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Inside Research Ghostwriting Prevalence Among AMWA and EMWA Members (2005 to 2014) Volume 31 Number 1 / Spring 2016 WWW.AMWA.ORG ELECTRONIC EDITION Inside Research Ghostwriting Prevalence Among AMWA and EMWA Members (2005 to 2014) Meta-analyses: Merits, Limitations, and Application of the PRISMA Statement Practical Matters Ensuring an Effective Quality Control Process What Medical Writers Should Know About Drug Access/Reimbursement in the United States and Preparation of AMCP Dossiers THE OFFICIAL JOURNAL OF THE AMERICAN MEDICAL WRITERS AssOCIATION, THE RESOURCE FOR MEDICAL COMMUNICATORS AMWA ENGAGE Connect and Collaborate Join Discussions Share Resources Get Engaged AMWA COMMUNITY engage.amwa.org Register Early for Best Rates Medical Writing & The preeminent education 2016 Communication and networking event Conference for medical writers and AMWA communicators. OCTOBER 5-8|DENVER, CO Trends and Opportunities for Medical Communicators www.amwa.org/conference V31 N1 50 SPRING 43 Confidence limit Contents 2016 40 95% CI 33 Point estimate 30 90% CI 25 Confidence limit 20 99% CI 10 RESEARCH Responders Percent 3 28 Ghostwriting Prevalence Among AMWA and EMWA 0 Members (2005 to 2014) � Cindy W. Hamilton and Adam Jacobs 12 Meta-analyses: Merits, Limitations, and Application of the PRISMA Statement � M. Denise Daley 20 PRACTICAL MATTERS Ensuring an Effective Quality Control Process � Lima Chutkan What Medical Writers Should Know About Drug Access/ 24 Reimbursement in the United States and Preparation of AMCP Dossiers � Linda L. Rice and Jessie Wolfe Galson 30 28 YOUR STATS REFRESHER! Confidence Intervals � Thomas M. Schindler 30 SOCIAL MEDIA Tips for Searching Social Media � Cynthia L. Kryder 32 2016 CONFERENCE PREVIEW New for 2016: AMWA’s Medical Writing & Communication Conference � Yeshi Mikyas 34 AMWA NEWS From the President � Stephen N. Palmer 32 AMWA’s First Class of Certified Medical Writers In Memoriam: Guy Whitehead, PhD, 1920–2016 � Flo Witte Past Presidents of AMWA Remember Guy Whitehead AMWA Education Now Includes AMWA Online Learning � Kristina Wasson-Blader 36 V31 N1 / 2016 MORE Contents EDITOR Victoria J. White, MA, ELS SECTION EDITORS Around the Career Block Hilary Graham, MA 39 BOOK REVIEWS Commonplaces Lora Arduser, PhD The Malaria Project: The U.S. Government’s Secret Media Reviews Ruth Taswell, MA Mission to Find a Miracle Cure Practical Matters Julie Ravo Regulatory Insights Jennifer Grodberg, PhD, RAC (US) � Reviewed by Karen Potvin Klein Science Series MaryAnn Foote, PhD After You Hear It’s Cancer: A Guide to Navigating Social Media Cynthia L. Kryder, MS, CCC-Sp the Difficult Journey Ahead Your Stats Refresher! Thomas M. Schindler, PhD, MA � Reviewed by Nicole M. Van Hoey REGULAR CONTRIBUTORS Freelance Forum Brian Bass, MWC Health Trackers: How Technology Is Helping Us Melissa L. Bogen, ELS Monitor and Improve Our Health Sherri Bowen, MA, ELS � Reviewed by Ananya De Lori De Milto, MJ Cherie Dewar Cathryn D. Evans 42 FREELANCE FORUM Debra Gordon, MS � Brian Bass, Melissa L. Bogen, Lori De Milto, Cathryn D. Donna L. Miceli Evans, Elizabeth L. Smith, and Ruwaida Vakil Phyllis Minick Elizabeth L. Smith Do you specialize in freelance medical writing in Ruwaida Vakil, MS, Editor any particular way, such as by therapeutic area, In the Service of Good Writing Laurie Endicott Thomas, MA, ELS industry, or types of projects? EDITORS AT LARGE Elizabeth Gardner, ELS Is it easier to find business if you are a freelance Jennifer Minarcik, MS medical editor or a freelance medical writer? Peggy Robinson, ELS What tips to do you have for a new freelance EDITOR EMERITUS Lori Alexander, MTPW, ELS, MWC trying to build a portfolio of samples? EDITOR IN MEMORIAM Ronald J. Sanchez 2015–2016 PRESIDENT Stephen Palmer, PhD, ELS 2015–2016 PUBLICATIONS 46 IN THE SERVICE OF GOOD WRITING ADMINISTRATOR Ann Winter-Vann, PhD EXECUTIVE DIRECTOR Susan Krug, CAE What Does Therefore Mean? GRAPHIC DESIGNER Amy Boches, biographics � Laurie Endicott Thomas EDITORIAL OFFICE: [email protected]. Abbreviated instructions for 48 CALENDAR OF MEETINGS authors are available in this issue, with more detailed instructions available at: www.amwa.org/journal. ADVERTISING: Contact Laura Gaenzle at [email protected]; (717) 430-2351. All advertising is subject to acceptance by AMWA and should be for products and services relevant to professional medical communicators. AMWA AMWA JOURNAL MISSION STATEMENT is not responsible for the content of advertising and does not endorse any advertiser or its products or services. The AMWA Journal expresses the interests, concerns, and SUBSCRIPTION: The AMWA Journal is published quarterly. Subscription is included expertise of members. Its purpose is to inspire, motivate, with AMWA membership. Nonmember subscriptions cost is $75 per year. inform, and educate them. The Journal furthers dialog CONTACT: American Medical Writers Association, 30 West Gude Drive, #525, Rockville, MD 20850-4347. Phone: (240) 238-0940; Fax: (301) 294-9006; among all members and communicates the purposes, Email: [email protected]. goals, advantages, and benefits of the American Medical The AMWA Journal is in the MLA International Bibliography and selectively indexed in Writers Association as a professional organization. the Cumulative Index to Nursing and Allied Health Literature (CINAHL) print index, the CINAHL database, and the Cumulative Index of Journals in Education (CIJE). The opinions expressed by authors contributing to the Journal do not necessarily reflect the opinions of AMWA or the institutions with which the authors are affiliated. The association accepts no responsibility for the opinions expressed by contributors to the Journal. ©2016 American Medical Writers Association. All rights reserved, worldwide. ISSN 1075-6361 CH R RESEA Ghostwriting Prevalence Among AMWA and EMWA Members (2005 to 2014) By Cindy W. Hamilton, PharmD, ELS,a and Adam Jacobs, PhDb aVirginia Commonwealth University School of Pharmacy, Richmond, VA, USA and Hamilton House Medical and Scientific Communications, Virginia Beach, VA, USA; bPremier Research, Wokingham, UK ABSTRACT Introduction: Ghostwriting, defined as undisclosed substantial “A lack of transparency results in distrust contributions by medical writers, is considered to be unethi- and a deep sense of insecurity.” cal by the American Medical Writers Association (AMWA), the —Dalai Lama European Medical Writers Association (EMWA), and other pro- fessional associations. Methods: To determine the prevalence of ghostwriting among hostwriting, defined as undisclosed substantial con- medical writers coincident with educational campaigns, we tributions by medical writers to manuscripts pub- initiated a Web-based, self-administered, confidential survey lished in medical journals, has long been recognized G 1 of AMWA and EMWA members in 2005 and repeated it in 2008, as unethical. Without transparency, readers are denied the 2011, and 2014. We focused on manuscripts to which survey opportunity to judge the potential influence by groups with participants had made substantial contributions and now special interests and other conflicts. Allegations of bias and report final findings from all surveys. other transgressions have a domino-like effect and tarnish not Results: The number of participants with valid data was 843 only the reputations of medical communicators but also the in 2005, 773 in 2008, 620 in 2011, and 410 in 2014. The mean entire profession of medical communication as well as their weighted percentage of manuscripts with undisclosed con- sponsors.2-4 tributions was 61.8% (95% confidence interval [CI], 59.0% to During the last 10 to 15 years, professional and trade orga- 64.6%) in 2005, 41.7% (95% CI, 38.6% to 44.7%) in 2008, 33.0% nizations representing medical writers, journal editors, and (95% CI, 29.7% to 36.3%) in 2011, and 34.4% (95% CI, 30.2% to the pharmaceutical industry have attempted to clarify and 38.5%) in 2014. In univariate analyses, participants familiar with expand authorship guidelines, including how to distinguish more authorship guidelines were less likely to have undisclosed the legitimate role of professional medical writers from that contributions; regression coefficients ranged from -6.6% (95% of ghostwriters. For example, the American Medical Writers CI, -8.5% to -4.8%) in 2005 to -10.6% in 2014 (95% CI, -13.1% to Association (AMWA) adopted a position statement on the -8.0%; all P values <.001). contributions of medical writers to scientific publications in Conclusions: The 44% decrease in the rate of manuscripts with 2002,5 and the European Medical Writers Association (EMWA) undisclosed contributions between 2005 and 2014 is encour- published more detailed guidelines in 2005.6 In 2005, the aging, but the 34% rate of ghostwriting among medical writers International Society of Medical Publication Professionals remains unacceptable. While these findings should not be gen- (ISMPP) was founded to enhance medical publication integ- eralized to the overall prevalence of ghostwriting in the litera- rity and transparency and to improve standards and best ture (because survey participation was restricted to AMWA and practices. Recently, ISMPP supported the development and EMWA members who made substantial contributions to manu- publication of the third version of the Good Publication scripts), our findings suggest the need for further collaborative Practice (GPP3) for communicating industry-sponsored efforts to promote transparency and to conduct research about research.7 The International Committee of Medical Journal how to achieve best practices in medical
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