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Chasing Medical Miracles: The Promise and Perils of Clinical Trials
Chasing Medical Miracles The Promise and Perils of Clinical Trials Author:Alex O'Meara 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. Chasing Medical Miracles is the first book to give readers a behind-the-scenes look at the complicated world of clinical trials and how a multibillion-dollar industry of priva... more »te companies conducting clinical trials with little oversight has quietly become a major part of the American medical establishment. O'Meara reveals what every health-conscious person needs to know about how drugs, devices, and procedures are tested and approved. 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 trialthree 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. "A page-turner . . . What makes his memoir unique and captivating is that he steeped himself in the culture of clinical trials, entering not as a naive and ill-informed subject but as a fully informed and tenacious advocate of the trial, which he hoped would liberate him from having to wear an insulin pump. His personal story is so compelling . . . A useful counterpoint to the detached, scholarly approach of social scientists and ethicist"Sheldon Krimsky, American ScientistMr. O'Meara himself has served as a clinical-trial guinea pig, and he writes with authority about the growing ranks of people who make something of a living from taking not-yet-FDA-approved drugs . . . Mr. O'Meara is adept at portraying clinical trials and in discussing ethical concerns about CROs possibly skewing results to favor the interests of the drug companies that hire them, and about the financial incentive for clinical-trial applicants to lie about their medical history."Scott Gotlieb, Wall Street Journal
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 subjectranging from terror to euphoriato 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 expensiveup to $500 million for a single drugpharmaceutical 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
"When O?Meara was presented with an opportunity to participate in a clinical trialwhich may or may not have cured his type-1 diabeteshe embarked on a quest to slake his journalist?s curiosity. More than merely chronicling his own personal experience, however, he sweeps through the entire industry of clinical trials to amass a compendium of available knowledge . . . The concluding and most valuable chapter contains a checklist for potential participants to consult before signing a clinical-trial consent form. Must reading for anyone considering participating in a clinical trial, whether to test treatment for an illness they have been diagnosed with or not."Booklist (starred review)
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 failurehope. 'I'm still able to say, "At least I tried,"' O'Meara notes.?Publishers Weekly« less