dChan - Q Origins Project Archive

Conflicts of Interest in Vaccine Policy Making

Majority Staff Report

Committee on Government Reform

U.S. House of Representatives

June 15, 2000

Section I

Introduction

In August 1999, the Committee on Government Reform initiated an investigation into Federal vaccine policy. Over the last six months, this investigation has focused on possible conflicts of interest on the part of Federal policy-makers. Committee staff has conducted an extensive review of financial disclosure forms and related documents, and interviewed key officials from the Department of Health and Human Services, including the Food and Drug Administration and the Centers for Disease Control and Prevention.

This staff report focuses on two influential advisory committees utilized by Federal regulators to provide expert advice on vaccine policy:

The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC); and

The CDC's Advisory Committee on Immunizations Practices (ACIP).

The VRBPAC advises the FDA on the licensing of new vaccines, while the ACIP advises the CDC 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 interest and recuse themselves from participating in decisions in which they have an interest. The Committee's investigation has determined that conflict of interest rules employed by the FDA and the CDC have been weak, enforcement has been lax, and committee members with substantial ties to pharmaceutical companies have been given waivers to participate in committee proceedings. Among the specific problems identified in this staff report:

§ The CDC routinely grants waivers from conflict of interest rules to every member of its advisory committee.

§ CDC Advisory Committee members who are not allowed to vote on certain recommendations due to financial conflicts of interest are allowed to participate in committee deliberations and advocate specific positions.

§ The Chairman of the CDC's advisory committee until very recently owned 600 shares of stock in Merck, a pharmaceutical company with an active vaccine division.

§ Members of the CDC's advisory Committee often fill out incomplete financial disclosure statements, and are not required to provide the missing information by CDC ethics officials.

§ Four out of eight 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.

§ 3 out of 5 FDA advisory committee members who voted to approve the rotavirus vaccine in December 1997 had financial ties to pharmaceutical companies that were developing different versions of the vaccine.

A more complete discussion of specific conflict of interest problems identified by Government Reform Committee staff can be found in Sections 4 and 5 of this report. To provide focus to the discussion, this report examines the deliberations of the two committees on one specific vaccine – the Rotavirus vaccine. Approved for use by the FDA on August 31, 1998, the Rotavirus vaccine was pulled from the market 13 months later after serious adverse reactions to the vaccine emerged.

https://vaccineinfo.net/issues/conflictofinterest/conflicts_of_interest.shtml#:~:text=%C2%A7%20The%20CDC%20routinely%20grants%20waivers%20from%20conflict,participate%20in%20committee%20deliberations%20and%20advocate%20specific%20positions.

Financial disclosure forms and waivers granted to committee members who participated in these meetings were analyzed, along with their votes and actions taken during the meetings.