Olivieri Medical Dispute Settled

Olivieri Medical Dispute Settled

On all sides, the relief was obvious. Last week, the poisonous, 2 ½-year feud that pitted internationally acclaimed blood researcher Dr. Nancy Olivieri against the prestige and power of Toronto's Hospital for Sick Children ended in a face-saving compromise. Olivieri, who consistently refused to back down in the dispute over the safety of an experimental drug she was testing, was demoted on Jan. 7 from her position as head of the hemoglobinopathy program at Sick Kids. In exchange for the reversal of that decision, Olivieri, who is also head of a similar program for adults at the Toronto Hospital and a professor at the University of Toronto, agreed to move her office from Sick Kids to the Toronto Hospital next door. The manoeuvre means that Olivieri, who is looking for a cure for sickle cell anemia and thalassemia - inherited and usually fatal blood disorders - will continue to have full responsibility for the care of about 450 children and adults at both hospitals. Olivieri, 44, is clearly relieved that she has her job back and that both she and the handful of colleagues who stood by her can put the ordeal behind them. "The pressures and the humiliation were very difficult," she says.

If the high-profile standoff was unusually acrimonious and protracted, its resolution was stunningly swift. After the demotion, the University of Toronto Faculty Association - essentially, the professors' union - called on University of Toronto president Robert Prichard to step in. During a marathon negotiating session last week in his spacious offices, the two sides remained in separate rooms with their lawyers while Prichard, the university's lawyer John Murray, and two world-renowned experts in blood disorders shuttled between them. Throughout the day and evening of Jan. 25, advice from David Nathan, head of Harvard Dana-Farber Cancer Institute, and David Weatherall of the University of Oxford, became a crucial part of the three-page agreement that was finally signed at about 1:30 a.m on Jan. 26.

The two emphasized the importance of Olivieri's research and advised the hospital on the best way to resolve the dispute. But according to Clayton Ruby, one of Olivieri's lawyers, "Prichard was the guy who made it work. He kept appealing to everyone's better natures." Characterizing the confrontation as "unprofitable and heartbreaking," Ruby predicted that the worst is over. Everyone involved has an "obligation they feel keenly," he said, "to the community, to the patients and to medical research. That, I hope, will carry them through."

The agreement is clearly aimed at repairing a badly frayed relationship. As well as reinstating Olivieri, the hospital has agreed to pay her legal expenses, up to a maximum of $150,000, and to cover her costs if she is subsequently sued by Toronto-based Apotex Inc., the manufacturer of the drug she was testing, over her claims that the medication is ineffective and unsafe. Both sides have agreed not to sue one another over any events prior to the date of the agreement. Sick Kids has also promised to withdraw a Jan. 6 letter it sent to Olivieri and three of her colleagues - doctors Brenda Gallie, Helen Chan and Peter Durie - reminding them of the hospital's bylaws on communicating with the media without prior approval. Prichard said that, while such bylaws might be relevant in another situation involving the hospital's communications with the public, the letters were "silly, inappropriate and ineffective" in Olivieri's case and had "absolutely no place in trying to suppress debate and dissent." But the "defining issue" during the negotiations, he said, really revolved around preserving Olivieri's research program. Added Prichard: "This hospital literally saves the lives of thousands of children every year and Dr. Olivieri's work is of international significance. The worst thing for a researcher is to be spending all her time on a distraction like this."

For both sides, there will be much to get over. In late 1995 and early 1996, Olivieri became concerned that deferiprone, a new drug she was testing for Apotex, might be ineffective. When she took her findings to the company, it insisted she had misinterpreted her results, stopped the clinical trials and threatened to sue if she went public with her conclusions. Although the hospital's research ethics board instructed Olivieri to change the consent form so that patients were made aware of her concerns, and to report her findings to the federal government, Olivieri says the hospital administration failed to offer her moral or legal support in her dispute with the drugmaker. Later in 1996, Olivieri also began to fear that deferiprone might cause dangerous levels of iron to accumulate in the liver. The case made headlines last August, after Olivieri published her findings in the influential New England Journal of Medicine.

A few matters remain outstanding. A grievance launched by the university's faculty association on behalf of Olivieri, Gallie, Chan and Durie in December is unaffected by last week's settlement. And the hospital's medical advisory committee is continuing to assess a December report on the case by a three-person panel, led by Dr. Arnold Naimark, former president of the University of Manitoba. In it, Naimark concluded that Olivieri should have reported her findings sooner to the hospital's research ethics board. Olivieri, who has questioned Naimark's objectivity because the University of Manitoba received $120,000 from Apotex during his tenure, says that despite the 1996 threats from Apotex, she notified patients within a week of concluding that deferiprone might have harmful side-effects.

The case may ultimately be remembered for its impact on an issue that leading researchers say is critically important: the growing dependence of institutions like hospitals and universities on the research dollars supplied by companies. Alan Goldbloom, a pediatrician who is vice-president of academic and clinical development at Sick Kids, says that the hospital has already taken steps to protect the integrity of its research procedures. The hospital has hired a full-time manager to oversee the negotiation of contracts between researchers and companies that fund their work, and a second position may be created. The hospital has also convened a task force to review the clinical research process. "The individual dispute was a Sick Kids issue," Goldbloom says, "but the problem is a worldwide issue. Nobody has written a book on this. Many people at comparable institutions are looking forward to what we come up with, because everybody is trying to manage a very complex area." New standards are likely to be put in place, Goldbloom added, so that researchers will not have to "start from scratch with each contract."

Included in last week's settlement terms is a short sentence promising that Olivieri will be granted a paid "mini-sabbatical" of six weeks as soon as her superior at Toronto Hospital "judges it to be possible." Olivieri is almost sheepish when she admits she has no specific plans for filling the time, except to get back to her research on sickle cell anemia and thalassemia. "I must be a very overfocused individual," she says. "I miss it. It's what I haven't been able to do. I have people who say I am only happy when I am looking at data and it's close to that. There's a real elation to feeling you are moving a field forward - and we haven't felt that way for a long time."

Maclean's February 8, 1999