Vaccine approval process criticized

A recently published House Government Reform Committee staff report criticized the Food and Drug Administration and the Centers for Disease Control for routinely allowing scientists with conflicts of interest to serve on two influential advisory committees that make recommendations on vaccine policy.

The report focused on the advisory committees' review of the rotavirus vaccine in 1997 and 1998, which won unanimous support in both committees despite concerns about the drug's side effects. Within one year, the vaccine, made by Wyeth Lederle, Radnor, PA, had to be pulled from the market because it was linked to severe bowel obstructions in infants.

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. Four out of eight CDC advisory committee members who supported the vaccine had conflicts with the same companies. The staff report concluded 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:

•Â 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.

•Â 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.

•Â Another member of the CDC's advisory committee held a lucrative patent on a rival rotavirus vaccine under development by another drug company. 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 Rotashield that he recused himself because of a "perception of conflict."

The staff report also 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 and is routinely waived. Ownership of up to $100,000 in stock is considered a "medium involvement" conflict that is also eligible for waiver. According to the report, 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."

The report concluded 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 (R-IN) called on HHS Secretary Donna Shalala to implement reforms to crack down on conflicts of interest in the two committees. Burton wrote, "It has become clear over the course of this investigation that the [Vaccines and Related Biological Products Advisory Committee] and the [Advisory Committee on Immunizations Practices] 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." PR