Research quietly under way at area hospitals
Quietly and without fanfare, medical professionals have been contributing to a growing body of science through clinical trials of drugs not yet approved by the Food and Drug Administration.
Some researchers say their role in bringing new therapies and treatments to the marketplace shouldn’t be such a well-kept secret. A local chapter of the Association of Clinical Research Professionals enhances awareness of the research occurring in Greater Des Moines, and also serves as a clearinghouse and resource for individuals wanting to participate in the trials.
“People expect clinical trials to be done at research medical centers, and they’re very much unaware of the numbers of research professionals in and around Des Moines,” said Tina Higginbotham, a research consultant at Iowa Methodist Medical Center’s Office of Research and a member and past president of ACRP. “We certainly have had some participants here who were thankful it was done in Des Moines, Iowa, and they had an opportunity to participate.”
In their search for ways to reduce the risk of stroke during bypass surgery, heart surgeons began experimenting in the late 1990s with a dispersion cannula designed at Iowa Methodist Medical Center. Their research showed the device reduced the risk of a heart attack by 75 percent, and for the past three years, medical technology giant Edwards Lifesciences has been aggressively marketing it.
“It’s standard of care in many places,” said cardiac surgeon Dr. Ron Grooters. “The Mayo Clinic is using this cannula now, and it was thought of here.”
In large part, medical research at Des Moines hospitals slips quietly under the radar screen. “People don’t have any idea what we’re doing here,” Grooters said. “We keep it to ourselves.”
Mark Polich, director of Iowa Heart Center’s clinical research department, said researchers across the country are amazed at the number of clinical trials occurring in Iowa’s capital city and the fact that it was the first testing ground for a number of devices that are now used throughout the health-care community. “There’s a perception there isn’t a lot of research work done in Des Moines – we get that from the industry,” said Polich, who leads a department of 17 researchers. “But they’re amazed at the size of our department.”
Some of the medical advancements occurring in Des Moines have a significant “gee whiz” factor, said Rob Schweers, a spokesman for the Iowa Heart Center, a private group of 55 physicians who practice at both Mercy Medical Center’s Iowa Heart Hospital and at Iowa Health System hospitals, including Methodist and Iowa Lutheran Hospital. But the bulk of the hundreds of research projects occurring at the city’s hospitals are clinical trials to determine the efficacy of prescription drugs not yet approved by the Food and Drug Administration.
“I’m pretty choosy,” Grooters said of his participation in the trials. “I don’t have a lot of time and it has to fit with my schedule.
“We don’t have all the capabilities; we’re not like the University of Iowa, which has lots of people doing research,” he said. “I pick and choose what I think will be the most effective.”
For the past year, Grooters has been studying the effectiveness of Hemolink, an investigational agent from an emerging class of drugs called oxygen therapeutics. The new drug is a human-derived hemoglobin researchers think will reduce the need for blood transfusions during bypass surgery. Early testing showed the oxygenating agent reduced blood usage by about 30 percent. Unsatisfied with the findings, the FDA ordered more trials, Grooters said.
“What’s great about this is, it has a shelf life of up to three years, and blood has a shelf life of about six weeks,” Grooters said. “And it maintains its oxygenation capability, where old blood takes up to six hours to carry oxygen. This really oxygenates better than blood.”
Dr. Robert Zeff, a cardiac surgeon, is the principal investigator for the multi-institutional trial of Hemolink at Iowa Heart Center. “These agents don’t have the same properties as blood, including the ability to fight infection or create blood clots for healing,” he said. “Instead, they are designed to carry oxygen throughout the body.”
With few exceptions, bench research is rare in Des Moines. What does occur is limited to a handful of devices such as the dispersion cannula or the new medication-coated coronary stents, developed at Iowa Heart Center, that greatly reduces the odds that arteries will renarrow.
Most of the drug trials at Des Moines hospitals are either Phase II or Phase III prescription drug trials. In Phase I trials, small numbers of healthy people are given an experimental drug in a blind study to determine the effects of its components. Small numbers of sick people are given the drug in Phase II trials to determine the most effective dosage and measure the medication’s side effects. Phase III studies, which involve thousands of sick patients, test the effectiveness of larger doses of the drug. In Phase IV follow-up studies after FDA approval, the drug is evaluated for its long-term effect and how well it compares with others on the market.
Polich said up to 60 drug trials are under way at any given time at Iowa Heart Center, where he has headed the Clinical Research Department since 1987, “when the group decided this was an important thing to do.”
Its strong relationships with pharmaceutical manufacturers and reputation for doing high-quality work have put Iowa Heart Center in the position to turn down more drug trials than it accepts, Polich said. Each trial is evaluated to determine if it’s good science, if it’s beneficial to patients and if other studies are competing for the same patient population.
Clinical trials have been going on at Iowa Methodist for many years, but the hospital only created a formal research department about three years ago. “Pharmaceutical companies are constantly engaging physicians and hospitals for assistance,” said Tina Higginbotham, a research consultant for the Office of Research and Clinical Studies. “There are plenty of physicians interested in participating, but they didn’t have the background to do it on their own, or didn’t have the nursing staff to take on an additional task such as conducting clinical trials.
“It’s not for everybody,” she said. “It does take more money, it does take more effort and you do have rigid protocols you have to follow. There has to be a commitment on the physician’s part to serve as principal investigator on a clinical trial.”
Before trials can take place, the protocol for the study goes through a rigorous approval process before the Institutional Review Board, a local panel that includes doctors, clergy, lawyers and lay people. Some trials go before a central IRB, but Iowa Health System, Methodist’s parent organization, requires that clinical drug trials at its hospitals be cleared by its IRB, Higginbotham said.
Patients participating in drug trials go through an equally arduous approval process to ensure they know the risks involved. “We do a number of trials with a lot of risk involved – it’s in the consent forms – but the potential benefits outweigh the risk,” Polich said.
Some patients may receive no benefit at all from the drugs being tested, but participate for various other reasons, Higginbotham said. “A lot of times, they’re not going to receive a direct benefit,” she said, “but it might further research for their children or grandchildren or someone in the future.”
“Midwesterners have a sense of community and commitment to science,” Polich said. “On the coasts, people ask, ‘What’s in it for me?’ But here, 60 to 70 percent consent if they’re eligible.”
Physicians also take part in clinical trials for a variety of reasons, but the primary motivation is the access trials offer to new groundbreaking drugs that may improve a patient’s chances of surviving an illness. “Doctors like to be stimulated with the latest and greatest,” Polich said, “but it’s primarily patient-focused.”
He said the large number of clinical trials under way in Greater Des Moines indicates health-care professionals are constantly looking for ways to enhance the standard of care. “They understand the clinical trial route is the best way to do this,” Polich said.
Some medical specialties, such as oncology and cardiology, are quickly evolving sciences, but progress is frustratingly slow in other areas, said Dr. Daniel Gervich, an infectious disease specialist who is participating in several trials of drug therapies to reduce the mortality of septic shock or severe sepsis syndrome.
“In the last 40 years, there’s only been modest improvement in mortality, in spite of newer antibiotics and advances in our ability to support organ-system failure,” said Gervich, who is part of a private group of physicians who practice at Mercy.
The most recent area of focus of the research, the interaction of powerful chemicals naturally occurring in the body, has resulted in FDA approval of only one drug, a drotrecoginalpha marketed under the name of Xirgris, in 25 years.
Gervich is participating in a Phase IV study of Xirgris to determine if it is an appropriate treatment for other infectious diseases. Earlier studies suggested it might be, but the statistical significance wasn’t documented by researchers. “In Phase IV, we can find more candidates for drugs,” he said.
Though progress in finding drug therapies for infectious diseases that cause organ failure may seem excruciatingly slow, Gervich said the studies currently under way represent a first step in a larger body of science.
“In three to five years, there will be multiple options, some of which may supplant Xirgris or work in combination with it and add to or multiply its benefits,” he said. “One thing is for sure: Ten years down the road, we will look back and see that our tools and drugs to salvage people were very limited. We will view our understanding and tools as being crude.”