Professional medical writing and ghostwriting
A professional medical writer and a ghostwriter can do the same drafting work, and what separates them is whether the writer's contribution and its funding are disclosed and whether the named authors did the work their byline claims. Where that line falls is argued over, and so are the harm ghostwriting has done to patients and readers and whether it counts as research misconduct.
Ghost authors, ghostwriters and guest authors
There are three main unethical authorship practices, and they are told apart by whether the person meets the authorship criteria and whether they are identified in the manuscript. A ghost author meets the authorship criteria but is not listed as an author. A ghostwriter does not meet the criteria, and their involvement is not disclosed: they are not listed in the acknowledgments. A guest author, also called a gift or honorary author, does not meet the criteria and is nevertheless listed as an author; the authorship is given rather than earned, and the person may or may not have contributed to the manuscript. None of the three should be tolerated, whether it occurs in industry or in academia.
An especially problematic industry practice is publishing a study prepared by a hired medical writer but signed by an academic guest author, invited to add their name without meeting the authorship criteria. In that case guest authorship is accompanied by ghostwriting, which occurs when a published article fails to acknowledge the original writer's contribution. Ghostwriting can also occur when an academic research group uses a professional writer to draft an article from data the group generated. When the group retains control of the data and the final analysis, however, there is less concern about bias in reporting the results, and the appropriate remedy is to report the writer's role and contribution explicitly in the article.
Writing assistance and the word ghostwriting
In 2008 the role of medical writers in developing research publications received heightened attention through several articles in the medical literature and the coverage they drew in the lay press, in a controversy that followed two articles and an accompanying editorial in the Journal of the American Medical Association. In the view of AMWA's leadership, many of those articles did not distinguish ghostwriting, the failure to disclose the contribution a medical writer made, from the assistance medical writers give to legitimate authors. AMWA avoids using the word ghostwriting for medical writing assistance and encourages its members to refrain from using it.
AMWA's leadership read the editorial's call to name those who provided writing assistance in the acknowledgments as a major advance in recognising the value of medical writers. When medical writing assistance had been in the crosshairs before, that value had been overlooked: the unacknowledged use of a writer was seen to undermine a manuscript's integrity, and the acknowledged use of one was not considered. In 2005, for instance, the editor of the Clinical Journal of Oncology Nursing announced that its editorial board would reject manuscripts written by medical writers or communication companies, in an attempt to stop what she called the fraudulent practice of ghostwriting.
At that time others in the scientific research field also began to clarify what ghostwriting means. A task force of the American Association of Medical Colleges, in a draft report on industry funding of medical education, held that transparent writing collaboration with attribution between academic and industry investigators and medical or technical writers is not ghostwriting. By 2008 the Institute on Medicine as a Profession had defined ghostwriting as any written work published under the name of health care personnel that was written in part or in full by pharmaceutical industry staff or paid writers. An editorial in Nature Medicine separated two kinds of ghostwriting: writing a paper for which the writer receives no author credit but is probably paid, which it called not illegal and hardly unethical, and authoring a paper to which one contributed no work, which it called more troublesome. AMWA's leaders read it as distinguishing ghostwriting from ghost authorship.
One physician writer held in 2009 that ghostwriting had for many years been an acceptable and honest occupation: it meant putting another person's views, research or clinical findings into good, readable form suitable for publication, and hundreds of books and articles, many of them medical, were produced that way without difficulty. Since the JAMA articles about the Merck case, in his view, many writers had assumed that the word has a dishonest connotation, implying one who distorts the original true meaning of the material for devious reasons, and that definition of it is incorrect. He justified the practice by the fact that not everyone is skilled in everything: some great researchers or clinicians may write below an acceptable level, just as many writers cannot lay claim to research or clinical skills, and an author who wants results that are fully understandable and suitable for publication hires a writer to make them so. Physicians and scientists who publish fall roughly, by his account, into those who write their own work completely, those who require a ghostwriter, and those in between who need heavy editing to produce a finished product. Dishonesty in an article can arise from any source, but it would be unusual for ghostwriters to alter the original findings on their own, because it would make no sense and writers put into good rhetoric what they are told. So most of the time, he held, dishonesty must come from the researcher, the physician or the sponsor, and any breach, whether slanting, distortion, mistruths or lies, is dishonest whoever commits it and should be called to attention in exact terms.
Ghostwriters were criticised for their role in some of the oseltamivir studies, writing to the manufacturer's instructions, and the BMJ alleged that a paper by Treanor and colleagues, published in JAMA in 2000, used ghostwriters. The manufacturer confirmed that medical writers were used to help draft some of the papers, called this neither unusual nor secretive and common practice in the scientific community, and said that at the time of writing and submission it was not standard practice for professional medical writers to be named on manuscripts. In its account, it was common practice during the period in question, 1999 to 2002, for scientific medical writers to provide writing support while the authors had full access to the data and full and final review of the publications, and since the introduction of the Good Publication Practice guidelines for pharmaceutical companies in 2003 it had complied with the practice of acknowledging professional medical writers. It also refuted the influence of its marketing department in inserting key messages. Treanor and colleagues stated that the pivotal adult treatment trial published in JAMA in 2000 was not ghostwritten, and the BMJ replied that while it accepted his assurance that he was unaware his paper was ghostwritten, that did not mean it was not, and that the manufacturer's evasive answers only reinforced its concerns.
What separates a professional medical writer from a ghostwriter
Professional medical writers disclose their involvement and their funding source, usually in the acknowledgments, and follow ethical publication practices throughout the development of a manuscript, and these practices distinguish them from ghostwriters.
A freelancer who is often asked whether she is a ghostwriter answers that she is not, because she works according to GPP4, the fourth edition of Good Publication Practice, and her work is acknowledged.
The term ghostwriter applies where the true author of a piece of work is not directly credited, and so it is often associated with suspicion and distrust. Two new medical writers who took up the question in 2015 both held that medical writers are not ghostwriters, and each named a different fundamental difference between them.
One ground is visibility. On the surface the two look alike: both are professional writers providing a service to paying clients, creating literature published under somebody else's name. But a ghostwriter's identity and contribution are never revealed, so without insider knowledge no reader could tell that the named author did not create the work alone, or what level of assistance was given. The invisible cannot be held to account. A professional medical writer, by contrast, is identifiable in the material produced, typically through the acknowledgment section of a journal article, and that transparency, with the accountability and openness to judgement it implies, encourages ethical behaviour by making unethical behaviour hard to hide. Nor does a ghostwriter need to hold to the standards of a medical writers' association or of the second edition of Good Publication Practice: a ghostwriter can simply write what the paying party asks, regardless of ethics, accountability or the potentially disastrous public health consequences of misreported science.
The other ground is governance, and the writer who gives it also grants a resemblance. Conventional ghostwriting can be considered an elegant art, found in autobiography, fiction, non-fiction and magazine writing as well as academic literature, and the academic case is controversial because the person paid to write the publication took no part in designing or executing the work, so there is a risk that the study will be misrepresented. Medical writers resemble ghostwriters in some respects: they do not devise the studies they write, are not always credited, and are paid according to the complexity of the document.
What separates the two, on this account, is that medical writers are governed by guidelines and policies. A medical writer is a specialist who generates scientific documents clearly and effectively while ensuring compliance with all necessary regulatory guidelines, and producing a clinical study report, a safety report or a patient narrative means simultaneously comprehending the roles of the clinicians, statisticians, publishers, auditors and, most importantly, the client. Those guidelines and policies are the ICH's and those of EMWA, AMWA and ISMPP, which in his view ensure that writers adhere to ethical practices and so prevent the publication of misconstrued and fraudulent information. The medical writer is responsible for representing a product fairly and ethically, based on the data available and in accordance with the ICH guidelines and medical writing policies, but the client must also ensure that the final document depicts the product or study accurately, so, he holds, the debate over ghostwriters in academia should not make writers its scapegoats. The argument that medical writing services are detrimental to research needs rethinking, on the same account. Medical writers, in his view, provide a professional, high-quality and cost-effective way of communicating scientific information.
One medical writer who called herself a ghostwriter left academia for medical writing drawn by the knowledge that the work helped the sick, and by flexible hours and good pay, and at first enjoyed working directly with the physicians responsible for the work. As she moved to larger companies, the gap between writer and researcher widened and the ethical burden of what she wrote became more apparent, until she was unwilling to turn what she was given into something marketable. The new writer who cites her case was sure many writers had shared that experience at least once in their career, but did not believe it was the norm, and hoped it was not; his own experience, though limited, had been extremely positive, among highly skilled, ethical colleagues who take pride in work for which they may not be credited. Outsourcing of services such as medical writing is increasing in the medical and pharmaceutical industries, and in his view the perception of medical writers as ghostwriters is likely to continue for some time. Yet nobody calls the trials of a clinical research organisation ghost trials or its clinicians ghost clinicians, and nor, he argues, should medical writers be called ghostwriters: they should be regarded as highly skilled, ethical people with a strong medical and scientific background who meet the ever-increasing need for effective scientific communication.
Disclosure and what the named author did
In 2010 the editor-in-chief of Mayo Clinic Proceedings reported that, even with full disclosure, he still found numerous instances of ghostwriting. In one article he had recently received, the disclosure stated that the authors had received editorial support in developing the outline and draft, assembling tables and figures, collating author comments, copyediting, fact checking and referencing, and the editors asked, "What the heck did the nominal author do?" The three reviewers assigned to the paper, who knew the named author, all judged it slanted and said he would never have written it that way.
In the same editor's account, medical writers and editors supply clear and concise communication, familiarity with the style and formatting rules of numerous journals, an appreciation of accurate and informative figures and tables, and a safeguard against authors committing omissions. Their role has been somewhat misinterpreted in dealings with industry, particularly when investigators and authors buy into the myth that they are too busy to conduct their own work and that someone else has to do it for them.
One bioethicist drew the line, in 2008, at what an editor supplies. In his view, every paper must originate with a scientist or scientific author who has done the study, and that person must take the first stab at writing before calling someone in to edit. Those editing should not supply substantive content: their task is to achieve better clarity of expression, provide conciseness and improve readability, not to supply data, analysis or interpretation, and if they supply them, they are the author.
The harm ghostwriting does
In industry-controlled research, several examples have revealed ghostwriters inserting concealed marketing messages favourable to a company's product, and academics recruited as guest authors despite not fulfilling the authorship criteria.
Ghostwriting, together with ghost authorship and non-declaration of funding sources or conflicts of interest, has in the past contributed to incomplete and misleading publication of scientific data, which harmed patients prescribed inappropriate drugs. In two of several such scandals, over Merck's rofecoxib and Wyeth's hormone-therapy drugs, ghostwritten articles mitigated apparent risks, failed to report adverse events including patient deaths, and promoted unsupported benefits and off-label uses, with leading academics listed as authors to provide a veneer of independence and credibility. Without transparency in authorship and funding, readers could not see the conflicts of interest and so could not judge the integrity and validity of the work. The scandals led a US senator to investigate ghostwriting practices in the medical literature, and he expressed concern at the lack of transparency in medical ghostwriting.
One new writer traces the pressure behind such practices to a conflict inherent in the industry. A pharmaceutical company develops medicines for the public good and is also required to generate revenue for shareholders; to sell a drug it must raise awareness of it and persuade clinicians to prefer it, which creates commercial pressure to optimise how the drug is perceived, a pressure that may encourage poor publication practices such as these. Medical writers, in the same writer's account, act as a check on that pressure: by adhering to publication, authorship and reporting guidelines, they help academics, investigators and companies publish data ethically, with completeness, transparency and integrity. Through ethical publication practices, the writer can help prevent harms to patients such as those ghostwriting contributed to in the Merck and Wyeth scandals, and can help build trust and credibility in the pharmaceutical and medical industries.
A bioethicist described ghostwriting as anonymously authoring documents for publication in scientific journals in the name of academic researchers, and argued that it corrupts the unbiased search for truth that should be the essence of legitimate science and costs physicians their trust in the literature they depend on when making decisions about patient care.
One ghostwriting case he gave as an example of the harm involved a combined oestrogen-and-progestin product that gained popularity in the mid-1990s for menopausal symptoms, with strong messaging suggesting that it was also effective in preventing cardiovascular disease, osteoporosis, Alzheimer disease, colon cancer and more. A Women's Health Initiative study meanwhile produced strong evidence associating oestrogen with increased rates of cardiovascular disease (22%), breast cancer (26%), heart attack (29%), stroke (41%) and pulmonary embolus (113%). Those concerns had been minimised or negated in the product's literature, and thousands of physicians, confused about what to believe, went on prescribing hormone-replacement therapy for patients with menopausal symptoms.
Ghostwriting as research misconduct
A BMJ feature suggested that ghostwriting on behalf of drug companies has a long history. It gave a few examples, historical ones going back to the early twentieth century and recent ones, of large pharmaceutical companies using professional medical writers to write articles anonymously that portrayed their product favourably and then paying academics to be named as authors, and argued that the potential influence on content and conclusions creates problems with data integrity and accountability. The feature noted possible benefits of professional writers, who fill a needs gap, write well and can increase efficiency. But in an EMWA reviewer's reading in 2012 it seemed dismissive of the value of professional organisations such as EMWA and of their codes of practice and qualifications, and it suggested that even an acknowledged writer could still be considered a ghostwriter, a position against EMWA's at the time.
One commentary, reported in 2012, argued that ghostwriting and guest authorship should be considered research misconduct, since both perpetrate a fraud on an unsuspecting public and profession, and that bodies such as the Office of Research Integrity should include them in their official definitions of misconduct. It held that ghostwriting was then perceived as a slight failing rather than as an unethical practice, and that in this culture ghostwriting and guest authorship are fool's gold, an unspoken permission to fatten curricula with redundant reviews and predominantly lower-impact clinical research. It also separated the two acts: guest authorship can be seen as a form of plagiarism, because using someone's name implies credit for work done by someone else, while the same probably cannot be said of ghostwriting, since a ghostwriter willingly creates text for attribution to others. Academics, sponsors and medical writers engage in ghostwriting for many reasons, on its account, such as enhancing professional standing, product promotion and employment respectively.
In 2011 the head of the US National Institutes of Health was reported to hold that ghostwriting of federally funded research may be punishable by the US Department of Health and Human Services, and to have written in a letter that in some cases ghostwriting could be considered plagiarism, which the department's Office of Research Integrity treats as a form of research misconduct. If plagiarism is proven, the possible consequences for researchers range from a letter of reprimand to debarment, a temporary suspension from seeking research grants.