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Canadian Whistle blower spills medical-ethics myths Gail Johnson - Straight.com VIA theFilter.ca July 06, 2006 The media constantly bombards us with what’s new in health research. What we don’t hear about nearly as often is just how corrupt the world of medical inquiry is. No one knows this better than Nancy Olivieri. The Toronto pediatrician and former drug researcher raised concerns about the effects of an experimental drug on participants in an industry-sponsored study that started in 1993. Consequently subjected to ruthless and relentless professional and personal scorn, Olivieri found herself embroiled in several legal battles, some of which continue to this day. At a recent Vancouver lecture, Olivieri explained that her case has resulted in many myths surrounding medical ethics and accountability, like this one: “the truth will prevail”. She’d like to see truth win, but she admits she’s not all that confident. First, some background. In 1993, Olivieri began researching a drug made by Canadian pharmaceutical giant Apotex—which she never referred to by name during her talk at the latest SFU President’s Forum—to treat thalassemia, a genetic blood disorder. Three years later, she and some of her coworkers raised issues about the drug’s safety and efficacy. The researchers didn’t want to stop the study but they did want permission to tell patients and give them the option to discontinue the trial. Apotex disagreed. When Olivieri revised patient-information forms to reflect her concerns, the company acted swiftly. “Seventy-two hours later, they terminated the trials and I was threatened with all legal remedies should I publish to the scientific community,” Olivieri said at the June 7 forum. What followed was, in Olivieri’s words, a “witch-hunt”. Not only was Apotex against her; so were her employers, the University of Toronto and the Hospital for Sick Children. At her lecture, she claimed those organizations smeared her honesty and competence and worked to convince others that she was guilty of research and medical misconduct. At the time, the university was up for a donation from Apotex; in 2001, the company gave U of T’s pharmacy faculty a $5-million gift. Over the years, the hospital has sent Olivieri four letters of dismissal (which she fought and had overturned). A former coresearcher, Dr. Gideon Koren (who still works at the Hospital for Sick Children), sent anonymous hate mail to her and her supporters. (He was found to be the author via a DNA sample obtained from a licked stamp.) Lawsuits between Olivieri and Apotex are ongoing. “The first myth is that the truth will prevail,” said Olivieri, who teaches pediatric medicine at U of T and heads Hemoglobal, a charity that treats Sri Lankan children with thalassemia. “Speaking the truth is always dangerous when those in power are wrong. But the more convincing your story is, the harder the bureaucracy will work to create a culture of uncertainty around the truth. “The second myth is…that science will win out. This is very unlikely. Who repeats, or would repeat, an industry-sponsored trial that had been unilaterally terminated? Not our publicly funded bodies. We’ve seen that raw data…can be appropriated and reinterpreted by industry-allied scientists. “Myth number three is that it cannot happen again,” she continued. “Not exactly. Secrecy clauses are still allowed in 40 to 66 percent of North American institute and clinical trials.” For proof, look no further than the U.S. Food and Drug Administration, which suppressed information about increased suicide risk among youths taking certain antidepressants and deadly cardiac problems associated with Vioxx. “Myth number four: Researchers and drug companies are going to get into trouble—big trouble—if they don’t tell the truth,” Olivieri added. “That’s the biggest myth. The problem is, as in the Vioxx story, people who tell the truth are not commonly rewarded. Article Posted at www.KnowledgeDrivenRevolution.com “Instead of myths, here’s the truth: it is said that if you have God, the facts, the law, and the press on your side, you have a 50-50 shot of defeating bureaucracy. I don’t know about God, but I did have some of the best on my side, and I’m still very much in the middle of this after a decade. I used to try to close on an optimistic note when I would talk about this, but I think this audience deserves to know that’s not very authentic anymore. I, as an insider…think the profession has lost.” Arthur Schafer, director of the University of Manitoba’s Centre for Professional and Applied Ethics, told the forum that cases like Olivieri’s are not isolated. “Virtually all of medical practice and medical research in Canada, North America, and Western Europe floats on a sea of drug-company money,” he said, noting it’s no secret that doctors and medical students get gifts from pharmaceutical companies, from pens to all-expenses-paid holidays. “I have never met a single doctor or medical student who believed he or she was in any way influenced by the fact that drug companies funded their research or bought their fancy dinner,” he said. “When medical research is paid for by the pharmaceutical industry, the results come out dramatically more favourably to industry products than when funding is industry-independent.” Schafer explained that people don’t understand what constitutes a conflict of interest; you don’t necessarily have to behave corruptly. “There’s the principle of reciprocity. When you accept a gift, even a trivial gift, your judgment is biased, the way you weigh the evidence is biased, your sense of what’s fair and right is sometimes quite subtly shifted.” Drug companies, he added, don’t allow their employees to accept gifts. Michèle Brill-Edwards, formerly Health Canada’s senior physician responsible for drug approvals, said conflicts of interest stem from privatization and deregulation. Two decades ago, she said, there was a team of about 100 people at Health Canada that would vet research studies. If a study was poorly designed, that team would, by law, tell the company to restructure it. “Today…there’s no act of intervention by the department [Health Protection Branch] to actually alter a trial and safeguard the patients,” she told the forum. “We have a public policy in Canada of voluntary compliance. In other words, it’s saying ‘We don’t need well-informed, educated medical and scientific people governing the research process in Canada because we can trust companies to do the right thing.” Although the speakers painted a bleak picture of the state of research integrity in Canada, Brill-Edwards offered a solution. She suggested that people refuse to take part in clinical trials unless and until the industry makes those trials independent and able to generate reliable, sound knowledge that is not distorted by money. About KDR \| \| Home \| \| Weekly Features Archive	Weekly Weekly Features Archive
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Canadian Whistle blower spills medical-ethics myths

Gail Johnson - Straight.com VIA theFilter.ca
July 06, 2006

Apotex and Health Canada The media constantly bombards us with what’s new in health research. What we don’t hear about nearly as often is just how corrupt the world of medical inquiry is. No one knows this better than Nancy Olivieri. The Toronto pediatrician and former drug researcher raised concerns about the effects of an experimental drug on participants in an industry-sponsored study that started in 1993. Consequently subjected to ruthless and relentless professional and personal scorn, Olivieri found herself embroiled in several legal battles, some of which continue to this day. At a recent Vancouver lecture, Olivieri explained that her case has resulted in many myths surrounding medical ethics and accountability, like this one: “the truth will prevail”. She’d like to see truth win, but she admits she’s not all that confident.

First, some background. In 1993, Olivieri began researching a drug made by Canadian pharmaceutical giant Apotex—which she never referred to by name during her talk at the latest SFU President’s Forum—to treat thalassemia, a genetic blood disorder. Three years later, she and some of her coworkers raised issues about the drug’s safety and efficacy. The researchers didn’t want to stop the study but they did want permission to tell patients and give them the option to discontinue the trial. Apotex disagreed. When Olivieri revised patient-information forms to reflect her concerns, the company acted swiftly.

“Seventy-two hours later, they terminated the trials and I was threatened with all legal remedies should I publish to the scientific community,” Olivieri said at the June 7 forum. What followed was, in Olivieri’s words, a “witch-hunt”. Not only was Apotex against her; so were her employers, the University of Toronto and the Hospital for Sick Children. At her lecture, she claimed those organizations smeared her honesty and competence and worked to convince others that she was guilty of research and medical misconduct. At the time, the university was up for a donation from Apotex; in 2001, the company gave U of T’s pharmacy faculty a $5-million gift. Over the years, the hospital has sent Olivieri four letters of dismissal (which she fought and had overturned). A former coresearcher, Dr. Gideon Koren (who still works at the Hospital for Sick Children), sent anonymous hate mail to her and her supporters. (He was found to be the author via a DNA sample obtained from a licked stamp.) Lawsuits between Olivieri and Apotex are ongoing.

“The first myth is that the truth will prevail,” said Olivieri, who teaches pediatric medicine at U of T and heads Hemoglobal, a charity that treats Sri Lankan children with thalassemia. “Speaking the truth is always dangerous when those in power are wrong. But the more convincing your story is, the harder the bureaucracy will work to create a culture of uncertainty around the truth.

“The second myth is…that science will win out. This is very unlikely. Who repeats, or would repeat, an industry-sponsored trial that had been unilaterally terminated? Not our publicly funded bodies. We’ve seen that raw data…can be appropriated and reinterpreted by industry-allied scientists.

“Myth number three is that it cannot happen again,” she continued. “Not exactly. Secrecy clauses are still allowed in 40 to 66 percent of North American institute and clinical trials.” For proof, look no further than the U.S. Food and Drug Administration, which suppressed information about increased suicide risk among youths taking certain antidepressants and deadly cardiac problems associated with Vioxx.

“Myth number four: Researchers and drug companies are going to get into trouble—big trouble—if they don’t tell the truth,” Olivieri added. “That’s the biggest myth. The problem is, as in the Vioxx story, people who tell the truth are not commonly rewarded.

Article Posted at www.KnowledgeDrivenRevolution.com

“Instead of myths, here’s the truth: it is said that if you have God, the facts, the law, and the press on your side, you have a 50-50 shot of defeating bureaucracy. I don’t know about God, but I did have some of the best on my side, and I’m still very much in the middle of this after a decade. I used to try to close on an optimistic note when I would talk about this, but I think this audience deserves to know that’s not very authentic anymore. I, as an insider…think the profession has lost.”

Arthur Schafer, director of the University of Manitoba’s Centre for Professional and Applied Ethics, told the forum that cases like Olivieri’s are not isolated.

“Virtually all of medical practice and medical research in Canada, North America, and Western Europe floats on a sea of drug-company money,” he said, noting it’s no secret that doctors and medical students get gifts from pharmaceutical companies, from pens to all-expenses-paid holidays.

“I have never met a single doctor or medical student who believed he or she was in any way influenced by the fact that drug companies funded their research or bought their fancy dinner,” he said. “When medical research is paid for by the pharmaceutical industry, the results come out dramatically more favourably to industry products than when funding is industry-independent.”

Schafer explained that people don’t understand what constitutes a conflict of interest; you don’t necessarily have to behave corruptly. “There’s the principle of reciprocity. When you accept a gift, even a trivial gift, your judgment is biased, the way you weigh the evidence is biased, your sense of what’s fair and right is sometimes quite subtly shifted.”

Drug companies, he added, don’t allow their employees to accept gifts.

Michèle Brill-Edwards, formerly Health Canada’s senior physician responsible for drug approvals, said conflicts of interest stem from privatization and deregulation. Two decades ago, she said, there was a team of about 100 people at Health Canada that would vet research studies. If a study was poorly designed, that team would, by law, tell the company to restructure it. “Today…there’s no act of intervention by the department [Health Protection Branch] to actually alter a trial and safeguard the patients,” she told the forum. “We have a public policy in Canada of voluntary compliance. In other words, it’s saying ‘We don’t need well-informed, educated medical and scientific people governing the research process in Canada because we can trust companies to do the right thing.”

Although the speakers painted a bleak picture of the state of research integrity in Canada, Brill-Edwards offered a solution. She suggested that people refuse to take part in clinical trials unless and until the industry makes those trials independent and able to generate reliable, sound knowledge that is not distorted by money.

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