Chasing Medical Miracles: The Promise and Perils of Clinical Trials

Walker & Co. (2009)
Abstract
Journalist Alex O’Meara is one of the more than twenty million Americans enrolled in a clinical trial—three times as many people as a decade ago. Indeed, clinical trials have become a $24 billion industry that is reshaping every aspect of health-care development and delivery in the United States and around the world. As O’Meara chronicles, twentieth-century medical trials have led to epic advances in health care, from asthma inhalers and insulin pumps to heart valves and pacemakers. And yet, although regulations safeguard against grossly unethical tests, significant problems are still associated with how clinical trials are carried out and reported. For example, despite eight clinical trials for Vioxx before the FDA approved it in 1998 for use as a painkiller, Merck took it off the market in 2004, too late for the eighty-eight thousand Americans who suffered heart attacks while taking Vioxx and the thirty-eight thousand who died. _ Chasing Medical Miracles is the first book to give readers a behind-the-scenes look at the complicated world of clinical trials, revealing how a multibillion-dollar industry of private companies conducting them with little oversight has taken root and quietly become a major part of the American medical establishment. Whether you are participating in a clinical trial, considering that option, or interested in our medical system, Alex O’Meara’s ground-breaking_book is essential reading. Alex O’Meara is a freelance journalist who has worked for the City News Bureau of Chicago, Newsday , the Baltimore Sun , and many other media organizations. In an effort to cure his type-1 diabetes, he participated in a risky and groundbreaking clinical trial to receive a transplant of islet cells from several cadaver pancreases. This is his first book. He lives in Bisbee, Arizona. Journalist Alex O’Meara is one of the more than twenty million Americans enrolled in a clinical trial—three times as many people as there were a decade ago. Indeed, clinical trials have become a $24 billion industry that is reshaping every aspect of health-care development and delivery in the United States and around the world. As O’Meara chronicles, twentieth-century medical trials have led to epic advances in health care, from asthma inhalers and insulin pumps to heart valves and pacemakers. And yet, although regulations safeguard against grossly unethical tests, significant problems are still associated with how clinical trials are carried out and reported. For example, despite eight clinical trials for Vioxx before the FDA approved it in 1998 for use as a painkiller, Merck took it off the market in 2004, too late for the eighty-eight thousand Americans who suffered heart attacks while taking Vioxx and the thirty-eight thousand who died. Chasing Medical Miracles is the first book to give readers a behind-the-scenes look at the complicated world of clinical trials, revealing how a multibillion-dollar industry of private companies conducting them with little oversight has taken root and quietly become a major part of the American medical establishment. Whether you are participating in a clinical trial, considering that option, or interested in our medical system, Alex O’Meara’s book is essential reading. “Americans have long_been mystified about how new drugs are developed. Though the term ‘clinical trial’ has entered the popular lexicon, most people still don’t know what goes on behind the scenes._ Chasing Medical Miracles tells the truth about the byzantine world of clinical trials. O’Meara exposes the ethics of medical research both in the U.S. and abroad. Essential reading for anyone who wants to understand how new medicines are developed.”—Joe Graedon, M.S., and Teresa Graedon, Ph.D., authors of The People’s Pharmacy “This travelogue of ‘the most dangerous part of medical discovery’ moves from O’Meara’s own experience as a research subject—ranging from terror to euphoria—to a broader exploration of the ethics and economics of clinical trials._He describes a landscape populated by brave and often desperate patients, whose heroism is integral to finding tomorrow’s cures.”— Robin Marantz Henig , author of Pandora’s Baby: How the First Test Tube Babies Sparked the Reproductive Revolution “In the ethically murky world of clinical trials, Alex O’Meara’s book is an illumination. Whether probing the use of_Third World people to test U.S. drugs, or revealing that the goal of clinical trials is not to cure anyone but to obtain data, Chasing Medical Miracles is educational in a valuable and troubling way.”—Stephen P. Kiernan, author of Last Rights: Rescuing the End of Life from the Medical System “Readers who assume that the trials only occur at academic medical centers will be surprised by the author’s findings. As they multiply and grow wildly expensive—up to $500 million for a single drug—pharmaceutical companies are hiring clinical-research organizations, profit-making enterprises that recruit subjects, pay them and perform studies in their own facilities. These organizations continue to migrate overseas to save money and escape FDA oversight . . ._[O’Meara] does a capable job of revealing alarming problems that must be addressed.” — Kirkus Reviews “Enjoy this bracing tour through the history, horror, and headaches of clinical trials, described by a guide with both a detached delivery and knowledgeable perspective. Former Newsday and Baltimore Sun reporter O'Meara, a Type I diabetic, signed up for a trial offering a possible cure, so he may be more than a little invested in how trials work. But his self-interest is a compelling element as he surveys a $24-billion-a-year industry that affects the lives of 20 million Americans. His investigation briskly sails through the interests that spark clinical trials, the money that pays for them and the bonanza of cash and/or equipment and medications for developing countries where researchers find it cheaper to recruit trial subjects. Best and most sweetly, however, the book delves into the human guinea pigs, such as gene therapy trial participant whose death raised questions about government oversight and the self-interest of the lead researcher. O'Meara presents lessons from a medical front that offers something more important than success or failure—hope. 'I'm still able to say, "At least I tried,"' O'Meara notes.”— Publishers Weekly
Keywords Clinical trials  Clinical trials Moral and ethical aspects  Clinical trials Law and legislation  Drugs Testing  Drugs Moral and ethical aspects  Pharmaceutical industry Moral and ethical aspects  Clinical Trials as Topic  Clinical Trials as Topic ethics  Clinical Trials as Topic legislation & jurisprudence
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Call number R853.C55.C45 2009
ISBN(s) 0802719902   9780802716965   0802716962   9780802719904
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