From Eileen Holderman: Below, is a sample letter to HHS Secretary Burwell in opposition to HHS's IOM and P2P initiatives to redefine ME/CFS. Advocates requested a sample letter, so feel free to use this letter (in part or in its entirety) to show your opposition (not participation or buy-in) to the IOM and P2P. This letter can be sent right away or at any time, as this is an ongoing advocacy protest. October 21, 2014 Dear Secretary Burwell: I am writing to state my opposition to the Health and Human Services (HHS) initiatives - the Institute of Medicine (IOM) and the Pathways to Prevention (P2P) - to redefine Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Nearly 1 million American men, women, and children, and over 17 million worldwide, suffer from the neuroimmune disease, ME/CFS. I join multitudes of advocates, patients, caregivers, ME/CFS researchers and clinicians, and other stakeholders, in opposition to IOM and P2P. There are numerous reasons for my/our opposition to these initiatives to redefine this disease, many of which I list as follows: * We do not need more Government-sponsored clinical and/or research definitions for ME/CFS. Our ME/CFS experts already developed a research and clinical definition called The Canadian Consensus Criteria (CCC). HHS has created numerous erroneous definitions (i.e. Fukuda, Reeve's Empirical, etc.), which include innumerable people in the patient population that do not really have ME/CFS - and this has terribly harmed patients with ME/CFS. HHS's IOM and P2P seek to, yet again, create more definitions for ME/CFS which will further harm patients. * We do not need HHS bureaucrats who are not ME/CFS experts to redefine this disease. Our 50 ME/CFS expert researchers and clinicians already reached a consensus on a research and clinical definition for ME/CFS - the CCC - which they have been using for 10 years and for which they have agreed to refine as necessary. The 50 ME/CFS experts sent former Secretary Sebelius a letter urging her to refrain from reaching out to groups such as IOM to redefine ME/CFS and urged HHS to adopt the CCC in all Government agencies. Again, IOM and P2P use mostly, and in some circumstances, entirely, non-ME/CFS experts - actions which will harm patients. Please click on the link to read the Expert's Letter to former Secretary Sebelius: * We do not need another Government-sponsored name for this disease. In 1969, The World Health Organization (WHO) acknowledged and coded the name of the disease - Myalgic Encephalomyelitis (ME) - which is the name used and endorsed by most nations, experts, and patients around the world. In 1988, HHS renamed the disease Chronic Fatigue Syndrome (CFS) knowing that a name already existed for the disease and knowing their new, unscientific name would harm patients. Again, HHS/IOM aims to create yet another name for this disease - possibly Chronic Multi-Symptom Illness (CMI) - the name IOM alluded to for ME/CFS in their earlier VA/IOM report - and a name that will further harm patients. * We do not need more Government waste of taxpayer dollars on corrupt initiatives to redefine a disease that has been correctly defined. ME/CFS receives only $5 million a year from NIH in research and causes billions annually in lost productivity due to high rates of disability from the disease. ME/CFS experts established research and treatment centers around the country through private and institutional funding that need Federal funding for their research - but don't receive it. Instead, IOM and particularly, P2P, ignore the ME/CFS experts' biomedical research in favor of non-experts' psychosocial research, resulting in recommendations of CBT, GET, and anti-depressants, instead of recommendations of anti-virals, immune modulators, and other biomedical treatments. This tactic will save Government and insurance companies big money! As IOM and P2P bury 30 years of biomedical research and over 5000 peer-reviewed scientific publications on ME/CFS, HHS will save huge sums of money because they will not have to fund biomedical research or pay for long term disability and other Government entitlements for patients with ME/CFS. And Government related health insurance companies will save massive sums when they deny ME/CFS patients the biomedical tests and treatments they need. * We do not need more Government misinformation about ME/CFS disseminated to physicians, health insurance carriers, the public, and the press. Our ME/CFS researchers and clinicians have published a case definition - the CCC, 2 Diagnostic and Treatment Primers, over 5000 scientific papers, video lectures, PowerPoints, books, and resource guides about the disease. National and State patient advocacy organizations have published materials online and in hard copy with reliable information for patients and their caregivers. Yet, IOM and P2P are charged with publishing their reports which HHS will use to "educate" doctors, nurses, insurance companies, the public, and members of the press. HHS's dissemination of the erroneous information from IOM and P2P will gravely harm patients. My letter of opposition to HHS's IOM and P2P is part of the ongoing protest which includes: CFS Advisory Committee (CFSAC) recommendation urging the use of the CCC, ME/CFS Experts' Letter calling for the CCC, Advocates' Letter calling for the CCC, petition signed by over 6000 stakeholders calling for the cancellation of the IOM Contract and calling for adoption of the CCC, Facebook, Twitter, Thunderclap, letter, email, and phone campaigns calling for the CCC and condemning IOM and P2P, meetings with Congressmen, protests and demonstrations, media coverage, collaborations with Gulf War Illness patients, Freedom of Information Act (FOIA) requests, and even a lawsuit filed against HHS and NIH for non-compliance with an IOM FOIA, resulting in a Federal-Court finding of the Government's violation of Federal law. My opposition to IOM and P2P is a complete rejection of these initiatives to redefine ME/CFS. HHS should not consider my letter of opposition as participation or buy-in - because it is not. This is a letter of opposition for the public record. Thank you for your attention. Eileen Holderman ME Advocate US citizen cc: Francis Collins (NIH), Thomas Frieden (CDC) Sylvia.Burwell@hhs.gov (Secretary of HHS) Francis.Collins@nih.hhs.gov (Director of NIH) Tomfrieden@cdc.gov (Director of CDC) From Jeannette Burmeister: P2P: “Pleased to Participate?” Not. Count me out! Here is my open protest letter to Secretary Burwell (with carbon copies to Dr. Collins and Dr. Frieden) regarding the ME/CFS P2P program. As you will note, I am not engaging substantively at all. Instead, I am protesting the process all the way. Anybody should feel free to borrow the language in this letter in whole or in part for their own letter in this ongoing protest campaign, which can be sent to the email addresses listed at the end of this post. Dear Secretary Burwell, AHRQ has asked for public comments on the draft “evidence review” report prepared for the agency as part of the NIH-driven ME/CFS Pathways to Prevention (“P2P”) program. I am one of many patients who refuse to participate in the commenting process. Count me out! In other words, let me stress, for the avoidance of any doubt, that this open letter is in no way to be construed as participation in, or engagement with, the ME/CFS P2P program. Instead, I protest this ludicrous and dangerously unscientific process in the strongest way possible. As an ME patient and advocate, I will not participate in this kangaroo court the outcome of which is preordained to set back ME/CFS research for decades and which is so unalterably contrived, ill-intentioned and scientifically unsound as to invite only condemnation, not participation or cooperation. The "evidence review" report prepared for AHRQ by non-ME/CFS experts is only part of this Kafka-esque charade of a process, the ME/CFS P2P, which will conclude with a two-day "workshop" of individuals who are not experts in the field and a "jury" deliberation of those non-ME/CFS experts who will have all of 24 hours to write the final report. You or anybody with a scientific background—or with any common sense, for that matter—cannot, in all honesty, believe that this process will result in any scientifically valid outcome. A jury model is about as incompatible with science as one can imagine. Remember Galileo Galilei and how well a jury of non-experts worked for him? Is that how HHS, NIH and AHRQ see their role: in the same vein as the Roman Catholic Church of the 17th century conducting inquisitions and witchcraft trials? The insincere call for public comments on a rigged game is a contemptible farce. I will not—by giving substantive comments—provide HHS with the opportunity to claim that patients were heard and that their input was considered when any public comments are guaranteed to be ignored, as they were with respect to the IOM panel where comments were also feigned to be sought. The final report produced by the non-experts will guide future NIH-funded research, which has been at a paltry $5 million a year—an inexcusably and unconscionably pitiful amount for a debilitating and complex disease such as ME/CFS, which, of course, has lead to an irremediably flawed “evidence” base. That in turn, makes the P2P process just about as unfit for this disease as one can imagine. The community is in agreement that a catastrophic result of the P2P process seems to be HHS's intention. Otherwise, HHS would abandon it immediately before the agency causes more harm to patients by forcing them to continue fighting the P2P at tremendous cost to their health and by ensuring a disastrous outcome for patients delivered at the hands of non-experts. For your information, I am attaching an analysis of the P2P “jury model” that I wrote after this stroke of genius was initially announced to the public during the first ME/CFS IOM meeting in January. Sincerely, Jeannette K. Burmeister Patient, Patient Advocate and Attorney at Law cc: Dr. Francis Collins, NIH Dr. Tom Frieden, CDC Attachment: P2P: “Patients to Purgatory” or the Jury Model Stood on its Head, February 7, 2014 Sylvia.Burwell@hhs.gov cc: Francis.Collins@nih.hhs.gov Tomfrieden@cdc.gov For Holderman’s and Burmeister’s prior letters in opposition to the IOM and P2P, please click on this .