Vioxx may be gone from the market but the litigation against Merck rages on and consultants for the plaintiff (Ross et al.) have written an article exposing “guest authors” and “ghost writing” practices in publications concerning rofecoxib (Vioxx).
I cringe every time the term “ghost writing” comes up in connection with the medical and scientific writing profession. Are we really “ghost writing” when we, medical writers, draft manuscripts for clients in the pharmaceutical industry? Is this unethical? Let’s see what the experts say.
Citing Rennie et al. (1994), Ross et al. defined ghost writing as “failure to designate an individual (as an author) who has made a substantial contribution to the research or writing of a manuscript.”
According to the World Association of Medical Editors (WAME), “ghost authorship exists when someone has made substantial contributions to writing a manuscript and this role is not mentioned in the manuscript itself.” However, it is not quite clear where the role of the medical writer should be mentioned in the manuscript.
The International Committee of Medical Journal Editors (ICMJE) is much clearer with its guidelines which provide that “authorship credit should be based on 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; and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3.”
Based on the ICMJE criteria, most medical writers clearly do not qualify for authorship. So where does the role of the medical writer come in? ICMJE states that “all contributors who do not meet the criteria for authorship should be listed in an acknowledgments section.”
I, therefore, object to Ross et al.`s definition of “ghost writing” in their paper as non-compliant ICMJE`s guidelines.
The paper also referred to “an industry specializing in medical writing” as if this is something new. Though are no figures available, it is quite a common and accepted practice in the healthcare and pharmaceutical industry to employ the services of professional writers to write press releases, educational materials, clinical documents, submission dossier, and yes – scientific papers.
The American Medical Writers Association (AMWA has been in existence since 1940 and the European Medical Writers` Association (EMWA) since 1989. These organizations have established guidelines and code of conduct. Members of these organizations have drafted and proposed the “Good Publication Practice (GPP): Guidelines for Pharmaceutical Industries.”
Ross et al.`s article, although aimed to question the credibility of Merck, also placed medical writers in a bad light. Whereas the article gives the number of papers with financial disclosures, it does not give the number of papers which acknowledged the use of medical writing services as provided for in the ICMJE guidelines.
I do not condone data manipulation as well as blatant misleading publication strategies such as the examples cited by Ross et al. as having been practiced by Merck. I simply want to defend medical writing as a valid profession.
Medical writers play an important role in the drug development process. Clinicians and biomedical scientists are busy people. As chief investigators and head of laboratories, they do not have the time to sit down and write papers.
In the academia, writing is usually delegated to PhD students and postdocs. In the pharmaceutical industry, writing is mainly done by trained and accredited medical writers who may be in-company or on-contract. Based on data provided to us, we try to write the text to the best of our ability. In the process the health care industry is benefited by fast and timely publication of scientific information which could be crucial to public health.
According to a statement drafted by several AMWA members
“We believe that medical writers are valuable to the writing process and can facilitate and speed the publication of important scientific information. Professional writers ensure that the literature cited is current; the study and statistical methods are complete, appropriate, and adequately detailed; and the author’s interpretation of the study findings is clearly and concisely communicated. Because of their contributions, manuscripts may be reviewed more easily by peer reviewers with fewer queries to be answered before final acceptance.
Medical writers have an important role in conveying valuable information to physicians and others in both a clearly communicated and a timely manner.”
However, as medical writers, we also have the duty to maintain the ethical standards of our profession. We can do these by
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advising our clients on GPP especially in authorship and acknowledgement of medical writing services rendered.
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refusing to take part in or condone data manipulation and other scientific misconduct.
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advising our clients on complete transparency by conflicts of interest and financial involvement.
Only then can we stand and lift our heads proudly to declare that we are not “ghost writers”, but professional medical writers.
References:
Joseph S. Ross, Kevin P. Hill; David S. Egilman; Harlan M. Krumholz. Guest Authorship and Ghostwriting in Publications Related to Rofecoxib A Case Study of Industry Documents From Rofecoxib Litigation. JAMA 299:15, April 16, 2008.
D Rennie, A Flanagin. Authorship! Authorship! Guests, ghosts, grafters, and the two-sided coin. JAMA 271: 469 - 471. Feb 1994.
E Wager, EA Field, L Grossman. Good publication practice for pharmaceutical companies. Curr Med Res Opin. 2003;19(3):147-8
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Time was when pleuripotent stem cells were supposedly only available from human embryos which led to heated debates on ethics and morality.
