Toronto to investigate drugs firm

September 18, 1998

Canada's highest-funded medical research university has agreed to investigate allegations that a pharmaceuticals company suppressed negative findings on one of its drug trials.

Leading researchers at the University of Toronto threatened to take their work elsewhere if an investigation was not launched into the case of Nancy Olivieri, a professor of paediatrics and a renowned blood researcher at The Hospital for Sick Children, who was threatened with legal action after breaching a confidentiality agreement with Apotex Inc.

In 1995, the Canadian pharmaceuticals firm began funding her research into a drug that helped reduce the iron build-up in thalassaemia patients who have had to receive frequent red blood cell transfusions.

An early trial showed some success for the yet-to-be approved drug, deferiprone (also known as L1), with patients showing a steady decline in iron levels. But by autumn 1995, Dr Olivieri and colleague Gary Brittenham began seeing a drop in the drug's effectiveness. They took those patients with rising iron levels off the drug and warned the pharmaceuticals company's head of research of their new findings.

Apotex's senior vice-president of scientific affairs, Michael Spino, downplayed the information. When Dr Olivieri began insisting that a new consent letter be drafted to warn thalassaemia patients of the risks, she was dropped as chair of the study's steering committee and was threatened with legal action if she expressed her views to patients.

Recently, Dr Spino told The Toronto Globe and Mail newspaper: "There has not been an attempt to suppress data, but rather to prevent what we consider to be misinformation from being disseminated."

Despite having lost her position on the study, Dr Olivieri wrote an article in the New England Journal of Medicine and continued to warn colleagues, regulatory officials and patients of her findings.

With the threat of a lawsuit hanging over her, research colleagues became disenchanted with the university and its affiliated teaching and research hospital for not coming to the researcher's defence.

More than half of the hospital's researchers and doctors signed a petition calling for an investigation. The university told The THES it saw the matter as a scientific dispute and had to try to mediate between the doctor and the company.

On September 9, the hospital announced it would hold an investigation. It named Arnold Naimark, director of University of Manitoba's centre for the advancement of medicine, to review the circumstances relating to the L1 clinical trial.

Dr Olivieri said she was disappointed with the announcement. The parameters of the inquiry had been set up despite recommendations from Dr Olivieri's representatives that at least five people with expertise in medical ethics, conflicts of interest and clinical trial methodologies and regulation be named.

Dr Olivieri said that the "unilateral decision to appoint only one scientist raises serious concerns".

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