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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panels, only to be withdrawn in less than a year after reports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.
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