Friday, October 29, 2010

Judy Mikovits is our Frederick Banting

Between traveling to Minnesota to help his daughter, attending conferences on ME/CFS, writing posts on his blog, cleaning a small apartment (toilet too) in NY for short term rental money (cash for research and treatment), the Patient Advocate has a few moments where he tries to retrieve a little of his former life, much of which has evaporated (the PA is not complaining).

This week in NYC, the PA went to a fascinating show on the history of insulin at the New York Historical Society. The Patient Advocate has a long-time interest in diabetes as a close family member has type 1 diabetes. So the Patient Advocate knows something about this illness also.

The story of insulin is a fascinating one and the show itself was quite amazing, with many original and fascimile documents. The Patient Advocate bought a book called "Breakthrough" - authored by Thea Cooper and Arthur Ainsberg. The book tells the story of the discovery of Insulin and the last minute "resurrection' of Elizabeth Hughes (and others). Elizabeth was the daughter of the Secretary of State, Charles Evans Hughes. While the story line is riveting, the book suffers from various shortcomings, not the least is that it was written by two people - a fatal formula. Ultimately the book is a "poor read", as it suffers from unnecessary and misleading modern "flourishes". In other words the authors make shit up, they "dramatize" situtions that never happened. In this sense it is very "modern" and idiotic. This almost gets in the way of the essential narrative of this powerful story - and ultimately led the PA to go to the local public library and get out an older book on Frederick Banting, the Canadian inventor of insulin.

While reading "Breakthrough", the Patient Advocate had drumming through his head repeatedly - "Judy Mikovits is our Frederick Banting, Judy Mikovits is our Frederick Banting".

Frederick Banting has always been a favorite of the Patient Advocate - and it is no secret that Dr. Judy Mikovits is also a favorite of the PA, and has been for some time.

The idea of the cure for diabetes came to Banting late at night after he read a recent article on the illness. He knew almost nothing about diabetes and had no access to a lab. Circumstances unfolded, mostly of his own doing, allowing him to do research over the summer of 1921.

Later he had this to say about scientific discovery:

"We do not know whence ideas come, but the importance of the idea in medical research cannot be overestimated. From the nature of things ideas do not come from prosperity, affluence, and contentment, but rather from the blackness of despair, not in the bright light of day, nor the footlights' glare but rather in the quiet, undisturbed hours of midnight, or early morning, where one can be alone to think. These are the grandest hour of all, when the progress of research, when the hewn stones of scientific fact are turned over and over and fitted in so that the mosaic figure of truth, designed by Mother Nature, long go, be formed from the chaos."

In the middle of that night Banting had an insight and wrote down 25 words outlining his idea. Where to look occurred to him in a flash - and to only him. A similar situation arose in 2007 when Mikovits attended a meeting in Barcelona. Through happenstance, and upon further reflection (Mikovits too had no clue about ME/CFS.), Mikovits too had a flash of insight: "It's a retrovirus." Like Banting, Mikovits went looking, and with a little necessary luck (which also accompanies "special people") she stumbled on XMRV. And the world turned. In both cases there had been prior suspicion or identification of the "culprit", but no one had been able to substantiate it. In both cases it took the arrival of a "special person" to unlock the key.

Upon the discovery and production of insulin by Banting, immediate efforts were taken by others to marginalize him - to "take him out". The PA is reminded of the story of a government figure (CDC, NIH?) approaching a very well known scientific colleague of Mikovits and warning him to "distance himself from the WPI". This functionary stated that "the WPI is going to be taken out"

The idea of an unknown (hick) person, Banting, making the insulin discovery was intolerable to the academics around him -although Banting (like Mikovits) did have some close allies. The worst part of the insulin story involves a particular fellow named Macloed, who, for no good reason except self-aggrandizement, ended up sharing the Nobel Prize with Banting. Through the early years, Banting had to keep his head in order to hold onto his invention. Continuous efforts were made to take him out of the equation and substitute others. Eventually, through doggedness, Banting was able to get the recognition that he deserved. He resolved not to be pushed aside and fought back. Banting had guts.

Banting came from modest circumstances and had no larger aspirations beyond solving this specific problem. He had what is known as "intellectual curiosity". He wanted an answer and in no way was prepared for what lay in store for him. The negative assaults that he had to endure altered his view of the world - at the very same time that hundreds of patients were being saved. It is a convoluted and sad, yet exhilerating, story. People are really strange and the Patient Advocate does not want to speculate on what they are really "after".

Banting had a little trouble moderating his anger towards those who wanted to take him out. These were unsettled waters for Banting to negotiate and he was forced to rely on more primitve instincts that he learned in his upbringing on a farm. Some of his lab partners were afraid of him - afraid of being physically assaulted. Our own favorite, Judy Mikovits, gives the impression of wanting to also "punch out" a few people. The Patient Advocate speculates that he was sitting right behind two very good targets at the recent CFSAC Science Day.

For his entire life, Banting had a deep personal attachment to his patients, in spite of his own somewhat rough personality. He liked the idea of saving children (and adults). He was personally invested in his practice and kept up a lifelong interest and exchange with his patients. In other words he had empathy, a quality that is increasingly absent in the world in which we live. Judy Mikovits too has this empathy with patients - witness the recent NJCFS meeting.

As a result of the insulin discovery, there was a great amount of room for additional people to get involved in this positive effort. In the ME/CFS world we are now seeing this on a daily basis. It occurred in the 1920's - there were other heroic collaborators in the unfolding drama of insulin - and it is happening now, right now in ME/CFS.

All this sounds vaguely familiar doesn't it?

Conclusion? Seeing this exhibit (reading this book) cemented the idea in the Patient Advocate's mind that Judy Mikovits is our own Frederick Banting.

Wednesday, October 27, 2010

Dr. Stefan Sarafianos

A press release was issued today from the laboratory of Dr. Stephanos Sarafianos. Dr. Sarafianos teaches at the Bond Life Sciences Center at the University of Missouri - Columbia. Collaborators on the XMRV research are Donald Burke, Marc Johnson, and Shan-Lu Liu, who are also Bond Life Sciences Center investigators. They all work in the molecular microbiology and immunology department at the University of Missouri.Here is the research - on the right hand side of the page under "Unraveling the mysterious XMRV virus."This is all quite amazing and who would have expected this? One thing that it indicates is that many places are terribly interested in figuring out XMRV, what it does, how it operates, and what to do about it. This can be seen as nothing but good news. Dr. Sarafianos also gets NIH funding for HIV studies.

Monday, October 18, 2010

NJCFS conference day - Dr. Judy Mikovits.

The NJCFS association puts on an annual conference day, often at the Sheraton in Eatontown, N.J,. in mid to late October. This organization is one of the best state ME/CFS organizations and their conferences are uniformly strong.

This year's NJCFS conference on October 17 was the best that the Patient Advocate has attended. It was also the most well attended as people came from all over to hear Dr. Judy Mikovits from the Whittemore Peterson Institiute give a lecture on the most recent research connecting XMRV (and its variants) to ME/CFS. They were not disappointed.

Dr. Mikovits gave a smashing one hour talk, rattling along at a high rate of speed, covering an astonishing amount of ground. The Patient Advocate has followed Mikovits' talk since 2007 and identified her very early on as a very special researcher. This talk was very hard-hitting, dense and delivered very quickly. It far extends the Patient Advocate's capacity to give this talk the justice that it deserves. Fortunately the talk was visually recorded and will be available on DVD in six weeks. Get ahold of it and watch it.

In the first part of the lecture Mikovits:

-drove quickly through the history of various published papers that establish the association of a family of gamma retroviruses with ME/CFS.

-went over familiar ground with the problems of the negative studies, and stated her arguments against contamination

-cited "greater sequence diversity than originally observed", stating that "Variation is our friend"

-twice cited Sandy Ruschetti's importance in this research, including a key role in isolating the virus,

-spoke of how hormones and inflammatory cytokines turns on the viruses

-speculated about reservoirs, where the virus hides, where it doesn't

-gave examples of teasing out XMRV with different testing devices.

-stated that "sample processing is everything",

-stated that the association of XMRV-related viruses is stronger in ME/CFS than in prostate cancer

-reiterated that the WPI is the only one who has isolated virus from ME/CFS specimens.

-talked about subgroup P

-indicated that X -variant and P-variant are two independent viruses

-found x and found p in individually cloned viruses

-stated that XMRV and its variants is not a mouse virus

-stated that this is not a recombination, but a new human retrovirus

In the second Part of the lecture she presented data on the XMRV work being done in UK. Along the way she mentioned:

-50 UK samples went to two independent labs, each tested multiple ways

-David Bell (recently retired) is working as a clinical consultant, presumably with the WPI

-ME/CFS is not a woman's disease

-Ruschetti cultured samples from Alter cohort and found x-variant in all of them

-found complete concordance between viral isolation and detection of antibody reactivity in UK plasma

-Lo's primers picked out negatives as positives

-Conclusion: found evidence of HMRV in >70% ME/CFS meeting CCC criteria

-1st generation testing will get better.

Finally Dr. Judy talked of XMRV-related virus in family and other illness

-presented Cheney's patient XMRV information

-showed family trees with illness association

-detection of XMRV in 16 of 17 families with neuroimmune illness

- "Methods matter!"

-HMRV research is in it infancy as much more research needs to be done.

This was an astonishing talk and its implications are far reaching. This gal has blown the lid off of ME/CFS research and it is going to be interesting to see where things go from here as the WPI continues to dig deeper into research (with unpublished papers) and at the same time reach out to others in an attempt to build a coalition to make inroads into this illness. The Patient Advocate, along with many others, sees the momentum coming out of this research and the possibilities and it is time to drop the detachment and give the WPI and its affiliates any help that one can, in any form. This lecture, along with others the day before, clearly point where things are going with ME/CFS research and treatment.

There are other reports on the internet on this conference. The Patient Advocate would recommend reading them to get a fuller picture.

ILADS conference 2010 - Dr. Joseph Brewer

The third presentation that drew the attention of the Patient Advocate was a talk by Dr. Joseph Brewer entitled "XMRV and CFS". The PA heard Dr. Brewer give this lecture at the Whittemore Peterson Institute in August 2010. At that time, the Patient Advocate found himself standing next to a tall fellow and reading his name tag: Dr. Joseph Burrascano. What was Dr. Burrascano doing at an XMRV event? His presence, in a nutshell, demonstrates the outreach of the WPI. Thanks to Burrascano four or five XMRV/ME/CFS/Infectious Disease doctors where invited to the ILADS conference.

Dr. Joseph Brewer is an Infectious Disease doctor who practices in Kansas City. Dr. Brewer has worked with both HIV and CFS patients for 25 years. He also has treated many Lyme patients. As far as the Patient Advocate knows, Dr. Brewer has the most long-term experience in dealing with both HIV and CFS, putting him in the catbird seat for diagnosing and treating XMRV and its variants.

In his lecture Dr Brewer gave a brief 101 course on retroviruses. In the course of this presentation the familiar terms came up: transmember protein, surface glycoproteins, endogenous, exogenous, gammaretroviruses, xpr-1 receptor (unknown function), x and p rv, envelope spiked proteins, chemokine co-receptors, cytoplasm of cells, reverse transcriptase, double stranded viral dna, protease, two single strands of rna. Many of these terms have a poetic sound to them.

Dr. Brewer stated that he has been treating a small group of patients with antiretrovirals. The results so far have been mixed. About a third have gotten better, about a third have had very slow partial improvement and about a third have not improved at all. The thought is that these patients, and most XMRV+ patients, have an X variant (XMRV) and a P variant (PMRV) - and, most importantly, that these are two separate viruses, although both from a group of closely related viruses. Speculation is that the current drugs with activity against XMRV work against the X variant and not the P varian. (However it is important to state that Dr Brewer did not say this in his lecture. He said that we just do not know at the moment.) Presumably work is currently going on to identify drugs that will nail the P variant.

Dr. Brewer also talked about Nuclear Factor kappa B and Interferon A and their role in inflammatory illness. He mentioned that data is changing daily - in other words, things are moving fast.

According to Dr. Brewer, XMRV is potentially associated with Parkinson's, chronic Lyme disease, MS, ALS - as well as ME/CFS. In his practice, 90% of his XMRV+ patients are Lyme Disease. (The Patient Advocate had heard previously that all of Dr. Brewer's Lyme patients are XMRV+) Four our of four of his MS patients are XMRV+, 1 out of 1 ALS patient is XMVR+, and 1 out of 1 Parkinsons patient is XMRV+.

With this information, Dr. Brewer paints a very interesting and frigthening picture. It was difficult for the Patient Advocate to determine if this small bomb hit home with the conference attendees or if they just yawned. Dr Brewer, time-tested and a veteran, will remain at the very forefront of the XMRV treatment battle and the Patient Advocate and others will look to his leadership.

Dr. Brewer concluded his lecture saying that it could be surmised that lyme is an XMRV-related disease. What the lyme audience thought of this the Patient Advocate does not know.

It has been pointed out that Dr Andrea Kogelnik, director of the Open Medicine Clinic in Mountain View, CA, also gave a presentation but the Patient Advocate missed this, as he was on his way to Eatontown, N.J. to hear Dr. Judy Mikovits.

Sunday, October 17, 2010

ILADS conference 2010 - Dr. Jose Montoya

Dr. Jose Montoya of Stanford gave a lecture at the ILADS conference entitled ‘Viral Induced CFS – the Stanford Perspective”.

Dr. Montoya has not been seen on the ME/CFS lecture circuit since the June 2008 HHV-6 conference. Dr. Montoya was “the main squeeze” at that conference when he gave a much anticipated preliminary report on the Roche-sponsored Valcyte trial of 30 patients - 20 treated patients and 10 controls. The report delivered that day was a great disappointment to many of the ME/CFS patients as the trial failed to confirm the previously very positive reports from several smaller pilot studies. In the Roche study preliminary report, fatigue improvement came up short. However the majority of treated patients did have significant cognitive improvement. Dr. Montoya indicated that much more analysis of the results was necessary. As far as the Patient Advocate knows, no update of this study was presented until this ILADS lecture. Through a complex statistical analysis Dr. Montoya seemed to establish that Valcyte treated patients improved in fatigue categories in several categories compared to placebo. Cognitive improvement was also noted.

In these studies Dr. Montoya used elevated IgG antibodies to EBV and HHV-6 as diagnostic markers and also as measures of improvement. The hope was that these elevated antibodies would recede with treatment, and that they could be “read”.
Dr. Montoya presented data of movement, up or down in a predictable fashion, of neutrophils and monocytes with Valcyte treatment in various patient populations.

In a bit of a surprise, Dr. Montoya reported on more recent efforts at Stanford to develop a cytokine profile to be used as both a diagnostic treatment marker and to measure treatment improvement. Dr. Montoya thinks that he is close to publishing this work, but he wants to make sure “that he gets it right”. Dr. Montoya indicated that he was interested to make his raw data available on the Internet (to pre-screened individuals). In other words, Dr. Montoya is willing to share information.

Two other groups, one with Kilmas and one at the WPI, are working on cytokine/chemokine marker/trackers. The Patient Advocate believes that immunological markers for tracking treatment progress will be published in the coming months. Whether these separate efforts have any continuity will be seen. Whether there has been any cooperatation between these three groups is unknown. If not, the Patient Advocate wonders why not?

The Patient Advocate asked Dr. Montoya if he knew Dr. Dale Guyer -and Dr. Montoya said no. The PA asked Dr. Montoya if he worked with Dr. Brewer and he said no. The Patient Advocate thinks this is going to change. Dr. Montoya works at Stanford in virtual isolation. His colleagues at Stanford have never been overly excited about his work in ME/CFS. Recently it has been reported that he is working with Dr. Lerner. Various people are reaching out to Dr. Montoya to get him more tightly involved in future diagnostics and treatment of ME/CFS. This doctor is one of the very best, a real human being. If Dr. Montoya can develop his own cytokine signature, he will most likely begin trials of the most advanced treatment ideas. Dr Montoya is a courageous and humanistic doctor who wants to help patients.

The PA asked Dr. Montoya if he were testing his patients for XMRV. He said no, but that Stanford was developing its own test. The PA asked him why didn’t he just use the one from VIPdx? To the Patient Advocate this seems the most logical solution - to lease the test from VIPdx. Why reinvent the wheel?

The Patient Advocate assumes Dr. Montoya’s work will be published. It was terrific to see this very sympathetic and serious doctor/researcher giving a public lecture again. The Patient Advocate looks forward to a greater role for Dr. Montoya in future diagnostics and treatment. We need this man to take a larger role.

ILADS conference 2010 - Dr. Marcus Conant

The Patient Advocate came to the ILADS conference in Jersey City, NJ to hear several talks. The ILADS organizers departed from past practices and invited five non-ILADS members to give presentations. In the PA’s estimation, this is in reaction to the changed ME/CFS topography since October 2009. There is no other explanation for it. Dr. Burrascano, a major lyme doctor, obviously engineered having these HIV/XMRV/Infection Disease doctors give presentations. Things are changing at the ILADS conference.

The Patient Advocate paid his conference fee to hear three presentations. Foremost among these was Dr. Marcus Conant, a relative newcomer to the ME/CFS field at the age of 73. If you want to learn more about Dr Conant look here. The Patient Advocate was not disappointed. This guy is great. We will be seeing more of Dr. Conant as XMRV moves relentlessly along.

Dr. Conant gave a talk entitled “Lessons - learned from HIV”. Dr. Conant, who was in the front lines of the AIDS diagnosis and treatment, is no shrinking violet. In the early 1980's he was one of a very few doctors in San Francisco who were willing to deal with doomed patients - often dead in weeks or months. Dr. Conant speaks his mind and he does not flinch. He began his talk by referencing the plague of 1348 and drew parallels, past and present, to it. He spoke in an impassioned fashion of the advocacy problems of trying to defeat ignorance, and how to move the agenda forward. His presentation had very humorous – even caustically absurd - moments to it, indicating the complex and emphathetic nature of his rangy personality. His central recommendation is to define the cause and to focus the research. In doing this Dr. Conant recommended not groveling, not fawning, not eliciting sympathy - just moving forward with clarity and determination. He encouraged activism and self-reliance regarding research, saying “Congress is your last resource, not the first”. Dr. Conant obviously does not get sidetracked or waste his time talking to non-helpful individuals. On the other hand he urges efforts toward inclusion - not fracturing - by trying to bring your adversaries to your side of the issues. The talk was deeply emotional and Dr. Conant, an unknown to most of the attendees, made a strong connection, as he was given a spontaneous standing ovation by the entire 200+ people in the hall.

The Patient Advocate has read on the internet that Dr. Conant has left his practice in San Francisco and come to New York because of an interest in this new retrovirus named XMRV. This was confirmed in conversation with him. The Patient Advocate surmises that Dr. Conant thinks that XMRV is a potential player in ME/CFS. Dr. Conant presents lyme and its affiliate, ME/CFS, as an infectious disease. With this in mind the Patient Advocate sees Dr. Conant as “an advocate for ME/CFS research and treatment”. At a minimum Dr. Conant’s expertise can be involved in upcoming treatment trials of antiretroviral drugs in ME/CFS patients.

The atmosphere of the ILADS conference was diametrically opposed to the CFSAC Science Day, which should be canceled. Much of this was due to the ILADS presentations of these four pro XMRV-related infectious disease physicians. There was none of the self-satisfied, politically-motivated vapors that filled the HHS conference room. The Patient Advocate saw Science Day as an attempt to put the breaks on further revelations about the connection of XMRV. The PA has to ask, why is this?

It becomes increasing obvious to the Patient Advocate that the FDA and others are really freaked out over the blood supply, and their responsibility for this. The FDA is going to be exposed to insurance claims coming from those who have been made sick through transfusions. This is a repeat of the AIDS epidemic. It is in their interest to string this out, until the Blood working group reports - and longer.

Other reasons for these delaying tactic were advanced to me by a knowledgeable and insightful friend:

“Where the money has not simply disappeared, or been poured down a rathole, it went to fund the amateur psychiatry of Stephen Straus or Bill Reeves. (Nobody seemed concerned at the time about them publishing work far outside their areas of expertise, except, as always Lenny Jason.) Avoiding exposure of this, with concomitant collateral damage to institutions, and future funding, is the first priority of those in charge. As second goal is to wrest control from WPI, so new research serves to provide more funding for the same institutions who screwed around, wasted time and treated funding for this subject as a kind of slush fund to cover miscellaneous expenses not covered by other allegations.

A third goal is to avoid committing the federal government to paying disability, or diagnostic and treatment costs, for another few million people. Current expenditures for HIV run around $1,000 per person per month -- for life. Since we are talking about another retrovirus and some of the same drugs, costs for treating ME/CFS are unlikely to be lower. Taking on a new $1,000,000,000/month liability was not in the Congressional plans for medical reform. Projected funding is already inadequate without this."

Yesterday was Conant, Montoya and Brewer. Today it is Mikovits.

Wednesday, October 13, 2010

Put this gal in charge - let her run the show.

The Patient Advocate listened to the public testimony at the CFSAC, many of which were inspired presentations.These testimonies are available on the internet. The ME/CFS patients and advocates are articulate, passionate and focused - each in a different way. Their collective testimony is the very best and strongest part of these meetings.

The Patient Advocate would like to highlight one testimony and make a suggestion. Let's get rid of all the people on the CFSAC committee and put Dr. Joan Grobstein in charge. Let her pick the new members. Dr. Grobstein, 11 years ill with ME/CFS, can run things from her couch in her home. The HHS can hire as many assistants as necessary - and they can be trained to deal with the new ME/CFS committee head in a manner that is conducive to her illness.

Watch how much clarity and direction that Dr. Grobstein packs into the measly five minutes that they give her.

CFSAC - Day 2
Dr. Grobstein is "Public comment - Speaker 2". Take the time to watch this. (Hopefully it will be posted soon on youtube for more easy access.)

The Patient Advocate also presents Dr. Grobstein's written 2010 testimony, which includes some important suggestions not included in her oral presentation. It is worth reading.

CFSAC Written Testimony October, 2010
Joan Grobstein, M.D.

I am a former neonatologist who had to retire from practice in 2000 due to illness. I have had ME/CFS since 1999. Before retiring I worked at the Neonatal Intensive Care Units of Children’s Hospital of Philadelphia and the Hospital of the University of Pennsylvania.

At this Committee’s meeting a year ago, I spoke about science and MyalgicEncephalomyelitis/Chronic Fatigue Syndrome, or ME/CFS. Specifically, I addressed the negative impact of the CDC’s “empirical” definition of CFS on scientific research into the causes of and potential treatments for ME/CFS. A resolution was passed at that meeting stating that the “CFSAC rejects the empirical definition” of CFS. Despite this recommendation, the CDC has published 3 papers in the past year using the “empirical” definition, including a paper which was unable to find any evidence of XMRV in blood from a cohort of patients with “empirically” defined CFS or in healthy controls, and another paper which discussed personality features and personality disorders in the same group of patients. At the last CFSAC meeting six months ago, Dr. Unger stated that she stood by the CDC’s estimate of the number of people affected by CFS in the United States, a number based on the “empirical” definition. There is no evidence that the CDC has paid any attention to the expressed views of this Committee about the “empirical” definition. Communication with the leadership of the CFS program at the CDC about the definition and other issues has been next to impossible for other professionals involved with ME/CFS as well.

At the same CFSAC meeting six months ago, I confined my comments to the
Committee’s charter, at the Committee’s request. At that meeting, an amendment was made to the Function section of the charter to include the statement “the current state of knowledge about the epidemiology, etiology(s), biomarkers, and risk factors relating to Chronic Fatigue Syndrome and identifying potential opportunities in these areas”. The words etiology(s) and biomarkers are not in the current version of the charter on the Committee’s website.

It must be frustrating to members of the Committee to have their recommendations ignored so blatantly. Taxpayers are spending a reported $130,000 each year on this Committee. We do expect effectiveness. I’m sure the dedicated experts who take the time to serve on the Committee also expect that their recommendations will be implemented, especially the ones that are revenue-neutral.

These are big issues: (1) that the Center for Disease Control of the United States of America is continuing to use a discredited definition in publications about CFS, and (2) that the charter of this Committee ignores the importance of a search for the cause of a disease that affects one million Americans and their family members. But today I want to move on from discussions of science and bureaucracy and talk about medicine.

Medicine is an applied science. Doctors take scientific facts and apply them in real world situations in order to improve the lives of real people. Part of the reality of medical practice is that sometimes doctors don’t yet have all the information we need to make a fully informed decision. And yet we must act. For example, a patient arrives in the emergency room in shock and we may not initially know why. But we have to act. We draw tests to clarify the cause of the patient’s low blood pressure at the same time that we start IV infusions to treat the low blood pressure. We may give antibiotics for the most likely infections before we know what the infection is, or even if infection is the cause of the patient’s condition. We act.

At the present time, there is no action for patients with ME/CFS. We know, for example, that many patients have low blood pressure and orthostatic intolerance, yet there is no recommendation to treat the low blood pressure, or even to do tests to establish its cause, in the CDC’s CFS “toolkit” for professionals. We know many patients have chronic viral infections, yet there is no recommendation to treat those infections. The CDC “tool kit” for CFS does not recommend testing for any infections. We know that many patients have abnormalities of immune function yet there is no recommendation to treat those abnormalities. We know a lot about Canadian Consensus Criteria-defined ME/CFS, but we don’t apply that knowledge to treat the disease.

In the past year we have learned a lot about MLVs, including XMRV, which present an attractive, although as yet unproven, hypothesis about the underlying cause of ME/CFS: a newly identified family of retroviruses may affect the immune system causing patients to be susceptible to various new or re-activated viral infections, as well as other possible infections, and perhaps themselves are causing much of the diverse symptomatology of the disease. It is time to act. Despite the incompleteness of our knowledge, we can treat. We must treat.

We know from past clinical trials that some patients improve, if not recover completely, when treated with antivirals appropriate for the viral infections that they have as demonstrated by appropriate lab tests. These clinical trials include, but are not limited to: enteroviruses, as shown by Dr. Chia, various herpesviruses, as shown by Dr. Lerner, and HHV-6, as shown by Dr.Montoya. Other infectious agents that have been shown to be common in ME/CFS patients include chlamydia, mycoplasma, and parvovirus, among others. I propose a randomized controlled trial of XMRV positive patients in which patients are randomly assigned to two groups: half the patients receive treatments for the infections that they are shown to have, and the other half receive treatments for the infections that they are shown to have and, in addition, are given the three antiretrovirals that have been shown by Dr. Singh to be active against XMRV: raltegravir, zidovudine and tenofovir. The primary outcome measure should be Karnofsky score, i.e., patient functionality. This is what patients care about: what they are able to do in their daily lives. Appropriate measures of the other, non-retroviral, infections should also be followed as secondary outcome measures. There is no currently accepted measure of XMRV activity, but it is not necessary to follow viral counts or to have an accepted immunological marker to establish efficacy of anti-retroviral treatment. Improved patient functionality or a more rapid eradication of other infectious agents will establish efficacy. Raltegravir, zidovudine and tenofovir have been used in thousands of AIDS patients, and their safety profiles are well understood.

I’m sure some will argue that there should be a third group in this trial, a group that receives no treatment for the infections that they have. I personally think that it would be unethical to include a group that receives no treatment. The word Tuskegee comes to mind. Although, ME/CFS patients were not deliberately infected, unlike the men in the Tuskegee experiment, it
is, in my opinion, unethical not to offer treatment to patients with known infections. However, I do realize that the current standard protocol for ME/CFS at this time is not to test for other infections, and, even if found, not to treat them. As a physician, this is unacceptable to me.

One could also argue that a third group should receive antiretrovirals alone. I am not opposed to this. I suspect all infections will need to be treated, but, since this is not documented, it is a reasonable question to research.

People with ME/CFS have been extremely patient with the medical and scientific community. However, our patience is not inexhaustible. Despite the cautionary mumbling of some physicians and scientists, people want to be treated for this serious, debilitating illness. We read the scientific papers on the internet. Despite our intermittent brain fog, we are not stupid. We will seek treatment. We will not wait for scientists to satisfy their intellects and establish who is “right”. If clinical trials are delayed too long it may be impossible to find untreated patients to enroll. At a certain point, it will also be impossible to claim therapeutic equipoise, because the mass of anecdotal evidence will be impossible to ignore.

Research cannot be done without funding, and funding for ME/CFS research at the NIH has been abysmally low. The NIH website gives an estimate of 5 million dollars, or about 5 dollars per patient, for 2010. ME/CFS received no ARRA funding for 2010. It is time to establish designated funding levels for ME/CFS.

I have spent my life working primarily as a clinician, not a researcher. I am therefore not particularly familiar with different types of grants or the mechanism of organizing randomized controlled trials with NIH funding. I have neither the time or the energy to get that information now, and it is not my job to do so. A request for proposals should come from the NIH for the necessary projects. More research dollars are urgently needed for this significantly underfunded, serious illness. It is time to act.

Many thanks to all the people who serve on this Committee and support this Committee. It is my hope that the future will soon be much brighter for people with ME/CFS.


Switzer WM, Jia H, Hohn O, Zheng H, Tang S, Shankar A, Bannert N, Simmons G, Hendry RM, Falkenberg VR, Reeves WC, Heneine W., Absence of evidence of xenotropic murine leukemia virus-related virus infection in persons with chronic fatigue syndrome and healthy controls in the United States., Retrovirology. 2010 Jul 1;7:57.

Maloney EM, Boneva RS, Lin JM, Reeves WC, Chronic fatigue syndrome is associated with metabolic syndrome: results from a case-control study in Georgia. Metabolism. 2010 Sep;59(9):1351-7. Epub 2010 Jan 27.

Nater UM, Jones JF, Lin JM, Maloney E, Reeves WC, Heim C, Personality features and personality disorders in chronic fatigue
syndrome: a population-based study, Psychother Psychosom. 2010;79(5):312-8. Epub 2010 Jul 28.

John K. Chia, Andrew Y. Chia, Ribavirin and Interferon-a for the Treatment of Patients with Chronic Fatigue Syndrome Associated with Persistent Coxsackievirus B Infection: A Preliminary Observation, The Journal of Applied Research, Vol. 4, No. 2, 2004

A Martin Lerner, Safedin Beqaj, James T Fitzgerald, Ken Gill, Carol Gill, James Edington, Subset-directed antiviral treatment of 142 herpesvirus patients with chronic fatigue syndrome, Virus Adaptation and Treatment 2010:2 47–57

Singh IR, Gorzynski JE, Drobysheva D, Bassit L, Schinazi RF., Raltegravir is a potentinhibitor of XMRV, a virus implicated in prostate cancer and chronic fatigue syndrome., PLoS One. 2010 Apr 1;5(4):e9948

Tuesday, October 12, 2010

Science Day

On Tuesday October 12, 2010, the Health and Human Services Department held the first Science Day in their architectural monstrosity at 400 Independence Avenue. It was billed as “CFS Science Reviews”. This conference day was not an auspicious beginning (if indeed this is a beginning). Perhaps the coordination of a day-long CFS conference should be left to someone else besides HHS? This so-called Science Day was webcast - so everyone can make up their own mind. As far as the Patient Advocate is concerned he could have taken the day off and not missed anything. This Science Day was like a bad CFS 101 course - a mishmash at best. Perhaps it was well intended - who knows? The fact that there were some highpoints does not discount the fact that this is what is called a “lost opportunity”.

The Patient Advocate would have hoped that this conference had some real thrust or energy to it. It had none. After all there are things happening in the real world with ME/CFS. At a minimum the PA would expect the conference to focus on recent developments in the field. There could have been an effort to consolidate ideas that have emerged since October 2009. Let’s fight it out in the open.

This much we know. This Science Day would not have happened but for the Science paper. None of us would have been sitting in that room today if it were not for the Science paper. Instead of focusing on the unfolding reality, scrupulously careful efforts were made to not mention the WPI (the name showed up on one slide) or Mikovits. This was, of course, non-sensical.

Instead the day proceeded as if nothing had changed in the last year. It was like a compressed version of the 2007 Ft. Lauderdale CFS conference – varied rehashed subject presented as a ghastly bore. The problem was mostly contextual – so the Patient Advocate suspects intention. Someone was trying to deliver a message here.

Consider for a moment the ways and manners of the organizers of the InvestinME organizers in London. They make a great effort to focus on a specific theme. They choose their speakers carefully in order to synthesize or draw tighter a particular ME/CFS issue. As the ME/CFS research has consolidated in the last two years, InvestinME's focus has sharpened. There is nothing smug about these UK organizers. They resist acting out their prejudices and keep an open mind. In London, the spectator, in this case the Patient Advocate, comes away enlightened and excited by the coming together of threads and ideas. The PA can count on the 2011 InvestinME conference to be very exciting.

Today’s conference was exactly the opposite - a set of finely wrought loose ends, with a bit of grinding teeth thrown in.

Today’s conference was neither exciting nor useful. For starters little care was given to present a clear thrust, either through research or through treatment. The speakers hailed from both areas and presented a great unevenness. Here is the line-up.

The Patient Advocate has seen Dr. Nancy Klimas speak on a number of occasions. Today she really sparkled and came across as a high-minded champion of the ME/CFS clinician/researchers. Since October Klimas seems to have found her niche and is energized as the PA has never seen her before. More power to Dr. Klimas, as the ME/CFS community needs more of these kind of people. Dr. Klimas gave the very best version of her standard talk of the immune system, emphasizing the potential of immune modulating treatments (as opposed to retroviral attack drugs). Her work in developing a cytokine profile to track and assess progress in treatment was very exciting - and a bit clearer than she has presented before. The Patient Advocate wonders whether Klimas’ cytokine profile dovetails with the work being done at the WPI and by de Meirleir? It is the PA’s view that means are currently at hand, or shortly will be, for measuring viral load and immune function. The grousing from the virologists in this regard is a red herring. It is time for treatment trials to begin.

The Patient Advocate had last seen Professor Ron Glaser in 2007, when he gave a fascinating talk on EBV and its “masks”. Since then Dr. Glaser has disappeared from the CFS lecture scene, but today he resurfaced, newly armed with NIH grant money, which he mentioned one too many times for the PA's taste. Once again Dr. Glaser gave a very compelling talk, similar in many ways to the 2007 talk (if not the same one). The Patient Advocate wondered about the inclusion of this talk, and where it fit into the current picture, especially since there are so many other compelling subjects and physician/researchers who could reflect more dynamically on the changing topography of this illness. The PA would pay to see Dr. Glaser talk - but in another setting please!

The obligatory grousing about XMRV was fully represented by Professor Stuart Legrice, who gave a “report” on the 1st annual XMRV conference. Where do they find these people? His “report” emphasized and then reemphasized the need for caution, the need to be careful, the need to go slow, the need for time for science to go at its own pace, and the plea to not do anti-retroviral trials (except if trackers are developed). It was all a bit thick. The most interesting part of his talk was that after waving repeatedly all the flags for caution, including the repetitive emphasis that the Science study was possibly the product of contamination, he covered his backside regarding the reality that something might actually materialize out of this “XMRV thing”. The Patient Advocate could hear, in the background, alarm bells going off. This little lab in Reno, no matter how things evolve, has turned the world of these virologists upside down.

The Patient Advocate has no assurance about how all this is going to turn out with XMRV (although the PA does have his suspicions). This kind of “overview” presenting a heavily slanted view, supposedly weighing “both sides”, does not further the conversation. In fact it tends to hinder the conversation. This man states the obvious, but in an unfriendly and supercilious manner. None of this would bother the Patient Advocate except that he has heard it before. The Patient Advocate sensed this virologist was grinding an axe, delegated by other interests, and indeed seemed ridiculous and embarrassing. Am I to believe that this fellow has my best interest in mind? Who needs these patronizing sanctimonious admonitions? Is he talking to me?

Professor Alan Light began the afternoon session. He and his wife do serious and important research in exercise and fatigue. He gave one of the most compelling research talks at the Reno conference in March 2009. This was an expanded version of that talk. Once again the Patient Advocate wondered where this research fit in, especially given the need to focus? The Patient Advocate, if it were up to him, would have invited only clinician/researchers (and Mikovits) and let them have a go at each other. These are the people who are holding the keys to the lock – not Light, not Glaser, not Jason, not that other guy.

Leonard Jason was his usual amusing and sharp self. Frankly, as smart and convoluted as he is, the Patient Advocate is getting tired of Dr. Jason getting platform time - when there is so much more actionable information out there. Now is the time for action, not talk. The PA believes that Professor Jason research has been useful in focusing dialogue and definitions, but where will this end? – and what does it mean for the current, accelerating situation? The Patient Advocate thinks that the reality has shifted in ME/CFS research. The talking part of this illness needs to be down-regulated, and the action part of the illness needs to be up-regulated.

So much talk and time is focused on defining the patient population. To the PA, this is one of the big mysteries of "research". The Patient Advocate believes Dr. Bell when Bell says that no other disease presents itself as CFS. There is nothing like it and its outlines are clear. The PA himself, a sculptor, believes that he can diagnose this illness. Most ME/CFS patients also believe this. This is not the big mystery that it is made out to be.

The best part of the day was left for the end. Once again the Patient Advocate got to hear Dr. A. Martin Lerner, an I.D. doctor who himself was disabled with CFS for six years. Dr. Lerner is a modern American hero, and he has single-handedly brought betterment to many patients. (The Patient Advocate has tried to consult with Dr. Lerner, but this has not been allowed.) Dr. Lerner has kept detailed records of hundreds of virally compromised patients and has recently, with the help of others, assembled studies of his treatment protocols. The Patient Advocate heard Dr. Lerner in 2008 in London and the PA will reprint what he wrote about Dr. Lerner then - as most of the essential matter remains the same.

“Dr. Martin Lerner made a longer presentation on his work sponsored by the A. Martin Lerner Foundation. This was the first time, I believe, that Dr. Lerner has spoken in the UK; and there was the sense that few members of the audience had a clear idea who he was or what he does. Dr. Lerner presented a lecture similar to the one that can be seen on the Internet, with the significant addition of recent long-term data. Dr. Lerner is probably the most experienced doctor in using anti-virals for subsets of CFS in the world. Highlights of the lecture are expressed here. Dr. Lerner has compiled six years of data of 180 patients, including 5000 visits and 45,000 pieces of information.

Dr Lerner has separated the 180 patients into two groups with similar demographics: Group A (138 patients) - CFS Herpes virus illness (EBV, HCMV, and HHV6, in some combination) with no coinfections, and Group B, CFS Herpes virus illness (EBV, HCMV, HHV6 in some combination), with co-infections (Lyme, Babesia, etc). He presented information only on group A. Lerner uses the Fukada definition. Patients in Group A were identified through positive IgM recombinant p18 monoclonal VCA, abnormal Holter monitor assessment and abnormal cardiac wall assessment. More specific details of this screening are publicly available. Specific long-term pharmacokinetic therapy, (Valacyclovir, Valgancyclovir) was administered to each patient. Using his own Energy Index (EI) point score (1-10), Lerner determined the mean score for 138 patients at baseline was 4.5. The mean final EI point score was 6.0. These data indicate that specific long-term pharmacokinetic administration of Valacyclovir/Valgancyclovir provides long-term significant benefit to Group A patients. There was no toxicity to this long-term antiviral therapy. In answer to a question, Dr. Lerner indicated that there were remarkable improvements to heart irregularities.

Dr. Lerner strongly believes that viral subset CFS treatment options exist right now, today. His foundation is working on a DVD training film for physicians. While Dr. Lerner holds various patents on his treatment protocols, with several more pending, he gives every indication of being a dedicated practitioner and researcher who wants to get his information on antiviral treatment to a wider audience.”

There were general questions after both the morning and the afternoon sessions. They were uniformly academic questions, obscure, nonsensical, centrifugal – except for two very sharp question by Cort Johnson and one great question by Dr. Joan Grobstein, which first they tried to avoid having her ask and then they didn't want to answer.

There is momentum in the ME/CFS world, and this conference did not in any way advance this. In fact, in the unreality of the majority of presentations, the conference did its best to hamper movement forward. The Patient Advocate would recommend canceling future Science Days and letting others, like InvestinME and the WPI, take care of coordinating research and treatment.

Disgusted, the Patient Advocate took the train out of town. The PA is heading for the ILADS conference in Jersey City, where, for the first time ever, ME/CFS/HIV doctors have a large presence in the form of Dr. Joseph Brewer, Dr Marcus Conant and Dr. Jose Montoya and others. On Sunday October 17th Judy Mikovits and Susan Levine speak at the NJCFS conference in Eatontown, N.J. Let’s hope Dr. Levine gets on board. These conferences will be more stimulating for the non-politically minded.

Please don't miss the patient testimony of my friend Joan, scheduled as the first presenter on Wednesday morning.

Saturday, October 9, 2010

A couple of newspaper articles

The Patient Advocate believes, with recent developments, that there is strong evidence that his daughter has crossed over into the Infectious Disease category. (The PA has known this for eight years.) Consequently the PA has begun looking for I.D. doctors in the Twin Cities. His daughter needs a real doctor. The initial inquiries have not been promising. The first response from an I.D. doctor was "This is really new stuff. XMRV may be related, may not. Unknown if cause. But no antiretrovirals known to target XMRV." This did not give the PA much of an opening as it was a fine drawn mixture of inaccuracies and ignorance, disguised behind hubristic certainty. Next up was a response from a virologist: "The bottom line is that the jury is still out on this. In my opinion the CFS/XMRV connection isn't going to pan out, but we'll see". Both of these semi-carefully crafted responses, for which the Patient Advocate is supposed to be thankful - as these Important People take their time out of a busy schedules to write an answer - close the door and yet leave it open a crack. Both are equally progressive and courageous in their opinions. It appears to the PA that most physicians in the Twin Cities believe that ME/CFS is a psychological illness. Where have we heard this before? It is pure shit. The more optimistic of these people say to "get into a clinical trial". That is such a helpful suggestion - as there are, at the moment, no clinical trials available. In addition most clinical trials are localized - and my daughter is housebound. Clinical trials for ME/CFS will never happen in MN. So this getting an I.D. doctor is going to be difficult.

Recently the Patient Advocate read a story in the WSJ - the same newspaper which features our friend Amy Marcus. This article is on the subject of clinical trials, the agonizingly slow development of drug therapies (Provenge is a great example) and what some patients are trying to do about it. The Patient Advocate believes the subject of this article might have relevance to potential ME/CFS treatments. If we wait for large scale clinical trials we will have a long wait - about 100 years.

Here is the article.

In another article in the NYTimes the Patient Advocate reads about bees. The PA is aware that bees have been having their problems over the past few years. What struck the interest of the Patient Advocate was the front page story of an immunologic dysfunction in bees that involves viruses, fungi, immune dysfunction and the gut. While reading this article the PA keep wondering when they were going to mention ME/CFS. With all due respect to bees and the NYTimes, why can't we have a front page article on ME/CFS and leave the bees take care of themselves. People first, bees second.

Tuesday, October 5, 2010

"Time for Action" Campaign

"Time for Action" Campaign
For ME/CFS Patients, Their Families and Friends

Organizers: Robert Miller, Rivka Solomon, Charlotte von Salis

On the heels of the September 7, 2010, historic NIH meeting with ME/CFS patients and their families, now is the time to let our federal health agencies know we are expecting big changes. The more they hear from us now, the more they'll listen to us next time we meet. Our "Time for Action" campaign is advocacy made easy -- yet it will have a huge impact. We ask patients, their families and friends to email, call and/or fax NIH Director Collins and NIAID Director Fauci with this simple question every day, starting today. (Please Cc: emails to Robert Miller at:
Dear Directors Collins and Fauci,

What have you done for ME/CFS today? Patients and their families are waiting.

Name: John Doe (or John)
Location: Miami, FL
Time: Sick 12 years

Contact info:
1) National Institutes of Health
Director Francis Collins
Cc to:
Phone: 301-496-2433
Fax: 301-402-2700

2) National Institutes of Allergy and Infectious Disease
Director Anthony Fauci
Cc to:
Phone: 301-496-2263
Fax: 301-402-3573

For inspiration, here's our "How To" video: