Apotex-Olivieri Affair: a Case Study in BioEthics. Dr. James A. Smith, PEng
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1 Apotex-Olivieri Affair: a Case Study in BioEthics Dr. James A. Smith, PEng BME 100 class; Feb. 2012
2 After Viewing The Video What struck you most about it? Questions? Concerns? v=yxiaqxsws6e
3 Let s go over the facts Add details that were not mentioned in Dr. Olivieri s address
4 Thalassaema Inherited blood disorder Abnormal haemoglobin Does not bind & release oxygen Chronic fatigue, bone deformities, death Treatment Blood transfusions (3-6 weeks) Iron Overload Side Effect Hepatic fibrosis, cirrhosis & death
5 Treating Iron Overload Chelation Agent binds with iron & expels it Experts: Weatherall & Olivieri Deferoxamine: standard in 1980s Subcutaneous injection Daily with pump hours Demanding Need for oral alternative!
6 Nancy Olivieri Hematologist Professor of Medicine Head of Hemoglobinopathy Research Program at Sick Kids (Toronto) 1989: begins works on deferiprone (L1) 1993: Contract with Apotex 50% sponsorship Photo: University Health Network
7 Apotex Canadian Pharma. Company (1974) Largest producer of generic drugs in Canada e.g. ASA (generic Aspirin ) $1B in sales per year CEO & Chair: Bernard Sherman Worth $3.3B Forbes List: #334 Apotex Homepage Photo: CanadianBusiness.Com
8 Where are they? Apotex Sick Kids Ryerson
9 The Contract 1995 Olivieri & colleagues receive LA-02 contract Confidentiality provision (3 years after trial) NEJM: favorable effect of deferiprone on iron balance LA-03 trial displays undesirable iron conc.
10 Changing the Trials Olivieri wants consent forms changed Why? Inform patients of negative results Apotex requests HSC REB not be informed Olivieri submits to REB Apotex submits differently to REB REB: change the consent forms
11 Action May 96 Olivieri attempts to tell patients Apotex cancels sponsorship Apotex remind O. & colleagues of secrecy Legal action threatened VP reminds of nondisclosure agreement
12 Outside Help June 96 Olivieri contacts U of T Dean of Medicine Many Toronto hospitals are teaching hospitals for U of Toronto Mediate dispute? Apotex review board finds Olivieri wrong Errors in drug administration Errors blamed on Apotex ending trials early Apotex denies consent for O. s pubs
13 Conference Publication Olivieri presents LA-03 in Florida Liver biopsies done to examine toxicity Accelerated progression of fibrosis Colleague Koren stops working with O. Publishes positive deferiprone results (see Naimark report)
14 End of L1 Prescription Feb 1997 New biopsies requested Patients informed of results Olivieri stops L1 (deferiprone) prescriptions REB informed Apotex states L1 is safe Informs admin & patients
15 Admin Doesn t Agree & Olivieri Publishes Sept. 97: Olivieri not satisfied with Dean U of T admin can t find enough specifics (Naimark Report) Nov. 97: Olivieri publishes abstract L1 was discontinued in all patients because of safety concerns
16 Dismissal & Report #1 April 98 Olivieri complains of working conditions HSC interprets as resignation; dismissal Summer Olivieri refuses to share data with Apotex Publishes liver toxicity in NEJM Dec. 98 Naimark Report (HSC Board of Trustees) says HSC did not act improperly
17 Firing & Rehiring & Lobbying Jan 99: O. fired from head of Hemoglobinopathy Rehired & told HSC will support her U of T President writes to P.M. (Canada) Lobbies for Apotex Later apologizes
18 Colleagues turn on each other Dr. Koren found to be anon. source of letters against Olivieri He s source for Naimark Report Suspended & Chair revoked
19 College of Physicians and Surgeons of Ontario Dismisses case of HSC vs. Olivieri O. acted in best interest of patients Can. Assoc. of Uni. Teachers Report U of T didn t protect Olivieri High personal cost $300,000 in defending herself
20 Further Reading The Drug Trial by Miriam Shuchman Based on Olivieri s case Wife of Donald Redelmeier (CMAJ editorial board) Letter by Dr. Olivieri is response to CMAJ review of The Drug Trial (2006) Apotex Webpage: Uni. Health Network Webpage
21 References Introduction to the Olivieri Symposium, A. M. Viens & J. Savulescu, J. Med. Ethics; v30; p1-7, Academic Freedom in Clinical Research, D. G. Nathan & D. J. Weatherall, New England Journal of Medicine; v347; p , 2002.
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26 Solutions? Sponsorship? Regulation? Whistleblower Acts? Conflicts of interest Financial (paid by ) Personal (family members, friends) How would you have acted? As the sponsor As the researcher
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