Abroad at Home; Reform Or Wreck?
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In 1960 the Food and Drug Administration received an application to market in this country a tranquilizer called Thalidomide, said to induce calm and sleep with no side effects. Described as a miracle drug, it had been on sale in Europe for two years. Dr. Frances Kelsey of the F.D.A. was given the application to review. She was cautious because Thalidomide had an unusual chemical structure. She asked the Merrell Company, which wanted to market it, for more information. Early in 1961 Dr. Kelsey saw in a British medical journal a doctor’s letter saying that patients who had used Thalidomide for a long time developed a nerve inflammation in their fingers. She wondered whether fetuses would be similarly affected if pregnant women took the drug. She asked more questions, irritating Merrell officials. Over the previous year or two a strange medical phenomenon had appeared in West Germany and Britain. Children were born with grotesque deformities, lacking arms and legs. No one knew the reason. Then, in November 1961, a German doctor traced the cause to Thalidomide. Women who took the drug early in pregnancy were liable to have deformed children. Thalidomide was withdrawn from the market. An estimated 10,000 deformed children were born in Europe and elsewhere because of Thalidomide. But except for one trial distribution, the drug was kept out of the United States — kept out by a skeptical, determined F.D.A. doctor who was denounced, Morton Mintz of The Washington Post wrote at the time, as “a bureaucratic nitpicker.” If Newt Gingrich and his supporters have their way, no F.D.A. doctor like Frances Kelsey will again be able to block distribution of a drug like Thalidomide. For the F.D.A. is a prime target of the radical Republicans. Speaker Gingrich has described the F.D.A. as “the leading job-killer in America.” That encapsulates a right-wing view that delay in approving new drugs and medical devices is hurting American manufacturers. More : query.nytimes.com |