the decision-making process seemed crucial for the preparedness program’s very existence, to safeguard the trust between CDC and its public health partners, and to secure the agreement and participation of public health agencies, health care organizations, professional associations, and other constituencies.

CDC has long been a leader in protecting the public’s health by playing many roles, including supporting state and local health departments, supporting and evaluating the nation’s immunizations programs, and performing the epidemiology and laboratory functions of communicable disease control. CDC’s leadership role and the centrality of scientific evidence to its mission (CDC, 2004) are apparent in the agency’s relationships with public health agencies and in CDC’s performance in response to major crises, such as the SARS outbreak of 2003. The committee asserts that CDC’s leadership role depends in part on the agency’s ability to function as the definitive voice of science-based public health; its decisions and recommendations must always be seen as emerging logically from the best available scientific and public health reasoning. Many in the public health community did not perceive that to be the case during the smallpox vaccination program. Indeed, the national security context may have complicated CDC’s ability to provide and communicate scientific and public health reasoning in the development of smallpox vaccination policy; CDC leadership may have been unable to disclose some of the underlying data, or such information may not have been made available to CDC itself.

The committee recognizes that public health policy decisions are not made solely on the basis of conclusive scientific data although science is accorded an extremely high value. The circumstances surrounding the smallpox vaccination policy at the interface between public health and national security interests were conducive to decision-making with little or no attention to public health and scientific imperatives. Those circumstances made CDC’s role as the voice of science-based public health even more critical, yet CDC appeared unable to communicate in its typically transparent and clear manner. Furthermore, the implementation of the smallpox vaccination program was characterized by targets that were established and changed, phases that were established and eliminated, and recommendations that were sought—from ACIP and from the present IOM committee—and then not followed (Brown, 2002; CDC, 2002b, 2003b; McGlinchey, 2003a). Although it is not surprising that the program changed and its goals shifted, little or no explanation was given of the reasoning behind the decisions. In the short term of the program’s implementation, the unanswered questions and concerns that overshadowed the program contributed to problems and delays. In the long term, those issues may have created barriers to strengthening preparedness and may have impaired reliance on CDC as the nation’s definitive public health



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