NIH Obliquely Dismissed 725 Voices While Stating that Patients' Input Matters

  MEadvocacy’s Question and Reply at the NIH Telebriefing, March 8, 2016 MEadvocacy took part in the 10:00 am EST teleconference today from the NIH, which included a capacity of 100 listeners.  There was an initial introduction by NIH director Dr. Francis Collins, followed by presentations from NINDS director Dr. Walter Koroshetz, NINDS program director Dr. Vicky Whittemore, primary investigator Dr. Avindra Nath and lead investigator Dr. Brian Walitt. The presentations were followed by a Q&A period. Advocates had the opportunity to submit questions that were addressed by the panel, if chosen during the allotted time period. MEadvocacy will elaborate on the full briefing at a later date.  For this blog, we are submitting the question that we posed to the NIH followed with their reply. Continue reading

How Activism Empowers Progress

  Lately, we have noticed a disturbing trend. Various members of the ME community  have been chastising vocal activists/advocates for being too militant, because they’re afraid that somehow this anger will be used against them, or they just find anger distasteful in general. The majority of advocates are women. Traditionally, women are socialized to be polite, submissive, and not rock the boat. This leads us to believe that there may be different cultural and social perspectives at play. In the United States, the First Amendment of the US Constitution guarantees freedom of speech, freedom of peaceable assembly, and the right to petition for redress of governmental grievances. Continue reading

Misinformation About a Disease Has Dire Consequences

  __________________________________________________________________  Many look to our ME and CFS clinicians to transform into white knights coming to the rescue of a very neglected and mistreated patient population. More specifically, to take up the battle to confront the biased government institutions. We suspect politics are at play, and understand many of the well-known clinicians have become reliant on government funding or fear government retribution. How do they fight without losing their ability to run their clinics? Can they strongly speak out against the government and stop perpetuating the inaccurate institutional bias causing neglect and harm? Especially when these are taught to the thousands of doctors and medical professionals.   We are grateful for the researchers and clinicians who have not been biased and have worked hard in our community to do research and treat patients in this hostile climate. __________________________________________________________________ Misinformation at the CDC Grand Rounds The Chronic Fatigue Syndrome: Advancing Research and Clinical Education, CDC Grand Rounds took place on February 16, 2016. See video of entire meeting here. There were four speakers at the meeting: Dr Charles Lapp, Dr. Elizabeth Unger, Dr. Anthony Komaroff and Dr. Avindra Nath. For this blog we will concentrate on Dr. Lapp’s presentation. Charles W. Lapp, MD - Medical Director, Hunter-Hopkins Center, P.A.: “Clinical Presentation of Chronic Fatigue Syndrome" - (Watch Dr. Lapp’s presentation here.) Continue reading

Follow Up Reminder Email to Collins

  MEadvocacy has not received a reply from Dr. Collins to the e-mail, which included the petition, sent on Monday Feb. 15, 2016 (see our blog NIH and CDC: You Got Mail). In the time since the original email was sent, Dr. Nath presented at the CDC Grand Rounds. Our petition outlined the reasons why we called for the cancellation of the study and since then new and disturbing information has been uncovered. We have sent a reminder email and gave Dr. Collins a response due date: end of Friday Feb. 26, 2016.   Subject Line:  Follow-up from Feb 15, 2016 e-mail re - URGENT  - IMMEDIATE ACTION NEEDED Petition: NIH/CDC: Stop the CFS Study Using Reeves Definition & Cancel the Study’s Presentation at the Feb. 16th CDC Grand RoundsDear Dr. Collins: We have not received your reply for the e-mail below. We would appreciate a response by end of Friday Feb. 26, 2016.In the time since the original email and petition were sent, Dr. Nath presented at the CDC Grand Rounds. Our petition outlined the reasons why we called for the cancellation of the study and since then new and disturbing information has been uncovered. The choice of Dr. Brian Walitt as lead clinical investigator is an outrage. Dr. Walitt has a biased predisposed opinion of  “syndromes such as fibromyalgia and chronic fatigue”. He states that they are “psychosomatic” and are just a “range of normal”. Certainly the NIH had knowledge of Dr. Walitt’s beliefs yet, chose to put him in charge. In fact Dr.Walitt’s own research (see link) into chemobrain comparing chemo patients’ neuropsychological symptoms to those of somatoform diseases like fibromylagia and chronic fatigue syndrome, rings close to your statement on the Charlie Rose Show, “by understanding fatigue in CFS, it will lead to understanding fatigue in other illnesses like cancer.” Dr. Nath himself praised Dr. Walitt during the CDC Ground Rounds, “I would like to particularly thank Dr. Brian Walitt who is the lead clinical investigator of this study at NIH and Doctors’ Unger and Lipkin as members of the executive committee for their valuable advice." In addition, the study design calls for comparing ME/CFS patients to recovered Lyme patients and functional movement disorder patients. Choosing these cohorts, along with the selection of Dr. Walitt as lead clinical investigator, indicates a purposeful objective: to prove a relationship between the disease ME and somatoform disorders and by choosing a second cohort that is more likely to further obfuscate the study by comparing a post-infectious group of Lyme patients, a patient community whose testing approved by the CDC is fraught with controversy and whose patients are prone to developing chronic Lyme infection when they are supposed to remain asymptomatic. The ME community is justifiably angry by these choices that NIH has made in studying ‘fatigue’ -  as opposed to a study of the neuroimmune disease, ME, with a study design approved by ME expert researchers (who have experience studying ME patients), as well as ME advocates and ME patients. Since our petition went out over a week ago, we feel it is reasonable to expect a reply from your office at end of Friday Feb. 26, 2016. Regards, Mary Ann Kindel Joni Comstock Tracey Smith Gabby Klein Colleen Steckel Members of the Advisory Group of MEadvocacy Email CC:  Dr. Avindra Nath at NIH; Dr. Brian T. Walitt at NIH; Dr. Tom Frieden at CDC; Dr. Elizabeth Unger at CDC; Dr. Walter Koroshetz at NIH; Dr. Vicky Holets Whittemore at NIH; Secretary Sylvia Burwell at HHS; Colleen Steckel at MEadvocacy

NIH and CDC: You've Got Mail

  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

A Blast From The Past: A Review By Maryann Spurgin, Ph.D.

    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:…/20…/ 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

Further Analysis of NIH Clinical CFS Study

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

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