Conflicts of Interest in Vaccine Policy MakingMajority Staff ReportCommittee on Government ReformU.S. House of RepresentativesAugust 21, 2000
TABLE OF CONTENTS
Section I Introduction Page 1Section II Laws and Regulations Page 3Section III Rotavirus and the“RotaShield” Vaccine Page 7Section IV Food and Drug AdministrationVaccines and Related BiologicalProducts Advisory Committee Page 12Section V Centers for Disease Controland PreventionThe Advisory Committee onImmunizations Practices Page 21Section VI Conclusions andRecommendations Page 35
Conflicts of Interest in Vaccine Policy MakingMajority Staff ReportCommittee on Government ReformU.S. House of RepresentativesAugust 21, 2000
Section IIntroduction
In August 1999, the Committee on Government Reform initiated an investigation into Federalvaccine policy. Over the last eight months, this investigation has focused on possible conflicts of interest on the part of Federal policy-makers. Committee staff has conducted an extensivereview of financial disclosure forms and related documents, and interviewed key officials fromthe Department of Health and Human Services, including the Food and Drug Administration andthe Centers for Disease Control and Prevention.This staff report focuses on two influential advisory committees utilized by Federal regulators toprovide expert advice on vaccine policy:1. The FDA’s Vaccines and Related Biological Products Advisory Committee(VRBPAC); and2. The CDC’s Advisory Committee on Immunizations Practices (ACIP).The VRBPAC advises the FDA on the licensing of new vaccines, while the ACIP advises theCDC on guidelines to be issued to doctors and the states for the appropriate use of vaccines.Members of the advisory committees are required to disclose any financial conflicts of interestand recuse themselves from participating in decisions in which they have an interest. TheCommittee’s investigation has determined that conflict of interest rules employed by the FDAand the CDC have been weak, enforcement has been lax, and committee members withsubstantial ties to pharmaceutical companies have been given waivers to participate incommittee proceedings. Among the specific problems identified in this staff report:
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The CDC routinely grants waivers from conflict of interest rules to every member of itsadvisory committee.
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CDC Advisory Committee members who are not allowed to vote on certainrecommendations due to financial conflicts of interest are allowed to participate incommittee deliberations and advocate specific positions.
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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.
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Members of the CDC’s advisory committee often fill out incomplete financial disclosurestatements, and are not required to provide the missing information by CDC ethics officials.
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Four out of eight CDC advisory committee members who voted to approve guidelines forthe rotavirus vaccine in June 1998 had financial ties to pharmaceutical companies that weredeveloping different versions of the vaccine.
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3 out of 5 FDA advisory committee members who voted to approve the rotavirus vaccinein December 1997 had financial ties to pharmaceutical companies that were developingdifferent versions of the vaccine.A more complete discussion of specific conflict of interest problems identified by GovernmentReform Committee staff can be found in Sections 4 and 5 of this report. To provide focus tothe discussion, this report examines the deliberations of the two committees on one specificvaccine -- the Rotavirus vaccine. Approved for use by the FDA on August 31, 1998, theRotavirus vaccine was pulled from the market 13 months later after serious adverse reactions tothe vaccine emerged. Financial disclosure forms and waivers granted to committee memberswho participated in these meetings were analyzed, along with their votes and actions takenduring the meetings.