Lybrel, the new contraception pill for women from Wyeth Pharmaceuticals was just given its ok by the FDA and I have to really wonder why. This drug, will reduce or in some cases eliminate a women’s period while protecting against unwanted conception. While I, as a man, should have little to say about this issue, I will bring up a few concerns I have about this drug.
First off, what kind of long-term studies have they done on this drug and its potential for creating health issues down the road? I can pretty much guarantee that the answer is no. As with the use of HRT (hormone replacement therapy), I see the potential of opening a can of worms that will cause women who take this drug to have an increased risk of certain cancers and cardiovascular disease.
Second issue is the findings from the study which indicated that half the women enrolled in studies of Lybrel dropped out, said Dr. Daniel Shames, a deputy director in the FDA’s drugs office. Many did so because of the irregular and unscheduled bleeding and spotting that can replace scheduled menstruation. I find this somewhat disturbing when fifty percent of the people studied drop out because of unwanted on intolerable side-effects. The response by the FDA? “If you think you don’t want to go down this road, this is not for you,” Shames told reporters. Hey, if it turns out this drug had other unwanted side-effects tough luck? This is just not an acceptable stance for a government agency to take that is supposed to be protecting the public.
Others have said that Lybrel should really help women who suffer from nausea, headaches, cramping and other problems during their period. Problem with that statement is that this “benefit” wasn’t even studied!
On other main problem I have here is that this drug is seemingly trying to treat a natural process known as menstruation as if it were some sort of disease. University of New Hampshire sociologist Jean Elson had this to say “For women in that situation, I certainly can understand the benefits of taking these kinds of medications, but for most women menstruation is a normal life event — not a medical condition, why medicate away a normal life event if we’re not sure of the long-term effects?” Why indeed.
The last issue I have hear is that while this drug does seem to be effective at lowering the risk of getting pregnant, because it eliminates periods, a women who does somehow get pregnant won’t be aware of it as there will be no missed periods to tip her off. Because of the need to be health conscious during the early stages of pregnancy, like with folic acid supplementation to prevent some birth defects, this can be a dangerous problem.