Ampligen Sunk

The FDA announced on December 1, 2009 that Ampligen would not be approved at this time. They asked for new trial - larger, more expensive trials. This was a shocker. The FDA erected a very high bar for the dysfunctional folks at Hemispherx. Hemispherx will not been get their feet off the ground this time. Ampligen is finished.

There is intention here - lasar-like intention. The FDA does not want any acknowledgement that CFS might be a neuro-immune disorder - or a physiologial disorder of any kind. They are constitutionally allergic to any association with a physical illness. It is now painfully obvious that the FDA and the CDC will do anything within their power to disconnect any sense of "reason" from this illness. This is bad news for the sufferers of this disease.

Hemispherx is complicit in this absurd dance with the FDA, but it looks like it was all pre-ordained, no matter. Over the years Hemispherx has demonstrated an extremely poor ability to relate to any government agency - and this probably extends to anyone or anything. They have set themselves up for a whipping.

Still it is hard for me to believe this decision. It puts a beating on the entire CFS community. I was convinced that the present circumstance conspired in such a way that the FDA would have to approve Ampligen -or at least give it conditional approval. An objective analysis of the situation would lean towards this drug being approved, or partially approved.

How do I know that the FDA has gone out of their way to sandbag Ampligen and all those who might benefit from it? First is that the FDA is not as prissy as they make themselves out to be. They approve many insufficient and half-baked drugs and appliances, including some that are frighteningly dangerous. In such instances strict guidelines are set up. Second, there response is disingenuous and not believable. If what the FDA says about Hemispherx' trials is true, the FDA could have rejected Ampligen five minutes after the NDA was filed. There was no reason for the long delays - from Feb 24 to May 24 to whatever. They obviously waited until the announcement would do the most damage to the momentum of current CFS/ME research. The FDA wants to poison the air - and this has been successful in doing this. This announcement is a real downer.

Everyone knows that Ampligen is not the answer; everyone knows that it is not the silver bullet. But it might have been part of the answer. Efforts are ongoing to identify those patients who might benefit from Ampligen. Now we don't have to worry about that. It has been taken off the table as the only drug designed for CFS. Its rejection will go a long way towards other drug companies refraining from developing similar or new drugs to deal with this neuro-immune disease. The die is cast and nothing will ever be approved for CFS.

What does this tell us? It tells us to shy away from the U.S. government and their help. Change might be on the way, but it is not in CFS government research or sponsorship. It tells us that the only way forward is through private initiative and through doing what we can to support such efforts. It will be interesting to see if the CDC can derail the WPI efforts. Take notice: they are going to try.

Chris

Immuknow

The Patient Advocate has known about the Immuknow test from Viracor for several years. Here are some quotes from the Viracor site:

“ImmuKnow is a noninvasive biomarker of immune function that assesses cellular immune status by detecting cell-mediated immunity (CMI) in adult immunosuppressed patients. It measures the concentration of adenosine triphosphate (ATP) released from CD4 cells following cell stimulation.”

“ImmuKnow is the first and only FDA-cleared blood test to measure the vitality of a patient's immune system.”

This means that the test is regulated and that it does as advertised. The Immuknow test takes a small sample of blood and exposes it to a proprietary reagent (made by Cylex) that stimulates the CD4 cells. ATP activity is measured in these CD4 cells. Viracor has created a scale (<225 – weak immune response, 225-525 – moderate immune response and >525 – strong immune response) and this test is a measurement of immune function. The Immuknow test is used for tracking immune function in AIDS management and in transplant patients who take immunosuppressant drugs. It is being tested in diabetic patients undergoing Islet Cell transplant. At a CFS conference, Dr. Dharam Ablashi suggested using it for CFS. The PA is unaware of anyone with CFS actively doing it - except for his daughter. A number of CFS patients were given this test and their average number was 281. Further information on the Immuknow test is available at the Viracor website. The Immuknow test is a quick and easy blood test that can be done through various labs, including Focus Diagnostics.

Ablashi’ study of 2005 , using Dr. Daniel Peterson’s patient population, tested the functionality of the global T-cell response using an FDA cleared response for cell-mediated immunity assessment (Cylex Immune Function Assay, ImmuKnow) - and these cellular responses with compared to patients with HIV and immunosuppressed transplant patients. The ImmuKnow test was assessed based on the amount of ATP express in ng/ml. All three groups has median immune function that was not statistically different. The transplant patients averaged 259 ng/ml ATP, followed by HIV patients at 263 and CFS patients at 281. CFS patients showed consistency with both the transplant and HIV patients - with the majority of patients in the median zone, followed by patients in the low zone, with the smallest percentage in the strong zone. More can be read in Ablashi’s and Krueger’s book Human herpervirus-6.

Dr. Dale Guyer uses this test in his practice and has a positive feeling about it, believing that the numbers rise as the immune system becomes stronger. This Patient Advocate is not aware of other doctors using this test.

Judy Mikovits and serendipity – how lucky we are.

The Patient Advocate took a picture of Judy Mikovits from the 2009 UK conference DVD and gave it to his daughter, saying, “This is the woman who is going to make you well”. My daughter put Judy’s picture on the wall of her room where she rests.

The Patient Advocate first saw Judy Mikovits at the CFS conference in Ft. Lauderdale, FL in January 2007. She was presenting a paper on “Incidence of Chromosomally Integrated HHV-6 (CIHHV-6) in a Cohort of CFS patients with Clonal TCR-g and Lymphoid Malignancies”. The PA did not take any special note of this lecture except to note that Dr. Mikovits talked like a typewriter.

In April of 2008, the PA saw Dr. Mikovits give another presentation in London. The PA’s report at the time said this: “The last major lecture was an incredibly high-powered presentation by the American researcher, Dr. Judy Mikovits. She is the research director of the new Whittemore-Peterson Institute of Neuro-Immune disease in Reno, NV. In a lecture of which I understood next to nothing, she gave every indication that this institute has the funding, the drive and the independence to reveal some important elements of this disease. She also indicated a no-nonsense willingness to cooperate with others world-wide in this struggle. I have seen many scientists make presentations, and this gal was amazing. With this presentation, along with the others, there was a clear picture that the Americans were back in the UK doing what they do best.”

Another attendee of this conference wrote this: “Dr Judy Mikovits is Research Director of the Whittemore Peterson Institute in Nevada and she presented a most enthralling presentation on the focus the Institute's research although most of the technical detail was way over my head. The research looks at abnormal inflammatory response to viruses and part of it piggybacks off Dr Kerr's work.”

Of the Reno conference in 2009, the PA wrote this: Mikovits, the director of the Whittemore-Peterson gave a slam-bang talk, one similar to what she delivered in the UK last May. However, this time she had less time and she really had to whirl through it. This gal is generally accepted as being a serious researcher and in a position to get some results. She is obviously bringing money and people over from her former research field in cancer. Here is a quote from Judy Mikovits that surfaced on Cort Johnson’s site after the Reno conference: “We have a piece of data that would just knock your socks off but I’m not showing it. “

The PA has developed the habit of sitting through days of scientific or quasi- scientific lectures. It is possible to nose out the more scientifically interesting talks, even for a non-scientist. After awhile one can sense the “cannon fodder” talks that dominate all of these conferences – those happy little academic talks that are going to go nowhere.

Consequently this Patient Advocate was ready to really listen to Judy Mikovits in May 2009 at the London CFS/ME conference. “Dr. Judy Mikovits, who astonished so many folks at this conference last year, was back for another lecture. She made her usual complex and far reaching talk, most of which passed over my head. (I should have studied biochemistry.) Her work at the Institute involves sub-setting CFS through gene array chips and cytokine testing. The Institute is moving very fast and I get a sense that specific information is going to emerge here sooner rather than later. Certainly talking to Annette Whittemore and hearing Mikovits and Peterson makes one sense something is afoot, although they are smart enough not to say anything. During the question period Dr. Mikovits was asked if they had been working on a specific virus involved in CFS. She coyly answered, almost in a whisper, “yes” - and then she followed up that there is a novel virus not previously associated with CFS and that the WPI had submitted their research paper for publication at Science magazine.”

And then came October 9, 2009 and the world of CFS/ME turned.

The connection between Judy Mikovits and the Whittemore-Peterson Institute was a bit of serendipity. Dan Peterson was giving the last lecture of the day at a HHV6 conference in Spain in 2005. Judy Mikovits was in the audience and responded to Dr. Peterson’s plea to the audience (during the question period) for help with a problem that he was having. Ten of his CFS patients had developed mantle cell lymphoma and he was stumped. The following comes from an interview with Mikovits on Cort Johnson’s site: “These people were getting lymphoma and they were getting it before anyone gets lymphoma and to me that says virus.” “My background is in virus caused cancers. My training for over 22 years at the NCI was in how viruses dysregulate the immune system and cause disease – cancer. So when he told me to come meet with him after the talk I beat my way up to the front of the room because it was the only interesting thing that I had heard at the meeting, and I said, “There is something there, that’s a smoking gun”, so I gave him my card, told him that I’m interested, told him what I thought was going on, and he and Annette invited me out to Reno. Within two weeks of that meeting, they talked about setting up a summer research program.”

Judy Mikovits showed up in the right place at the right time. However, she is not solving this problem on her own. Many physicians and researchers have plowed the ground ahead of her. She is the beneficiary of many efforts.. It is a bit like volleyball. The ball is controlled, set up and then spiked. Judy is the spike.

From all accounts, Dr. Mikovits has great empathy with the CFS/ME patient population. All good artists have empathy for their subject. An artist, as well as a scientist, benefits from “attachment to the subject”. This empathy, this connection. does not come easy, and is not taught in schools. Not everyone has it. It is inherent in the personality of the individual. Dr. Mikovits seems to “have it”. A recent article in the Reno Gazette Journal had a personal bit about Dr. Mikovits: "My grandfather was dying of cancer, and nobody would talk about it," Mikovits said. "One day I said to him, 'Don't you know you're dying?' And he said, 'Don't say that. I don't want your grandmother or your dog, George, to know." "He was dying of cancer, and nobody would talk about it. That's what bothered me most."

Annette Whittemore has spoken of how much Dr. Judy Mikovits lab collaborators enjoy working with her. “Dr. Judy”, as her students call her, is both disciplined and relaxed, with a good sense of humor. “Dr. Judy” works long hours, setting the tone and direction. Others follow suit.

A recent article in the Reno Gazette Journal has a number of good quotes from Mikovits.

About the moment of truth with XMRV: “It was January 22, and we were in a San Diego restaurant called the Yard House,” said Mikovits, who had gone there with fellow scientist Vincent Lombardi to present the results of their research to Frank Ruscetti and Robert Silverman, two of the world’s leading virologists. “We kept waiting for them to say something,” Mikovits said. “I was nauseous. Bob (Silverman) waited a long a time, and then he looked up and said, ‘Well, this is going to change their world.’” 
And it has.

About getting traction: “They want us to send them the (XMRV) retrovirus so they can screen huge libraries of compounds and see what they have that could work,” Mikovits said. “They already have drugs to treat HIV, so they could redesign a compound for the XMRV virus. Since they already have FDA approval, they could get something out to people fast.”

"I've gotten more than 100 e-mails from physicians, and I've gotten calls from the head of the Mayo Clinic and the clinical director at Sloan-Kettering," she said. "Those people wouldn't take the time if they didn't think this was a significant finding."

"We've got about 500 samples from the United Kingdom, and we also were approached by the head of the syndrome organization in Spain," she said. "We eventually expect to collaborate with many other countries: Norway, Germany and others. Everybody is asking if we can test their samples and asking how they can get in the clinical trials."

About the Barcelona presentation in October 2009: "They applauded before I gave my presentation," she said. "It was such a surprise, because they never applaud before a presentation."

The Abstract and the Real

All this viral research and treatment is heady stuff, riddled with uncertainly. On a daily basis the Patient Advocate has to deal with much more mundane matters. There are some items that can be helpful and the PA will list some of them now, some of the things that have been useful to his daughter.

Oasis bedroom: (see Lisa Nagy)

Stair lift:
In order for my daughter to get outside, the Patient Advocate has installed a stair lift. The PA researched the subject on the internet and talked to a number of companies. He learned all about stair lifts and learned that they are very expensive. The PA bought one on Craig’s list in 2007 from a fellow who lived on the beautiful plateau above Red Wing, MN. This fellow's wife has MS and had recently been institutionalized. I asked this fellow if his wife had taken LDN and he said yes, but it had done nothing to halt her descent. In my search I discovered that many folks are trying to dump their stair lifts and the used price can be quite inexpensive, relatively speaking. I drove down to Red Wing, bought my two sons Red Wing boots, and picked up the stair lift. Back in St Paul, I installed the lift in a day or two, gleaning advice from a local distributor of the particular brand that I purchased. They were extremely helpful, especially in cutting it down to the right size. This job taught me one thing: I do not want to install stair lifts for a living. With this stair lift my daughter is able to easily go up and down the stairs as she wishes. A year later I ended up buying and installing another one for the stairs off her porch. This purchase and installation followed the pattern of the first one. I bought a used starlit - a different brand - off Craig’s list from a fellow in Robbinsdale, MN. His mother had passed away and he was moving on. His mobile home and motorcycle were sitting in his driveway, ready to take off to points unknown.

FIR (Far Infrared) sauna:
In doing the Acumen and Biolab mitochondrial tests (suggested by Dr. Myhill), information was revealed that indicated that use of a FIR sauna might be beneficial. The PA did some research on the subject and found that they too are very expensive. There are several kinds of FIR saunas: closets, domes, and blankets. The PA settled on getting a dome sauna. Noodling around the PA found a used FIR sauna - almost new - at Arrowroot, a local health food store in Bryn Mawr PA. The woman who originally purchased it had used it twice and returned it. Such are the values of the bourgeois. The store was willing to part with it for a greatly reduced price. They also shipped it to MN as part of the deal. They were happy to get rid of it, I was happy to get it. I had it sent to a friend’s house in St. Paul, MN and it sat on her porch until I arrived in MN several weeks later. It was snowing when I arrived, and it had been for some time. It was January 2008 and there were large snowdrifts everywhere. I schlepped the somewhat heavy and awkward sauna across the snow to my rental car, slipping and sliding in the dark. This was not what I had in mind when I shipped it to MN from the mild climate of Philadelphia. I got it to my daughter’s apartment and set it up, to make sure that it still worked. I was a bit concerned as my friend had left it on her porch in sub freezing weather for several days. I had asked her to put it inside but that did not happen. The world is not a perfect place. It is difficult to have total remote control. Upon investigation, the FIR sauna worked fine. Later, much later, my daughter started using the sauna. It provided great benefit in reducing nickel.

XM radio:
I have listened to XM satellite radio for a number of years. They have hundreds of channels including all sorts of music, talk, old time radio, oldies, sports, news and business. It is a bonanza for someone who likes to listen to the radio, for someone who can embrace that culture. I got the idea of buying a subscription and a radio for my daughter. I drove out to a local mall in MN and purchased a portable XM box and set it up in her room. My daughter was a bit skeptical about this, but soon became an excited listener of music, talk shows, news and baseball. Supposedly the world of radio has seen it’s day, -but it’s magic can still be summoned up by the chronically ill or others who want to invite a variety of airwave situations into their life. It is particularly useful to those who have light sensitivity and to those who employ a disciplined form of resting and pacing - as advocated by Bruce Campbell.

Water Filter:
This PA is convinced that it is important to control all things that the patient puts into their mouth. Meat should be anti-biotic free and free range. Water should be filtered. This PA bought a water filter from a fellow in MD suggested by Dr. Jacob Teitelbaum. Teitelbaum says, "The filter that I have found to be most effective is made by Multi-pure. Multi-pure filters can be obtained from Bren Jacobson at 410-224-4877."

Pedometer:
Following the advice of Dr. Benjamin Natelson, the PA bought a pedometer that my daughter wears. This allows us to determine how much she moves on the average day. It also gives us a baseline to gauge increase or decrease in the ability to move around. Some pedometers are more accurate than others and it is important to get one that works well. We tried a number that were misleading, until we focused on the one that Dr. Natelson recommends in his fine book, Your Symptoms are Real. Dr. Natelson, who practiced for years in Newark, NJ, now practices in New York City. Dr Natelson is a doctor who does fine research in CFS/ME. His suggestions on the use of a pedometer and on the increasing of the “energy envelope” are very useful and practical.

Mini-trampoline:
This was the suggestion of Dr. Karen Vrchota of Winona, MN. Dr. Vrchota is a very kind and compassionate CFS/ME doctor. She has growing experience with this disease and engages it in the most professional and respectful manner. She is open to suggestion and listens carefully. A mini-trampoline, used in even the most minimal way, say four bounces, helps the lymphatic system of the body. It is a partial replacement for exercise for those who cannot exercise. The movement on the trampoline, even the most modest, makes the body think it is exercising. In this way it can be a great help to CFS/ME patients. I bought a Cellerciser mini-trampoline. The are others, but I would pay the money for a good one.

Shower chair:
A shower chair can be useful in the shower. Shower chairs can be purchased in a variety of places including drugstores, medical supply stores and places like Target.

Nickel-free cookware:
In order to limit the ingestion of nickel, this PA bought nickel-free cookware for his daughter. All stainless steel cookware has nickel in it. Nickel-free cookware is not cheap. This idea is a continuation of the notion of being careful what goes in the mouth of a chronically ill patient. I was able to find two brands, Silit and Chantel.

Head set for phone:
The PA bought a head set that plugs into the phone. It is like one of those things that operators wear. His daughter uses it when she is on the phone. It was purchased at Radio Shack

Lisa Nagy

When this Patient Advocate was attending the CFS conference in Ft. Lauderdale in 2007, he met a very interesting gal. Her name is Lisa Nagy and she was unsuccessfully trying to raise awareness at this conference for environmental poisoning. Living in San Diego and working as an ER doc, Lisa became mysteriously sick. Lisa was sick for many years with what turned out to be environment poisoning. She has cured herself, with help from others, and now is a powerful advocate of diagnosis and treatments for environmental poisoning. Dr. Nagy’s story can be found here.

Environmental poisoning affects many CFS/ME patients, often as a secondary reaction to the CFS/ME itself. CFS doctors like Cheney take toxicity from the environment seriously, although he thinks of environmental poisoning as a peripheral item to CFS/ME. For those of you that are interested Dr. Nagy has a website and is available for consultation on environmental issues. I have spoken with her on several occasions and she is very knowledgeable and helpful in her suggestions for my daughter. Among other things, she recommends that ill patients create an Oasis bedroom. This means removing all EMF devices, purchasing a mattress and bedding that does not have fire retardants, PBBs and other toxins, and using charcoal air filters in all rooms, but particularly in the bedroom She recommends several air filters.

Dr. Nagy works closely with Dr. William Rea, the foremost expert in environmental testing and treatment. He runs a clinic in Dallas TX. At the moment Dr. Nagy does not practice medicine. but she has applied for a license in MA where she now lives. She travels to environmental conferences - gathering information, and giving lectures. Environmental illness seems to overlap in many instances with CFS/ME in much the same way as thyroid issues or MCP or Gulf War Syndrome. For those with environmental issues, Dr. Nagy can be very helpful.

Dr. Dale Guyer

In the pursuit of his daughter's betterment, this Patient Advocate has written about a number of CFS/ME doctors. The PA admires many researchers and doctors including Myhill, Vrchota, Cheney, Peterson, Chia, Levine, Enlander and de Meirleir. The PA is a particular admirer of Dr. Dale Guyer, who practices medicine in Indianapolis, IN. Dr. Guyer has a number of patients who are active on the Prohealth CFS/ME Message Board. Dr. Guyer is knowledgeable, kind, patient - and reserved in his treatments. His use of antivirals can be found in the following document, available on Prohealth from 2007. (A more general treatment protocol was revealed in Dale Guyer, M.D., on Treating Chronic Fatigue Syndrome & Fibromyalgia: “Covering the Bases & Peeling Back the Layers of the Onion”, published a year earlier.)

“Antiviral medications have generated considerable scientific attention in the primary and adjunctive treatment of CFIDS and FMS - in the subset of the population with a viral component as part of individual etiology.

Through the years, I have noted a few good additive results with medications such as Famvir, Valtrex, and occasionally Acyclovir and Amantadine. Over the last year, thanks to the work of Dr. Jose Montoya at Stanford University, I have found that ValcyteTM offers another option that can really be the proverbial “icing on the cake” for many afflicted with CFIDS. Like other clinicians, my own experience with antiviral medications is that they are often very helpful with occasionally dramatic benefits, adding another viable alternative to the landscape of treatment options.

Some years ago, I had doubts that antiviral meds could add significantly to the management of CFIDS. Retrospectively, the doubts stemmed largely from becoming accustomed to observing good results with therapeutic strategies I was already using.

On many occasions, I have noted that comparatively simple treatments often deliver extraordinary results - Transfer Factor,1 oxidative therapies, Intravenous Vitamin (IV) therapy and vitamin B12 shots, to mention a few. Obviously, no protocol represents a “one size fits all” strategy. Clinicians are still required to find unique treatment strategies for unique patients.

Recently, I followed two male high school students who were very physically active prior to development of severe cases of mononucleosis. Following the episodes over the next six months, I noted that both students exhibited the classic findings of CFIDS. Both also responded almost immediately to a cocktail of IV Therapy, Transfer Factor and broad-spectrum nutritional supplementation. One patient eventually competed in an international martial arts competition in Germany, while the other returned to twice daily football practice in the heat of the Indiana summer - a challenge even for those without CFIDS!

In addition, my earlier opinions were based in large part on not observing impressive results with antiviral medications - at least not as good as I came to expect from other therapies.

Along the way, a good friend - Kristin Loomis, who in addition to being very knowledgeable is also the Executive Director of the HHV-6 Foundation - encouraged me to continue to give antivirals a try. I must say she, as usual, proved correct. Last year, she introduced me to the research of Dr. Montoya2, a Stanford infectious disease specialist; and since then I have seen often very good success with Valcyte.

In 2007, we began collecting data on the results of adding Famvir and Valcyte to individual treatment plans as clinically warranted. The formal results will be presented at the International College of Integrative Medicine meeting in Nashville in March 2008. In the meantime, I want to share observations that I have made over the last several months on very intriguing clinical findings that include the broad array of subjective improvements patients report while on antiviral therapy.

One interesting case involves a gentleman undergoing treatment for bipolar disorder for years. During his last office visit, he remarked that since starting Valcyte not only did the CFIDS symptoms reduce substantially, but he also noticed more motivation - for example, mowing the lawn and enjoying it, something he had not done in years. The patient reported that his lithium dose was reduced from 1200 mg daily to 300 mg daily.

Others have reported a restored sense of joy and humor - feelings absent for years, in addition to improved libido, decreased anxiety and depression, improvement in asthma and allergic symptoms, positive clinical changes in autoimmune disorders such as Crohn’s Disease, rheumatoid arthritis, and even one case of rare ALS type progressive motor neuron disease.

As our clinical experience demonstrates, our evolving understanding of the pervasive role viral activity in human health expands. We are beginning to understand that chronic viral activity may be present in the population at levels higher than previously assumed and not just involved in the etiology of CFIDS.

Can we predict which patients will do well with antiviral therapy?

Overall, it would appear that patients who fare better have a classic “viral” provoke history - i.e., they had a case of a “viral-like” illness, never got better, and over time keep going downhill. Duration of symptoms may be six months or 20 years. I have observed a few cases where these symptoms started after receiving a vaccine, such as the flu vaccine, and another case that appeared to begin after receiving a tetanus vaccine. In addition, patients will have consistent lab findings, including: depressed natural killer cells, low adrenal function, hormone deficiencies, elevated RNase-L3 levels, and elevated viral antibodies to Human Herpesvirus Six (HHV-6), cytomegalovirus (CMV), Epstein-Barr virus (EBV) and occasionally other viruses.

As a rule of thumb, individuals who experience milder symptoms of shorter duration [accompanied by elevated levels of] IgG (Immunoglobulin G) to EBV seem to do well with Famvir. However, patients more severely affected for a longer duration with antibodies more skewed to HHV-6 or CMV will often need Valcyte.

Younger individuals with shorter duration of symptoms tend to get better faster, while people over 40 or those with several years of symptoms may need a few months to start getting back on track. Often even after six months of Valcyte or Famvir, we will maintain some individuals on a low dose of Famvir or Valcyte in the 50 mg range (a dose we compound because it is not commercially available).

Another important issue is the necessity to take a comprehensive view of CFIDS.

Often, physicians desire to treat CFIDS simplistically like we might address a sore throat - one cause, one solution. Undoubtedly, theories come and go relating to CFIDS, but in my experience, physicians who get optimal results evaluate all contributing factors, listen well, and integrate therapeutic support strategies to address contributing issues, such as: adrenal dysfunction, sub-clinical hypothyroidism, neurotransmitter imbalances, nutritional deficiencies, endocrine problems (depleted levels of DHEA, growth hormone, testosterone) - to name a few.

In my experience, taking a more comprehensive approach accelerates the process of restoring health, while simultaneously diminishing the likelihood of feeling exhausted, depleted and miserable while taking antiviral medication.
The inclusion of antiviral therapy in CFIDS has in my experience been a great addition. Like any stand-alone therapy, it may not offer the big difference we want to see; however, when combined with other supportive therapies, it offers a giant step forward in restoring wellness in individuals with CFIDS.”

One comment on the above article focused on the issue of the toxicity of these antiviral drugs for the CFS patient population.

While it was an oversight that Dr. Guyer did not speak to this issue in his discussion, he is very sensiitve to the issue and quite cautious in prescribing antiviral medication to CFS patients. As can be noted by his general attitude, Dr. Guyer is intent on strengthening the CFS patient in a variety of ways in order to prepare the patients for antivirals. Dr. Guyer prescribes antivirals to those patients whom he believes can tolerate them - and often he does so in a very low dose (and builds up). It is worth noting that Dr. Derek Enlander stated at the NJ CFS/ME conference that he had given Valcyte to 120 patients (again under a careful controlled setting) and had not had any adverse effects. Dr. Enlander indicated that Valcyte benefited about 40% of the patients to whom he prescribed

NJCFSA conference October 18,2009

Dr. Derek Enlander received an Achievement Award on October 18, 2009 from the NJ CFS/ME Association. Prior to receiving the award, Dr. Enlander gave a lecture on recent research and treatment possibilities for CFS/ME. The information presented in the lecture can be culled from the internet or from DVDs of his lectures. The presentation was similar to others that I have seen. In other words there was not much that was new. Enlander outlined his protocol - a Hepapressin combo-injection and the use if Immunoprop, Catapult and other things. His current treatment of CFS/ME results in “improvement” in 55-60% of his patients. Dr. Enlander also focused on the Methylation cycle and cited the work of Rick van Konynenburg. He was optimistic about the future for CFS patients, emphasizing that there is hope.

This Patient Advocate took note of a few items. Among them were –

- Dr. Enlander has used Valcyte in 120 patients and none of them had suffered adverse effects. He tests them carefully for the first four weeks. He says his success with Valcyte is less than the 75% success rate of Montoya. I think he said it was more like 40%.

- Dr. Enlander spoke of a patient who was legally blind from HHV6. After treatment with Valcyte her vision is 20/20.

- Dr. Enlander spoke of the recent paper about XMRV and his comments mirrored ideas that he has expressed on the internet. He is excited about the study and states that it needs to be replicated by an independent lab. Dr. Enlander said that he was sending patient samples to Jonathan Kerr in the UK, who is in the process of testing the XMRV hypothesis.

- Dr. Enlander has a grant to do XNRV testing.

- Dr. Enlander is testing de Meirleir H2S hypothesis.

- These observations are an indication that CFS/ME doctors and researchers are communicating and joining forces.

- This Patient Advocate asked Dr. Enlander about Ampligen and his opinion was mixed. He himself used this drug on his patients a number of years ago but stopped with the problems that were circulating around Ampligen, most of which had nothing to do with the drug efficacy. Dr. Enlander is neutral towards Ampligen at this point, although he did say it has potential toxicity issues. Some patients who took Ampligen got much worse on the drug and suffered long-term effects.

This of course contradicts the more rosy picture presented by Hemispherx. There was a Hemispherx representative at this conference. She repeated information about Ampligen included in company statements. She said nothing that I had not heard before. Hermispherx expects an FDA decision by the end of the year and the recent delays are perhaps manufacturing issues or toxicity issues, both of which seem to be minor problems, at least from her point of view. Where this all leads for Ampligen, no one knows. The PA asked her is anyone had died in the trials, and she said no. She said that Ampligen has a very good safety record and it did not have toxicity problems in the many doses that have been given over many years. She said that Lapp, Peterson and Bateman use the drug in the U.S. She said that de Meirleir does not use it as much as he did. So, to this PA, the picture on Ampligen remains cloudy.

Dr. Susan Levine presented results of two small research trials that she has done. While a practicing physician in NYC, Dr. Levine also likes to do research. Dr. Levine has presented her viral research at this conference in other years. She has also received the NJ CFS/ME Achievement Award. Dr. Levine is an impressive and devoted physician. Many of her patients were in attendance. Dr Levine makes an effort to include young medical people and potential doctors in her practice and research. She is thinking down the road - to the future of CFS practitioners. One of her younger colleagues - Alexandra Volper - won a scholarship award at this conference. She was tremendously impressive in her acceptance of this award. She follows in a line of very dynamic and committed young future physicians to win this modest award of $3,000. It was great to see her.

Dr. Levine was cautious about this recent XMRV study. She pointed out that it was “scary” to think that a retrovirus was involved. It must also be remembered that Dr. Levine was part of the failed attempt to replicate the de Freitas trial.

The PA got the feeling that no one really knows where this XMRV research is going – but that everyone was very interested. The one person who seems to be driving the interest and who does not seem to be wavering is Judy Mikovits. This is going to be interesting.