Answering the ghostwriting charge
The charge that medical writers are ghostwriters has been answered by the profession itself: by rebutting the caricature of the work it rests on, by the argument that writers must be their own advocates while working to the highest ethical standards, by educating members, by letters to the newspapers and journals that carried the charge and joint replies from the writers' associations, and by a proposal to bring every party to one table.
What the charge gets wrong
In one experienced writer's 2013 call to advocacy, attacks by journalists, politicians and the lay public tend to be triggered by publications that professional medical writers are associated with, and they find fault in the content, in perceived obfuscation of it, or in perceived deceptive authorship practices. The word ghostwriter is used with great frequency, and it is often misapplied or ill-defined, if it is defined at all. Ben Goldacre and other critics also ignore what changed in the five years before 2013: authorship standards created and enforced, including standards requiring transparency; codes of ethics established by the professional associations, EMWA's among them; and attempts to educate every stakeholder about the difference between a professional writer's disclosed contributions and ghostwriting.
A 2013 review of Ben Goldacre's book Bad Pharma found that it seems to use medical writing and ghostwriting interchangeably and ignores the considerable efforts EMWA and other medical writing organisations have made against ghostwriting in the medical literature. The book describes professional medical writing as pharmaceutical companies paying professional writers to produce academic papers to their own commercial specifications and then getting academics to put their names to them, and it calls ghostwriting papers for academics with no input a bread-and-butter activity of the profession. The review called this a caricature drawn from a few examples of bad practice, mostly from the 1990s, bearing little resemblance to how medical writing is practised today and backed by nothing but old individual cases, and it said there is no evidence that such abuses were common even in the 1990s; it likened the book's claim to claiming that most doctors are serial killers on the strength of Harold Shipman. Nobody would believe the claim about doctors, the review reasoned, because most people know what doctors do, but medical writing is not a well-known profession, so many of the book's readers probably do not know what medical writers do and will simply believe the description. In 2013 EMWA restated its guidelines on the role of medical writers in developing peer-reviewed publications in a position statement on ghostwriting.
The 2013 call to advocacy made the same objection to the book later that year: like many other critics, Goldacre conflates professional medical writers, who provide clarity, accuracy and comprehensibility with full disclosure, with ghostwriters, who are less transparent about their contributions, and he revives the outdated figure of the ghostwriter and ghost publication manager working behind the curtain. Although he is trained in a field that depends on empirical evidence, he falls back, as many critics do, on anecdotal statements.
The founder of one publications-planning company holds that criticism such as Sismondo's 2007 article in PLoS Medicine, which leaves the impression that companies like his will do anything for money, an impression he calls untrue, challenges the moral code of the people who do the work, and that anyone who makes it had better fully understand the people they are discrediting. To the cynics' charge that his real concern is losing the ability to place ghost-authored or ghost-managed articles for clients, he answers that his company does nothing "ghost": it is clear about its involvement with manuscripts and follows Good Publication Practice and the ICMJE criteria on authorship and acknowledgment. He puts the problem down to a lack of understanding of why such companies exist. In his account, not long ago, medical writing was a small cottage industry of mostly freelance writers who took assignments directly from pharmaceutical companies. As the demand for their services and the expectation of good writing grew, and new regulatory requirements came in, more demand was placed on the companies to get their data published; they lacked the resources to respond, so they went outside for the expertise, and a thriving service industry was created. He points out that writing assistance does not come from the service industry alone. Many major academic institutions have writing staff, whose work does not differ from that of an agency writer or a freelancer, and those writers, like the writers at companies such as his, have potential biases; academic investigators need to get published to win grants and promotion.
Advocacy and ethical practice
The Global Alliance of Publication Professionals puts part of the blame for the confusion of medical writers with ghostwriters on the profession itself. In its leader's words, writers have been confused with ghostwriters for far too long, and the profession needs to give journalists around the world the information they need to write well-informed and balanced articles about medical publication professionals. In the alliance's view, differentiating professional medical writers from ghostwriters may look like an old issue inside the profession, but it is not one outside it. If outsiders do not understand or value the work, the alliance asks whose fault that is, and it finds the irony of communicators not communicating well evident and harsh.
One 2009 award address argued that writers must become advocates for themselves and for their community of professionals. On that view, the misperceptions exist only because critics do not know what medical writers do or how they do it. The address urged writers to educate their colleagues, family and friends, and held that they must conduct research that furnishes irrefutable evidence and metrics of the value they add and of their integrity, since if they do not do it, nobody will do it for them.
The 2013 call to advocacy held that, for the most part, the criticism had gone unanswered. Writers are potentially the strongest and most influential voice for refuting misinformation about their role, and they must educate their critics about the value they bring to communications about new therapies. The role and contributions of the professional medical writer must be clarified and emphasised, and each writer can exercise an effective voice by joining in the corrective response. Interest among writers in turning public perception around was considerable, but few formal and coordinated attempts had been made, so, given the lack of a concerted voice, its author believed a grassroots movement was required and called for discussion of how to create an effective coalition to change public perception. Conversations with friends, colleagues and family are opportunities too: once those people appreciate writers' position, they may carry accurate information on to a broader audience.
A 2013 editorial in EMWA's journal held that all medical writers must always work to the highest ethical standards: some criticisms of unethical ghostwriting in the pharmaceutical industry have been well founded, and the last thing writers want is to give critics more examples of bad practice to point to. Writers can also be ready to challenge critics who perpetuate myths about ghostwriting that the evidence does not support. They should be quick, too, to challenge unethical behaviour from colleagues when they see it.
Ethics education for members
Because the integrity of the profession is built on the ethical practices of its members, AMWA was seeking ways to improve its members' awareness and understanding of the ethical issues in their work during the 2008 controversy over articles in the Journal of the American Medical Association. Its executive committee urged workshop leaders to build ethics into their workshops, determined that every annual conference should carry at least one special session devoted to ethics, and was exploring making an ethics workshop mandatory for the core certificate. The association also offered publication-ethics resources on its website, with links to other organisations' guidance and a template letter for requesting appropriate acknowledgment, and its journal undertook to keep educating members about conflict of interest, appropriate acknowledgment and the principles of authorship. In the association's view, the issue of medical writing assistance will be clarified only through continued efforts by ethical medical communicators to educate the scientific community and the public, as when clear descriptions of the services a medical writer provides and of how to work with one were directed at medical fellows.
Letters and joint replies
The 2008 controversy over the JAMA articles unified AMWA's membership and highlighted its dedication to the profession. No other topic in the history of the association's listserves had generated as much traffic, with more than 1,500 postings. Members wrote to local papers that had carried the coverage, others volunteered to help the association carry its message on larger scales, and the association wrote swiftly to JAMA, the New York Times and the Chronicle of Higher Education, the last two of which published its letters. Those letters let the association distinguish ghostwriting from legitimate medical writing assistance and draw positive attention to itself and to the profession. In a 2008 letter to the New York Times, AMWA's president restated the association's advocacy for full acknowledgment of a medical writer's contribution, including full disclosure of potential conflicts of interest such as financial support, on the ground that transparent disclosure of the roles of contributors avoids ghostwriting and lets readers judge how far a research report can be credited.
AMWA's members also answered the charge in outside publications. In 2008 one member's letter to a neurology news title explained the legitimate role of medical writers in scientific publications, cited the association journal's editorial on the subject, linked to the association's position statement on the role of medical writers, and recommended full disclosure of that role as a way to curb abuse. A letter from four writers in a biotechnology journal clarified the role of medical writers in articles reporting clinical trials and noted the contributions the American, European and Australian associations had made in educating their members about ethical practice.
AMWA answered the 2009 press coverage with a letter and with resources on its website. After a September 2009 New York Times article reported ghostwriting as rife in medical journals, one of several pieces the paper had run on the subject since August, the association's president wrote a letter to the editor, which the paper published ten days later. The letter held that ghostwriting is unethical and must be distinguished from collaboration between researchers, who are the authors, and professional medical writers, whose contributions and financing are disclosed, and it invited others to join the effort to promote transparency and awareness of ethical guidelines. The association's website then gained an expanded guidelines and ethics area carrying a copy of the letter and a set of frequently asked questions on the importance of ethics to medical communicators. The questions cover ethical responsibilities and how to disclose both the contributions medical writers make to journal articles and the source of the funding, and members were encouraged to use them in discussion with colleagues and the public.
The associations answered a 2016 attack jointly. On 30 August 2016 an article appeared in the British Medical Journal that EMWA described as attacking the important and ethical contributions of medical writers to the scientific literature, and EMWA, in partnership with AMWA, ISMPP and the Global Alliance of Publication Professionals, responded through the journal's rapid-response channel. AMWA's president told members in October 2016 that the article showed the profession still haunted by ghostwriting, and that AMWA, with EMWA, had swiftly supported detailed responses from ISMPP and the alliance refuting its claims; she read the speed of the joint response as evidence of the community's dedication and of how small its world is. By EMWA's account, all four organisations had been working toward transparency and disclosure for more than fifteen years, and great progress had been made, although more could still be done in some areas. At the same time, one of AMWA's past presidents was carrying on efforts to increase the transparency of authorship through proper acknowledgment of medical writers in peer-reviewed publications.
The associations answered jointly again in 2021. In March 2021 an article by Del Paggio and colleagues in JAMA Oncology reported on several aspects of randomised oncology trials, including the use of professional medical writers. Without providing any evidence, in EMWA's account, it asserted that there was reason to be concerned that medical writers may unduly influence the interpretation of trials, that their role was contrary to accepted scientific principles whereby first authors should take responsibility for writing their own manuscripts, and that they were unlikely to have a neutral effect on trial reporting. In the same section, EMWA adds, it insinuated that their involvement violated the ICMJE authorship criteria. AMWA's president judged that the article cast a negative, if not insulting, light on the role and intent of medical writers in manuscript development.
The reply was a letter to the editor, endorsed by the leaders of EMWA, AMWA and ISMPP. The associations' accounts differ on where it began: EMWA's credits its special interest group on medical communication with initiating it, while in AMWA's accounts AMWA swiftly engaged EMWA and ISMPP and its leaders drafted the letter in partnership with representatives of the other two. The letter refuted the statement that medical writers introduce "spin", on the ground that studies have been conducted and no such evidence exists. It pointed to studies showing that writers' involvement improves adherence to reporting guidelines, gives more complete reporting of trial results and a greater rate of publication over time, and lowers the risk of retraction for misconduct. It described writers as highly trained professionals, many with advanced degrees in the life sciences, who help scientists achieve clear, objective and understandable descriptions of study data, who are trained in good publication practice, and whose organisations have developed principles of ethical conduct. In EMWA's account, the three organisations' endorsement of the letter showed the importance of ongoing alignment and exchange between the medical writing organisations. AMWA's summary of the letter adds that writers' expertise improves accuracy, timeliness and adherence to ethical conduct, and counts their commitment to Good Publication Practice (GPP3), to ethical principles in scientific publishing and to their organisations' codes of conduct as a significant benefit of working with them. The letter was published on 26 August 2021, alongside two other letters and the article's authors' response to all three.
In the view of AMWA's president and one of her co-authors, although writers share an understanding of their own value, it is imperative to answer such attacks publicly to safeguard the profession's reputation. EMWA's special interest group advises that writers who come across published negative statements about medical communicators should inform the professional organisations, so that adequate responses can be made.
A publishing cooperative
The same publications-planning company founder argued in 2007 that key stakeholders in medical publishing were becoming more biased and more extreme in their positions on disputed issues, such as the value of industry-sponsored trials, what constitutes conflict of interest, and the acceptability of manuscripts prepared by writers who do not have full status as an author. To bridge the divide and end an environment of mistrust and misperception, he proposed a medical publishing cooperative: publishers, editors, ICMJE representatives, pharmaceutical company publications specialists, academic and industry authors, service professionals and representatives of AMWA, the International Publication Planning Association and ISMPP at the same table, with legislative representatives and the National Institutes of Health invited. Its immediate goal was to get every party to the table to present its side, because people's roles and professions should be understood before aspersions are cast against them. Little attention, in his view, has been paid to what the stakeholders have in common, such as an interest in fair and balanced publications and the knowledge that what is published can directly affect the lives of patients, and cooperation can be sought on that ground in place of an us-against-them attitude. It should be possible to find solutions that respect the roles that financial and academic influence have in medical publishing, and the group could serve as a bellwether for positive change in the medical publications arena. Its ultimate goal was common ground marked by the acceptance of all the players and the roles they perform in medical publications, and his idea was that the group would communicate the results of its discussions through a definitive publication in the medical and lay press. Everyone has their own set of biases, in his view, and the workable position is to understand and admit them, which is another way the cooperative could help.
He expected some journal editors to decline, given the disdain some of them have for the pharmaceutical industry and for the services of publications-planning companies, which they term ghostwriting and ghost management. He thought the National Institutes of Health might decline too, because in 2005 it had barred its scientists from any consulting involvement with pharmaceutical companies, to the point that they cannot even hold pharmaceutical company stock, a rule he called inappropriate. He presented the idea to about fifty people at a publisher's 2006 annual meeting for the editors of its journals, where it was better received than he had expected, and in 2008 the cooperative was still a proposal that someone needed to get off the ground.