Fracture study in medical journal renews debate over researchers' financial ties
- From: TC <tunderbar@xxxxxxxxxxx>
- Date: Wed, 25 Jul 2007 16:46:00 -0000
http://www.medbroadcast.com/channel_health_news_details.asp?news_id=12942&rss=67&rid=999999&channel_id=1001&rot=3
Fracture study in medical journal renews debate over researchers'
financial ties
Jul. 24, 2007
Provided by: Canadian Press
Written by: LINDSEY TANNER
CHICAGO (AP) - A new study showing that padded hip protectors didn't
prevent fractures in the elderly has renewed questions about hidden
drug industry ties to medical research.
Three of the authors of the study on bone breaks didn't tell editors
of an influential medical journal, which is publishing their research
Wednesday, that they had consulted for or received research money from
the makers of bone-strengthening drugs. That potential conflict was
discovered by The Associated Press.
Editors of the Journal of the American Medical Association - which has
tough rules on financial disclosure - had asked the authors about any
conflicts and were told there were none. The researchers said later
they didn't believe their industry connections were relevant because
the study of hip fractures didn't involve bone drugs and didn't
recommend them.
The editor of JAMA agrees. Dr. Catherine DeAngelis said that in this
case, the drug company connections didn't violate the journal's
detailed financial disclosure policy.
DeAngelis said she believes her journal is being unfairly scrutinized
by The AP, which found the researchers' ties to drug companies through
searches on the Internet and through a consumer database.
"This has nothing to do with drugs," she said. "At what point do you
say, 'Come on, is this a witch hunt?' "
Undisclosed corporate ties by scientists affect other journals, too.
Yet editors of JAMA essentially made the journal a lightning rod for
the issue last year when they toughened their financial disclosure for
authors and announced the changes in an editorial.
A close reading of JAMA's guidelines suggests the fracture study
authors' ties to drug makers are "clearly relevant," said Dr. Michael
Callaham, president of the World Association of Medical Editors. "It's
a slam dunk," he said.
A consumer advocate with the Center for Science in the Public Interest
agrees. Readers could easily interpret the study to say that since hip
protectors don't work, "I guess I better take the drugs," even if
that's not what the authors intended, said Merrill Goozner. The
consumer advocacy group runs a database on scientists' financial ties,
an effort to combat corporate influence on science.
In this case, reporting such ties "seems to me to be a no-brainer,"
Goozner said.
There is strong evidence that studies funded by industry or done by
researchers with industry ties are more likely to have results
favouring corporate interests.
Disclosing those ties enables readers to better judge a study's
credibility. While many journals have added or improved disclosure
policies, standards vary widely. There's no consensus on what
constitutes relevant financial interests.
The hip protector study "is a nice illustration of how complicated it
can be," Callaham said. "It's a huge problem and I think we haven't
gotten very far in addressing it."
Callaham said there's a move toward more uniform standards, but with
thousands of medical journals worldwide, it's a challenging task.
JAMA announced its tightened disclosure policies in July 2006 after
twice in two months, researchers failed to report financial ties to
industry.
Days later, The Associated Press discovered another breach in which
authors of a JAMA study linking severe migraines with heart attacks in
women failed to disclose ties to makers of drugs for migraines or
heart-related problems. That led to a published correction and
explanation from the authors who didn't think their ties were
relevant.
C.K. Gunsalus, special counsel at University of Illinois and an expert
on ethics and integrity in research, said failure to disclose often is
an innocent mistake.
"People say, 'I know my heart is pure,"' she said. "You minimize your
own conflicts."
Still, the onus to disclose ties is on the researcher, she said, and
it would be difficult for journals to crack down by investigating
every author who submits a study manuscript.
In the latest case, the new study involved 1,042 nursing home
residents who were assigned to wear a cushiony pad on only one hip.
Results over several months showed just as many fractures on the
padded hip as on the unprotected side.
The hip pad in the study is no longer on the market, but lead author
Dr. Douglas Kiel, a Harvard Medical School researcher, said the
results probably would be similar for other "energy absorbing" cushion-
like pads still being sold.
Previous studies on hip protectors and fractures have produced
conflicting results.
A JAMA editorial called the new study's results inconclusive. Hip
protectors are designed to be worn on both hips; wearing it on only
one side might increase chances of a dangerous fall onto the protected
hip, the editorial said.
Kiel said the study was broadened to examine an improved pad and that
results are due soon.
He said bone-building drugs could be one of several options to hip
protectors for older patients, but that they are not ideal for nursing
home residents because they take a year or more to work and these
patients often are already taking many other drugs. But he also said
the drug company money he and his colleagues have received is not
relevant to the current study because it wasn't a comparison of both
treatments.
"We have no financial disclosures with hip protectors," Kiel said. "We
were asked repeatedly by the editors whether we were following JAMA's
full disclosures and we said yes."
.
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