March 27, 2001  
NE09
U OF T, 8 HOSPITALS SET POLICY ON RESEARCH FINDINGS
--- OLIVIERI-APOTEX WOES 'AVOIDABLE'
By Vanessa Lu - Health Policy Reporter
       

The University of Toronto has reached an agreement with its eight teaching hospitals on setting out research policies and ethical guidelines, including one that might have prevented the entire Nancy Olivieri controversy.

Under the new policy, it states "peer review is the cornerstone of excellence in research and that scientists should have the right to disseminate the results of their findings."

It means no agreements will be negotiated "that allow research sponsors to suppress or censor research results."

Olivieri has been embroiled in a bitter fight with the Hospital for Sick Children and the University of Toronto over her research into the drug deferiprone, made by Apotex.

Apotex, which terminated a clinical trial in 1996, threatened to sue Olivieri for violating a confidentiality clause after she indicated she would go public with her concerns about the drug's safety.

Apotex maintains the drug, which is used to treat thalassemia, a rare genetic blood disorder, is safe.

U of T's dean of medicine Dr. David Naylor said he believed if the new research policies had been widely implemented the whole Olivieri-Apotex conflict would likely have been avoided.

"It would have precluded much of the trouble that arose," Naylor said. "Every contract must have an exit provision that allows for the reasonable exercise of discretion to draw concerns to public attention."

The policy also states that all contracts must have a mechanism to resolve disputes, such as ensuring safety questions can be adjudicated.

As well, Naylor said an industrial sponsor would only be allowed a delay of six months for patent work or market research before research would be published.

"The concept that one could indefinitely suppress or censor the results is not acceptable," he said.

When contacted for comment yesterday, Olivieri would say only, "I'm surprised because my very recent dealings with a clinical trial agreement seems completely inconsistent with this statement."

Naylor emphasized that while the Apotex controversy has drawn much media attention, there are often conflicts among researchers, colleagues, sponsors and students.

"This is not just about one incident. This is a worldwide set of trends and pressures," he said, adding biotechnology research is expected to grow with a focus on genetic and molecular medicine.

"The stakes will be higher because of genetic issues. We will also see continued expansion of industry sponsorship for research," Naylor said. "The more discoveries you make, the more pressure there will be to bring those discoveries to application."

Naylor said the agreement takes a tougher line on declaration of conflicts of interest.

The affiliated U of T hospitals are Sunnybrook and Women's College Health Sciences Centre, The Hospital for Sick Children, Mount Sinai, University Health Network, St. Michael's, Centre for Addiction and Mental Health, Baycrest Centre for Geriatric Care and Toronto Rehabilitation Institute.

 
       
Copyright (c) 2001 The Toronto Star