333 



possible * * * dangerous action." ^* He also alleges that the foundation 

 had conmiitted itself to large orders of vaccine from commercial pro- 

 ducers, who stood to lose if the program fell behind schedule; this 

 circumstance contributed a further source of urgency.®^ 



The interaction of safety and quantity production had many aspects 

 of concern. Dr. Shannon and others in PHS had, indeed, questioned 

 the validity of Dr. Salk's process for inactivating the virus with 

 formalin. Another question had been with respect to the use of mer- 

 thiolate as a preservative.^^ ]\Iore generally, Dr. Jolin Enders, who 

 later received a Nobel Prize for his contribution to virology research 

 that had opened the way to development of the Salk vaccine, had 

 predicted that: 



For a long time, researchers will be concerned with such matters as the dura- 

 tion of immunity, the determination of whether dissemination of the virus is 

 reduced in the community, and whether resistance established as the result of 

 vaccination will be reinforced and maintained, as Dr. Salk believes, through 

 repeated inapparent infection of natural origin.^" 



One difficulty encountered by PHS in disclosing its own share of 

 responsibility for error in the development of quantity production of 

 the vaccine derived from the legal constraint that prevented public 

 disclosure of problems encountered in manufacturing processes over 

 which it maintained surveillance.^^ However, the June 10 report of 

 PHS to the President publicly revealed both a deficient scientific base 

 and a generally deficient industrial base in manufacturing operations. 

 Although somewhat belatedly, PHS recognized these problems,®^ and, 

 as indicated in the June 10 report, took steps to correct them. 



To cut through the uncertainties that had accumulated about the 

 vaccine and its safety, the House Committee on Interstate and Foreign 

 Commerce resorted to a panel of scientific experts as a source of 

 objective advice on the situation. The panel was able to draw on the 

 information in the June 10 report, as well as on data from its own 

 sources. The panelists reflected the controversy prevailing in the scien- 

 tific community about the vaccine. However, it was contrary to cus- 

 tomary scientific procedure in the resolving of the issue, to put pres- 

 sure on the group of scientists to poll their membership on the matter ; 

 a more usual method is the systematic and deliberate winnowing of 

 the evidence, and if necessary the gathering of new evidence, until a 



8* Fisher, op. cit., p. 71. 



86 Ibid., pp. 73-74. 



*8 Carter, op. cit., p. 261, observed that PHS officials had insisted on the use of merthio- 

 late as an additive, while Dr. Salk had not. Field experience revealed that it reduced the 

 antigenicity of the type I virus strain in the vaccine. Thereafter, PHS requirements 

 omitted this item. 



^ As quoted in Carter, op. cit., p. 260. 



»' According to the Code of Federal Regulations. "Information in the records or posses- 

 sion of the [Public Health], Service obtained by the Service under an assurance of confi- 

 dentiality which the Surgeon General or his authorized representative determines to be 

 necessary for the purpose of any research, survey, investigation, or collection of statistical 

 data may be disclosed only with the consent of the person, association, or agency to 

 which such assurance was given . . ." or if necessary to prevent epidemic or oppose legal 

 action against a U.S. employee. Information relating to the licensing of a biological may 

 be disclosed, at the discretion of the Surgeon General, ". . . only to Federal, State, or 



8» See : Technical Report on Salk Poliomyelitis Vaccine, op. cit. Detailed statements on 

 the lack of adequate science base were not given by the PHS in congressional testimony 

 in 1955. Later statements detailing the problems were made in congressional testimony : 

 Testimony of Dr. Leonard Scheele, in U.S. Congress, House Committee on Interstate and 

 Foreign Commerce. Extension of Poliomyelitis Vaccination Assistance Act, Hearings before 

 a subcommittee of the * * * on H.R. 8704, a bill to extend through June 30, 1957, the 

 duration of the Poliomyelitis Vaccination Assistance Act of 1955, January 24, 1956 S4th 

 Congress, 2d session. (Washington, U.S. Government Printing Office, 1956), pp 11-12 and 

 James A. Shannon, M.D., Director of the NIH. PHS, U.S. Department of Health. Educa- 

 tion, and Welfare. "NIH — Present and Potential Contribution to Application of Biomedical 

 Knowledge." Op. cit., pp. 72-86. 



