"Ghost authoring" refers to making substantial contributions without being identified as an author. "Guest authoring" refers to being named as an author without having made substantial contributions. "Ghostwriting" refers to assisting in presenting the author's work without being acknowledged. The term "ghostwriting" is often used to encompass all three of these practices.
With medical ghostwriting, professional writers and other parties are paid — commonly (but by no means always) by pharmaceuticals and medical devices manufacturers — to produce manuscripts for conference presentations, scientific publications, explicitly promotional distributions, patient education materials, continuing professional education activities' contents, and other communications. In the pharmaceuticals and medical devices industries, physicians and other scientists are frequently permitted or paid to attach their names to these manuscripts, which are then promulgated at meetings, distributed to patients and caregivers, presented as marketing instruments, or published in textbooks and medical journals. These scientists or physicians may have little involvement in the research or the writing process.
The rules for authorship and contribution of the International Committee of Medical Journal Editors (ICMJE, informally known as "the Vancouver Group" from the locale of the group's first meeting, Vancouver, British Columbia, Canada) are a single, universally-respected set of guidelines for describing authorship of and contribution to professional medical publications. The document "International Committee of Medical Journal Editors: Authorship and Contributorship" is considered the definitive statement of ethical requirements for how authorship in medical journal articles (the prime forum for medical professional publication) and the degree to which a given writer is deemed to have contributed to the content of a medical journal article are determined. This document contains a succinct statement of the rules for determining authorship of and contributorship to medical journal articles:
An “author” is generally considered to be someone who has made substantive intellectual contributions to a published study, and biomedical authorship continues to have important academic, social, and financial implications. An author must take responsibility for at least one component of the work, should be able to identify who is responsible for each other component, and should ideally be confident in their co-authors’ ability and integrity. In the past, readers were rarely provided with information about contributions to studies from persons listed as authors and in Acknowledgments. Some journals now request and publish information about the contributions of each person named as having participated in a submitted study, at least for original research. Editors are strongly encouraged to develop and implement a contributorship policy, as well as a policy on identifying who is responsible for the integrity of the work as a whole.
While contributorship and guarantorship policies obviously remove much of the ambiguity surrounding contributions, they leave unresolved the question of the quantity and quality of contribution that qualify for authorship. The ICJME has recommended the following criteria for authorship; these criteria are still appropriate for journals that distinguish authors from other contributors.
Authorship credit should be based on 1) substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3.
When a large, multicenter group has conducted the work, the group should identify the individuals who accept direct responsibility for the manuscript. These individuals should fully meet the criteria for authorship/contributorship defined above, and editors will ask these individuals to complete journal-specific author and conflict-of-interest disclosure forms. When submitting a manuscript authored by a group, the corresponding author should clearly indicate the preferred citation and identify all individual authors as well as the group name. Journals generally list other members of the group in the Acknowledgments. The NLM indexes the group name and the names of individuals the group has identified as being directly responsible for the manuscript; it also lists the names of collaborators if they are listed in Acknowledgments.
Acquisition of funding, collection of data, or general supervision of the research group alone does not constitute authorship.
All persons designated as authors should qualify for authorship, and all those who qualify should be listed.
Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content.
Some journals now also request that one or more authors, referred to as “guarantors,” be identified as the persons who take responsibility for the integrity of the work as a whole, from inception to published article, and publish that information.
Increasingly, authorship of multicenter trials is attributed to a group. All members of the group who are named as authors should fully meet the above criteria for authorship/contributorship.
The group should jointly make decisions about contributors/authors before submitting the manuscript for publication. The corresponding author/guarantor should be prepared to explain the presence and order of these individuals. It is not the role of editors to make authorship/contributorship decisions or to arbitrate conflicts related to authorship."
Compliance with the International Committee of Medical Journal Editors' Uniform Requirements for Manuscripts Submitted to Biomedical Journals is voluntary. A list of medical journals which have stated that they follow the Uniform Requirements for Manuscripts Submitted to Biomedical Journals is maintained by the International Committee of Medical Journal Editors with the following caveats:
"The following is a list of journals whose editors or publishers have contacted the International Committee of Medical Journal Editors (ICMJE) to request listing as a journal that follows the ICMJE's Uniform Requirements for Manuscripts Submitted to Biomedical Journals. The ICMJE cannot verify the completeness or accuracy of this list. There may be some journals that follow the ICMJE recommendations, but have never requested listing. There may be some listed journals that do not follow all of the many recommendations and policies in the document."
How closely individual medical journals and authors of medical journal articles comply with ICMJE guidelines is a largely self-policed matter. The ICMJE document "Uniform Requirements for Manuscripts Submitted to Biomedical Journals:Publishing and Editorial Issues Related to Publication in Biomedical Journals: Corrections, Retractions and "Expressions of Concern" " is the section of the ICMJE Uniform Requirements laying out guidelines for how potential or actual scientific error and scientific fraud ought to be dealt with. It refers readers to the relevant guidelines from the Committee for Publication Ethics (COPE) - specifically COPE's flowcharts outlining a systematic approach toward scientific error and possible fraud.
Medical ghostwriting has been criticized by a variety of professional organizations representing the drug industry, publishers, and medical societies, and it may violate American laws prohibiting off-label promotion by drug manufacturers as well as anti-kickback provisions within the statutes governing Medicare. Recently, it has attracted scrutiny from the lay press lawmakers the Institute of Medicine, and the National Institutes of Health. as well. It is permitted at some institutions, including the University of Washington School of Medicine, while it is prohibited and considered a particularly pernicious form of plagiarism at others, such as Tufts University School of Medicine and the University of Pennsylvania School of Medicine.
Scandals involving prominent physicians researchers have been reported at over a dozen universities in the United States, however, there have been no reports of any professors being disciplined. Professor Trudo Lemmens of the University of Toronto School of Law argues that ghostwritten papers help protect companies when they are sued in court.
Professional medical writers can write papers without being listed as authors of the paper and without being considered ghostwriters, provided their role is acknowledged. The European Medical Writers Association have published guidelines which aim to ensure professional medical writers carry out this role in an ethical and responsible manner. The use of properly acknowledged medical writers is accepted as legitimate by organisations such as the World Association of Medical Editors and the British Medical Journal. Moreover, professional medical writers' expertise in presenting scientific data may be of benefit in producing better quality papers.
It is difficult to determine how frequently ghostwriting occurs due to its covert nature. A 2009 New York Times article estimated that 11% of New England Journal of Medicine articles, 8% of JAMA, Lancet and PLoS Medicine articles, 5% of Annals of Internal Medicine articles and 2% of Nature Medicine were ghost written. Between 1998 and 2005 Wyeth had 26 papers promoting hormone replacement therapy (HRT) published in scientific journals.
Previously secret internal Wyeth documents providing evidence of this are viewable on the Drug Industry Document Archive. It also appears to have occurred in 75% of industry funded trials between 1994 - 1995 approved by the Scientific Ethical Committees for Copenhagen and Frederiksberg. Of the articles published from 1998 to 2000 regarding sertraline, between 18% and 40% were ghost written by Pfizer. A questionnaire using comparable methods in 2005 and 2008 with a 14-28% response rate found a decrease in number of people who reported ghostwriting among professional medical writers.
Most pharmaceutical companies have in-house publication managers who may either manage the writing of publications on the company's drugs by a team of in-house medical writers or contract them out to medical communication companies or freelance medical writers. Reprints of the articles can be distributed to doctors in their offices or at medical meetings by drug company representatives in lieu of product brochures. This practice might be illegal if it effectively constitutes advertising or advocating use of the drug for non-approved indications or dosages. Payments to medical ghostwriters may be augmented with consulting contracts, paid trips to teach continuing medical education courses, or grants. The academics or doctors are known as "KOLs" ("Key Opinion Leaders") or "TLs" ("Thought Leaders").
On June 24, 2010, Senator Charles E. Grassley, Ranking Member of the United States Senate Committee on Finance issued a report on medical ghost writing. The report said, "The Committee was provided with documents from recent lawsuits involving Wyeth’s hormone therapy products. The documents showed that Wyeth hired a medical communications and education company, DesignWrite Inc. (DesignWrite), to draft review articles regarding the breast cancer risk of hormone therapy products and then invited academic researchers to sign on as the primary authors."
- AMWA Ethics FAQs, Publication Practices of Particular Concern to Medical Communicators"
- Sismondo S (September 2007). "Ghost management: how much of the medical literature is shaped behind the scenes by the pharmaceutical industry?". PLoS Med. 4 (9): e286. doi:10.1371/journal.pmed.0040286. PMC 1989751. PMID 17896859.
- Fletcher, Robert (2005). "Ghost writing initiated by commercial companies". J Gen Intern Med 20 (6): 549. doi:10.1111/j.1525-1497.2005.41015.x.
- Rennie, D.; Flanagin, A. (1994). "Authorship! Authorship! Guests, ghosts, grafters, and the two-sided coin". JAMA 271 (6): 469–471. doi:10.1001/jama.1994.03510300075043.
- Studdert; et al. (2004). "Financial Conflicts of Interest in Physicians' Relationships with the Pharmaceutical Industry—Self-Regulation in the Shadow of Federal Prosecution". NEJM 351 (18): 1891–1900. doi:10.1056/NEJMlim042229. PMID 15509824.
- Mathews, Anna Wilde (December 13, 2005). "At medical journals, paid writers play big role". Wall Street Journal.
- Elliot Ross, "How drug companies' PR tactics skew the presentation of medical research", Guardian 20 May 2000 http://www.guardian.co.uk/science/2011/may/20/drug-companies-ghost-writing-journalism
- House of Commons Health Committee (2005) The influence of the pharmaceutical industry. London: The Stationery Office Limited.
- Project On Government Oversight, "Frequently Asked Questions about Medical Ghostwriting", June 28, 2011 http://www.pogo.org/pogo-files/alerts/public-health/ph-iis-20110620.html
- Project On Government Oversight, "Frequently Asked Questions about Medical Ghostwriting", June 28, 2011
- Boseley, the Guardian, February 7, 1992
- Giombetti, 1992, "UW's Friendly Corporate Ghostwriter", Eat the State Vol. 6, No. 19
- Krimsky, Sheldon (2003). Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research?. Lanham: Rowman-Littlefield. ISBN 0-7425-1479-X.
- Thacker, Paul, "How Scientific Literature Has Become Part of Big Pharma's Marketing Machine and How Being Nice Hurts Canada: 5 Questions with Ghostwriting Expert Trudo Lemmens", Project On Government Oversight, Jun 22, 2011
- Jacobs, A.; Wager, E. (2005). "European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications". Curr Med Res Opin 21 (2): 317–321. doi:10.1185/030079905x25578.
- Article requirements — BMJ resources
- Schultz, H. Y.; Blalock, E. (2007). "Transparency Is the Key to the Relationship between Biomedical Journals and Medical Writers". Journal of Investigative Dermatology 127 (4): 735–737. doi:10.1038/sj.jid.5700794.
- Wilson, Duff; Singer, Natasha (September 11, 2009). "Ghostwriting Is Called Rife in Medical Journals". The New York Times. Retrieved May 12, 2010.
- Singer, Natasha (August 5, 2009). "Ghostwriters Paid by Wyeth Aided Its Drugs - NYTimes.com". The New York Times. Retrieved May 12, 2010.
- Jacobs, A.; Hamilton, A. (2009). "Decreased evidence of ghostwriting in a 2008 vs 2005 survey of medical writers". The Write Stuff 18 (2): 118–123.
- Grassley, Charles, ed. (June 24, 2010). "Ghostwriting in Medical Literature". Minority Staff Report,111th Congress,United States Senate Committee on Finance. Washington, DC. Retrieved 2010-07-11.