332 



fied in op]:)Osition to a tifrhtly controlled Federal program. With the 

 support of these groups, the administration was able to win acceptance 

 for a program wntli a minimum of Federal involvement. 



The technical issues of efficacy and safety of the vaccine were more 

 difficult to resolve. Some members of congressional committees investi- 

 gating the distribution issue questioned their own qualifications or 

 jurisdiction to weigh these matters. The PHS had taken measures to 

 strengthen its procedures concurrently with the hearings. While these 

 actions were initiated by PHS after its own assessment of the vaccine 

 management procedures, congressional pressure may have helped to 

 motivate PHS assessment and subsequent corrective action. Un- 

 doubtedly, many Members of Congress were gratified by the changes 

 in PHS procedures. Yet there still remained unanswered questions 

 about both the PHS procedures and the vaccine itself. 



The public had been led to expect wide distribution thajt season of 

 an effective vaccine ; this was in question by late June. Confusion about 

 vaccine quality and safety had been evidenced in PHS management 

 throughout the spring : PHS had licensed the biological, suspended its 

 approval, reviewed the manufacturing process without revealing its 

 findings, promulgated new standards, and then renewed the program. 

 Members of Congress sought to learn more about the steps taken by 

 PHS to correct deficiencies in its licensing procedure. Moreover, not 

 wanting to underwrite distribution of a potentially hazardous bio- 

 logical, they wanted to learn how great a calculated risk was involved. 



One flaw in the Salk vaccine procedure was attributable to the un- 

 precedented nature of its sponsorship. The National Foundation for 

 Infantile Paralysis was funded by donations from millions of Amer- 

 icans in annual voluntar^^ campaigns. It was eager to fulfill its pledges 

 to the pu])lic, and had extensively publicized Dr. Salk's vaccine as the 

 first major fruit of its work. The unorthodox manner in which the 

 medical development was publicized hampered its acceptance by the 

 medical profession. ]Many physicians and public health authorities 

 hesitated to take a stand on its use because the results of the testing 

 program had not been circulated through the normal channels of scien- 

 tific and medical literature. Medical periodicals could not publish the 

 report in time for the vaccination program to begin before the start 

 of summer. The National Academy of Sciences had declined to sponsor 

 a conference to announce the results of the report. And Carter asserted 

 that the NFIP had refused an offer from the American Medical Asso- 

 ciation to uiidertake a prepubli cation review of the field trial results.^^ 



Congressional review of PHS procedures in bringing the vaccine to 

 quantit}' production turned up other flaws, although PHS and DHEW 

 witnesses released the details of the operation piecemeal and with ap- 

 parent reluctance. The nature of the calculated risk, which the Francis 

 report had said was based on an estimated 60 to 90 percent effectiveness 

 of the vaccine, was rendered suspect by the manufacturing variables 

 associated with large-scale production. It began to appear that PHS 

 had not fully evaluated safety requirements, and had miscalculated 

 the procedures needed to assure an adequate safety margin for quaiitity 

 production. A ccording to Fisher, the vaccine advisory committee estab- 

 lished by NFIP had "* * * lacked sufficient safeguards to prevent 



«3 Carter, op. clt, pp. 247-248. 



