"The fact that you're mentioning Vioxx and Propecia in the same phrase in an attempt to bolster our confidence in Propecia is a very strange way of supporting your argument."
Everybody has to decide for themselves whether they are comfortable or not with propecia. I mentioned vioxx because you made the reference to the withdrawl of major medications recently, and I was expanding on that point (as you were discussing Vioxx without naming it). It is useful for others to know how medications are approved and later monitored (and post-marketing surveilance is used). It is inevitable that at the completion of phase III trials some drugs are approved with side-effects that only greater use will reveal.
To say that there is no monitoring or mechanism that allows adverse events to be monitored is incorrect. The behind the scenes discussion and "who knew what when" will be key in this episode... T
.........The initial Vigor trial from 2000 was a single relatively small trial (8000) which raised questions of vioxx safety. Others of the same time showed it was safe. "One possibility was that it was the result of chance. Another was that the problems were caused by Vioxx. And the third was that naproxen provided heart protection and had skewed the results. Merck researchers looked for data from other studies, aware that studies of two other little-used painkillers in the same class as naproxen had shown cardioprotective effects.
In the spring of 2000, Merck researchers also reviewed safety data from a continuing study in which Vioxx was being used in patients with Alzheimer's disease to test a theory that the painkiller might slow the disease's progress. Dr. Reicin said that there was no evidence in that study, which had started in 1998, that Vioxx posed a risk.
Merck researchers soon concluded that naproxen was cardioprotective. Some academic researchers, including some who consulted for Merck, also supported this theory."
The agency hired a cardiologist to take a careful look at the studies, and it summoned a panel of independent experts to discuss the data publicly.
The panel met in February 2001, and while several members expressed concerns about the heart risks, none suggested that the drug be withdrawn. Doctors on the panel who treated ulcers argued that Vioxx's protective effects far outweighed its possible harm to the heart; cardiologists argued that the drug's possible harm to the heart was a real problem. All agreed that more studies should be done.
In early 2000, the company had started a clinical trial to determine whether Vioxx could prevent the recurrence of colon polyps. Merck decided to intensely monitor the cardiovascular condition of patients in that test, known as the Approve trial, as well as subsequent studies. Dr. Reicin said last week that she and others at Merck felt devastated when they learned this past September (9/04) about the findings from the colon polyp trial. But she said she believed that running the trials as the company did was the best way to learn whether the drug had a problem or not.
"We did our best to think of the most comprehensive study we could have done," she said. "I'm sorry that I didn't know four years ago what I know now, but the data didn't lead us there four years ago." ......................."
There was surveilance and discussion since the release of vioxx in 1999. There was suspicion but not the kind of evidence needed for withdrawl in 2000. With the evidence obtained in summer 2004 it was withdrawn. The Vigor study was not supressed, it was available and debated. No advisory panel was calling for the withdrawl of the drug in 2000. The next data was in 2004. The study of 8000 (vigor) was not designed to look at cardiac death, could not answer the "why" of this unexpected result, and could not disprove that naprosyn in the control group (or random events) did not explain it.
I will agree that drug reps should have marketed it with this known question more loudly stated, but up to 2004 it was only that... A question and suspicion. The FDA and Merk did discuss whether a new study would help, and studies currently underway were chosen. A free, aggressive FDA might have pulled the drug based on an arthritis study of 8000, but it is hard to know if it would have given what they knew then (other benign studies)...
I do agree that the FDA should have a freer hand in approving drugs and removing drugs from the market when needed... However as it is now it takes years and an expected 500million dollar annual income for companies to even try to bring a new drug to market. This is the reason that I do not expect any innovative FDA approved alopecia drugs in the future (we're cheap

). A "safer" system is also a slower less responsive system.
I say this all to illustrate my view that physicians and the pharmacies arent Evil but rather involved in a complicated process...
I dont think that there are any legitimate hints that propecia has serious irreversible side-effects (beyond the occasional breast) but if your confidence in the production, development and approval process is so marginal you probably shouldnt take any perscription medication. It is always a risk/benefit choice, and with your predisposition you cant be comfortable with the risks.