Drug companies' marketing efforts
may sometimes be more subtle than pens emblazoned
with their product's name or full-page ads in leading
medical journals.
Some journal editors say they
regularly receive submissions that appear to be written
by the drugmakers' marketing machines, not the scientists
whose names appear as authors.
Such a practice would violate
the guidelines of the Pharmaceutical Research and
Manufacturers of America, or PhRMA, the prescription
drug industry's trade group, on the communication
of clinical trial results. According to the PhRMA
guidelines, anyone involved in analyzing, interpreting
or writing up clinical trial data "should be recognized
appropriately in resulting publications."
It is not known what proportion
of papers submitted to medical journals are ghostwritten.
But of the 70 to 80 manuscripts her journal receives
each month, two to four present suspiciously glowing
reports of a drug's benefits or excessively critical
appraisals of its competitors, says Martha Gerrity,
co-editor of the Journal of General Internal Medicine.
Many are reviews of previous research and not new
clinical trial findings, she says.
"What is surprising is the growth
in the number of manuscripts where the pharmaceutical
industry is trying to manipulate the medical literature,"
says Gerrity, of the Oregon Health & Science University
in Portland. Her journal posted a commentary online
about one such article last month.
Adriane Fugh-Berman, an adjunct
associate professor of physiology and biophysics at
Georgetown University, described how a British medical
education company, on a drugmaker's behalf, asked
her about a year ago to write a piece about interactions
between herbs and warfarin, a generic anticoagulant,
or blood thinner. When the company sent her a one-sided
draft under her byline, Fugh-Berman says, she declined
to get involved.
Months later, slightly reworked
and under a different byline, the paper was submitted
to the Journal of General Internal Medicine
The article came full circle when the journal's editors
asked Fugh-Berman, known for her expertise on herbal
supplements, to review it. When she told the editors
of the paper's history, they rejected it.
"Diligence of medical editors
and reviewers will continue to be the first line of
defense against the sullying of the medical literature
by biased 'reviews' whose motivation is commercial,
not scientific," Gerrity and co-editor William Tierney
wrote in an editorial accompanying Fugh-Berman's commentary.
In response to the warfarin article
incident, the World Association of Medical Editors
posted a statement online calling the ghostwriting
of manuscripts "dishonest and unacceptable."
Catherine DeAngelis, editor of
The Journal of the American Medical Association,
says, "This has been going on forever." Before she
became an editor, DeAngelis says, she got a call a
month asking her to put her name on a paper she didn't
write, a practice she describes as "manipulation by
for-profits to alter what's in the (medical) literature
so they could sell their products."
Gerrity's journal doesn't name
names, but Fugh-Berman says the education company
approached her on behalf of AstraZeneca, which was
seeking Food and Drug Administration approval of Exanta,
a new anticoagulant. The FDA eventually rejected Exanta.
"The manuscript will be completely
objective, and there will be no promotion of any drug,"
an education company employee said in an introductory
e-mail to Fugh-Berman. "It is intended to highlight
the inadequacies of current anticoagulation treatment
and practices."
Valerie Siddall, AstraZeneca's
head of global publications, says the drugmaker "made
no secret of the fact that we actually are very interested
and very active in anticoagulants as an area of research."
But, she says, the medical education
company made "a really awful error" in presenting
Fugh-Berman with a completed manuscript before getting
her input.
Siddall says the named author
of the version submitted to the internal medicine
journal "had full editorial control about what went
in the paper.