371 



serious apprehensions of the centralization of Federal authority, the American 

 Medical Association in its fear has euchred itself into the astonishing posture of 

 supporting the position that it is better to have nonefBcacious drugs or those whose 

 efficacy is as yet unestablished released freely to the American physician and 

 the American public, rather than have those made available only when their 

 usefulness in therapy has been determined or its probability is of so high an 

 order that no one could object. 



As I understand Dr. Hussey's statement, he believes that the practicing physi- 

 cian, dealing with individual patients, should be the one who determines the 

 efficacy, the reliability, and potency as well as the particular effect of a drug, 

 realizing that the effect varies from patient to patient and in a given patient 

 from time to time, depending on circumstances, as influenced by the biological 

 and biochemical individuality of each person. It takes great experience and 

 clinical wisdom to be able to dissect out the features of existence which are 

 natural and those related to disease. It is a wise physician who can elevate the 

 alterations, if any, and their direction and degree, as they are induced by a 

 specific therapeutic regimen or the employment of a particular drug or combina- 

 tion of drugs in a single patient, and generalize his results. Granting with him 

 that we frequently imply "on the average" when we speak in general terms, when 

 we deal with a patient we are considering only one person. Let me emphasize a few 

 difficulties of allowing the good old American do-it-yourself approach of using 

 the wonderful yeomanry of practicing physicians and the mass of patients in the 

 United States as a willing army of guinea pigs to determine the efficacy of new 

 drugs or to specify the degree and nature of established ones. Every physician his 

 own Pasteur.^ 



Recommendations of the National Academy of Sciences 



The review of FDA that Secretary Flemming had requested be made 

 by the National Academy of Sciences-National Research Council, was 

 completed and a report submitted September 27, 1960. It warned that 

 "The increasing rate at which medical research is expanding and new 

 and powerful drugs are being developed is multiplying the number of 

 potential hazards to be controlled.'' Accordingly, the report offered 

 11 recommendations, of which five were of particular relevance to the 

 thalidomide episode that was shortly to develop. These recommenda- 

 tions were: 



(1) The FDA should be given statutory authority to require proof of the 

 efficacy, as well as the safety, of all new drugs. Treatment of a patient with 

 an ineffective drug in place of an effective one may jeopardize his recovery. 

 This is true even though the drug may not be intrinsically harmful, and even 

 though the specific condition for which the drug is given may not be ordinarily 

 regarded as life-threatening. 



(5) The committee believes that the information supplied to physicians 

 concerning drugs should be not only accurate, but also complete, and that the 

 date of such information is essential to its proper evaluation. It therefore 

 endorses the proposed amendments to present labeling requirements published by 

 the Commissioner in the Federal Register for July 22, 1960. 



(6) The committee considers that the advertising of pharmaceuticals requires 

 more careful regulation than that of products unrelated to the prevention and 

 cure of disease. It therefore recommends that careful study be given to the prob- 

 lem of coordinating the supervision of labeling, promotional material, and other 

 advertising of drugs, now divided among several agencies of the Government, and 

 to means of ensuring that all information concerning drugs conveyed to the 

 profession and the public by whatever media be in conformity witli scientific 

 fact. 



(8) The staff members responsible for processing applications should be 

 supported to the utmost in their efforts to obtain submission of truly dependable 

 scientific information on the efficacy and safety of the products. The data 

 initially submitted by the manufacturer are not always of sufficient quality and 

 quantity to permit a sound decision as to the merits of the product. 



(10) The committee urges the Commissioner to seek such authorization as 

 may be necessary to establish an advisory organization of scientific and technical 



33 Ibid., pt. 1, p. 267. 



