Monday, April 21, 2014

High Noon at the IOM

The deadline for sending comments to the IOM for their upcoming public session is Tuesday, April 22. I encourage everyone to send comments. These become part of the public record - by law. 

Why is this important?

The IOM contract and the P2P panel represent a turning point in our history. Thirty years ago, HHS tried to bury us with a silly name and a vague definition that made it impossible to conduct meaningful research. But, even after three decades of neglect - and outright dereliction of duty  - we are still here.

There is no doubt in anybody's mind that HHS intends for the IOM not simply to bury us, but to drive so many nails in our coffins that we will never be able to rise again. And yet, it was quite clear from the public meeting in January that the IOM is on the defensive.

Fifty of the world's leading experts in ME/CFS signed a letter to HHS, telling them that the IOM contract was a waste of time and money. And scores of patients and advocates have kept up a steady stream of pressure ever since.

They may have bigger guns, but we have more of them. And we have the U.S. Constitution.

The Bill of Rights

HHS would like us to sit down and shut up.

But I, for one, will never give up my First Amendment rights. They will have to pry my laptop from my cold, dead fingers before I give up my right to free speech. 

This is not a good time to remain silent. If we say nothing, we are giving tacit acceptance of whatever the IOM decides to do. We can't dispute their decision afterwards if we say nothing now.

Public records are the only means of providing solid evidence that the ME/CFS community 1) opposes the IOM contract, and 2) wants the immediate adoption of the CCC and the name to be changed to ME.

The IOM is challenging us to a showdown. We should lock and load.

The following are one advocate's comments to the IOM. Feel free to use them as a template.

Send comments to this address before April 23: mecfsopensession@nas.edu

If you miss the deadline use this address: mecfs@nas.edu

____________________________________

To: mecfsopensession@nas.edu

Dear Dr. Mundaca-Shah,

Please make my comment available in the Public Access File.

The IOM asked the ME/CFS patient community to weigh in on two questions:

1) In your opinion, what are the most important issues that healthcare providers should be educated about when it comes to diagnosis of ME/CFS?

a. Healthcare professionals must stop ignoring the seriousness of this illness, and stop psychologizing it.

b. Healthcare professionals must stop trying to get patients to exercise their way out of it. This is just making patients much sicker. Educate healthcare professionals about Post-Exertional "Malaise" (i.e. Post-Exertional Collapse). For instance, if a patient (diagnosed or not) tells a doctor that when they exercise they are incapacitated for days, that should set off alarm bells for healthcare professionals, and they must then educate the patient on how to (try to) avoid Post-Exertional "Malaise"/Collapse.

c. Healthcare professionals must use the Canadian Consensus Criteria for ME/CFS or the International Consensus Criteria for ME/CFS. They should not refer to the CDC's website or literature for ME/CFS, as it is inaccurate and the recommendations in it are hurtful to patients.

d. Healthcare professionals must be willing to do house calls for those who are too sick to leave their homes to get to a doctor's office. There are many of us in this situation, alone and without help or medical care.

2) What are your thoughts on the current terminology used to describe this disease:Myalgic Encephalomyelitis/Chronic Fatigue Syndrome? If you could suggest new terminology, what would you suggest and why?

a. Firstly, the name "Chronic Fatigue Syndrome" is inaccurate, grossly demeaning and very inappropriate given the severity of the illness. It belittles the disease and the suffering of the patients. Many of us remain homebound or bedridden for decades.

b. Secondly, the illness should be called what the World Health Organization calls it, M.E. -- myalgic encephalomyelitis. Recent research has found inflammation in the brains of patients with ME/CFS, which validates the name ME. This research must be acknowledged by the IOM.

c. Lastly, the name should not be further watered down and called "Multi-system" or "multi-symptom" anything.

Thank you for your time and attention.

[YOUR NAME]

Friday, April 18, 2014

Neuroinflammation Found in People with ME


The study this article refers to was presented at the IACFS/ME conference in San Francisco. It was, perhaps, the most significant piece of research presented at the conference.

For decades the term "myalgic encephalomyelitis" has been debated among scientists (and rejected by those who believe the disease is psychological) because there was no proof of inflammation in the central nervous systems of patients with ME. (Not even the extensive damage to the dorsal root ganglia of Sophia Mirza's spine was accepted as proof.)

This study is the first to show definitive evidence of microglial activation in the brains of people with ME. Microglia are the first line of immune defense in the central nervous system, which means microglial activation is an indicator of inflammation. Chronic activation of microglia can lead to excitotoxicity, a mechanism that has been proposed for both Gulf War Illness and Autism (Blaylock, "Chronic Microglial Activation and Excitotoxicity Secondary to Excessive Immune Stimulation: Possible Factors in Gulf War Illness and Autism”). Excitotoxicity has also been put forth as a mechanism of ME/CFS by a number of clinicians and researchers, including Drs. Paul Cheney, Jay Goldstein, Morris and Maes, Martin Pall, and, most recently, Jarred Younger.

This study not only lays to rest the CNS inflammation argument, it accounts for cognitive impairment, sensory and pain sensitivity, and dysautonomia in ME/CFS patients - and it unequivocally supports myalgic encephalomyelitis as the proper name for this disease.
______________________________

Press Release, Medicalxpress, 4/4/14

Toward a clearer diagnosis of chronic fatigue syndrome

Researchers at the RIKEN Center for Life Science Technologies, in collaboration with Osaka City University and Kansai University of Welfare Sciences, have used functional PET imaging to show that levels of neuroinflammation, or inflammation of the nervous system, are higher in patients with chronic fatigue syndrome than in healthy people.

Chronic fatigue syndrome, which is also known as myalgic encephalomyelitis, is a debilitating condition characterized by chronic, profound, and disabling fatigue. Unfortunately, the causes are not well understood.

Neuroinflammation - the inflammation of nerve cells - has been hypothesized to be a cause of the condition, but no clear evidence has been put forth to support this idea. Now, in this clinically important study, published in The Journal of Nuclear Medicine, the researchers found that indeed the levels of neuroinflammation markers are elevated in CFS/ME patients compared to the healthy controls.

The researchers performed PET scanning on nine people diagnosed with CFS/ME and ten healthy people, and asked them to complete a questionnaire describing their levels of fatigue, cognitive impairment, pain, and depression. For the PET scan they used a protein that is expressed by microglia and astrocyte cells, which are known to be active in neuroinflammation.

The researchers found that neuroinflammation is higher in CFS/ME patients than in healthy people. They also found that inflammation in certain areas of the brain - the cingulate cortex, hippocampus, amygdala, thalamus, midbrain, and pons - was elevated in a way that correlated with the symptoms, so that for instance, patients who reported impaired cognition tended to demonstrate neuroinflammation in the amygdala, which is known to be involved in cognition. This provides clear evidence of the association between neuroinflammation and the symptoms experienced by patients with CFS/ME.

Though the study was a small one, confirmation of the concept that PET scanning could be used as an objective test for CFS/ME could lead to better diagnosis and ultimately to the development of new therapies to provide relief to the many people around the world afflicted by this condition.

Dr. Yasuyoshi Watanabe, who led the study at RIKEN, stated, "We plan to continue research following this exciting discovery in order to develop objective tests for CFS/ME and ultimately ways to cure and prevent this debilitating disease."

Abstract: Yasuhito Nakatomi, Kei Mizuno, Akira Ishii, Yasuhiro Wada, Masaaki Tanaka, Shusaku Tazawa, Kayo Onoe, Sanae Fukuda, Joji Kawabe, Kazuhiro Takahashi, Yosky Kataoka, Susumu Shiomi, Kouzi Yamaguti, Masaaki Inaba, Hirohiko Kuratsune, Yasuyoshi Watanabe, "Neuroinflammation in patients with chronic fatigue syndrome/myalgic encephalomyelitis: a 11C-(R)-PK11195 positron emission tomography study", The Journal of Nuclear Medicine, vol.55, No.6, 2014, DOI: 10.2967/jnumed.113.131045

Tuesday, April 15, 2014

Chronic Fatigue Syndrome after Swine Flu Vaccination

I may look cute, but I'm really a pathogenic gammaretrovirus.
Two case studies concerning ME/CFS recently appeared in the British Medical Journal. They are of interest because in both of these cases, CFS (as stated by the authors) was triggered by a vaccine.

Flu vaccines contain attenuated viruses, the theory being that the virus in its weakened state will not produce the illness, but will merely generate antibodies to resist it. However, in these two cases, both women developed long-lasting symptoms that did not resolve.

The obvious conclusion one can draw from these cases is that the women suffered from an immune system impairment before receiving the vaccine. But, if that were true, they would have shown symptoms after previous viral infections.

Another consideration is that viruses can recombine to form new viruses. For example, in mice, the spleen focus-forming virus (SFFV) genetic envelope can recombine with an endogenous retrovirus to form a new pathogenic virus. (Hoatlin et al)

Given the number of people who report having a flu-like illness just before falling ill with ME/CFS, it is not too great a leap to propose that the disease itself may be the result of recombinant viral genes. This was how XMRV was created, and there is no reason why other viruses - for example, one that creates PEM, mitochondrial impairment, neurological injury, and immune dysfunction - can't do the same.

There is a real possibility that in their haste to discredit XMRV's role in the pathogenesis of ME/CFS, scientists may have thrown the baby out with the bathwater.
_________________________

Should influenza vaccination be mandatory for healthcare workers?

By Sean Lynch and Dr. Mike Jefferys. British Medical Journal March 21, 2014

We report two cases of Chronic Fatigue Syndrome (CFS) after Swine Flu vaccination.

CLINICAL BACKGROUND CASE ONE

Mrs A was a 52 year old married lady of Caucasian background, working in a profession allied to medicine in a Devon hospital. At the time of vaccination she had no known health problems. Routine vaccination for swine flu was recommended by Occupational Health in January 2010.

Stiffness and pain developed in all her joints 2 days after immunisation and she needed time off work. Her current symptoms then developed over the following two weeks. She noticed impaired concentration and pronounced fatigue. Fatigue was brought on by minor degrees of activity, was not fully relieved by rest and had associated post-exercise myalgia. She described her muscles feeling weak, leaden and aching. Other principal symptoms were that she had a struggle to get her breath and at times lost her voice. She also described difficulty in gripping things. She was housebound for two months after the onset.

There was a minor car accident a few months before the onset of these symptoms without any major physical or psychological injury. At the onset of her symptoms she was on Hormone Replacement Therapy, (as she was menopausal) which was stable and without adverse effects. She had been referred for ENT investigation of dysphonia eight years before, thought to be post-viral. No fatigue syndrome was documented then. ENT investigations and blood tests (including thyroid function) were normal and after speech therapy she made a full recovery.

Past medical and surgical history was otherwise negative as was psychiatric, drug and alcohol and forensic history. She did not smoke or use alcohol. Positive aspects of the family history were that her mother had depression when she was younger and Mrs A’s older sister has a history of chronic fatigue syndrome.

She was investigated in respiratory medicine and ENT, but no serious pathology of the ENT, cardiovascular or respiratory systems was found and no preceding viral illness was implicated. Dysphonia was again diagnosed and possible dysfunctional breathing (but with normal saturation). She had speech therapy and physiotherapy. A phased return to work was arranged (on reduced hours), but she could not maintain this and was signed off sick by her general practitioner. 15 months after the onset of her complaints she was referred by her general practitioner to the local CFS/ME service. At this time fatigue was her principal complaint and respiratory and vocal symptoms were less prominent.

Investigations as per NICE guidelines for CFS (1) were performed by her general practitioner before referral and were unremarkable. She was assessed and discussed by the multidisciplinary CFS/ME team and her notes thoroughly reviewed before a diagnosis of chronic fatigue syndrome was made conforming to criteria as per NICE guidelines (1). No current or lifetime psychiatric diagnoses were detected and her fatigue was of definite onset, severe, persistent and medically unexplained.

Both individual and group treatment was offered by occupational therapists in the CFS/ME service (based on current NICE guidelines). Despite the intervention, her severe fatigue has persisted and she has not been able to return to work.

CASE TWO

Mrs B is a 46 year old married lady of Caucasian background. She was employed as a specialist nurse within a Devon Hospital and had no preceding health problems before this episode. She had a flu-like illness at the time of the Swine flu pandemic in Winter of 2009, with shortness of breath, low energy and chest infection (treated with antibiotics). Her symptoms lasted six to eight weeks with this illness, but she made an unremarkable recovery. She had no physical complaints before she was given the combined swine flu and influenza vaccination at work in October 2012. The routine vaccination for swine flu was recommended by the Occupational Health Department.

2-3 days after the vaccination she became extremely lethargic with low energy, not relieved by resting and pains in her leg muscles and areas of tenderness over her knees and thighs. She also described clear post-exercise myalgia. She had sharp occipital headaches (not relieved by painkillers) and ringing in her ears, which was worse under stress. She also described pins and needles and twitching in her arms and legs and hands (like a vibration). These symptoms were worse on the left side of her body. In addition, she described difficulties with short term memory and concentration and difficulties with word-finding (using the wrong word or forgetting common words).

She was investigated in primary care and in view of a family history of multiple sclerosis was seen by a local neurologist and also had a second opinion from a Professor of Neurology at a local University hospital.

Stiffness and pain developed in all her joints 2 days after immunisation and she needed time off work. Her current symptoms then developed over the following two weeks. She noticed impaired concentration and pronounced fatigue. Fatigue was brought on by minor degrees of activity, was not fully relieved by rest and had associated post-exercise myalgia. She described her muscles feeling weak, leaden and aching. Other principal symptoms were that she had a struggle to get her breath and at times lost her voice. She also described difficulty in gripping things. She was housebound for two months after the onset.

Past medical and surgical history was a history of a right sided wrist injury many years before and a regional pain syndrome managed by an orthopaedic surgeon and Pain management service with reasonable recover. Otherwise history was negative as was drug and alcohol and forensic history. She did not smoke and her use alcohol was sparing and well under safe recommended limits. Positive aspects of the family history were that her non-identical sister who is two years younger has been diagnosed with MS. Her mother had renal disease during pregnancy which has persisted since then. Her maternal grandfather had the onset of Parkinson’s disease in his fifties.

Psychiatric history was of a period of mild reactive depression/adjustment disorder after divorce 6 years before the present illness, for which she received brief counselling. There was no other history of note, history of self-harm, or other psychiatric contact. She had a difficult bereavement when her infant son died in hospital 15 years earlier.

She was on no prescribed medication at the time of assessment. She had bought multivitamins, magnesium and evening primrose oil. She has been mostly housebound since this episode and cannot usually get out of the house without aid. She had severe difficulties in a range of physical activities, needing to use a stick or wheelchair for mobility and needing help from her husband with daily household tasks and at times showering and dressing. She had difficulties also in a range of cognitive tasks, such as reading, conversation, taking in new information, remembering appointments. Mental state examination revealed some anxiety and irritability and edginess and one panic attach (2-3 days before the assessment). Her mood was normal and reactive with no negative thought content or thoughts of self-harm. Her sleep has been unrefreshing and disturbed and her appetite decreased (but no weight change). There were no other somatic complaints.

Investigations as per NICE guidelines for CFS (1) were performed by her general practitioner before referral and were unremarkable. She was assessed and discussed by the multidisciplinary CFS/ME team and her notes thoroughly reviewed before a diagnosis of chronic fatigue syndrome was made conforming to criteria as per NICE guidelines (1). No current or lifetime psychiatric diagnoses were detected and her fatigue was of definite onset, severe, persistent and medically unexplained.

Both individual and group treatment was offered by occupational therapists in the CFS/ME service (based on current NICE guidelines). Despite the intervention, her severe fatigue has persisted and she has not been able to return to work.

DISCUSSION

During the previous pandemic of Swine Flu, possible complications of vaccination were reported (e.g. Guillain-Barre Syndrome, multiple sclerosis), but remain controversial (2,3). The recent vaccination programme for Swine Flu was introduced rapidly to deal with the serious public health threat of the pandemic and the UK Government rolled out this programme first for at risk groups and also for health staff.

Potential risks of immunisation causing aberrant immune responses have been suggested in some cases of chronic fatigue syndrome, but causality remains unclear (4). Chronic fatigue syndrome has also been reported in confirmed sufferers of swine flu (5), but we are not aware of any published case reports of chronic fatigue syndrome with onset after Swine Flu vaccination. Factors associated with the onset of chronic fatigue syndrome are difficult to assess, but there did not appear to be any other obvious triggers in Mrs. A’s case.

A definite causal relationship between vaccination and chronic fatigue syndrome is not claimed here, all that has been established is a possible temporal relationship. By its definition, Chronic Fatigue Syndrome, needs to be present for at least four months or six months (depending on the case definition), which highlights the case for longer post-vaccination surveillance if this possible adverse outcome is to be considered.

CONFLICTS OF INTEREST

We are not aware of any competing commercial, clinical or academic conflicts of interests.
Written permission has been given for us to report the case by the patient concerned. To protect their confidentiality certain details have not been mentioned in this report.

Sean Lynch MBChB FRCPsych PhD MBA DIC *
Consultant Psychiatrist, Wonford House Hospital, Exeter and Honorary Associate Professor, Peninsula College of Medicine and Dentistry
Corresponding author, assessed patient and prepared body of case report

Dr. Mike Jefferys BSc MBBCh FRCP
Consultant Physician, Royal Devon and Exeter Hospital NHS Foundation Trust
Reviewed medical notes to confirm diagnosis and contributed to development of case report

Dawn Cutts SROT MBAOT
Head Occupational Therapist, CFS/ME Service (North and East Devon), Arlington Centre, Exeter Community Hospital, Whipton, Exeter, Devon
Involvement with patient treatment and contributed to case report

Jessica Guy BSc(Hon) Occ. Therapy
Specialist Senior Occupational Therapist, CFS/ME Service (North and East Devon), Arlington Centre, Exeter Community Hospital, Whipton, Exeter, Devon
Involvement with patient treatment and contributed to case report

Abby Burton BSc (Hon) Occ. Therapy
Senior Occupational Therapist, CFS/ME Service (North and East Devon), Arlington Centre, , Exeter Community Hospital, Whipton, Exeter, Devon
Involvement with patient treatment and contributed to case report

Acknowledgement: We are grateful for the administrative support and help in preparing the report from Julie Lawry, service administrator.

REFERENCES

1. Chronic fatigue syndrome / Myalgic encephalomyelitis (or encephalopathy): diagnosis and management in adults and children Clinical guidelines, CG53 – Issued: August 2007 NICE

2. KE Nelson . Invited commentary: influenza vaccine and Guillain-Barre syndrome–is there a risk? Am J Epidemiol. 2012 Jun 1;175(11):1129-32.

3. LT Kurland , CA Molgaard , EM Kurland , WC Wiederholt , JW Kirkpatrick . Swine flu vaccine and multiple sclerosis JAMA. 1984 May 25;251(20):2672-5.

4. OD Ortega-Hernandez , Y Shoenfeld . Infection, vaccination, and autoantibodies in chronic fatigue syndrome, cause or coincidence? Ann N Y Acad Sci. 2009 Sep;1173:600-9.

5. R Vallings. A case of chronic fatigue syndrome triggered by influenza H1N1 (swine influenza). J Clin Pathol. 2010 Feb;63(2):184-5.

Saturday, April 12, 2014

An interview with Sonya Marshall-Gradisnik

The following interview with Sonya Marshall-Gradisnik appeared in Get It Magazine recently. Marshall-Gradisnik's contributions to the field of ME/CFS research have been impressive. Here she talks about how she got involved in ME/CFS research, and offers some insights into her work.
____________________

Cutting Edge Science, Get It Magazine, March 2014

Real Life with Sarah Blinco

Professor Sonya Marshall-Gradisnik from Griffith University is a biomedical researcher specialising in Chronic Fatigue Syndrome.

She and her team are leading the way in extraordinary international initiatives being fostered right here on the Gold Coast.

"You're one of the world's Ieading biomedical researchers specialising in Chronic Fatigue Syndrome (CFS). Can you explain some of your most exciting recent findings and what they mean for sufferers of CFS?"

The CFS research team that I lead has found significant changes in white blood cells in CFS patients. White blood cells are important as they are the cells in the blood that fight off infections, viruses and bacteria. We have found the function of these cells has been significantly reduced and we have also found significant changes in some genes that control the function of these white blood cells. Collectively these findings suggest these white blood cells may be involved in the pathology of this illness. Furthermore, it gives us hope that we may be able to identify CFS patients using these changes as currently there is no diagnostic test for CFS. Consequently diagnosis of CFS takes typically greater than twelve months which can be not only frustrating for the patients as they do not have a timely answer, but it is very costly to the healthcare system as a number of unrelated tests have to be conducted to ensure the patient is negative for these other tests prior to being confirmed with CFS.

"You've managed to secure several million dollars worth of competitive research grants. How difficult is this process, and how important it is to continue this research?"

It is extremely difficult to secure research funding for any type of biomedical research and applying for funding CFS biomedical research is I think even more difficult due to such factors of the stigma associated with this illness. However, in saying that, the Queensland government and the Mason Foundation, which is a national funding granting agency, have significantly provided me with research funds where the findings have been world first and suggest the possible involvement of the immune system in the pathology of this illness. I am very of proud these findings and the world first results we continue to report, as they are unravelling the potential cause of this illness as well as they show we may be coming up with some markers that may assist in early diagnosis of this illness. The development of a screening test using these potential markers we have found is an area that we are developing, as this test could be applied early in a patient's illness which may not only help the patient and the physician, but also help reduce healthcare costs.

There still is a great deal of research to be undertaken in this area as my team as well as other groups at Stanford University are now focusing on genes and how cells communicate. We are only beginning to understand the possible role of the immune and the endocrine systems and potentially how they may be involved in the development of CFS, so this area of focus in CFS remains a high priority for our team and international groups as well. There is still so much to be done not only in the research area but also in helping CFS patients with a clinic that has physicians where CFS patients can visit to work with their regular doctor to assist them with their illness. Finally, as CFS symptoms vary - some CFS patients are profoundly affected with not only being fatigued, but they are predominately affected with significant changes in memory function, cognition, cardiovascular and gastrointestinal health problems; these collective clinical symptoms and the severity of these symptoms need further investigations.

"You've established the first Australian CFS research/medical clinic at Griffith University; what will it mean for people to now have access to such a facility?"

There has been significant interest locally, interstate and overseas from CFS patients and clinicians. This clinic is located in the Griffith Health Centre, where our research centre is also located. Having the clinic and the research centre in the same building will enable patients to have access to clinical services as well as potentially participate in CFS research we are conducting. This model is truly unique as it is the only research and clinical services to be offered anywhere in the world to be housed under the same building which is unique and has not gone unnoticed by international agencies, such as the Centre for Disease Control and Prevention (USA) and members of the Medical Research Councils (UK) who visited in December last year.

"How did you originally become interested in this area of research?"

I am an immunologist and back in 2007 I met an amazing clinician from Queensland Health who was, and incidentally still is, as passionate about biomedical research in the area of CFS. Back then we both had a few ideas and tested them in a couple of small CFS research projects with one research student. Let us say the results were promising and it snowballed from there.

"What is your advice for young women aspiring to work in a science based career?"

There is no substitute for hard work; however, it is also important to surround yourself with positive people who also share your vision and are able to offer you guidance as well as keep you on track. It is always important to seek advice and listen to those around you as no one ever knows all the answers. These are key areas that I think anyone who would like a career in science may need to follow in the first instance, and then as your career develops establishing a network of people not only in science but outside your field to ask advice enables you to assess everything from different angles which is often invaluable. Always stay in contact with your peers as this is an invaluable network that will enable to you to tap into people that may have other resources and skills that you may need and it enables you to develop/complement your skill set as you progress throughout your
career.

I will not deny, a career in science is hard work and the hours are sometimes challenging. However, to develop a question that you can test and see if it is correct (or not) is truly wonderful as you are able to work like a detective and also think creatively - I have the best job!

"What are your goals for the coming couple of years?"

For the coming twelve months I have some big objectives as I would like to set up the first Australian Brain and Tissue bank for CFS patients. This will enable research to progress very rapidly as researchers would have access to tissue to assess potential changes in these tissues and how this may be key in the development of the illness. This ultimately may lead to clinical trials in the coming years.

As CFS has varying severities, some CFS patients are isolated at home as they are house bound or\ bed bound and vary rarely are able to have consistent medical attention. These patients mostly communicate through social media and it is for this reason I would like to achieve in the coming twelve months to fund raise for a mobile patient transport vehicle. This will enable patients to be collected from their homes and be transported to the CFS clinic or if they have other medical appointment as currently there is not such services available in Australia. I would like to raise the funds for such vehicles where patients in the south east Queensland area or Northern NSW region would have access to the CFS clinic and allied health services.

The ongoing research that I lead I would hope grows from the current group of 10 to be larger, and is even more diverse in the area of developing a nursing model of care for CFS patients.

Currently I am liaising with a national pathology collector to assist me with allowing me to have pathology collection sites in Sydney,Melbourne and Canberra for CFS patients so they are able to have their blood and tissue collected, where these specimens are transported toour research centre to further examine the possible role of the immune, genes and endocrine systems in the possible role of this illness. In turn, further enhancing the CFS research and clinical database that has been developed by the national research centre I lead.

Sometimes the objectives I set may seem overwhelming, however, the challenges CFS patients face are far more significant, and for that reason I think my objectives are not too great.

Wednesday, April 9, 2014

IOM Posts Agenda for May 5 Meeting, Raising at Least One and a Half of My Eyebrows

Beam me up, Scottie. There's no intelligent life down here.
The IOM has posted its agenda for the public meeting to be held on May 5, 2014. (You can view the agenda here.)

If there is anybody who still believes that the IOM knows what it's doing, the list of speakers for that meeting should leave them scratching their heads.

The inclusion of Megan Arroll to speak about cognitive problems is not just baffling, it is mind-boggling. Megan works for the Optimum Health Clinic, which offers the following service to patients with ME/CFS:
"The clinic offers a 3-month intervention which consists of a combination of neuro-linguistic programming (NLP), emotional freedom technique (EFT), life coaching and hypnotherapy/self-hypnosis constructed in a manner specific to the needs of those with ME/CFS. The primary aim of this approach is to reduce the anxiety that is associated with having a debilitating and unpredictable condition, improve emotional well-being and help individuals slowly manage and increase their activity within their own limits (ie, pacing)."
It goes without saying that the clinic claims a significant success rate, as all such clinics do. In fact, Megan published a paper about the "improvement" in ME patients after participating in their program. (Read the paper here.) The basic premise behind OHS' approach, and indeed all "treatment programs" that utilize NLP, EFT, CBT, the Lightning Process, and so on, is that ME/CFS is caused by stress, therefore it can be treated by "life coaching." (Note: If stress caused ME/CFS, everyone on the planet would have it.)

I can't help but wonder, if the IOM committee were convened to review case definitions of Parkinson's disease, would they invite someone with training in neuro-linguistic programming? And why stop at NLP practitioners? There are some great stress reduction techniques out there. How about past-life regression? (I've heard past lives can wreak havoc on cognitive function.) Chakra balancing? Astral projection? If the IOM committee wants to consider every angle, the sky's the limit.

The inclusion of Akifumi Kishi is also puzzling. Akifumi Kishi is a Postdoctoral Fellow in the Division of Pulmonary, Critical Care and Sleep Medicine at the NYU School of Medicine. He has published two papers with Benjamin Natelson about sleep disturbance in people with ME/CFS and/or fibromyalgia. He is most certainly not an expert on ME/CFS, or on sleep disturbance in this patient group. The best Kishi can do is present the results of the two studies he published, neither of which was particularly well designed. (He did not so much as mention the alpha wave disruption in ME/CFS found by Moldofsky, an anomaly associated with all autoimmune diseases.)

Leonard Jason will be speaking on case definitions and diagnosis. They could not have chosen a better person to cover this topic. Nevertheless, the expression "casting pearls before swine" comes to mind. If the IOM committee can't tell the difference between the contributions of a psychologist who thinks ME/CFS is stress-induced and an epidemiologist with Jason's long experience, then how will the committee make a distinction between people who think "It's all in their heads" and researchers who know that numerous immune, neurological and metabolic abnormalities drive the disease?

The answer is that it won't. The whole idea behind the IOM committee and the P2P panel is that they will approach this complex disease tabula rasa - without an idea in their heads, which means giving equal weight to all theories, no matter how unfounded they may be.

Nothing could be more dangerous for patients with ME/CFS than people with blank slates for brains.

Let's write on those slates. Send an email to the IOM!

But can you boycott the IOM process and still send an email?

Of course! A boycott doesn't work if you don't let people know you are boycotting them. (Remember all those "Boycott Grapes" bumper stickers?)

Tell the committee that you do not support the IOM process. Tell them to adopt the CCC and tell them to change the name CFS to Myalgic Encephalomyelitis.

Go here to read Eileen Holderman's response to the committee's invitation.

Go here for the questions to be addressed by this meeting's invitees. Feel free to address them!

Everything we say becomes part of public record, so let's flood the IOM mailbox with what should be done.

Use this address before April 23 (These comments will be read by the committee before the meeting.)
mecfsopensession@nas.edu

Use this address after April 23
mecfs@nas.edu

Monday, April 7, 2014

Eileen Holderman Turns Down IOM Invitation

The third meeting of the Committee on Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome will be held on May 5-6, 2014. On May 5, there will be an afternoon-long session that is open to the public. Anyone may view it via webcast. (Click here for more information.)

Written comments may be submitted to the committee. There is no deadline or character limit. All written comments will be placed in a Public Access File in compliance with Section 15 of the Federal Advisory Committee Act.

Comments for the open meeting should be sent here:
mecfsopensession@nas.edu

Comments received by April 23 will be distributed to the committee before the meeting on May 5. After April 23, written comments should be sent to the project email address:
mecfs@nas.edu

Much like the first public meeting, members of the ME/CFS community have been invited to make presentations. Eileen Holderman, CFSAC patient advocate, was one of the invitees.

In the following letter, she states her reasons for turning the IOM down. I strongly encourage everyone to follow Eileen's example. Make your opposition to the IOM contract part of the public record by sending a comment.
________________

April 1, 2014

Dear Dr. Mundaca-Shah:

Thank you for your invitation to speak to the IOM Committee on the topic of patient experience and diagnosis. And thank you for your patience in my reply - I recently returned from the IACFS/ME Conference.

For numerous reasons stated below, I must decline your speaking invitation. I am part of a vast patient advocacy movement that opposes the HHS/IOM Contract to redefine Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). There are many reasons for my (and other advocates') opposition, many of which are as follows:

* The Chronic Fatigue Syndrome Advisory Committee (CFSAC), for which I serve as a member, made a recommendation to the Secretary of the Department of Health and Human Services (HHS) in October, 2012 to convene a workshop with only ME/CFS experts (researchers, clinicians, advocates and patients) to reach a consensus on a research and clinical case definition for ME/CFS starting with The Canadian Consensus Criteria (CCC). Unfortunately, HHS did not implement our recommendation to the Secretary. Instead, HHS contracted with IOM and is utilizing a majority of non-ME/CFS experts, spending 1 million dollars of taxpayers' money for a study that will take 18 months to complete, and which has the potential to devise a worse definition than CDC's Fukuda and a worse name than CDC's chronic fatigue syndrome.

* 50 ME/CFS experts have reached a consensus on a research and clinical case definition for ME/CFS called the Canadian Consensus Criteria (CCC) which they have been using for over 10 years and for which they have committed to refine. The 50 experts sent a letter to Secretary Sebelius and Government Health Agency Officials expressing their opposition to the HHS/IOM Contract to redefine the disease and urged HHS to adopt the CCC as they have; their letter was also sent to the Institute of Medicine (IOM).

* Over 170 advocates have sent a similar letter to Government Officials and IOM expressing the same opposition to the HHS/IOM Contract and have also urged the Government Health Agencies to adopt the CCC, as the experts have recommended.

* Nearly 10,000 patients, caregivers, advocates, and medical professionals have signed 2 petitions stating objections to the HHS/IOM Contract to redefine ME/CFS and urging The Department of Health and Human Services to adopt the CCC for ME/CFS.

* Advocates have launched letter, email, call, Facebook, and Twitter campaigns to oppose the HHS/IOM Contract to redefine ME/CFS.

* Advocates have appealed to Congress with letters, emails, calls, and meetings on Capitol Hill to cancel the HHS/IOM Contract and have called on Congress to look into the issue to stop the waste of taxpayers' money for something we already have - a clinical and research case definition for ME/CFS called the CCC.

* An advocate attorney has filed a lawsuit in US District Court against HHS and NIH for non-compliance with a FOIA request pertaining to the IOM Contract. The same advocate filed complaints with (a) the Office of the Inspector General regarding the IOM's organizational conflict of interest and related legal issues and (b) the HHS Competition Advocate.

* Numerous advocates/attorneys have filed Freedom of Information Act (FOIA) requests concerning the HHS/IOM Contract.

* Advocates contacted the media and press and participated in numerous radio, TV, and online interviews and articles about the HHS/IOM redefinition issue. One article about the IOM redefinition issue, by a freelance journalist who writes for the New York Times and other outlets, received over 90,000 hits on an Internet news site and over 8000 Facebook shares.

* Advocates demonstrated in San Francisco and in Washington, DC to protest the HHS contract with IOM and attracted press coverage of the demonstrations.

* Advocates for ME/CFS collaborated with advocates for Gulf War Illness (GWI) to support both communities' opposition to the VA/IOM Contract for GWI and the HHS/IOM Contract for ME/CFS. Both communities voiced concerns about the VA/IOM reports which recommended clinical "treatment" of CBT, GET, and anti-depressants for patients with GWI and ME/CFS - "treatments" known to be ineffective and in most cases harmful to patients.

* Advocates wrote and submitted a position paper on case definition to HHS, and wrote articles, blogs, and opinion posts opposing the HHS/IOM Contract to redefine the disease.

* Advocates and patients traveled at great detriment to their health and finances to voice their opposition to the HHS/IOM Contract at the January 27, 2014 IOM meeting in Washington, DC.

The above mentioned initiatives by advocates, patients, and ME/CFS experts have been and continue to be important to protect the best interests of a million Americans, and 17 million worldwide, who suffer from ME/CFS and to move research and treatment forward. The majority in the ME/CFS community have spoken in a unified voice that ME/CFS experts already agreed on a criteria - the CCC, so it is time to use the limited funds the Government allocates to this disease for research and treatment to improve the lives of those disabled by this serious neuroimmune disease. The advocacy initiatives will continue undeterred and will continue to call for the cancellation of the HHS/IOM Contract.

Again, I thank you for the invitation to speak to the IOM committee about patient experience and diagnosis, but must decline for the reasons stated above. However, if you will permit me to make a dissenting, but respectful public comment in Washington or via webcast, I would accept that opportunity, particularly because I would have new information to address regarding the latest VA/IOM report for GWI, which has relevance to the HHS/IOM redefinition issue.

While I did give opposing public comment at the podium during the January 27, 2014 IOM meeting, I did not submit formal written comments, so please accept this email, which summarizes what I said at the meeting, as part of the IOM public record, and I will share my email with the ME community, as well.

Thank you for your consideration.

Best regards,

Eileen Holderman
ME Advocate

Friday, April 4, 2014

Bio-ethics and ME tweet chat on April 7th

The following message is from @Katiissick

There will be an open twitter chat on bioethics and ME on April 7, at 8:30 PM Eastern time (5:30 PT) thanks to Jennifer Chevinsky, a medical student who hosts a weekly bioethics chat on Twitter.

These chats attract health care professionals, ethicists, and the general public. You are welcome to join in the dialogue and share your ideas. All you need is a twitter account! It is an opportunity to raise awareness, and there are big chances that many will learn about ME and its devastation at the personal and societal levels.

The April 7 chat is focused on the following questions:

1. Are there ethical or societal effects of calling the disease Myalgic Encephalomyelitis versus Chronic Fatigue Syndrome? How do disease names affect perceptions?

2a. Myalgic Encephalomyelitis is often misdiagnosed and/or mistreated. What additional harms can misdiagnosis and/or mistreatment expose individuals, healthcare professionals, and society to?

2b. A Patient with Myalgic Encephalomyelitis has been held in a Denmark psychiatric facility since February 2013 against her will. What conditions should be met to ethically commit a patient?

3a. Myalgic Encephalomyelitis is not 'rare,' but it can be considered unpopular. What makes (or should make) a disease more likely to get funding or research money?

3b. What makes (or should make) a disease more likely to be taught in medical education? How does it affect the patient population if it is not taught?

4. How can you, patients, health care professionals, and/or others help remove stigma from diseases such as myalgic encephalomyelitis? What's one thing you have learned tonight?

In order to participate in the chat, all of your tweets need to include #bioethx in them.

A few websites facilitate twitter chats, including www.tweetchat.com You will need a twitter account and login information, enter the hashtag (bioethx) and enter the virtual room.

There are many Twitter Chats related to health care. You can visit http://www.symplur.com/healthcare-hashtags/tweet-chats/ to look up the different chats and their schedules. Chats are also a great opportunity to increase your contacts outside our patient community and speak out about your experiences. Sunday evening's #HCSM (health care social media) are usually a lot of fun!

There are common sense rules when taking part in a tweet chat. 

1) Answer the questions with their number A1, A2a, A2B etc.

2) Stay on topic, and engage in the discussion.

3) Make sure you have the #bioethx in your tweet otherwise it is not seen by others in the chat or recorded. Other hashtag of use are #mecfs #neuroME #CDC #HHS #NIH #meded #hcldr (health care leaders)

Twitter can be powerful as you can direct advocacy to interest groups, like the NIH and CDC. For instance, Dr Frieden at the CDC has an account. The Center for Infection and Immunity (@CII722) (Columbia university) has a twitter account and tweets about ME. We can increase awareness by engaging with different groups and people outside our community. Twitter does that.

The chat will be recorded and will be available afterwards if you missed it. I will update as available.

Share widely and join us on April 7th at 8:30 EST!

Feel free to add me on twitter @Katiissick