Letter of advocacy version February 2012

Mr Stephen Harper, Prime Minister

Mrs Leona Aglukkaq, Minister of Health

Dr Alain Beaudet CIHR

Dr. David Butler-Jones, Chief Public Health Officer

Mr Mike DeJong, British Columbia Health Minister

Mr James Moore, MP Port Moody

Dr Perry Kendall, British Columbia Health Officer

Dr David Patrick, research director Complex Chronic illnesses, Vancouver

Mrs Libby Davies NDP Health Critic

Mrs Hedy Fry, Liberal Health Critic

Mrs Pamela Fayerman, Vancouver Sun Journalist

cc/ Mrs Margaret Parlor, National ME/FM Action

cc/ Dr Ellie Stein

cc/ Dr Alison Bested

cc/ Dr Bruce Carruthers

February 15^th 2012

This letter to you today  aims at finding answers as for why patients with ME/CFS are neglected, stigmatized, discriminated against and left behind, and what is Canada planning to do to help over 411 000 patients in Canada who have no health care and not much respect. If this letter has been sent to you, it's because you have a role to play. It could be sent to all provincials health minister, however has not due to lack of resources, and health from the author. Feel free to share to all concerned.

ME (Myalgic Encephalomyelitis, also known as Chronic Fatigue Syndrome) is a severe and chronic condition that affects over 411 000 citizens in Canada, according to the 2010 Community Health Survey, 23% more than in 2005. It is one of the most neglected disease, and funding levels by the canadian government is abysmal, assessed at 6 cents per patient per year for the last 10 years. Moreover, ME is an orphan disease, meaning it does not belong to any medical specialty, which means that patients have virtually no access to  competent health care, and most specialists do not want to follow up with patients with ME due to the complexity of care, lack of education in regards to this disease and needs of support with disability insurance. ME is not a psychiatric illness and is not about being tired all the time.

Misconceptions, stigma and discrimination abounds in our society and among our doctors. Dr Carruthers is one canadian co-author of a few papers describing and defining our illness. (Carruthers et al, 2011, Journal of Internal Medicine). One reputable expert for ME patients, Dr Nancy Klimas, says that ME can be just as or more disabling as a late stage HIV/AIDS patient, progressive MS or congestive heart failure. Patients die early of cancer, heart disease or suicide. It is however difficult to track these deaths due to the lack of documentation from physicians. They may also not make the connection between ME and co-morbidities.

There are many complex issues that needs to be taken care of and it is in my opinion that the canadian government, the CIHR and Public Health Agency needs to organize a task force to answer the needs of a disabled population that keeps growing. It is noted that similar conditions like fibromyalgia and multiple chemical sensitivities receive the same neglect and in total, it consists of over 1.1 million citizens with unmet health care needs and related cost to society including high rate of disability.

Your Honorable Health Minister and all, here are a few areas of focus that need to be addressed:

1) Medical education.

ME is not taught in medical schools. Physicians then resort to information on the internet for education and accuracy of such education is often questionable. For instance, my physician was convinced for the first 18 months of my illness that I was clinically depressed and that ME was treated with anti-depressants. A common myth also is that exercise helps patients with ME. In fact exercise triggers inflammatory cytokines which induces relapse. See references below, Light and colleagues.

In order to provide health care to 411 000 patients in Canada, physicians need to be educated about our illness. Moreover, ME needs to be assigned to a medical specialty. Recently following a recent publication of results of a clinical trials in Norway, it was found that Rituximab has significantly helped 67% of patients with ME compared to 12% placebo control  (15 patients in each groups). I personally wrote to the Canadian Rheumatologic Association and 12 rheumatologists in British columbia, asking to be considered for Rituximab. I got 3 answers. One of which said the physician had no time nor the interest to care for patients with ME. please know that rheumatologist, in my experience, have no interest or knowledge in caring for patients with ME. It is to be noted that these results are stronger than the effectiveness of Rituximab in rheumatoid arthritis, which is an approved medication for this illness. Also, one week following the publication of the norwegian study, their government apologized to their ME patients for neglect in health care. I can personally discuss multiple instances of refusal of care, disrespect, and such. My fellow patients also have experiences of this kind. Moreover, the unavailability of testing such as  Natural Killer cells count and function, intracellular pathogens, CD-4 and lymphocyte enumeration, viral titers, tilt table test and access to autonomic dysfunction specialty and treatment are all vital to the care of patients with ME. Viral reactivation is one key feature of our illness, including HHV-6, HSV, VZV,CMV, EBV, Parvo B-19 and enteroviruses such as Coxsackie-B. Why do physicians not think that these tests are important and explain the degree of illness?

Medical students highly rely on experienced professors to learn the art and science of medicine. These professors have not learnt what ME is, or have erroneous knowledge of this disease. Patients need to be involved in ME curriculum Sources of knowledge need to be considered and the preferable one is www.iacfsme.org.

2) Epidemiological studies

Is ME infectious? Can it be transmitted sexually,? Vertically? Casual contacts? How can you explain many members of a same family who are ill with a combination of ME, Lyme, fibromyalgia, autism? In the USA there is about 1 out of 3 US Gulf War Veterans who have "Gulf War Illness". Is this also the case in Canada, masked by diagnosis of depression, post traumatic stress disorder, fibromyalgia and such?

As I mentioned above, there has been an increase of a staggering 23% in reported case of ME in Canada, yet there does not seem to be any concerns about this piece of information.

Most cases present with a viral onset. I am one of them . In my case, I was working as a RN and received saliva from a patient, straight in my mouth and contracted EBV. Or was it just EBV? I also have HHV-6 reactivated, along with Parvo B-19, Coxsakie B-2 and B-6. The last 2 tests were performed in the USA, and prescribed by a caring american physicians who also tested my natural killer cells, which function is much decreased with patients with ME. I am paying out of my pocket for the health care I get in the US. Moreover, results that I bring back to my physicians are discarded and not taken seriously.

Epidemiological studies are much needed, and careful decision about case definition need to be considered. Certain case definition such as the CDC empiric criteria and Fukuda criteria increases the chances to include fatigued and/or depressed patients and this has been reasons why many research studies have been inconclusive. Collaboration with IACFSME, the international scientific association is recommended. Canada needs to keep up with Norway and the USA and offer the best available health care for patients with ME, some of whom have been ill for decades.

3)  Bio-medical research and clinical trials

Health Canada needs to fund research for ME at the same rate as comparable illnesses, for instance rheumatoid arthritis or multiple sclerosis. Currently, there is zero funding. Please stop sweeping this illness under the carpet. Stop stigma and discrimination. You have achieved heaps with HIV AIDS, so why not with an illness that robs citizens and their family of a normal life, and prevents them to work, and contribute to society? You have funded 5 millions dollars for a study on liberation therapy for multiple sclerosis. The prevalence of MS is more than 3 times less as ME, and the level of disability varies just as our disease.

Canada has the technology to perform advanced genetic, deep sequencing and high tech testing. Why not put it to great use?

To those who will say that research teams can apply for funding through competitions I am telling you that Canada needs to encourage research for ME, using proactive measures. Researchers will naturally veer towards paths of least resistance, where funding abounds and chances to get funded are real. Cancer, HIV/AIDS, diabetes, cardio-vascular diseases come to mind. It is time to end discrimination in health care and provide opportunities for all. Please reward scientists willing to step out of the normal boxes and willing to research our illness.

There are no official drugs to treat ME. However there are drugs available in the market that are used by different groups. Health Canada can assist with making these drugs available for our illness, here are a few examples:

A) Imunovir (Isoprinosine): this drug is known to improve natural killer cell function. It has been used by Dr Nancy Klimas in Miami for 2 decades. Dr Byron Hyde in Ottawa has used it in a clinical trials. For obscure reasons, the approval for our disease has not happened and there is a special note under physician info telling them this drug is not approved for our disease. Dr Klimas has to order this drug in Canada for her american patients, yet no canadian physician will prescribe it. Risks to patients are minimal, and since the natural killer cells are essential to cancer prevention, wouldn't it be important to restore this function in patients with ME?

B)Ampligen- has been stuck in phase 3 trial for over 15 years now, in the US. A few centers in the US are now offering the drug, why is it not offered in Canada? I can answer the question myself: no medical specialty, no care, no drug trials. Please end the vicious cycle before more citizens contract the illness.

C) Rituximab has shown superb results in the recently published study (Mella et al. PLoS One, 2011) which showed that patients with ME had significant improvements from Rituximab, administered in the same fashion as for rheumatoid arthritis patients. Critics mentions that Rituximab has significant risks and that is not appropriate for patients with ME. Sadly, these critics have no idea of the severity of our illness. Dr Mella, an oncologist and co-author of the research, mentioned  that this disease is severe and disabling enough to warrant aggressive treatment. Moreover, no serious complications including infusion related or infections were encountered during the course of their trial.

D) Long term anti-viral therapy: Valcyte, Valtrex and novel antivirals. The work of Dr Montoya and Dr Lerner have shown that some patients improve with the long term use of anti-viral like Valcyte and Valtrex in order to control reactivation of herpes viruses which is well known for patients with ME. Yet, patients are laughed at if they simply ask their doctors, and even infectious disease doctors refuse to test for these. These treatments need to be offered to patients in Canada in the same way these treatments are offered for HIV/AIDS patients. Testing for viruses is greatly restricted in Canada and titers are not offered. This is a problem. A fellow patient with ME had great problems getting health care with pericardial effusion, in fact she was turned away from emergency after presenting with chest pain. She traveled all the way to Germany for a heart biopsy which proved she had active Parvo B-19 infection. Worse is coming back, she had a terrible time finding a physician to treat her for the infection.

Sadly, most of the time, because we have the words "chronic fatigue syndrome" attached, we are treated as malingerers, psych patients, tired people and attention seekers. Patients with ME have highly unmet health care needs and it needs to be addressed. It has been like this for decades. Many papers lead to a biological cause, notably, infectious, immunologic or rheumatologic. Please end discrimination and stigma and offer equal opportunity for health care for all of us.

4) Finding the right partners

All governments should be ashamed of the history of ME, notably Great Britain and the United States. Neglect and abuse come to mind. The history can be summarized by an excellent article by journalist David Tuller and book by journalist Hillary Johnson.

David Tuller: Chronic Fatigue Syndrome and the CDC: A Long, Tangled Tale

http://www.virology.ws/2011/11/23/chronic-fatigue-syndrome-and-the-cdc-a-long-tangled-tale/

Hillary Johnson: Osler's Web ( www.oslersweb.com)

It is absolutely critical that the same mistakes do not happen again.

The PACE Trial from the UK has received a fair amount of press. It suggest that ME can be treated with cognitive behavioral therapy and graduated exercise therapy. However this study contains gross flaws, considering they use a mix of depressed patients, fatigued patients and mild ME patients. I am suggesting you read the comments attached to this paper and that you use the conclusions of this paper very, very cautiously. HIV/AIDs is not treated with CBT or GET and  neither should we.

The CDC has misappropriated funds in the 1990's, and has diluted the ME/CFS definition to include depressed patients. They have avoided researching infectious agents and have spread a whole lot of misinformation to physicians around the world.

Please network with reputable experts in the field, notably, Dr Dan Peterson (Incline Village), Dr David Bell, Dr Enlander, Dr Byron Hyde, Dr Bruce Carruthers, Dr Nancy Klimas, Dr Jose Montoya, Dr Andreas Kogelnik,

Dr Cincy Bateman, Dr Charles Lapp, the Whittemore- Peterson Institute, Dr Paul Cheney, Dr De Merleir ( Belgium) are the known experts in the field ad get much respect and trust from the patients. Those are also the physicians that have made progress in understanding the disease.

It is now time for Canada to step in and make use of our scientists and resources to find treatments and allow patients to have a normal life, and be productive in society.

I have written other advocacy (plea letters) in the past, and I was redirected to various organisms (College of physicians, CIHR, provincial governments) some of whom have redirected me back to Health Canada. Please! I am a very sick person fighting for my life! Patients with cancer, AIDS, MS and others have organizations to do the advocacy for them and these organizations are very successful in attracting attention. In contrast, folks at National ME/FM Action are currently too sick to answer emails, and otherwise there is no one. once again, due to the fact that no medical specialty is responsible for ME and CFS, we continue to fall into the cracks of the system. I am asking for your help on behalf of hundreds of thousands of sick patients with a disease that is discriminated against. Mrs Aglukkaq has awarded 5 millions to research liberation therapy, I am sure she can do something for 411 000 (and growing) with no health care at all and no funding at all for critical research.

In March 2011 the BC government has volunteered 2 millions dollars for a clinic and a study for patients with Complex Chronic Illnesses which includes ME, Fibromyalgia and Lyme disease. At the time of writing this letter, one year later, we are still waiting to find out who will be the medical director. The help, the treatments are largely anticipated, but will there be any treatments? How long is it going to take? What about fellow patients from other provinces? Will there be enough physicians and staff to meet the demand? Will there be appropriate testing, the type that applies to our illness?

I thank you for your attention and eagerly wait for much needed health care.

Kati Debelic

References:  

Fluge Ø, Bruland O, Risa K, Storstein A, Kristoffersen EK, et al. 2011 Benefit from B-Lymphocyte Depletion Using the Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-Blind and Placebo-Controlled Study. PLoS ONE 6(10): e26358. doi:10.1371/journal.pone.0026358

Ekua W Brenu1, Mieke L van Driel1,  Don R Staines,  Kevin J Ashton,  Sandra B Ramos,  James Keane, Nancy G Klimas and Sonya M Marshall-Gradisnik 2011  Immunological abnormalities as potential biomarkers in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis Journal of Translational Medicine 2011, 9:81 doi:10.1186/1479-5876-9-81

Carruthers, B. M., van de Sande, M. I., De Meirleir, K. L., Klimas, N. G., Broderick, G., Mitchell, T., Staines, D., Powles, A. C. P., Speight, N., Vallings, R., Bateman, L., Baumgarten-Austrheim, B., Bell, D. S., Carlo-Stella, N., Chia, J., Darragh, A., Jo, D., Lewis, D., Light, A. R., Marshall-Gradisbik, S., Mena, I., Mikovits, J. A., Miwa, K., Murovska, M., Pall, M. L. and Stevens, S. (2011), Myalgic encephalomyelitis: International Consensus Criteria. Journal of Internal Medicine, 270: 327–338. doi: 10.1111/j.1365-2796.2011.02428.x

Schutzer SE, Angel TE, Liu T, Schepmoes AA, Clauss TR, et al. 2011 Distinct Cerebrospinal Fluid Proteomes Differentiate Post-Treatment Lyme Disease from Chronic Fatigue Syndrome. PLoS ONE 6(2): e17287. doi:10.1371/journal.pone.0017287

Broderick G, Fuite J, Kreitz A, Vernon SD, Klimas N, et al. A formal analysis of cytokine networks in chronic fatigue syndrome. Brain Behav Immun. 2010;24:1209–1217. [PMC free article] [PubMed]

Lerner AM, Beqai S, Fitzgerald JT, Gill K, Gill C, et al. Subset-directed antiviral treatment of 142 herpesvirus patients with chronic fatigue syndrome. Virus adaptation and treatment. 2010;2:47–57.

Kogelnik AM, Loomis K, Hoegh-Petersen M, Rosso F, Hischier C, et al. Use of valganciclovir in patients with elevated antibody titers against Human Herpesvirus-6 (HHV-6) and Epstein-Barr Virus (EBV) who were experiencing central nervous system dysfunction including long-standing fatigue. J Clin Virol. 2006;37(Suppl 1):S33–38. [PubMed]

J Chia, A Chia, M Voeller, T Lee, R Chang Acute enterovirus infection followed by myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and viral persistence J Clin Pathol 2010;63:165-168 doi:10.1136/jcp.2009.070466v

Hollingsworth KG, Hodgson T, Macgowan GA, Blamire AM, Newton JL Impaired Cardiac Function in Chronic Fatigue Syndrome measured using Magnetic Resonance Cardiac Tagging. J Intern Med. 2011 Jul 27. doi: 10.1111/j.1365-2796.2011.02429.x.

Leonard A. Jason, Abigail A. Brown, Erin Clyne, Lindsey Bartgis, Meredyth Evans, and Molly Brown

Contrasting Case Definitions for Chronic Fatigue Syndrome, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome and Myalgic Encephalomyelitis

Eval Health Prof 0163278711424281, first published on December 7, 2011 doi:10.1177/0163278711424281

Jones, D. E. J., Hollingsworth, K. G., Jakovljevic, D. G., Fattakhova, G., Pairman, J., Blamire, A. M., Trenell, M. I. and Newton, J. L. (2012), Loss of capacity to recover from acidosis on repeat exercise in chronic fatigue syndrome: a case–control study. European Journal of Clinical Investigation, 42: 186–194. doi: 10.1111/j.1365-2362.2011.02567.x

Jonathan R. Kerr, John Gough, Selwyn C. M. Richards, Janice Main, Derek Enlander, Michelle McCreary, Anthony L. Komaroff, and John K. Chia

Antibody to parvovirus B19 nonstructural protein is associated with chronic arthralgia in patients with chronic fatigue syndrome/myalgic encephalomyelitis

J. Gen. Virol. 2010 91: 893-897.

Kaushik, N., Fear, D., Richards, S. C. M., McDermott, C. R., Nuwaysir, E. F., Kellam, P., Harrison, T. J., et al. (2005). Gene expression in peripheral blood mononuclear cells from patients with chronic fatigue syndrome. Journal of Clinical Pathology, 58(8), 826-832. Copyright 2005 Journal of Clinical Pathology. Retrieved from http://dx.doi.org/10.1136/jcp.2005.025718

Light, A. R., Bateman, L., Jo, D., Hughen, R. W., VanHaitsma, T. A., White, A. T. and Light, K. C. (2012), Gene expression alterations at baseline and following moderate exercise in patients with Chronic Fatigue Syndrome and Fibromyalgia Syndrome. Journal of Internal Medicine, 271: 64–81. doi: 10.1111/j.1365-2796.2011.02405.x

Mathew, S. J., Mao, X., Keegan, K. A., Levine, S. M., Smith, E. L. P., Heier, L. A., Otcheretko, V., et al. (2009). Ventricular cerebrospinal fluid lactate is increased in chronic fatigue syndrome compared with generalized anxiety disorder: an in vivo 3.0 T (1)H MRS imaging study. NMR in Biomedicine, 22(3), 251-258. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/18942064