Sign up for our free newsletter
Free D.C. news, delivered to your inbox daily.
The Food and Drug Administration (FDA) review mechanism depends on the probity and scientific accuracy of the companies submitting products, the personalities of the agency officials handling the reviews, and outside advisers. In Deadly Medicine (Simon & Schuster), Virginia writer Thomas J. Moore explains how that mechanism malfunctioned with a class of drugs called anti-arrhythmics. Instead of preventing irregular heartbeats, anti-arrhythmics caused them—perhaps killing thousands of patients. Instead of pausing to check experimental data, the companies forged ahead, eager to get to market first even if it meant glossing over damaging information. Instead of trusting its conservative instincts, FDA acceded to the arguments of manufacturers and advisers who turned out to have significant stakes in approval of the products. Moore, a senior fellow at George Washington University’s Center for Health Policy Research, analyzes the medical advances, market forces, and subtle biases that brought these products first into the spotlight and then into severe question. Besides a skillfully drawn and gripping portrait of how FDA works, Medicine is a polemic assailing the agency and drug makers for moving incautiously on products whose risks, in hindsight, can be glaringly clear. “The public does not fully understand how dangerous and partially tested most drugs are,” says Moore. “If the manufacturers do not address these questions, they are likely to wake up and face an outraged and dramatically changed public.”