Congress hits FDA, CDC on vaccine conflicts of interest

Source: ICIS News

2000/08/23

WASHINGTON (CNI)--A Congressional committee Wednesday accused the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) of "routine" conflicts of interest by allowing scientists with ties to the drug industry to serve on policy advisory committees.

A report issued Wednesday by Republican staff members of the House Government Committee concludes that "conflict of interest rules employed by the FDA and the CDC have been weak, enforcement has been lax, and [advisory] committee members with substantial ties to pharmaceutical companies have been given waivers to participate in committee proceedings."

In a 10 August letter, Government Committee Chairman Dan Burton (Republican-Indiana) called on Health and Human Services (HHS) Secretary Donna Shalala to implement reforms to crack down on conflicts of interest on the FDA and CDC committees.

One panel makes recommendations to the FDA on the approval of new vaccines, while the other advises the CDC on guidelines for the administration of vaccines.

The House 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. The drug won unanimous votes of support in both committees.

But within one year, Wyeth Lederle's Rotashield vaccine was pulled from the market after it was linked to severe bowel obstructions in more than 100 infants.

According to the report, 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 of interest because of connections with the same companies, according to the Congressional report.

The staff report concludes that the FDA and CDC advisory committees demonstrated "a lack of vigilance" in their review of the rotavirus vaccine, with the CDC's committee rushing to approve guidelines for the drug even before the FDA had licensed it.

In his letter to Shalala, Burton said: "It has become clear over the course of this investigation that the [FDA-CDC advisory panels] 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."

An FDA spokeswoman said the agency "goes out of its way" to make sure that members of its advisory committees are acting in an ethical manner. She also noted that there are few infectious disease experts, making crossover with the drug industry likely.