NCPA - National Center for Policy Analysis


February 25, 2005

The Bush administration recently announced plans to establish a Drug Safety Oversight Board, which will provide data on risks and benefits of drugs after they have been marketed. However, determining the risks of pharmaceutical drugs can be tricky, says the Wall Street Journal.

The FDA has no "single threshold at risk," that leads to the removal of a drug from the market. Instead experts must weigh the benefits of a treatment compared to the risks for certain patients. For example:

  • While Vioxx increases the risk of heart trouble in some patients, it reduces the risk of bleeding ulcers in others, which cause 15,000 deaths per year; in fact, an FDA panel recently approved Vioxx's return to market.
  • Lotrenox, used to treat irritable bowel syndrome, was pulled in 2000 based on the risk of intestinal injuries, but it was returned to market after many patients on the drug suffered relapses and had no suitable alternatives to Letrenox.
  • The breast cancer drug Herceptin increases the risk of heart failure, but clinical trials have shown it extends the life of patients with a specific kind of tumor.

The problem with many drugs is that they are not narrowly targeted to patients whose benefit of use will outweigh their risk. Ira S. Nash of New York's Mount Sinai Medical Center notes that many people took a Cox-2 who didn't need it, some of whom turned out to have heightened risk for heart complications.

Robert Temple, director of the office of medical policy in the FDA's drug center believes that in the future, genetic advancements will allow more "direct therapy," where drugs are targeted to individuals who will benefit most from specific drugs in spite of their risks.

Source: Ron Winslow, "What Makes a Drug Too Risky? There's No Easy Answer," Wall Street Journal, February 16, 2005.

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