3.94 



of research in the United States. General acceptance of recognized procedures and 

 curtailment of the poor or pseudo-research that has sometimes been followed 

 will necessarily improve research on drugs to the benefit of science, the subjects 

 of investigations, and society. 



With respect to new drugs, FDA — after its expansion in staff — was 

 able to keep up with the industry. However, the review of combined 

 safety /efficacy of established drugs was an "overwhelming task." Fi- 

 nally, in January 1966, Dr. James Goddard became commissioner of 

 FDA and sought the assistance of the Division of Medical Sciences 

 of the National Academy of Sciences-National Research Council to 

 help FDA with the added task. In June a proposal was submitted and 

 in July a contract was signed. During the summer of 1966, 180 experts 

 in 30 panels were assembled, supported by a professional staff of 13. 

 The drug industry was invited to submit briefs on all drugs that had 

 entered the market from 1938 to 1962. When the project got underway, 

 it was found that 237 firms had submitted 2,824 briefs covering about 

 3,600 drug formulations. About 85 percent of the formulations submit- 

 ted were prescription drugs; 40 percent were combinations of two or 

 more active principles. The assessment of these drugs entailed some 

 10,000 to 15,000 separate therapeutic judgments. Where there were 

 many different brands of the same generic drug, the panels decided to 

 assume "therapeutic equivalence." (For example, there were 140-odd 

 brands of reserpine, and to "ask for well-controlled studies on all 

 brands would be to ask for the impossible.") By November 11, 1968, 

 87 percent of the planned reports by the Academy had been made to 

 FDA. Findings were that about 6 percent of drugs examined were "to- 

 tally ineffective." Some drugs were found effective for all claimed pur- 

 poses: others were effective for some. It was important that "in respect 

 of about two-thirds of all drugs reviewed, it has been recomnj ended 

 that important changes in labelling be made." *^ 



As the reports of the NAS-NRC drug evaluation panel were com- 

 pleted, they were turned over to FDA and in due course were acted 

 upon, by the issuance of FDA findings. Drugs found ineffective would 

 be withdrawn from the market, either voluntarily by the manufacturer 

 or by legal proceedings if necessary. Manufacturers of drugs found 

 "possibly effective" would be given an opportunity to provide the re- 

 quired "substantial evidence" to support labeling claims; if such evi- 

 dence was not forthcoming, or was found insufficient by FDA, such 

 drugs would also be removed from the market. According to Herbert 

 L. Ley, Jr., who replaced Dr. Goddard as FDA Commissioner, "The 

 one thing I've tried to make clear is that we've still got a big stick and, 

 where appropriate, we will still use it." ^^ 



The first NAS-NRC report on drug effectiveness concerned a group 

 of bioflavonoid compounds, derived from citrus skins, and assertedly 

 specific for various forms of bleeding. These the panel rated "in- 

 effective" for the purposes alleged. The question as to what would 

 happen when FDA attempted to effect the withdrawal of these com- 

 pounds from the market on the basis of the panel finding was raised 

 by one medical journal, which stated : 



"^Material in this paragraph derived from: R. Keith Cannan. The Drug Efficacy Study 

 of the National Academy of Sciences-National Research Council. Council for the Advance- 

 ment of Science Writing. Nov. 11. 1968. Evanston, 111. Multilith, 15 p. 



88 Morton Mintz, FDA Report Notes Sale of Many Useless Drugs During 1938-62. Wash- 

 ington Post. (Sept. 15, 1968), p. A5. 



