The Globe and Mail
October 31, 2001
Scientific inquiry:
The fight's just starting
By NANCY OLIVIERI
The Report of the Committee of Inquiry on the Case Involving Dr. Nancy Olivieri, the Hospital for Sick Children, the University of Toronto, and Apotex Inc. is hard for me to read. It opens old wounds for me and my closest supporters as we study its 540 pages.
The Report relates what happened to us after I insisted on reporting unfavourable results on a new drug being tested by me in clinical trials to my patients in those trials and in others worldwide, the scientific community and regulatory agencies.
Apotex, the drug's manufacturer, disputed my findings. It threatened legal action should I inform patients or publish my findings, and abruptly terminated the trials. Neither the University of Toronto nor The Hospital for Sick Children, both anticipating large donations from Apotex, supported me in fulfilling my ethical obligations to my patients or my scientific obligations to the public. The report makes a series of general recommendations that, if enacted, would help ensure both medical research and the public interest are protected from inappropriate corporate influence.
As it documents, what followed my announcing my findings was five years of personal vilification, reprisals, and harassment. It notes that The Hospital for Sick Children's Physician-in-Chief, Dr. Hugh O'Brodovich "put forward incorrect allegations and testimony" against me to the Hospital's Medical Advisory Committee. It says that Dr. Gideon Koren, the previous Associate Director of the Hospital's Research Institute "attempted to discredit Dr. Olivieri by dishonest means" and was responsible for forwarding anonymous hate mail to my colleagues. Following Apotex's termination of the clinical trials, it says, Dr. Koren continued to receive funding from Apotex, which in turn continued to promote his scientific opinions regarding its controversial drug.
I am pleased that the report fully vindicates me. But after five years, my colleagues and I have lost faith in the administrations of the hospital and University of Toronto, whose duty it is to protect researchers' academic freedom and the public's right to know. More important than setting the record straight are the general lessons to be learned from this saga.
The Committee of Inquiry's first recommendation is to require that all agreements for industrial sponsorship of clinical research should expressly insist that investigators not be prevented from informing patients, other researchers and physicians, and the scientific community of any perceived risk. (Contrary to the university's recent claims, every day restrictive contracts are offered to researchers and are still not being challenged by its administration.)
The report calls on every Canadian university, faculty of medicine, and university-affiliated health-care institution to put in place a policy consistent with its industrial sponsorship recommendation. It urges the Association of Universities and Colleges of Canada to develop and enforce a policy governing industry-university relationships. It calls on the Canadian Association of University Teachers to find new ways of vigorously defending the academic freedom of clinical researchers, and it recommends that AUCC and CAUT co-operatively undertake an ongoing program to promote academic freedom and ethical conduct of research.
Finally, it recommends that Health Canada impose a requirement that clinical investigators neither be asked, nor agree, to limit their freedom to disclose risks in any drug trials, calling on Health Canada to conduct an independent investigation when a clinical trial is prematurely terminated as a result of a dispute between the sponsor and researcher over any risk to patients.
All these general remedies should be acted on immediately. But my experiences at The Hospital for Sick Children and the University of Toronto make me pessimistic: Real change will only happen when the respective boards of these institutions recognize that they have a duty to govern on behalf of the public. They should have taken the lead in insisting on protection of the public interest, but over and over, failed to do so.
The report concludes: "Given the current absence of the necessary protections [the situation my colleagues and I faced] could occur at many institutions across Canada." And that's the real issue in this case - the responsibility of our universities and university-affiliated hospitals to serve the public interest, even when it means standing up to powerful corporations who provide desirable funding and whose resources will always outstrip those of a group of scientists.
Not one of us believes that the report represents the end of this struggle -- that's still being fought, on several fronts. But if we act on the committee's recommendations, it might be the end of the beginning.
Nancy Olivieri, on staff at The Hospital for Sick Children, is on sabbatical at the University of London, where she is reading for a masters in medical ethics and law.