US government officials are failing to enforce conflict of interest regulations and are allowing experts with industry ties to sit on vaccine approval panels, charges a US Congressional committee report.

The report was prepared by the House Committee on Government Reforms, whose chairman, Dan Burton, has been an outspoken critic of US vaccination policies. Burton, a conservative Republican from Indiana, believes his grandson may have developed autism as the result of vaccinations.

The report focuses on two expert panels involved in the recent approval of a vaccine against rotavirus developed by Wyeth Lederle Vaccines and Pediatrics, called RotaShield (see Lancet 2000; 356: 318-22). This vaccine was approved in December, 1997, after favourable review by the panels, only to be withdrawn in less than a year after reports suggested that there might be a link between the vaccine and cases of bowel obstruction due to intussusception.

The committee investigators found that both panels -- the Vaccines and Related Biological Products Advisory Committee, which makes recommendations on the approval of new vaccines to the US Food and Drug Administration (FDA), and the Advisory Committee on Immunisation Practices, which advises the US Centers for Disease Control and Prevention (CDC) -- included experts who appeared to have conflicts of interest.

Some committee members owned stock in companies producing similar vaccines; others had received honoraria and grants from companies and institutions that stood to gain should the vaccine be approved; and several worked from institutions that had financial ties to companies with interests in the decision.

"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", charges the report.

Linda Suydam, senior associate commissioner of the FDA who oversees the selection of the FDA's advisory panels says her agency requires all panellists to disclose conflicts of interest. And when these interests are substantial panellists are not allowed to participate in panel deliberations.

But she noted that many top scientists in a field have ties to pharmaceutical companies and in making its selections the FDA must "balance the expertise they can bring with their ties to industry".

Suydam also noted that many of the industry ties described in the committee report involved researchers whose universities had received grants or had contracts with pharmaceutical companies, often for projects unrelated to the researchers' work. Such "institutional ties", she argues, should not be grounds for excluding an expert from participation.

Michael McCarthy

Lancet September 2, 2000; 356: 837 - 840.