388 



days of hearinG:s, 53 witnesses) had been recorded by the House Com- 

 mittee on Interstate and Foreifrn Commerce, chaired by Eepresenta- 

 tive Harris: and Senator Humphrey had accumulated 774 paires of 

 testimony and exhibits (2 days, 10 v/itnesses'l on the management of 

 the investigative phase of thalidomide in the United States. (His Sub- 

 committee on Reor.o'anization and International Orfjanizations of the 

 Committee on Government Operations would continue its agency 

 coordination study, throus-h further hearinsrs in 1963, totaling; 3,228 

 paofes of documentation, and would issue its final report May 5. 196(1.) 



There was abundant evidence as to the need for strenjithened legis- 

 lation to control the management of prescription drufjs in the United 

 States. There was also a considerable consensus— amone: physicians, 

 the pharmaceutical manufacturers, and their respective associations — 

 as to specific provisions the leffislation should contain. A major diffi- 

 culty, however, lay in the fact that the initial sponsor, Senator Kefau- 

 ver, had sought to combine druT and medical reform with economic 

 reform. The Administration had be«n content to focus on the issue of 

 drug safety and efficacy, gi^nng almost no attention to the price and 

 monopoly issues. 



The various hearings presented many indications of interactions 

 and conflicts between ]orofessional motives of medical health and eco- 

 nomic motives of profit and competitive advantage. It might well have 

 appeared to Senator Kefauver and his associates that part of the 

 motivation for (or at least, acquiescence in) commercial promotion of 

 drugs with insufficient attention given to formal requirements of drug 

 safety lay in the highly profitalile nature of the drug industry. How- 

 ever, this emphasis tended to create an adversars^ atmosphere in the 

 Kefauver hearings, and to divert attention from the very consider- 

 able consensus on the fundamental requirements for drug safety. The 

 latter set of correctives might perhaps have been regarded as useful 

 to provide a "coattail" effect, to win congressional acceptance of the 

 economic reforms. However, there were inherent difficulties in combin- 

 ing these two sets of legislative actions. The combining of them 

 threatened to jeopardize acceptance of any legislation, it intensified 

 the complexity of an already nearly unmanageable problem, multiplied 

 the separate issues, and superimposed economic significance on issues 

 in which there was sometimes no technical agreement among phy- 

 sicians themselves. Among the issues that emerged from the various 

 hearings, the following aspects of medical health and safety seem to 

 have been particularly salient : 



1. The equivalence of generic drugs from various drug houses: 



2. The amenability of the drug industry to control by the application of the 

 free enterprise methods of profit and competition : 



3. The desirability of a limitless num.ber of additional drugs, differing in 

 greater or less degree from those already available : 



4. The competence of the practicing physician to judge for all his patients 

 the efficacy, safety, and economy of any particular drug, and to decide on the 

 trade-offs among these factors in view of — 



Numbers of innovative drugs with minor differences ; 



Numbers of detail men from drug houses ; 



Numbers of tests, each inherently partial, of variant drags: 



Volume of information about medicine, and the need for specialization ; 



Increased pressures by patients to participate in diagnosis and treatment ; 



Pressures on physicians to work with brand names ; 



Tendency to associate drug quality with brand or drug house; and 



Pressure on drug houses to expand and develop new markets. 



