Ghostwriting in medical journals Elise Langdon-Neuner Baxter BioScience METM 2006

Ghostwriting as old as literature sometimes almost as reputable as the oldest profession METM 2006

Medical ghostwriting is different Ghostwriting goes against the spirit of authorship responsibility David sharp after attending EMWA conference 1998 Doctors prescribing habits are influenced by papers they believe to be written by independent experts METM 2006

What is medical ghostwriting? Someone who assists with writing a paper but does not meet all 3 ICMJE criteria for authorship and whose contribution is not acknowledged ICMJE guidelines do not define ghostwriting but require writing assistance to be acknowledged www.icmje.org METM 2006

Who is a ghostwriter? Author’s editor- first draft done by author Is heavy editing light ghostwriting? Barbara Gastel CBE Views Writer employed by drug industry- article drafted by writer, but prominent doctors/scientists put their names to it METM 2006

Industry writer Review articles Original report of clinical trial Marketing tool for pharma: concealed pharma controls slant and data inclusion i.e. biased to market company’s products opinion-leader author more influential with doctors who prescribe drugs Original report of clinical trial Writer collates data from different centres: Do authors have access to data? METM 2006

Healy and Cattell’s findings 55 CMD articles All favourable to Pfizer 1 mentioned an adverse effect 41 non-CMD articles 20 negative results 16 reported adverse effects Interface between authorship, industry and science in the domain of therapeutics. British journal of psychiatry (2003) 183: 22-27 METM 2006

Not just marketing new drugs Promoting off-label drugs Franklin (whistleblower) said Parke-Davis ran ghostwriting schemes, promoting drugs off-label accounted for 78% of sales of Neurontin getting around FDA prohibition on advertising off-label uses Discrediting competitor Prof. Fugh-Berman solicited to author article highlighting problems with Warfarin. Competing drug not mentioned and pharma involvement undetectable. Creating a market Wyeth needed to cast obesity as a major medical problem to justify risks against its 3% efficiency over placebo– 100s of deaths METM 2006

“Medical journals are an extension of the marketing arm of drug companies” Richard Smith (former editor) BMJ “Journals have devolved into information laundering operations for the pharmaceutical industry” Richard Horton editor Lancet METM 2006

Author’s editor Not acceptable for some journal editors: How can authors who are too busy or whose writing skills are so poor that they need help guarantee the quality of their research? Ghostwriting is only acceptable if English is not author’s first language METM 2006

ICMJE require acknowledgement of writing assistance But it’s seldom acknowledged: Why not? Ignorance of requirement/guidelines Authors too embarrassed Deliberate deceit Fear paper less likely to be accepted for publication METM 2006

EMWA-AMWA Survey Acknowledgement % Always 187 25% Usually 183 Rarely or never, but I am not opposed to the practice 354 47% Rarely or never because I am opposed to the practice 23 3% METM 2006

Ghostwriting detection Peer review rarely detects ghostwriting – detection mostly serendipitous How are journals encouraging ghosts to show up? METM 2006

Contributorship Conflict declaration BMJ ask authors of review articles: have you been prompted or paid to write? was the article written by you or a medical writer? METM 2006

EMWA guidelines Medical writers: Should ensure author involvement as early as possible May draft article, but author must control content Should be acknowledged (+ their source of funding) but writers have right to withdraw their names in exceptional circumstances METM 2006

What if ghosts remain in the dark? METM 2006

WAME Guidance to editors (April 2005) publish a notice that a manuscript has been ghostwritten, along with the names of the responsible companies and the submitting author; alert the authors' academic institutions, identifying the commercial companies; provide specific names if contacted by the popular media or government organizations; and share their experiences on the WAME Listserve and within other forums. METM 2006

Problems for medical writers Restrictions from employers: Forbid acknowledgement Require writers to disguise themselves by replacing the name of the medical writing agency with that of the author’s institution in File Properties of the Word document manuscript before submission Prescribe wording “I was given, an outline, references and a list of drug-approved phrases. I was pressured to rework my drafts to position the product more favourably” One reviewer discovered pharma in File Properties and rejected METM 2006

Are medical writers authors? ICMJE author definition Someone who: Conceived or designed study or Acquired data or Analysed or interpreted data + Every author must have: Drafted the article or revised it for intellectual content and Approved the final version to be published METM 2006

Access to study data problem ‘opinion leader’ authors have not conducted the research, do not have access to the data, and cannot share the data EMWA guidelines–both the medical writer and named authors must have access to study data METM 2006

Medical writers can add value Quality of writing probably better More.. results of research will enter public domain than if left to the investigator Some communication agencies might encourage disclosure of interest David Healy and Dinah Cattell Brit J Psychiatry METM 2006