In 2001, the American Journal of Kidney
Diseases published an article that touted the use of synthetic
vitamin D. Its author was listed as Alex J. Brown, an
associate professor at Washington University in St. Louis.
But recently, that same article was featured as a work
sample by a different person: Michael Anello, a free-lance
medical writer, who posted a summary of it on his Web
site. Mr. Anello says he was hired to write the article
by a communications firm working for Abbott Laboratories,
which makes a version of the vitamin D product. Dr. Brown
agrees he got help in writing but says he redid part of
the draft.
It's an example of an open secret in medicine: Many
of the articles that appear in scientific journals under
the bylines of prominent academics are actually written
by ghostwriters in the pay of drug companies. These seemingly
objective articles, which doctors around the world use
to guide their care of patients, are often part of a marketing
campaign by companies to promote a product or play up
the condition it treats.
Now questions about the practice are mounting as medical
journals face unprecedented scrutiny of their role as
gatekeeper for scientific information. Last week, the
New England Journal of Medicine admitted that a 2000 article
it published highlighting the advantages of Merck &
Co.'s Vioxx painkiller omitted information about heart
attacks among patients taking the drug. The journal has
said the deletions were made by someone working from a
Merck computer. Merck says the heart attacks happened
after the study's cutoff date and it did nothing wrong.
The Annals of Internal Medicine tightened its policies
on writer disclosure this year after a University of Arizona
professor listed as the lead author of a Vioxx article
in 2003 said he had little to do with the research in
it.
The practice of letting ghostwriters hired by communications
firms draft journal articles -- sometimes with acknowledgment,
often without -- has served many parties well. Academic
scientists can more easily pile up high-profile publications,
the main currency of advancement. Journal editors get
clearly written articles that look authoritative because
of their well-credentialed authors.
Increasingly, though, editors and some academics are
stepping forward to criticize the practice, saying it
could hurt patients by giving doctors biased information.
"Scientific research is not public relations," says Robert
Califf, vice chancellor of clinical research at Duke University
Medical Center. "If you're a firm hired by a company trying
to sell a product, it's an entirely different thing than
having an open mind for scientific inquiry. ... What would
happen to a PR firm that wrote a paper that said this
product stinks? Do you think their contract would be renewed?"
Drug companies say they're providing a service to busy
academic researchers, some of whom may not be skilled
writers. The companies say they don't intend for their
ghostwriters to bias the tone of articles that appear
under the researchers' names.
Authors "have to sign off on everything," says Mark
Horn, a Pfizer Inc. medical director. "This is properly
viewed as a way to more efficiently make the transition
from raw data to finished manuscript." Professors who
get writing help generally say they give the writers input
and check the work carefully.
The criticism of ghostwriting is one of several issues
that have put scientific journals on the defensive. Even
journal editors acknowledge they have sometimes done a
poor job of detecting when articles cherry-pick favorable
data to promote a particular drug or treatment. Some health
insurers have stopped taking what they read in the journals
on faith and are employing analysts to scrutinize articles
for negative data that are buried.
It's hard to say how widespread ghostwriting is. An
analysis presented at a medical-journal conference in
September found that just 10 percent of articles on studies
sponsored by the drug industry that appeared in top medical
journals disclosed help from a medical writer. Often the
help isn't disclosed. An informal poll of 71 free-lance
medical writers by the American Medical Writers Association
found that 80 percent had written at least one manuscript
that didn't mention their contributions.
In the case of the vitamin D article, Dr. Brown says
Abbott asked him to write it but he didn't have time.
He had written an earlier article on the subject. "They
said they would have one of their people write it, update
my old review article and I would check it," he recalls.
Mr. Anello, a Milwaukee writer who studied biochemistry
at the University of Wisconsin, says he wrote the new
article. "I've done a lot of ghostwriting jobs," he says,
adding that sometimes he works closely with the named
authors.
Dr. Brown says he had to rewrite "at least 30 percent
to 40 percent" of Mr. Anello's draft. In retrospect, he
says, he probably should have asked Abbott who Mr. Anello
was and "if that person should be acknowledged." Abbott
said the article's content was "under the complete discretion"
of Dr. Brown and didn't discuss details. The journal's
managing editor declined to comment because the journal
is under new management.
Following questions from The Wall Street Journal, Mr.
Anello removed the article summary from his Web site.
Until recently, his online bibliography listed other scientific
publications he has written under others' bylines that
have yet to be published. The byline on one was "author
to be named."
Medical writers frequently have scientific backgrounds.
Some work for universities, drug companies or medical-communications
firms, while others are free-lancers who typically get
$90 to $120 an hour. A communications firm may charge
$30,000 or more to have a team of writers, editors and
graphic designers put together an article. Some of these
firms are part of larger companies in publishing and advertising
such as Thomson Corp. and Reed Elsevier PLC.
Elsevier's Excerpta Medica unit helps clients craft
publications for prestigious scientific journals. Elsevier
itself publishes many such journals, most notably The
Lancet. Excerpta Medica says on its Web site that its
relationship with its corporate parent's journals "allows
us access to editors and editorial boards."
But Sabine Kleinert, an executive editor at The Lancet,
says she has never worked with Excerpta Medica and rejects
articles that have a marketing spin. "Promotion has a
different goal than publishing a legitimate research study,"
says Dr. Kleinert. She suspects companies sometimes influence
medical writers "to write it up in a certain way to make
a product sound more efficacious than it is."
A 1999 document that turned up in a lawsuit describes
Pfizer's publications strategy for its antidepressant
Zoloft. The document, prepared by a unit of ad giant WPP
Group, includes 81 different articles proposed for journals.
They would promote the drug's use in conditions from panic
disorder to pedophilia.
For some articles, the name of the author was listed
as "TBD," or "to be determined," even though the article
or a draft was listed as already completed. Several of
the listed articles ultimately ran in scientific publications
-- including one in JAMA, the Journal of the American
Medical Association -- without disclosing the role of
outside writers.
In a statement responding to questions from The Wall
Street Journal, Pfizer said agencies sometimes "pull together
first draft manuscripts" based on information provided
by researchers who will serve as authors. It says the
academics who were later given credit as lead authors
of the "TBD" articles were instrumental in designing the
studies that the articles described. The lead authors
said they had input into the drafts and approved the final
papers.
In recent years, more journal editors have begun demanding
that academic authors of studies explain their exact roles
and disclose any work by medical writers. The editors
say the writers can perform a valuable role so long as
it's disclosed to readers.
Writers agree -- and the American Medical Writers Association
is pressing for greater acknowledgment of its members'
work. But some medical writers say they fear articles
with full disclosure are likely to get bounced. Editors
"say they want disclosure, but if you do it, they scream,
'ghostwriter!' " says Art Gertel, who oversees medical
writing at Beardsworth Consulting Group in Flemington,
N.J. "Despite the cries for transparency, the journal
editors still feel that there's an element of corruption
if a medical writer is paid by a drug company."
Catherine DeAngelis, JAMA's editor in chief, says even
a conscientious journal can only go so far in policing
academics. "I don't give lie-detector tests to people,"
Dr. DeAngelis says.
BMJ, a British medical journal, has one of the toughest
disclosure policies, but it can get misled. Last year,
a note at the end of a BMJ article on painkillers and
asthma said the article was "conceived and initiated"
by its three academic authors. Lead author Christine Jenkins
"performed the analysis and drafted the paper," the note
said, adding that the work wasn't funded by a drug company.
Dr. Jenkins is a senior researcher at Australia's Woolcock
Institute of Medical Research, which has ties to the University
of Sydney.
In fact, a medical writer paid by GlaxoSmithKline PLC
helped draft the manuscript, the drug company confirms.
The analysis was almost identical to an earlier, unpublished
one that the company says was "initiated" by that writer.
Both analyses concluded that acetaminophen or Tylenol
(sold under a different name by GlaxoSmithKline in Britain)
was safer for asthma patients than aspirin or other painkillers.
Dr. Jenkins says the structure of her work was "suggested"
by the company version but she and the other authors did
their own analysis. Dr. Jenkins says she personally "wrote
a very large chunk" of the BMJ article and worked closely
with the writer. Dr. Jenkins and GlaxoSmithKline declined
to give the writer's name.
Dr. Jenkins says she didn't know that the company paid
the writer. GlaxoSmithKline didn't pay Dr. Jenkins for
the BMJ article, but the company previously paid her to
speak at a conference and has given a major grant to the
Woolcock Institute.
In a statement, GlaxoSmithKline says the paper "should
have disclosed the involvement of a medical writer compensated
by GSK." The company says it "regards the omission as
a lapse on the part of GSK."
Fiona Godlee, BMJ's editor, says Dr. Jenkins "should
have declared the involvement of the medical writer."
Dr. Godlee says the journal will print papers that involve
a medical writer, but she believes "the actual authors
have to be incredibly closely involved."
When articles are ghostwritten by someone paid by a
company, the big question is whether the article gets
slanted. That's what one former free-lance medical writer
alleges she was told to do by a company hired by Johnson
& Johnson.
Susanna Dodgson, who holds a doctorate in physiology,
says she was hired in 2002 by Excerpta Medica, the Elsevier
medical-communications firm, to write an article about
J&J's anemia drug Eprex. A J&J unit had
sponsored a study measuring whether Eprex patients could
do well taking the drug only once a week. The company
was facing competition from a rival drug sold by Amgen
Inc. that could be given once a week or less.
Dr. Dodgson says she was given an instruction sheet
directing her to emphasize the "main message of the study"
-- that 79.3 percent of people with anemia had done well
on a once-a-week Eprex dose. In fact, only 63.2 percent
of patients responded well as defined by the original
study protocol, according to a report she was provided.
That report said the study's goal "could not be reached."
Both the instruction sheet and the report were viewed
by The Wall Street Journal. The higher figure Dr. Dodgson
was asked to highlight used a broader definition of success
and excluded patients who dropped out of the trial or
didn't adhere to all its rules.
The instructions noted that some patients on large doses
didn't seem to do well with the once-weekly administration
but warned that this point "has not been discussed with
marketing and is not definitive!"
The Eprex study appeared last year in the journal Clinical
Nephrology, highlighting the 79.3 percent figure without
mentioning the lower one. The article didn't acknowledge
Dr. Dodgson or Excerpta Medica. Dr. Dodgson, who now teaches
medical writing at the University of the Sciences in Philadelphia,
says she didn't like the Eprex assignment "but I had to
earn a living."
The listed lead author, Paul Barre of McGill University
in Montreal, says Excerpta Medica did "a lot of the scutwork"
but he had "complete freedom" to change its drafts. Dr.
Barre says he helped design the study and enroll patients
in it. In statements, J&J and Excerpta Medica
offered similar explanations of the process. J&J
says it regularly uses outside firms "to expedite the
development of independent, peer-reviewed publications."
A J&J spokesman said he wasn't familiar with
the details of the instruction sheet and referred questions
about the highlighted data to Dr. Barre, who said he never
interacted with J&J's marketing department and
doesn't believe the article was biased. He said the higher
figure was "more representative" because those patients
followed the study's rules. "Without wanting to distort
data, you always want to put the spin that's more positive
for the article," Dr. Barre says. "You're more likely
to get it published."
Hartmut Malluche, an editor of Clinical Nephrology,
declined to comment on details of the article. The journal
doesn't require authors to disclose the role of medical
writers. But after hearing Dr. Dodgson's story, Dr. Malluche
said he would suggest changing the policy. "It's not good
if the company has control over the article," he says.
Some academics are protesting ghostwriting. Adriane
Fugh-Berman, an associate professor at the Georgetown
University School of Medicine, says she received an email
last year from a company hired by drug maker AstraZeneca
PLC. The email offered her the chance to get credit for
writing an article. " ... (W)e will forward you a draft
for your input so that you would need only to review and
then advise us of any changes required," it said.
She says she was shown a draft but declined the offer.
Then the Journal of General Internal Medicine asked her
to peer-review a version of the same article, submitted
by a different researcher. She decided to go public, and
wrote about her experience in the journal.
AstraZeneca and the communications firm say it was all
a mistake. Dr. Fugh-Berman should have been shown a different
article from the one she was later asked to peer-review,
they say. The article for peer review was in fact written
by the author who submitted it to the journal, they say.
AstraZeneca says it "does not support the practice of
ghostwriting" and always discloses any support it gives
to academic authors.
John Farrar, a pain expert at the University of Pennsylvania,
says he once turned down a company's offer to give him
a ghostwritten draft about a study on which he had worked.
"They said, 'That's unusual,' " Dr. Farrar recalls. He
wanted to write the manuscript himself because "you can
put your spin on it. ... The way it is written -- the
way it's structured -- is yours."