Thalidomide and Leprosy: Did the FDA Err in 1961?

¶ … Thalidomide Although the United States succeeded in averting the same thalidomide tragedy that occurred in Europe by refusing to approve the drug, some observers counter that the action introduced unnecessary delays in the approval of many useful drugs. Given that thalidomide is now accepted as an effective treatment for leprosy, this paper provides an evaluation concerning whether Dr. Frances Kelsey was correct in stopping the development of thalidomide in the United States in 1960, followed by a summary of the research and important findings in the conclusion.

In 1961, two doctors working independently in Australia and Germany determined that thalidomide, a sedative and n anti-nausea drug that was being prescribed for pregnant women, was responsible for a wave of birth defects (Carpenter, 2010). Based on their analysis of the available data concerning thalidomide, the two physicians, Drs. McBridge and Lenz, determined that thalidomide caused birth defects when taken during the first trimester of pregnancy (Carpenter, 2010).

In this regard, Carpenter reports that, "Tragically, thousands of pregnant women had taken thalidomide during this window of pregnancy because of its utility as an anti-nausea drug" (2010, p. 240). Besides the dozens of high-profile physical deformities caused by thalidomide, there were additional uncounted thousands who suffered from brain and internal organ damage (Carpenter, 2010). In addition, the actual number of women who experienced stillbirths as a result of taking thalidomide have never been determined (Carpenter, 2010).

In addition, Brown (2009) estimates that approximately 10,000 infants had been born with severe limb malformations by 1961 to women who took thalidomide during their pregnancies and countless more were aborted. Following the two physician's warnings, the drug was recalled from European markets by the European drug manufacturer; however, the U.S. pharmaceutical company, Merrell, continued to press its claims for approval of thalidomide to Dr.

Frances Kelsey, a medical officer with the Food & Drug Administration, that the mounting evidence from Europe was erroneous with respect to the birth abnormalities and the drug should still be approved in the United States (Carpenter, 2010). According to Carpenter, "Kelsey rejected this assertion and again imposed the burden of proof upon Merrell. As the stories became more numerous and as the link between drug and defects became clearer, Merrell quietly withdrew the new drug application in March 1962" (2010, p. 240).

Consequently, while more than a million of doses of thalidomide were being taken by pregnant women in West Germany in 1960, expecting mothers and their unborn children in the United States were protected from the ravages of this drug by the actions of Dr. Kelsey. Following several decades of additional research with thalidomide, the FDA announced that it would approve the drug for the treatment of erythema nodosum leprosum, a type of dermatological complication resulting from leprosy, or Hansen's disease (Annas & Elias, 1999).

As a result, thalidomide is once again available but new laws concerning its use are believed to be adequate for protecting women from the same nightmarish outcomes that were experienced during the early 1960s (Annas & Elias, 1999). In addition, researchers are investigating thalidomide's potential for treating inflammatory lung diseases (Brown, 2009). Conclusion Tens of millions of American baby boomer parents owe.