Conflict of Interest Hearing -Hearing June 15, 1 pm & Info

[Guest guest]

Had heard this was today and now see that it is June 15, 1 p.m.

Sheri

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Below is information posted at Congressman Dan Burton's web site regarding

the hearing on Thursday, June 15, at 1 pm.

http://www.house.gov/reform/press/00.06.13.htm

Committee Examines Possible Conflicts of Interest in Vaccine Development

Thursday hearing 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. in

room 2154 of the Rayburn Building.

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

Dean, General Services Administration

Panel 2:

Dixie Snider, Assistant Surgeon General, Executive Secretary - ACIP, CDC

Malone, Legal Counsel - CDC

Cherry, Executive Secretary, VRBPAC - FDA.

A. Suydam, Senior Associate Commissioner - FDA

Jennie Slaughter - FDA

Bill Freas - FDA

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Sheri Nakken, R.N., MA wwithin@...

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