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Research Article

Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints

  • Aaron S. Kesselheim mail,

    akesselheim@partners.org

    Affiliations: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, United States of America, Harvard Medical School, Boston, Massachusetts, United States of America

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  • Michelle M. Mello,

    Affiliation: Department of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts, United States of America

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  • David M. Studdert

    Affiliations: School of Law, University of Melbourne, Melbourne, Australia, School of Population Health, University of Melbourne, Melbourne, Australia

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  • Published: April 05, 2011
  • DOI: 10.1371/journal.pmed.1000431
  • Published in PLOS Medicine

About the Authors

Aaron S. Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, United States of America
Aaron S. Kesselheim
Harvard Medical School, Boston, Massachusetts, United States of America
Michelle M. Mello
Department of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts, United States of America
David M. Studdert
School of Law, University of Melbourne, Melbourne, Australia
David M. Studdert
School of Population Health, University of Melbourne, Melbourne, Australia

Corresponding Author

Email: akesselheim@partners.org

Competing Interests

ASK reports consulting for the Alosa Foundation, a nonprofit organization that runs the Independent Drug Information Service and is not affiliated in any way with any pharmaceutical company. From 2008–2009, ASK served as an expert witness for the state of Texas in a lawsuit against Merck related to improper promotion of rofecoxib (Vioxx). From 2007–2008, ASK helped develop an educational program to encourage evidence-based prescribing, with funding from a grant derived from the settlement of a fraud case regarding improper promotion of gabapentin (Neurontin).

Author Contributions

ICMJE criteria for authorship read and met: ASK MMM DMS. Agree with the manuscript's results and conclusions: ASK MMM DMS. Designed the experiments/the study: ASK DMS. Analyzed the data: ASK DMS. Collected data/did experiments for the study: ASK DMS. Wrote the first draft of the paper: ASK. Contributed to the writing of the paper: ASK MMM DMS. Contributed to the design of the study: MMM.