Can you expand on this, please?
I understand that ICC says that ME should be separated out from CFS (leaving a CFS diagnosis that does not include ME). I disagree with that approach. It's possible the Americans on the committee disagreed with this, but went along for consensus and realizing this was an international document and a lot of people outside the US take your approach.
The ICP's largest group of authors by nationality is American.
“Primer Consensus: The authors, representing twelve countries, reached 100% consensus through a Delphi-type process.” The American ICP authors include:
Klimas, Nancy G, MD;
clinician and researcher: microbiology, immunology, allergy
Professor of Medicine and Director: Institute for Neuro-Immune Medicine, Nova Southeastern University, Ft. Lauderdale-Davie, Florida
Director: GWI and CFS/ME Research Center, Miami Veterans Affairs Medical Center, Miami, Florida, USA
Bateman, Lucinda, MS, MD;
clinician: internal medicine with focus on ME & FM
Fatigue Consultation Clinic, Salt Lake City
Utah hospital affiliation: Salt Lake Regional Medical Center
Adjunct Instructor: Departments of Anesthesiology and Family and Preventive Medicine, University of Utah, Salt Lake City, Utah, USA
Bell, David S, MD, FAAP;
clinician and researcher: paediatrics
Retired clinical paediatrician with many years of experience of ME and CFS, Lyndonville, New York
Department of Pediatrics, State University of New York, (SUNY – Buffalo) New York, USA
Chia John, MD;
clinician and researcher: internal medicine - infectious diseases, immunopathogenesis
Clinical assistant professor: Harbor-UCLA Medical Center, University of California, Los Angeles, CA
Director: EV Med Research, Lomita, California, USA
Light, Alan R, PhD;
researcher: physiology, neuroscience, medical neurobiology and neuroanatomy, mechanisms of pain & fatigue
Professor: Anesthesiology and Neurobiology and Anatomy; Molecular and Cellular Neuroscience, University of Utah School of Medicine, Salt Lake City, Utah, USA.
Light, Kathleen C, PhD;
researcher: behavioral medicine – physiological dysregulation in chronic pain and fatigue disorders, behavioral factors in cardiovascular disease, health benefits of family support, minority and women’s health issues
Professor: Anesthesiology and Psychology, University of Utah School of Medicine, Salt Lake City, Utah, USA.
Stevens, Staci, MA;
exercise physiology
Director: Workwell Foundation, Ripon, California, USA
In addition, Dr. Judy Mikovits was an original ME-ICC author.
A year ago, Dr. Unger noted that the “opinions of advocates, clinicians and researchers remain divided about whether CFS and ME are the same or different entities.” She complained, “I have gotten lots of communication from people saying that CFS is different from ME. I have got people that insist that it is the same thing. I think that there is disagreement. There is confusion in the field about whether it should be the same thing, whether it should be two things, whether it should be a hyphen name. Until there is clarity of what we are talking about, we cannot give good guidance.” Dr. Unger added, “We are following the discussions with interest and would consider any consensus that is reached by patient groups and the scientific community going forward.”
Dr. Lee told the CFSAC Spring 2012 meeting, “I get e-mails all the time and one of the big ones that I keep getting is, 'Do not put ME in there. It’s different than CFS.”'
In the CFSAC Fall 2012 videos, the FDA & Drug Development presentation (39:07) asks:
Why so few applications? Because the Core is still in question:
- no accepted definition for disease – and controversy besides
- no accepted method for measuring how patients with CFS or ME feel or function
- no accepted biomarker to provide a simple, quantitative measure of disease presence or activity.
Would you invest in developing a treatment surrounded by such uncertainty?
Sandra Kweder elablorates:
And I think if you ask companies, they'll tell you, here is the answer: What companies want is, they need predictability. They need to understand what it is they're studying. How to measure the effect. That is the key. That I am convinced is why there are so few clinical trials and drug development for this condition. The clinical trial community is scattered and fractionated. There is not a large collective effort to change this situation. I firmly believe that once there is, things will change. I can give you examples of where that has happened, conditions that have had absolutely the same challenges: irritable bowel syndrome, functional dyspepsia, depression, prostate cancer and fibromyalgia (which is not on the list). All of those conditions have the same problems. All of them have new methods of study and growing therapeutic armamentariums
because a generally agreed upon definition with signs and symptoms and measurement tools that could be employed for that condition were agreed upon, developed, and then there was able to be movement forward (
www.youtube.com/watch?v=IGASSh7YV3s).
Perhaps the FDA will offer additional advice to ME and CFS advocates on Thursday:
Myalgic Encephalomyelitis and Chronic Fatigue Syndrome Webinar: Working Together for Change
The Office of Special Health Issues will be hosting a 1 hour webinar that will discuss Patient Advocacy.
The discussion will include presentations from other patient representatives and patient organizations on how they effectively worked with the FDA and other entities.
There will be an opportunity for those of you who live and struggle with Myalgic Encephalomyelitis and Chronic Fatigue Syndrome to ask questions about patient advocacy and how to effectively work with government agencies and drug developers.
http://www.fda.gov/Drugs/NewsEvents/ucm319188.htm