Medical researchers are warning that a "poisoned" atmosphere has developed at Toronto's renowned Hospital for Sick Children as a result of legal threats and intimidation by a pharmaceutical company against one of the hospital's doctors.
Dr. Nancy Olivieri has been the target of legal threats by Apotex, a Toronto-based drug manufacturer, since going public with the negative results of her study of the company's drug deferiprone. The company is touting the medication as a treatment for thalassemia, a potentially deadly disorder that causes iron to accumulate in the liver and heart.
The company began studying the drug in 1993, and in 1996 Dr. Olivieri was given a research contract to further investigate the drug's effectiveness. She also signed a confidentiality agreement with Apotex. But after her study began to show that the drug was failing in nearly 40 percent of her patients, she went public with her findings, most recently in the New England Journal of Medicine.
As the conflict between the doctor and the drug company escalated, Dr. Olivieri hoped the hospital would support her since its own ethics board recommended she disclose her findings to all regulatory and health agencies.
Instead, the hospital, on two occasions, tried to fire her, Dr. Brenda Gallie said.
Dr. Gallie is one of 140 doctors and researchers at the hospital who have signed a petition demanding a review of the relationship between the hospital and Apotex.
"We could be entering a dark age at Sick Kids," she said, adding that the hospital administration has made it "very clear there would be absolutely no effort to investigate the many questions left hanging by the Apotex drug trial issue."
While the hospital has ordered a review of its policies and procedures for clinical trials of drugs, the hospital's relationship with Apotex will not be re-examined, Dr. Gallie said.
Potential conflicts, they claim, include Dr. Michael Spino, a member of the hospital's clinical pharmacology department who is also Apotex' senior vice president of scientific affairs. Though Spino was appointed to the hospital in 1979, before Apotex was founded, his name recently has been removed from the hospital department's letterhead to downplay any suggestion of a conflict of interest, said Michael Strofolino, the hospital's president.
Further fueling the controversy is the battle between Dr. Olivieri and Dr. Gideon Koren, head of the pharmacology department.
Koren, whose research was also funded by Apotex, has defended the drug and accused Dr. Gallie of defaming him by calling the results of his study "obscure" and using shoddy methods to prove a "dangerous" drug is safe.
Despite Dr. Olivieri's "doom and gloom" about the drug, Koren said it works in some cases but not in others and simply needs further study.
Dr. Gallie, the hospital's director of cancer and blood research, said Apotex has used Koren's studies "to say the drug is safe and Dr. Olivieri's interpretation is wrong."
But Koren said he "does not support the drug" and never would do anything to convince anyone about the benefits of the drug.
As a scientist, "I cannot and never intend to," he said.
In a prepared statement, Apotex said its data supports "the safety and efficacy of the drug, and we are proceeding with international regulatory filings for marketing approval."
Trial of the drug is continuing in Italy, the company said, refusing further comment on the dispute with Dr. Olivieri.