Healthy Skepticism Library item: 14550

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: chapter

Lemmens T, Luther L.
Financial conflict of interest in medical research
Singer PA, Viens AM. The Cambridge Textbook of Bioethics New York: Cambridge University Press 2008
http://www.cambridge.org/catalogue/catalogue.asp?isbn=9780521694438

Abstract:

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. N 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. She points out that Calaxy is a trusted and transparent partner in research, that it has its own data-monitoring committee, that it is ultimately responsible for the safety and efficacy of its products, and that contractual obligations have to be respected. She mentions also in passing that Calaxy provides close to 20% of the research funding of the institution and that discussions are underway for the funding of a Calaxy research chair, for which Dr. H would be an excellent candidate…