NCPA - National Center for Policy Analysis


April 6, 2005

Users of the popular eczema medications Elidel and Protopic were stunned by the recent announcement that the Food and Drug Administration now requires the medicines to carry "a strong advisory about a cancer risk." However, there is no real clinical evidence for any association with cancer. The FDA appears to have deployed its "nuclear option" for other reasons, says the Competitive Enterprise Institute (CEI).

The FDA officially based its reasoning for the cancer warning on animal studies that found "the risk of cancer increased as the amount of the drug given increased." Yet the animal studies are hardly convincing:

  • In one study of mice, the researchers found no skin cancer in animals that were exposed for two years to 27 times the normal human dose.
  • A study of monkeys that found cancers increased as the dose increased had the animals given the medicine at even higher levels than the mice.
  • The dose was also administered orally when the medicine is meant for external use only.

The animal data clearly cannot be generalized to typical human use of the products, says CEI.

So, if there is no clinical evidence, why did the FDA choose to deploy the "nuclear option?" The FDA panel's primary concern was over the success of the products in penetrating the market. They were particularly concerned about the aggressive marketing of the product both to physicians and consumers.

By using the "nuclear option," the FDA has undoubtedly created other problems. Some people for whom Elidel was the most appropriate medicine will no longer be prescribed it. And the warning has also opened the door for trial lawyers, creating massive extra liabilities for the drugs companies at the same time as reducing their income and thereby increasing the price of all medication, says CEI.

Source: Iain Murray, "Nuclear Medicine," Competitive Enterprise Institute, April 4, 2005.

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