The US National Institutes of Health (NIH) is hosting a telebriefing on Tuesday to “share information about [their] upcoming activities and to gather feedback” from the ME/CFS advocacy community. They have limited phone lines and said they want to make sure to address questions from representatives from community organizations and leaders, so the call is not open to the entire public, but the NIH asked that everything discussed be shared publicly. We have recommended that all future calls be open to the entire community – YouTube Live is one of several technologies that would not limit participation – and that the call be recorded.
#MEAction sent a list of questions to the NIH based on the comments gathered from the community on our site. Thank you to everyone who participated. We have asked that these questions be addressed during the call and on their website. We will be sending additional community questions soon but felt that these urgently needed to be answered.
Here are the submitted questions, summarized and collated (we have also sent a link to the original questions and comments in full):
- Patients have expressed strong concern about the selection of Dr. Brian Walitt as lead clinical investigator. He has written and spoken about ME/CFS and other illnesses being psychosomatic in spite of biological evidence to the contrary. Why was he chosen for the study?
- Patients have expressed similar concerns about Drs. Gill and Saligan. Why were they chosen for the study?
- NIH has chosen to compare ME/CFS patients to people with the controversial functional movement disorder. Why did NIH choose this group?
- NIH has chosen asymptomatic Lyme patients as another comparison group. Can you confirm that these patients are intended to be the post-infection, symptom-free group? How will NIH select these patients to make sure they are really asymptomatic and don’t have chronic Lyme?
- Why was Lyme infection chosen versus HHV6, EBV or other infections already suggested as a trigger to ME/CFS?
- Why was multiple sclerosis not chosen as a comparison group, as other recent ME/CFS studies have done? Would NIH consider replacing the FMD or Lyme Comparison groups with an MS group?
- Patients have expressed concerns that 40 patients is too small of a sample. Why did you choose this number? Would NIH consider dropping one of the comparison groups and adding in 20 more ME/CFS patients?
- How will ME/CFS patients be selected for the study? Walk us through the process and tell us which criteria and assessment tools will be used for patient selection and to validate the diagnosis.
- Will NIH share all data generated from the study with outside researchers?
- Will patients have access to their test results?
- Will NIH coordinate research plans with the ongoing study led by Dr. Ron Davis, who is studying severely ill, bedbound ME/CFS patients? It makes sense for NIH to leverage this private investment to maximize what is learned from both studies.