Dr. Nancy Olivieri vs. Sick Kids Hospital/Apotex/U of T
Introduction

Dr. Nancy Olivieri is a haematologist who used to work for the Hospital For Sick Children in Toronto. Her final clinical research project at the Hospital For Sick Children was to research the effectiveness of a new iron chelating drug developed by Apotex to be used on patients suffering from autosomal blood disorders known as thalassemia[1]. Thalassemias are inherited blood disorders that result in the body producing a lower than normal healthy red blood cell count; lower than normal haemoglobin levels are also produced. Haemoglobin is an important iron-rich protein in the body that transports oxygen throughout the body and is also involved in the removal of carbon dioxide from the body. This protein is made up of four peptide chains, two alpha and two beta chains, which gives rise to the two main forms of thalassemia. α-thalassemia is when there are defects in the alpha chains and β-thalassemia occurs when there are defects in the beta chains [2]. Persons suffering from thalassemia are prone to an iron overload in their blood, usually a result of frequent blood transfusions. High blood iron levels can result in damage to the heart, liver and several endocrine glands[3].

One treatment option for thalassemia patients is iron chelation therapy. This treatment method utilizes chelating agents to aide in the removal of metals from the body. The drug at the centre of this issue is Deferiprone, the structure of which and its chelated form are shown below.


deferiprone.jpg chelated_deferiprone.jpg
Figure 1. Structure of Deferiprone and its iron-chelating form.



The goal of Deferiprone is that the chelated iron can now move from the organs where the high levels have formed to eventually be excreted from the body.
The heated issue surrounding this drug involves three main players; Dr. Olivieri, The Hospital For Sick Children and Apotex. Apotex had been developing Deferiprone and had the drug in the clinical trial stages which were being conducted at the Hospital For Sick Children. Dr. Olivieri was a researcher in the clinical trials and observed results that suggested patients being administered Deferiprone were developing hepatic fibrosis [4]. Dr. Olivieri felt obligated to inform her patients about the findings, even though it meant possible legal action from Apotex. Ignoring the legal warnings from Apotex, Dr. Olivieri published her findings two years later and found herself summoned to court for her actions[1].

This case is significant because it is an excellent example of the problem of regarding the safety of the public in health care matters. Many people agree Dr. Olivieri did the right thing and informed her patients of a risk that she deemed serious as a medical professional while others see her disregard for the proper protocol set out by the hospital and industry as an abuse of positional power.

More detailed information can be found in the following sections:
__**Chemical Content of Deferiprone**__
__**Issues and Stakeholders Surrounding Deferiprone Clincal Trials**__


References for this page
[1] A. Viens and J. Savulescu. 2004. “Introduction to The Olivieri symposium”. Journal of Medical Ethics 30 (1): 1–7.
[2]H. Kazazian. 1990. “The thalassemia syndromes: molecular basis and prenatal diagnosis in 1990.” Seminars in Hematology 27(3): 209 – 228.
[3]V. Hoffbrand, A. Cohen and C. Hershko. 2003. “Role of deferiprone in chelation therapy for transfusional iron overload.” Blood 102: 17 – 24.
[4] N. Olivieri and G. Brittenham. 1997. “Iron-Chelating Therapy and the Treatment of Thalassemia.” Blood 89: 739 – 761.