IOM in Control
Once the statement of task and budget are finalized, the committee works independently to come to consensus on the questions raised.
Once the statement of task and budget are finalized, the committee works independently to come to consensus on the questions raised.
The IOM’s website makes it clear that once the contract is signed, the IOM is in complete control of the process. If the IOM’s goal is to be viewed as that of an independent and objective player, it only makes sense that it retain full control over the process. By the time the ME/CFS community learned of the contract, it was already past time to elicit changes to it.
The IOM, of course, knows of the protests and has met with advocates as well. Now that the ball is in their court, we finally got a chance to see them in operation as they released a ‘provisional’ list of the 15 panel members that will create the new ME/CFS definition for doctors.
The list can be changed. The IOM’s statement on this list is
Please note that the appointments made to this committee are provisional, and changes may be made. No appointment shall be considered final until we have evaluated relevant information bearing on the committee’s composition and balance.
The list may not please those who want the panel composed only of ME/CFS experts, and it does contain a couple of head-twisters (an expert on the effects of ethnicity on mental illness?), but it also contains a very strong core of ME/CFS experts and several of the non ME/CFS experts had backgrounds in areas like creating diagnosis, creating clinical guidelines, and symptom assessment.
ME/CFS experts made up a majority (8-7) of the panel.
Strong Core ME/CFS Panel
The IOM did not rely on conservative figures to fill the ME/CFS experts role. The panel does include middle of the road figures (Dr. Natelson, Dr. Bateman), but it also includes Dr. Lerner, a physician and researcher focused on viruses, Dr. Lily Chu, an MD with ME/CFS who has not been shy about sharing her thoughts about the shoddy treatment chronic fatigue syndrome has received, a sometimes outspoken advocate Dr. Nancy Klimas (“I would rather have AIDS than ME/CFS”), Dr. Ronald Davis who has an son ill with ME/CFS, and finally, and most surprisingly, Dr. Betsy Keller, an exercise physiologist whose work provides physiological proof for the existence of post-exertional malaise.
No ME/CFS experts focusing on behavioral approach to this illness were included. Some of the panel members including Dr. Klimas, Dr. Bateman, Dr. Natelson and Dr. Chu, are articulate individuals willing to take a stand when necessary. Several have engaged in collaborative processes in the past and are presumably comfortable working in this kind of environment.
CCC/ICC, Experts Letter Signers
Four of the eight ME/CFS experts had co-authored either the Canadian Consensus Criteria (Klimas, Lerner), the International Consensus Criteria (Klimas, Bateman), or the Experts letter protesting the IOM contract (Chu, Klimas, Lerner.)
The fact that three of the panel members signed the Experts letter protesting the IOM contract means the IOM was willing to include a large block of critics, and the experts were willing to put aside their objections and proceed.
The core of ME/CFS physicians (Bateman, Klimas, Lerner, Natelson) each of whom has treated ME/CFS for decades and one of whom had ME/CFS (Lerner) and one M.D. who has ME/CFS (Chu), will, no doubt, receive special notice as the panel works on creating a clinical description of ME/CFS.
(The one missing figure for me, and he’s only missing because once again he has not been included on an ‘experts panel’, is Dr. Peterson. When is our foremost expert on treating immune and pathogen mediated ME/CFS patients going to get his say?)
Dr. Lucinda Bateman, Fatigue Consultation Clinic
Dr. Bateman is regarded as one of the premier diagnosticians in the field. Her sister’s struggles with chronic fatigue syndrome prompted Dr. Bateman to open the Fatigue Consultation Clinic devoted to the care of ME/CFS and FM patients in 2000. Dr. Bateman has served on the board of directors of the CAA, the IACFS/ME, and the CFSAC. Dr. Bateman co-authored the International Consensus Criteria for ME.
Dr. Lily Chu, International Association of Chronic Fatigue Syndrome / Myalgic Encephalomyelitis (IACFS/ME)
Lily Chu, M.D., M.S., is a board member of the International Association for CFS/ME and Stanford University’s ME/CFS Initiative. She was a panel member at the FDA Stakeholders Meeting. She signed the Experts letter protesting the IOM contract. She is a well-known ME/CFS advocate.
Dr. Ronald W. Davis, Stanford University School of Medicine
A world leader in the genomics field, Dr. Ronald Davis, Ph.D., directs the Stanford Genome Technology Center. This is a large laboratory focused on developing novel technologies in the medical field. Dr. Davis has authored hundreds of papers and recently received the prestigious Gruber Award. He’s a board member of the Open Medicine Institute, is currently engaged in a genetic study of ME/CFS, and has a son with a severe case of ME/CFS.
Dr. Betsy Keller Ph.D., Ithaca College
Dr. Betsy Keller has been doing repeat exercise tests for disability assessments for chronic fatigue syndrome patients for the past ten years. She will obviously be a strong proponent for ensuring that post-exertional malaise plays a major role in the new diagnostic criteria, and she can back that claim up with study evidence. (A paper is in the works.) Check out an interview with Dr. Keller here.
Dr. Nancy Klimas, Nova Southeastern University
Dr. Nancy Klimas is… well… Dr. Nancy Klimas. Physician, researcher, and advocate, Dr. Klimas has filled just about every role possible in the ME/CFS universe. An immunologist, Dr. Klimas now directs Nova Southeastern’s Institute for Neuro-Immune Medicine, which conducts research into and provides for people with chronic fatigue syndrome and Gulf War Illness. Check out more on Dr. Klimas here.
Dr. A. Martin Lerner, Oakland University
A professor of infectious disorders and a past director of a clinical virology laboratory, Dr. Martin came down with and successfully resolved his case of chronic fatigue syndrome several decades ago. Since then he treated many people with ME/CFS, and has published several studies suggesting antiviral treatments can be effective.
Dr. Benjamin Natelson, Beth Israel Medical Center, New York
A neurologist, Dr. Natelson ran one of three federally funded CFS research centers for almost a decade. He has authored several books on chronic fatigue syndrome. One of his current research projects seeks to validate 10 years of findings suggesting that ME/CFS patients without depression exhibit distinct neurological markers compared to ME/CFS patients with depression. He currently directs the Pain and Fatigue Center in New York. His wife, Gudrun Lange, a neuropsychologist, also treats and researches chronic fatigue syndrome. He has co-authored over 250 papers.
Dr. Peter Rowe, Johns Hopkins Medical Institutions
A physician and researcher, Peter Rowe, M.D., was one of the first researchers to uncover the presence of orthostatic intolerance in chronic fatigue syndrome. Another well-published author, his recent paper proposes that ‘neuromuscular strain‘ both sensitizes the central nervous system and affects cognition in ME/CFS/FM. Dr. Rowe has directed the Chronic Fatigue Clinic at the Johns Hopkins Children’s Center since 1996.
Non ME/CFS Experts
Experience in their chosen fields marks most of the non ME/CFS experts on the panel. Most are well published and some are leaders in their field.
Dr. Ellen W. Clayton (Chair) – Vanderbilt University
The Chair, Dr. Ellen Clayton, has published two books and over 100 journal articles and is described as an internationally respected leader in the field of law and genetics. She co-founded the Center for Biomedical Ethics and Society. She appears to be on the committee because she’s had experience chairing IOM committees (five of them, thus far).
Dr. Margarita Alegria – Harvard Medical School
A well published author with over 10 citations in 2013 alone, Dr. Margarita Alegria’s work has focused mostly on the intersection between race and mental illness including the disparity in mental health expenditures between ethnic groups as well as how prevalent mental illnesses are in different ethnic groups. She is a full professor at Harvard Medical School. Her focus on underserved groups perhaps has some resonance with ME/CFS, but it’s not otherwise clear why she’s on this panel.
Guideline Support – Panelists Presumably Added Because of Their Experience in Producing Guidelines, etc.
Dr. Charles S. Cleeland – M.D. Anderson Cancer Center The University of Texas
Another well published researcher, Dr. Cleeland has focused on the symptom burden present pre- and post-cancer. He is part of a group asserting cancer patients symptoms should be charted more carefully and taken into account when assessing treatment effectiveness. A 2011 Cleeland study concluded that more than 1 in 4 cancer survivors had severe symptoms even after successful treatment for cancer. His focus on assessing the degree of pain, fatigue, and other symptoms in cancer and post-cancer fatigue would seem to make him an excellent ‘outside’ choice for the panel. His other research interests include the effects of pain on brain activity.
Dr. Theodore G. Ganiats, M.D., University of California, San Diego
Dr. Ganiats has been involved in the development of clinical guidelines for numerous disorders (the IOM says over 50) and has published on a wide variety of subjects. He’s currently the executive director of the UCSD Health Services Research Center.
Dr. Cynthia D. Mulrow
Two of Dr. Mulrow’s papers include Diagnostic Test Accuracy and Clinical Decision Making and Trustworthy clinical guidelines. Mulrow also collaborated on two 2001 efforts to summarize research evidence regarding case definitions, prevalence, natural history, and treatments in chronic fatigue syndrome. She has been director of the San Antonio Cochrane Collaboration Center and the San Antonio Evidence-based Practice Center, and is senior deputy editor of Annals of Internal Medicine and adjunct professor of medicine at the University of Texas Health Science Center at San Antonio.
Betty Diamond, M.D. – The Feinstein Institute for Medical Research North Shore-LIJ Health System
A former president of the American Association of Immunology, Dr. Betty A. Diamond, M.D. has headed numerous programs, and is now the head of the Center for Autoimmune and Musculoskeletal Diseases at The Feinstein Institute. Another highly published autoimmune researcher, her research has focused on lupus in particular.
Dr. Michael L. Shelanski, Columbia University
Another well-published researcher, Dr. Shelanski’s laboratory focuses on the molecular aspects of neurological degeneration. Michael Shelanski, M.D., Ph.D., serves as chairman of the department of pathology and cell biology at Columbia University, co-director of the Taub Institute, and director of the Medical Scientist Training Program. It’s not clear why this molecular biologist is present on a panel to produce a clinical description of ME/CFS, but there he is. 🙂
The DHHS has been so tight-lipped that it’s hard to tell what they’re thinking, but with the creation of the provisional panel it’s clear the contract is going forward, and with this panel, I would argue that it should. A good, widely disseminated clinical definition could be a huge boon to the ME/CFS community.
It would produce ‘widely accepted diagnostic criteria’ and replace the kind of ad hoc definition currently used (if used at all) by physicians. It should decrease the rate of misdiagnoses (mostly depression and anxiety) and increase the rate of proper diagnoses. Drug developers will gain assurance that a more or less well-defined market is there for them. (Currently it’s believed that about 20% of people with ME/CFS are diagnosed, leaving a market of 200,000 patients, not the millions that studies suggest are out there.) Emphasizing post-exertional malaise, as the definition will surely do, would de-emphasize fatigue and reduce the rate of dangerous exercise prescriptions.
It would produce a basis for diagnosis of ME/CFS that most other disorders have. Any IOM-produced definition would, we presume, immediately become widely disseminated on medical websites.
A Diagnostic Tool – Nothing More, Nothing Less
The committee will consider the various existing definitions and recommend clinical diagnostic criteria for the disorder to address the needs of health care providers, patients, and caregivers.
The IOM contract is to produce a diagnostic tool in the form of a description of ME/CFS so that doctors, nurse practitioners, and other first-line healthcare providers can recognize it when they see it. The IOM is not tasked with recommending treatments for ME/CFS, nor stating what the cause of ME/CFS is, nor determining whether it’s a physical or psychological disorder, nor creating a research definition.
The IOM is tasked with producing a descriptive document that provides criteria to help physicians know ME/CFS when they see it.
I don’t think the CCC, ICC, or Pediatric definition were done in vain. They were collaborative efforts produced by experts in the field, some of whom are on this panel, which should lay the groundwork for a new definition. The contract specifically points the panel in their direction, and in the direction of the CDC’s multicenter study. That study, of course, is using patients selected by top ME/CFS practitioners. Time will tell but my guess is that the clinical definition produced will look much like the CCC and ICC definitions.
(The panel may also recommend name changes. Dr. Klimas led the way for the AACFS name change (to IACFS/ME) when she was president at that organization.)
The IOM created a provisional panel with a strong core of ME/CFS experts, surrounded them with several members with a background in diagnostics, clinical guidelines and symptom assessment, brought in an experienced Chair (with no link to the issues involved), and then added an immunologist and a neurologist. ME/CFS experts make up a slight majority on the panel (8-7).
It appears that the IOM’s MO was to bring in ME/CFS experts with an emphasis on treating physicians to advise them on what ME/CFS looks like and then and provided them with support in the logistics of actually creating a definition.
You can make comments and request regarding the panel here until the 23rd of December. For me, I am going to thank them for their choices of ME/CFS experts, and request that more ME/CFS experts such as Dr. Peterson be included.
Despite the DHHS’s early missteps, the IOM contract may in the end provide a real boon for doctors and patients.
Share your pain, make friends, find new treatment options, check out recovery stories and more in the Health Rising ME/CFS, FM and Chronic Pain Forums here