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How to Test Drugs on Kids? FDA Starts the Debate

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"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.

Ironically, when members of Congress grilled the University of Southern California researchers in 1972 about the chloramphenicol experiment, they at first criticized the researchers for withholding needed drugs by including a placebo group, Murphy says. It was not until someone observed that most of the deaths were among babies in the group receiving treatment that the researchers were criticized for administering the antibiotic.

All of this leaves the FDA with a lot of ground to cover in a short time. FDA officials themselves have requested 332 studies involving children, of which they estimate about 282 will be conducted. Thanks to financial incentives passed by Congress in 1997, such as granting six additional months of marketing exclusivity rights for drug makers who conduct voluntary studies of their products on children, the number of studies initiated by someone other than the FDA has exploded over the past few years.

But for the FDA, that is good news, Murphy says. While some may believe that the USC experiment was unfounded, the principle that guided those researchers 40 years ago still applies today, she says. "Unless you have convincing evidence, nobody's going to believe you."

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