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COPYRIGHT 2002 Health Law Institute
I. Introduction
The case of Dr. Nancy Olivieri, the Hospital for Sick Children (HSC), the University of Toronto, and Apotex Inc. (hereinafter the "Olivieri case") is critically important to an understanding of the issues central to contemporary health research and the safety of research participants. First, the case illustrates the huge stakes in such research--not only billions of dollars, but the health of Canadians. Second, the case played out at a crucial time in the history of the regulation of health research. Like other recent high-profile cases, it challenged the ways in which research is governed at the local and national levels and fuelled calls for significant governance reform. (1) Finally, it is relevant not only nationally but in individual communities right across the country. What happened in Toronto could have happened (and could still happen) anywhere in Canada. To pursue the promises and avoid the perils of contemporary health research, it is essential to attend to the lessons of this case.
Full consideration of the Olivieri case was a daunting task. The Committee of Inquiry into it reviewed thousands of documents, conducted many hours of interviews, and produced a report with 540 pages of text and 1230 footnotes. (2) In this paper, the three committee members summarize the facts of the Olivieri case and highlight some of the most significant lessons to be learned, particularly in relation to the obligation of investigators to disclose risks to trial participants and to the academic freedom of researchers, whether or not their findings are adverse to their sponsors' interests. (3)
II. Overview
In this paper, we review the facts of the Olivieri case relevant to the issues we wish to highlight, the issues raised by these facts, and the recommendations made by the Committee of Inquiry. Our message is that the research ethics community (Research Ethics Boards (REBs) and research ethics experts), the research community, hospital and university administrators, Health Canada, and everyone else involved in research, must work together to protect the public interest. We must raise our colleagues' awareness, work with our institutions' administrations, lobby funding councils, lobby the federal, provincial, and territorial governments, and encourage public involvement. We must actively seek the realization of the considerable promises of research while just as actively seeking to avoid its perils.
III. The Facts
The Committee of Inquiry
Appointment
In 1999, the Canadian Association of University Teachers (CAUT) commissioned a Committee of Inquiry into the case of Dr. Nancy Olivieri, HSC, the University of Toronto, and Apotex Inc.. They asked us - Dr. Jon Thompson (Chair of the Mathematics and Statistics Department at the University of New Brunswick), Dr. Patricia Baird (University Distinguished Professor at the University of British Columbia and member of the Department of Medical Genetics) and Dr. Jocelyn Downie (Associate Professor of the Faculties of Law and Medicine at Dalhousie University) - to serve on this Committee. We did not seek appointment to the Committee and we served without any remuneration.
In our initial discussions, we decided that we would serve only if we could be independent of CAUT and any other person or organization. We therefore asked CAUT to make special arrangements to ensure our independence. For example, we were provided with our own office in Toronto, our research assistants reported only to us, and independent legal counsel was retained. CAUT also agreed to refrain from comment on the case until the Committee completed its inquiry and published its report. CAUT also undertook to have the report published as submitted and in its entirety, in fact, the report was delivered to CAUT at the same time as it was released to the public on October 26, 2001. (4)
Terms of Reference
The Terms of Reference for this Committee of Inquiry were as follows:
1. To investigate the sequence of events leading to and subsequent to the crisis at the Hospital for Sick Children and the University of Toronto involving Apotex Inc. and Dr. Nancy Olivieri, her colleagues, students, and others who may have been connected with her in this matter.
2. To determine whether there were breaches of medical research ethics and clinical ethics.
3. To determine whether there were breaches of or threats to academic freedom.
4. To determine whether changes in Dr. Olivieri's working conditions during this period impaired her and her colleagues' ability to conduct their scientific research and treat their patients.
5. To make any appropriate recommendations.
The Process
The Committee received from CAUT an initial collection of relevant documents. On the basis of these documents and the experience each member brought to the Committee, we contacted a large number of people who had been involved and invited them to meet with us, provide us with documents, and suggest the names of other individuals who might have relevant information. Additional people were contacted as their involvement became known to us.
It is important to note that the administrators of the University of Toronto and of HSC, Apotex Inc., and a number of other individuals, declined our invitation to participate. However, it is equally important to note that the potential disadvantage of these gaps in participation was substantially offset by our access to a large quantity of relevant correspondence and documents originating with the administrations of the University, HSC, Apotex, and other non-participants. These thousands of documents included the Naimark Report (5)--a prior report on the case which the board of HSC had engaged Dr. Naimark and two associates to carry out over a three month period. While the HSC, the University, and Apotex participated in it, neither Dr. Olivieri nor her supporters did. We closely examined the Naimark Report, those of its documents deposited in the HSC library archives, and a number of additional documents relied on by the Naimark Report but not deposited in the archives. In addition, our base of information included a large number of documents written by those who chose not to participate in our inquiry. We therefore believe we had a comprehensive set of relevant information regarding all players in the dispute.
Beginning on October 31, 1999, the Committee visited Toronto several times to conduct interviews. Persons interviewed typically brought documents with them and forwarded additional ones later. Additional interviews were conducted by telephone. We also requested additional documents and received substantial quantities of materials in response.
On March 26, 2001 we sent letters to a number of individuals and organizational heads providing, in each case, a summary of the information we had pertaining to their involvement (letters were sent to those about whom we were intending to make significant findings of fact). We invited them to comment on this and to provide us with any corrections or further information. Some, but not all, of the recipients of these letters had previously declined to participate. The letters again invited their participation and invited them to provide information to the Committee. Some recipients of these letters replied and we included copies of these replies in our Appendix (mostly they were reiterations of the desire not to participate or warnings that legal action might be taken against us). (6)
The inquiry process had two main phases. The investigation phase extended from September 1999 to June 2001. This phase was followed by an evaluation phase where each Committee member conducted their own separate final review of the relevant documents and of information gathered through the investigation phase. This was done to further ensure that each member of the Committee reached his or her own independent conclusions. We reached the same conclusions and the report issued on October 26,2001 is the unanimous report of the Committee. (7)
Background and Context
National Context
The Olivieri case arose in a particular national context that developed quickly from the mid-1980s to the mid-1990s. Universities, teaching hospitals, and individual researchers were under increasing pressure to seek corporate sponsorship for research. Public institutions were not sufficiently attentive to the inadequacies of their policy infrastructures to protect the public interest in the face of these new pressures. Policies and practices had not changed to take into account the new ethical challenges at the institutional level in addition to the traditional challenges of research ethics at the researcher-participant level. (8)
Local Context
Since the early 1990s, the University of Toronto and Apotex had been discussing a major multi-million-dollar donation intended to allow a new biomedical research centre to be built at the University. It would have been the largest donation the University had ever received ($20 million to the...
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