STOP GRADED EXERCISE THERAPY TRIALS FOR ME/CFSHundreds of patients have reported harm — some becoming housebound or bedbound, indefinitely — from graded exercise therapy (GET). Objective criticism from scientists and journalists have argued that there is no correlation between participation in GET and recovery. Yet public resources continue to fund trials such as MAGENTA, a UK trial of graded exercise therapy in children ages 8-17. After the feasibility study on 100 children is completed, MAGENTA will likely expand to a larger trial, with more young patients recruited. MAGENTA’s public documents, including the participant-information sheets given to prospective patients and their parents/carers in the feasibility trial do not convey the magnitude of the harm reported by patients. A document addressed to parents reads “We have used both treatments [GET and activity management] in our service and we are not aware of side effects. Studies in adults have also not shown that there are any side effects.” Therefore, the children in MAGENTA and those responsible for their well-being may not have given adequately informed consent. The rationale for performing additional GET studies in ME/CFS such as MAGENTA rest on the shoulders of the fundamentally-flawed PACE trial. PACE’s flaws are so well-known and so profound that over 40 scientists and doctors, including pediatricians, have signed an open letter stating that PACE’s “major flaws... have raised serious concerns about the validity, reliability and integrity of the findings”. Thousands have demanded retraction of PACE’s “misleading” analyses and 24 ME/CFS charities in 14 countries have demanded that its data be released for reanalysis: PACE is no basis for a trial in children or adults. Please sign now, and share this petition widely. Join with us to protect our community from research that ignores the biological realities of ME/CFS and promotes a potentially harmful therapy. You can find more information at: www.stopGET.org Are you a UK citizen or resident? If so, sign this UK parliament petition: https://petition.parliament.uk/petitions/166601. We aim for it to reach 10,000 signatures — fast — which guarantees a government response.
NIH: Put ME/CFS patients at heart of research design processThe patient community has several concerns about the trial: • The proposed Lead Clinical Investigator has referred to “somatoform illnesses, such as... chronic fatigue syndrome”  and several other researchers on the project have a psychogenic focus to their work. • The inclusion of a control group (now removed) with what the NIH considers to be a psychogenic disorder (functional movement syndrome) appears to suggest a psychogenic influence on the research approach. • Another proposed control group for the trial consists of post-Lyme patients, but the controversy over the accuracy of diagnostic tests for Lyme may make it an unsuitable control. • The study appears small, with only 40 ME/CFS patients, raising the question of whether it is big enough to detect useful effects, especially in the presence of subgroups. • A preliminary study design has been announced before any consultation with patients, and communication has been piecemeal. These factors — especially the psychogenic elements — are contributing to a collapse in confidence in the study among patients and are likely to seriously hinder the recruitment of patients to the study. We believe these concerns could have been addressed and avoided and the trial design improved upon if patient input and experience had been integrated from the beginning. In future, we want to be involved in helping to design ME/CFS research from the ground up. Patient participation matters. Our community is wary of government institutions, and for good reason. We have had a long history not only of neglect but on occasion of active obstruction. However, we believe that this distrust will be overcome quickly if the NIH demonstrates clear communication and decisive action. Patients are experts in their lived, direct experience of the disease and know best what aspects of it are important. Many have also studied the science. Some even had careers in science before they were struck down. All can contribute: all want to contribute. Without our input, the study will be the lesser; and without our input, patients will not trust it. Patients are desperate for good research and we want your — our — study to be excellent. We understand  that a patient advisory committee will be set up and we urge you to convene it as soon as possible. Let us work with you, right from the beginning, and build together a study that both researchers and patients can celebrate without reservation. READ MORE: Design of the NIH post-infectious ME/CFS study http://www.meaction.net/design-of-the-nih-post-infectious-mecfs-study/ Patients’ concerns about the study design http://www.meaction.net/patients-concerns-about-the-study-design/ Simon McGrath article explaining the science in the study http://www.meaction.net/2016/03/03/extraordinary-nih-mecfs-study-may-be-most-comprehensive-and-in-depth-ever/ REFERENCES:  http://www.ncbi.nlm.nih.gov/pubmed/25573802 http://www.meaction.net/2016/02/17/qa-about-patient-involvement-act-up-and-rfas-with-dr-nath/