403 



The criteria of merit are relative for all these different sets of 

 parameters. 



A single criterion sometimes rises up as salient as was the case 

 with sulfanilamide in 1938, and thalidomide in 1962. Social or political 

 actions to rectify gaps or spur lagging parts of the total effort do 

 not appear to arise in response to scientifically determined needs, 

 but in response to the shock of recognition of real danger to high 

 social values. This is perhaps mainly because the values themselves 

 are not clearly arranged in any generally accepted scientific hierarchy, 

 such as that a degree of miprovement in one value, such as reduc- 

 tion in mtensity of pain, is comparable with a degree of improve- 

 ment in another, such as rate of recuperation or healing. In short, 

 operationally the goals of medicine are seen as corrective, rather 

 than progressive. This state of affairs does not seem likely to change 

 until specific national goals are formulated, agreed to, and made in- 

 strumental in the field of medicine. Possibly this suggests the need for 

 a study group or institution to look at medical organization in the 

 United States in its entirety, relative to national goals of health — or, 

 in a broader sense, at the arrangements for adapting persons in the 

 United States to their environment. National goals of health may in- 

 deed be best achieved by more emphasis on improving and adjusting 

 the environment to man (with his limited capability for adjustment 

 to his environment) rather than by relying so heavily on the use of 

 drugs and related medical strategies for adapting man to his environ- 

 ment. It is evident that the field is one in which values are deeply 

 held, strongly expressed, and far from consensual. Objectivity is no- 

 where more needed, and more difficult to preserve. Decisions as to 

 whether, on balance, a drug is meritorious involve the exercise of the 

 highest degi'ee of judiciousness, coupled with the systematic accumula- 

 tion and evaluation of data generated under rigorously controlled 

 circumstances. Ultimately, it is not possible to make such decisions 

 without reference to the total question of the purpose of medicine. 

 In this area, the formulation of national policy is perhaps at its most 

 difficult. 



At the very least, it can be observed that in view of the cost in time 

 and effort to produce the tens of thousands of pages and uncounted 

 thousands of man-days of congressional and professional effort re- 

 quired to produce the Kefauver-Harris bill, this arduous process can 

 be employed only sparingly and for the resolution of grave and mo- 

 mentous questions. It would seem advantageous, also, to clear away 

 the technical underbrush and to structure the issue with clarity, pre- 

 cision, and objectivity, before subjecting it to the ultimate processes 

 of congressional resolution. 



