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The Drug Trial

The Drug Trial

Nancy Olivieri and the Science Scandal that Rocked the Hospital for Sick Children
edition:Paperback
also available: Hardcover
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Excerpt

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.

From the Hardcover edition.

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Conscious Caregiving Guide
Excerpt

Sometimes the greatest gift you can give a loved one is to show them that you are still able to enjoy your life to the fullest while caring for them. When your loved one sees you prioritizing your own health and your own needs, it may ease their mind and their guilt about being a burden on you. So many times we think we have to sacrifice ourselves for our loved ones, but what if we can continue living our lives to the fullest while still finding creative ways to meet their care needs?

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Caregiving Insights
Excerpt

I was of the belief that taking care of myself was selfish and that Self-care was a foreign concept. To be a good person, worthy of this life, I had to give all I had to others. I realize now that it is not possible.. So, as my caregiver, I beg you to lead by example and care for yourself first. Don't allow yourself to fall into the same trap I did. Don't give so much of yourself that your physical and emotional body crashes.

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Excerpt

Sometimes the greatest gift you can give a loved one is to show them that you are still able to enjoy your life to the fullest while caring for them. When your loved one sees you prioritizing your own health and your own needs, it may ease their mind and their guilt about being a burden on you. So many times we think we have to sacrifice ourselves for our loved ones, but what if we can continue living our lives to the fullest while still finding creative ways to meet their care needs?

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Shut Away

Shut Away

When Down Syndrome Was a Life Sentence
edition:eBook
also available: Paperback
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