DRUG SAFETY: Docs Call For Watchdog Panel

      Writing in today's New England Journal of Medicine, a group of doctors calls for the creation of an independent panel to monitor the ongoing safety and effectiveness of drugs approved by the Food and Drug Administration. Reporting to the panel would be mandatory. Despite the fact that adverse drug reactions are one of the six leading causes of death in the country, once a drug is approved, neither patients nor pharmaceutical companies currently are required to report adverse reactions to the FDA (Reuters Health, 12/16). Lead author Raymond Woosley of Georgetown University Medical Center and colleagues note that only "one in 100 serious reactions ever gets reported."

Conflict Of Interest
      The FDA, Woosley and colleagues argue, is not the best choice as a patient advocate once a drug has been approved. They write, "When things go wrong, you don't want to go to the agency and say, 'Now, you put this drug on the market, did you kill someone? Did you make a mistake?'" (Rubin, USA Today, 12/16). The authors call for an independent panel modeled after the National Transportation Safety Board, "which investigates airline accidents and can find fault with the airline or with the standards of the Federal Aviation Administration and suggest changes when necessary." In addition to monitoring drug safety, the panel envisioned by the authors could also compare a drug's effectiveness to other available treatments Reuters Health, 12/16).

Over My Dead Body
      Recent rumblings in Congress and in the medical profession lead Woosley to speculate that "the climate is right to seriously consider the idea." The Journal of the American Medical Association reported this year that adverse drug reactions are a leading cause of death, and an editorial called for creation of a new FDA safety monitoring board. Further, the FDA has had to pull several drugs from the market this year for safety reasons. On Capitol Hill, three members of Congress commissioned the General Accounting Office to study how drug safety is regulated. Democratic aides, however, said an independent panel "wasn't likely, given the GOP's animosity toward the FDA." Though the National Academy of Sciences has been calling for an independent board since 1970 and "a congressional commission echoed that call" ten years later, the creation of a safety panel has faced staunch opposition both from drugmakers and the FDA. The FDA insists its reviewers can safely "monitor products once they are on the market." Alan Holmer, president of the Pharmaceutical Research and Manufacturers of America, said, "We oppose the creation of a second bureaucracy to duplicate the good work of the FDA" (Sharpe, Wall Street Journal, 12/16). Click here to read the entire NEJM article.