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Fewer Medical Journal Articles Planted by Phantom Authors 4-14-08
BALTIMORE, April 14 -- The day of using skilled writers with dubious agendas
to secretly turn out journal articles for ostensibly independent researchers may
be largely past, according to insiders.
After a spate of scandals involving high-profile ghost-authored papers published
in the 1990s and early 2000s, accusations of more recent wrong-doing are hard to
come by, MedPage Today has found.
"I don't have data, but my impression is that ghost-authoring is declining,"
said Michael Altus, Ph.D., of Baltimore, a freelance medical communications
writer who said he had done some of this kind of work himself in the 1990s.
To be sure, when done with proper acknowledgment and without serving a corporate
agenda, some ghostwriting is tolerated and even welcomed by journal editors as
well as researchers.
"Even some of the best academic institutions hire substantial numbers of people
who are medical writers and medical editors to help their researchers write
their papers, clearer papers," said George Lundberg, M.D., editor-in-chief of
Medscape Journal of Medicine and a former editor of the Journal of the American
Medical Association.
"I don't think that's bad," he added. "As an editor, I like to receive a paper
that's well written."
Indeed, even critics of ghostwriting acknowledge that it has benefits beyond
readability. For example, it may allow publication of more information than
might happen if senior clinicians had to undertake it without assistance.
But a stream of incidents suggests that ghostwriting sometimes had become
ghost-authoring. A writer -- often hired by a medical communications company
working for a drug or device firm -- would draft an article from scratch and
then a bona fide, ostensibly independent scientist is recruited to serve as
"author."
The nominal author may be paid in cash. But more often, the reward is simply a
publication that requires little or no work.
The scientist is usually given a free hand to edit the article, but in most
cases the original concept and much of the wording remains the company's.
Veterans of the pharmaceutical industry said such arrangements were commonplace
for many years.
However, a series of well-publicized scandals earlier this decade put the
practice in a harsh spotlight, leading the major journals to tighten their
policies.
A 2003 investigation published in the British Journal of Psychiatry found that a
medical communications company hired by Pfizer had spearheaded publication of 55
papers about sertraline (Zoloft) in the peer-reviewed literature.
The British Journal of Psychiatry authors, David Healy, M.D., and Dinah Cattell,
R.M.N., of the University of Wales, unearthed court papers revealing that the
company kept close tabs on the status of papers in the publishing pipeline.
Several papers had authors listed as "TBD," suggesting ghostwriters had produced
them but scientist-authors had not been lined up.
They also found evidence that in many cases, the nominal authors of papers did
not have full access to the data they were ostensibly reporting.
Allegations also arose that Warner-Lambert, which Pfizer acquired in 2000, had
used ghostwriters in a market-building campaign for gabapentin (Neurontin), also
based on internal company papers obtained during litigation.
In early 2005, Adriane Fugh-Berman, M.D., a complementary medicine researcher at
Georgetown University, reported in the Journal of General Internal Medicine that
she had been approached to serve as author of an already-drafted review article.
She rejected the offer, only to see a "revised but recognizable version of the
manuscript," under another researcher's name, sent to her by JGIM for peer
review. It also appeared to be part of a market-building campaign on behalf of
an investigational drug being developed by AstraZeneca, she said.
Later that same year, the New York Times published an investigation of Merck's
reporting of the ADVANTAGE trial, one of several it sponsored to compare
rofecoxib (Vioxx) to naproxen.
It quoted the lead author of a study of rofexocib, published in the Annals of
Internal Medicine in 2003, as saying that the drug's manufacturer had actually
written the paper.
"Merck designed the trial, paid for the trial, ran the trial," Jeffrey Lisse,
M.D., of the University of Arizona, told the newspaper. "Merck came to me after
the study was completed and said, 'We want your help to work on the paper.' The
initial paper was written at Merck, and then it was sent to me for editing."
News reports and outraged commentaries about industry-sponsored ghost-authoring
sprang up across the lay media. The Wall Street Journal produced its own expose
in late 2005, with reports appearing in Forbes, BusinessWeek, and other
high-profile publications as well.
Since then, journals and the medical communications industry have sought -- at
least rhetorically -- to put an end to unethical ghost authorship.
Spurred in part by the episode reported by Dr. Fugh-Berman, the World
Association of Medical Editors in 2005 adopted a statement calling ghost
authorship "dishonest and unacceptable." It said that hired medical writers "can
be legitimate contributors," but their roles and affiliations should be
described in the manuscript.
A model developed by the International Committee of Medical Journal Editors sets
a three-part test that researchers must meet in order to be listed as an author.
It's been adopted by the New England Journal of Medicine, JAMA, and other major
journals.
Under these rules, authors must have made substantial contributions to the study
conception, design, or data acquisition or interpretation underlying the paper;
they must have helped in the writing; and they must give final approval of the
version to be published.
Pharmaceutical and medical communications companies have gotten into the act
too. The Pharmaceutical Research and Manufacturers Association in Washington has
issued ethical guidelines that do not allow ghost authorship.
"Such personnel must act in conjunction with the investigator-author," according
to the PhRMA guidelines. "Their contributions should be recognized appropriately
in resulting publications -- either as a named author, a contributor, or in
acknowledgments depending on their level of contribution." Similarly, a medical
communications trade group has put together a somewhat more strongly worded
guideline.
However, these guidelines are not a condition of membership, and not all
companies have publicly endorsed them, according to Liz Wager, a biomedical
writer in England who helped draft the medical communications version. Merck
endorsed them, among others.
It's not clear what role these policies may have played, but insiders who work
in medical communications today say the more egregious forms of ghost-authoring
have become uncommon.
"The reason, again my impression, is that the [medical communications companies]
paid attention to the unfavorable publicity about ghost-authoring and changed
their practices," said Dr. Altus, the Baltimore freelance writer.
He noted that these companies now openly discuss ethical issues involving
writing-editing services at conferences, which was not formerly the case.
"Again, I don't have data, but I just felt it in the air [at a 2007 meeting of
medical communications writers] that the atmosphere is changing."
On the other hand, total transparency is not yet the rule everywhere.
One freelance writer, who asked that she and her client company not be named,
said she had recently written large sections of manuscripts for researchers
without acknowledgment in the published article.
"I have done both medical and scientific journal manuscripts with varying
amounts of editorial input from the primary author," she said.
"However, in every case the data [are] provided by the author, the relevant
literature and the interpretation is provided by the author," she said. "I help
them with writing a persuasive scientific argument but I don't develop the
argument myself based on their data."
She said she is not told who hires her client. "My impression has been, for the
[review articles] that I have done, that they were not from pharma, but that is
just my impression."
She said her experience with ghosting review articles was that "the writer
compiles the information but is not really the intellectual driving force of
deciding which literature is included in the review."
On the other hand, clinical study reports she has written have originated with
pharmaceutical companies.
She added that the academic scientists she works with always have final approval
on manuscripts before they're submitted.
Others remain unconvinced that pharmaceutical companies have undergone a genuine
change of heart.
"Merck's ghost management of the ADVANTAGE trial paper was described as an
'unusual practice' when it was reported in the New York Times," wrote Sergio
Sismondo, Ph.D., a researcher at Queen's University in Kingston, Ontario, last
October in the Public Library of Science Medicine.
"Given the amount of data that pharmaceutical companies control, the number of
publication planning agencies that openly advertise on the Internet, the number
of medical writers, the existence of two associations for publication planners,
and meetings organized and reports written for them, we can conclude that ghost
management is common," he wrote.
Dr. Fugh-Berman, who has become outspoken on ghost-authoring, said she thinks
the practice is "alive and well," although she provided no recent examples.
Dr. Lundberg at Medscape said some ghost-authoring still probably slips by, and
he isn't happy about it.
"I don't know how a journal can curb the practice when ghost-authoring is well
concealed," said Dr. Altus.
Dr. Fugh-Berman countered that journals could ask more questions of named
authors. She pointed to the authorship form required by American Family
Physician, which asks specifically about writing assistance and the role of
medical communications companies in developing the article.
Disclosure forms and policies at the NEJM and JAMA do not specifically require
manuscripts to include details on contributions of those providing "editorial
assistance."
JAMA asks bylined authors to declare their own specific contributions, but NEJM
does not go even that far. "In keeping with the tradition of scientific trust,
we do not ask that the specific contributions of individual authors be reported
to us," according to NEJM's current instructions to authors.
Editors at JAMA and NEJM declined to be interviewed for this article.
Dr. Lundberg said that when readers see an acknowledgment of "editorial
assistance," they understand that the named authors did not do all the writing
themselves.
"In those situations, I think the named authors do truly vouch for the content
in its entirety, and that's really what the reader wants," he said.
Dr. Sismondo said awareness of the ghosting issue can help journal editors
"recognize signs of behind-the-scenes work."
Harold Sox, M.D., editor of Annals of Internal Medicine, said that getting
articles directly from a communications company is one tipoff, although it does
not happen often.
In such cases, he said two editors read the article, and they make inquiries
about the company's role.
Much more common is submission from an author, with an acknowledgment
identifying someone as providing "editorial assistance."
"Ideally, we'd be calling and saying, what exactly did they do," he said.
But he conceded that his journal didn't have a policy of doing that routinely.
"We should," Dr. Sox said.