For Immediate Release:
Contact: Sean M. Spicer
23 August 2000
Burton Critical of Vaccine Approval Process
Staff Report Details FDA and CDC Conflicts in Approval of Controversial Rotavirus
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
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
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."
Committee on Government Reform
2157 Rayburn House Office Building
Washington, DC 20515 · (202) 225-5074