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Author! Author! Who Should Be Named in a Published Study? An Ethics Case Study CME

Sheryl Mitnick, RN, MPH; Michael Werner, JD

http://cme.medscape.com/viewarticle/714405

From American College of Physicians Ethics Case Studies

The Case

Doctors Perry and Robin are internist colleagues who would like to participate in the research endeavor, further their careers and serve as principal investigators for a diabetes study. Neither physician has ever conducted clinical research or been published in a professional journal. Their extensive clinical experience providing care for diabetic patients has motivated them to explore the possibility of developing an investigator-initiated trial in collaboration with Prescribe Rx, a pharmaceutical company that manufactures drug SGR. The physicians believe that drug SGR has the potential to reduce diabetes-related complications.

Dr. Robin arranges a meeting for himself and Dr. Perry with several Prescribe Rx executives whom he had met through his wife, the vice president for human resources at the company. The executives agree to provide the physicians with grant funding to conduct a pilot study. In addition, they agree that the company will provide the drug without cost to the participants. A research statistician employed by Prescribe Rx, Joan Smith, Ph.D., is assigned to provide support and guidance for the physicians in the conduct and analysis of the study.

Drs. Perry and Robin develop a protocol with the statistician's assistance. Dr. Perry recruits patients and other physicians to participate in the study while Dr. Robin hires additional staff to assist with clinical tasks and data management. They plan to collaborate on the analysis of the data and writing the manuscript.

Dr. Perry invites Dr. Harmon, a friend since medical school, to participate in the study. Dr. Harmon, an internist with a large diabetic population in her practice, is confident that Dr. Perry's involvement will result in a worthwhile effort and she agrees to recruit patients.

Drs. Perry and Robin each enroll patients onto the study and along with Dr. Harmon and the other physicians forward the data to the company statistician for analysis. They are encouraged by the preliminary results and are anxious to publish, both for the opportunity to contribute to their area of medicine and to gain respect from their colleagues.

The following year at their medical school reunion, Dr. Harmon asks Dr. Perry about the research study. Dr. Perry replies that Dr. Robin has recently informed him that although they wrote the paper together, the company statistician heavily edited Dr. Perry's work and therefore he does not meet the qualifications to be named as an author. Instead he will be listed as a contributor, along with many others, including Dr. Harmon. Dr. Robin will be listed as the sole author, even though Dr. Perry is fairly certain that the company statistician actually wrote the final version of the manuscript. Dr. Perry also expresses his discomfort with the fact that Dr. Robin has failed to disclose that his wife is employed by the pharmaceutical company that provided the drug, funding and statistical support. According to Dr. Perry, Dr. Robin has justified the omission with the explanation "My wife was not involved with the study."

On her way home from the reunion, Dr. Harmon thinks about her conversation with Dr. Perry. She wonders whether Dr. Robin is correct in excluding Dr. Perry from a position of authorship, whether Dr. Robin himself qualifies as an author of the article, and why the company statistician is not listed as a co-author. She also worries about having her name listed as a contributor on a publication in which an author's relationship with the pharmaceutical company is not fully disclosed. Dr. Harmon contemplates her obligation to report the potential misconduct and her options for raising her concerns about the publication of the research.

Commentary

The case study above illustrates several ethical concerns but this discussion will be limited to authorship and conflict of interest disclosure in biomedical publications. Accurate attribution of authorship and disclosure of potential conflicts and industry relationships in biomedical publications is an integral part of the ethical research process. The pharmaceutical industry has a vested interest in portraying products favorably by highlighting safety and efficacy through presenting attractive risk-benefit profiles. "Ghost management" has been described as the "systematic effort to control and shape multiple steps in the research, analysis, writing and dissemination of articles by pharmaceutical companies or their agents.^[1] "The use of peer-reviewed journals by the pharmaceutical industry has included designing, conducting and publishing studies primarily as a marketing tool.^[2-4] Industry-supported meta-analyses are reportedly less comprehensive in selection of studies included^[4] and more likely to endorse the experimental drug,^[5] despite results that are not statistically favorable.^[6,7] Industry use of ghostwriters and guest authors who have been recruited for their academic affiliations without fulfilling authorship criteria veils hidden agendas and masks conflicts of interest. Statisticians involved in protocol development and analysis or preparation of manuscripts are the most commonly excluded industry ghostwriter authors.^[1,8,9] Transparency of authorship and industry relationships, on the other hand, assists readers with evaluating research findings.

Authorship

Named authors must fit the three criteria detailed in the guidelines promulgated by the International Committee of Medical Journal Editors (ICMJE)^[10]: They are:

1. Substantial contributions to conception and design, 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.

According to ICMJE, all people who meet the three criteria should be named as authors, and only the people who fit the guidelines should be named as authors. Those who participate in the study but do not meet the requirements of authorship should be acknowledged as contributors.^[10] The American College of Physicians (ACP) and World Association of Medical Editors (WAME) have adopted these ICMJE guidelines pertaining to authorship.^[11]

Drs. Perry and Robin were equal partners in the study conception and design and together wrote the initial draft of the manuscript. The extensive revision by the company statistician, Dr. Joan Smith, does not diminish Dr. Perry and Dr. Robin's contribution. If the physicians approve the final version, both they and the statistician, should be named as authors.

The omission of the company statistician's name makes her a ghost writer.^[12] Ghost writers are sometimes employed by companies with a commercial interest in the research topic to shape the tone and content of the manuscript. Although ghost writers have significant control over how the information is presented, they take no responsibility for the study. Industry employees and contractors that meet authorship criteria must identify their role in the study as authors; to do otherwise is "dishonest and unacceptable.^[13]" Dr. Smith, the company statistician, participated in the study development, conducted the data analysis and had significant control over the manuscript and should therefore be listed as an author.

To minimize disputes, the WAME advocates that authorship assignments be worked out at the beginning of a study. If the authors are changed at any point, the change should be accompanied by a written request to the journal editor from all original authors explaining the change.^[13] Here, it appears that the doctors planned to co-author the manuscript from the beginning, and both names should still be listed. In addition, although the physicians did not anticipate that the statistician would have such an extensive role in the project, she meets the criteria and should be named a co-author. If researchers fail to delegate roles from the start, a good way for them to settle a dispute over authorship would be to submit a letter (or multiple letters) to the journal editor, detailing the situation and seeking advice regarding who should be named as an author in the final publication. Another possible alternative if the journal editor is unable or unwilling to settle the disagreement would be for the authors' sponsoring institution to resolve the authorship dispute.^[12]

Disclosure of Conflicts of Interest

All parties involved in a research study are ethically obligated to disclose all conflicts and any potential conflicts of interest.^[14] According to the ACP Ethics Manual, physicians conducting research must specifically disclose all financial interests.^[11] Readers have a right to know who had a financial stake in the outcome of the study, thus the funding source must be disclosed, and all researching and publishing parties must list their roles and interests in the study.^[12] Silence is not an acceptable method of conveying that there is no conflict of interest: all parties must actively state that there is no potential conflict of interest, or must declare the specific conflicts. In this case, it would be unethical for Dr. Robin to state that he has no relationships that could pose a potential conflict of interest, since his wife is an executive at Prescribe Rx.

While it may be true that Dr. Robin's connection to Prescribe Rx through his wife might not actually influence the study, he is nonetheless obligated to disclose this relationship. In this particular situation, Dr. Robin's wife, as vice president of human resources, would likely have no input on decisions regarding research and development funding. However, as a company employee, her compensation package in all likelihood includes stock options. Therefore, she (and in turn, Dr. Robin) could potentially benefit financially from positive study results that would raise the company's stock price. Therefore Dr. Robin would have an incentive to publish a favorable study.^[15]

The ethical course of action would be for Dr. Robin to disclose his wife's relationship with Prescribe Rx, and allow the journal editor and readers to decide whether the relationship poses a serious enough conflict of interest to potentially taint the study. Ultimately, it is not Dr. Robin's responsibility to determine whether or not the relationship influences the study, and he must disclose the relationship even if he firmly believes that it has no impact on the research.

Dr. Harmon's Responsibility

Because credit and responsibility are ethically inseparable,^[13] as a named contributor on the study, Dr. Harmon is jointly responsible for the integrity of the study's research. Now that she is aware of an undisclosed potential conflict of interest, which may or may not have influenced the study outcome, she should report it to the journal editor.

This is probably a difficult situation for Dr. Harmon because she did not solicit this information, and she may not even know Dr. Robin personally. She might suggest to Dr. Perry that he again raise the issue with Dr. Robin and encourage Dr. Robin to discuss it with the journal editor. Dr. Perry might be reluctant to confront Dr. Robin about this, in addition to the authorship status of himself and the company statistician. Alternatively, Dr. Perry could approach the journal editor with this information instead, as he has firsthand knowledge and was more closely involved in the research process. However, if Dr. Perry declines to report Dr. Robin's conflict of interest, Dr. Harmon shares responsibility for alerting the journal editor about both the ghost author and Dr. Robin's failure to disclose his relationship with the drug company.

References

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13. World Association of Medical Editors. WAME Policy Statements. http://www.wame.org/resources/policies (accessed December 14, 2009).
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