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Abstract

Many medical journal articles are ghostwritten and have honorary authors. This entry brieﬂy describes the phenomenon and the pharmaceutical industry’s roles in creating these articles. In the interest of marketing, the pharmaceutical industry commissions manuscripts to publish its data, analyses, and viewpoints and then ﬁnds authors to submit them to medical journals for publication. Medical journals have responded with deﬁnitions of authorship intended to deﬁne and discourage ghostwriting and honorary authorship, though these efforts have had limited success. A number of bioethicists and philosophers have looked at the phenomenon and have adopted a wide variety of perspectives on it as an issue in bioethics. They range from seeing ghostwriting in terms of plagiarism, breaches of trust, facilitating fraud, serving commercial interests, and violating research ethics. This entry examines and assesses those perspectives and lists some possible ways of addressing the problem.

Introduction

Ghostwriting has long been a topic of discussion within medical science, prompting many studies, commentaries, and admonishments, a result mostly of the ghostwriting of medical journal articles by the pharmaceutical and medical device industries. Ghostwriting prompts two very different types of concerns. The ﬁrst of these is about appropriate credit: a ghostwritten article is attributed to those listed as its authors and fails to credit its writers. For example, local power imbalances within a department or laboratory might allow some people to demand authorship and to exclude it from others. The result helps the careers of those with more power and harms those with less. Appropriate credit, though, is primarily a professional concern within academic medicine and is not obviously of real interest to bioethics.

A second reason for concern with ghostwriting involves hidden inﬂuences on and hidden conﬂicts of interest in published medical literature. In particular, pharmaceutical companies and, to a lesser extent, medical device and other health related companies use medical journal articles to promote their products. In some cases, pharmaceutical companies hire contract research organizations (CROs) to run trials, have their own statisticians analyze the data, hire professional ghostwriters to produce manuscripts, ask academics to serve as authors on those manuscripts, and pay communication companies to systematically shepherd them through publication in the best possible journals (Sismondo 2009). Other cases may not involve primary research, as when a review article, opinion piece, or letter is prepared for one or a small group of authors (McHenry 2010). The authors are generally academics or prominent physicians who have some relationship with the sponsoring companies but also can stand as representatives of important markets – they tend to be located in more wealthy countries, though nothing prevents researchers in less developed countries from being authors used to aid efforts in particular local markets. The resulting articles affect the overall tenor of the medical literature and can be used in face-to-face promotion to doctors or promotion of a drug more generally. Thus, the second concern about ghostwriting, its hidden inﬂuence on medical science and practice, should be of considerable interest within bioethics. However, as discussed below, there is some disagreement about exactly why it is a bioethical issue.

The hidden inﬂuence is certainly signiﬁcant, although it is difﬁcult to determine how signiﬁcant. As recently as the 1980s, the majority of the pharmaceutical industry’s outsourced clinical research went to university-based medical researchers. However, approximately 70% of the industry’s funding for outsourced research today goes not to academic researchers and units but to CROs, which neither make ownership claims on data nor expect to publish it under their own names. So 70 % of industry funding goes to research that, if published under an academic author’s name, is to some extent “ghost managed” (Sismondo 2009). Ghost management is unseen or obscured control by a pharmaceutical company of multiple stages of the planning, research, analysis, and publication of a journal article. It is not widely seen, because legitimate authorship and contributions to research are somewhat ﬂexible categories and because very few of the people involved have interests in revealing the ghost management of research and publication.

A large number of communications ﬁrms specialize in producing, placing and tracking journal articles, a practice known in the trade as “publication planning” or “strategic communication planning.” Many of these ﬁrms energetically promote themselves and the services they offer, some with ﬂashy websites highlighting their ability to write, track, and publish journal articles and to produce attractive outputs displaying the results of their work. The trade of ghostwriting of medical journal articles arose in the 1980s and 1990s and today is large enough to accommodate two industry associations that represent publication planners: The International Publication Planning Association (TIPPA) and the International Society for Medical Publication Professionals (ISMPP). Both associations organize conferences, offer member services, and have committees to develop policy. The second of the two has even developed sets of ethical guidelines for medical writing.

Given the amount of data that pharmaceutical companies control, the number of ﬁrms that openly advertise on the Web that they provide publication planning services, and the fact that there are two associations for publication planners, the conferences and workshops organized for them, we can conclude that ghost-managed research and publication is common.

Ethical Dimensions

Authorship Problems

The International Committee of Medical Journal Editors (ICMJE) recommends authorship criteria for medical journals. The ICMJE criteria specify that authors are deﬁned in terms of, and must meet all of, the following:

Substantial contributions to the conception or design of the work or the acquisition, analysis, or interpretation of data for the work; and drafting the work or revising it critically for important intellectual content; and ﬁnal approval of the version to be published; and agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved (ICMJE 2013).

Versions of the ﬁrst three criteria have long been in place. The fourth was added in 2013, in response to issues like those discussed in this research paper .

The ICMJE deﬁnition tends to restrict authorship: the only people who qualify will have been involved in multiple stages of the research and writing of the article. Thus, in addition to addressing issues of appropriate credit, the ICMJE is recommending criteria that recognize fewer and more important authors, which might be seen as a cultural preference within medicine. Restriction of authorship poses some difﬁculty when it comes to large-scale medical research, however. In general, biomedical research is increasingly decentralized and complex, and teams distribute tasks widely. A large clinical trial, for example, may involve hundreds of physician collaborators who recruit and deal with subjects in sites around the globe. It may involve experts in statistics, pharmacology, multiple substantive medical specializations, and other ﬁelds, including technical writing. Moreover, accepted practices do not require medical authors to write articles, as mere writing is often left to junior colleagues and principal investigators. In this context, there may be nobody who meets ICMJE criteria for authorship of manuscripts derived from a signiﬁcant research project. It is not just the ICMJE criteria that pose a problem, because often there are no authors in any traditional senses (Kukla 2012).

In response to some of the problems with traditional ideas of authorship, some medical editors have attempted to move in a very different direction. In the 1990s, Drummond Rennie, then the Deputy Editor of the Journal of the American Medical Association, proposed replacing the notion of “author” with that of “contributor,” whose precise contributions would be listed (Biagioli 1998). Rather than restricting authorship to a few, this proposal expands contributor ship to many. It has not, however, been taken up. A few medical journals, such as Neurology, have similarly deﬁned authorship in an expansive way, requiring that everybody who makes substantial contributions to a manuscript be listed as an author.

Medical journals have multiple difﬁculties in addressing ghostwriting, though. First, they typically want to address both of the two concerns at the top of this research paper . Promoting “appropriate” credit as a professional or cultural matter within medicine may push in opposite directions than does combating hidden inﬂuence on medical journal articles. Second, at the practical level, ghostwriting is by deﬁnition hidden. Therefore, approaches to reducing its incidence typically must start by attempting to expose it, perhaps by designing and implementing procedures that trace histories of manuscripts – all difﬁcult tasks. Third, medical journals are open to, or even encourage, submission of pharmaceutical company manuscripts. Pharmaceutical companies control an immense quantity of data. The industry as a whole provides considerably more funding for clinical trials and related research than do national granting agencies. The clinical trials that companies support tend to result in highly cited articles, and some of them are important and newsworthy. Thus, medical journals generally do not want to adopt policies that reduce the number of manuscripts coming from pharmaceutical companies.

Plagiarism

One approach to understanding and addressing the problem is to consider ghostwriting as a kind of plagiarism (Anekwe 2010). For medical scholars to serve as authors on ghostwritten manuscripts could easily be considered plagiarism, even if the ghostwriters and their employers offer consent to or encourage those medical scholars to take credit for the work. The majority of authors of medical journal articles are based in universities, and almost all universities already have policies against plagiarism; as a result, it may be possible to prosecute titular authors of ghostwritten manuscripts via their universities. The plagiarism framework immediately addresses both the concern about appropriate credit and that about hidden inﬂuence, because it focuses narrowly on the relationship between author and ghostwriter. This is an advantage because it locates the problem in such a way that the medical profession should take note and locates it so that, in principle, it could be dealt with by governance structures familiar to medicine.

However, by the same token, this is a relatively formal approach to identifying a problem with ghostwriting. Small shifts in the practices that currently produce ghostwritten medical journal articles may pull ghostwriting apart from plagiarism. Many universities lack policies that would ban their faculty from authoring all kinds of ghostwritten work (Lacasse and Leo 2010). Even if that situation changes, if authors and ghostwriters have short conversations about the content of manuscripts to be written, and if ghostwriters are recognized in the footnotes as having provided professional writing assistance, then it will be very difﬁcult to demonstrate that anything unacceptable has happened. Norms within medicine do not require that authors write articles in anything like the way that norms within the humanities and most social sciences require.

The difﬁculty with the formal approach is closely connected to a difﬁculty with overly formal authorship criteria generally. The publication planners who work for pharmaceutical companies are very familiar with the ICMJE criteria for authorship. Consequently, they adjust their practices so that ghostwriters and other behind-the-scene actors do not qualify for authorship (Matheson 2011). Simply by not allowing anyone other than the named authors to give ﬁnal approval on manuscripts, they ensure that nobody other than the named authors can qualify for authorship (because of the 3rd of the ICMJE criteria). And to qualify those named authors, companies can have asked them to serve on advisory boards, to recruit patients, to examine manuscripts, etc., in efforts to establish the basis for arguments that aim to legitimize small contributions as claims on authorship, should they be challenged.

Another problem with the plagiarism approach is that it focuses on authors, rather than on the large structures that underpin pharmaceutical company-led ghostwriting. People who agree to serve as authors on manuscripts to which they have contributed little – or an amount that is not enough to normally qualify as authors – may be morally culpable, but the root of the hidden inﬂuence problem lies in the interests of powerful companies, in tandem with pressures on university faculty members to publish frequently. With the companies able to provide attractive manuscripts, ﬂattery, and cover, we can expect people to continue signing on as undeserving authors. Moreover, universities have so far proven reluctant to prosecute their researchers, some of whom are academic stars. It is difﬁcult to have conclusive evidence that particular papers are ghost managed to the extent that their authors do not deserve credit on them, and so it is difﬁcult to criticize those authors for anything more than misdemeanors, such as failing to acknowledge writing assistance. To this point, most medical schools have responded to scandals and potential scandals by being more concerned about protecting the reputations of their more prominent faculty than about ensuring the integrity of the medical literature (e.g., Belluz 2011). For this and other reasons given in this section, authors are probably weak foci of attention, both theoretically and practically.

Breakdowns Of Trust

Another approach to understanding the hidden inﬂuence problem of ghostwriting connects it neatly with a standard issue in bioethics. Physicians do not see pharmaceutical companies’ full inﬂuence on published medical science and so do not see important conﬂicts of interest behind that published work. When they read ghostwritten articles, physicians tend to place more trust in them than they should or at least fail to identify potential reasons for distrust. But this means that patients’ trust in their physicians’ understanding of medical science is also misplaced. The entire breakdown in the bases of trust results in a hidden failure of informed consent (Almassi 2014).

Undoubtedly, ghostwriting creates a problem for informed consent. However, there are many reasons to think that weakened informed consent is at most a small side effect of the ethical problems with ghostwritten medical science.

If ghostwritten articles weaken informed consent, they do so as part of a much larger issue concerning physicians’ relation to published research. Most likely, there are many physicians with only a cursory understanding of contemporary clinical research. As such, this aspect of informed consent may be on very weak grounds to begin with. At the least, one can ask a great many questions, such as: Do physicians generally understand how clinical research is performed and published? Do they understand that clinical research is not a mechanical activity and that innumerable judgments are made about protocols and how to implement them and how to process, interpret, and represent the data? Do physicians understand that the complexities of current clinical research result in the work of large clinical trials being widely distributed? Do they understand how peer review works and that it is only a check that there are no obvious major problems in research or papers as presented?

Focusing on conﬂicts of interest, do physicians generally look at or care about conﬂicts of interest reported in medical journal articles? Or do they instead assume that declarations of conﬂicts make journal articles more credible (Loewenstein et al. 2012)? Or that research methods in place in medical science are strict enough to make conﬂicts of interest irrelevant? If physicians do not, in general, pay much attention to conﬂicts of interest, then it may be that the hidden conﬂicts of interest in ghostwritten articles pose no additional or special problem for chains of trust.

Ghostwriting in medicine also is clearly morally problematic when informed consent is not at issue. For example, in domains or situations in which patients do their own reading of medical science, and do not rely on physicians for information, hidden inﬂuence is still signiﬁcant. There is a breakdown in the bases of these patients’ trust in the medical literature, but because there is no informed consent, there is no failure of informed consent. This suggests that a more important root of the problem is one around reliable or disinterested science.

In light of these questions, the challenge to informed consent may turn out to be neither a major problem in practice nor the crux of the problem with ghostwriting. But breakdowns in the bases for trust remain an important issue.

Fraud

We might understand the issue of ghostwriting in terms of the dangers it poses for the advancement of knowledge or patient safety. Analyses have challenged aspects of some known ghosted publications, and there have been a handful of accusations of misconduct or fraud. McHenry (2009) suggests that fraud may be the important ethical problem with ghostwriting: “If the results of industry-sponsored clinical trials were reported honestly, then aside from the question of deception and plagiarism, ghostwriting would not present a serious concern for advancing knowledge.” In this scenario, it is the security or reliability of medical knowledge that is important. The identities of the people who analyze the data, write it up, and make other decisions along the way to published research matter only to the extent that hidden inﬂuence might allow for the corruption of science by corporate interests.

The industry studies that we now know to have involved fraud have unquestionably contributed to many people’s suffering or death. Since ghost management of industry research is the norm, it is implicated in these cases of fraud. However, among the huge number of studies done by or for the industry, relatively few have been demonstrated to be fraudulent. Our evidence base on fraud is limited, so demonstrated cases must make up only a subset of total cases. However, there are reasons to believe that fraud is infrequent in ghost-managed pharmaceutical industry research. Ghost-managed work succeeds at being published, at being well regarded, and thus at marketing products by being of apparent high quality; editors, reviewers, and readers ﬁnd value in these articles. Pharmaceutical companies have the resources to produce high-quality research and should not generally have to rely on fraudulent research or data. In addition, their highly bureaucratized management structures should be expected to limit the incidence of outright fraud, even while they may enforce certain systematic biases.

While scientiﬁc misconduct of the kind that we label “fraud” is extremely important, it likely is not common enough to be the central bioethical concern around ghostwriting. However, a cousin of fraudulent science, interested science, is at the heart of ghost-managed research.

Science In The Private Interest

Ghostwritten pharmaceutical industry work serves marketing goals. “What is the purpose of publications?” asks a Pﬁzer sales document (quoted in Moffatt and Elliott 2007). The “purpose of data is to support, directly or indirectly, the marketing of our product” comes the response. Almost invariably, companies that do publication planning recognize this, advertising that their work will contribute to sales of sponsors’ products.

Ghost-managed research and publication is controlled from above by a relatively uniﬁed set of actors with narrow interests and is at least partly oriented toward marketing. Science, including even relatively formulaic clinical research, is heavily laden with choices. These decisions made may be more or less justiﬁable. However, no matter how justiﬁable the particular decisions, when one narrow set of interests exerts inﬂuence on choices at multiple stages of research, writing, and publication, those interests will strongly shape the resulting articles. This is not to say that other medical science is interest-free, but interests represent a concern in pharmaceutical industry research because they will tend to line up and build on each other.

Articles in medical journals have real effects, which is why pharmaceutical companies invest considerably in their publication. Published scientiﬁc articles are sources of medical information holding very high authority. They are extensively used by sales representatives to validate claims of the efﬁcacy of drugs and address physicians’ concerns about contraindications and side effects. Even independent of sales reps, responsible physicians and medical researchers search the literature to gather evidence about the best treatments. Systematic reviews and meta-analyses, to which increasing numbers of physicians and researchers turn, almost all start with the published literature.

The ghost management of research and publication means, for a start, that some data are highlighted and other data may be ignored or suppressed, almost certainly in ways that harm patients (McHenry 2010). Even if all data were treated equally, studies would have been designed around company interests rather than patient interests, shaping the results. In addition, some hypotheses are explored more fully than others, some questions are asked more prominently than others, and some areas researched more heavily than others, again driven by company interests rather than patient interests. Articles might be designed for off-label marketing, circumventing regulators’ efforts to balance harms and beneﬁts in drug approvals. Companies might have strong interests in raising awareness of certain diseases, to the point of “disease mongering” (Moynihan and Cassels 2005). Ghostly pharmaceutical research and publication chains medical science to commercial interests. For obvious reasons, this is damaging to patients’ and publics’ health.

Violations Of Research Ethics

There is a further important consequence of the recognition that much industry science is done and published for marketing purposes. Such research, usually involving human subjects, is performed not primarily to increase knowledge for broad human beneﬁt but as part of advertising campaigns (Sismondo and Doucet 2010).

The Nuremberg Code and the Declaration of Helsinki require that the very real risk of medical research on human subjects be justiﬁed in terms of possible health beneﬁts from increased knowledge. Science done for marketing purposes poses a major problem for research ethics: it means that apparently ethically sound research, carried out with patient consent, approved by ethics boards, and appearing to respect the principle of equipoise, is nevertheless deeply suspect. Research carried out primarily for marketing purposes places patients at risk for the sake of private proﬁts, not public knowledge.

All of the actors who participate in the performing and publication of ghost-managed research – pharmaceutical companies and employees in their medical departments, contract research organizations, physicians who recruit or treat subjects, publication planners, ghostwriters, authors, and medical journals – are contributing to this serious failure of research ethics. That is, all of these actors are complicit in unjustiﬁably putting trial participants’ health and lives at risk.

Conclusion

The solutions to problems of ghostwriting and broader ghost management must involve reducing the effects of pharmaceutical company interests on medical science. In other words, they must involve pulling apart marketing and research. Because of the closeness with which they are connected today, this is not likely to happen. Here, for example, are a number of difﬁcult or unlikely steps:

Prescribers should ignore scientiﬁc articles provided by sales reps, because those articles are likely to have been ghost managed and in any case are being provided to support company interests. In fact, prescribers should not read industry sponsored research, because one cannot in general tell the difference between commercially driven and fully independent sponsored research.

Researchers should refrain from serving as authors on articles unless they have made genuine and substantial contributions to the research, analysis, and writing and are willing to take responsibility for the article and its consequences.

Medical journals should require authors to describe in detail their contributions to articles and should scrutinize those descriptions. They should stop pandering to the industry for important manuscripts. More controversially, they should stop publishing sponsored research altogether.

Medical schools and universities should punish plagiarists. To assist this, medical schools should reduce the value they place on pharmaceutical company sponsorship of research.

Governments should pursue legal action against pharmaceutical companies for illegal marketing. The Ofﬁce of the Inspector General of the USA has made some steps in this direction, arguing that individual pharmaceutical companies have defrauded federal health-care programs through illegal marketing. The resulting settlements have put in place very wide-ranging procedures to limit many unethical and inappropriate actions. Among other things, these corporate integrity agreements often reduce the inﬂuence of marketing goals on scientiﬁc publications.

Governments should sequester drug research and marketing more broadly. They might take clinical trials out of the hands of drug companies and fund necessary trials through taxes on those companies. Or they could redeﬁne the allowable scope of drug companies, dividing them into research entities and marketing entities. Governments are unlikely to act in such a way, because they are themselves highly conﬂicted, typically seeing the pharmaceutical sector as an important part of new high-tech economies, not to mention as sources of political contributions.

Again, none of these remedies is easy or likely to happen, an indication of the extent to which medicine currently is driven by major commercial interests.

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