THE DIRTY SECRET OF PEDIATRICS...THE MAJORITY OF DRUGS PRESCRIBED FOR CHILDREN HAVE NEVER BEEN TESTED IN YOUNGSTERS....

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Kids in demand for Drug studies> > By n Neergaard> > AP MEDICAL WRITER> >> > WASHINGTON (AP) -- It's the dirty little secret of pediatrics: Unknown to> > most parents, the majority of drugs prescribed for children have never> been> > tested in youngsters to determine how well they work or even the best> dose.> >> > Pediatricians often must guess how to use medications originally developed> > for adults -- from allergy relievers and antibiotics to painkillers -- in> > their tiniest patients.> >> > That's finally changing: Clinical trials of medications in children are> > suddenly booming, and the Food and Drug Administration expects more than> > 18,000 youngsters to participate in the next few years.> >> > But how do families pick a safe study? After all, the government recently> > shut down several adult clinical trials for breaking vital patient-safety> > rules, including one study that killed an 18-year-old.> >> > Children's studies also broach new ethical questions. Already, researchers> > are offering enticements like gift certificates to Toys 'R Us to reward> kids> > for getting poked and prodded, and about one-fourth pay families. Typical> > payments are $200 to $400, but parents have been offered $1,000 to sign up> > their kids.> >> > Although ``we are very excited'' that crucial research is finally under> way,> > ``there are special issues involved in pediatric trials,'' stressed FDA> > pediatrics chief Dr. Dianne , who is leading efforts to ensure> children> > are studied properly.> >> > Manufacturers have had no incentive to study children because doctors> legally> > can prescribe adult products to youngsters. That changed two years ago> when> > Congress granted manufacturers an extra six months of patent protection if> > they voluntarily test products pediatricians prescribe.> >> > Then, this December, an FDA rule will mandate that any new adult drug that> > could be used in children with the same disease must undergo pediatric> study.> >> > Some 180 pediatric drug trials have begun or are being planned, and the> FDA> > has requested another 129 even before the December rule kicks in.> >> > ``Kids are not just small adults,'' explained Kearns, pediatric> > pharmacology chief at Children's Mercy Hospital in Kansas City, Mo., one> of> > the few places that specializes in testing children's medicines.> >> > Indeed, bodies handle drugs differently at different ages. A tragic> example:> > In the 1960s, several newborns died because doctors didn't know their> > immature livers couldn't process the adult antibiotic chloramphenicol. In> > contrast, some of today's antibiotics require a 50 percent higher dose for> a> > 1-year-old than for a teen, because the toddler's body eliminates those> drugs> > faster, Kearns said.> >> > Studies aren't just for sick kids. Say your child is prone to hay fever> but> > is not sniffling today. She'd be a candidate to swallow one dose of an> adult> > antihistamine and have blood samples drawn to check metabolism, thus> > confirming the right dose. These dosing studies require spending up to a> day> > in a clinic, giving blood and a small side-effect risk, in hopes doctors> can> > improve treatment of future patients.> >> > Longer studies are usually for sick kids, and sometimes involve a placebo.> > Take the inhaled antibiotic Tobi, approved to treat a lung infection in> > cystic fibrosis patients at least 6 years old. Taking Tobi before age 6> might> > ward off the infection instead of just treating it, but it also might be> > dangerous. Comparing Tobi with a dummy pill in babies and preschoolers is> the> > only way to know, but some parents find that a tough choice, says Dr.> Pamela> > Zeitlin of Baltimore's s Hopkins University.> >> > How should parents weigh studies?> >> > --Make sure you fully understand a study. Kearns spends up to an hour> > discussing a study before ever handing parents a consent form, which> should> > explain risks in laymen's terms.> >> > --Ask who's running the study. University-based research, particularly at> > pediatric specialty centers, may get more careful oversight.> >> > --Look for pediatric expertise. If your child will test a stomach drug,> look> > for a pediatric gastroenterologist. Adult doctors can miss children's> subtle> > signals of side effects, like not playing or eating less.> >> > --Ask not only about drug side effects but about study procedures. How> will> > doctors minimize blood tests and pain?> >> > Consider the experience of Janine Berardi. The Canton, Mass., woman pored> > over a 17-page consent form before letting 6-year-old Nichole test an> adult> > immune-system drug called Avonex for her juvenile arthritis. Still she was> > surprised when Nichole screamed at the weekly injections -- until the> doctor> > suggested simply rubbing an anesthetic cream onto her skin before the> shots.> > Now Nichole's swollen joints are much better, and the shots quieter.>

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