378 



risk. In Germany, the question was "resolved" by requiring that it be 

 decided in each individual case by a physician in attendance — in other 

 words, by placing the drug under prescription. As Dr. Taussig said : 



In April 1961, a new form of polyneuritis appeared : tingling of the hands, 

 sensory disturbance, and later, atrophy of the thumb and motor disturbances. 

 It was soon recognized that the long continued use of Contergan in adults was 

 responsible for polyneuritis; furthermore, unless the drug was promptly dis- 

 continued, the polyneuritis was irreversible. Thereafter, the drug was placed 

 upon prescription.'* 



Medical determination that thalidomide was associated with pho- 

 comelia 



A more seridus side effect of thalidomide gradually came to light 

 during 1961-62, when statistically significant evidence was developed 

 indicating that when the drug was taken during the first 3 months 

 of pregnancy there was as much as a 50-,50 chance (elsewhere, more 

 than two chances in five) that the child would be deformed. The mech- 

 anism causing the deformity was not characterized at this time; it 

 was suggested that the action of the drug was not positive, but indirect, 

 because some expectant mothers exposed to the hazard were delivered 

 of normal offspring. The tentative conclusion appears to have been 

 that thalidomide was coupled with some fairly common genetic char- 

 acteristic to bring about phocomelia. 



The incidence of phocomelia occurred at different periods in different 

 countries, depending on the availability of the dnug to expectant 

 mothers. Its effects were first evident in Germany, where the drug first 

 came on the market. In retrospect, the medical profession seems to 

 have been slow to appreciate the importance of this new disorder. 

 There had been "perhaps a dozen cases of phocomelia in 1959, whereas 

 in the preceding decade there had been perhaps 1,5 in all of West Ger- 

 many." The numbers increased rapidly thereafter. 



During 1960 almost every pediatric clinic in West Germany had seen infants 

 suffering such defects. In Miinster there had been 27, in Hamburg 30, and in 

 Bonn 19. 



In October 1960, at the annual meeting of the pediatricians of the 

 Federal Republic of Germany, at Kassel, two extreme cases of phoco- 

 melia were the subject of an exhibit. The physicians who presented this 

 exhibit "regarded it as a new clinical entity." Despite the considerable 

 incidence of phocomelia in Germany during the preceding months, 

 "the exhibit did not attract a great deal of attention." 



When the German pediatricians gathered at Diisseldorf for their 

 1961 meeting. November 20, "almost all pediatricians were aware of 

 the outbreak of phocomelia." Indeed, "almost every clinic in West Ger- 

 many had admitted three times as many such infants in 1961 as in 1960. 



^ Helen B. Taussig, M.D. "A Study of the German Outbreak of Phocomelia." op. cit.. in 

 Humphrey hearingrs, op. cit.. pt. 1, p. 103. Apparently Dr. Taussig's referencp to the "new" 

 form of polyneuritis was not Intended to differentiate it from the form reported in England ; 

 however, her description of its symptoms and prognosis indicate that it was somewhat 

 more serious than the earlier English accounts had suggested. 



