Editor's Comment: This ground-breaking letter was sent to members of the United States Department of Health and Human Services on May 12th by a group of ME/CFS patients. You can support this letter by signing this petition. Change the definition – change the name!
Read the full text of the letter HERE.
Date: May 12, 2013
To: Secretary Sebelius, Dr. Howard Koh, Dr. Thomas Frieden, and Dr. Francis Collins
CC: Dr. Janet Woodcock, Dr. Beth Unger, Dr. Susan Maier, Dr. Nancy Lee, CFSAC members
Subject: Need for Focused Attention on Myalgic Encephalomyelitis (ME)
Dear Secretary Sebelius, Dr. Koh, Dr. Friedan, and Dr. Collins
We are writing to express our strong concerns with the Department of Health and Human Services (DHHS) current definition activities related to "Chronic Fatigue Syndrome” (“CFS”). We believe DHHS is moving in a direction that is unproductive and harmful to patients. This letter outlines the basis for these concerns and the steps we believe must be taken to rectify the situation.
Throughout the twentieth century, there have been occurrences of a complex, disabling disease characterized by unrefreshing sleep, flu-like symptoms, impairment of memory and other cognitive impairments, orthostatic intolerance, debilitating weakness, pain, fever and the hallmark symptom of post-exertional malaise (post-exertional neuroimmune exhaustion). This disease has been shown to cause severe dysfunction of neurological, immune, endocrine and energy production systems and, since 1969, has been classified as a neurological disease called myalgic encephalomyelitis (ME) by the World Health Organization.The name myalgic encephalomyelitis is still used elsewhere and is used herein to refer to this disease and to clearly distinguish it from the non-specific term “CFS”.
Following the outbreak in Incline Village, the CDC named the disease chronic fatigue syndrome (CFS) instead of myalgic encephalomyelitis and developed the first of a number of fatigue-focused case definitions. Today, the term “ME” is rarely used in the U.S. and instead, ME patients are almost always given a diagnosis of CFS.
Unfortunately, according to the CDC website, “CFS” can be defined by at least 5 disparate CFS definitions (see Table 1). Three of these, the 2003 Canadian Consensus Criteria, the 2011 ME International Consensus Criteria, and the Pediatric definition, describe the essential and hallmark features of ME. But the two most commonly used definitions, the 1994 Fukuda and 1991 Oxford definitions, focus on fatigue, do not require core ME symptoms like post-exertional malaise, cognitive problems and unrefreshing sleep and allow the inclusion of primary psychiatric illness. In fact, Oxford does not require any symptoms except for 6 months of disabling fatigue for a patient to be given a diagnosis of CFS.
As a result, the term “CFS” has become an amorphous umbrella associated with a diverse set of unrelated conditions that include depression, deconditioning, medically unexplained chronic fatigue, school phobia, and for some researchers and clinicians, fatigue due to “excessive rest” or “false illness beliefs”. In clinical practice, doctors give a CFS diagnosis to a heterogeneous mix of patients – those with ME, those with the varied conditions listed above, those who have been misdiagnosed or those whose doctors use CFS as a catchall diagnosis for fatigue.
ME is unquestionably a complex disease and its heterogeneity is real. But this “heterogeneity” is a manufactured artifact of the amalgamation of diverse definitions and unrelated patient populations into one clinical entity called “CFS”. Tragically for ME patients, this has obscured ME in a “web of confusion”, which has confounded ME research, virtually precluded drug development and resulted in widely divergent prevalence estimates. This confusion has also negatively impacted clinical care, led to inappropriate and sometimes harmful “one size fits all” clinical guidelines applied to all “CFS” patients and created a climate in which physicians routinely dismiss ME as not real or not serious.
There is an urgent need to stop perpetuating this confusion and start researching and treating the disease that these patients actually have – myalgic encephalomyelitis.
Given the current embrace of these non-specific “CFS” definitions and the failure to directly engage ME patients and ME experts in the current DHHS definition initiatives, we believe that the outcome of these DHHS initiatives will further exacerbate an already intolerable situation.
The following steps are necessary in order to move forward with improved research and treatment for patients with ME:
- Adopt a disease appropriate case definition: ME, as defined by the Canadian Consensus Criteria (CCC), must be recognized by DHHS and the United States government for the serious and debilitating disease that it is. ME is not a subtype of “CFS”. The CCC must be adopted now as the baseline case definition for this disease. It can be evolved as additional knowledge is gained, the definition is operationalized and markers are validated. We do not need more years of study to fix what is so clearly broken today.
- Stop using “CFS”: The terms "Chronic Fatigue Syndrome" and "CFS" must be permanently abandoned along with the overly broad, two-decades old Fukuda and Oxford definitions. By using non-specific criteria that have become associated with such a diverse set of unrelated conditions, these terms and the accompanying definitions have become medically and scientifically meaningless. They are impeding forward progress and DHHS should discontinue their use. DHHS should also discontinue the dissemination of “CFS” clinical information, like the ‘one size fits all’ CDC CFS Toolkit,ii that uses a non-specific disease description and includes clinical findings and recommendations for all patients based on Oxford, Empirical or chronic fatigue studies.
- Manage the transition to the Canadian Consensus Criteria: This includes the adoption and proactive dissemination of appropriate medical guidance like the International Association for CFS/ME Primer, available through DHHS’ Guidelines.gov. It also includes the establishment of a research program focused on ME, updated insurance guidelines for Medicare/Medicaid, the establishment of disability guidelines for ME and similar transition activities. Most importantly, it must include a plan to care for those patients who have received a diagnosis of "CFS” but do not meet the CCC criteria for ME. These individuals should be properly evaluated and diagnosed where possible. If unexplained conditions remain, additional studies will be needed to understand these conditions and establish more appropriate names and definitions. The continued use of the overly broad “CFS” and Fukuda for these patients is not appropriate.
- Engage ME stakeholders in the planning and implementation: In keeping with President Obama’s commitment to Open Government, the key stakeholders – ME patients and ME experts – must be engaged in a full and open partnership to plan for and ensure implementation of this change. We are the ones that best understand this disease and will provide valuable input to these activities.
For decades, ME patients have borne the brunt of the failure to correct the flaws with how “CFS” has been defined. We will not accept this situation any longer.
The FDA Stakeholder Workshop has provided a unique opportunity to approach this disease in new ways, starting with the definition. It is time to adopt the Canadian Consensus Criteria as the baseline case definition for ME research and clinical care and move forward from there. Doing so will energize the wheels of research and drug development and begin to directly improve the lives of the many Americans stricken with this devastating disease.
We look forward to partnering with you to make this a reality for patients. We respectfully request a response to our concerns along with an explanation of how ME patients and ME experts will be engaged in this process by June 5, 2013. Do not hesitate to contact us if you need additional information.
Chronic Fatigue Syndrome, Fibromyalgia and Chemical Sensitivity Coalition of Chicago
The Fibromyalgia-ME/CFS Support Center, Inc.
CFS/Fibromyalgia Organization of Georgia, Inc.
Rocky Mountain CFS/ME and FM Association
MAME (Mothers Against Myalgic Encephalomyelitis)
Speak Up About ME
PANDORA (a.k.a. CFS Solutions of West Michigan)
Wisconsin ME/CFS Association, Inc.
Independent Patient Advocates
Bobbi Ausubel, Denise Lopez-Majano, Jean Harrison, Rich Carson, Mike Munoz, Meghan Shannon MS MFT, Lori Chapo-Kroger, R.N., Matina Nicolson, Eileen Holderman, Kati Debelic, R.N., Donna Pearson, Marly Silverman, Mary Dimmock, Leela Play, Suzan Jackson, Pat Fero, MEPD, Justin Reilly, J.D., Rivka Solomon, Joan Grobstein, M.D., Mary Schweitzer, Ph.D., Jill Justiss, Tamara Staples, Mindy Kitei, Charlotte von Salis, J.D., Michele Krisko, Michael Walzer