All Fall Down For ME, 2:30 to 3PM, Sunday, May 12th, Westminster

To commemorate international ME/CFS Awareness Day, and to draw media attention to the plight of people suffering from ME/CFS, All Fall Down for M.E. is holding a lie-in across from the House of Commons in London, UK, on May 12, at 2:30 PM. All Fall Down for M.E. is a cross-charity event with no particular charity affiliations, although we particularly support those which promote and fund biomedical research

Disclaimer: Please note that everyone taking part in this event is responsible for their own safety and wellbeing; the organisers do not take responsibility. The police have been informed and since this is public land they have assured us we have the right to demonstrate here, they will support us and that there is no risk of arrest – unless someone does anything that is likely to endanger the health & safety of others.

While collapsed, we need to show that this is not enjoyable: the person with ME has to do this in order to survive/exist. We suggest you bring a black sheet/cloth/bin bag to cover your body to signify a living death. Please bring props such as eyemasks, sunglasses, ear defenders, possibly feeding tubes etc to convey:

The exhaustion to the point of collapse after minimal activity; the nerve, joint and muscle pain unresponsive to painkillers; the physical weakness; the cognitive dysfunction with thinking & memory problems; the inability to tolerate light and noise; the faintness & dizziness particularly when standing; nausea; rest or sleep bringing little or no relief; plus many other symptoms. This is what our loved ones have to suffer, day after day, after month, after year, with no end in sight. A living death.

Since Old Palace Yard is cobbled, you may also wish to bring something to lie on, but please make it as ‘dead-looking’ as possible i.e. no bright colours.

Please bring banners if you wish but think about who may hold them while you are lying on the ground. We plan to have those with banners at the back, with those collapsed on the ground in front of them. We plan to film & photograph the event from an angle that gives maximum impact to the sight of those collapsed on the ground, with the Houses of Parliament in the background.

Ideas for straplines: M.E – a living death, it could be YOU or your child. Biomedical Research urgent.

You may want to wear a sash or sign saying, for example: My son, M.E 6 years; my wife M.E 20 years; my Dad M.E …; my sister….and so on.

Our aims are: to raise awareness among the public and government about how severe & long-lasting M.E can be; how common it is; how it can strike healthy, happy individuals out of the blue, particularly our children and young people; and that we urgently need far more investment in biomedical research to discover cause(s), effective treatments and hopefully a cure – before it’s too late.We also need far better training for doctors etc. on the latest knowledge about M.E.

With this demonstration, as well as depicting the severity of the illness, we will be honouring those who have actually died from M.E. and also the courage of all those who continue to fight on in the hope of a living life.

THANK YOU!!

This weekend was a huge success! There were 3,946 free downloads of Chronic Fatigue Syndrome: A Treatment Guide, 2nd Edition, bringing the total number of free book downloads to 13,613!

There really are no words to describe how satisfying it is to be able to give away all these books. It is a great privilege to offer something tangible to the CFS/ME community, something that might help people find their way to recovery. I am also deeply honored that so many individuals and organizations have taken the time to support this effort by spreading the word via Facebook, their websites, blogs, on forums and boards, and by writing reviews. This is how "word-of-mouse" works in the modern world. It's a thing of beauty - and great power.

I know that if we can all come together to accomplish this minor miracle, we can join our hands to accomplish any goal we set our minds to.

Thank you all.

FREE on Saturday, April 20th and Sunday, April 21st - Chronic Fatigue Syndrome: A Treatment Guide, 2nd Edition

I am giving away free copies of the CFS Treatment Guide again. Please help me spread the word by posting the announcement below on Facebook, on your blog, on forums, or wherever you can. So far, I've given away over 9,000 copies.

Chronic Fatigue Syndrome: A Treatment Guide, 2^nd Edition will be free on Saturday, April 20th and Sunday, April 21^st on Amazon.com The book includes over 100 effective treatments, spanning the full range of pharmaceutical and complementary modalities, an in-depth discussion of symptoms with cross-referencing to appropriate treatments, the latest research into the causes and mechanisms of the illness, doctors' protocols, coping techniques, special sections for managing chemical sensitivities, dietary restrictions and the special needs of children, as well as extensive appendices covering resources, locations of doctors and clinics, local, national and international organizations, and internet ordering information. The book also features over 2600 useful links to further reading, research articles, and patient reviews.

Dr. Charles Lapp, director of the Hunter-Hopkins Center, calls this the book “every patient should have.”

A Kindle is not needed to read this book. Amazon provides free apps that allow eBooks to be read on computers, iPads, phones and other devices.

(Anybody from abroad who has problems downloading the book can simply contact me via the "contact us" tab and request a PDF or a .mobi (Kindle) file.)

For more information go HERE.

Vistide Effective in Treating Herpesvirus Infected Chronic Fatigue Syndrome (ME/CFS) Patients

Dr. Dan Peterson By Cort Johnson First published on Simmaron Neuroimmune Research Foundation. April 9, 2013 as "Report from Paris: Peterson Reports Antiviral (Vistide) Effective in Treating Herpesvirus Infected Chronic Fatigue Syndrome (ME/CFS) Patients" “These results show objective endpoints, subset selection, and recovery. There were complete responders and partial responders among severely ill CFS patients with HHV6 or CMV. These are encouraging results for this subset and further well-designed trials should be pursued to confirm them.” Dr. Dan Peterson. At the HHV6 Conference in Paris, France today Dr. Peterson reported on the results of a retrospective study following 65 severely ill chronic fatigue syndrome patients given a course of Vistide from 2005-2012 for HHV6 and/or HCMV infections. Despite the interest in pathogens in ME/CFS, antiviral studies are rare and this is the first one reported for this drug. Vistide (Cidofovir) gets a lot less press than other antivirals and immunomodulators (Ampligen, Rituximab, Valcyte, Valtrex) used in this disorder probably because the drug requires a  complex infusion protocol, frequent blood tests because of the rare but real possibility of  serious kidney side effects, and is expensive  (although it can be covered by insurance). This combination – infusions, frequent blood tests and expense – requires close physician follow-up. With Dr. Peterson’s specialized focus on patients with dysfunctional natural killer cells, however, he may be most consistent about testing for herpesviruses, which are known to be active in ME/CFS patients. After three decades of focusing on immunologically challenged ME/CFS patients, Peterson may be more experienced at pathogen detection and treatment than any other practitioner in the field, and so it’s not surprising to find the first Vistide study coming from his office.  In an interview, a former patient of his said, ‘he leaves no stones unturned’; when he finds something he goes after it ‘aggressively’. In his presentation he stated almost 30% of  his patients test positive for HHV-6 or human cytomegalovirus (HCMV) (PCR, rapid culture, antigenemia), and a whopping 50% test positive for Epstein-Barr virus (EBNA). Serious Drug For A Serious Illness Vistide (Cidofovir) is FDA approved for the treatment of cytomegalovirus (CMV) in patients with AIDS. (Cytomegalovirus is a member of the herpesvirus family.) and it’s been used off-label to treat  human papillomavirus, BHK virus, herpes simplex virus, vaccinia virus infections. The Black Box warning on Vistide speaks for itself: "Cases of acute renal failure resulting in dialysis and/or contributing to death have occurred with  few as one or two doses of Vistide. The “recommended dose, rate, frequency of Vistide injections must not be exceeded.” The Study A positive response was denoted by a negative pathogen test, improved fatigue and cognitive functioning determined by an interview with Dr. Peterson and  the patient’s self reports after the trial. Response Full Responders - Patients were deemed to be full responders if they were able to completely return to work or to work-related activities Partial Responders – demonstrated significant improvement of symptoms but were unable to return to work or work related activities. Non-Responders – Did not demonstrate any measurable improvement post-treatment Results Dr. Peterson reported that seventy percent of patients were full (able to return to work) or partial (significant increase in functionality) responders; a very high rate of success in a illness characterized by a poor response to treatments.  Only thirty percent of Vistide recipients did not have a significantly positive response to the drug. No serious side effects were seen; ironically the minor side effects seen were attributed to a drug, Probocenid, used to ensure Vistide was safe. It’s not clear what percentage of ME/CFS patients will test positive for HHV6 or cytomegalovirus in other practices but this type of response suggests the drug may be being under-used. With the FDA Stakeholder’s meeting  coming up in three weeks and the Chronic Fatigue Initiative’s pathogen discovery study results due to be published later this year, Dr. Peterson’s presentation is timely. (Unfortunately, Dr. Peterson was not invited to present at the FDA Stakeholder’s Meeting.) Dr. Peterson called for placebo-controlled, double-blinded multi-center studies that address Vistide’s efficacy, examine its effects on the immune system and study the mechanisms of increase in VO2 max scores in ME/CFS. Sample Cases Dr. Peterson reported on several cases, all of whom were men – something Dr. Peterson has said he likes to do to break up the notion that only women get this disorder. A 27-year-old college graduate  unable to work because of  constant flu-like symptoms, weakness and marked cognitive decline (math!) presented with low NK functioning, low VO2 max and HHV6 and cytomegalovirus infection. He was able to return to work after 24 weeks of bi-weekly infusions. His VO2 max on the exercise test went up went up 23%,  his NK cells a remarkable 400% and he tested negative for both viruses at the end of treatment. He had had ME/CFS for three years. A 54-year-old former high school teacher unable to work due to extreme fatigue, flu-like symptoms and cognitive problems severe enough to keep him from being able to grade his students papers presented with active HHV6 and cytomegalovirus infections and low NK cell functioning and VO2 max. He was able to return to work after 24 weeks of bi-weekly infusions. His VO2 max increased 47%, his NK function test went up 20% and he tested negative for both viruses. He had had ME/CFS for five years. The third patient had classic, acute onset ME/CFS which progressed to seizures. Both serum and cerebral spinal fluid tested positive for HHV6. At the end of the Cifodovir trial the viral load in his cerebral spinal fluid dropped from 3670 copies/ml to undetectable levels. Serum HHV6 was dramatically reduced (47,000 copies/ml to 3,000 copies/ml). Still symptomatic and experiencing cognitive problems, he was nonetheless able to return to work. Conclusions The retrospective study indicated Vistide (cifodovir) can have dramatic effects on functional capacity in HHV6 and/or HCMV infected ME/CFS patients. Increasing VO2 max appeared to be critical to increasing functionality as the partial responders did not increase their VO2 max while on Cifodovir. At the FDA Advisory Meeting for Ampligen Dr. Bateman noted that VO2 max test results probably were, given the exertional problems in ME/CFS, the most difficult to ‘move’ test result in this disorder. VO2 max levels in Dr. Peterson’s patients prior to Vistide administration were exceedingly low; they appeared to in the ‘very low’ range even for people for 65 years of age and older. Vistide moved those test results about 20% on average; leaving them still, it appeared, below normal but sufficient enough for a significant increase in functionality. A Vistide Example The VO2 max tests suggested most patients had not returned to full health and Dr. Peterson has said he knows of few complete recoveries. I interviewed a former patient of Dr. Peterson’s several years ago. Faced with the loss of his career and the ability to care financially for his family, Vistide turned out to be a godsend. Cut down by acute onset ME/CFS, his VO2 max score topped out at an unbelievably low 15 (which qualified him for heart disease) and he was a ’2′ out of 10 on his own energy scale (had trouble sitting up to eat). Within a month on Vistide he was at a ’4′; the next month he was a ’5′ and sleeping soundly for the first time since he’d gotten sick. The next month he was a ’7′ and his VO2 max tests had doubled to 28; still far below the 44 expected at his age, but an amazing increase, nevertheless. Three months later he was at ’90%’, back at work and able to do everything except exercise. CMX001 – The Future Vistide?  Dr. Peterson didn’t report on CMX001 in Paris, but sitting in the background of all this is a analogue of Vistide called CMX001 which appears to be a safer and more effective,  if not yet available, version of it. A 2012 review named CMX001 as one the ‘ten hot topics’ in antiviral research. Chimerix Pharmaceuticals modified Vistide so that it can easily be taken up into the  tissues. That means no need for infusions, no worries about kidney problem and according to Chimerix, dramatically increased effectiveness. CMX001 has been in development for  some time but just this March the FDA awarded the drug ‘fast track’ status for the prevention of cytomegalovirus infection.  Phase II trials are finished  and Phase III trials will get underway this year. Given Dr. Peterson’s success with Vistide, FDA approval of CMX001 could be very good news for ME/CFS patients with HHV6, HCMV and/or possibly EBV infections. Wrap Up In a retrospective study Vistide proved to be effective in treating severely ill ME/CFS patients with HHV6 and HCMV infections. Dr. Peterson called for double-blinded, placebo-controlled studies to further study Vistide’s efficacy and mechanism of effect. The CFI’s pathogen discovery studies due out this year should shed light on what percentage of ME/CFS patients could benefit from Vistide. A Vistide analogue under development called CMX001 which does not require infusions and does not effect the kidneys could be boon for ME/CFS patients with herpesvirus infections if it is approved by the FDA. CMX001 was given fast-track status by the FDA earlier this year.

Is Chronic Fatigue Syndrome an Autoimmune Disease?

For decades, a heated debate has raged over the nature of the illness known variously as chronic fatigue syndrome (CFS) and/or myalgic encephalomyelitis (ME). Historically, the two warring camps have been divided between “it’s all in their heads” and “we’re still looking.” But while both sides have consistently referred to CFS/ME as an “enigma,” it turns out the source of the illness may very well have been under everyone’s nose the whole time.

In the May 2013 issue of Discover Magazine, an article by Jill Neimark bearing the intriguing title, “Are B-Cells to Blame for Chronic Fatigue Syndrome?,” chronicled a remarkable discovery: wiping out the B-cells of patients with CFS/ME can actually cure the illness.

In 2007 Øystein Fluge and Olav Mella, two Norwegian oncologists at Haukeland University Hospital in Bergen, Norway, accidentally discovered that rituximab, a drug employed to treat Hodgkin’s lymphoma (as well as autoimmune disorders such as rheumatoid arthritis and Wegener's granulomatosis) cured several of their patients with CFS/ME. The news made instant headlines.

Inspired by their success, Fluge and Mella conducted a pilot study of rituximab on three patients with CFS/ME. The patients were given rituximab in an open-label trial (that is, the patients knew they were receiving the drug). All three patients experienced significant improvement; two of them responded within six weeks and the third had a delayed response, occurring six months after treatment. The positive effects lasted for between 16 and 44 weeks. After relapse, the patients were administered another dose of rituximab, with the same positive results. The investigators hypothesized that B-cells of the immune system might play a significant role in CFS, at least for a subset of patients, and that “CFS may be amenable to therapeutic interventions aimed at modifying B-cell number and function.”

The positive results of this, as well as a second open-label trial, led Drs. Fluge and Mella to conduct a larger study with a more rigorous design to test the effects of the drug. In 2009 they initiated a double-blind, placebo-controlled phase trial with 30 CFS/ME patients. As in the earlier open-label studies, the responses to rituximab were significant. Sustained overall improvements were noted in 67% of the patients (as opposed to 13% of the control group). Four of the rituximab patients showed improvement past the study period. The authors concluded that the delayed responses starting from 2–7 months after rituximab treatment, in spite of rapid B-cell depletion, “suggests that CFS is an autoimmune disease and may be consistent with the gradual elimination of autoantibodies preceding clinical responses.”

The unprecedented success of these small trials has led to a $2.1 million privately funded initiative spearheaded by the Norwegian nonprofit group, ME and You.

This is all very topical, but is it news? Dr. Paul Cheney, an immunologist, and one of the physicians who treated CFS/ME patients during the Incline Village outbreak, stated nearly thirty years ago that CFS/ME was the result of immune system upregulation. In fact, the prevailing theory during the 1980s and 1990s was that the immune systems of people with CFS simply did not shut off after the initial infection, but remained on “high.” This was considered the driving force behind CFS/ME, and, not coincidentally, is the basis for autoimmune disease.

Nonetheless, the idea that CFS/ME was an autoimmune disease languished for decades, even though the on-the-ground evidence has been apparent all along. The waxing and waning symptoms that are typical of CFS/ME are also typical of autoimmune diseases. Frequent comorbidities of CFS/ME with autoimmune diseases - e.g. Sjögren’s Syndrome and Hashimoto’s disease - were tip-offs that an autoimmune process was involved. And even if researchers didn’t care to take symptoms and comorbidity into account, there were dozens of studies documenting immune system abnormalities, particularly increased inflammatory cytokines, as well as a high incidence of markers such as antinuclear antibodies (ANA), and anti-cardiolipin antibodies (ACA), both of which are associated with autoimmunity.

The sad fact is that although the evidence was there, it was ignored. In a recent review of the accumulated evidence for autoimmunity in CFS/ME (in a chapter titled “Chronic Fatigue Syndrome/Myalgic Encephalomyelitis and Parallels with Autoimmune Disorders”) Ekua Brenu and associates site over 180 related articles. Their conclusion? "CFS/ME may have a potential to be described as autoimmune, as this is the only consistent immunological abnormality associated with CFS/ME.”

Given the thorough nature of the review, Brenu's conclusion, however cautious, is warranted. And, bearing out Brenu's review, as well as the rituximab studies, in March 2013 a UK study by Bradley et al found an increased number of naïve B-cells in patients with CFS/ME. An increase in naïve B-cells is a hallmark of autoimmune disease.  In short, if it walks like a duck, and it quacks like a duck, it’s a duck.

Apropos of the rituximab studies, and as an excuse for not noticing the duck-like nature of CFS/ME, Neimark quotes rheumatologist Jonathan Edwards as saying, “T-cells were in fashion for a long time. B-cells were just considered boring.” It is hard to imagine that the absence of research on fully half of the immune system could be due to the whims of fashion, but whimsy is only part of the explanation for this exercise in mass denial. The other component is that the major players in our health care system - government agencies, researchers, physicians, insurance companies – have had a vested interest in perpetuating the myth that CFS/ME is an unknown and unknowable entity.

Norwegians, apparently, have less invested in the myth. When the results of Fluge and Mella’s rituximab study were made public, the Norwegian Directorate of Health Deputy Director Bjørn Guldvog was prompted to issue a televised apology. "I think that we have not cared for people with ME to a great enough extent,” he said. “I think it is correct to say that we have not established proper health care services for these people, and I regret that."

We look forward to hearing something similar from the CDC.

References:

1. Neimark, Jill. “Are B-Cells to Blame for Chronic Fatigue Syndrome?” Discover Magazine. May, 2013.

2. Fluge, Øystein, Olav Mella. “Clinical impact of B-cell depletion with the anti-CD20 antibody rituximab in chronic fatigue syndrome: a preliminary case series.” BMC Neurol. 2009 Jul 1;9:28

3. Fluge, Øystein, Ove Brulan, Kristin Risa, Anette Storstein, Einar K. Kristoffersen, Dipak Sapkota, Halvor Næss, Olav Dahl, Harald Nyland, Olav Mella. “Benefit from B-Lymphocyte Depletion Using the Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-Blind and Placebo-Controlled Study.” PLoS ONE 6(10): e26358. doi:10.1371/journal.pone.0026358

4. “Will MEandYou be the first to crowdfund a clinical trial?” ME and You.

5. Hokama, Yoshitsugi, Cara Empey Campora, Cynthia Hara, Tina Kuribayashi, Diana Le Huynh, and Kenichi Yabusaki. “Anticardiolipin Antibodies in the Sera of Patients with Diagnosed Chronic Fatigue Syndrome.” Journal of Clinical Laboratory Analysis. 23 : 210–212 (2009).

6. Brenu, Ekua W., Lotti Tajouri, Kevin J. Ashton, Donald R. Staines and Sonya M. Marshall-Gradisnik. “Chronic Fatigue Syndrome/Myalgic Encephalomyelitis and Parallels with Autoimmune Disorders” in Genes and Autoimmunity - Intracellular Signaling and Microbiome Contribution. Spaska Angelova Stanilova, ed. InTech. March 2013.

7. Bradley, A. S.,  B. Ford, A. S. Bansal. "Altered functional B cell subset populations in patients with chronic fatigue syndrome compared to healthy controls". Clinical & Experimental Immunology. Volume 172, Issue 1, pages 73–80, April 2013.

A shorter version of this article was originally published on Blogcritics on April 7, 2013 as "Is Chronic Fatigue Syndrome an Autoimmune Disease?"

Silence = Death. Time is running out...

Over the past three decades people with CFS/ME have been thoroughly ignored. Worse than that, we have been blacklisted. Academics who want to study the illness have been ousted from their positions. Physicians have been forbidden to treat us. What few funds have been granted for research have been stolen. We've been ridiculed in the press, rejected by the health care system, abandoned by people we thought were our friends.

Haven't you had enough? I know I have.

On April 25 and April 26, 2013 the FDA is holding a public workshop on treatments for CFS/ME (chronic fatigue syndrome/myalgic encephalomyelitis). CFS/ME specialists will speak, as well as patients. Is this merely another smokescreen? A stalling tactic to make it appear as if the government agencies responsible for our health actually give a hoot?

Quite possibly yes. But, in this case, the intent does not matter. What matters is public outcry.

Nothing promotes change as much as the voices of thousands of people crying out for it. The larger the number, the more likely it is that something will happen. What is that "something"? Is it funds to research treatments? Yes. Is it for CFS/ME to be recognized by physicians as a legitimate disease, rather than a form of neurosis? YES. Is it to change the $*&^%*! name? YES!

We can't get any of those things accomplished unless we tell them what we want, which is exactly what they hope won't happen. They'd like us to disappear. The question is, are we going to cooperate and hold out tongues? Or are we going to speak our minds?

Anybody in the world can post a written comment on the FDA website. But as of this morning, only nine people have posted comments. Let's tell them what we want. Let's tell them we want funding for effective treatment, that we want CFS/ME specialists involved in research, that this illness has devastated our lives. The comment period ends on April 8th, so this window of opportunity is closing fast.

We need to make our voices heard! If we remain silent, we will continue to be ignored.

Here is the link to submit a short comment. (Instructions: Where they ask you to put your organization, you can put your local support group or regional/state ME organization. Where they ask for your representative, put your congressman if you are in the US. Find yours here: http://www.house.gov/representatives/find/
Where they ask for your category, scroll to the bottom and enter "individual consumer.")

http://www.regulations.gov/#%21submitComment;D=FDA-2012-N-0962-0004

Here is the link to read more about the meetings:
https://www.federalregister.gov/articles/2013/03/11/2013-05562/drug-development-for-chronic-fatigue-syndrome-and-myalgic-encephalomyelitis-public-workshop

CDC Issues Formal Apology to CFS/ME Sufferers, Changes Name

Unexpected Decision Signals the End of an Error

By A. Lotta Blarney

April 1, 2013. The Atlanta Centers for Disease Control and Prevention (CDC) issued a surprise statement this morning, announcing that it was changing the name of the disease formerly known as chronic fatigue syndrome (CFS) to Post-Infectious Low Energy Syndrome.

“The CDC feels that PILES more accurately reflects the seriousness with which we take this illness,” said CDC director, Thomas Frieden, in a press conference held early this morning. “We are sorry for the decades of misunderstanding caused by the use of the word ‘fatigue.’”

The CFIDS Association of America, while voicing its approval over the removal of the “f” word, expressed some reservations in a tweet to its 1400 followers. “Fatigue gone, now have piles.”

Though the AMA declined to comment, the American Board of Colon and Rectal Surgery welcomed the change in nomenclature, citing its years of experience in treating illnesses of a similar nature.

The CDC concurred. “People with PILES now have their own specialized branch of medicine,” said Frieden. “This is a name we can all get behind.”