WASHINGTON (AP) - When it comes to medicine, the nation's children often are treated like little adults. Instead of getting pills and shots specially formulated for them, they are given smaller portions of drugs that may end up harming them, say lawmakers who want to continue federal support of pediatric research.

"Only a fraction of the drugs on the market have been tested for safety to children," said Sen. Christopher Dodd, D-Conn. "It's a lot like playing Russian roulette with our kids."

Dodd and others are seeking another round of federal money and the renewal of policies that encourage drug companies to develop new pediatric medicines or test drugs for their potential to help children.

Congress will consider renewing the Food and Drug Administration program that extends lucrative brand-name patents for six months if companies conduct FDA-approved research on children. To be eligible, drugs must have the potential to help children. A Senate health panel will hold a hearing Tuesday on the incentives.

Sen. Mike DeWine, R-Ohio, said there have been 332 new studies on drugs' potential to help children since the program started three years ago, compared with 11 in the previous six.

"We had to step in," he said.
The program is set to expire this year. House lawmakers have stressed the risk of letting the plan lapse.

"Many drugs used in children will not be tested because there's no economic incentive to do so," Rep. Billy Tauzin, R-La., the chairman of the House Energy and Commerce Committee, said at a hearing last week.

"We now have information on how to make medicines that really work for children," said Dr. Phil Walson of Cincinnati, a member of the American Academy of Pediatrics. "Sometimes kids need lower doses, sometimes higher doses."

FDA has approved the marketing of 28 medicines to help children, specifically those who suffer from high blood pressure, skin disorders and AIDS.

The program has also helped drug researchers overcome a resistance to research on children, said Dr. Robert Ward, a Salt Lake City pediatrician who specializes in treating newborns.

Studies on children are often more expensive for companies, he said. They are less cost-effective because far fewer children than adults consume prescription medicines. There are concerns as well about the ethics of involving children in research studies.

Ward added that sometimes problems with a medicine in child research can effectively kill its chances as a product for adults.

"Adults don't realize children are afflicted with a lot of the same disorders that are afflicting us," Ward said. "And they require the same types of drugs in different dosages. You can't do same things you do with adults."

Walson said the revised program should include generic and over-the-counter drugs. Medicines like erythromycin for infections or dopamine for high blood pressure could be better developed for child use, he said.

Lawmakers are also considering provisions to make sure that new safety information is promptly added to products; to encourage the FDA to quickly deliver information to pediatricians; and to create a new office of pediatric therapeutics at the FDA.

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