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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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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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The Hormone Boost

The Hormone Boost

How to Power Up Your Six Essential Hormones for Strength, Energy and Weight Loss
edition:Paperback
also available: Hardcover
tagged : diets, nutrition
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Excerpt

The conversation that started me down the Hormone Boost path made me realize how many people these days fit into a “just okay” mold—a way of existing from day to day that isn’t awful but sure isn’t great, either. Perhaps you feel the same way. When I stopped and really thought about it, I realized this shouldn’t have come as a surprise. In my practice, I hear from people all the time—all day, every day, in fact—about what they want more of, or what they want to improve. There’s a lot of common ground in these discussions, and chances are good that you’ve had the same thoughts from time to time (or maybe more often). This, then, is where we begin: with the biggest and most important areas in need of a boost.

How ’bout a Boost of These?.?.?.

While there is an almost endless supply of areas in our daily lives that can be improved, the following seven are the ones that crop up most often in the discussions I’ve had about well-being.

Energy

Regular sleep and regular exercise combined with a thoughtful diet should be sufficient to give anyone the energy they need for a busy life. The thing is, if we’re not getting the right kinds of sleep, practicing the right exercises or eating the right foods, we can wreak havoc on our energy levels without even knowing it. If part of how you’re managing your days right now requires the assistance of regular caffeine intake or high-sugar foods or an afternoon nap, you’ll be interested in The Hormone Boost’s plan to power up your energy by targeting the specific hormones and habits that affect it most intensely.

Strength

Being strong isn’t just about being able to open the pickle jar without special implements or assistance. It’s also about creating the optimum conditions for your body to take care of itself and move freely through the world. Whatever your limitations are (in terms of health, work or mobility), a stronger body will improve your energy and quality of life. It can even make sitting at a desk for several hours more manageable, and allow you to burn more fat while doing it! Strong bodies also age more gracefully and recover from illness and injury more quickly. We’re not able to get any younger, but we can always get stronger. The Hormone Boost plan will show you how.

Memory

We might not notice our memory gaps in this always connected ultra-digital world. Can’t remember a celebrity’s name? You can IMDB it. Worried about forgetting a new contact’s number? Put it in your smartphone. Never before have we had so many devices stand in for memory. As a result, unsurprisingly, our memories are not as strong as they used to be. (I once nearly drove myself crazy trying to remember an actor’s name—and I refused to look it up online. It took me three days but I trusted that her name was in there, and sure enough, it was: Reese Witherspoon. Boom.) It’s impractical to disengage completely from all of your devices and external reminders, but you can give your memory a genuine boost by attending to the hormones that give it strength and longevity. Quicker, more intense memory recall is part of a strong, active brain—and it supports your mental acuity.

Metabolism

It’s hard to be healthy and energetic and fit without metabolic support. As I mentioned previously, I went through an intense struggle with my metabolism after graduating from university, and again six years later, after naturopathic medical school. During both periods, my strict diet and rigorous exercise sessions failed to help me lose weight or keep it off. It was during those times that my hormonal health concerns forced me to realize that the formula calories in – calories burned = weight loss was by no means complete. Hormones are the body’s powerhouse; the processes they drive sustain every aspect of health and fat-burning potential (a.k.a. metabolism). Boosting your metabolism means augmenting your capacity to generate and use energy—and that is naturally connected to your health, energy and fitness levels.

Confidence

Regardless of your size or style, you should be confident. Full stop. The people I am most drawn to are those who just seem entirely comfortable with themselves—people who own their worth, who wouldn’t trade places with anyone. This is what I wish for all of my patients and friends, because it can make such a massive difference in every area of your life: professionally, personally (especially in intimate relationships), physically. Confidence walks with a straight back and long strides and a general peace with the world. Balancing your hormones, especially those discussed in this book, will allow you to generate confidence in your sense of surety and comfort with your body, your life and your relationships.

Immunity
The twenty-first century has brought with it an amazing number of quick fixes and surface shortcuts—and we rely on them to make our lives easier in countless ways. Too often, though, we don’t stop and think about the challenges this reliance is creating. Take hand sanitizer. While effective in the immediate biological sense (e.g., after using the toilet), its prevalence is making it harder and harder for our bodies to build up their own immunities. Ditto for antibiotics, which, when overprescribed, compromise our ability to fight off seemingly minor viruses and bacteria. I’m not suggesting you swear off sanitizer entirely or avoid a doctor’s prescription, but I invite you to explore what a hormonally boosted immune system can do. If the metabolism is the body’s powerhouse, the immune system is Neighborhood Watch: it monitors comings and goings and does its best to ensure you’re safe. A hormone boost to the metabolism increases not only its efficacy but also your overall safety.

Mood

Boosting your mood has a more subtle impact, in some ways, than boosting your metabolism or immune system. A mood boost won’t necessarily help you lose a few pounds or fend off the flu that’s going around. But our moods are pervasive, and they have the power to change our perspective, our schedule and our interactions. Wake up in a bad mood? You might swear at the thought of hard-boiled eggs for breakfast and grab a croissant instead. Have an unexpectedly tense confrontation with a client or colleague? You might “treat” yourself to a beer as soon as you get in the door, to help unwind after that adrenalin-inducing conversation. When you’re in a good mood, you are more patient (you’ll walk home rather than jump in a cab), make better choices (cheerfully crunch that salad—and those abs!) and attract the good energies of others (that stranger you bumped into at the produce stand just happens to be a trainer at your local gym and invites you in for a free session). Boosting your mood will have a thousand small positive effects in every area of your life.

The Hormone Boost has been diligently researched and designed to boost every part of you. We’ll explore each boost area and its corresponding hormones thoroughly, unpacking the science behind hormonal health and tracing the connections between what we do and how we feel. I’m also thrilled to be able to share with you some amazing successes from my practice; they demonstrate just how important hormonal health is in all areas of your life. And each chapter will leave you with my recommendations for boosting the hormones that are integral to powering up your body, your mind and your fat-loss efforts. Specifically, we’re going to focus on a group of hormones I’ve come to think of as “the fat-loss six.”

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Beauty in a Box

Detangling the Roots of Canada's Black Beauty Culture
edition:Paperback
also available: eBook
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Crystal Gridwork

Crystal Gridwork

The Power of Crystals and Sacred Geometry to Heal, Protect and Inspire
edition:Paperback
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Born to Walk

Born to Walk

The Transformative Power of a Pedestrian Act
edition:Paperback
also available: Audiobook Hardcover eBook
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Excerpt

This book is about the transformative properties of walking. About fissures that anyone can explore. It is the outcome of an experiment both personal and journalistic, an attempt to understand my addiction, to see how much repair might be within range.

I have tried to structure it in a logical way, exploring one main benefit of walking in each chapter. This is a problematic construction: the anecdotes, statistics and conclusions overlap and magnify one another. There are also geographic boundaries to stumble over. While I touch down in Asia, Africa and Latin America, the focus is on the United States, the United Kingdom and Canada. The cultural and economic forces that have shaped the Anglosphere (our cities and habits, our health and happiness) have incubated a distinct set of challenges.

Maturity, we are told, means accepting that the world is broken. Yet, what if some simple patches were possible? All of the people I spoke to or spent time with, outstanding in diverse fields, have demonstrated, in one way or another, that a renewed emphasis on walking, even in communities facing stacked odds, could be a small step toward somewhere better. That my fix just might be a fix.

Generations of writers have gone down this road. Wordsworth, Thoreau, Solnit, Chatwin and scores of others have crafted lyrical poems, essays and books about the power of walking. I bow at their feet. These classics are more relevant now than ever, and they have kindled a resurgence. In 2014 alone, French philosopher Frédéric Gros published a manifesto about the subversive ability of walking to mine the “mystery of presence”; British author Nick Hunt retraced the 80-year-old footsteps of scholar Patrick Leigh Fermor across Europe on a quest to find what remains of the kindness of strangers; historian Matthew Algeo looked back at an era when competitive walking was America’s most popular spectator sport; and naturalist Trevor Herriot embarked on a prairie pilgrimage, wielding “a metaphysics of hope against the dogma that we are aimless wanderers in a world whose chaotic surface is the sum total of reality.” This indispensable paper trail gave my ideas shape and scope.

One of the first guides I talked to was a doctor named Stanley Vollant, the first Aboriginal surgeon from Quebec. A son of the Innu nation, Vollant was striving to inspire hope among Canada’s indigenous peoples by leading group hikes hundreds of miles long, reviving the routes and rhythms of his ancestors. There was a walk coming up. He invited me to tag along.

At the time, I was bogged down by work and domestic responsibilities. But our conversation continued to resonate. “When you begin a journey, you don’t know why,” Vollant had said sagely. “The trail will show you the way.”

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