First, do no harm  pg. 2

Brown, who has earned national recognition for her research on blood pressure regulation, now has a grant to try to weed out the biologic mechanisms for angioedema induced by ACE-inhibitors. One of her concerns, she says, is, “How do you study something that is still a pretty rare side effect?”

At first glance, it would seem that if a drug has gone through the rigors of discovery and development, through clinical trials and FDA approval, any adverse side effects should have already been observed and noted. After all, isn’t it the responsibility of the FDA to ensure that only safe drugs are put on the market?

The answer is yes—if only it were that easy.

Deadly elixir

Of late, scientists and regulators have been anxiously grappling with the problems posed by post-marketing surveillance of approved pharmaceuticals. What may seem like a miracle cure in controlled clinical trials, several thousand people strong, may become a totally different animal once it is released to the open market and prescribed by tens of thousands of physicians to millions of patients.

Ignoring strict warning labels, many patients take medicine off-label, meaning they take it for illnesses for which it hasn’t been approved. They also take combinations of drugs that counteract each other’s beneficial effects, under-dose to save money or take more than the recommended dose to try to get quicker relief.

Even more confounding is the fact that two patients with the exact same disease can follow the exact same treatment plan—and the drug works beautifully for one, but doesn’t help the other patient at all.

All of these challenges have served to usher in a new era of pharmacoepidemiology—the study of pharmaceuticals among populations of patients. According to Wayne A. Ray, Ph.D., director of Division of Pharmacoepidemiology at Vanderbilt, the field first emerged in the aftermath of two therapeutic disasters.

In 1937, a Tennessee drug company began selling Elixir Sulfanilamide, a sulfa drug used to treat streptococcal infections. More than 100 people, many of them children, died after taking the medication, which was dissolved in a toxic component of antifreeze. In response, Congress passed the Pure Food, Drugs and Cosmetics Act of 1938, requiring products to be rudimentarily tested for safety before they reached consumers.

The second disaster involved the drug thalidomide, marketed in the 1950s and early ’60s as a sleeping pill and a cure for morning sickness in pregnant women. Thalidomide caused profound birth defects in more than 10,000 children in 46 countries before it was pulled from the worldwide market.

Although a pharmacologist at the FDA, Frances Oldham Kelsey, M.D., Ph.D., prevented thalidomide from being marketed in the United States, the side effects were so catastrophic that in 1962 the United States began requiring that drugs undergo well-controlled studies demonstrating efficacy before they can be sold to consumers.

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