Cellulite isn’t an urgent health risk for anyone, but many people who have it and others who worry about developing it, are intrigued to learn that Dr. Leroy Young, M.D., FACS, is conducting a clinical study right here in Washington on the efficacy of a new drug to reduce the dimpling appearance of this common unwanted skin condition.
Dr. Young, who joined Mercy Clinic team of physicians Jan. 1, smiles when people question him about the cellulite study. It’s a cosmetic concern, yes, but one that many people would be interested in reducing or eliminating all together, he said.
It wasn’t hard to find people interested in volunteering to participate, especially since it’s so close to home.
Mercy Health Research-Washington, which opened earlier this year, is located in the space that was once going to be a three-bed hospital for Patients First Health Care, before it merged with Mercy.
The facility, which is attached to the east end of the Mercy South building (formerly Patients First) but with a separate entrance, includes four treatment rooms and two labs. Local patients enrolled in clinical studies come here for their doctor visits and treatments, saving the time and expense of driving into St. Louis.
Staff includes Dr. Ann-Elizabeth Mohart, who was with Patients First for 10 years and conducting research for the last two years, and Dr. Young, who has 35 years of experience in plastic surgery and research.
There also are three study coordinators and a manager of clinical research, Donna Straatmann, who comes once a week from the Mercy Health Research center in Creve Coeur to work in Washington.
The addition of Mercy Health Research-Washington is a coup for the local hospital, said Mercy Hospital Washington President Terri McLain, but it’s also a great thing for the entire community,
“It really is a nice opportunity to participate in these studies, where typically you would have to travel into St. Louis, so we are very excited,” she said.
From Allergies to Acne to High Cholesterol
There are a number of other research studies now or soon-to-be under way at Mercy Research Center-Washington. Conditions include dust mite allergies, adolescent and adult acne, cardiovascular events, type II diabetes, gout, keloid excision, abdominal scar revision and high cholesterol.
That’s a study about which Dr. Mohart is particularly excited.
“I think it’s going to revolutionize the way we treat cholesterol,” she remarked. “It’s all over the world. It’s a worldwide study.”
The center is currently recruiting people to sign up for its studies. The criteria varies for each study, but is generally strict in terms of age and health status.
“If they are a woman, they have to have no plans to get pregnant,” Dr. Mohart noted. “They have to prevent pregnancy, because these are new meds, we don’t know if they would be damaging to the fetus.
“And they have to have certain health status. They can’t have end-stage disease of any kind. So no one with cancer who is actively in treatment; liver or kidney disease is a disqualifier, if it’s severe enough. And if they are on certain medicines, they can’t be in the study.
“Anything that could really affect their health dramatically and affect their involvement in the study,” said Dr. Mohart.
Those who are accepted into the studies receive many benefits, including completely free medical care and medication for the duration of their time in the study, which can be years.
“Depending on the study, they can get pretty extensive blood work, physicals, medical supplies, medications, all free. Everything we do is free,” said Dr. Mohart.
“Patients don’t get billed for anything. Their insurance never gets billed. There’s no cost whatsoever.
“So for patients who have no insurance and no resources, if we can get a really good, safe study that’s a good fit for them, it’s a great solution for them,” said Dr. Mohart.
All of the blood work and other testing, such as EKG or physicals, is done on site.
“We have our own lab where we spin the blood down and get it ready to process,” Dr. Mohart noted.
Even better, patients are paid for participating in studies. Depending on the study and how much time is involved, a person can receive as much as $30 to $150 per office visit to compensate them for their time and travel expenses.
“Most of our visits are like a standard doctor visit, 30 to 40 minutes,” said Dr. Mohart. “Some of them are more involved, it just depends on the study.”
In addition to these perks, patients often tell Dr. Mohart they feel good about being part of the research because it’s helping find new medications and solutions to real health problems.
“Especially our older patients say they want to do this because they want to feel like they’ve done their part to give back to medicine, and that’s the only way we get better health care, by doing research,” she said. “You don’t get it by just getting lucky in the office. You have to do really dedicated studies. Every drug we have now came out through a study, and devices too.”
People who are willing in volunteering for a future study can fill out a form with their contact information and the health areas in which they are interested.
They also can check the website, www.mercy.net/practice/mercy-health-research-washington.
Research Is Funded by Private Companies
The studies that are being done at Mercy Health Research-Washington currently are funded through contracts with private companies, said Dr. Mohart, typically pharmaceutical companies.
“They seek us out and say, ‘We have a study. Would it be a good match for your patients?’ ” she said. “If so, we contract with them and they pay Mercy.”
The doctors are very careful about what studies they agree to conduct. They have to be right for the community and local patients.
“We get studies every day by email to look at, and there are many that we think just aren’t good studies,” said Dr. Mohart.
“Sometimes just looking at the protocol of what’s involved, you can tell it will be hard to find patients to qualify or there’s just so much required that it’s going to be a painful study that patients aren’t going to want to stay in or if you look into the medication and you have concerns.
“We have turned medicines down for that. I feel if it’s not something I would take myself there is no way I would ever ask a patient to try it.”
The companies funding the research in no way affect the results, stressed Dr. Mohart. Likewise, she and Dr. Young cannot accept a study if they have any kind of relationship or business involvement (incuding owning stock) with the funding company.
“The FDA and ethics boards audit us and look at our (studies), because research is an area where ethics is so important to make sure that patients are protected, that they understand what they are involved in and also that the data has good integrity,” said Dr. Mohart.
“And we do have studies with medicines where the data isn’t good, where we say we have safety concerns.
“We had a study we just shut down prematurely for that,” she said. “The company just said, ‘There’s too many safety concerns. We’re not going to take this drug any further.’ ”
There is a lot of documentation that goes along with each and every one of these studies. Even though the drugs are not FDA-approved, Mercy Health Research-Washington has to account for every pill.
“The regulations for that are very strict,” said Dr. Mohart. “These are considered investigational products, so they have to be really guarded. They are kept behind locked doors and we have to keep a tight inventory on them . . . it’s technically a medicine that we don’t know as much about and they want to make sure no one is accidentally taking it. And it’s only people in the study who are taking it.”
Dr. Young comes to Mercy Health Research-Washington with 35 years of experience in plastic surgery and research.
He grew up in eastern Kentucky and graduated medical school and general surgery at the University of Kentucky-Lexington.
Dr. Young began his career at Washington University, where he worked for 23 years before going into private practice with Body Aesthetic Plastic Surgery in Creve Coeur.
He currently lives in Wildwood but has purchased property in Washington and plans to move here soon.
When the opportunity to work at Mercy Health Research-Washington came up, he knew it was the right move.
“My real interest is in research,” said Dr. Young. “I’ve done clinical plastic surgery for a long time.
“I’ve done research in some capacity for about 35 years, but I wanted to concentrate on clinical trials work, and I think it would have been difficult to continue to be active with practice in plastic surgery and do both.
“And it was also just a good place to work. (Mercy) has a lot of resources and infrastructure. And so it was a chance to work in a place that was seriously committed to doing research and has a good reputation for that,” said Dr. Young.
Plus, it was a chance to work with his daughter — Dr. Mohart.
“That’s not an opportunity you would get many times,” Dr. Young remarked.
He joked that their family get-togethers are more like a Mercy picnic, since his daughter is married to Dr. John Mohart, a cardiologist also with Mercy Clinic.
Cosmetic Studies Can Have Bigger Implications
It’s easy to think of plastic surgery as only for completely cosmetic procedures, like the aforementioned cellulite study. But plastic surgery research holds hope for many patients with serious illness, Dr. Young pointed out — particularly those with any kind of sclerosis.
“One of our major interests is in scarring,” he said. “Actually the holy grail of this is to end up with scarless wound healing.
“Scarring is really a visible form of fibrosis, which is how the body heals,” he explained. “And almost half the mortality in the world annually is from diseases that produce fibrosis.
“So if we can block fibrosis, we would dramatically change the health and well-being all over the world, because things like atheroscerosis (hardening of the arteries), cirrhosis (scarring of the liver and poor liver function) and scleroderma (which affects the skin and, in some cases, internal organs), all these things that involve that are manifestations of fibrosis, internal scars,” said Dr. Young.
In other words, research done on healing external scars could have implications on internal scarring conditions and diseases.
“Getting rid of visible scarring, or at least minimizing it, is obviously a starting point,” he noted.
Contact Mercy Health Research-Washington at 636-390-1544.