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Pictures of Health Summer 2005
Balancing Act
Mentoring and start-up funding for new clinical scholars helps their research and their patients.
By Brenda Hudson
 Discovering tomorrow’s new treatments and cures is only one aspect of a clinical researcher’s mission; many researchers also are clinicians treating today’s patients. But balancing time and energy between clinical care and clinical research is challenging for health-care providers interested in pursuing research—even to the point of discouraging potential researchers from entering the field, curtailing future breakthroughs.
“We call it the death spiral,” says Mark Paller, assistant vice president for research at the Academic Health Center. “Clinical researchers just starting out don’t secure research grants right away, so they spend a greater portion of their time in the clinic, where they are also able to earn money [to support their academic appointment].” The more time they spend in the clinic, explains Paller, the less time they have to “really contemplate and develop their research skills. And so, they’re ultimately unsuccessful.”
To encourage success, the University has introduced a new initiative, the Clinical Research Scholars Program, which provides mentoring and financial support to junior faculty pursuing clinical research. “We felt that clinical researchers deserve the same start-up package that we give to basic scientists,” says Paller. Basic scientists, who do not see patients, initially are ensured “protected time” to conduct research, as well as financial backing to set up their labs.
In its first year, five researchers have been accepted in the clinical scholars program, four supported by the AHC and one supported by the National Institutes of Health. The program combines a mentored research project with 75 percent protected time and $50,000 per year for research activities for up to three years.
These clinical scholars will also receive training in research methods, an area in which clinicians do not always have experience. “The program is designed to provide researchers with initial support, with the goal that they eventually will be able to support themselves with grants,” says Paller.
The researchers aren’t the only ones writing grants and seeking funding. Paller has requested funding from the NIH, which would be used to expand the clinical scholars program. Currently, the program is supported by the AHC and the researchers’ departments and colleges.
“The Academic Health Center is committed to encouraging clinical research,” says Paller. He adds that the consequence of its decline is too serious. If there were a lack of clinical researchers, “we’d be frozen in time. There would be no medical progress.” Paller believes there has never been a better time to be a clinical researcher. “The opportunities [in clinical research] are greater now than they have been at any time during my career. There is a tremendous increased ability to understand health and disease at a molecular and cellular level,” he says, which can lead to better treatments and cures.
In its first year, the program has funded projects, outlined below, by clinical scholars and mentors from the Medical School, the College of Pharmacy, and the School of Nursing.
Mukta Arora
Hematologist Mukta Arora hopes to improve the lives of patients undergoing transplantation. Her research focuses on ways to overcome graft-versus-host disease, in which the new organs “attack” the host. This condition is opposite to organ rejection typically associated with transplantation. GVHD affects 50 percent of bone marrow transplant survivors and is fatal in 50 percent of cases, says Arora.
Working with mentor and transplant physician Daniel Weisdorf, Arora will design clinical trials to identify better treatment strategies in GVHD in bone marrow transplantation. By examining gene expression in GVHD patients and correlating clinical outcomes, she hopes to understand why the condition occurs, as well as to predict outcomes and to target specific treatments.
Mark Kirstein
Pharmacy professor Mark Kirstein investigates how anticancer agents metabolize differently in patients. Collaborating with his mentor, thoracic oncologist Robert Kratzke, he aims to find out what influences how people respond to a commonly used chemotherapy drug, gemcitabine.
“We already know there is a large variability when the same dose of a particular drug is given to different patients,” says Kirstein. Those differences may be due to how ill a person is, what other medications they take, and whether they’ve had chemotherapy before. Other factors may be involved, too, such as genetics. “I’m particularly interested in DNA sequences,” he says, which could explain why some patients clear the drug from their system more slowly and experience higher toxicity than others.
Kirstein and Kratzke will measure drug levels in patients’ blood over the course of treatment. They will also assess DNA sequences in key genes involved with gemcitabine metabolism to determine whether genetics plays a role in variability of patients’ response and toxicity to gemcitabine. They hope this will lead to more effective, tailored drug dosage for patients.
Michael Kotlyar
Can antidepressants change the way smokers react to stress? That’s one of the questions Michael Kotlyar hopes his research will answer. He’s looking at the physiological responses smokers have to stress with and without the antidepressant Paxil. “When people smoke, their heart rate and blood pressure go up,” he says. “The same reaction occurs when people are stressed. And when stressed people smoke, the reaction is even greater.” Pharmacy professor Kotlyar, working with tobacco researcher Dorothy Hatsukami, wants to know if taking Paxil can reduce the negative effects of stress in smokers.
The study, which has since received funding from the NIH, measures heart and blood pressure rates in smokers before and after undergoing the mental stress challenges of giving a speech and conducting mental arithmetic. He expects that those who take Paxil will have lower heart and blood pressure than those who don’t take the antidepressant.
If antidepressants help reduce stress responses, Kotlyar hopes they may help reduce relapse for those who do quit smoking, since stress is an important reason many people start smoking again. Additionally, this may lead to approaches that reduce cardiovascular risk in smokers who won’t stop smoking.
Diane Treat-Jacobson
Diane Treat-Jacobson, a nursing professor, is interested in how exercise can help people suffering from claudication, a painful, debilitating symptom of peripheral artery disease in which muscles in the legs cramp during activity. “The pain, like a vise, comes with exercise and goes away with rest,” says Treat-Jacobson. “It comes often when people walk a block or two, so consider what that means to someone’s life.” In addition, those with claudication are at a greater risk for heart attack or stroke. Currently, there are few effective noninvasive interventions.
Although treadmill exercise has been used to improve patients’ walking ability, it’s very painful. But Treat-Jacobson read the report of a research study that indicated arm cycling also improved claudication symptoms. “I thought, this should be confirmed, so I designed a study to test comparison of arm training to treadmill training and also to a combination of both with a control group of neither,” she says. If performing arm exercise, which isn’t painful to patients, causes changes throughout the body that lead to improved symptoms in the legs, Treat-Jacobson and her mentors, Jean Wyman of the School of Nursing and Nigel Key of the Medical School, believe this may help many sufferers of claudication by reversing the cycle of debilitation.
Rocco Ricciardi
Surgeon Rocco Ricciardi wants to ease decision-making for patients facing difficult surgical choices. As a colorectal surgeon, Ricciardi has seen firsthand how patients and clinicians grapple with important choices in health care. Physicians can sometimes act “paternalistically,” says Ricciardi, describing situations in which physicians decide on treatment based on what he or she believes is in the patient’s best interest. “Unfortunately, this approach fails to consider the individual patient’s values or personal preferences.”
Ricciardi prefers shared decision making. “This approach recognizes that there are complex tradeoffs that must be made in some difficult treatment decisions. In shared decision making, patients are fully informed of treatment risks and benefits, while consideration is given to patients’ values and preferences regarding treatment options,” he says.
Ricciardi, along with mentor and surgeon Robert Madoff, is devising a “decision aid” for the treatment of malignant colorectal polyps. Deciding on treatment for malignant polyps is often quite difficult, says Ricciardi, requiring that patients understand not only the condition, but their own preferences regarding surgery, the potential spread of cancer, and need for close surveillance. Ricciardi believes a decision aid will assist patients in making complex choices while considering personal values and preferences.
All of the researchers agree that combining clinical work and research is a challenging yet rewarding career. While they continue to devote a part of their work to patient care, this Clinical Research Scholars Program will act as the booster rocket to launch their investigations of tomorrow’s breakthroughs.
New Director for Clinical Research
The clinical scholars program is one of two major initiatives identified to further support clinical research at the University by an AHCwide task force set up in 2003. The second is the need for an executive director for clinical research. Jasjit S. Ahluwalia, M.D., M.P.H., M.S., previously at the University of Kansas School of Medicine, will fill that position as of Sept. 1. Ahluwalia will oversee the clinical scholars program and all clinical research in the Academic Health Center.
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