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Headlines vs Guidelines:

March 18, 2009

Thomas Gegeny, MS, ELS

Envision Scientific Solutions

• President-elect, American Medical Writers Association

Will Media Attention and Public Scrutiny

Eventually Yield to Recognition of Best Practices

in Industry-sponsored Medical Publications?

Where did “ghosts” come from?

What is “Ghostwriting?”

Ghostwriting occurs when documents (manuscripts, posters, reports) are written by someone who is not listed as an author and not acknowledged for those contributions.

“Ghost authoring” occurs when someone’s name appears as author on a document to which they did not contribute substantively.

Neither ghostwriting nor ghost authoring is ethical.

What about the busy professional?

• Researchers

• Healthcare providers

• Company executives

• Business leaders

• Many others

What might be “ghostwritten?”

• Books

• Essays

• Reports

• Presentations

• Speeches

• Letters and correspondence

So when, if ever, is this acceptable?

Research is different

• In research-based publications, the role of authors is both central and essential: Authorship connotes responsibility for the data and how it was acquired.

• The research process has grown increasingly complex; more people with specialized skill sets are collaborating toward the final product.

• Demands on time and resources have increased, so the importance of the team-based approach has grown.

How it should not work

Drug Company

Academic

Researcher

(“Author”)

Publication

Agency

Medical Writer Publication

(journal article,

congress presentation, etc)

Publication funding Research funding

How it should work

Drug Company

Academic

Researcher &

Author

Publication

Agency

Medical

Writer

Publication (journal article,

congress presentation, etc)

Is this phenomenon unique to the pharmaceutical industry?

• Many academic (and often corporate) practices equate merit and recognition with seniority and status

• Team effort may be emphasized or preferred over recognizing individual contributions

What about academia?

• Publications = Tenure/job security (aka, “publish or perish”)

• You scratch my back. . . .

• “Salami science”

• Department head/chair as last author on all publications

• Other examples?

Why authorship matters

“Since authorship has become the currency of research

credit, and the output of individual academics and entire

departments is judged on their publication record,

authorship abuse is not a victimless crime. The career of a

researcher wrongly denied authorship of a paper may

suffer, while guest authors may receive undeserved credit

and benefit materially from this.”

Wager, Maturitas, 2009; 62: 109-112

Shades of Gray?!

Other interests are involved (media, legal, government, etc). So how do we sort out hype from truth?

Guidelines, ethics, & education

What is the role of professional medical writers?

• Technical assistance

– Develop and edit content at authors’ direction/guidance

– Assist with reference gathering, literature searches

– Combine review comments into subsequent revisions

– Circulate drafts for further review/finalization

• Unique expertise

– Skill and facility with language and clear communication of data and scientific concepts

– Familiarity with writing and publication guidelines, journal requirements, and other publications standards

• Assistance: Editorial, fact-checking, or administrative (eg, routing/collecting author disclosure forms)

International Committee of Medical Journal Editors (ICMJE)

• Criteria for authorship 1. Substantial contributions to conception and design,

or acquisition of data, or analysis and interpretation of data

2. Drafting the article or revising it critically for important intellectual content

3. Final approval of the version to be published

• To be authors, individuals must meet all 3 criteria

International Committee of Medical Journal Editors (ICMJE)

• “All contributors who do not meet the criteria for authorship should be listed in an acknowledgments section.”

– People who provided technical help, writing assistance, etc.

– Supervisor or department chair who provided general support.

• “Financial and material support should also be acknowledged.”

Good Publications Practice

• Authors/contributors determine publication content and retain responsibility for it.

• Medical writer begins draft after consultation and discussion with named authors.

• Adequate time is given for author comment.

• Writer remains in close contact with authors.

• Authors approve final version before it is submitted.

• Lead author is responsible for submitting piece to the journal and acting as the primary contact.

• Contribution of the medical writer is acknowledged.

AMWA Guidelines/Ethics Page: www.amwa.org (About AMWA)

American Medical Writers Association (AMWA)

Position statement on the contribution of medical writers to scientific publications:

“The American Medical Writers Association (AMWA) recognizes the valuable contributions of medical communicators to the publication team. Medical communicators who contribute substantially to the writing or editing of a manuscript should be acknowledged with their permission and with disclosure of any pertinent professional or financial relationships. In all aspects of the publication process, medical communicators should adhere to the AMWA Code of Ethics.”

AMWA Code of Ethics

• Principle 1: Biomedical communicators should recognize and observe statutes and regulations pertaining to the materials they write, edit, or otherwise develop.

• Principle 4: Biomedical communicators should work only under conditions or terms that allow proper application of their judgment and skills. They should refuse to participate in assignments that require unethical or questionable practices.

ISMPP Response

“We wish to correct the misperceptions of ISMPP resulting

from the commentary by Dr. Sismondo. . . . We contend

honorary or guest authorship violate the basic tenets of

authorship promulgated by the ICMJE. . . . ISMPP believes

the practice of withholding deserving contributors as authors

only perpetuates the negative perception of industry

scientists (many of whom came from academia). However,

change is unlikely unless journal editors/reviewers treat

manuscripts based on their content, not on authors’

affiliations−as advocated by the Council of Science Editors.”

Council of Science Editors

• White Paper on Promoting Integrity in Scientific Journal Publications

• www.councilscienceeditors.org/ editorial_policies/white_paper.cfm

• Section 2.2 Authorship

World Association of Medical Editors (WAME)

• Authors should "have undertaken the work described and have ensured that the manuscript accurately reflects their work, irrespective of whether they took the lead in writing or sought assistance from a medical writer."

• "Ghost authorship exists when someone has made substantial contributions to writing a manuscript and this role is not mentioned in the manuscript itself."

• “Not all contributors necessarily qualify for authorship. . . . each contributor’s participation can be made transparent by a statement, published with the article, of their names and contributions.

International Society of Medical Publication Professionals (ISMPP)

The “medical writer’s role is to produce manuscripts based on (1) scientific or clinical data and (2) a thorough literature search to identify and assess relevant publications on the topic. Ideally, such writers collaborate with the designated authors . . . . to enhance the quality of the manuscript and reduce delays, thus freeing the researchers to focus on . . . responsibility for the publication’s overall content, tone, and accuracy.”

Norris et al. Current Medical Research and Opinion,

2007;23(8):1837–1840

International Society of Medical Publication Professionals (ISMPP)

• Belief that “medical writers can often improve the efficiency and effectiveness of manuscript preparation by working with the research team to develop clear and concise manuscripts in a timely fashion.”

• Endorsement of contributorship model (cites WAME recommendations)

Norris et al. Current Medical Research and Opinion,

2007;23(8):1837–1840

European Medical Writers Association (EMWA)

• “The involvement of medical writers and their source of funding should be acknowledged.”

• “Identifying the writer’s funding source ensures transparency and makes readers aware of any potential conflicts of interest.”

• “Vague acknowledgements of the medical writer’s role, such as ‘providing editorial assistance’ should be avoided as they are open to a wide variety of interpretations.”

Jacobs A, Wager E. Curr Med Res Opin, 2007;23(8):1837–1840

American Association of Medical Colleges (AAMC)

• Report on Industry Funding of Medical Education (June 2008)

• Ghostwriting defined as “the provision of written material that is officially credited to someone other than the writer(s) of the material.”

• “Transparent writing collaboration with attribution between academic and industry investigators, medical writers, and/or technical experts is not ghostwriting.

• “The unacknowledged, undisclosed provision of content should not be permitted. . . .”

Checklist for Authors Using Medical Writers: A Practical Tool to Discourage Ghostwriting

GØtzsche et al. PLoS Medicine, 2009; 6(2): 122-125

A change of tune? One case study: Clinical Journal of Oncology Nursing

Editorial: “. . .the CJON Editorial Board made a decision to reject manuscripts that have been written by medical writers or communication companies. One of the primary purposes of this journal is to develop the publication skills of oncology nurses, and accepting manuscripts that originate with a medical writer defeats that purpose. . . . Any oncology nurse who takes care of acutely ill patients on a daily basis has every skill needed to write a manuscript. Substantial help is available to you from editors, editorial board members. . .” (CJON, 9, p 669, 2005)

Joint AMWA & EMWA Response

“. . .We support the more balanced approach of BMJ, which requires that professional medical writers be named as contributors and that their funding be fully disclosed. This policy is consistent with the standards set by the International Committee of Medical Journal Editors (2006) . . . . The American Medical Writers Association and the European Medical Writers Association have taken an active role in discouraging ghostwriting, in which the role of medical writers and their funding are not disclosed . . . . We appeal to you to join us in our efforts and to reconsider your policy on the publication of professionally written papers.”

Current CJON Author Instructions

CJON endorses the International Committee of Medical Journal Editors (ICMJE) recommendations for authorship. . . . All contributors who do not meet the criteria for authorship should be listed in an acknowledgment.

Examples of those who might be acknowledged include those who provided purely technical help, writing assistance, or general support. . . . Authors should inform the editor via email if they received an honorarium for developing the manuscript and/or if a medical writer or communication company was utilized in any way in the preparation of the manuscript.

How to ensure compliance, transparency, and ethics in all publications?

Work according to a current and comprehensive publications policy

Author agreements/contracts that clearly define author roles, responsibilities, expectations, etc

Documentation of each publication’s development: more important than ever

Disclosure of medical writing and editorial assistance every time

Educating and engaging stakeholders (clients, authors, publishers, etc.) whenever relevant opportunities arise

The End?

Open Discussion/Audience Q&A

Next ISMPP U

• Topic: Ethical Issues in Medical Publishing with Maja Zecevic, North American editor for The Lancet

• Date: May 20

• Time: 12 Noon EST

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