This fall, The University of Alabama’s Department of Biological Sciences will begin research to prove a treatment of chronic pain in patients with gastrointestinal disorders and fibromyalgia.
Carol Duffy, an assistant professor in the department with a research concentration in the herpes simplex virus type one, will head the research side of the project alongside William Pridgen, a private practice general surgeon at Tuscaloosa Surgical Associates.
Pridgen said he began working on the clinical side of a hypothesis 12 years ago, when he could not successfully treat several of his patients’ chronic pain problems.
“I did a lot of reading, trying to find the culprit, and I came to the conclusion that it must be something viral that stays in all of us and acts up with stress, and then I came to the herpes family,” Pridgen said.
To see if the herpes virus was a causative agent, he started treating 74 patients with this diagnosis in two ways. Pridgen gave the first group a drug that would treat HSV-1 and treated the second group with the same drug, in addition to a pill typically used to treat arthritis.
The patients who took the two pills had much better results, which led him to patent the drug combination, Pridgen said.
Duffy said she knew he was onto something, but while his hypothesis is sound, it has not been proven.
“Before we can get FDA approval and for the medical community to start prescribing this diagnosis, the hypothesis has to be tested several different times and ways,” she said.
Duffy has begun collecting tissue samples she will examine in University labs for the HSV-1 virus from Pridgen’s diagnosed patients and a control group made up of people with unrelated GI problems.
“Hopefully, by quantifying the amount of the herpes virus present in these patients, it will prove that it is causing the fibromyalgia and chronic GI problems, and then we can prove his drug prescription treats it,” Duffy said.
The pair is also in the process of raising funds to hire a company to clinically test the drug combination in 10 randomized sites across the country, which is another step required for FDA approval.
“The company, which costs about $3 million, will track the patients’ progress with both pain scores and blood samples,” Duffy said. “This drug trial will start in February 2013 and will take around a year.”
Pridgen said if all goes well in this step, they will be able to license off of different portions or even all of their findings to sell to a larger company who will be able to make the drug combination an effective prescription to this diagnosis for all doctors to use.
“My primary goal is to make patients better, and the patent gives me the power to influence what happens from here with this drug,” Pridgen said.
This important research being done on campus serves to remind Lindsey Cobb, a junior majoring in pre-med and chemical engineering, about the dual role professors serve on campus.
“Hearing about this exciting research campaign not only looks great for the prestige of our University, but also should remind students that professors are responsible for a lot of interesting work other than teaching, and their research can provide great opportunities for student involvement,” Cobb said.