Occupy CFS

In this post, we present profiles of the eight members of the Institute of Medicine ME/CFS definition panel who are known to the ME/CFS community in some capacity. Many, but not all, of them are ME/CFS experts in that they work predominantly in that area. You can read about the team who put these profiles together and the methods we used in this previous post.

Important disclaimer: Many of us know one or more of these panelists quite well. They are our doctors, our colleagues, our friends. We strove to be as objective as possible, and applied all the same research methods and questions here as we did for the other panelists.

Lucinda Bateman

Dr. Lucinda Bateman has specialized in the treatment of ME/CFS and fibromyalgia since 2000. She was educated at Brigham Young University (BA, MS) and Johns Hopkins University (MD). She practiced general internal medicine from 1991 through 2000, and then opened her Fatigue Consultation Clinic. Dr. Bateman’s sister suffered from the disease, and died from non-Hodgkins lymphoma in 2001.

Dr. Bateman has participated in research in a variety of ways. She provided patients for laboratory studies investigating XMRV and cytokine expression after an exercise challenge (the remarkable Light studies). Given her position as a solo practitioner with no university appointment, she has also participated in clinical trials for treatments including Ampligen, Cymbalta, and the Synergy trial. Dr. Bateman has also received substantial payments for speaking and research from pharmaceutical companies, including Eli Lily, Pfizer, and Forest.

Given her significant contributions to ME/CFS policy issues, it is not surprising that Dr. Bateman was nominated to the IOM panel by at least six sources. She served on the CFS Advisory Committee (2005-2010), the Board of Directors and Scientific Advisory Board of the CFIDS Association, and the board of the IACFS/ME. She also co-founded and serves on the board of OFFER (Organization for Fatigue and Fibromyalgia Education and Research).

Dr. Bateman is a co-author on the ME-ICC definition, and withdrew her signature from the expert letter in support of the CCC. Her clinic is part of the CDC multisite study, and Dr. Bateman has participated in multiple physician education efforts, including some of the CDC’s Medscape courses. Dr. Bateman brings a great deal to the IOM panel: her experience caring for more than 1,000 ME/CFS and fibromyalgia patients; her research and clinical trial experience; her physician education experience; her general internal medicine experience; and her long dedication to participating in ME/CFS policy issues.

Lily Chu

Dr. Lily Chu holds degrees from the University of Washington (BS, MD) and University of California, Los Angeles (MSHS) and is board certified in both internal medicine and geriatric medicine. Dr. Chu is also a patient with ME/CFS and is very knowledgeable about issues including definition, diagnosis, treatment, and disability.

Prior to her illness, Dr. Chu was a geriatrician at The Permanente Medical Group in San Francisco. She worked as part of multidisciplinary teams in her clinical practice and in her research into pain assessment in the elderly, quality of care and quality improvement. She has collaborated on articles that provided retrospective analysis, cross-sectional descriptive studies, and method reviews with a focus to improving the methods used. This experience will be of benefit as the IOM panel undertakes a systematic review to develop clinical diagnostic criteria for ME/CFS.

Dr. Chu has consulted with non-profit, academic, research and government groups on matters related to ME/CFS. She is a board member for the IACFS/ME and the Stanford Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Initiative. Her work with the Stanford initiative involves identifying and participating in activities that benefit patients, researchers and healthcare providers by expanding their knowledge base to improve care. Dr. Chu spoke on two panels at the April 2013 FDA Drug Development Workshop, and collaborated with Dr. Leonard Jason to conduct a patient survey prior to the meeting. The results of the survey were submitted to the FDA and were incorporated into the FDA report. Dr. Chu has participated in the CFS Advisory Committee’s review of the CDC website on CFS, and she was nominated to the Committee this year.

Dr. Chu was nominated to the IOM panel by at least two sources, and we found no conflicts of interest or payments from pharmaceutical companies. Dr. Chu joined in the experts’ letter advocating the adoption of the CCC. She brings the perspective of both the patient and the clinician-scientist to the panel, a combined skill set that is extremely relevant to the panel’s work.

Ronald Davis

Dr. Ronald Davis is Director of the Stanford Genome Technology Center. He has spent his career co-inventing techniques that have become the cornerstones of gene technology: the mapping of coding RNA which led to the discovery of RNA splicing; the use of restriction endonucleases for joining DNA fragments; the development of the first DNA microarray for gene expression profiling; and the method for constructing genetic linkage maps which made the Human Genome Project possible.

Dr. Davis has an incredible legacy of publications and patents. He has won numerous awards, including the very prestigious Gruber Genetics award in 2011. He was elected to the National Academy of Sciences (a sister institution to the IOM) in 1983, but has not served on any IOM committees. Based on his academic career alone, he would be a prestigious member of the panel and could address the many questions about ME/CFS and genomics.

But Dr. Davis has another qualification that has introduced him to many in the ME/CFS community: his son Whitney is very ill with ME/CFS. Dr. Davis has turned his formidable mind and experience to unraveling the genetics of ME/CFS. Through his own CFS Research Center at Stanford and his partnership with the Open Medicine Institute, Dr. Davis will sequence the entire genome of study participants and search for microbial causes of the disease (although a great deal has not been disclosed about the study design). Dr. Davis is on the board of the Open Medicine Institute but not the Open Medicine Foundation, a non-profit. OMI is a California B-corp and, among other things, is one of the participating locations in CDC’s multisite study.  Dr. Davis was interviewed by Ryan Prior for The Blue Ribbon documentary, and Ryan told me that one of Dr. Davis’s comments (at approximately :21) inspired one of the slogans for the film.

Many of us had never heard of Dr. Davis prior to the IOM panel announcement, and I originally listed him as a non-expert. He was nominated by at least one ME/CFS source, and our team was excited by what we learned about him. It is quite clear that Dr. Davis brings his family experience and formidable scientific mind to the panel’s task. However, it is important to note that like many other panelists, he has no clinical experience working with ME/CFS patients and no experience in creating clinical case definitions.

Betsy Keller

Dr. Betsy Keller may not predominantly work on ME/CFS, but she has certainly become a growing contributor to the field. She received a Master’s and PhD in exercise science from the University of Massachusetts. Overall, her research has focused on childhood obesity and the effect of exercise on maximizing function through all phases of life. In the last ten years, however, Dr. Keller has followed the path of Dr. Christopher Snell and Staci Stevens investigating the role of exercise capacity in ME/CFS.

Her first ME/CFS patient exercise test was performed on an Ithaca woman who could not travel to Stevens’ lab. Dr. Keller described the same reaction to the results as Stevens experienced: there must be something wrong with the equipment. She presented research at the 2011 IACFS/ME conference, and collaborated with Dr. Maureen Hanson to provide an exercise component to Hanson’s XMRV work. Dr. Keller reportedly has additional ME/CFS studies and publications underway, and provides two-day cardiopulmonary exercise testing to ME/CFS patients.

Dr. Keller was recently nominated to the CFS Advisory Committee by Dr. Hanson, and signed on to the expert letter advocating for the immediate adoption of the CCC. Beyond that, she has not taken a public position on the ME/CFS case definition, nor does she have expertise in developing such definitions. While Dr. Christopher Snell and Staci Stevens received more nominations to the IOM panel, Dr. Keller can bring a similar expertise with two-day CPET and interpreting those unusual results in ME/CFS patients.

Nancy Klimas

Dr. Nancy Klimas has earned the title “ME/CFS expert” through almost twenty years of work on this disease. She studied ME/CFS and ran a clinical practice at the University of Miami for many years. In 2012, Dr. Klimas opened the Institute for Neuroimmune Medicine at Nova Southeastern Unversity, where she also chairs the Department of Clinical Immunology.

She has consistently been among the most successful ME/CFS researchers in securing funding from NIH and the Department of Defense, including a $4 million grant announced last month. Dr. Klimas was one of the pioneers of ME/CFS crossover research, incorporating CFS patients into Gulf War studies. Her collaborations with Dr. Mary Ann Fletcher, Dr. Gordon Broderick, and others, have led to some of the most extensive work characterizing immune system abnormalities and systems networking in this field. Dr. Klimas has combined her clinical practice and research, applying information learned at bedside or bench to the other. She is participating in the CDC multisite study, and has conducted clinical trials on Ampligen.

Dr. Klimas has contributed to ME/CFS issues in numerous ways. She is past president of the IACFS/ME, served on the CFS Advisory Committee from 2007-2012, and also served on the CFIDS Association Scientific Advisory Board. She is a Principal Investigator with the Chronic Fatigue Institute, and has spoken at hundreds of meetings including the April FDA Workshop and last month’s Mt. Sinai ME/CFS conference. Dr. Klimas has been interviewed for the Canary in the Coalmine documentary, and is perhaps most quoted for telling the New York Times that given the standard of care in 2009, she would rather have AIDS than ME/CFS.

Out of all the panelists, Dr. Klimas has probably made the most public statements on the ME/CFS case definition. She is a co-author of both the CCC and ME-ICC definitions. She signed the expert letter urging HHS to adopt the CCC. Dr. Klimas was nominated to the IOM panel by at least six sources, so it’s clear that she is widely regarded as a vocal and highly qualified expert on the subject.

 

Martin Lerner

Dr. A. Martin Lerner is an infectious disease specialist with an MD from Washington University School of Medicine. He served as Chief of the Division of Infectious Diseases and Professor of Internal Medicine at Wayne State University School of Medicine, 1963-1982. Dr. Lerner now treats CFS and tick-borne diseases at his Treatment Center for Chronic Fatigue Syndrome, and is a Professor in the Department of Internal Medicine at Oakland University William Beaumont School of Medicine.

Dr. Lerner believes that ME/CFS is caused by persistent herpes virus infection, including Epstein-Barr virus, Cytomegalovirus and HHV-6, singly or in combination. In both his research and clinical practice, Dr. Lerner has focused on identifying and treating these persistent infections. As part of diagnosing ME/CFS, Dr. Lerner uses 24-hour Holter ECG monitoring. He believes that abnormal results are a biomarker for CFS, and that absence of abnormal results indicates fatigue is not caused by CFS. In 2010, Dr. Lerner published the results of a retrospective review of his clinic data showing that 74% of selected patients dramatically improved after treatment with valacyclovir or valganciclovir. He presented these results at the CFS Advisory Committee Science Day on October 12, 2010.

Dr. Lerner is the only infectious disease specialist on the panel, a critical role, and reportedly is recovered from ME/CFS himself. We found no evidence of conflict of interest. Dr. Lerner is a co-author on the CCC, and signed the experts’ letter in support of adopting that definition. His strong views on the causation and diagnosis of ME/CFS are relevant to the IOM panel’s task.

 

Benjamin Natelson

Dr. Benjamin Natelson is a neurologist with a long history of both patient care and ME/CFS research. He was a Professor of Neurology and Neurosciences at the University of Medicine and Dentistry of New Jersey, now part of Rutgers University. While at UMDNJ, Dr. Natelson led one of the NIH’s CFS Cooperative Research Centers before all the centers were closed in 2002. Now Dr. Natelson provides an integrated approach to patient care and research at the Beth Israel Medical Center and Albert Einstein College of Medicine.

Dr. Natelson’s research on ME/CFS has examined the role of the central nervous system in ME/CFS and other diseases. He has researched fibromyalgia, Lyme Disease, Gulf War Illness and ME/CFS patients. Among his notable studies is the finding of unique proteome markers in the cereberospinal fluid of ME/CFS patients and evidence that CFS and fibromyalgia are different illnesses. Dr. Natelson has collaborated extensively with Dr. Dane Cook, incorporating submaximal exercise challenge into much of his work. Dr. Natelson has generally been one of the more successful researchers in obtaining NIH funding, including a $2 million grant earlier this year shared with collaborators at Weill Cornell Medical College.

Dr. Natelson’s clinical practice is widely recognized, and does incorporate very gentle physical conditioning along with other treatments. He’s written two books for patients and spoken at numerous venues, including the Massachussetts CFIDS/ME & FM Association in 2012 and the NIH State of the Knowledge meeting in 2011. His clinic is a participant site in the CDC multisite study.

Dr. Natelson was nominated to the IOM panel by at least four ME/CFS sources. He did not sign the expert letter regarding the CCC (although his wife, Dr. Gudrun Lange, did). In 1994, Dr. Natelson was part of the International CFS Study Group that contributed to the Fukuda definition. Since that time, Dr. Natelson has become a “splitter,” believing that subtypes can be identified through biomarkers and symptom constellations. His focus on the involvement of brain disease and encephalopathy in ME/CFS is highly relevant to the IOM panel.

Peter Rowe

Dr. Peter Rowe is Professor of Pediatrics at Johns Hopkins University School of Medicine, and Director of the Chronic Fatigue Clinic at Johns Hopkins Children’s Center. After receiving degrees at Trinity College (BA) and McMaster University Medical School (MD), Dr. Rowe has spent most of his professional career at Johns Hopkins. Dr. Rowe started the Chronic Fatigue Clinic in 1997, and it has grown into the largest and most respected pediatric ME/CFS practice in the country.

Dr. Rowe is a clinician-researcher, like many other ME/CFS experts, and he pioneered investigation into the orthostatic intolerance issues that frequently accompany the disease. In 1995, Dr. Rowe and his collaborators published two seminal papers on the issue. The first reported evidence of neurally mediated hypotension in seven adolescents, and the second reported the same results in 23 adults. Treatment with Florinef and/or beta blockers showed promise for treatment in both groups. In 2001, Rowe and colleagues reported the results of a placebo-control trial of Florinef in adults that did not show a statistically significant difference between the groups. However, both Dr. Rowe and many ME/CFS patients have continued to use treatment for neurally mediated hypotension and report positive results. As a result of Dr. Rowe’s work, testing and treatment for orthostatic intolerance is considered standard of care among ME/CFS experts. Dr. Rowe has pursued other hypotheses in ME/CFS research, including the connection to Ehlers-Danlos and neuromuscular strain, and has received support from NIH and non-profit sources. Dr. Rowe has presented on these topics many times, including via webinar, the NIH State of the Knowledge Workshop in 2011, and the April 2013 FDA Drug Development Workshop.

In addition to clinical and research efforts, Dr. Rowe has participated in numerous ME/CFS policy efforts. He has served on advisory boards for the CFIDS Association several times (1999-2002, 2013- present), as well as NIH grant review committees, and the NIH Chronic Fatigue Syndrome Coordinating Committee of the NIH (1999-2002). Also of note is his role as a peer reviewer on the systematic evidence review authored by Dr. Cynthia Mulrow (discussed in a previous post). Dr. Rowe has participated in some of the CDC physician education efforts, and given presentations to the CFS Advisory Committee. We found no evidence of pharmaceutical payments or other conflicts of interest.

Dr. Rowe was nominated to the IOM panel by at least seven ME/CFS sources, more than anyone else that we could confirm. He did not sign the experts’ letter and is not a co-author on any ME/CFS disease definition paper. His clinical expertise focused on pediatric ME/CFS will be an important asset to the panel, as is his knowledge of orthostatic intolerance issues associated with the disease.

Acknowledgements: This post was a group effort, and would not have been possible without the assistance and participation of Lori Chapo-Kroger, Claudia Goodell, Chris Heppner, Denise Lopez-Majano, Mike Munoz, Darlene Prestwich, Tamara Staples, WillowJ, and one advocate who wished to remain anonymous.

 

In this post, we present profiles of the seven members of the Institute of Medicine ME/CFS definition panel who were unknown to the ME/CFS community. You can read about the team who put this together and the methods we used in this previous post.  In assessing conflict of interest in these profiles, we defined conflicts very narrowly. We looked for direct financial interests that could influence panel members in defining ME/CFS. For example, payments from disability insurance companies would be highly relevant and potential conflicts. The conflicts assessments presented in this post are limited to those direct interests. In a future post, we will share a summary of our discussion about whether to define conflicts more broadly and consider other types of financial issues.

 

Ellen Wright Clayton, Chair

Simply put, Dr. Ellen Clayton is a heavy hitter. She holds joint faculty appointments to the Vanderbilt University School of Law and Medical School. She received degrees from Duke University (BS), Stanford University (MS), Yale University (JD), and Harvard University (MD). For more than thirty years, she has focused on the crossroads of law, ethics and medicine in genetic testing. Dr. Clayton has established expertise in newborn and pediatric genetic screening issues, and co-founded Vanderbilt’s Center for Biomedical Ethics and Society. She directed that Center for twelve years, and has served on more than forty Vanderbilt University committees since her arrival there in 1988. More recently, Dr. Clayton has focused on genetic biobanks and big data projects, including the International HapMap Project and the Human Genome Organization. While some of these issues are relevant to ME/CFS research, particularly given the growing number of biobanks and big data, Dr. Clayton has no discernible subject matter expertise in ME/CFS or in creating case definitions.

However, Dr. Clayton has a remarkable amount of Institute of Medicine experience. She was elected to the IOM in 2006, but her IOM service dates back to 2002 when she began a five-year term on the Board on Health Sciences Policy. She has served on a total of ten committees since 2003, and chaired four of them. Specifically, Dr. Clayton chaired the Committee to Evaluate the HHS Program on Family Planning in 2009, and now chairs the Standing Committee on Family Planning. Dr. Clayton co-chaired the Committee on Commercial Sexual Exploitation and Sex Trafficking of Minors in the United States which just issued its report in September 2013. Her combination of legal and pediatric experience was particularly relevant here. Finally, Dr. Clayton chaired the Committee to Evaluate Vaccine Safety, which delivered its report in 2011. The Committee investigated the evidence for a number of adverse events connected to vaccines, including autism and chronic fatigue syndrome. While there was causal evidence for many adverse events, no connection was found with autism or CFS. Two other members of that committee are of interest: Dr. Anthony Komaroff, a well-known and highly regarded ME/CFS expert, and Dr. Betty Diamond, who has also been appointed to the IOM ME/CFS panel and who is profiled below.

In addition, Dr. Clayton has been a member of the IOM Advisory Council since 2010, and in 2012 she was appointed to a three-tear term as Chair of the Board on Population Health and Public Health Practice. In October this year, Dr. Clayton received the David Rall Medal for exemplary service to the IOM. The medal is awarded to a member of the IOM that has demonstrated “a commitment substantially above and beyond the usual expectations of a committee chair.”

Bottom line? Dr. Clayton knows IOM. She has already chaired four committees, including one investigating the controversial topic of vaccine safety. She has a distinguished academic career, demonstrable leadership capacity, and significant influence at the IOM itself. We found no evidence of financial conflict of interest or bias on ME/CFS. However, it should be noted that Dr. Clayton has no experience in creating case definitions, and little public knowledge of ME/CFS. She may have been selected as chairman for her IOM process experience, her ability to tackle big issues, and (perhaps) because this panel has already been so controversial.

Margarita Alegria

Dr. Margarita Alegria is a psychologist with a focus on mental health population research. She holds degrees from Georgetown University (BA), the University of Puerto Rico (MA), and Temple University (PhD). Her academic career has been spent at the University of Puerto Rico and at Harvard University, where Dr. Alegria has been Director of the Center for Multicultural Mental Health Research (CMMHR) since 2002. She has served as a consultant to multiple academic institutions and an expert presenter for Shire US, Inc., a pharmaceutical company. According to her CV, Dr. Alegria served on the Steering Committee for the DSM-V Developmental Workgroup in 2001, and has been a grant reviewer for NIH. Her work has been funded by NIH and most recently by PCORI. Dr. Alegria’s research has focused on mental health disparities and care delivery in multicultural populations, and this is also the mission of multiple research projects at the CMMHR.

Dr. Alegria was elected to the Institute of Medicine in 2011. She currently serves on the Board on Population Health and Public Health Practice (chaired by Dr. Ellen Clayton, profiled above).  Dr. Alegria served on the Committee on Standardized Collection of Race-Ethnicity Data for Healthcare Quality Improvement, which issued its report in August 2009. She also served on the Committee on The Mental Health Workforce for Geriatric Populations that delivered its report in July 2012. Finally, Dr. Alegria is a member of the Committee on Initial Assessment of Readjustment Needs of Military Personnel, Veterans, and Their Families which issued two reports in March 2010 and March 2013. While these reports do discuss fatigue and related syndromes like Gulf War Illness, they do not discuss ME/CFS in a substantive way.

The HHS announcement of the IOM contract stated that the committee would include expertise in behavioral health, and Dr. Alegria fits that category. We think it is safe to assume that ME/CFS advocates would prefer for psychologists/psychiatrists to be kept far away from this panel, although that was never likely given the large body of research in this area. Dr. Alegria has not done any research on ME/CFS, but she does have several publications that may give some advocates pause. Two papers examine the connection between physical symptoms and mental health services delivery. In 2010, Dr. Alegria co-authored a paper that concluded, “physical symptoms are an important component of common mental disorders such as depression and anxiety and predict service use in community populations.” A followup paper in 2012 found that the presence of physical symptoms was not a barrier to mental health service use by some minority populations. Finally, Dr. Alegria co-authored a paper finding comorbidity between neurasthenia and psychiatric disorders. The term neurasthenia has been controversially applied to ME/CFS, as recently as this year.

Despite these publications that relate to psychology and somatic symptoms, they represent a tiny fraction of Dr. Alegria’s body of work. We found no evidence that she believes ME/CFS is psychogenic in origin, or that she supports CBT as a treatment for the disease. In addition, we found no conflicts of interest or negative bias.

Charles Cleeland

Dr. Charles Cleeland is a psychologist by training, but has focused his work on pain and cancer studies. He is Chair of the Department of Symptom Research, Division of Internal Medicine, University of Texas MD Anderson Cancer Center and is also director of the Pain Research Group at that institution. Dr. Cleeland has authored more than 350 publications, many of which are focused on pain. He is a past president of the American Pain Society, and member of the International Association for the Study of Pain. This research is potentially relevant given the prominence of chronic pain for many ME/CFS patients. In addition, Dr. Cleeland is familiar with animal models of sickness behavior (such as Dr. Glaser’s work) and “hypothesizes that inflammation and its downstream toxic effects represent a significant biological basis for subjectively reported clusters of symptoms, cognitive impairment, and neuropathies.”

A closer look at Dr. Cleeland’s work also shows him to be interested in quality of life measures, outcome measures, symptom burden, cognitive impairment (usually as a result of cancer treatment), and cancer-related fatigue (CRF). Dr. Cleeland has helped develop three symptom inventory scales:  The Brief Pain Guide, a widely used self-assessment scale of pain and function (used by Dr. Fred Friedberg in a CFS study); the MD Anderson Symptom Inventory (MDASI), a multi-symptom patient-reported outcome (PRO) measure focused on core symptoms that have the highest frequency and/or severity in patients with various cancers and treatment types; and the Brief Fatigue Guide, an assessment of cancer-related fatigue and quality of life. Each of these scales are validated self-assessment measures of symptom severity, function, and symptom impact, at least in cancer if not other conditions.

In 2011, Dr. Cleeland edited Cancer Symptom Science: Measurement, Mechanisms, and Management, for which he was also co-author of the Introduction and three chapters. Keeping in mind that he was the editor of the book and not the sole author, it is interesting to note that chronic fatigue syndrome is mentioned in several places in the book. CFS is characterized as a physiological illness (with a viral connection implied), and in more than one place the book mentions that studying the brain mechanisms of CFS could “help us form hypotheses relevant to the cortical processing of cancer-related fatigue.”

Dr. Cleeland co-chairs an independent and multidisciplinary work group: Assessing Symptoms of Cancer Using Patient-Reported Outcomes, that is developing recommendations for symptom measurement in oncology clinical trials, with financial support from pharmaceutical companies. ASCUPRO has noted that the fatigue in CFS, multiple sclerosis, cancer and other diseases is pathological, may differ between disease states and may possibly require different fatigue measures. Dr. Cleeland has chaired NIH and NCI advisory groups in the area of pain and symptom research. He has also participated in clinical trials to improve cancer pain management, including in under served populations. Dr. Cleeland receives substantial NIH support for his work. He is neither a member of the IOM, nor has he served on any IOM committees.

We have not found evidence of conflict of interest or negative bias. We also did not find direct evidence that Dr. Cleeland is familiar with ME/CFS definition issues. However, as we have noted, Dr. Cleeland does seem to recognize that CFS (at least) is physiological, and is concerned about symptom burden and cognitive function. Dr. Cleeland’s expertise in the creation and application of patient-reported outcome measures is highly relevant to ME/CFS, as evidenced at the April FDA Drug Development Workshop. Understanding epidemiological data and measurement questions will also likely be part of the ME/CFS case definition effort. These factors and his expertise with pain both suggest Dr. Cleeland could play a positive and significant role in the ME/CFS case definition study.

Betty Diamond

Dr. Betty Diamond is a rheumatologist educated at Harvard University (BA, MD). She is chief of the Autoimmune Disease Center at North Shore-LIJ Health System, and head of the Center for Autoimmune and Musculoskeletal Diseases at The Feinstein Institute for Medical Research. The Feinstein Institute is an enormous research institution focused on disease-oriented research, and receiving $45 million per year from NIH.

Dr. Diamond’s laboratory studies the role of B cells in the systemic lupus, an autoimmune disease. Her team has also investigated whether autoantibodies might cause brain injury if they penetrate the blood-brain barrier. These antibodies may contribute to acquired changes in cognition or behavior in people with and without autoimmune disease, as well as autism or PTSD. Her discoveries have led to the development of possible treatments for lupus, and Merck funds lupus treatment research at Feinstein. She has conducted clinical trials in lupus and rheumatoid arthritis, and has published extensively in these fields.

When she joined the Feinstein Institute in 2007, Dr. Diamond was the third-largest recipient of NIH funds in the New York metropolitan area.  She is a past president of the American Association of Immunologists and in 2008 received the Lupus Foundation of America’s Evelyn V. Hess Research Award for lifetime achievement in lupus research. She has also won an NIH MERIT award, which is intended to “provide long-term grant support to investigators whose research competence and productivity are distinctly superior and who are highly likely to continue to perform in an outstanding manner.” Investigators do not apply for MERIT awards; they are selected by NIH Institute Councils for their excellence in research. Beyond bench and clinical trial research, Dr. Diamond’s group provides consultation services to lupus patients, and she has spoken about the racial and economic disparities that impact lupus and autoimmune disease research. Dr. Diamond was elected to the IOM in 2006, but has only served on one Committee, the Review of Adverse Events in Vaccines which was chaired by ME/CFS panel chair Dr. Ellen Wright Clayton (profiled above).

Not surprisingly, given her clinical trial research, Dr. Diamond has multiple connections to pharmaceutical companies. She received approximately $19,000 in 2010-2012 for consulting services to Pfizer, Merck, and EMD Serono. She previously served on the scientific advisory board of Anthera Pharmaceuticals and is a scientific advisor to Sequenta, Inc., a biotech company focused on clinical diagnostics based on immune system status.

Dr. Diamond’s experience as a rheumatologist and in autoimmune disease research is highly relevant to ME/CFS, especially given the research advances published in the last several years. She is passionate about her work and helping people with lupus, and has had a successful and distinguished career in her field of study. We found no indication that Dr. Diamond is familiar with ME/CFS definition issues, nor did we find any evidence that she has preconceived ideas about the disease that could create negative bias.

Theodore Ganiats

Dr. Theodore Ganiats is a Professor of Family and Preventive Medicine at the University of California San Diego (UCSD) School of Medicine, where he received his own medical degree. His research focuses on outcomes measures, quality of life assessments, and how outcomes research is translated into the clinical setting. He also maintains a clinical practice specializing in family medicine and primary care at the UCSD Health System and was Chief of the Division of Family Medicine from 1986 to 1997.

Dr. Ganiats is the Executive Director of the UCSD Health Services Research Center, a non-profit research organization focused on understanding how clinical and treatment services affect health outcomes.  Projects have included mental health prevention, mental health services, PTSD outcomes for veterans receiving cognitive processing therapy, as well as a variety of studies such as TB diagnostics and diabetes prevention programs. He has well over 100 publications, focused mainly on outcomes research. We found only one payment for consulting and travel from Pfizer in 2010.

Dr. Ganiats was elected to the IOM in 2006, and served on the Committee on Oral Health Access to Services, which delivered its report in 2011. Last month, he was nominated by the American Academy of Family Physicians to a vacancy on the Board of Governors for PCORI. Dr. Ganiats has represented the AAFP on a number of clinical guidelines committees, which seems like a natural fit with the IOM ME/CFS study. However, his ties to the AAFP may give some advocates pause, given some of their publications on ME/CFS. (I analyzed some of that material last year.)

We did not find any evidence that Dr. Ganiats has a bias about ME/CFS. However, one of his close colleagues appears to have one. Dr. William J. Sieber is the Research Director for the division of Family Medicine, and has co-authored papers with Dr. Ganiats. Dr. Sieber is also a part of Inner Solutions for Success, which provides consultation and coaching services to healthcare professionals. Dr. Sieber’s bio page includes a slide deck titled “Calming the Anxious Brain.” Some of the material on CFS in that presentation is accurate, but it also includes statements like this: “Metabolism of CFS patients is normal so symptoms are due to psychological factors, with mental fatigue considered a lack of motivation (brain is major consumer of resting cellular energy!)” (p. 21)

Dr. Ganiats brings expertise in family medicine (a stated interest of the IOM study) and outcomes measures (an important part of operationalizing a case definition). He also has broad experience in creating clinical practice guidelines and measuring how outcomes research translates to the clinical setting. All of this is highly relevant to the IOM ME/CFS study. We do not know what, if anything, Dr. Ganiats knows or thinks about the disease, but his connections with the AAFP and Dr. Sieber at least raise the possibility that Dr. Ganiats may believe the disease is something very different from what we all understand it to be.

Cynthia Mulrow

Dr. Cynthia Mulrow is an adjunct professor of medicine at the University of Texas Health Science Center at San Antonio. Dr. Mulrow received her MD from Baylor University, but has spent most of her professional career specializing in research methodology, systematic review, and evidence based medicine. She is a senior deputy editor for the Annals of Internal Medicine, and former director of both the San Antonio Cochrane Collaboration Center (now closed) and San Antonio Evidence-Based Practice Center.

Dr. Mulrow has been on the faculty at the Health Science Center since 1987, and also served as a member of the U.S. Preventive Services Task Force from 1998 to 2002. She has authored many publications on systematic reviews, and evidence based clinical guidelines.  Her focus is the methods “that aid comprehensive collation, unbiased and explicit evaluation, and systematic summarization of available research.” It is not at all surprising that the IOM sought to include this expertise on the panel.

Dr. Mulrow was elected to the IOM in 2007, and has served on two consensus panels. The first examined Cognitive Rehabilitation Therapy for Traumatic Brain Injury and delivered its report in 2011. The second panel examined Standards for Developing Trustworthy Clinical Practice Guidelines.  Its report, also issued in 2011, recommended eight standards for developing rigorous, trustworthy clinical practice guidelines. Dr. Mulrow has also participated in several IOM workshops, including a discussion of data standards for PCORI.

All of this experience makes Dr. Mulrow very qualified to tackle the massive systematic evidence review that will be part of the IOM ME/CFS study. However, this will not be the first time she has worked on an evidence review for chronic fatigue syndrome. In 2001, Dr. Mulrow led the contract at the San Antonio Evidence-Based Practice Center to do a systematic review on Defining and Managing Chronic Fatigue Syndrome. Obviously, the science was different in 2001, but one of the main conclusions of the review was

Definitions, developed primarily by expert knowledge and consensus, have evolved over time. A few comparative research studies support the concept of a condition, characterized by prolonged fatigue and impaired ability to function, which is captured by the case definitions. The superiority of one case definition over another is not well established. The validity of any definition is difficult to establish because there are no clear biologic markers for CFS, and no effective treatments specific only to CFS have been identified.

It’s important to note several things about this report. First, the technical experts and peer reviewers included: Dr. Leonard Jason, Dr. Nancy Klimas, Dr. Anthony Komaroff, and Dr. Peter Rowe, as well as others not so well-regarded by the ME/CFS community such as Dr. Simon Wessely and Dr. Peter White. Second, the Agency for Healthcare and Research Quality is embarking upon another systematic review as part of NIH’s Evidence-based Methodology Workshop, which will (hopefully) update and expand the 2001 analysis.

Also in 2001, Mulrow and colleagues published Interventions for the Treatment and Management of Chronic Fatigue Syndrome in the Journal of the American Medical Association. The review followed the same approach that the current IOM study appears to be using, in that “CFS was taken to mean all illnesses, including ME and PVFS with symptom complexes similar to CFS, unless otherwise stated.” (p. 1360) The analysis found that there was no significant association between the definition used and treatment study outcome (p. 1366). However, the paper also reports many weaknesses and limitations in the treatment studies, including the failure to characterize baseline functionality in a standardized way. CBT and GET were considered promising, but “All conclusions about effectiveness should be considered together with the methodological inadequacies of the studies.” (p. 1367)

The main issue regarding Dr. Mulrow is whether she can look at the ME/CFS world of 2013 with fresh eyes. There have been scientific advances since the 2001 review, but many challenges in the data remain. We found no evidence of any statements or publications by Dr. Mulrow about ME/CFS since those 2001 papers, so we do not know if she has a dogmatic and unchanged view. It is possible that she will be an asset to the panel, both for her methodological expertise and her previous examination of the data. That will depend on whether she is able to examine the evidence and listen to the panelists without undue bias.

Michael Shelanski

Dr. Michael Shelanski is Chairman of the Department of Pathology and Cell Biology at Columbia University.  He received an MD/PhD from the University of Chicago. Dr. Shelanski’s research has focused on cell and animal model approaches to study memory disruption and synaptic dysfunction in Alzheimer’s and other neurodegenerative diseases. Dr. Shelanski is on the faculty of the Taub Institute at Columbia, an NIH-funded Alzheimer’s disease research center. His extensive publications cover cell biology, neuropathology, gene expression, and impact on disease. Dr. Shelanski has received extensive funding from NIH for his work, and has served on multiple advisory committees and boards during his career, as well as the editorial boards of many scientific journals.

Dr. Shelanski was elected to the Institute of Medicine in 1999, but has only served on a single committee: the Review of the Appropriate use of AFIP’s Tissue Repository Following its Transfer to the Joint Pathology Center committee. The committee’s report, issued in October 2012, made recommendations regarding the preservation and use of the Army’s extensive repository during its transition. The repository is significant for, among other things, preserving the tissue that made the genomic sequencing of the 1918 influenza virus possible.

We found no evidence for conflicts of interest, nor did we find any connection or bias regarding ME/CFS. However, Dr. Shelanski’s participation in the panel is a bit of a puzzle. Certainly research into neurodegenerative conditions could be relevant to ME/CFS, and Dr. Shelanski is clearly a distinguished scientist. His work has focused on cell biology and animal models, more of a “bench” than “bedside” approach. Given that the IOM panel will be creating an evidenced-based clinical case definition, we do not understand Dr. Shelanski’s qualifications to create such a definition or a plan for disseminating the definition to health professionals.

Acknowledgements: This post was a group effort, and would not have been possible without the assistance and participation of Lori Chapo-Kroger, Claudia Goodell, Chris Heppner, Denise Lopez-Majano, Mike Munoz, Darlene Prestwich, Tamara Staples, WillowJ, and one advocate who wished to remain anonymous.

 

My plan upon the announcement of the Institute of Medicine panel was to provide detailed write ups on all the members within 48 hours. Reality smacked me upside the head after about 24 hours. I am working with a wonderful team to get this done, as you will see, but many of us have had medical appointments and family situations this week, and all of us are personally affected by the severe limitations of ME/CFS in some way. The project is taking a bit longer than anticipated, but I expect that the first group of profiles on the seven “Unknowns” will be ready later today. For now, I would like to explain our methods so that you can see how we pulled all of this together.

The Team: I am lucky to be working with a great team of fellow advocates: Claudia Goodell, Chris Heppner, Lori Chapo-Kroger, Denise Lopez-Majano, Mike Munoz, Darlene Prestwich, Tamara Staples, WillowJ, and one advocate who wished to remain anonymous.  I posted requests for help several weeks ago on Facebook, this blog, and at least one ME/CFS forum. All of the team volunteered, although some may have needed encouragement. Before the announcement of the panel, we formulated research questions and collected sources to guide the work. Several of us did practice dry runs of these questions and adjusted based on what we learned. I assembled a list of nominees from as many sources as possible, and that helped, but half of the panel were completely new names to us. The team was on standby for the panel announcement, and we got to work within 30 minutes of the announcement. I am deeply grateful to each volunteer for their tremendous work, and this project would not have been remotely possible without all of their involvement.

The Goals: The project has evolved as we’ve researched and discussed our findings. We now have three goals, and will address them in successive posts over the next few days:

1. To provide well-researched profiles of each of the 15 panelists to help the community assess and provide feedback to IOM.
2. To share our own discussions about the panelists and overarching issues. While we do not represent every viewpoint in the community, we do cover a fair part of the spectrum. We will share with you the questions and conclusions that we have discussed.
3. To propose a response to IOM. We may not be able to reach consensus within our team, we’ll do our best to share a cohesive response with you. We will also provide more information about how you can submit feedback to IOM as well.

The Methods: To prepare the well-researched profiles, we have examined numerous sources. We focused on characterizing the individual’s career, involvement with the IOM, and their relevant expertise. We screened curriculum vitae, publication history, and nonprofit work. We looked for conflicts of interest and bias, and screened the unknowns for any position or familiarity with ME/CFS or overlapping conditions. We watched videos of their talks and examined their funding history. We’ve discussed what we found about the unknowns as a group, raising more questions. Finally, I collaborated with team members to draft and refine the profiles. Now you know why I am so grateful to the team for their extensive work!

What Next: The first batch of profiles will go up later today. Our goal is to post all the profiles by the end of the day tomorrow, and then move on to our assessments of the panel. Stay tuned!!

 

The Institute of Medicine has posted the provisional panel for public review and comment. I am working with a group of advocates to research all the members, seek out bias or conflicts of interest, and bring that information to you as quickly as possible. For now, here is the list categorized by ME/CFS expert and non-expert members.

ME/CFS Experts* (7 of 15)

• Dr. Lucinda Bateman
• Dr. Lily Chu
• Dr. Betsy Keller
• Dr. Nancy Klimas
• Dr. Martin Lerner
• Dr. Benjamin Natelson
• Dr. Peter Rowe

Non-Experts (8 of 15)

• Dr. Ellen Wright Clayton
• Dr. Margarita Allegria
• Dr. Charles Cleeland
• Dr. Ronald Davis
• Dr. Betty Diamond
• Dr. Theodore Ganiats
• Dr. Cynthia Mulrow
• Dr. Michael Shelanski

More to come!!!!!

*Upon further reflection, I think it’s important to note that not all of these folks are experts in the sense that they predominantly work on ME/CFS. However, all of them are known to the community in some capacity and have done ME/CFS related work.

Understanding the CFS Advisory Committee is not limited to what happens in the meetings. The paths that lead members to their seats at the table are very important too. Regular readers of this blog know that I’ve tracked the nomination sources for all the members. I now have new information about how Dr. Gary Kaplan was nominated to the Committee, and it potentially changes the full context of the Committee balance. In fact, I can now show you a very disturbing trend in which nominations seem to be the most successful under Dr. Nancy Lee.

When Dr. Gary Kaplan was appointed to the CFS Advisory Committee last month, he very kindly gave me an interview. I published a profile of him on October 25th.  I asked Dr. Kaplan who had nominated him to the CFSAC, and he told me that he was nominated a year ago by a unnamed patient of his at HHS. I did not include that comment in my profile of Dr. Kaplan because I did not want to risk exposing this person as a patient, if he or she has not gone public about the illness.

I followed up, as I now do with every new member, by filing a Freedom of Information Act request for all letters of nomination submitted in support of Dr. Kaplan. Amazingly, I received a response a month later (the fastest I have EVER received a FOIA response).

The documents reveal that Dr. Kaplan was not nominated by a patient. Dr. Kaplan nominated himself to CFSAC on August 17, 2011. The FOIA letter further states “there are no other nominations submitted on his behalf.”

Now, there’s nothing wrong with nominating yourself to CFSAC. People do it all the time. What frustrates me about this situation is that Dr. Kaplan didn’t simply tell me that this is what he did. I emailed Dr. Kaplan and asked if he would like to comment on the discrepancy. Dr. Kaplan replied:

You are correct I self nominated for the committee. I submitted the application so long ago I forgot the specifics of the process. I was told about the committee and encouraged to submit an application for selection to the advisory board by a patient of mine who works for HHS.

I certainly hope that this was an honest mistake and fuzzy recollection. The sources of CFSAC nomination are a matter of public record, and are an important part of the operation of the Committee.

Tallying the Members

The Federal Advisory Committee Act requires that advisory committees have a balance of views and members. No single source or type of source should dominate appointments. This is why I have been tracking how the members get to the table. With the addition of Dr. Kaplan to CFSAC, the nomination sources break out as follows:

• Nominated by CFSAC members: Dr. Gailen Marshall and Dr. Adrian Casillas
• Nominated by CDC: Dr. Lisa Corbin
• Nominated by The CFIDS Association: Dr. Dane Cook
• Nominated by PANDORA: Eileen Holderman and Steve Krafchick
• Nominated by the Miami CFIDS Support & Advocacy Group: Dr. Mary Ann Fletcher
• Nominated by academic colleague: Dr. Jordan Dimitrikoff
• Nominated themselves: Dr. Susan Levine, Rebecca Patterson Collier, and Dr. Gary Kaplan

Nominees from advocacy groups (4 combined) and self-nominations (3) predominate. However, five members will depart the committee in 2014: Marshall, Cook, Holderman, Krafchick, and Levine. Look at what that will do to the balance:

• Nominated by CFSAC members: Dr. Adrian Casillas
• Nominated by CDC: Dr. Lisa Corbin
• Nominated by the Miami CFIDS Support & Advocacy Group: Dr. Mary Ann Fletcher
• Nominated by academic colleague: Dr. Jordan Dimitrikoff
• Nominated themselves: Rebecca Patterson Collier, and Dr. Gary Kaplan

Self-nominees will dominate, but barely. Nominations for new members were due October 28th, and we will all be watching final selections with great interest.

However, there is a disturbing trend in the recent appointments that may not bode well for those recent nominees. Six appointments have been made since Dr. Nancy Lee became Designated Federal Officer in late 2011. Half of those appointees (Rose, Collier and Kaplan) nominated themselves, which strikes me as very high. All three also live in the DC metro area, which is another odd imbalance. The remaining three (Casillas, Corbin, and Fletcher) each came from a different source: a current member, CDC, and an advocacy group, respectively.

But more disturbing than the nomination sources is the level of ME/CFS specific knowledge these members have brought. Dr. Fletcher is the only person with ME/CFS research experience, and Dr. Kaplan is the only one with ME/CFS specific clinical knowledge. The rest all acknowledged relatively little familiarity with ME/CFS scientific and political issues. For example, Dr. Corbin said at her first meeting that she was not aware there were any alternative definitions to Fukuda. Dr. Casillas admitted that his first meeting made him recall patients who probably did have ME/CFS that he had not recognized at the time.  Only one of the six, Dr. Fletcher, was known to the ME/CFS advocacy community prior to appointment to the Committee.

Coincidence or master plan? The trend of appointing members with no experience with CFSAC and/or little familiarity with ME/CFS is very troubling. If substantial ME/CFS expertise is not appointed to the Committee in 2014, then the FACA requirement of membership balance will likely be violated, to say nothing of the damage that these neophyte members would do to the Committee’s work.

 

 

November has become a gratitude month in the US, with Thanksgiving happening this week. Last year, I posted a list of ME/CFS related things I was grateful for, and I think it might be a healthy tradition to maintain.

1. I am grateful for an online gratitude group that a friend invited me to join. It is such a joy (and sometimes a challenge) to practice gratitude, but I am practicing.

 

2. I am grateful for the Freedom of Information Act. CFSAC, NIH and government agencies must disclose certain information upon request, and FOIA is the only way we can get access to it.

 

3. I am grateful for resourceful advocate researchers. We would not know half the things we do about the Institute of Medicine contract and other government initiatives without the sharp thinking and persistent searching of these advocates.

 

4. I am grateful for the IOM controversy – WAIT! Don’t freak out – I am grateful for the IOM controversy because it has galvanized many people to become involved in advocacy for the first time or in new ways. We need new eyes, new pens, and new blood in the movement.

 

5. I am grateful to the ME/CFS experts willing to serve on the IOM committee.

 

6. I am grateful for the steps advocates have taken to come together, to communicate, and to coordinate.

 

7. I am grateful for Public Citizen.

 

8. I am grateful to Toni Bernhard for her wonderful books, blog and friendship.

 

9. I am grateful to my “research assistant,” and I only wish I could pay her.

 

10. I am grateful for a fellow patient’s success in getting a graduate degree. It means there is hope for so many of us, especially young people who got sick before being able to go to college.

 

11. I am grateful for the FDA and for the April Drug Development Workshop.

 

12. I am grateful that I was able to travel to Maine for a family vacation this summer.

 

13. I am grateful for River Ducks Ice Cream for reasons that have nothing to do with ice cream.

 

14. I am so grateful that I was able to visit a dear friend/fellow patient for the first time in person.

 

15. I am grateful for Canary in a Coal Mine, and the team working with Jen Brea to make it happen.

 

16. I am grateful to all my confidential sources. They have made some of my advocacy work possible.

 

17. I am grateful that I still have enough hope that I am willing to try new treatments. I am grateful that some of them have helped.

 

18. I am grateful to a doctor for being willing to take me on.

 

19. I am grateful to the ME/CFS patients who talked me out of attempting NaNoWriMo this year. You were right.

 

20. I am grateful to the people who accepted nomination to the CFSAC. It will not be easy.

 

21. I am grateful to Carol Head for taking on the challenge of leading the CFIDS Association.

 

22. I am grateful for the opportunity to bring our story to new audiences.

 

23. I am grateful to be recognized for the work on this blog.

 

24. I am grateful for my laptop. Writing would not be an option without it.

 

25. I am grateful for short hair, because the sensation of hair brushing my neck had become intolerable.

 

26. I am grateful for my Fitbit. It has changed my pacing approach.

 

27. I am grateful to the friend who brought a kale salad for lunch one day, and I’m grateful that I liked it.

 

28. I am grateful to my husband and family.  You make it possible for me to survive this disease.

 

29. I am grateful to my best girl friends: A, K, D, M, M, and T. You make it possible for me to laugh at this disease.

 

30. This has been the hardest year of my life. I am grateful that I am still here and that I have not given up.

 

31. I am eternally grateful that you are still here, reading my blog and sharing this journey with me. You are having a tremendous impact on my life.

I am very pleased to share space today with Mary Dimmock. She has written this guest post about which disease HHS has asked IOM to define. Her conclusion will probably increase any concerns you have about the IOM study. Mary has given us all permission to repost this article.

 

Mary Dimmock

HHS recently issued an FAQ about the IOM contract. As Jennie Spotila, Erica Verillo, Lois Ventura and Jeannette Burmeister pointed out, the FAQ falls far short of providing useful answers, is misleading and leaves critical questions unanswered.

Like the fundamental question: “What disease is HHS developing definitions for – ME or the diverse conditions that meet the overly broad “CFS” criteria?

I recently asked that question of both IOM’s Kate Meck and HHS’ Dr. Nancy Lee. From their answers, which I summarized below, the only possible conclusion is that the IOM study is intended to establish diagnostic criteria for the diverse conditions that meet the overly broad “CFS” criteria and that ME will be treated as a subgroup.

All of us, patients, advocates and experts alike, must reject this as completely unacceptable. We must call on HHS to acknowledge that ME is not part of the overly broad CFS. We must continue to call on HHS to adopt the Canadian Consensus Criteria.

We all know the problem. ME, the neurological disease characterized by post-exertional malaise, cognitive issues and immunological dysfunction has been buried inside of “CFS”, a diverse collection of medically unexplained fatiguing conditions. Numerous authors, especially Dr. Jason of DePaul, have reported extensively on the serious research and clinical problems caused by these overly broad CFS definitions, definitions that lump biologically unrelated conditions together. Dr. Bruce Carruthers summed it up simply, “There is a poignant need to untangle the web of confusion caused by mixing diverse and often overly inclusive patient populations in one heterogeneous, multi-rubric pot called ‘chronic fatigue syndrome.”

Having rejected the Canadian Consensus Criteria as unacceptable, HHS is conducting three separate initiatives to develop its own criteria. But what does HHS intend to do about the “web of confusion” that ha been created by “CFS”? What disease will these new criteria describe?

The ME/CFS IOM Statement of Work is ambiguous on this point as it uses the same jumbled, non-specific disease labels that have gotten us into this mess to begin with. The SOW states:

the Committee will consider the various existing definitions and recommend consensus clinical diagnostic criteria for this disorder [ME/CFS]. . .
The Committee will also distinguish between disease subgroups . . .
For the purposes of this document, ME/CFS shall be used to refer to Myalgic Encephalomyelitis (ME), Chronic Fatigue Syndrome (CFS), Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS), Neuroendocrine Immune Disorder, and other terminologies in use for this illness.

I asked both Kate Meck at the IOM and Dr. Lee, the designated federal official for the CFS Advisory Committee (CFSAC) to clarify what “scope of disease” had been specified in the IOM contract. Has the IOM been contracted to develop clinical criteria specifically for ME? Or has IOM been contracted to develop clinical criteria for the range of unrelated fatiguing conditions that meet the “CFS” criteria? I asked Dr. Maier of NIH and Dr. Beth Collins-Sharp of AHRQ a similar question on the NIH Evidence Based Methodology Workshop process and am waiting on a promised response.

Here’s a summary of the responses I received from Dr. Lee of HHS and Kate Meck of the IOM:

Both Dr. Lee and Ms. Meck said that the scope of disease to be covered by the new clinical criteria has not been specifically defined at this point and that this will need to be defined as the process goes forward.

Dr. Lee indicated that the panel itself would need to resolve this issue and that possible outcomes could be ME as a subgroup of the broader CFS, ME as part of a spectrum that includes these other conditions, or ME as a separately defined disease. Ms. Meck indicated that HHS would be asked to clarify what scope of disease was intended at the first meeting. I raised the concern with Ms. Meck that the scope of disease directly affects panel selection and evidence base selection but she felt that the panel and process would be able to adjust as needed.

In a follow-up email, Dr. Lee confirmed the above statements but also reiterated an earlier point she had made that the IOM task list specifies that the “committee will also distinguish between disease subgroups”. She also said that in order for the target audience – defined as the primary care physicians – to effectively use the resultant guidance, “it is important to start a bit broad and then have criteria which distinguishes between subgroups.”

These answers are profoundly disturbing.

First, the statement that the scope of disease has not yet been defined is frankly hard to believe. This is a million dollar contract and panel selection is due to be announced soon. How can such a critical issue as the scope of disease to be covered by the new criteria be undecided at this point? If it really is undecided, who will decide and how? What criteria have been used to select the panel? And will that panel still be the appropriate one once a decision is reached on what disease or diseases the new criteria will cover?

But the statements about subgroups and spectrum of illnesses are much more disturbing.

Yes, ME is a complex disease that needs to be broken down into legitimate subgroups in order to better understand the disease and the treatment options. Perhaps those subgroups are based on whether onset is sudden or not, the level of severity of the disease or the nature of the immune profile and viral load. But let’s be realistic. What is the likelihood that the panel selected for the IOM study is going to be able to identify proper subgroups of ME itself when our experts are still working through that? Or when the evidence base lacks the ME specific studies – studies done with proper ME definitions – that would be needed to substantiate ME subgroups?

At the same time, we have an agency with a long-term commitment to studying medically unexplained chronic fatigue as the single clinical entity, “CFS”. We have an agency that has taken the position that Oxford, Fukuda and the Canadian criteria all describe the same set of patients for whom one set of clinical guidance is appropriate. We have an agency that questions the scientific evidence surrounding even post-exertional malaise and its measurement while simultaneously rejecting the Canadian Consensus Criteria because it does “not account for scientific evidence developed since 2003.” We have the CDC’s Dr. Unger, rhetorically asking at the May 2013 CFSAC “If a patient doesn’t have [PEM], wouldn’t you still manage them as a “CFS” patient?” And we have the IOM adopting the same overly broad view of CFS as HHS in recent IOM publications on Gulf War Illness.

Now we have Dr. Lee stating that the target audience of the new criteria is the primary care physicians and that they need criteria that start broader and then distinguish between subgroups. What about the patients who desperately need criteria that accurately reflect their disease?

What are we to conclude from all this? HHS has not committed to criteria specific to ME. HHS is not talking about the proper subgroups of ME that we all envision. HHS intends the IOM study to define criteria for the broader set of CFS conditions, with ME characterized as a subgroup. Or worse, ME becomes a subgroup of the even broader chronic multisymptom illness (CMI).

Either way, this will be a disaster that will degrade ME research and worsen the abysmal clinical care and stigma that ME patients receive today. This is the nightmare scenario that we all fear.

If HHS truly wants to reverse the chaos and the grievous harm to patients caused by years of sloppy definitions, it will first and foremost declare that ME, the disease described by the Canadian Consensus Criteria, is not the same disease as the overly broad “CFS” and should not be considered as either a subgroup of CFS or part of a spectrum of CFS diseases.

And if HHS cares not only about primary care physicians but also about the ME patients that they treat, it will acknowledge the harm done to patients by its clinical guidelines as reported at a recent Mount Sinai conference. CDC will immediately highlight PEM as a hallmark symptom of ME, will provide “black box warnings” about the adverse effects of exercise on ME patients and will point clinicians to the Canadian Consensus Criteria and the IACFS/ME primer.

Beyond that, HHS needs to immediately require that the Canadian Consensus Criteria be used in every study funded by NIH, even if it is used in parallel with Fukuda as an interim step.

Patients, advocates and experts alike must demand and accept no less, especially in the context of the IOM study and the NIH Evidence Based Methodology process.

 

After more than four months, Assistant Secretary Dr. Howard Koh has finally responded to our request for an investigation into the allegations that Dr. Nancy Lee attempted to intimidate at least two voting members of the CFS Advisory Committee. His response boils down to something along the lines of, “Ok people, move along, nothing to see here.” In fact, his letter is so dismissive of the allegations and so vague on what he’s done about it, that it barely qualifies as a response at all.

Quick Review of The Facts

At the May 2013 CFSAC meeting, Eileen Holderman and Dr. Mary Ann Fletcher said that they had been intimidated by Dr. Nancy Lee and threatened with removal from the Committee for expressing their views. They said a third CFSAC member had also been intimidated.

On June 12, 2013, forty-six organizations and advocates wrote to the General Counsel and requested that he investigate the allegations.

On June 21st, the matter was referred to Assistant Secretary Koh. On August 22nd and September 20th, we wrote to Dr. Koh and requested an update on the investigation. We received no response or acknowledgement of our requests.

A Non-Responsive Response

In an letter to Mary Dimmock dated October 31st (but not received by her until November 7th), Dr. Koh finally responded. You can see the full letter here, but I’ll parse the salient points for you:

The concerns that have been expressed by the members will be taken into consideration as the Committee moves forward in working to accomplish its mission.

This makes no sense at all. Eileen Holderman and Dr. Fletcher did not express “concerns.” A concern is something along the lines of I’m-concerned-that-we-don’t-get-meeting-materials-in-advance. That’s a concern that can be “taken into consideration.” Holderman and Fletcher made allegations of improper conduct by the Designated Federal Officer of the Committee. That’s more than a concern. But Koh doesn’t even acknowledge the nature of the allegations. Nor does he describe what he did to investigate them.

However, it is important to understand that the Designated Federal Officer for CFSAC, Dr. Nancy C. Lee, has authority to engage in private conversations with individual members of CFSAC.

I am not aware of anyone disputing that Dr. Lee can talk to individual members of CFSAC. The allegations were not about the propriety of Dr. Lee talking to CFSAC members. The allegations were about what she said.  This is what we asked the General Counsel to investigate: Did Dr. Lee tell one or more members of CFSAC that he or she could be removed from the Committee for expressing a point of view? That is the question that must be answered.

These discussions may be confidential in nature . . .

Um, okay. As far as I am aware, CFSAC doesn’t deal in matters of national security. They don’t receive confidential corporate documents the way members of FDA advisory committees do. I have no idea what’s so hush hush about it. But even if I accept the proposition that certain discussions are confidential, I hear something a bit ominous in this comment from Dr. Koh. By telling us that those discussions might be confidential, is he saying that Holderman and Fletcher have done something wrong in making their allegations public? Is he actually claiming that they are not permitted to disclose conversations that, at least in their opinion, represent improper behavior by a federal official? Seriously? Is he suggesting that there will be a backlash against any member who speaks out about that kind of behavior? Really?

. . . and also may involve providing information about the rules and regulations of the Federal Advisory Committee Act as they relate to managing CFSAC and the roles and responsibilities of the Committee members.

Permit me to decode this for you.  What this sentence tells me is that Dr. Koh did look into the allegations, although he is completely silent on who he spoke with or what that involved. The sentence also tells me that his conclusion is that Dr. Lee provided information to Holderman and Fletcher (and perhaps the third member too) about the rules and regulations of FACA as it applies to them, and that is the only thing Dr. Lee did.

This simply does not add up. FACA does not state that advisory committee members can be removed for expressing their points of view.  After all, the advisory committee exists for members to do precisely that. Furthermore, FACA requires that advisory committees have a balance of membership and views, so removing a member for expressing a different point of view would unbalance the committee and potentially violate FACA.

Either Fletcher and Holderman are not telling the truth about what Dr. Lee said to them, or Dr. Lee is not telling the truth about what she said to them, or there has been some kind of epic misunderstanding that Koh has failed to identify. And since Koh’s letter gives us no information about whether an investigation was conducted, who was interviewed, and what the findings were, we have no ability to unravel this mess.

All engaged in this activity should conduct themselves in a manner that is conducive to respectful and candid discussions.

I think this sentence is code for: one or more people are not conducting themselves appropriately and they should knock it off. Of course, the letter does not specify who needs to knock it off. But read between the lines. He has already said that Lee behaved appropriately. So the only people left to knock it off would be the CFSAC members who complained.

Completely Unacceptable

This non-responsive response is unacceptable for so many reasons, it’s hard to know where to begin. We started with seeking advice from multiple sources, including legal, political and advocacy sources. After consultation with a variety of sources, Mary Dimmock has sent a second letter to the General Counsel of HHS. You can read the full letter here, but these are the main points:

• Dr. Koh failed to adequately investigate and resolve the allegations.
• Dr. Koh’s letter contains no evidence or assurance that these allegations are unfounded.
• The failure to resolve the allegations is not at all conducive to respectful and candid discussions.
• Public trust and confidence in the work of the Committee has been undermined and all but destroyed.
• The public cannot trust that Committee members are free to provide honest advice to the Secretary.

The letter then renews our request, that the General Counsel and not Dr. Koh:

investigate these allegations immediately, and establish whether any voting member of the CFSAC has been intimidated or threatened for expressing their opinions. At a minimum, your response should detail what steps were taken to investigate, your findings on the facts that support or refute the allegations, and what specific corrective action has been taken.

Will it work? I’m not certain. On the one hand, the General Counsel handed us off to Koh before. On the other, Koh’s response is so vague and the issue of public trust so significant, that the General Counsel certainly should step in and do the right thing. I think it’s vitally important to get matters like this on the public record. We are accumulating more and more evidence of a systematic pattern of ignoring our concerns, downplaying the seriousness of the situation, and flat out subversion of good government practices. There are plenty of other people who are interested in this sort of thing, even if the General Counsel isn’t.

It never ceases to amaze me. Do they think we’re stupid? Do they think that hand waving and “These aren’t the droids you’re looking for” Jedi mind tricks actually work? Or are they counting on the media or Congress or the Office of Inspector General* being completely uninterested in what’s going on? We’ll see.

 

Note: Remember, there is a difference between the Office of the General Counsel (which “supports the development and implementation of the Department’s programs by providing the highest quality legal services”) and the Office of Inspector General (which is “dedicated to combating fraud, waste and abuse and to improving the efficiency of HHS programs.”)

Public comment for the CFS Advisory Committee is due next Friday, November 29th. That’s not much time to prepare and submit comments, but I believe that you should if at all possible (instructions are here). Here’s why:

CFSAC and HHS need to hear your voice. Your input and point of view is important. CFSAC members and HHS employees need to hear it. By submitting public comment, you have a chance to speak to them and tell them what you think. The Federal Advisory Committee Act requires that the public be given such opportunities. Use it.

We are building a record. One of the advantages of the CFSAC meetings is that everything is on the record. When it comes to public comment, this is important. We need to be able to point Congress, policy makers, and the media to evidence of the government’s action and inaction on ME/CFS. One source of such evidence is the CFSAC public record.

We need to educate people. There are voting and ex officio members who join CFSAC with little or no understanding of what it means to live with this disease or which policy issues are of greatest concern to us. That’s not necessarily the members’ fault. I’ve been told that HHS currently provides no orientation for new members. The only way to be sure that members know about our perspectives is to share them through public comment.

Speaking isn’t enough. Technically, you can get a public comment slot without submitting something in writing. But your five minutes of comments won’t be part of the official record of the meeting. The meeting minutes no longer summarize public comments, so the only way your comments are officially captured is through written submission. It’s true that the videos of the meetings are available, but it’s not officially part of the record and no one will know where to look for your comments.

It has a direct and cumulative effect. There have been meetings where something said in comment is quoted by a committee member during discussion. There are also trends over time that have a less direct but cumulative effect, such as complaints about the CDC Toolkit. Coordination of multiple comments around a particular theme is especially effective.

We need to hear each other. I know I have learned from listening to your public comment. Sometimes you reframe an issue in a way I never thought of, and raise concerns to new levels of importance. Sometimes I am simply moved by what you said or how you said it. Hearing from you helps me think about the issues, and also inspires me to keep doing this work. And I certainly hope my public comment has been helpful to you!

More ways to comment. With this meeting, prerecorded video comment is once again being accepted. You can also submit comments in writing only, speaking only, or writing and speaking. Since this meeting is by webinar, in person comment will only occur by telephone.

I know it’s hard to write even one page of comment. I haven’t written mine yet! But it is very, very important to put your thoughts on the record. If you want to participate in public comment for the upcoming meeting, here is what you need to do:

• Register for the meeting before November 29th. Indicate that you wish to provide public comment.
• Follow the public comment instructions. There are specific requirements for pre-recorded video comments and written comments (including page limits and file format).
• Check out my testimony tips from last fall for ideas on giving effective public comment.

Above all, speak your truth and let your voice be heard. It really matters.

 

I am honored to have been nominated for a WEGO Health Activist award in the Best in Show: Blog category! You can see my profile page, and endorse the nomination if you are so inclined, here.

To create my profile page, I had to write a description of what I try to do here. It was actually amazing to me when I thought about all the subjects I’ve covered here since creating the blog in February 2012. I devote most of my advocacy energy here: to researching and writing posts to help other advocates in the work they do, and to sharing my personal experiences with treatment and coping. It’s a lot of work, and I have sacrificed other things I want to do in order to keep writing here.

I am deeply grateful to the person who nominated me, and to everyone else who has told me how much this blog means to them or has helped them. Working in isolation means I send these posts out into the world, not knowing if they will be read or if they will help anyone. I’m humbled to hear that you appreciate what I’m doing.

My profile description reads like a year-in-review, and if you find Occupy CFS helpful to you, then I hope you will consider endorsing my nomination. Whether or not you click the endorse button, I thank you for reading my blog and sharing this journey with me.

I started my blog, Occupy CFS, in February 2012 with one goal: to give voice to what it means to have ME/CFS. I write about the full spectrum of living with ME/CFS. I’ve investigated NIH funding for ME/CFS research, and I’ve written extensively about the federal CFS Advisory Committee. I have filed multiple Freedom of Information Act requests and have reported my findings through the blog in an effort to create accountability for the government’s actions. I have personally participated in opportunities to provide public input, such as public comment at the Advisory Committee meetings, testimony to a Senate hearing on chronic pain, and FDA public meetings on ME/CFS, and have encouraged other advocates to participate as well. I was accepted into the FDA’s Patient Representative Program this year, and have been sharing what I’ve learned with the community.

Research findings and application to clinical care are a big concern for ME/CFS patients. I try to explain the complicated science in simple ways so that patients can understand and use the information. Sometimes, inaccurate information is published in medical journals and I discuss that on the blog, and co-authored a letter published in the journal American Family Physician.

My blog is not just about politics and research. I’ve documented my own advanced exercise testing and experimentation with medications and behavioral techniques (like pacing). I have written very personal essays about my inability to have children and my spiritual struggle to live with ME/CFS. I posted a video of myself on a bad crash day to show people what it looks like.

Through all of my writing, I am motivated by a fundamental goal: to speak the truth about living with ME/CFS. Too many patients live in isolation and disability, invisible to the world. We routinely conceal or minimize our suffering, even with family and friends. No more! I want to give voice to the struggle. I want patients to use information as power. That is my mission on my blog.