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.
Painkillers or pain suppressors are actually inhibitors of the inflammatory chemical Cox-2. 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.
In an article published in the JAMA (online Journal of the American Medical Association), the chairman of the Cleveland Clinic Foundation’s Department of Cardiovascular medicine lambasted the companies making these drugs as well as the FDA.
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. This corporate eagerness is to blame for causing a serious health problem in society today.
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.
The research indicates that there was considerable rise in the major cardiovascular problems. The companies responded immediately to the controversy. Pfizer agreed to stop advertising and added a warning of possible heart and blood clotting problems to Bextra’s label. 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. They also warned that naproxen was not to be used for more than 10 days unless prescribed by a doctor. What the FDA does not perhaps know is that half of the arthritis patients also suffer from some heart disease.
A large number of medical scientists insist that clinical trials before launching a formulation should be made mandatory by the FDA.
The FDA will meet along with federal advisors, rheumatologists, cardiologists and agency researchers to review and resolve the issue some time in late January. Their agenda will also consider whether or not drugs like Bextra and Celebrex are to be removed from the market.
Changes at the White House are also going to have some positive effects on FDA. When Congress regroups again, the medical community expects a legislation that will make the FDA better equipped, better funded and better placed to make independent clinical trials of drug safety.
