Lisa DeTora, PhD, MS, Hofstra University; Faith DiBiasi, BSc, MBA, AstraZeneca; Laura Dormer, BSc, Becaris; Eline Hanekamp, PhD, Excerpta Medica; Dikran Toroser, PhD, Merck & Co., Inc.; Leslie Citrome, MD, MPH, New York Medical College
Can we pay authors for work that leads to a publication? This is a pressing question often faced by medical publication professionals. Good Publication Practice 2022 (GPP 2022) and its predecessors provided guidance on author payments. New questions on author payments and corresponding GPP 2022 guidance are addressed here, as well as further explanation of GPP 2022 wording and expanded scope compared with earlier GPP iterations.
Several GPP 2022 authors prepared this article to offer clarity. Frequently Asked Question (FAQ) responses issued by the GPP 2022 authoring team are also available for reference, and provide greater detail on specific actions that medical publication professionals can take.
Key points
- GPP 2022 does not change earlier GPP guidance regarding compensation or reimbursements to authors.
- Given the expanded scope of GPP 2022 relative to GPP3, new wording was inevitable regarding many topics, including author payments.
- Corporate integrity agreements and legal frameworks create important frameworks as to whether or how compensation may be offered to a publication author for different kinds of work.
History of a problem
Payments related to publications of company-sponsored research, especially those associated with authorship, have been an area of concern and debate for decades. Incidents of ghostwriting became headline news in the early 2000s.[i] In 2010, Senator Charles Grassley led an investigation and report on Ghostwriting in Medical Literature,[ii] which highlighted the lack of transparency in medical publications of company-sponsored studies and called into question associated ethical practices. In this environment, the Office of the Inspector General issued corporate integrity agreements (CIAs) to pharmaceutical companies to ensure compliance with various polices and regulations. CIAs remain a significant enforcement tool for publication ethics in the US.
Eight CIAs issued to pharmaceutical companies between 2009 and 2012 specifically addressed publication practices.[iii] Resulting fines levied and process controls imposed on offending parties were a significant factor that led pharmaceutical companies to stop paying authors for their time when working on sponsored papers. Companies did not want to be accused of influencing an author’s thinking or to be seen as rewarding prescribing practices by paying a physician to work on publications. The strategy of not paying authors to draft or review publications was considered conservative and thought to be the safest approach to minimize the potential for introducing bias into the medical literature. Making sure that authors met authorship criteria, avoiding undue influence, and disclosing writing support and any author conflicts of interest were mandated in some CIAs and were formally adopted by other companies.
Eight CIAs issued to pharmaceutical companies between 2009 and 2012 specifically addressed publication practices. Resulting fines levied and process controls imposed on offending parties were a significant factor that led pharmaceutical companies to stop paying authors for their time when working on sponsored papers.
The original Good Publication Practice (GPP) guideline,[iv] published in 2003, considered practices related to publications of clinical studies, a focus that continued in GPP2 and GPP3. Each of these guidelines commented on the impropriety of ghostwriting and of paying authors to lend their names to work they did not write. Over time, this language may have become conflated with the conservative position of not compensating authors for time spent on publications that was prompted by CIAs.
GPP 2022 differs in scientific scope from prior GPP iterations by addressing biomedical publications beyond clinical studies and including stakeholders, such as patients, not previously discussed in GPP guidance.
The Good Publication Practice Guidelines for Company-Sponsored Biomedical Research: 2022 Update (GPP 2022) differs in scientific scope from prior GPP iterations by addressing biomedical publications beyond clinical studies and including stakeholders, such as patients, not previously discussed in GPP guidance. Questions have arisen regarding changes in language related to author reimbursements and compensation presented in GPP 2022 in the light of this expanded scope. To be clear, GPP 2022 does not take a new position on author reimbursements and compensation as compared with prior GPP iterations.
To be clear, GPP 2022 does not take a new position on author reimbursements and compensation as compared with prior GPP iterations.
GPP 2022: implications of the current guidance
Elizabeth Wager, who served as an author on GPP, GPP2, and GPP3, has explained that the original intention of language about “author payments” in GPP2[v] and GPP3[vi] was to prevent unethical practices, such as paying experts to lend their names to ghostwritten papers or providing payments far exceeding fair market value to entice experts to inappropriately support work (https://www.youtube.com/watch?v=QYhWaEO-7Bk). The GPP 2022 text was developed to clarify this point, as well as to better encompass its larger scientific scope and the expanding role of patients and other stakeholders in the publication of company-sponsored research. There were no changes in any basic requirements or philosophy as it relates to compensating or reimbursing authors for time spent on publications activities from GPP3 to GPP 2022. However, it was inevitable that new language should be developed in line with the expansion of GPP 2022 to cover biomedical publications generally and not only clinical studies.
Importantly, it is not permissible to violate a CIA or to otherwise contravene applicable laws or institutional policy, and GPP 2022 indicates that laws must be respected. However, the ethical principles inherent to GPP 2022 do not prohibit compensation to authors, including patient authors. Since it is permissible to compensate authors, including patient authors, for various activities without violating the ethical principles inherent to GPP 2022, medical publication professionals must consult applicable legal agreements and limitations. To be clear, if any monetary compensation is deemed appropriate and is offered to authors for participation in publication-related activities, the compensation must be set at a fair market rate and must be transparently disclosed as required by law or journal or conference guidelines.
The nature of guidelines means that GPP 2022 cannot require sponsors to offer compensation for time spent in writing or reviewing manuscript drafts or making nominal critical comments. Similarly, patients, patient advocates, government employees, or academics are not required to accept monetary or other compensation offered in the context of publication activities, even if that compensation is nominal or at a fair market rate. For example, patients who receive financial assistance from other sources may not be able to accept such payments. Each company and author must make reasonable and ethical decisions in the context of their own legal, professional, and institutional circumstances and policies. Companies may engage in other practices, like making donations in the name of publication authors to patient advocacy groups or other charitable organizations, should authors be unable to accept payment.
If any monetary compensation is deemed appropriate and is offered to authors for participation in publication-related activities, the compensation must be set at a fair market rate and must be transparently disclosed as required by law or journal or conference guidelines.
Investigators and patient authors may be invited to design new data analyses or engage in other work in conjunction with a publication plan. In such cases, some attention should be paid to usual practice for payment for such work, whether directly to the individual or that individual’s employer, as applicable. If an independent consultant or steering committee member would normally be compensated for performing such work, then it is not unreasonable for an academic investigator or a patient participant to expect to be treated equitably within the framework of their institution’s policies and procedures.
Facing the future
As the publication profession becomes more complex and engages with more stakeholders and as novel communication opportunities arise, author payment considerations are likely to also become increasingly complex and will remain an area of active discussion. Of course, expectations and policies regarding many aspects of publication ethics have evolved over time, and GPP has advanced as well from the original publication in 2003, to its current iteration, GPP 2022.
Since its founding, ISMPP has been a driving force for improving publication processes and fostering constructive consideration of publication ethics, in line with other organizations. We strongly encourage members of the ISMPP community to reach out to the GPP 2022 Steering Committee (gpp2022@ismpp.org) with questions and concerns and to continue to engage in thoughtful debates about these matters.
[i] DeTora LM, Carey MA, Toroser D, Baum EZ. Ghostwriting in biomedicine: a review of the published literature. Curr Med Res Opin. 2019 Sep;35(9):1643-1651. doi: 10.1080/03007995.2019.1608101. Epub 2019 May 22.
[ii] Grassley C. Ghostwriting in Medical Literature. Minority Staff Report. Washington (DC): US Senate; 2010 Jun 24. Retrieved 24Feb2024 from https://www.grassley.senate.gov/imo/media/doc/Senator-Grassley-Report.pdf.
[iii] Rodino FJ. Corporate Integrity Agreements: What They Say About Publications, Publication Planning, Transparency, and ICMJE. Ther Innov Regul Sci. 2013 Jan;47(1):50-56. doi: 10.1177/2168479012470648.
[iv] Wager E, Field EA, Grossman L. Good publication practice for pharmaceutical companies. Curr Med Res Opin. 2003;19(3):149-54. doi: 10.1185/030079903125001767.
[v] Graf C, Battisti WP, Bridges D, et al. for the International Society of Medical Publication Professionals. Good publication practice for communicating company sponsored medical research: the GPP2 guidelines. BMJ 2009;339:b4330. doi: 10.1136/bmj.b4330.
[vi] Battisti WP, Wager E, Baltzer L, Bridges D, Cairns A, Carswell CI, Citrome L, Gurr JA, Mooney LA, Moore BJ, Peña T, Sanes-Miller CH, Veitch K, Woolley KL, Yarker YE; International Society for Medical Publication Professionals. Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3. Ann Intern Med. 2015 Sep 15;163(6):461-4. doi: 10.7326/M15-0288.