by Sonia Shah
THE BODY HUNTERS
Also by Sonia Shah
Crude: The Story of Oil
THE BODY HUNTERS
Testing New Drugs on the World’s
Poorest Patients
SONIA SHAH
NEW YORK
LONDON
Foreword © 2006 by David Cornwell
© 2006 by Sonia Shah
All rights reserved.
No part of this book may be reproduced, in any form, without written permission from the publisher.
Requests for permission to reproduce selections from this book should be mailed to: Permissions Department, The New Press, 38 Greene Street, New York, NY 10013.
Published in the United States by The New Press, New York, 2006
Distributed by W. W. Norton & Company, Inc., New York
LIBRARY OF CONGRESS CATALOGING-IN-PUBLICATION DATA
Shah, Sonia.
The body hunters : testing new drugs on the world’s poorest patients / Sonia Shah.
p. cm.
Includes bibliographical references and index.
ISBN-13: 978-1-59558-831-9
1. Pharmaceutical policy—Developing countries. 2. Pharmaceutical industry—Corrupt practices—Developing countries. 3. Drugs—Prescribing—Developing countries. 4. Drug utilization—Developing countries. 5. Medical ethics. I. Title.
RA401.D44S532006
362.17'82—dc22
2005058394
The New Press was established in 1990 as a not-for-profit alternative to the large, commercial publishing houses currently dominating the book publishing industry. The New Press operates in the public interest rather than for private gain, and is committed to publishing, in innovative ways, works of educational, cultural, and community value that are often deemed insufficiently profitable.
www.thenewpress.com
Composition by Westchester Book Composition
This book was set in Palatino
10987654321
Contents
Foreword by John le Carré
Preface
1Clinical Trials Go Global
2The Placebo Control
3Growing the Pharma Monolith
4Uncaging the Guinea Pig
5HIV and the Second-rate Solution
6South Africa: Drug Trials and AIDS Denialism
7Outsourcing to India: The One Billion Body Politic
8Calibrating Ethical Codes
9The Emperor Has No Clothes: The Vagaries of Informed Consent
10Tipping the Scales
Conclusion
Notes
Acknowledgments
Index
Foreword
JOHN LE CARRÉ
This book is an act of courage on the part of its author and its publishers. Ever since I wrote The Constant Gardener, I have received approaches, and sometimes complete typescripts, from investigative writers determined to lift the veil on the darker side of the world’s most profitable trade: the pharmaceutical industry. Where a proposed book seemed to have merit, and was not weighed down with mountains of medical jargon, I passed the word to literary agents and publishers’ readers. Yet not one of the authors, so far as I was ever aware, saw his project realized. And if, months later, I delicately inquired why not, the answer, however wrapped up, was always the same: too risky.
And you might find it comic or outrageous or, if you are of my mind-set, illustrative of the stranglehold of unrestricted corporate power that the topic that is closest to all our lives, and closest to the concerns and responsibilities that we feel for one another, should be deemed too risky for public debate.
You might also find it outrageous that our treasured legal system, originally designed to protect our freedoms, should be the instrument of their suppression. Yet such is the reputation of the gunslinging lawyers of Big Pharma, so unlimited the industry’s wealth, so vast its reach into politics, the media, and the very heart of the medical profession and the bureaucracy that sustains it, that publishers have good reason to believe that, in picking a fight with Big Pharma, they are committing their company to a five-star lawsuit, countless hours of office time, disenchanted stockholders, and copies pulped before they reach the stores.
Yet, little by little, the veil is indeed being lifted. The outsourcing of clinical trials to countries where sick people are so poor they are ready to sign up to anything, whether or not they can read what’s on the consent form, is now public knowledge. The tendency of Big Pharma to promote phantom, or at best speculative, maladies and then supply the cure for them, is now public knowledge.
The corrupt recruitment of large numbers of doctors in general practice and teaching hospitals to prescribe a particular medical project is now public knowledge
The corrupt recruitment of large numbers of doctors in general practice and teaching hospitals to prescribe a particular medical product is now public knowledge.
The ever-growing list of dangerously under-tested products that have been wished upon the public by supposedly impartial government bodies is public knowledge, as are the links between members of such bodies and the pharmaceutical companies that manufactured them.
It is also public knowledge, since they themselves have owned to it, that learned medical journals of supposed integrity have carried glowing accounts of this or that pharmaceutical product, only to discover they were written not by the august Professor of Something who has put his name to them but by their manufacturers.
But perhaps the worst of Big Pharma’s many sins is its persistent encroachment, by means of a combination of lavish sponsorship and moral blackmail, on the integrity of biomedical research at every level, with the consequent ever-growing scarcity of unbought medical minds.
Using clear, accessible language and carefully annotated case histories, Sonia Shah has struck a blow for all who dream of harnessing the huge power for good that is invested in the pharmaceutical industry, of seeing its products made available to those who most need them, and of curtailing the greed that drives its worst practices.
Cornwall, England
February 2006
Preface
“The blood of those who will die if biomedical research is not pursued will be upon the hands of those who don’t do it.”
—Joshua Lederberg, PhD, Nobel laureate1
“I mean, shit, we learn by climbing over the bodies of humans.”
—Murray Gardner, MD, University of California
HIV researcher2
“Field trials are indispensable. . . . If, in major medical dilemmas, the alternative is to pay the cost of perpetual uncertainty, have we really any choice?”
—Donald Frederickson, MD, former National
Institutes of Health (NIH) director3
My life and the lives of some of my closest relatives continue thanks to the interventions of modern medicine, a scientific art that has marched forward in fits and starts on a bedrock of clinical research. The drugs that enabled me to survive an emergency cesarean section, those that allow my son to breathe despite allergic asthma, the other ones that correct a hormonal deficit in my mother have been administered to us with success and confidence in part because they’ve been tested in hundreds and perhaps thousands of human subjects in experimental trials. Not only that: these successful drugs emerge from a slurry of countless other failed drugs, each of which was also tested on scores of warm bodies, some of which may have been harmed by their shortcomings.
There’s nothing terrible about the truth that medical research imposes burdens. But generally speaking, we don’t like to know it. We don’t like to see it. The very notion of experimenting upon humans sounds sinister. And yet, if anything, we only want ever more drugs to help or enhance us, and more data to assure our trembling selves of th
eir safety and effectiveness. The response to these contradictory desires has been the same since the mid-1800s, when scientists hell-bent on dissecting animals skirted the outcries of British antivivisectionists by cloaking their slicing in secrecy. Today, savvy drugmakers loudly publicize new medical products, but conduct the required experimentation quietly. And so, while we exult in, bicker over, and complain about the products of medical research—how much do the drugs cost? who pays? what are the side effects?—the vast business of percolating new drugs burrows underground.
If the history of human experimentation tells us anything, from the bloody vivisections of the first millennium to the Tuskegee Syphilis Study, it is that the potential for abuse will fall heaviest on the poorest and most powerless among us.
The trend within the drug industry to conduct their experimental drug trials in poor countries is, as yet, in its infancy. But it is growing fast. Major drugmakers such as GlaxoSmithKline, Wyeth and Merck—already conducting between 30 and 50 percent of their experiments outside the United States and Western Europe—plan to step up the number of their foreign trials by up to 67 percent by 2006, according to USA Today. And while armies of clinical investigators in the United States shrink, dropping by 11 percent between 2001 and 2003, those abroad fatten, increasing by 8 percent over the same period, according to a 2005 study by the Tufts Center for Drug Development. “The outsourcing of drug research is beginning to accelerate,” reported the Washington Post in May 2005.4
And all the pressures on the profit-driven industry, pushing it toward speed and ever-lower costs; Americans’ contradictory love of new drugs and skittishness about participating in the experiments that make them possible; the increasing desperation of hordes of patients in developing countries deprived access to useful medicines; and the immediate financial needs of the cash-strapped public hospitals and clinics meant to serve them suggest the trend will only grow over the coming years. Many leaders in developing countries, faced with crumbling facilities, minuscule budgets, and towering health crises make arrangements for more industry trials, not fewer.
It is a trend that cries out for public review. That’s because the consequences of the multinational drug industry’s trek into the developing world go far beyond the fates of the patients roped into their trials and then discarded afterward. After all, many will be helped, at least for the brief moments of their participation, and that is not insignificant.
More troubling are the potential implications for health care in poor countries. As clinical trials become an ever-larger cash cow for strapped hospitals and clinics, a larger portion of scarce resources gets diverted away from providing care. In many countries governments have stoked the trend by tightening up patent laws, easing ethics reviews of experiments, and converting medical record keeping into industry-friendly English. Nurses, doctors, and other clinicians already overwhelmed with needy patients find themselves with even less time for healing when institutional priorities shift from treating the ill to experimenting upon them for drug companies. And whether it is a quickie experiment or a well-intentioned study, if ethical oversight is shoddy or patient subjects uncomprehending of its purposes, the mistrust engendered runs deep, contaminating all of Western medicine’s offerings, including life-saving vaccines and medicines.
The business of experimentation in developing countries intensifies the pressure to crack open these markets for the sales of new brand-name drugs too, by adding the quid pro quo demands of local clinicians and government officials proffering their patients as experimental fodder. Pfizer, Eli Lilly, GlaxoSmithKline, and other drug giants jostle at the borders of India, Brazil, Russia, and China, foreseeing huge markets for their cholesterol-lowering, antidepressant, and erectile-dsyfunction-alleviating blockbusters. The industry’s philosophy of equating medical innovation with “new products” is especially pernicious in places where simpler solutions have yet to be attempted. While innovative approaches to the health dilemmas posed by the lack of clean water and safe food, for example, are needed, the answer does not lie in new brand-name drugs. And even when new products are indeed what are most needed, from new malaria drugs to cures for sleeping sickness, those that aid the poorest are generally of little interest to drug companies, which commit themselves to the financial needs of their investors. The more likely result will be a drug-marinated class of rich alongside a meds-famished poor. In that case, brand-name drug sales in poor countries will worsen inequality, not correct it. And as has been well documented, inequality itself worsens the health of the have-nots even more.
Finally, we need to open up the debate over the very idea of using human bodies as experimental matter. For some, performing the work of an experimental test subject is the same as, say, taking a job in a factory. But for many others, industry trials in poor countries offer an impossible choice—be experimented on or die for lack of medicine—that undermines human rights. In the streets of Lagos and the halls of international AIDS conferences, people from developing countries are condemning Western scientists’ use of them as guinea pigs. The body hunters disregard the growing outcry at their peril.
1
Clinical Trials Go Global
On a dull October day in 2003 a clutch of physicians and scientists meet in a windowless conference room in the basement of a Washington, DC, hotel. John Wurzlemann, MD, flashes a photograph of modern-day Poland on a white screen to a handful of his colleagues. A generic urban scene, with glittering steel-and-glass buildings encircled by cement sidewalks appears. Wurzlemann, a rumpled, soft-spoken man, grins ruefully. “Most of Poland does not look like this,” he notes, in a deep scratchy voice. “Most of it looks like how it looked in 1939,” during the Nazi and Soviet invasions. “My father went to Poland ten years ago, and he said nothing had changed since the 1930s. Everything just got older.”
And sicker. Just how sick Eastern Europeans have become was the topic of Wurzlemann’s late-afternoon lecture that day. Broke, malnourished, and fatally enamored of cigarettes, Eastern Europeans were dropping dead in scores, he told the crowd. While in the United States deaths from cardiovascular disease had been falling steadily since the 1960s, in Eastern Europe cardiovascular disease had mushroomed to epidemic proportions and killed people far more rapidly.1 Wurzlemann was nothing if not blunt. “Disease for disease,” he said, “they are more likely to die.”
Wurzlemann moved quickly through his PowerPoint presentation, offering up a deluge of discomfiting facts and figures. “Hungary has the highest rate of cervical cancer mortality. . . . Breast cancer rates are higher. . . . Cancer mortality among men in Poland is the highest in Eastern Europe. . . . Suicide rates are a lot higher.”
He paused briefly for a slide showing a map of Europe, which had blood-red marks indicating the death rate from all causes. “What it shows,” Wurzlemann said, as the audience gazed on silently, “is that as you go east, people die in increasing waves.” Indeed, it looked as if a bottle of red ink had been spilled over the map of Russia. The stain had spread over all of Eastern Europe too, but France, Italy, and Spain were nearly pristine, marred by a scant few speckles. National borders marked the difference between life and death, drawn in whispery black lines.
The Eastern Europeans were ailing not only because their air was polluted, their food less abundant, and their water dirtier, Wurzlemann said. The amount of money the Polish government coughed up to provide health care to each of its citizens was about one-fourth the sum typical in Western Europe. Such paltry investments typified the region. As a result, preventive techniques, early diagnostic methods, and medical treatments that had transformed killer diseases into manageable chronic illnesses and better in the West were as rare as those shiny skyscrapers. Wurzlemann didn’t mention it, but the same could be said for much of the rest of the world too, where well over half of humanity has been brutally left behind in the quest for good health and longevity.
Wurzlemann took a deep breath and turned to his expectant audience. He himself had enjoyed the ben
efits of the West’s good health, wealth, and education, although two generations before him had hailed from ailing Poland and Russia. He grinned and softly muttered, almost to himself: “It is really upsetting, frankly.” Then he briskly returned to his presentation and its scripted points.2
The speakers who followed Wurzlemann offered their own tales of woe from Latin America, Asia, and South Africa. Ordinarily, a group of physicians confronted with such information would respond with any number of suggestions aimed at alleviating the burden of misery. Might more health care training help? Cheaper drugs? More research into disease etiology? Better diagnostic techniques? But neither Wurzlemann nor the other speakers had traveled to Washington, DC, that day to persuade their colleagues to help the impoverished sick of the developing world, at least not in the standard way that doctors generally try to help patients.
They had gathered because multinational drug companies like Pfizer, Eli Lilly, and Merck had a business problem. Industry labs were bursting with spanking new compounds and insight into which human tissues to aim them at, courtesy of new techniques first pioneered by genetic engineers and biotechnologists in the 1970s. “There are more investigational new drugs, more experimental treatments today . . . than ever before,” former Food and Drug Administration commissioner Mark McClellan exulted before a meeting of industry researchers in 2003.3 But just as the biotech revolution took off, the pipeline turning those new compounds into sellable products had started to clog. Proving new drugs worked in humans, as required by the FDA, had become a spectacularly complex, expensive, and time-consuming endeavor, a constant cause for complaints from industry analysts and investigators. Clinical trials were a “vast canyon” that eviscerated new drugs; a veritable “valley of death,” they said.4 “Large trials have become the norm,” bemoaned another. “All professionals taking part are now reconciled to the idea that such trials will take forever and will cost the earth.”5
