320 



I don't think it is the function of this committee to determine the quality of 

 this product. If we have to do that, I want to resign now because I am not 

 capable of going into it. I think distribution is what we are interested in."' 



In the Senate hearings, the chairman had stated its concerns in his 

 opening statement thus : 



First, we would like to know whether we now have a safe poliomyelitis 

 vaccine * * * Secondly, is it sound public policy, from a public health point of 

 view to encourage and urge our local communities to vaccinate just as many 

 children as possible, as quickly as the vaccine become available, or as soon as 

 possible before the onset of the 1956 polio season? ^* 



However, Senators Allott and Purtell protested that this double 

 objective, especially that of looking into technical problems, had not 

 been agreed to in executive session. They added, furthermore, that the 

 witness roster, consisting mainly of the Secretary and other spokesmen 

 for DHEW, would need to be augmented to insure objective coverage.^^ 



Accordingly, these two committees did not probe deeply into ques- 

 tions of efficacy and safety of the vaccine, nor was any additional can- 

 vass made to find disinterested witnesses who could enlighten them on 

 these technical matters. Scientific and technical information was forth- 

 coming from PHS and DHEW most usually only in response to in- 

 tensive interrogation by committee members. Because the situation was 

 in flux — PHS had suspended the program, revised standards, encoun- 

 tered manufacturing difficulties, halted production without public ex- 

 planation, and then renewed it---it was evident that clarification was 

 needed. Testimony before the two committees did not altogether satisfy 

 the need. 



Initial congressional prohes of the safety and efficacy issue 



DHEW spokesmen appeared to be on the defensive. They explained 

 that they had done everything possible to foresee and to correct faulty 

 production and testing standards and asserted that the situation was 

 under control. These answers did not quiet congressional anxieties, nor 

 serve to allay criticism being expressed in editorial comment at the 

 time.^^ Congressional inquiry into technical matters touched on — 



timing and extent of publicity attached to the Francis report ; 



licensing and testing responsibilities of PHS ; 



danger of contracting hepatitis from impurities in the vaccine ; 



need for additional research ; 



need for a substitution of strains ; 



the merits of an oral (attenuated) versus an injected (killed) 

 vaccine; and 



factors to be evaluated in determining calculated risk. 



In his first appearance before the Congress, in testimony before the 



House Banking and Currency Committee, Dr. Scheele explained that 



there were three types of virus which caused polio, and that, according 



to the results of the Francis report, the Salk vaccine was 60 to 90 per- 



^ House. Committee on Banking and CuiTency. Salk vaccine hearings, op. cit., p. 22. 



3* Senate. Committee on Labor and Public Welfare. Poliomyelitis vaccine hearings, 

 op. cit., p. 7. 



35 Ibid., pp. 8-9. 



3« Several stories in the New York Times had such leads as : U.S. PHS orders temporary 

 withdrawal from use of vaccines made by Cutter Laboratories of Berkeley. Calif., as six 

 cases of paralytic polio occur in children recently inoculated (New York Times, Apr. 28, 

 1955, p. 1) ; Salk urges thorough probe to determine whether there is link between 

 vaccine and polio cases (New York Times, Apr. 28, 1955, p. 1) ; Three doctors report 

 studies indicate vaccine was contributing cause in 10 polio cases in Idaho (New York 

 Times, May 5, p. 21) ; and, Scheele urges suspension of Inoculations continue until after 

 plant-by-plant check of manufacturing process (New York Times, May 9, 1955, p. 1). 



