Hi, Harry!
Unfortunately, it gets even worse than that with Merck!! According to this article in Forbes (mind you - I have no opinion on the validity or accuracy of it), Merck DID have tests that showed a problem. Cardiologists warned them of the potential problem based on Merck's OWN 8,000 person study, but Merck dismissed the result. hmmmmmmm.....interesting.......they even quote a Vanderbilt epidemiologist in this article. He says "We need to investigate why the [safety] signals were ignored."
THEN there were three more studies done that Merck ignored. And then FINALLY, another one of Merck's own studies (originally designed to show Vioxx's benefits), apparently instead, to Merck's surprise and I'm CERTAIN "dismay", confirmed what the cardiologists had warned them of three years earlier, so Merck itself pulled it off the shelf. Here's a good question.......were any of these above studies ever published?
Man, oh man....you can't even blame it on the legal system (litigation) this time, but there is already speculation running rampart about the sharks now coming out of the woodwork ready to file lawsuits on several other drugs. One of them is a drug (Neurontin) used for MS symptoms, BUT it is being attacked judicially ONLY because of Pfizer's mistake in outwardly promoting its off-label uses (which is illegal), i.e. for "unapproved uses". Still, as this article says, the injury lawyers are jumping on the bandwagon, one class action suit already has been filed regarding Neurontin. (Hey, and I'm in law, too!) I sit the fence, of course, because I can usually see both sides. (I'd probably be rotten as a Judge. LOL) In any event, to my knowledge, Neurontin is quite helpful for MS. It would be a shame to see something possibly pulled or jeopardized (and note: there is no indication of that happening!) because of economic downfall instead of bad efficacy of the drug itself. (Still, that was sort of "not smart" on behalf of Pfizer to outright
promote non-approved use.) Hey, here's a question I need to legally research to answer: If a drug company goes under, or stops making a drug for reasons other than safety (such as economic), does that negate their patent on their drugs, thereby allowing other manufacturers to pick it up?
Yea..........where WAS the FDA? Well, wait..........how closely does the FDA follow drugs AFTER approval? Are they even expected to? Once approval has been given, I think they are out of the loop at that point. Sort of like someone who marries you.........if you want a divorce later, you need to go see.........gulp...........a lawyer!
I haven't read anything about the Senate Committee matter. Maybe because the FDA wanted to stay out of it completely? That's just pure politics going on there, I'd say.
Deb
EDIT: Well, I tried to give the FDA the benefit of the doubt. But Harry is right, one of their responsibilities is to keep watch over the drug and its safety after approval, also.
