http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/
journal.pmed.0040286&ct=1
Ghost Management: How Much of the Medical Literature Is Shaped Behind the
Scenes by the Pharmaceutical Industry?
Sergio Sismondo
Funding: Research for this article was supported in part by a grant from
the Social Sciences and Humanities Research Council of Canada. The funder
played no role in the decision to submit the article or in its preparation.
Competing Interests: The author has declared that no competing interests exist.
Citation: Sismondo S (2007) Ghost Management: How Much of the Medical
Literature Is Shaped Behind the Scenes by the Pharmaceutical Industry? PLoS
Med 4(9): e286 doi:10.1371/journal.pmed.0040286
Published: September 25, 2007
Copyright: © 2007 Sergio Sismondo. This is an open-access article
distributed under the terms of the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any
medium, provided the original author and source are credited.
Abbreviations: CHC, Complete Healthcare Communications; CMD, Current
Medical Directions; CRO, contract research organization; MECC, medical
education and communication company
Sergio Sismondo is at Queen's University, Kingston, Ontario, Canada.
E-mail: [EMAIL PROTECTED]
>From Ghost Writing to Ghost Management
"What is the purpose of publications?[The] purpose of data is
to support, directly or indirectly, the marketing of our product." [1]
There are many reports of medical journal articles being researched and
written by or on behalf of pharmaceutical companies, and then published
under the name of academics who had played little role earlier in the
research and writing process [2-14]. In extreme cases, drug companies pay
for trials by contract research organizations (CROs), analyze the data
in-house, have professionals write manuscripts, ask academics to serve as
authors of those manuscripts, and pay communication companies to shepherd
them through publication in the best journals. The resulting articles
affect the conclusions found in the medical literature, and are used in
promoting drugs to doctors.
For example, as reported in The New York Times [4], an Annals of Internal
Medicine article on Merck's "Advantage" trial of Vioxx omitted some trial
participants' deaths. Distancing himself from the Annals article, first
author Jeffrey Lisse said in an interview that "Merck designed the trial,
paid for the trial, ran the trialMerck 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" [4].
Such incidents have provoked many commentaries about ghost writing in the
medical press. This article enlarges the focus from ghost writing to the
more general ghost management of medical research and publishing: when
pharmaceutical companies and their agents control or shape multiple steps
in the research, analysis, writing, and publication of articles. Such
articles are "ghostly" because signs of their actual production are largely
invisible-academic authors whose names appear at the tops of ghost-managed
articles give corporate research a veneer of independence and credibility.
They are "managed" because those companies shape the eventual message
conveyed by the article or by a suite of articles. As discussed below, a
substantial percentage of medical journal articles (in addition to meeting
presentations and other forms of publication, which are not the focus here)
are ghost managed, allowing the pharmaceutical industry considerable
influence on medical research, and making that research a vehicle for
marketing.
Ghost writing and honorary authorship are not in and of themselves
scientific problems, though they become so when they shape science to meet
particular interests [1]. Some honorary authors are senior professors and
chairs of departments, who are added to articles because of local academic
politics rather than at the request of drug companies [15,16]. Some busy
independent research units hire writers to improve manuscripts; Max Lagnado
has argued that professional medical writers can "benefit the scientific
community when used in a responsible manner" [15]. In any case, the writing
of a manuscript may not be the key point at which behind-the-scenes
influence is exerted: study design, statistical analysis, or the choice of
placement of manuscripts may be equally important.
It has been repeatedly and firmly established that pharmaceutical company
funding strongly biases published results in favor of the company's
products [17-19]. Ghost management amplifies that bias, because when one
set of commercial interests exerts influence at multiple stages of
research, writing, and publication, it will shape the resulting article. In
turn, bias affects medical opinion and practice, and ultimately, patients.
How Common Is Ghost Management?
Because ghost management is hidden, we cannot tell how common it is from
published exposés. Current practices in the medical sciences legitimately
allow people to serve as authors on the basis of narrow contributions.
Therefore many near-honorary authors find little reason to feel
uncomfortable with their roles. Fully honorary authors may not see enough
of the process of the production of their articles to know that they are
ghost managed. Finally, it is not in the interests of writers, authors, or
sponsors and their agents to reveal ghost management processes; hence a
number of the published accounts of ghost management have stemmed from
legal proceedings and investigative journalism. So how common is ghost
management?
Much of the information on ghost writing does not help to answer this
question. Surveys to quantify rates of ghost writing do not address the
ghost management phenomenon, because management may not involve writing,
and writing may not be managed [20,21]. However, information about ghost
authors, people who should be receiving author credit, strongly suggests
that ghost management is common. A study comparing protocols and
corresponding publications for industry-initiated trials approved by the
Scientific-Ethical Committees for Copenhagen and Frederiksberg in 1994-1995
found evidence of ghost authorship in 75% of these publications (95%
confidence intervals, 60%-87%) [22]. Company statisticians were common
unacknowledged contributors, but so were the creators of trial designs and
protocols, and the writers of manuscripts. The study also found that most
(172 of 274) trials for which protocols had been submitted were never
begun, completed, or published.
A Benchmark Study
The most solid information available on ghost management comes from the
work of David Healy and Dinah Cattell. A lawsuit in which Healy was
involved allowed access to a document listing 85 manuscripts on sertraline
that were being coordinated for Pfizer by the medical education and
communication company (MECC) Current Medical Directions (CMD) [9,23]. The
document lists other agencies as the vendors of some of the documents, and
some authors "TBD" (to be determined), so it is almost certain that a
number of these 85 manuscripts were written by professional writers acting
for Pfizer, possibly via CMD.
More importantly, all of the manuscripts were being managed very carefully,
as CMD was aware of submission dates, journals' requests for revisions,
target dates for those revisions, and projected publication dates. Authors
were not acting independently. The document is peppered with comments such
as "First draft with author for review," and "Manuscript submitted to
American Journal of Psychiatry 7/98. Confidence intervals requested by
journal. Revised manuscript resubmitted 9/98" [24]. Most manuscripts were
published in prestigious medical journals between 1998 and 2000, with
academic researchers listed as their authors. The resulting articles are
Pfizer's early contribution on the literature on sertraline, but bear few
marks of Pfizer's influence, let alone disclosure of Pfizer's contributions
to multiple stages of their research, writing, and submission.
These 85 manuscripts became a significant portion of all of the articles
published on sertraline. A general Medline search of 1998 to 2000
(performed December 2006) found 479 results with the keyword "sertraline,"
and 211 with "sertraline" in the title. This suggests that between 18% and
40% of articles on sertraline in this key period were managed by Pfizer
through this one MECC, large enough percentages to have substantial effects
on the overall shape of the medical literature on this drug.
Healy and Cattell claim that the CMD articles are uniformly positive about
sertraline, and they note under-reporting of side effects in these
articles. Compared to other articles on sertraline (i.e., those not
coordinated by CMD), the CMD articles were published in more prominent
journals, had nearly twice as many authors per article, had authors who
were on average twice as prolific, and garnered nearly three times as many
citations (20.2 versus 7.7 in Healy and Cattell's analysis) [23].
Apparently, CMD was effective at helping publish these articles in a
visible way.
While we cannot know all of the ways in which the CMD document represents
other publication efforts, there is strong evidence that ghost management
of medical research is common and is part of campaigns by pharmaceutical
companies to publish favorable results and key marketing messages.
MECCs and Ghost Management: A Supply-Side Analysis
A survey in 2001 identified 182 MECCs in the United States, up from 153 in
1998 [25]. A number specialize in producing, placing, and tracking journal
articles, known in the trade as "publication planning" or "strategic
communication planning." While these firms hide details of their work-from
potential critics and competitors-they also energetically promote
themselves and their services. Many have flashy Web sites highlighting
their ability to prepare meeting presentations and publish articles.
In preparing this article, I spent six hours searching web pages for MECCs
offering publication planning or similar or overlapping services to the
pharmaceutical industry, and found 23 (list available from the author).
This is not an estimate of the number of such firms, but indicates how
common they are. There may be many more firms providing publication
planning, including some not uncovered in this search, and some not
advertising these services on the Internet. For example, CMD was not among
the 23 found, as its current Web site lists only medical education and
meeting services as core capabilities. Pharmaceutical companies also do
publication planning in-house, though one industry source estimates that
in-house planning makes up only 20% of this business [26]. On the other
side, it is possible that some of the identified firms misrepresent
themselves, and perform only minimal publication planning.
Pharmaceutical companies control an immense quantity of data. The industry
provides twice as much funding for clinical trials and related research as
do not-for-profit agencies [27]. Of industry funding, 70% goes to CROs that
neither make ownership claims on data nor expect to publish the data
themselves: CROs perform research to order [28]. By its nature CRO research
tends to be ghostly. The 30% of industry funding that goes to academic
researchers often also comes with strings attached that can allow sponsors
to prepare drafts, edit drafts, delay publication, prevent full access to
data, and so on-in short, creating conditions that allow for ghost
management [29-31].
In a primer on publication planning, the director of one MECC defines the
activity as: "gaining product adoption and usage through the systematic,
planned dissemination of key messages and data to appropriate target
audiences at the optimum time using the most effective communication
channels" [32]. These channels are such things as: "publications, journal
reviews, symposia, workshops, advisory boards, abstracts, educational
materials/PR." Influencing scientific opinion in the service of marketing
is the clearly stated goal here. The author of this article therefore makes
scientific and commercial goals equal stakeholders in communication: in a
chart he juxtaposes "Where shall we publish this study?" with "Who are our
customers?" and "What can we claim from the results?" with "What are our
customer needs?"
Complete Healthcare Communications (CHC) claims on its banner that it "has
honed the systems and skills needed to develop the intellectual heart of
pharmaceutical marketing-the publication plan. The result for your product?
A continuum of awareness, interest, and prescriber confidence" [33]. CHC
will manage article submissions to meetings, and as samples of its service
it provides hypothetical lists of abstracts and presentations, with their
status, dates of presentation, etc. On its Web site is a list of ten
hypothetical trials and at least 24 articles that can be written from them,
which will lead to a completed bibliography of publications [34].
CHC includes among its clients Pfizer, Sanofi-Aventis, Ortho Biotech,
Wyeth, Schering-Plough, Shire, AstraZeneca, and other pharmaceutical
companies. It provides testimonials from sponsors and authors. A Johns
Hopkins author writes "Very nice outline! You guys are quite organized!! I
think it's superb. Very fair and balanced. I'm not used to working with
such excellent writers!" CHC claims to have written and submitted over 500
manuscripts, with an acceptance rate of 80%. CHC is able to achieve such a
rate with resources far beyond the reach of most researchers: not only are
all of its studies fully supported by the largest of pharmaceutical
companies, but it boasts a team of 40 medical writers, editors, and
librarians.
Other agencies offer very similar services. As described in an article by
three of its managers, the Medical Knowledge Group starts publication
planning with a phase of exploring "key messages" and "author/journal
options" before designing any publications to incorporate those messages
[35]. It then tracks those and competitors' messages using its own
information management tool. (Like CMD, the Medical Knowledge Group was not
included when I conducted my web search, underscoring the limitations of
that search.) Another MECC, Envision Pharma, says that "data generated from
clinical trials programs are the most powerful marketing tools available to
a pharmaceutical company." Envision will work from early on in the process
to ensure "consistent message dissemination," will plan and track the "data
dissemination plan," and will produce "scientifically accurate,
commercially focused abstracts, posters, and primary and secondary
publications" [36].
In addition to the publication planners, a much higher number of medical
writing companies and individual writers create articles and presentations
without engaging in broader publication planning; these may be adjuncts to
publication planners. To provide an indication of the scale, the American
Medical Writers Association boasts a membership of more than 5,000 [37];
judging from the organization's officers and the content of its
conferences, it appears to be dominated by MECCs [38,39].
Several of the publication planning firms identified are owned by major
publishing houses. For example, Excerpta Medica is "an Elsevier business"
and writes that its "relationship with Elsevier allows access to editors
and editorial boards who provide professional advice and deep opinion
leader networks" [40]. Wolters Kluwer Health draws attention to its
publisher Lippincott Williams & Wilkins, with "nearly 275 periodicals and
1,500 books in more than 100 disciplines," and to Ovid and its other
medical information providers, emphasizing the links it can make between
its different arms [41]. Vertical integration is attractive in the industry
as a whole: at least three of the world's largest advertising agencies own
not only MECCs, but also CROs [13].
Ghost management of medical journal publications is clearly a substantial
business, employing thousands of marketers, writers, and managers. It is
large enough that the industry has established the International
Publication Planning Association. This organization, which appears to be
dominated by pharmaceutical companies, organizes meetings, keeps a
directory of experts, and gives awards to honor planners [42]. In addition,
the International Society for Medical Publication Professionals also
organizes meetings, has committees to develop policy, and posts job
advertisements [43]. Both of these associations compete with for-profit
companies offering similar services, such as the Center for Business
Intelligence, which held forums for Strategic Publication Planning in 2005
and 2006 [44].
Discussion
Merck's ghost management of the Advantage trial paper was described as "an
unusual practice" when it was reported in The New York Times [4]. 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. The CMD document obtained
by Healy suggests that during key marketing periods as many as 40% of
published articles focusing on specific drugs are ghost managed [24]. Even
if the more typical figure is half that, ghost management exerts a huge
force on the shape of scientific opinion on new drugs, and does so in the
service of marketing.
Articles in medical journals have real effects upon physician prescribing
behavior, which is why pharmaceutical companies invest so much in their
publication. Journal articles are heavily used in detailing, to validate
claims and rebut worries. Even independent of detailers, responsible
physicians and medical researchers search the literature to gather evidence
about the best treatments. Published scientific articles are the sources of
medical information with the highest authority. Systematic reviews and
meta-analyses almost all start with the published literature-so even fully
independent reviews are influenced by ghostly activities. Therefore, the
ghost management of journal articles is a step in the intervention into
medical practice.
There are no straightforward solutions, short of large changes to the
nature of medical publishing and/or research, changes that would
effectively sequester pharmaceutical company funding from research and
publishing [45] or from marketing [46]. Until such changes come about, at
least we can hope for more awareness of and responsiveness to the issue.
Peer review has not been proven to be an effective tool for quality
control, so we cannot rely on journals' peer review systems to guard
against biases created by ghost managing [47-49]. Indeed, MECCs are
effective at creating publishable articles and getting them published in
peer-reviewed journals. Nor are current disclosure measures effective.
Major journals have put in place strong disclosure procedures, but while
these might disallow extreme forms of ghost management, many forms of it do
not run afoul of any rules other than failure to acknowledge some
contributors and facilitators. With awareness of the issue, however,
perhaps journal editors can recognize signs of behind-the-scenes work. They
can refuse to deal directly with publication planners, and they can ask
authors repeatedly about under-recognized and over-recognized contributors,
facilitators, and influences; systematic adoption of a strong "film credit
model" of authorship, in which authors rigidly and closely specify their
roles, might aid in those efforts [50]. Such efforts would have to go
hand-in-hand with penalties for misconduct [12]. Although not discussed
here, MECCs ghost manage other forms of publication including academic
meeting presentations, and thus program committees of these meetings face
similar issues.
Universities and academic health centers should prohibit contracts that
allow sponsors to draft, edit, or suppress articles, or that allow sponsors
to keep data from authors; they should even prohibit sponsors from
facilitating publication. Universities should also take disciplinary action
against investigators who serve as authors on ghost-managed articles.
Meanwhile, investigators need to be aware of the mechanisms of ghost
management of work that goes under their names, and to refuse to
participate. Perhaps they need to be more modest about how many articles
they can publish, and more realistic about the amount of effort, legwork,
and/or creativity it takes to publish an article. In a presentation on its
Web site, the MECC Envision mentions the "author dilemma: Who are they? Why
are they authors? What is their role?" [51] All authors should ask the same
questions of themselves.
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