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> The Apotex/UofT saga
      - Introduction
      - Olivieri NEJM paper
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      - Role of Sick Kids
      - Role of the U of T
      - Role of Apotex
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WHY WE EXIST - THE APOTEX / UofT SAGA
Introduction

Excerpt from:
A Historic Case of Academic Freedom

Prof. Arthur Schafer, Director of the Centre for Professional and Applied Ethics at the University of Manitoba, has called the Olivieri case "the greatest academic scandal of our era". Not since the Crowe case at United College (now University of Winnipeg) in the late 1950s has there been a case of such magnitude and historic importance. The Crowe case dealt with religion and the church. In our era the problem is the corrosive effects of for-profit corporations on our public institutions, such as hospitals and universities. "The federal government's encouragement of partnerships between such public institutions and private companies is a response to its failure to provide adequate funding for research", said Bill Graham. "The scandal at HSC is a symptom of the sickness inside Canadian health care and research funding".

At the time of the scandal the University of Toronto was in the process of negotiating a corporate donation of 20 to 30 million dollars for a new medical building from the same drug company, Apotex Inc., which is at the heart of the HSC scandal.

Prof. Nancy Olivieri's research is of immense importance locally and internationally. The two inherited blood diseases, thalassimia and sickle cell disease, are the world's most common single gene disorders. They presently affect 1 in 7 people on the globe, mostly from the Mediterranean, Asia, the Middle East, Africa and Indonesia. Prof. Olivieri's clinical research program is the key link in the international chain of research into finding an effective and humanly acceptable treatment. That is because Toronto has the largest multicultural population of any large city in the world. The only effective treatment so far is very painful and difficult for patients to maintain. Apotex's drug, deferiprone, seemed a likely candidate, but Olivieri found that it was not effective in many cases; later she found that it was actually toxic. She informed her Research Ethics Board, her patients, and the federal regulatory bodies. She published her findings in the prestigious New England Journal of Medicine. Apotex Inc. threatened her with legal action because the contract she signed contained a confidentiality clause. Neither the Hospital nor the University provided her with legal and professional assistance, despite her pleas.

After much delay, HSC unilaterally set up a review process headed by Arnold Naimark, former President of the University of Manitoba. Naimark had a previous relationship with the drug company, Apotex, and was a Director on the CIBC Board of Directors chaired by Al Flood, who is also a member of the HSC Board of Trustees. Prof. Olivieri refused to cooperate with the Naimark review after HSC disregarded her suggestions for two additional members and gave Naimark carte blanche to select his own additional members, which he did after the bulk of the evidence and interviews were already completed.

UTFA and CAUT Enter the Picture

In November 1998 the CAUT Council unanimously adopted a statement deploring the lack of response by U of T and HSC and calling for in independent and unimpeachable inquiry into the scandal. Bill Graham and Rhonda Love met with President Prichard and Provost Sedra to urge them to call for an untainted, independent inquiry; but they refused. On December 3rd the U of T issued a 12 point position statement on the Olivieri case, saying that, while Prof. Olivieri is "a respected and valued member of the Faculty of Medicine with a distinguished record of academic achievement," and "is entitled to the full freedoms, rights and privileges of all members of the faculty including vigilant protection of her academic freedom," the University supports the Naimark review and "regrets Dr. Olivieri's continuing refusal to participate" in it. The Naimark Report was issued on December 8th. CAUT's press statement said it "does not deserve the stamp of credibility" because it "glosses over major Hospital failures" and wrongly blames Olivieri for allegedly failing to report her findings of toxicity to the Research Ethics Board.

On December 16th UTFA filed grievances on behalf of Olivieri, Gallie, Chan, and Durie, charging the University with failing to protect their academic freedom and to protect them from discrimination, harassment and intimidation. It filed an Association grievance, charging the University with violating policies guaranteeing faculty members certain rights and freedoms. Ironically, it was on that very day that HSC, in a closed meeting of its "Chiefs," fired Olivieri as Director of the Haemoglobinopathy program because of a letter written to HSC by Olivieri's lawyers, Clayton Ruby and Beth Symes. The letter referred to the ethnic backgrounds of the patients in Olivieri's Program and stated that as the number of patients had grown from 150 to 450 the clinical support had been reduced by 42%. It asked for additional coverage to enable Prof. Olivieri to meet the terms of her research grants and still be able to supervise the clinical care of the patients.

21 Days in January

On January 6th, 1999 Prof. Olivieri and her Counsel met with HSC administrators to address the needed additional support for the Program in Haemoglobinopathy. Instead, she was handed a letter of dismissal as Director and a "gag order," accusing her of "a concerted effort to discredit the Hospital leadership, thereby undermining public confidence in the Hospital." The same "gag order" was delivered to Profs. Gallie, Chan, and Durie. The letter of dismissal contained an entirely different set of allegations from those minuted in the Chiefs' meeting of December 16th.

CAUT and UTFA held a press conference the next day, denouncing her dismissal as Director because carrying out her clinical research required her to have full responsibility for the patients in the Program. They demanded her immediate reinstatement and the creation of an independent inquiry into the scandal. Profs. Gallie and Durie, defying the "gag order," also spoke at the press conference. Letters from physicians around the world, including Drs. Weatherall and Nathan, began to pour into the University and the Hospital, all demanding Prof. Olivieri's reinstatement so that her world-class research could continue unimpeded. Derek Bok, former President of Harvard, also telephoned the University. The Alliance for Public Accountability, the Urban Alliance on Race Relations, and other groups wrote; the American Association for the Advancement of Science asked for particulars.

But the University of Toronto remained unmoved. Against the advice of the world experts on clinical trials and the diseases in question the University was listening to its own "colleagues" at HSC who insisted that removal as Director would not affect Prof. Olivieri's ability to carry out her research. They were willing, they said, to have a "colleague," appointed by Dean Aberman in consultation with Prof. Olivieri, carry out a review of the opposing opinions.

At a Joint Committee meeting with the University administration on January 11th, UTFA argued that Prof. Olivieri had been dismissed in violation of University policies and natural justice, and demanded she be reinstated prior to any discussion of a review. The U of T Bulletinreported that Prichard characterized UTFA's position as creating a "catch 22." Rhonda Love said, in response, that "the administration was definitely in a difficult situation, but it was not of our making. Prof. Olivieri is entitled to peer review, and her peers happen to be in the U.K. and U.S.A."

UTFA also brought to the administration's attention that the Affiliation Agreement between HSC and the U of T had expired on December 31st, 1998. It warned the administration not to renew the Agreement without ensuring full rights and freedoms for clinical faculty members at HSC. Two days later, on January 13th, the University rushed through a renewal of the Agreement for one year. It did not demand protections for faculty members at HSC, but merely expressed the University's "intention" to "begin a process of negotiation. . . to discuss the harmonization of policies in keeping with the recommendations of the Naimark Report." UTFA immediately added the issue to its Association grievance.

Sir David Weatherall of Oxford and Dr. David G. Nathan of Harvard came to Toronto, at the request of CAUT, along with Dr. John Porter, Professor of Medicine at University College, London, and Dr. Alan Schechter of Bethesda, Maryland. All are international experts on clinical trials and haemoglobinopathies. At first, a scientific review of Prof. Olivieri's Program was planned in order to address the relation between the leadership of the Program and the clinical research, and also the proper level of institutional support needed to maintain the Program. But the University President intervened, objecting to the review and to the participation in it of Drs. Weatherall and Nathan because they had declared themselves on the side of Olivieri. CAUT responded by inviting them to Toronto to attempt to convince the University that Prof. Olivieri's research would be destroyed by her removal as head of her Program. Drs. Porter and Schechter, then, undertook to carry out the scientific review. They spent several days in Toronto, meeting with Prichard, Aberman, and many others. Their report will be forthcoming.

In the meantime, on January 12th, Provost Sedra wrote to UTFA to say that the President had been informed of Prof. Olivieri's dismissal several days prior to its being announced, and that he had cautioned HSC that Olivieri should be given a chance to respond to the allegations against her before any final decision was made. Sedra reported that the President had warned HSC that "in the absence of such a process, the University could not support the Hospital's decision." Clearly, HSC had disregarded the President's warning. Yet, the Provost argued that the University did not have the jurisdiction to order Prof. Olivieri's reinstatement, but it "remains fully committed to ensuring that Dr. Olivieri's freedom to undertake her research is unimpeded."

UTFA responded, saying the University had (1) failed to come to her defense when she was threatened by Apotex; (2) failed to conduct its own inquiry into the scandal at HSC, and to support CAUT's call for an independent inquiry; (3) failed to advise Prof. Olivieri and UTFA of the Hospital's decision to dismiss her; (4) failed publicly to protest the "gag order" imposed by HSC on Olivieri and her colleagues; (5) failed to take steps to have her reinstated so she could continue her research; and (6) failed to seize the opportunity, given the expiration of the Affiliation Agreement, to ensure that Prof. Olivieri and other clinical faculty members at HSC are fully protected by the University's policies on faculty rights and freedoms, including academic freedom.

The University continued to ask for a review carried out by one of Dean Aberman's "colleagues." They had refused to take the advice of Prof. Brenda Gallie, Prof. Olivieri's immediate research supervisor, on grounds that she had launched a grievance against the University. At the request of the Provost, UTFA and CAUT arranged to have Prof. Olivieri herself give testimony to the administration as to why her research was destroyed by her dismissal. The meeting was held on January 20th. The meeting lasted for more than three hours as Prof. Olivieri spoke in great detail about her clinical research program and answered all the questions put to her by the President, Provost, and Dean. The administration then caucused. When they returned, they reverted to the question of which of the Dean's "colleagues" could carry out the review of who was right: the international experts or the HSC "colleagues," none of whom was an expert in clinical trials.

On the following weekend, Drs. Weatherall, Nathan, Porter and Schechter arrived in Toronto at the invitation of CAUT. It was then that the University decided to act. "To their credit," said UTFA/CAUT President Bill Graham, "the University, in the end, did the right thing. They weighed in against the Hospital to bring about Olivieri's reinstatement as head of the program. President Prichard deserves our deep gratitude. This has been a success story from the sides of U of T, UTFA and CAUT." "But," he added, "the scandal at HSC remains to be thoroughly investigated. CAUT's Academic Freedom and Tenure Committee will take up the issue of an independent inquiry at its next meeting. We hope the University will participate in the inquiry when it is launched."

 
Copyright 2001 Doctors for Research Integrity.