If Dr. Pridgen is right, his protocol for treating fibromyalgia could end up turning the medical world’s conception of FM (and perhaps even chronic fatigue syndrome) on its head. The first treatment trial had good results but they didn’t exactly turn the FM world upside down. Geoff Langhorne asked him about that in an interview a couple of months ago and I followed up with my own questions.
A confident Dr. Pridgen explained why the first trials result were good but not earth-shattering and why the next trial results will be better. First some background.
How it Happened
“It was never my intention to be involved in Fibromyalgia” William Pridgen
Pridgen didn’t start out to treat fibromyalgia – he was simply trying to get at what was causing the diarrhea/constipation and abdominal pain in his patients. Both he and his mother – a virologist – recognized that the pattern he kept seeing –stubborn symptoms which got better with treatment then got worse, and then better and then worse – could reflect a virus getting reactivated, then knocked down, reactivated then knocked down. Throw in the fact that his patients gut problems typically got worse during stressful events and a herpesvirus infection became a viable option.
Pridgen started off giving a couple of his patients a single antiviral herpesvirus drug. The fact that some of the patients did get better encouraged him, but it was not until he combined it with the anti-inflammatory Celexicob (Celebrex) that he really began to see results.
The big surprise was that his patients were reporting relief from a whole panoply of other symptoms. Their fatigue, their headaches, their muscle and joint pains, their sleep problems, their difficulty relaxing – all were improved. By the time twenty or thirty patients had reported this he really began to take notice.
“Holy crud!” in the interview he stated, “I discovered something.”
He switched gears and began offering the drug combo to people with chronic fatigue syndrome and fibromyalgia. He lambasted the idea that fibromyalgia or chronic fatigue syndrome are difficult diagnoses to make. As soon as he knew what these illnesses looked like, he said, anyone working in his office could spot them immediately.
Fixing What’s Broken
Patients tended to sporadically improve early with the full effects showing up after about three months. He wasn’t just treating herpesvirus infections, however. Asserting that these diseases “break things”, he also worked on their treatment resistant sinusitis, acid reflux, thyroid issues, insomnia, anxiety, and depression.
In fact, his first step was to figure out what was broken and fix it and then put them on the drug combo “. He said “if you’ve done a good job with the first half” then 12 to 14 weeks into the treatment program a “switch” often gets flipped with people feeling a whole lot better.
Geoff then asked a great question – would you characterize this as a cure or a successful treatment? Pridgen stated that you can’t “cure” or eliminate viruses, but that he did feel that his treatment protocol was getting at the core of the disease. Note, however, that Dr. Pridgen did put that qualifier – “If you’ve done a good job with the first half” – in. It’s important to treat the depression or generalized anxiety disorder, symptomatic gallbladder disease, severe reflux and chronic nonseasonal sinusitis, etc. for his combination treatment to optimally work.
His protocol, he believes, is much more effective at symptom reduction than the drugs currently approved for fibromyalgia. He does not feel those meds get at the core of the disorder: his does.
Herpes Simplex Virus-1
The predominant virus he believes that is causing the pain in fibromyalgia is herpes simplex virus-1 (HSV-1). HSV-1 has been put in the “fever-blister” category; it causes some unpleasant symptoms and nothing more. Pridgen believes that view and the accompanying attitude of benign neglect towards the virus HSV-1 are disappearing.
HSV-1, it turns out, isn’t always so benign, after all. Yes, the initial infection is usually mild. And yes, essentially everyone, including healthy people, is exposed to and carries HSV-1 in their body.
Like the other herpesviruses, however, HSV-1 persists in the body hanging out in the neurons. After the initial infection, HSV-1 is able, in some people, to become reactivated, travel up the axon of the neuron to the nerve centers – waiting to be reawakened by a stressor.
Studies indicate that almost any stressor including colds, eczema, menstruation, emotional and physical stress, stomach upset, fatigue or injury can reactivate it. It can cause encephalitis and blindness, and some evidence suggests it’s associated with Alzheimer’s disease.
Vaccines for HSV-2, a close cousin to HSV-1, are being worked on. If HSV-1 does end up being the cause of fibromyalgia, Pridgen believes widespread HSV-2 vaccination could, just as vaccines have put an end to measles, chickenpox, hepatitis and other viral illnesses, help put an end to fibromyalgia. A vaccine, by the way, could also potentially help some people who already have fibromyalgia much like the shingles vaccine helps people with Varicella Zoster reactivation.
The First Trial
“We didn’t get a 60-70% efficacy, because it wasn’t our ideal dose and a lot of patients had other conditions they couldn’t get fixed in a trial like that.”
If you’ve been following the Pridgen story you’ve probably heard of people who’ve tried the Famvir/Celebrex combination who’ve done well and others who haven’t. Pridgen addressed the variability in results in his protocol by asserting that the doses aren’t set and that many of the participants had more than fibromyalgia to deal with.
The trial was less restrictive than most other phase 2 (FDA approved) FM trials where men or people with severe depression weren’t allowed to enroll. He said they pretty much let everybody with FM in.
He also stated that if the patients failed to commit to fixing the secondary problems they didn’t do as well. The FDA also required only one dose be used in the trial – and that dose was not their “favorite” one.
Fifty-three percent of the patients in the trial had at least a thirty percent reduction in pain. That’s a good but not great figure, but Pridgen noted that almost forty percent had at least a fifty percent reduction in pain – and that’s a very good figure for FM. Already their stats, he stated, may prove to be better than the three FDA approved drugs for FM – and he hasn’t been able to use the dose he ultimately intends to market. He stated that some of the world class experts on IMC’s scientific advisory board have said they had “never seen pain data like this” for FM before.
The Next Trials
The next phase three trials, though, will be slightly more selective as the fibromyalgia patients will not have as many “extra conditions”.
It’s going to take time to raise the money and then do two phase III trials – which can be run side by side. While there may be one dose that works best for the most people, Pridgen asserted that no dose is perfect for this variable population and they’ll probably do a dose-ranging study to get at the variability.
They’re trying to get FDA to fast-track the next trials. My guess is that patient enrollment will not be a problem; they expected it to take nine months to enroll the last study and they did it in three.
When asked how the phase three trials are coming Pridgen stated, “We’re moving as fast as we can….This is not an easy process.”
“I feel very confident that the next two trials will be far more impressive”.
Dr. Pridgen appears to be utterly confident he’s on the right track. He said he’s seen a 1,000 plus FM patients and an equal number of chronic fatigue patients.
“If a patient does what we tell them to do and they jump through the appropriate hoops it’s unbelievable what happens to these people – they do so much better” Skip Pridgen
When the Blue Ribbon Project came to Tuscaloosa, it was the only place, he said, they saw people getting better.
He said he’s seen “countless” patients get well and go on with their lives, including very ill patients. “I’ve had some tremendously ill patients who get their life back….get back to working again.”
They come from all over. He gets the protocol started and then refers them back to their physicians. His Canadian and Australian patients have a good chance of continuing with the protocol because their physicians are more open minded, but the Brits often run into a wall so unless they can cross the Atlantic, presently they are receiving little support from their own medical profession.
Dr. Pridgen Talks
When do you expect the study to be published?
Dr. Carol Duffy is feverishly working on the manuscript and should be submitting it for publication this summer, hopefully in one of the premier pain journals.
How did you, a surgeon, end up treating people with gut problems?
Many general surgeons perform endoscopies in their practice of medicine.
How did you get the idea to combine the antiviral with an anti-inflammatory?
I was merely giving them a NSAID for their joint pains, and serendipitously noticed the two drugs when combined had unexpected benefits. I’d never heard of anti-inflammatories used to hit viruses before. Virologists have known for two decades, though, that NSAID had antiviral properties.
You presented a very different model of fibromyalgia at the Rheumatology Conference than rheumatologist are used to. I don’t know if anyone has looked at fibromyalgia as a herpesvirus disorder let alone treated people with antivirals. What kind of reception did your talk receive?
Lot’s of questions, none too difficult to answer and generally it was well received even if the attendance was not ideal.
I know someone who couldn’t tolerate the Famvir but did very well on Celebrex for six months when everything fell apart again.
There are other options, and if his physician had reached out to me, I would have given the physician everything they needed to help that patient.
What can you say about the gut tissue biopsy results?
The preliminary data was presented a little over a year ago at an international virology meeting, and for patients who have FM 100% of those patients have HSV-1 data in their biopsies and 80% have a protein that is found only in cells that are actively infected with HSV-1.
If HSV-1 is found in the guts of FM patients is it your guess that it’s probably reactivating elsewhere?
The vagus nerve is the nerve that controls the gut and the virus lives in its ganglion. We postulate that there are two other major sites, the sinuses, and the urinary bladder, that are also likely sites of chronic reactivation.
If it’s active in the gut would you expect to see an increased incidence of cold sores in FM?
Approximately 30% of the population suffers from cold sores. If you go to the innovativemedconcepts.com site you will be able to watch a couple of video’s that explain this better.
You tried several different combinations of drugs and Famvir turned out to be the antiviral of choice for the fibromyalgia patients in your study. Do you have any idea why Famvir was more effective than the other drugs?
(Dr. Pridgen said that’s a trade secret for now.)
In your experience are people who improve dramatically able to get off the drugs and maintain their improvement for a considerable amount of time?
Absolutely not! The moment they stop the meds the next time they are severely stressed the condition returns. You can’t stop diabetes, hypertension, and cholesterol medications and you can’t stop these.
What is the timeline for the phase III study or studies?
Plans are underway for the near future.