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?
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.
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.