutane, an acne drug, properly.

In order to protect women from themselves the FDA decided to only allow these women to receive proper care if they sign their life away 1) register their personal medical information with the government, and 2) submit to pregnancy tests. [Accutane is contraindicated in pregnancy.]

So the FDA paid a lot of money to a private company to enroll patients in a program (iPledge) designed to prevent pregnancies from happening in those patients.

It's now over a year later, and the results are in. Let's see how well 100 million dollars of your tax money protect women from themselves:

122 pregnancies reported in the program's first year.

[That's about the same as the number reported annually before the FDA tightened restrictions on the drug.]

Another 37 pregnancies in the four months since.

An additional 19 pregnancies in women who took the drug despite never enrolling in iPledge.

Just 10% of the 122 women who conceived while taking the drug provided the detailed, follow-up information needed by the FDA to improve the program.

Faced with these stellar results of the iPledge program, the sage advisers to the FDA learn a lesson and decide that minor changes would ease access to Accutane and its generic competitors without further increasing those troubling pregnancies.

Not to be outdone, I also learn a lesson: I must get into this protecting-women-from-themselves racket. Not only is it lavishly funded--$100 million in Accutane protection here, half a billion or so in abstinence-only "education" there--but there is no expectation of, you know, actual results. If that's not the absolute cherry on top of the yummy cake of treating women like utter morons and getting paid for it I don't know what is.

Seriously, I can be as incompetent and patronizing as the next government subsidized person out there. So, if you have any ideas on ways to protect women from their very own selves feel free to send them my way.

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At 6:13 AM, Blogger Cindy said...

Ha, I just finished 7 months of the ridiculous iPledge program while I was on Accutane. When they first told me what I had to go through to get the Accutane, I was angry. It was a complete waste of time but maybe that's also because I'm 30 years old and don't need my hand held. I had no idea so much money was spent on the program. What a pain. Luckily, by the last few months I was on Accutane, my dermatologist didn't bother making me get the pregnancy test every month.

At 7:39 PM, Blogger ema said...


Thank you for sharing your experience.

At 2:41 AM, Blogger KT said...

This is hilarious. Thanks for shedding light on this. I just finished a 6-month course of Accutane, and I felt ridiculous logging in every month and "pledging" not to get pregnant. Funny thing - they require you to be on two forms of birth control while taking the pills. Abstinence and lesbianism do not count.

At 4:04 PM, Anonymous Anonymous said...

This was the most ridiculous experience ever. I am on my second round of Accutane, and it has not gotten any better. Heaven forbid you should notice a problem with the system. There is absolutely NO WAY to contact an individual within this private company. You either fit their cookie cutter mold, or you don't. In my case, I don't fit as a result of their error--it doesn't matter that I carefully timed my round of Accutane to fit between training programs for various marathons, but--their error is going to cost me a month of training, IF nothing else goes wrong. It would take two seconds to fix, it this private company bothered doing more with its 100 million dollars than just setting up a computerized phone tree. Booo!


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