A DOSE OF COMMON SENSE

A DOSE OF COMMON SENSE
St. Louis Post-Dispatch: Size isn't the only difference between children and adults. The way they metabolize medications is another.
Prescription medicines are tested for safety and effectiveness, but until recently they only were tested on adults (men, usually). That has made selecting the right medicine -- and the right dose -- something of a challenge for pediatricians.
But three years ago, the Food and Drug Administration tried to change that. For the first time, it required that drugs be tested for safety and effectiveness in children. Earlier this year, the Bush administration announced it would suspend that requirement, but the outcry from physician groups and children's advocates prompted a reversal. Then, last month, a federal court in Washington overturned the testing rule. In response to a suit filed by three conservative and libertarian groups, a judge concluded that the agency had overstepped its authority.
Even before that ruling, a bipartisan bill to require drug testing in children had been working its way through Congress. A Senate committee approved it in August, but has not been voted on by the full Senate. Despite the heavy workload still facing lawmakers, Congress should find a way to approve it during the lame-duck session.
Testing requirement
Two legitimate objections have been raised to the testing requirement. The first is that it adds to the already high price of medications. Testing would be required even for drugs that weren't specifically intended for use in children. That's because once a drug is on the market, doctors are free to prescribe it to whomever they see fit.
But the added cost of testing pales in comparison with the money wasted on ineffective or unsafe medication used to treat kids. Recent studies have documented a dramatic increase in the number of psychiatric drugs prescribed for children, even though most of these drugs were not specifically intended for children. That underscores the importance of testing for safety and effectiveness.
The second, more substantial, objection involves the ethical implications of testing in children. There are risks. But without carefully designed, controlled and well-monitored studies, every child becomes a guinea pig. The massive, unstandardized experiment in which they participate can't generate any useful data -- or be used to prevent harm to others.
A study published the November issue of Pediatrics, the journal of the American Academy of Pediatricians, found that prescription medications caused about 3,750 serious injuries or deaths in children under the age of two between 1997 and 2000.