Congress revamps program to study, label children's drugs

<br>WASHINGTON (AP) _ Rontrell Windham underwent a kidney transplant at an Ohio hospital and was sent home five days later with a drug designed to keep his body from rejecting the new organ. <br><br>The

Monday, January 28th 2002, 12:00 am

By: News On 6

WASHINGTON (AP) _ Rontrell Windham underwent a kidney transplant at an Ohio hospital and was sent home five days later with a drug designed to keep his body from rejecting the new organ.

The 11-year-old was instructed to take one pill twice a day.

Rontrell is much younger than the majority of patients with end-stage renal disease or the 370,000 Americans living with dialysis or transplanted kidneys. Still, he received the same dosage given to adults.

In the past, doctors for the 5 percent of kidney transplant recipients who are children, like Rontrell, would have had to use body weight as their guide to calculate the proper dosage.

Now, incentives given by Congress to drug companies have prompted them to study finer measures for proper pediatric dosages for prescription medication.

Congress last month approved an updated version of the program, allowing it to expand and continue five more years.

``If the typical adult takes two milligrams and Rontrell is half the size of an adult, we would have estimated that he would need one milligram,'' said his doctor, John D. Mahan of Columbus Children's Hospital.

But early pediatric drug tests showed children need an even lower dose than that to avoid serious complications such as infection and bleeding, Mahan said.

``There's just no way we could have known that,'' Mahan said.

Rontrell is participating in a three-year drug trial to determine the drug's best use for children.

The Best Pharmaceuticals for Children Act was sponsored by Sens. Mike DeWine, R-Ohio, and Christopher Dodd, D-Conn., in 1997. It allows the Food and Drug Administration to extend lucrative brand-name patents for six months to companies that conduct FDA-approved research on children.

The FDA says drug companies have proposed 469 studies for children's drugs since 1997, compared with 11 studies conducted in the previous six years. Pediatric information is now being added to the labels of at least 28 products, including medications to treat HIV and AIDS, diabetes, pain and asthma.

``What parents don't realize is that before this act was passed, more than 80 percent of the drugs we used on children were never studied for children,'' Mahan said.

Children were underdosed, overdosed and put at risk for a host of harmful side effects.

``It's not just a matter of following a children's weight,'' said DeWine, who has eight children and six grandchildren. ``Things are different with kids. Unless you do the testing, you just don't know.''

The latest bill directs the FDA to establish the Office of Pediatric Therapeutics to coordinate children's drug tests and oversee the safety of children used in clinical trials.

It also calls for $200 million to be set aside to pay companies selected by the FDA to research certain established drugs that already have exceeded their patent.

Drug testing on adults began in the 1970s. Before that, much of the pharmaceutical industry's clinical studies were conducted on animals.

Testing children wasn't considered an option, said Dr. Philip D. Walson.

Besides the ethical concerns about using children as subjects, such studies are less cost-effective because far fewer children than adults consume prescription medicines, said Walson, a pediatrician at Cincinnati Children's Hospital Medical Center.

``But we live in a system where (pediatric testing) won't happen unless there is an incentive,'' he said.

Critics argue the program has provided a windfall to the pharmaceutical industry at the expense of ordinary Americans. Longer patents postpone the introduction of lower-priced generics.

Supporters said parents and grandparents would not begrudge paying more for an extra six months if they knew it would ensure children receive the right dosages.