NIH Clinical Study: A Case of Continued Institutional Bias

  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

Further Correspondence with Dr. Unger at CDC

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 Advisory Group Member On behalf of the Advisory Group:Joni ComstockMary Ann KindelGabby KleinColleen Steckel

Introducing Mary Dimmock's Summary: 'Thirty Years of Disdain'

  “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 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 Comments and questions welcome at [email protected]   ** Blog revised March 2018: Originals links no longer work. Updated with new links.

MEadvocacy Opts Out of CDC’s Technical Development Workgroup

  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 Advisory Group Member  

MEadvocacy Submits Comment to DOL

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 (a project of, 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. 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. 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 Members of the Advisory Board

Update on the ERISA Disability Changes Blog

  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’.  

MEadvocacy Statement Regarding the Creation of the US Action Working Group

Today an announcement went out about a new US Action Working Group which has been formed with the intent of increasing impact in advocacy efforts, with allowance that some of the group’s members can opt in or out of different projects. MEadvocacy was recently invited to join this group.  Our advisors spent several days in communication with the organizations and individuals clarifying the plans involved in defining this group. After much deliberation, we decided we will better serve the ME patients that we represent by continuing as we have in the past, therefore we opted out of the group.  We will continue with our stated mission and pursue our declared goals of advocating for ME criteria (CCC or ICC or better) to be used for diagnostic and research criteria in the US, as well as urging the NIH to fund ME research to the order of $250 million a year which is commensurate with other similarly burdened diseases.  This has been our direction from the start; being a voice for the myalgic encephalomyelitis community, with a strong focus on the severely affected.

Analysis of CFSAC August 2015 Recommendations for the IOM Criteria

  The Chronic Fatigue Syndrome Advisory Committee (CFSAC) provides advice and recommendations to the Secretary of Health and Human Services (HHS) through the Assistant Secretary for Health on issues related to Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME/CFS). It meets twice a year.  The last meeting took place August 18 and 19, 2015. The theme of the meeting was HHS’ response to the Institute of Medicine (IOM) and Pathways to Prevention (P2P) reports on redefining ME/CFS.  A CFSAC working group was created to work on recommendations for these reports which were presented at the meeting.  Tackling all the recommendations and information provided at the meeting would be too long to include in one blog.  Since we believe that the diagnostic and research criteria are a crucial element, we decided to concentrate on the recommendations which reference the criteria.  The Criteria  The 1991 Oxford criteria, published in the U.K., was created to describe both CFS of unknown etiology and a sub-type of CFS called post-infectious fatigue syndrome.  This criteria has been used in research for CFS, including in the infamous PACE trial. Because of its inclusiveness and broadness, the research achieved with the Oxford criteria cannot be relied on.  The 1994 CFS Case Definition (Fukuda criteria) was a research criteria proposed  by the "International Chronic Fatigue Syndrome Study Group", led by the Centers for Disease Control and Prevention.   It demands six months of severe fatigue along with any four of the following eight symptoms to receive a diagnosis of CFS: substantial impairment in short-term memory or concentration; sore throat; tender lymph nodes; muscle pain; multi-joint pain without swelling or redness; headaches of a new type, pattern, or severity; unrefreshing sleep; or post-exertional malaise lasting more than 24 hours.  The 2003 Canadian Consensus Criteria (CCC) was initiated by Health Canada and written by ME/CFS experts. The CCC posits that post exertional malaise and cognitive problems are hallmarks of this disorder and are necessary for a diagnosis. In addition,diagnosis requires two or more neurological/cognitive manifestations and one or more symptoms from at least two of the categories of autonomic, neuroendocrine and immune manifestations, in addition to multiple major criteria of fatigue, post exertional malaise and/or fatigue, chronic pain and sleep dysfunction.  The 2011 International Consensus Criteria (ICC), is the most current criteria created by an international group of ME/CFS experts.  This is considered an ME criteria, closest to the one described by Dr. Ramsay in 1956.  The six month waiting time for diagnosis is dropped. There is the mandatory symptom of PENE (post exertional neuroimmune exhaustion).  It is also accompanied by symptoms from neurological, immune/gastrointestinal/genitourinary, and energy metabolism/transport impairment categories. It demands a reduction of at least 50% of pre-illness activities.  The 2015 Proposed IOM Criteria was created by the Institute of Medicine panel of expert and non-expert professionals.  The proposed clinical criteria for diagnosis requires a significant loss of function that persists for six months, post exertional malaise and unrefreshed sleep.  In addition, it requires one of two of the following; cognitive impairment or orthostatic intolerance.   History Preceding the Launch of the IOM Criteria Although there were two newer criteria created (the 2003 CCC and 2011 ICC) since the 1994 Fukuda, the Department of Health and Human services (HHS) persistently insisted on the exclusive use of the outdated, overly broad, Fukuda criteria both for research and diagnostic criteria.  In September 2013,Clinicians, researchers and advocates entreated HHS to recognize and adopt the CCC which was an updated and more accurate criteria for the disease.  CFSAC urged HHS to adopt the CCC as well with a recommendation to convene a workshop of ME/CFS stakeholders to work on advising whether it needed any updating. Top ME/CFS researchers started using CCC criteria in addition to the Fukuda criteria for determining patient cohorts.  Since the NIH only recognized the Fukuda definition for grant applications, researchers could not just evaluate per the CCC criteria.  HHS did not heed the voice of the community and in 2013 stubbornly and secretly contracted with the IOM to create, yet again, another government supported definition for the disease.  This contract was heavily disputed by the great majority of medical specialists as well as patient advocates and patients.  Yet, HHS forged ahead and the 2015 IOM criteria was created without guidance on treatments, as instructed by HHS.  Some in the community have accepted the new IOM clinical diagnostic criteria as an improvement to the currently used Fukuda because of its inclusion of the hallmark feature of post-exertional malaise (PEM) as one of the mandatory symptoms. Many others, including MEadvocacy, argue that it actually falls short of the already available CCC and ICC.  They feel that this new criteria from the IOM is too broad, inclusive and does not describe the serious neuro-immune disease, myalgic encephalomyelitis.  Why are Case Definitions Consequential?  In the preface to the ICC, its authors explain the need for accurate definitions: “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’. We believe this is the foremost cause of diluted and inconsistent research findings, which hinders progress, fosters skepticism, and wastes limited research monies.”  Some have argued that since the IOM criteria are to be used for clinical diagnostic purposes, and not for research, there is no need for such “tight” criteria.  One problem with this line of thought is the fact that the US government has a history of muddling the aim of previous criteria.  For example, the Fukuda criteria were created for research purposes yet, they have been used for diagnosis as well.  No request has been made by HHS to come up with new research criteria.  Which criteria do you think will be used for federal research going forward?  Will they continue to use the inefficient Fukuda? There is evidence, as in Francis Collins’ recent statements of support of the IOM report, that they will start using the new IOM criteria for their research initiatives.    Another complication and confusion will arise when the medical profession starts diagnosing patients with the IOM criteria. Clinicians may observe that many of their ME/CFS patients will have contrasting symptoms or treatment responses compared to the patient populations that are evaluated in the research studies or in other international patient populations such as Canada.  Thus, if the research studies find certain treatments successful but the same results are not carried in the clinical settings, the research may be thrown out as uncredible by the medical community.  Incidentally, CFSAC recommendation #4 advocates for the use of the CCC criteria for federally funded research: “CFSAC recommends that federally-funded research specify use of the 2003 Canadian Consensus Criteria as a research case definition for patient selection (in addition to other requirements established for specific research purposes) using standardized and uniform assessment methods and measures for applying the definition.”  The importance of selecting the correct patient group in criteria for the disease has been highlighted in the newest paper by Norwegian scientists titled:‘What exactly is myalgic encephalomyelitis’.The paper states: “The use of broad inclusion criteria has created a heterogeneous patient population, also within research. This has increased the risk of erroneous conclusions, misdiagnosis and incorrect treatment . For myalgic encephalomyelitis, the Canadian criteria and the international consensus criteria have in our view increased the accuracy of diagnosis due to their greater specificity and clearer delineation of the disorder from other forms of fatigue.” How Well Does The IOM Criteria Select ME Patients?  In his paper ‘Reflections on the IOM's systemic exertion intolerance disease’, ME/CFS researcher, Dr. Leonard Jason, ran an analysis to answer this specific question.  In his study of patients who are referred to a specialty clinic and those who self identify to have CFS, the same group was found to have the disease with the IOM criteria as with the Fukuda criteria. Most in this group were already diagnosed as having ME or CFS by clinicians who already accounted for exclusionary conditions.  Since the IOM criteria does not require the exclusion of other conditions, a group using IOM criteria will be more inclusive of misdiagnosed patients. Jason’s paper ‘Unintended Consequences of not Specifying Exclusionary Illnesses for Systemic Exertion Intolerance Disease’ suggests that his “findings indicate that many individuals from major depressive disorder illness groups as well as other medical illnesses were categorized as having SEID.”    Frank Twisk published a paper; ‘A Critical Analysis of the Proposal of the IOM to Replace ME and CFS by a New Diagnostic Entity Called SEID’. In the paper, he proposes that some of the characteristic symptoms of ME, as described by Dr. A. Melvin Ramsay, are not present in the IOM criteria.  These include muscle fatigability, circulatory impairment and exhaustion of the central nervous system after minor physical activity, as well as the chronic relapsing course of the disease. There are two reasons for these omissions, Frank proposes. 1- These symptoms have not been adequately investigated. (lack of quality research and studies) 2- It is mainly CFS diagnosed patients that have been studied, in the research relied upon [during the IOM’s evidence based evaluation], as opposed to ME patients. This second point made by Twisk is really key to our subject.  If most of the research and studies that the IOM panel relied upon used CFS patients as per Oxford or Fukuda criteria, the resulting criteria will reflect those findings.  In essence, the IOM criteria then is a CFS criteria, not ME. CFSAC Recommendations for Improving the IOM Criteria  Recommendation #4 specifies use of the 2003 CCC criteria be used for any federally-funded research. If this is implemented, the patient population used for research would be a significant improvement over previous studies.  Please read recommendations #8, 9 and 10 to see the details of what CFSAC has added to the IOM criteria.   See video of the presentation of these recommendations here.  In her preface to these recommendations, patient advocate and CFSAC voting member, Donna Pearson stressed that the CFSAC working group that created the recommendations did not attempt to “revise” the IOM criteria.  Their effort went toward suggesting more details to be included so that the clinician can better diagnose patients.  The following recommendations therefore mainly provide for more guidance to be included with the literature of the IOM criteria.  The main concerns that the group found with the IOM criteria were the following: Recommendation #8 provides for: Inclusion of an “overview” of the disease. Objective testing identified in the IOM report be included. The language “unrefreshed sleep” be changed to “sleep abnormalities”. More descriptive language, from the IOM report, to be included with the core symptoms. Immune dysfunction, neurological dysfunction and pain symptoms among other frequently reported symptoms be reflected with the core symptoms in all materials. The expanded version of the criteria be used in criteria material.  Recommendation #9 advocates for the proposed IOM criteria to be validated and refined if needed within two years by disease experts.  In recommendation #10, the following are suggested to be included in the guidelines: A disease overview including a statement that the disease includes immune, neurological and cognitive impairment, sleep abnormalities, and autonomic dysfunction. Clinical guidelines for assessing post-exertional malaise (PEM). Information about appropriate treatments and care. List of differential diagnosis. List of co-morbid conditions that are experienced with the disease. Statement about the inappropriateness and dangers of cognitive behavior therapy (CBT) and graded exercise treatment (GET) as treatments for this disease. Resource list with links back to the IOM report. How Does the IOM Criteria Compare to the CCC Criteria?  You can read about the comparison of the IOM and CCC criteria here.  The differences between the two criteria are highlighted in the graphic below:  Will the improvements of CFSAC recommendations to the IOM criteria bring us closer to the CCC criteria?  We commend the CFSAC working group for their monumental achievement in creating all these important recommendations to HHS.  Their effort has brought about (if implemented by HHS), many improvements to the IOM criteria and may cause the cohort of diagnosed patients to contain a larger percentage of patients that would meet ME criteria.  However, MEadvocacy believes that more needs to be done to bring the IOM criteria in-line with ME criteria.    The one proposed alteration to the actual IOM criteria language by CFSAC was to change “unrefreshed sleep” to “sleep abnormalities”.  The other recommendations involved the addition of data, such as explanations how PEM affects ME/CFS patients as well as the additional information of symptoms like immune dysfunction (but not as an inclusion in the core symptoms).The essential list of exclusionary diseases as well as co-morbid manifestations are recommended to be included as well.  A final analysis shows that the CFSAC recommendations are an improvement to the original IOM criteria by the fact that it is more descriptive and includes the much needed list of exclusionary diseases and comorbidities.  Unfortunately, it fails in achieving the accuracy of the CCC by not demanding that neurological manifestations, immune dysfunctions and muscle pain be part of the mandatory core symptoms.  Taking Frank Twisk’s analysis into consideration, the IOM criteria (even when improved with the CFSAC recommendations) does not describe the core neuroimmune symptoms of myalgic encephalomyelitis; “(long-lasting) post-exertional muscle fatigue/weakness and signs of cerebral dysfunction”.    Looking Forward to Future Progress  If implemented, the CFSAC recommendation #4 should ensure that going forward, the 2003 CCC will be the sole criteria used for all research.  This should technically retire the use of the Oxford and Fukuda criteria for research purposes.  We are hopeful that 2016 will see real progress toward research on patients who have ME. We are excited to see the success and growing support that Dr. Davis’ End ME/CFS Project is experiencing.  Their “Giving Tuesday” fundraising effort has come through with over $100,000.  In addition, they have received some large private anonymous donations which will definitely make a difference.  The Open Medicine Foundation (OMF) has recently announced that due to the generous donations and added knowledge, they have added more tests to the OMF ME/CFS Study.They have uploaded an updated list of tests and an updated full description of the study.  We hope that the next few years will bring biomedical diagnostic criteria that will clean the muddied waters left from the varied poorly defined diagnostic criteria.  What Can You Do?  Edit - One Click letter to Congress is no longer available. Help us educate patients so they can become their own advocate by sharing/ liking this blog on social media platforms; liking/and or sharing the MEadvocacy facebook page posts; and liking/retweeting MEadvocacy tweets. Donate to the research of severe ME patients, such as the Open Medicine Foundation (OMF).  

Instead of Sending Me a Holiday Message...

One of our volunteers, Sonya Irey, recently had a birthday.  She requested in place of a happy birthday post from her Facebook (FB) friends and family, that they help with myalgic encephalomyelitis (ME) advocacy efforts. We thought this was such a great idea, we wanted to share it in hopes that you can make a similar request.  Please feel free to copy and paste into your own FB post or e-mail.  You may personalize this message, such as replacing ME with ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome) because some of the recipients of this message recognize ME/CFS as the term currently used to designate the disease ME.  As, we prefer the disease name Myalgic Encephalomyelitis, since we correlate the disease name to the specific diagnostic criteria the Canadian Consensus Criteria (CCC) or International Consensus Criteria (ICC). Below is based on Sonya’s birthday post (shared here with her permission) with some changes made by The Holiday Season is fast approaching, and I'm asking for one small gift from all of my family and friends. In the same amount of time it takes to post a holiday message, would you instead please: 1. Go to, enter your zip code, and click on the Contact Forms for each of your reps. Copy and paste the letter below to tell Congress that you support ME research. It would mean so much to me to have your support! 2. Click on the link: Constituent Letter to Congressperson to tell Congress electronically that you support ME research. It literally takes about 5 seconds and help MEadvocacy reach their goal. 3. Sign the #‎MEAction funding equality petition at Americans and foreign nationals can both sign. Just click on either U.S. or Global, then go to Your Location and enter your zip code. Then, click Sign the Petition. This literally takes about 10 seconds. 4. Please also consider sharing this post to your wall and encouraging your friends to help. Doctors who treat both AIDS and ME say they'd rather have AIDS. People often compare the ME battle for recognition, funding, and treatment to the AIDS movement. Yet there's almost no public funding for ME research. So I'm asking for your help. It's people like you, who know someone with ME, who can spread the word and make a difference for me and others with this terrible disease. Thank you, my friends, for caring and making this a truly meaningful holiday. #‎CureME  #MyalgicE #SevereME #MEadvocacy #MECFS Letter to Congress - please read, share, copy, and send! You can find out who your reps are at   Dear Senator/ Representative, I am writing to you as a constituent and deeply concerned citizen. I need you to be a champion in Congress for the severely debilitating, chronic, neuro-immune disease Myalgic Encephalomyelitis (ME), mostly known in the U.S. as Chronic Fatigue Syndrome (CFS). ME patients are too sick to advocate for themselves. So, despite recent media attention, this condition doesn’t have the widespread awareness that other severe diseases do. That’s why political action on ME patients’ behalf is so vital. Specifically, I need your help to increase National Institutes of Health (NIH) funding and to modify Department of Health and Human Services (HHS) diagnostic criteria for this horrific disease. An estimated one million Americans suffer from ME, a long-term disease that primarily targets young, previously healthy adults from diverse ethnic and socioeconomic backgrounds. The disease is so severe; it renders a quarter of its patients bedbound and unable to care for themselves. More than half are disabled and can’t work, attend school, or participate in daily life activities. ME patients do not spontaneously recover. The U.S. Institute of Medicine (IOM) calls patients with ME “more functionally impaired than those with type 2 diabetes, congestive heart failure, [or] multiple sclerosis.” Doctors familiar with both AIDS and ME say they'd rather have AIDS. The Centers for Disease Control (CDC) estimates ME’s annual burden on the U.S. economy to be $17-24 billion. However, the NIH consistently places ME at the rock bottom of its budget, with barely $5 million/year. This is less than the NIH allocates for hay fever, and is nowhere near its allocation for other similarly burdensome diseases: - ME: About $5 per patient per year in NIH funding ($5 million in 2015) - Multiple Sclerosis (MS): About $250 per patient ($103 million in 2015) - HIV/AIDS: About $2,500 per patient ($3 billion in 2015) As a result, ME still has no known cause, no FDA-approved treatment, and no cure. The lack of progress in ME research over the past 50 years is appalling, and is reflected in the absence of a standard of care for ME or even a knowledgeable response from most medical practitioners when encountering these patients and their families. The NIH has responded to past requests for increased funding by saying that few researchers are interested in studying ME. However, there are currently Nobel Laureates, several members of the National Academy of Sciences, biochemists, biophysicists, geneticists, immunologists, neuroscientists, experts in public health and infectious disease, epidemiologists, and physicians who are eager and ready to study ME, if adequate funding were available. Many of these researchers have written an open letter to U.S. senators dated 8/17/15, to express their interest and enthusiasm. The letter also notes that there is widespread agreement, both inside and outside the U.S. Government, on the imperative of dramatically increasing ME research resources. Recently, NIH has stated that it hopes its renewed focus and efforts on ME will lead to more research funding. However, new NIH announcements have not included any additional money. NIH has also said that it can't increase ME funding because it doesn't set specific budgets for individual disorders. Yet, the NIH does set specific budgets for its Centers and Institutes, including its Cancer Institute, Institute of Diabetes & Digestive & Kidney Diseases, Institute of Arthritis & Musculoskeletal & Skin Diseases, etc. The NIH also issues RFAs with specific budget commitments, and it develops internal Institute concepts and initiatives with specific budget estimates. The problem is that ME is not part of this budget planning process. ME doesn't have a "home" institute or center, and it hasn't had a new RFA in over 10 years. Accordingly, these deficiencies need to be corrected if NIH is to realize its “hope” of increased ME/CFS funding. To move the science forward on ME, the disease also needs well-defined diagnostic criteria. HHS’s Chronic Fatigue Syndrome Advisory Committee (CFSAC), ME medical experts, ME patients, their advocates, and their families have entreated the HHS to strike its current, overly-broad ME/CFS diagnostic criteria in favor of the well-defined, globally-accepted Canadian Consensus Criteria (CCC), which was established in 2003 by a team of international ME medical experts. The International Association of Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (IACFS/ME), the field’s professional organization, has officially endorsed and adopted the CCC standards, as have at least 50 ME medical experts, almost 200 ME advocates, and more than 6,000 patients. The 2011 International Consensus Criteria (ICC) revision is also well-established and alternatively acceptable. In conclusion, as a deeply concerned citizen and your constituent, I strongly urge you to use your powers and direct HHS to: 1. Fund biomedical research for ME in the amount of $250 million, which is commensurate with similarly burdensome diseases; 2. Establish authority for researching ME within the National Institute of Neurological Disorders and Stroke (NINDS), which currently leads the Trans-NIH ME/CFS Working Group; 3. Issue a new RFA that sets aside a significant amount of funding for new ME research; and 4. Endorse the well-defined, globally-accepted Canadian Consensus Criteria (CCC) for U.S. ME diagnosis and research. By taking these four critical steps, you will eliminate the greatest obstacles to finding an ME cure and thereby significantly ease the enormous physical and economic burden of ME on millions of American patients and family members. Thank you for your attention. I look forward to your response on this matter. Recent media coverage of ME/CFS: 11/3/15 Business Insider: What is Chronic Fatigue Syndrome? November 2015 Oprah Magazine: Chronic Fatigue Syndrome Finally Gets its Due 10/8/15 The Atlantic: Chronic Fatigue Patients Push for an Elusive Cure 10/5/15 The Washington Post: With His Son Terribly Ill, a Top Scientist Takes on Chronic Fatigue Syndrome 8/17/15 Science Magazine: Lobbyists Seek New Funds for Chronic Fatigue Syndrome Research…/lobbyists-seek-250-million-new… Doctors speak out about ME/CFS: "[ME/CFS] is one of the most disabling diseases that I care for, far exceeding HIV disease except for the terminal stages.”—Dr. Daniel Peterson, doctor and researcher “[An ME/CFS patient] feels effectively the same every day as an AIDS patient feels two months before death; the only difference is that the symptoms can go on for never-ending decades.” —Prof. Mark Loveless, Head of the AIDS and ME/CFS Clinic at Oregon Health Sciences University “Although [ME/CFS sufferers] are ill with a debilitating flu-like illness every day of their lives, neighbors and even friends and family insist they look “just fine.” It’s an unfortunate fact that our culture has yet to accept the harsh reality of chronic disease; often, its ravages are invisible to the naked eye. ”—Dr. David Bell, ME/CFS clinician and researcher “If I had to choose between the two illnesses [HIV and ME/CFS], I would rather have HIV... My HIV patients for the most part are hale and hearty thanks to decades of research and billions of dollars. Many of my ME/CFS patients, on the other hand, are terribly ill and... experience a level of disability equal to that of patients with late-stage AIDS and patients undergoing chemotherapy… ME/CFS, which impacts a million people in the United States alone, has had a small fraction of the research dollars directed towards it."—Dr. Nancy Klimas, AIDS and ME/CFS researcher and clinician "We’ve documented, as have others, that the level of functional impairment in people who suffer from CFS is comparable to multiple sclerosis, AIDS, end-stage renal failure, chronic obstructive pulmonary disease.”– Dr. William Reeves, former CDC Chief of Viral Diseases Branch Researchers’ Open Letter to U.S. Senators:   Dear Senator, We the undersigned scientists are writing to express our interest and enthusiasm for researching myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), a common and disabling illness long ignored by our nation’s health agencies. Many of us have had a very difficult time securing adequate funding. Others have been unable to determine even how to apply for funding, as no institute within the NIH has responsibility for researching ME/CFS. The NIH has responded to requests for increased funding by stating that few researchers are interested in studying the illness. On the contrary there are Nobel Laureates, several members of the National Academy of Sciences, biochemists, biophysicists, geneticists, immunologists, neuroscientists, experts in public health and infectious disease, epidemiologists, and physicians eager and ready to study this disease, were adequate funding made available. The undersigned are just some of those researchers. We have so much to learn and large studies are needed to understand how to help patients regain their health. With societal costs in the tens of billions of dollars each year, an infusion of government funding could quickly repay that investment. Currently, ME/CFS is massively underfunded compared to other diseases of similar severity and number of patients. The NIH allocates just $5 million per year to study this illness, which affects between 836,000 and 2.5 million Americans. Patients suffering from ME/CFS deserve funding proportional to and commensurate with other diseases with similar patient populations. The Institute of Medicine, a special HHS advisory committee, and a recent NIH­ appointed expert panel all agree: It is imperative to increase research funding for ME/CFS. If invited to apply for NIH funding via a new Request for Applications (RFA), we would eagerly submit grant proposals. Sincerely, Linda Tannenbaum, Executive Director Open Medicine Foundation Ronald W. Davis, Professor of Biochemistry and Genetics, Stanford University School of Medicine, Member of the National Academy of Sciences Susan Levine, MD Researcher and Clinician, Private Practice New York, New York Visiting Fellow, Cornell University Ithaca, New York Peter C. Rowe, MD, Professor of Pediatrics, Director, Pediatric Chronic Fatigue Clinic, Johns Hopkins Children’s Center, Maryland Alan R. Light, PhD, Professor, Department of Anesthesiology and Department of Neurobiology and Anatomy, University of Utah, Salt Lake City, Utah Kathleen C. Light, PhD, Researcher, Professor, Department of Anesthesiology, University of Utah School of Medicine, Salt Lake City, Utah Zaher Nahle, Phd, MPA, Vice President for Research and Scientific Programs, Solve ME/CFS Initiative, California Leonard A. Jason, PhD Professor of Psychology DePaul University Chicago, Illinois Derek Enlander, MD, MRCS, LRCP Attending Physician Mount Sinai Medical Center, New York ME CFS Center, Mount Sinai School of Medicine New York, New York David L. Kaufman, MD, Medical Director, Open Medicine Institute, California Staci Stevens, MA, Exercise Physiologist, Founder of Workwell Foundation, California Jared Stevens, B​S,​Clinical Coordinator, Workwell Foundation, California Dorothy Hudig, PhD, Professor of Immunology, Department of Microbiology and Immunology, University of Nevada School of Medicine Reno, NV Patrick O. McGowan, PhD, Assistant Professor, University of Toronto Scarborough Centre for Environmental Epigenetics and Development (CEED) Department of Biological Sciences Cell and Systems Biology, Psychology, Physiology Toronto ON Marcie Zinn, PhD, Neuroscientist, D​ePaul University Chicago, Illinois Mark Zinn, C​o Founder, NeuroCognitive Research Institute, Dublin, Ca Jarred Younger, PhD, Associate Professor, Departments of Psychology, Anesthesiology, and Rheumatology, University of Alabama at Birmingham David Maughan, PhD, Professor of Molecular Physiology & Biophysics, Emeritus, University of Vermont School of Medicine Burlington, VT Lucinda Bateman, MD, Medical Director at Bateman Horne Center, Salt Lake City, UT Isabel Barao­Silvestre, PhD, Assistant Professor, School of Medicine, University of Nevada, Reno

Why MEAdvocacy Does Not Applaud the News from NIH...Yet

  The Announcement  The myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) community has welcomed and applauded the National Institutes of Health (NIH) News Release announcing a strengthening of efforts by the NIH to advance research for the disease.  The overwhelming feeling is that the promises outlined in the announcement ushers a new era of hope for the long suffering ME/CFS patients.  NIH Director Francis S. Collins, M.D., PhD. assures: “I am hopeful that renewed research focus will lead us toward identifying the cause of this perplexing and debilitating disease so that new prevention and treatment strategies can be developed.”    The notice announces the readjustment of the Trans-NIH ME/CFS Research Working Group.  It will now be chaired by Walter J. Koroshetz, M.D. and assisted by Vicky Holets Whittemore, PhD- representative for the Department of Health and Human Services (HHS) on the Chronic Fatigue Syndrome Advisory Committee (CFSAC).  They will discuss gaps in research and look for scientific opportunity. This Group will be led by the National Institute of Neurological Disorders and Stroke (NINDS).  Although we are wary of yet one more working group, we hope this might result in more vigorous research into the disease.  It is not clear at all though how much and from where new funds will be coming from.  The notice states: “The Working Group includes representation from 23 NIH institutes, centers and offices” - yet no word about patient or advocate representation!  Francis Collins, personally, called a few advocates/patients to impress on them his commitment to bring focus to this “perplexing and debilitating disease”.  In addition, Collins appeared on the station.   See transcript here.  Collins says about CFS “it’s a very heterogeneous collection of individuals”. “They can’t get out of bed...exertion makes it worse.”  He promises to bring new technology to study this mysterious disease.  By understanding fatigue in CFS, it will lead to understanding fatigue in other illnesses like cancer. This announcement has prompted patient groups and advocates to sign a letter of thanks and a show of eagerness to work along with the Director of NIH.   We believe that applauding this announcement is premature.  The History  It is important to remember the history and context in which this promissory note presents itself. For the past 30 years HHS/NIH has given us many empty promises.  HHS spent decades trying to bury the disease of Myalgic Encephalomyelitis (ME) - read “Thirty Years of Disdain”by advocate Mary Dimmock.  Despite all the advocacy efforts from the community to bring on a change, nothing has actually changed.  In the past two years, HHS has been under attack by many advocates who have fought hard against the Institute of Medicine (IOM) and NIH Pathways to Prevention (P2P) governmental imposed actions. This advocate rebellion was augmented by the voice of disapproval of the IOM study from ME/CFS experts (via experts’ letter to Secretary Sebelius). Yet, HHS ignored the overwhelming voice of the ME/CFS community.  HHS’s malfeasance was made clear with attorney and advocate, Jeannette Burmeister’s, successful lawsuit against them for their violation of Freedom of Information Act (FOIA) requests for IOM documents. NIH was a named defendant in the lawsuit which, among many things, included misrepresentations under penalty of perjury! The very serious allegations by CFSAC voting members that the designated Federal officer (DFO), Dr, Nancy Lee,  intimidated and threatened them was never taken seriously by HHS.  (read advocate and past CFSAC voting member, Eileen Holderman’s, testimony) The call for investigation into this malfeasance by patient groups and advocates was never satisfactorily resolved and was basically dismissed.  All this dismissal, malfeasance and neglect of the patient/advocate community has eroded whatever little trust advocates and patients had for HHS and those employees who up until now have been responsible for creating policy for the health and welfare of the ME/CFS patients.  The Questions  This welcome overture by the Director of NIH is a refreshing start but too many questions remain unresolved to take this leap of faith.  Although some allusions have been made, to date, no Request for Application (RFA) has been issued.  Vague words of promise of more funding have been made with no concrete figure of increase in actual extramural ME/CFS funding.  There has been no clear action of ME/CFS being moved out of Women’s Health into one of the NIH institutes.  There is mention of a promise for a small clinical trial at the NIH center.  But, skepticism remains as to patient selection.   The notice states: “..with plans to enroll individuals who develop fatigue following a rapid onset of symptoms suggestive of an acute infection.” Is this going to be another trial of a “fatiguing illness”?    A year after the unrolling of the IOM  and the P2P reports, more questions remain which the community is still waiting to get answered.  Will the IOM criteria be used as presented in the IOM report?  ME/CFS scientists, doctors, advocates, patient groups and patients have voiced their opposition to the criteria.  It is shown to be too broad and does not exclude other possible diseases whether physical or psychological. It is not representative of Myalgic Encephalomyelitis patients.  It has not been tested and proven to select true ME patients.  At their last meeting of this year, CFSAC recommended additions and changes to the IOM criteria, which, if implemented, would greatly strengthen the deficiencies in the IOM recommendations Yet, HHS/CDC/NIH seems to have forged ahead without attention to CFSAC, which was charged by HHS to come up with the recommendations.    Which criteria will be used for upcoming research endeavors?  The IOM was only charged with creating diagnostic criteria - not research criteria. To date, NIH has used the Fukuda criteria for research.  Will Fukuda continue to be used for research studies?  Fukuda leaves out the distinguishing symptom of post exertional malaise (PEM).  In effect, research will be using an even broader criteria than in diagnosis.  How does this make sense?  The IOM and P2P reports recommend the retirement of the Oxford criteria.  There has been no formal acceptance of this recommendation from the government.  In spite of this recommendation, NIH just published an article, “Exercise and Therapy, ’useful and helpful’ for chronic fatigue syndrome”, on Medline promoting the faulty British PACE “fake” treatments of graded exercise therapy (GET) and cognitive behavior therapy (CBT) for ”Chronic Fatigue Syndrome”!  Apparently, the Centers for Disease Control (CDC) has taken their own initiative. Ignoring CFSAC recommendations and without any official announcement of approval of the IOM criteria, they are currently working on developing new ME/CFS educational material based on the IOM report.  They are recruiting patients to help them with this.  They have hired McKing Consulting, out of Fairfax, VA to head this project.  In addition, CDC is conducting 4 focus groups and 12 patient interviews. Their only criteria for patients is their word that they have been diagnosed with CFS or ME by a doctor.  See here.  The Most Important Question  The most important question remaining is: Which disease is the government talking about? Is it Chronic Fatigue Syndrome or Myalgic Encephalomyelitis?  The IOM report makes a distinction between CFS and ME.  They state that they are not the same.  Dr. Francis Collins as well, talks about ME being different.  Yet, none of them have defined it nor selected criteria for it.  The new US ICD-10 CM medical coding has separate coding for CFS and ME.  Myalgic Encephalomyelitis is coded under Neurological diseases.  CFSAC, at their August 2015 meeting, recommended the use of the ME ICD code along with the IOM criteria that includes CFSAC updates. It is 4 months since that meeting and we have not received any response from HHS to this recommendation as well as the other 14 CFSAC recommendations.  We at have made our mission known from the start.  We represent patients suffering from Myalgic Encephalomyelitis using ME criteria - CCC or ICC.  We withhold our applause until the above questions get resolved and we see real concrete action by HHS.