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This is a freely accessible online resource for everyone involved in publication planning. Help us build the site into a valuable resource for, amongst others, medical writers and communications professionals, pharmaceutical industry managers, medical journal editors and publishers. Please send your ideas, contributions and comments about the articles to the Editor of The Publication Plan, Mary Greenacre. If you have any other comments about the service, the web site, or questions about advertising and sponsorship, please contact the Publisher, Peter Llewellyn.

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COMMENTARY << Best practice

Wyeth’s Use of Medical Ghostwriters Questioned Published 12 December 2008 This article in the New York Times reports that Wyeth, the pharmaceutical company, paid ghostwriters to produce medical journal articles favorable to its hormone replacement therapy Prempro, according to Congressional letters seeking more information about the companys involvement in medical ghostwriting. At least one article was published even after a federal study found the drug raised the risk of breast cancer. [Link to original source material]

Making Sense of Non-Financial Competing Interests Published 30 September 2008 This editorial by PLoS Medicine editors explores the potential impact of non-financial competing interests (or private interests). [Link to original source material]

Patient confidentiality and consent to publication Published 10 September 2008 An editorial in the BMJ discusses the impact of the UK Data Protection Act on publication of case histories with regard to obtaining patient consent for publication. The article links to several other articles discussing the ethics of publishing a case history which the BMJ declined 2 years ago because patient consent could not be obtained – the article was subsequently published in an Australian journal (where the authors are based). [Link to original source material]

The role and responsibilities of co-authors Published 6 September 2008 The Lancet provides an editorial emphasising that co-authors must take responsibility for the integrity of the published work and condemning guest authorship. This follows retraction of an article from an academic research group after serious flaws in its conduct were found and the subsequent attempts of some co-authors to distance themselves from the work. [Link to original source material]

Industry-sponsored clinical research: a broken system Published 3 September 2008 Critical discussion in JAMA on industry support of clinical trials. [Link to original source material]

Guest authorship, mortality reporting, and integrity in rofecoxib studies Published 27 August 2008 This issue of JAMA devotes considerable space to further debate on guest/ghost authorship and mortality reporting in rofecoxib studies, with 13 letters on the topic. Some of the letters add further thoughts to the debate. However, some come from authors defending themselves against the accusations of guest authorship, accompanied by replies from the authors of the original article and editorial. [Link to original source material]

The role of healthcare communications agencies in maintaining compliance when working with the pharmaceutical industry and healthcare professionals Published May 2008 In this CMRO article, Angela Cairns and Yvonne Yarker of Gardiner-Caldwell Communications and Scientific Connexions discuss the internal processes of their group of companies to ensure compliance with GPP. [Link to original source material]

Nothing to see here Published May 2008 An editorial in Nature Biotechnology delivers a stinging criticism of the JAMA articles on the use of ghostwriters and guest authors by Merck in preparation of Vioxx publications. It points out that pharmaceutical research is a team effort, so it is hardly surprising that some people conduct the research, whilst others write the papers. The article also highlights that Merck's publication practices 5 years ago pre-date guidelines that most pharma companies currently follow. Although the Nature editorial agrees with many of the JAMA recommendations to crack down on ghostwriters and guest authors (most of which are included in current industry publication practice guidelines), it believes that some recommendations go too far and imply that all industry research is somehow unreliable. It concludes that stigmatising all papers from industry on the basis of the Vioxx analysis is unjustified and discriminatory. [Link to original source material]

Bridging the divide: a call for a Medical Publishing Cooperative. An interview with Daniel J Donovan Published Q2 2008 This article in the Journal of the American Medical Writers Association (AMWA) describes Dan Donovan's idea to establish a Medical Publishing Cooperative. He proposes to include representatives from the pharma industry and agencies, publishers, journal editors, the International Committee of Medical Journal Editors (ICMJE), academia, AMWA, The International Publication Planning Association (TIPPA) and the International Association for Medical Publication Professionals (ISMPP), with the aim of getting the different stakeholders to understand each others' roles and points of view. The ultimate goal is to 'find common ground that will be marked by acceptance of all the players and the roles that they perform in medical publications'. Dan hopes that the group would come up with solutions that respect the roles of the different parties and produce positive change in the medical publications arena. [Link to original source material]

Guest authorship and ghostwriting in publications related to rofecoxib Published 16 April 2008 Ghostwriting and guest authorship are discussed in the April 16 2008 issue of JAMA. Two related articles in the same issue of JAMA are also available via the link below. [Link to original source material]

Impugning the integrity of medical science. The adverse effects of industry influence Published 16 April 2008 Here, the Editor-in-Chief and Executive Deputy Editor of JAMA comment on two related articles in the April 2008 issues about rofecoxib publications. They also make some far-reaching suggestions about actions that journals could take to improve transparency of industry involvement and reduce the potential for data manipulation e.g. industry sponsors of clinical trials should not take primary responsibility for data collection and analysis and preparation of manuscripts; statistical analysis should be conducted by independent statisticians; physicians should not participate in speaker's bureaux nor accept gifts. [Link to original source material

Ghostwriters Used in Vioxx Studies, Article Says Published 15 April 2008 This article in the New York Times comments on articles in JAMA on ghostwriting and guest authorship on rofecoxib publications. [Link to original source material]

The dangers of polarization in publications Published October 2007 This poster by Dan Donovan, presented at the 2007 conference of the American Association of Medical Writers, describes the dangers of stakeholders in the publication planning arena taking up entrenched positions that are becoming increasingly extreme.. [Link to original source material]

Ghost management: How much of the medical literature is shaped behind the scenes by the pharmaceutical industry? Published September 2007 An interesting article in PLoS Medicine looking beyond 'ghost writing' to 'ghost management' of publications. [Link to original source material]

International Society for Medical Publication Professionals (ISMPP) position statement: the role of the professional medical writer Published 29 June 2007 This position statement and support for the role of the professional medical writer from ISMPP was published in Current Medical Research and Opinion. [Link to original source material]

Medical writers and peer-reviewed journals: understanding the rules and responsibilities Published 18 June 2007 Liz Wager explains the concerns about the role of medical writers in developing peer-reviewed publications and helps writers and communications companies keep abreast of recent guidelines and new journal policies. Published in the KeywordPharma Expert Reviews series, the full report is available to download free of charge, sponsored by Caudex. [Link to original source material]

Best practice guidelines on publication ethics: a publisher's perspective Published 29 November 2006 This article from Blackwell Publishers, published in the International Journal of Clinical Practice, describes their position on ethical principles of scientific publishing. It covers aspects such as editorial standards and processes, transparency of funding, research integrity and ownership of ideas. [Link to original source material]

Good Publication Practice: why we need another set of guidelines Published 23 April 2003 This 3-way group of representatives from industry, journal editors and academia got together in 1998 to discuss and improve understanding of how publications from industry-sponsored research are developed. The meeting led to the production of the Good Publication Practice (GPP) guidelines, Good Publication Practice: Guidelines for Pharmaceutical Companies. [Link to original source material]

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