The Greatest Academic Scandal of Our Era

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Subject: The Greatest Academic Scandal of Our Era
The Greatest Academic Scandal of Our Era
by James Turk, Executive Director, CAUT
The following article is reprinted with the permission of the author. It first appeared in the University of Calgary Faculty Association newsletter, "Interview", May 1999.

"The greatest academic scandal of our era" is how Professor Arthur Schafer, Director of the Centre for Professional and Applied Ethics at the University of Manitoba, has described the widely-reported case of Dr. Nancy Olivieri. The experiences of Dr. Olivieri highlight the question about the proper relationship between university researchers and private industry.

Dr. Olivieri is a clinical professor at the University of Toronto and the Hospital for Sick Children and a world expert on the blood disorders -- thalassimia and sickle cell disease. Her clinical research program in Toronto is the key link in an international chain of research centres focusing on these diseases.

In the course of her research on a new medication to treat thalassimia, Dr. Olivieri concluded that the new drug may have serious negative consequences for some patients. She felt obliged to publicize her findings but was threatened with a lawsuit by Apotex, Inc., a Canadian drug maker that had been funding her clinical trials. Dr. Olivieri had signed a confidentiality agreement with Apotex some years earlier.

Dr. Olivieri turned to the Hospital for Sick Children and the University of Toronto for support in her quest to fulfil her medical and public responsibility to publicize her findings. She found no support. Nevertheless, she informed her Research Ethics Board, her patients and the federal regulatory bodies. She then published her findings in the New England Journal of Medicine. Subsequently, the Hospital stripped her of her responsibilities as director of its haemoglobinopathy program, and the University of Toronto refused to intervene with the Hospital or Apotex. During this period, the University was negotiating with Apotex for a multimillion-dollar donation to the University for a new medical building.

After considerable pressure from Dr. Olivieri´s colleagues and other researchers as well as substantial media attention, the Hospital unilaterally set up a limited review process headed by Dr. Arnold Naimark, a former president of the University of Manitoba. His impartiality was in question because the U of M had received a donation from Apotex during his presidency. Amidst considerable criticism of the inquiry, Dr. Naimark added two additional inquiry members after most of the inquiry´s work was completed.

At that point, last November, the Canadian Association of University Teachers (CAUT) jumped into the fray. CAUT Council unanimously passed a resolution deploring the actions of the Hospital for Sick Children and the University of Toronto. CAUT called for a genuinely independent inquiry and asked CAUT´s Academic Freedom and Tenure Committee to examine the matter.

In mid-December, the University of Toronto Faculty Association (UTFA) filed grievances on behalf of Dr. Olivieri and several of her colleagues who had also been disciplined by the Hospital charging the University of Toronto with failing to protect their academic freedom and to protect them from discrimination, harassment and intimidation. It also filed an Association grievance charging the University with violating policies guaranteeing faculty members certain rights and freedoms.

Later, it was learned that the very same day the Hospital had had a secret meeting of its chiefs of services and decided to fire Dr. Olivieri as Director of the Haemoglobinopathy program because they objected to the tone of a letter written by Dr. Olivieri´s lawyers. But it was not until January 6, 1999, that Dr. Olivieri was informed of her dismissal as Director. Simultaneously, Dr. Olivieri and three of her colleagues -- including the head of cystic fibrosis research, the head of blood and cancer research and a senior research colleague of Dr. Olivieri -- were slapped with a gag order forbidding them to talk with the media except if authorized by the Hospital. The reason given for Dr. Olivieri´s dismissal bore no resemblance to the minuted item for the December "chiefs" meeting. The Toronto Globe and Mail published a leaked copy of that meeting´s minutes.

CAUT and UTFA held a press conference the next day, denouncing Dr. Olivieri´s dismissal and demanding her immediate reinstatement. Letters from eminent researchers from around the world began to pour into the Hospital and the University, expressing outrage at the treatment of Dr. Olivieri and her colleagues.

The University and the Hospital remained unmoved. When CAUT and UTFA discovered, days later, that the affiliation agreement between the University and the Hospital had expired on December 31, both organizations approached the University and insisted that it not renew the agreement until full academic freedom for clinical faculty at the Hospital was assured. Two days later, in secret, the University renewed the agreement without the necessary assurances of academic freedom.

CAUT asked several of the world´s leading medical researchers to come to Toronto to intervene in this matter. Sir David Weatherall of Oxford; Dr. David Nathan, head of the Dana Farber Cancer Institute at Harvard; Dr. John Porter, Professor of Medicine at University College, London; and Dr Alan Schechter of the National Institute of Health in Bethesda, Maryland, all accepted the invitation and came to Toronto. All are experts on clinical trials and haemoglobinopathies.

Drs. Porter and Schechter undertook a review of Dr. Olivieri´s program and Drs. Nathan and Weatherall joined CAUT President Bill Graham, CAUT AF&T Chair Pat O´Neill, representatives of UTFA and of the researchers in a series of meetings with U of T President Rob Prichard and other U of T and Hospital officials.

The meetings won vindication for Dr. Olivieri and her colleagues. Dr. Olivieri was reinstated as head of her research program, reporting directly to the Toronto Hospital´s Physician-in-Chief, and remains on active staff at the Hospital for Sick Children. The HSC will cover her legal costs up to $150,000 and will assume responsibility for legal costs should Apotex sue her for releasing her research findings. Dr. Olivieri will receive a 6-week "mini-sabbatical" now and a 12-month paid sabbatical within the next three years. The HSC has withdrawn its gag order, and the U of T´s Dean of Medicine has agreed to provide Dr. Olivieri with an additional $45,000 in each of the next two years for senior research support.

This agreement leaves unresolved the larger issue of academic freedom for clinical faculty. As well, there still has been no proper investigation of the attempts to prevent Dr. Olivieri publishing her findings nor a revised agreement with the Hospital to prevent such occurrences in future.

CAUT´s Academic Freedom and Tenure Committee is continuing its review of the case. CAUT is also asking all faculty associations at universities with medical schools and teaching hospitals to gather the university-hospital affiliation agreements. CAUT will systematically review these agreements and report on their findings.

CAUT is also exploring the broader issue of corporate-university partnerships and what is required to assure academic freedom and university autonomy.
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http://www.mcmaster.ca/mufa/turk.htm

[21-07-2006,10:18]
Anonymous
(in reply to: The Greatest Academic Scandal of Our Era)
It was a medical scandal, involving the Hospital for Sick Children and UofT med school.

The Globe and Mail
October 31, 2001

Scientific inquiry:
The fight´s just starting
By NANCY OLIVIERI

The Report of the Committee of Inquiry on the Case Involving Dr. Nancy Olivieri, the Hospital for Sick Children, the University of Toronto, and Apotex Inc. is hard for me to read. It opens old wounds for me and my closest supporters as we study its 540 pages.

The Report relates what happened to us after I insisted on reporting unfavourable results on a new drug being tested by me in clinical trials to my patients in those trials and in others worldwide, the scientific community and regulatory agencies.

Apotex, the drug´s manufacturer, disputed my findings. It threatened legal action should I inform patients or publish my findings, and abruptly terminated the trials. Neither the University of Toronto nor The Hospital for Sick Children, both anticipating large donations from Apotex, supported me in fulfilling my ethical obligations to my patients or my scientific obligations to the public. The report makes a series of general recommendations that, if enacted, would help ensure both medical research and the public interest are protected from inappropriate corporate influence.

As it documents, what followed my announcing my findings was five years of personal vilification, reprisals, and harassment. It notes that The Hospital for Sick Children´s Physician-in-Chief, Dr. Hugh O´Brodovich "put forward incorrect allegations and testimony" against me to the Hospital´s Medical Advisory Committee. It says that Dr. Gideon Koren, the previous Associate Director of the Hospital´s Research Institute "attempted to discredit Dr. Olivieri by dishonest means" and was responsible for forwarding anonymous hate mail to my colleagues. Following Apotex´s termination of the clinical trials, it says, Dr. Koren continued to receive funding from Apotex, which in turn continued to promote his scientific opinions regarding its controversial drug.

I am pleased that the report fully vindicates me. But after five years, my colleagues and I have lost faith in the administrations of the hospital and University of Toronto, whose duty it is to protect researchers´ academic freedom and the public´s right to know. More important than setting the record straight are the general lessons to be learned from this saga.

The Committee of Inquiry´s first recommendation is to require that all agreements for industrial sponsorship of clinical research should expressly insist that investigators not be prevented from informing patients, other researchers and physicians, and the scientific community of any perceived risk. (Contrary to the university´s recent claims, every day restrictive contracts are offered to researchers and are still not being challenged by its administration.)

The report calls on every Canadian university, faculty of medicine, and university-affiliated health-care institution to put in place a policy consistent with its industrial sponsorship recommendation. It urges the Association of Universities and Colleges of Canada to develop and enforce a policy governing industry-university relationships. It calls on the Canadian Association of University Teachers to find new ways of vigorously defending the academic freedom of clinical researchers, and it recommends that AUCC and CAUT co-operatively undertake an ongoing program to promote academic freedom and ethical conduct of research.

Finally, it recommends that Health Canada impose a requirement that clinical investigators neither be asked, nor agree, to limit their freedom to disclose risks in any drug trials, calling on Health Canada to conduct an independent investigation when a clinical trial is prematurely terminated as a result of a dispute between the sponsor and researcher over any risk to patients.

All these general remedies should be acted on immediately. But my experiences at The Hospital for Sick Children and the University of Toronto make me pessimistic: Real change will only happen when the respective boards of these institutions recognize that they have a duty to govern on behalf of the public. They should have taken the lead in insisting on protection of the public interest, but over and over, failed to do so.

The report concludes: "Given the current absence of the necessary protections [the situation my colleagues and I faced] could occur at many institutions across Canada." And that´s the real issue in this case - the responsibility of our universities and university-affiliated hospitals to serve the public interest, even when it means standing up to powerful corporations who provide desirable funding and whose resources will always outstrip those of a group of scientists.

Not one of us believes that the report represents the end of this struggle -- that´s still being fought, on several fronts. But if we act on the committee´s recommendations, it might be the end of the beginning.

Nancy Olivieri, on staff at The Hospital for Sick Children, is on sabbatical at the University of London, where she is reading for a masters in medical ethics and law.

[21-07-2006,14:54]
Anonymous
(in reply to: The Greatest Academic Scandal of Our Era)
I´m not reading all of that. Summarize it, bitch.
[22-07-2006,12:45]
Anonymous
(in reply to: The Greatest Academic Scandal of Our Era)
^ troll, seriously, turn off your computer and go to bed. You have been at this for at least the past 4 days. You are going to go mad if you don?t stop. The human brain needs some rest, and you need help. Tomorrow morning is good time for you to take the first step and seek help. I recommend you walk into the hospital with a paper bag over your head, a sign around your neck "I seek help", and walking up and down the main entrance ringing a bell. They will then take you to happy place with lots of happy pills. This is a flame, nobody should respond.
[22-07-2006,15:07]
Anonymous



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