375 

 IV. The Thalidomide Story 



45 



There are several accounts of the origin of the drug thalidomide 

 According to Dr. Helen B. Taussig, an authority on the drug, she was 

 told in Germany that "the drug was first conceived of as a sedative by 

 a Swiss pharmaceutical firm, compounded by them in 1954, tried on 

 animals and found ineffective and therefore discarded." ^^ Subse- 

 quently, it was reinvented ("several years later"') b}- Grunenthal. Ac- 

 cording to an official of the American company that sought to intro- 

 duce the drug into the United States, the drug was "first synthesized by 

 Chemie Grunenthal G.m.b.H., Stolberg, West Germany, in 1953." *' 

 The molecular structure of the compound was such that it was viewed 

 as a candidate for usefulness as a sedative or sleep-inducing drug. 

 Again, according to Dr. Taussig, Grunenthal tried the drug on ani- 

 mals, and found that it had no effect. However — 



This firm went one step further and thought it must be a good drug. Perhaps 

 it would be good for epilepsy. The company made and marketed the drug as an 

 anticonvulsant. The drug was found worthless for epilepsy but it made man 

 sleep. Thereafter it was .sold as a sleeping tablet. It had a prompt action, gave 

 deep natural sleep and left no hangover. It was a ''safe" drug. Man could not 

 commit suicide. The drug was manufactured '"by the ton" and its sale was tre- 

 mendous. By 1960 it became Germany's most popular sleeping tablet and tran- 

 quilizer.^ 



As told by the Merrell Co., "The drug was tested in animals and 

 then in humans. Grunenthal found it to be highly efficacious as a seda- 

 tive-hypnotic, producing normal sleep. The toxicity of thalidomide 

 was extremely low in both animal and clinical testing. No LD-50 

 (median lethal dose) could be established." "^^ It does not appear that 

 thalidomide was introduced into the German market with undue haste. 

 Although synthesized by Grunenthal in 1953 (or possibly 1954) it was 

 not placed in commercial u.se imtil 1957. 



The drug evidently caught on. It sold as a sleeping tablet, a sedative, 

 a tranquilizer: as an additive along with other drugs it was used as 

 a medication for grippe, neuralgia, asthma, and as a cough medicine ; 

 it was also found useful as an antiemetic in early pregnancy. Dr. Taus- 

 sig noted that it was an excellent and inexpensive sedative, and that its 

 sale was tremendous. 



*6 The chemical characterization of the compound, as given by Frank N. Getman, Wil- 

 liam S. Merrell Co., is "alpha (N-phtalimide) gliitarimide.'' 



^ Prepared statement of Dr. Helen B. Taussig on H.R. 6245. In U.S. Congress. House. 

 Committee on the Judiciary, Drug Industry Antitrust Act. Hearings before the Antitrust 

 Subcommittee (Subcommittee No. 5) of the * * * on H.R. 6245, a bill to amend and supple- 

 ment the antitrust laws with respect to the manufacture and distribution of drugs, and 

 for other purposes. Mav 17, 18, 23, and 24, 1962. Serial No. 32. (Washington, U.S. Govern- 

 ment Printing Office, 1962) , p. 430. 



" Circular letter "to all physicians" signed by Frank N. Getman, William S. Merrell Co. 

 Included in pt. 1, p. 121, of IJ.S. Congress. Senate. Committee on Government Operations. 

 Interagency coordination in drug research and regulation. Hearings before the Subcom- 

 mittee on Reorganization and International Organizations of the * * * agency coordination 

 study. (Pursuant to S. Res. 276, 87th Cong., S. Res. 27, 88th Cong., and S. Res. 27, as 

 amended. 8Sth Cong.) Review of cooperation on drug policies among Food and Drug 

 Administration, National Institutes of Health, Veterans' Administration, and other agencies. 

 (Washington. U.S. Government Printing Office, 196.3 and 1964.) Pt. 1, Aug. 1 and 9, 1962; 

 pt. 2. Supplementary exhibits and index to pts. 1 and 2, Aug. 1 and 9, 1962 ; pt. 3, the 

 Bureau of Medicine in the Food and Drug Administration, Mar. 20, 1963 : pt. 4, Testimony 

 and exhibits (including subsequent correspondence) on specialized drugs and drug prob- 

 lems : (1) Drugs for mental illness; (2) Antibiotics; (3) Drug testing; (4) Neonatal 

 pharmacy; and (5) Communication on drug emergencies, Mar. 21, 1963; pt. 5, Testimony 

 and exhibits (including subsequent 196.3-64 correspondence) on (1) Commission on Drug 

 Safety; (2) Pharmaceutical Manufacturers Association: (3) Medical education on drug 

 therapy and other drug issues. June 19, 1963 ; and pt. 6. Testimony and exhibits (including 

 subsequent 196.3-64 correspondence) on drug activities of the American Medical Association 

 (hereafter referred to as Humphrey hearings, parts). 



« Helen B. Taussig. M.D., "A Studv of the German Outbreak of Phocomelia." JAMA. 

 (Vol. 180. June 30, 1962. pp. 80-88.) Reprinted in Humphrey hearings, pt. 1, op. cit., p. 103. 



*^ Circular letter, op. cit., in Humphrey hearings, pt. 1, p. 121. 



