Healthy Skepticism Library item: 17374

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: Report

Thompson J, Baird P, Downie J
Report of the Committee of Inquiry on the Case Involving Dr Nancy Oliveri, the Hospital for Sick Children, the University of Toronto, and Apotex Inc
2001 Oct 26
www.law.ualberta.ca/centres/hli/userfiles/10_2moelorifrm.pdf

Abstract:

THIS CASE INVOLVES ISSUES of research ethics and academic freedom so
important to the public interest that it has attracted national and international
attention. It occurred in a context that quickly developed from the mid-1980s to
the mid-1990s of increased pressures on universities, teaching hospitals and
individual researchers to seek corporate sponsorship for projects. Public
institutions were not conscious of the inadequacy of their policy infrastructures
for protecting the public interest in this new environment, and policies and
practices had not been changed to take into account the new circumstances.
It was possible for clinical investigators to sign contracts with industrial
sponsors for research trials containing provisions that protected the sponsors’
interests, but not the public interest or the safety of trial participants. This
meant a dispute could arise between the ethical and legal obligations of an
investigator to inform participants of unexpected risks, and the contractual
right of a sponsor to insist that information on risks not be communicated and
to terminate a trial without prior notice. The academic freedom of an
investigator to publish adverse findings and inform the scientific community
could be at issue.
Such a dispute arose in this case, and it was compounded by oversights,
mistakes or misjudgments by individuals, public institutions, a private
corporation, and inquiry panels. In some instances the mistakes were under-
standable, and are more clear with the benefit of hindsight and the full
documentation available to us. In other instances, serious wrongs were
committed. In these instances substantial redress and calling to account are
appropriate.