Medical Center on cutting edge of drug treatments

By S. Heather Duncan - hduncan@macon.com

When Becky Meyer was diagnosed with breast cancer at age 61, her doctor and an oncology research nurse at The Medical Center of Central Georgia offered her a new treatment: a drug called Avastin.

The drug is known to cut off blood flow to cancerous tumors but hasn’t yet been approved by the Food and Drug Administration for use on her type of breast cancer.

Meyer, a retired nurse, went home and talked with her husband about it. She researched Avastin online. She decided she trusted her doctor.

Meyer said yes.

Nine months later, she has had surgery and chemotherapy and is still taking the Avastin. The regimen seems to have whipped the cancer, she said.

“I feel like I’ve done really well,” Meyer said. “I hope my having taken this drug will help them with the treatment of this disease in the future.”

The Avastin trial is one of about 30 currently running at the Medical Center, which also continues to follow the subjects of about 20 other past studies, said hospital clinical research manager David King.

The hospital’s status as a research institution and its partnership with Mercer University means that Macon has long been an incubator for new treatments, some of which are now considered the gold standard, research managers say. Mercer also participates in outpatient trials independently, as do some private doctors in the city.

But although trials put the Medical Center and its patients on the cutting edge of new research, they also pose risks. The treatments haven’t been broadly approved by the FDA, and sometimes the side effects and interactions aren’t yet understood.

By law, patients must be informed of those risks before deciding whether to participate. It can be a difficult decision that sometimes must be made immediately, as in the case of trauma or heart attack patients.

Raj Patel, a doctor of internal medicine with the hospital and Mercer, noted that participating in research increases the prestige of the hospital. But the real point is providing better treatment for the types of disease most often seen at the Medical Center, he said.

For example, as a Level 1 trauma center in a region with rampant heart disease and diabetes, the Medical Center often looks for trials focused on these specialties — even though they can be some of the most complex to conduct, Patel said. Consent and treatment must happen very rapidly.

A few years ago, the hospital participated in the trial of a blood substitute for use with trauma victims. The trial became controversial because generally its subjects couldn’t agree to participate until after they had already received the product.

PAST AND CURRENT STUDIES

Contrary to the stereotype, most drug trials aren’t last-ditch efforts to cure terminal illness, King said.

Nevertheless, many Medical Center trials have dealt with cancer or heart disease. And Mercer has been a pioneer in trials for HIV and AIDS treatment, having been a trial site for many of the most common therapies used today, said Sophia James, research administrator for the Mercer Medical School in the department of internal medicine.

“Mercer has never done a study of a drug that wasn’t later approved,” she said.

For cancer treatment, the hospital conducts inpatient studies and works with Central Georgia Cancer Care on trials that continue through outpatient treatment.

“We’re starting to look more at targeted therapies that do things like shrink tumors or inhibit the formation of blood vessels to tumors,” said Julie Gioscio, an oncology research nurse at the Medical Center.

For example, the hospital participated in the trial of Herceptin, a drug that slows or stops the growth of the cells that make tumors grow faster and come back after treatment. Herceptin is now a standard breast cancer treatment, she said.

The Medical Center is known for its heart center, which has often tried out new devices in its catheterization lab, said Carrie Knott, cardiovascular research manager.

In 2002, the hospital helped test the first drug-coated stents. Stents are metal mesh tubes used to hold an artery open to maintain blood flow. Drug-coated stents are now commonly used to inhibit the growth of scar tissue, reducing blockages and the need for additional surgery, Knott said.

A current trial is testing which medicines work best for patients who have both high blood pressure and heart failure, Patel said.

“We have a large population with heart failure in Macon,” he said. “We also have a big problem with high blood pressure and diabetes.”

Patients get involved in these trials through different avenues. Most are approached, as Meyer was, by their doctor and a hospital research coordinator.

Some refuse. Knott said patients may say “they don’t want to be a guinea pig.”

Others volunteer. Cancer patients may seek out a trial they have read about online and drive to Macon from an hour away to participate, Gioscio said.

Newspaper advertisements were used to attract Macon-area subjects for hypertension and arthritis treatment trials, James said.

James noted that trial participants actually see their doctors more often than they would otherwise and receive more follow-up tests, all at no extra charge.

“So patients often feel they get more attentive care in a trial,” James said.

PRIOR CONSENT IN EMERGENCIES

Some types of trials, especially those that deal with subjects who are in life-or-death emergencies, are conducted without patients directly consenting first.

Several years ago, the Medical Center was the only test location in Georgia for PolyHeme, a blood substitute being developed for use on the battlefield and in other situations when blood supplies are limited. Because the trial focused on trauma victims, most patients were unconscious when the product was first given. The study provoked outrage among some national consumer groups.

Instead of traditional consent beforehand, the FDA approved using community education campaigns to inform people that they could obtain armbands to wear all the time for more than a year, which would exclude them from the study.

The Medical Center held eight town hall meetings at different times and locations across Bibb and Jones counties — advertised in the newspaper — and set up a toll-free hotline for comments or opt-out requests, said study coordinator Deborah Kitchens. Attendance at most of the meetings was sparse, she said.

Kitchens estimated that she gave out 400 armbands, including 200 requested by a single church. About 80 percent of the armbands were requested by Jehovah’s Witnesses, who frequently refuse blood transfusions for religious reasons, she said.

In the study, PolyHeme was given instead of a salt solution to patients in an ambulance. For the first 12 hours of treatment — or six units of PolyHeme, whichever came first — they continued to receive the product instead of blood transfusions, Kitchens said.

But as soon as the patient arrived at the hospital, the patient or family member had to be informed about the PolyHeme and provide consent for it to continue, she said.

“If we didn’t have consent, we had to document every 15 to 30 minutes why we didn’t,” she said. Patients could pull out of the study at any time.

After the television program “20/20” ran a story about the lack of advance consent in the PolyHeme trial, some Macon residents called, cursing at Kitchens.

“You don’t tell Americans they don’t have a say-so in their care,” she said. “They lose it.”

But she compared the trial to the many times when an emergency responder decides which hospital to take an unconscious patient. Despite criticism of the trial, Kitchens said she thinks the hospital would conduct a similar experiment in the future if a promising product became available. None of the local subjects had adverse reactions to PolyHeme, she said.

“We were interested because it was a trauma trial, and I just think we need something like this,” Kitchens said. “You hear things all the time about blood banks running dry.”

In addition, PolyHeme has a longer shelf life than blood and can be given to anyone regardless of blood type.

Since the trial, PolyHeme still has not been approved by the FDA. King said the hospital frequently never learns the results of the full studies in which it participates.

The Medical Center currently is involved in another trial of a product delivered in ambulances, although patients are only enrolled if they are capable of consenting.

The study is testing out a solution of glucose, insulin and potassium for preventing a threatening heart attack or to reduce the risk of serious complications and death from a heart attack while it’s occurring, said Kelly Joiner, assistant director for The Medical Center EMS.

Macon is one of eight sites across the country involved in the study, which is designed to include 880 patients in all, she said.

“If found effective, it will change our standard of care across the nation,” she said. “It will be a cost-available drug for ambulances to carry.”

Previous studies have shown the solution to be most effective when it’s given as early as possible, so trying it before the patient even reaches the hospital makes sense, she said.

“There’s not a lot of research in EMS, and it’s needed,” Joiner said. “There’s a greater understanding in the medical community that EMS is an under-utilized resource. We’re the first medical professional that people see, and for people in rural areas, we may be with them for almost an hour before they arrive at the hospital.”