One grey area is whether companies should disclose "medical writing support provided by pharmaceutical companies to authors of clinical studies" and for "editorial services." See article PMLive article here.
"Medical writing services" and "editorial services" are very vague terms and, so, it is often unclear what is meant by these terms. However, in scholarly and journalistic literature surrounding pharmaceutical company marketing and promotion techniques, it has become clear that part of what is meant by "medical writing support" and "editorial services" may be the commonly used practice of medical ghostwriting and guest authorship.
Medical ghostwriting occurs when a pharmaceutical company commissions one (or more) Medical Education Communication Company (MECC), Medical Writing Organization (MWO), or Contract Research Organization (CRO) to conduct clinical trials as well as plan and write the manuscripts, subsequent reviews of these trials, and other editorial services which are discussed below. Prominent, trusted physicians and experts in the field are, then, recruited and paid to sign their names as authors on these pre-written manuscripts, which are submitted for publication in peer-reviewed medical journals. It is unclear how much access the "guest authors" have to the data and ghostwritten manuscripts, or whether guest authors are permitted to make revisions to the manuscript prior to publication.
This process is called ghostwriting because the original manuscript author(s) are not named as authors on the final published manuscript, while the recruited physicians or experts are named, despite their limited or lack of involvement in the clinical trial or study design, methods, data collection and analysis, and writing of the manuscript. Sometimes, ghostwriters are thanked in the "Acknowledgements" and "Contributions" sections of published peer-review papers as follows: "The authors would like to thank [insert name(s)] for their editorial contributions." This may vary or be non-existent in ghostwritten articles.
Ghostwriting is part of a larger scheme called "publication planning," a process by which pharmaceutical, biotechnology, medical device, and medical supply companies produce, publish, and release articles in medical journals, abstracts and posters at conferences, meetings, and symposia, to establish key marketing messages. This process is closely monitored to ensure that the sponsoring companies' medications are being effectively promoted. This process has been known to disseminate information embedded with factual errors, misrepresentation, overstated benefits, and understated risks of medications being promoted.
At the International Society for Medical Publications Professionals (ISMPP), Shire took the position that "medical writing support" should not be reported under the Sunshine Act. Representatives from Pfizer and AstraZeneca said that their companies should report "medical writing support" under the Sunshine Act.
An AstraZeneca public operations lead justified its position because "...for primary research from company-sponsored studies, publication support was both of value for the author as well as the pharma company" and takes a fair-market approach to this reporting by assigning a "fair average market price" for each of the main publication types and they vary according to the level of support" [emphasis added]. Decoded, this may mean that companies pay for "medical writing support" services, which vary based on how much "support" is given. In this context, support may mean anything from company-commissioned copy-editing, to full manuscript revision, to medical ghostwriting of entire scholarly articles, abstracts, posters, and more.
Ghostwriting is not a one-time activity. An article by Georgetown University Medical Center's Dr. Adriane Fugh-Berman revealed that, for highly marketed drug classes or drugs, such as hormone replacement therapy (HRT), ghostwriting and publication planning span years and, sometimes, more than a decade, to promote prescription medications.
In this article, Fugh-Berman reveals that an MECC was commissioned by Wyeth over 12 years (1996-2004) to promote HRT. In this time, the MECC planned, created and/or managed:
- hundreds of advisory boards,
- 1000 abstracts and posters,
- 500 clinical papers,
- over 10,000 speakers' bureau programs,
- over 200 satellite symposia,
- 60 international programs,
- dozens of websites,
- and many more printed and electronic materials, all of which have served to influence physicians' prescribing choices of HRT in favor of Wyeth's product.
Various publication types included in these publication planning and marketing strategies include:
- full-length review articles
- case reports
Fugh-Berman also revealed the financial sums paid by Wyeth for some of these "medical writing support" services. These figures were released pursuant to litigation involving Wyeth. The costs of different publication types between 1997-2003 are as follows:
- manuscripts: US$25,000 each
- secondary publications (articles that follow clinical trial reports, reviews, and subsequent analyses of medication performance): US$20,000-25,000
- poster writing: US$8,500
- abstract production: US$4,000
- editing manuscripts: US$10,000
- editing abstracts ("written by author or other agency"): US$2,000
It is clear that the discrepancies between pharmaceutical companies' opinions on which payments are to be disclosed must be resolved.
The Haunting of Medical Journals: How Ghostwriting Sold “HRT”
Pharma companies differ on Sunshine Act payment definition: Confusion about whether provision of editorial services is transfer of value
Ghostwriting at elite academic medical centers in the United StatesThe social and cultural shaping of medical evidence: Case studies from pharmaceutical research and obstetric science
Access to information and the right to health: The human rights case for clinical trials transparency
Senator moves to block medical ghostwriting
Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles
Profits and plagiarism: The case of medical ghostwriting
What should be done to tackle ghostwriting in the medical literature?
Ghost management: How much of the medical literature is shaped behind the scenes by the pharmaceutical industry?
Challenging medical ghostwriting in US courts
Guests, ghosts and trust: Guest authorship and ghostwriting in publications related to Rofecoxib - A case study of industry documents from Rofecoxib litigation
Wyeth's ghostwriters falsely promoted hormone replacement therapy
The murky world of academic ghostwriting
Drug 'reports' found to be faked
Wyeth paid writers to promote hormone therapy: study
Merck publishes fake journal to promote Vioxx and Fosamax