Regulation Policy

The FDA's Thalidomide Record

When a German scientist identified the risks of birth defects due to Thalidomide some 40 years ago, the Food and Drug Administration congratulated itself for its failure to approve sales of the drug in the U.S. But those familiar with the case say the FDA had literally done nothing. A junior official at the agency had simply dawdled over the drug manufacturer's application, thus delaying approval.

Now the agency has approved sale of the drug for use only in leprosy treatments, of which there are only some 50 cases a year nationwide.

But there could be enormous benefits from Thalidomide for treating a host of other conditions.

  • It is thought that Thalidomide injures fetuses by halting the proliferation of blood vessels -- an effect that also shows tremendous promise for starving malignant tumors.

  • It also holds great promise for the treatment of macular degeneration in the eye, and in the treatment of brain and breast cancer.

  • Since it also powerfully affects the immune system, it might be useful in AIDS patients.

  • While the manufacturer is forbidden to publicize these other possible uses, doctors are technically free to prescribe Thalidomide as they see fit.

Those who understand the approval process contend that if Thalidomide proves successful in combating these other conditions, the successes won't make it onto the label for years, if ever.

They say the agency has executed a deft political move. It has taken responsibility for the outcomes of a minute number of leprosy cases, while avoiding responsibility for the thousands of "off label" prescriptions it full well knows will follow. Meanwhile, people who might have benefited from Thalidomide treatments will die through ignorance of the drug's potential saving powers.

Source: Peter Huber (Manhattan Institute), "FDA Caution Can Be Deadly, Too," Wall Street Journal, July 24, 1998.

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