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The Simmaron ME/CFS Physicians Roundtable Pt. II: Talking Treatments

  [ 10 votes ]   [ 5 Comments ]
By Cort Johnson • www.ProHealth.com • July 30, 2013

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Reprinted wtih kind permission from Simmaron Foundation.

By Cort Johnson

Round-Table 

Simmaron Research likes to get people talking. At the FDA Workshop earlier this year, they booked a room, invited patients and physicians and then held a physicians round-table with some of the field’s top doctors.

Part II of a three-part series focuses on Dr. Peterson of Sierra Internal Medicine /Simmaron Research Institute, Dr. Klimas  - the director of the Center for Neuroimmune Studies at Nova Southeastern University, and Dr. Enlander, the Director of the Mt. Sinai ME/CFS Research Center talking about chronic fatigue syndrome treatment.

Dr. Peterson – Simmaron Research Institute

Dr. Peterson started off the treatment section with some hopeful news. Powerful new immune drugs such as immune modulators and cytokine blockers), he said, that have been and are being developed, can have dramatic effects in the right patients.

(Rituximab is an example of a new approach that paid off. The first of its class of drugs (monoclonal antibodies), Rituximab (Rituxan) opened up a new arena of drug development. Similarly, Ampligen and other Toll-like receptor affecting drugs offer new approaches to immune modulation. Drug repurposing efforts that are finding new uses for old drugs present some intriguing possibilities. An abortifacent, mifepristone, for instance, boosts natural killer cell functioning.

Breakthroughs in other fields are providing other opportunities. Studies documenting the role natural killer (NK) cells and the innate immune system play in preventing cancer have piqued drug developers interest enough the  several NK cell boosting drugs are in development.

A Treatment Philosophy

Some ME/CFS patients, believe it or not, are relatively easy to treat. Patients with easily characterized viral infections have a clear treatment protocol waiting for them. If a parvovirus infection is found, for instance, it can be easily treated. Dr. Peterson has found that the ‘wait and see’ approach so often prescribed by doctors with ME/CFS in hopes that the patient will just get better is a mistake.  He’s found that, in his group of patients, treating aggressively early is more effective.

Dr. Peterson proposes more aggressive approaches to ME/CFS early may forestall problems later if the disorder progresses.

(This brings to mind the story of someone I know whose doctor used a less strong antiviral (Valtrex) for a significant period of time only to switch to a stronger but potentially more toxic antiviral (Valcyte) after his patient deteriorated significantly. The patient then experienced a dramatic and lasting recovery.)

We’ll see that fighting pathogens in ME/CFS is not a cut-and-dried, one-size-fits-all process, and that physicians differ somewhat in their approach. In more complicated cases, for instance, Dr. Peterson is experimenting with combining immune and anti-viral treatments, and thus far is getting some encouraging results.

Dr. Peterson’s use of the antiviral Cidofovir (typically used to fight eye infections caused by cytomegalovirus in AIDS patients) demonstrates how differently even this small group of physicians sometimes approaches infections.

Cidofovir (Vistide)

“Cidofovir is not a panacea for this disease, but I think it demonstrates clearly how we should be subsetting and treating the treatable people,” Dr. Peterson.

Dr. Peterson uses Cidofovir regularly in patients with documented HHV6 and cytomegalovirus (CMV) infections.  (Since he employs more spinal taps than the other doctors at the Roundtable, he probably also finds more HHV6/CMV infections.)

Gunnar Gottschalk, Dr. Peterson’s research assistant, gave an overview of  the Vistide results seen in Dr. Peterson’s practice. Vistide is an expensive drug with potentially serious side effects that requires a rather complex infusion process.  Most patients need to relocate to the Reno/Lake Tahoe area to get at least 12 infusions.  Once they start the infusions they need to get three blood tests a week.  Vistide is difficult to administer, and its no surprise that most ME/CFS docs are not using it.

Gunnar reported, however, that a retrospective analysis indicated that 70% of ME/CFS patients with HHV6/CMV infections achieved a positive response.  He highlighted three patients: two achieved substantial gains in VO2 max and their viral titers dropped to zero, and all three returned to work after being disabled.

The retrospective analysis indicated significant drops in viral titers, increases in VO2 max (but not to normal) in full responders, and increased NK cell functioning in the group as a whole. Of the full responders Gunnar estimated two-thirds were able to maintain their health and one-third had to restart the treatment after 6-8 months.

When asked to compare Valcyte’s side effects with Vistides, Gunnar said that his experience was that people appeared to have a harder time on Valcyte than Vistide.

CMX001

Then there’s CMX001, the lipid-based analogue of Cidofovir produced by Chimerix that appears to be both more potent and better tolerated and which is beginning phase III (final) trials.

If CMX001 passes muster at the FDA it will present new possibilities for herpesvirus treatment in ME/CFS

Simmaron believes it has patients that will fit Chimerix’s criteria and is trying to get them into the trials.  (Chimerix, by the way, generated $118 million dollars in gross proceeds when it went public a couple of months ago. Chimerix projects Phase III trials for CMX001 treatment of CMV infections in stem cell transplant patients will be finished in 2015. Since the drug is on fast-track status, the FDA will rule on it more quickly than usual once the data is in). Exactly what Vistide is doing (besides knocking down the virus) is unclear.

On the immune end, it’s possible Vistide is relieving pathogen-associated NK cell dysfunction (although Dr. Peterson thinks more than that is going on) but it’s unclear why the VO2 max readings in his patients go up.  Gunnar did allude to the fact that some deconditioning probably was present in these very disabled patients, but Dr. Peterson thinks cytokine induced mitochondrial dysfunction may be occurring.

HHV6 and Chromosomal Integration

The tricky problem of HHV6 chromosomal integration should be noted. People who have HHV6 integrated into their chromosomes will always, whether the virus is active or not, test positive for HHV6 via PCR. Retrospective studies are never proof of a drug’s effectiveness; you need a placebo-controlled, double-blinded study for that. But retrospective studies do provide the pilot data that could support a trial. (I was told that Dr. Peterson’s Paris presentation generated a lot of interest.) This retrospective study is an instance of a doctor combing through and analyzing their past data, and hopefully we’ll see more of it in the future.

Graded Exercise and Cognitive Behavioral Therapy

“I wish graded exercise and cognitive behavioral therapy worked,”said Dr. Peterson. After mentioning the CDC toolkit (which emphasizes CBT and GET and does not suggest ANY laboratory testing be done) Dr. Peterson said he wished CBT/GET worked, and then said it might be helpful for patients who’ve gotten well enough, but that even if it was, it’s simply not available. For all the talk on CBT and GET, Dr. Peterson knew of no trained practitioners in the US, except for one associated with Dr. Klimas’ clinic.

Dr. Nancy Klimas – Director of the Center for Neuroimmune Studies at Nova Southeastern University

“I’m a splitter not a lumper. I try very hard to find …intervention points,” Dr. Klimas

An  Autonomic Nervous System Focus

Earlier this year Dr. Klimas reported that gene expression tests done during and after exercise suggested that the autonomic nervous system ‘tanks’ first in ME/CFS during exercises, and then drags down the immune system with it.  Her research suggests autonomic nervous system problems trigger an ‘inflammatory cascade’ which then causes much of the post-exertional malaise that occurs in this disorder.

Dr. Klimas exercise studies suggest the problems in the autonomic nervous system trigger problems in the immune system

It was no surprise, then, to hear her say that she spends a great deal of time early on with her patients trying to get that ‘volatile’ autonomic nervous system under control.  (This is an example of translational medicine; i.e., translating research results (gene expression findings) into practical applications in the clinic.) This ANS-immune cascade problem, by the way, appears to be independent of pathogen or antibody results; it’s a core issue present in many patients.

Pathogens and Immune Modulation

With regard to pathogens, Dr. Klimas said most of her patients with high antiviral loads/antibodies will be on antivirals, but generally more gentle ones such as Famvir (famciclovir). She noted, though, that a danger lurks when less-strong drugs inadequately control the virus: it can then ‘break free’ and develop resistance not just to that drug but to others in its class.  A virus that develops resistance to Famvir, for instance, will probably also be resistant to Valcyte. Dr. Klimas then made a plug for controlled clinical trials of Vistide in ME/CFS.

“We don’t really know how to distinguish which group is autoimmune and which group has chronic viral activation.”

One has the feeling that the only thing keeping Dr. Klimas, an immunologist, from tinkering more with the immune system in her patients was lack of sufficient data. Referring to the weird immune ying/yang often seen in ME/CFS (some parts of the immune system being over-activated and some parts under-activated), she said she’d love to be able to knock down the immune activation present and build up immune cell functioning, but that building up cell functioning in a patient whose immune system is already overcharged could trigger an autoimmune response. Since no autoantibodies have been associated with ME/CFS, it’s difficult to tell if an autoimmune response is already present.

Some indirect tests can help; high CD4/CD8 ratios, for instance, are suggestive of autoimmunity, and high CD8 levels suggest a pathogen is present. If her flow cytometry tests show high CD4/CD8 ratios, she’s ‘very nervous’ about doing anything to bump up the immune system.

Imunovir (Isoprinosine)

Dr. Klimas has had good success with Isoprinosine in ME/CFS

Dr. Klimas has seen an 85% response rate to Immunovir biologically, and it can generally double up NK cell functioning. She obtains pharmaceutical grade Immunovir from Canada Newport Pharmaceuticals and a similar and cheaper over-the-counter preparation called Inosine is available in the US.  Anecdotally she doesn’t think she’s getting as good a response from Inosine. Equilibriant – includes mushroom extracts that enhanced NK function in Chinese studies. Got lots of stuff in there.

Monoclonal Antibodies

A group of patients with extraordinary immune readings; i.e., TNF-a levels hundreds of times above normal, are prime targets for monoclonal antibody drugs (such as Etanercept) that target specific immune factors. In these patients, Dr. Klimas usually brings in a rheumatologist to get the drug.

Expect more news on this in the future, as a great number of monoclonal antibodies coming out of cancer research should be hitting the market, some of which may be able to assist NK functioning. Dr. Klimas said there’s “Some pretty cool stuff in the pipeline”.

Low Dose Naltrexone

Low Dose Naltrexone (LDN), not Lyrica or Cymbalta, is Dr. Klimas’ first line treatment for fibromyalgia-type pain.  A recent study found that it reduced FM pain by roughly 60% without the toxicity of Lyrica and Cymbalta.  She called the science behind LDN (which is not produced in a low-dose form by drug companies but is readily available at compounding pharmacies) ‘riveting’. That’s pretty strong endorsement of an ‘underground drug’ that is getting more and more attention despite its Achilles heel of not being marketed in low-dose form by Big Pharma.

Dr. Enlander – Mt Sinai ME/CFS Research Center 

GcMAF

Dr.  Peterson asked about GcMAF. Dr. Klimas said she hasn’t used it, but Dr. Enlander’s been using it for two years–first by injection and now mostly in his own yogurt mixture. Dr. Cheney probably may have started the GcMAF saga in ME/CFS first with a trip to Italy several years.  A yogurt mix was available, but when one of Dr. Enlander’s patients tried to make it the cost was  $3,000. In the end, Dr. Enlander’s bacteriologists at Mt. Sinai produced the mixture (MAF878) (and at a cost of $120!). Dr. Enlander does believe the injections are probably more effective, but he’s gotten good results for both.


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DISCUSS THIS ARTICLE   (5 existing comments) Post a Comment 


The Simmaron ME/CFS Physicians Roundtable Pt. II: Talking Treatments
Posted by: jhampton
Aug 14, 2013
I am wondering how safe this would be for those who are also suffering from Auto Immune Diseases such as Lupus? I suffer from Lupus, Systemic Fibromyalgia, Chronic Fatigue Syndrome and an entire host of other health problems which are all associated from these disease. I have HORRIBLE Side Effects from most ALL Medications I take. I am unable to take most medications due to the horrible side effects. I would be leary of taking this medication due to how sensitive my body is to medications. I have been left with permanete health problems due to some of these medications. I am extremely afraid to take anymore medications than I am already on. Nothing really helps much. I manage to suffer through each and every day.
Reply Reply

LND
Posted by: damadarby
Aug 14, 2013
The LDN really does help me.
Reply Reply

LDN, GcMAF, Mono, and Lyme
Posted by: Sandy10m
Aug 15, 2013
I have had CFS for almost 30 years, and I didn't get a diagnosis until 2005. In 1984, I had Cytomegalovirus (CMV) that put me in bed for a week. I relapsed in 1987 and was in the hospital for a week, then bedridden for another 2 weeks, testing positive again for active CMV. I had more episodes over the years, but nothing as bad as those two. Then in Oct 2012, I finally tested positive (using the new test from the lab in Sharon PA) for Lyme, which we always suspected I had (since childhood) because of my intolerance for taking Vitamin D3. We started with the natural treatments (Samento and Banderol), but a series of stressful events, including the bad flu in Jan, pushed my health over the edge, and I was bedridden again, despite being on all the natural treatments. I gave in to my doctor, who is an expert on Lyme, CFS, FM, and autoimmune, and I started the medications. Low-Dose Naltrexone (LDN) has been absolutely amazing. My standard dose is 1.5 mg, not 3 mg like most people, but if you take it, you will ramp up in 0.5 mg steps. It works by slightly boosting the levels of endorphins in your brain. There is a newly discovered branch of the immune system that depends upon endorphin levels. With CFS and FM (and most autoimmune), this immune branch is inactive due to low endorphins. With this tiny boost in endorphins, all the negative immune functions (autoimmune, allergies) went away, and the good immune functions (actually fighting diseases) came back. It's an immune balancer. So, for the autoimmune person who is afraid to take anything, you must try the LDN, please. The only thing is that you cannot have any alcoholic beverages, which most of us can't have anyway, or morphine-based medications. My doctor prescribed IV antibiotics, first Rocephin, and now Claforan due to gall stones from Rocephin. With the addition of colloidal silver (either oral or IV), the antibiotics got a turbo boost, and suddenly I started feeling better. A recent journal article proving silver teamed up with the modern antibiotics was astounding, and I believe that's what helped me get better. I am also taking Larrea RX (1 pill twice a day empty stomach) for the Epstein Barr Virus (EBV) that popped up over the last few years. We have no idea what happened to CMV (which seems to be gone) and why EBV is now active, but the Larrea RX is helping (but not the raw chapparal because it's too hard on the liver for long-term therapy). I am also doing IV GcMAF. Instead of injecting the GcMAF into muscle (which I cannot tolerate), I am putting the GcMAF into saline twice a week and injecting it into the IV port, and it's working great. So, for those of you that are wondering if you should try all this, you DEFINITELY should. Find a doctor that knows about these treatments, even if you have to fly in to see them. My doctor in Santa Rosa has patients from Europe coming to see him. He knows what's he's doing, and I am proof of that. LDN is a great place to start, and you get that from a compounding pharmacy. It balanced my immune system and prepped it for the coming medications that are now helping me. Good luck, everyone.
Reply Reply

 
forgot Valcyte et al
Posted by: Sandy10m
Aug 15, 2013
Because of the Lyme, I cannot take Valcyte or any other anti-viral listed here to go after the viruses. The anti-virals work by shutting down your immune system because the viruses live in the immune system, but this is the exact opposite of what you need when you have Lyme. So, the Lyme gets treated first, and the EBV gets treated with Larrea RX because the Larrea RX interferes with the virus at a different stage (doesn't work the same as the anti-virals. If you don't have Lyme, then you can do the anti-virals and will probably feel better. But, there currently is no anti-viral that will treat EBV, or none that I could find in my research.

 

 
forgot GcMAF injectable vs. yogurt
Posted by: Sandy10m
Aug 15, 2013
I also tried the GcMAF yogurt instead of the GcMAF injectable. The yogurt did nothing for me, while the injectable did great things by giving my immune system some new resources to fight the infections. So, keep that in mind when you're deciding between the yogurt and the injectable GcMAF.

 

 
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