Documenting Instanity

RU 486 question from Hugh

Hugh asks (and by the way I don't like his permalink-for-the-week "feature" on his new blog):

Ru-486 is strongly implicated in four deaths, and the pill is still on the market, unaccompanied by at least a warning? Is that pro-choice politics or good science? And have trial lawyers filed their first class action suit on behalf of the 460,000 who have taken the pill since its approval in the U.S. in 2000?

I would appreciate from scientists and attonreys with experience some specific FDA actions under similar circumstances.

I am not a doctor or a biochemist but I do know the following having followed the initial FDA process on a tip from a friend who is a biochemist.

1. RU-486 is actually 2 drugs. You take the first and then the second a proscribed time later.

2. The company that makes the second drug warns all doctors that their drug has never been tested by them for this purpose and the recommend against using it for that purpose.

3. In almost every other country where RU-486 is legal the woman must return to the doctor for the second drug and remain under observation for a period of time due to the significant possibility of heavy bleeding.

So the answer to Hugh's question is that it is politics, bad science and bad medicine. #2 above can be explained two different ways. I am also not a lawyer but I suspect the drug company's very public warnings worldwide virtually eliminates them being sued when people die. So either the company is perfectly happy to take the money while using this legal trick to lower their costs -OR- they know that this is bad medicine and will cause death or severe injury in a significant number of cases and they feel they HAVE to warn against it.

#3 above has only one explanation. It is bad medicine and bad politics. The pro-abortion-on-demand crowd wants to make sure that a minor girl can take the drugs to have an abortion without her parents' knowledge. To achieve that goal they are putting the very lives of every woman or girl who takes this drug at risk.

posted by mailgeek @ 5:48 PM