FDA accused of bypassing clinical trial requirements on several painkillers; licenses for several popular drugs now under review

• 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.