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.

MEadvocacy’s Question

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:

Showing 10 reactions

  • Julie Houska
    commented 2016-04-08 15:06:50 -0400
    Thank you for your comments. The comment period has expired. However, if you still wish to comment, please do so on our Facebook page. Thank you for your interest.
  • Mary Schweitzer
    commented 2016-03-09 23:49:23 -0500
  • Fern M.
    commented 2016-03-09 22:08:16 -0500
    I noticed that Dr. Koroshetz quickly veered away from mentioning anything about advocates and experts and researchers. He certainly didn’t and/or couldn’t give an answer to the specific questioning.

    We (patients, advocates and researchers) don’t want to continually be negative when hearing and reading about the goings-on in the NIH regarding ME, but what else can we all do? They still don’t “get it.”
  • Mary Schweitzer
    commented 2016-03-09 17:45:15 -0500
    Great comments. Shanta, I particularly liked “These are not dogs at the veterinarian’s office.” And Mark, when you combine “American exceptionalism” with “we at NIH know best” you get a really insular outcome! It’s a self-fulfilling prophecy – what NIH knows about the disease is what NIH knows about the disease. I don’t know how to explain to them how inappropriate Walitt’s research and interview response are. And he is certainly NOT an expert on the disease – none of them are. Lipkin is heavily involved in research on the disease, but he’s a virologist, not an EXPERT on the disease. Beth Unger? Really? And Walitt – and his buds. I’d rather they had people who knew nothing about the disease than people who could spread disinformation. Trying to figure out how to EXPLAIN that to them. (Though I do love the veterinarian comment.)
  • Allyson Day
    commented 2016-03-09 15:10:59 -0500
    Dr. Koroshetz, “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.” Read: “We don’t want any interference from ME experts. And we haven’t bothered to look up ME Advocacy groups Who are you again?”
  • james hall
    commented 2016-03-09 12:37:23 -0500
    This is just another brush-off to the M.E. community, How ignorant do they think we are that this answer holds any merit! A lawyer/journalist would have a field day with this response! these are the people we need with us when there is any form of communication with any agency!
  • Mark Camenzind
    commented 2016-03-09 01:56:40 -0500
    It is hard to believe Wallit is involved and hope he can be sent back to nursing and get people who appreciate this is very medical, not psych disease. It is good that other groups like already have started a severe M.E. patient Biomarker study and hope both groups can share and cross fertilize ideas. The patients in Calif Stanford Area could also have different causes and symptoms vs the patients in MD, so good to have not all eggs in one basket and some variations in approach. The NIH funding is better than last year presumably, but more extramural studies are also needed, so hope NIH and philanthropists worldwide can help fund to keep this all progressing at a higher speed. NIH should in parallel fund other R&D groups since not all good ideas are at NIH, and many on the outside have been studying this more methodically much longer, incl in Norway Sweden, Australia, Columbia University, DePaul and many clinicians nationwide. More of these relative experts should be included. Great to see new approaches also including Younger at U AL. We need more attracted to this field incl at leading Universities. Exhaled gases need to be looked at also since non-invasive and can be fast tests. The patient is one factor, but the homes might also contribute due to lack of air circulation, possible mold, outgassing, local pollutants and other factors. We all just wish this was funded more, such as $250M per year, to get real progress. Spending $3B per year for AIDS by NIH vs <<$100M per year on the more common M.E. CFS is still gross discrimination by NIH, CDC, HHS and our Federal Government. Hope next elections can bring in people who will grow NIH by $5B per year and include many more extramural studies to Cure M.E.!
  • Shanta Kamath
    commented 2016-03-08 23:21:00 -0500
    I notice a failure to hear the question as it advocates including patient input from experience, their direct knowledge of the disease, patient participation through respectful attention to their informed perspective in the course of designing the research. Replacing this desired inclusion of self-advocacy on the part of the ME community, there is a marked and distressing tendency on the part of Walitt, in particular, to discuss why severely ill patients would not be good as objects of research within the protocols the researchers had already developed without considering the patients as consumers in a focus group toward research design, for example. In short, the answer objectifies the patient, rejecting the question’s regard for them as subjective but valid agents of information that could guide the researchers. These are not dogs at the veterinarian’s office.They can speak and have as much or more capacity to observe something about the disease as other “experts.” Second, it is clear that the researchers know the exercise protocol will cause stress and be dangerous for the severely affected patients; they say so! I have read many times now that the experience of these patients was that due to misconceptions, they had been forced into overexertion that harmed them, so it might be valuable to look at all that information and experience so as not to repeat the same mistakes with newer sufferers who have not yet been harmed but may be harmed by ill-informed protocols. These bedridden people who can barely leave bed want to tell you something important about their understanding of what you are doing. You might want to listen to what that is, not in a patronizing, deescalating, public relations talking way as above, but in a substantive, intelligent way that humans try to work together to learn the truth about something important to all of the stakeholders. I don’t have ME. My lifelong friend who does is smarter and more vital in her personality and more credible than so many doctors and researchers are to me when they can look at someone like her and not “get” who they are looking at and think the word “invalid,” in either of the two pronunciations and senses, could ever be applied.
  • Mary Schweitzer
    commented 2016-03-08 22:46:39 -0500
    I don’t think they are all villains. BUT, they are keeping it too internal, and it can be captured.

    I think they are conflating bedridden with homebound. They should be able to take homebound patients.

    I have asked them to send a representative to the Invest in ME conference in May. I just learned that Invest in ME already offered – and continues to offer – to pay all the costs.

    So why aren’t they sending anybody? They need to be urged.

    I really like Nath, but I really do not trust Walitt. had he said, “Well I THOUGHT I knew what CFS was when I said it was somatoform, but it turns out i was mistaken” – I would have been okay with that. But the thing about "the head is connected to the neck’ is the worst type of biopsychosocial claptrap. He’s from the “National Institute of Nursing Research” at NIH. I think two of his buddies are also on the committee. Not exactly high level. (frankly)

    We deserve better than that.
  • Justin Reilly
    commented 2016-03-08 22:29:20 -0500
    Oh yeah, they’ve been listening to the experts including patients all along and involving them! That’s why the Principle Investigator says it’s Somatization and the Protocol gave the Reeves Criteria as the “CFS” definition it was going to use. Give me a friggin break! More NIH BS and lies. Surprise, surprise!