NCPA - National Center for Policy Analysis


January 5, 2005

Simply banning drugs is not the answer to reducing risk, says USA Today. In fact, all-out bans on drugs such as Celebrex may save a few lives but will likely subject many more patients to pain, disability and even premature death.

The real issue is the Food & Drug Administration's competency in monitoring new drugs. While changes in the FDA's approval processes are urgently needed, patients who benefit from drugs that carry potential risks should not be denied them. For example:

  • A recent study indicates that Celebrex increases the risk of heart attack and stroke, but previous studies showed the opposite; furthermore, another study indicates that Celebrex poses fewer risks than over-the-counter naproxen (Aleve).
  • If Celebrex was pulled from the market, many patients who suffer the pain of arthritis would have to switch to other medications which may increase their risk for bleeding ulcers, which result in about 16,000 deaths per year.

Moreover, overreaction to risks causes harm to patients by:

  • Delaying the approval process for drugs that carry certain risks but also bring significant, life-saving benefits to patients.
  • Distorting the level of risk; for example, the recent link between naproxen and cardiac risk is based on fewer than 3 percent of 2,500 elderly patients suffering heart attacks or strokes.
  • Jeopardizing patient health; for example, antidepressants are associated with an increased suicide risk in children, but they have also reduced suicide rates in 15 nations by over 30 percent.

Instead of complete bans, the FDA might consider restricted uses on drugs that provide overwhelming benefits compared to marginal risks. After all, no drug is completely risk-free.

Meanwhile, patients and doctors should be the ultimate decision makers in whether the cardiac risk of Celebrex outweighs its benefits, says USA Today.

Source: Editorial, "The Vioxx/Celebrex Dilemma: Who Should Take the Risk?" USA Today, December 27, 2004.


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