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Hospital IRBs are "On the Take"--Tainted by Conflicts ofInterest_NEJM Print E-mail
Wednesday, 29 November 2006
A study in The New England Journal of Medicine shatters the last myth about the integrity of the current system of checks and balances in medical research.

Those who approve research protocols, ethics committees--called, institutional review boards, IRB--are riddled with conflicts of interest. 
 
In the study, led by Eric Campbell of Massachusetts General Hospital and Harvard Medical School, 575 members of IRBs at 100 universities were surveyed; they were promised anonymity.

About 36% - or more than 200 respondents - reported at least one form of industry financial ties in the previous year. Roughly 15% - or about 80 respondents - said that in the previous year, they were asked to review at least one research study that was sponsored by a company with which they had a relationship or by a competitor of that company. Both situations constitute a conflict of interest, the study's authors noted.

Of those respondents, more than half said they always disclosed their conflict to other board members, but 35 percent said they rarely or never did.  Bottom line: Nearly one in five said that regardless of their conflicting ties, they always voted on whether to approve the proposed clinical study.

Like the doctors, the researchers, the instituions, and government agencies, IRBs are  "On the Take" (that's the title of a book by Dr. Jerome Kassirer, a former editor of the NEJM).


Contact: Vera Hassner Sharav
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http://www.msnbc.msn.com/id/15954759/ Hospital boards too closely tied to industry Panels that oversee experiments tainted by conflicts of interest, study finds
The Associated Press
Updated: 7:33 p.m. ET Nov 29, 2006

A survey of hospital review boards that watchdog experiments on patients
shows that one in three members takes money from companies that make drugs
and medical devices that come under study.

What's more, many of those with conflicts rarely or never disclose their
financial ties, researchers found.
The study of 100 university medical centers is said to be the first to look
at financial conflicts of interest on hospitals' institutional review
boards. IRBs are little-known committees responsible for protecting patients
in research experiments.

The study's findings are alarming, said some patient advocates.
If the review board "is riddled with financial conflicts of interest, it's
not going to be as protective as it should be," said Dr. Sidney Wolfe,
director of the Public Citizen's Health Research Group.
The study was published in this week's issue of the New England Journal of
Medicine.

Corporate funding of medical research is common and a mainstay in the
translation of scientific discoveries into medical treatments. But in the
last five years, there has been heightened scrutiny of the financial ties
between researchers and the companies that make experimental drugs and
devices. The question: Do medical researchers always act in the best interest of
science - or patients - if they are also getting royalties, consulting fees
or other benefits from the makers of the products being tested?

Volunteer boards
All federally funded research must be reviewed and approved by IRBs, which
consider patient safety as well as ethical conflicts. Most members of these
boards are volunteers, usually doctors or scientists themselves, who get no
extra pay for their service.

They are expected to be more sensitive to ethical concerns than the
researchers they monitor, said Dr. Jerome Kassirer, a former New England
Journal of Medicine editor who wrote a book in 2005 on medical conflicts of
interest.

Now researchers are "finally getting around to looking at all the ways that
pharmaceutical companies can have an adverse influence on health," Kassirer
added.

In the study, led by Eric Campbell of Massachusetts General Hospital and
Harvard Medical School, 575 members of IRBs at 100 universities were
surveyed; they were promised anonymity.
About 36 percent - or more than 200 respondents - reported at least one form
of industry financial ties in the previous year.

Roughly 15 percent - or about 80 respondents - said that in the previous
year, they were asked to review at least one research study that was
sponsored by a company with which they had a relationship or by a competitor
of that company. Both situations constitute a conflict of interest, the
study's authors noted.

Of those respondents, more than half said they always disclosed their
conflict to other board members, but 35 percent said they rarely or never
did. Nearly one in five said that regardless of their conflicting ties, they
always voted on whether to approve the proposed clinical study.

Federal regulations bar IRB members from voting in a review of a study in
which they have a conflict of interest. "This (the study's results) reflect
a significant lack of law enforcement," Wolfe said.

Lack of awareness
It may also reflect a lack of awareness, said Campbell, the lead author.
Of all the study's respondents, fewer than half said their review boards had
a formal written definition of what makes a conflict of interest.

As for patients, a second study published in the journal, suggested that
those fighting for their lives were more focused on being cured than
worrying about conflicts of interest by researchers.

The study, led by researchers at the National Institutes of Health, involved
cancer patients enrolled in clinical trials. Most said such conflicts did
not worry them, and 77 percent knew little about the issue.

C 2006 The Associated Press. All rights reserved. This material may not be
published, broadcast, rewritten or redistributed.

C 2006 MSNBC.com 

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