Re: Should journals stop publishing research funded by the drug industry?
Should journals stop publishing research ... written by ghostwriters?
The answer to this question is resounding “yes” and we don’t expect any debate about it. However, as an international group of professional medical writers (NOT ghostwriters), we do want to debate Smith and Gøtzsche’s suggestion that the pharmaceutical industry’s use of ghostwriters is (note present tense) common practice.1
Like Smith and Gøtzsche, we abhor ghostwriting and agree that this practice is scientific fraud. The fight against ghostwriting must continue, regardless of who sponsors the research (industry, government, academia etc...). Nevertheless, the BMJ readership should be aware of the initiatives that have been adopted to address ghostwriting, particularly from professional medical writers and industry sponsors. These initiatives, which continue to expand and involve, include:
1. Completion of the first large (469 respondents) survey of current industry publication practices (the Global Publication Survey). The results clearly demonstrate the progress being made against ghostwriting practices in industry. A manuscript has been submitted for publication and, in keeping with transparency efforts, the dataset will be made available for others to interrogate.
2. Completion of the first systematic review on the evidence related to the prevalence of ghostwriting.2 The results clearly show how original evidence on the frequency of ghostwriting has been misreported in subsequent publications. There is no excuse for ghostwriting, but there is also no excuse for inaccurate reporting of its frequency. A manuscript has been submitted for publication, and in keeping with transparency efforts, the dataset will be made available for others to interrogate.
3. Introduction of a credential (Certified Medical Publication Professional) for writers to help editors, peer-reviewers, readers, authors, and sponsors identify if a medical writer has knowledge of ethical publication practices. A CMPP-qualified medical writer has had to pass an exam on 150 topics related to ethical publication practices. They can guide authors and sponsors (whether from industry or not) on what is required to comply with best practices. There are now more than 800 CMPP-qualified medical writers around the world. Anyone can check if a writer is CMPP-qualified by searching the CMPP directory at http://www.ismpp.org/cmpp-directory. Clearly, there are medical writers who do follow ethical publication practices without being certified, but the CMPP program (which has required considerable financial and human resources to establish and maintain) is a very practical and tangible example of how professional medical writers are trying to combat ghostwriting.
4. Introduction of a Code of Conduct that will punish any CMPP-qualified medical writer found to have brought the medical publication profession into disrepute.
5. Development of position statements from international industry associations that explicitly ban ghostwriting (see http://clinicaltrials.ifpma.org/clinicaltrials/fileadmin/files/pdfs/2010...).
6. Development of publication policies by sponsors, as well as by professional medical writing associations and companies, that explicitly ban ghostwriting, as well as guest- and ghost-authorship (see those by the American Medical Writers Association - www.amwa.org, the European Medical Writers Association – www.emwa.org, the International Society for Medical Publication Professionals – www.ismpp.org).
7. Use of audits by sponsors and professional medical writing companies to determine how well authors and professional medical writers are adhering to these policies. Policies without audits are impotent. The Global Publication Survey will provide valuable data on audit use.
8. Publication of an anti-ghostwriting checklist3 that is freely and readily available to authors around the world to document to editors and peer-reviewers that medical writing support has been used appropriately and...(this is the kicker)...that editors can ask the authors for an audit trail that validates the ethical and legitimate use of writing support.
9. Collation of evidence on the value and ethics of professional medical writers (see www.gappteam.org). Editors have agreed that professional medical writers offer a legitimate and valuable service4 and research has now shown that manuscripts prepared with professional medical writing support are of higher quality (eg, based on adherence to CONSORT),5 are published more quickly,6 and less likely to be retracted for misconduct7 than those prepared without writing support.
In summary, we abhor ghostwriting and, as professional medical writers, we want BMJ readers to be aware of numerous initiatives that are helping to combat this unethical practice. Our experience and recent evidence indicate it is not common practice in industry.
1. Smith R, Gøtzsche PC, Groves T. Should journals stop publishing research funded by the drug industry? BMJ 2014;348:g171
2. Stretton S, McGee S. Systematic review on the prevalence of ghostwriting: misleading, misguided, and mistaken ‘evidence’. Curr Med Res Opin 2012;28(1):S9-19.
3. Gøtzsche PC, Kassirer JP, Woolley KL, et al., What should be done to tackle ghostwriting in the medical literature? PLoS Med 2009;6(2):e1000023.
4. Chipperfield L, Citrome L, Clark J, et al. Authors' Submission Toolkit: a practical guide to getting your research published. Curr Med Res Opin 2010;26(8):1967-1982.
5. Jacobs A. Adherence to the CONSORT guideline in papers written by professional medical writers. Medical Writing 2010;19:196-200.
6. Bailey M. Science editing and its effect on manuscript acceptance time. AMWA Journal 2011;26:147-152.
7. Woolley KL, Lew RA, Stretton S, et al. Lack of involvement of medical writers and the pharmaceutical industry in publications retracted for misconduct: a systematic, controlled, retrospective study. Curr Med Res Opin 2011;27:1175-1182.
Professor Karen Woolley, Mr Art Gertel, Dr Cindy Hamilton, Dr Adam Jacobs, members of the Global Alliance of Publication Professionals (GAPP; www.gappteam.org)
Competing interests: Disclosures: All GAPP members have held, or do hold, leadership roles at associations representing professional medical writers (eg, AMWA, EMWA, DIA, ISMPP, ARCS), but do not speak on behalf of those organizations. GAPP members have or do provide professional medical writing services to not-for-profit and for-profit clients. Further details can be found at www.gappteam.org