In 1990, Dr. Mark Kaminski and his colleague, Dr. Richard Wahl (now at Johns Hopkins) stood before a CT scan of clinical trial patient #4. What they saw was absolutely nothing and, in the treatment of lymphoma, seeing nothing means everything. With just one week of treatment, a 36-ounce tumor had completely disappeared. In fact, four out of the 10 subjects in that very first clinical trial experienced complete remissions.
What the doctors had learned was that by combining a man-made or "monoclonal" antibody with radioactive iodine, they could treat the malignant cells without damaging surrounding healthy tissue. When the drug (I-131 tositumomab) is injected into the bloodstream, it seeks out a unique protein found on the surface of lymphoma cells. It then binds itself to the cells and the radioactive iodine quickly destroys them. Unlike chemotherapy, this type of immunotherapy has very few side effects. There is no nausea or hair loss, and treatment is typically completed in one week with only two injections.
Drs. Kaminski and Wahl believed in their new treatment, as did their patients, but convincing the rest of the medical community would take hard work and perseverance. Similar types of immunotherapy had been studied since the 1970s but the results were less than conclusive, leaving many oncologists and cancer researchers skeptical at best.
After the initial clinical trial, the treatment was sent out to a number of other cancer centers to see if its initial astounding results would be replicated. In these trials, 50 percent of patients who were no longer responding to chemotherapy were helped; 20 percent of those who were helped showed complete remission that lasted years.
Finally, the FDA began looking into the treatment. Several of Dr. Kaminski's clinical trial subjects traveled to Washington at their own expense to testify concerning the drug's effect on their cancer and their lives.
While the hearings continued, Dr. Kaminski embarked on another phase of clinical trials to determine the effectiveness of I-131 tositumomab as a front-line treatment for an incurable type of non-Hodgkin's lymphoma called follicular lymphoma, which is the second most common type of lymphoma. The doctor was convinced that it would be even more effective if it were used in place of chemotherapy. "It just made sense that if you had a patient who was less damaged by other therapies that the treatment would be that much better," he explains. "The real aim is to cure the disease, not just to put it into remission."
In 2003, the FDA finally approved the new drug (now known commercially as Bexxar) for the treatment of low-grade or follicular non-Hodgkin's lymphoma when other treatments have failed.
In 2005, the results of Dr. Kaminski's most recent clinical trials were published in The New England Journal of Medicine. The study demonstrated that 95 percent of the participants, who had never been treated with chemotherapy, responded to Bexxar treatment; 75 percent had a complete response. Of those in remission, 75 percent continued to be disease-free after five years.
Today, Dr. Kaminski is continuing his work in radioimmunotherapy as a cancer treatment. He is currently conducting several clinical trials to assess Bexxar's effectiveness in treating other types of non-Hodgkin's lymphoma.
Dr. Kaminski credits his academic role at the University of Michigan for his research tenacity. "Michigan provides the ideal academic setting. There is a good balance between clinical work and laboratory work, between seeing patients and having the time to reflect on what needs to be done for them," he said. "It was very helpful to me to be well acquainted with the disease we were treating and to see first-hand how patients were responding to other treatments. When you are in the trenches day in and day out, you have greater insight into what your patients need."
Dr. Kaminski's outlook on life and his approach to research is marked by determination and optimism. "Through it all," he says, "we persist. We don't let go. We are not satisfied with giving up."
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Why are racial and ethnic minorities, women, and the elderly more likely to be under treated for chronic pain? That’s a question Dr. Carmen Green, Associate Professor, Department of Anesthesiology, University of Michigan Medical School has been exploring for nearly a decade.
Did you know that one in six Americans and one in two elders experience chronic pain? “Simply put, if you are a minority, female, elderly, or a low income person you may have less access to quality pain management,” says Green. “We are committed to understanding what influences the quality of acute, chronic, and cancer pain care. Our hope is that by studying the pain complaints of minority persons and those who are vulnerable or underserved, as well as their experience with pain care, we will be able to highlight some of the reasons for disparities in pain management in general – so that we can actually improve pain care for all.”
To this end, Green and her colleagues are using clinical research to take a closer look at these differences – both at an institutional and national level. “Studies show that factors such as age, race, and gender may influence the outcomes in pain care,” says Green. “We’re looking at the patient and healthcare disparities in the context of pain. We’re also focusing on how physicians, nurses, and pharmacists make decisions about pain care while examining physician/patient communication -- to improve the quality of pain care, including the diagnosis and treatment. We hope our work will increase awareness among both patients and healthcare providers.”
The World Health Organization considers pain to be the third most important public health issue today. “It’s the number one reason why patients see their doctors,” says Green. “Fundamentally, pain management costs this country more than heart disease and cancer combined, but it receives less attention. The prevalence of pain is also increasing. It’s clear that if we don’t do something about how to successfully manage and treat pain, it will interfere with our ability to successfully age.”
Committed to pain research for most of her career, Green admits, “We could not do this important work without our clinical volunteers. They truly inform our research and help us understand the unique implications and variations on the pain experience. They are our partners in improving the quality of pain care.”
After graduating from Michigan State University – College of Human Medicine with an M.D., Green completed a residency in Anesthesiology, and a fellowship in Pain Management at the University of Michigan Medical School. Green also serves as Medical Director for the Acute Pain Service at the University of Michigan Health System.
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For more than a decade, Dr. Kenneth Jamerson has led some of the world’s most significant studies of hypertension, or elevated blood pressure. Recently, as Medical Director of the Program for Multicultural Health at the University of Michigan Health System, he has turned his focus to the alarmingly high incidence of high blood pressure in African Americans (1 in every 3 individuals), a minority population more likely to develop this condition than any other group in the world.
“We used to believe that African Americans were genetically predisposed to develop high blood pressure,” says Jamerson, “but studies show there is little evidence of a genetic component.” Using clinical research to explore racial disparities in the treatment of elevated blood pressure levels, Jamerson and his colleagues are gaining insight into why African Americans make up such a disproportionate share of patients.
In an African American community intervention study, Jamerson and his colleagues established that lifestyle modifications outside of the physician’s office resulted in decreased blood pressure, long term weight loss, and lower cholesterol levels. “It’s an empowering and wonderful road of discovery,” says Jamerson. “Prior to our research, it was thought that if you were an African American with high blood pressure, there was only a limited amount you could do. But, with the right treatment -- including early detection, proper medication, lifestyle changes, and patient education -- people can actually turn things around.”
Jamerson has also led clinical trials to explore whether strong blood pressure control or the use of anti-high blood pressure drugs can slow the progression of kidney failure in African Americans whose condition is linked to hypertension. His findings show that certain blood pressure control drugs reduce the chance of developing kidney failure. “This finding is of particular importance to African Americans with high blood pressure who are up to 18 times more likely than Caucasians with high blood pressure to suffer kidney damage severe enough to require dialysis.”
“People will live longer because of this type of research,” says Jamerson. “With benefits that reach beyond elevated blood pressure, this work will also help to highlight racial disparities in the treatment of diseases like prostate cancer and breast cancer.”
Jamerson completed his M.D. at the University of Michigan in 1986. He serves as Professor of Internal Medicine at the University of Michigan Medical School. As Vice President of the International Society on Hypertension in Blacks, he plays a leading role in educating patients and doctors about high blood pressure treatment in African Americans.
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Dr. Richard Ohye understands the importance of constantly striving to study new ways to improve patients' lives. As a pediatric heart surgeon and a member of the Michigan Congenital Heart Center, Ohye performs lifesaving operations every day. Ohye and his colleagues have used clinical research to determine that new surgery methods can reduce complications and speed recovery, so that young patients can get out of the hospital sooner and back to the business of childhood. The surgeons' study compared conventional cardiac surgery to a new technique using a robot controlled by the surgeon. Although this robotic-assisted surgery has helped millions of adults, some doctors feared that children were too small for the robot to operate on safely. Ohye and his colleagues demonstrated that not only was the robotic system safe, it led to fewer complications and faster recovery times.
"In five or so years, perhaps we'll perform most of the basic procedures with the robot's help," Ohye predicts. "But for now, we're starting with building the case for its safety and its cost-effectiveness, in certain types of cases. And we're finding that parents of our patients are embracing it, and in some cases even asking for it." Dr. Ohye has dedicated his career to caring for children's hearts. After graduating from the University of Pennsylvania, Dr. Ohye received his medical degree from the Ohio State University. He then continued on at the Ohio State University Hospitals where completed his General Surgery and Thoracic Surgery residencies.
Dr. Ohye has also been committed to research throughout his career. While completing his residency, Dr. Ohye also completed a two-year Research Fellowship in Transplant Immunology. Dr. Ohye then completed a fellowship in Pediatric Cardiac Surgery at the University of Michigan. He now serves as the Director of the Pediatric Transplantation and Pediatric Cardiac Surgery Fellowship Programs.
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© Michigan Institute for Clinical & Health Research
Last updated on: Wednesday, 21-Jul-2010 13:39:34 EDT