NIH awards total of $1.3m to Lipkin, Klimas, Hanson

Sasha

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@Gingergrrl in the #MEAction article there is a link to a letter from Ron Davis regarding information and reasons they gave and his responses. I'm not sure if you missed it that. Seems to me that it was all about the fact that they wanted this to cost 500,000 only.

But the Lipkin grant was for $766,000 so the reason they gave wasn't consistent with what they were doing even for other ME projects, let alone other medical projects.
 

aimossy

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That was from a different dept of funding though @Sasha It isn't cohesive front end doesn't know what back end is doing it seems. Different dept - different funding 'supposed' remit. I was referring though only to the info from Davis letter.
 

Scarecrow

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Sorry if I missed the explanation (if there is one?) but how & why were these three studies approved but Ron Davis and OMF's study denied?
But the Lipkin grant was for $766,000 so the reason they gave wasn't consistent with what they were doing even for other ME projects, let alone other medical projects.
That was from a different dept of funding though @Sasha It isn't cohesive front end doesn't know what back end is doing it seems. Different dept - different funding 'supposed' remit. I was referring though only to the info from Davis letter.
Yes it was a different department and the other, crucial difference is that Ron Davis's first request was for $5M (in annual awards of $1M over 5 years ). In a historical context, that's a LOT! of money for a study of ME.
 

Scarecrow

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@leokitten As you're 'our man at the NIH' I thought you would have the best chance of knowing the answer to my question.

The Award Notice Date to Hornig and Lipkin was August 14th. How long could a decision in principal have been in the pipeline? I'm thinking about timing with regard to @viggster's open letter to Francis Collins. Is that pure coincidence or could he have influenced the decision?

Within the last few months I vaguely remember either Lipkin or, more likely, Hornig (at the reddit Q&A, maybe) stating that NIH funds had been secured for ME but with no further information.
 

leokitten

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@leokitten As you're 'our man at the NIH' I thought you would have the best chance of knowing the answer to my question.

The Award Notice Date to Hornig and Lipkin was August 14th. How long could a decision in principal have been in the pipeline? I'm thinking about timing with regard to @viggster's open letter to Francis Collins. Is that pure coincidence or could he have influenced the decision?

A grant awarded in August underwent second-level review and advisory Council final decision usually two months prior back in May. Here's a good explanation:

http://www.niaid.nih.gov/researchfunding/grant/strategy/pages/5time.aspx
 

Scarecrow

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Well that's interesting. Thanks @leokitten

Lipkin already got knocked back twice for funding for ME/CFS as he described in this interview by Mindy Kitei (CFS Central) and I think we've all presumed that this was for the gut microbiome study. Does anyone know if that was ever conclusively confirmed?

In the pages that leokitten linked, it states that only one resubmission is allowed. I wonder if a special case was made for this award.
 

jimells

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The Award Notice Date to Hornig and Lipkin was August 14th.

The CFSAC meeting on Aug 18 would have been a perfect time for NIH to make a big announcement about the grant and puff themselves up a bit. Instead they used their platform to insult the researchers.

What the hell is going on here? Is it possible they are so incompetent that their own CFSAC rep doesn't know about a major grant for the very illness she is supposed to be working on?

Or is there some huge conflict going on behind the scenes between the researchers and NIH?
 

Sasha

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The CFSAC meeting on Aug 18 would have been a perfect time for NIH to make a big announcement about the grant and puff themselves up a bit. Instead they used their platform to insult the researchers.

What the hell is going on here?

You're absolutely right that that situation is weird as heck.
 

waiting

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Well that's interesting. Thanks @leokitten

Lipkin already got knocked back twice for funding for ME/CFS as he described in this interview by Mindy Kitei (CFS Central) and I think we've all presumed that this was for the gut microbiome study. Does anyone know if that was ever conclusively confirmed?

In the pages that leokitten linked, it states that only one resubmission is allowed. I wonder if a special case was made for this award.

I seem to recall some NIH (?) person at the CFSAC encoraging researchers to re-submit grant applications that had been denied -- & to re-submit -- repeatedly, not just once. Wonder if that was a different department.

(Not to mention that continually re-submitting seems like a colossally inefficient way to do things.)
 

FancyMyBlood

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Yes it was a different department and the other, crucial difference is that Ron Davis's first request was for $5M (in annual awards of $1M over 5 years ). In a historical context, that's a LOT! of money for a study of ME.

Interesting observation. I read Davis' letter yesterday and I believe he stated he didn't apply to NIAID because they don't fund ME/CFS research. Yet at the same they did fund Lipkin's research.

Would it be as easy as just reapply the grant proposal to NIAID? Wishful thinking, I know.

Edit: Here's the NIAID part of David's response to the NIH:

NIH: “I am writing to inform you that the NINDS Extramural Science Committee did not approve your request to submit an R01 application with a budget over $500,000 to NINDS. The Committee was concerned that the grant does not fall in the NINDS mission since it will measure markers and biomarkers in the peripheral blood from individuals with ME/CFS and there are no neurological outcomes in the grant. They also suggested that the application is more appropriate for NIAID, so I suggest you contact Program staff at NIAID to discuss whether or not the application is appropriate for their Institute.”

Response: I believe they don’t want to fund either grant and are pushing us to another Institute even though NIAID has publicly stated they will not support research on ME/CFS/SEID. The IOM report has made it clear that there are cognitive issues with this disease. The fact that many of our severe patients cannot talk, listen to spoken words or read should indicate neurological involvement possibly similar to stroke, which they clearly support. Furthermore, there is considerable research looking for blood biomarkers for stroke patients. I am mystified why if they support stroke and other neurological diseases, they refuse to support ME/CFS/SEID research. The IOM and P2P reports both state the urgent need for research support. This research proposal addresses many of the critical needs specified in these reports. This should be viewed as an opportunity for NIH to show leadership and quickly initiate research activity.
 

leokitten

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Well that's interesting. Thanks @leokitten

Lipkin already got knocked back twice for funding for ME/CFS as he described in this interview by Mindy Kitei (CFS Central) and I think we've all presumed that this was for the gut microbiome study. Does anyone know if that was ever conclusively confirmed?

In the pages that leokitten linked, it states that only one resubmission is allowed. I wonder if a special case was made for this award.

When looking again at RePORTER http://projectreporter.nih.gov/project_info_details.cfm?aid=9102389&icde=25862560

I realize that Lipkin's project was funded as an R56, so this could be the reason. See more info here http://grants.nih.gov/grants/funding/r56.htm
 

Scarecrow

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leokitten

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Well spotted. I'd never have realised the significance. So the grant code is hidden in the project number. It took me a while to see it.

Hmmmm.

Highlighting from http://grants.nih.gov/grants/funding/r56.htm:
The High Priority, Short-Term Project Award, R56 grant will fund, for one or two years, high-priority new or competing renewal R01 applications with priority scores or percentiles that fall just outside the funding limits of participating NIH Institutes and Centers (IC).

The R56 Award will provide limited, interim research support based on the merit of the pending application. This support is designed to enable the Principal Investigator to gather additional data for revision of the current application. R56 funding will end after one or two years or when the applicant succeeds in obtaining a traditional research project grant.

These one- to two-year awards will underwrite highly meritorious applications and will be funded at levels set by the IC, which can range up to levels recommended by the initial review group and approved by Council.

The R56 award will help early career stage scientists trying to establish research careers as well as experienced scientists who can benefit from interim funding while they revise their applications.

Meaning that Lipkin's R01 grant application did not receive a high enough ranking to be fundable but the NIH decided that it was high-priority enough to give it interim funding for one year so that he can gather additional data to revise his R01 application.
 

Scarecrow

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Highlighting from http://grants.nih.gov/grants/funding/r56.htm:


Meaning that Lipkin's R01 grant application did not receive a high enough ranking to be fundable but the NIH decided that it was high-priority enough to give it interim funding for one year so that he can gather additional data to revise his R01 application.

http://www.cfscentral.com/2014/05/candid-conversation-with-dr-ian-lipkin.html
Ian Lipkin said:
I have been in competition now twice to get funded, and the people there who reviewed me gave me abysmal scores. And the critiques of my work were unfair, and one of the people who critiqued my work said, in fact, that this is a psychosomatic illness. I was floored. I protested, and for reasons that are obscure to me this same individual wound up back on the study section, and I got a similar unfundable score. Am I upset about this? Absolutely.
I'd hazard a guess that if he's required to submit another R01, it will be for appearances.
 

leokitten

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Scarecrow

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Hopefully after getting $733,000 from NIAID he will have some interesting results in a year so that when he resubmits for an R01 to continue he will have more data to stand on as this will help focus on particular hypotheses and push up his review scores.
This is why I find the situation so weird although I'm sure that there is something I'm not understanding. I'm trying to make sense of a system that I'm unfamiliar with on limited facts.

The combined total of the crowdfund (including that recent $0.5M donation) and the NIAID grant is approximately $1.5M.

I seem to recall that the original goal was $1.27M for the full study. So it's hard to see how the $733,000 R56 grant can be considered interim since it should allow the study to be completed. Of course, the results of the study may well lead to further work but this would surely involve an entirely new request.
 
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