Posted on 09/23/2006 4:56:20 AM PDT by baseball_fan
...Sen. Charles E. Grassley (R-Iowa), who has led a number of investigations into the workings of the FDA in recent years, said the agency's reaction to a report it had commissioned speaks volumes.
"The FDA appears to be focused on damage control rather than addressing its core problems," Grassley said in a statement. "As a science-based agency, the FDA is remarkable for its lack of introspection, second-guessing, and failure to assess its own performance and capabilities in a systematic way."
Much of the institute's report focused on a central gap in drug regulation: While the FDA demands strict data on efficacy and safety from clinical trials before approving a new drug, less attention is paid after the drug reaches the market.
A safety problem that occurs once in every thousand patients, for example, would be unlikely to show up in clinical studies of a few hundred people, but it could result in thousands of serious side effects once the drug is approved and being taken by millions. The current system for monitoring adverse effects is nowhere near as systematic as the evidence collected before approval, the report said.
Besides, said R. Alta Charo, a panel member and bioethicist at the University of Wisconsin at Madison, patients who participate in drug trials are carefully selected, and hardly typical of patients in the real world who usually suffer from more complex problems.
"A drug tested in a few hundred or thousand people is very different when used by millions, especially over long periods of time and in conjunction with other supplements," she said.
(Excerpt) Read more at washingtonpost.com ...
"The FDA requested the review after the withdrawal of Vioxx in 2004 generated a firestorm of criticism over its drug safety program.
The widely used drug was pulled from the market by manufacturer Merck after a company-sponsored study confirmed that patients taking Vioxx were more likely to suffer heart attacks than those who did not."
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i.e. science is only as good as the political will to do the right thing?
ping
So the solution is to do more testing and add a few more years to the drug approval process? If you thought drugs were already too expensive, you haven't seen anything yet.
FDA should be abolished in favor of a non-profit, independent agency.
Amen to that. Additionally, why do we even bother ? The Europeans seem to get drugs approved faster than the FDA can, so why can't we share data from European drug trials and streamline the whole process ?
That said, there are many drugs that Europe and Canada have had available for some time that probably should be more readily available here. The only real solution is to get politicians out of the decision-making process and empower decision makers that will also have it made clear that they shoulder a huge responsibility that will chew them up and spit them out if they misuse it.
Is this supposed to be humor?
"this sounds more like the federal drug agency is working. the drug was found to have a increased risk after it was released and was recalled..."
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i looked up vioxx on wikipedia (accuracy not guaranteed) to see where things stand. between the observation that "FDA analysts estimated that Vioxx caused between 88,000 and 139,000 heart attacks, 30 to 40 percent of which were probably fatal" and "In 2005, advisory panels in both the U.S. and Canada encouraged the return of rofecoxib to the market, stating that rofecoxib's benefits outweighed the risks for some patients. The FDA advisory panel voted 17-15 to allow the drug to return to the market," i guess it would depend on the definition of "working.":
[Merck publicly announced its voluntary withdrawal of the drug from the market worldwide on September 30, 2004.
In addition to its own studies, on September 23, 2004 Merck apparently received information about new research by the FDA that supported previous findings of increased risk of heart attack among rofecoxib users (Grassley, 2004). FDA analysts estimated that Vioxx caused between 88,000 and 139,000 heart attacks, 30 to 40 percent of which were probably fatal, in the five years the drug was on the market.
On November 5 the medical journal The Lancet published a meta-analysis of the available studies on the safety of rofecoxib (Jüni et al., 2004). The authors concluded that, owing to the known cardiovascular risk, rofecoxib should have been withdrawn several years earlier. The Lancet published an editorial which condemned both Merck and the FDA for the continued availability of rofecoxib from 2000 until the recall. Merck responded by issuing a rebuttal of the Jüni et al. meta-analysis that noted that Juni omitted several studies that showed no increased cardiovascular risk. (Merck & Co., 2004).
In 2005, advisory panels in both the U.S. and Canada encouraged the return of rofecoxib to the market, stating that rofecoxib's benefits outweighed the risks for some patients. The FDA advisory panel voted 17-15 to allow the drug to return to the market despite being found to increase heart risk. The vote in Canada was 12-1, and the Canadian panel noted that the cardiovascular risks from rofecoxib seemed to be no worse than those from ibuprofen[11] -- though the panel recommended that further study was needed for all NSAIDs to fully understand their risk profiles. Notwithstanding these recommendations, Merck has not returned rofecoxib to the market.]
source: http://en.wikipedia.org/wiki/Vioxx
My Neurosurgeon gave me Vioxx to control pain. I specifically asked him if there were any known side effects, as I knew it was fairly new on the market. He said no. Well, Vioxx killed my gall bladder. I had great pain, have expenses from surgery, lost an organ and now have scars. However, since my heart didn't suffer damage, I guess I am not worthy of being included in the class action lawsuit. Makes me sick.
No kidding!
It takes something like 13 years to get a drug approved by the FDA in this country.
Defund the FDA and let a private organization do the job. Problem solved.
agreed. government is the problem, not the solution.
This goes for most things the government interferes with.
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