Under the Influence: The Interplay among Industry, Publishing, and Drug Regulation

ABSTRACT

The relationships among academe, publishing, and industry can facilitate commercial bias in how drug efficacy and safety data are obtained, interpreted, and presented to regulatory bodies and prescribers. Through a critique of published and unpublished trials submitted to the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval of a new antidepressant, vortioxetine, we present a case study of the “ghost management” of the information delivery process. We argue that currently accepted practices undermine regulatory safeguards aimed at protecting the public from unsafe or ineffective medicines. The economies of influence that may intentionally and unintentionally produce evidence-biased—rather than evidence-based—medicine are identified. This is not a simple story of author financial conflicts of interest, but rather a complex tale of ghost management of the entire process of bringing a drug to market. This case study shows how weak regulatory policies allow for design choices and reporting strategies that can make marginal products look novel, more effective, and safer than they are, and how the selective and imbalanced reporting of clinical trial data in medical journals results in the marketing of expensive “me-too” drugs with questionable risk/benefit profiles. We offer solutions for neutralizing these economies of influence.

KEYWORDS:

• Antidepressants
• clinical trials
• conflict of interest
• ghostwriting
• medical journals
• regulatory process

Acknowledgments

We would like to thank Emily Wheeler, Shannon Peters, Justin Karter, Akansha Vaswani, Chris Schuck, Madeline Brodt, and Bob Whitaker for their assistance and for their helpful comments and feedback.

Disclosure

L.C. is the principal investigator for an RO3 grant funded by AHRQ: R03HS022940-01A1. L.C. has no industry conflicts of interest. No other authors report any conflicts of interest.