Worcester Doctor on Leading Edge of Clinical Trials

Wednesday, May 16, 2012

Sandy Meindersma, GoLocalWorcester Reporter

John Shennette talks with Dr. Charles Birbara while undergoing treatment

Located just a block away from the Memorial Campus of UMass Memorial Medical Group, Dr. Charles Birbara and his staff are working feverishly to help bring new drugs to market.

Dr. Birbara, a Rheumatologist, founded the Clinical Pharmacology Study Group 22 years ago with Clinical Nurse Manager Mary Coughlin, and since then, the practice has been involved in bringing nearly a dozen drugs to market, including Humira, Orencia, Actmera and Celebrex.

“When Humira was approved, we already had more people on it than the rest of the country,” Dr. Birbara said.

Clinical Pharmacology Study Group works primarily with medications that treat system inflammations like arthritis, psoriasis and Crohn’s disease. Dr. Birbara said that his office has treated thousands of patients over the years.

With a staff of nine, the group currently working on five different studies for rheumatoid arthritis, a long term study for Crohn’s disease, two studies for ankylosing spondylitis (inflammation of the bones and joints in the spine), one for psoriatic arthritis and one for psoriasis.

Benefits of Clinical Trials

Dr. Birbara, who said that patients for his clinical trials usually come from within 50 miles, said that he has treated patients from New York, Florida and New Mexico.

“We had one young woman from New York, who had psoriasis on her face,” Dr. Birbara said. “She was referred to us by her dermatologist and her face was all cleared up.”

Dr. Birbara said patients who participate in his clinical trials receive excellent care, at no cost to them.

“The drug manufacturers pay for everything,” he said. “All medications are free, all the lab studies, and all the clinical care is done free of charge. It’s a big advantage for them. The attention to detail is enormous.”

“We follow patients extremely carefully,” Coughlin said.

Coughlin said that some of the arthritis patients have been followed for as many as ten years.

“We have one patient who was newly diagnosed, and we were able to bring him on,” Dr. Birbara said.

Dr. Birbara said that his patients get access to some of the newest medications on the market, including those that are not yet FDA approved.

Options When Traditional Treatments Fail

Tina Webb hopes that her experimental treatment for Crohn's disease will improve the quality of life.

For some, a clinical trial becomes an option when traditional treatments fail.

Tammy Webb, 48, who has had Crohn’s disease for the last 30 years, was receiving her first treatment of Stelara, which has FDA approval for psoriasis, but not Crohn’s disease.

“We have high hopes for Tammy,” Dr. Birbara said. “She has failed with every possible medication – all the standard non-biological treatments for Crohn’s.”

“I suffer from diarrhea, fevers and bloating,” Webb said. “And I’ve had six surgeries.”

Webb received her first treatment intravenously, will return in a month for a follow up injection, and then will receive treatment every three months.

“Most patients will see some response to treatment within three months, but many respond as quickly as the next day,” Dr. Birbara said.

New Types of Treatments

Dr. Birbara said that initial treatments were chemical based, but science has advanced to using biologic agents, which are larger molecules, grown in laboratory animals, instead of a chemical agent that is constructed in the lab.

“It’s quite amazing what we’ve been able to do,” he said. “Biologic agents inhibit those chemicals that contribute to the growth of the disease.”

Dr. Birbara said that biologic agents have revolutionized how rheumatoid arthritis is treated and changed the expected treatment outcomes.

“RA is progressive, but right now our goal of treatment is to eliminate the progression, and put the disease into remission, with no possibility of joint deterioration.”