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non-competitive/application withdrawn (see below)).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
|
Application
Withdrawn For Amendment
|
|
X
|
X
|
X
|
PA 02-034
|
2006
|
$0
|
Application
Withdrawn For Amendment
|
|
X
|
X
|
X
|
PA 05-030
|
2006
|
$0
|
Application
Withdrawn For Amendment
|
|
X
|
X
|
X
|
PA 05-030
|
2007
|
$0
|
Application
Withdrawn For Amendment
|
|
X
|
X
|
X
|
PA 05-030
|
2007
|
$0
|
Application
Withdrawn For Amendment
|
Pending Award - $0 Funded (7)
|
Grant
|
Title
|
Investigator
|
PA/RFA
|
Year
|
Award
|
Grant Status
|
|
X
|
X
|
X
|
PA02-034
|
2006
|
$0
|
Pending Award
|
|
X
|
X
|
X
|
OD06-002
|
2006
|
$0
|
Pending Award
|
|
X
|
X
|
X
|
OD06-002
|
2006
|
$0
|
Pending Award
|
|
X
|
X
|
X
|
PA 05-030
|
2006
|
$0
|
Pending Award
|
|
X
|
X
|
X
|
PA 05-030
|
2006
|
$0
|
Pending Award
|
|
X
|
X
|
X
|
OD06-002
|
2007
|
$0
|
Pending Award
|
|
X
|
X
|
X
|
PA 05-030
|
2007
|
$0
|
Pending Award
|
FUNDED GRANTS
First Time Grants Awarded (8)
|
Grant
|
Title
|
Investigator
|
PA/RFA
|
Year
|
Award
|
Grant Status
|
|
I RO1
HDO43301-01A1
|
CF in Adolescents
|
Taylor
|
PA02-034
|
2003
|
509,257
|
Awarded
|
|
1 R21 AI054478-01
|
Sleep/Cytokines
|
Natelson
|
PA02-034
|
2003
|
629,309
|
Awarded
|
|
1 RO1
ES0115382-01
|
Proteomics CSF
|
Baraniuk
|
OD06-002
|
2006
|
379,720
|
Awarded
|
|
1 RO1 NS055670-01
|
ANS in
CFS
|
Biaggioni
|
OD06-002
|
2006
|
385,500
|
Awarded
|
|
1 RO1 NS055672-01
|
CBT and
CFS
|
Antoni
|
OD06-002
|
2006
|
342,219
|
Awarded
|
|
1 R21 AA16636-01
|
Neuropeptide Y
|
Fletcher
|
OD06-002
|
2006
|
200,321
|
Awarded
|
|
1 R21 AA167-1-01
|
Mast Cells
|
Theoharides
|
OD06-002
|
2006
|
275,906
|
Awarded
|
|
1 R01
A10565723-01A2
|
Biomarkers
|
Fletcher
|
PA02-034
|
2007
|
381,875
|
Awarded
|
Continuation/’Enlargement’ Grants Awarded (9)
|
Grant
|
Title
|
Investigator
|
PA/RFA
|
Year
|
Award
|
Grant Status
|
|
2 RO1 A1054478-02
|
Sleep/Cytokines
|
Natelson
|
PA02-034
|
2004
|
334,904
|
Awarded
|
|
5 R01 HD043301-02
|
CF in Adolescents
|
Taylor
|
PA02-034
|
2004
|
567,009
|
Awarded
|
|
5 R01 A1054478-04
|
Sleep/Cytokines
|
Natelson
|
PA02-034
|
2005
|
643,207
|
Awarded
|
|
5 R01 HD043301-03
|
CF in Adolescents
|
Taylor
|
PA02-034
|
2005
|
568,159
|
Awarded
|
|
5 R01 A1054478-04
|
CF in Adolescents
|
Taylor
|
PA02-034
|
2006
|
627,427
|
Awarded
|
|
5 R01 HD043301-04
|
Biomarkers
|
Fletcher
|
PA02-034
|
2006
|
499,114
|
Awarded
|
|
5 R01 A1054478-05
|
Sleep/Cytokines
|
Natelson
|
PA02-034
|
2007
|
572,643
|
Awarded
|
|
5 R01 ES015382-
02
|
Proteomics CSF
|
Baraniuk
|
OD06-002
|
2007
|
374,068
|
Awarded
|
|
5 R21 AA016636-02
|
Neuropeptide Y
|
Fletcher
|
OD06-002
|
2007
|
194,989
|
Awarded
|
To
Be Paid (4)
|
Grant
|
Title
|
Investigator
|
PA/RFA
|
Year
|
Award
|
Grant
Status
|
|
X
|
X
|
X
|
PA02-034
|
2007
|
481,756
|
To Be Paid
|
|
X
|
X
|
X
|
OD06-002
|
2007
|
383,750
|
To Be Paid
|
|
X
|
X
|
X
|
OD06-002
|
2007
|
344,250
|
To Be Paid
|
|
X
|
X
|
X
|
OD06-002
|
2007
|
153,281
|
To Be Paid
|
Institute
Participation
AI – National of Allergy and Infectious Diseases (NAIAD) - $3,189,365
HD- National Institute of Child Health and Human Development (NICHD) - $1,644,435
NS- National Institute of Neurological Disorders and
Stroke (NINDS) - $737,719
ES – National
Institute of Environmental Health Services (NIEHS) - $753,788
AA – National Institute
of Alcoholic Abuse and Alcoholism
(NIAAA) - $671,216