DEADLY MEDICINE
by Thomas J. Moore
The story begins with a new heart drug created in the research laboratories of the 3M Company. In animals, this drug appears unusually effective in suppressing irregular heartbeats. Hoping for a blockbuster, 3M launches clinical tests in humans and plans how to seize the market from competing companies. But as medical researchers test Tambocor, as the drug is called, the first signs of potential trouble appear. At Stanford University, a doctor warns that this type of powerful drug may be dangerous. Other experiments fail to demonstrate the expected benefits of such drugs. But with the support of their clinical doctors and with millions of dollars invested in Tambocor, 3M moves ahead and seeks approval from the FDA. Other companies also follow suit with similar drugs.
Questions about the safety of Tambocor have already reached the medical review staff at the FDA in Washington, D.C., where a behind-the-scenes drama takes place. 3M presses for approval of Tambocor, while the FDA staff tries to interpret the meaning of reports that some patients who have taken the drug suddenly drop dead. Without a green light from the FDA, Tambocor may be doomed.
The final chapters in the story unfold as 3M gets to the marketplace and, using all the skills of a modern pharmaceutical manufacturer, persuades doctors to use Tambocor. At the same time, an important clinical trial begins. The National Institutes of Health launch an experiment with more than a thousand patients to measure the benefits of Tambocor and two similar drugs. The shocking results of that study-and the response of the doctors and companies who promoted these drugs-bring the tragedy to a powerful conclusion.
Deadly Medicine is a human story about the brilliant and driven doctors who worked on Tambocor and similar heart drugs-at pharmaceutical companies, within the FDA, and at university medical research centers. It provides a vivid and disturbing account of the system by which drugs are discovered, tested, and marketed to doctors. Through the tragic story of how tens of thousands of patients died prematurely from one class of heart drugs, Deadly Medicine also exposes major flaws in this system.
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