Posted on 08/19/2005 4:37:07 PM PDT by The SISU kid
No single person has come to more represent the big questions about drug safety that emerged following the withdrawal of Merck's painkiller Vioxx than the Food and Drug Administration's David Graham.
And now that a Texas jury has awarded the widow of one Vioxx patient $253 million, Graham, who works in the FDA's Office of Drug Safety, is more critical than ever. Of the drug, and his employer, for whom he doesn't speak.
"If the judgment is that there's blood on Merck's (nyse: MRK - news - people ) hands," Graham says, "there's blood on the FDA's hands as well."
Graham has estimated that Vioxx killed some 60,000 patients--as many people, he points out, as died in the Vietnam War. He says that fundamental problems at the FDA led to those deaths. "People should turn to Congress and demand a drug safety system that is free from corporate influence--and a distinct center for drug safety."
In Graham's eyes, the problem at the FDA is that the same scientists who approve drugs are the ones charged with deciding whether or not they are safe enough to remain on the market when problems crop up. "There is no feedback or review process to say, 'You guys have made a big mistake,' " he says. When problems are recognized by drug safety officers, it can be hard for the message to take hold.
Graham says that he thinks there should be formal, periodic reviews of the safety of new medicines--and that the FDA should release documents that explain its reasoning.
"The FDA does not think anything it did is a mistake," he says. "None of its decisions are evidence-based."
(Excerpt) Read more at forbes.com ...
This guy must be bullet-proof.
I can hardly wait to see the FDA's reponse to him.
May I assume from your screen name that you are of Finnish ancestry? Lot's of SISU up here where I live....
My elderly father has been in agony ever since Vioxx was withdrawn from the market. The doctors recommended operations on his knees, hardly a reasonable option at his advanced age. Fortunately, he saved several months' supply of Vioxx and began taking it again. He feels better than he has in months. Some risks, frankly, are worth taking.
Vioxx killed 60,000 people? Hmm. (makes expression of doubt)
My 83 y/o dad suffers from arthritis. Vioxx and similar drugs were magic for him. Sadly they have been or are being withdrawn. I suspect another cause for the deaths.
For some, it's worth the risk to ease the pain. Nothing is w/o side effects. I still think the drug needed to be studies under more controlled circumstances. How many people who died were elderly and suffering from heart problems already?
My doctor now prescribes a different anti-inflammatory drug called mobic. It helps, but not as well as vioxx.
Yes, it did.
Makes you wonder just how many people will have to drop dead before we realize we are in deep s**t due to bird flu or a terroist mass casualty attack with a bioweapon.
It is a quality of life thing. My mother suffers from osteoarthritis. Vioxx was the only thing she could take. Now she lives in daily pain.
My problem is more minor as I only needed it occasionally but when I do oh boy do I need it.
I now have the option of the totally useless over the counter stuff or the mind dulling stuff.
Whee! I can either have my brain dulled from pain or from drugs. Oh joy!
Drug companies opened THEMSELVES up to these lawsuits by directly marketing (using slick ad campaigns) to consumers (most who don't have a clue about their medical health) which in turn made these patients DEMAND these powerful drugs from their docs.
It's like marketing camshafts to commuters.
</Donning Asbestos Suit>
From the article:
"Graham has estimated that Vioxx killed some 60,000 patients--as many people, he points out, as died in the Vietnam War. He says that fundamental problems at the FDA led to those deaths. "People should turn to Congress and demand a drug safety system that is free from corporate influence--and a distinct center for drug safety."
In Graham's eyes, the problem at the FDA is that the same scientists who approve drugs are the ones charged with deciding whether or not they are safe enough to remain on the market when problems crop up. "There is no feedback or review process to say, 'You guys have made a big mistake,' " he says. When problems are recognized by drug safety officers, it can be hard for the message to take hold.
Graham says that he thinks there should be formal, periodic reviews of the safety of new medicines--and that the FDA should release documents that explain its reasoning.
"The FDA does not think anything it did is a mistake," he says. "None of its decisions are evidence-based.""
No evidence??? All the evidence the FDA needs is in the form of kickbacks, sweetheart deals, and lots and lots of money from the pharma companies...
I like the idea of a nice big monkey wrench being thrown in the middle of the drug approval process. Might save a couple lives...
Jenny
Well that's strange, since Vioxx was never marketted as a superior pain killer, but rather a pain killer that wouldn't cause "gastic discomfort"
Maybe you're suffering from a bit of anti-placebo effect?
I took Vioxx also for a short time for pain and after the recommended doses, the pain was gone. It was a great drug for me.
They still make Celebrex; they just don't advertise it any more.
However, I am certain you are correct, and that it is all a placebo effect. I probably do not really have any pain at all, but am only deluding myself that I do. Those bulging discs are probably no big deal as long as I take the appropriate sugar pill. I'm sure glad you posted. I'm cured!
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