382 



When a firm decides to use a new drug for experimental clinical trials, they 

 have to get from the person to whom they want to ship this drug a statement 

 purporting to show that he is an expert, and why — that he is connected with the 

 principal hospital in a major State, that he has this facility and that facility. And 

 then they have to keep a careful record of whom they shipped it to and how 

 much they shipped.** 



That information, he said "* * * is available to us if we go and ask 

 for it." He added, later on, that "* * * this whole business of drug test- 

 ing has to be a very carefully watched procedure, and a very carefully 

 balanced procedure, because on the one hand you can deny the public 

 drugs for which they have much need for their health and safety, or you 

 can make mistakes in the direction of doing great harm." ^^ 



The FDA also attached importance to the question of pre-natal ef- 

 fects of drugs that might be taken by pregnant women, 



* * * One, [said Commissioner Larrick, in answer to a question] that the drug 

 is specifically offered for pregnant women — each one of the doctors in the New 

 Drug Section pays particular attention to the evidence that it is safe for those 

 women. If it is silent on the question of pregnant women, and it is a drug which, 

 by the very nature of the thing, would be taken by all women, pregnant or not, 

 the New Drug people are requiring a specific statement in the literature to the 

 doctor which says this has not been tested for this purpose. [And later] Food 

 and Drug requires it, on each new drug application.'"' 



The FDA also attached importance to the question of prenatal ef- 

 fects. This policy was in line with a recommendation by the Committee 

 on the Fetus and Newborn, of the American Academy of Pediatrics, 

 which had recommended : 



(1) Existing drugs and agents that are developed in the future for use in the 

 fetus and in infants must be subjected to more extensive preclinical investigation 

 than is being carried out at the present time. 



(2) In order to pursue these principles, it is recommended that drug labeling 

 should specifically indicate the extent of existing information concerning the use 

 of the agent in the fetus and the infant."^ 



Arrangements for the clinical testing of thalidomide were set forth 

 in exhibit 42 of the hearings by Senator Humphrey's Subcommittee on 

 Interagency Coordination in Drug Research and Regulations, under 

 the title '' 'Kevadon Hospital Clinical Program' of the William S. 

 ]Merrell Co." '- This exhibit included a manual which "* * * had been 

 used in connection with a meeting which the firm had held for its em- 

 ployees October 25 and 26, 1960." Objectives of the program, as set 

 forth in the manual, were : 



(1) To contact teaching hospitals (any hospital having a resident-intern train- 

 ing program) and the chief and senior members of the departments of surgery, 

 medicine, anesthesiology, and obstetrics-gynecology for the purpose of selling them 

 on Kevadon and providing them with a clinical supply. 



(2) To eventually accumulate a series of clinical reports on Kevadon's in- 

 dications as they apply within different departments of a hospital. 



(3) To perfect and develop the best iK)ssible detail story for the national 

 introduction of Kevadon. 



The scope of the planned program was to set up "approximately 

 800 established studies, averaging 20 patients per study." Said the man- 

 ual : ""We are principally interested in contacting the most influential 

 physicians who would have occasion to use Kevadon." 



68 Humphrey hearings, op. cit., pt. 1, p. 42. 

 88 Ibid., p. 43. 

 •" Ibid., pp. 44-45. 



Ti "The Effect of Drugs Upon the Fetus and the Infant." Pediatrlca, (October 1961, 

 vol. 28. No. 24), p. 678, reproduced in Ibid., pp. 45-46. 

 '2 Ibid., pt. 1, pp. 259-267. 



