Ghosts of Vioxx Past: Medical Writing Under Attack
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
A season of retractions, a question of accountability
So early in the year and already so many high-profile retractions in the biomedical field.
Retraction 1 [1]: A review paper [2] published in Best Practice & Research Clinical Rheumatology was retracted by the Harvard researcher Lee Simon after the software eTBlast and the database Déjà vu [3] marked the paper as a possible plagiarism. The paper supposedly had 55% text similarity with another paper published in 2003.
Retraction 2 [4]: Nobel prize winner Linda Buck retracted a 2001 Nature paper on the olfactory system [5] which she co-authored due to inconsistencies and inability of other researchers to reproduce the published results. Although Buck was named co-author, the primary author Zhihua Zou was cited “as solely responsible for providing data and figures for the paper” [4]. Buck won together with Richard Axel, the Nobel Prize in physiological medicine in 2004.
Retractions 3 and 4 [6]: One paper in Science [7] and another in Nature Chemical Biology [8] are being retracted by Korean researchers after doubts over the “scientific truth” of these molecular biology papers arose. The team of researchers in question works at the prestigious Korea Advanced Institute of Science and Technology (KAIST), led by the senior scientist Tae Kook Kim.
Issues to be linked to these stories are scientific integrity and author(s) [and co-author(s)!] accountability. Especially the accountability part. Who is accountable in cases of doubts and disputes? The supervisor or the PhD student? The team leader or the junior researcher?
References:
- Review article retracted amid plagiarism claims. Nature 451, 619 (2008).
- Simon LS. The treatment of rheumatoid arthritis. Best Pract Res Clin Rheumatol. 2004 Aug;18(4):507-38.
- Errami M. Déjà vu–a study of duplicate citations in Medline. Bioinformatics. 2008 Jan 15;24(2):243-9.
- Nobel prizewinner’s paper retracted. Nature 452, 13 (2008).
- Zhihua Z et al. Genetic tracing reveals a stereotyped sensory map in the olfactory cortex. Nature 414, 173-179 (8 November 2001).
- Korean institute inquiry prompts two retractions. Nature 452, 267 (2008).
- Won J. et al. A magnetic nanoprobe technology for detecting molecular interactions in live cells. Science 309 (5731):121 – 125; July 2005.
- Won J. et al. Small molecule-based reversible reprogramming of cellular lifespan. Nature Chem. Biol. 2, 369–374; 2006.
“Something is rotten in the state of…
…science” if I may borrow from and rephrase Shakespeare.
The highest ethical standards – we expect no less from men and women of science. Yet, recent events brought to light just how short they can fall from these expectations.
“Neither a borrower nor a lender be: For loan oft loses both itself and friend.”
Case # 1: Duplication and plagiarism.
Borrowing from the works of others and our own without proper citation is, in the scientific community, unethical behaviour of the highest magnitude. Using the software eTBLAST, bioinformatics searched through 62,213 Medline entries and found 0.04% cases of potential plagiarism and 1.35% cases of potential duplication [1, 2]. These citations are recorded on Déjà vu, a database of potentially duplicated and plagiarized scientific articles.
One of its first victims comes from no less than that icon of higher learning – Harvard itself. Two review papers, published about 1 year apart by different authors in 2 different journals have 55% similarity [3].
The countdown is running for other papers listed in the Déjà vu database as scrutiny continues. The journals are suddenly waking up to the fact that unethical behaviour in science is more rampant than previously thought. But isn’t it ironic that anti-plagiarism software - the very tool that academia is using to prevent plagiarism by students – is the one that would cast serious doubt on scientific credibility?
“To tell, or not to tell, — that is the question.”
Case #2: Breach of confidentiality.
A referee for the New England Journal of Medicine committed a major breach of confidentiality by leaking an unfavourable manuscript to a drug company [4]. I’m referring to the Avandia (rosiglitazone) issue (see 25 Nov 2007post) and how a referee faxed a copy of the manuscript [5] to the drug’s manufacturer GSK before it was officially published. The confidentiality of the peer review process is sacrosanct and breaching this confidentiality is a major scientific misconduct.
This reflects current concerns about conflicts of interest among authors, editors, and referees (who are most of the time, all one and the same) due to financial support from pharmaceutical companies. Another reason to call for non-industry-sponsored clinical research.
“There is nothing either good or bad, but thinking makes it so.” And getting caught.
References:
[1] Errami M et al. (2008). Déjà vu—A study of duplicate citations in Medline. Bioinformatics 24(2):243–249.
[2] Errami M & Garner H (2008). A tale of two citations. Nature 451:397-399.
[3] http://www.boston.com/news/health/blog/2008/01/a_harvard_rheum.html
[4] Vastag B (2008). Reviewer leaked Avandia study to drug firm. Nature 451:509.
[5] Nissen SE & Wolski KN (2007). NEJM 356:2457–2471.