NIH intramural research program update

[JayS]

I'm posting this with a little trepidation, because it will probably make me look like I am defending Walitt or carrying water for NIH. I do think Walitt on the study is problematic, and I don't like that NIH hired him in the first place.

You're in a weird position, granted. If there weren't so many red flags for people--huge ones, not piddly trivial nothings that are made into big deals because people want to be angry or negative or something--I seriously doubt anyone would care if you were actually carrying water for NIH or whatever. But remember, you were downplaying the issue of Walitt since it was discovered--which, again, was after the weird rollout of the protocol 'just to secure an index number' or whatever. That's why the thing with Julie seemed really strange--as in, that's where you chose to direct anger?

There should be no need for patient input on study design--but since there is, does what's happened so far strike you as the work of people acting in good faith? Do you think we really want to act like petulant childish assholes? Come on. They've moved forward in a way that suggests they have zero understanding of the issue they've been given new, special instructions on, since it's been handled so badly in the past. (If we're giving them the benefit of the doubt.) But every time something else turns up that the community at large considers problematic, it points more towards the conclusion that all of this is done on purpose, and they don't care what any of us think.

 

[Valentijn]

But every time something else turns up that the community at large considers problematic, it points more towards the conclusion that all of this is done on purpose, and they don't care what any of us think.

I don't think it's the case that this has necessarily happened deliberately. So far only 5 of the 30 investigators seem to have bizarre ideas regarding CFS, fatigue, and/or scientific methodology in general. 10 more look completely sane, and another 2 probably aren't a problem.

I think what happens is that these quacks have published regarding CFS or fatigue previously, and someone probably found them when searching for investigators in the NIH with experience in the disease. If that was the case, and there were good intentions, that person did not then read any of their research, which is rather unimpressive.

Alternatively, it's possible that volunteers were called for, and the quacks were among those who found the project attractive.

At any rate, there are possibilities which do not involve bad faith, bur rather mere negligence. So I think we should give the study organizers the benefit of the doubt for now. And we should also be 100% insistent on getting the quacks off of the team.

 

[JayS]

Fair enough--it's not like I want to assume they're acting in bad faith. Or view it in a way that constitutes a judgment along those lines. But they haven't made it easy, now, have they.

I don't think Walitt or whoever appointed him, even, is the problem here. The problem is that the idea that he's an appropriate choice--and Gill, and the others--is obviously held by people in charge. Are their minds going to change even if they feel forced to make changes? I kind of doubt it. Outcry from the community hasn't exactly been an effective tool at changing minds about this disease.

Only time will tell. I'm trying to keep an open mind. But I can't say I'm terribly optimistic.

 

[Ecoclimber]

You can't put the toothpaste back in the tube once it's out. Look what happened to the GWI veterans group. If out team didn't get ahead by researching the 9 IOM reports on the Gulf War Veterans, we would be in a different place. By fighting to get me/cfs researchers on the panel, it prevented the BPS school from taking over.

The Changing Nature of Fibromyalgia Frederick Wolfe and Brian Walitt
Why Fibromyalgia Succeeded
"The primary requirement for the success of psycho-cultural illness is that it must not be perceived as being psychological (not real). Disorders that are primarily psychogenic attract societal attention and disapprobation, particularly when they ask for social advantage or disability pensions. The rise of fibromyalgia and the disputes it has engendered represents the age-old battle over psychogenicity. All other things being equal, fibromyalgia should have failed. It began as a simple local pain disorder, but evolved over time into one that had multiple somatic symptoms and features that many considered psychosomatic. If these features were the death knell of neurasthenia, they should have also spelled the death of fibromyalgia. But they didn’t. The era was different, and powerful cultural forces stood behind fibromyalgia and fought against the idea of a psychogenic illness

Their viewpoint is to label everything as a psychogenic illness by making it look like it's a real disease. Do you see what they are saying. The decepion they are fostering on the patient population of a deliberate cover-up

This could be a serious end around the IOM report which they may not have expected. A backdoor to null the IOM report.

 

[A.B.]

I think the neglect may be quite intentional. They think that CFS is neurasthenia. They think that neurasthenia was a fashionable label for symptoms that only exist in the mind of the patient. They think that psychiatry made neurasthenia disappear by labelling it as all in the mind. They are trying to do the same with CFS. By discriminating, neglecting, bullying, and abusing CFS patients they are trying to "cure" what they believe is some form of mass hysteria.

How embarassing it would be for them having to admit that patients are actually sick.

"They" would be Shorter, Wessely, Strauss, White, etc. and their ideological followers.

Odd how in their history lessons they forget that claims of psychosomatic causation turn out to be complete nonsense.

 

[anciendaze]

There is too much concentration on an organized conspiracy pushing a single viewpoint. What I was talking about above was the way we have layers of organization with competing criteria. From an organizational political perspective this is a reasonable compromise. From a different standpoint we have Nath and Lipkin present to guarantee that any evidence of organic causation will meet stringent standards, while the presence of Walitt, Gill, etc. ensures that there will be ample consideration for plausible psychobabble.

The end result of such structures is endless controversy which never gets anywhere near resolution. This guarantees that the next Presidential administration and Congress will find a situation open to any change recommended from the top. The organization itself has not committed to any position, and will not until "the science is there". With this set up the science is unlikely to ever be there.

 

[Ecoclimber]

There is no need for FND control group. There is no need for a Lyme group. There is no need to place Wallit as lead clinical investigator when more qualified investigators are available. We are researching ME/CFS and do not need alternative and complentary investigators. They should expand the cohort so statistically they would have better success finding biomarkers which to me is a key purpose of this clinical trial.

There is no conspiracy. It's about conducting a clinical trial in the best interest of the ME/CFS patients to further advance research as to the cause of this illness. I've been told from sources who are quite knowledgeable, this clinical trial is not going to do it in the current construct

 

[duncan]

The FMD control group can be linked to individuals who psychologize illnesses.

The Lyme control group can be linked to individuals who seem to diminish or even demean the patient experience in some.

From a scientific perspective, neither control group makes any sense. Even the Lyme Team cannot guarantee their controls will be disease free. So why are they there?

Both control groups - and those who brought them - should be precluded from this effort.

 

[ukxmrv]

D) He is being used as the token psychosomatic expert (in the leadership group) to placate the BPS crowd, but deliberately not given enough power to stuff it all up.

I doubt he will have the final say or veto over patient selection. Certainly hope he doesn't.

That's what we keep getting told about the MRC and other groups in the UK. That there are token psych lobbyists in there. Yet coincidentally or not, they are still not producing the type of meaningful work that patients need and deserve.

It's either that "something" happens when the groups are mixed and a situation of stalemate occurs or the true powers are still in the hands of the psych lobby and they are there because this is the area that is still in command and has the blessing of the higher ups.

 

[BurnA]

I've been told from sources who are quite knowledgeable, this clinical trial is not going to do it in the current construct

Can you explain what you mean by this ?

 

[acer2000]

I don't agree that we should bargain with ourselves and accept a "token psychosomatic researcher" on the team. (If that is even what it is). Many of us have been sick for 10 years or more, some much longer. Some of us have given our lives to this disease. I know the NIH is a political organization on some level, but if from the get go they need to horse trade to get a team together it doesn't bode well for this study or us as a group. People faced with difficult problems work very hard to get the best team together to solve them. This doesn't appear to be whats going on here. And until we get more than a superficial explanation (like the one posted on #meaction) I don't think its inappropriate to be skeptical and voice concern.

 

[TiredSam]

Political considerations blah blah. Gaining the trust of participants and the wider ME community is also a political consideration, so if they must be political they can consider all the political factors.

Every workplace has political considerations, but that's a pretty poor excuse to offer for letting down the people they are supposed to serve.

 

[viggster]

But remember, you were downplaying the issue of Walitt since it was discovered

I don't think I did that, but I guess it's a matter of interpretation. I was pointing out that a) Walitt is not in charge of the study, as so many are now repeating; b) As the protocol is written now, Walitt would evaluate patients only after they were referred to NIH by clinical specialists.

I'm also on record in this thread saying he is not a good choice for the study & that I wish NIH had not hired the guy.

And yes, when people accuse Julie Rehmeyer of "not having backbone" for wanting to interview someone (anyone), that makes me angry. Julie is a dear friend who was a lifeline for me when I was at my worst. She's writing a book that could be a huge help for public understanding of our illness. Anyone who suspects Julie does not have the broad interests of the patient community close to her heart needs to read her Slate article about PACE.

 

[Ecoclimber]

http://solvecfs.org/NIH-Study?utm_c...al&utm_source=twitter.com&utm_campaign=buffer

The Solve ME/CFS Initiative held a phone call with Vicky Whittemore, Ph.D., of the National Institutes of Health yesterday regarding our concerns over staffing of the NIH’s new intramural study on ME/CFS.

Specifically, our organization is concerned about the appointment of Dr. Brian Walitt, who is the Lead Associate Investigator on the study under the leadership of Principal Investigator Dr. Avi Nath. As other advocates have reported, Dr. Walitt has made public comments regarding his belief that ME/CFS and fibromyalgia are psychosomatic. Dr. Whittemore was very receptive to our strong opposition to Dr. Walitt’s participation in the study, but said that she has no role in the study design or staffing; that rests with Dr. Nath.

Solve ME/CFS Initiative President Carol Head will continue to raise the concerns over Dr. Walitt when she meets with NIH officials in D.C. on March 8 along with fellow advocate Mary Dimmock.

 

[viggster]

does what's happened so far strike you as the work of people acting in good faith

The main thing I see is a new, understaffed program inside a giant bureaucracy making communications mistakes. I don't know why Walitt was chosen - I don't think anyone in the patient community does. If anyone has REAL information from inside NIH, it'd be great to hear it.

Also, many people in the community seem convinced that NIH had all along wanted to only use Reeves criteria. From what people at NIH have told me and other advocates, that is not the case. I guess if people want to believe in the worst, they'll believe that NIH had it out for us all along and no new information will counter that.

I'm frustrated because I see both sides making fundamental, big mistakes in communications and trust building
- NIH is not being open and transparent about their process for putting things together
- Some patient advocates are getting info from NIH and not sharing it; and some patients are assuming the worst

I wish NIH had incorporated patient input earlier in this process - that would have been a huge help. The people running this trial now say they want patient input, and I hope they are sincere and will listen carefully.

Yesterday I heard that NINDS Director Koroshetz is planning a call with patient representatives in the next week or two. That's a good step.

Also, yesterday someone was complaining that Collins did not respond to their email but he communicates with me and Bob & Courtney Miller because we're his 'favorites'. I guess here's what I'll say about that:

- NIH, Collins, NINDS, all of them need points of contact. I'm a point of contact because I used to work there, I knew Collins professionally, and his communications director was a mentor of mine. The Millers are a point of contact because they got President Obama to write Collins a letter asking about NIH's ME/CFS plans. Carol Head is a point of contact because she runs the largest NGO working on this illness.

In my first conversation with Collins on this stuff, he told me he reads every email he receives, and he said he had been moved by many of the stories he receives from people with ME. He's running a $30 billion agency, has 20,000 people who work for him, and spends much of his time (especially in Feb.) justifying his agency's existence and its budget to Congress. It's not possible for him to respond to every email he gets. To give you some perspective, I know people pretty high up at NIH who spend months and months and months trying to get 5 minutes of his time.

Brian

 

[Sasha]

That's all cheering - thanks, @viggster, for passing on your info. We're lucky that you're a point of contact and that you're passing the good stuff onto us here.

The study has its dodgy bits and all of that could have been headed off at the pass by better communication. But I have the impression that they're now learning fast and want to do better. I'm optimistic that all of this will get sorted out.

This study has such enormous potential. I've been re-reading the slides from Dr Nath's presentation and so much of it is just amazing. It wouldn't take many changes to turn it into our dream study.

 

[viggster]

Also, I'm feeling a little defensive because Hillary Johnson has decided to attack me on twitter (without engaging with me), and someone called me an NIH shill. Well, I wonder if a gobsmacked shill would have sent this to the NIH director. (This is most of my letter to him from Feb. 8):

Dear. Dr. Collins,

It has taken me longer than I had planned to get back to you, but I do appreciate the call from you last fall. Thank you for taking an interest in our illness and pushing for positive change at NIH.

However, I am growing concerned that the good will among patients generated by your announcement is slipping away. The NIH's responses to the latest recommendations from the CFS Advisory Committee disappointed many patients, including myself. Nearly every response was dismissive of CFSAC's earnestly thought-out recommendations. These responses have patients worried that positive change is not happening quickly enough.

Here are some ideas about how NIH can continue to build a bridge to the patient community.

- Patient involvement in NIH's research plans is vital. Appointing a patient representative - and possibly an organizational representative as well - to the Trans-NIH Working Group on ME/CFS would be a hugely positive step. [xxx and xxx] would make excellent patient advocates. They are both reasonable, forward-looking people with deep knowledge of ME/CFS research. Zaher Nahle of the Solve ME/CFS Initiative would be a good choice for an organizational representative. The ad hoc meetings Drs. Koroshetz and Whittemore have hosted recently are important, but I think it's much more important to formalize patient and advocate involvement.

- The NIH researchers involved in the new ME/CFS research effort could host an online Town Hall for patients, advocates, clinicians, and researchers. Such an event would show openness and a willingness to consider patient input.

- Patients are waiting to hear about dedicated funding for extramural researchers. The growing cohort of ME/CFS researchers in the US working on biomarkers, cellular and molecular pathology, and potential treatments desperately needs funding. An RFA or some other mechanism dedicating a pot of money would be a very positive step. The NIH response to the CFSAC recommendation of an RFA repeated an unfortunate line that I thought had been debunked: That there are few to zero "good quality" ME/CFS funding applications. With Congress boosting the NIH budget, and with the 10% HIV/AIDS set-aside expiring, now is the perfect time for a dedicated external ME/CFS budget.

- NIH could consider funding ME/CFS Centers of Excellence to bring together clinicians and researchers. There are enough experts in the US for two or three such centers, which have been instrumental in pushing ahead new treatments for other disorders.

- NIH researchers working on ME/CFS could invite outside experts in for a seminar series. I'm sure many of the researchers I've gotten to know would love to share their work with NIH colleagues. Such a seminar series would cost very little but could build a lot of goodwill. I could suggest a list of researchers to invite.

- The clinical protocol posted recently suggests the NIH will be using the outdated Reeves criteria to select patients. These criteria do not include the hallmark symptom of ME/CFS identified by the IOM - post-exertional malaise. Using Reeves criteria will draw in a heterogeneous group of patients, including some who have chronic fatigue - the symptom - but do not have post-exertional malaise and do not have ME. Patients are dismayed that the IOM's work in this area has been ignored. The P2P group by NIH convened also made this important distinction and suggested research criteria must include post-exertional malaise. The NIH team has missed an opportunity here to proactively communicate how and why they are designing the study this way. Channels of communication need to be more open.

Thanks for reading this note. I am happy to discuss any of this with you.

BV

 

[Sasha]

someone called me an NIH shill.

I'm sorry to hear that, Brian. It amazes me how people do this kind of thing to people who are doing their best for us.

Excellent letter!

 

[Aurator]

"Collins seems to think its okay to communicate with a few gobsmacked PWME in hopes they can tell a million pissed off PWME how to think."
That's raw emotions doing the talking; understandable in a way perhaps, but needlessly personal and hurtful.

Collins hasn't done anything yet for me to think ill of him - the reverse really - and I might be living in a bunker by now if I were him. But let's hope he understands with absolute clarity where all this hurt and anger is coming from. All patients want is to get better; that's all they've ever wanted, and they sorely don't want to see the NIH foul this one up. The ball is in your court, NIH.

 

[shannah]

I see Carol Head has raised the issue of Walitt with Vicky Whittemore at NIH.

"Dr. Whittemore was very receptive to our strong opposition to Dr. Walitt’s participation in the study, but said that she has no role in the study design or staffing; that rests with Dr. Nath."

"Solve ME/CFS Initiative President Carol Head will continue to raise the concerns over Dr. Walitt when she meets with NIH officials in D.C. on March 8 along with fellow advocate Mary Dimmock."

More at

http://solvecfs.org/NIH-Study