Every medication prescribed by a physician has undergone rigorous testing through clinical trials prior to approval by the Food & Drug Administration. Without this testing, life-saving effects could not be made available to the general public. MidMichigan Health’s Cardiovascular Research Department is helping to make this testing possible.
By participating in clinical research trials, volunteers like Donald Hartz of Midland help to further advancements in medical therapy and technologies.
The trial in which Hartz participates in is investigating the effects of long-term treatment with a particular weight loss medication among patients who have had heart issues. He joined the trial in December 2014. So far, he has not had any cardiac-related concerns during the trial and he’s lost weight. The trial is ongoing and Hartz will continue to participate.
“It’s been interesting,” Hartz said. “Since it is a double-blind study, I don’t know if I’m getting the real medication or a placebo. In fact, no one knows. I take the pill twice a day as instructed.”
He said he doesn’t know if he’s lost weight because of the pill or from changing his habits. “The real focus for me has been on my diet,” Hartz said. “The biggest benefit has been all of the education and help I’ve received.”
Hartz is of German heritage, and used to eat a heavy ‘meat and potatoes’ diet. “It’s what I grew up with, and what I still enjoy,” he said. “But I’m smarter now than I was two years ago and I’m definitely eating differently.”
“One tool provided by the study is an online diet plan,” Hartz said. “I can go online at any time and enter the food I’ve eaten or plan to eat and then I can read about what that means as far as calories, sodium, etc. It also gives me options – alternatives and the calorie counts, where to buy them, things like that.” He said that if he entered a food item such as a rotisserie chicken from a grocery store, the program would also give him information about the advantage of home-cooked chicken.
Another part of the study requires that Hartz keep an accurate record of what he eats. “At the end of the day, I enter what I’ve eaten that day and it gives me the total calories. I try to stay within the 1,500 – 2,000 calorie range. I don’t eat as much as I used to. Age does slow the metabolism. Plus, this time of year, because I’m not as active, I don’t need to eat as much.”
His initial involvement in the study came about a few years after he had heart surgery. “In January 2006, I had a triple bypass surgery,” Hartz said. The surgery came as quite a surprise, as his cholesterol and blood pressure did not indicate a problem. However, both of his parents had similar heart problems. “I learned a lot about the heredity factor. After the surgery, I am now one of many who consults a cardiologist at least once a year.”
It was his cardiologist, Interventional Cardiologist William Felten, M.D., who offered Hartz the opportunity to participate in the trial. “Dr. Felten explained it all and gave me lots of information,” he said. “I was very interested in the potential benefits. Most of all, if it could help people in the future, I wanted to be a part of it.”
As part of the trial, Hartz checks in with the Cardiovascular Research Department four times a year. “Every third visit, they run a full set of labs and do an exam to see how things are going,” he said. While he never felt that his weight held him back in the past, he admits that after losing 35 pounds, he feels better. “I started at 240 pounds, and now I’d like to lose a bit more.”
Hartz is twice retired; once after decades with Dow Corning, then after another nine years of running his own consulting business that focused on process reengineering. A numbers and data man by nature and occupation, he finds the trial intriguing, educational and not at all invasive or cumbersome. “This isn’t the kind of study where people are peeking over my shoulder,” Hartz said. “They are encouraged and I found them really good to work with.”
“There is not a bit of downside,” Hartz said. “I look at the personal benefit to me – the improved diet – and regardless of whether or not I’m taking the medicine, it’s been positive for me. My cholesterol is very low, I sleep better and my wife says I no longer snore. I’m extremely happy that they asked me to participate and I’d do it again.”
Health systems like MidMichigan Health are where most clinical research trials take place, as they offer one-on-one care and attention that leads to higher patient compliance. When patients stick to the requirements of a trial, longer studies can be conducted and more valuable data is collected. Clinical trials operate under strict safety guidelines. All risks must be explained to – and understood by – potential participants. They also follow a rigorous patient screening process.
Trials currently taking place at MidMichigan Health can be viewed by going to www.clinicaltrials.gov and typing in “MidMichigan Health” or going to www.midmichigan.org and searching ‘clinical trials.’ As everyday heroes throughout the Great Lakes Bay Region continue to participate in clinical research trials, MidMichigan Health will remain a valuable resource in the fight against heart disease and the advancement of cardiovascular treatments.