GULF WAR ILLNESS RESEARCH PROGRAM (GWIRP CDMRP DOD)

Anthony HardieChair, Programmatic Panel, GWIRP CDMRP

Director, Veterans for Common Sense

MARCH 3, 2016, WASHINGTON, DC: Institute of Medicine Panel: Evaluation of Research Management by DoD CDMRP

DISCLAIMER: The views expressed in this presentation are those of the author and may not reflect the official policy of the Department of the Army, Department of Defense, or the U.S. Government.

About the Treatment-FocusedGulf War Illness CDMRP

Gulf War Illness (GWI) Overview “Scientific research . . . supports and further

substantiates . . . that Gulf War illness is a serious physical disease, affecting at least 175,000 veterans of the 1990-1991 Gulf War, that resulted from hazardous exposures in the Gulf War theater.”1 (p.1)

Symptoms typically include widespread pain, cognitive difficulties, debilitating fatigue, gastrointestinal problems, respiratory symptoms, sleep problems, chronic headache, and other abnormalities not explained by established medical diagnoses or standard laboratory tests; affects 25-32% of the nearly 700,000 veterans of the 1991 Gulf War.2

SOURCES: (1) Research Advisory Committee on Gulf War Veterans' Illnesses (RAC), U.S. Department of Veterans Affairs, “Gulf War Illness and the Health of Gulf War Veterans: Research Update and Recommendations, 2009-2013.” Washington, D.C.: U.S. Government Printing Office, May 2014. Retrieved Jan. 24, 2016, www.va.gov/RAC-GWVI/RACReport2014Final.pdf (2) Gulf War Illness Research Program (GWIRP), Congressionally Directed Medical Research Program, U.S Department of Defense, Program Website. Retrieved Jan. 24, 2016, http://cdmrp.army.mil/gwirp.

Why is there a Gulf War Illness CDMRP? DoD and VA efforts had focused on stress,

psychological issues, and causation complexities. No priority to find evidence-based treatments to

improve GWI veterans’ health and lives. Federal efforts failed in nearly all regards, yielding no

identifiable quality of life improvements for affected veterans

Extensive criticism of prior federal efforts by VSO’s, Congress, the media, and Gulf War veterans and their advocates

Gulf War Illness CDMRP created by Congress in FY06, in response to demonstrated need for a treatment-focused GWI medical research program, outside of VA.

Congressional Intent

The FY08 National Defense Authorization Act (NDAA) conference report directed the Secretary of the Army to utilize the authorized funding… to undertake research on Gulf War Illnesses. Conferees also directed that activities under the Gulf War Illnesses program include: Studies of treatments for the complex of symptoms known as “Gulf

War Illness” No studies based on psychiatric illness and psychological stress as

the central cause Competitive selection and peer review to identify research with the

highest technical merit and military value

Annual letters from the Senators and Representatives to the Defense Appropriations Subcommittees provide similar guidance.

5

Gulf War Illness CDMRP FocusThe GWIRP focuses on funding innovative, competitively peer-reviewed research to:(1) provide a better understanding of the pathobiology underlying GWI, (2) identify objective markers (biomarkers) for improved diagnosis, and (3) to develop treatments for the complex of GWI symptoms and their underlying causes.

GWIRP Emphasizes IOM’s Two Recommended GWI Case Definitions

SOURCE: p. 74, National Academies of Sciences, Engineering, and Medicine. 2016. Gulf War and Health, Volume 10: Update of Health Effects of Serving in the Gulf War, 2016. Washington, DC: The National Academies Press.http://www.nap.edu/catalog/21840/gulf-war-and-health-volume-10-update-of-health-effects

Gulf War Illness CDMRP Overview Vision: “Improve the health and lives of veterans

who have Gulf War Illness.1

Mission: Fund innovative Gulf War Illness research to identify effective treatments, improve definition and diagnosis, and better understand pathobiology and symptoms.1

Treatment-focused; Peer-Reviewed; Research is competitively selected. 1

CDMRP’s are specifically funded in each annual Defense Appropriations Act; FY16, $20m.

1SOURCE: Gulf War Illness Research Program (GWIRP), Congressionally Directed Medical Research Program, U.S Department of Defense, Program Website. Retrieved Jan. 24, 2016, http://cdmrp.army.mil/gwirp.

GWIRP Appropriations & Awards

FY06 FY08 FY09 FY10 FY11 FY12 FY13 FY14

GWIRP Appropriation $5M $10M $8M $8M $8M $10M $20M $20M

Award MechanismNumber of funded awards

Exploratory Hypothesis Development Award 2

Idea Award 2

New Investigator Award 4

Investigator-Initiated Research Award 6 8 7 8 6 4 10 6

Investigator-Initiated Research Expansion Award 6

Innovative Treatment Evaluation Award 2 2 1 0 5 5

Clinical Trial Award 2 0 0 1 0 1 0

Consortium Development Award 3

Consortium Awards 2

Total Awards (Pre-applications) 8 (81) 12 (113) 9 (43) 13 (82) 8 (57) 6 (83) 16 (87) 21(112)

Ear

ly

Idea

Mor

e M

atur

e Id

eaTr

ansl

atio

nal/

Clin

ical

GWIRP Portfolio

TREATMENT STUDIES20 awards, $15,383,916

FY06, FY08–FY14Congressional Appropriations

= 93 Awards$89M

PATHOBIOLOGY19 awards, $13,510,179 ANIMAL MODEL

DEVELOPMENT

GENETICS/GENOMICS DISCOVERY

PATHOBIOLOGY

POPULATION-BASED STUDIES

CLINICAL BIOMARKERS

CLINICAL TREATMENTS

CONSORTIUM

Funded Topic Areas

GWI CDMRP Program Cycle

January 2015

August 2015

September 2015

January 2016

March 2016

May 2015

October 2015

*As needed

Pre-Application Review Adds Value Removes non-competitive proposals

early Reduces waste:

Investigators submitting clearly non-competitive pre-proposals don’t expend needless effort developing a full proposal that stands no chance of getting funded

Reduces costs, time expended, administrative burden, etc.

VA vs. GWI CMDRP Awards, Funding  VA GWIRP-CDMRP

During this FY

VA Funding Expended this FY

# of New Proposal Funded

this FY

# of New Proposals Funded with this FY’s appropriated

funding

Amount of the

Appropriation made for this

FY

New Appropriation Made during this FY (for future

year)

2011 $5.54 m 3 8 (CY2012) $8 m $10m (for FY12)

2012 $6.72 m 7 6 (CY2013) $10 m $20m (for FY13)

2013 $7.94 m 7 16 (CY2014) $10 m $20m (for FY14)

2014 $9.73 m 5 21 (CY2015) $20 m $20m (for FY15)

2015 $11.63 m 8 TBA (CY2016) $20 m $20m (for FY16)

2016 TBD TBD TBD (CY2017) $20 m TBD (for FY17)

Avoiding Duplication of Effort No GWI Research Program at NIH or elsewhere in the federal

government In recent years, VA has been funding treatment-focused

research for Gulf War Illness; includes symptomatic treatment testing (7 RCT’s as of Sep. 2015), animal models of exposure leading to treatment development, etc.

Active, ongoing, substantive VA-GWIRP engagement: VA ,Gulf War Illness program manager participates in Vision Setting,

Programmatic Panel meetings: Formal presentation of VA GW Research Portfolio, Strategy, etc. Active, ongoing interaction between VA and GWIRP Active in PP discussions of funding overlapping or duplicative

proposals or aims VA staff serves as voting member of External Advisory Boards

overseeing GWIRP Consortia

GWIRP Priority Areas

Improve understanding of pathobiology and symptoms

Improve definition and diagnosis

Identification of effective treatments

Gulf War Illness CDMRP Portfolio

~1/3 of Funded Studies are Testing treatmentsSome are symptomatic-focusedSome are mechanistically informed/informing

~2/3 of Funded Studies are Mechanism FocusedIdentifying treatment targetsIdentifying biomarkersImproving diagnosisImproving definitionImproving understanding of the underlying

pathobiology Most GWIRP-funded studies are active and

remain in the pipeline

FY16 GWIRP Programmatic Panel Anthony Hardie, former Staff Sergeant

USA (Chair)Florida Veterans for Common Sense

Roberta F. White, Ph.D. (Chair Emeritus) Boston University School of Public Health

Daniel Havlichek, M.D. Michigan State University

Carlos Maldonado, Ph.D.Department of Veterans Affairs

K. Jeffrey Myers, M.D.U.S.Department of Veterans Affairs

Marni Silverman, Ph.D.Henry M. Jackson Foundation for the Uniformed Services University of the Health Sciences

Andrea White, Ph.D.University of Utah

David K. Winnett, Jr., Captain USMC Retired Veterans for Common Sense

CAPT Mark Lyles, D.M.D., Ph.D. United States Naval War College

Fiona Crawford, Ph.D. Roskamp Institute

Gulf War Illness CDMRP:Emerging Results

GWIRP Treatment Findings♦Coenzyme Q10 (CoQ10) found to reduce pain, fatigue, cognitive and certain other

symptoms in veterans with GWI FY06 IIRA Dr. Beatrice Golomb, University of San Diego (GW060036) Published in 2014 Neural Computation 26(11): 2594-2651

♦Acupuncture may improve some GWI symptoms, including pain, fatigue, sleep quality, and cognitive symptoms FY08 CTA Dr. Lisa Conboy, New England School of Acupuncture (GW080059) Published in 2012 Contemp Clin Trials 33(3):557-562

♦Carnosine found to increase cognitive function and reduce gastrointestinal symptoms in veterans with GWI FY06 IIRA Dr. James Baraniuk, Georgetown University (GW060044) Published in 2013 Glob J Health Sci 5(3):69-81

♦Xylitol- and saline-based nasal irrigation may mitigate respiratory (chronic rhinosinusitis) and fatigue symptoms in GWI FY10 ITEA Dr. David Rabago, University of Madison, WI (GW100054) Published in 2015 Contemp Clin Trials 41:219-226

GWIRP Mechanistic Findings Low-dose sarin nerve agent exposure –

a key 1991 Gulf War and OIF exposure -- produces long term changes in brain neurochemistry of mice (Morris, GW060050), destroying an earlier myth that only high-level exposures that cause acute symptoms lead to potential chronic health effects. Low-dose sarin was one of multiple Gulf War exposures.

GWIRP Mechanistic Findings 2015 The stress hormone corticosterone exacerbates

the neuroinflammatory response following a single dose of a sarin surrogate, in essence negatively ”priming" the immune system of mice exposed to a sarin surrogate. S. Lasley, Univ. of Illinois & J. O’Callaghan, CDC NIOSH, Published in 2015, J Neurochem 133(5):708-21 (GW080150)

Epigenetic alterations in the hippocampus of rats exposed to GW chemicals and stress persist one year later. L. Pierce, Tripler Army Medical Center, HI, Published in 2015, FASEB J 29:814.6 (GW120033)

GWIRP Mechanistic Findings Neuroimmune changes found in veterans with GWI

following exercise have provided new objective evidence for GWI patients’ complaints of “failure to recover” following exercise and new directions for treatment pathways. (Klimas, GW080152) (Yet VA/DOD still recommending non evidence-based exercise as a GWI treatment. -VA/DOD Chronic Multisymptom Illness Clinical Practice Guideline, 2014)

Molecular modeling of the body’s “control system” in GWI patients, based on a myriad of biological samples (Broderick, GW093042) is now incorporated into a larger consortium study to try to “reset” these dysfunctions. (Morris, GW120045)

GWIRP Mechanistic Findings Gulf War chemicals have been found to damage

mitochondria, which generate cellular energy but when disrupted produce GWI symptoms. (Golomb, GW093063, GW120071, GW130106; Shoffner, GW080138). A related treatment, CoQ10, has been shown to be effective in helping reduce symptoms. (Golomb, GW060036).

Veterans affected by GWI show prolonged post-exercise recovery of phosphocreatine, consistent with a role for mitochondrial dysfunction. FY12 IIRA Dr. Beatrice Golomb, University of San Diego. Published in 2014 PLoS One 9(3):e92887

GWIRP Mechanistic Findings Gulf War chemicals led to persistent neuroinflammation and

neuropathological changes in an animal model of GWI. The researchers were also able to identify novel biological pathways, correlate the results with outcomes, and identify potential treatment targets.  (G. Ait-Ghezala, Roskamp Institute, Sarasota, FL (GW100076)

Repeated exposures to Gulf War chemicals, at doses below those associated with acute toxicity, result in persistent alterations in axonal transport in the brain. A. Terry, Georgia Regents Univ., GA, Published in 2015, Neurotoxicology 47:17-26 (GW110073)

Epigenetic alterations in the hippocampus of rats exposed to GW chemicals and stress persist one year later. L. Pierce, Tripler Army Medical Center, HI, Published in 2015, FASEB J 29:814.6 (GW120033)

Gulf War Illness CDMRP:In-Process Studies

GWIRP Consortia: Broad, Interdisciplinary, Inter-institutional collaborationsUnderstanding Gulf War Illness: An Integrative Modeling Approach Dr. Mariana Morris, Nova Southeastern University (GW120045)

♦ Characterization of multi-system dysfunction in mouse models of GWI using validation and direction from computational biology

♦ Integration of human and animal studies using computational modeling to identify mediators and test putative therapeutics

♦ Goal is to develop a translational model for rapid identification of targets and prediction of effective therapeutic interventions

Brain-Immune Interactions as the Basis of Gulf War Illness Dr. Kimberly Sullivan, Boston University (GW120037)

♦ Brings together researchers from 5 sites♦ Series of clinical and preclinical studies to test for

chronic brain-immune activation and chronic inflammation

♦ Goal is to identify brain-immune pathways that can be targeted for intervention

Some In-Progress GWIRP Treatment Evaluations Novel Anti-inflammatories (Younger, GW130015) Inflammation reduction (Bach, GW130025). Intranasal insulin (Golier, GW110054) Methylphenidate plus a GWI-Specific Nutrient Formula

(Kaiser, GW130047) Mifepristone (Golier, GW060048) Monosodium Luminol (Shetty, GW130037) Naltrexone and Dextromethorphan (Meggs, GW080064) Nasal Irrigation for Chronic Rhinosinusitis and Fatigue

(Rabago, GW100054) Polyphenol Preparations (Pasinetti, GW130070)

GWIRP Alternative Therapies Acupressure (Lin, GW110019) Acupuncture treatment protocol development

(Conboy, GW130028) Cognitive therapy for improvement of sleep quality

(Nakamura, GW100068) Portable vestibular stimulator (Serrador,

GW130093) Probiotic for bowel symptoms (Tuteja, GW093043) Yoga for pain management (Bayley, GW130022)

Treatment Trials Awarded in 2015 (FY14 Funds)

D-cycloserine (Dr. Rosemary Toomey, Boston University)

Vagus Nerve Stimulation (Dr. Benjamin Natelson, Beth Israel Medical Center, NY)

Anti-inflammatory compound Anatabine (Dr. Fiona Crawford, Roskamp Institute)

Low FODMAP (carbohydrate) diet (Dr. Ashok Tuteja, Western Institute for Biomedical Research)

Liposomal Glutathione and Curcumin (Dr. Nancy Klimas, South Florida Veterans Affairs Foundation for Research and Education, Inc.* / Dr. Richard Deth, Nova Sotheastern)

Mitochondrial cocktail (Dr. Beatrice Golomb, University of San Diego)

*within the VA healthcare system

Gulf War Illness CDMRP:What Makes it Unique?

What Makes GWIRP Unique? Treatment-focused – a model for other environmental injuries

and Toxic Wounds. Unique in the federal government. GWIRP/CDMRP funds any qualified researcher; VA funds only

VA-employees Includes “Consumer” (patient advocate) reviewers, who offer

focus, urgency, and impact insight. GWIRP: 1991 Gulf War veteran living with Gulf War Illness

Special emphasis on interdisciplinary and inter-institutional research collaborations to better solve complex issues than single researchers working alone.

GWIRP is relatively small by federal research funding standards.

GWIRP Military Relevance According to a 2014 update report of the Congressionally-mandated Research Advisory

Committee on Gulf War Veterans’ Illnesses (RAC), “Scientific research [since 2008] . . . supports and further substantiates . . . that Gulf War illness is a serious physical disease, affecting at least 175,000 veterans of the 1990-1991 Gulf War, that resulted from hazardous exposures in the Gulf War theater.”

Studies reviewed in the report found an elevated incidence of Lou Gehrig’s disease (ALS) among Gulf War veterans as well as significantly elevated rates of death due to brain cancer among those who were most exposed to the release of nerve gas by the destruction of the Khamisiyah Iraqi arms depot.

In addition to improving the health of Gulf War veterans, important discoveries made by the Gulf War Illness CDMRP may also help protect current and future American service members who are at risk of similar toxic exposures.

    

SOURCES: (1) Research Advisory Committee on Gulf War Veterans' Illnesses, Gulf War Illness and the Health of Gulf War Veterans: Research Update and Recommendations, 2009-2013, p. 1. U.S. Government Printing Office, Washington, D.C., 2014. (2) RAC, pp. 23-25. (3) RAC, pp. 23-26. (4) RAC, pp. 1; 4; 5; 13; 78; 83. And: Institute of Medicine, N. R. C., 2010. Gulf War and Health: Volume 8 - Health Effects of Serving in the Gulf War. The National Academies Press, Washington, DC, pp. 10; 260-64.

Support for the Gulf War Illness CDMRP

Gulf War Illness CDMRP Scientific Support

“Veterans who continue to suffer from these discouraging symptoms deserve the very best that modern science and medicine can offer to delineate the true underlying cause of these symptoms in order to speed the development of effective treatments, cures, and, it is hoped, preventions. The committee suggests a path forward to accomplish these goals and we believe that, through a concerted national effort and rigorous scientific input, answers can likely be found.” –IOM Gulf War & Health Vol. 8, 2010 (p. x)

SOURCE: Institute of Medicine. Gulf War and Health, Volume 8: Update of Health Effects of Serving in the Gulf War. Washington, DC: The National Academies Press; 2010.

Gulf War Illness CDMRP Scientific Support “Scientific research .... supports and further substantiates .... that Gulf War

illness is a serious physical disease, affecting at least 175,000 veterans of the 1990-1991 Gulf War, that resulted from hazardous exposures in the Gulf War theater.”(7)p.1

“Symptoms typically include some combination of widespread pain, headache, persistent problems with memory and thinking, fatigue, breathing problems, stomach and intestinal symptoms, and skin abnormalities.”(7)p.2

“Gulf War veterans who were most exposed to the release of nerve gas by the destruction of the Khamisiyah Iraqi arms depot have significantly elevated rates of death due to brain cancer” (7)p.2 ...elevated rates of ALS (Lou Gehrig’s Disease) (7)p.2... and there are concerns for the health of this vulnerable population as time progresses. (7)p.2

“Important progress has been made... However, much work remains to be done.” (7)p.1

“Congress should maintain its funding to support the effective treatment-oriented [GWIRP].” (7)p.14

SOURCE: (7) Research Advisory Committee on Gulf War Veterans’ Illnesses (RAC). ulf War Illness and the Health of Gulf War Veterans: Research Update and Recommendations, 2009-2013. Washington, D.C.: U.S. Government Printing Office; April 2014.

Gulf War Illness CDMRP Supporters Supported by: American Legion; AMVETS; Association of the U.S.

Navy (AUSN); Burnpits360; Disabled American Veterans (DAV); Lung Cancer Alliance; National Gulf War Resource Center (NGWRC); National Vietnam & Gulf War Coalition; Paralyzed Veterans of America (PVA); Sergeant Sullivan Center; Toxic Wounds Task Force; Veterans for Common Sense (VCS); Veterans of Foreign Wars (VFW); Vietnam Veterans of America (VVA).

The FY15 Independent Budget Veterans Service Organizations (IBVSO’s, composed of AMVETS, DAV, PVA, VFW, and 53 other organizations that serve veterans) stated that the Gulf War Illness CDMRP, “has made great strides in the short time it has been operating.”5 (pp. 126-27)

Strong support from GWI CDMRP Patient Advocates (Consumer Reviewers)

SOURCE: The Independent Budget for the Department of Veterans Affairs: Fiscal Year 2015. http://www.independentbudget.org/2015/IB_2015.pdf. Accessed February 26, 2015.

Gulf War Illness CDMRP Congressional Support Very strong, bipartisan, bicameral

Congressional support. FY16: 70 co-signers included House

Veterans’ Affairs Committee Chair, Ranking Member, 5 Subcommittee Chairs/Ranking Members, Key Senators

Last funding increase doubling GWIRP funding was supported unanimously on House floor vote.

Conclusion

Thank you! Questions?

More information:

• CDMRP: http://cdmrp.army.mil • CDMRP-GWIRP: http://cdmrp.army.mil/GWIRP• VCS: veteransforcommonsense.org

Additional Information

Gulf War Illness CDMRP: Patient Advocate Consumer Reviewers

What is vs. What Could Be“Health care harms patients too frequently and routinely fails to deliver its potential benefits. Indeed, between the health care that we now have and the health care that we could have lies not just a gap, but a chasm.” –IOM committee on a 21st Century healthcare system

IOM Panel on 21st Century Healthcare System The IOM committee on Shaping the Future for Health for the

21st century (Publication: “Crossing The Quality Chasm: A New Health System For The 21st Century,” 2001) formulated a set of ten simple rules, or general principles, to inform efforts to redesign the health system.

To help in achieving these improvement aims, the committee deemed that it would be neither useful nor possible to specify a blueprint for 21st-century health care delivery systems. Imagination abounds at all levels, and all promising routes for innovation should be encouraged.

At the same time, the committee formulated a set of 10 simple rules, or general principles, to inform efforts to redesign the health system.

These rules are:

Aims for the 21st-Century Health Care System

The IOM committee on Shaping the Future for Health for the 21st century (Publication: “Crossing The Quality Chasm: A New Health System For The 21st Century,” 2001)

The committee proposed 6 aims for improvement to address key dimensions in which today’s health care system functions at far lower levels than it can and should.

A health care system that achieved major gains in these six dimensions would be far better at meeting patient needs. Patients would experience care that was safer, more reliable, more responsive, more integrated, and more available.

Patients could count on receiving the full array of preventive, acute, and chronic services from which they are likely to benefit. Such a system would also be better for clinicians and others who would experience the satisfaction of providing care that was more reliable, more responsive to patients, and more coordinated than is the case today.

Core Aims for Health Care: Safe: avoiding injuries to patients from the care that is intended

to help them. Effective: providing services based on scientific knowledge to

all who could benefit, and refraining from providing services to those not likely to benefit.

Patient-centered: providing care that is respectful of and responsive to individual patient preferences, needs, and values, and ensuring that patient values guide all clinical decisions.

Timely: reducing waits and sometimes harmful delays for both those who receive and those who give care.

Efficient: avoiding waste, including waste of equipment, supplies, ideas, and energy.

Equitable: providing care that does not vary in quality because of personal characteristics such as gender, ethnicity, geographic location, and socioeconomic status

21st Century Healthcare System “Rules”

1. Care is based on continuous healing relationships. Patients should receive care whenever they need it and in many forms, not just face-to-face visits. This implies that the health care system must be responsive at all times, and ac cess to care should be provided over the Internet, by telephone, and by other means in addition to in-person visits.

2. Care is customized according to patient needs and values. The system should be designed to meet the most common types of needs, but should have the capability to respond to individual patient choices and preferences.

3. The patient is the source of control. Patients should be given the necessary information and opportunity to exercise the degree of control they choose over health care decisions that affect them. The system should be able to accommodate differences in patient preferences and encourage shared decision making.

4. Knowledge is shared and information flows freely. Patients should have unfettered access to their own medical information and to clinical knowledge. Clinicians and patients should communicate effectively and share information.

21st Century Healthcare System “Rules”

5. Decision making is evidence-based. Patients should receive care based on the best available scientific knowledge. Care should not vary illogically from clinician to clinician or from place to place.

6. Safety is a system property. Patients should be safe from injury caused by the care system. Reducing risk and ensuring safety require greater attention to systems that help prevent and mitigate errors.

7. Transparency is necessary. The system should make available to patients and their families information that enables them to make informed decisions when selecting a health plan, hospital, or clinical practice, or when choosing among alternative treatments. This should include information describing the system’s performance on safety, evidence-based practice, and patient satisfaction.

8. Needs are anticipated. The system should anticipate patient needs, rather than simply react to events.

9. Waste is continuously decreased. The system should not waste re- sources or patient time.

10. Cooperation among clinicians is a priority. Clinicians and institutions should actively collaborate and communicate to ensure an appropriate exchange of information and coordination of care.

Consumer Reviewers: Why?

Why does the CDMRP include Consumer Reviewers on their scientific peer review panels?

Participation of consumers leads to an expanded perspective by both scientists and consumers.

Consumers keep the needs of the consumer community at the forefront of scientific discussions and scientists are reminded of the human dimension of the disease.

There is improved understanding of the benefits and burdens imposed upon patients participating in research studies.

Consumers bring back hope for a cure, better treatment, or quality of life for those living with their disease/injury/condition generated by their participation and understanding of the focus of the research that might be funded.

This results in increased awareness by consumers of the importance of research and a stronger relationship between the scientific community and the consumer community.

Congress on Consumer Reviewers“The inclusion of patient advocates in the CDMRP peer review has been a highly regarded addition to the process, and the Committee believes that these voices provide a valuable contribution.”

SOURCE: Senate Report 113-211 - DEPARTMENT OF DEFENSE APPROPRIATIONS BILL, 2015; July 17, 2014. (S. Rpt. 113-211, p. 254) URL: https://www.congress.gov/congressional-report/113/senate-report/211

Consumers: Few Gulf-War related organizations Each consumer brings individual

viewpoint based on individual health and healthcare delivery experiences

CDMRP Consumer Reviewer Evaluation Criteria

IOM CDMRP Panel:Congressional Intent

Congressional Direction, 2014“In order to build on this collaboration, the Committee directs the Department to contract with the Institute of Medicine [IOM] to evaluate the Congressionally Directed Medical Research Program [CDMRP] and provide a report to the congressional defense committees not later than 12 months after enactment of this act. The report should include an evaluation of the CDMRP two-tiered peer review process, its coordination of research priorities with NIH, and recommendations for how the process can be improved. The Committee notes that the peer review system used in the CDMRP is the recommendation of a 1993 IOM report and was modeled after the NIH system. The inclusion of patient advocates in the CDMRP peer review has been a highly regarded addition to the process, and the Committee believes that these voices provide a valuable contribution.” SOURCE: Senate Report 113-211 - DEPARTMENT OF DEFENSE APPROPRIATIONS BILL, 2015; July 17, 2014. (S. Rpt. 113-211, p. 254) URL: https://www.congress.gov/congressional-report/113/senate-report/211

Congressional Direction, 2014

Congressional Direction, 2015“Last year, the Committee directed the Department to contract with the Institute of Medicine to evaluate the Congressionally Directed Medical Research Program and provide a report to the congressional defense committees within 12 months. This report will include an evaluation of the Congressionally Directed Medical Research Program's two-tiered peer review process, its coordination of research priorities with NIH and recommendations for how the process can be improved. The Committee looks forward to receiving this report in its efforts to continue to ensure that Government investments in medical research are maximized.”  SOURCE: Senate Report 114-63 - DEPARTMENT OF DEFENSE APPROPRIATIONS BILL, 2016; June 11, 2015. (S. Rpt. 114-63, p. 202) URL: https://www.congress.gov/congressional-report/114th-congress/senate-report/63/1

Congressional Direction, 2015

National Academies Inscription