NEWS - Study monitors may often have financial conflicts

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Study Monitors May Often Have Financial Conflicts (Update2)

By Fay Cortez

Nov. 29 (Bloomberg) -- About one-third of review-board members who monitor

patient studies at U.S. hospitals take money from companies whose products

are being tested, researchers say.

Institutional review boards, or IRBs, evaluate proposed studies to make sure

patients are protected and ethical standards are followed before they're

approved. The survey of 574 board members at academic centers found 36

percent had potential conflicts, including being paid for consulting or

speaking, receiving royalties or getting research funding.

The findings, published tomorrow in the New England Journal of Medicine,

come as the U.S. National Institutes of Health and scientific publications

are cracking down on financial links between medical professionals involved

in studies and drugmakers. The survey is the first to review such links

within IRBs, and shows conflicts often exist before a study even begins, the

researchers said.

" It's clear that people who have relationships with companies who are

sponsoring a study shouldn't be voting on those studies,'' said

, an assistant professor of health policy at Harvard Medical School

and Massachusetts General Hospital. ``More should be done and could be done

to inform and educate IRB members about what their institutions require and

what they should do about these relationships.''

Doctors, researchers and other staff members at medical centers volunteer to

serve on IRB committees. They aren't paid for the work, and the member lists

aren't public. In some cases, the researchers found that members didn't

disclose their ties, or didn't know the institutions rules.

Patients Don't Care

A second study found 90 percent of cancer patients enrolled in trials

weren't concerned about ties between their doctors, health care centers and

drug companies making the experimental medications they received. To most

patients, it didn't matter if their doctors owned company stock, received

royalties on drug sales, or were paid for other activity, the survey found.

The results suggest that disclosing possible conflicts to patients isn't an

effective or fair way to deal with financial ties between health providers

and industry, said Ezekiel Emanuel, chair of the clinical center at the

National Institutes of Health's department of clinical bioethics.

" We should stop thinking of the patient or the research participant as a

safeguard in any way,'' Emanuel, the senior author of the paper, said in an

interview today. :If you have a serious cancer, this is something you don't

want to focus on.''

Instead, researchers, academic centers, industry and public health officials

instead should ensure that the oversight system for dealing with conflicts

is in place and effective, he said.

" Participants are obviously trusting the institutions to get it right, and

it's the responsibility of the institution to do it right,'' said.

Didn't Know Procedures

In 's survey, one-third of IRB members didn't know the procedure for

disclosing conflicts of interest. About 15 percent said a proposal came

before their board in the last year from a company they had a relationship

with, or a competitor. Of them, 58 percent disclosed the conflict and

two-thirds didn't vote on the proposal.

The members weren't worried about the relationships. More than 85 percent

said conflicts that other members had never negatively affected the group's

decisions and almost 93 percent said the IRB always took appropriate action.

The fact that the members thought reviews were unbiased by financial

interests is reassuring, said Korn, senior vice president of the

Association of American Medical Colleges, in a telephone interview today.

The results are hard to interpret, he said, since the study didn't

differentiate between a $500 honorarium granted to one researcher and a

$10,000 or greater grant that federal agencies consider significant. In

addition, research funding from a specific company shouldn't create a

conflict for an individual member voting on another company proposal, he

said.

Shouldn't be Banned

People with conflicts shouldn't be banned from serving on institutional

review boards, or IRBs, doctors said. The close relationships can improve

cooperation, understanding and accelerate the pace of drug development,

though they must be disclosed and managed, according to and

Nabel, director of the National Heart, Lung and Blood Institute.

Still, the lack of knowledge about reporting relationships and the failure

of institutions to provide guidance about them raise questions about the

impact conflicts have on the protection of patients, Nabel wrote in an

editorial.

" Maintaining the public's trust in the research process and its willingness

to participate are paramount in ensuring the continued development of new

medical knowledge,'' she said. " And doing so requires vigilance and

transparency.''

To contact the reporter on this story: Fay Cortez in Minneapolis at

mcortez@...

Last Updated: November 29, 2006 18:54 EST

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Mayo Clinic in Rochester

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s Hopkins Medicine

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