Thirty Years of Disdain

THIRTY YEARS OF DISDAIN How HHS and A Group of Psychiatrists Buried Myalgic Encephalomyelitis Mary Dimmock Matthew Lazell-Fairman December 2015 What I would most like to see is that fatigue is not abandoned as a subject for careful consideration because of further failures of CFS case definitions or frustrations arising out of shrill pressures to justify an entity of dubious validity.1 —Stephen Straus of the U.S. National Institute of Health (~1994) Preface 3 Matthew’s Story 5 Introduction 8 Myalgic Encephalomyelitis 9 The Burial of ME and the Birth and Perpetuation of CFS 14 Emergence of the Psychogenic View 14 Emergence and Broadening of the CFS Definitions 16 Reemergence of ME and Conflation of ME and CFS 19 The Debate over PACE 20 The Current Situation with the Definitions 22 Bad Science and Questionable Medical Ethicality 26 The Impact of Bad Definitions 28 Abysmal Medical Care 30 Bad Clinical Guidelines and Medical Education 30 Additional Challenges in Clinical Care 33 Flawed Epidemiological Research 35 Lack of Research and Research Funding 39 Paltry NIH Funding 39 Bias, Misunderstanding, and Lack of Agency Interest 40 Exiled by NIH Institutes and Centers 44 Lack of a Strategy and Follow-up on Key Gaps 45 A Failure in Leadership 46 Stalled Drug Development 48 Inadequate Support Mechanisms 50 HHS’s Stakeholder Engagement And Cross-Agency Coordination 52 HHS’s Failure to Listen to the Key Stakeholders of its Action 52 Lack of Interagency Coordination and Planning 55 CFS as a Social and Political Creation 57 The Architects of the Dominant Paradigm 58 The “Enablers” 61 Changing the Dominant Paradigm 64 Advancing ME Research and Clinical Care 65 Appendices and References 67 Appendix 1: Summary of the Primary CFS, ME/CFS and ME Definitions 67 Appendix 2: Estimated Prevalence Rates across Key Definitions 68 Appendix 3: Key Resources 69 Bibliography 72 Thirty Years of Disdain: How HHS Buried M.E. December 2015. (M. Dimmock, M. Lazell-Fairman) 2 Preface In 2010, I was nearing the end of a 31-year career in the pharmaceutical industry when my son, Matthew Lazell-Fairman, suddenly fell victim to myalgic encephalomyelitis (ME), a disease that causes profound neurological, immunological and energy production dysfunction and a level of debility worse than congestive heart failure, multiple sclerosis and end-stage renal disease. Since then, I have watched, helpless and heartbroken, as this disease has ripped his life to shreds, turning the promise of a vibrant and spirited future into a soul-crushing existence, at times so unrelentingly harsh and circumscribed, so brutal, so cornered, and with so little hope that I have wondered how he has managed to keep going. Compounding the heartbreak, it has been disturbing to watch as the world around my son, including his own doctors, has not only dismissed his disease but also ridiculed him for believing that it is real and serious. Worst of all has been the realization that my son is paying this terrible price because the U.S. government has so badly mismanaged the ME crisis since before he was even born. Everything I thought I understood about disease research, drug development, and the delivery of clinical care has been turned on its head. This isn’t science or medicine as I had come to know them but rather a parade of psychogenic bias, neglect, bad science, flawed public policy, and the political agendas of powerful people and institutions that have sentenced ME patients to the medical equivalent of the most squalid slum in the poorest country on earth. The political decisions taken over the last thirty years have polluted research, perverted clinical care, and shipwrecked ME patients with a life-threatening dose of stigma, disbelief and medically induced harm. As a result of 2015 reports by the Institute of Medicine (IOM) and the National Institute of Health (NIH), the situation is beginning to change. But it is not yet known whether that change will be of a speed, magnitude, direction, and serious commitment that honors the weight of this crisis – the extreme debility of patients, the complete lack of approved diagnostics and treatments, the stagnation in research and epidemiology; the widespread medical disbelief in the disease; and the utter lack of appropriate medical care and patient support structures. Band-aids, small point solutions, and incremental changes to business as usual are not acceptable substitutes for the sweeping changes that are needed to correct this medical tragedy. As a nation, we have the opportunity to make rapid change for ME patients but to achieve that, the U.S. Department of Health and Human Services (HHS) must exert its leadership position and finally takes the bold, committed, fully resourced, and urgently executed steps necessary to correct this terrible injustice. The medical community must learn about this disease and how to appropriately manage it and stop harming ME patients with inappropriate treatments and disbelief. And as a community, we must demand what we need, not accept what we are given. About this document: For anyone new to this disease, the story of what has happened to ME patients is difficult to understand as it is obscured by a mish-mash of disease labels, bad disease definitions, sloppy science, and misinformation. The objective in creating this manuscript was to compile a detailed reference that shines a light on how neglect, political agendas and bad science have impacted research, clinical care, and ME patients and what has to change to move forward. The focus is on the policy decisions and political and social forces that have held ME hostage since the mid- 1980s, including how HHS and a group of psychiatrists have controlled the way in which this Thirty Years of Disdain: How HHS Buried M.E. December 2015. (M. Dimmock, M. Lazell-Fairman) 3 disease has been viewed, studied, and treated. Because this history is convoluted and open to interpretation, this manuscript may have unintentionally omitted or misinterpreted some key information. Any substantial errors or omissions will be corrected. Comments can be sent to [email protected] About the use of disease labels in this document: This field has been confounded by the adoption of overly broad and fatigue-focused “CFS” definitions that do not require key features of ME and are linked to psychogenic causes. Magnifying this muddle has been the interchangeable use of disease names (e.g. “CFS,” “ME,” ME/CFS,” and now “SEID”, etc) to refer to any of a set of twenty disparate ME and CFS definitions. Together, the bad definitions and sloppy naming practices have created confusion on the nature of ME, which has impeded not only research and medical care, but also even simple communication. To avoid this confusion, this manuscript uses only the term “myalgic encephalomyelitis” when referring to the neuroimmune disease with its characteristic post-exertional malaise. This name was chosen not because of a personal preference for the name but because ME is the historical name of this disease, adopted by the World Health Organization in 1969. The term “chronic fatigue syndrome” is used to refer to the fatigue-centered disease definitions that do not require the hallmark symptoms of ME. Other terms, such as “ME/CFS” and “CFS/ME” are used when the HHS agency uses that term, as with NIH’s Trans-NIH “ME/CFS” workgroup. This document can be found at http://bit.ly/The_Burial_of_ME_Summary. A longer version with additional content and references is available at http://bit.ly/The_Burial_of_ME_Background. Feel free to link to the document, print for personal use or quote as long as you cite the authors, the title, the version date (December 2015) and the link. Many of the references cited in this document are available online and can be quoted directly. As this document may change, we ask that you link to it rather than posting it elsewhere. I want to acknowledge the huge debt of gratitude that I owe to the many patients, researchers, and clinicians who have been fighting this battle for many years, sometimes decades, in spite of continued dismissal by HHS. Their painfully gained knowledge and experience has been and continues to be my teacher. I am honored to know them and to learn from them. Finally and most of all, I want to thank my son for his inspiration and encouragement to pursue this project. In spite of his young age, he quickly and accurately sized up the institutional barriers and neglect that he and all ME patients have been up against. He understood the importance of telling this story even when he became unable to do so himself. The vision, the heart, and the soul of this project belong to him. Mary Dimmock Thirty Years of Disdain: How HHS Buried M.E. December 2015. (M. Dimmock, M. Lazell-Fairman) 4 Matthew’s Story My son, Matthew, was always determined to take on challenges beyond his years. When he was 12, he declared that he wanted to learn to skydive and was heartbroken to learn that safety regulations dictated that he wait until he turn 18. When I asked why he was so disappointed, he said that he didn’t want to reach the end of his life and discover that he had missed his chance to experience the world. He went skydiving on his eighteenth birthday. That type of quiet determination and hunger for experience defined my son. It drove him to study in Hanoi, Vietnam during college and to devote himself to academics, achieving high honors and departmental awards. It led his advisor to say that he had one of the most incisive and analytical minds of any student that she had ever taught.

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