3. Ghosts in the Machine: Publication Planning 101

1 Andreas Lundh, Sergio Sismondo, Joel Lexchin, Octavian A. Busuioc, and Lisa Bero, ‘Industry Sponsorship and Research Outcome’, Cochrane Database of Systematic Reviews 12 (2012).

2 When I began looking at it, almost nobody had written about publication planning – indeed, it seemed that nobody outside the industry had even noticed its existence – but at around that time, several other researchers started publishing about it. In particular, Adrienne Fugh-Berman and Alistair Matheson published interesting analyses of the activity. See Adrienne Fugh-Berman and Susanna J. Dodgson, ‘Ethical Considerations of Publication Planning in the Pharmaceutical Industry’, Open Medicine 2, no. 4 (2008): e33–36; Adrienne Fugh-Berman, ‘The Haunting of Medical Journals: How Ghostwriting Sold “HRT”’, PLoS Medicine 7, no. 9 (2010): e1000335; Alastair Matheson, ‘Corporate Science and the Husbandry of Scientific and Medical Knowledge by the Pharmaceutical Industry’, BioSocieties 3, no. 4 (2008): 355–382; also Alastair Matheson, ‘The Disposable Author: How Pharmaceutical Marketing is Embraced Within Medicine’s Scholarly Literature’, Hastings Center Report 46, no. 3 (2016): 31–37.

3 Wyeth, ‘Publication Plan 2002 – Premarin/Trimegestone HRT Working Draft’ <http://dida.library.ucsf.edu/tid/awb37b10>.

4 David Healy and Dinah Cattell ‘Interface Between Authorship, Industry and Science in the Domain of Therapeutics’ British Journal of Psychiatry 183: 22–27; Joseph S Ross, Kevin P. Hill, David S. Egilman and Harlan M. Krumholz, ‘Documents from Rofecoxib Litigation Related to Rofecoxib: A Case Study of Industry Guest Authorship and Ghostwriting in Publications. JAMA 299, no. 15 (2008): 1800–1812.

5 David Healy and Dinah Cattell ‘Interface Between Authorship, Industry and Science in the Domain of Therapeutics’ British Journal of Psychiatry 183: 22–27.

6 Joseph S Ross, Kevin P. Hill, David S. Egilman and Harlan M. Krumholz, ‘Documents from Rofecoxib Litigation Related to Rofecoxib: A Case Study of Industry Guest Authorship and Ghostwriting in Publications. Journal of the American Medical Association 299, no. 15 (2008): 1800–1812.

7 Alistair Matheson, personal communication. Though they are locally consistent, they may vary from country to country. See Andrew Lakoff, ‘The Anxieties of Globalization: Antidepressant Sales and Economic Crisis in Argentina’, Social Studies of Science 34, no. 2 (2004): 247–269.

8 Quintiles, ‘Scientific Communication’ <http://www.quintiles.com/services/brand-and-scientific-communication> [accessed 22 July 2016].

9 Documents related to Wyeth’s campaign and PC(2) can be found in Prempro Products Liability Litigation, Drug Industry Document Archive <http://dida.library.ucsf.edu> [accessed 7 July 2011]. Quotes here are from those documents, unless otherwise noted.

10 Adrienne Fugh-Berman, ‘The Haunting of Medical Journals: How Ghostwriting Sold “HRT”. PLoS Medicine 7, no. 9 (2010): e1000335.

11 Natasha Singer and Duff Wilson, ‘Menopause, as Brought to You by Big Pharma’, New York Times, 12 December 2009.

12 E.g. Complete Healthcare Communication <http://www.chcinc.com/> [accessed 20 December 2006].

13 Speaker at TIPPA Midwest meeting, St. Louis, 2011. Data kindly provided by Elliot Ross.

14 Envision Pharma <http://www.envisionpharma.com/publicationsPlanning/> [accessed 20 December 2006]. Watermeadow Medical <https://www.ashfieldhealthcare.com/gb/healthcare-agency-gb/watermeadow-gb/> [accessed 21 March 2017]. Adis Communications <http://www.pharmalive.com/content/supplements/gpms/2004/adis.cfm> [accessed 20 December 2006].

15 Most measurement of return on investment of publications is in terms of readership. Watermeadow Medical, for example, advertises, ‘we employ unique alternative metrics to identify the most relevant communication channels and measure the true reach of your publications and data’. See Watermeadow Medical <https://www.ashfieldhealthcare.com/gb/healthcare-agency-gb/watermeadow-gb/> [accessed 21 March 2017].

16 Michael Oldani, ‘Thick Prescriptions: Toward an Interpretation of Pharmaceutical Sales Practices’, Medical Anthropology Quarterly 18, no. 3 (2004): 325–356.

17 Gardiner-Caldwell Group <http://www.thgc-group.com/> [accessed 29 November 2007].

18 Ariel L. Zimerman, ‘Evidence-Based Medicine: A Short History of a Modern Medical Movement’, AMA Journal of Ethics 15, no.1 (2013): 71–76.

19 Jon N. Jureidini, Jay D. Amsterdam, and Leemon B. McHenry, ‘The Citalopram CIT-MD-18 Pediatric Depression Trial: Deconstruction of Medical Ghostwriting, Data Mischaracterisation and Academic Malfeasance’, International Journal of Risk & Safety in Medicine 28, no. 1 (2016): 33–43 <doi 10.3233/JRS-160671>.

20 Jon N. Jureidini, Jay D. Amsterdam, and Leemon B. McHenry, ‘The Citalopram CIT-MD-18 Pediatric Depression Trial: Deconstruction of Medical Ghostwriting, Data Mischaracterisation and Academic Malfeasance’, International Journal of Risk & Safety in Medicine 28, no. 1 (2016): 33–43 <doi 10.3233/JRS-160671>, 37.

21 Jon N. Jureidini, Jay D. Amsterdam, and Leemon B. McHenry, ‘The Citalopram CIT-MD-18 Pediatric Depression Trial: Deconstruction of Medical Ghostwriting, Data Mischaracterisation and Academic Malfeasance’, International Journal of Risk & Safety in Medicine 28, no. 1 (2016): 33–43 <doi 10.3233/JRS-160671>, 35.

22 Christina Goetjen and Mary Prescott correspondence, 2001, <https://www.industrydocumentslibrary.ucsf.edu/drug/docs/#id=pymf0220> [accessed 4 January 2018].

23 Jon N. Jureidini, Jay D. Amsterdam, and Leemon B. McHenry, ‘The Citalopram CIT-MD-18 Pediatric Depression Trial: Deconstruction of Medical Ghostwriting, Data Mischaracterisation and Academic Malfeasance’, International Journal of Risk & Safety in Medicine 28, no. 1 (2016): 33–43, at 38. The comment about the ‘masterful stroke of euphemism’ is in Charles Flicker, Amy Rubin and Paul Tiseo correspondence, 2000 <https://www.industrydocumentslibrary.ucsf.edu/drug/docs/#id=jjbn0225> [accessed 6 April 2018]; Jay Amsterdam drew my attention to this.

24 Jon N. Jureidini, Jay D. Amsterdam, and Leemon B. McHenry, ‘The Citalopram CIT-MD-18 Pediatric Depression Trial: Deconstruction of Medical Ghostwriting, Data Mischaracterisation and Academic Malfeasance’, International Journal of Risk & Safety in Medicine 28, no. 1 (2016): 33–43, at 40.

25 It was strategic decisions like these that led to the study being part of a lawsuit, and led to the interest in it and the manuscript by Jureidini and colleagues. The manuscript was published as Karen Dineen Wagner, Adelaide S. Robb, Robert L. Findling, Jianqing Jin, Marcelo M. Gutierrez and William E. Heydorn, ‘A Randomized, Placebo-Controlled Trial of Citalopram for the Treatment of Major Depression in Children and Adolescents’, American Journal of Psychiatry 161, no. 6 (2004): 1079–1083.

26 Leemon B. McHenry, ‘Ghosts in the Machine: Comment on Sismondo’, Social Studies of Science 39, no. 4 (2009): 943-947.

27 Jeffrey Lacasse and Jonathan Leo (personal communication) drew all of these comments to my attention, in the context of their work on rebuttals to accusations of ghostwriting. The Pfizer statement is quoted in Julie Steenhuysen, ‘Drug Co. Paid Writers to Promote Hormone Therapy’, Reuters, 8 September 2010 <https://uk.reuters.com/article/health-us-hormone-therapy/drug-co-paid-writers-to-promote-hormone-therapy-idUKTRE6874E220100908>. The University of Pennsylvania’s statement is reported in Ellie Levitt, Psychiatry Chairman Faces Ghostwriting Accusations’, The Daily Pennsylvanian, 3 December 2010 <http://www.thedp.com/article/2010/12/psychiatry_chairman_faces_ghostwriting_accusations>. MECC founder Thomas Sullivan defends the psychiatry textbook in Thomas Sullivan, ‘New York Times: The Un-Ghost Writing of the Distant Past’, Policy and Medicine, 2 December 2010 <http://www.policymed.com/2010/12/new-york-times-the-un-ghost-writing-of-the-distant-past.html>.

28 David Bloor, Knowledge and Social Imagery (London: Routledge & Kegan Paul, 1976).

29 For example, J.E. Bekelman, Y. Li, and C. Gross, ‘Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review’, Journal of the American Medical Association 289, no. 4 (2003): 454–465; Joel Lexchin, Lisa Bero and Benjamin Djulbegovic, ‘Pharmaceutical Industry Sponsorship and Research Outcome and Quality: Systematic Review’, British Medical Journal 326, no. 7400 (2003): 1167–1170; Andreas Lundh, Sergio Sismondo, Joel Lexchin, Octavian A. Busuioc, and Lisa Bero, ‘Industry Sponsorship and Research Outcome’, Cochrane Database of Systematic Reviews 12 (2012).

30 See Retraction Watch <http://retractionwatch.com/> [accessed 8 January 2018].

31 Gardiner Harris, ‘Doctor’s Pain Studies were Fabricated, Hospital Says’, New York Times, 10 March 2009.

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