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How to Test Drugs on Kids? FDA Starts the Debate


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Sep. 12, 2000 (Washington) -- In March 1958, researchers at the University of Southern California in Los Angeles began a study to determine the effects of the antibiotic chloramphenicol on premature infants. By February 1959, over 60% of the babies who had been given the drug were dead. In total, 52 of the 126 children enrolled in the study eventually died. But the researchers never halted the study, despite knowing that chloramphenicol could kill.

"We discussed stopping the study early, and the decision was made ... that unless you have convincing evidence, nobody's going to believe you," one of the researchers said later. The study's goal was to discredit the use of that antibiotic in infants -- a practice that may have resulted in thousands of more deaths, the researchers said in their defense.

Now, more than 30 years later, U.S. health officials once again want convincing evidence about drugs' effects on children. To make it happen, the FDA has passed a rule requiring drug makers to conduct clinical trials aimed at determining the effectiveness and effects of commonly used medications on children, beginning this December.

There is a surprising lack of information about the appropriate use of prescription drugs in children, the FDA says. The agency estimates that more than half of the drugs approved every year that are likely to be used in children are neither adequately tested nor labeled for children, leaving doctors to determine the appropriate doses. Information on drug safety and effectiveness is especially sparse for children under age 2.

But in an effort to avoid past mistakes, FDA officials this time are consulting experts on how to establish the guidelines for these types of studies. Those consultations began this week with a number of meetings between FDA officials, pediatric specialists, and experts in other medical specialties such as oncology. The issue at the heart of the discussions: To what level of risk or discomfort can a child be ethically exposed to in a clinical trial?

Dianne Murphy, MD, associate director of pediatrics at the FDA, says the agency believes that these trials should be conducted using only people who may benefit. But whether the studies ethically can include a placebo group largely remains a point of contention, she says.

A placebo generally is a sugar pill or other facsimile of the real drug being studied used for comparison purposes. It has no treatment benefit. While some scientists and the FDA believe that side effects and clinical benefits of a drug cannot be determined without the use of a group taking only a placebo, others argue that it is unethical to leave children untreated -- even when the child suffers from a nonfatal disease, such as a skin rash.

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