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How to Test Drugs on Kids? FDA Starts the Debate


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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