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.
Announcer: Our next question comes from Joni Comstock, your line is open.
Joni Comstock: Hi, I represent MEadvocacy, a grassroots, non-profit organization advocating for patients suffering from ME.
Our focus is the severely affected patients, most of whom are homebound and bedbound. Some are so sick they are unable to care for themselves.
We were dismayed to learn that the protocol and design for the intramural study has been well underway without any input from the ME/CFS expert clinicians, researchers, as well as from the patient and advocate community.
This became even more disturbing as so many flaws were revealed about the study. These deficits showed us that many of the ingrained agency misconceptions of the disease still exist and have not been clarified. Therefore, we initiated and delivered a petition with 725 signatures to Dr. Collins, to stop the study and start it from scratch with stakeholders input from the get go.
Because of ingrained institutional misconceptions, whether deliberate or not, we expect the NIH to engage the expert community on any ME/CFS study from the moment of its inception.
They should have input throughout the entire process.
This includes: the planning and implementation of the design, recruitment, trial, analysis, study outcome, peer review publication, and the publicity.
Do you intend to respond directly to MEadvocacy about the petition and how do you plan to incorporate our concerns?
Reply from Dr. Koroshetz and Dr. Walitts at NIH
Koroshetz: Let me just start at ah ..I appreciate your concerns. And ah...Our intent is to reach out and get input from a wide variety of folks with expertise and with experience in this illness.
And we have been doing that right from the beginning at NIH through the trans NIH working group, through CFS advisory committee.
We have had multiple meetings with experts in the field and with advocacy groups.
And, I must say it has been a challenge for us, because there are...we may not have reached out to everybody and we apologize for that.
It has been very been difficult to know exactly who everybody is and that’s the reason we have these calls and this is not going to be the last of our calls. But, it’s only the beginning. And, we will learn from patients.
I think the history of medicine is, that as you work with patients, the patients teach you lessons.
So I think the major teachers at the NIH really have to be the patients who have made the sacrifice to join the protocol, to come in to the clinical center and to work with the doctors.
I think that’s where a lot of the input is going to come.
The protocol itself, Brian can correct me if I’m wrong, but the protocol is always a work in progress. So, the protocol gets put up, it has to get approved, then it moves forward. Then there are amendments, then they have to get approved again, then it moves forward so and the protocol is something that is gonna have to be tested.
We will be probably bringing in control persons to see if they can manage the protocol as it stands before we bring in patients with ME/CFS and put them through the protocol as it stands.
So, so I think we are definitely interested in getting input.
But the truth of the matter is that scientists at the NIH have.. they have to be the ones who have to be empowered to work with their patients to try to get at the bottom of these..what is the biologic nature of ME/CFS.
So, we are very interested to move ahead.
And we can’t, you know, take all patients with ME/CFS. The very severe cases, who are homebound, I think would certainly not be wise to start there.
Um ..Brian do you have any points on that?
Walitt: Part of the protocol is to look at post exertional malaise which requires pushing patients a bit, being able to exercise, being able to do things.
Taking a homebound population and stressing them more… may lead to untoward consequences for patients and we need to be concerned about those things. It’s definitely a very important population to study, but that might be for the next phase.
Koroshetz: And I think the clinical Center does have the ability to bring people into the hospital who are in, in very poor condition. Because it is a hospital, it has 24 hour nursing. So it is something that we could potentially get to it at some point. But I think it would be probably unwise to start there.
So again, I apologize to the community for the perception that we are not listening, because we are very much listening. And, we will continue to listen and we will continue to communicate the best we can, so thank you very much for that.
Summary of NIH Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Research Study:
MEadvocacy petition to Dr. Collins with 725 signatures:
Trans-NIH ME/CFS Working Group:
CDC Multi-Site Clinical Assessment of CFS: