Adam Jacobs

European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications

ABSTRACT Background: Many papers in biomedical journals are drafted not by the named authors, but by professional medical writers working under the direction of those authors, usually funded by pharmaceutical companies. Although this practice can improve both the quality and speed of publications, it has attracted controversy as a result of concerns about the inappropriate influence of pharmaceutical companies. Objectives: To define ethical standards for professional medical writers who prepare papers for publication in medical journals. Consensus methods: Guidelines were drafted after a 4-round Delphi consultation among a group of experienced medical writers. The guidelines were then further refined by seeking comments on the draft from a range of interested parties. Findings and conclusions: The guidelines stress the importance of respecting widely recognised authorship criteria, and in particular of ensuring that those listed as named authors have full control of the content of papers. The role of medical writers must be transparent, which normally means a mention in the acknowledgements section, together with a statement about funding. Writers and authors must have access to relevant data while writing papers. Medical writers have professional responsibilities to ensure that the papers they write are scientifically valid and are written in accordance with generally accepted ethical standards.

Poor compliance with reporting research results – we know it’s a problem … how do we fix it?

Summary If patients knew that most results from clinical research were not shared as completely or as quickly as they should be, how many patients would volunteer for research studies? If patients knew this problem was worse for government-funded research than pharmaceutical industry-funded research, how many would want their tax dollars allocated to government-funded research? We may live in an era of evidence-based medicine, but when the accessible evidence base is being built so incompletely and slowly, patients and the medical research community clearly have a problem. Indeed, despite the ethical, scientific, and potentially, legal, responsibilities researchers have to report results in a timely manner… they are struggling to do so. And, although much attention has focused on results reporting for industry-funded research, it appears that the situation for non-industry-funded research is similar or far worse. Nobody appears to occupy the moral high ground when it comes to reporting results, but all funders and researchers have a moral duty to do so. Quite simply, results don’t report themselves. We propose that professional medical writers (not ghostwriters) could help ensure results are reported in a complete, timely, and ethical manner. Readers are encouraged to evaluate the evidence summarized below and to suggest other potential solutions to the results reporting problem. The ultimate beneficiary of timely communication of research results will be patients.

Time to Finger Point or Fix? An Invitation to Join Ongoing Efforts to Promote Ethical Authorship and Other Good Publication Practices

In this commentary, we present evidence that unethical authorship (eg, guest and ghost authoring) and other publication practices are not restricted to the pharmaceutical industry; they also occur in academia. Such practices are not an industry problem—they are a research problem. To enhance trust in industry-sponsored research, companies have made rapid and far-reaching changes to their publication guidelines, policies, and procedures. Professional medical writers have adopted, and continue to implement, these changes. Although evidence indicates that industry practices are improving, there is certainly more to do, both in industry and academia. We invite readers to join ongoing efforts to promote ethical publication practices.

Mythbusting Medical Writing: Goodbye, Ghosts! Hello, Help!

ABSTRACT To meet ethical and scientific obligations, authors should submit timely, high-quality manuscripts. Authors, however, can encounter ethical (e.g., authorship designation) and practical (e.g., time and resource limitations) challenges during manuscript preparation. Could professional medical writers—not ghostwriters—help authors address these challenges? This essay summarizes evidence countering three myths that may have hindered authors from considering the use of professional medical writers. Authors with sufficient time, writing expertise, and reporting guideline knowledge may meet their obligations without writing assistance. Unfortunately, not all authors are in this position. Decisions about writing support should be based on evidence, not myths.

Don't be a fool - Don't use fool's gold

When ghostwriting and legitimate professional medical writing are conflated, many are fooled. Professional medical writers are not ghostwriters, but your readers may not appreciate this distinction after reading the article “Ghostwriting: Research Misconduct, Plagiarism, or Fool’s Gold?” by Bosch and Ross. We agree with Bosch and Ross that ghostwriting is research misconduct, but we believe their definition of ghostwriting is incomplete. Ghostwriters are ghosts not only because their contribution is unknown (since they may or may not qualify for authorship), but also because their involvement and funding source are not disclosed. In conrast, professional medical writers adhere to ethical publiation practices and disclose their involvement and funding ource. If professional medical writers meet authorship riteria, they should be named as authors. The distinction between ghostwriters and professional medical writers is not a matter of semantics. Ghostwriting is unethical; professional medical writing is an ethical and legitimate practice and profession. As reinforced in a aper co-authored by BMJ editor Trish Groves, “many joural editors recognize that help from a professional writer an raise reporting standards, improve compliance with uidelines, and elevate overall editorial quality.” Indeed, the World Association of Medical Editors advises that “editors should make clear in their journal’s information for authors that medical writers can be legitimate contributors.” Evidence shows that manuscripts prepared with proessional medical writing assistance are:

Blanket ban on tobacco funded research risks missing out on good quality studies

It is easy to understand the BMJ ’s policy on refusing research funded by the tobacco industry, given the harm that the industry does.1 However, a blanket policy of rejecting all research from the tobacco industry makes me uncomfortable. This policy is based on nothing other than an ad hominem fallacy.2 Much research funded by the tobacco industry is …

Commentary: Professional responsibilities

The three papers by Pyke et al., O’Kelly et al., and Matcham et al. address an important topic, namely the role of statisticians in publications of clinical trial results. Publications are extremely important, as they are the way by which the results of clinical trials are disseminated to the world at large. Publications may be used by clinicians as the basis for treatment decisions, and may also be used by meta-analysts in arriving at evidence-based recommendations. The consequences of inaccurate data in publications can therefore be extremely serious, as they could lead to poor treatment decisions, which in some cases could be fatal. The authors of these three papers are therefore to be congratulated for tackling what is an important and difficult issue. There are two main ways in which papers can mislead: through incompetence and through deliberate attempts to manipulate the data. There is a widely held perception that the second of those is the greater risk in industry-sponsored studies, although the opposite may be true. Recent research has found that, when errors in papers are serious enough to warrant a retraction, the reason for the retraction is less likely to be misconduct in industry-sponsored studies than it is in independent studies [1]. Pyke et al. are therefore correct to question the assumption inherent in JAMA’s policy of requiring independent reanalysis only of industry-sponsored studies, namely that industry-sponsored studies are somehow less trustworthy than independent studies. Nonetheless, as Pyke et al. also acknowledge, there is no room to be complacent about the quality of clinical trial publications. There are undoubtedly many publications of poor quality, both from within and out with the industry, and statisticians have an important role to play in improving publication quality. This initiative by this group of statisticians nicely complements an initiative that I was involved in a few years ago as president of the European Medical Writers Association. Medical writers are also intimately involved in publications for the pharmaceutical industry, and we in EMWA published guidelines designed to improve the ethical standard of publications written by professional medical writers [2]. There is some evidence that this has started to bear fruit, at least as it affects ‘ghostwriting,’ the practice of failing to disclose that a medical writer has assisted with writing an article. Since the publication of the guidelines, the role of medical writers is more likely to be openly declared in the acknowledgement section of a paper than it used to be, although there is still a way to go before transparency and acknowledgement is universal [3]. Our guidelines do not have a narrow focus on ghostwriting, but also emphasize the wider professional responsibilities of medical writers. The professional responsibilities of statisticians in ensuring the quality of publications of clinical trial results are arguably greater than those of medical writers. The statistical aspects of a clinical trial paper are often crucial for the overall interpretation, so the statistician has an important role in ensuring that they are accurately described. One important aspect of that accurate description is to ensure that the status of objectives in the publication matches that in the protocol, for example that secondary objectives are not magically promoted to the status of primary objectives when the true primary objectives turn out to be disappointing. The frequency of published objectives not matching pre-specified objectives is worryingly high [4], and although there is no reason to believe that this mismatch is any more prevalent in industrysponsored trials than in independent trials, industry statisticians nonetheless have an important duty to remain vigilant in guarding against it. Matcham et al.’s recommendation that protocols should be made publically available is therefore welcome, as it provides a useful safeguard against flipping of objective priorities. Another welcome recommendation is that statisticians should be authors of papers. Gøtzsche et al. investigated the authorship status of statisticians, and found that statisticians were frequently not authors of papers [5], although doubtless in many of the cases they investigated the statistician would have fulfilled generally accepted criteria for authorship. Being an author of a paper should emphasize the important point that the statistician must take professional responsibility for the scientific accuracy of the paper. Taking that professional responsibility seriously is undoubtedly an important step towards more reliable publications.