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Vioxx Problems Known Years Before Recall
Date:11/23/2009

ally effective therapeutics, a system must be established that makes full use of all existing evidence."

A similar drug, Bextra, was also pulled from the market for safety concerns, but Celebrex, a drug in the same class as Vioxx, remains available.

Dr. Steven E. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic and one of the early watchdogs of Vioxx, hailed the findings. "This remarkable manuscript provides compelling evidence that the adverse cardiovascular effects of rofecoxib could have been detected several years prior to the withdrawal of the drug."

The findings highlight the need for major changes in the current system for development, approval, promotion and post-marketing surveillance of drugs in the United States, he added.

"We need full transparency in the reporting of adverse events observed during development and early usage of all drugs, but particularly for new molecular entities such as rofecoxib," Nissen said. "Selective publication of favorable findings have repeatedly concealed serious safety risks."

"Aggressive marketing, through industry-sponsored Continuing Medical Education and direct-to-consumer advertising, have facilitated overuse of new agents before their full benefits and risks could be assessed," he added. "Finally, a weak system for post-marketing surveillance has allowed unsafe medications to remain on the market long after evidence of an unfavorable risk-benefit relationship might have been detected.

Since the Vioxx episode, the FDA has tightened some requirements. As of 2007, results of clinical trials must be posted on an FDA Web site within a year of a trial's conclusion.

Still more is needed, experts like Nissen believe. "It is an unfortunate legacy of the Vioxx debacle that the problems that led to this public health catastrophe remain unresolved," Nissen said. "Sadly, this could happen again."

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