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How to Test Drugs on Kids? FDA Starts the Debate

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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.

"An investigator's chief concern ought to be the health and well-being of her patients," Charles Weijer, MD, cautioned FDA officials at the meeting, which included several representatives from Europe who are working on developing international standards. The standards set by the FDA also will set a precedent for what happens abroad, cautioned Weijer, a bioethicist and an assistant professor of medicine at Dalhousie University in Nova Scotia.

Still, there are several areas in which researchers agree, says Robert Temple, MD, director of medical policy at the FDA's Center for Drug Evaluation and Research. Overall, they agree that placebos may be used when there is no alternative therapy. They also agree that neither children nor adults should be denied treatment if they are suffering from a life-threatening disease.

As for nonfatal diseases, using alternative study designs could help bridge the opinion gap among researchers, Temple says. Among those is a simple method that would test the standard treatment vs. the standard treatment plus the new drug -- in effect making the group getting the standard treatment act as the placebo group.

But while this type of study could help test certain drugs in fields such as oncology, or cancer, it is unlikely to help researchers looking at disorders for which there is no standard treatment regimen, such as depression, Temple says. In those areas, the most effective studies would test the drug in question against a placebo, while allowing patients to withdraw if they exhibit serious symptoms.

The debate over placebos is not the only issue the FDA faces in its quest to involve children in clinical trials, Murphy says. For example, the FDA must determine how to design the informed consent form, a form designed to ensure that study participants understand the risks.

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