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The best way to calm down concerns about doctors' and
researchers' financial conflicts of interest is to require full disclosure,
according to an expert report that adds its voice to a growing chorus. A panel
of the National Academies' Institute of Medicine (IOM) says faculty
members at medical institutions should be required to report all industry
money they receive from outside their institution to special
committees. {{U}} {{U}} 1 {{/U}} {{/U}}But
IOM's mostly voluntary plan has an important selling point, some say: It could
head off more-intrusive federal regulations. Panel members agreed that some
action is called for. "Many relationships between researchers and industry
are very constructive, but it has to be overseen and kept in bounds," says panel
chair Bernard Lo, a bioethicist at the University of California, San
Francisco. {{U}} {{U}} 2 {{/U}} {{/U}}Similar
concerns resulted in a ban on all such payments to scientists at National
Institutes of Health, Lo notes. More recently, as part of an ongoing
investigation, Senator Chuck Grassley has identified several psychiatrists who
allegedly failed to disclose hundreds of thousands of dollars in consulting
income. Disclosure is "a critical but limited first step"
toward addressing conflicts of interest, the IOM panel concludes. {{U}}
{{U}} 3 {{/U}} {{/U}}Companies should also disclose money given to
institutions, scientific societies, patient groups, and basic researchers, the
report says, because their work can lead to clinical trials.
Three of the 17 panel members recommended that physicians and researchers
themselves also be required to publicly report their financial ties with
companies, including stock.{{U}} {{U}} 4 {{/U}} {{/U}}
As a rule, the report says, institutions should ensure that if a
significant conflict exists, a researcher "may not conduct
research with human participants" unless his
or her role is essential to the
research.{{U}} {{U}} 5 {{/U}} {{/U}} Many of
these steps have been recommended in past reports from the Association of
American Medical Colleges (AAMC), which has also endorsed the company payments
database. But not all schools have followed AAMC's advice. "We give a
pretty clear warning," Lo says. "If the institutions don't get their act
together, they're really inviting the legislators to step in."
A. It urges research and physician organizations to develop a standard reporting
format. And it endorses a proposal similar to one from Grassley to require that
drug and device companies report payments to physicians in a public
database. B. That, he warns, could lead to "very, very blunt"
regulations and "a risk that valuable relationships will be cut in ways that
will hurt patients." C. The policy recommended by IOM would be
far more intrusive than current U.S. rules, which require National Institutes of
Health grantees to report to their own institutions outside income of more than
$10,000 per year. D. The report also recormnends that
institutions ban faculty members from accepting drug company gifts, serving as a
spokesperson for a company, and authoring articles ghost-written by
industry. E. Such payments would also have to be reported
publicly by the companies. F. But the others disagreed partly
because they felt it would be expensive, could intrude on privacy, and would not
add much to the company database. G. IOM decided to undertake
the study two years ago amid growing concerns that academic researchers who took
drug company payments were withholding data from publication or otherwise
biasing results.