Medical Writers - First Clinical Research

Vol. 2, No. 3, March 2006

“Can You Handle the Truth?”

Medical Writers: Who Are We? By Susanna J Dodgson Abstract The aim of this study was to determine how medical writers define themselves and are defined by others. Functional definitions differed in the three professional societies to which medical writers belong: the American Medical Writers Association (AMWA), the European Medical Writers Association (EMWA) and the Drug Information Association (DIA). A fourth professional association, the International Committee for Medical Journal Editors (ICMJE), affects the daily activities of medical writers through its work on medical journal manuscripts. However, ICMJE neither defines medical writers, nor even acknowledges their existence. The definition of medical writers in the sole U.S. graduate degree-granting program in biomedical writing: “Medical writers are trained scientists who translate data that they have analyzed, and may have created, into prose, tables and figures, on behalf of a sponsor from the private or public sector.” The study’s conclusions are that medical writers, their employers, and their educators need to understand the profession of biomedical writing if medical writers are to have status as healthcare professionals in the pharmaceutical industry. Introduction To pharmaceutical industry outsiders, professional medical writers are a recent invention of the late-20th century, along with clinical research organizations (CROs), fax machines, and the Internet. But are they? Who are medical writers? We answered this question by looking at published documents from professional organizations to which medical writers belong and an organization with the power to control the visibility of medical writers. We also reviewed the laws governing clinical trial documentation that have been largely responsible for creating the need for medical writers in the pharmaceutical industry. Methods Our search for laws that affect the pharmaceutical industry focused on the FDA website (http://www.fda.gov). For definitions of medical writers, we searched the following websites: American Medical Writers Association (http://www.AMWA.org), European Medical Writers Association (http://www.EMWA.org), Drug Information Association (http://www.DIA.org), and International Committee of Medical Journal Editors (http://www.ICMJE.org). Requests for further information about AMWA led to an invitation to visit the library of Edith Schwager. This search yielded early information on AMWA and its predecessor, the Mississippi Valley Medical Editors Association. Linda Fossati Wood, a founder of the DIA Medical Writing Special Interest Committee, provided information on medical writers in the DIA.

Subscribe free at http://www.firstclinical.com. © 2006 Susanna J Dodgson

Results Federal Laws Clinical trials generate a vast amount of data that needs to be translated into prose for professional publications and governmental authorities. The emergence of clinical trials as the gold standard for professional and government acceptance of new therapies is primarily responsible for the emergence of the medical writing profession. The need for standards in the development, approval and marketing of devices, drugs and biologics can be directly linked to several acts of Congress in the 20th century. The first was the Pure Food and Drug Act of 1906, its update in 1938, the Durham Humphrey Amendment in 1951, and the Kefauver-Harris Drug Amendment in 1962.1 Other acts that have affected the approval of therapies and their marketing are the Hatch-Waxman Amendment in 1984, which increased the number of generic drugs the Food and Drug Administration (FDA) approved for marketing, and the Prescription Drug User Fee Act of 1992, which has resulted in more rapid FDA approvals of new drug applications. 1 American Medical Writers Association (AMWA) In 1940, Harold Swanberg led the initiative to form the Mississippi Valley Medical Editors Association (MVEA). The MVEA became the American Medical Writers Association in 1949. Dr. Swanberg claimed that every article in Index Medicus was written by a medical writer.2 This statement is true in some sense. However, few authors are professional medical writers. With the formation of MVEA, the medical industry began to recognize the profession of biomedical writing and its practitioners, medical writers. AMWA maintained a precise definition of a medical writer from 1952 through at least 1965. It used this definition to qualify and name “Fellows” – members considered to be expert medical writers. Around 1965, the definition was abandoned, along with the requirement that only physicians could be president of the Association.2,3 As of 1965, AMWA members qualified as Fellows by meeting 2 of the 4 following criteria: •

Member has 10 or more articles listed in Index Medicus.

•

Member has served as editor, associate, assistant or managing editor in an Index Medicus journal.

•

Member has written 1 or more books on a scientific topic.

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Member has served as president or secretary of a generally recognized medical or scientific society.

As AMWA has become more inclusive, its membership has changed. During the 1950s, 90% to 100% of AMWA Fellows were physicians. By the 1960s, this percentage had dropped to 70%.2 By 2005, less than 5% of the membership of AMWA were physicians, demonstrating the evolution of medical writing from a physician sideline to a separate profession.3 AMWA’s website illustrates just how inclusive the association has become: “The more than 5,000 members from around the world include a variety of biomedical communicators: Administrators, Advertisers, Audiovisual Producers, Authors’ Editors, College and University Professors, Journal Editors, Pharmaceutical Writers, Editors, and Managers, Public Relations Specialists, Publishers, Reporters, Researchers, Scriptwriters, Statisticians, Translators. “If you write, edit, or are employed in the field of biomedical communication as a teacher or as a specialist in multimedia, public relations, advertising, or marketing, Subscribe free at http://www.firstclinical.com. © 2006 Susanna J Dodgson

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you belong in AMWA. AMWA enhances the professionalism of freelance medical writers and editors and of those employed by a hospital, medical school, clinic, health sciences center, foundation, or nonprofit association, or by a pharmaceutical, medical communication, or biotechnology company. “Membership in AMWA is open to anyone interested in any aspect of biomedical communication. Student membership is available to full-time students.” 3 AMWA thus defines a medical writer by functional activity, with no reference to clinical qualifications such as R.N., R.Ph., R.D., M.D., D.O., or Pharm.D., or the scholarly science qualifications of M.S. or Ph.D. The concept of “Fellow” no longer exists. A recent article in the official AMWA journal addressed, but did not answer, the question of whether a medical writer needs any science background at all.4 AMWA does not offer professional certification as a measure of competence. However, it offers Professional Development Certificates to members who complete a minimum level of activities. The 1965 requirements for elevation of a member to a Fellow of AMWA are unrecognizable in current requirements. In the 21st century, AMWA honors as Fellows members who have served the organization. Fellows do not need any specialized training, or even work with medical documents of any sort: “Fellowships (no more than 5 each year) are presented to members of AMWA to recognize substantial contributions to the goals and activities of AMWA and professional accomplishments that have been recognized by their peers. Candidates must have been active members in good standing at least 5 consecutive years immediately before fellowship nomination. Members (who may include nominees) may submit nominations. The Fellowship Committee proposes the recipients, whose names are then submitted to the Board of Directors for approval.” 3 In the interest of inclusiveness, AMWA has thus opened its membership ranks to anyone able and willing to fill out the application form and pay the membership fee. It no longer attempts to set standards for competence based on demonstrated performance. European Medical Writers Association (EMWA) EMWA was founded in 1989. Its goals are similar to those of its American counterpart, AMWA, with which it was affiliated for more than a decade. EMWA is now separate, with its own constitution and executive committee, and is currently incorporated in Switzerland. It has about 550 members, so is about one-tenth the size of AMWA. Whereas 40% to 60% of AMWA members have undergraduate or graduate degrees in life sciences, 80% to 90% of EMWA members have such qualifications. EMWA members lacking scientific qualifications are mostly editors of medical journals. Although EMWA, like AMWA, does not restrict membership based on qualifications or accomplishments, its members more closely follow the 1965 requirements for AMWA Fellows. EMWA’s website defines EMWA primarily as a professional development organization: “[The aim of the founders] was to provide a forum to promote standards of excellence in medical writing by furthering the professional development of members and increasing awareness of medical writing throughout Europe. “By 1999, EMWA ... became a Company Limited by Guarantee, established its own educational committee and developed an educational programme to provide certification as a European trained Medical Writer. EMWA ... includes academics and professionals working in-house or freelance for pharmaceutical and medical


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communications companies, research institutes, and in the field of scientific journalism. “EMWA is a great place to pick up the skills needed to broaden your horizons as a medical writer. EMWA’s aim is to provide educational and social networking opportunities for its members.” 5 EMWA’s website nowhere defines a medical writer. Its Professional Development Programme offers certificates for completion of coursework, but, like AMWA, EMWA does not set standards for competence based on demonstrated performance. Drug Information Association (DIA) DIA is an organization of about 23,000 pharmaceutical industry professionals.6 Although medical writers comprise only a small fraction of the its membership, DIA merits mention because of its formation in 2001 of a special interest action committee (SIAC) for medical and scientific writing. Currently, the SIAC has 220 members.7 Additionally, since 2000, DIA has offered an annual workshop for medical and technical writers. DIA members in the SIAC are mostly medical writers whose jobs include analyzing data and preparing documents for regulatory agencies, as demonstrated by topics in the 2005 annual meeting: protocol development, experience with CTD and eCTD, preclinical writing, EU Clinical Trials Directive, Clinical Trial Registry, presenting data, pharmacovigilance and the medical writer, compiling appendices for the CSR, postsubmission activities for the medical writer, managing medical writers, and freelance writing.6 Neither the medical and scientific writing SIAC nor the DIA itself defines a medical writer. Membership in the medical writing SIAC is open to all members of DIA. Every other year, the SIAC runs a 2-day conference for medical writers. International Committee for Medical Journal Editors (ICMJE) A group of editors from top-tier medical journals met in Vancouver, Canada in 1978 and started ICMJE.8 Their original goal was to set standards for publishing manuscripts. ICMJE now issues annually updated guidelines for preparing manuscripts for submission to their journals. These guidelines include descriptions of “ethical principles in the conduct and reporting of research.” These ethical principles include instructions for preparing and evaluating manuscripts for publication and guidelines for preparing data and rules for which data can be considered for a publication. The importance of ICMJE for medical writers goes beyond describing the architecture of a manuscript. ICMJE guidelines define who is an author. According to the 2005 ICMJE Uniform Requirements, an author of a medical journal article must: •

Substantially contribute to the concept and design of the study, OR acquire data, OR analyze or interpret data, and

•

Draft the article OR revise it critically for important intellectual content, and

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Give final approval of the version to be published.8

Thus, a medical writer may write 100% of an article, contributing significant insights along the way, but receive 0% of the authorship credit. Although the ICMJE guidelines affect the daily lives of medical writers, the ICMJE website neither defines nor even mentions the role of medical writers. Medical writers have generally been invisible in writing manuscripts from clinical trial data. This practice has been described by the author, and has also been described in the Wall Street Journal.9,10 However, like autobiography ghost writers, medical writers are, occasionally, discretely acknowledged.


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Graduate and Certificate Programs in Biomedical Writing The Philadelphia College of Pharmacy, the first U.S. School of Pharmacy, is part of the University of the Sciences in Philadelphia (USP). In 1997, it created the first, and still only, U.S. graduate-degree Program in Biomedical Writing. Enrollment is increasing 10% to 15% per year; more than 250 students have taken courses and over 35 graduate medical writers have earned the accredited degree Master of Science in Biomedical Writing. Most graduates of the Biomedical Writing Program find employment in the pharmaceutical industry, so the definition of medical writer that is used in the Program reflects the needs of the pharmaceutical industry: “Medical writers are trained scientists who translate data that they have analyzed, and may have created, into tables, figures and prose, on behalf of a sponsor from the private or public sector.” Not all students entering the Program have formal undergraduate or graduate training in science, although the majority does. However, by the time they have finished the Program, they have been trained in scientific thought, clinical trial data analysis and clinical biostatistics reporting, and are awarded a Master of Science. 11 USP also offers 12-unit Certificates in Marketing Medical Writing and Regulatory Medical Writing. The University of Chicago Graham School of Journalism offers a 3-credit Medical Writing Certificate.12 Unlike industry association certifications, both of these certifications are endorsed by university-accrediting bodies.13 Discussion Thousands of trained professionals will write or co-write medical documents this year. Many of these persons consider themselves professional medical writers because their principal occupation is to write medical documents. Although professional societies support professional medical writers, they do not define the term or offer certification based on demonstrated competence. ICMJE does not even acknowledge their existence. In many industries, the best communicators occupy the senior management positions, supervising the technical people. In the pharmaceutical industry, the technical people – physicians and scientists – supervise medical writers, often the best communicators. Medical writers with scientific training have the potential to make contributions to pharmaceutical companies that go well beyond medical writing. Professional medical writers emerged as an essential part of the clinical team that processes mountains of data into the complex documents required by regulatory agencies for reviewing marketing applications and safety updates, and for drug labels; by government agencies for public disclosure of threats to public health; for scientific articles; and by advertising agencies for marketing purposes. Professional medical writers frequently specialize in either regulatory writing or marketing writing. Marketing writers prepare slide presentations, professional and advisory meeting summaries, monographs, sales representative training documents, and convert clinical trial data into medical journal articles. While the laws were being passed and the need for medical writers was increasing, the industry was producing organizations for healthcare professionals and members of the pharmaceutical industry. These organizations, particularly AMWA, were as important in the emergence of the medical writer as the changing laws, because they allowed clinical scientists working as medical writers to interact and determine better and quicker ways to convert raw data into intelligible documents.


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Since none of the four professional organizations surveyed formally define medical writers, we are unable to compare their definitions with the one we use at the University of Sciences in Philadelphia. Medical writers are neither defined nor discussed by ICMJE, indicating that medical writers should be governed by the same guidelines as any other contributor and be listed as an author on any manuscript to which they have substantially contributed and given final approval. Medical writers preparing manuscripts from data they have either created or analyzed certainly meet all criteria of authorship and should be given final approval, and should thus be included as authors on these manuscripts. The fact that ICMJE needs to define an author indicates a serious problem that emerged around the 1950s, around the same time as the emergence of clinical trials.14 In the author’s opinion, the requirements for authorship are inadequate and reward plagiarism by persons who have not created or analyzed data, nor have turned these data into narrative form. Additionally, even these requirements are not met by all authors. One study examining the incidence of honorary authorship and ghost authorship in Cochrane Reviews found that 39% of the reviews examined had evidence of authors who did not meet the ICMJE criteria.15 Another study found discrepancies between the requirements and practice of medical journals whose editors are in ICMJE.16 The author has described this practice of honorary or guest authorship at length previously.11 The function of the medical writer in preparing medical journal manuscripts is of interest to task forces convened by AMWA and EMWA and has resulted in papers about guidelines for medical writers in preparing these documents.17-19 The speed with which medical writing has become a clinical profession has taken academic institutions, professional societies, and government agencies by surprise, as evidenced by the sanctioned abuse of medical writers who prepare preclinical and clinical documents for which other healthcare professionals take full credit. The author concludes that the lack of understanding of the function of the medical writer by the industry should surprise no-one, considering that even the professional societies of medical writers do not define the profession. Acknowledgments Thanks to AMWA’s “Dear Edie” (Ms. Edith Schwager) for her enthusiastic decades-long work in AMWA and AMWA-DVC and for opening her house and books for research. She is truly a “living treasure” of AMWA. We also thank Cynthia Hamilton, Pharm.D. and Danny A Benau, Ph.D. for reviewing the manuscript. Review does not imply endorsement of the opinions of the author. References 1.

The Evolution of U.S. Drug Law. Food and Drug Administration. Last accessed 10/12/04 at http://www.fda.gov/fdac/special/newdrug/henlaw.html

2.

Swanberg H. History of the American Medical Writers' Association. American Medical Writers Association, Washington, DC, 1965

3.

American Medical Writers Association. Membership Directory. Last accessed 2/16/06 at http://www.amwa.org

4.

Hudson S, Gelderloos J, Vivirito M. Which comes first: the scientist or the writer? AMWA Journal. 2005;20(3):105-8

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European Medical Writers Association website. Last accessed 2/16/06 at http://emwa.org Subscribe free at http://www.firstclinical.com. © 2006 Susanna J Dodgson

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Drug Information Association website. Last accessed 2/16/06 at http://www.diahome.org

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Fossati Wood L. Personal communication, September 2005

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International Committee for Medical Journal Editors (ICMJE). Last accessed 11/10/06 at http://www.icmje.org

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Mathews AW. Ghost Story. Wall Street Journal. New York, N.Y.: Dec 13, 2005. p A1

10. Dodgson SJ. Plagiarism in the Pharmaceutical Industry. The Write Stuff. 2005;14(3):8790. Last accessed 2/16/06 at http://www.emwa.org 11. Biomedical Writing Program of the University of the Sciences in Philadelphia. Last accessed 2/16/06 at http://www.usip.edu/graduate/biomedwriting/index.shtml 12. University of Chicago Graham School of Journalism. Last accessed 2/16/06 at http://grahamschool.uchicago.edu/pdf/courses/MWECERT.pdf 13. University of the Sciences in Philadelphia Accreditation Statement. Last accessed 11/11/05 at http://www.usip.edu/graduate/pharmbiz/accreditation.shtml 14. Dodgson SJ. Evolution of clinical trials. The Write Stuff. In press. Will be accessible at http://www.emwa.org 15. Bates T, Anie A, Marusic M, Marusic A. Authorship Criteria and Disclosure of Contributions, Comparison of 3 General Medical Journals with Different Author Contribution Forms. JAMA. 2004;292(1):86-8 16. Mowatt G, Shirran L, Grimshaw JM, et al. Prevalence of honorary and ghost authorship in Cochrane reviews. JAMA. 2002 Jun 5;287(21):2769-71 17. Hamilton CW, Royer MG. AMWA 2002 Task Force on the Contributions of Medical Writers to Scientific Publications. AMWA Journal. 2003;18(1):13-16. Last accessed 2/16/06 at http://www.amwa.org 18. Jacobs A, Carpenter J, Donnelly J, et al; European Medical Writers Association's Ghostwriting Task Force. The involvement of professional medical writers in medical publications: results of a Delphi study. Curr Med Res Opin. 2005 Feb;21(2):311-6 19. Jacobs A, Wager E. European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications. Curr Med Res Opin. 2005 Feb;21(2):317-22. _____________________________________ Susanna J Dodgson, B.Sc.(Hons), Ph.D., is Professor of Biomedical Writing and Director of the Master of Science Biomedical Writing Program at the University of the Sciences in Philadelphia and a member of AMWA, EMWA and DIA. Contact her at (215) 596-8512 or s.dodgso@usip.


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