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Executive Summary

Incentives for private sector vaccine research and development should be increased through federal subsidies or tax credits to compensate for the low profit margin on the products, the public interest group Advocates for a Safe Vaccine recommends in an interim report released Feb. 7. The report explains that government contributions to vaccine R&D "could be accomplished by direct federal financing by subsidy or grant, or by indirect financing by the utilization of a tax credit." It adds that governmental support, "however constituted, should permit the private sector to make a profit from the product." "One root cause of the lack of a safe pertussis vaccine is the perception by the pharmaceutical industry and others of the lack of profit potential in DTP vaccine," the report states. It asserts that "since approximately half of the DTP vaccine in this country is sold to various governmental agencies, and since such 'public sector' purchases usually involve purchasing from the 'lowest bidder,' it is apparent that this marketing does not provide enough incentive to private investment for research and development of a safer vaccine." Govt. support for vaccine R&D is considered by the authors of the report to be more effective than providing limited immunity to mfrs. for liability litigation. "It is a widespread belief that the industry's current attempt to gain immunity is merely a false panacea; the real problem is product profitability," the report states. The report, prepared by Andrew Dodd (Torrence, Calif. firm Ward, Dodd, Gaunt & Denver) and Anne Werum Lambright (Charleston, West Virginia firm Preiser & Wilson), chairman and vice chairman respectively of Advocates for a Safe Vaccine, was presented at a Feb. 7 press briefing held to Dissatisfied Parents Together. The non-profit educational group is composed of parents who are concerned about severe adverse reactions to the pertussis vaccine. Sen. Hawkins And Rep. Waxman Plan To Reintroduce Vaccine Compensation Bills in March Advocates for a Safe Vaccine further recommend that a bill "should contain provisions which permit sealed bid purchasing contracts by any level of government (federal, state, city, etc.), but only from the lowest bidder with the best and safest vaccine." The report maintains that "under the current 'low bid' system, mfrs. have chosen not to spend adequate money theoretically necessary for research to improve their DTP products. It is apparently felt that since DTP vaccines are (erroneously) perceived to be safe there is not enough demand to justify production of a safer and more expensive vaccine." Sen. Hawkins (R-Fla.) introduced a vaccine compensation bill in November 1983 and Rep. Waxman (D-Calif.) introduced a similar bill in June 1984, but neither made it out of committee in the last Congress. Both Hawkins and Waxman plan to hold hearings and introduce similar bills in March. The original House and Senate versions of the measure allowed vaccine injury victims the option either to seek compensation that was fixed by legislation or to seek damages in court. Both Waxman and Hawkins are expected to retain the dual option provision when their bills are reintroduced. At the press conference, Advocates for a Safe Vaccine criticized industry for being slow in the development of a safer pertussis vaccine. The group states in its report that "the production of a less toxic vaccine is and has been economically and technologically feasible." As support for that position, the report includes a July 1978 memo from Lederle President Robert Johnson to R. J. Vallancourt, a member of Lederle's biological section, in which Johnson says a Russian pertussis vaccine "is considered to be one of the best in the world" and outside the Eastern Bloc the vaccine by Burroughs Wellcome is considered the best. "All U.S. vaccines are considered more reactive than our foreign colleague's product," Johnson states, adding that "the South American vaccines fair even worse than ours." A recent report by the Institute of Medicine's Cmte. on Issues and Priorities for New Vaccine Development predicted that an acellular pertussis vaccine could be licensed in the U.S. in three to five years ("The Pink Sheet" Jan. 7, p. 11). Last year Wyeth initiated clinical trials on an acellular pertussis vaccine originally developed in Japan by Takeda ("The Pink Sheet" June 25, T&G-6). In addition, the Institute of Medicine report noted that several U.S. mfrs. are developing their own acellular vaccines. The report observed, however, that the reduction in morbidity and mortality with the improved vaccine would be small.

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