When Spokane pediatrician Stephen Luber isnt seeing his regular patients at Rockwood Clinic here, hes likely these days to be studying the effectiveness of vaccines for whooping cough or meningitis, or researching possible new remedies for attention deficit hyperactivity disorder, respiratory syncitial virus, or cervical cancer.


Luber, who routinely serves as principal investigator here for a host of pharmaceutical clinical trials, has been a catalyst for bringing more than 50 national and international trials, most of them related to children, to Rockwood in the past 10 years.


In that role, Luber has been an eyewitness to pharmaceutical advancements in such pediatric health concerns as asthma, influenza, E. coli infection, strep throat, skin infections, ADHD, and immunizations, he says.


Our overall goal is to advance the technology of large groups of people, says Luber.


We are very careful to select the kinds of studies that offer kids something that is very positive, he adds.


He points to studies aimed at preventing respiratory syncitial virus infections in at-risk infants, the first study he initiated here in 1995, where kids in the trials benefited from the monoclonal antibody (which is now standard care) three years before the drug Cynagis came into standard use.


Luber isnt the stereotypical pediatrician. Although his office door is dotted with photographs of young patients and a crayon drawing from a youthful admirer, the wall in his small office, among the obligatory framed certificates and awards, includes evidence of his less gentle side: a trio of colorful rugby photographs. He played that rough and tumble sport in 1970 for a club team at Stanford University, where he was then a graduate student. He asserts that he was one of only two players on that years rugby team who didnt also play football on Stanfords Rose Bowl championship football team led by all-American quarterback Jim Plunkett. Luber, who says he is now feeling the painful aftermath of having played rugby, says he later went on to play for a Bay Area Turning Side rugby club that won a national championship.


He also defied the norm by not making the decision to become a doctor until after graduating from Harvard University with an MBA in 1969 and working in a community design role in Boston and in an administrative capacity at a Stanford-sponsored health clinic in Livingston, Calif.


I liked what the doctors were doing more than administration, he says, and enrolled in medical school, graduating with a specialty in pediatrics from the University of California in San Francisco in 1975.


After three years of residency, Luber worked for 16 years as a partner at a health clinic in the Ketchum-Sun Valley, Idaho, area, where he says he was the only pediatrician within 100 miles. He moved to Spokane in 1994.


A high ranking


Rockwood Clinic ranks among the top pediatric research groups in the nation, asserts Luber. He says the clinic averages five or six pediatric pharmaceutical studies a year, and has done as many as 10 in one year.


Its a useful adjunct to the business, but no one is growing wealthy, he says. Its hard to run a consistent research program and keep it in the black. Its not an easy thing.


Pharmaceutical companies regularly spend heavily to document the safety and effectiveness of medications theyre developing. In one study for a vaccine for rotavirus, what Luber calls the leading cause of death among the worlds children, West Point, Pa.-based Merck & Co. spent more than $1 billion to include 80,000 participants, including about 140 infants at Rockwood Clinic, in a Phase 3 study. Phase 3 is the trial level which an experimental drug is close to being licensed by the U.S. Food and Drug Administration for public use.


With progress payments made by the pharmaceutical companies to the clinic while the studies are under way, Luber says an average 18-month study will reimburse Rockwood about $2,000 for each patient enrolled in a trial.


That money helps to pay for the time of the clinics doctors, supervisors, and administrators, as well as to pay stipends to participants in the study, immunizations when necessary, and expenses created by the voluminous paperwork required to meet both the drug makers and FDAs requirements.


It doesnt include any travel expenses a doctor might incur when reporting study findings to sponsoring pharmaceutical companies, which are paid separately, says Luber.


Providers at Rockwood arent required to participate in studies the clinic takes on, but most of the nine childrens specialists on staff there currently are working to some degree on various studies, says Luber. In addition to providing a financial incentive to doctors, the studies help them offer their patients the latest and greatest in health developments, he says.


Rockwoods pediatric clinic has established a track record with pharmaceutical companies and the contract research organizations that locate study sites for them, and both now come to Rockwood to get studies done, says Luber.


He says specific standards have been adopted internationally that must be adhered to in performing clinical research.


One trend he sees in such research involves the decreasing use of placebos, or fake pills.


The common approach now, he says, is to compare an experimental drug with the accepted standard of care, or the drug most commonly used to treat an illness.


Its unethical to take a patient off of their standard of care to test a new controller, Luber says.


Most of the pharmaceutical studies done under Lubers supervision at Rockwood Clinic have been Phase 3 studies. When the drug company reaches this stage, it has a pretty good idea that their product is going to work, Luber says.


The number of participants in the 52 studies Luber has supervised since 1995, five of which currently are under way, has ranged from six to 160 patients, he says. Studies can last as long as four years or be as short as three weeks, depending on the nature and extent of what is being studied.


Some of the most important pediatric work Rockwood has been involved in over the years involves studies on ADHD, for adults as well as for children, and on medications to treat the disorder, says Luber. As many as eight ADHD drugs have been tested and, Weve done some incredible work on vaccines, he says.


In addition to testing a new adolescent whooping cough vaccine, a drug to prevent meningitis, and other vaccines, Rockwood also has been involved in studies to combine and reduce the number of shots required to protect infants from measles, mumps, rubella, and chicken pox, Luber says.


Lubers articles have been published at least nine times in various medical journals, and he often has been asked to speak on pediatric issues to medical groups in Washington, Oregon, Idaho, Utah, and California.


Yet, with all those studies, written documents, and speaking engagements involving so many different areas of health care, Luber says he is primarily a practicing pediatrician, a job that consumes about 80 percent of his working time.


Although only about 20 percent of my time is spent directly on studies, there is a lot of overlap with my daily practice, he says. If Im not a viable pediatric practitioner, Im not a viable pediatric researcher.