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73 °F Forecast | Road Cams Sunday, April 4, 2004 Today's News | Classifieds | Autos | Homes | Jobs | Tempo | Health | Community | Home Delivery SECTIONS Home Page Local News Sports Business Obituaries Life Opinion - Politics AP News Weather Classified Archives Site Map EXTRA Newspaper in Education Personals Movie Times TV Times E The People CLASSIFIEDS Find a Car Find a Home Find a Job Find a Rental Place an ad eSouthernOregon Automotive Communities Entertainment Publications Recreation Calendar CUSTOMER SERVICE Frequent Questions Advertising Information Home Delivery Employment Contact Us Media Kit Network Affiliate Email Story to a Friend March 14, 2004 Dr. Dennis Linden talks with Sunny Mills of Grants Pass about her progress in one of his clinical trials. Linden says he enjoys research because it keeps him in touch with the latest developments in medicine and technology. Mail Tribune / Jim Craven A test case Drug trials bring national research home to the Rogue Valley By BILL KETTLER Mail Tribune Kent Petersen drives from Lake Oswego to Medford every other Sunday to get medicine for free that he couldn’t buy at any price. When Monday morning rolls around, the 52-year-old transpor-tation planner leaves his motel room and drives to the Clinical Research Institute on Crater Lake Avenue. Nurse technicians draw a blood sample, check his blood pressure, give him a thorough physical and send him home with another two weeks’ supply of a drug that might cure his diabetes. Petersen is one of about 60 people across the United States testing a medicine that researchers hope will rejuvenate cells in the pancreas that produce insulin. When he learned about the drug trial on the Internet, he jumped at the chance to participate, even though it meant two monthly trips to Medford for three months. "I’ve had diabetes for more than 35 years," he said during a break in a recent medical exam. "I’ve taken over 20,000 injections in my life. You can imagine if that was something in your daily routine, you’d want to get rid of it." Dr. Edward Kerwin arranged to have the drug tested in Medford. An allergist by training, Kerwin has conducted drug trials alongside his regular practice for 10 years. Advertisement "For six half-days I’m wearing my allergist hat," he said. "The other six half-days I’m a clinical research physician. I love being able to do both." Kerwin’s handsome office building just off Highway 62 makes him perhaps the most-visible part-time medical researcher in Southern Oregon. But he’s by no means the only one. Dozens of Rogue Valley physicians have recruited hundreds of patients for drug trials while they continue to treat patients. At the Medford Medical Clinic alone, physicians had 37 drug trials under way during the first week in March. Local doctors have studies in progress or being organized for drugs that treat everything from asthma and Alzheimer’s disease to depression, drug addiction and prostate cancer. "Most doctors have a passion for learning and understanding medical science," Kerwin said. "Clinical research gives us an excuse to do that." Clinical research "forces you to be on the cutting edge of the latest trends in technology and health care," said Dr. Dennis Linden, a Medford internist who also conducts trials. "Research forces (physicians) to really think about what they’re doing and how they’re doing it." Physicians also like to bring their patients new medicines that might not reach the market for years, said Dr. Walter Emori, a Medford rheumatologist. "Studies give patients a chance to try the newest drugs being developed in carefully monitored conditions." Testing drugs for efficacy and side effects is a critical phase of the long and expensive process of bringing new medicines to market. Pharmaceutical companies must test their promising drugs on thousands of people before they can win market approval from the federal Food and Drug Administration. Rather than try to recruit all the testers in one metropolitan area, they often spread the testing among dozens of smaller communities to ensure that the drugs will be tested on a wide range of people. It’s sometimes easier to recruit 10 people in each of two dozen small communities than 250 people in a metropolitan area, said Alan Goldhammer, a vice president of Pharmaceutical Research and Manufacturers of America, a national trade association known by the acronym of PhRMA. "If five pharmaceutical companies are studying a new allergy drug and they each need 2,500 patients for a trial, that’s 12,500 patients," Goldhammer said. "They’re not all going to find those patients in the same area." Goldhammer said electronic data transmission makes small-town drug trials feasible. "All the reports are done electronically," he said. "It’s not as complicated a business as it formerly was." Patients who enroll in studies generally get free medical care and free drugs for the duration of the trial as well as a small cash stipend (typically $100 to $300) to compensate them for their time. In exchange, they agree to undergo regular medical examinations for as long as the study lasts. A 12-week study, for example, might require a patient to spend an hour in the physician’s office once every two weeks. "Patients get a lot of attention, and they like that," Linden said. "I had a fellow enrolled in an insulin study that lasted six months. He didn’t want it to end. "Basically, if you’re in a drug study you’re probably getting more tightly scrutinized health care than anyone else," he said. "Patients who participate in trials are the most protected patients anywhere." "We bond with a lot of our patients," said Jean Hall, research coordinator at Medford Medical Clinic. "It’s not like the 15-minute visit with your doctor. We spend an hour with patients. They get to be our friends." Drug trials in the Rogue Valley typically use medicines that already are determined to be safe for human use. The tests that ascertain whether drugs are safe for humans are conducted on smaller groups under tightly controlled conditions. Drug companies pay physicians for their time they spend in trials and pay wages for nurses and research assistants who help physicians conduct the trials and manage the volumes of paperwork that each patient generates. "Physicians are well compensated (for drug trials)," Linden said, "but no more than they would be in private practice." Drug companies also budget funds in each trial for advertising to recruit patients. All the bills account for some of the estimated $815 million that is spent over the span of 10 to 14 years to bring a new drug to market, said PhRMA’s Goldhammer. "The companies spend a lot of money," Linden said, "to ensure that everything is done to the highest possible standard. "Drugs today are so expensive because they’re tested beyond belief." Many physicians limit their involvement in drug trials to their practice specialty. Rheumatologist Emori, for example, participates only in studies that involve treatments for arthritis and osteoporosis. "We are asked to do any number of studies outside rheumatology," Emori said. "I don’t even consider those because they’re not in my area of expertise." Physicians often reject study proposals if they can’t see real benefits for patients. "I only do studies where there’s something good for the patient," Linden said. He recently declined to participate in a study that would have required patients to be anesthetized and have a tube passed into their stomach three times during 12 weeks. "That’s not something patients would want to do," he said. Hall, the research coordinator, said patients who are willing to participate in trials play a critical role in developing new medicines. "We call these people modern-day heroes. The only way we’ve gotten where we have with our medicines is because people have participated in trials." Reach reporter Bill Kettler at 776-4492, or e-mail [email protected] Web has information about clinical trials Information about many clinical trials can be found on the World Wide Web at a site maintained by the National Institutes of Health. The site provides basic information about trials and who may qualify. It can be searched by disease, location or sponsor. A search last week for trials in Medford indicated 12 studies recruiting volunteers willing to test new medications for stroke, depression, multiple sclerosis and irritable bowel syndrome, among others. The Web address is: www.clinicaltrials.gov . 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