Reference no: EM131451436

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THE OLIVIERI CASE

In April 1993, Dr. Nancy Olivieri, head of the hemoglobinopathy program at the Hospital for Sick Children (HSC), the teaching hospital for the University of Toronto in Canada, signed an agreement with the Canadian drug company Apotex to undertake clinical trials on a drug called deferiprone (referred to as L1 during the study). The drug was designed to help children with thalassemia, an inherited blood disorder that can cause the fatal buildup of iron in the blood. The agreement that Olivieri signed with Apotex included a clause (later referred to as a "gag clause") that specifi cally prevented the unauthorized release of any fi ndings in the trial for a period of three years: As you now [sic], paragraph 7 of the LA-02 Contract provides that all information whether written or not, obtained or generated by you during the term of the LA-02 Contract and for a period of three years thereafter, shall be and remain secret and confi dential and shall not be disclosed in any manner to any third party except with the prior written consent of Apotex.

Please be aware that Apotex will take all possible steps to ensure that these obligations of confi dentiality are met and will vigorously pursue all legal remedies in the event that there is any breach of these obligations. The existence of this clause was to prove signifi cant to the relationship between Olivieri and Apotex. After reporting some initial positive fi ndings in the trial in April 1995, Olivieri reported in December 1996 that longterm use of the drug appeared to result in the toxic buildup of iron in the liver of a large number of her pediatric patients-a condition known as hepatic fi brosis. When she reported the fi ndings to Apotex, the company determined that her interpretation of the data was incorrect. Olivieri then contacted the hospital's Research Ethics Board (REB), which instructed her to change the consent form for participation in the trial to ensure that patients were made aware of the risks of long-term use of the drug. After copying Apotex on the revised form, the company notifi ed Olivieri that the Toronto trials were being terminated effective immediately and that she was being removed as chair of the steering committee of the global trial that included patients in Philadelphia and Italy. When Olivieri notifi ed Apotex that she and her research partners, including Dr. Gary Brittenham of Case Western Reserve University in Cleveland, were planning to publish their fi ndings in the August 1998 issue of the New England Journal of Medicine, Apotex Vice President Michael Spino threatened legal action for breaching the confi dentiality clause in her agreement with the company.

Olivieri then asked the HSC administration for legal support in her forthcoming battle with Apotex. The administrators declined. She then approached the University of Toronto, where the dean of the Faculty of Medicine declined to get involved on the grounds that her contract with Apotex had been signed without university oversight and that the university would never have agreed to the confi dentiality clause in the fi rst place. "Olivieri forged ahead with the publication despite this [lack of support] and instantly became celebrated as a courageous whistleblower in the face of corporate greed." The situation was further clouded by reports that the University of Toronto and HSC were, at the time, in the process of negotiating a $20 million donation from Bernard Sherman, the CEO and founder of Apotex. The bitter relationship with her employers was to continue for several years, during which time she was referred to the Canadian College of Physicians and Surgeons for research misconduct and dismissed from her post at HSC, only to be reinstated following the aggressive support of several of her academic colleagues, including Dr. Brenda Gallie of the division of immunology and cancer at HSC, who led a petition drive that succeeded in garnering 140 signatures in support of a formal enquiry into Dr. Olivieri's case. That enquiry was undertaken by both the Canadian College of Physicians and Surgeons, which found her conduct to be "exemplary," and by the Canadian Association of University Teachers, whose 540-page report concluded that Dr. Olivieri's academic freedom had been violated when Apotex stopped the trials and threatened legal action against her.

The two-and-a-half-year battle ended in January 1999 when an agreement was brokered between the university, HSC, and Olivieri thanks to the efforts of two world-renowned experts in blood disorders-Dr. David Nathan of Harvard and Dr. David Weatherall of Oxford who intervened on the basis of the international importance of Dr. Olivieri's research. Working with the president of the University of Toronto, Robert Pritchard, and lawyers for both parties, a compromise settlement was reached that reinstated Olivieri as head of the hemoglobinopathy program at HSC, covered her legal expenses up to $150,000, and withdrew all letters and written complaints about her from her employment fi le. As part of the agreement, a joint working group appointed by the University of Toronto and the university's Faculty Association was chartered with the task of making "recommendations on changes to university policies on the dissemination of research publications and confl ict of interest and the relationship of these issues to academic freedom.