Re: Ghostwriting: the importance of definition and its place in contemporary drug marketing
I thank Alison Rapley and colleagues on behalf of the International Society for Medical Publication Professionals (ISMPP), the Global Alliance of Publication Professionals (GAPP) and the writer’s associations, for jointly considering my request for greater trade transparency.(1) I recognize the integrity of these correspondents and the honesty and professionalism of the writers. I consider the ethical difficulties of the sector to arise in large measure from differences between the cultural norms of business and those of medicine and science. I believe writers have a valid role in medicine provided it is properly attributed and disclosed, and would be pleased to advise the trade, and indeed the corporations, on ethical publication practices.
In my previous response to ISMPP and GAPP, I made a number of critical transparency requests in order to establish publicly where the trade draws the line between transparency and secrecy.(2) I thank all these trade associations for responding clearly and collectively. Considering these transparency requests in turn:
A. With respect to journal literature developed since 2000 with the goal of informing prescribing, the trade has not agreed to reveal:
(i) Exactly what has been published, i.e. provide a list of the articles it has developed.
(ii) The publication plans, key messages, educational objectives and other commercial considerations underpinning the development of this literature.
(iii) The names of the medical professionals and thought leaders it has worked with during this time, the projects they worked on and the products they helped market.
B. The trade has not agreed to identify any past ghostwritten articles it may know of, in which the role of writers is undisclosed. Neither has the trade agreed to encourage writers who know of such articles to identify them. It has not agreed to overlook confidentiality clauses which prohibit writers from identifying such articles.
C. For future journal articles to be placed in medicine’s public academic forum, the trade has not agreed to disclose the associated publications plans, scientific platforms or other strategic or marketing documentation informing this literature, or details of any intellectual property rights relating to content or drafts. Furthermore, the trade has not agreed to inform the public how much money, approximately, changes hands in the development of this these articles.
The trade’s collective refusal to meet these transparency requests is very clear and I commend the associations again for responding frankly. The line between transparency and secrecy in the respect of industry-financed, peer reviewed academic medical literature has been drawn, with an affirmation of continued, substantial commercial secrecy. It is for editors, readers, prescribers, patients and the public to decide if this is the kind of science and literature they want.
I also address two other points arising from this dialogue:
1. There is clearly a divergence between my opinions and those of the publications trade on what constitutes good attribution, disclosure and labelling in medical journal articles. I believe more needs to be done to foreground industry’s role and end the use of academics in an advocacy role. I believe writers should be credited as coauthors whenever they compose a manuscript or edit it for significant intellectual content – an approach taken by the journal Neurology (3). The trade associations disagree. One notable point is these correspondents’ repeated citation of the ICMJE in justification of their position. I have argued here and elsewhere that the ICMJE should review its Recommendations in respect of authorship, attribution, disclosure and labeling, given the potential vulnerability of the current guidance to misattribution and marketing.(4)
2. It is also clear that the trade associations differ with me on the definition of ghostwriting. I have argued that ghostwriting should be defined in terms of authorship; the associations believe it should be a matter of disclosure. As my article describes, Study 329, which is widely considered ghostwritten but in which the writer is disclosed in the small print, is a good test of these perspectives. In my opinion, Study 329 is ghostwritten despite the inconspicuous disclosure of the writer; but by the industry definitions provided in my article, it is not. Once again, this points to the need for the ICMJE to revise its authorship rules – to strengthen attribution, to do writers justice, and to ensure that a sensible definition of ghostwriting is restored within medicine.
References
1. Rapley A. Ghostwriting: the importance of definition and its place in contemporary drug marketing. Rapid Response. BMJ 2016;354:i4578. http://www.bmj.com/content/354/bmj.i4578/rr-6 Accessed October 4 2016
2. Matheson A. Ghostwriting: the importance of definition and its place in contemporary drug marketing. Rapid Response. BMJ 2016;354:i4578. http://www.bmj.com/content/354/bmj.i4578/rr-4 Accessed October 4 2016
4. Matheson A. The ICMJE Recommendations and pharmaceutical marketing--strengths,
weaknesses and the unsolved problem of attribution in publication ethics. BMC Med
Ethics 2016;17:20
Competing interests:
I am a supporter of innovative pharmaceutical research and have affection for, and friendships within, pharmaceutical corporations and also the marketing and publications trade, whose employees I consider to be ethical and professional. As stated in my article, between 1994 and 2012 most of my income came from consultancy and writing services provided to pharmaceutical corporations, either directly or via marketing agencies. In 2015 I acted as a paid expert witness on behalf of the plaintiffs in a US federal legal action against a drug company.
Rapid Response:
Re: Ghostwriting: the importance of definition and its place in contemporary drug marketing
I thank Alison Rapley and colleagues on behalf of the International Society for Medical Publication Professionals (ISMPP), the Global Alliance of Publication Professionals (GAPP) and the writer’s associations, for jointly considering my request for greater trade transparency.(1) I recognize the integrity of these correspondents and the honesty and professionalism of the writers. I consider the ethical difficulties of the sector to arise in large measure from differences between the cultural norms of business and those of medicine and science. I believe writers have a valid role in medicine provided it is properly attributed and disclosed, and would be pleased to advise the trade, and indeed the corporations, on ethical publication practices.
In my previous response to ISMPP and GAPP, I made a number of critical transparency requests in order to establish publicly where the trade draws the line between transparency and secrecy.(2) I thank all these trade associations for responding clearly and collectively. Considering these transparency requests in turn:
A. With respect to journal literature developed since 2000 with the goal of informing prescribing, the trade has not agreed to reveal:
(i) Exactly what has been published, i.e. provide a list of the articles it has developed.
(ii) The publication plans, key messages, educational objectives and other commercial considerations underpinning the development of this literature.
(iii) The names of the medical professionals and thought leaders it has worked with during this time, the projects they worked on and the products they helped market.
B. The trade has not agreed to identify any past ghostwritten articles it may know of, in which the role of writers is undisclosed. Neither has the trade agreed to encourage writers who know of such articles to identify them. It has not agreed to overlook confidentiality clauses which prohibit writers from identifying such articles.
C. For future journal articles to be placed in medicine’s public academic forum, the trade has not agreed to disclose the associated publications plans, scientific platforms or other strategic or marketing documentation informing this literature, or details of any intellectual property rights relating to content or drafts. Furthermore, the trade has not agreed to inform the public how much money, approximately, changes hands in the development of this these articles.
The trade’s collective refusal to meet these transparency requests is very clear and I commend the associations again for responding frankly. The line between transparency and secrecy in the respect of industry-financed, peer reviewed academic medical literature has been drawn, with an affirmation of continued, substantial commercial secrecy. It is for editors, readers, prescribers, patients and the public to decide if this is the kind of science and literature they want.
I also address two other points arising from this dialogue:
1. There is clearly a divergence between my opinions and those of the publications trade on what constitutes good attribution, disclosure and labelling in medical journal articles. I believe more needs to be done to foreground industry’s role and end the use of academics in an advocacy role. I believe writers should be credited as coauthors whenever they compose a manuscript or edit it for significant intellectual content – an approach taken by the journal Neurology (3). The trade associations disagree. One notable point is these correspondents’ repeated citation of the ICMJE in justification of their position. I have argued here and elsewhere that the ICMJE should review its Recommendations in respect of authorship, attribution, disclosure and labeling, given the potential vulnerability of the current guidance to misattribution and marketing.(4)
2. It is also clear that the trade associations differ with me on the definition of ghostwriting. I have argued that ghostwriting should be defined in terms of authorship; the associations believe it should be a matter of disclosure. As my article describes, Study 329, which is widely considered ghostwritten but in which the writer is disclosed in the small print, is a good test of these perspectives. In my opinion, Study 329 is ghostwritten despite the inconspicuous disclosure of the writer; but by the industry definitions provided in my article, it is not. Once again, this points to the need for the ICMJE to revise its authorship rules – to strengthen attribution, to do writers justice, and to ensure that a sensible definition of ghostwriting is restored within medicine.
References
1. Rapley A. Ghostwriting: the importance of definition and its place in contemporary drug marketing. Rapid Response. BMJ 2016;354:i4578. http://www.bmj.com/content/354/bmj.i4578/rr-6 Accessed October 4 2016
2. Matheson A. Ghostwriting: the importance of definition and its place in contemporary drug marketing. Rapid Response. BMJ 2016;354:i4578. http://www.bmj.com/content/354/bmj.i4578/rr-4 Accessed October 4 2016
3. Neurology. Information for authors. http://www.neurology.org/site/misc/auth2.xhtml
4. Matheson A. The ICMJE Recommendations and pharmaceutical marketing--strengths,
weaknesses and the unsolved problem of attribution in publication ethics. BMC Med
Ethics 2016;17:20
Competing interests: I am a supporter of innovative pharmaceutical research and have affection for, and friendships within, pharmaceutical corporations and also the marketing and publications trade, whose employees I consider to be ethical and professional. As stated in my article, between 1994 and 2012 most of my income came from consultancy and writing services provided to pharmaceutical corporations, either directly or via marketing agencies. In 2015 I acted as a paid expert witness on behalf of the plaintiffs in a US federal legal action against a drug company.