367 



University Hospital and the District of Columbia General Hospital, 

 and past president of the Diabetes Association of the District of Co- 

 lumbia. Dr. Loube reported the results of an analysis of 15 volumes of 

 case studies submitted to FDA by the company producing chlorpro- 

 pamide. He concluded that the drug had been effective in some cases 

 (excellent control in 196 and good in 123, of a total of 41o cases exam- 

 ined) . He oifered it as his personal opinion that both tolbutamide and 

 chlorpropamide represented "valuable additions to our therapeutic 

 armamentarium in the management of diabetes." The side effects of 

 chlorpropamide were not "prohibitive of the effective use of this medi- 

 cation when properly administered." However, its side effects were 

 "distinctly of sufficient importance to be carefully brought to the atten- 

 tion of any physician who plans to use chlorpropamide * * *." ^^ 



Preceding Dr. Dolger's appearance that had triggered the episode, 

 the subcommittee had taken testimony from Dr. Alexander Marble of 

 Boston, associated with the Joslin Clinic, specializing in diabetes. He 

 had observed that tolbutamide had been "remarkably free from im- 

 portant side effects," but that the "position of chlorpropamide had 

 been diffidult to evaluate." Dr. Marble deplored the paucity of "exact 

 data as to the total number of cases (of jaundice induced by the 

 drug)." He concluded: 



Because of this initial success, it can be confidently predicted that as time goes 

 on new and different oral hypoglycemic agents will he developed and introduced. 

 With regard to each new compound as it appears, the physician must always ask 

 the two questions mentioned earlier: (1) Does it work? (2) Is it safe? In the 

 present age when advances are being made with such rapidity in the synthesis of 

 new compounds which have a variety of effects in the body, it is imperative that 

 all concerned use great caution in employing new agents in human beings. 

 Chemical agents must first be evaluated thoroughly in animals. On the other 

 hand, the application of knowledge gained in the laboratory and the cautious 

 trial of new drugs in human patients must continue if advances in therapy are 

 to be made.^ 



The need for strengthening of arrangements for drug evaluation 



One of the last witnesses to appear before the subcommittee was Dr. 

 Maxwell Finland, associate professor of medicine at Harvard Medical 

 School. He suggested that there was a need for a more thorough, sys- 

 tematic, and objective arrangement for the testing and evaluation of 

 drugs before their admission to general use. It was evident, he said, 

 that "the evaluation of new therapeutic agents must be in the hands of 

 individuals who are as competent, well trained, and well motivated as 

 those engaged in any other research ventures and that they are as likely 

 to tjurn up new fundamental findings as others with equal skills, but 

 they are also more certain to provide useful results of immediate im- 

 portance." He testified that he had tried to interest both the National 

 Research Council and the drug industry "to set up subcommittees or 

 panels in different medical areas for the independent evaluation of 

 drugs, supported from funds provided either by the pharmaceutical 

 industry as a whole, or by governmental or other nonprofit agencies 

 but not tied to individual products or firms." ^4 



An alternative approach might be the creation of study sections 

 under the National Institutes of Health to fund testing centers, where 

 there would be "an adequate supply of clinical materials, proper staff, 

 and the necessary backgi'ound for such activities." 



»Ibld., pp. 11185, 11326. 



S3 Ibid., p. 11138. 



2* Ibid., pt. 24, p. 13932. 



