CHAPTER FOURTEEN— THALIDOMIDE: THE COMPLEX 

 PROBLEM OF DRUG CONTROL IN A FREE MARKET 



I. Introduction 



In an earlier chapter the generalization was oifered that all applied 

 research aims to improve the compatibility between man and his en- 

 vironment. The unic|ue quality of applied research in the fields of 

 medicine and drugs is that it aims to improve this compatibility by 

 altering man himself. The subject of this chapter is the case history of 

 tlie thalidomide episode, 1961-62, which concerned a drug that made 

 modest contributions to general human compatibility with environ- 

 ment, but at a cost of selective but extremely grave incompatibilitj^ to 

 some. The purpose of the study is to ascertain how information about 

 this defective drug came to the Congress, and what responses were 

 elicited by the information. 



The thalidomide case involves a drug whose purpose was to over- 

 come the relatively minor physiological inconveniences of insomnia and 

 morning sickness. Its defect was that under some circumstances it 

 produced delayed side effects of tragic and disastrous magnitude: in 

 particular, it inhibited the formation and growth of arms and legs of 

 unborn children. Longstanding methods of drug testing had not 

 brought to light these adverse consequences, which were functionally 

 related to the circumstances under which it was used. These conse- 

 quences were not discovered until the drug had been introduced into 

 wide commercial and prescription usage, both by itself and as an in- 

 gredient in drug mixtures.^ 



Owing to a chain of fortunate circumstances, the United States 

 escaped almost unscathed from the consequences of the drug. How- 

 ever, the narrow escape was well publicized, and served to dramatize 

 the need for strengthening public control over procedures for the 

 introduction of new drugs into use. 



Medical and "phai^maceuticaX ethics in a free enterprise economy 



Intractably complex and virtually unresolvable issues are raised 

 in the political consideration of the control of biochemical prescrip- 

 tions for sickness, or for the control over management and procedures 

 in the drug industry. Various attempts, over the years, have been 

 made to find a political solution to the contradictions growing out 



1 Once a drug has entered general use, its incorporation into other drugs can be extensive. 

 Later hearings showed that this had happened with thalidomide. Eventually, it was found 

 to be available in drugstores (with or without prescription) under different names and 

 in different mixtures aggregating 100 or more forms. It is not evident that any of these 

 forms were obtainable in the United States, but it is established that they were widely dis- 

 tributed elsewhere, and might come to the United States through nonmedical channels. For 

 a discussion of this problem, see U.S. Congress. Senate Committee on Government Opera- 

 tions. Interagency drug coordination. Report of the » * * made by its former Subcommittee 

 on Reorganization and International Organizations, pursuant to S. Res. 27, 8Sth Cong., as 

 amended, extended by S. Res. 288, 88th Cong., resolutions authorizing a study of "Inter- 

 agency Coordination, Economy, and Efficiency." Activities of the Federal Government in 

 drug research, resrulation. clinical use. and purchases, 80th Cong., 2d. sess. S. Rept. 1158 

 (Washington, U.S. Government Printing Office, 1066), pp. 16-17. (Humphrey report.) 



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