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Old problems, new possibilities

November 15, 2004|by ANDREA ROWLAND

andrear@herald-mail.com

Until recently, Sandra Seymour's rheumatoid arthritis crippled her quality of life.

The registered nurse at the Veterans Administration Hospital in Martinsburg, W.Va., said she experienced severe pain in her hands and feet, her joints ached, and she was tired all the time.

"It was pretty rough in the beginning, trying to work and hurting badly," said Seymour, 58, of Charles Town, W.Va. "It got very difficult for me. I thought I was going to have to retire - and I wasn't ready to retire."

Then she volunteered to participate in a clinical trial for a new rheumatoid arthritis drug that fights the disease on a biological level. Once a month, Seymour travels to rheumatologists Steven Klein's and David Malamet's Osteoporosis & Clinical Trials Center in Hagerstown for an intravenous dose of Abatacept. The first year of the trial for the Bristol-Myers drug was a "blind study"; the local trial's 12 participants didn't know if they were receiving the drug or a placebo, said Kathleen Renee, clinical research coordinator.

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But for the past six months Seymour and her cohorts have been receiving monthly infusions of Abatacept. Nurse Emilee Draper, who monitors clinical trial participants at the Hagerstown center while they receive their medication, said it's been gratifying to watch the patients get their lives back.

"I feel close to normal again," Seymour said. "It's been a real lifesaver to me."

Testing ground for new drugs


Patients can take part in clinical studies that cover medical problems and conditions ranging from AIDS and aging to strokes and schizophrenia, according to information from the National Institutes of Health Clinical Center in Bethesda, Md. Participants pay nothing for the drugs but must qualify for studies and agree to terms outlined by the sponsoring pharmaceutical company. Studies at the Osteoporosis & Clinical Trials Center vary in duration from a few weeks to three years, and all trials have different requirements, research coordinator Kelly Weicht said.

But the trials share one common denominator - they're all needed to get new drugs on the market, Dr. Klein said.

"People who live with pain all the time don't even realize what they're putting up with," he said. "These drugs can turn people's lives completely around. These are blockbuster drugs."

Without participants, trials are shelved and the promise of new treatments dims. Klein fears that fate awaits one of the most exciting clinical trials that his practice is offering - a study of a once-a-year intravenous treatment for osteoporosis in men. The test drug is Zometa, which is already approved for the treatment of calcium disorders but not osteoporosis, Klein said. Only two men had signed up for the study as of Monday, Nov. 8.

"Men are apathetic to osteoporosis because it's not big on the radar screen, but it's a bigger problem for men than people think. One out of five osteoporosis patients are men," Klein said. "We've already had two companies close clinical trials due to enrollment. When that happens, we're left with questions we'll never get the answers to."

Robert Elburn of Waynesboro, Pa., signed up for another clinical trial involving Zometa - a study to test the drug's effectiveness at preventing bone density loss in patients taking steroids. Such patients can lose 5 percent to 10 percent of their bone mass within the first six months of steroid use, Klein said.

"It's all new to me," said Elburn, 42. "But if it helps, that's great."

Human guinea pigs


It's true that clinical trial participants are guinea pigs - "carefully monitored guinea pigs," Klein said.

"They know they're monitored very closely. We talk with them. We examine them. We do the prescribed labs," he said.

Clinicians who administer trials must follow strict protocols specific to the drug and disease being studied, Klein said. The U.S. Food and Drug Administration appoints a panel of trial advisers, called an Institutional Review Board, to develop trial protocol based upon all factors that must be monitored during the study, he said.

"The FDA's mission is to protect the public," Klein said. "I can't waver from that protocol."

Most clinical studies pose risks of short-term, minor discomfort, but some volunteer subjects experience complications that require medical attention, according to information on the NIH Clinical Center Web site at www.cc.nih.gov. The specific risks associated with any research protocol are described in detail in the consent document, which participants must sign before taking part in research.

The major risks of participating in a study also are explained in full, Klein said.

A trial's informed consent statement includes detailed information about the study - its duration, the number of visits required, and medical procedures and medications included - expected outcomes, potential benefits and possible risks, according to information from the NIH Clinical Center.

The Institutional Review Board gives final approval of the sponsoring pharmaceutical company's consent form, ensuring that the form offers full disclosure of trial risks, Klein said. The board also is charged with making sure that advertisements for clinical trials are fair and balanced; for example, an ad can't emphasize the word "free" with regard to participation because the FDA considers that language coercive, Klein said.

"The reason people are supposed to go into trials is because it's best for them," he said.

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