Issues+and+Stakeholders+Surrounding+Deferiprone+Clincal+Trials


 * __Case Information__**

Beginning in 1990, Dr. Nancy Olivieri began working on clinical trial studies for a new iron-chelating drug called deferiprone. The drug development was sponsored by Apotex Inc. who funded the clinical trials for a group of scientists involved with the Hospital For Sick Children, where the clinical studies were being performed, and the University of Toronto, one of which was Dr. Olivieri who is a internationally recognized expert in the field of blood disorders [1]. Dr. Olivieri, along with the other scientists involved in the clinical trials are subject to follow standard set of ethical practices in terms of how the trials are carried out and the non-disclosure agreement. After the clinical trials had been going on for approximately six years Dr. Olivieri began to have concerns about this new iron-chelating agent. Her first concern was that she believed that the drug was not effective enough as an iron chelating agent to be of therapeutic use and then she later came to the belief that deferiprone could also cause toxicity issues [2]; she reported this to the Canadian division of Apotex Inc. that was sponsoring the trials [1]. Apotex Inc disputed her findings regarding the potential risk to patients and advised Dr. Olivieri that she should not be informing her patients about these unproven risks. The next step taken in this case was done by Dr. Olivieri, who brought her findings to the Research Ethics Board (REB) at the Hospital For Sick Children. Dr. Olivieri's findings were substantial enough that the REB instructed her to report her findings to the Health Protection branch, a section of Health Canada, and to other doctor's who are involved in any way with deferiprone [1]. Along with instructing Dr. Olivieri to report the findings, the REB advised Dr. Olivieri to request changes to the research consent forms to allow for patients to be informed of the risk. Upon hearing this request to change the consent forms, Apotex immediately terminated the clinical trials and told Dr. Olivieri that all information pertaining to the clinical trials was confidential and any mention of her findings would result in legal actions against her unless Apotex approved. Obviously Apotex would never approve Dr. Olivieri to publish any findings that made deferiprone seem unsafe; which is the main issue surrounding this legal situation. There are many people who support the right of Dr. Olivieri to publish her academic findings, regardless of any confidentiality agreements, so long as the health and safety of the patients are priority. There are also many people who believe that the confidentiality agreement entered into by Dr. Olivieri should be honoured, regardless of potential risks to patients.

In 2000, after being harassed by Apotex for several years, Dr. Olivieri filed a defamation class action lawsuit against Apotex. Apotex responded by launching their own counter defamation class action lawsuit against Dr. Olivieri. The legal battles went on for just under four years, 2004, until eventually a settlement was reached were both parties agreed to 'not to disparage one another' and Apotex was ordered to pay Dr. Olivieri $800,000[5]. However, believing in her right of academic freedom, Dr. Olivieri published several papers and gave several presentations on the risks of deferiprone and about the unethical practices of Apotex, which Apotex believed to be in direct violation of the 2004 settlement agreement. Due to her actions, Apotex believed that it was not entitled to pay Dr. Olivieri that money saying that she breached the agreements of the settlement; disputes over this payment went on for four years until the Supreme Court of Ontario's justice George Strathy ordered Apotex to make the payment to the doctor [4]. This resulted in the filing of another class action defamation lawsuit by Apotex against Dr. Olivieri where Apotex had claimed half a million dollars in damages while giving 35 examples of conduct that breached the 2004 settlement [5]. This legal battle is still going and none of the charges have been proven in the Supreme Court of Ontario. Legal analysts say that Apotex could actually end up being rewarded $800,000, the amount it was required to pay out to Dr. Olivieri in 2008. The main reason for the length of the trial is that Apotex is defining 'disparaging' is too broad; which is preventing the courts from believing that Dr. Olivieri has committed actions which violate the 2004 settlement.

The University of Toronto, being an academic institution, ended up on the side of Dr. Olivieri, siting that Apotex had acted inappropriately and that it was the university's responsibility to defend Dr. Olivieri. Nothing ever became of this except for a statement released by the university asking Apotex to desist legal action against Dr. Olivieri [1].

The Hospital For Sick Children never took any action to support Dr. Olivieri; there is evidence that the hospital actually tried to go against Dr. Olivieri [3] even though she was employed at the hospital at the time. The hospital was well aware that Dr. Olivieri's freedom of academic expression was being violated but did nothing because it did not want to get openly involved in the dispute between academics and industry since the hospital is heavily associated with both ends of the science spectrum.

Though the University of Toronto believed that Dr. Olivieri had a right to express academic freedom it never actually supported Dr. Olivieri in any way during the legal battles she and several other doctors supporting her fought over a period of several years. This may have been caused in part by fact that the university was negotiating a 30 million dollar donation from Apotex to the university and its affiliated hospitals, which includes the Hospital for Sick Children [6]. This led Dr. Olivieri to file a class action lawsuit against the University of Toronto and Hospital Sick Children, whom she was both employed by at the time, feeling that it was the responsibility of her employers to legally defend her right to speak freely about her academic work. The details surrounding the settlement have been kept confidential, although several estimates have the settlement as being quite a generous figure which will allow Dr. Olivieri to continue her research for the foreseeable future without having to rely on the University of Toronto or the Hospital for Sick Children [6].

__**References for this page**__ [1] F. Baylis. 2004. The Olivieri debacle: where were the heroes of bioethics? //Journal of Medical Ethics// 30; pp. 44 - 49. doi: 10.1136/jme.2003.005330 [2] N. Olivieri, G. Brittenham, C. McLaren, D. Templeton and A. Burt. 1998. Long-Term Safety and Effectiveness of Iron-Chelating Therapy with Deferiprone for Thalassemia Major. //The New England Journal of Medicine// 339 (7); pp. 417 - 424. [3] J. Thompson, P. Baird and J. Downie. //Report of the committee of inquiry on the case involving Dr. Olivieri, the Hospital for Sick Children, the University of Toronto and Apotex Inc. Toronto.// CAUT, 2001. [4] CAUT. 2012. Apotex vs. Olivieri: An Attack on Academic Freedom. //CAUT Bulletin// 59(2). [5] E. Church. New Chapter in Apotex Legal Battle. FAIR Magazine/Globe and Mail. December 1st, 2008. [6] A. McIlroy. //Olivieri, supporters reach settlement:Scientists reach deal with U of T, hospital in fight over academic's right to speak freely.// Globe and Mail. November 13, 2002.