Bioethics ISSN 0269-9702 (print); 1467-8519 (online) doi:10.1111/j.1467-8519.2008.01702.

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Volume 24 Number 6 2010 pp 273–283

PUBLICATION ETHICS AND THE GHOST MANAGEMENT OF MEDICAL

PUBLICATION

SERGIO SISMONDO AND MATHIEU DOUCET

Keywords
publication ethics, ABSTRACT
research ethics, It is by now no secret that some scientific articles are ghost authored – that
sponsorship bias, is, written by someone other than the person whose name appears at the
ghost management top of the article. Ghost authorship, however, is only one sort of ghosting.
In this article, we present evidence that pharmaceutical companies engage
in the ghost management of the scientific literature, by controlling or
shaping several crucial steps in the research, writing, and publication of
scientific articles. Ghost management allows the pharmaceutical industry to
shape the literature in ways that serve its interests.
This article aims to reinforce and expand publication ethics as an impor-
tant area of concern for bioethics. Since ghost-managed research is pri-
marily undertaken in the interests of marketing, large quantities of medical
research violate not just publication norms but also research ethics. Much
of this research involves human subjects, and yet is performed not primarily
to increase knowledge for broad human benefit, but to disseminate results
in the service of profits. Those who sponsor, manage, conduct, and publish
such research therefore behave unethically, since they put patients at risk
without justification. This leads us to a strong conclusion: if medical journals
want to ensure that the research they publish is ethically sound, they should
not publish articles that are commercially sponsored.

Medical research is risky. This is particularly true of clini- profoundly mistaken. While the public good cannot be
cal trials that test new drugs or devices. Such risks are served by keeping the results of research from the public
justified on the basis of the potential benefits of increased eye, mere publicity, even in a reputable medical journal, is
medical knowledge, and so publicity is necessary for not sufficient. In order to know if published research is
ethical research. Publicity in this context generally means ethically justified, it is important to ask not only if the
publication in a medical journal, so publication is a results have been published, but also why and how they
central element in ethical research. Nonetheless, publica- were published.
tion ethics generates little attention relative to research This article aims to reinforce and expand publication
ethics. It is generally assumed that ‘there’s no such thing ethics as an important area of concern for bioethics. We
as bad publicity’: as long as the results of the research are argue that the commercial management of much of the
published in an appropriate forum so that others can scientific literature has worrying implications for the
learn from them, the research is assumed to have met the ethics of a significant amount of medical research. This
publicity criterion for ethical research. This assumption is leads us to a strong conclusion: if medical journals want

Address for correspondence: Mathieu Doucet, Queen’s University – Philosophy Dept, John Watson Hall, Kingston, Ontario K7L 3N6, Canada.
Email: [email protected]

© 2009 The Authors. Journal compilation © 2009 Blackwell Publishing Ltd., 9600 Garsington Road, Oxford OX4 2DQ, UK and 350 Main Street, Malden, MA 02148, USA.
274 Sergio Sismondo and Mathieu Doucet

to ensure that the research they publish is ethically sound, institutions to that aim to foster ethical publication prac-
they should not publish articles that are commercially tices. Prominent among these are the Committee on Pub-
sponsored. lication Ethics (COPE) and the International Committee
of Medical Journal Editors (ICMJE), whose criteria for
authorship have been widely adopted.5
PUBLICATION ETHICS Scientific misconduct in publication, from plagiarism
and fabrication to duplicate publication and questionable
Research ethics is largely concerned with the treatment authorship practices, is frequently explained by pointing
of patients, and so addresses issues such as dangerous to the pressures generated by the ‘publish or perish’
research, equipoise, patient consent, and paternalism. culture of academia.6 Efforts to regulate or improve pub-
The ethics of publication are relatively ignored. Some lication ethics therefore either have a moralistic tone,
discussions of research ethics, however, do consider encouraging individual researchers to act with integrity,7
issues surrounding publication, largely under the guise of or else focus on the role that institutions most directly
‘research integrity.’1 Such discussions address violations connected to academic science – scientific societies, uni-
of specifically scientific or academic norms, such as those versities, and teaching hospitals – can play in regulating
dealing with plagiarism, fabrication of data, duplicate publication practices.8
publication,2 and, in particular, authorship.3 The last of Focusing exclusively on professional ‘publish or
these has become an issue because of the prevalence of perish’ pressures ignores an important additional source
multi-authored articles produced in a distributed way, of violations of publication ethics in medicine: commer-
which has led some to suggest abandoning ‘authorship’ in cial pressure from the pharmaceutical industry for publi-
favour of ‘contributorship.’4 cations that reflect favourably on their products. The
Just as interest in research ethics led to the creation of effects of this pressure can be seen in concern over con-
Institutional Review Boards and the requirement that flicts of interest, publication bias, withholding of data,
research proposals receive ethics approval, specific inter- duplicate publication, ‘salami slicing’, and other practices
est in publication ethics has led to the creation of several designed to shape the scientific literature favourably.
While commercial pressures have serious effects on
1
M. Iverson et al. Scientific Societies and Research Integrity: What Are the integrity of publication, they are relatively ignored
They Doing and How Well Are They Doing It? Sci Eng Ethics 2003; 9: in discussion of publication ethics.9 Both professional
141–155; N.H. Steneck. Fostering Integrity in Research: Definitions, and commercial pressures, however, play important
Current Knowledge, and Future Directions. Sci Eng Ethics 2006; 12:
53–74.
roles in many of the most important breaches of publi-
2
J. Brice & J. Bligh. Author Misconduct: Not Just the Editors’ Respon- cation ethics, when, for example, pressures to publish
sibility. Med Educ 2004; 39: 83–89; A. Caelleigh. Roles for Scientific meet opportunities to publish presented by commercial
Societies in Promoting Integrity in Publication Ethics. Sci Eng Ethics interests.
2003; 9: 221–241; I. Chalmers. Role of Systematic Reviews in Detecting
Violations of publication ethics are not separate and
Plagiarism: Case of Asim Kurjak. Br Med J 2006; 333: 594–596; R.B.
Daroff & R.C. Giggs. Scientific Misconduct and Breaches of Publica- distinct from violations of the ethical norms governing
tion Ethics. Neurology 2004; 62: 352–353; M.J. Farthing. Authors and the treatment of patients in research. Meeting the
Publication Practices. Sci Eng Ethics 2006; 12: 41–52; F.J. Gilbert &
A.R. Denison. Research Misconduct. Clin Radiol 2003; 58: 499–504;
5
Iverson et al., op. cit. note 1; A.V. Neal et al. Correction and Use of the COPE. 2003. Committee on Publication Ethics Guidelines on Good
Biomedical Literature Affected by Scientific Misconduct. Sci Eng Ethics Publication Practice. Available at http://www.publicationethics.org.uk/
2007: 13; Steneck, op. cit. note 1. guidelines [Accessed 23 June 2008]; ICMJE. 2006. Uniform Require-
3
P. Borry et al. Author, Contributor or Just a Signer? A Quantitative ments for Manuscripts Submitted to Biomedical Journals: Writing and
Analysis of Authorship Trends in the Field of Bioethics. Bioethics 2006; Editing for Biomedical Publication. Available at www.icmje.org
20: 213–220; Farthing, op. cit. note 2; A.H. Jones. Can Authorship [Accessed 23 June 2008].
6
Policies Help Prevent Scientific Misconduct? What Role for Scientific Borry et al., op. cit. note 3; Brice & Bligh, op. cit. note 2; Gilbert &
Societies. Sci Eng Ethics 2003; 9: 243–256; M.T. Laflin et al. Publication Denison, op. cit. note 2; Sheikh, op. cit. note 3.
7
Ethics: An Examination of Authorship Practices. Am J Health Behav Brice & Bligh, op. cit. note 2.
8
2005; 29; A. Sheikh. Publication Ethics and the Research Assessment Caelleigh, op. cit. note 2; Iverson et al., op. cit. note 1.
9
Exercise: Reflections on the Troubled Question of Authorship. J Med COPE, for example, puts anonymized summaries of the cases it con-
Ethics 2000; 26; K.L. Woolley et al. Declaration of Medical Writing siders on its website. As of 2008, it listed 20 cases of disputes between
Assistance in International Peer-Reviewed Publications. JAMA 2006; authors, 20 of failure to obtain informed consent, and 18 of plagiarism.
296: 932. By contrast, only 4 cases were categorized as ‘Drug Company’ and 4 as
4
D. Rennie et al. When Authorship Fails: A Proposal to Make Con- ‘Financial Interest,’ and one of these was categorized as both, making
tributors Accountable. JAMA 1997; 278: 579–585; R. Smith. Reinvent- for a total of only 7 cases. COPE. Cases. Available at http://www.
ing the Biomedical Journal. J Neurosci 2006; 26: 9837–9838. publicationethics.org.uk/cases [Accessed 23 June, 2008].

© 2009 The Authors. Journal compilation © 2009 Blackwell Publishing Ltd.

 Publication Ethics and the Ghost Management of Medical Publication 275

publicity criterion is required if putting patients at risk is is only rarely acknowledged in journal publications.13
to be justified; but this criterion cannot be met by pub- Even sponsorship, the company funding of the trial, is
licity that violates the ethical norms governing publica- omitted from many meeting abstracts.14 For this reason
tion. A closer look at publication practices is therefore we might see publication planning as the ‘ghost manage-
a vitally important part of research ethics: in ignoring ment’ of medical research and publication. We apply the
breaches of publication ethics, the scientific community term ghost management when pharmaceutical companies
risks allowing as ethically sound research that it should and their agents control or shape several crucial steps in
find deeply worrying. the research, writing, and publication of articles: these
articles are ghostly because signs of their actual produc-
tion are largely invisible, and managed because the com-
panies shape the eventual message conveyed by the article
GHOST MANAGEMENT10 or suite of articles. Companies aim to maximize the
number of publications from positive trials, minimize
Pharmaceutical companies perform and sponsor a sig- those from negative trials, and ensure that the results of
nificant amount of medical research and analysis, espe- the study are published promptly and in prominent jour-
cially clinical trials, but also meta-analyses, reviews, nals.15 Ghost management makes apparently scientific
epidemiology, laboratory science, and health economics research a marketing tool.
research. Especially in the past two decades, these com- There have been a number of individual reports of
panies have developed systems that treat knowledge as a the ghost management of medical journal articles and
resource to be carefully developed and used to affect the meeting presentations.16 However, because it is typically
opinions of researchers and practitioners. Publication of invisible, some of the best demonstrations of the existence
pharmaceutical company-sponsored research in medical and effects of ghost management have resulted from legal
journals, and its presentation at conferences and meet- action.
ings, is now governed by ‘publication plans’ that extract Court proceedings showed that in 1996 Wyeth hired
more scientific and commercial value out of data and the medical education and communication company
analyses through carefully constructed articles. This has (MECC) Excerpta Medica to prepare ten manuscripts
brought medical publishing into the ‘marketing era.’11 to help market its diet drug dexfenfluramine (Redux) in
The number of articles that pharmaceutical companies
produce is large, and the numbers on particular drugs are 13
P.C. Gøtzsche et al. Ghost Authorship in Industry-Initiated Ran-
tightly correlated with the sales of those drugs. Research domised Trials. PLoS Med 2007; 4: 47–52; B. Moffatt & C. Elliott.
is created with publication and marketing in mind. As Ghost Marketing: Pharmaceutical Companies and Ghostwritten
expressed by industry experts, ‘Historically, Phase IV Journal Articles. Perspect Biol Med 2007; 50: 18–31.
14
T. Finucane & C. Bolt. Association of Funding and Findings of
studies were primarily conducted to support a product’s
Pharmaceutical Research at a Meeting of a Medical Professional
commercialization; now they are increasingly conducted Society. JAMA 2004; 117: 842–845.
to maximize it.’12 15
H. Melander et al. Evidence B(i)ased Medicine – Selective Reporting
The work of publication planners is largely unseen. To from Studies Sponsored by Pharmaceutical Industry: Review of Studies
gain commercial value from research, articles publicizing in New Drug Applications. Br Med J 2003; 326: 1171–1173.
16
A. Barnett. 2003. Revealed: How Drug Firms ‘Hoodwink’ Medical
it are written under the names of independent medical
Journals. The Observer Dec. 7, 2003; P. Baty. 2005. When Access to
researchers, though company authors may also be re- Data is a Real Bone of Contention. Times Higher Education Supplement
cognized. The work of pharmaceutical company statisti- Nov. 25, 2005; D. Blumenthal et al. Withholding Research Results in
cians, reviewers from a diverse array of departments, Academic Life Science. Evidence from a National Survey of Faculty. J
medical writers, and the publication planners themselves Am Med Assoc 1997; 277: 1224–1228; A. Fugh-Berman. The Corporate
Coauthor. J Gen Intern Med 2005; 20: 546–548; M. Gruzuk & C. Jones.
2003. CBC Marketplace: Inside the Business of Medical Ghostwriting.
10
In this section we summarize and amplify an earlier description by Canadian Broadcasting Corporation. Available at http://www.cbc.ca/
one of us of the ‘ghost management’ of medical research and publica- consumers/market/files/health/ghostwriting/ [Accessed 6 Dec 2008];
tion. S. Sismondo. Ghost Management: How Much of the Medical M. Larkin. Whose Article Is It Anyway? The Lancet 1999: 354; A.W.
Literature is Shaped Behind the Scenes by the Pharmaceutical Industry. Matthews. 2005. Ghost Story: At Medical Journals, Writers Paid by
PLoS Med 2007; 4: e286. Industry Play Big Role; Articles Appear Under Name Of Academic
11
K. Applbaum. 2004. The Marketing Era: From Professional Practice Researchers, But They Often Get Help; J&J Receives a Positive ‘Spin’.
to Global Provisioning. New York: Routledge. Wall St J December 13; S. Ngai et al. Haunted Manuscripts: Ghost
12
H.E. Glass & D.W. Dalton. Profiles of Phase IV Investigators and Authorship in the Medical Literature. Account Res 2005; 12: 103–114;
Subsequent Prescribing of the Study Drug. J Pharm Mark and Manage M. Peterson. 2002. Madison Ave. Has Growing Role In the Business of
2006; 17: 3–17. Drug Research. New York Times Nov 22.

© 2009 The Authors. Journal compilation © 2009 Blackwell Publishing Ltd.

276 Sergio Sismondo and Mathieu Doucet

medical journals. Excerpta wrote the manuscripts and aware of submission dates, requests for revisions, target
located authors, paying them between $1000 and $1500 dates for those revisions, and projected publication dates.
for their editing work.17 Most of those manuscripts never The document includes comments such as ‘First draft
saw print, because the drug was withdrawn from the with author for review,’ and ‘Manuscript submitted to
market. American Journal of Psychiatry 7/98. Confidence inter-
Internal documents about Parke-Davis’s promotion of vals requested by journal. Revised manuscript resubmit-
its drug gabapentin (Neurontin) in the 1990s became ted 9/98.’22 Most of these manuscripts were published
available through litigation. Steinman and co-workers in important medical journals between 1998 and 2000,
examined approximately 8000 pages of these court docu- with academic researchers listed as their authors. This
ments to identify promotional strategies through research group of 85 manuscripts became 40% of articles pub-
and publication, continuing medical education, advisory lished between 1998 and 2000 containing ‘sertraline’ in
boards, and consultants meetings.18 Parke-Davis em- the title.23 The articles were published in more prominent
ployed a ‘publication strategy’ in order ‘to disseminate journals than were others on sertraline, had nearly twice
the information as widely as possible through the world’s as many authors per article, had authors who were on
medical literature’ (including information relevant to off- average twice as prolific, and were cited three times as
label uses). The company had a stated goal of publishing often.24
the positive studies, and there are instances of non- In a separate phenomenon, some trials are ‘seeding
publication of negative studies. As part of the same strat- trials,’ created to increase physician familiarity with a
egy, Parke-Davis supported further publications through drug or directly increase prescriptions. A US Federal
MECCs. One ‘grant request’ from a MECC proposed investigation revealed that in some of Schering-Plough’s
developing a group of 12 articles on gabapentin with a post-marketing trials of its hepatitis C treatment Intron
‘consistent message’ and a focus on, among other things, A, liver specialists were paid between US$1000 and $1500
‘emerging uses.’ The proposal suggested topics, journals, per patient enrolled in the trials; patients’ insurance plans
titles, and authors. paid the $20,000 annual cost of treatment.25 Merck’s large
Lawsuits about rofecoxib (Vioxx) allowed a systematic ADVANTAGE trial of Vioxx, involving more than 5500
study identifying 96 published articles (24 on clinical patients, was similarly a seeding trial. It was created by
trials and 72 review articles) on which Merck had worked its Marketing Department, as internal documents state,
prior to their publication, and which were later published to allow investigators to ‘[g]ain experience prior to and
mostly under the names of academic first authors.19 For during the critical launch phase.’26 The trial was nomi-
example, one document lists eight review articles for nated for an internal Merck marketing award.
which the MECC Scientific Therapeutics had intended Cases revealed by litigation are not isolated or unusual.
authors and journals, and estimated delivery dates of first While MECCs doing publication planning generally do
or second drafts. Ghost-managed review articles were not reveal details of their work – to either potential critics
likely to be single-authored by academics, who were espe- or competitors – they promote themselves and the ser-
cially likely not to declare financial support for the vices they offer. Many have flashy websites highlighting
work.20 their ability to write, track, and publish journal articles,
A legal action gave psychiatrist David Healy access and to produce transparent and attractive outputs dis-
to a document listing 85 articles on the drug sertraline playing the results of their work. In 2001 there were 182
(Zoloft or Lustral) being handled by a public relations established MECCs in the United States and many more
firm Current Medical Directions (CMD) for Pfizer.21 All elsewhere.27 More than 50 (!) of these, some of them
of the manuscripts were carefully managed, as CMD was
17 22
C. Elliott. The Drug Pushers. The Atlantic Monthly April 2006: Current Medical Directions. 1999. Worldwide Publications Status
82–93. Update: Zoloft (Sertraline HCl). New York: 37.
18 23
M.A. Steinman et al. Narrative Review: The Promotion of Gabap- Sismondo, op. cit. note 10.
24
entin: An Analysis of Internal Industry Documents. Ann Intern Med Healy & Cattell, op. cit. note 21.
25
2006; 145: 284–293. G. Harris. 2004. Medical Marketing Treatment by Incentive; As
19
J.S. Ross et al. Guest Authorship and Ghostwriting in Publications Doctor Writes Prescription, Drug Company Writes a Check. New York
Related to Rofecoxib: A Case Study of Industry Documents From Times, June 27.
26
Rofecoxib Litigation. J Am Med Assoc 2008; 299: 1800–1812. K.P. Hill et al. The ADVANTAGE Seeding Trial: A Review of
20
Ross et al., op. cit. note 19. Internal Documents. Ann Intern Med 2008; 149: 251–258.
21 27
D. Healy & D. Cattell. Interface between Authorship, Industry and G. Golden et al. Medical Education and Communication Compa-
Science in the Domain of Therapeutics. Br J Psychiatry 2003; 183: nies: An Updated In-Depth Profile. J Contin Educ Health Prof 2002;
22–27. 22: 55–62.

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 Publication Ethics and the Ghost Management of Medical Publication 277

having hundreds of employees, advertise publication- access to those publishers’ journals, and possibly through
planning services on the Internet (list available from the reprint sales and supplement fees. Vertical integration
authors). may be attractive in the industry as a whole: at least three
To take only one example, Watermeadow Medical of the world’s largest advertising agencies own not only
describes in some detail how it engages in strategic com- medical communication companies, but also contract
munications activities at every stage of the product life- research organizations (CROs).31
cycle. The goal is to ensure that, well before and after a Ghost management is a large enough trade for the
new drug receives regulatory approval and is brought to industry to have established two professional associa-
market, ‘decision makers are aware of its attributes and tions: The International Publication Planning Associa-
benefits, through appropriate communication channels tion (TIPPA), and the International Society for Medical
and within an ethical framework.’ To this end, early in Publication Professionals (ISMPP).32 Both organize
the process Watermeadow identifies ‘high-profile opinion meetings, have committees to develop policy, post job
leaders’ who can act as advocates for a new drug. The advertisements, and provide useful links. ISMPP has
firm coordinates the production of ‘abstracts, posters, developed a set of ethical guidelines for medical writing,
white papers, primary manuscripts, review articles, etc.’ discussed briefly below. These associations compete with
The company taps into ‘strong relationships with for-profit companies offering similar services, like the
international academic thought leaders’ to ‘fuel clinical Center for Business Intelligence.33
debate, educate on cutting-edge developments and As should be already clear from the above, publication
encourage product use.’ Publication planning is only one planning is an activity that spans both research and pub-
aspect of the overall communications plan, but it is a lishing, and even extends to the downstream uses of pub-
major one: ‘By maximizing the product support in the lications. Publication planners would ideally be involved
scientific literature, [Watermeadow clients] can take at early stages of research, to achieve consistency in the
advantage of one of the most influential communication message of publications, to maximize their number, to
channels for healthcare and scientific audiences. Impor- allow later publications to refer to earlier ones, and to
tantly, this also ensures optimal return from other mar- ensure the number of publications peak at the launch of
keting and promotional activity.’ These broad-spectrum the product.34 As one planner at the 2007 ISMPP meeting
communications activities are undertaken not only to said:
increase doctors’ awareness of the drug’s existence and
This is what utopia looks like from an industry per-
confidence in its alleged efficacy; they are also ‘pivotal in
spective. We have agreement and alignment on a plan,
achieving an effective return on the investment for a
not even just a publication, a full plan, investigators on
product, maximizing adoption on the basis of clinical
board, agencies lined up, everybody ready to play and
benefits.’ In a delightfully ambiguous phrase, Water-
we’re going to get this done in a timely way, in an
meadow says their services can ‘establish unmet medical
orderly fashion, and things work like clockwork.35
need’, leaving it unclear whether they aim merely to
discover, or actually to create a need for their sponsor’s Ghost management of medical research and publica-
products. Whichever it is, Watermeadow’s self- tion, then, is a substantial business, employing substan-
promotion makes it quite clear that publication planning tial numbers of marketers, writers, and managers. Given
is an integral part of a marketing campaign.28 Healy’s results, described above, it is reasonable to con-
Pharmaceutical companies also do some publication clude that approximately 40% of journal reports of clini-
planning in-house, though industry sources estimate that cal trials of new drugs (and, more anecdotally, perhaps
in-house planning makes up only 20% of that business.29
Several MECCs – including Carus Clinical Communica-
tions, Excerpta Medica, Wolters Kluwer Health and
com/ [Accessed 5 Sept 2008], Excerpta Medica. 2008. http://www.
Thomson Scientific Connexions –are divisions of major
excerptamedica.com//index.cfm [Accessed 5 Sept 2008].
publishing houses.30 ‘Synergies’ result from improved 31
Peterson, op. cit. note 16.
32
TIPPA. 2008. http://www.publicationplanningassociation.org/about.
28
Watermeadow Medical. 2008. http://www.watermeadowmedical. aspx [Accessed 5 Sept 2008]. ISMPP. 2008. http://www.ismpp.org/
com/ [Accessed 5 Sept 2008] [Accessed 5 Sept 2008].
29 33
Medical News Today. 2005. 80% of Pharmaceutical Medical Publi- Center for Business Intelligence. 2008. http://www.cbinet.com/
cations Spending Outsourced in 2004. Medical News Today 7 Mar. [Accessed 5 Sept 2008].
30 34
Carus Clinical. 2008. http://carusclinical.com/, Thompson Scientific S. Sismondo. Ghosts in the Machine: Publication Planning in the
Connexions. 2008 [Accessed 5 Sept 2008]. http://www.sciconnex.com/ Medical Sciences. Soc Stud Sci, forthcoming.
35
[Accessed 5 Sept 2008], Wolters Kluwer. 2008. http://www.wkhealth. Ibid.

© 2009 The Authors. Journal compilation © 2009 Blackwell Publishing Ltd.

278 Sergio Sismondo and Mathieu Doucet

a higher percentage of meeting presentations on clinical times more likely to report results favorable to the
trials) are ghost managed through to publication. company than is independent research.37 Undoubtedly,
ghost management is part, though only part, of the
cause of this phenomenon.38 In general, we have reason
ETHICAL PROBLEMS OF GHOST to believe that any time strong interests fund research,
that funding will bias the results.39
MANAGEMENT
Precisely because sponsorship biases results so
strongly, industry management of research needs to be
Multiple factors work to create the conditions for ghost
‘ghostly.’ Biased literature can have its effects only if it
management: Unsurprisingly, when companies control
appears to be independent, and so ghost management is
research and publication, the medical literature tends to
hidden because pharmaceutical companies know that
contain much more positive views of those companies’
they have something to hide: guest authors are part of a
products. This makes it easier for pharmaceutical com-
largely successful attempt to disguise conflicts of interest
panies to use scientific research to market their products.
and the biases that they create. Pharmaceutical compa-
Publications have more marketing value if they appear to
nies and publication planners are willing to risk the minor
be at least somewhat independent of the companies them-
scandals that come from occasional revelations of ghost-
selves. Therefore their prominent authors are typically
written journal articles, because the value of academic
affiliated with universities or other research institutions.
sponsorship outweighs the cost of those scandals.
Meanwhile, academics have a strong interest in publica-
Authors and researchers who participate in such research
tions, particularly in prominent journals. They are there-
are allowing themselves to be used in the service of phar-
fore often willing to participate in ghost-managed work,
maceutical profit. Worse, as we argue, they are putting
even to the point of serving as authors on publications
trial subjects at risk without justification.
when they have not met ICMJE requirements for author-
If ghost-managed research is primarily undertaken in
ship. Medical journals also benefit from the publication
the interests of marketing, then this suggests that signifi-
of ghost-managed medical articles, because these articles
cant quantities of medical research involving human sub-
tend to be well cited, and because pharmaceutical com-
jects is performed not primarily to increase knowledge for
panies may want to purchase thousands of reprints for
broad human benefit, but to disseminate results in the
distribution to physicians, giving journals another source
service of profits. Since the risk of medical research on
of profit.
human subjects is justified by the prospect of health
Many different parties – pharmaceutical companies,
benefits from increased knowledge, as required by the
MECCs, academic researchers, and medical journals –
Nuremberg Code, the Declaration of Helsinki, and sub-
therefore have reasons to collude in the ghost manage-
sequent guidelines, much of the scientific research cur-
ment of the medical literature. Each of these reasons is
rently published in medical journals is ethically
ethically problematic on its own. Combined, they lead to
problematic. This is a major problem for research ethics.
a situation where very little of the research carried out by
It means that apparently ethically sound research, carried
authors or published by medical journals should be
out with patient consent, approved by ethics boards, and
counted as ethically justified.
appearing to respect the principle of equipoise – though
Medical journal articles that form parts of publica-
given the way funding biases results, equipoise is typically
tion plans are pieces of medical science: they represent
violated40 – is nevertheless deeply suspect. Research
scientific research and conform to the standards of
carried out primarily for marketing purposes places
science well enough to pass peer review and be pub-
lished in scientific journals. But they, like the science
ship and Research Outcome and Quality: Systematic Review. Br Med J
they represent and embody, are driven by marketing 2003; 326: 1167–1170; S. Sismondo. Pharmaceutical Company Funding
concerns. In addition to the evidence offered in the last and its Consequences: A Qualitative Systematic Review. Contemp Clin
section, we can see clear evidence of the driving role of Trials 2008; 29: 109–113.
37
marketing in the strong pro-sponsor bias that much of Bekelman et al., op. cit. note 36; Lexchin et al., op. cit. note 36.
38
that research displays. Pharmaceutical company funding S. Sismondo. How Pharmaceutical Industry Funding Affects Trial
Outcomes: Causal Structures and Responses. Soc Sci Med 2008; 66:
has been repeatedly shown to affect published results 1909–1914.
strongly.36 Company-sponsored research is roughly four 39
D. Bloor. 1976. Knowledge and Social Imagery. London: Routledge
& Keegan Paul.
36 40
For example, J. Bekelman et al. Scope and Impact of Financial Con- J. Fries & E. Krishnan. Equipoise, Design Bias, and Randomized
flicts of Interest in Biomedical Research: A Systematic Review. JAMA Controlled Trials: The Elusive Ethics of New Drug Development.
2003; 289: 454–465; J. Lexchin et al. Pharmaceutical Industry Sponsor- Arthritis Research and Study 2004; 6: 250–255.

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 Publication Ethics and the Ghost Management of Medical Publication 279

patients at risk for the sake of private profits, not public drugs is more often supported by governments and foun-
knowledge. Pharmaceutical companies and their agents dations than by pharmaceutical companies.43 As for clini-
are not the only parties to blame for this violation of cal trials and related research, we have already shown
research ethics: both the academic researchers who par- that much pharmaceutical company research is in the
ticipate in such research or allow it to be published under service of marketing, and so could be simply unnecessary.
their names, and journal editors who publish it are also Though it remains to be empirically demonstrated, we
deeply implicated in unjustifiably placing human research believe that drug development – i.e. turning novel
subjects at risk. research into products – can be done by generic compa-
nies and government agencies.
Alternatively, governments, again acting together,
could force the division of pharmaceutical companies
ADDRESSING GHOST MANAGEMENT into entities that do research and development and enti-
ties that produce and distribute drugs, with strict limits –
At the root of the problem is the fact that pharmaceutical along the lines of anti-monopoly strictures – on the
companies are engaged in both research and marketing. amount of contact between them. To the extent that drug
There are strong interests, then, in shaping the research to research by non-state agencies is valuable, it should find
serve marketers’ ends. Thus we support the call for the support between grants and market mechanisms.
sequestration of drug research from drug marketing.41 On a more modest scale, and not requiring coordina-
That is both a laudable goal on the largest scale and can tion, regulators such as the FDA and the European
inform more local responses to ghost management. Medicines Evaluation Agency could prohibit pharmaceu-
While ghost-managing research is ethically problem- tical companies and their agents from distributing scien-
atic for pharmaceutical companies and MECCs, we do tific data, by prohibiting them from stating anything
not believe that either will stop doing it in the absence of about their products other than what would be very
strong pressure or sanctions from other actors, on whom closely specified upon approval of the drug. This would
we focus here. Those other actors are regulators, academ- dramatically reduce the promotional role of drug repre-
ics, and medical journals. sentatives. Complementing this policy would be a pro-
hibition on pharmaceutical company sponsorship of
continuing medical education. Thus, physicians who
(a) Regulators wanted to learn more about particular drugs would have
to themselves turn to the scientific literature, somewhat
Governments, acting together, could end monopoly reducing the value of the ghost management of research.
rights on pharmaceuticals. Without exclusive rights, pro- In the US, the trend is in the opposite direction, with
ducers of drugs would face generic competition across the legislation, court rulings, and regulatory change tending
board. They would, then, have little incentive to engage to grant companies more freedom in their ability to
in expensive marketing of their products, because that promote drugs; both the FDA and the courts seem to be
marketing would benefit competitors as well as them- leaning toward allowing unlimited distribution of pub-
selves. Pharmaceutical companies will argue that such a lished scientific articles.44
regime would reduce the incentive for research and devel- One form of regulation that will not work is self-
opment, but that is not obvious. Only a small minority of regulation. ISMPP, for example, has recently adopted a
drugs are genuinely novel and are improvements over code of ethics.45 The code encourages ISMPP members to
their forerunners.42 The basic research leading to new apply the standards of professional organizations such as
41 43
M. Angell. 2004. The Truth About Drug Companies: How They US Congressional Joint Economic Committee. 2000. The Benefits of
Deceive Us and What to Do About It. New York: Random House; M. Medical Research and the Role of the NIH. Washington, DC. Acces-
Doucet & S. Sismondo. Evaluating Solutions to Sponsorship Bias. J sible through the US Federal Government’s Document Services.
44
Med Ethics 2008; 34: 627–630; T. Hubbard & J. Love. A New Trade Food and Drug Administration. 2008. Guidance for Industry: Good
Framework for Global Healthcare R&D. PLoS Biol 2004; 2: 147–150; Reprint Practices for the Distribution of Medical Journal Articles and
A. Schafer. Biomedical Conflicts of Interest: a Defence of the Seques- Medical or Scientific Reference Publications on Unapproved New Uses
tration Thesis – Learning from the Cases of Nancy Olivieri and David of Approved Drugs and Approved or Cleared Medical Devices (Draft
Healy. J Med Ethics 2004; 30: 8–24. Guidance) http://www.fda.gov/oc/op/goodreprint.html [Accessed 30
42
Food and Drug Administration. 2004. CDER NDAs Approved in April 2008]; Sismondo, op. cit. note 34.
45
Calendar Years 1990–2004 by Therapeutic Potential and Chemical International Society for Medical Publication Professionals. 2007.
Type. Center for Drug Evaluation and Research. Available at http:// ISMPP Code of Ethics. Available at http://www.ismpp.org/pdf/
www.fda.gov/cder/rdmt/pstable.htm [Accessed 6 Dec. 2008]. 94_80_ISMPP%5b1%5d.Code.of.Ethics.pdf [Accessed 6 Dec. 2008].

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280 Sergio Sismondo and Mathieu Doucet

the ICMJE and the Consolidated Standards for Report- moralistic tone, as if a lack of ‘integrity’ among research-
ing Trials (CONSORT).46 Other industry guidelines ers, rather than the economic influence of the pharma-
include the Good Publication Practices (GPP) for phar- ceutical industry, is the main cause of ethically flawed
maceutical companies and the guidelines of the European research. If such authors are to avoid unethical and
Medical Writers Association (EMWA).47 Such self- deceptive practices, they need more than moralistic scold-
imposed standards miss the point, since they do not ing. They require, most of all, genuine alternatives to
address the conflict between science and marketing that engaging in hidden marketing.
leads to biased literature. Merely regulating MECCs Authors need such alternatives if their research is to be
while preserving the current institutional structure will ethically defensible; but they also require them for self-
ensure that trials continue to be ghost managed, and that interested reasons. They might believe that participating
patients continue to be put at risk for commercial gain. in industry-funded, ghost-managed research is the only
way for them to do cutting edge science but, in fact, they
are ensuring that such research is actually carried out by
(b) Authors others. 70% of pharmaceutical company funding goes not
to academic researchers but to CROs that do not expect
It is abundantly clear that academic researchers who
to publish their research under their own names.49 Even
appear as authors on articles to which they have contrib-
part of the remaining 30% of industry-funded research is
uted little or nothing are behaving unethically. Such
likely to include some that is ghost-managed from begin-
authors violate accepted norms of authorship, but much
ning to end.50 The current system of industry sponsor-
more importantly they help to hide conflicts of interest.48
ship, then, is one in which academic researchers do little
They lend their credibility to research that is likely to be
truly independent research and where they are valued
biased and is performed for its marketing value, and is
more for contributing a façade of independence than sci-
therefore, as we have already argued, ethically flawed
entific insight. This puts such researchers in a dangerous
from the beginning. For the sake of some academic credit
position: by participating in ghost-managed research they
and perhaps a small consulting fee, then, these authors
undermine the independence for which the pharmaceuti-
unnecessarily put patients at risk, and directly contribute
cal industry values them. Each scandal diminishes their
to pharmaceutical companies’ marketing efforts. Those
value; and they would do well to wonder whether the
marketing efforts are intended to convince physicians
pharmaceutical industry might eventually decide to
to see health conditions differently, to think more – and
abandon the façade and simply take ownership of its
more highly– of particular drugs, and to be more likely to
research. If so, then academic researchers would lose
prescribe those drugs. Thus academic deception is in this
both their sources of funding and their claim to do inde-
case a serious breach of responsibility to the public.
pendent and cutting edge science. If they want to do the
But such behaviour is simply at the end of a spectrum
ethically right thing, or if they simply want to do real,
that includes activities few find remarkable. Although
independent science, academic researchers would be
many authors could act with a great deal more integrity
better served by a system that allowed them to carry out
than they do, the vast majority of authors do not act with
their research without interference from pharmaceutical
malign intent: they are simply doing research within the
companies and their ghost-manager proxies.
institutional contexts in which they find themselves.
It would be unfair, then, to focus criticism entirely on
Many discussions of publication ethics adopt an overly
such authors and researchers, who are, after all, caught in
46
CONSORT. 2006. The CONSORT Statement. Available at http:// an unethical system that they had little part in designing.
www.consort-statement.org [Accessed 6 Dec. 2008]. Moreover, ghost management is a completely normal
47
E. Wager et al. Good publication practices for pharmaceutical com- part of medical science: those who, for the best of
panies. Curr Med Res Opin 2003; 19: 149–154, also available at http:// reasons, want to do interesting medical research might
www.gpp-guidelines.org/ [Accessed 6 Dec. 2008]; A. Jacobs & E.
understandably feel that they have little choice but to
Wager. European Medical Writers Association (EMWA) guidelines on
the role of medical writers in developing peer-reviewed publications.
49
Curr Med Res Opin 2005; 21: 317–321, also available at http:// P. Mirowski & R. van Horne. The Contract Research Organization
www.emwa.org/Mum/EMWAguidelines.pdf [Accessed 6 Dec. 2008]. and the Commercialization of Scientific Research. Soc Stud Sci 2005;
48
For our purposes we can ignore issues of fairness in violations of 35: 503–584.
50
norms of authorship: The under- or unacknowledged contributors – Blumenthal et al., op. cit. note 16; J. Lexchin. Implications of Phar-
medical writers, company statisticians, and others – are part of different maceutical Funding on Clinical Research. Ann Pharmacother 2005; 39:
economies of authorship, and while the inappropriate academic credits 194–197; M.M. Mello et al. Academic Medical Centers’ Standards for
accumulated by over-acknowledged contributors are real, their impor- Clinical-Trial Agreements with Industry. N Engl J Med 2005; 352:
tance fades in relation to the health consequences of ghost management. 2202–2210.

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 Publication Ethics and the Ghost Management of Medical Publication 281

participate in pharmaceutical industry structures. In munication between publication planners and journal
order to carry out research that is both scientifically editors. For example, the editor of a top-ranked journal
meaningful and ethically sound, authors require help said, ‘The way to get an article published easily, which is
from other agents. what our goal is and yours, is to avoid practices that are
going to slow things up and slow the period of time before
you can start enjoying the acclaim and the revenue that
(c) Medical Journals comes with successful publication in a big journal.’
Medical journals are an essential link in the chain that Another expressed appreciation for medical writers, and
connects research and marketing: since major medical suggested that to meet ICMJE guidelines authors have
journals have the most authority among sources of a responsibility to insist on ‘early active involvement in
medical information, considerable work of ghost man- the research project’ not ‘to sign off on already-written
agement is aimed at placing articles in such journals. manuscripts, particularly in review articles’. This editor
Journals make some efforts to prevent ghost manage- clearly understood the planners’ activities and goals.53
ment and ghost authorship. The most important set of These journal editors are violating the spirit of their
criteria for authorship of medical papers is that of the own rules. They do so because publication planners
ICMJE, adopted by most journals. According to these handle some of the more important manuscripts they can
criteria, publish: reports of randomized, controlled trials or other
major studies authored by well-regarded researchers.
Authorship credit should be based on 1) substantial These manuscripts will go on to be cited much more often
contributions to conception and design, or acquisition than others on the same topic,54 both on their own appar-
of data, or analysis and interpretation of data; 2) draft- ent strengths and because publication planners will them-
ing the article or revising it critically for important selves cite them. Drug representatives will use reprints of
intellectual content; and 3) final approval of the these articles to buttress their sales pitches, in the process
version to be published. Authors should meet condi- earning the journals reprint fees and further promoting
tions 1, 2, and 3.51 the articles themselves. Clearly, medical journals face
substantial conflicts of interest when dealing with ghost-
Ghost-managed papers will typically violate one or more
managed manuscripts, as they do with sponsored manu-
of these requirements of authorship. When publication
scripts in general.55
planners and industry researchers, rather than the aca-
Medical journals should be concerned with advancing
demic authors whose names appear on the paper, do
medical knowledge in the service of human health, not
most of the work of designing the trial, analysing the
with acting as part of the marketing arm of the pharma-
data, and drafting the article, the academics who receive
ceutical industry. They should therefore make every
credit do not truly meet the ICMJE criteria. Despite this,
effort to ensure that they do not publish ghost-managed
medical journals publish large numbers of ghosted
articles. No doubt many editors, like many researchers,
papers: again, roughly 40% of articles on recent drugs are
see themselves as engaged in the publication of honest
managed by publication planners.
scientific research, and as doing so within a commercial
Journal editors might plead ignorance, but implausi-
system that they had no part in designing. They would
bly, at least in general. At a recent meeting of ISMPP, one
be understandably offended to be accused of being cor-
of the two international associations of publication plan-
porate shills. Despite their noble intentions, however,
ners, the speakers included editors of three of the very
these journal editors are –perhaps unknowingly or unin-
best regarded medical journals, one person representing
tentionally – engaged in the publication of unethical
a journal editors’ organization, and a representative of a
research. It is true that they are often unable to deter-
major international publisher of many journals. Some of
mine positively whether authorship on a particular
these people took the opportunity to promote their jour-
article is illegitimate or inappropriate. However, at a
nals during their talks. A few other publishers and jour-
minimum, they should refrain from dealing with
nals were represented by booths at the trade show
MECCs, and insist that contact people on submitted
associated with the meeting.52 Moreover, it was clear
manuscripts be authors. This would at least force
from the conference as a whole that editors recognized
authors to serve as intermediaries on manuscripts, which
the roles of their audience, and that there is routine com-
53
Sismondo, op. cit. note 34.
51 54
ICMJE, op. cit. note 5. Healy & Cattell, op. cit. note 21.
52
ISMPP. Program of The 3rd Annual Meeting of ISMPP. Philadel- 55
J. Lexchin & D. Light. Commercial Influence and the Content of
phia, 2007 [available from authors]. Medical Journals. Br Med J 2006; 332: 1444–1447.

© 2009 The Authors. Journal compilation © 2009 Blackwell Publishing Ltd.

282 Sergio Sismondo and Mathieu Doucet

is more contact with manuscripts than authors some- publish the data in the closest to raw form as possible,
times now have. Journals, acting together, should also and engage in serious critiques of the trials that they
develop and enforce much more strict penalties for vio- publish, rather than simply printing industry-approved
lation of ICMJE rules. For example, they should bar advertisements.
anybody found guilty of illegitimately serving as an In refusing to publish industry-funded or ghost-
author from publishing in any medical journal for some managed articles, journal editors can avoid the moral
considerable period. stain of putting patients at risk for commercial profit. On
As a further step, journals should not provide reprints its own, this is an important reason to reject such articles.
for commercial purposes. Former BMJ editor Richard But journal editors have an additional reason: refusing
Smith reports a case in which a journal sold $1 million to publish sponsored articles can help researchers escape
worth of reprints of a single article to a company, enough from a system that pushes them to conduct unethical
to provide copies to most practising physicians in North research. Medical journal editors occupy a position of
America and Western Europe.56 Authors may want a relative power compared with individual authors and
reasonable number of copies of an article to distribute to researchers. As long as MECCs can boast of acceptance
colleagues, but numbers in excess of a few hundred are rates of 80%58 in journals that have rejection rates above
being used for marketing purposes. 90%, researchers will quite understandably feel that the
Ideally, though, journals should refuse to publish any only way for them to publish in major medical journals
industry-sponsored trials. There is no other way entirely is to accept pharmaceutical funding and the ghost man-
to remove commercial conflicts of interest and their agement that often accompanies it. A refusal on the part
resulting biases. If journals want to avoid being morally of medical journals to publish industry-sponsored trials
implicated in putting patients at risk for the sake of com- would give authors and researchers an important reason
mercial gain, they must stop publishing articles that do to refuse to engage in industry-funded research, and it
just that. Certainly the dozen most major journals are in would give them a prestigious venue for such research.
a good position to do so. Their rejection rates are so high Journals would not only be protecting their own ethical
that they could easily afford to do so without running integrity; they would also be helping researchers and
short of high-quality articles to publish. JAMA and the authors to act with integrity.
NEJM, for example, have rejection rates as high as 94%.57
If they refused sponsored trials, publication in their pages
could become even more prestigious, since articles ap- CONCLUSION
pearing in their pages would be free of commercial bias
and so much more likely to be ethically sound. We have argued that authors and journal editors are
We do not mean to suggest that suppressing data is complicit in unjustifiably putting trial participants at risk.
the solution to unethical research. The results of ethical On its own, this is bad enough, and would be a serious
research should certainly be widely publicized, because breach of research ethics even if it rarely, or even never,
of their value to medical knowledge. But, if many trials led to significant adverse health effects. But such practices
are carried out primarily for the purposes of marketing do have serious effects on health. Moreover, these effects
rather than increasing medical knowledge, then our pro- are not confined to trial participants but potentially
posal will not lead to the suppression of data. Without extend into the general public.
prestigious publication venues, companies will have no Studies that display a significant pro-sponsor bias play
reason to undertake marketing-oriented research. Far an important role in the drug approval process, in clinical
from leading to a glut of suppressed data, our proposal practice guidelines, in physicians’ prescribing practices,
would lead to fewer trials. This is no bad thing: if some and even, in some cases, in patients’ beliefs about which
industry-sponsored trials are unethical, then we should treatments they should pursue. Sometime, this means
want there to be fewer of them. And companies can still that drugs that should be neither approved nor prescribed
post data from their other trials to public databases, as end up in wide use, the recent Vioxx controversy being
they have largely committed to do in any case. If, on the only one prominent example. In such cases, patients are
other hand, journals insist on continuing to publish the not merely put at risk by the way ghost management uses
results of industry-sponsored trials, then they should medical research for marketing purposes: they are actu-
ally harmed. Not only does ghost-managed research put
56
R. Smith. Medical Journals and Pharmaceutical Companies: Uneasy
58
Bedfellows. Br Med J 2003; 326: 1202–1205. See, for example, Gardiner-Caldwell Group. 2007. http://www.thgc-
57
A. McCook. Is Peer Review Broken? The Scientist 2006; 20: 26–35. group.com/ [Accessed 15 Dec 2007].

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 Publication Ethics and the Ghost Management of Medical Publication 283

trial participants at risk, it threatens the health of millions pharmaceutical research from marketing completely.
of patients who take drugs that might otherwise not be Short of such a radical solution, however, authors and
prescribed. It may, through disease-mongering, alter phy- journal editors still have an obligation to the public to
sicians’ and potential patients’ conceptions of health and refrain from engaging in, or publishing, ghost-managed
disease, leading to more perceptions of disease and more research. Otherwise, they are putting public health at risk
prescriptions.59 for the sake of private profit.
Ghost management therefore has serious implications Sergio Sismondo’s current research concerns the political economy of
for health, both for trial participants and for the public at pharmaceutical knowledge, especially related to the industry sponsor-
large. The best way to eliminate the dangerous health ship of clinical trials. He is also the author of An Introduction to Science
effects of ghost management would be to separate and Technology Studies (Blackwell 2004), and other general and philo-
sophical works in that field. See www.sismondo.ca
59
R. Moynihan & A. Cassels. 2005. Selling Sickness: How the World’s Mathieu Doucet is a doctoral candidate in the Department of Philoso-
Biggest Pharmaceutical Companies are Turning Us All into Patients. phy at Queen’s University. His current research is in ethics and moral
Vancouver: Greystone Books. psychology.

© 2009 The Authors. Journal compilation © 2009 Blackwell Publishing Ltd.