A chronic pain condition and numerous gastrointestinal disorders may all be caused by a virus. That’s a Tuscaloosa-based surgeon’s theory likely headed for a clinical trial early next year and one drawing support from Dr. Carol Duffy, an assistant professor in the Department of Biological Sciences. The two are teaming up to conduct a clinical trial that will test the effectiveness of a combination of two drugs in treating fibromyalgia.
Duffy is serving as the chief scientific advisor for Innovative Med Concepts, a company started by Dr. William “Skip” Pridgen, the physician who first came up with the theory about certain conditions being caused by a virus.
The clinical trial, pending FDA approval, will involve 140 fibromyalgia patients at 10 sites around the country and the researchers hope it will begin by February 2013. Results from lab work performed by Duffy could further support trial results and also lead to a potential diagnostic tool for physicians treating patients who exhibit fibromyalgia symptoms.
The unnamed medicines have previously shown to be effective in treating the virus at the center of Pridgen’s theory. He earlier filed a provisional patent on the repurposing of both of these drugs for the treatment of fibromyalgia and various gastrointestinal disorders, as they had not previously been known as treatment options for those conditions.
Pridgen, who has treated more than 3,000 patients with chronic gastrointestinal issues and, more recently, chronic pain, says his theory began developing after seeing periodic recurrences of many of his patients’ discomforts. He theorized there was some type of persistent infectious agent present. Even though there were periods of relief, he observed that many patients were getting sicker.
Pridgen theorized it might be a virus, so he prescribed an anti-viral drug for their treatment. His patients responded positively. Upon those patients’ return, they indicated that not only were their GI problems much better, but other problems, including chronic fatigue, fibromyalgia, depression and anxiety were improving, and that their energy levels were rising.
Duffy explains that viral infections can easily recur and that most people become infected when they are children. During this initial infection the virus particles travel up the nerves to a ganglion, a mass of nerve cells.
“The viral DNA just sits there the rest of your life,” Duffy says. Stress or, for women, even hormonal changes, can cause the virus to re-activate, travel back down a nerve branch and result in more inflammation.
The two medicines to be tested within the clinical trial work in different ways to counter viruses, Duffy says. In a related tissue study she will be looking to confirm the virus’ presence in the affected patients. This information, along with lab work done on patients’ responses to the two drugs during the clinical trial will then potentially be used to develop a quantitative test to determine whether a person has fibromyalgia.
Chronic pain and fibromyalgia are just two of a number of other chronic conditions that may be made better by this combination therapy, the researchers say. Fibromyalgia is the most severe condition, so it was selected as the first condition to be studied.
If the clinical trial and tissue study prove Pridgen’s theory correct, Innovative Med Concepts would then potentially approach pharmaceutical companies to gauge their interest in buying the patent and making the drugs available for fibromyalgia and a number of other conditions.