358 



of the divided objectives of the proprietary driiir industry. This in- 

 dustry strives, on the one liand, to earn a profit for its activities in 

 tlie development, manufacture, and sale of its product. On the other 

 hand, it strives to serve the public by makin<r available an increas- 

 inorly extensive array of biochemical means of treating disease. 



In its efforts toward the former goal, the proprietary drug indus- 

 try invites supervision along with all other major inciustries, as to 

 its conformity with public policy regarding competition, pricing ar- 

 rangements, tax and accounting practices, and the like. In its role 

 as an adjunct of the medical profession, reinforced by its extensive 

 interaction with physicians in the testing and evaluation of its new 

 products, and the extensive emploj^ment of physicians for its leader- 

 ship and research, the drug industry is confronted with public ex- 

 pectations of ethical standards, progress in the development of effec- 

 tive drugs, assurance as to the reliability of its products, and a share 

 of the responsibility imposed on itself by the medical profession. 



The interface within the drug industry itself, between the profit- 

 making aspe<it and the medical aspect, presents untoward difficulties. 

 The profitmaking aspect is reflected in a preoccupation with sales, 

 dramatic innovations, advertising, "detail men*' on the road, patent 

 protection of unique features, and horse tradinsf of licensing arrange- 

 ments. The medical aspect is reflected by the. involvement of the in- 

 dustry in the lives and recovery to health of human beings, the issu- 

 ance of pure and reliable drugs, and in the intricate technical problem 

 of insuring the effective and safe, restrained, medically controlled 

 use of powerful new biochemical agents that induce major changes 

 in human metabolism, resistance to disease, genetic transmission of 

 characteristics, and organic and external ph3^sical structure. The com- 

 mercial problem of introducing new product lines by techniques that 

 build and sustain a healthy profit picture overlaps the medical prob- 

 lem of communicating to prescribing physicians the best available 

 guidance as to the contributions, constraints, and side effects of these 

 same new drugs to achieve the goal of a healthy public. 



Emphasis on heightened economic motivation of the drug industry 

 to insure to the consumer the benefits of intense price competition 

 was the primary concern of the drug hearings that immediately pre- 

 ceded the thalidomide episode. Insistence on this aspect may not in 

 the long run turn out to be compatible with the maintenance of tight 

 control and high ethical responsibility of a national institution inti- 

 mately involved with the health of the public. 



Background of the thai IdoTnide episode 



For most of human histor}^ drugs came from nature, from the work- 

 ing of simple natural processes, and from common chemical substances. 

 Thus, tannic acid (a treatment for burns) w^as leached from oak bark 

 and acorns. Ethyl alcohol, both a drug and a solvent for manj' drugs, 

 was produced by fermentation of sugar or starch, and distillation of 

 the product. The two chlorides of mercury were useful as drugs, one as 

 a physic and the other as a powerful and higlily toxic disinfectant. A 

 major source of drugs was alkaloids extracted by alcohol solution 

 from plants, such as digitalis (foxglove), morphine (opium poppy), 

 atropine (nightshade), quinine (cinchona tree), and strychnine (nux 

 vomica) . 



