380 



syndrome continued to obscure the magnitude of the disaster; these 

 were : 



Wide availability of the drug without prescription or record of 

 use. 



Absence of formal arrangements for the recording of births of 

 abnormal infants. 



IJeluctance of parents to reveal infant abnormality. 

 Unprecedented medical character of the disaster. 

 Timelag between cause and effect. 

 Apparently innocuous nature of the cause. 



The \ariety of diiferent brand names and mixtures associated 

 with the drug. 



The absence of systematic national or international warning- 

 system. 



The possibility that there were (and are) other causes of fetal 

 abnormality than thalidomide, and the fact that thalidomide did 

 not invariably cause abnormality even when taken in the "sensitive 

 period"' of fetal development.^^ 

 Numbers of cases are not meaningful by themselves because the ex- 

 tent of injury varied from minor to total. Apparently, about one-third 

 of the deformed infants did not survive. However, the extent of phys- 

 ical and emotional wreckage that resulted was widespread.'^" 



Fortunate exclusion of thalidomide from U.S. markets 



An application for approval of "Kevadon" (the United States and 

 Canadian name for thalidomide) as a new drug was received by the 

 Food and Drug Administration from the "William S. Merrell Co., 

 September 12, 1960. Tlie application was assigned to Frances O. Kelsey, 

 M.D., of the FDA staff for processing. It was her first assignment. The 

 application would receive automatic approval in 60 days— on Novem- 

 ber 13, 1960 — if not previously acted upon. However, FDA could re- 

 turn the application on grounds of "insufficient data" which would 

 have the effect of delaying the beginning of the 60-day period. Dr. 

 Kelsey repeatedly exercised this option, which distressed the applicant. 

 From the company's point of view, a drug in common use in other 

 countries without any reported adverse side reactions was being 

 arbitrarily blocked by bureaucratic officiousness. Later on, however, 

 the company would have reason to be extremely grateful for this de- 

 laying action which was to save countless lives, prevent an epidemic 

 of phocomelia of untoward proportions, and obviate the possibility of 

 financial liability in the millions, even billions, of dollars. 



Dr. Kelsey was later to explain that her repeated requests to the 

 company for further information were motivated by the fact that 

 thalidomide in the body "* * * behaved rather differently from other 

 drugs that were rather closely related ; and furthermore, animal studies 

 did not parallel human experience." ^^ When she learned, by chance, of 

 the first British report of peripheral neuritis, early in 1961 (from the 



•« This sensitive period was deflned as "between the 28th day and the 42d day Onclnsive) 

 after conception or the .^Oth to the 60th day after the first day of the last menstrnal period." 

 (Helen B. Taussisr. M.D. "Medical Intellisrence." New England Journal of Medicine (July 

 11, 10(53). pp. 02-94. Reprinted in Humphrey hearings, op. cit.. pt. 4. p. 1020.) 



«= Newsweek magazine reported (Mar. 4, 1968), p. 80, that "of the .5.000 thalidomide 

 babies born in Germany only about 2,600 are alive today. There are about 400 Knglisl] tlialid- 

 omide children still living." The article describes some of the prosthetic technology being 

 devised to alleviate their physical incapacity. 



83 Humphrey hearings, op. cit., pt. 1, p. 15. 



