Footnotes

• ↵* In addition to the cirrhosis that is caused by iron loading in the liver, as a result of the frequent number of blood transfusions received, there were also a very large number of thalassaemic patients who were more susceptible to contracting Hepatitis C from the tainted blood supply back in the 1980s and 1990s (which causes liver damage).

• ↵† It can also be administered intravenously. While intravenous administration avoids side effects such as skin irritation, it also has other side effects associated with it, such as infection or thrombosis of the catheter. Patients are generally advised to use subcutaneous administration, and have intravenous administration as a secondary option.

• ↵** The report by the College of Physicians and Surgeons of Ontario is on file with the author. It is also available on the website address given in reference 9.

• ↵*** Dr Gary Brittenham, hepatologist at Case Western Reserve University, and one of Olivieri’s coinvestigators.

• ↵**** Prospective randomised controlled trial to compare effectiveness and safety of L1 to DFO (approximately 65 patients in Toronto and Montreal).

• ↵***** Safety study to assess particular risks associated with L1 (approximately 200 patients in Canada, Italy, and the United States).

• ↵‡ Continuation of the compassionate use long term study of L1 (approximately 25 patients).

• ↵†† Dr Gideon Koren, clinical pharmacologist, HSC, and one of Olivieri’s coinvestigators

• ↵††† In order to assess and monitor iron loading, thalassaemia major (TM) patients were required to undergo regular liver biopsies to obtain tissue to assess liver histology and to be tested to provide a hepatic iron concentration as a mean of evaluating total body iron stores. Hepatic histology and iron concentration provide the best assessment of the safety and efficacy of iron chelation therapy.

• ↵****** Dr Stanley Zlotkin, chair, HSC REB (until July 1996).

• ↵†††† The Health Protection Branch has since been renamed the Health Products and Food Branch of Health Canada. The Health Protection Branch was a branch of government responsible for managing risks and benefits related to health. The new organisation is responsible for managing risks and benefits related to health products and food.

• ↵††††† Pathologist, Toronto General Hospital (now part of the University Health Network).

• ↵†††††† Dr Hugh O’Brodovich, Paediatrician in Chief, HSC.

• ↵††††††† Dr Melvin Freedman, Head, Division of Haemotology/Oncology, HSC

• ↵******* Dr Gallie was also head of the blood and cancer research section where Dr Olivieri’s haemoglobinopathy research program was located.

• ↵‡‡ Individuals interested in this case are encouraged to read the Naimark report.

• ↵‡‡‡ Individuals interested in this case are encouraged to read the Oliveri report.

• ↵‡‡‡‡ The complaint was not by HSC itself, but by a member of its staff, Dr Laurence Becker.

• ↵‡‡‡‡‡ The experience of researchers like Dr Olivieri has even served as fodder for novelists. For instance, in John le Carré’s recent novel, The Constant Gardener, he writes: “As my journey through the pharmaceutical jungle progressed, I came to realise that, by comparison with reality, my story was as tame as a holiday postcard. ... I drew on several cases, particularly in the North American continent, where highly qualified medical researchers have dared to disagree with their pharmaceutical paymasters and suffered vilification and persecution for their pains”.

• Adrian Viens was one of Dr Olivieri’s research assistants in the summer of 1998 and 1999. In addition, Viens and Olivieri collaborated on a journal article (along with six other coauthors) concerning iron overload and iron chelating therapy in Haemoglobin E-β thalassemia. This collaboration was not related to the L1 clinical trial (see:

  Olivieri NF, de Silva S, Premawardena A, et al. Iron overload and iron chelating therapy in haemoglobin E-β thalassemia. Journal of Pediatric Hematology/Oncology2000;22:593–7

  OpenUrl
  ).