The act gives brand-name companies an exclusive share of the market for six months.
By MEGAN SCULLY
STATES NEWS SERVICE
WASHINGTON-- Ohio's senior senator is pushing to renew legislation that could lead to increased clinical trials for children, an issue that has raised several ethical questions for doctors and medical researchers.
The Better Pharmaceuticals for Children Act, which was passed in 1997 and is up for reauthorization this year, provides incentives to brand-name pharmaceutical companies that test drugs for children, who have been long neglected by pharmaceutical companies because of the economic and health risks involved.
Reauthorizing the legislation is key to continuing research on treatment for sick children -- a research practice that has grown exponentially since the law was enacted four years ago, said Sen. Mike DeWine, R.
"The basic problem has been that 80 percent of the drugs on the market were never tested for children," said DeWine, a sponsor of the original legislation. "The reason is pure economics. Drug companies see no economic interest in doing the tests."
Market exclusivity: Under the legislation, pharmaceutical companies that test a drug for use by children get an additional six months of market exclusivity before generic manufacturers can produce the drug.
Since 1997, 332 pediatric drug studies have been undertaken, compared to 11 studies in the six years prior. Of the drugs that have been studied, 28 have been labeled for children, including Ibuprofen products, Abacavir, a drug that treats HIV, and Midazolam, a sedative.
With the increased clinical trials also come several uncertainties, including ethical questions surrounding the relatively new research field of drug testing on children.
Extra care: But at Rainbow Babies and Childrens Hospital in Cleveland, extra care is taken to ensure that children are not put at risk during a study, said Dr. Jeffrey Blumer, chief of the hospital's division of pediatric pharmacology.
Dr. Blumer, who said clinical studies on children at the Cleveland hospital have been successful and have never resulted in sickness or death of a study participant, added that pediatric drug testing is an essential step to curing and treating illnesses.
"I have concerns about clinical testing on children, however, I think this law has done a tremendous amount to bring us out of the Dark Ages and get us the information we need to treat children safely and effectively," he said.
"There's no substitute. I can't do it in a test tube. Children are not little rats, they aren't little monkeys and they aren't little dogs."
Concerns: Children metabolize drugs differently because the organs involved -- namely the kidney and the liver -- are not as developed as in adults.
Oftentimes, he added, children need a higher dosage than adults because of the way their bodies react to medicines, making some treatments ineffective.
"This research that's being conducted does bear some risks for children, but that's much better than what's going on now," said Mark Isaac, director of public policy for the Elizabeth Glaser Pediatric AIDS Foundation. "We are conducting every day a national experiment and giving untested drugs to children."
Another concern is that the legislation leads to increased prices for pharmaceuticals because it gives brand name drug makers an exclusive share of the market for an extended period of time.
The Generic Pharmaceutical Association estimates that the legislation has cost consumers more than $4 billion, while an Food and Drug Administration Survey indicates that pharmaceutical costs increased $695 million -- or about 0.7 percent -- a year as a result of the legislation.
"We think that's a legitimate cost to bear," Isaac said.