Your Signatures Have Been Delivered The deadline for the petition to the National Institute of Health (NIH) and the Centers for Disease Control and Prevention (CDC) to stop the NIH intramural clinical ‘fatigue’ study and its presentation by Dr. Nath at CDC’s Tuesday’s Grand Rounds was completed Sunday Feb 14th at midnight. We are happy to report that the total count for signatures to the petition is 725. Your voices matter! Continue reading
Note from Maryann Spurgin This book review, my evisceration of the Wessely school, was written in 1997, and since it is of relevance today, I have given permission to others to put it in their blog and on their sites. I want to make it clear, however, that if written today I would not use the terms "CFS" or "ME/CFS," since CFS is a govt construct that encompasses many diseases. In 1997, however, the term ME was not in use. Please read this keeping in mind that the article was from 1997. It you would like to read my other articles they are on my now-archived website: https://web.archive.org/…/20…/http://www.cfids-cab.org/MESA/ New Age "Science" or Pseudoscience: A Review of Mark Demitrack's and Susan Abbey's Chronic Fatigue Syndrome: An Integrative Approach to Evaluation and Treatment The basic thesis of Demitrack's and Abbey's book, Chronic Fatigue Syndrome: An Integrative Approach to Evaluation and Treatment, is that the condition is a post-infectious, but culture-specific, behavioral and interpretive disorder, or at least, it is a condition caused and perpetuated by behavior and interpretation. It occurs in patients who refuse to exercise because they misinterpret their symptoms as severe and as representative of damage to the body. The patients' belief system is responsible for their failure to recover, since it leads to deconditioning, the real source of the patients' debilitation. Continue reading
The Design of the Study Implies a Purpose MEadvocacy published a blog yesterday about the posted US National Institute of Health (NIH) Study 16-N-0058 Chronic Fatigue Syndrome (CFS) Clinical Summary which stated, “This study is currently recruiting participants.” We presented flaws and weaknesses of the study. We have initiated a petition calling on NIH to cancel the study, and calling for the CDC to cancel Dr. Nath’s presentation of this study at Center for Disease Control’s Grand Rounds fast approaching, this Tuesday February 16th. (Please note the link to the protocol of the NIH study has gone dark early this morning. See this web archived link for screenshot.) Since then, unofficial NIH responses to criticisms of the study protocol have been circulating on social media. Tracey Smith has written a great analysis of the remaining issues present with this proposed work. Continue reading
The Promise Dr. Francis Collins, director of the NIH, in a statement of October 2015, promised the ME/CFS community that he will take actions to bolster research on the disease. He assured us by stating that he will “intensely study individuals with ME/CFS”. Among other promises, he revealed that an intramural study at the NIH clinic will commence shortly involving researchers from several of NIH’s institutes including NINDS. This news of renewed interest by NIH toward ME/CFS research was highly praised by many advocates, patient organizations and non-profit research organizations. Recently, it was revealed that Dr. Avindra Nath, chief of infections of the nervous system section of the NINDS will be presenting at the CDC Grand Rounds meeting on February 16, 2016. His topic of discussion will be "Post-Infectious Chronic Fatigue Syndrome: Intramural Research at the National Institutes of Health". The news that such a well respected researcher was getting involved with ME/CFS was hailed by advocates as proof that NIH means business this time. MEadvocacy issued a blog warning of the premature sentiments of satisfaction: “Why MEadvocacy Does Not Applaud the News from NIH...Yet”. We explained why we were skeptical of these promises based on previous biased actions by NIH and CDC toward ME patients. In addition, we pointed out that these were just mere words. We were holding our applause until we saw tangible actions. Continue reading
We have previously posted about Dr. Unger’s invitation to MEadvocacy requesting our participation in the Technical Development Workgroup (TDW) for the Center of Disease Control and Prevention (CDC), here. We explained why MEadvocacy decided to opt out of the CDC’s workgroup. We subsequently got another email from Dr. Unger which we are posting below as well as MEadvocacy’s reply to Dr. Unger. The reason for posting this on a public blog is in the interest of transparency as well as further explanation of MEadvocacy’s stance. Email from Dr. Unger to MEadvocacy: 1/25/2016 Dear Tracey, Please allow me to give you a little more explanation about our reply to your question. I was a member of the CFSAC working group that provided recommendations about the IOM report to the committee. The idea to develop a mechanism to gather thoughts from all stakeholders before preparing our web page arose directly as a result of this valuable experience. One of the many areas of debate was how to incorporate additional symptoms cited by CCC and ICC. The short response perhaps belies our sincere interest in assuring a process in which divergent points of view can be heard. It is clear that there is not consensus in the field, but it is important to move forward together, agreeing on what we can and figuring out how to work through areas of disagreement. CDC feels that the prestige of the IOM committee should be leveraged to disseminate important information about this illness to the medical community so that patients can get the care they need from understanding health care providers. We hope that you will reconsider your decision. Best wishes, Beth Unger Email from MEadvocacy to Dr. Unger: 2/3/2016 Dear Dr. Beth Unger: Thank you for your email asking MEadvocacy to reconsider its position. As we have stated in our previous reply, MEadvocacy is committed to advocating for Myalgic Encephalomyelitis (ME), as defined by the CCC or ICC criteria. This criteria was recommended by CFSAC in 2012, by experts as well as by advocates and patients, thousands of whom have signed letters and petitions to the Secretary of HHS. ME is a serious acquired neuro-immune disease. It is currently coded as a neurological disease by both the WHO and the US ICD-10-CM under code G93.3. ME's disease criteria are not adequately captured in the US governmental health agency-sponsored IOM report that cost taxpayers one million dollars. This money would have been better spent researching biological markers for the disease. The IOM criteria are overly broad. A patient without any neurological or immune dysfunction can be diagnosed with the IOM criteria resulting in including patients who do not have the disease coded under G93.3. We refuse to endorse diagnosing ME patients by using overly broad criteria and/or training providers on doing so. It is murky criteria like the IOM and Fukuda that have prevented progress. This has directly led to the misdiagnosis of many patients as well as the lack of biomarkers and no FDA-approved treatments. There have been too many early deaths of ME patients as well as those suffering from extremely poor quality of life for decades. Promoting the IOM criteria is bound to skew the clinical picture physicians see of the patient population. Lumping different groups of patients into a ‘one criteria wastebin’ has the potential of treatments being prescribed which work for one group but may be harmful for others within the same criteria. Therefore, we must decline taking part in the CDC workgroup with a predetermined outcome that is driven by, as you described it: “CDC[’s] feel[ing]s that the prestige of the IOM committee should be leveraged to disseminate important information about this illness to the medical community.” To this day, our specific question has not been answered as to whether the workshop would allow for the inclusion of symptomatology laid out in the CCC and ICC. Your above email again fails to do so and we cannot help but feel that this is an answer in and of itself. It simply makes no sense for MEadvocacy to be involved in a process that disseminates information to the medical community about a disease that, based on abundant past experience with other definitions, is likely to be harmful to ME patients. Sincerely, Tracey Smith MEadvocacy.org Advisory Group Member On behalf of the MEadvocacy.org Advisory Group:Joni ComstockMary Ann KindelGabby KleinColleen Steckel
“If you want to understand today, you have to search yesterday." ~Pearl Buck In order to understand the enigma of a hidden epidemic of one million men, women and children in the U.S. suffering from the debilitating disease, myalgic encephalomyelitis, one needs to understand the history of the disease. Hillary Johnson wrote the epic book‘Osler’s Web: Inside the Labyrinth of the Chronic Fatigue Syndrome Epidemic’ where she depicts the history of the disease, spending nine years investigating the failure of the medical establishment to take the disease seriously as well as repeated governmental health agency malfeasance. Her book documents the history from 1984 to 1995. Since then, there has been a lack of documentation recording the history of events and actions that reflect the concerted institutional effort to bury the disease ME. Mary Dimmock, ME advocate, along with her son, Matthew Lazell-Fairman, who suffers from severe ME, stepped up to the plate with their document, ‘Thirty Years of Disdain (Background): How HHS and a Group of Psychiatrists Buried Myalgic Encephalomyelitis’** (full version). This is an invaluable account of her and her son’s personal story trying to navigate the medical labyrinth of this disease, as well as an in-depth, referenced historical and political account of the disease that encompasses Johnson’s account and expands to the present time. The community was eager to read this important historical report. Some have asked Mary if she would deliver a shorter version for patients for whom reading long text is taxing. Again, Mary and Matthew came through and delivered their short summary version** to our community. This strategic document is very timely. The necessity of this type of historical documentation has come to the forefront again. We are in the midst of yet another struggle with the Department of Health and Human Services (HHS), accepting ME as the distinct neuro-immune disease that was identified in the early 1930’s. In lieu of adopting ME criteria such as the Canadian Consensus Criteria (CCC) or the International Consensus Criteria (ICC) as requested by stakeholders, the Chronic Fatigue Syndrome Advisory Committee (CFSAC), medical experts, patients advocates and patients, HHS stubbornly and secretly hired the Institute of Medicine (IOM) for a million dollars and instructed them to create another set of criteria. The IOM panel was charged to bring evidence, based on research that predominantly used broad CFS criteria such as the Oxford and Fukuda, thereby excluding many ME symptoms and its treatments. The use of this broad IOM criteria will result in greatly reducing the probability of finding meaningful biological biomarkers as well as FDA approved treatments. This added delay will only prolong patients’ suffering since the general medical establishment will not be informed of current treatments that ME experts have been using with measurable success with their ME patients.As this blog is being written, the Centers for Disease Control and Prevention (CDC) is preparing to use the IOM report to inform doctors on how to manage ME/CFS/SEID patients this February 16th, 1:00 pm - 2:00 pm EST, “CDC Grand Rounds Presentation on Chronic Fatigue Syndrome” which is being webcast to thousands of providers, researchers, and the public. Click here for link. As we have reported, the CDC is also busy working on disseminating the results of the IOM report and criteria on their own website and for educational purposes to health professionals. This will have adverse consequences since this criteria does not distinguish the neuroimmune disease, ME. It lumps everyone together into another broad CFS definition.Join MEadvocacy with our aim to raise awareness of this danger and avoid another thirty years of disdain. From Mary Dimmock’s introduction: In May 2015, my son and I released Thirty Years of Disdain, a review of how myalgic encephalomyelitis has been handled over the last thirty years. I've updated that document to reflect key events in 2015 and condense it. The document is available at http://bit.ly/The_Burial_of_ME_Summary Myalgic encephalomyelitis (ME, also called chronic fatigue syndrome) is a devastating, complex disease that causes widespread impairment in neurological, immunological, autonomic, and energy production systems. ME patients are more functionally impaired than those with congestive heart failure, multiple sclerosis, and end-stage renal disease. Many of the estimated one million Americans with ME are too disabled to work, resulting in an estimated U.S. economic impact of $19-24 billion a year. The disease strikes both sexes and all ages. There are no FDA approved treatments and recovery is rare. Yet, for the last thirty years, political agendas, institutional neglect, and bad science have buried ME under a vague condition of "fatigue," often associated with mental illness. The most widely accepted treatments have been cognitive behavioral therapy and graded exercise, used to convince patients they are not really sick, just deconditioned. Medical care is abysmal and too often results in physical harm. ME patients have been so neglected, disbelieved, and stigmatized that some have lost hope and committed suicide. Thirty Years of Disdain examines the forces and factors that have denied the reality of ME and resulted in such a misguided national and international response. It examines how that misguided response has impacted research and drug development, degraded clinical care, and stigmatized and harmed ME patients. It shines a light on the magnitude of systemic change that is needed to correct this medical travesty and give ME patients hope in the future. The recent government response to its own advisory committee’s August 2015 recommendations shows just how far we still have to go. The longer version of this document, also updated, is available at http://bit.ly/The_Burial_of_ME_Background. Comments and questions welcome at firstname.lastname@example.org. ** Blog revised March 2018: Originals links no longer work. Updated with new links.
MEadvocacy, along with other patient organizations and advocates have been invited to serve on a Technical Development Workgroup (TDW) for the Center of Disease Control and Prevention (CDC). The role of this group will be to provide input on educational materials to doctors and upgrading the CDC website based on the IOM report. The advisory group of MEadvocacy deliberated whether we would serve ME patients best by presenting the “ME view” at this working group. We ultimately decided against taking part in this workgroup based on the fact that a key question we asked Dr. Unger about what information could be brought up at these meetings, was not directly answered. Furthermore, it has become very clear that the U.S. government health agencies have no regard for their own advisory committee and are not acting in good faith to benefit ME patients. This fact was verified with the Department of Health and Human Services’ (HHS) empty reply to CFSAC’s recommendations of August 2015. Another year of delays and distraction from any real substantive actions, while we have a deteriorating patient population and aging experienced advocates who have been demanding serious and urgent actions from the government for 30 years. MEadvocacy is committed to supporting the ME patient population and will find alternative solutions to educating medical professionals and the public on the disease myalgic encephalomyelitis and we welcome any suggestions on this topic. The following is our reply email to the CDC: Dr. Unger (c/o Ariel Weiss): MEadvocacy received an invitation to participate on the Technical Development Workgroup (TDW) on December 17th, 2015. We have been awaiting an answer from Dr. Unger to a critical question that we posed on December 30th, 2015. The question was: Will there be any allowance for information of symptoms that appear on the CFSAC recommendations, CCC and/or ICC, yet are not listed on the IOM to be heard and taken into consideration? Despite our numerous follow up emails requesting an answer to our question, Dr. Unger and the CDC failed to fully and directly answer our question. Finally, yesterday, January 21st, 2016 the following reply came from Ariel: We are aware of the CFSAC comments on the IOM and these are being included for discussion. This reply does not take our full question into consideration. It is actually using the tactic of deflection. MEadvocacy’s concern was not solely CFSAC’s recommendations to the IOM. Our inquiry was specifically about the allowance of citing symptomology from the Canadian Consensus Criteria (CCC) and the International Consensus Criteria (ICC). MEadvocacy is a non-profit organization advocating for patients suffering from the neuroimmune disease Myalgic Encephalomyelitis (ME). We promote the use of ME criteria such as the Canadian Consensus Criteria (CCC) and the International Consensus Criteria (ICC) as well as the original name myalgic encephalomyelitis. Furthermore, the recent release of HHS’s responses to the CFSAC August 2015 recommendations has revealed the total disregard of input from any stakeholder outside the government agencies. There has been no effort in implementing any of CFSAC’s recommendations. Based on the deflection of our key question and the total disregard of the voting members of CFSAC’s input, we have no confidence in the equity of the process and that the voice of MEadvocacy will carry any weight with the CDC. We have therefore decided to opt out of the CDC workgroup tasked with updating educational material and website based solely on the IOM. Sincerely, Tracey Smith MEadvocacy.org Advisory Group Member
Today, January 19, 2016, is the deadline to submit comments to the Department of Labor’s proposed new rules to the ERISA law which govern long term disability (LTD) policies. Jeannette Burmeister brought this issue to light with her blogs summary of the proposed rules, instructions and sample comment and additional guidance for commenting, MEadvocacy’s advisory group composed and submitted their comment in the hope that these new rules affecting ERISA law, if adopted, will improve the chances for disabled ME patients to collect their long term disability benefits. As we have outlined in the comment, many ME patients have had to struggle in their quest for LTD benefits. Too many have lost the fight and have been left in financial hardship. The cards have been stacked against patients for too long. We are particularly grateful for the review, legal analysis and revisions by Jeannette Burmeister. COMMENT We represent MEadvocacy.org (a project of May12.org), a non-profit organization that advocates for patients suffering from Myalgic Encephalomyelitis (ME). ME is a serious neuroimmune disease, affecting an estimated 1 million Americans. About a quarter of ME patients are so disabled as to render them bedbound. The majority are disabled to the extent of being unable to work. Since there are currently no FDA-approved treatments for this disease, ME patients are left to suffer for a long time—sometimes for decades. Many of these patients are affected by ERISA, which governs employer-sponsored long-term-disability (LTD) insurance benefits. Patients have been negatively impacted by the existing law, which favors the insurance companies over the disabled claimants by denying jury trials and punitive damages, by providing, generally, an abuse-of-discretion standard of judicial review, by not recognizing and counteracting the obvious conflicts of interest of the disability insurance carriers and, finally—through the existing claims-procedure regulations—by permitting unreasonable, unjustified and obstructionist tactics by the insurance companies administering the claims-review process. We are therefore encouraged by the Department of Labor’s proposed new regulations, which—although they do not and cannot legally address the issues of jury trials or punitive damages—do address in an effective manner the claims-administration process in a way that would bring a degree of fairness and objectivity into the claims-adjudication process and help balance the scales, which have been severely tilted against the claimants. MEadvocacy.org supports the proposed changes because they have the potential to improve the fairness of the process, not just for ME patients, but for all who are vulnerable during a difficult time in their lives. Not only are these patients faced with difficult and painful life changes as a result of becoming disabled, but they are forced into an unfair battle they are ill-equipped to deal with. Many of these patients have lost their battle to obtain LTD benefits necessary for a minimally acceptable standard of living. One such patient describes her lost battle as follows: I became disabled with ME in 2003. My employer had paid into my disability insurance for over 10 years. By the time I had to stop working, I was so disabled that I could not walk more than 20 steps a day. I could not stand for more than 2 minutes. My doctor was a world-renowned medical expert in my disease. He submitted extensive paperwork outlining the severity of my disease and he wrote a letter to my disability insurance company stating that I was too disabled to do ANY work and, furthermore, that he was not optimistic that I would ever be able to return to work. I had applied for Social Security Disability Insurance (SSDI) and after a complete review, including being seen by the Social Security Administration’s doctor, I was approved for SSDI at first try. Yet, unexplainably, I was denied disability from my LTD insurance. The person who reviewed my case at my LTD insurance was a disabled person himself, but he had the ability to work and therefore was known to deny most claims because he felt if he could work, so could other disabled people. None of the people reviewing my case had any knowledge of, or experience with, my disease, ME, and therefore could not understand how serious and disabling this neuroimmune disease can be. They simply disagreed with my own doctor who was an expert as well as the SSDI doctor without explaining what they were basing that disagreement on. After I appealed, I finally got their records and saw that they had spent a lot of money and time trying to find any basis to deny my claim rather than to fairly adjudicate it, for example by ordering an outside expert review. They had investigators watching me and looking into my social-network activities and yet, could not find any information proving or even suggesting that I was not disabled. At the end, I just gave up fighting because it was just making me sicker. The new proposed ERISA regulations, for example the new conflict of interest rules, would have helped ensure that this claimant received a fair review in her quest for LTD payments: The claims adjudicator who reviewed her case was hired by her insurance company because he was known by the industry to deny cases. It was not explained why the insurance company came to a different conclusion than the claimant’s own physician as well as the Social Security Administration without even performing an outside expert review. With the new regulations, this would not have been permissible. The insurance company’s case paperwork on this claim only became available to the claimant upon appeal. Had the proposed regulations been in effect, it would have been available upon denial and may well have facilitated a positive outcome for the claimant given the ability, under the proposed regulations, for the claimant to challenge the denial more effectively. Please note, that twelve years later, this patient is still very ill and too disabled to work and yet, has not received a cent in long-term disability payments! Another patient’s battle with LTD was equally unfair: I had paid into LTD for 8 years. I became disabled in 2000. At the time I applied, I had been off work for 6 months and had not improved - I was still housebound and mostly bedridden. My first contact with the LTD carrier was when a case manager called me up and screamed at me “Why can’t you work! I’m going to deny your claim!” Needless to say, this type of abuse and intimidation was extremely upsetting. My initial claim was indeed denied, with no explanation as to why. I hired an ERISA disability lawyer for the appeal. That was denied. We sued and went to federal court. I won my case - the court ordered the LTD insurance company to pay my claim as they had acted in bad faith on several issues. The LTD carrier appealed. Just as the case was about to go to federal court again (where I stood a very good chance of winning), we entered into a settlement - I received pennies on the dollar of what I should have been paid. Ironically, I submitted the same medical information to the Social Security Administration, which applies a standard much stricter than the “own occupation” standard that was specified in my LTD plan: the “any occupation” standard. Nevertheless, I was approved for benefits “on the record” at the ALJ level. The fact that I was approved for Social Security under this much stricter standard didn’t matter to the LTD insurance company - they said it wasn’t relevant to my claim. The new proposed ERISA regulations would have also helped this claimant: The claims adjudicator was obviously biased from the outset to deny the claim without first performing a thorough evaluation or ordering an outside expert review, and possibly may have received some kind of compensation for denying claims. The proposed prohibition of employing claims adjudicators based on their likelihood to deny a claim would potentially have prevented the baseless denial of this claim. The insurance company’s paperwork on this claim was only available to the claimant after the appeal of the denial. With the proposed new regulations, it would have been available a step earlier—after the denial—and that might have aided the claimant in winning her appeal without going to court. The insurance company would have had to explain why it denied the claim, including why it disagreed with the treating doctor and with the Social Security Administration. It also would have had to provide to the claimant any internal rules, giving the claimant a fairer chance to respond after the denial. These are just two examples of countless others who similarly were wrongfully denied their rights to collect on long-term-disability benefits that were promised to them through their LTD insurance policies. As the law stands today, a U.S. LTD insurance company has nothing to lose by denying claims because even if they lose, they only have to pay the amount of the claim plus, generally, attorneys’ fees (which are not always fully awarded) without any other liability. Disabled claimants have an insurmountable road ahead of them to fight for what should legitimately be theirs. Many are in such a weakened and ailing state that it takes too much effort to continue fighting and the insurance companies count on that knowledge. They make it so difficult and draw out the process so much that many simply give up. This is not fair practice. MEadvocacy.org hopes that these new proposed ERISA rules will help even out the playing field and that, in the future, disabled claimants will not have to face such daunting, enervating and unfair obstacles in pursing their legitimate claims and that the new regulations will lead, in more instances, to just outcomes. Sincerely, Colleen Steckel and Joni Comstock for MEadvocacy.org Members of the Advisory Board
ERISA laws are very complicated and we are grateful to Jeannette Burmeister for her excellent blogs outlining the new proposed additional laws which will benefit patients in their fight for long term disability. This is a complicated matter and in our attempt to simplify, we have taken shortcuts with our blog about the subject issued on 12/31/05, which we regret. All credit for bringing this issue to the attention of the ME community as well as the interpretation of intricate details should go to Jeannette Burmeister. We refer you to Jeanette’s two blogs on the subject for complete information about the issue and how to participate, including a sample letter: Thoughts About M.E. blogs ‘Department of Labor Proposes Lowering Bar for ERISA Disability Claims, Requests Public Comments’ and ‘Proposed ERISA Disability Regs: Instructions and Sample for Public Comments’.