402 



drug characteristics. There was also a general public, and possibly also 

 professional, education as to the dangers as well as the values of 

 prescription drugs : leading to awareness of the need for improved 

 social management of drug usage, and awareness that small concentra- 

 tions of chemicals in the environment, over long periods of time, can 

 have subtle but possibly dangerous effects on mankind. 



Some important questions central to thalidomide appear to remain 

 unanswered, however, in spite of the vigorous legislative and adminis- 

 trative efforts at correction. Eventually an apparently satisfactory 

 solution must be found to the thorny issue of "human guinea pigs," 

 necessary for the testing of new drugs, and to w^hat extent there 

 should be unrestricted resort to this process without the justification of 

 an expectation of significant addition to medical capabilities.^^'' 



Unrestricted freedom of research in developing new drugs involves 

 specific risks, not by those conducting it but by those who happen by 

 accident to be appropriate subjects; moreover, the reward for success 

 does not seem related either to those who perform the research or run 

 its risks. 



Another issue is that of the choice between a high degree of free- 

 dom of enterprise (with self-regulation by industry) in the develop- 

 ment, testing, promotion, and sale of prescription drugs^ versus a high 

 degree of bureaucratic control of these activities. What combination 

 of free enterprise and Government control best serves to optimize 

 social and health values? Wliat form of management of drug control 

 is calculated to enable the physician to serve the patient best ? Broadly 

 speaking, drug control and management aims at an optimum balance 

 of progress toward patient safety, medical effectiveness, medical con- 

 venience, least cost, and political acceptability of the system. It does 

 not appear that any of these aspects can be stressed at the expense of 

 the others — or ignored in the process of considering the others. It is 

 also apparent that achievement of a perfect and steady state in any of 

 these aspects is not feasible. 



Moreover, drug management is not itself a final or ultimate goal, 

 but rather one of many means employed by the medical profession to- 

 ward the achievement of some measure of progress toward the remote 

 and unattainable goal of making man compatil^le with his en\dron- 

 ment. The goal is unattainable because man is not himself in a "steady 

 state," biologically speaking. His genetic heritage changes in the 

 course of time and every generation encounters its own medical prob- 

 lems. Moreover, the environment of man changes as the human cul- 

 ture and its artifacts change — with new micro and macro insults to 

 the environment. The biological response of man, himself changing, to 

 these environmental changes, generates a never-ending problem for 

 the physician. The safety and efficacy of drugs, as one of many medical 

 tools, must be considered in this changing context. The multiplicity of 

 drugs with their infinity of purposes, degrees of merit, and ranges of 

 hazards, is merely one more complicating factor in the total problem. 



"9 An amendment to the Kefauver-Harris bill attempted to deal with this problem in this 

 language : (FDA) regulations shall provide * * * that experts using such drugs for in- 

 vestigational purposes * * * will inform any human beings (used as drug sub.iects) and 

 will obtain the consent of such human beings or their representatives, except where they 

 deem it not feasible or * * * contrary to the best interests of such human beings. Public 

 Law 87-781, sec. 505 (i). Subsequentlv the amendment was administratively interpreted by 

 FDA rulings and public policy memoranda from the Office of the Surgeon General. See 

 Dr. Freeman H. Quimby. Medical Experimentation on Human Beings. Library of Congress. 

 SP 151, Apr. 24, 1968. 



