Staff Report Details
FDA and CDC Conflicts in Approval of Controversial Rotavirus
Vaccine
A House Government Reform Committee
staff report published this week criticized the FDA and the CDC
for routinely allowing scientists with conflicts of interest
to serve on two influential advisory committees that make recommendations
on vaccine policy.
The report concludes 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.”
In an August 10 letter, Chairman
Burton called on HHS Secretary Donna Shalala to implement reforms
to crack down on conflicts of interest on the two committees.
The FDA’s Vaccines and Related Biological Products Advisory
Committee (VRBPAC) makes recommendations on the approval of new
vaccines. The CDC’s Advisory Committee on Immunizations
Practices (ACIP) makes recommendations on guidelines for the
administration of vaccines. The Government Reform Committee staff
report found that the majority of members of both committees
have financial ties to vaccine manufacturers or hold patents
on vaccines under development.
The report focuses on the advisory
committees’ review of the controversial rotavirus vaccine
in 1997 and 1998. Despite concerns about potentially serious
side effects of the drug, it won unanimous votes of support in
both committees. Within one year, the vaccine, made by Wyeth
Lederle, had to be pulled from the market because it was causing
severe bowel obstructions in infants that required surgery to
correct. One baby died.
The Committee found that three
out of the five full-time FDA advisory committee members who
voted for the vaccine had financial ties to Wyeth Lederle or
two companies developing rival rotavirus vaccines -- Merck and
SmithKline Beecham. Four out of eight CDC advisory committee
members who supported the vaccine had conflicts with the same
companies. The staff report concludes that the committees demonstrated
a “lack of vigilance” in their review of the rotavirus
vaccine known as “Rotashield”, with the CDC’s
committee rushing to approve guidelines for the vaccine even
before the FDA had licensed it.
Other highlights from the staff
report include:
One physician who voted to recommend
the rotavirus vaccine on the FDA’s advisory committee received
$255,000 per year in research funds from the maker of the vaccine,
Wyeth Lederle. She received a waiver from the FDA to vote on
the issue because her research for Wyeth focused on other vaccines.
One member of the CDC’s
advisory committee who was not allowed to vote on the rotavirus
vaccine because of a conflict was allowed to participate in closed-door
working group meetings that drafted the committee’s recommendations
for the vaccine. He was also allowed to make an impassioned plea
for approval of the vaccine at the full committee meeting.
Another member of the CDC’s
advisory committee held a lucrative patent on a rival rotavirus
vaccine under development by Merck. Despite this conflict, the
doctor voted three times on recommendations regarding Wyeth’s
vaccine. It was not until the committee voted to rescind its
recommendation of the rotashield that he recused himself because
of a “perception of conflict.”
The staff report takes issue
with the FDA’s lax guidelines for conflicts of interest.
For instance, under the FDA’s rules, ownership of up to
$25,000 of stock in a vaccine sponsor is considered a “low-involvement”
conflict that is routinely waived. Ownership of up to $100,000
in stock is considered a “medium involvement” conflict
that is also eligible for waiver. Until some time in 1999, the
Chairman of the CDC’s advisory committee owned 600 shares
of stock in Merck, one of the world’s largest vaccine manufacturers.
The chairwoman of the FDA’s advisory committee also owned
stock in Merck.
The staff report finds that the
CDC’s practice of automatically granting annual waivers
to all members of its committee for one-year periods “does
not lend itself to a healthy respect for the conflict-of-interest
rules.” (Members who have direct conflicts with the sponsor
of a vaccine are generally not allowed to vote on that company’s
products, but they are free to participate in working groups
that draft the recommendations and in committee deliberations
leading up to the vote.)
In his letter to Secretary Shalala,
Chairman Burton stated:
“For the public to have
confidence in the decisions made by their government, they must
be assured that those decisions are not being affected by conflict
of interest.”
“It has become clear
over the course of this investigation that the VRBPAC and the
ACIP are dominated by individuals with close working relationships
with the vaccine producers. This was never the intent of the
Federal Advisory Committee Act, which requires that a diversity
of views be represented on advisory committees.”
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