Just days after announcing
a crackdown on researchers who do not disclose drug
company ties, the editor of a prestigious medical
journal says she was misled again — this time
by the authors of a study linking severe migraines
to heart attacks in women.
All six of the study's authors have done consulting
work or received research funding from makers of treatments
for migraines or heart-related problems. Their research
appears in Wednesday's Journal
of the American Medical Association, a week
after the crackdown was announced.
The authors said they did not report their financial
ties because they did not believe they were relevant
to the study.
Dr. Catherine DeAngelis, JAMA's editor in chief,
said journal editors did not know about the ties until
The Associated Press brought them to her attention
late last week.
"We'll get killed," she said, referring to the potential
damage to the journal's reputation.
She said she would have published the authors' associations
with drug makers had she known about them. "Let me
decide what's pertinent or not," DeAngelis said. "The
issue is not what can those companies possibly gain;
it is the issue of perception."
Last week, JAMA disclosed that the authors of a depression
study failed to report ties to makers of antidepressants.
And two months ago, the journal reported similar omissions
from authors of a study linking certain arthritis
drugs to cancer.
JAMA has long required researchers whose articles
it will publish to sign statements disclosing all
potential financial conflicts. An editorial last week
said JAMA was getting tougher as a result of the recent
breaches. JAMA's new policy, effective in January,
requires disclosures even before articles are accepted
for publication.
Other leading medical journals, including the
New England Journal of Medicine, JAMA's main
competitor, have disclosure requirements, but DeAngelis
said hers are the toughest. Editors say disclosures
are necessary to help readers judge the reliability
of research.
JAMA posted a letter online Tuesday from the authors
explaining the omissions, DeAngelis' response and
a correction. DeAngelis said they would also be published
in an upcoming print edition of the journal.
"Authors should always err on the side of full disclosure,"
she wrote in her response.
Dr. Tobias Kurth, the study's lead author, said the
researchers were not trying to mislead the journal.
He said they believed their financial ties were irrelevant
because the study does not promote drug treatment,
but rather reports a potential link between women
with severe migraines and an increased risk of heart
attacks.
"They do not represent a conflict of interest," he
said in a telephone interview.
Kurth, a scientist at Harvard's Brigham and Women's
Hospital, said he has received research funding from
the makers of Bayer aspirin, Tylenol and Advil —
pain relievers sometimes used to treat migraines.
Co-author Nancy Cook said in an e-mail that she received
"minor compensation" for a one-time consulting stint
for Bayer, but that she did not think it was relevant
to her work on the migraine study.
"I do believe that conflicts sometimes exist and
should be disclosed, but I hope this issue does not
get overblown by the media," Cook said. "I think that
could harm the reputations of honest and well-meaning
researchers and lead to public mistrust where none
is warranted."
Dr. Frederick Freitag, a Chicago migraine specialist
not involved in the study, said the ties should have
been reported, even if they had no effect on the research.
"You still owe it as a matter of appropriate disclosure
to lay your cards on the table" or risk having somebody
ask, "What are you hiding?" he said.
Freitag said he has ties with numerous drug companies
because they fund important research.
Dr. Jerome Kassirer, a former New England Journal
editor and outspoken critic of drug company influence
over doctors, said JAMA editors appear not to have
done their homework. "It sounds like they're being
sloppy," he said.
DeAngelis said that the criticism is unfair, and
that JAMA lacks the manpower to check every researcher's
background. "I'm not God and I'm not the
FBI," she said.
She said the publicity probably will make others
who haven't disclosed potential conflicts reconsider.
"I suspect we are going to have a whole bunch of
disclosures over the next few weeks because authors
are going to see how dead serious we are," DeAngelis
said.
