Treatments, lower drug costs, the hope of clinical trials

[RandyW]

New treatments, lower drug costs, the hope of clinical trials

Originally published January 06, 2009

By Ashley Andyshak

News-Post Staff

Photo by Bill Green

Dr. Nathan Wei, who heads the Arthritis and Osteoporosis Center of Maryland in Frederick, chats with patient Marvin Burcham, 53, of Hancock. Burcham had pain that started in his fingers spread to his shoulders and then the rest of his body, and it nearly kept him from getting out of a chair.

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Few people like to be called a guinea pig.

But doctors say volunteering to test new drugs can help keep costs down and help promising new prescriptions gain approval more quickly.

Dr. Nathan Wei, who heads the Arthritis and Osteoporosis Center of Maryland in Frederick, has involved his patients in clinical research for 30 years, and said he has seen medical care improve drastically in that time.

"The most we could do 30 years ago was alleviate the symptoms," Wei said. "We really had very little in the way of treatment, but we've been able to change that."

Most of Wei's patients have either rheumatoid arthritis, an auto-immune disease that targets the joints, or osteoarthritis, caused by breakdown of cartilage in the joints. Arthritis drugs can greatly improve a patient's quality of life, but they don't come cheaply, Wei said.

Only about one in 10,000 compounds discovered in laboratories are approved by the Food and Drug Administration, Wei said, and the process takes more than 15 years. In 2006, drug testing and approval cost more than $1 billion, he said, and once a drug is approved, the pharmaceutical company is entitled to just five years of patent protection before generic versions are allowed on the market.

"They have to put a high price on drugs to recoup their losses," he said. For example, a year's worth of rheumatoid arthritis drug Enbrel can cost $18,000.

However, the biggest roadblock, and expense, in developing new drugs is recruiting patients for clinical trials, Wei said. To make prescriptions more affordable, he encourages his patients to participate in the trials he oversees at his office on Thomas Johnson Drive.

For themselves and the future

Patient motivation for participating in a clinical trial varies, Wei said. Most say they do it to help others, while some do it to get paid (many studies reimburse participants for travel expenses, and others offer a small stipend).

For some participants, desperation draws them in.

A few years ago, Mary Ann Marvil's pain became so severe that she began to think she had broken a hip.

"The pain is overwhelming," she said of her condition, which Wei diagnosed as fibromyalgia, a chronic pain condition. Marvil also has rheumatoid arthritis and osteoarthritis, she said, and once she was properly diagnosed, she was more than happy to participate in Wei's trials.

Marvil, 59, of Sharpsburg, said she hasn't had any negative side effects from any of the trial drugs. One drug did nothing to help her, so Wei pulled her out of the test, she said. Participants can also choose to remove themselves from a trial at any time.

Marvil said she participates not only for herself, but for future generations who may be at risk for her conditions.

"There may be risks, but it's not a good quality of life (with arthritis)," she said. "(Participating in trials) keeps people from going through the trial and error that can take years. I need to feel better, but you also need broader perspectives."

About three years ago, 53-year-old Marvin Burcham, of Hancock, found himself as desperate as Marvil. Pain that started in his fingers spread to his shoulders and then the rest of his body, and it nearly kept him from getting out of a chair. He faced a six-week wait to see a rheumatologist in Hagerstown, so a friend referred him to Wei.

Since that first visit, Burcham has participated in several trials at Wei's office.

"I had nothing to lose," Burcham said. "If I had other options, maybe I would have thought about it."

Burcham's latest trial tested the effectiveness of cancer drug Rituxan on rheumatoid arthritis. Though the trial has ended, Burcham said his insurance will cover his next dose so he can continue treatment.

Wei isn't the only local doctor promoting clinical drug trials. Frederick Memorial Hospital Regional Cancer Therapy Center is host to more than 20 trials, studying drugs for all types of cancer, including breast, colon, lung, prostate, kidney and pancreatic, said coordinator Shelley Francella. About 40 patients are involved in active trials and another 140 are in follow-up care, she said.

Though all eligible cancer center patients are asked to participate in trials, Francella said doctors don't want trial participants to feel like they're part of an experiment, at least in a negative sense.

"We want to make sure they know that they're not guinea pigs and that they're getting the gold standard of treatment," Francella said. "We're not doing anything radical; they're getting standard therapy plus. That's how we make advances in treating cancer."

Some patients, especially those with colon cancer, ask to be enrolled in trials, in hopes of finding a more successful treatment, she said.

A last chance

For some of Dr. Mark Turco's patients, a clinical trial may be their last shot at saving a limb.

Turco, the director of Frederick Memorial Hospital's cardiac catheterization lab and the Center for Cardiac and Vascular Research at Washington Adventist Hospital, is trying to recruit local patients with Critical Limb Ischemia for a worldwide study of Tamaris.

Critical Limb Ischemia occurs in later stages of Peripheral Artery Disease, a condition that hardens large arteries in the leg and restricts blood flow. The condition affects 70,000 Americans every year and leads to skin ulcers, lesions, and some of the nearly 150,000 amputations performed annually, Turco said.

Researchers hope Tamaris will allow the body to produce new red blood cells which can then serve areas that need more blood in these patients, Turco said. Once the study is in full swing, it will comprise more than 400 patients in 30 countries, Turco said, and Washington Adventist will be the regional site.

Turco oversees more than 20 other trials at the Center for Cardiac and Vascular Research, and said the promise of a new treatment isn't the only benefit trial participants receive. The regular, consistent checkups can help them improve even faster.

"The added surveillance is many times very beneficial, and this is one of the reasons we see patients who are in clinical trials do better than general patients," Turco said.

The free extra care is what drew Tom Merritt in.

Merritt, 72, said he signed up for his first trial in 2002 for a selfish purpose: the free medical care, prescriptions and blood tests provided to participants.

"I've always been concerned about cholesterol," he said. "I did it mainly to get pills and medical checkups."

Merritt is in his second year of a study at Wei's office, testing the effectiveness of prescription Celebrex compared to over-the-counter naproxen and ibuprofen. He has had arthritis in his knees for nearly 20 years, but said the disease hasn't slowed him down much. He still works full-time at Fort Detrick and maintains his home on two acres near Middletown.

Merritt said he's not really concerned with the outcome of the research he is a part of.

"I'm not that interested in final results, as long as I'm healthy," he said.

But no matter what brings participants into a trial, Francella said their basic purpose is the same.

"Ultimately being in a clinical trial is an unselfish act," Francella said. "You're participating in a trial that may not benefit you directly but will help people down the road."