12 September 2016: from Al Weigel – President and CEO, International Society for Medical Publication Professionals [ISMPP]… ISMPP’s long-standing position is that “ghostwriting” – defined by Laine and Mulrow in 2005 as “individuals who wrote the paper but are not acknowledged” – is an unacceptable practice. ISMPP fully supports the role of professional medical writers and the complete and transparent disclosure of their involvement in medical publications and the source of their funding. In fact, the contributions and expertise of medical writers working with authors is associated with more complete reporting of the results of clinical trials and higher quality content.
Over more than a decade, disclosure of the role of medical writers [and their funding] in contributing to medical publications has progressed to become standard practice today. The involvement of medical writers, statisticians, and others are made fully transparent to journal editors and peer reviewers, and ultimately to the readers of the published literature, along with the authors’ disclosures and potential conflicts of interest. Through their interactions with authors, medical writers are important contributors to the timely and complete dissemination of clinical data in the medical literature…
15 September 2016: from Serina Stretton, Cindy Hamilton, Jackie Marchington, Art Gertel, Julia Donnelly – Global Alliance of Publication Professionals [GAPP]
… At the core of Matheson’s article are claims that there is no distinction between ghostwriters and professional medical writers, and that the pharmaceutical industry uses medical writers to insert commercial messages into the peer-reviewed literature. We completely agree with and support the International Society for Medical Publication Professionals [ISMPP] response to Matheson’s claims that there has been no “rebranding of ghostwriting” by industry and that rather, “there has been a positive evolution of transparency and completeness in medical publications reporting industry research.” As GAPP has stated consistently, professional medical writers are NOT ghostwriters because they ARE transparent about their involvement, are strictly prohibited from ghostwriting, and work within ethical publication guidelines that require authors to contribute to and control the content at every step of the publication process…
21 September 2016 from Alastair Matheson21 September 2016 from Alastair MathesonWeigel and Stretton both object to my article by emphasizing their trade’s commitment to “transparency”. My analysis shows, however, that modest transparency and small print disclosure, while better than nothing, paradoxically provides an apparatus for subtle misattribution, concealment and spin. My article discusses this as a cultural problem within medicine for which many stakeholders are responsible. It is important not to lay the blame at industry’s door alone. As Stretton rightly points out, it is journals that make authorship rules, and decide how disclosures should be presented to their readers…
Numerous articles are produced for journal publication every year, scientific platforms and publications plans are developed, academics are recruited to participate as authors, trade writers draft manuscripts, and substantial payments pass from corporations to agencies, but little of this activity is in the public domain. Indeed, the process has been characterized as ‘ghost management’. Commercial secrecy has no place in an open scholarly discourse. Since this literature has been placed within the public academic forum with the goal of informing treatment decisions, readers and their patients have a right to know exactly what commercial considerations were at work in its development, and who was paid by whom to create the material…
30 September 2016 from Alison M Rapley, President, European Medical Writers AssociationThe International Society for Medical Publication Professionals (ISMPP) and Global Alliance of Publication Professionals [GAPP] have already provided detailed responses to the issues raised in the article by Alastair Matheson. The American and European Medical Writers Associations [AMWA and EMWA] fully support these responses which were prepared by medical communications leaders who have been on the forefront of assessing and establishing ethical and robust professional standards. These standards included input from editors of first-tier peer-reviewed medical and scientific journals. There was no pharmaceutical industry review or input into these rapid responses. Clearly Dr Matheson’s interpretation of what constitutes ethical transparency differs from that of these major medical communications organizations representing thousands of professionals working around the globe, as well as differing from that of the International Committee of Medical Journal Editors [ICMJE] who represent more than 500 medical journals.
The undersigned organizations have been working towards transparency and disclosure for more than 15 years and invite all interested parties with a stake in the future of effective and ethical medical publications to tender constructive suggestions directly to them.
Alison Rapley – President, European Medical Writers Association
Brian Bass – Past President, American Medical Writers Association
Al Weigel – President and CEO, International Society for Medical Publication Professionals
Serina Stretton – Global Alliance of Publication Professionals
British Medical Journal – Rapid Responseby Alastair MathesonOctober 7, 2016The debate following my article has culminated in a very rare, and unaccommodating, joint public statement on transparency by the three foremost trade associations of the commercial publications industry – the International Society for Medical Publication Professionals [ISMPP] and the European and American Medical Writers Associations [AMWA and EMWA].They have been joined in this statement by the Global Alliance of Public Professionals [GAPP], the most active advocacy group for the trade. In this statement, these groups have given their official response to a series of specific transparency requests which I made in order to clarify where the trade stood on secrecy and transparency in its development of medical journal articles. The trade chose to meet none of these requests, indicating its commitment to continued secrecy on these aspects of the medical publications business.
In particular, the trade did not agree to reveal any details of the commercial publications plans, scientific platforms, product positioning and key messages underpinning its past, and future, journal articles; nor did it agree to release details about its recruitment and use of “key opinion leaders”; nor details of intellectual property rights; nor any indication of how much money its companies receive from industry clients to plan and develop these articles. All this information is to be remain withheld from the readers of this literature and their patients. Most remarkably, the trade did not agree even to disclose exactly what it has published. It did not agree to provide simple lists of its published output; it did not agree to disclose any secret ghostwriting it may be aware of in the published journal literature; and it did not agree to encourage writers to disclose such articles, or to waive their confidentiality agreements if they do so.
This affirmation of continued commercial secrecy on these aspects of medical journal literature – made directly to the medical community itself, in a leading medical journal – will be of broad ethical and policy concern. The joint statement ends by claiming the trade has been “working towards” transparency and disclosure for 15 years. There is clearly a long road yet to travel…
I’ve noticed that sometimes there is a long, extremely detailed piece on (say) FDA or CMS policies by the head of the agency, perhaps with elaborate tables and graphic figures, and no reference anywhere to any coauthor or writing assistance. It’s always seemed doubtful to me that said head-of-agency actually wrote the whole thing from first word to last, filling in the table cell by cell, and with no help. But no ghostwriter credit in sight.
Bruce,
Excellent point!