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Freedom of Information Act Reveals Breakdowns in Federal Government's Research Program For Chronic Fatigue Syndrome (ME/CFS) by Cort Johnson

CFS SPECIFIC GRANTS SUBMITTED TO THE NIH 2003-2007 (FOIA) (March 2008)


Background
  This document charts the fate of CFS specific grants to the CFS SEP and the Neuroimmune RFA Review Panels from 2003-2007. The very low numbers of awarded grants of the past six years suggested that success rates of CFS grant proposals were either very low or very few researchers were applying for grants or both. This FOIA was submitted in an attempt to figure where the roadblocks in the CFS grant funding process at the NIH are.

First Time Grant Success Rate:
A primary reason of the FOIA was to determine the success rate of ‘first-time’ CFS grant applications. NIH officials have stated that the CFS grant success rates are similar to those found NIH-wide but its been unclear whether they were lumping in CFS grants with FM and other grants or if they were including ‘continuation grants’; i.e. already approved grants whose funding need at some point to be renewed by the panel in their statistics. Both of those would likely increase the grant success rate. This FOIA specified that only CFS-specific grants be included.

(*Unfortunately since the NIH refused to provide titles, authors, etc. of the rejected grants it’s impossible to tell how many of those were first-time grants and how many were rejected renewals. Several factors argue against having many rejected renewals; renewal grant acceptance rates are generally much higher than first time grant success rates and the low numbers of active grants suggests few renewal grants would be present. I assume that all of the rejected grants are first-time grants. An appeal of the NIH’s decision not to provide author's names/grant titles is underway).

FINDINGS 

A Very Low Reward Rate - Based on the supposition that all the rejected grants were first time applications the first-time grant success rate for CFS researchers was 8/57=14%. Even with the special grant package of 2006 (RFA) the NIH managed to fund on average just over I new study a year on CFS with eight studies funded from 2003-2007.

Difficulty Getting Past the CFS SEP Review Panel - The biggest single roadblock for CFS researchers was getting past the initial review panel. Of the 57 new CFS grant application over half (29) were stopped at the review panel stage for various reasons (triage reviewed non-competitive/application withdrawn (see below)).

High rates of 'triage reviewed non-competitive grants   – the most common fate of a CFS research grant application (@30%) was to be ‘triage reviewed non-competitive'. These are grants that the review panel unanimously agreed fell into the bottom fifty percent in terms of quality. They are given comments but not a full review and are returned to the applicant unscored.

CFS advocates have repeatedly raised the specter of review panels populated with few researchers with CFS expertise rejecting high percentages of CFS grants. A recent grant application by Andrew Lloyd provides a case in point. The score given Dr. Lloyd’s application before an RFA review panel with at least some CFS expertise reportedly just missed the cutoff point. After Dr. Lloyd reconstituted his application to incorporate the RFA reviewers suggestions it was judged ‘non-competitive’ by a subsequent CFS SEP review panel and was returned unscored.

High Rejection Rates at the Institute Level – the last stage of the review process, the final review before an Institute panel, was even more difficult. Since CFS is multi-systemic in nature its grants end up before a variety of Institute review boards. The data in this FOIA indicates that over the past five years 28 new CFS grants (ICD Withdrawn/Pending Award/Awarded (see below)) appeared before different Institute Review Panels. A CFS grant application had about a 25% of getting funded at this stage; the Institutes funded 28%, rejected 46% and placed 26% in an unfunded holding category (Pending Award).

RFA Acceptance Rates vs. PA Acceptance Rates. Greatly reduced acceptance rates for Program Announcement initiated grant proposals (8%) indicates that CFS researchers have only a small chance of getting their grants funded under the dominant funding mechanism they encounter at the NIH. RFA initiated grant proposals, on the other hand, had a 31% chance of getting funded.

Program announcements (PA's) are statements the NIH publishes that indicate which subjects they are interested in funding. No funds are specifically set aside to fund them, however. RFA's (Requests for Applications) are similar to PA's except that a specific amount of money is set aside to fund them. RFA's are much more attractive to researchers than PA's.

Seventy-five percent of PA grants were halted at the review panel (Non-competitive -9, Withdrawn for Amendment – 12); fifty percent of RFA grants were.

While ‘withdrawn for amendment’ was a common fate (@30%) of a grant initiated through a program announcement (PA), none of the neuro-immune grant applications were ‘withdrawn for amendment’.

PA initiated grants also far lower acceptance rates at the last step in the grant acceptance process; the Institute Review. While all five of the RFA grants that made it to the final review were funded (100% success rate) a PA grant had less than 1 chance in four of being funded (23%).

The differing outcomes for RFA vs. PA grant applications indicate the Institutes are unlikely to fund CFS research grants if they have not specifically committed funds to do so ahead of time. It implies that under ‘business as usual’ conditions CFS grants get lost in the competitive grant review process and suggests that special circumstances (e.g. RFA’s) are needed to get the Institutes to ‘concentrate’ their focus on CFS. It also indicates that if the NIH is committed to building a viable CFS research program it needs to institute programs with dedicated funding such as RFA’s, Research Centers or Centers of Excellence.

The Missing Neuro-immune RFA Grants? – Dr. Hanna reported the NIH was pleased with the response of the researcher community to the one funded grant effort for CFS the NIH has produced over the past five years – the Neuroimmune RFA of 2006. At one point relatively early in the process Dr. Hanna reported that 29 applications had been received. But the FOIA only lists 16 applications (code (0D06-002) eight of which were rejected immediately (‘non-competitive’), three of which were ‘pending award’ and have not been funded, and five which were funded. Sixteen grant applications is about half the total expected.

It’s known that early in the process Dr. Hoffeld returned grants he felt did not fit the subject matter of the grant. This raises the question whether Dr. Hoffeld rejected almost half the grants submitted to the RFA panel before they made it to the first review?

Conclusions. CFS researchers have little chance of getting their grants funded under the dominant funding mechanism used in the CFS program at the NIH – the program announcement. According the FOIA from 2003 through the first part of 2007 the NIH funded only eight new grants on CFS. These are remarkable figures for a disease the Department of Health and Human Services own studies shows afflicts approximately a million Americans, causes high rates of disability and costs the economy tens of billions of dollars a year.

Summary Table

Grant Status

 

Number

Triage Reviewed – Judged Non-Competitive

 

17

Administratively Withdrawn by Institute or Center Director

 

13

Applications Withdrawn For Amendment

 

12

Pending Award ($0 Funded)

 

7

Funded Grants (First time) Awarded

 

8

Continuation/’Enlargement’ Grants Awarded

 

9

To Be Paid

 

4

Total Grant Reviews By CFS SEP

70

*Grey = not-funded / Green = funded

 

Grant Status Explanation

Triage Reviewed Non-Competitive (17) – These grants are given comments but not a full review and are returned to the applicant unscored.

Administratively Withdrawn by the Institute or Center Director (13) – these grants made it through the review process and to a final review by the Institutes where they were rejected.

Applications Withdrawn for Amendment (12) – These applications were withdrawn for amendment by the applicants. 

Continuation/ ‘Enlargement’ Grants (9) – These are already awarded grants which came up for review again and were rewarded again. In one case a small (R21) grant was turned into a large (RO1) grant.

Funded Grants (8) – As opposed to continuation grants these are new first time applications which were rewarded.

Pending Award ($0 Funded) – These are grants which may or may not receive funding in the future but which have received no funding.

To Be Paid (4) – These are grants whose funds have been awarded but had not yet been disbursed. Most appear to be continuing funding for first time grants originating in the Neuroimmune RFA; they are not new grants.  

_________________________________________________________________

 APPENDIX:  FOIA DATA

NON-FUNDED GRANTS

Triage Reviewed – Judged Non-Competitive (17)

Grant

Title

Investigator

PA/RFA

Year

Award

Grant Status

X

X

X

PA02-034

2003

$0

Non-Competitive

X

X

X

PA02-034

2003

$0

Non-Competitive

X

X

X

PA02-034

2005

$0

Non-Competitive

X

X

X

PA02-034

2005

$0

Non-Competitive

X

X

X

PA02-034

2005

$0

Non-Competitive

X

X

X

PA05--03

2006

$0

Non-Competitive

X

X

X

OD06-002

2006

$0

Non-Competitive

X

X

X

OD06-002

2006

$0

Non-Competitive

X

X

X

OD06-002

2006

$0

Non-Competitive

X

X

X

OD06-002

2006

$0

Non-Competitive

X

X

X

OD06-002

2006

$0

Non-Competitive

X

X

X

OD06-002

2006

$0

Non-Competitive

X

X

X

OD06-002

2006

$0

Non-Competitive

X

X

X

OD06-002

2006

$0

Non-Competitive

X

X

X

PA05--03

2006

$0

Non-Competitive

X

X

X

PA05--03

2006

$0

Non-Competitive

X

X

X

PA05--03

2007

$0

Non-Competitive

Administratively Withdrawn by Institute or Center Director (Made it to the Final Review – Rejected) (13)

Grant

Title

Investigator

PA/RFA

FY

Award

Grant Status

X

X

X

PA 02-034

2003

$0

Administratively Withdrawn by ICD

X

X

X

PA 02-034

2003

$0

Administratively Withdrawn by ICD

X

X

X

PA 02-034

2004

$0

Administratively Withdrawn by ICD

X

X

X

PA 02-034

2004

$0

Administratively Withdrawn by ICD

X

X

X

PA 02-034

2004

$0

Administratively Withdrawn by ICD

X

X

X

PA 02-034

2004

$0

Administratively Withdrawn by ICD

X

X

X

PA 02-034

2004

$0

Administratively Withdrawn by ICD

X

X

X

PA 02-034

2004

$0

Administratively Withdrawn by ICD

X

X

X

PA 02-034

2004

$0

Administratively Withdrawn by ICD

X

X

X

PA 02-034

2005

$0

Administratively Withdrawn by ICD

X

X

X

PA 05-030

2006

$0

Administratively Withdrawn by ICD

X

X

X

PA 05-030

2006

$0

Administratively Withdrawn by ICD

X

X

X

PA 05-030

2006

$0

 

 

 

 

 

 

 

Applications Withdrawn For Amendment by Applicant (12)

Grant

Title

Investigator

PA/RFA

FY

Award

Grant Status

X

X

X

PA 02-034

2003

$0

Application Withdrawn For Amendment

X

X

X

PA 02-034

2004

$0

Application Withdrawn For Amendment

X

X

X

PA 02-034

2005

$0

Application Withdrawn For Amendment

X

X

X

PA 02-034

2005

$0

Application Withdrawn For Amendment

X

X

X

PA 02-034

2005

$0

Application Withdrawn For Amendment

X

X

X

PA 02-034

2005

$0

Application Withdrawn For Amendment

X

X

X

PA 02-034

2006

$0

Application Withdrawn For Amendment

X

X

X

PA 05-030

2006

$0