A harsh, firsthand look at clinical research.
To cure his diabetes, freelance journalist O’Meara underwent an experimental pancreatic islet-cell transplant. The procedure didn’t work, and the experience inspired him to explore the subject. After admitting that trials have produced miracles from antibiotics to vaccines to pacemakers to CT scans, the author gets down to the business of recounting the disasters. He begins with two of the most frequently cited examples: the gruesome Nazi experiments on concentration-camp inmates and the shameful Tuskegee study in which nearly 400 syphilitic black men were left untreated so the clinicians could observe the effects of the disease. Moving to the present day, O’Meara describes studies in which subjects died, concentrating on the specific mechanics of each study. 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. The author looks at studies that cut corners and conceal bad results, and he profiles Americans who earn a living by participating and desperately poor foreigners who sign up under the false impression that they will receive free medical care. In the final chapters he concedes that most trials run uneventfully and produce positive results.
Despite the title, O’Meara passes lightly over the promises of clinical trials to emphasize the perils, but he does a capable job of revealing alarming problems that must be addressed.