Medical writing: vigilance for ethics

As of the beginning of this year, the American Medical Writers Association (AMWA) has added its code of ethics to membership application and renewal materials. New and renewing members are asked to indicate that they have read and accepted the principles of the code. The goal is to increase awareness of ethical principles and, it is hoped, to contribute to maintenance of high ethical standards among medical writers.

AMWA, despite its name, is an organisation of medical writers from not only the United States but also around the world. Its members come from a variety of disciplines, including academic, pharmaceutical, marketing and regulatory.

The code of ethics itself is not new. It was first developed in 1973 and revised in 1989, 1994, and 2008. The 1994 revision came in response to a Food and Drug Administration (FDA) guideline that proposed severe restrictions on industry-sponsored medical writers. AMWA worked with the regulators to educate them on what medical communicators actually do and also strengthened the code of ethics by adding wording about “scientific rigour” and “fair balance.”

The code, intentionally brief, consists of a preamble that explains the role of AMWA in promoting excellence in medical communication, followed by eight principles to be applied in developing materials in the various media in which medical writers work. Among the principles are recognition and observance of applicable statutes and regulations; application of objectivity, scientific accuracy and rigour; maintenance of the highest professional standards, whether or not the materials they develop fall under the purview of any regulatory agency; and insistence on conditions that allow them to properly apply their own judgment and skills, with refusal to participate in assignments that require unethical or questionable practices. Additional principles include professional development, respect for the confidentiality of materials provided by clients, and expectation and acceptance of fair remuneration of and acknowledgment for their services.

AMWA will not enforce adherence to the code of ethics, and the organisation does not encourage individuals to become “ethics police.” Its goal is rather to increase awareness of ethical issues and principles.

Ethical issues are also addressed by AMWA’s sister organisation, the European Medical Writers Association (EMWA, www.emwa.org). EMWA includes on its website its own guidelines on the role of medical writers in developing peer-reviewed publications. The guidelines include the importance of respecting and acknowledging the role of medical writers in the development of scientific publications.

American Medical Writers Association (AMWA) Annual Conference 2008

Under the title “Setting the Pace,” the American Medical Writers Association (AMWA) held its 68th Annual Conference on October 23–25 in horse country, Louisville , Kentucky . More than 1000 medical communicators with a wide range of expertise and interests attended. This year, AMWA offered a full programme of 97 certificate and non-certificate workshops, as well as 38 open sessions in which panels of experts addressed issues of concern to present and potential medical writers.

The Walter C. Alvarez Award, for excellence in communicating healthcare developments and concepts to the public, went to T.L. (Tedd) Mitchell , MD , President and Medical Director, The Cooper Clinic, Dallas Texas . His witty and entertaining address was, “Move Yourself: Getting Americans Back on the Path to Good Health.” Mitchell tweaked the host state for the conference, noting that it has the highest tobacco consumption in the United States . In an illustration of absurdity, he showed a picture of men using the escalator rather than the stairs on their way to a gym, ostensibly for exercise. Another showed before-and-after pictures of Michelangelo’s David; “before” was the familiar slim young man, and “after” was an electronically altered image showing a chubby, middle-aged man with voluminous love handles. Mitchell presented a series of charts documenting the epidemic of obesity and other health problems. His message was clear: we all need to take individual action to maintain our physical fitness and reduce the risk of serious, preventable health problems.

AMWA’s highest award, the Harold Swanberg Distinguished Service Award, for major contributions to medical communication and the medical profession, went to Norman Grossblatt, the man behind the Board of Editors in the Life Sciences (BELS) exam for editors. Grossblatt’s speech was a reminiscence called, “A Life in the Day of a Manuscript Editor” (no, that’s not a typo!) that recounted the many technological changes that have advanced the editing process over recent decades. From the days of handwritten mark-ups of paper manuscripts he recalled the development of early copy machines yielding pages that were of questionable quality and quickly became brittle and discoloured. (And how many people remember the purple mimeograph?) Since those days, tremendous technological advances, such as the replacement of typewriters by computers, have eliminated much of the paper and speeded the review process, with reviewers able to review manuscripts entirely on screen and circulate their comments instantly via e-mail. The result is a process that is vastly different from that of a few decades ago. On the other hand, the current process still requires real human beings to do the actual editing.

Further information about AMWA can be found at www.amwa.org .

AMWA Annual Conference 2007

Under the title Legacy of Leadership, the American Medical Writers Association (AMWA) held its 67th Annual Conference on October 11–13 in Atlanta, Georgia. About 1000 medical communicators of all stripes attended. As always, AMWA offered a full programme of 95 certificate and non-certificate workshops, as well as 43 open sessions in which panels of experts addressed issues of concern to present and potential medical writers. Of note, AMWA launched its new science fundamentals certificate programme.

Formal banquets provided the setting for presenting key AMWA awards. The John P. McGovern Medal, for pre-eminent contributions to medical communication, was awarded to Julie L. Gerberding, MD, MPH, Director of the Centers for Disease Control and Prevention (CDC). In Dr. Gerberding’s absence, Steven L. Solomon, MD, Director of the Coordinating Center for Health Information and Service at CDC, accepted the award on her behalf. He then spoke of the challenges and opportunities of communicating science “in a flat world where information is perpetual, pan-global, participatory, personalised, and portable, as well as sometimes unedited, uncredentialled, unverified, untruthful, and unethical.”

The Walter C. Alvarez Award, for excellence in communicating healthcare developments and concepts to the public, went to Jeffrey P. Koplan, MD, MPH, Vice President for Academic Health Affairs at the Woodruff Health Sciences Center, Emory University in Atlanta. Dr. Koplan discussed major health challenges such as avian flu and obesity that threaten all nations and showed how working with people in other parts of the world is yielding solutions to common health problems.

AMWA’s highest award, the Harold Swanberg Distinguished Service Award, for major contributions to medical communication and the medical profession, went to Elliott Churchill, MS, MA, President of A World of Words. Churchill spoke of “mountains, molehills, and memories”, describing her long career as Senior Communications Officer at CDC, which included work with local physicians and other healthcare professionals in more than 90 countries.

Many of the workshops and open sessions focused on the nuts and bolts of medical writing and preparation of regulatory documents, training materials, and other types of documents. However, workshops also addressed principles of pharmacoeconomics, as well as ethical standards. Open sessions included public health challenges in an era of global connectivity and communication revolution; the twin epidemics of obesity and diabetes; predictive health (a novel paradigm for disease prevention); emergency health care: an emerging national crisis; health care on the margins: reaching out to the disenfranchised; and heart disease in women and AHA’s guidelines for cardiovascular disease prevention in women.

Further information about AMWA can be found at www.amwa.org.

Robert Hand is a former president of the Delaware Valley Chapter of AMWA.