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30 - Financial conflict of interest in medical research

Published online by Cambridge University Press:  30 October 2009

Trudo Lemmens
Affiliation:
Associate Professor University of Toronto Canada
Lori Luther
Affiliation:
Faculty of Law University of Toronto Canada
Peter A. Singer
Affiliation:
University of Toronto
A. M. Viens
Affiliation:
University of Oxford
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Summary

Dr. H is an expert on the treatment of depression. A pharmaceutical company, Calaxy Inc. signed a contract with Dr. H and his institution for a multisite three-year study on the efficacy and safety of a new antidepressant, Xanadu, for use in pregnant women. The contract stipulates that Dr. H will have access to all data for final analysis and that all publications based on the study will be submitted for final approval to the sponsor before public disclosure. Dr. H's budget includes money for finder's fees for clinicians who recruit patients into the trial and rewards for clinician–researchers whose patients remain in the trial for the duration of their pregnancy. In the course of the trial, Dr. H becomes worried about potential negative effects of Xanadu on newborns. He reveals his concern to the company, requests immediate access to all the data, and indicates that he will reveal his concerns at an upcoming international meeting. The company refers to a contradictory opinion of an internal data-monitoring committee set up by the sponsor, refuses to provide full access to the data, and points out that researchers have to obtain final approval of the sponsor before any public discussion of the results. Shortly after, Dr. H receives from Calaxy an abstract discussing the interim results of the study, accepted for presentation at an international conference. Dr. H is first author on the abstract, which does not contain any reference to his concerns. Dr. H contacts the chair of his department, Dr. I, who is a remunerated board member of Calaxy.[…]

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Chapter
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Publisher: Cambridge University Press
Print publication year: 2008

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