Developing good scientific publishing practices: one pharmaceutical company’s perspective

Abstract

Background:

The scientific publishing practices of the pharmaceutical industry have been heavily criticized in recent years due to the inherent conflict of interest that arises when a pharmaceutical company publishes findings around its own drugs.

Scope:

Eli Lilly and Company (‘Lilly’) strives for transparency in its day-to-day activities, and, here, shares its principles, policies and practices on publishing “Lilly-sponsored” research.

Findings:

A conflict of interest does not necessarily equate to biased presentation of research findings, and operating a successful, for-profit business and maintaining a focus on improving the health of patients are not mutually exclusive goals. There is, however, potential for bias, and it is incumbent upon a for-profit to develop publication principles, policies and practices to address this. To this end, Lilly’s Principles of Medical Research states that ‘Lilly discloses publicly all medical research results that are important to patients, healthcare providers or payers – whether favorable or unfavorable to a Lilly product – in an accurate, objective, and balanced manner …’ The preparation of publications of Lilly-sponsored research involves close collaboration between external (i.e., academic or otherwise non-industry employees) and Lilly scientific researchers (including scientific writers), with both serving as authors. Lilly does not support ‘ghost’ or ‘guest’ authorship. Authorship is not just recognition of contribution but also public acknowledgement of responsibility for content, and all authors are expected to take an active role in developing the manuscript in line with the International Committee of Medical Journal Editors-based authorship requirements. This is agreed to by authors before the manuscript is started. Lilly provides external authors with access to the trial data for manuscript development. Lilly does not pay external authors for their involvement in manuscript development. Scientific writers at Lilly, often with advanced scientific degrees, offer both scientific and writing expertise in manuscript development and play a project management role. Their role is transparent, and they are included as authors or appropriately acknowledged.

Conclusion:

Lilly has an ongoing commitment to appropriate publishing practices. Sharing company publication principles, policies and practices is one way to demonstrate this commitment and encourage and facilitate open dialogue among all those involved in drug development.

Key words::

• Authorship
• Conflict of interest
• Ghostwriting
• Guest authorship
• Pharmaceutical industry
• Scientific publishing

Transparency

Declaration of funding

This paper was prepared by employees of Eli Lilly and Company.

Declaration of financial/other relationships

All authors have disclosed that they are full-time employees and stockholders at Lilly.

Some peer reviewers receive honoraria from CMRO for their review work. The peer reviewers of this paper have disclosed that they have no relevant financial relationships.

Acknowledgment

The authors thank the following individuals for intellectual review. At Lilly: Steven Paul (former Executive VP Science and Technology and President of Lilly Research Laboratories); Tim Garnett (Senior VP Development Center of Excellence and Lilly Research Laboratories, and Chief Medical Officer); Donald Therasse (VP Global Patient Safety); Mark Lange (Assistant General Counsel); David Cox (Clinical Research Scientist); Anne Norris (Ethics and Compliance Consultant); Elcira Villarreal, Anita DuBois, Jeff Clemens, Joe Janssen and former-employee Michael Mihm (Scientific Communications). At Indiana University Purdue University (IUPUI): Eric Meslin, Director of the IU Center for Bioethics, Associate Dean for Bioethics and Professor of Medicine at IU School of Medicine. We thank Joe Janssen, Scientific Communications, Lilly, for providing the publications in which Lilly is involved in publishing.