The committee of inquiry into the dispute involving Dr. Nancy Olivieri, the Hospital for Sick Children, the University of Toronto, and Apotex Inc. issued its long awaited report in October. Two years in the making, the report warns tougher measures are needed to protect patients' rights and ensure clinical drug trials are free from the influence of drug manufacturers.

"What happened in this case could happen in any part of the country," said Jon Thompson, who chaired the committee. "The controversy arose in a context where public institutions now have to rely more on funding from private corporations, but haven't put in place adequate policies and practices to protect the public. A series of misrepresentations, mistakes and misjudgments compounded the problem in this case."

The case of University of Toronto clinician Dr. Nancy Olivieri has been the focus of international attention since Apotex, corporate sponsor of her clinical drug trials of its drug, attempted to suppress her findings of unexpected risks. The company abruptly terminated the trials and issued warnings of legal action against Olivieri should she inform her patients at the Hospital for Sick Children of the risks, or publish her findings.

The committee of inquiry found that despite the interference by Apotex, Olivieri fulfilled her ethical obligations. After the controversy became public in 1998, she was nevertheless accused of misconduct by Apotex and certain senior hospital and university staff. The committee's report documents that these allegations were incorrect, yet were used by the hospital as the basis for serious public actions against Olivieri. Apotex subsequently used the hospital's actions to defend the reputation of its drug.

"The hospital and the university should have defended vigorously the right of clinical researchers to disclose risks to research subjects and patients," said committee member Patricia Baird. "They had a responsibility to protect the public interest and academic freedom from inappropriate actions by Apotex, but they did not do so."

CAUT is demanding the Hospital for Sick Children, the University of Toronto and Health Canada immediately act on the recommendations of the committee.

"The seriousness of this case demands immediate action," said CAUT president Tom Booth. "The ethical duties of researchers, academic freedom, the rights of patients and the public interest must never again be compromised in this way."

The committee's report contains 31 recommendations, including:

• Contracts involving industrial sponsorship of clinical research should never prevent researchers from informing patients or the scientific community of any risks.
  
• All universities and affiliated teaching hospitals should have in place policies and practices that are effective in protecting academic freedom, as well as principles of research and clinical ethics.
  
• Health Canada should review the current regulation of health research and make appropriate changes to protect the public interest and the rights of patients who volunteer to be subjects of research.
  
• The university and the hospital should provide redress to Olivieri for the unfair treatment she has received.
  

Committee member Jocelyn Downie said tougher new national standards governing clinical research are desperately needed to replace the patchwork of different rules that currently exist.

"Conflicts of interest are not being properly dealt with through current rules and regulations governing research," she stated. "The safeguards we have now aren't working."

The report also calls on the hospital and the university to address inappropriate conduct by certain individuals and committees. It details instances of false and misleading testimony presented to reviews established by the hospital, and cases where researchers published favorable findings on Apotex's drug, but failed to disclose their funding support by the company. Failures by hospital administrators and committees to provide due process are documented.

"One critical lesson to be learned is that it's essential medical faculty be given the same rights of academic freedom as all other faculty members," Booth said. "Without that protection and guarantee of independence, the integrity of clinical research will be compromised and the public interest will suffer."

Rhonda Love, president of the University of Toronto Faculty Association, welcomed the report, and said it's timely given the University of Toronto is currently in negotiations with its teaching hospitals over an alternative funding arrangement that would strip clinical faculty of academic freedom.

"If this arrangement is concluded, the Olivieri case could be the tip of a very big iceberg," Love said.

The report also criticizes CAUT for not acting quickly enough to defend Olivieri after first learning of the details of the case.

"We recognize we have to change the way we deal with cases involving violations of academic freedom," Booth admitted. "We will be acting more quickly and more aggressively to defend academic freedom."

He said CAUT will use the report to campaign for fundamental reforms to ensure university researchers are freed from the influence of special interests.

"As a first step, universities and teaching hospitals should prohibit any contracts and agreements with industry sponsors that in any way prevent researchers from disclosing risks to the public," he said. Adding that "Health Canada should mandate that no clinical researcher ever be required to give up the duty to disclose risks to patients."

The committee of inquiry was established in 1999 by CAUT. While appointed by CAUT, members of the committee agreed to serve without remuneration and only on condition they would be independent of CAUT and any other person and organization.

The committee's 500 page report is available at on the CAUT website. The Olivieri Report, published by James Lorimer & Company Ltd, is also available in bookstores, or through Formac Distributing.