370 



(1) Submission by drug manufacturers to AMA of the same data they supplied 

 to FDA on new drugs ; 



(2) AMA analyses of these data (and others). Publication in the Journal of 

 the American Medical Association (JAMA) of a preliminary report, with follow- 

 on information in a column on "New drugs and developments in therapeutics." 



(3) Inclusion of all such data in a monograph on "New and NonofScial drugs," 

 in hard cover, indicating for each drug after several months of its general use, 

 the following categories of information : 



Chemical or biological identity, including pertinent properties ; 

 Actions and uses; 

 Associated side effects : 

 Toxicity and precautions ; and 

 Dosage and routes of administration. 



(4) Annual publication of an AMA Handbook on Drugs, presenting evaluated 

 information for single-entity drugs and drug mixtures under class headings, to 

 inform the physician on — 



(a) The nonproprietary and trade name or trade names of the drug: 

 ( & ) The name of the manufacturer or manufacturers ; 



(c) A quantitative statement of composition by generic name or names: 



(d) The claimed indications for the drug ; 



(e) The stated contraindications, side effects, and precautions ; 

 (/) The manufacturer's recommended dosage; 



(g) The available dosage forms ; and 

 ( h ) An overall appraisal of the drug.*" 



In addition, the AMA board of trustees had proposed to the U.S. 

 Pharmacopeial Convention a joint program on drug nomenclature, 

 with provision for final authoritative decisions in case of failure to 

 reach accord with the manufacturer. Provision would be made also 

 for coordination of this program with international bodies having 

 related functions.*^ 



Objectives of the AMA were described by Dr. Hussey as follows : 



We want all physicians to be well trained and fully informed on all aspects 

 of the practice of medicine. 



We want this body of knowledge and reservoir of skills to include a high degree 

 of competency in the selection and proper use of drugs. 



We want a continuing and expanding flow of useful drug products placed at the 

 disposal of these physicians.^^ 



It does not appear that the AMA program was responsive to the 

 problem of the drug industry with the issue of economics versus pro- 

 fessionalism. Its acceptance of the flow of new drugs into use was 

 unqualified, as was its confidence in the capability of the medical 

 profession to regulate both itself and the drug industry. Nevertheless, 

 the measures proposed by Hussey seem to have been constructive, and 

 to provide a starting point for national coordination of new drug 

 safety. 



Exception was taken to the AMA position — that drug efficacy was a 

 matter for determination by the individual physician — by William B. 

 Bean, M.D., professor of internal medicine. School of Medicine, Iowa 

 State University. He believed efficacy was a subject that required deter- 

 mination on the basis of controlled clinical investigation by qualified 

 investigators, followed by reasonable and expert evaluation. He con- 

 tinued : 



Very few people, be they laymen or practicing physicians, have any groundodly 

 learned comprehension of the extraordinary complexity and the great difficulty 

 of e.-^t.nblishing even the smallest scientific fact. Because of its very real and 



30 



-' Drug Industry Antitrust Act. Hearings, * * * pt. 1, op. eit., pp. 39-41. 

 •^ Description of this program is contained in a statement reprinted in full in Ibid, dd 

 4R-49. 



■"« Ibid., p. 39. 



