"Hanging Fire" – Dr. John Chia

I remember well the ME/CFS researcher Jonathan Kerr. Many people might not remember that he wrote a paper on enteroviral involvement in ME/CFS, a copy of which can be found here.

“The role of enterovirus infection as a trigger and perpetuating factor in CFS/ME has been recognized for decades.”

Soon after this, Jonathan Kerr "was disappeared" from ME/CFS research. I wonder where he is? I miss his efforts on our behalf. The more I think about his departure, the sadder I get. In the last few years we have lost a number of serious ME/CFS researchers. These losses have been distressing.

On a less disturbing note, we might put forth the idea that ME/CFS research has never been so broad and far-ranging as it is today. Some would say that we are making progress, and that hope stands right around the corner (probably leaning against a wall, whistling - or smoking a cigarette).

In this world of optimism, one astonishing item continues to be set aside or ignored: the enteroviral association with ME/CFS established by Dr. John Chia. Something needs to be done about this. Dr. John Chia's critical work should be put center stage. Dr. Chia holds in his hand a key to unlock a part of this illness.

Recently there has been a fine set of video interviews with this unsung hero of ME/CFS. Part one can be seen here with the others following. These interviews are conducted by Llewellyn King, who speaks with a knowledge and ease that is admirable. Llewellyn King’s series ME/CFSAlert has focused on many clinicians and researchers. However, this four-part interview with Dr. John Chia is the best. It is worth viewing these videos more than once - for the key points to sink in.

Ten years ago, Dr. Chia’s son Andrew became sick with what turned out to be ME/CFS. In his desire to help his son, Dr. Chia did what many smart people do - he turned to the past (history) - and studied the early literature of ME. Things fell into place for Dr. Chia as he reviewed the older, known connection of ME/CFS to enteroviruses. Enteroviruses fit the picture.

Early clinicians in the field, especially Ramsey and Richardson, suspected enteroviral involvement. This belief held particularly true in the UK, where the disease is known by its proper name - Myalgic Encephalomyelitis (ME). 

If one wants to get a real fright about the seriousness of this illness and what enteroviruses can do in the human body, read John Richardson’s “Enteroviral Medicated EncephalomyelitisSyndrome Pathologies”.

In time, the pursuit of an enteroviral association with ME/CFS lapsed. There are several reasons for this.

In 2007 Dr. Chia and his son Andrew Chia reignited this enteroviral idea and published a paper demonstrating a strong association of enteroviruses in ME/CFS.  The surprising and convincing aspect of their study was that they were looking at real human tissue – stomach biopsies. This is hardly ever done in ME/CFS research.

As a researcher/clinician, Dr. Chia has constructed a world of his own. He has gathered his profound insights through making no great new discovery. He has just connected the dots. His studies are the product of persistent, dogged effort. As he says, his work is not sexy. Dr. Chia and his son continue to build research into enteroviral involvement in ME/CFS.

Since his paper was published in 2007, no one has tried to substantiate or replicate his work. Why? How can his be?

Dr. Chia has left “something of significance” for us sitting on the table in plain view.  To get further with this it needs to be taken up by someone else. No thinking is involved. All it needs is the hard work of replication.

(InvestinME has done a great service in elevating Dr. Chia’s research. They invite him to speak each year. Unfortunately, his research efforts are at a standstill with his ideas gaining no traction. What is Dr. Chia supposed to do – replicate his own study?)

Anyone familiar with the research world of ME knows the implications of nailing down one corner of the illness through substantiating an association with an infectious agent.  Let me repeat that: if you nail down one corner of this illness with an infectious agent, you nail down the whole thing.

Instead, everyone wants to go in their own direction and solve this illness on their own. Is that the idea? - Everyone comes up with their own idea that will never be substantiated? Is this how real science is done today? Does the ME/CFS research world have to be that constricted?

Why doesn’t the Whittemore Peterson Institute (WPI), Mt Sinai ME/CFS Center, Ben Natelson, Peterson’s Simarron Research Foundation, Klimas’ Nova Institute for Neuroimmune Medicine, the Chronic Fatigue Initiative, Kolgenick’s Open Medicine, Jose Montoya at Stanford, or the CAA, step up to the plate and substantiate Dr. Chia's work?

The most likely person to pursue the enteroviral connection in ME/CFS is Ian Lipkin at Columbia. Lipkin has an inquisitive nature. I would be surprised if he is doing tissue biopsies, which seems the way to go.

It is time for someone to make a serious effort to replicate Dr. Chia’s work - and to find out what exactly it means. 

Nothing would get the government agencies or the drug companies interested faster than scientifically demonstrating a viral association to ME/CFS.

You can petition the government as long as you want but nothing will change until the science is built in a coherent fashion. Giving them a replicated study of Dr. John Chia’s work would be a very good first step. It would put a sudden halt to the research merry-go-round of the last twenty-five years. 

Whoever participates in this will get a very big feather in their cap. 

Dr. John Chia with Llewellyn King

Just today I was speaking to a friend about Llewellyn King's gifts at interviewing people. Here is another example of his fine work, another section of an interview with Dr. John Chia. Dr. Chia is one of the very finest minds working in the field of ME/CFS.

Dr. John Chia with Llewellyn King, 3rd section

Here is the third section of a very fine interview with Dr. John Chia. The interview is conducted by Llwellyn King. Mr. King does us a great service in conducting these ME/CFS Alert interviews, and presenting ME/CFS information with such clarity. Clarity is something that is in short supply in this illness.

This interview should be required viewing material for anyone who is interested in this illness. Dr. Chia has a firm grasp on a very significant aspect of this complex illness. His ideas are attached to solid evidence - also something that is in short supply in this illness. It is always surprising to me that more clinicians and researchers are not assisting Dr. Chia and his ideas, which incidentally are not new ideas, but take us back to the very first studies of this illness in the UK.

It would be nice to have some validation of Dr. Chia's ideas through other clinical studies involving other clinicians and researchers. Perhaps I am just not privy to this information, but it seems that Dr. Chia is working on his own here - and to me this is a problem, as he has what looks like a significant part of the answer.

I wonder what Dr. Chia would think of Anatabloc? I wonder if he uses it with his patients?

I have written in other posts about Dr. John Chia - for those who might be interested.

More with Dr. John Chia - Llewellyn King Interview

Here is the second part of an ME/CFS Alert interview with Dr. John Chia. Llewellyn King does such a fine job at interviewing his subjects, proving that interviewing is an art. And his subject here, Dr. Chia, is about the best. Dr. Chia has done a great deal of clinical research characterizing a significant insult or pathogen in many ME/CFS patients - enteroviruses (various coxsackie and echo viruses). Here Dr. Chia speaks about treatment with oxymatrine (Equilabrandt), which seems to work in about 50% of cases.

I wonder if any hepatitis drugs in the pipeline would be useful for enteroviruses?

I also wonder if there is some manner in which oxymatrine could be made to be beneficial in a higher percentage of patients - a pretreatment of some sort with diet, gut ecology, and MAF-like substances. Any number of other ways to help lower the collective burden on the immune system might raise the success rate of oxymatrine. Dr. Chia seems to be such an innovator and so individualistic in his thinking - one would have to believe he is thinking along the lines of how to improve efficacy of the one weapon that he has against enteroviruses.

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.

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.

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.