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Winner of the Writers' Trust of Canada's Shaughnessy Cohen Prize for Political Writing and the Canadian Science Writers' Association's Science in Society Book Award.
Poison-pen letters, possible medical misconduct and a swirl of competing accusations that led to two inquiries – the Olivieri affair ended careers and shook the international research establishment. A riveting anatomy of Canada’s most controversial drug trial, by the medical journalist who helped break the story.
In August 1998, a medical scandal erupted in the national and international media whose consequences still reverberate. A charismatic young doctor named Nancy Olivieri, working with young people who suffered from a rare blood disorder, stated that she had discovered serious problems with an experimental drug manufactured by Canada’s largest drug company, Apotex. Though her research contract required her to remain silent, she decided she had no choice but to warn the patients enrolled in her trials. Apotex retaliated by cancelling her research and slamming her reputation. In the aftermath, Olivieri became a whistleblower applauded in academia and the media for standing up to powerful corporate interests.
The Olivieri affair spawned two inquiries and multiple lawsuits, but the full story of Canada’s biggest science scandal has never been told – until now. In the hands of psychiatrist and medical journalist Miriam Shuchman, the debacle over the pill called L1 is revealed as a modern morality play in which every crack in the system of scientific research, corporate financing and peer review stands out in stark relief.
By talking with the people whom both Olivieri and Apotex wanted to heal – the young men and women struggling to have normal lives despite debilitating treatment – Shuchman also brings us the moving story of the toll on patients’ health when battles break out among the physicians and researchers aiming to heal them.
- Sales Rank: #2054032 in Books
- Published on: 2005-05-03
- Released on: 2005-05-03
- Original language: English
- Number of items: 1
- Dimensions: 6.32" h x 1.26" w x 9.32" l, 2.00 pounds
- Binding: Hardcover
- 464 pages
Review
“The book is a great cautionary tale about the complexity, benefits and dangers of academy-industry partnerships.” –The Globe and Mail
“It is a story of colossal egos and rushes to judgment, of rivalries and revenge, and of character assassination and serious harm to patients, to doctors and to Canada’s largest drug company.”
–The New York Times
“[Shuchman] writes in clear, expository prose with a judicious calm. . . . The general reader will find it a fascinating and accessible window into the intense emotion, and fierce, often irrational rivalries that can engulf even the most normally dispassionate researchers.”
–Winnipeg Free Press
About the Author
Miriam Shuchman is a psychiatrist with a background in medical ethics, who teaches at the State University of New York at Buffalo. Her feature articles on ethics and psychiatry have appeared in the New York Times, the Los Angeles Times, the Washington Post and the Globe and Mail, as well as on CBC Radio and National Public Radio in the United States. Her articles on medical whistleblowers have appeared in the Annals of Internal Medicine, the British Medical Journal and the Canadian Medical Association Journal. Dr. Shuchman trained in psychiatry at the Harvard Medical School and studied ethics at Dartmouth College. The Drug Trial is her first book.
Excerpt. © Reprinted by permission. All rights reserved.
Prologue
In August 1998, a story about a doctor named Nancy Olivieri grabbed headlines in Toronto. The articles stated that Olivieri had discovered serious problems with an experimental drug manufactured by Canada’s largest pharmaceutical company, a Toronto-based generics manufacturer called Apotex. The drug at the centre of the scandal is a white tablet called L1, or deferiprone, intended for use by patients with the inherited blood disorder thalassemia. Olivieri planned to tell patients about the problems, as required by her hospital. But Apotex played dirty pool, ejecting her from their research program, cancelling the study she was running to test the drug and threatening her with court action if she went public. The scandal was in the news for months. And for four years, legal charges and personal accusations flew back and forth between Olivieri, the company and Toronto’s Hospital for Sick Children, where Olivieri worked.
Parts of this story are well known. The CEO of the drug company Apotex is a billionaire alumnus of the University of Toronto, where Olivieri is a professor. At the same time that Apotex was funding Olivieri to test its drug on patients in a clinical trial, he was offering to put scores of millions toward university research facilities and teaching hospitals such as the Hospital for Sick Children, where Olivieri ran the treatment program for patients with thalassemia. The hospital and the university didn’t step in to defend Olivieri against the company’s threats when they arose. Determined to tell her patients and scientific colleagues about her discoveries, she became a whistleblower, publicly accusing Apotex of suppressing her discoveries. She also blamed her home institutions for allowing it to happen because they didn’t take up her cause. News of her plight shocked academics, and they sprang to her support. She has won medal after medal for courage.
In 1998, her hospital sponsored its inquiry to figure out what had happened; two years later, Canada’s national organization of university faculty associations conducted its own. But the inquirers lacked the power of the coroner or the courts: they couldn’t compel disclosure, ensure confidentiality or allow for appeals. John le Carré spoke to Olivieri and spun a fictional account of the events. Casting her as Lara from Leningrad, he wove her into The Constant Gardener, his recent novel about the human costs of Big Pharma’s corporate greed. Yet the full story of the science scandal that rocked Canada is not as convenient as fiction, and it turns out to be far more shadowy than le Carré imagined.
This is a complex story about medical research and the rules that govern it. Those rules are science’s moral code, the standards scientists live by and train under. Here are a few examples: "Don’t lie about your work." "Don’t steal someone else’s work and claim it’s your own." "Report your findings; don’t bury them." The rules should be easy to follow, but in the fiercely competitive world of modern medical science, they’re not.
In studies of new drugs, the research involves patients, so there are additional strictures: "Don’t ask patients to volunteer for an experiment that’s likely to harm them." "Report the serious side effects of an experimental drug." "Allow patients to drop out of an experiment at any time." The rules for research on humans are discussed in numerous places — the Belmont Report, the Declaration of Helsinki, the Nuremberg Code, National Institutes of Health (NIH) regulations, Food and Drug Administration (FDA) regulations, Canada’s Tri-Council guidelines. They’re supposed to be enforced locally by hospitals and universities, and if violations are widespread, federal authorities at the FDA, the NIH or Health Canada can get involved, even to the point of shutting down research at a university.
Yet the rules for doing science aren’t well understood, and newer rules about how to conduct research in an era of public-private partnership are still being hammered out, largely as a result of fiascos such as the one I am about to explore. The debacle of Nancy Olivieri and the pill to save thalassemia patients revealed every crack in the system. It is emblematic of what happens when the standards for scientists’ behaviour and the lines of institutional accountability are unclear.
The saga also unfolded against the background of an ongoing debate over drug research. Those who want greater protection from risky drugs point to innocent victims killed by dangerous prescriptions and lay those deaths at the feet of profiteering drug companies or unwitting drug agencies that approved products too quickly. On the other side, people with rare diseases for which few treatments are available demand the right to decide for themselves how much risk to bear, and urge drug agencies to speed the approval of products in the pipeline.
But at its core, this is a story of scientific rivalry and revenge. "Good scientists will tell you that being a good scientist requires a very competitive spirit in this day and age," said a sociologist of science, Harriet Zuckerman, in the mid-1980s, around the time that L1 was discovered. "It isn’t really clear what the causal relationship is. Maybe you have to be competitive in order to succeed, but maybe succeeding also helps you be competitive."
In the story of Nancy Olivieri and L1, highly successful scientists fought intensely for predominance over a tiny territory — the field of drug treatment for thalassemia. A pharmaceutical company got into the mix and the result was the scientific version of a Greek epic, with researchers battling over ideals, such as the well-being of patients and the integrity of their work, while simultaneously
competing against one another for power and position. At first, Olivieri was the epic’s heroine, telling the secrets of how her science had been thwarted by her enemies. The ferocity of the drug company’s retaliation caught and held our attention. The truth, however, remained obscured until much later, when others emerged to tell the rest of the tale, speaking mostly in whispers to one another. To disentangle a whistleblower’s moment from the legend that’s grown up around her, we’ll need to bring some of those other conversations into the open. Then we may begin to understand what happened here.
Most helpful customer reviews
0 of 2 people found the following review helpful.
A good book for understanding bioethics
By T. Nguyen
The book was written very details but with easy-reading style. I think it will help you to understand various aspects of scientific research and bioethics.
8 of 12 people found the following review helpful.
The Forgotten Victims
By A. Battaglia
The David vs Goliath story that came out of the saga of the trials of the iron chelating drug, deferiprone, may have made for good reading and good newspaper sales, but just being the smaller guy, or girl in this case, does not make you anymore right than Goliath. The stubbornness exhibited by Dr. Oliveri in this case may have endeared her to the press and public, but it unfortunately may also have cost many thalassemia patients their lives. This book exposes the inner goings-on that tarnish the aura of Dr Oliveri and her David-like stand against the drug company, Apotex.
Deferiprone was a new iron chelator developed by Apotex, to remove the deadly excess iron that accumulates in the blood of thalassemia patients who must receive regular blood transfusions to stay alive, as their own bone marrow cannot create a sufficient supply of functional red blood cells. If not removed, this iron will eventually destroy the organs and kill the patients. Until deferiprone was developed, there was only one other medicine that could be used to remove iron and it involved painful nightly subcutaneous injections that went on for 10 or more hours each night. Because of the pain of the long injections and side effects of the drug, many patients do not comply fully with the treatment, leading to iron overload and eventual death. Deferiprone is an orally administered drug and showed the promise of much better chelation compliance.
Dr Oliveri was commissioned by Apotex to run trials on deferiprone to determine both its effectiveness and any possible side effects. After her early trials, Oliveri became concerned that deferiprone was not safe and began the fight that would lead to it never being approved in Canada and the US, even as it has been approved throughout most of the rest of the world.
Shuchman's book gives in great detail, the inner workings of this process and no one comes out smelling like roses. Neither side behaved in the most ethical of manners but while Apotex was roasted in the press, Oliveri was treated like a champion of the little guy. What we find in Shuchman's book is that this is not so much the story of a champion as it is the tale of stubbornness. In spite of what appeared to be serious flaws in her research, Oliveri has refused to revisit her research and has instead, stood in the way of the approval of the drug. With her stature enhanced by her fight against the drug Goliath, Oliveri has wielded much influence.
The main winner in this case was the competing drug company, who coincidentally, recently released their own oral chelator, which reached the market in swift fashion once the patent on their subcutaneous chelator expired. The losers then and now, are the patients who have been deprived of this medicine because of a dispute that would never have happened if a doctor would have been willing to revisit her trials and admit to the inherent flaws in her research. Study after study was done elsewhere and never were her findings repeated. Some researchers write off Oliveri's research into deferiprone as having a too small group of participants, many of whom already had liver damage from iron overload. The result has been that deferiprone has been approved and is used in many countries. Studies have shown that deferiprone is a superior chelator in terms of removing iron deposits from the heart and since heart failure is the number one cause of death among thalassemics, this is quite significant. When I attended the International thalassemia conference in Dubai in January of 2006, I was somewhat amazed at the matter of fact acceptance that deferiprone has gained among doctors and researchers throughout most of the world. here in North America, people are still under the impression that the drug is not safe, while in most other places it is a key part of the arsenal of drugs being used to treat thalassemia.
For years Oliveri has been treated as a hero in her fight against Apotex and portrayed as the victim. She is not. The real victims are the patients who have been deprived of this drug and have died as a result, my best friend among them. Dr. Shuchman has done a great service reminding us that the little guy is not always in the right. Each case should be judged on its own merits and the media should have the responsibility to fully investigate the truth just as Shuchman has done here.
5 of 8 people found the following review helpful.
A Well Researched Book That Undercuts the Traditional "Drug Companies Behaving Badly" Story
By A.T.
When Miriam Shuchman first broke the story on CBC and started researching her book, she found that the usual story of "drug companies misbehave" didn't quite explain all of the facts. She *does* document plenty of that, though -- but in this book, pretty much *everyone* misbehaves.
Dr. Shuchman deserves a lot of kudos for coming forward with this book. Many of the quotes are anonymously attributed (but were fact-checked by the publisher), an unsettling indication of the chilling atmosphere surrounding the whole affair. Where egos are concerned, no one is safe from legal action and other retaliatory measures.
This book's contribution to the literature on conflicts of interest is to show that conflicts of interest can be more than simply financial. Publicly funded academic researchers can be motivated by personal rivalries and the drive to achieve academic success just as much as commercially driven drug company researchers can be motivated by money. I hope this book obtains a wide reading.
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