Key to Abbreviations
A. Overview
B. Lessons To Be Learned
C. Findings
D. Recommendations
Report
1. The Committee of Inquiry
2. Background Information
3. Policy Context
4. The Context of Associat
Key to Abbreviations
A. Overview
B. Lessons To Be Learned
C. Findings
D. Recommendations
Report
1. The Committee of Inquiry
2. Background Information
3. Policy Context
4. The Context of Associations between Apotex Inc. & the University of Toronto
5. Review & Analysis of Events
The Toronto L1 trials (LA-01 and LA-03
Designing and organizing the international trial (LA-02)
Progress of the Toronto trials (LA-01 and LA-03
Concerns arising in 1995
Identification of the first risk
Trial terminations and legal warnings
Post-termination events
Expanded disclosure
Ongoing legal warnings
Trial close-outs and another stoppage in supply of L1
Identification of the second risk
Events at the Hospital from June 1997 to August 1998
Removal of Dr. Olivierl as Program Director
Events at the University of Toronto
The Naimark Review Process and Report
The Medical Advisory Committee Proceedings
The MAC allegations in regard to liver biopsies
The central role of Dr. Koren in the L1 controversy
Involvement of the CAUT and the UTFA
Public interest, public policy, contracts, and legal representation
The Involvement of Government Regulatory Agencies
NOTES
APPENDICES*
*Appendix I contains a detailed table of contents for the entire report.
"Bending over backwards to be fair (a posture making keyboard access difficult, thus accounting for some inelegant prose)and under considerable legal duress -- a cheeky appendix consists entirely of letters from various notables threatening to sue if the report is published -- the three-person committee pursues a paper trail of bungled hearings, bureaucratic ineptitude and scientific dishonesty."
- Bill Bruneau Vancouver Sun - Opinion Page
"The report, commissioned by the Canadian Association of University Teachers, fully vindicates Dr. Olivieri and calls on universities, teaching hospitals and the federal government to adopt protection for people taking part in drug trials."
- Sarah Schmidt National Post
"The Report of the Committee of Inquiry...is hard for me to read. It opens old wounds for me and my closest supporters as we study its 540 pages.
"...I am pleased that the report fully vindicates me. But after five years, my colleages and I have lost faith in the administrations of the hospital and the 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.
"...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."
- Dr. Nancy Olivieri Globe and Mail
