384 



[To distribute such a large quantity of] what was still in the United States 

 au "experimental" drug exposed a very considerable number of potential patients 

 to some degree of risli (p. 22) . 



Of the 1,2(57 doctors who received the drug, only 276 gave written reports to 

 the manufacturers; 102 doctors gave verbal reports (p. 28). 



[Of the 1,267], only 647 doctors stated that they had signed a statement of 

 qualification (p. 23). 



Hundreds of "investigators" failed, contrary to the traditions of science, to 

 keep adequate records. They did not know which patient they had given the 

 drug to, at what dosage, or when (p. 25). 



In addition to drawing its own conclusions, the report also quoted 

 the opinions of a number of other critics who vouchsafed such views 

 as the following : 



In some respects the pharmaceutical industry manifests a split personality. 

 A most unfortunate example of this was the manner in which the clinical 

 evaluation of thalidomide was conducted. While the clinical testing of this 

 drug was managed by the medical department, it was handled in the usual 

 professional manner. But when clinical research was taken over by business 

 enterprise it became tainted with some of the worst features of commercialism. 



It is unfortunately true, as the thalidomide incident so well illustrates, that 

 the drug industry does not now always adhere to high standards, either in 

 planning the investigation, selecting the investigators, or providing the investi- 

 gators with full information about the hazards that may be expected in con- 

 ducting the clinical trial. 



Certainly, the most casual observer would reject the desultory returns from 

 over 1,200 physicians, to whom was entrusted the clinical trial of thalidomide. 

 Their results could have no scientific significance or validity. Yet. this formula 

 for deriving new drug introduction and acceptance has obtained for many years. 



The final toll of thalidomide was reported on by FDA for the sub- 

 committee, September 28, 1963, as follows : 



Our final figure for such deformity cases, in which the drug was taken or 

 reportedly taken during the first trimester of pregnancy, is 17. 



In 10 of these cases, the drug was produced in the United States and given 

 by American inve.stigators. The deformities which occurred in these cases were 

 as follows : 

 Deformities : Numier 



1. Absence of legs and forearms 1 



2. Deformed hands and arms 2 



3. Absence of arms and hands 1 



4. Deformed arms and legs 2 



5. Webbed toes, 3-chambered heart 1 



6. Cleft palate, deformed sex organs 1 



7. Absence of both arms and 1 leg ; red birthmark on face 1 



8. Deformed arms, hands and fingers, and feet ; red birthmark on nose 



and upper lip 1 



In the remaining seven cases, thalidomide from foreign sources was reportedly 

 taken during the first trimester, and the resulting deformities were as follows : 

 Deformities : Number 



1. Absence of legs and forearms 1 



2. Deformed hands and arms 2 



3. Deformed arms and legs 1 



4. Internal organs reversed, deformed heart 1 



5. Deformed arms, hands, fingers, and feet ; red birthmark on nose 



and upper lip 1 



6. Underdeveloped right ear, no soft palate, heart murmur, facial 



paralysis 1 



Commented the subcommittee report: "Thalidomide triggered a vast 

 educational process which is still continuing * * *." 



The United States has been saved from mass disaster by the good fortune that 

 a new drug application (1 of over 400 in any given year) had landed on the 



