1,000 signatures reached
To: NIH Director Dr. Francis Collins, Dr. Walter Koroshetz, Dr. Avindra Nath
NIH: Put ME/CFS patients at heart of research design process
ME/CFS is a decades-long public health emergency. Patients have waited a long time for the National Institutes of Health (NIH) to take action proportionate to the scale of the crisis and the devastation wrought by the disease. The proposed NIH study of post-infectious ME/CFS offers an opportunity for great progress, but this opportunity can only be fully realized with transparency and the involvement of patients.
Therefore we, the undersigned, ask the NIH to:
• include patient representatives in the design process of this and future NIH ME/CFS studies at the earliest possible stage;
• set up a transparent and participatory process for the selection of those representatives; and
• not move forward with this study until input from the patient representatives has been incorporated.
Why is this important?
The 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.
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/