Health Sciences Report Spring 2005

Pediatric Pharmacotherapy Center Will Advance Safe Drug Treatment
Not Your Average Dose

By Cindy Fazzi

Photos by Steven Leitch

Call it the University of Utah Health Sciences Center"s "Field of Dreams"-or call it the Pediatric Pharmacotherapy Center (PPC). But the College of Pharmacy and the School of Medicine"s Department of Pediatrics believe that, if they build it, basic and clinical scientists will come, and together they will advance the safety of drug treatment in children.

The University"s Pediatric Pharmacology Program hopes someday to become a full"fledged center. But why the need for one? There are few pediatricians trained in clinical pharmacology, and no such interdisciplinary center with collaboration between a College of Pharmacy and a Department of Pediatrics exists in the United States to train future generations of experts, according to Robert M. Ward, M.D., neonatologist, professor of pediatrics in the School of Medicine, and director of the Pediatric Pharmacology Program, and William R. Crowley, Ph.D., professor and chair of the College of Pharmacy"s Department of Pharmacology and Toxicology.

"In pediatrics alone, there are probably fewer than 50 pediatricians around the country who are trained in clinical pharmacology and no more than 10 who are also neonatologists," said Ward, a national expert in the field. Ward and Crowley were part of a group of faculty members and researchers who met for a two"day retreat in 2003. "We all had a common interest in addressing issues that affect drug treatment of children"s diseases," said Crowley. "We're already collaborating in different research projects. So it was just a matter of gauging how much interest there was in moving this collaboration forward."

The group was unanimous-everybody wanted an interdisciplinary program that would design, develop, and advance new drug treatments for pediatric patients.

The group was unanimous-everybody wanted an interdisciplinary program that would design, develop, and advance new drug treatments for pediatric patients.

Ward and Crowley, who serve as coordinators, are part of a steering committee that includes Edward B. Clark, M.D., professor and chair of the pediatrics department; John W. Mauger, Ph.D., professor and dean of the College of Pharmacy; H. Steve White, Ph.D., professor and scientific director of the pharmacy college"s Anticonvulsant Drug Develop"ment Program; and J. Michael Dean, M.D., professor and chief of the pediatrics department"s Division of Critical Care.

The committee believes that the lack of trained professionals in the field is as serious as the dearth of information on appropriate dosage and adverse effects of drugs in children, both of which underline the necessity and the urgency of creating PPC.

"When I began work in pediatrics in 1974, most of the information about many of the drugs we used was based practically on hearsay," said Ward, who served as medical director of Primary Children"s Medical Center (PCMC) newborn intensive care unit for nine years. "Most drug therapies were extrapolated from adults and older children."

Pediatricians generally calculate a dosage based on the patient"s weight and height, but Clark said such a method is wanting. "The fact is, kids are not small adults. And relying on averages is not enough," said Clark, PCMC medical director.

Pediatricians also depend on drug handbooks, drug labels, published studies, and their own experiences in determining dosage for young patients. They generally prefer older medications, simply because they're familiar with them.

"We often don"t begin to use the newest medications until somebody has published results," said Ward. The problem is even more pronounced when treating newborns and preemies who are the least"studied group, he said.

For Ward, finding ways to address the issue became as important as treating children and doing research. He chaired the American Academy of Pediatrics Committee on Drugs that wrote policies for the country"s 55,000 pediatricians and worked closely with the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) to promote the study of the effects of drugs in children.

Ward also was involved in the development of several laws, including the 1997 FDA Modernization Act, which extended a drug"s patent for six months as an incentive for the manufacturer to conduct a clinical trial among children, and the subsequent Best Pharmaceuticals for Children Act of 2002 (BPCA), which created an Office of Pediatric Therapeutics within the FDA. Ward contributed many provisions to BPCA, as well as to the 2003 Pediatric Research Equity Act, which requires any new drug likely to benefit children to be studied in children. "The reality is that new drugs that are successful in treating adults will be used to treat children, because adult diseases-with the exception of geriatric diseases-do occur in children, although less frequently," said Ward.

Although key national initiatives are in place, Ward and Crowley think there"s a lot more that needs to be done, including training future pediatric pharmacology professionals. "To study drugs in the pediatric population, we need to train the next generation of researchers," said Ward. He and Crowley believe that the U, through the proposed PPC, is the most logical place to do this.

It already has a Pediatric Pharmacology Program (launched in 1997) that conducts clinical trials involving more than 540 local children. The drug investigations began in 1999, with the help of a $247,000 grant from the PCMC Foundation. Last year, the program was chosen by the National Institute of Child Health and Development as one of its 13 Pediatric Pharmacology Research Units across the country, giving the program a five"year, $1.5 million grant.

The program has ongoing investigations of pediatric drugs for such conditions as gastroesophageal reflux disease and high blood pressure, as well as a vaccine for rotavirus, which causes diarrhea and results in the deaths of hundreds of thousands of children overseas. In the U.S., rotavirus is the leading cause of hospitalization due to diarrhea in children.

The U also has the advantage of tapping expertise from the Eccles Institute of Human Genetics, the Huntsman Cancer Institute, and various departments and divisions within the medical school.

"Another strength we have in Utah is that families here recognize the importance of research. They understand that studies will help their children and the larger population. There"s a real sense of altruism," said Ward.

The PPC steering committee is currently developing a seminar program and applying for a training grant. The goal is to have an outreach program within three years.

"Bench to bedside to bench" sums up PPC"s goal. "We want laboratory research to be quickly translated to therapeutic entities, which can then suggest further research problems that can be addressed through partnerships of basic and clinical scientists," said Crowley.

Pediatricians need support from the scientific and academic community, said Clark. "They shouldn"t have to work it out on their own."

Initial areas of research emphasis include pediatric epilepsy and other neurological disorders, management of pediatric pain, and pharmacogenomics of adverse drug reactions in pediatric cancer patients.

PPC may not necessarily be a building, but a program and entity that will be funded internally and externally, said Crowley. "Pediatric pharmacology is currently not at a level where we want it to be," said Crowley. "We want a program that will help young faculty members pursue productive research careers and really help establish the discipline."

PPC organizers are calling on faculty members and researchers (inside and outside of the U) who are interested in sharing their expertise to improve drug treatment in children. "This is going to be a unique collaboration between basic and clinical scientists," said Crowley.

Clark envisions the center playing a key role in changing current practice and standards in pediatric pharmacotherapy. "By the end of this decade, we"d like to see that drug therapy is based on a child"s individual characteristics, rather than averages," he said.

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