THE FILES
These documents aim to promote transparency around these issues.
In December 2018, Drs Brenda Gallie and Nancy Olivieri wrote to the University Health Network CEO Kevin Smith. This letter is a comprehensive summary of concerns of safety issues in UHN patients, relevant history of deferiprone in Toronto and elsewhere, questions about the “Deferiprone Data Package” provided to Health Canada.
Taking a step back, these links report the findings of Freedom of Information (FOI) requests, which revealed that in 2010 Apotex was providing substantial funding including unrestricted educational grants to the Red Cell Disorders Program at UHN from which Dr Olivieri had been dismissed months before (for no cause). FOI revealed correspondence between Apotex, Dr. Richard Ward, and Health Canada respecting market approval of deferiprone, and requests from Dr. Richard Ward for Apotex funding.
In 2011 Dr Richard Ward and Eric Yeo wrote this letter to the United States Food and Drug Administration in which they stated they “…cannot state how strongly we support [the market approval of deferiprone at the FDA]”. Their letter also reports data which are substantially different to the findings — including with respect to deferiprone doses, blood safety monitoring, and evaluation of deferiprone effectiveness – that were identified in the medical records of UHN patients and published by Drs Brenda Gallie and Nancy Olivieri.
Drs. Gallie’s and Olivieri’s PLoS paper was published in February 2019. This paper reported the switching of 41 UHN patients from first-line licensed agents to deferiprone, a drug which was not licensed for sale over the six years, 2009 to 2015, during which it was prescribed to UHN patients. The paper reported findings of: liver enzymes, diabetes, control of liver iron, cardiac responses and indications for deferiprone. The authors observed: “Exposure to deferiprone, over six years while the drug was unlicensed, in the face of ineffectiveness and serious toxicities, demands review of the standards of local medical practice”.
On Feb 27, the day on which Gallie and Olivieri’s paper was released, The Toronto Star published this article: “UHN patients given unlicensed drug that led to diabetes, liver dysfunction and one death, study finds”).
Read Toronto Star article here.
Following publication of Drs. Gallie’s and Olivieri’s PLoS paper, and publicity in the Toronto Star, the UHN issued a statement from its PR department “on Behalf Of Gillian Howard, Vice President, Public Affairs & Communications, University Health Network.” With respect to this Statement two points are important:
1. Over many years Drs Gallie and Olivieri had brought concerns including whether informed consent had been provided to UHN patients to the attention of many UHN administration and lawyers. 2. The upcoming Review was to involve: (a) an expert in the treatment of thalassemia patients (b) an external expert (c) agreed upon candidates with these qualifications.
In the Toronto Star article, unnamed “UHN officials” were quoted as having “potential quality concerns [about Drs Gallie and Olivieri’s PLoS study].” Drs Gallie and Olivieri’s responded to this in this letter, and also encouraged the UHN to obtain all relevant details at source within the UHN regarding safety, an approach Drs Gallie and Olivieri had urged for many years.
In letters of March 5, March 7 and March 13, 2019, Drs. Gallie and Olivieri urged that the Independent Review of Patient Care which had been promised by CEO Kevin Smith move forward, outlined the critical minimally necessary aspects of a Review, provided important background on how this situation may have developed, and described ongoing problematic issues with patient care.
Drs Gallie and Olivieri next encouraged UHN to obtain the names of the patients who had been switched from licensed therapy to unlicensed therapy:
In a letter, followed by two Appendices, Drs Gallie and Olivieri sent Dr. Michael Baker Guiding Principles for the Independent Review of Patient Care:
Drs Gallie and Olivieri informed Mr. Brian Porter, Chair, Board of Trustees University Health Network that “it is essential to meet the UHN’s legal and ethical responsibilities to the patients who were switched to deferiprone, the patients who are being prescribed it now and may be provided with it in the future, UHN patients more generally, UHN physicians and staff, Health Canada, and the public.” Drs Gallie and Olivieri also asked Mr Porter seven key questions in this letter:
Drs Gallie and Olivieri sent another letter stating that they wanted to inform all patients of harms suffered:
Drs Gallie and Olivieri send another letter urging disclosure to patients:
Dr. Richard Ward and others (Binding et al 2019) reported that 71 UHN patients were switched from licensed therapy to unlicensed deferiprone between 2009 to 2015.
Throughout June 2019, Drs Gallie and Olivieri communicated with UHN about this paper and the Independent Review of Patient Care.
Drs Gallie and Olivieri having heard no update on the Independent Review of Patient Care, sent two letters in July 2019:
Drs Gallie and Olivieri learn that a review had been conducted by Dr. Isaac Odame without their knowledge:
Drs Gallie and Olivieri requested the details of the review conducted by Dr. Odame:
Gallie and Olivieri again requested the details of the review conducted by Dr. Odame:
Gallie and Olivieri write: “It is dismaying is that you continue to refuse to provide us with any details of this Review. We can only assume, as we describe here, that an adequate Review has not taken place. The UHN has not yet acted consistent with its responsibilities to oversee the safety of patients.”
One of Canada’s leading ethicists, Professor Arthur Schafer, Founder and Director Emeritus of The Centre for Professional and Applied Ethics, University of Manitoba, Canada has provided an analysis of the key ethical issues of this explosive situation.
Latest Letter to University Health Network, sent March 9, 2020
On March 9, 2020, a letter signed by 88 distinguished researchers, ethicists, drug safety advocates and physicians was sent to Kevin Smith (CEO University Health Network), Dr. Brian Hodges (Chief Medical Officer, University Health Network) and Dr. Amit Oza (Head of Hematology/Oncology, University Health Network). This letter urged that these individuals in authority at The University Health Network (UHN), undertook to ensure that Drs. Nancy Olivieri and Brenda Gallie were able to disclose to UHN patients the harms which Drs Olivieri and Gallie had identified in their study: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0211942
Those 88 experts agreed with Drs. Gallie and Olivieri that it was their duty to inform patients who had suffered clinical harms during the exposure to unlicensed deferiprone. These harms (and death) had been revealed and exposed only as a result of their research conducted over five years by Drs. Gallie and Olivieri. The letter urged Smith, Hodges and Oza to recognize the researchers’ ethical obligation to allow patients to be informed, as well as the right of patients to be informed.
Eighteen months later there has been no reply to this letter