Doctor stresses importance of drug trials
An isle lab is testing new antipsychotic drugs for children
Getting volunteers for medical trials has become increasingly difficult because of negative feelings about drug companies, medications and the ethics of such studies, Dr. Denis Mee-Lee said.
"It really affects the ability to discover new medications," he said, stressing the importance of clinical trials.
"We need to keep reminding folks if we are going to improve treatment, we need to do good medical research to evaluate the medications that are being discovered and developed."
Mee-Lee is principal investigator at the Hawaii Clinical Research Center, 1750 Kalakaua Ave., which is investigating new atypical antipsychotic drugs for children and adolescents with either schizophrenia or bipolar symptoms.
The newer drugs have proved effective for adults, but no research has been done on their use for children and adolescents, he said.
"The concern generally of the Food and Drug Administration and society has been the ethics of doing research on children," Mee-Lee said. "The problem, of course, is if we don't do the research, those medicines never will get tested for efficacy and safety of children.
"Doctors desperate to help children and adolescents who have psychotic symptoms end up using the medications anyhow," he said, "and that's not good medicine, because we haven't done the research."
The center has three studies to evaluate two of the atypical antipsychotics for adolescents who have either schizophrenic or bipolar symptoms, Mee-Lee said.
Ten volunteers are needed for each study, he said. If they do well, he said they will be eligible to continue using the medications without charge in a six-month extension of the study.
Although the FDA has not approved use of the new- generation antipsychotic drugs in children, "children are the fastest-growing category of users of antipsychotic drugs," Medco Health Solutions Inc. recently reported.
The company, which manages prescription drug benefit programs, said the number of children age 19 and under using antipsychotic medicines rose 73 percent from 2001 to 2005, compared with a 37 percent increase among 20- to 44-year-olds.
Older medications might have a lot of side effects, Mee-Lee said. So although no research has been done on use of the new drugs for children with psychotic or mood disorder problems, like bipolar illness, he said, "pediatric psychiatrists really have no alternative but to use them for many of their patients."
He said the Hawaii Clinical Research Center has many safeguards to assure patient safety, and in 17 years of research and more than 200 studies, it has a "perfect record of absolutely no serious harmful effects" to patients.
Rigorous health screening is conducted for every volunteer to ensure they are appropriate candidates for the study, and patients are told about all possible adverse reactions and what to do if they feel something is not right, Mee-Lee said.
"Clinical supervision over all participants is much more intense during a study than in treatment," he said, adding that research staff is always available 24 hours a day with staff backup.
"We've had patients who did not respond well to the investigational drugs, but we're proud of the safety record with our study subjects," Mee-Lee said.
The child's health comes first, he said, explaining that children who are not responding to medications in a trial are pulled out of it and put on medicine with a better chance of helping them.
He said information gained from the studies will allow the center to recommend treatment that could help a child.