Forwarded by PROVE (Parents Requesting Open Vaccine Education)
From the Committee on Government Reform comes the following: Committee Examines Possible Conflicts of Interest in Vaccine Development
A hearing on Thursday will probe pharmaceutical industry influence over key Federal advisory committees.
Washington D.C., – Chairman Dan Burton (R-IN) today announced that the Government Reform Committee will hold a hearing to examine possible conflicts of interest in two key federal advisory committees involved in vaccine approval. The hearing will take place on Thursday, June 15, at 1:00 p.m.
Background:
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. The Committee has 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 has discovered that many individuals serving on two key advisory committees have 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 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.
The Committee will examine several specific problems including:
* 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 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 leave key details out of their financial disclosure statements, and are not required to provide the missing information by CDC ethics officials.
Thursday’s hearing will focus on 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 vaccine was pulled from the market one year after approval after it was found to cause severe bowel obstructions.
* Anticipated witnesses include ethics and advisory committee officials from the FDA and the CDC:
Panel 1: Marilyn L. Glynn, General Counsel, Office of Government Ethics James Dean, General Services Administration
Panel 2: Dixie Snider, Assistant Surgeon General, Executive Secretary – ACIP, CDC Kevin Malone, Legal Counsel – CDC Nancy Cherry, Executive Secretary, VRBPAC – FDA. Linda A. Suydam, Senior Associate Commissioner – FDA Jennie Slaughter – FDA Bill Freas – FDA
Committee on Government Reform: Congress Examines Conflicts of Interest in Vaccine Development
planetc1.com-news @ 9:45 am | Article ID: 961087511
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