Article in Search of an Author: Exciting Collaboration or Unethical Conduct? (with Facilitator Guidance) Case inspired by the true story of Adriane Fugh-Berman1 Case written by Marin Gillis, LPh, PhD, Director of Medical Humanities and Ethics University of Nevada School of Medicine Judy Hanrahan, MA University of Nevada, Reno 1 A. Fugh-Berman. (2005). The corporate coauthor. Journal General Internal Medicine, 20: 546-48. References The following list contains resources cited in the facilitator’s guidance sections of this case and other useful references. American Association of Medical Colleges (AAMC). (2008). Report on industry funding of medical education. AAMC Press: Washington, DC. Elliott, C. (2004). Pharma goes to the laundry: Public relations and the business of medical education. The Hastings Center Report, 34(5): 18-23. Flanagan, A. et al. (1998). Prevalence of articles with honorary authors and ghost authors in peer reviewed medical journals. Journal of the American Medical Association, 280(3): 222-24. Fugh-Berman, A. (2005). The corporate coauthor. Journal General Internal Medicine, 20: 546-48. Healy, D., & Cattell, D. (2003). Interface between authorship industry and science, in the domain of therapeutics. British Journal of Psychiatry, 183: 23-27. Institute on Medicine as a Profession. (2010). Conflicts of interest resources. <http://www.imapny.org/>. Martinson, B.C., Anderson, M.S. and de Vries, R. (2005). Scientists behaving badly. Nature 43: 737-38. Mathews, A. (Dec 13, 2005). Ghost story: At medical journals, writers paid by industry play big role. The Wall Street Journal. Moffatt, B. & Elliott, C. (2007). Ghost marketing: Pharmaceutical companies and ghost written journal articles. Perspectives in Biology and Medicine, 50: 18-31. Petersen, M. (Nov 22 2002). Madison ave. has growing role in the business of drug research. New York Times. Smith, R. (2005). Medical journals are an extension of the marketing arm of pharmaceutical companies. PLoS Med 2(5): e138. Page 1 You are a physician practicing internal medicine at a prominent academic medical center who is becoming a leader in the field of translational malaria research, having published in mid and top tier medical journals. You have been approached by a private Medical Education and Communications Company (MECC) to review an article on the negative side effects of chloroquine (AralenTM), quinine sulfate (QualaquinTM), and hydroxychloroquine (PlaquenilTM). Facilitator Guidance: Discussion Topics Private Medical Education and Communications Companies (MECCs): Companies hired by pharmaceutical and medical device firms for medical public relations (more about these firms on the next page). Questions for Students What is translational research? What should you be suspect of? Is it common for academics to be asked to review articles? For whom does one commonly review? Answer: It is part of the duty of professional academics to review articles and books for students and colleagues, journals, conferences, and publishers. This can be a formal or informal process; the formal process is known as peer-review (see a more detailed discussion of peer-review on the next page). Page 2 In a subsequent phone call from a company associate, you are offered a $5,000 honorarium and the opportunity to have your name listed as first author. The representative also lists the journals in which they believe the article would likely be published; you are impressed by the list. The article is accurate and well-written, and since you are in an academic medical center, having a peer-reviewed publication in a prestigious journal would be helpful for career advancement. Facilitator Guidance: Discussion Topics Ghostwriting: MECCs typically produce drafts of articles specified to order by their client. Academics serve as ‘authors’ and are usually given an honorarium for this ‘service.’ When the article appears in the journal the academic is listed as the author, and the contributions of the real authors, from the MECC, are not disclosed. The real authors working for the MECC are the ‘ghostwriters.’ The MECC may charge the pharmaceutical company or device manufacturer up to $30,000 per article. Free-lance ghost authors are paid approximately $90-120 per hour. Peer-review: The peer-review process is a formal review process that is implemented by publishers and academic conference organizers. It is rare to be remunerated for reviewing an article; however, it is common to receive a small remuneration for doing a review of book length projects. In reviewing an article or book, one makes editorial and even more substantial suggestions/revisions to the manuscript. In the case of journals, books and conferences, the manuscript usually has 2-4 reviews. A decision is made whether to publish the article/book or include the article on the conference program based on these reviews. Career advancement, tenure: Explain to students the career advancement/tenure system in academic medicine. Conflict-of-interest: See resources at the Institute of Medicine as a Profession. Pros and cons of industry/university collaboration: Pros—funding, resources, innovation, cutting-edge research, manufacturing. Cons—because of patents knowledge sharing and scientific collaboration are risked, diversion of faculty from teaching, research direction directed externally, career development delays for post-docs and fellows. Culture of scientific research: Intrinsic value of science and the need for truth and disclosure in the scientific method. Questions for Students What should you do? Is there anybody at our institution to talk to? Is there anybody outside of our institution? Where are there policies regarding ghostwriting (regional, national, institutional level, and specialty-specific)? Discuss how conflicts of interest compromise scientific integrity. Answer: Collaborations are disguised and used for pharmaceutical marketing not for the advancement of science. Page 3 You are immediately suspect, and approach your mentor who informs you that the MECC has a standing contract with Bristol–Leyers-FibbTM who have recently developed an artemisinin-derived pharmaceutical that would be directly competing with the treatments described in the paper. She also informs you about the medical center’s research integrity policy. Your academic medical center follows the AAMC policy recommendations found in the “Report on Industry Funding of Medical Education” (2008) which states, “Academic medical centers should prohibit physicians, trainees, and students from allowing their professional presentations of any kind, oral or written, to be ghostwritten by any party, industry, or otherwise” (p. 8). You decline the company’s offer. Facilitator Guidance: Discussion Topics Mentoring: Discuss how to find a mentor and the importance of mentoring. Specific conflict of interest policy at host academic medical center/hospital/university Ghostwriting harms: Harmful to public health (e.g., VioxxTM), ghostwritten articles almost always contain undisclosed conflicts of interest, and undermine science (research appears to come from a disinterested source, negative data hidden, scientific record corrupted). Questions for Students Why is ghostwriting in science wrong? Why do pharmaceutical companies hire MECCs to find authors for their research articles? Answer: A review article is written by the MECC to evaluate the current state of a particular issue, disease, or therapy (Brennan 1994), here the negative side effects of current treatment options for malaria, but not those of the new drug/device manufactured by the pharmaceutical company that has hired the MECC. In this case the article reviews the negative side effects of alternative treatment options. A well-respected expert in the field is recruited as the author, and the well-written ghost article is published by a prestigious journal. Pharmaceutical reps will distribute the journal reprints to physicians as part of their marketing campaign. The prominence of the author and journal serve as an independent, unbiased, authority. “The quality of the journal will bless the quality of the drug,” former BMJ Editor-in-chief, Richard Smith (2005). How common do you think this practice is? Answer: Conservative benchmarks for ghostwriting of papers published in biomedical journals is roughly 10% (Mathews 2005). In one study 10.8% of all early and midcareer scientists admitted to “inappropriately assigning authorship credit” at least once in the past three years (Martinson, Anderson, and de Vries 2005). Finally, a study in JAMA found evidence of ghostwriting in 11% papers when looking at six leading journals (Flanagan 1998). Page 4 Some months later, you are surprised to see the name of an old friend of yours from residency as first author of a review article on malaria treatment side effects in Malaria in Review, a top tier medical journal. Your interest piqued, you flip to the article only to find the exact article you were asked to ‘review’ by the medical communications firm. Facilitator Guidance: Discussion Topics None identified Questions for Students What do you do? Does it matter that it is someone you know? Page 5 You call your friend and voice your concerns. He does not understand your complaint and claims that he made substantial contributions to the article after it was offered to him by the same MECC that contacted you. Since you have the original article you are able to discern that in fact there were only minor revisions made. You decide to write a formal business letter to the editor of the journal to explain that you suspect scholarly misconduct and why scholarly misconduct should be taken seriously by the journal. Facilitator Guidance: Discussion Topics Difficult conversations: Discuss strategies for initiating difficult conversations. Questions for Students How should you start the conversation with your friend? How in-depth should your conversation with your friend from residency be? Should you tell him that you know only minor revisions were made to the article? Do you accuse him of attributing false authorship to himself? Do you let him know that you plan on writing a letter to the editor? What is a major revision? What is a minor revision? Answer: Minor revisions include text corrections to fix mistakes and/or make the writing flow better (e.g., syntax, diction, punctuation), but do not alter the argument of the manuscript. Page 6 In Class Group or Take Home Assignment Produce a formal business letter to the editor of Malaria in Review, explain that you suspect scholarly misconduct and why scholarly misconduct should be taken seriously by the journal. Your letter should be 1 – 1½ pages. Editor’s Address: Jane Addams, MD, PhD, FACP Editor-in-Chief Malaria in Review c/o Malaria in Review PO Box 1492 Chicago, IL 60608 You have retained the following (which you need not produce): Letter asking you to review the article A copy of the article you were originally asked to review Your letter declining to be listed as an author Facilitator Guidance: Do an Internet search for “Business Letter Format” and have the students follow the format of your choice. Page 7 Grading Checklist ID Number: I. Word Count: Style (block, modified block, or semi-block: Policies 1. Have I abided by the UNSOM honor pledge and the UNR academic dishonesty policy when I wrote my letter? Yes No 2. Is this letter my original work? Yes No 3. Am I handing my letter in on time? Yes No 4. Is my letter the appropriate length? Yes No 5. Is my letter written in complete English sentences? Yes No 6. Is my letter on topic? Yes No 7. Is my letter grammatical, properly punctuated, and written in prose appropriate for a formal business letter? And, have I spellchecked and proofread my entire letter? Yes No Yes No Yes No 10. Am I courteous/respectful when addressing other’s views? Yes No 11. Have I named the document containing this checklist and my letter appropriately? Yes No 12. Have I included the date, sender’s address, & inside address? Yes No 13. Is the salutation properly addressed & punctuated (i.e., Dr. Juan Williams:)? Yes No 14. Is my paper consistently formatted in either block, modified block, or semi-block format? Yes No 15. Have I used black text and a legible font size (10 pt or 12 pt)? Yes No 16. Are the body and closing of my letter written properly (i.e., first paragraph has a friendly opening and a statement of the main point, second paragraph begins to justify the importance of the main point, followed by continued justification, etc.)? Yes No 17. Have I properly listed the enclosures? Yes No 8. Where appropriate have I included a citation in the format listed above for each quotation, reference or paraphrase in the letter? Leave blank if you have no quotations, references or paraphrases. 9. Is my writing clear and straightforward, and concise? II. Formatting