498 



Initially, the question was as to Federal versus State distribution; 

 later, in the House Commerce Committee, the question of vaccine 

 safety was explored. 



Sources, kinds of technical information for Congress. — The dis- 

 tribution issue was not considered in primarily technical terms. Most 

 witnesses favored Federal aid to the States, to support State and local 

 distribution. The witnesses were Government officials in DHEW, State 

 health officers, and spokesmen for the American Medical Association. 

 As the hearings progressed, evidence appeared of confusions within 

 DHEW over the safety of a vaccine being offered for mass national 

 distribution under Government sponsorship. In tlie Commerce Com- 

 mittee, a series of questions on this issue was raised in advance of hear- 

 ings. These were discussed by j^hysicians representing DHEW, supple- 

 mented by a DHEW report on the new vaccine. The strengthened 

 PHS standards were described. Discussion addressed the relative 

 safety of inactivated (Salk) versus attenuated (Sabin) vaccine. A 

 panel of 13 leaders in virology and public health was organized for the 

 subcommittee by the National Academy of Sciences ; it was chaired by 

 Dr. John R. Paul, of the Yale University School of Medicine. The panel 

 explored the various aspects of safety of the Salk vaccine, and agreed 

 that the highly virulent Mahoney strain should be dropped from the 

 group of strains used to prepare it. The panel was divided as to 

 whether the national program of distribution should be pursued. 

 (Pressed for a vote, the panelists reluctantly divided as follows: for 

 continuation, eight; for discontinuance, three: abstentions, three.) It 

 was made clear that the use of any vaccine involved risk, that accelera- 

 tion of the introduction of the Salk vaccine increased its risk, that any 

 mass medical program had some statistical probability of a number of 

 adverse reactions, and that a vaccine tended to become safer as experi- 

 ence accumulated about its production and use, and as results were 

 reported of further research into its standardization and medical 

 effects. 



Decision. — Legislation was enacted to provide $34.5 million to the 

 States for the fiscal year 1956, to distribute vaccme without a means 

 test. (The House Commerce Committee expressed satisfaction with 

 PHS improvement of review and surv^eillance procedures.) 



Decision locus. — There appeared to be a consensus on the general 

 prmciple in committees and floor votes of both Senate and House. 



Assessment. — The emergency, and congressional interest in it, gen- 

 erated pressures that caused a review of administrative organiza;tion 

 and procedures within PHS dealing with certification of vaccines for 

 national use. Subsequent introduction of other vaccines was handled 

 with less confusion and more systematic provision for public safety. 



Commentary. — The risk inherent in any new vaccine was intensified 

 in the case of the Salk vaccine by the unorthodox manner of its an- 

 nouncement. Political pressure caused a further telescoping _ of the 

 time sequence of its distribution, owing mainly to the short time be- 

 fore the annual peak incidence of the disease would occur. Risk was 

 present regardless of whether or not the vaccine wasusecl; but benefit 

 could come only if it was used. Accordingly, the relative risks involved 

 in use or nonuse became a political question, although one that only 

 the medical profession was qualified to examine. The question re- 

 maining is whether the "adversary proceeding" of the panel discus- 



