E-drug: Olivieri; need for better patient protection in drug trials
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CURB INDUSTRY INFLUENCE OVER DRUG TRIALS, REPORT
URGES
(Toronto, October 26, 2001) The Committee of Inquiry into the
dispute involving Dr. Nancy Olivieri, the Hospital for Sick Children,
the University of Toronto, and Apotex Inc. issued its report today
warning tougher measures are needed to protect patients' rights
and ensure clinical drug trials are free from the influence of drug
manufacturers.
"What happened in this case could happen in any part of the
country," said Committee chair Dr. Jon Thompson. "The
controversy arose in a context where public institutions now have
to rely more on funding from private corporations, but haven't put
in place adequate policies and practices to protect the public. A
series of misrepresentations, mistakes and misjudgments
compounded the problem in this case."
The case of University of Toronto clinician Dr. Nancy Olivieri has
been the focus of international attention since Apotex, corporate
sponsor of her clinical drug trials of its drug, attempted to suppress
her findings of unexpected risks. The company abruptly terminated
the trials and issued warnings of legal action against Dr. Olivieri
should she inform her patients at the Hospital for Sick Children of
the risks, or publish her findings.
"The Hospital and the University should have defended vigorously
the right of clinical researchers to disclose risks to research subjects
and patients. They had a responsibility to protect the public interest
and academic freedom from inappropriate actions by Apotex, but
they did not do so," said Committee member Dr. Patricia Baird.
"Conflicts of interest are not being properly dealt with through
current rules and regulations governing research," added Committee
member Dr. Jocelyn Downie. "The safeguards we have now aren't
working."
The Committee of Inquiry found that, despite the interference by
Apotex, Dr. Olivieri fulfilled her ethical obligations. However, after
the controversy became public in 1998, Dr. Olivieri was accused of
misconduct by Apotex and certain senior Hospital and University
staff. The Committee's report documents that these allegations
were incorrect, yet were used by the Hospital as the basis for
serious public actions against Dr. Olivieri. Apotex subsequently
used the Hospital's actions to defend the reputation of its drug.
The committee's report contains 31 recommendations, including:
- Contracts involving industrial sponsorship of clinical research
should never prevent researchers from informing patients or the
scientific community of any risks.
- All universities and affiliated teaching hospitals should have in
place policies and practices that are effective in protecting
academic freedom, as well as principles of research and clinical
ethics.
- Health Canada should review the current regulation of health
research and make appropriate changes to protect the public
interest and the rights of patients who volunteer to be subjects of
research.
- The University and the Hospital should provide redress to Dr.
Olivieri for the unfair treatment she has received.
The report also calls on the Hospital and the University to address
inappropriate conduct by certain individuals and committees. It
details instances of false and misleading testimony to reviews
established by the Hospital, and instances where researchers
published favorable findings on Apotex's drug, but failed to disclose
their funding support by the company. Failures by Hospital
administrators and committees to provide due process are
documented.
The committee of inquiry was established in 1999 by the Canadian
Association of University Teachers (CAUT). The members of the
Committee agreed to serve without remuneration and only on
condition that they would be independent of CAUT and any other
person and organization.
Full copies of the report are available on-line at
www.dal.ca/committeeofinquiry/
Barbara Mintzes
Centre for Health Services and Policy Research
University of British Columbia
#429-2194 Health Sciences Mall, UBC
Vancouver BC V6T 1Z3 Canada
Tel (604) 822 0565; Fax (604) 822 5690
bmintzes@chspr.ubc.ca
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