Thalidomide Comes Back

“We will never accept a world with thalidomide in it,” wrote Randolph Warren on July 17, 1998, the day after the US Food and Drug Administration licensed a chemical that had, between 1956 and 1962, caused birth defects in as many as twelve thousand children. Warren heads the Thalidomide Victims’ Association of Canada. He was born with lower-body phocomelia after his mother was given thalidomide for nausea during pregnancy: the bones of his legs failed to develop, leaving his feet to articulate directly with his pelvis. His arms are shorter than usual, and each of his hands has only four fingers. Randolph Warren describes himself as a thalidomider.

The drug was rehabilitated in 1998 to treat a rare but serious condition called erythema nodosum leprosum (ENL), a complication of Hansen’s disease (also known as leprosy). No more than one hundred new cases are diagnosed each year in the US. But in making their intensely controversial decision, FDA regulators were in effect also saying that thalidomide could now be prescribed for unapproved use in many other diseases as a drug of last resort. Endorsement by a US government agency appeared like a betrayal to many thalidomiders. For while other countries had suffered epidemics of birth defects some forty years before, the US had uniquely protected itself from harm through the stubborn integrity of a legendary FDA official, Dr. Frances O. Kelsey, who in the Sixties prevented the FDA from approving the drug.

But it was the FDA itself which, in 1995, invited the manufacturers of thalidomide to look again at a drug that had, in their words, “the capacity to cure.”1 By 1996, an advisory committee set up by the FDA was reconsidering thalidomide’s capacity to cause birth defects. It concluded that if thalidomide was to be licensed, the FDA somehow had to “ensure that no pregnancy occurs while a patient is taking the drug.” In September 1997, the FDA, together with the National Institutes of Health and Centers for Disease Control and Prevention, convened a public workshop to discuss the evidence for and against thalidomide. Randy Warren was an invited speaker, along with Frances Kelsey.

The renewed use of thalidomide was based on the drug’s encouraging effects on patients with AIDS, various cancers, and diseases in which the body’s immune system attacks its own tissues. At the conference Kelsey set out the history of drug regulation in the US, and the way in which the thalidomide scandal helped to bring about more stringent rules for evaluating drugs. Warren spoke about the difficult balance between thalidomiders’ twin fears of unregulated access to the drug and the wider use that would inevitably follow its regulated availability. In his view, the first fear outweighed the second. He supported temporary approval of thalidomide but with several stipulations. The word “thalidomide” should always be used next to any other name for the drug. Patients must be fully informed about side effects. Doctors who prescribed thalidomide must be certified to do so. Research should seek…

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