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Introduction to the Olivieri Symposium As Chronic Fatigue, Failure to Thrive, Growth Deficiencies, Bone Deformities, a M Viens, J Savulescu and Eventually Death

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Introduction to the Olivieri Symposium As Chronic Fatigue, Failure to Thrive, Growth Deficiencies, Bone Deformities, a M Viens, J Savulescu and Eventually Death INTRODUCTION 1 The Olivieri symposium haemoglobin. The abnormal haemoglo- J Med Ethics: first published as 10.1136/jme.2003.006577 on 10 February 2004. Downloaded from ....................................................................................... bin that is produced cannot properly bind and release oxygen, and, if left untreated, can result in symptoms such Introduction to The Olivieri symposium as chronic fatigue, failure to thrive, growth deficiencies, bone deformities, A M Viens, J Savulescu and eventually death. Consequently, the primary goal of ................................................................................... treatment is to provide frequent blood Adrian Viens, Guest Editor of this Olivieri symposium, and Julian transfusions (approximately every three to six weeks) to maintain a normal Savulescu, the Editor of JME, set the scene for the symposium. haemoglobin level. As a result of the continuous blood transfusions, how- In failing...[her] when she needed in the Canadian and international news ever, there exists a progressive accumu- them most, it is now clear that some media, to changes in the governance of lation of iron in organs such as the members of the University’s Faculty public health, academic medicine, and liver, heart, and pituitary gland. Haemosiderosis, or iron overload, can of Medicine heard her muffled cries biomedical publication that have lead to hepatic fibrosis & cirrhosis,* of academic freedom from the back resulted, to the lives directly touched and altered forever, the Olivieri affair cardiomyopathy, endocrinopathies, and room, yet their response was to has had a number of wide reaching even death. serve another round of drinks and effects on a number of people. There is Thus, the secondary goal of treatment turn the music up louder. With the much to be learned from this case. is to remove the iron accumulation bombshell revelations in the...affair, Although there have been articles in using a chelator to bind to excess body the plug may have been pulled on the medical and bioethics literature iron and promote its excretion from the this business sponsored party, and discussing the Olivieri affair, this special body. For more information on the hopefully a sober re-examination of symposium represents the first sus- thalassaemias (thalassaemia major), the university’s neglected role and tained analysis of some of the central see the papers by DJ Weatherall NF responsibility toward independent ethical issues and lessons that can be Olivieri.56 inquiry and academic freedom can learned from such cases. It is hoped that Since the 1980s, Deferoxamine, also begin.1 this symposium will provide for those called DesferalH, has been the standard engaged with similar issues and cases of care to treat iron overload for patients These guys don’t get one thing— a fruitful and informative examina- with thalassaemia. Deferoxamine is we’re not going away. This isn’t a tion of professional ethics, research usually administered daily or on alter- personal vendetta. This is something ethics, academic freedom, and related nate days by subcutaneous infusion I want patients to be protected from considerations. administered over 10 to 12 hours from when I’m dead, fifty years from The Olivieri affair has raised a number a small battery operated pump.À now.2 of important normative questions con- The needle is usually injected in the cerning the substance and limits of abdomen, arm, or leg and is very [The Olivieri affair is] not a mystery particular theoretical commitments and uncomfortable and can leave needle novel, but instead the latest skuldug- how ethical judgments and norms are marks, skin irritation, and scar tissue. http://jme.bmj.com/ gery at Toronto’s Hospital for Sick implemented in practice. The issues As a result of the tedious and painful Children.1 surrounding the Olivieri case are not administration and issues of body novel. Unfortunately, issues of patient image, some patients (especially adoles- The legal assaults which you have safety, conflict of interest, and academic cents and teenagers) find it difficult to endured in your battle against the freedom continue to plague many areas comply with the demanding regime. drug company, and in your battle of biomedicine. The Olivieri affair has, Given this, there was significant against the medical establishment however, gripped the attention of phy- interest in finding an iron chelator that appear to have been fought with the sicians, researchers, and bioethicists could be taken orally to improve com- on October 1, 2021 by guest. Protected copyright. type of uncommon bravery that is around the world as a prime example pliance. While Deferoxamine had sig- rarely seen. It is for this reason that of the limitations of ethics review at nificantly improved the prognosis of our trustees have unanimously cho- multiple levels. thalassaemic patients, the prospect of sen to recognise you for this most In the introduction to this sympo- finding an efficacious alternative ther- prestigious award.3 sium, we shall begin by very briefly apy for iron overload was seen as a very explaining the disease and therapy at [The Olivieri affair resulted from] a the centre of this case. We go on to ........................... provide a timeline of the most salient fundamental misreading of the issue *In addition to the cirrhosis that is caused by as a mere contractual and scientific events in the Olivieri affair. We conclude iron loading in the liver, as a result of the dispute…[it is] Canada’s worst aca- by discussing the contributions to this frequent number of blood transfusions received, demic and research scandal in symposium and how they bear on the there were also a very large number of ethical issues surrounding this case. thalassaemic patients who were more suscep- decades…[Since 1998, Olivieri tible to contracting Hepatitis C from the tainted has been] demoted, then restored, blood supply back in the 1980s and 1990s then harassed. She has been I. THALASSAEMIA AND ITS (which causes liver damage). À smeared with allegations attacking TREATMENT It can also be administered intravenously. her competence, integrity, sanity Thalassaemia major, also known as While intravenous administration avoids side effects such as skin irritation, it also has other and personality….4 Cooley’s anaemia or Mediterranean anaemia, is an inherited blood disorder side effects associated with it, such as infection or thrombosis of the catheter. Patients are he Olivieri affair is one of the most caused by a mutation in the beta chain generally advised to use subcutaneous admin- important events to occur in of the haemoglobin molecule that istration, and have intravenous administration Tresearch ethics. From its dominance results in the production of abnormal as a secondary option. www.jmedethics.com 2 INTRODUCTION welcome and promising improvement to N 1992 encountered. Apotex requests to J Med Ethics: first published as 10.1136/jme.2003.006577 on 10 February 2004. Downloaded from the quality of life of thalassaemic examine the data before consent N Olivieri begins working with Dr patients. forms are changed and the Hos- Brittenham.*** Noted haematologist and researcher pital for Sick Children (HSC) at the Hospital for Sick Children and N 1993 Research Ethics Board (REB) or professor of medicine at the University N Food and Drug Administration research ethics committee is noti- 9 of Toronto, Dr Nancy F Olivieri was a (FDA) informs Drs Olivieri and fied of findings (CPSO, p5); 7 natural choice to investigate the poten- Brittenham that completion of (Olivieri report, pp 125–33). tial safety and efficacy of a new oral iron three studies—LA-01,**** LA- N In September, Dr Olivieri submits chelator in thalassaemia. As head of the 02,***** LA-03` —would be neces- separate protocol to Apotex inves- large and productive Hemoglobinopathy sary before commercial licensing tigating patients excluded from Research Program, Dr Olivieri (and of L1 could occur. LA-03 trial to observe loss of colleagues) had the research experience sustained efficacy in L1. Dr Drs Olivieri and KorenÀÀ sign and expertise, and patient population, to N Olivieri also informs Apotex of contract with Apotex for LA-01 conduct such important research. her obligation to communicate trial (approximately 50% spon- her findings of reduced efficacy to sored by MRC, 50% sponsored by HSC REB. (CPSO,9 p 6); (Olivieri II. TIMELINE OF EVENTS Apotex). In the construction of this timeline report,7 11 entitled ‘‘Progress of the primarily three documents were used: N 1994 Toronto trials [LA–01 and LA–03]’’ (i) the Canadian Association of and ‘‘Concerns arising in 1995’’). N Planning for LA-02 is commenced. University Teachers’ Report of the N In October, HSC REB requires a Committee of Inquiry on the Case Involving N 1995 revised protocol for LA-03 study in Dr Nancy Olivieri, the Hospital for Sick N Research contracts are tendered to order for study to continue. Apotex Children, the University of Toronto, and Drs Olivieri and Brittenham for agrees to study patients in which Apotex Inc, hereafter referred to as the LA-02 trial. Contained within the response to L1 was suboptimal, but Olivieri Report; (ii) the report by Arnold contract is a confidentiality provi- continues to refuse to agree to Naimark, Bartha M Knoppers, and sion in which all information con- inform the REB of suboptimal Frederick H Lowy, Clinical Trials of L1 9 cerning the trial is to be kept findings. (CPSO, p 6); (Olivieri (Deferiprone) at the Hospital of Sick
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