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Medford clinics testing experimental treatments

A device being tested in Medford that sends electricity through the brain could help relieve pain in patients suffering from fibromyalgia.

It's just one of dozens of new medical treatments and drugs being tested by two clinical research centers in Medford.

The treatments could ease suffering from a variety of conditions, including chronic pain, low testosterone in men, dust mite allergies, diabetes and chronic pulmonary obstructive disease, commonly known as COPD.

"It's an exciting time in medical research," said Dr. Edward Kerwin, medical director of the Clinical Research Institute of Southern Oregon on Crater Lake Avenue and founder of the Allergy and Asthma Center of Southern Oregon. "Sometimes we think America is not making progress the way it used to. But the U.S. and other countries are making great improvements."

Sunstone Medical Research, which also conducts clinical trials in Medford, is testing the fibromyalgia device at its center on East Barnett Road. 

"It sends a mild electrical current across the brain," said Dr. Chris Alftine, a primary principal investigator with Sunstone. "It's been successful in Europe in treating mild depression. The voltage is less than an AA battery."

Researchers believe patients with fibromyalgia have higher levels of neurotransmitters in the brain that signal pain. The brain's pain receptors also overreact to pain signals, according to the Mayo Clinic, which has campuses across the nation.

Alftine said magnetic resonance imaging shows dramatic differences in the pain areas of fibromyalgia patients' brains compared to people who don't have the disorder.

"They literally experience more pain," he said.

Sunstone also has conducted clinical trials on an innovative drug that could replace opioid painkillers.

Concern about opioids is rising in the Rogue Valley and across the nation because of their addictive nature and side effects that include sedation, constipation and sometimes lethal respiratory depression. Prescription opioids can also serve as a gateway drug to street narcotics such as heroin.

"The possibility we could move away from opioids exists," Alftine said.

A class of pain medication called monoclonal antibodies works by attacking proteins that are part of the body's ability to detect pain from chronic conditions, he said.

"They wipe out the body's ability to sense needless pain. The antibody finds the protein in the bloodstream and binds to it. The body clears it out as foreign," Alftine said.

The antibodies showed powerful pain-relieving effects when tested at Sunstone, he said.

"We gave the drug to people with chronic, severe back pain and it evaporated without them having to use narcotics," Alftine said.

The Food and Drug Administration stopped trials of the drug after higher rates of hip arthritis and replacements occurred in patients, he said.

Alftine believes patients may have had underlying hip problems that worsened when they suddenly increased their physical activity after experiencing pain relief.

He hopes trials of the drug can continue in the future.

Alftine said Sunstone conducts clinical trials of drugs that have been tested for initial safety in humans.

The drugs previously have been tested on animals and then on human volunteers without the medical problems being studied.

At Sunstone, drugs are given to participants with the diseases being studied, Alftine said.

Sunstone's job is to recruit subjects, know clinical trial protocols, administer trial treatments, collect data and monitor the health of subjects. To ensure research is neutral or "blind," Sunstone doesn't analyze the data, he said.

Government agencies, foundations and other organizations, individuals and pharmaceutical companies usually pay for clinical trials, according to the National Cancer Institute.

Common side effects during trials at Sunstone include nausea, rashes and yeast infections, Alftine said.

While the majority of study participants receive research drugs, a minority will receive placebos, he said.

"Our primary problem is patients don't feel a benefit and want to stop participating because the drug is not working or they're getting the placebo," Alftine said.

Study participants can drop out of trials whenever they want, he said.

He said patients experience improvements in more than half of studies when given test medications.

While some people enroll in studies because they believe they will get cutting-edge medical care, Alftine cautioned clinical research should not be confused with medical treatment.

"We don't do trials to treat people. We do trials to test drugs. If patients benefit, that's a bonus," he said.

Helen, a Phoenix resident who asked that her last name not be used, has enrolled in several clinical trials at Sunstone as she battles COPD.

Affecting an estimated 24 million Americans, COPD is an umbrella term for progressive lung diseases characterized by increasing breathlessness, according to the Washington, D.C.-based COPD Foundation. 

Reliant on Social Security payments, Helen, 79, uses money she earns from the trials to pay for car repairs and other needs.

"I think of it as a part-time job," Helen said.

Study participants often are reimbursed for their time and travel expenses.

A former smoker, she uses supplemental oxygen while sleeping, driving, shopping for groceries and doing small chores such as cleaning her cats' litter boxes. She has to pay someone else to do chores like vacuuming.

"After I clean the litter boxes and walk down the hall, I'm gasping for air," Helen said.

During one drug trial with Sunstone, she said she felt no different and believes she may have received a placebo.

Helen said she felt better during other trials.

"I wasn't as out of breath. I felt like I was breathing better," she said.

She has experienced various side effects, including hoarseness when she would blow into a device to measure her lung function, as well as a deep cough.

Helen doesn't expect a cure from the trials. She also has congestive heart failure and hopes her heart gives out before she reaches the end stages of COPD, when patients can experience gasping and a sense of suffocation.

"Dying of COPD is not very pleasant," she said. "It's going to kill me. Smokers beware. You can get COPD through secondhand smoke, too."

Alftine said various classes of COPD drugs being tested by Sunstone work in different ways. They can dilate the airways by relaxing muscle tissue lining the airways, or suppress airway inflammation, which leads to less mucous production and fewer spasms.

The Clinical Research Institute focuses on trials related to COPD, asthma and allergies.

The institute plans to test inhaled insulin — which could replace insulin injections for diabetics — to see whether it's as effective in people with COPD and asthma, Kerwin said. 

Another trial tests whether a pill placed under the tongue could relieve dust mite allergies, he said.

A new inhaler that combines three different medicines could be an improvement over current dual-medicine inhalers, Kerwin said.

Sunstone conducts more wide-ranging clinical trials, including pill and injectable treatments for men with low testosterone, drugs for overactive bladder, a gel for diabetic foot ulcers and drugs to counteract constipation caused by opioid painkillers.

Kerwin said there is exciting research going on in the Rogue Valley that could have widespread benefits.

"We're working with very novel treatments," he said.

 Reach reporter Vickie Aldous at 541-776-4486 or by email at valdous@mailtribune.com.

 

Certified clinical research co-coordinator Amy Myers-Peterson, left, demonstrates an experimental fibromyalgia treatment device at Sunstone Medical Research in Medford. It sends an electrical current across the brain in the hope of lessening pain in fibromyalgia sufferers. Mail Tribune / Bob Pennell