Saturday, December 22, 2012

Llewellyn King interview with Dr. John Chia



Here is an excellent interview by Llewellyn King with Dr. John Chia of Torrance, CA. Dr. Chia is one of the foremost clinician/researchers in ME/CFS focusing on patients who have enterovirus involvement. Once Dr. Chia starts talking I always want to hear more - as this doctor has his finger on the pulse of a significant part of this illness. Fortunately, Llwellyn King promises us more conversation with Dr. Chia in an upcoming interview. Llewellyn King does a very great service in bringing interviews with significant players in this illness, those who are looking for answers. The full set of interviews of ME/CFS Alert can be found here on youtube.


Thursday, November 29, 2012

A few notes on ILADS 2012 Boston


I attended the ILADS conference in Boston at the Westin Waterfront. For the three days I was in Boston, I got up early at my friend's house and biked the five miles to the hotel on one of those fabulous city bikes. The hotel is situated in a newer waterfront development area that was very reminiscent of similar areas in Amsterdam or Hamburg. Riding through downtown Boston got a little dodgy at times, especially after darkness descended and the cold set in, at times with heavy rain.

This was the first time that I had attended an entire ILADS conference. I assigned myself the usual task - to seek out additional insights in trying to help my daughter. She has a complex neuro-immune illness that includes, in some proportion, Lyme disease. She was treated with antibiotics for six months in 2005 to no effect - except that it tore up her gut. (So much for antibiotics.) Repairing the damage has taken a few years. Most recently, in 2011, she tested positive for borrelia with the new culture test from Advanced Laboratory. Dr. Burrascano gave his pitch for this test at this conference - and he certainly has me convinced. Surprisingly there was not a lot of conversation about the game-changing nature of this test - although the lab itself did indicate that they were continuing to work towards some sort of validation, and they did say that a few insurance plans are now covering it.

These complex illness situations are difficult to figure out but, in my daughter's instance, this positive culture test underscored the idea that lyme is part of the complexity of her illness - substantiating previous indications on tests from Igenex and Neurosciences. I have encouraged others to take this test, but with little result, as most do not want to spend the $600. My daughter's resolve is to not take antibiotics again - at least not at the present time. It seems that ILADS doctors are big on antibiotics, although some do use other medicinals and treatments. In this sense ILADS has its territory staked out and one gets the sense that the ILADS world is an industry unto itself. For instance Cowden or Buehner or Klinghardt don't bother to attend. One wonders if they would be welcome, although the first two were represented by displays promoting their treatments and products.

This was an exceedingly well-run conference. It was a long three days of listening and watching. The conference starts early and runs into the evening, with a wide variety of presentations. The conference organizers are obviously trying to touch a lot of bases at the same time. There is a good balance between serious lectures, workshops, breaks for networking, and mid-day meals for eating and talking. The meals and tea breaks allow for intermingling of people - which is sometimes difficult for an outsider. The food was excellent - and healthy too. The conference was very close to full capacity. Clinicians, researchers, advocates and patients come from all over the world.

Many of the "big guns" of lyme treatment and research attended this conference, Horowitz, Cameron, Burrascano, Shor, McDonald, Savely, Sapi, Stephen Bock, Kenneth Bock, Schwartzbach, Nathan, Donta, Jemsek.

There was a great deal happening at the conference so I will only mention a few things that stood out for me.

One of my favorite Lyme clinicians is Dr. Richard Horowitz. He seems a little more aggressive than most. He believes that lyme and its coinfection illnesses are part of a larger complex, what he calls MCIDS -multiple chronic infectious disease syndrome. Here is a video of him talking about MCIDS. His lecture starts at 23:50.

I have never been able to understand the split between Lyme and ME/CFS. To me they seem like the same disease - each a form of acquired immune deficiency. But these two illness worlds do not seem to overlap in the real world. There is very little crossover. With this in mind....I was surprised to see Dr. Kenny De Meirleir at this conference. He gave a lecture on injectable GcMAF. This was a shortened version of his lecture at Mt. Sinai, which can be seen here. Dr. De Meirleir's lecture provoked some serious interest among a number of people, but it was surprising to me that there was not a larger audience for this talk. GcMAF or MAF 314 did not seem to be on the radar of the members of this conference. My own repeated references to the efficacy and benefit of MAF 314 brought almost no response.

Dr. Kenneth Bock gave a fine talk on Transfer Factors. This, of course, is old and almost forgotten information. It was good to see it advanced again.

Rich van Konynenburg was scheduled to make a presentation of his concept of methylation blockage and glutathione depletion. Unfortunately Rich died suddenly in late September. This was a great loss for the community of neuro-immune illness. Dr. Neil Nathan gave an abridged version of Rich's concepts, pointed people in the right direction to find his work  and spoke with deep feeling of this loss. Rich's lecture at Mt. Sinai in the fall of 2011 can be found here.

It was a great pleasure to meet Diana van Konynenburg at a get-together of the Ratna Ling group, a reception in remembrance of Rich van Konynenburg. Rich was a member of this group since its inception. Ratna Ling was a privately sponsored group of clinicians and researchers who met a few times a year to discuss aspects of neuro-immune illness. It was a powerful idea while it existed. I think the last year of sponsorship of this group was 2008. This reception allowed for a great amount of interaction among conference participants.

Another former Ratna Ling member in attendance was Dr. Judy Mikovits. It was great to see Dr. Mikovits and to realize, despite the turmoil in her life, she is back in business, attending conferences and giving presentations. Right after the ILADS conference, she spoke at the ME/CFS conference in Northern Ireland on November 12, 2012 - and she will be at the Physicians Roundtable in January. Dr. Mikovits seemed very focussed and was actively participating with many people.

For me the most powerful moment was three consecutive lectures on the last morning by Dr. Armin Schwarzbach, Dr. Alan McDonald and Dr. Eva Sapi. All three of these lectures had a sharpness to them - combining significant ideas and insights built on past research, while advancing the possibility of a positive leap into the future. These kinds of "visionary" lectures are not often seen amid the reams of statistics and clinical observations that are piled high in many other talks. The three of them in a row was impressive.

I was unfamiliar with Dr. Schwarzbach and I was very pleased to meet him and hear his presentation. Dr. Schwarzbach runs a research and treatment clinic in Augsburg, Germany. The clinic website is here. Dr Schwarbach's talk was entitled "Chlamydia Pneumoniae and Borrelia Burgdorferi as Intracellular and Cystic Bacteria: A Study of Symptoms, Laboratory Problems and Therapeutical Consequences".

I confess that I was a little taken aback by the talk of Dr. McDonald and wish very much that I could hear it again. It immediately sent me to read more about him on the internet. Dr. McDonald received a spontaneous standing ovation, which is unusual at conferences. The only other one that I have seen was for Dr. Marcus Conant several years ago.

Dr. Evan Sapi did a fine job following Dr. McDonald - a tough assignment. She highlighted her groundbreaking, ongoing research into biofilms.

One other talk that was significant to me was by Dr. John Aucott, whose talk was entitled "Microbiologic and Immunologic Events in Early Lyme Disease".

ILADS will be streaming selected lectures in the US and Canada on December 1 and 2. The schedule can be viewed here. Consult the ILADS website for streaming days in Europe and Australia.  Most of the presentations that I found interesting are not included in these streaming events. These include De Meirleir, McDonald, Sapi, Burrascano on the culture test, Neil Nathan on methylation, Aucott and Schwarzbach.

For more complete coverage of Lyme conferences I refer you to Scott Forsgren's site, here. Scott always does first-rate coverage.

Thursday, November 22, 2012

"Microbial Ecosystem Therapeutics" - Dr. Emma Allen-Vercoe, microbiologist


Following up on my post of probiotics and other ones on gut ecology, here is a recent lecture by Dr. Emma Allen-Vercoe at the Universtiy of Guelph in Canada. It is entitled "A New Paradigm in Medicine: Microbial Ecosystem Therapeutics". Dr. Allen-Vercoe is a microbiologist and her biography can be found here.

This lecture is a good discussion of emerging research in gut ecology. Dr. Allen-Vercoe presents her own exciting research ideas including describing the "MET" project. She also speaks of regulatory problems in moving forward with this treatment. This part is worrisome.

The link was sent to me by an ME/CFS friend who prefers to remain anonymous. I thank him for this tip.

Sunday, November 18, 2012

Adult Stem Cell Video for Muscular Dystrophy





Several years ago there were reports of Dr. Paul Cheney taking ME/CFS patients to Costa Rica and Panama for autologous stem cell treatments. The stem cells were harvested from the patients' fat or bone marrow and reinjected back into the patient after being manipulated in some fashion. The reported results were uncertain, and very little has been heard since about stem cells for ME/CFS patients.

The adult stem cell treatments of patients of Dr. Cheney were done at Stem Cell Institute in Panama as well as an institute in Costa Rica (which was eventually closed). The Stem Cell Institute is the brainchild of Dr. Neil Riordan. The webage of the Institute is here. Neil Riordan's professional page is here.

The main treatment thrust of the Stem Cell Institute is in other areas than ME/CFS. The Institute focuses on spinal cord injuries, MS and Muscular Dystrophy. The above video follows the treatment of Ryan Benton, a patient with Muscular Dystrophy.

The video was made by Peter Cairns. Peter Cairns and I met Dr. Neil Riordan by chance at a dinner after an XMRV-related conference at the Whittemore Peterson Institute in the summer of 2010. Many researchers and clinicians were invited to this conference to share information on neuro-immune illnesses.


Saturday, November 10, 2012

"I never met a probiotic that I didn't like."


Three times this past summer I took the long and difficult drive from PA to MN and back. Along the way I listened to podcasts, piano music (Brahms, Scriabin and Hersch) or ballgames. A few weeks ago, by chance, I heard a program on NPR's Science Friday that was right up my alley. It is entitled "Microbes benefit more than the gut".

 It can be found here.

Dr. Susan Lynch, an associate professor of medicine at UC San Francisco, discussed her recently published study on microbial diversity in the sinuses. An abstract of the study is here. During this interview Dr. Lynch touched on several of my favorite subjects including gut ecology, fecal transplants and Corynebacterium tuberculostearicum. (This is a bit of a joke.)

Dr. Lynch brings up several connections between the terrain of the sinuses and that of the gut - and what might be happening when things get out of whack.

Probiotics is a "hot" field these days.  I have a Google alerts on probiotics. Each day I read what comes across the screen. A year's study of probiotics research yields some valuable information.

The biggest news in the gut biome field was published in June 2012.  A significant mapping study of the gut biomes of over 240 normal people was presented by the Human Microbiome Project. "By mapping the normal microbial make-up of healthy humans using genome sequencing techniques, the researchers of the HMP have created a reference database and the boundaries of normal microbial variations in humans". Information about this study can be found here and elsewhere.

Various companies are studying and working on probiotics and probiotic formulations. The following is a selection of some interesting items.

Here is an article of studies indicating that Oxalobacter formigenes eats oxalates - with the possibility of reducing the chance of developing kidney stones. O. formigenes is not yet commercially available.

Micropharma is a company doing serious probiotic work. Here is an article on a probiotic formula that improves blood lipids and cholesterol. One of their main products is Cardioviva.

Another probiotic company is Chr. Hanson. This company has developed lactobacillus rhamnosus GR-1 in conjunction with Dr. Gregor Reid. Dr. Reid used this probiotic in a pilot study in Tanzania. This study inspired Marco Ruggiero to pursue his research into MAF 314.

Chr. Hanson has also developed a bifidabacterium, BB-12. BB-12 and LGG recently surfaced in this study involving colds and college students. Chr. Hansen has a page devoted to the research into this well-studied probiotic.

Dr. Reid is one of the foremost researchers in probiotics. As a microbiologist at the Lawson Health Research Institute in London, Ontario,  Dr. Reid co-developed a combo probiotic of Lactobacillus rhamnosus GR-1 and lactobacillus reuteri RC-14. It is marketed by Chr. Hansen and Jarrow, sold under the name of Fem-dophilus. Here is Dr. Reid on youtube speaking about this combination of Lactobacillus Rhamnosus GR-1 and Lactobacillus Reuteri 14 on yeast. Here is Dr. Reid talking more fully on probiotic research.

More recently Dr. Reid has stated that "Beneficial bacteria are indeed capable of degrading pesticides and sequestering toxic chemicals".

In this article, Dr. Reid lists those probiotics that he believes have been well studied.

Dr. Reid will be part of a one-day conference at NYAS in June 2013.

Most doctors - even those dealing with ME and other neuro-immune illness - do not give enough attention to gut ecology - and do even less to try to improve it. It does not seem to occur to them that gut ecology has something to do with immunce status or even autoimmunity. These gut changes, undertaken by patients, take time and effort to yield results. According to Dr. Kenny De Meirleir, turnover of gut ecology takes months. A state-of-the art Metagenomics test is available at Redlabs BE for tracking progress. A paper is soon to be published in regards to this test.

Gut ecology lies close to the center of this illness - and the ecology of the gut can be improved. Research and experience have pointed me towards specific agents. These are some good ones:

VSL #3
Fem-dolpholis (lactobacillus rhamnosus GR-1, l. reuteri RC-14)
Culturelle (reuteri GG)
Custom Probiotics (various, including lactate -free)
Mutaflor (E.coli Nissle)
Arabinogalactan

The FDA has recently blocked the sale of Mutaflor in  the US and Canada. The reason? - the FDA claims Mutaflor is a a biological drug requiring trials and approval. Welcome to the future.

Recently I have become aware of Arabinogalactan. Arabinogalactan and its capabilities can be read about here.  Among other things larch arabinogalactan increases NK cell function. Here is an abstract from 1999.

And then there is MAF 314. 
This probiotic yogurt formula produces a tremendous amount of MAF. MAF decreases nagalase in the body.  Nagalase is a bad-boy enzyme. Nagalase levels can be measured at Vitamin Diagnostics (Health Diagnostics). The exact effect of this MAF 314 is unknown, and it is apt to remain that way for awhile. Beyond producing MAF, MAF 314 acts as a super-probiotic, delivering over thirty "good bacterias" in each dose. MAF-like probiotic formulas can be produced in the home, using existing probiotics and colostrum.

It is of interest that Dr. Gregor Reid is experimenting with his own version of a MAF-like probiotic, one which Professor Ruggiero says is very close to his own MAF 314. Dr. Ruggiero is working steadily to make MAF 314 more readily available.

Of course none of this improvement in gut ecology can be disconnected from diet - from what the patient puts in her mouth. Diet can also be treated now. Consult Dr. Myhill, Dr Terry Wahls, or Dr. Natasha Campbell-McBride. The key activity is limiting or eliminating carbohydrates. Dr. Burrascano emphasizes the need to cut out carbohydrates. More clinicians need to approach treatment of neuro-immune illnesses with this global approach. (This is not exactly news to many patients. See this 1999 site. )

Research into gut ecology is steady and on-going. While patients suffering from this debilitating illness are waiting for research into the pathogens that might or might not be responsible, it might be worth taking note of the gut biome research and strive to do what one can now - even though the treatments are somewhat general at this point.

All of the above is presented for informational purposes only. It should not be construed as medical advice. Always consult a physician (if you have or can find one).

Wednesday, November 7, 2012

ME Newry, Northern Ireland conference November 11, 2012




This is a video of a presentation of Rich van Konynenburg at the Mt. Sinai conference in NYC on November 20, 2011. Rich presented his concept of methylation blockage and glutathione depletion in ME/CFS. This video of Rich van Konynenburg at Mt. Sinai is a compressed version of a three-hour lecture given in Sweden, which can be seen here.

Rich van Konynenburg died suddenly on September 25, 2012. This was a tremendous loss for all of us. He was a very compassionate human being, with a very special mind and heart.

Rich was scheduled to speak at the 2012 conferences of ILADS in Boston on November 3, 2012 . At the ILADS conference, Dr. Neil Nathan, a long-time friend and collaborator, stepped in and presented a lecture of Rich's ideas about methylation blockage and glutathione depletion in ME/CFS. Dr. Nathan's lecture was based on Rich's notes. Neil Nathan did a fine job at a difficult assignment. Rich was also lined up to speak at the ME conference in Newry on November 11, 2012. Dr. Enlander, a long-time admirer of Rich van Konynenburg and the Chair of the conference, has dedicated the Newry ME conference to the memory of Rich van Konynenburg.

Speakers at the Newry conference include Dr. Charles Shepherd, Dr. Judy Mikovits, Dr. William Weir, and Dr. Chris Roelant.

This video was made by Peter Cairns.

Monday, October 22, 2012

CFSAC testimony - Dr. Joan Grobstein on Responsibility




The CFSAC committee met again on October 3-4, 2012. Public testimony can be seen in the above youtube clip and an accompanying one. As usual the testimonies of patients and advocates were varied, heartfelt and stirring. Over the years these presentation have done a great deal to publicly give a face to ME/CFS and to elaborate, in the most personal and often harrowing terms, the toll that it takes on patients. Collectively these testimonies are the strongest evidence of the case against the government for   their weak response to this medical emergency. This year there is some slight evidence that the CFSAC committee and the federal government itself, principally the FDA, is waking up from their long slumber and beginning to take ME/CFS seriously.

Many years ago I came to realize that the testimonies of Dr. Joan Grobstein are particularly articulate and insightful. Dr. Grobstein has the capacity to distill various problems down to their essential matter - and to cut out the crap. Dr. Grobstein has repeatedly clarified the central issues and constructed a path that will lead us out of the quagmire impeding research and treatment into this illness. It has always been my opinion that this woman should be given a position where she could "make things happen". Certainly her background as a physician gives her a unique and important perspective. When concerned people are gathered to design a plan of how to attack this illness, Dr. Grobstein's name should be first on the list.

Dr. Joan Grobstein's oral presentation at the October CFSAC meeting begins at 38:50 on the youtube video . Previous testimonies of Dr. Grobstein are available elsewhere on this blog or on youtube. Each of them is noteworthy.

In no way should this focus on Dr. Grobstein be seen as diminishing the myriad fine efforts of all the participants in the public testimony. Their testimonies do us all a very great service and I thank these individuals for the special time and effort that it takes to give testimony.
  • Two important items of Dr. Grobstein follow: The first is a transcript of Dr. Grobstein's oral statement delivered at the CFSAC meeting. The second is Dr. Grobsteins' five-page written submission.

"Hello.  I’m Dr. Joan Grobstein.  I’m a physician.

My topic is responsibility.

Recently we’ve seen accomplished scientists honestly and courageously admit that their original findings about XMRV were mistaken.  They took responsibility for an error.  At its best, this is how science works:  form a hypothesis, test the hypothesis, revise the hypothesis.  We would like to see the same honesty and courage from scientists at CDC about the empiric definition.  The hypothesis that the empiric definition defines the same disease as either Fukuda or the Canadian definitions has been tested and found to be wrong.  Scientists at CDC must take responsibility for this error.  The original paper on XMRV in ME/CFS patients has been retracted. CDC should retract all papers using the empiric definition or, at least, rename them to indicate that they are studies of Idiopathic Chronic Fatigue and major depression, not ME or CFS.

NIH must also take responsibility:  fund studies that will clarify the definition controversy, as it did with XMRV.  Because we saw money appear quickly to study XMRV, we know that funds are available.  It’s clear that CDC’s new study about the definition is unlikely to be impartial.  They are vigorously defending their position.  During a recent phone contact with patients Dr. Unger said CDC could be “lumpers one day and splitters the next”.  This is a remarkably unscientific statement.  The scientific method demands that we rigorously define the conditions of our investigations.  Without understanding this, how can Dr. Unger be trusted to undo the harm to ME and CFS patients that the definitional conflict has caused?  Leaders at CDC must take responsibility and ensure that science done at CDC is impeccable.  There are biomarkers for Canadian-defined ME/CFS patients.  Does CDC wish to conceal that these biomarkers are not found in empiric-defined CFS patients?

Turning now to the responsibilities of the voting members of CFSAC, its staff, and its ex officio members, we’re all aware that very few recommendations made by this Committee have been implemented.

For example, CFSAC made three specific revenue-neutral recommendations  which have been ignored.  The first, from 2009, condemned the use of the empiric definition.  Despite this recommendation, CDC continues to publish studies using the empiric.  The second recommended removing the Toolkit from the CDC website.   The third recommended making IACFS/ME’s Primer widely available.  These last two recommendation were made 4 months ago.  Today, the Toolkit remains on the CDC website.  Meanwhile, CFSAC’s own website has a new link to the Toolkit and no link to the Primer.

Who’s responsible for the lack of action?  Committee members have fulfilled their responsibilities.  It says on the website they “asked” that these three things be done.  On the contrary, they are experts, and, as such, they made recommendations to the Secretary.  Yet neither the ex officio members nor the staff have apparently worked on implementation.  Dr. Koh’s comments gave no indication that he is aware of the importance of these recommendations.  In a letter to advocates explaining his refusal to meet, Dr. Koh said, “CFSAC provides a mechanism to ensure stakeholders are engaged and have the
opportunities to offer input.”  Instead, it appears that CFSAC provides a mechanism to ensure stakeholders are contained and have opportunities to offer input that will be ignored.  So what is the point of CFSAC?  If it cannot accomplish these small, high impact tasks how can it accomplish what we really need:  significantly increased funding for research, better education and improved clinical care?  CFSAC costs $235,000 annually.  That sum could fund a study of natural killer cell function in Canadian-defined patients, or create a mechanism to identify an undiagnosed low-income patient, or educate a few more physicians.  I’m a taxpayer.  I’m concerned that we’re spending almost a quarter of a million dollars each year on a committee whose recommendations are routinely ignored by DHHS.

Here’s a suggestion.  Ask ex officio members to take responsibility.  Ask staff members to assign each recommendation to the agency or agencies with responsibility for implementing that recommendation.  Ask each ex officio member to report on activities to implement each recommendation at every meeting.  If nothing is happening ask for explanations from higher levels within the agencies.

We need to see progress. 

[Please read my written testimony which contains other suggestions for progress.]


If you fund it they will come.

Progress in our understanding of ME and CFS has been hampered by a lack of funding for good research.  We have been told by the NIH that funding levels are low because very few high quality applications are received addressing these diseases.  Yet we are told by researchers who have had repeated success in obtaining NIH funding for research in other areas that their applications for funding for projects concerning CFS have been repeatedly rejected.  Funding for clinical trials has been rare.  This has resulted in a vicious cycle:  few people enter the field out of fear that they will not be able to obtain funding, and thus there is a smaller pool of high quality applicants and applications.  It is time to break that cycle with dedicated funding for ME and CFS research.

Following the model that resulted in Requests for Applications issued on September 21, 2012, by the National Cancer Institute, I suggest that several Institutes at the NIH develop a list of provocative questions (PQs) about ME and CFS that then lead to Funding Opportunity Announcements, using RO1 and R21 mechanisms.  The total funding available in the NCI announcements was $64-84 million.  In addition, $21 million was made available for a Clinical Trials Network, something that is also desperately needed to further our knowledge of ME and CFS.   The relevant institutes that should be involved in developing the PQs are:  National Cancer Institute (increased incidence of early malignancy),  National Eye Institute (multiple ophthalmologic problems), National Heart, Lung, and Blood Institute (orthostasis, post-exertional malaise and altered blood volume), National Human Genome Research Institute (increased incidence in family members), National Institute of Allergy and Infectious Diseases (multiple co-infections, possible infectious etiology, immunological abnormalities), National Institute of Arthritis and Musculoskeletal and Skin Diseases (joint and muscle involvement), National Institute of Child Health and Human Development (pediatric ME and CFS), National Institute on Deafness and Other Communication Disorders (hyperacusis), National Institute of Diabetes and Digestive and Kidney Disorders (associated irritable bowel syndrome), Nation Institute of Environmental Science (associated chemical sensitivity), National Institute of General Medical Science (basic processes of cellular energy allocation), National Institute of Mental Health (adjustment of patient, family and community to chronic disease), National Institute on Minority Health and Health Disparities (no access to diagnosis or treatment for minorities and low-income individuals), National Institute of Neurology Diseases and Stroke (cognitive dysfunction, sleep disorders, autonomic nervous system dysfunction, possible disorders of glymphatic system), National Institute of Nursing Research (need for nursing care for homebound and bedbound patients, quality of life in a chronic illness), National Center for Complementary and Alternative Medicine (patients forced to use alternative medicine because no mainstream treatments available), NIH Clinical Center (clinical studies of bedbound patients), and National Center for Advancing Translational Sciences (need for rapid implementation of bench science in these diseases).

Many of these divisions are already represented on the Trans-NIH ME/CFS Research Working Group.  This group should be tasked with formulating the Provocative Questions with the input of both expert clinicians, who have been working with affected patients for years, and also expert patients.  Because patients have been largely abandoned by the scientific and medical communities, many have developed considerable expertise in pathophysiology and available therapeutics. We know which Questions are the most Provocative, because we live with these questions every day.

The Working Group is currently reported to be meeting monthly.  An accelerated schedule will be necessary to develop and prioritize the Provocative Questions, so that RFAs can be issued as soon as possible.  A high priority should be given to studies of potential therapeutic agents, because there are no therapeutic agents currently approved for the treatment of ME or CFS.  Similarly, there are no validated biomarkers to use for diagnosis or to follow responses to therapies.  This is also a very high priority.  Of note, expert clinicians are using therapies that they believe to be effective and also use biomarkers to evaluate those therapies.

Unlike cancer, which has been well-funded and extensively studied for decades, ME and CFS have largely been ignored.  Although there are over 5000 published studies, most are small and many have not used rigorous criteria for inclusion of subjects.  The required funding for this first initiative is therefore larger than in the cancer initiative described above.  It is, of course, impossible to know how much funding is needed to advance our knowledge of ME and CFS to the point where patients’ lives will be measurably improved.  However, it is possible to make an educated guess based on current NIH funding for Multiple Sclerosis, a disease which causes a similar level of disability and may well be a related or overlapping condition.  MS is estimated to affect approximately 400,000 Americans and receives $121 million per year from NIH for research.  ME and CFS are estimated to affect at least 1,000,000 Americans.  It therefore seems reasonable to allocate $302 million annually to ME and CFS research.


A Barrier to Productive Research Besides Funding


The biggest problem for ME and CFS research has been a somewhat esoteric one:  there have been multiple definitions of the disease, some of which have been overly broad, have not focussed on the most important and unique features of the diseases, and have been shown to include large numbers of patients with other disorders as their primary diagnosis.  This has resulted in wildly varying results  and has made it appear that there are no consistent biomarkers or responses to therapeutic agents.  It has also given an erroneous picture of the diseases.  For example, because large numbers of patients with major depressive disorder were included in cohorts defined by a definition developed by the CDC (the empiric definition) and probably also by another definition developed by physicians in the UK (the Oxford criteria), it has appeared that ME and CFS could be psychological disorders which may respond to cognitive behavioral therapy and a program of increasing exercise intensity (called graded exercise therapy or GET).  However, even in this diluted population the benefits of these therapies are quite minimal.  There is evidence that GET is actually harmful to patients with ME and CFS defined by more stringent criteria preferred by expert clinicians.  It is therefore extremely important that research funded by the NIH use an appropriate definition during patient selection.

The International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (IACFS/ME), an organizations of clinical and research experts, has recommended using the Canadian Consensus Criteria (CCC) to define ME/CFS in its CFS/ME Primer for Clinical Practitioners.  Patient groups also support this definition.  Thus, it seems reasonable to use this definition in NIH research.

Most (but not all, as noted above) research in the past has used the Fukuda definition, developed at the CDC in 1994.  The problem with Fukuda is that it does not insist on post-exertional malaise, which is probably the cardinal symptom of ME.  It also does not give a higher priority to the presence of other very important features of ME:  orthostasis (not even mentioned in Fukuda), cognitive dysfunction and sleep disorders.  Until the issues in the definition are clarified, it will be necessary for every study funded by the NIH to also classify patients using Fukuda and, in addition to standard data analysis, to separately analyze the data for patients who meet Fukuda criteria and those who meet Canadian criteria (many will meet both).  Thus, over time it will get clearer if there are distinctions between groups defined by these two criteria.  It seems likely that CCC defines ME and Fukuda defines a less-specific group that has been called CFS.  However, only consistent data analysis will provide this clarification.

There was recently an effort among researchers, including the CDC, to establish a minimal data set for ME and CFS research in order to begin to answer some of the questions about differences between definitions and also basic information about the diseases.  However, I have recently heard that this effort has stalled, for unclear reasons.  This is unfortunate.  This could be one of the Provocative Questions:  what data should be collected in every study in order to make patient cohorts uniform (or at least clarify when they are not) and enhance our understanding of these diseases?  An NIH-funded review of the 5000 studies already done to see whether the definition used correlates in any way with the results would be very helpful.

The only study that is currently being done about the definition is a study by the CDC.  This is problematic, because the CDC is the originator of both the Fukuda and the empiric definitions.  They have continued to publish research using the empiric definition as recently as this year, although it has been condemned by CFSAC (see below), and most researchers now agree that it is overly broad and that research using the empiric definition is biased toward demonstrating psychopathology in CFS.  Although it is possible that the next CDC definition will be an improvement, this seems unlikely.  In a recent question-and-answer session with patients, the head of the CDC’s CFS program, Dr. Elizabeth Unger said that she thought the CDC could be “lumpers one day and splitters another” (lumpers referring to more inclusive definitions and splitters to more precise ones).  She also said that she thought that heterogeneity has been the barrier [to moving forward in our understanding of ME and CFS].  It is unnerving that she thinks that heterogeneity is the barrier, and yet she is unwilling to improve consistency by promoting a splitter-definition over a lumper.  She may feel more of an allegiance to past failed efforts of the CDC to appropriately define the diseases than she does to rapidly advancing research that will help to alleviate the suffering of patients.

It is obvious that more research must be done to specifically address the problems that the multiple definitions have created.  NIH should be actively promoting this effort.  A possible solution is an NIH-funded symposium whose task would be to address the definition problem and the resulting methodological challenges with the goal of creating standards for research within a year.   

It is important that outside groups either validate or challenge CDC’s efforts.  However, this should not delay other research, especially in the areas of biomarkers and therapeutics.  Patients should not have to wait for therapies because researchers are squabbling over the small details of definitions.  We have two serviceable definitions:  Canadian and Fukuda.  For now, the best solution is probably to recruit only patients who meet both sets of criteria, but it may also be possible to use a study design that incorporates patients who meet one and/or the other.  It is also possible to improve Fukuda by requiring post-exertional malaise.  In any case, it must be very clear what definition is used, and it will be important to analyze data collected in such a way that it can be leveraged to clarify the definition problem.  It is vital that the definition used be stated in the abstract to the article, so that clinicians and researchers can rapidly ascertain the study’s relevance to their patient population.  Continuation of the effort to delineate minimal data sets is also very important. 


Yet another barrier:  will


To members of the patient community it does not appear that HHS is really interested in promoting research or other solutions to the problems and challenges that American citizens with ME and CFS face.  We have asked to meet with high level officials in the Department and have been told that our only avenue of communication with the Department is the Chronic Fatigue Syndrome Advisory Committee (CFSAC).  Patients have attended meetings of the Committee with great difficulty and at great personal cost.  The Committee has made some excellent recommendations to the Secretary, but these recommendations have mostly not been implemented.  Most recently, three revenue-neutral recommendations have been ignored:  a condemnation of the empiric definition (2009), a recommendation to remove the CDC’s clinical guidelines from their website (2012--see Mary Dimmock’s testimony about the Toolkit), and a recommendation to post the IACFS/ME Primer instead (2012).  There have also been multiple recommendations to increase funding for research and for centers of excellence for research and clinical care.  NIH research funding for CFS is currently $6 million per year.  This level of funding is 220th out of 232 diseases.  There is no funding for ME, i.e., no funding that requires using the Canadian definition.  There are no centers of excellence.

No HHS official has given an explanation as to why the three important, revenue-neutral recommendations (empiric definition, toolkit and primer) have been ignored.  To date, Dr. Koh’s comments have given no indication that he is aware of those recommendations or of their importance.  At this point, many patients are asking, what is the point of this committee?  If it cannot accomplish small tasks that probably only require a single bureaucrat’s signature how can it ever accomplish something more substantive like significantly increased funding for research, education and clinical care?  What, then, is the purpose of this committee?  CFSAC costs $234,532 annually. This money could fund a study of natural killer cell function in Canadian Consensus Criteria-defined ME/CFS patients and/or a study to determine appropriate dosing of rituximab for ME.  As a taxpayer, I am extremely concerned that we are spending nearly a quarter of a million dollars each year on a committee whose recommendations are routinely ignored by HHS.  We have begun discussions about this problem with our legislators.

We feel that CFSAC, as it is currently functioning, is not meeting our need for an urgent, coordinated and fully funded federal response to ME and CFS.  Here is a link to the reply we received from Dr. Koh, Assistant Secretary for Health, when we asked to meet with him and key deputies to discuss our concerns:  http://bit.ly/TnoClG .  The full text of the letter can also be read in testimony submitted to CFSAC by Denise Lopez-Majano.  Of note, in response to a request for patients to have direct input on the Ad Hoc workgroup Dr. Koh stated, “While the [Ad hoc] workgroup and its charge are inherently internal to HHS, some of the members are also ex officio members of the CFSAC where they hear the stakeholder perspective. CFSAC provides a mechanism to ensure stakeholders are engaged and have the opportunities to offer input.”  I would suggest that CFSAC keeps stakeholders engaged in activity that consistently leads to no results and gives the opportunity to offer input that is consistently ignored.  This has to change.

If CFSAC is to become a more effective avenue for cooperation between the patient, clinical and research communities and the federal government that produces substantive action to rapidly improve the lives of citizens with ME and CFS, we need to see some changes in how it functions.  We need to be able to question the ex officio members and Dr. Koh directly.  We need frequent updates on the activities of the Ad hoc workgroup (we have had none to date).  We need to see the promised report from the NIH the State of the Knowledge conference 18 months ago.  We need to discuss many other important issues.  We need to see substantive recommendations implemented.  We need to see progress.  If CFSAC continues to be ineffective and its recommendations are ignored, it should be disbanded.  A more productive process must be implemented.  We need to meet with Dr. Koh and key deputies from HHS to discuss these issues.

We look forward to a better future.




Wednesday, October 10, 2012

"See you later"


The news comes that XMRV Global Action  (0n Facebook) is saying "Auf Wiedersehen". This is a bit of disappointing news to say the least. It seems that the world of ME/CFS information and communication is shrinking dramatically in the last few weeks.

Since late 2009, XMRV Global Action has been a clearinghouse for information on neuro-immune illness. They did a first-rate job and their site was the go-to site for many of us. Somehow they were able to consolidate the important current issues without a lot of clutter. This of course is useful to many who cannot spend a long time on the computer - or for those who have trouble focussing.

This website was extremely useful to me over the years and I am not sure how I am going to replace their information feed. I can say the obvious. I won't be able to. I am going to miss a great deal of information now - information that was essential to form an opinion and a course of action with this difficult illness.

As a daily reader of the site I want to thank the six or eight sponsors, those who ran the site, for their generous daily efforts. What they did was just great. It could not have been done better and many of us are indebted to their joint enterprise. Hopefully someone else will be able to step forward and fill the void left by their departure. Certainly those who ran this site have given others a fine matrix to follow.

Friday, October 5, 2012

Mold – “A Tough Tussle”


The fantastic writer Ambrose Bierce wrote a short story, a quite frightening piece, called “A Tough Tussle”. The story concerns a Civil War soldier’s deadly nighttime struggle with an unseen or unknown terror. “A Tough Tussle” and Brainerd Byring’s frightening incident come to mind when I think of my own experience with another unknown or unseen terror: Mold.

My daughter got sick with a neuro-immune illness in 2002 and stayed about half sick for three or four years when she went downhill.  Prior to her downhill crash in 2006 she moved to St. Paul, MN from NYC.  In St. Paul she lived in the same apartment until May 2012.

I became suspicious of the building in which my daughter lived after reading about mold as a complication for neuro-immune illnesses. I went through her entire building, attic and basement, and saw no evidence of water damage or water intrusion. I spoke to her landlord who has owned the house for thirty years, and he said that there had been no water intrusion in the time that he owned the building. Upon closer questioning he did reveal that when he first bought the building, he looked into a square hole (no longer there) in the floor of the basement and was surprised to see water, and that something floated by on the surface of the water indicating that the water was moving. This gave me an idea and I went to the historic society of St. Paul and found a map of the property prior to the house being built in 1920. It appeared from this map that the house had been built on a stream bed.

Over a period of several years I did two ERMI tests of my daughter’s apartment and they were both high. They registered 11 and then 7, both with an extremely high Aureobasidium pullulans.  As with all molds it is difficult to find out much about this strain  - except that it is associated with water. This made sense if the house was actually built on a stream bed. Aureobasidium pullulans does not seem to be a dangerous mold, but who knows?

During these years my daughter was too sick to consider moving from the premises.

Circumstances led me to move into the apartment below my daughter. It is a two apartment building so I had control of the entire building. I was shocked in October 2011 to get an even higher ERMI test for the ground floor apartment, which I now occupied – 17, including another sky-high Aureobasidium pullulans.

With this test I decided to do what I could to remediate this building. In the next month I went over every square inch of the building, first cleaning it and then spraying every surface with a concoction of vinegar, borax, oil of oregano, vodka and clove. I cleaned and did the mold treatment on all floors, walls and ceilings including the basement and the attic. I found a small amount of mold in the basement eaves that I remediated myself.

I did another ERMI test that came down significantly but was still irritatingly high. Of course, with my remediation, I was unable to get into the walls or the floors.

At this point I bought a number of dehumidifiers and was able to lower the humidity in the basement to about 40%. It is believed that mold does not grow under 50% humidity. I was shocked to find the humidity in the attic was close to 100%. The reason for this was that the landlord had put insulation down on the floor of the attic, a short-term solution for insulation, but one that will lead to the roof rotting. I pointed this out to him, did him a favor, and took up the insulation. Thus, I was able also to lower the humidity in the attic below 50% with a dehumidifier.

This remediation was completed in November 2011, and the low humidity in the building continued until my daughter was able to move out of the apartment in May 2012.  Over that time, November 2011 to May 2012, she made slow but steady improvement with one major setback. However, she was strong enough on May 2, 2012 to make this move to an apartment ten blocks away – and the move went without incident. 

There are various other reasons – beyond mold remediation - that one might point to for her improvement – primarily the introduction of the probiotic formula MAF 314. This occurred simultaneously with the mold remediation – in October 2011.

My daughter’s slow progress has continued in her new apartment. While she is better, she still remains quite ill.  I have not done an ERMI test in the new space.

Over the last few years she has done a number of tests that measure global cytokine activity or inflammation or NK cell function. Among them are:

c4a – at Jewish National lab, Denver

In 2011 my daughter’s c4a was 15,210 (0-2830). In March 2012 it had come down to 7,377 (0-2830). I imagine that it would be even lower now. I will find out soon.

MMP-9 – at Quest

In 2010 her MMP-9 was 888 (0-985).  Disregarding the Quest lab's normal parameters, Dr. Ritchie Shoemaker says that anything over 332 is high. In March 2012 her MMP-9 was 1325 (0-985). In September 2012 her MMP-9 dropped to 272.

Functional NK (LU30) - at Focus lab

Over the past year my daughter's functional NK cell has gone from 17 to 21 to 34 (9/2012).

There is another useful test which I need to repeat. It is a urine test from Realtime labs and measures three mycotoxins.

Do I think my daughter’s illness was caused by mold? No, I do not think that mold caused her illness. Do I think that mold was a complicating factor? I think the evidence points to this, but, like all things with this illness, we will never really know. I think she lived in a sick building.

Friday, September 28, 2012

"All there, all the time." - Rich van Konynenburg


It was with great sadness that I learned of the death of Rich van Konynenburg. Rich did a tremendous amount of good for patients with neuro-immune illness. He was a beloved figure.

Rich's background was in engineering. He was retired from a job at Lawrence Livermore Laboratories when he got hooked, through chance, into applying his intellect and fine mind to the complexities of ME/CFS. He stumbled into the field as many do - through having a friend with ME/CFS. What a wonder and a delight this chance happening was for the rest of us!

Rich van Konynenburg - an independent, non-medical, unaffiliated researcher - has done a tremendous amount to "get at" this illness. The operative words here are independent and unaffiliated. Bringing betterment to this patient population became his life. He connected to the patients and felt their isolation and frustration.

It was said about the painter Georges Braque that he was "all there, all the time". Well Rich too was "all there, all the time".

About ten years ago Rich formed an idea about this illness - the essentials borrowed from an Autism treatment of Jill St. James and Amy Yasko. Rich transferred this Autism treatment, with adjustments, to ME/CFS, developing, through analysis, the idea that glutathione depletion was a critical problem in this illness. Applied to ME/CFS, the idea was a good one, it had legs, and the theory put into practice has brought a great deal of betterment to many ME/CFS patients. Over the years, Rich elaborated, researched and promoted his concept of a methylation block/glutathione depletion as a central, perhaps the central, feature with these neuro-immune illnesses. Once in, he displayed perseverance, love, support, empathy, resolve, intelligence and an astonishing array of other wonderful human qualities. As far as I could see, this fellow had no downside.

Rich van Konynenburg will not be replaced. He is truly irreplaceable.

For a number of years, Rich was a member of the Ratna Ligne group, a privately financed alliance of clinicians and researchers. It was here that he was able to present his big picture concepts of the working of this illness. It was here that he forged long-term relationships with other thinkers.

I first heard of Rich van Konynenburg from Dr. Karen Vrchota of Winona, MN. Dr. Vrchota was an early believer in Rich's ideas of methylation blockage, with accompanying glutathione depletion. Dr. Vrchota introduced my daughter to the protocol and over time, it has benefited her. A number of years ago, Rich wrote an analysis on my daughter. He was interested in her case as it was so well documented. What did I learn from reading this analysis? I learned that this is a complex multi-faceted illness that has to be taken apart and attacked in pieces. I learned that there are existing therapies that can help with this illness. I learned that certain things need to be done for other things to be added.

In time, Rich built a relationship with Dr. Tapan Audhya at Vitamin Diagnostics and asked Dr. Audhya to construct a test or series of tests that accurately measures reduced glutathione and various components in the methylation cycle. With these tests patients were able to identify the problem - and more importantly were able to track progress. These few simple supplements supporting the therapy remains one of the essential actionable treatments for this illness. A great many people have experienced positive benefit with the methylation protocol and testing.

In 2009, Rich did a privately funded treatment study with Dr. Neil Nathan. The study can be found here. The positive study results warranted further controlled study, which has not been done.

I first encountered Rich van Konynenburg in January 2007 in Fort Lauderdale at the IACFSME conference. Rich presented a "poster paper" on the methylation blockage concept. This meant that he  "posted" a visual display of his research ideas (for selected hours).

At this conference, after each series of lectures, there was an "open microphone" question period. Rich was quick on his feet, always first to the microphone, waiting to ask his question. At the end of his question time, he would move to the end of the line, hoping to ask another question. His questions were always articulate, specific, challenging, thoughtful and respectful. Always they connected his theory to the existing, mostly abstract, dogma being presented at the conference. One looked at this situation and wondered, what is wrong with this picture?

Why is this fellow Rich asking the questions? Why is he not up front, on the lectern, giving a lecture and presenting his ideas? It made no sense to the perceptive viewer. After all, Rich had a thoroughly constructed theory, a practical and researched idea, an idea that was actionable, and one that could be studied and tested. All this was too much for the powers that be.

The response from the dias to his politely framed clarifications were always the same - a lackluster indifference. What did they ultimately think of Rich voicing his ideas publicly? At the next conference it became clear. At the 2009 Reno conference they canceled the open microphone and took questions through writing, enforcing a situation where they could control the flow.

In Reno, I asked Rich about this change of format. He just looked at me and smiled that wonderful wry smile of his - and said nothing. My conclusion was that he "had seen it before". Rich's response was to move on, to give renewed effort to the avenues afforded to him - the poster paper presentations.

I saw Rich in Reno in 2009, in Ottawa in 2011, in Bethesda at the NIH and in NY at the Mt. Sinai ME/CFS Center conference in 2011. Rich was always the same, engaging anyone who would listen to his ideas. At conferences he could be seen standing from the beginning of the day to the end conversing with anyone from Dr. Cheney to the newest patient or advocate. Rich had a passion for the subject and no bias. One never got the sense that he was talking down to you. He was fascinating.

More recently, and to our collective good fortune, Rich van Konynenburg reached a broader audience in the presentations of his work. He gave a comprehensive three-hour lecture on his theories in Sweden a year ago, which can be viewed here. He also made a shorter version of this lecture at the Mt. Sinai ME/CFS conference in New York in November 2011. This conference was organized by Dr. Derek Enlander. Video footage was made of this lecture and will be available online. There is a blog post on his presentation at this conference here.

Rich was scheduled to speak at the November 2-4 ILADS Lyme conference in Boston. This lecture will now be given by his friend and research colleague Dr. Neil Nathan. Rich was also scheduled to talk in Belfast on Novermber 11, again at the invitation of Dr. Enlander.

Perhaps now the NIH will pick up on his research idea and run studies to conclude what the rest of us already know: Rich's protocol brings benefit to a large number of patients.

The death of Rich van Konynenburg is a devastating loss to the ME/CFS community. Patients all across the world are crying because of this very sad news.

Sunday, September 2, 2012

Fitbit


A few years back I bought and read a book by Dr. Benjamin H. Natelson called Your Symptoms are Real. I have read a great many books on neuroimmune illness, CFS, diet, lyme disease, gut ecology, B12 and so on. Dr. Natelson’s book did not distinguish itself in any particular way - except for one detail. On page 161, Dr Natelson mentioned the benefit of using a pedometer to track increased or decreased movement in illnesses involving fatigue and Post Exertional Malaise. This seemed a good idea so I bought the pedometer type that he suggested (Yamax 701) and had my patient begin wearing it. Like many things the novelty of compiling data on steps taken per day diminished - and more serious circumstances emerged that overwhelmed us, and the pedometer was set aside. However I did not lose interest in nor did I forget the idea – and the subject has revisited me.

Four months ago I stumbled, through my son Peter, upon a newer type of pedometer called a Fitbit. This device is worn clipped on a belt or pants and counts both steps and stairs climbed. What I found most interesting was that this device downloads its information wirelessly to a program on your computer. In this way, it collects or compiles all the data over days, months and years. It has a small way station where you can charge the battery. Each time this way station is plugged into the computer it automatically and wirelessly downloads the most recent information. This download can be done on a daily or weekly basis.

The Fitbit costs about $100 and you can read more about it here: fitbit.com

The wonderful thing about the Fitbit tracker is that it provides objective information or relatively objective information. This is particularly welcome news in an illness that has no tracker of betterment or improvement on therapy. Everything in ME/CFS is self-reported - subjective reporting of the patient, usually via a form. This pedometer device eliminates the uncertainty, bias and confusion of subjective reporting, at least in one category.

The Fitbit purports to be accurate. To me accuracy is less important than consistency. In my case, I pay less attention to the daily steps and more attention to the monthly steps. The program for the Fitbit graphs movement in daily, weekly, monthly and yearly categories.

I know of a number of ME/CFS patients who use this device. All attest to its benefits. One of them has used this device now for four months. She puts it on and gives it no thought - except to program it or recharge the battery. One great advantage is that health care supporters can access the information. For the month of May, this particular patient took an average of 1800 steps per day. In the month of August, the steps averaged 3000. The months in between indicated gradual, measured improvement.

(The question of why this improvement has taken place is another, very confusing matter, and will be addressed in later posts.)

The Fitbit can be used for both general tracking and for specific situations. For instance, if a patient was beginning a new therapy, like GcMAF or Rituximab or Enbrel, he or she could use a Fitbit device to establish a baseline. Over the next six months or so, the patient and physician could both get important information about the patient’s increased or decreased ability to move. The numbers tell the story.

Through my experience with diabetes I have been convinced of the importance of tracking devices. A tracker, particularly a tracking blood test, is absent in ME/CFS - and there is a great need for something to be developed. With existing testing there are various possibilities – NK functionality (LU30), CD57, c4a, MMP-9, Methylation panel, Acumen mitochondrial testing, Nagalase or a combination of all of these. Perhaps others would have suggestions here?

In fighting through the variables of this illness, one longs for something specific, something one can accept for real or as real. In a small way, the Fitbit does its part.

Sunday, August 12, 2012

Dr. Denise Faustman, researcher


Since 1990, for unspecified reasons, I have been reading every day about diabetes. Over that time, I have followed diabetes research and treatment closely. I have learned a great deal about the illness, but I know very little about the actual science of the research.

Since about 2002 I have been reading extensively about ME/CFS and other immune dysfunction illnesses. Again, I have no scientific knowledge upon which to draw.

While I have no scientific or medical background, I believe that it is possible to gain a "feel" for these illnesses- diabetes and ME/CFS -  in spite of being scientifically ignorant. In both situations I have no built-in prejudices and have no vested economic or career interest in either field that might interfere with my judgements. In other words, I have no connection to the "Industry" of these illnesses. Most importantly I have always tried to connect to gifted people who can flesh out my own "insufficiencies".

Years ago I was privileged to meet Al Mann, the founder of Minimed. With his small, flexible and innovative company, Minimed, Al Mann greatly improved the maintenance possibilities of diabetic patients. Al Mann was an amazing man who cared deeply about patients - and it was a sad day when Minimed was sucked up by the large Minnesota company, Medtronic.

Early on, in learning about diabetes. I stumbled upon the work of Dr. Richard Bernstein. At the time Dr. Bernstein and his ideas about diet and diabetes were highly discredited by mainstream endocrinologists. Since that time, Dr. Bernstein's ideas have gained great currency. His book can be purchased here. There are intimations of Dr. Bernstein's ideas in Dr. Joseph Burrascano's imploring Lyme patients to ditch the carbs.

Diabetes, at the moment, is a maintenance illness. With slightly more information, perhaps ME/CFS can reach this status? More needs to be known about the etiology of ME/CFS.

In this post I am unable to list all the diabetes researchers that I admire and follow. Instead I would like to focus on one of them: Dr. Denise Faustman of Massachusetts General Hospital. I have written a previous blog post on Dr. Faustman here.

Dr. Faustman is back in the news this week with a very small, early stage paper publication in PLoS ONE.  The proposed treatment, a relatively safe tuberculosis vaccine in use for eighty years, is apt to yield no profits for the pharmaceutical industry.

The hope is that this vaccine can shut down the autoimmune reaction in type 1 diabetes (and perhaps other autoimmune illnesses). Perhaps ME/CFS researchers Mella, Fluge, Peterson, and Kolgenik are reading about Dr. Faustman's work? I certainly hope so.

Several articles on Dr. Faustman's paper can be found here and here.

From the Bloomberg article:

"Faustman and her colleagues at Massachusetts General in Boston are working to get the vaccine to market. After their early findings in studies with mice, she said they tried to interest every major drug maker in developing the vaccine as a possible cure for diabetes. All told her there wasn't enough money to be made in a cure that used an inexpensive, generically available vaccine, Faustman said."

This publication is very exciting news for those interested in a solution for type 1 diabetes. However major questions rear their ugly heads. Why is there so much resistance to this research? Why is Dr. Faustman so isolated with this research after so many years? Who is going to finance further research? In the big picture, these questions are disturbing - and yet they are so familiar, familiar also to those who know the history of research into ME/CFS.

Dr. Faustman outlines her research and answers some pressing questions in several youtube videos, the first from 2012, the second from the year before.






Dr. Faustman is a very impressive researcher. She does not look like she is going to be dislodged from pursuing her interests. She gives me hope that there are other individuals out there looking for unique solutions to complicated medical questions - and specifically that there will be some spill-over into ME/CFS/lyme diseases.



Saturday, August 11, 2012

"The Garden"


In the course of my job as patient advocate for my daughter, I travel to various places - CA, London, New York City, Ottawa, Brussels. Most of the time I am mired down in patient advocate work, which is only partially rewarding. One positive reality is that I do get to meet many extraordinary people - and this could certainly be the subject of another and longer post. In these travels there are moments of relief -  ducking into the National Gallery to view my favorite painting (Titian's The Death of Acteon), a hot dog with mustard and sauerkraut on the corner of 69th and Lexington on a sweltering day, checking out the Gauguin painting at the Indianapolis Museum of Art, or going to an Orchestra concert in Minneapolis.

Gauguin, 1889

Throughout the mid-West there are these extraordinary museums reflecting broad and deep collecting interests of past inhabitants of these towns - Minneapolis, Detroit, Cleveland, Cincinnati, and St. Louis.

This summer I had the privilege of visiting with Dr. Dale Guyer at his Institute of Molecular Medicine in Indianapolis. I really admire this clinician. I have learned fundamental approaches to ME/CFS from him. At the end of my time with him, I asked if I could have a picture taken with him. Dr. Guyer suggested that we go out into "The Garden" for the picture.

I stepped out back of his clinic and encountered an astonishing world.

Chris Cairns and Dr. Dale Guyer

In the approximately 1/2 acre behind his clinic, Dr. Guyer has planted a vast array of conifers and Japanese Maples. Dr. Guyer explained to me that the two plants directly behind us in the above photo were recently added and are of a species that is quite rare, yet can exist in the environment of Indianapolis.



I can only assume that Dr. Guyer has made every single decision in regards to the plantings and combinations of this rare and beautiful garden. One can discern from the photos the care taken regarding color, variety, size and placement of each and every plant, stone and path. The reality is very powerful. Everything is calculated to deliver the greatest visual and emotional impact. Nothing is haphazard and the entirety has a sense of oneness, of great unity. It is like a gigantic three dimensional painting.



It occurs to me also that this garden is an extension of Dr. Guyer's skill and experience as a physician. Certainly the garden gives a clear insight into the complexity of his personality. His staff jokes that when he gets really refined in his medical practice, he will just send his patients out back to sit, resonate and heal in the environment.






I spent some time walking around "The Garden" and took a few pictures. My only regret was that I did not stay longer, and I have thought about this space and its effect on me a great deal since then. It is very seldom that I am swept away by a spot and enter into a suspended space where I am lost or do not know where I am. This is the profound effect of this garden as you walk into its midst. Suddenly you are transported to - who knows where? It is another world, a world suspended from the raucous existence of modern life.



Dr. Guyer's garden reminded me of another favorite destination of mine, a place that I have not been for many years, but to which I yearn to return: Bok Gardens and Tower in Lake Wales, FL. Although Bok Tower is much different than Dr. Guyer's garden, it has the same powerful effect on the visitor. Much of the impact comes from not expecting it. Bok Garden takes you into a suspended world where you are suddenly and completely detached from yourself. I suppose many people, like me, return there for solace and removal from life's travails - and to reacquire a bit of peace or peace of mind.

I asked Dr. Guyer what he does in his Garden? He says that he sits there in the evening with a glass of wine.

It is not possible this morning to leave this appreciation of Dr. Dale Guyer and his garden without mentioning a recent article that appeared this morning. The article is found here and concerns gut ecology. Both Dr. Guyer and Dr. Kenny De Meirleir  have emphasized the need to heal the gut. It is a central issue in ME/CFS to both of them. Recent research into the gut environment begins to confirm what a number of ME/CFS physicians and researchers believe - that gut ecology might very well be at the center of this illness. If one wonders - as I do - why MAF 314 brings improvement to the patients who have access to it, this article suggests an answer.

Wednesday, August 8, 2012

Questions for CDC - from Dr. Joan Grobstein


The CFSAC listserv has announced a conference call with the CDC for tomorrow, August 9, from 11:00 am to noon EST.  The toll-free phone number is:  866-705-4314.  The access code is:  78687644.  The full announcement is available on Co-Cure at:  https://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind1208b&L=co-cure&F=&S=&P=60

Questions for the CDC can be submitted to:   CFSPCOCACall@cdc.gov

These are the questions I have submitted to the CDC for discussion tomorrow:


For Dr. Unger:


1)  If this call is patient-centered, why is all the information flowing from you to us, i.e. why are we asking the questions and you are giving the answers? The patient community has demonstrated repeatedly that information disseminated by the CDC about ME/CFS is inaccurate.  Because so little information is available to our doctors, we have been forced to become very informed patients.  Shouldn't you be listening to us?

2)   What did you learn from the last set of calls and what changes have you implemented as a result of them?

3)   Given the importance of a rapid response in epidemiological investigations, have you developed a protocol for identifying and investigating geographic or family clusters of ME/CFS as soon as they are reported to you?

4)   Have you initiated any studies of current geographic or family clusters?

5)   Have you taken any steps to make ME/CFS a reportable disease so that clusters will be identified?

6)   Are there any longitudinal studies of appropriately-defined ME/CFS (not Consensus definition-defined) in progress?

7)   Is the CDC making any efforts to identify the sickest, house-bound patients?

8)   The CFSAC recommended that the Toolkit be removed from the CDC's website and that it should no longer be distributed at its June, 2012 meeting.  Why hasn't this been done?  Why is there no mention of the IACFS/ME Primer as an alternate source of information?  Why is the link to the Toolkit still active on the CFSAC website?

9)   The only definition that is immediately obvious on the CDC website is Fukuda, and this is the only definition mentioned in the CDC's CME activity.  Why is there no mention of other definitions more acceptable to the patient community and of the controversy that surrounds the definition?

10)  When and how do you plan to attempt to resolve the definition issue?  Does CDC think that it alone should determine the definition?  Do you plan to resolve it based on a single study of six (or seven?) practices?  Have you built into the design of that study a method to ensure that the practices are consistent with each other?  If one or more of the practices has looser standards and include(s) patients who only meet the definition for Idiopathic Chronic Fatigue will that practice or practices be separated out as (an) outlier(s)? When will that study be published?  Are you aware of the recent Maes, Twisk and Johnson study (Psychiatry Research, in press, available online) that shows that ME, CFS and CF can be distinguished accurately using post-exertional malaise and inflammatory biomarkers?  Before you try to develop a better definition do you plan to ask for the input of other stakeholders, including patients, who may have additional information to offer?  Will the IACFS/ME be an equal partner?  Will other specialty organizations be involved?

11)  Has the previously-announced five-year strategic plan been shelved?  Has it been replaced by another plan?  If so, where can we find it?

12)  What ME/CFS research projects are currently underway at CDC?  What definition do they use to identify patients?

13)  What is the next study that we can expect to see CDC publish?  Is it designed to imply that ME/CFS is a psychological disorder?

14)  What is the total annual budget for ME/CFS at CDC for the last ten years, and what is the current annual budget as well as the budget for the next two years?  Is, as recently reported, the budget actually decreasing?

15)  The CDC CME program states "Importantly, no scientific evidence exists to indicate that CFS is contagious or that it can be transmitted from person to person."  Would it not be more accurate to state "Given the existence of family and geographic clusters, there is certainly reason to suspect that an infectious agent is involved.  However, no single agent has yet been proved to cause the disease.  Given the high incidence of viral and other co-infections, such as EBV and HHV-6 among others, it is reasonable to test for these pathogens and consider treatment, if present.  Individual clinicians have reported treatment successes with this strategy.  Further research is necessary."?

16)  At the CFSAC meeting in June, 2012, Dr. Peter Rowe reported that over 80% of his patients have orthostatic intolerance.  At what level of prevalence of this potentially treatable symptom will the CDC decide to recommend that all patients be tested and treated for OI?  Do 100% of patients have to have the symptom before CDC recommends testing and treatment?

17)  At the CFSAC meeting in June, 2012, Dr. Peter Rowe reported that over 80% of his patients have post-exertional malaise.  There are now two measures of post-exertional malaise in the literature:  Pacific Fatigue Laboratory testing and gene expression testing.  At what point will the CDC include these tests in its recommendations for lab tests on its website?

18)  What constitutes a biomarker?  Why don't tests for orthostatic intolerance and post-exertional malaise qualify as biomarkers for ME?

19)  At the June, 2012, meeting Dr. Koh stated that the CDC has "made available clinical assessment data"  in its "research data center".  How can this data be accessed?

20)  The CDC CME program repeatedly refers to areas where increased research needs to be done.  What are you doing to make sure that adequate funding is available to make sure this research done?  Presumably, you are participating in the HHS cross-department ad hoc work group for ME/CFS.  If you aren't, who is the representative from the CDC on this panel?  What have these meetings accomplished to date?  Are you personally emphasizing that there are many areas where increased research is vital to improve our understanding and care for ME/CFS patients and funding for these projects must be increased?  Is there any move in these meetings toward a strategic plan for research?  Have there been more than two meetings?

21)  Obviously, there are too many questions here to answer in an hour.  When can we expect to have a longer, more substantive meeting with the CDC to have a bidirectional discussion of the many issues and develop a strategic plan to address them effectively?


For Dr. Jason:


1)  Can you describe the difference between a clinical and research definition?

2)  You are a researcher.  Do you think your opinions of a clinical definition are more valid than a clinician's?

3)  You have done a large amount of very important research about the definitions of ME, CFS and ME/CFS.  Given that no definition is perfect and that you have demonstrated in your research that definitional disputes have had a significant negative impact on progress in researching ME, CFS and ME/CFS, do you think it is useful to propose another definition of ME at this time?  Do you think it is necessary to have a perfect definition or is an adequate defintion adequate?

4)  There is a new study by Maes, Twisk and Johnson (Psychiatry Research, in press, available online) that shows that ME, CFS and CF can be distinguished accurately using post-exertional malaise and inflammatory biomarkers?  How does this article affect your opinion about how to proceed to resolve the controversy over the definition?



Thank you,
Joan Grobstein, M.D.