377 



man drug in 1960. Up to that time the drug had had some 5 years (or 

 at least, three) of experimental testing and 3 years or more of wide 

 commercial use without reported incident. In some countries, including 

 Germany for 15 months, it had not even required prescription. Ac- 

 cording to Dr. Taussig, "at that time no one had reported any out- 

 ward side effects from thalidomide," ^^ j^ fact, later on, one of the 

 difficulties encountered by investigators who tried to identify some 

 drug as the cause of phocomelia, was that mothers of afflicted offspring 

 did not remember having taken Contergan (the German brand of 

 thalidomide) ; it was of no more consequence or more memorable 

 than aspirin. It had been available (up to April 1961) without pre- 

 scription. Moreover, ". . . nurses in German hospitals dispense sleep- 

 ing tablets as freely as nurses in the United States give laxatives." =* 

 There was no reason to suppose it to be anything other than a safe, 

 efficacious drug with no known side effects, and one that could properly 

 be sold very widely with a minimum of control. In short, a highly 

 profitable and useful product. 



E%rly evidences of thalidomide side ejfects 



Xo indication of adverse side effects of thalidomide appear to have 

 been reported, according to Dr. Taussig, until the latter part of 1960, 

 when German medical journals carried reports of a "new polyneuritis 

 associated with long-term use of the drug." ^^ At about this same time, 

 a letter to the editor of the British Medical Journal described four 

 parallel cases, all of whom had taken 100 mg. of Distaval (the British 

 brand of thalidomide) daily for 18 months to 2 years. Symptoms in- 

 cluded tingling and coldness of feet and hands, impaired muscular 

 coordination, and nightly leg cramps. The symptoms apparently dis- 

 appeared when the drug was suspended.^*' 



A representative of the clinical research departm^ent of the British 

 drug company producing Distaval responded, in a later issue of the 

 same journal, to say that on the basis of 4 years of clinical investiga- 

 tions there had been no indication, from either animal experimental 

 work or human clinical studies, to indicate "any significant toxic 

 hazard." However, early in 1960, "isolated reports were sent to [the 

 company representative] from various parts of the country describing 

 symptoms and signs suggestive of peripheral neuritis occurring in 

 patients receiving thalidomide regularly for periods of 6 months or 

 more." "^^^lile thalidomide had not been confirmed as the cause, the 

 writer went on, the company had been including warning informa- 

 tion about the possibility of this undesirable side effect in its literature 

 since August of 1960.^^ 



As time went on, apparently, this side effect was regarded by the 

 medical profession in Europe with increasing apprehension. The ques- 

 tion implicit in this concern (which was recorded explicitly in the 

 American re\aew of the drug's safety at about this time) was as to 

 whether the drug's contribution to human comfort and well-being 

 was enough to justify an evident but imperfectly defined medical 



" Helen B. Taussig, M.D. "The ThaUdomlde Syndrome," Scientific American, (August 

 1962. vol. 207, No. 2), pp. 29-35. Reprinted in Humphrey hearings, op. cit., pt. 1, p. 110. 



=*Ibid., p. 112. 



«Ibid., p. 110. 



6« British Medical Journal. (Dec. 31, 1960), p. 1954. Reprinted in Humphrey hearings, 

 op. cit., pt. 1. pp. 17-18. 



=*' British Medical Journal, (Jan. 14, 1961), p. 130. Reprinted in Humphrey hearings, 

 op. cit., pt. 1, p. 18. 



