I first heard about GcMAF in the fall of 2009 and began asking about it. Not too many people either knew about it or wanted to talk about it. I read about it on various sites, primarily here and in this Bill Sardi article here.
I wrote a question on Prohealth board. Harmod's responses are of interest:http://www.prohealth.com/me-cfs/blog/boardDetail.cfm?id=1379980
Most people in CFS/ME have not heard of this compound. A couple of CFS doctors, one is the US and one in Europe, are using this compound in a very small group of patients. One of them recently reported a strong positive response in one XMRV positive patient and improvement in an additional nine or ten patients who have just started on it. The compound is considered to be relatively safe. The best formulation is said to come from Israel, presumably this company. A less expensive formulation is produced in Europe and is undergoing small experimental trials.
There is a good overview of this compound and its activity at /www.gcmaf.co.uk/info/
I wonder if this compound would have any activity against XMRV? Judy Mikovits was unaware of the existence of GcMAF until last week. Perhaps she can ask around about it?
Sunday, May 30, 2010
Tuesday, May 25, 2010
London Conference May 24, 2010
(Richard Simpson, Martin Lerner, Invest in ME conference, 2008)
Here is my report from the Invest in ME conference in London that took place on May 24, 2010. This report is my attempt to communicate to others - to those patients who could not attend (including my daughter) - what I saw and heard. I am aware that this report reflects my own bias.
This is the fourth year that I have attended the Invest in ME conference in London. The guiding lights of this effort are Richard and Pia Simpson. These dedicated individuals work tirelessly to make this conference happen. Their hospitable and generous presence is felt everywhere, and I cannot imagine a CFS/ME speaker having a better platform from which to make a presentation.
The one-day conference takes place in a beautiful lecture hall at the very edge of St. James Park. During breaks you can go out and sit in the sun on a park bench and see the world go by. The hall seats 230 people. Each year this conference grows in number, and this year the hall was packed – mostly with patients and patient advocates. Soon the sponsors will have to find a bigger venue. Each year the appropriate government and public health officials are invited to attend and to make a contribution - and each year no one shows up. At least they show a great consistency. (In the UK one is startled by what the NHS does not provide for the citizens of this country. The health care for CFS/ME is Kafkaesque and anyone interested in government run health care should take a good look at this situation and disabuse themselves of their utopian dreams. The situation is pathetic and very sad for the patients, who are desperate.)
Invest in ME invites the top medical or research practitioners to present at this conference. Surprisingly (or not surprisingly) the participants are increasingly American researchers and doctors. The all-day conference delivers a disciplined and hard-hitting set of lectures, one after another. It is an exhausting but rewarding day and the audience member has a front row seat to the most current issues in CFS/ME, warts and all. In the past I have seen Garth Nicholson, Sarah Myhill, John Chia, Kenny de Meirleir, A. Martin Lerner, Basant Puri and Jonathan Kerr. The lectures are usually 45 minutes long and the day is broken into several sections with two tea breaks and a lunch break. A fine lunch is served. During the breaks conversation is encouraged and it is possible to buttonhole the speakers.
The concept behind this conference is healthier and more focused than the semi-annual meetings in the US. These US conferences, of which I have attended two, are four days long and have a great amount of “filler” or academic cannon fodder. The sponsors try to please everyone and in the process please no one. The viewer gets none of this feeling at the Invest in ME conference.
Mondays lectures started early with Dr. Leonard Jason. He is a good choice to get the day going. I have heard Dr. Jason speak a number of times and each time he is better. He has been previously well received at his conference and for good reason. He presents precise and well-organized statistical information attempting to define the parameters of CFS/ME in a legible and understandable fashion. Given the history of CFS/ME and its various confusions, this is not an easy task. Along the way, he delves into subject matter that is quite surrealistic, often bizarre and funny. Dr. Leonard works is a disciplined way, mostly on his own, out of DePaul University in Chicago. He strives towards clarity regarding the language and definitions of CFS, and he is appreciated and respected by a growing number of people.
Dr. Jason’s inclinations and work can be gleaned from the internet. This is true of all the speakers. My intention in writing this report is less to detail the contents of the lectures and more to give a feeling about the conference from my perspective. Things are changing with rapid dissemination of information worldwide and personally, I did not expect to learn a whole bunch of useful items that I did not already know. There were a few tidbits that I will include in this report.
The second presentation was a solid academic talk by Nora Chapman from the University of Nebraska. I imagine that the science of this talk passed over the head of most of the audience, including mine. Chapman and her associates have demonstrated that selection of defective enterovirus in heart and other tissues leads to persistent infections despite active antiviral immune responses. Paired with this lecture was Dr. John Chia, who also works with enteroviruses. Dr. Chia was back for the third straight year and he gave updated research information, including case studies, enumerating his belief that enteroviruses are a major causes in CFS/ME. Dr. Chia strikes a nice balance with his research ideas and his treatment possibilities. In this case, he spoke at length about Equilibrant (Oxymatrine) and its effectiveness in about half of his CFS patients. As he likes to point out, this is a quite a high percentage of success for any CFS protocol. Dr. Chia lectures can be seen online or on DVDs. Cort Johnson has several good interviews of and discussions with Dr. Chia on his site. Dr. Chia collaborates with his son Andrew on research. This year Andrew had to attend classes at the U of Southern California where he is in pharmaceutical school. Among other things he wants to learn and lobby for the development of anti-enteroviral drugs. I was hoping that Andrew could meet my son Peter, who is about his age. Peter was attending the conference and doing a little filming. Maybe next year, the two can meet.
After the morning break, Cheney gave a lecture on oxygen toxicity and diastolic dysfunction. Cheney’s big problem was squeezing his usual three-hour lecture into 45 minutes - and I can say that he did not do a good job of this. Twenty minutes into the lecture I turned to my son Peter and said that Dr. Cheney was proceeding as if he had three hours - and that he had better speed it up. He didn’t and the consequence was that Dr. Cheney had to just stopped in the middle of his lecture. However, it was not a big problem as any 45-minute slice of Dr. Cheney is worth its weight in gold, and this day was no exception. Dr. Cheney is a quite fantastic fellow. This was his first appearance at this UK conference. Most of what he presented can be culled from his research website or from his recent DVD from April 2009. Dr. Cheney gives credence to the new discovery of a retrovirus. After all, Dr. Cheney has long believed that a retrovirus could be at the center of this disorder. In his lecture, Dr. Cheney indicated that 38 of 47 consecutive patients in his practice were XMRV positive by culture testing at VIP lab.
Jonathan Kerr gave one of his exquisite low-key barely audible presentations. He plows along in his genetic work, this time speaking on his continuing work to subtype CFS by SNPs. In a nice bit of symmetry his slides matched his inaudibility - and they were completely washed out and unviewable. What was with this? I guess under current circumstances he was embarrassed to be at this conference and wished he were somewhere else. Dr. Kerr used to do very important work. Each year he seems to have less funding. In the past, at the end of his lecture, he would show his band of researchers, shrinking magnificently each year. This time I noticed that he didn’t show the usual picture of his colleagues - so I guess he doesn’t have any. This sophisticated research is fueled by cash and it seems to be drying up. Certainly the UK government gives him nothing. One gets the feeling that the research of this lonely aspirant languishes. He was going to fetch up with the WPI but I wonder what happened to that? Long ago it was my suggestion that Dr. Kerr move to the US where he could make a real contribution to CFS/ME research instead of stalling out. Surely he knows that there are a lot of Brits living in the US and if he moved to Minneapolis I would take him to Brit’s Tavern for a Speckled Hen.
Nancy Klimas spoke next. She has this sophisticated data sharing system run by Gordon Broderick of the University of Alberta, which could prove elemental in future studies. She gave a talk on immunological biomarkers, which others have described exquisitely This study ties in handsomely with what goes wrong in various pathways and extends the work of other studies. She has a loyal patient base with far reaching implications, including a new treatment center. I prefer Kerr’s quietness or Peterson’s dour seriousness to Klimas’ cheery optimism - to each his own. I have seen her talk on various occasions, perhaps five or six times, and I cannot personally get beyond the impression that "she overplays her part".
Towards the end of the day, things heated up a bit. Brigitte Huber gave a talk on her HERV-K18 research and then added a coda on XMRV. She did an unexpected and gratuitous job of sandbagging Judy Mikovits, who was the next speaker. Huber methodically went through her recent XMRV “study”, explaining in her officious voice that her PCR test was the “assay of choice” and “very sensitive”. She tested 228 samples, 112 from Susan Levine, 105 from Taylor in Chicago, and 11 from the HHV6 foundation. Then she put up a slide with red letters that said, “All samples were negative for XMRV integrase”.
Huber said, “We cannot see in our patients XMRV like in the Science article”. In a further confounding maneuver she hinted or charged that the WPI study was “contaminated”. This charge needs to be challenged, as it is a lie. As she was leaving the lectern Huber said in a wonderfully disingenuous voice (to no one special, but I suppose it was directed towards Judy Mikovits), “Sorry”. It was a revealing and weasily moment.
To me it is becoming obvious that certain people, especially doctors who have been treating patients unsuccessfully for years with half-baked treatments, or researchers who are connected to the academic research money tit, are trying to sink Mikovits and the WPI. This is not science; this is venality. This negative reaction has little to do with whether XMRV has any validity or not. That is a separate issue and there are two sides to the argument; and it needs to be fought out according to established scientific methods. I think that certain critics sense, perhaps correctly, that soon they might be out of a job.
The day before the conference, there was a brain storming session with the various participants at this conference – Cheney, Chia, Huber, Jason, Whittemore, Chapman. It is a great idea and discussion/disagreement (sometimes fierce) is often a necessary and useful result of such exchanges. In this afternoon session, Huber launched an attack on Mikovits. Mikovits did her usual job of defending herself. Huber left the group early (maybe to go shopping?). As she left Huber promised that she would not create a controversy by revealing her study results the next day.
Overnight Huber changed her mind, honest soul that she is, and made her awkward revelation. It was all quite unseemly, and did not fit the tone and tenor of this conference - which is heavily ladened with sick patients, hanging on by a thread. They make a great sacrifice to get to this conference, but not to hear this kind of shit. After all this is really not a scientific conference, and this nice bit of spite was entirely out of place.
When was the last time that Huber gave one iota of thought about CFS patients? I can tell you exactly – it was… Never!
I watched this with fascination, realizing that Huber in her righteousness had put her head on a block and asked to be kicked in the teeth. It was a great setup, a “once in a lifetime situation”, and Mikovits came through big-time, doing what she needed to do. She remained calm (inside she must have been boiling) and delivered a splendid lecture (the best that I have seen her do) and demolishing Huber. The effect was that Huber shrank down to the size of a pea. I had talked to Mikovits the day before about Huber and advised her in general to disregard her critics and just roll over this woman (not that Mikovits spends one moment listening to me). Some critics need to be rolled and this was just what happened. At the end of her lecture, Mikovits got a loud and sustained applause showing deeply felt appreciation.
The moderator of the conference once again was Malcolm Hooper, who represents the best of the UK ME doctors and researchers. Dr. Hooper is known for the Hooper files, which are included on the conference DVD to be released in several weeks. Dr. Hooper has an easygoing manner, moves things long nicely, keeps the conversation focused and gives helpful commentary when necessary. This man obviously has multiple gifts.
Invest in ME’s primary idea (I believe) in creating this conference was to bring the most recent research and treatment information to the UK, a tidal backwater in regards to recognition of the seriousness of this disease (not that the US is much better). Beyond this they want to facilitate these personalities to sit down and talk together and to share their ideas. In general CFS doctors and researchers are a lonely band of folks, comfortable and happy with their isolation. In other words their social skills are limited, especially in relating to each other. In the last few years, things have gotten much better in this regard, mainly due to this conference and a few other “retreats” of CFS/ME notables, supported by private donors.
The high-mindedness of these talks always disintegrates at the end of the day with a plenary session where patients and patient advocates plead for treatment advice – treatment readily available in the US and denied the patients in the UK. (Whether these treatments work or not is another conversation.)
The question is why, with so much of this information readily available, one would bother to attend this conference. It is a good question. My answer is that this conference allows me to get a sense of the direction of things, the “zeitgeist” of this field - and also to talk directly to the participants in the more informal parts of the conference. Unexpected things happen and one picks up bit of information or has other items reinforced. For instance, I got to hear Dr. Chia talk for a few hours at dinner. What a pleasure this was! I got to watch him “interrogate” a patient advocate about their patient. Dr. Chia seeks out particular symptoms and circumstances that occur at the onset of the illness. It is a bit like 19th century medicine - but CFS/Me is a 19th century disease. And this form of questioning yields answers for Dr. Chia.
I have been inclined towards Dr. Chia since I first heard him speak. He has a forthright, unadorned quality that is makes you pay attention. Dr. Chia has worked in the trenches for twenty or more years, learning about this illness the hard way, and developing his own resources to maintain and increase his research. Dr. Chia is definitely onto something “specific” - in a field where so much is elusive and speculative. If I were going to give a newcomer to this field a bit of advice (and I do not have a whole lot to give) I would recommend learning about Dr. Chia, his testing and his treatment. It is a good bet, and perhaps you will get lucky.
At another point, I got to hear Dr. Cheney give an informal mini-lecture on parts of his protocol: artusenate, minocycline, wormwood, and cell signaling factors. In regards to this last item Dr. Cheney related his enthusiasm about a new gel that he has made from afterbirth material. Citing studies on hamsters, Cheney described a process where non-stem cell material is extracted from stem cells and injected back into the hamsters, curing them as if it were stem cells. Dr. Cheney has made a similar gel from human afterbirth that gets a very strong reaction on his Echo machine, much stronger than any existing CSF. He is very excited about this.
I observed several individuals from the WPI doing their presentations and establishing connections. I can assure you that the announcement of the demise of the WPI is premature. They are moving faster than ever. The WPI is on a trajectory that will leave its critics in the dust. While others quibble over this and that, and lay traps to distract them, the WPI are putting all that aside and focusing on the task at hand. More specific and accurate testing is close at hand, as is means to track improvement in patient’s immune status, as well as clinical trials using various existing anti-retroviral drugs. Peptide T is still in the picture. (Another non-WPI source indicates that GCMAF might be a player.) (Time will tell in all this and the nay-sayers have put great effort into trying to cut off the funding and grants for the WPI. In this they have been somewhat successful, leaving it to the rest of us to do what we can to increase funding for this important scientific research.)
The WPI is in the process of projecting and clarifying their mission and of making collaborative connections with the international community in a manner that has never been seen before in this disease.
Needless to say, this was a great conference.
Christopher Cairns
Saturday, March 27, 2010
Setting the table
The job of the Patient Advocate is to “remain objective” - and to try to keep the big picture in mind. This is difficult - as CFS/ME is a disease of many small and seemingly disconnected parts. The PA has to juggle and consider all the elements, and to try to not let parts drift off unattended. I have tried to delineate these separate parts of this illness (as I see them) in other blog posts.
The disease of CFS/ME itself is known to fluctuate or “cycle” – often for unknown reasons. The patient can get better or worse without any clear explanation. However, occasionally things can get out of whack for a particular reason. This can be because of slippage and forgetting the maintenance.
Many supplements and drugs are suggested for the treatment of CFS/ME. The Patient Advocate tries to prioritize them. The PA spends a lot of time reading about various medicines and supplements. The PA’s ideas should not be taken as medical advice - as the Patient Advocate has no training in this area.
A few years back Dr. Paul Cheney offered his priorities for treatment. These suggestions were made prior to his more recent treatment modalities, However, all of these suggestions remain in his protocol - except for Nexavir, which has been replaced by a more complicated set of bison cell signalling factors. Dr. Cheney’s “key item” list includes:
Magnesium (non-oral) [SQ or Paste],
Klonopin 0.5 mg,
Hydroxycobalamin (by injection) @ high dose,
Isoprinosine,
Kutapressin (aka Nexavir)
Nancy Klimas also likes Isoprinosine, and looks forward to the results of a phase two trial that will never be forthcoming. She also points out that several supplements have small study track records of showing benefit to CFSers: Omega 3, Co-Q and Vitamin D, among others.
Here are some of the items that this Patient Advocate tries to keep an eye on, items that he feels can make a difference:
1. It is important, early on, to determine if the patient has Hashimoto’s thyroiditis. This autoimmune or viral attack on the thyroid is easy to diagnose – high TSH, high TPO antibodies, goiter, long list of symptoms. Hashimoto’s thyroiditis is eminently treatable, perhaps the most treatable disease in the world with one of the oldest “modern” medications. Treating this illness does take some time, and there is some uncertainty to doing it properly. Treatment includes dietary changes, supplements (Iodine, selenium) and thyroid hormone, either synthetic or natural. Treatment is for life. Benefit comes within 3-24 months on being stabilized on thyroid hormone at the correct dosage.
2. It is necessary to support the adrenals during thyroid hormone supplementation, particularly at the beginning. There are various ways to support the adrenals. These include low dose hydrocortisol, adaptogens, live cell therapy, salt and water, licorice and so forth. A poorly functioning or under functioning thyroid drags down the adrenals, so thyroid and adrenal problems go hand in hand. Taking thyroid hormone to stabilize the thyroid also stresses the adrenals - so attention has to be paid to support of the adrenal glands.
3. Magnesium is key to over 400 regulations in the body. Hence its importance. Magnesium is often low in CFS/ME patients. It is difficult to raise magnesium with oral supplements, although some oral supplements are better than others – magnesium glycinate, for instance, is more absorbable. Dr. John McClaren Howard’s testing at Acumen can determine if the patient has magnesium deficiency, thus precipitating low production of ATP in the mitochondria. Once the magnesium deficiency is realized, it can be treated. Dr. Myhill says that magnesium can be raised with daily (or every other day) low- dose (0.5 cc) sub-Q magnesium injections. Over time, magnesium levels can be raised and benefit derived from doing this. Taurine or lidocaine can be included in the injection to make it less painful. More than likely the injections have to be continued on a maintenance basis to keep the magnesium from depleting again. There seems to be something endemic to CFS regarding magnesium depletion, as if the disease itself precipitates a lowering of intracellular magnesium. Many drugs or supplements can also cause depletion of magnesium. The possibility of antibiotics or antivirals acting as a magnesium drain is very real. Magnesium has to be considered on an ongoing basis as long as the patient has the disease. It is not like you treat a little and then “get beyond” the supplementation. This is true of many things – co-Q. b12, carnitine, glutathione, omega 3, for instance, all need support.
4. It is important to keep an eye on Iron levels. Iron also tends to be low in CFS/ME patients. Low iron has a host of symptoms, many of which mimic low magnesium. Low iron is associated with a host of symptoms including photophobia, sleep irregularities, RLS, and muscle pain. Low iron can be difficult to raise. Supplements do not seem to raise iron easily - and it often takes a long time. Iron cream, a prescription item from Hopewell Pharmacy in NJ, is more effective in raising iron over time. Regular blood levels of iron and ferritin need to be measured in order to determine levels - and the effect of various forms of supplementation. Often iron injections are necessary to raise iron. Low ferritin is associated with thyroid dysfunction and balancing the thyroid function necessitates getting ferritin levels up into the mid-normal range.
5. Vitamin D is another element that is predictably low in CFS/ME patients. Again no one knows why this is. Vitamin D can be supplemented and the number can be raised over time. Often this involves daily supplement in the low thousands of I.E. Ten minutes daily in the summer sun can raise stores of vitamin D and it is important to build the vitamin D in this way if it is possible.
6. Nexavir is a cell signaling factor or peptide from pig’s liver. It is believed to be an immune shifter and to work in good percentage of patients. It comes in an injectable form or a gel, applied once a day. Patients complain about the smell of the gel but it is nothing. Doctors as diverse as Cheney, Guyer, de Meirleir, Enlander and Levine will prescribe Nexavir. Nexavir needs to be taken for six months or longer to determine effect. Nexavir is very expensive and is not covered by insurance.
7. My most recent favorite supplement is curcumin. Many small studies have been made of this Indian spice and the supplement has a modest but growing track record of lowering cholesterol, increasing good cholesterol and cutting inflammation, especially in the eyes. There are two curcurmin supplements that contend with one another for being the best or most absorbable – Meriva and nutravine longvida.
Through supplementation the patient can raise their vitamin D, iron, magnesium and fix their thyroid. Raising each of these items has to be seen in the larger context of strengthening the immune system. Improvement is often subliminal and not immediately obvious. In addition it is possible to raise b12 through sublingual or injection, carnitine, and co-Q-10, equally important in various instances as the above numbered items. More problematic is the raising of the anti-oxidant glutathione, which needs a more sophisticated set of supplements proposed by Rich van Konynenburg, information of which is readily available on the internet. (I need to write an entry on methylation supplementation and the glutathione blockage, which is so important as a treatment modality) Supplementation to increase gut ecology is also dicey and everyone is on their own in this complex nightmare to regulate the gut and make it work correctly – although again there are some broad parameters that can be learnt by the neophyte like myself.
The disease of CFS/ME itself is known to fluctuate or “cycle” – often for unknown reasons. The patient can get better or worse without any clear explanation. However, occasionally things can get out of whack for a particular reason. This can be because of slippage and forgetting the maintenance.
Many supplements and drugs are suggested for the treatment of CFS/ME. The Patient Advocate tries to prioritize them. The PA spends a lot of time reading about various medicines and supplements. The PA’s ideas should not be taken as medical advice - as the Patient Advocate has no training in this area.
A few years back Dr. Paul Cheney offered his priorities for treatment. These suggestions were made prior to his more recent treatment modalities, However, all of these suggestions remain in his protocol - except for Nexavir, which has been replaced by a more complicated set of bison cell signalling factors. Dr. Cheney’s “key item” list includes:
Magnesium (non-oral) [SQ or Paste],
Klonopin 0.5 mg,
Hydroxycobalamin (by injection) @ high dose,
Isoprinosine,
Kutapressin (aka Nexavir)
Nancy Klimas also likes Isoprinosine, and looks forward to the results of a phase two trial that will never be forthcoming. She also points out that several supplements have small study track records of showing benefit to CFSers: Omega 3, Co-Q and Vitamin D, among others.
Here are some of the items that this Patient Advocate tries to keep an eye on, items that he feels can make a difference:
1. It is important, early on, to determine if the patient has Hashimoto’s thyroiditis. This autoimmune or viral attack on the thyroid is easy to diagnose – high TSH, high TPO antibodies, goiter, long list of symptoms. Hashimoto’s thyroiditis is eminently treatable, perhaps the most treatable disease in the world with one of the oldest “modern” medications. Treating this illness does take some time, and there is some uncertainty to doing it properly. Treatment includes dietary changes, supplements (Iodine, selenium) and thyroid hormone, either synthetic or natural. Treatment is for life. Benefit comes within 3-24 months on being stabilized on thyroid hormone at the correct dosage.
2. It is necessary to support the adrenals during thyroid hormone supplementation, particularly at the beginning. There are various ways to support the adrenals. These include low dose hydrocortisol, adaptogens, live cell therapy, salt and water, licorice and so forth. A poorly functioning or under functioning thyroid drags down the adrenals, so thyroid and adrenal problems go hand in hand. Taking thyroid hormone to stabilize the thyroid also stresses the adrenals - so attention has to be paid to support of the adrenal glands.
3. Magnesium is key to over 400 regulations in the body. Hence its importance. Magnesium is often low in CFS/ME patients. It is difficult to raise magnesium with oral supplements, although some oral supplements are better than others – magnesium glycinate, for instance, is more absorbable. Dr. John McClaren Howard’s testing at Acumen can determine if the patient has magnesium deficiency, thus precipitating low production of ATP in the mitochondria. Once the magnesium deficiency is realized, it can be treated. Dr. Myhill says that magnesium can be raised with daily (or every other day) low- dose (0.5 cc) sub-Q magnesium injections. Over time, magnesium levels can be raised and benefit derived from doing this. Taurine or lidocaine can be included in the injection to make it less painful. More than likely the injections have to be continued on a maintenance basis to keep the magnesium from depleting again. There seems to be something endemic to CFS regarding magnesium depletion, as if the disease itself precipitates a lowering of intracellular magnesium. Many drugs or supplements can also cause depletion of magnesium. The possibility of antibiotics or antivirals acting as a magnesium drain is very real. Magnesium has to be considered on an ongoing basis as long as the patient has the disease. It is not like you treat a little and then “get beyond” the supplementation. This is true of many things – co-Q. b12, carnitine, glutathione, omega 3, for instance, all need support.
4. It is important to keep an eye on Iron levels. Iron also tends to be low in CFS/ME patients. Low iron has a host of symptoms, many of which mimic low magnesium. Low iron is associated with a host of symptoms including photophobia, sleep irregularities, RLS, and muscle pain. Low iron can be difficult to raise. Supplements do not seem to raise iron easily - and it often takes a long time. Iron cream, a prescription item from Hopewell Pharmacy in NJ, is more effective in raising iron over time. Regular blood levels of iron and ferritin need to be measured in order to determine levels - and the effect of various forms of supplementation. Often iron injections are necessary to raise iron. Low ferritin is associated with thyroid dysfunction and balancing the thyroid function necessitates getting ferritin levels up into the mid-normal range.
5. Vitamin D is another element that is predictably low in CFS/ME patients. Again no one knows why this is. Vitamin D can be supplemented and the number can be raised over time. Often this involves daily supplement in the low thousands of I.E. Ten minutes daily in the summer sun can raise stores of vitamin D and it is important to build the vitamin D in this way if it is possible.
6. Nexavir is a cell signaling factor or peptide from pig’s liver. It is believed to be an immune shifter and to work in good percentage of patients. It comes in an injectable form or a gel, applied once a day. Patients complain about the smell of the gel but it is nothing. Doctors as diverse as Cheney, Guyer, de Meirleir, Enlander and Levine will prescribe Nexavir. Nexavir needs to be taken for six months or longer to determine effect. Nexavir is very expensive and is not covered by insurance.
7. My most recent favorite supplement is curcumin. Many small studies have been made of this Indian spice and the supplement has a modest but growing track record of lowering cholesterol, increasing good cholesterol and cutting inflammation, especially in the eyes. There are two curcurmin supplements that contend with one another for being the best or most absorbable – Meriva and nutravine longvida.
Through supplementation the patient can raise their vitamin D, iron, magnesium and fix their thyroid. Raising each of these items has to be seen in the larger context of strengthening the immune system. Improvement is often subliminal and not immediately obvious. In addition it is possible to raise b12 through sublingual or injection, carnitine, and co-Q-10, equally important in various instances as the above numbered items. More problematic is the raising of the anti-oxidant glutathione, which needs a more sophisticated set of supplements proposed by Rich van Konynenburg, information of which is readily available on the internet. (I need to write an entry on methylation supplementation and the glutathione blockage, which is so important as a treatment modality) Supplementation to increase gut ecology is also dicey and everyone is on their own in this complex nightmare to regulate the gut and make it work correctly – although again there are some broad parameters that can be learnt by the neophyte like myself.
Thursday, February 18, 2010
Focus on Dr. John Chia, Researcher
The Patient Advocate wants to write about Dr. John Chia. Dr. Chia is an infectious disease specialist who worked on EBV for many years. He got involved in CFS/ME by happenstance. His son Andrew came down with an unknown illness just as Dr. Chia was becoming interested in enteroviruses. Dr. Chia connected the dots, solved his son's illness, and reforged a connection between CFS/ME and enteroviruses.
The Patient Advocate first saw Dr. Chia in Fort Lauderdale in 2007. Subsequently the PA has seen Dr. Chia give lectures at the Invest in ME conferences in London in May of 2008 and 2009 and also in Baltimore at the HHV6 conference in June 2008. The first two lectures can be purchased on DVDs from the Invest in ME group and the Baltimore lecture in on the internet here.
Dr. Chia will give another presentation in London in May 2010.
Dr. Chia believes that enteroviruses are involved in CFS/ME. He takes stomach biopsies from his patients and controls and stains them to identify enteroviruses. These viruses included Coxsackie B (1-6) and 32 different Echoviruses. Dr. Chia finds enteroviral involvement in 82% of his CFS patients and 20% of his controls. The study can be read here.
Dr Chia does not claim originality in this study. Instead he builds on a forgoteen but establish legacy of research in the UK, particularly of John Richardson (d.2003.) Coxsackie and other enterovirus were on the front lines of CFS/ME research until they faded from the picture for a variety of reasons. Such are the ways of science, especially in CFS/ME research. Dr. Chia, with his research, has brought enterovirus back into to picture.
Dr. Chia ultimately identified enteroviral presence through stomach biopsies, which proved that these viruses continue to live in the gut ecology. This flies into the face of the idea that enteroviruses are hit and run viruses.
Dr. Chia discovered an antibody test for Coxsackie and Echoviruses that is more specific than other labs. By serendipity, a sample from Dr. Chia’s office ended up in ARUP lab in Salt Lake City - and the results came back quite positive. Upon investigation, Dr. Chia discovered that this ARUP lab does a test that is more specific than other labs. This ARUP test reports antibody levels of Coxsackie B 1-6 and 5 of the 32 Echoviruses. An elevation of 1:320 (1:32) is considered to be significant., especially for b4. The number of the ARUP tests are:
0060055 Coxsackie antibodies by neutralization
0060053 echo virus antibodies by neutralization
If a patient is unable to get a stomach biopsy, the key is to get an antibodies test at ARUP.
My patient did tests at Focus labs and ARUP at the same time. Here are the results:
October 2009, at Focus Diagnostics
b1 1:16
b2 <1:8
b3 1:16
b4 1:16
b5 1:8
b6 1:8
October 2009, at ARUP labs
b1 <1:10
b2 1:320
b3 1:80
b4 >1:640
b5 1:10
b6 <1:10
Dr. Chia would consider the elevated Coxsackie b2 and b4 from the ARUP lab to be significant. The significance of this is heightened by the fact that the b4 is sustained at 1:640 in seven tests over a four year period.
Is there enteroviral involvement here and what is the treatment?
So far, Dr. Chia has been able to prove the existence of enteroviruses in the gut of his patients. This is a surprise to the CFS/ME community as most people had no clue about this. It took Dr. Chia’s individual thinking and persistence to look in this direction. Dr. Chia is aided in his research by his son and his wife. He introduces his lecture by saying that instead of going out to dinner, he, his wife and his son go to the lab. Dr. Chia speculates that if enteroviruses are in the gut, then they could be in the heart, the thyroid, the pancreas, and the brain. Proving the existence of enterovirus in tissue is a big deal - but it does not establish that it is the cause of the CFS/ME. Further research will perhaps elucidate the involvement.
In the meantime, Dr. Chia assumes that enteroviruses are a cause of CFS/ME in a large proportion of his cases. At the moment the treatments for enteroviruses are limited. Initially Dr .Chia gave a number of patients interferon, but he has stopped doing that because of toxicity problems and relapses after treatment. In the past few years, having stopped interferon treatments, Dr. Chia is using various Chinese medicines. He first used Matrine, which was literally difficult for patients to stomach. More recently he has been giving his patients Oxymatrine. Dr. Chia says that 53% of patients show betterment on Oxymatrine and a slightly higher percentage if they have Coxsackie B2 and B4. He recommends that Oxymatrine be started slowly and titrated up to a dosage level of 4-6 tablets a day. The patient can determine whether the Oxymatrine is effective with three months of treatment. The treatment is stopped if it does not bring betterment in this time period.
Dr. Chia imported the oxymatrine from China but worried about impurities. in the last few months he is making his own in the USA, a formula made conforming to FDA regulations and considered to be safe. There are some suspicious souls who feel that Dr. Chia has invented all this enteroviral CFS in order to sell his own supplements and this, of course, is a fantastic joke. Dr. Chia is one serious scientist and doctor, who strives mightily to bring clarity to a subsection of CFS/ME. It is anyone’s guess how large this subset really is. Cort Johnson’s linchpin site has more information on Oxymartrine here. The HHV6 Foundation has a patient forum with some discussion of Oxymatrine use.
Cort Johnson’s excellent site has two in depth interviews with Dr. Chia here and here.
The strangest aspect to this situation is that Dr. Chia makes uncertain headway in this world of CFS/ME. Somehow in this vague and confusing world of diagnosis and treatment of CFS/ME his ideas are a little to specific and scientifically proven. The world of CFS prefers to clamor towards unproven claims of the magic bullet – XMRV* for instance – putting aside serious research that stares at us right in the face. For instance, Dr. Chia applied for funding from a recognized CFS/ME organization to study the effect of Oxymatrine on CFS/ME patients, but was denied funding.
A noticeable exception to a general level of indifference towards Dr. Chia is his reception in the UK, where he has been invited to give lectures for three years running. It will be worthwhile keeping an eye on his research as Dr. Chia is really onto something and does not seem to want to be interrupted in his headlong effort to solve part of this illness. The unfortunate part of this situation is that with the clear indentfication of a potential cause of CFS/ME no funding is available to develop anti-enterovial drugs. Dr. Chia says it will be ten years before such drugs will be forthcoming. This is a long time to wait.
Dr.Chia is on the board of the Enterovirus Foundation which can be found here.
*This is not to say that XMRV research is not important. It obviously is tremendously important and bears following very closely. However since October 9th, the CFS/ME community has gone haywire over the possibilities of diagnosis and treatment for XMRV. It is ironic, in this environment, that doctors and researchers are not paying more attention to the longstanding enteroviral involvement with CFS/ME. It might be worthwhile to take a step backwards and look once again at the possibility that enterovirus are heavily involved in CFS/ME, with or without XMRV.
Tuesday, February 16, 2010
Gut treatment using the Metametrix GI Effects test
Many doctors, including Peterson, Cheney, Guyer, Myhill and de Meirleir advocate working on the gut and trying to get it into balance. This is not an easy enterprise. De Meirleir says that it takes months to redress the grievances of a dysfunctional gut. This is a slow rebuilding process and it takes time.
Dietary changes have been seen as essential to bringing the gut into line, particularly changes that involve avoidance or elimination. Many items need to be restricted or given up, depending on the specifics of the patient. Often this will involve cutting out white flour, sugar, caffeine, soy, dairy, wheat, tobacco, and alcohol. Adding fresh organic vegetables, low carbohydrates and lean meats along with bottled water is seen as a step in the right direction Many people do not want to constrict themselves in this way and make these substitutions, as they are already giving up so much with this disease. It takes a special type of patient to do this - especially as the results are not immediately or readily apparent.
One of the chief weapons in trying to control and alter the gut is the diagnostic stool analysis (CDSA). In the US, stool tests are done by Metametrix, Genovas, and Diagnostechs. In Europe the chief test is the fecal microbial analysis at RedLabs BE. Each of these tests have their particular advantages, which the reader can explore. Dr. Guyer uses the Metametrix. Dr. Vrchota uses Genovas. Rich van Konynenburg recommends the Diagnostechs. My patient has been using the Metametrix test for the past three years.
The first set of items - Predominant Bacteria (Obligate anaerobes and Facultative anaerobes) – are an important set of markers of the health of the immune system. “They provide colonization resistance against potentially pathogenic organisms, aid in digestion and absorption, produce vitamins and SCFA’s and stimulate the GI immune system.” Dr. Guyer says that these items should be on the right of the graph. If the little dots are to the left, this indicates that the item is low, and that it needs to be raised. Unfortunately, there is nothing that can be directly done to elevate these items or to bring them into a more normal range.
Bacteroides sp. along with Bifidobacteria sp. should be highest. The information about Clostridia sp., Prevotella sp. and Mycoplasma sp. is confusing, to say the least. Prevotella is one of the three bad boys that shows up on de Meirleir’s list, along with Enterococcus and Streptococcus. Prevotella can be lowered by taking oxbile or Creon (suggested by de Meirleir). Oxbile can be supplemented by itself, or as part of a pancreatic enzyme such as GNDL digestive Enzyme.
Two items that are key to good gut ecology are Lactobacillus and Bifidobacter. These two items are often very low in CFS patients. A low number of these two is a good indicator that the bad boys are in control. The patient can attempt to raise these items with Probiotics. There are many Probiotics available on the market. Some are seen as better than others. Treatment has to be personalized, and trial and error comes into play.
VSL #3 is seen as a quite good and well-researched probiotic. It is ordered on the internet. Culturelle, available in grocery stores and pharmacies, is also well researched, and has the advantage of being D-Lactate free. D-Lactate producing Lactobacillus and Bifidobacter probiotics are seen as a problem for CFS patients. Custom Probiotics makes a D-Lactate free combination of Lacto and Bifido. Harry, who runs Custom Probiotics, seems happy to talk about the advantages of his products, which he has designed himself. Mutaflor makes a probiotic that is seen as providing great benefit. This product can be purchased in Germany and shipped to America. De Meirleir and Cheney both use this product. Recently, Dr. Alan Logan on Cort Johnson’s most valuable site, has been promoting Align, a bifidobacterial probiotic. Align has a small amount of sugar in it, and is also D-Lactate free. Dr. Guyer recommends Allergy Research’s Russian Immune for boosting the immune system.
There is continuing research into various probiotics and their relationship to particular illnesses and to health in general. For instance. there is a probiotic in development that supposedly eats oxalates, for those of you that have that particular problem.
So it would be prudent to keep reading about probiotic research and keep in mind that it might also be useful to rotate probiotics.
One recipe for making gut ecology improvement might be this:
GNDL digestive Enzyme
Custom Probiotics, D-lactate free
Culturelle GG
Mutaflor
Russian Immune
Symbiotics Colostrum
Align
Glutagenics
Opportunistic Bacteria emerge for various reasons: lowered immunity, poor diet, parasites and so forth. Among these bacteria are Klebisella sp. and Citrobacter sp. They are identified and dealt with directly with anti-microbials or herbs.
Pathogenic Bacteria come next and include four items, including helicobacter pylori.
The Yeast/Fungi section will report on Candida. Candida is reported on the intensity of its presence, with various stages being indicated. Candida seems to plague CFS/ME patients. (Some people think candida is a cause of some CFS/ME.) Candida can be dealt with in several ways. The first way is through an anti-Candida, low-glycemic index, hypoglycemic diet. Information on this diet can be found is various places on the internet. Dr. St. Amand’s recommendations are particularly valuable. High candida can also be attacked by prescription drugs Nystatin and Diflucan - but the treatments often need to be repeated. Diet needs to be dealt with in a stringent fashion, and probiotics used to increase the proportion of good bacteria.
The Metametrix test identifies parasites in the gut. These can range from Hookworm and pinworms to a host of other parasites. Specific identification allows for specific treatments. Some of the most common parasites are listed in the Metametrix interpretative guide.
Adiposity index elevation is associated increased caloric extraction from food, whatever that means.
Beneficial SCFA (short chain fatty acids) are seen as wanting to be up in the normal range. “Production of SCFA in the intestinal lumen plays an important role in the maintenance of the intestinal barrier.” Low total SCFA and low n-Butyrate are seen as not being good. “Presence of short chain fatty acids and n-butyrate are essential for the health of the colon. In general, high normal levels of these could mean that there is an optimal fiber intake and a balanced bacterial population.”
These items are signs of intestinal health if they are present in the mid to upper normal range. Butyrate can be supplemented.
Propionate invites further questions for CFS/ME patients. Dr. Alan Logan wrote this: “Writing in the journal Physiology and Behavior (2004), these researchers showed that intestinal lactic acid, both L-lactate and D-lactate, as well as another potentially brain toxic fermentation product called propionate, were all involved in the behavioral disturbances.” So the picture with propionate is confusing.
Lactoferrin is a marker for gut inflammation and need to be treated if present.
Under Immunology, Fecal sigA is low - due to stress or high - resulting from immune response. Anti-gliaden sigA elevation is associated with gluten sensitivity.
Additional tests are self-descriptive and include ph, which seems to want neither to be too low or too high.
Digestion includes Elastase 1, which should be over 500. Low elastase 1 is associated with pancreatic insufficiency. High Triglycerides indicate malabsorption, and are high digestive fibers.
The last category is Absorption.
This Metametrix test provides a great deal of information. Much is known about the gut, but much is unknown. It is beginning to dawn on doctors that the gut might have something to do with immune function and chronic illness. In this Patient Advocates estimation, certain parts of the test are more important than others, particularly since there are treatments that can bring improvement. Certainly identifying pathogens, high enterococcus, high streptococcus, high prevotella, inflammation, low good bacteria can all point towards various treatments, diet, pharmaceuticals, probiotics, and herbs, that can bring improvement to the gut ecology.
And then there is the idea about biofilms that fills the CFS forums these days. What effect biofilms have on gut ecology is another story for another day.
Comments, corrections, suggestions, additions, and/or clarifications are welcome.
Dietary changes have been seen as essential to bringing the gut into line, particularly changes that involve avoidance or elimination. Many items need to be restricted or given up, depending on the specifics of the patient. Often this will involve cutting out white flour, sugar, caffeine, soy, dairy, wheat, tobacco, and alcohol. Adding fresh organic vegetables, low carbohydrates and lean meats along with bottled water is seen as a step in the right direction Many people do not want to constrict themselves in this way and make these substitutions, as they are already giving up so much with this disease. It takes a special type of patient to do this - especially as the results are not immediately or readily apparent.
One of the chief weapons in trying to control and alter the gut is the diagnostic stool analysis (CDSA). In the US, stool tests are done by Metametrix, Genovas, and Diagnostechs. In Europe the chief test is the fecal microbial analysis at RedLabs BE. Each of these tests have their particular advantages, which the reader can explore. Dr. Guyer uses the Metametrix. Dr. Vrchota uses Genovas. Rich van Konynenburg recommends the Diagnostechs. My patient has been using the Metametrix test for the past three years.
The first set of items - Predominant Bacteria (Obligate anaerobes and Facultative anaerobes) – are an important set of markers of the health of the immune system. “They provide colonization resistance against potentially pathogenic organisms, aid in digestion and absorption, produce vitamins and SCFA’s and stimulate the GI immune system.” Dr. Guyer says that these items should be on the right of the graph. If the little dots are to the left, this indicates that the item is low, and that it needs to be raised. Unfortunately, there is nothing that can be directly done to elevate these items or to bring them into a more normal range.
Bacteroides sp. along with Bifidobacteria sp. should be highest. The information about Clostridia sp., Prevotella sp. and Mycoplasma sp. is confusing, to say the least. Prevotella is one of the three bad boys that shows up on de Meirleir’s list, along with Enterococcus and Streptococcus. Prevotella can be lowered by taking oxbile or Creon (suggested by de Meirleir). Oxbile can be supplemented by itself, or as part of a pancreatic enzyme such as GNDL digestive Enzyme.
Two items that are key to good gut ecology are Lactobacillus and Bifidobacter. These two items are often very low in CFS patients. A low number of these two is a good indicator that the bad boys are in control. The patient can attempt to raise these items with Probiotics. There are many Probiotics available on the market. Some are seen as better than others. Treatment has to be personalized, and trial and error comes into play.
VSL #3 is seen as a quite good and well-researched probiotic. It is ordered on the internet. Culturelle, available in grocery stores and pharmacies, is also well researched, and has the advantage of being D-Lactate free. D-Lactate producing Lactobacillus and Bifidobacter probiotics are seen as a problem for CFS patients. Custom Probiotics makes a D-Lactate free combination of Lacto and Bifido. Harry, who runs Custom Probiotics, seems happy to talk about the advantages of his products, which he has designed himself. Mutaflor makes a probiotic that is seen as providing great benefit. This product can be purchased in Germany and shipped to America. De Meirleir and Cheney both use this product. Recently, Dr. Alan Logan on Cort Johnson’s most valuable site, has been promoting Align, a bifidobacterial probiotic. Align has a small amount of sugar in it, and is also D-Lactate free. Dr. Guyer recommends Allergy Research’s Russian Immune for boosting the immune system.
There is continuing research into various probiotics and their relationship to particular illnesses and to health in general. For instance. there is a probiotic in development that supposedly eats oxalates, for those of you that have that particular problem.
So it would be prudent to keep reading about probiotic research and keep in mind that it might also be useful to rotate probiotics.
One recipe for making gut ecology improvement might be this:
GNDL digestive Enzyme
Custom Probiotics, D-lactate free
Culturelle GG
Mutaflor
Russian Immune
Symbiotics Colostrum
Align
Glutagenics
Opportunistic Bacteria emerge for various reasons: lowered immunity, poor diet, parasites and so forth. Among these bacteria are Klebisella sp. and Citrobacter sp. They are identified and dealt with directly with anti-microbials or herbs.
Pathogenic Bacteria come next and include four items, including helicobacter pylori.
The Yeast/Fungi section will report on Candida. Candida is reported on the intensity of its presence, with various stages being indicated. Candida seems to plague CFS/ME patients. (Some people think candida is a cause of some CFS/ME.) Candida can be dealt with in several ways. The first way is through an anti-Candida, low-glycemic index, hypoglycemic diet. Information on this diet can be found is various places on the internet. Dr. St. Amand’s recommendations are particularly valuable. High candida can also be attacked by prescription drugs Nystatin and Diflucan - but the treatments often need to be repeated. Diet needs to be dealt with in a stringent fashion, and probiotics used to increase the proportion of good bacteria.
The Metametrix test identifies parasites in the gut. These can range from Hookworm and pinworms to a host of other parasites. Specific identification allows for specific treatments. Some of the most common parasites are listed in the Metametrix interpretative guide.
Adiposity index elevation is associated increased caloric extraction from food, whatever that means.
Beneficial SCFA (short chain fatty acids) are seen as wanting to be up in the normal range. “Production of SCFA in the intestinal lumen plays an important role in the maintenance of the intestinal barrier.” Low total SCFA and low n-Butyrate are seen as not being good. “Presence of short chain fatty acids and n-butyrate are essential for the health of the colon. In general, high normal levels of these could mean that there is an optimal fiber intake and a balanced bacterial population.”
These items are signs of intestinal health if they are present in the mid to upper normal range. Butyrate can be supplemented.
Propionate invites further questions for CFS/ME patients. Dr. Alan Logan wrote this: “Writing in the journal Physiology and Behavior (2004), these researchers showed that intestinal lactic acid, both L-lactate and D-lactate, as well as another potentially brain toxic fermentation product called propionate, were all involved in the behavioral disturbances.” So the picture with propionate is confusing.
Lactoferrin is a marker for gut inflammation and need to be treated if present.
Under Immunology, Fecal sigA is low - due to stress or high - resulting from immune response. Anti-gliaden sigA elevation is associated with gluten sensitivity.
Additional tests are self-descriptive and include ph, which seems to want neither to be too low or too high.
Digestion includes Elastase 1, which should be over 500. Low elastase 1 is associated with pancreatic insufficiency. High Triglycerides indicate malabsorption, and are high digestive fibers.
The last category is Absorption.
This Metametrix test provides a great deal of information. Much is known about the gut, but much is unknown. It is beginning to dawn on doctors that the gut might have something to do with immune function and chronic illness. In this Patient Advocates estimation, certain parts of the test are more important than others, particularly since there are treatments that can bring improvement. Certainly identifying pathogens, high enterococcus, high streptococcus, high prevotella, inflammation, low good bacteria can all point towards various treatments, diet, pharmaceuticals, probiotics, and herbs, that can bring improvement to the gut ecology.
And then there is the idea about biofilms that fills the CFS forums these days. What effect biofilms have on gut ecology is another story for another day.
Comments, corrections, suggestions, additions, and/or clarifications are welcome.
Wednesday, December 2, 2009
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 get their feet off the ground this time. Ampligen is finished.
There is intention here - laser-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
There is intention here - laser-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
Wednesday, November 4, 2009
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 (see picture above) 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’s 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 were compared to patients with HIV and immunosuppressed transplant patients. The ImmuKnow test was assessed based on the amount of ATP expressed 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 Herpesvirus-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 CFS doctors using this test. It is an easy blood test and relatively cheap and fast - $180. Whether it is useful or not, is anyone's guess.
Subscribe to:
Comments (Atom)