Drug Industry Ties To
Medical Research Still Widespread
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 that
they had consulted for or received research money from the makers
of bone-strengthening drugs.
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
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 favoring 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