Quest #46 February 2001

CANADA MAKES HISTORY IN ME/CFS AND FMS

By: Marjorie van de Sande, B.Ed., Grad. Dip. Ed,

Consensus Coordinator & Director of Education

In response to the many requests for the history of the National ME/FM Action Network, how our organization became involved with the Clinical Definitions and more information about the Consensus Document/Meeting, I will first give a brief synopsis of our organization and what we are about and then information about the consensus document/process.

National ME/FM Action Network: Background

Lydia Neilson, who had been helping at a national research organization for ME/CFS, realized there was a real need for support of the patients. She therefore left the research organization to start a national organization that would support myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and fibromyalgia (FM) patients.

On June 18, 1993 Lydia Neilson founded the National ME/FM Action Network which was granted charitable status. We are an independent organization but are in contact with over 450 support groups across Canada and work cooperatively with them.

Our mission statement is that: The National ME/FM Action Network advances the recognition and understanding of Myalgic Encephalomyelitis and Fibromyalgia through education, advocacy, support and research. The Network seeks to effect positive change in the attitudes, policies and practices of government, business and the general public."

Our motto is "People Helping People Helping Themselves".

Our logo is the maple leaf with geese flying in "V" formation which portrays working together cooperatively and supporting each other. It is based on the "The Goose Story"

As our name implies, we are an ACTION organization and get actively involved in issues that are of great concern to all of us. To this end, we have a second motto, "Don't React to unfairness but Act for change."

Our newsletter "Quest" keeps members informed of recent developments in research and legal areas, etc. and keeps them abreast of the progress of our many projects. They are too numerous to mention here but range from being instrumental in having the wording changed in the Disability Tax Credit form, to developing a national registry of doctors and lawyers knowledgeable about these illnesses, to developing a research/legal package. A couple of our current projects are an educational resource book full of information and teaching strategies for teachers and parents of children and youth who have ME/CFS, and we will are making a legal challenge to the Canada Pension Plan on the eligibility criteria for a disability pension and to Revenue Canada on the eligibility criteria of the Disability Tax Credit. Highlights of some of our accomplishments can be found on our website: http://www3.sympatico.ca/me-fm/action/ You can also visit our website 'ARCHIVES’ to read past newsletters.

The following points will give you some background as to what led up to the development of clinical definition/protocols documents. The National ME/FM Action Network successfully lobbied the federal government to proclaim May 12th as National ME/FM Syndromes Awareness Day. In honour of that day in May 1995, the Honourable Beryl Gaffney MP and other MPs representing the various provinces presented our petitions with over 15,000 signatures in the House of Commons, requesting recognition of ME/CFS and FM and funding for research of these illnesses. A few years ago we sent a questionnaire to 200 doctors who were knowledgeable about these illnesses, asking what was the most important thing that needed to be done towards recognition of these illnesses and assisting the medical community. Approximately 150 doctors replied and all voiced the opinion that clinical definitions and treatment protocols for these illnesses are of prime importance. The stage was set.

We recruited Dr. Anil Jain of Ontario and Dr. Bruce Carruthers of British Columbia, two of Canada's top experts in these illnesses, who kindly and generously donated their time and expertise to co-author the draft clinical definitions, diagnostic and treatment protocols documents. As consensus coordinator, I have had the privilege of working with these doctors for the past two and a half years.

Lydia presented the draft documents to Health Canada in July 1999. The Honourable Alan Rock, Minister of Health, responded, "The development of draft clinical definitions for ME/FM is a milestone in the fight against this complex and tragic condition". The National ME/FM Action Network worked in partnership with Health Canada on the review process for a year and a half.

The Expert Medical Subcommittee established by Health Canada selected two Expert Medical Consensus Panels, one for ME/CFS and one for FMS. This subcommittee of Health Canada also established the "Terms of Reference" for the panels. One of the stipulations was that at least one member of each panel must be nominated by each of the five stakeholder groups of government, universities, clinicians, advocacy and industry. The twenty-five doctors who were selected received over 80 nominations representing numerous nominations from each of the stakeholder groups. Four doctors from outside Canada were allowed to sit on each panel. A wide range of expertise was represented on the panels including rheumatologists, specialists in internal medicine and infectious disease, a neurosurgeon/ neuroresearcher, a haematologist, etc. There were treating clinicians, teaching university professors and researchers including world-renowned researcher, Dr. Kenny De Meirleir of Belgium who has approximately 300 scientific publications. His research on the dysfunction of the RNase L antiviral defense pathway may lead to a clinical marker for ME/CFS.

The panels have been reviewing the documents since December 2000. The consensus meetings were held in Toronto on March 30 to April 1, 2001.

Canada makes history in ME/CFS and FM as both expert panels came to consensus on their clinical definition /protocols document.

It will take several months before these documents will be published. The documents have to be finalized and sent back to the panels and then published in a reputable medical journal. Once they are published, we will be able to release the definitions and diagnostic and treatment protocols to the public.

The existing U.S. Center for Disease Control (CDC) definition for CFS and the American College of Rheumatology (ACR) definition for FM were established for research purposes. While these definitions serve a purpose for research, they are too restrictive in the clinical setting. The focus of the clinical definitions is to have the physician look at the whole spectrum of pathologies of these illnesses. The definitions are backed up in the documents by research findings. There are sections on diagnostic protocols and treatment protocols. This means that the family physician will have a "manual" that explains how to diagnose and treat these patients. Having the documents reviewed and endorsed by panels of experts gives them credibility and will empower the doctors treating these illnesses. For the patient, it means earlier diagnosis and appropriate treatment which is essential in order to lessen the impact of these illnesses.

The Honourable Allan Rock, who was unable to attend the consensus meeting, sent a written congratulatory message that was read at the meeting. The atmosphere of the welcome reception had an aura of excitement and the positive energy was absolutely electrical. Crystaal Corporation, which sponsored the consensus meeting, was awed at the enthusiasm of the doctors. They said that in all their years of working with the medical community they had never experienced such positive, productive and professional panels!

Dr. Jon Russell and Dr. Thomas Romano, who were both members of the panel that developed the existing ACR research definition for FM, add to the credibility of the clinical definition document. Dr. Nancy Klimas was excited about the unanimous agreement on the ME/CFS clinical definition and told me she previously had been on two panels in the United States to develop a clinical definition but they could not come to an agreement. When Dr. Dan Peterson, a recognized world expert in ME/CFS and was a treating physician for the Lake Tahoe epidemic, was asked what he thought of the clinical definition document for ME/CFS, his response was, "I love it, I love it, I love it!"

I would like to thank Lydia Neilson for her vision of clinical definitions, her commitment and her ongoing lobbying of Health Canada. I would also like to thank her for giving me the honour of introducing Dr. Jain and Dr. Carruthers at the Consensus Meeting. The National ME/FM Action Network would like to thank Health Canada for selecting excellent consensus panels. A very special thank you to all the members of the Expert Medical Consensus Panels for their enthusiasm and productive work, with a huge special thanks to Dr. Carruthers and Dr. Jain. Their dedication is overwhelming and they have been truly wonderful to work with.

Most sincere thanks to Crystaal for sponsoring the Expert Consensus Meeting – they made the weekend truly memorable. A very special thanks to Ann Hartshorn, director of New Products, and Frank Sze, manager of New Products. It was a pleasure to work with Crystaal and Science and Medicine Canada Inc., which is the company Crystaal contracted as organizers. We would like to thank Science and Medicine Canada Inc. for the excellent job they did, with special thanks to Gary Browne, vice-president of client services, and Dr. Brian Morris, medical director, who facilitated the consensus meetings. Thanks to Corrine Daymon, Janice Bortoluss and Pat Hislop who worked behind the scene. Also thanks to Dr. Philipa Corning, our vice president, who acted as secretary for the FMS panel at the meeting. And last but not least we thank all our members for your prayers and good wishes for a successful meeting!

FIBROMYALGIA EXPERT CONSENSUS PANEL: Dr. Steven Barron; Dr. Bruce Carruthers; Dr. Stu Donaldson; Dr. James Dunne; Dr. Emerson Gingrich; Dr. Dan Heffez, USA; Dr. Anil Jain; Dr. Frances Leung; Dr. Daniel Malone, USA; Dr. Thomas Romano, USA; Dr. Jon Russell, USA; Dr. David Saul; Dr. Donald Seibel.

MYALGIC ENCEPHALOMYELITIS / CHRONIC FATIGUE SYNDROME EXPERT CONSENSUS PANEL: Dr. Allison Bested; Dr. Bruce Carruthers; Dr. Kenny De Meirleir, Belgium; Dr. Pierre Flor-Henry; Dr. Anil Jain; Dr. Pradip Joshi; Dr. Nancy Klimas, USA; Dr. Martin Lerner, USA; Dr. James Mc Sherry; Dr. Dan Peterson, USA; Dr. Peter Powles; Dr. Jeff Sherkey.

As a small token of appreciation of their work, the National ME/FM Action Network presented Dr. Anil Jain and Dr. Bruce Carruthers with an award for their dedication and total commitment of the drafting of the ME/CFS and FM clinical definitions. These awards were presented to them at the welcoming reception, which was held the day before the consensus meeting. In addition, the New Brunswick ME/CFS Association honoured these doctors by its National Award echoing the praise our Network bestowed on doctors.

Marjorie van de Sande, our Director of Education, was recognized for her dedication and work as Consensus Coordinator. In this role, she has worked very closely with Dr. Carruthers and Dr. Jain on the development and coordination of the draft consensus documents over the last three years. She also acted as coordinator of the Expert Medical Consensus Panels and the Consensus Meeting. The National ME/FM Action Network presented her with an award in honour of her dedication and work. Marj van de Sande is also the recipient of the "National Award for outstanding commitment to those with Myalgic Encephalomyelitis and Fibromyalgia" from the New Brunswick ME/CFS Association. It goes without saying that without Marj's talents and commitment, it would have been difficult, if not impossible, to have had the consensus meeting with such a positive outcome.

Last but not least, our Network presented Crystaal Corporation with an award for sponsoring the Expert Consensus Meeting. Their encouragement and commitment helped make this event a complete success. Our vision became their vision.

We would also like to take this opportunity to ask you to honour the National ME/FM Awareness Day on May 12th by doing what you can to help raise funds for the National ME/FM Action Network for its many projects. Our work is continuing on the clinical definitions as well as with our other projects. Thank you all for your continued support of our organization.

Lydia E. Neilson, President CEO

Forty-Six dextral, unmedicated women with chronic fatigue syndrome diagnosed according to the Fukuda criteria (Atlanta Centre for Disease Control) were studied with quantitative EEG (48 channels) during eyes open, eyes closed, verbal and spatial cognitive activation. These were compared to 75 dextral healthy female controls. 20 1-second artifact free segments were selected. Sampling rate was 256/sec. Source localization findings will be reported here (LORETA). The CFS group had increased sources in the Eyes Closed condition in the 1-3Hz, and 21-50Hz bands in the left fronto-temporal regions. All the other significant findings, except one, showed that the controls had increased sources in the midline (fronto-occipital) and in the left temporo-parietal region. The exception is the Word Finding task where the controls had increased sources in the right temporo-parietal-occipital region (14-20Hz). The increased sources in the CFS group were maximum in the Eyes Closed condition in the slow frequency band (1-3Hz) arising from the inferior frontal gyrus and in the fast frequency band (21-50Hz) arising from the superior frontal gyrus. Another peak source was during Word Finding in the 14-20Hz band where the controls had increased sources emanating from the superior temporal gyrus. The increased sources in the peak regions are unilateral left frontal in CFS. During Word Finding the increased activity in the superior temporal gyrus seen in the controls may reflect increased transcallosal inhibition, with the result that the CFS group during verbal cognitive processing has relatively lower fast activity in the contralateral hemisphere.

Electrodermal psychophysiology was also carried out on 43 patients with CFS compared to 42 female controls. The prestimulus (tonic) electrodermal levels were lower in the CFS group (p < 0.001) while the prestimulus digital skin temperature was higher (p < 0.006). Further, habituation was significantly slower in the CFS group. Cerebral dysfunction of the fronto-temporal regions (L > R) in CFS is suggested by the EEG findings while the psychophysiological evidence indicates a down-regulation of autonomic sympathetic tone, of central origin (implicating inter-alia), mesial frontal regions and implying a state of relative right brain preponderance, presumably a consequence of the subtle left hemisphere dysfunction.

It is of interest to note that with respect to increased skin temperature unmedicated females with depression (n = 25) were similar to normals whereas with respect to phasic amplitude responses the depression group was lower and the CFS group similar to normals. Finally prestimulus electrodermal levels were significantly lower in the CFS group whereas here the female depressions were similar to normals. Thus we have three double dissociations indicating that psychophysiologically – in women – CFS and depression are independent categories.

In conclusion the source localization evidence and the psychophysiological findings indicate abnormal activation of the left frontal region in Chronic Fatigue Syndrome. Psychophysiological characteristics point to a down regulation of the sympathetic autonomic system and indicates that the changes seen in CFS are not those seen in women suffering from depression.

COMMENTARY - BY: Kate Andersen, M.Ed., Youth Consultant, National ME/FM Action Network

Dr. Pierre Flor-Henry, the principal researcher, is a neuropsychiatrist at the Alberta Hospital in Edmonton. This abstract of some of his groundbreaking Canadian research is quite mind-boggling. I have attempted to present the gist of it for readers like myself who get a bit overwhelmed by all the technical terms. I am not a neuropsychologist so please bear with me! Briefly, Dr. Flor-Henry and his team examined the brain waves and conducted other measurements of central nervous system function in 46 right-handed women with chronic fatigue syndrome who were not taking any medication. We can see right away that this team took pains to make sure that factors such as being left- or right-handed, known to be related to differences in the brain, or the effects of medication, would not confuse the results. As well, they were also careful to state which diagnostic criteria for CFS was used. I can't go into all the ramifications of the different diagnostic criteria, but stating which ones were used permits comparisons across studies, and helps to ensure we are not mixing up apples and oranges--that is, people with different illnesses.

The brain wave test used in this study was the electroencephalogram (EEG) and, as it is known to change in healthy people during times when eyes are open or closed, or when people are doing tasks such as speaking and doing puzzles, patients were tested under all of these different conditions. Most importantly, the patients' results were compared with those of a large number of "controls" on the same tests--that is, healthy women.

When the brain waves of women with CFS were compared with those of healthy women, there were some findings that were statistically significant--that is, there is an extremely low probability that they were due to chance. The CFS group had a different pattern of brain wave activity compared with healthy women in several ways. As well, special electrical skin-conductance

(electrodermal psychophysiology) tests were also carried out on 43 women with CFS and compared with those of 42 healthy women. Again, there were statistically significant differences between the women with CFS and the healthy women. The researchers believe that all these different findings add up to show that in CFS, in women, there are subtle but important abnormalities in the left hemisphere of the brain and that the autonomic nervous system is down-regulated. While all of these findings may prove to be useful in explaining ME/CFS symptoms in a number of ways, the researchers make particular note of the fact that in three separate ways they have shown that, in women [see note below], CFS and depression are not the same.

Footnote. Since this study involved only women, correctly speaking, the findings must be reported as "CFS in women".

I hope that we will have an opportunity to interview Dr. Flor-Henry about this study in a future issue.

Two new articles by Dr. Stu Donaldson (senior author) offer interesting new concepts in muscle activity and pain in fibromyalgia. The research suggests that muscles associated with the tender points are activated inappropriately with movement of the head. The articles show that rotation of the head causes muscles (i.e. in the knee, in the lower back, in the arms) to fire when they should be quiet. This activity was approximately twice as prevalent in fibromyalgia sufferers as compared to controls. Further analysis of the data indicates a central neurological basis for this rather than a metabolic component. These results will be published later this year. For more information contact Dr. Stu Donaldson at Myosymmetries, #300, 290 Midpark Way S.E., Calgary, Alberta T2X 1P1 Tel. (403)225-0900 - Fax: (403) 225-2389 - Email: myo@cadvision.com

Fibromyalgia, chronic fatigue syndrome and chronic pain claims are legend among those which have unduly challenged lawyers (and their clients) in the pursuit of fair compensation for injuries and disabilities. However, should we really be surprised at the attitude of insurers when certain physicians themselves have, for example, approached Chronic Fatigue Syndrome in a way that recently led one Alberta Judge to state:

"I was troubled by the evidence of Dr. Pearce. My first concern is that his diagnosis of the Plaintiff was done on the basis of a preconceived notion of what that diagnosis should be. It seems from his publications that Dr. Pearce is in the process of building a career based on the idea that there is no such thing as CFS and that people who claim to have that condition really have psychiatric problems…After Dr. Pearce had examined the Plaintiff and concluded that she had a psychiatric illness, the Defendant apparently decided that they would employ a private investigator to see if they could persuade the Plaintiff to engage in activities that presumably would show that she was ‘faking’ her condition".

Thankfully, that Court – in Baillie v. Crown Life Insurance Co. – had the insight and wisdom to prefer the opinion of the claimant’s expert, thus:

"The diagnostic impression is of chronic fatigue syndrome. The opinion of Dr. Pearce that such illness does not exist is bizarre since the illness has been recognized by the Atlanta Center for Disease Control, the American Medical Association…and there is enormous medical literature related to it".

The Court went on to find total disability in connection with CFS with the result that the payment provisions of the disputed benefits coverage were applicable.

The judiciary appears now to be moving in the right direction in demonstrating a greater awareness and acceptance of chronic fatigue syndrome and fibromyalgia as proper and sufficient diagnoses to support legal threshold claims of serious permanent impairment or long term disability claim criteria. In Dickson v. Canada Life Casualty Insurance Co., a 1996 decision of the Ontario Court (General Division), Elaine Dickson suffered soft tissue injuries to her neck, shoulders and low back after being thrown from a stationary motorcycle that was struck from the rear. In addition, she went on to experience difficulties with concentration and recall, and disturbed sleep, causing her to abandon her educational and recreational activities. She had abandoned attempts at physiotherapy and massage therapy as ineffectual and painful. The medical evidence put forward on behalf of Ms. Dickson presented a diagnosis of "physical changes associated with fibromyalgia".

At issue was whether Ms. Dickson’s claim could be brought within one of the exceptions to the then-existing general immunity afforded defendants in motor vehicle cases – namely, the plaintiff establishing the existence of a "permanent serious impairment of an important bodily function caused by continuing injury which is physical in nature". At that time, injuries that had at their pathologic origin a psychological or emotional bases were not viewed as compensable under the governing no-fault insurance regime. And, the onus of proof was cast upon the plaintiff to establish that her claim fell within the above-noted exception. The defendant’s insurer, of course, urged upon the Court that "fibromyalgia and related syndromes are not physical in nature but have psychological or emotional bases".

The Court’s underlying concern was that "the diagnosis of fibromyalgia, because its cause remains a matter of debate, would not be proven on a balance of probabilities to be an injury which is physical in nature". Moreover, it was not sufficient that the symptoms be physical (i.e. produce physically-disabling effects), since the physical symptoms associated with fibromyalgia and similar debilitating syndromes, according to the Court, could arise from sources other than physical injury. Nevertheless, the Court went on to find that:

Ms. Dickson had no pre-existing medical condition (other than typical life stresses associated with teen years) relevant to her current complaints;

There was no evidence of conscious or intentional exaggeration of symptoms;

Mechanical fitness (i.e. there being no observable mechanical injury) cannot be equated with the ability to perform a physical function where doing so results in intolerable pain; and

The timing and development of the chronic pain supported a finding of a causal link to the injury, it having followed upon soft-tissue injuries that did not resolve but indeed persisted and increased despite medical intervention.

The Court ultimately found that this was not a case where the impairment had as its source "cognitive, emotional or psychological genesis". Accordingly, Ms. Dickson was found to have met the onus of establishing that her claim fell within an exception to the immunity from liability otherwise afforded the defendant.

Progressive changes in the Ontario no-fault law have, since this case, sensibly removed the requirement of "physical" impairment to sustain a claim for damages. Nevertheless, this decision remains important and instructive because it is among a limited, although growing, body of jurisprudence that recognizes fibromyalgia and "similar debilitating syndromes" as legitimate medical conditions having physical and organic origins essentially on par with other health conditions which have historically attracted much less controversy and cynicism.

Swain v. Moore Estate is a very recent decision of the Superior Court of Justice of Ontario, and was the focus of a review by lawyer James Allin in the August/September 2000, Communication No.43 issue of Quest. The plaintiff, a 45-year-old highly-active mother and businesswoman, suffered extensive soft tissue injuries as a result of a serious motor vehicle accident in which the other driver was fatally injured. A combination of debilitating problems which included post-traumatic stress syndrome, fibromyalgia, chronic pain, anxiety, and depression was found by the Court to constitute the equivalent of "an extremely serious physical injury".

The Court considered Mrs. Swain’s injuries to be catastrophic in nature and, in doing so, assessed her general damages at $100,000.00, apparently the highest sum awarded in Ontario for such a claim. In this writer’s opinion, the Court’s impression of Mrs. Swain as being a highly credible witness and an extremely industrious, hard-working and family-oriented individual prior to the accident, added importantly to the judge’s acceptance of her fibromyalgia and chronic pain as genuine and on the level of "an extremely serious physical injury".

* * *

The following concluding observations are offered: Judicial attitudes appear to be changing in a positive direction. Insurers are being sent a signal that the casual dismissal by their adjusters of fibromyalgia, CFS/ME, and chronic pain claims will no longer be accepted by their claimants or the Courts. It remains particularly important, however, in pursuing these claims that the strongest supportpossible – in terms of both patient-care and medical-legal reporting – be forthcoming from health practitioners. Further, the claimant’s credibility and level of motivation (as perceived by insurers and judges) can create added advantages that leverage the success of such claims.

By: Nancy Bradshaw, Education Coordinator - Environmental Health Clinic - 1-800-417-7092 or (416) 323-6400 Ext. 4993

Dr. Lynn Marshall has been a Staff Physician and Physician Liaison at the Environmental Health Clinic, Sunnybrook and Women’s College Health Sciences Centre, Toronto, since it opened in 1996. She became the Medical Director on January 1, 2001, replacing Dr. Frank Foley. Dr. Foley is remaining as a Staff Physician with the clinic.

Dr. Marshall has been a Research Associate in the Environmental Hypersensitivity Research Unit at the University of Toronto since it began in 1994. She has earned an MD from Queen’s University and a Fellowship from the American Academy of Environmental Medicine. She has also been elected a Fellow of the Royal Society of Medicine in Great Britain.

WEB: http://www3.sympatico.ca/me-fm.action/