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In August 1999, the Committee on Government Reform initiated an investigation into Federal vaccine policy.1 This investigation focused on possible conflicts of interest on the part of federal policy-makers. The Committee conducted an extensive review of financial disclosure forms and related documents, and interviewed key officials from the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).
In the course of the investigation, the committee discovered that many individuals serving on two key advisory committees had financial ties to the pharmaceutical companies that manufacture vaccines. Often, these individuals were granted waivers to fully participate in the discussions that led to recommendations on vaccine licensing and adding vaccines to the Childhood Immunization Schedule.
Under federal law, members of advisory committees are required to disclose any financial conflicts of interest and recuse themselves from participating in decisions in which they have an interest. The Committee's investigation determined that conflict of interest rules employed by the FDA and the CDC were weak, enforcement was lax, and committee members with substantial ties to pharmaceutical companies had been given waivers to participate in committee proceedings.
The Committee noted several specific problems, including:
The CDC routinely granted waivers from conflict of interest rules to every member of its advisory committee.
CDC advisory committee members who were not allowed to vote on certain recommendations due to financial conflicts of interest were allowed to actively participate in committee deliberations and advocate specific positions.
The Chairman of the CDC's advisory committee until recently owned 600 shares of stock in Merck, a pharmaceutical company with an active vaccine division.
Members of the CDC's advisory committee often left key details out of their financial disclosure statements, and were not required to provide the missing information by CDC ethics officials.
Regarding the FDA and CDC approval of the controversial rotavirus vaccine in 1998 and 1999:
3 out of the 5 FDA advisory committee members who voted to approve the rotavirus vaccine in December 1997 had financial ties to the pharmaceutical companies that were developing different versions of the vaccine.
4 out of the 8 CDC advisory committee members who voted to approve guidelines for the rotavirus vaccine in June 1998 had financial ties to pharmaceutical companies that were developing different versions of the vaccine.
The rotavirus vaccine was pulled from the market one year after approval, after it was found to cause severe bowel obstructions.
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Program Director, Continuum Center for Health and Healing,
Beth Israel Hospital / Albert Einstein School of Medicine