Healthy Volunteers: The Inside Scoop
words by maryann brinley / photograph by pete byron
Rutgers students (left to right, clockwise ):
Shivam Patel, Dave Patel, Vrag Shah, Chirag Patel
and Hirsha Venkatamaran
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here are no dull days,” says Stephen Lowry, MD. And all the translational research
investigations being conducted by Lowry and his colleagues add to the 24 / 7 excitement
This surgeon is one of the most cited authors in immunology today and members of his department have been supported by grants non-stop since 1982.
He was the recipient of a $5 million National Institutes of Health (NIH) MERIT award given only to cutting edge researchers and also won a prestigious Flance-Karl Award from the American Surgical Association to recognize his contributions to the basic science of surgery. “The beauty of biology is to realize how
complex it really is.”
Recently, we caught up with this busy medical investigator and his clinical trials coordinator Susette Coyle, RN, and we also had a chance to get to know Chirag Patel, a junior at Rutgers University who participated as a volunteer in one of the surgery department’s clinical studies: “The Effects of Hospitalization on Heart Rate Variability and Circadian Rhythm in Healthy Human Subjects.” In fact, Patel and five other college buddies gave up spring break last year to “help make medicine better,” he says, and to raise money for juvenile diabetes by eating and trying to sleep their way through three days of hospitalization.
The range of research being conducted by the surgical department at RWJMS is broad and eclectic. For instance, a pneumonia investigation is just getting underway, in addition to a number of “vascular surgery trials,” according to Lowry, “and several in cardiac surgery, as well as “our own studies looking at how high doses of vitamin C might affect coronary artery and bypass surgical patients.” Lowry has also just completed research investigating biofeedback and inflammation. “We did this one with the Department of Psychiatry to determine if we could modulate the inflammatory response by activating the central nervous system mechanism’s vagal activity. Another one of our clinical studies you might find interesting looked at the time of day when inflammation ordinarily occurs and its severity. There is an assumption that many adverse medical events — strokes, heart attacks, other health complications, for instance — happen late at night or very early in the morning. And these events may have little to do with hospital staffing or commonly accepted processes of care.” Pre-clinical work is also leading up to a trial for the next implantable heart, the Abiomed.
Yet, not all trial participants are desperately ill. As Coyle explains, “When they hear the words ‘clinical trial,’ a lot of people automatically think of someone in extreme danger and see these trials as a way to acutely save patients. But our clinical trials are not always necessarily looking for new drugs or new treatments.” For example, Lowry adds, “We’ve been doing nutritional studies for years.” What happens when you continuously feed someone rather then giving them meals on a regular basis at intervals? And if you are a critically ill patient who is being given nutrients by feeding tube or vein, how is the immune system affected? “We have data suggesting that continuous feeding may dampen endogenous anti-inflammatory activities and therefore alter the immune system’s ability to respond to infections.”
Stephen Lowry, MD, chair, department of surgery, UMDNJ-robert wood johnson Medical School
Patel, who is a double major in economics and organizational communications, and his five Rutgers friends — Vraj Shah, Neel Patel, Shivam Patel, Dave Patel, and Hirsha Venkataraman — were part of these ongoing eating and sleeping investigations. (The Patel guys are not related.) This college crew wanted to raise money in memory of Vishal Bhagat, a young friend who died in 2005 from juvenile diabetes complications, and to start a new chapter of the DEPsi fraternity on the Rutgers campus. As Chirag Patel explains, “It’s hard to raise funds in this economy.” They saw the idea of volunteering for the trial as an opportunity. “It wasn’t going to hurt us and it would help our ultimate goal, the Vishal Bhagat Foundation and the Juvenile Diabetes Research Foundation.” So, after checking into the Clinical Research Center (CRC) at the Robert Wood Johnson Medical School last spring, two boys to a room, they were told they could order whatever they wanted to eat. “It was absolutely hilarious. The hospital food was amazing” and included two, three and sometimes four entrees every meal with “lots of dessert at night. We had to eat at intervals and some guys could hardly wait the required hours in between. They didn’t think they could make it to the next meal. We’d joke about how some of us were always hungrier than others but we all just love eating food. The medical team would take our blood and measure our heart rate just before eating. We had expected to get amazing sleep but they’d wake us up at night, too. But it was all for a good cause.”
Did the guys gain any weight consuming these massive quantities of hospital cuisine? “Not really,” Chirag says. “We actually lost weight because the food wasn’t fatty. Usually when we eat that much, especially at a restaurant, we feel sick afterwards. The food in the hospital was so good, we didn’t get sick.”
When spring break ended, they were also able to deposit a check for their efforts. Now, the word is out on campus, to raise money and awareness for juvenile diabetes. Chirag says, “We have a lot of people who are now interested in volunteering for clinical trials.” They are also planning a major service fund-raiser, “possibly a volleyball tournament” for their spring semester.
Lowry himself was a healthy volunteer in one of his own clinical trials many years ago exploring endotoxins, the byproducts of the cell walls of gram-negative bacteria like e. coli. When given in small amounts, endotoxins trigger the immune system to act as if an infection were present. Says this researcher, “The ultimate study of humans is of men and women themselves and I wouldn’t want to do anything to anyone I wouldn’t do to myself.”