Friday, December 30, 2005

RU-486 injury and death report

WebMD Medical News has published this article detailing the known severe side effects of the drug. It is pretty well written. It details the 8 deaths and 607 other severe "adverse events" known to have occurred world wide in the 460,000 doses give. This amounts to about 1.33 serious events per thousand doses given. It does note that the adverse reaction problems are probably much worse than the statistics shown.

"The FDA reports that only about 1% to 10% of adverse events for any given drug are ever reported," she says. "And in this case women may be even less likely to report problems because they may be ashamed."

Therefore we assume that the severe adverse reaction rate is more than 1 in 100, which is a cause for concern. The article also notes that they tried to get a statement from the manufacturer of Mifeprex (part of the RU-486 dose) to comment without success.

There are two things that the article does not note which I think are noteworthy. Danco Laboratories, the manufacturer of Mifeprex never released the drug for this purpose and does not condone doctor's prescribing it for this purpose. Some argue that this could be a legal shield from the inevitable law suits. They can continue to sell their drug while being shielded (to at least some degree) from being sued because they didn't participate in FDA approval for this use. Some argue that the manufacturer is making some moral statement publicly (investor relations) while raking in the bucks off of sales. It may be neither or both.

The second relevant point is that many of the adverse reactions could be dealt with very easily if women were kept under observation in a hospital for 24-48 hours after taking the drugs. We know that at least two of the U.S. deaths from bleeding occurred in teenage girls who were given the drugs without parental consent and sent home, only to bleed to death because they didn't want to tell Mom and Dad why they were bleeding. In some countries women are required to stay under observation for this reason. I believe the FDA did not impose an observation requirement because of lobbying on the part of groups like NOW who claimed that the treatment wouldn't be "available" to young girls who didn't want to inform their parents that they were pregnant and getting an abortion. This is, of course, an infringement on their right to privacy (read abortion) and not a situation of infringing on parental rights.

If we did impose an observation requirement two things would certainly happen.

1. We would have a much better idea of the actual adverse reaction rate.
2. Fewer women would have long term effects (including death) from their adverse reactions.

Just a thought.


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