Summary
A Cleveland area doctor claims the U.S. Food and Drug Administration approved several new pain killers before proper clinical studies had been conducted. As a result, the licenses for Vioxx, Celebrex, Aleve and Bextra, all heavily marketed to arthritis patients, are under review. Studies indicate that the drugs may be linked to increased heart disease.
Original source:
http://www.earthtimes.org/articles/show/1025.html
Details
The Food and Drug Administration of the U.S. found itself in the midst of a rather unpleasant controversy.
Recently the chief of Cleveland Clinic Foundation's Department of Cardiovascular Medicine blamed FDA for failing to insist on proper in-depth clinical trials before allowing licenses to few painkiller formulations.
The drugs Vioxx, Celebrex, Aleve and Bextra are aggressively advertised as pain relievers for arthritis patients.
However, a recent study has hinted that these popular drugs were responsible for increased cardiovascular problems.
Clinical study pinpointed Vioxx and Celebrex, are linked to increased heart troubles.
The third, Bextra, has also been associated with increased heart risks.
The blame rested largely with the FDA for allowing such formulations to be sold in the market without proper warnings on them.
These formulations were mass-marketed with a very unrealistic projection of their benefits.
Aggressive advertising was also blamed for the escalated public health risk posed by these drugs.
Consumers, usually arthritic patients, were lured by unrealistic expectations about pain relief and for better gastrointestinal conditions.
He pointed out that these companies did not wait for a sufficient warning period after approval and launched their products in the market with simultaneous multi-media, mega-bucks advertising campaigns.
Merck & Co. are reported to have spent $68.5 million to advertise their Vioxx, while Pfizer's had spent was $77.8 million on its Celebrex.
Bayer had poured $42.9 million for advertising Aleve, their OTC painkiller formulation known as naproxen in medical circle.
Merck called back its drug Vioxx from the market.
The
FDA also stepped up, last week, urging consumers who had a history or risk of heart problems to avoid using these pain killers.
A large number of medical scientists insist that clinical trials before launching a formulation should be made mandatory by the FDA.
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Thursday, January 20, 2005
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