NIH to patients, “We are your partners”

The National Institutes of Health’s (NIH’s) ‘New Deal’ for ME/CFS, particularly the intramural study, has had a very mixed reaction from the patient community.

Update: NIH gives update on consulting patients, and says RFAs will happen

On March 30 NIH revised it’s response to the CFSAC recommendations saying its new plans include RFAs (plural) and says the revamped Trans-NIH ME/CFS Working Group is  actively drafting a research strategy for ME/CFS and

This plan will also include ways in which the ME/CFS community will be invited to provide input and feedback to the process and plans going forward.

Patients have criticised both specifics of the study, such as using the controversial Reeves diagnostic criteria, and the failure to consult patients from the start. The lack of new cash for new studies so far has also led some patients to doubt the NIH’s commitment.
Francis Collins tells patients "We are your partners" Francis Collins tells patients “We are your partners
During the recent tele-briefing the NIH was clearly trying to mend fences. Director Francis Collins kicked off the call saying, “We are your partners”, and throughout the call senior NIH staff stressed how keen they were to listen to patients.
Collins emphasised that the NIH wanted to work together with the community to crack ME/CFS. He said, “We want to hear from you, that’s why we’re having this call today. And we’re listening carefully to the comments and suggestions you might have about how best to move this effort forward.”
Dr Walter Koroshetz, head of the Trans-NIH ME/CFS Working Group, echoed that sentiment, saying this call “was only the beginning”. Later he added “I apologise to the community for the perception that we’re not listening, because we are very much listening and we will continue to listen.”
He also highlighted the key role patients who take part in the study will play, saying the history of medicine shows how doctors can learn from patients. He pointed out that the week-long stay in hospital would allow the NIH to get to know patients and their cases in great detail, making them “major teachers” of the NIH.
Speaking about the intramural study he heads up, Dr Avindra Nath said “we are absolutely committed to getting input from patients [and patient advocacy groups] throughout the study itself.”

NIH plans to involve patients

Dr Vicky Whittemore listed several ways NIH is considering for engaging with patients:

  1. Staging more telephone conference calls with patients like the one last week.
  2. Beginning each Trans-NIH Working Group ME/CFS meeting with input from patients, e.g. by phone, or through a presentation.
  3. Making specific requests to the community for feedback on ideas the working group is considering.
  4. Using the new NIH website for study to invite feedback from the patient community.
  5. Holding workshops to develop ideas, inviting patient, clinical and research communities.

On top of that, Whittemore said the NIH was always open to more suggestions from the patients.
Whittemore also said the NIH is keen to reach out to the research and clinical community to get feedback from them in terms of what it’s thinking and planning – consulting ME/CFS experts has been another demand made by many patients.
The sentiments and plans are all great, and I can’t think of another ME/CFS study or research programme with anything like this level of patient engagement. The NIH deserves a good deal of credit for this work.
Of course, there is a lot of history with the NIH and patient community, where many in the community are angry with the NIH and still distrust it after decades of pitiful funding for ME/CFS. It will take time for trust to build from such a low base.

Not yet a partnership

Even the considerable steps the NIH has taken so far stop short of what many patients have demanded: a seat at the table itself, as true partners in the study. However, it does appear that the NIH has given that option some thought and implied it can’t be done. Intriguingly, Nath said “we looked into some of the legalities about patient advisory groups and it’s a little bit complicated at the federal government”.
I’ve asked for clarification on this from the NIH, but as yet have no answer. However, I have heard from elsewhere that there may be legal problems with giving patients a formal role in federal-funded studies. If anyone can shed any light on this, please leave a comment.

Signs that the NIH is listening

Much of what’s been discussed here relates to the future, both of the intramural study and the NIH programme more generally. It’s worth reviewing how the NIH has responded to patient concerns so far. There have been three major controversies with the NIH study:

  1. The use of the contentious and overly-broad ‘Reeves’ empiric criteria to select patients.

The NIH said that when it posted this information on its website it was a mistake, and the study will only recruit patients who also meet both Fukuda and Canadian Consensus criteria. In other words this ‘controversy’ was borne of a simple error by the NIH. (The alternative would be that NIH responded to patient concerns.)

  1. The use of functional movement disorder, FMD, as a control group – where FMD is seen by the NIH as an illness ultimately caused by psychological problems.

Many patients felt this was both inappropriate and a waste of resources. The NIH have now dropped the FMD controls group – without explanation – but this does appear to be a clear case of the NIH responding to patient concerns.

  1. The strong views held by a number of researchers on the study that psychological problems lead to illnesses such as ME/CFS. Dr Brian Walitt, the lead Clinical Investigator is the most senior researcher on the study with these views.

So far, it appears Walitt is set to stay on the study, though the NIH went to some lengths to reassure patients.
During the tele-briefing, Wilhelmina Jenkins asked Walitt about his views on ME/CFS, and he appeared eager to be seen to say the right thing. He said, “ME/CFS is a biological disorder. Research has shown that in every system of the body that has been investigated that there have been abnormalities when compared to healthy volunteers. If ME/CFS is all in your head, it’s only because your head is part of your body.”
That seems fine in and of itself – though some patients are concerned by the mismatch between these words and other recent ones he’s written and spoken both about ME/CFS and about fibromyalgia, an illness he sees as having much the same cause. There was no explanation for the apparent radical change in view. One advocate on the call expressed concerns even with the words Walitt did use.
Perhaps more relevant is what the NIH had so say about bias – which is patients’ primary fear about having someone like Walitt on board: will he and others on the study bias the results or the interpretation of the study? Walitt said earlier in the call “…I don’t have a bias. I don’t have an outcome that I hope to see except that we find an answer that makes people better.”
Lily Chu raised the issue of bias during the teleconference. In response, the NIH was adamant that neither Walitt nor anyone else could bias the study. Nath insisted that as the study focused on immune abnormalities that will be measured in his lab there can be “no element of subjective bias”. And while there were 26 investigators, Nath said “I ultimately interpret all of these things “, pointing out that there is also an advisory group that will oversee both the study as well as the findings. (Dr Ian Lipkin is one of the advisors, and has been very clear he doesn’t believe ME/CFS is a psychological condition.)
Koroshetz said the NIH was an unusual place where scientists really were purely focused on getting to the bottom of the problem, and he’d rarely – if ever – seen bias get in the way. As one of the world’s most prestigious research centres, the NIH may well have an unusually strong anti-bias culture, though many people might see bias as an inevitable part of the human condition.
What I found most convincing about the NIH’s stance against bias was Koroshetz’s stark comment during the call that bias would be a ‘career-breaker’ – surely a warning to researchers on the study to play it straight.
Of the three controversies, the first- the Reeves criteria- probably wasn’t one at all (and if it was, it ended up as a win for patients). The NIH responded to patient concerns over the second one by dropping the planned FMD control group. And while Walitt, and other researchers whose views concern patients, remain on the study the NIH went to some lengths to make a case that bias would not be an issue, and would be a career-breaker if it did happen.
On patient involvement, the NIH is clearly making an effort, both in stated intent – including from the head of the NIH, Collins, who made an unexpected appearance at the phone call – and in plans for more patient involvement. What’s offered isn’t yet what many patients would see as a true partnership, but it’s certainly a lot more than we’ve seen from the NIH before – or any other research group for that matter.
Of course, for many patients the NIH are starting from below zero, both because of its historical neglect of the illness and because of missteps over the study that was planned without any patient input. Not to mention the lack of new funding so far.  Repairing a broken relationship will take time, but my perception (and I am a Brit) is that the leadership of the NIH, at least, is sincere in its desire to engage with and work with patients. We’ll know more in the coming months as the NIH clarifies its plans for involving patients, and announces any RFA funding for ME/CFS.
There was only enough time to answer half-a-dozen questions at the phone call, and Koroshetz stressed that any patients can ask about the study, urging people to send their queries to [email protected]. More information, and an FAQ are available at the new dedicated website for the intramural study.
Dr Avindra Nath, principal investigator of the NIH intramural study, will be giving the Solve ME/CFS Initiative webinar on Thursday, April 21.


9 thoughts on “NIH to patients, “We are your partners””

  1. I would say here that what is needed is for reviewers to learn to recognize their own biases. What is bias to one person is common sense to another, making this distinction difficult. However, anyone who has worked with medical patients for any length of time can easily see that their thinking is affected by the illness itself. Think of even having a cold; most people’s thoughts are slower and less accurate. Then there are major medical issues such as cancer. When I saw cancer patients, I can tell you that 100% of them appeared to be depressed and anxious. So is this a chicken-or-egg problem? Does the illness cause the cognitive difficulties, or do cognitive difficulties cause the illness?
    Personally, I believe this problem was solved some time ago, since it can be shown unequivocally that MECFS is a major medical illness. Furthermore, it appears to be a type of chronic encephalitis (multiple studies bear this out). The predictions here are very important; first, that psychological “issues” will only be resolved by the patient recovering from the illness, and 2) even the presence of psychological issues in patients means no more than the presence of psychological issues in any other medical problem. So, are we going to go to the cancer wards and tell patients that CBT and GET will make them significantly better? Are we going to imply that they are causing their own misery? I sure hope not.

  2. It’s a big, complicated, time-consuming and somewhat expensive deal to establish an advisory group to the federal govt. (Disclosure – I’m a federal employee with many years of experience seeking public input on various topics.) Here’s a link to information about when and how it can be done: I suspect these may be the “legalities” NIH mentioned, which currently apply to CFSAC.
    Bureaucratically speaking, the other alternatives mentioned by Dr. Whittemore are easier to implement and run less risk of excluding/overlooking some patient voices. Maybe patients have preferences about how communications should occur (how often, through what mechanisms)? The petitions seem to me to be useful, but they aren’t two-way communications and I’m thinking dialogue is more desirable.
    I wonder if it might be possible/worthwhile to set up a poll or polls to elicit patient ideas and preferences?

    1. That’s a great idea Val! We have solicited comments and questions through this site and sent them to the NIH (they have not yet been answered) and have suggested other mechanisms that could be used to help aggregate broader input.

    2. Thanks for that link and background on the issues over having patient (or any other kind of non-govt) ‘advisors’. And I like the idea of a poll.

  3. Thank you for the write up, I understand people want to be hopeful. So do I but but I wanted to laugh when they said their was no bias at the NIH. Did we forget the decades of Strauss? The fact that they deny chronic Lyme exists? They also are still using the reeves criteria for selecting patients and only the CCC after from what we can tell.
    If we and you in Britain had only been neglected I would’t feel so nervous and angry about many of their choices. I can’t go into them all but they have actively fought, along with the HHS and CDC, to make us disappear into general fatigue and psychosomatic land and their choices to name these same people ME/CFS experts in this study is a slap in the face after the IOM and P2P said to stop that. No patients should be forced to work with the same people who have been calling them crazy for years.
    The phone call was theater that didn’t allow for follow up and the fact that they posted the final outline of the study just before the call shows that questions and points patients had didn’t matter. The very real problem that Walitt and many others have worked hard to make this a disease that is not taken seriously as a biomedical problem will stand.
    Lyme control was also blown off and they don’t seem to understand why it is problematic on a number of levels.
    At this point I would be happy with just making sure the study is filled with actual ME patients which is not at all clear at this point as no real clinical experts are doing the screenings. Just the fact that they name Walitt and Gill and ME experts is horrifying.

  4. Jonathan Edwards

    Thanks for an informative summary. My impression is that the NIH team are genuinely trying to get this right and I wish them all success – we need it. My only caveat is that if they want to convince other researchers in the field that they are unbiased they are not going to get very far saying ‘there is no bias at the NIH’. Productive collaborative science comes from everyone admitting that they are struggling to minimise the sea of bias that threatens to engulf us every minute. Good scientist joke and apologise about their biases and admit that nobody is better than anyone else from having a name on the doorway. What counts is good study design.
    International dialogue in ME/CFS research is now very good and we hope the NIH team will participate in that as soon as they have some data – or even before!

  5. We need to push for full R&D funding NIH+CDC = 250M/YR INCL extramural studies w key researchers like Ron Davis, Jason Leonard, Younger, OMF etc. To hedge bets, need also private funds for OMF severe ME study since funding limited. Hope Gates, Zuckerberg, Sean Parker, Tom Cook, Robert Metcalfe, many others and Rotaries can show leadership for R&D on this major, but severely neglected disease. If you have any connections to major philanthropist, please edicate them, since they could help make major progress quickly, working w patient groups & researchers like above and many others.

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