Physicians Regional seeks patients for clinical studies, including heart, spinal conditions

NAPLES, FLORIDA (October 22, 2011 by Naples Daily News) -- Physicians Regional Healthcare System is looking for a few good patients to enlist. In the past year, the hospital system has ramped up the number of clinical studies that physicians with its group practice are involved in and also in enrolling local patients.

To date, the group is taking part in about a dozen clinical studies aiming to reduce side-effects and symptoms of various conditions, to improve patients' quality of life. "Patients understand participating will help improve medical knowledge," said Dr. Arnold Alexander, an internist who is enrolling patients in three studies involving arthritis, diabetes and nuclear stress tests. Patients also have a sense of philanthropy that they will help others; for some patients they are getting medical care at no cost to them.

The studies at Physicians Regional are all in advanced stages, so risk already has been screened out in earlier stages. "I think we can say they are relatively safe," Alexander said. He first became involved in clinical trials at Cleveland Clinic Naples, which became Physicians Regional after it was acquired by Naples-based Health Management Associates.

Last year, Physicians Regional hired a research director, Rachel Barry, to help select which clinical studies to take part in. The research department now has two study coordinators, along with Barry, who helps to launch the local participation in studies and screen patients who could potentially meet criteria to take part.

"Doctors like to be at the forefront of (developments) and they like their patients to have access to new drugs," Barry said. "Do patients need a referral? The answer is no and they don't have to be a patient of our group, and we share some of the lab results with their primary-care doctor." Local participation isn't intended for patients to give up their relationship with their existing doctors outside of the Physicians Regional group, she said. 

One of the studies that Dr. Richard Gelb, a cardiologist, is overseeing locally involves heart attack survivors and a drug that may reduce an inflammation that is an identified risk factor for another heart attack. One of the studies that Dr. Richard Gelb, a cardiologist, is overseeing locally involves heart attack survivors and a drug that may reduce an inflammation that is an identified risk factor for another heart attack. The drug that Novartis has developed, which is injected, may block the interaction of that protein to a cell receptor to reduce the inflammation in the bloodstream.

"It (the drug) is given every three months, under the skin, like insulin," he said. "But at this point, we don't know if it is effective at all and for how long." The clinical trial is in the third phase of studies so it's been tested in animals and in small human trials and it's safety already is determined. So far, just three people locally are enrolled but Novartis will allow the group to enroll many more patients as long as they meet criteria, Barry said.

For patients who have suffered spinal compressions due to osteoporosis, cancer or falls, Dr. Michael Lusk, an orthopedic surgeon, is involved in a surgical study where a small pouch is used to undo a compression fracture in the spine rather than a balloon that is the traditionally used. Instead of using dye to inflate the balloon, which gets removed so that cement can be inserted to keep the compression fracture open, the pouch is inserted and the cement goes in the pouch. After the cement has set in about five minutes, the pouch is removed.

"The pouch comes out at the same time as the procedure (is done)," he said. The goal is that the cement stays in place better than what's been the experience at times when the balloon is used, Lusk said. So far, he's used the pouch with 14 patients. "It may indeed be a better tool than the traditional approach," he said.