Many fine details of DSMB organization and function relate to their most common and important use—oversight of double-blinded research-oriented clinical trials. The smallpox vaccination program is neither blinded, research-oriented, nor a trial. It is a public health program. Given the risk of the vaccine and the nation’s lack of familiarity with the vaccine and its adverse reactions, the committee applauds CDC’s plans nonetheless to establish a monitoring committee in the spirit of a DSMB. It also applauds the intent to have the board jointly oversee the data emerging from the military vaccination program and the civilian program. This sharing of information and pooling of scientific resources can only improve the success of the vaccination program and increase the chances of the safest smallpox vaccination program possible.

The committee has concerns about the organizational arrangements proposed for the DSMB and their influence on independence. Currently it appears that the DSMB will operate as a working group of the Advisory Committee on Immunization Practices (ACIP), a CDC advisory committee. This concern is in no way a reflection on either the competence or integrity of the ACIP members, its chair or executive secretary, the members of the military, or military advisory committees suggested for inclusion on the smallpox vaccine DSMB. Nevertheless, this close organizational tie to the government entities (DoD and CDC) responsible for the program violates one of the key attributes of all DSMBs—both real and perceived independence from the organizing group. A perception that the scientists overseeing the actual data on safety (who will have a responsibility for advising CDC whether the vaccinations are as safe as possible and for advising CDC whether to request the administration to halt an unsafe program) are not truly independent of those setting or overseeing policy could quickly imperil the smallpox vaccination program, not to mention the unintended consequences of eroding trust in all vaccination programs or all public health programs. The DSMB’s purpose should be perceived first and foremost as protection of vaccinees. If there are plans that could ensure independent function, this should be communicated in detail to this committee immediately. If CDC is unable to assure this independent functioning of the DSMB, the committee recommends that the proposed organizational arrangement be reconsidered.

Given that there will likely be serious adverse reactions, including death, from the vaccine, the committee believes that public trust in the management of the program is essential. It is important to preserve another key attribute of a traditional DSMB—the ability of the board to review data and deliberate in private. This is important for ensuring that the DSMB works in the best interest of the vaccinee, protected from any possible undue influence of the sponsoring agency. However, there will be great interest on the part of program managers, vaccinees, and the public in the



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