Ghostwriting in medical journals

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Ghostwriting in medical journals
Elise Langdon-Neuner Baxter BioScience
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Ghostwriting as old as literature sometimes almost
as
reputable as the oldest profession
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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

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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

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Who is a ghostwriter?

• Authors 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

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Industry writer

• Review articles
• Marketing tool for pharma
• concealed pharma controls slant and data
  inclusion
• i.e. biased to market companys 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?

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Healy and Cattells 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

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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

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Medical journals are an extension of the
marketing arm of drug companiesRichard Smith
(former editor) BMJ

• Journals have devolved into information
  laundering operations for the pharmaceutical
  industry
• Richard Horton editor Lancet

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Authors 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
  authors first language

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ICMJE require acknowledgement of writing
assistance

• But its seldom acknowledged Why not?
• Ignorance of requirement/guidelines
• Authors too embarrassed
• Deliberate deceit
• Fear paper less likely to be accepted for
  publication

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EMWA-AMWA SurveyAcknowledgement
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Ghostwriting detection

• Peer review rarely detects ghostwriting
  detection mostly serendipitous
• How are journals
• encouraging
• ghosts to
• show up?

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• 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?

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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

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What if ghosts remain in the dark?
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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.

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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 authors 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

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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

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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 guidelinesboth the medical writer and named
  authors must have access to study data

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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