December 15 2003
DEPARTMENT OF DEFENSE NATIONAL PRION RESEARCH PROGRAM
ARMY POSITION: The US Army Medical Research and Materiel Command
(USAMRMC) manages biomedical research programs that are part of the
Department of Defense (DOD) and Army budget submission. In addition, as
directed by Congress, the USAMRMC manages congressionally targeted
biomedical research programs.
One of the congressional research programs managed by the USAMRMC Office
of the Congressionally Directed Medical Research Programs (CDMRP) is the
National Prion Research Program (NPRP). The primary goals of the NPRP
are to support the development of diagnostic tests and means to prevent
and manage transmissible spongiform encephalopathies (TSE).
* Congress directed the DOD's involvement in the NPRP in fiscal year
* The USAMRMC was tasked by Congress to manage the $42.5 million (M)
NPRP appropriation, which was received by the USAMRMC in February
* TSE are of military relevance due to their potential threat to
food and blood supplies, and the health threats posed by TSE put
military beneficiaries in affected areas overseas at risk.
* The NPRP is conducted according to the two-tier review model
recommended in 1993 to the USAMRMC by the National Academy of
Sciences Institute of Medicine (IOM); this model has received high
praise from the scientific community, advocacy groups, and Congress.
* The USAMRMC negotiated with the IOM to assess the field of TSE,
focusing specifically on prion detection and disease diagnosis. A
progress report was received in August 2002, an interim report was
received in January 2003, and the final report was received in
* A meeting was held May 22-23, 2002 in which military, scientific,
regulatory, and public health stakeholders provided input on the
major issues in TSE research and received an overview of the
USAMRMC science management processes. Based upon the stakeholders'
recommendations, a smaller programmatic advisory group
(Integration Panel), composed of TSE experts from the military,
scientific, regulatory, industry, and public health communities,
* The FY02 NPRP investment strategy was determined by the
Integration Panel at a vision setting meeting held June 24-25,
2002. A request for proposals was released on August 2, 2002, and
136 proposals were received by the proposal submission due date of
October 30, 2002. Peer review was conducted December 4-6, 2002,
and programmatic review was conducted February 27-28, 2003.
Programmatic review deliberations were supported by an IOM interim
report on prion detection and diagnosis.
* The Integration Panel submitted a recommended for funding list of
38 proposals to the Commanding General, USAMRMC for approval. The
Commanding General, USAMRMC approved the award recommendations on
March 10, 2003. Award negotiations have been completed.
* Congress has not provided any follow-up appropriations for this
Disease Background. TSE refers to several apparently related diseases
including Creutzfeltd-Jacob disease (CJD) and its new variant (nvCJD),
kuru, bovine spongiform encephalopathy ("mad cow disease"), and others.
Except for nvCJD, the TSE appear to develop progressively over many
years, lead to extensive central nervous system vacuole formation, and
are invariably fatal. At present, definitive diagnosis can only be made
at autopsy. The diseases are relatively rare in humans but have been
documented most extensively in hoofed mammals. The current disease
theory attributes TSE to "prions," normal cell membrane proteins with
atypical three-dimensional configurations, transmitted by ingestion or
blood transfer. Although a Nobel Prize was awarded for the work
underlying this proposed mechanism (Prusiner, 1997), it remains
controversial because disease transmission traditionally is associated
with an agent capable of replication.
The health threats posed by TSE currently appear to involve food and
blood supplies. These health threats put military beneficiaries in
affected areas overseas at risk. Research and development of means for
diagnosis, prevention, and treatment face significant difficulties that
somewhat resemble those initially associated with the human
immunodeficiency virus (HIV). These include uncertainty about disease
mechanisms, TSE's slow progression in most cases, the lack of a
diagnostic tool, and uncertainty about similarity between the animal and
human diseases. In addition, TSE research requires BioSafety Level 3
facilities for some work.
Overview of the Program. The DOD NPRP was established in FY02 by Joint
Appropriations Conference Committee Report No. 107-350, which provided
$42.5M for research on prion disease. The Senate Appropriations
Committee Report No. 107-109 also specified that "The priority goal of
the Project's first phase is to rapidly develop a diagnostic test to
detect the presence of prion disease." A USAMRMC Steering Committee,
including representatives of the Walter Reed Army Institute of Research
(WRAIR), was convened to address TSE-related issues specific to military
missions and to support the NPRP based upon the USAMRMC's experience in
HIV detection and diagnosis. A meeting was held May 22-23, 2002 in which
military, scientific, regulatory, industry, and public health
stakeholders provided input on the major issues in TSE research and
received an overview of the USAMRMC science management processes.
Meeting participants included leading scientists and representatives
from the DOD (i.e., the WRAIR, the Assistant Secretary of Defense
[Health Affairs], the Armed Services Blood Program Office, and the
Veterinary Corps), the Departments of Health and Human Services
(including the National Institutes of Health, the Food and Drug
Administration, and the Centers for Disease Control and Prevention),
Agriculture, and Energy. Representatives from the Department of Veterans
Affairs and the American Red Cross also attended the meeting. Based upon
the stakeholders' recommendations, a smaller programmatic advisory group
(Integration Panel), composed of TSE experts from the military,
scientific, regulatory, industry, and public health communities, was
The FY02 NPRP investment strategy was determined by the Integration
Panel at a vision setting meeting held June 24-25, 2002. Four award
mechanisms were supported: two training award mechanisms and two
research awards mechanisms. Career Transition Awards are designed to
prepare individuals for careers in prion research and assist
investigators in overcoming the difficulties inherent in the field. The
goal of the Prion Techniques Fellowship is twofold: to encourage prion
researchers to develop new expertise that would enable them to broaden
the scope of their prion research, and to attract investigators into the
field of prion research by allowing them the opportunity to acquire the
necessary training. Idea Awards are intended to support proposals that
create or introduce a unique or unusual approach to the study of the
prevention, treatment, inactivation, or diagnosis of TSE, especially as
they relate to Chronic Wasting Disease. Finally, Investigator-Initiated
Research Awards sponsor basic and clinically oriented research in TSE
that will move the field toward development of an antemortem diagnostic
test for TSE.
A total of 136 proposals was received in response to the August 2, 2002
Program Announcement, and they were scientifically reviewed in December
2002. The Integration Panel reviewed the scientifically meritorious
proposals for programmatic relevance February 27-28, 2003. These
deliberations were supported by an interim IOM report titled "Advancing
Prion Science: Guidance for the National Prion Research Program." The
USAMRMC negotiated with the IOM to assess the field of TSE, focusing on
prion detection and disease diagnosis. The final report was delivered on
November 5, 2003. Another potential function of the Integration Panel is
to advise the DOD with respect to the long-term goals and objectives of
the NPRP. The Senate Appropriations Committee Report No. 107-109 also
"urges the President to appoint a multi-agency, secretarial level Task
Force to include the Departments of Health and Human Services,
Agriculture, Defense, Commerce, and Energy." To the knowledge of the
CDMRP, the President has not appointed this Task Force.
A total of 38 proposals was recommended for funding by the Integration
Panel. Award negotiations have been completed.
CDMRP Phone: 301-619-7071
CDMRP Web Site: http://cdmrp.army.mil
Greetings list members,
i wonder where this money went?
how was this money allocated?
how much was spent on actual TSE research and how much was
spent on wine/food/exotic dancers???
wonder if there is records on the spending of this money???