Friday, April 28, 2000 Olivieri case referred to regulatory body
Marina Jimenez
National Post
TORONTO - The Hospital for Sick Children has referred its concerns about Dr. Nancy Olivieri's interaction with patients during a drug trial to the College of Physicians and Surgeons.
The hospital's medical advisory committee spent 16 months investigating two central questions: Dr. Olivieri's alleged failure to report her concerns about the toxicity of L-1 to the research ethics board; and her continued use of the drug with patients.
Committee officials said yesterday they were prompted to refer the matter to the College of Physicians after being unable to "obtain a full and timely" response from Dr. Olivieri, who they said declined five invitations to meet with them.
"I can't speak for Dr. Olivieri in terms of why she has not responded in a way her colleagues would respond," said Sandy Aird, chairman of the board of trustees for the hospital. "We've encountered one roadblock after another ... We just want to get at the truth."
Unlike the hospital's 20-member medical advisory committee, which depends on the collegiality of physicians, the College of Physicians is a regulatory body with the power to investigate complaints and compel doctors to appear, Mr. Aird said.
Dr. Olivieri did not return the National Post's calls. But her lawyer issued a statement saying the hospital had abdicated its responsibility to conduct a fair investigation, and at the same time "attempted to smear Dr. Olivieri by insinuating that the allegations have substance and merit."
Dr. Paul Ranalli, a neurologist and a key supporter of Dr. Olivieri's, said she has all the documents to prove she behaved appropriately. "The hospital has implied the complete opposite of what happened," he said. "Dr. Olivieri was the first to alert patients and family members of the potential for toxicity of this drug."
Dr. Olivieri did submit three volumes of documents to the investigating committee, but declined to answer questions directly, said Dr. Larry Becker, head of the hospital's medical advisory committee.
Dr. Olivieri first raised the issue of L-1's toxicity in December, 1996, at the American Society of Hematology conference. She spoke of a drug in the same family as L-1 that causes liver damage in animals, and then described a progression of liver damage in eight patients with thalassemia, an inherited blood disorder, on L-1.
The following month, she drafted and later sent a letter to the U.S. Federal Drug Agency, saying no patient should remain on L-1 because of evidence it could exacerbate liver damage.
Yet, according to Dr. Becker, there are records of prescriptions written for patients as late as mid-February, 1997. As well, a research abstract notes that some of Dr. Olivieri's patients were studied until May, 1997. "This is an inconsistency," Dr. Becker said. "It's a mystery we'd like an answer to."
The hospital has asked the University of Toronto's chair of medicine to investigate allegations Dr. Olivieri failed to notify the research ethics board of her concerns that L-1 is toxic.
In her statement, Dr. Olivieri complained about the conduct of the hospital's medical advisory committee, noting it: heard witnesses in secret, failed to allow Dr. Olivieri's counsel to cross-examine witnesses, failed to disclose documents or respond to her lawyer's requests for information.
The college said it will review the matter to determine if there is enough evidence to refer it to a disciplinary hearing, which is open to the public.
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