Dr. Collins wants to mend fences - my call with him

[Bob]

Director of NINDS writes to ‪#‎ME‬‪#‎CFS‬ Patient about Commitment to Research, Acknowledgement of Serious Disease

So today, only two days from Thanksgiving, I am profoundly grateful for the amazing letter on ME/CFS that I just received from the Director of NIH's National Institute of Neurological Disorders and Stroke, which was copied to Senator John McCain.

https://www.facebook.com/kathryn.stephens.9/posts/1069259323098776

 

[Jennifer J]

@Bob, thank you for posting the above. It was exciting to read the letter. Tears of relief and I'm so hopeful. This sounds very promising.

I had a question about the second to last paragraph of the letter regarding funding. I wasn't sure how that works and if it was true. I went to the facebook link and below is what she wrote.

(I don't know how to make the below highlighted pink. It's from https://www.facebook.com/kathryn.stephens.9/posts/1069259323098776.)

It is incredibly reassuring to receive such an unequivocal statement on ME/CFS from such a high-level US Government leader, policymaker, and doctor. However, having worked in US Government planning and budgeting for over a decade, I do have questions about funding. The letter asserts that NIH lacks a set research budget for any specific disorder, not just ME/CFS. Although technically this may be true, NIH does have a set budget for each of its Centers and Institutes, including its Cancer Institute, Institute of Diabetes & Digestive & Kidney Diseases, etc. As these Centers and Institutes have their own agendas and funding needs, it would be instructive to learn: a) from where specifically the ME/CFS Research Working Group will access funding for grant proposals, and b) what mechanisms are in place to facilitate this allocation.

I'd also like to clarify that depression is not an innate symptom of ME/CFS. Rather, depression is sometimes -- but by no means always, or even usually(?) -- a secondary result of the intense and sudden onset of disability, isolation, and suffering caused by ME/CFS. The fact that depression is absent in so many patients, who persevere with hope and positivity despite enormous personal hardship and anguish, proves over and over again every day that psychological causes and treatments have no place in talks of ME/CFS pathology.

The ME/CFS community has come so far and has so much hope now for the future of this disease. However, we can't succeed without research funding. I plan to follow up on this letter with Dr. Koroshetz, Senator McCain, and my other Congressional representatives, shortly after the holiday. If you'd like me to send a letter to your Congressional representatives too, please let me know. Every effort helps, and I'd be thrilled to have your support.

 

[medfeb]

I'd add to Jennifer's comments...

As Jennifer says, NIH claims that it lacks a set aside budget for each disease but it does have funding allocated to each institute. Additionally, the funding for a given disease is fairly stable from one year to a next implying that its more than just an issue of what requests come in. Finally, NIH's strategic planning practice and NIH's current portfolio analysis process start with the institutes. So how is this disease positioned in both the funding allocation and strategic planning processes? The comment about steps being taken "that we hope will increase funding" is not encouraging.

Another concern is with his comment that the Trans-NIH group will be discussing and reviewing the IOM criteria. The IOM criteria are clinical criteria and not appropriate for research for a number of reasons. On the other hand, he does not mention the P2P's recommendation to hold a meeting of stakeholders to reach consensus on the research case definition.

Also missing - unless I missed it - is any commitment to RFAs. The usual mechanisms that have been used for this disease by NIH have failed to generate much researcher interest. CFSAC and congressional leaders have repeatedly requested RFAs for this reason but NIH has to date refused to grant them.

Finally, the discussion seems fairly internal. Where is the collaboration with the research community. Essential

 

[Anne]

Additionally, the funding for a given disease is fairly stable from one year to a next implying that its more than just an issue of what requests come in.

Exactly! I've been thinking this too - it doesn't make sense that the NIH each year project the same meagre $5 or 6 million for ME/CFS, and then it just happens to be that the incoming meritorious applications (meritorious enought to be funded) add up to that exact amount year after year - with no change when heavy-weights as Ian Lipkin and Ron Davis start sending in applications.

Clearly NIH policy in one way or another is behind the fact that we're stuck at $5 million.

How I wish they would issue an RFA!

@medfeb @viggster

 

[Bob]

This interview with Collins took place a while ago but I didn't know there was a video available.
Collins talks about CFS towards the end.
My video confusingly counts backwards, and the segment about CFS starts towards the end at 7.15.
If your video counts forwards then it's probably at about 16.00...
http://www.charlierose.com/watch/60643999

 

[jimells]

Oh, and it's absolutely necessary to stroke Fauci (or, as ACT-UP did, scare him) because he controls 70% of the world's research dollars through Collins.

A few days ago I watched "How to Survive a Plague" on the local PBS station. I was only mildly surprised to see good ole Dr Fauci at the center of the attention of the Act Up people. It sure is disheartening to see that the NIH has apparently learned little from the AIDS debacle, and that the very same people are still in charge. Whatever happened to "Retire at 50"?

 

[jimells]

The comment about steps being taken "that we hope will increase funding" is not encouraging.

That definitely caught my attention as well.

Also missing - unless I missed it - is any commitment to RFAs.

Yes, I mean, there is no mention of RFAs or PAs or the intent to issue any. Or how about even one Cooperative Research Center? There used to be - count 'em - three. Now there are zero - they were unceremoniously dumped in late 2003.

The letter's discussion of funding issues is disingenuous. It smells like CYA. Without a real commitment to funding it is all hand-waving and hot air, but it is presented so smoothly that one can easily read into it what one hopes to see. And who doesn't hope to see a real commitment to research?

The discussion about investigators is hardly different from the party line of the last few decades, which has been to blame the lack of research (and funding) on a lack of qualified applications and a lack of interest from researchers.

On the other hand the letter does highlight what bureaucracies do best - hold meetings and issue reports.

 

[Groggy Doggy]

A few days ago I watched "How to Survive a Plague" on the local PBS station. I was only mildly surprised to see good ole Dr Fauci at the center of the attention of the Act Up people. It sure is disheartening to see that the NIH has apparently learned little from the AIDS debacle, and that the very same people are still in charge. Whatever happened to "Retire at 50"?

Darn I missed that show on PBS; I really wanted to see it. Tommorrow on PBS is, "super genes with dr rudy tanzi" and 'brain maker with david permutter, md". the first is about "the future of genetics through self-directed biological transformation, sharing a mix of compelling stories as well as the lastest scientific research and actionable wisdom from a leading genetic researcher and author". the next is "new research has discovered a link between intestinal microbes and the brain, making it possible to navigate future mental health through gut ecology"

 

[Sean]

Hard to make a judgement about how serious they are until we see the money.

 

[Roy S]

http://cfstreatment.blogspot.com/2015/12/our-two-minutes-of-fame-collins-talks.html

This is a transcript of the relevant part of the Charlie Rose interview.

 

[duncan]

Why did he feel a need to justify looking at ME/CFS by being able to apply fatigue findings to cancer or some other disease?

(Please notice I refrained from complaining how he basically reduced ME/CFS to fatigue. Or made strangely minimizing observations like, "Sleep is not as refreshing as it should be"(???) Or, better still, when getting specific about other symptomology beyond fatigue: "You have other things," and "It's serious stuff." )

Perhaps my fav: "Why do people on chemotherapy get fatigue...Wouldn't it be nice to have that answered?"

 

[BurnA]

Why did he feel a need to justify looking at ME/CFS by being able to apply fatigue findings to cancer or some other disease?

(Please notice I refrained from complaining how he basically reduced ME/CFS to fatigue. Or made strangely minimizing observations like, "Sleep is not as refreshing as it should be"(???) Or, better still, when getting specific about other symptomology beyond fatigue: "You have other things," and "It's serious stuff." )

Perhaps my fav: "Why do people on chemotherapy get fatigue...Wouldn't it be nice to have that answered?"

Yeah that was odd, I mean it's as if it's a study into fatigue and that it might have widespread applications.

Strange reference to chemo, how about wouldn't it be nice for all the cfs/me patients to have a normal life and return to work ?

 

[SOC]

Why did he feel a need to justify looking at ME/CFS by being able to apply fatigue findings to cancer or some other disease?

My best guess is that this is how they are hoping to get funds for us... by saying that the research into ME/CFS will benefit a broader population. They might be able to snag some money from highly-funded programs like cancer if they can claim the research is for them as well. Collins is probably laying the groundwork for his arguments to the money people who have preconceived notions about the lack of importance of ME/CFS. "If we learn valuable information about fatigue by focussing on this specifically fatigued population, we can apply it to more complex and important conditions like cancer. Wouldn't that be valuable?"

Dr Klimas gets some of her ME/CFS research done by using PWME as patient controls (or somesuch) in GWS research, which can get funded when ME/CFS research cannot.

That sad truth is that even if Collins believes us, the vast majority of people don't. Among that vast majority are those who are going to be making decisions about our funding. He has to sell to the audience he has right now. We don't have time for him to spend 5 years convincing everybody ME is a serious, debilitating illness before he can drag money out of them.

 

[BurnA]

My best guess is that this is how they are hoping to get funds for us... by saying that the research into ME/CFS will benefit a broader population. They might be able to snag some money from highly-funded programs like cancer if they can claim the research is for them as well. Collins is probably laying the groundwork for his arguments to the money people who have preconceived notions about the lack of importance of ME/CFS. "If we learn valuable information about fatigue by focussing on this specifically fatigued population, we can apply it to more complex and important conditions like cancer. Wouldn't that be valuable?"

Dr Klimas gets some of her ME/CFS research done by using PWME as patient controls (or somesuch) in GWS research, which can get funded when ME/CFS research cannot.

That sad truth is that even if Collins believes us, the vast majority of people don't. Among that vast majority are those who are going to be making decisions about our funding. He has to sell to the audience he has right now. We don't have time for him to spend 5 years convincing everybody ME is a serious, debilitating illness before he can drag money out of them.

I don't buy it. Others may need to think of ways around funding for ME/cfs but Collins should be telling it like it is. It's a real disease and it needs real funding.
No excuses required.

 

[SOC]

I don't buy it. Others may need to think of ways around funding for ME/cfs but Collins should be telling it like it is. It's a real disease and it needs real funding.
No excuses required.

I agree that our vast needs should be judged on their own merits. We should get more funding because we need and deserve more funding. This is what is fair and morally sound.

But this is politics, not logic or science or even common sense. It's about playing the game. It makes me sick, quite frankly. I don't understand it. I don't agree with it. I, personally, can't work with it. But I have to acknowledge that it exists. You don't win if you don't play the game, no matter how stupid and irrational the game is.

 

[BurnA]

NIH drops special 10% set-aside for AIDS research

Not sure if this was discussed anywhere else but could this be positive for me/cfs ?

"The changes follow growing pressure in Congress and from some advocacy groups for NIH to reallocate its funding based on the public health burden a disease causes. In recent years, HIV/AIDS has been imposing a lower burden as death rates have dropped and treatments have improved."

 

[Never Give Up]

"Last year, Congress omitted instructions asking NIH to maintain the 10% AIDS set aside. NIH Director Francis Collins agrees: At a meeting of his Advisory Committee to the Director (ACD) today, he noted that no other disease receives a set proportion of the NIH budget and the argument that AIDS still deserves such a set-aside is “not a defensible one.”

"The reshuffling is “necessary” if “difficult” and “painful,” said virologist Ian Lipkin of Columbia University."

 

[Simon]

Simon - I think there will be opportunities for patients and advocates to have input in how the research at NIH is conducted. Already, Carol Head and Zaher Nahle of the Solve ME/CFS Initiative have met with the team at NIH that is organizing the intramural study. At some point (I don't know when), the NIH will begin recruiting patients for the study in Bethesda. I am sure Carol and Zaher will be informed of all this and I am working with others to make sure information gets to the community. It's all about building bridges and open channels of communication.

Hi Brian

Don't know if you have any insight on what might have gone with the intramural study, given the inappropriate use of the Reeves Empiric criteria, which is unlikely too have survived any patient scrutiny. (more on this)

Let me say I'm all for making this relationship work, and I appreciate Dr Collins's and the NIH's earlier pronouncements, but I am troubled by some recent developments.

Thanks

 

[jimells]

Why did he feel a need to justify looking at ME/CFS by being able to apply fatigue findings to cancer or some other disease?

Gee, now we know the answer - they are *still* not interested in researching our illness.

 

[Kati]

Hi Simon - I'm not privy to all of the details, but here's what I've gleaned. Vicky Whittemore seems to 'get it' - she understands the difference between chronic fatigue the symptom and ME/CFS the illness. But her boss, NINDS director Koroshetz, apparently does not get it. Now, I'm getting this second-hand so I can't 100% vouch for it. Various advocates have over the past few months had meetings with those two and have pushed for, a) a formalized role for patients and advocates in NIH research planning, and b) CCC criteria for the NIH clinical study. Neither suggestion has been acted on by the NIH team. Yesterday I sent a note to Dr. Collins explaining that things are not going well and NIH has a lot of work to do to get the patient community on board with what they're doing.

That said, yesterday Julie Rehmeyer heard from an NIH press officer that the clinical study protocol was mistakenly posted early. I hope this means there is still room for the NIH team to do a better job of listening to us. If they end up sticking with the protocol that was posted (it was not "announced" by NIH as some suggested...no one at NIH alerted anyone to it), I don't think it will be the total disaster some fear. If they do the 2-day exercise test properly, the study will find two groups of people - a group with PEM and a group without PEM. We already these two groups exist, so the NIH is kind of reinventing the wheel.

Several people are talking with the NIH team this week and expressing some of these sentiments. I hope they listen.

Brian

This morning @nindsnews published a 'storify' gathering of tweets regarding the study. Not many tweeted to them but it is an opportunity to get heard, on top of advocate who are able to reach out directly to key people.
https://storify.com/NINDSnews/chron...ign=website&utm_source=email&utm_medium=email