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[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]

      VA RESEARCH: FOCUSING ON FUNDING, FINDINGS, AND PARTNERSHIPS

=======================================================================

                              JOINT HEARING

                               BEFORE THE
                               
                         SUBCOMMITTEE ON HEALTH

                               JOINT WITH

               SUBCOMMITTEE ON OVERSIGHT & INVESTIGATIONS

                                 OF THE

                     COMMITTEE ON VETERANS' AFFAIRS
                     U.S. HOUSE OF REPRESENTATIVES

                     ONE HUNDRED FIFTEENTH CONGRESS

                             SECOND SESSION

                               __________

                         THURSDAY, MAY 17, 2018

                               __________

                           Serial No. 115-60

                               __________

       Printed for the use of the Committee on Veterans' Affairs
       
       
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                     COMMITTEE ON VETERANS' AFFAIRS

                   DAVID P. ROE, Tennessee, Chairman

GUS M. BILIRAKIS, Florida, Vice-     TIM WALZ, Minnesota, Ranking 
    Chairman                             Member
MIKE COFFMAN, Colorado               MARK TAKANO, California
BRAD R. WENSTRUP, Ohio               JULIA BROWNLEY, California
AMATA COLEMAN RADEWAGEN, American    ANN M. KUSTER, New Hampshire
    Samoa                            BETO O'ROURKE, Texas
MIKE BOST, Illinois                  KATHLEEN RICE, New York
BRUCE POLIQUIN, Maine                J. LUIS CORREA, California
NEAL DUNN, Florida                   CONOR LAMB, Pennsylvania
JODEY ARRINGTON, Texas               ELIZABETH ESTY, Connecticut
JOHN RUTHERFORD, Florida             SCOTT PETERS, California
CLAY HIGGINS, Louisiana
JACK BERGMAN, Michigan
JIM BANKS, Indiana
JENNIFFER GONZALEZ-COLON, Puerto 
    Rico
                       Jon Towers, Staff Director
                 Ray Kelley, Democratic Staff Director

                         SUBCOMMITTEE ON HEALTH

                     BRAD WENSTRUP, Ohio, Chairman

GUS BILIRAKIS, Florida               JULIA BROWNLEY, California, 
AMATA RADEWAGEN, American Samoa          Ranking Member
NEAL DUNN, Florida                   MARK TAKANO, California
JOHN RUTHERFORD, Florida             ANN MCLANE KUSTER, New Hampshire
CLAY HIGGINS, Louisiana              BETO O'ROURKE, Texas
JENNIFER GONZALEZ-COLON, Puerto      LUIS CORREA, California
    Rico

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                    JACK BERGMAN, Michigan, Chairman

MIKE BOST, Illinois                  ANN MCLANE KUSTER, New Hampshire, 
BRUCE POLIQUIN, Maine                    Ranking Member
NEAL DUNN, Florida                   KATHLEEN RICE, New York
JODEY ARRINGTON, Texas               SCOTT PETERS, California
JENNIFER GONZALEZ-COLON, Puerto      KILILI SABLAN, Northern Mariana 
    Rico                                 Islands

Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public 
hearing records of the Committee on Veterans' Affairs are also 
published in electronic form. The printed hearing record remains the 
official version. Because electronic submissions are used to prepare 
both printed and electronic versions of the hearing record, the process 
of converting between various electronic formats may introduce 
unintentional errors or omissions. Such occurrences are inherent in the 
current publication process and should diminish as the process is 
further refined.
                           
                           C O N T E N T S

                              ----------                              

                         Thursday, May 17, 2018

                                                                   Page

VA Research: Focusing On Funding, Findings, And Partnerships.....     1

                           OPENING STATEMENTS

Honorable Neal Dunn, Acting Chairman.............................     1
Honorable Julia Brownley, Ranking Member, Subcommittee on Health.     2

                               WITNESSES

Robin L. Rusconi J.D., Chair, Board of Directors, National 
  Association of Veterans' Research & Education Foundations......     4
Paul Klotman M.D., President, Chief Executive Officer, and 
  Executive Dean, Baylor College of Medicine, On behalf of 
  Association of American Medical Colleges.......................     5
Carolyn Clancy M.D., Executive in Charge, Veterans Health 
  Administration, U.S. Department of Veterans Affairs............     7

        Accompanied by:

    Rachel B. Ramoni D.M.D., Sc.D., Chief Research and 
        Development Officer, Veterans Health Administration, U.S. 
        Department of Veterans Affairs

                       STATEMENTS FOR THE RECORD

Roger Murray Executive Director, the Coalition to Heal Invisible 
  Wounds.........................................................    37
Rick Weidman, Executive Director for Policy & Government Affairs, 
  Vietnam Veterans of America (VVA)..............................    41
Ms. Jacqueline Garrick, LCSW-C, Whistleblowers of America........    43
National Association of Veterans' Research and Education 
  Foundations (NAVREF)...........................................    48

 
      VA RESEARCH: FOCUSING ON FUNDING, FINDINGS, AND PARTNERSHIPS

                              ----------                              

                         Thursday, May 17, 2018

             U.S. House of Representatives,
                    Committee on Veterans' Affairs,
                                     Subcommittee on Health
                                                   Washington, D.C.
    The Subcommittees met, pursuant to notice, at 10:03 a.m., 
in Room 334, Cannon House Office Building, Hon. Neal Dunn 
presiding.
    Present: Representatives Bergman, Dunn, Bost, Poliquin, 
Arrington, Higgins, Coffman, Brownley, Kuster, Rice, O'Rourke, 
Correa, and Lamb.

        OPENING STATEMENT OF NEAL DUNN, ACTING CHAIRMAN

    Mr. Dunn. This meeting has come to order. Good morning, I 
thank all of you for joining us today to discuss the Department 
of Veterans Affairs medical and prosthetic research program. 
Before I begin, I would like to ask unanimous consent for our 
friend and fellow Committee Member Congressman Coffman from 
Colorado to join us on the dais for today's proceeding, when he 
comes in we will seat him.
    Without objection, that is ordered.
    All right. Well, current law requires VA to conduct 
research in order to carry out more effectively the primary 
function of veteran's health administration in order to 
contribute to the Nation's knowledge about disease and 
disability. The VA research program has attracted high quality 
clinician researchers to VA medical centers and led to many 
important partnerships. This has resulted in discoveries that 
have benefitted everybody in this room. You will hear the VA 
tout some of these most notable discoveries this morning. They 
range from the pacemaker in 1959 to the shingles vaccine in 
2006.
    Despite these successes, the Committee has become 
increasingly concerned that the VA's research program is in 
need of refocusing in several important areas. First, it is not 
clear that the majority of the research that the VA conducts 
displays a concentrated focus on veteran specific conditions 
and concerns.
    There are many valuable research topics such as obesity and 
heart disease that are very deserving of research dollars and 
attention. But the VA's research program is meant to support 
research on issues that are unique to or particularly prevalent 
among veterans, and may not be receiving the funding and 
attention they deserve by other research entities. And these 
issues are such as toxic exposures, traumatic brain injuries, 
and post-traumatic stress disorder.
    Secondly, there are concerns that VA medical facilities are 
not complying with the VA policy by administering grants from 
outside entities through VA non-profit research and education 
corporations to the extent that is possible. The vast majority 
of VA researchers are duly appointed at both a VA medical 
facility and a nearby academic affiliate, which can create 
conflicts of interest when it comes time to determine where our 
given grant is administered.
    There are significant financial considerations inherent in 
that determination, and the VA has to make sure that the 
department is given due consideration and not leaving a cent of 
potential research funding on the table and out of the veterans 
reach. Finally, there are concerns that the VA's not getting a 
significant return on its investment in research overall.
    A statement from the record from the Vietnam Veterans of 
America said it perhaps most succinctly. ``How much of what VA 
research produced recently is of significant benefit to 
veterans?'' And I have no doubt that the VA's researchers are 
leaders in their field, making great progress on a regular 
basis, but we are not sure that enough of what VA researchers 
are discovering is being translated efficiently and effectively 
into the VA medical centers and clinics to benefit veterans 
across the country.
    I am grateful today for our witnesses for their attendance 
here this morning to discuss these issues with us. One thing I 
will note before yielding is that the Subcommittee on health 
will be holding another hearing on June 8th that will focus 
specifically on burn pit research. I am looking forward to that 
and diving deeper into that specific research efforts at that 
hearing and not today.
    I will yield to Ranking Member Brownley for any opening 
statement that she may at this time. Thank you.

     OPENING STATEMENT OF JULIA BROWNLEY, RANKING MEMBER, 
                     SUBCOMMITTEE ON HEALTH

    Ms. Brownley. Thank you, Mr. Chairman. This morning this 
Subcommittee will delve into issues involving VA's mission to 
discover knowledge, develop researchers and health care 
leaders, and create innovations to advance health care for 
veterans and the Nation.
    The successful advancement of this mission has positioned 
VA as the largest single provider of medical training in the 
United States. Today, over 70 percent of health care providers 
have received training through the VA. The partnerships VA has 
established with academic institutions and VA non-profit 
corporation have proven integral to VA's advancement of 
veteran-centric research.
    VA's relationship to its academic affiliates is essential 
if VA is to provide the level of health care that we all expect 
for our veterans. This is why Congress, the VA, and it academic 
affiliates must work together to address areas that need 
improvement.
    While our overall health care system reaps the benefits of 
VA inventions, VA also benefits by being able to rely on the 
high-quality providers and specialists that this type of 
research attracts. VA physicians are often on the leading edge 
of medical knowledge and leaders in their field of practice.
    For instance, earlier this year the Minneapolis VA 
published a study that found that opioid pain killer are no 
more effective than safer alternatives in long-term treatment 
of patients with chronic pain. Not only is this information 
timely but it will likely shape Federal policies surrounding 
the prescribing of opioids in the future and save thousands of 
Americans from falling victim to opioid addiction.
    Because of the important work VA's Office of Research and 
Development has accomplished, I wish to examine how we can 
better support VA research and research conducted by our 
academic affiliates in VA non-profit research corporations. I 
am concerned that VA's current research budget is not keeping 
pace with inflation. And if NIH awards significantly fewer 
research grants, this will have a negative effect on VA's 
ability to develop treatments for our veterans.
    If funding for VA research continues to be lacking, I want 
to know about how VA can continue to leverage private 
investment in non-profit funding through our non-profit 
research corporations and through our academic affiliates to 
make up for Federal research funding shortfalls.
    Finally, I want to continue to work with Ranking Member 
Kuster and our colleagues across the aisle to ensure VA is 
properly overseeing its research programs and the 
administration of NIH funded research through the VA's non-
profits research corporations and its academic affiliates.
    I would also like to better understand when it is 
appropriate for VA non-profit corporations and academic 
affiliates to administer NIH grants, and ensure VA is following 
its current policy directives. We need to come together to 
figure out the best way to ensure vital research to advance 
veterans health care needs is funded, and that it is 
administered properly so that this funding results in 
treatments that improve, and in some cases, save veterans 
lives. Educating our Nation's health care providers and 
developing medical breakthroughs to provide treatment to our 
veterans are part of VA's core mission. It is vital that we, as 
Members of Congress, support this mission.
    So thank you, Mr. Chairman, Dr. Dunn. And I yield back the 
balance of my time.
    Mr. Dunn. Thank you very much Representative Brownley.
    I will make note that Chairman Bergman and Ranking Member 
Kuster will be making closing statements at the end of our 
hearing. And so I welcome our panel, and I will introduce you 
now.
    First, we have Robin Rusconi, Chair of the Board of 
Directors for the National Association of Veterans' Research & 
Education Foundations. Next, we have Dr. Paul Klotman who is a 
nephrologist by training, the President and Chief Executive 
Officer, and Dean of Baylor College of Medicine, and here on 
behalf of the Association of American Medical Colleges. And I 
will make note that they are also the very first VA hospital 
ever.
    Also, Dr. Carolyn Clancy, Executive in Charge of the 
Veterans Health Administration for the U.S. Department of 
Veteran Affairs, and who is accompanied also by Dr. Rachel 
Ramoni, VA's Chief Research and Development Officer. Welcome 
panel, we thank you all for being here with us this afternoon.
    And, Mrs. Rusconi, I believe we will start with you. And 
you are now recognized for five minutes.

                   STATEMENT OF ROBIN RUSCONI

    Ms. Rusconi. Chairman Bergman and Dunn, Ranking Members 
Kuster and Brownley, distinguished Members of the 
Subcommittees, thank you for holding this important hearing.
    VA research is an essential but under-publicized element of 
the VA health care system. It has a distinguished history of 
discovery and innovation that has benefitted veterans and the 
Nation for over 90 years. The Congressionally authorized VA 
affiliated non-profit corporations are proud to support and 
augment VA research.
    My name is Robin Rusconi. Since 2014, I have been the 
executive director of the VA affiliated non-profit corporation 
located in Kansas City, Missouri. I am currently the chair of 
the Board of Directors for the National Association of 
Veterans' Research and Education Foundations, known as NAVREF.
    As a child of two World War II veterans, I am proud to be 
supporting the VA research program and helping improve the 
lives of veterans. NAVREF's mission is simple, we exist to 
advance the success of the VA affiliated non-profit 
corporations. I am here today to tell you about the great work 
of our non-profits, our potential for greater contributions, 
and the progress made since last year's hearing.
    We are pleased that the House Veterans Affairs Committee 
recognizes the importance of the non-profit corporations in the 
VA research enterprise. Over the last four years alone, the 
NPC's have administered over $1 billion in support of the 
research and education activities at VA medical centers.
    NAVREF and its members are excited too to support Dr. 
Ramoni's three strategic priorities for VA research; to provide 
greater access to clinical trials for veterans, to make VA data 
a national resource, and to achieve substantial real-world 
impact.
    While NAV--excuse me--while NAVREF is proud of all the NPCs 
have accomplished, we feel they have the potential to make even 
greater contributions. In June 2017 the House Veterans Affairs 
Oversight and Investigations Subcommittee held a hearing about 
VA research that included testimony from NAVREF. During that 
testimony, NAVREF made several recommendations. I would like to 
update you on the progress made on two of those 
recommendations.
    First of all, we were heartened to hear that the Office of 
Research and Development would engage an outside consultant to 
assess the need for VA to establish and enforce clear 
guidelines for administering Federal awards. Unfortunately, we 
are frustrated that the process has moved slowly, and we are 
concerned that the perspective of the non-profit corporation is 
not being fully investigated and appreciated.
    We believe the VA should enforce clear guidelines for the 
administration of extramural research activities that offer the 
NPC right of first refusal for all research efforts when the 
majority of this work occurs physically within the VA.
    Second, the VA's non-profit oversight board took several 
positive steps last October regarding the oversight reviews 
being conducted by the non-profit program office. Specifically, 
the NPOB created a clear appeals process, established an 
anonymous survey tool to receive feedback, and ensured 
oversight review out briefs include the full board of directors 
and the executive director of the non-profit corporation.
    Each of these changes have been in place for a short time, 
so it is too early to determine if they have been effectively 
communicated to local VA leadership and if they will have their 
intended impact. Additionally, we would like to see greater 
clarity on the scope of these reviews. Our members are all 
independent 501(c)3 corporations remain confused about what is 
subject to VA review and what may be out of scope.
    Thank you again for your attention to these matters. We 
greatly appreciate your continuing support of the VA research 
program and your support of the VA affiliated non-profit 
corporations. We look forward to working with you to achieve 
our vision of a Nation in which veterans receive the finest 
care based on innovated research and education.
    Mr. Dunn. Thank you very much, Ms. Rusconi.
    Dr. Klotman, you are now recognized for five minutes.

                   STATEMENT OF PAUL KLOTMAN

    Dr. Klotman. Thank you, Dr. Dunn. I really appreciate the 
opportunity to testify in front of you today. In addition to 
the Baylor College of Medicine, I also represent the 
Association of American Medical Colleges, which is a non-profit 
organization comprised of all the U.S. medical schools and 
major teaching hospitals including many of the VA hospitals.
    And I would like to thank the Full VA Committee for 
preserving the VA's clinical relationship with academic 
medicine in the VA mission act to ensure our Nation's veterans 
have access to clinical services at our institutions and 
receive the highest quality of health care.
    For this hearing I will share information on the research 
enterprise and the VA academic relationship through my 
experience as a clinician and researcher. For you--you may not 
know this, but I began my career as a trainee clinician 
physician scientist at the VA, and I was also supported by the 
NIH. I was a staff physician at the Durham VA for 13 years 
while at the faculty at Duke Medical School. And both my wife 
and I are partially supported by Duke to work at the Durham VA. 
I have spent 17 years in civil service between my time at the 
VA and the NIH. And, by the way, I am the Dean, my wife is also 
the Dean at the Duke Medical School, we all started our careers 
at the VA.
    The Michael DeBakey VA Medical Center in Houston was the 
first to affiliated with an academic partner, and has been 
affiliated with Baylor since 1949. Today, it is one of the VA's 
largest hospitals serving Harris County, Texas, in 27 
surrounding counties.
    Baylor physicians provide virtually 100 percent of the 
medical care at the DeBakey VA. The veterans from around the 
country are referred there, and Baylor physicians provide the 
clinical services often not available by other providers, same 
physicians at Baylor hospitals and the VA hospital.
    Medical schools fully integrate research and education with 
patient care, and these are very interdependent, as many of you 
physicians know, and to split those apart would really 
jeopardize the quality of care. Interestingly, the VA medical 
centers share the same tripartite mission of education, 
research, and clinical care. And by working together, we 
enhance the care for veterans--research that provides new 
treatments and train the next generation of health care 
providers, many of whom are then attracted to have a career in 
the VA.
    Our clinical research partnership has led to tremendous 
care for our Nation's veterans at the DeBakey VA. We have one 
of the ten VA trans-aortic valve replacements programs, it is 
only one of two in the country with expertise in bronchial 
stenting for patients with lung cancer and fibrosis, and is one 
of the few that has a designated stroke center.
    The DeBakey VA is the hub of our VISN, but it also gets 
national referrals with complex cases, second opinions, we have 
people sent from all over the country to our VA. And we have 
launch centers of excellence in cancer and Parkinson's Disease, 
post-traumatic stress disorder, liver transplant, epilepsy, 
substance abuse, and rehabilitation for mild to traumatic brain 
injury.
    Our faculty are absolutely passionate about improving 
quality of care for the veterans, as well as our other 
affiliated hospitals. As national leaders, they can rapidly 
implement new guidelines and best practice initiatives for 
medical conditions in the care of our veterans. This 
partnership has played an important role in the DeBakey VA 
achieving a four-star rating in just a six-month period of 
time.
    Research leads to medical advances, and Baylor and DeBakey 
VA have supported collaborations leading to innovation in 
mental health and cancer treatment, and prevention of 
antibiotic resistant infections, and chronic obstruction lung 
disease and emphysema, as well as cardiac care.
    Nationally, most VA researchers have joint appointments at 
the VA and the affiliated medical school, which to physician 
scientists views it as a huge advantage, and it is a real 
important recruiting tool. At DeBakey, VA researchers have 
faculty appointment at Baylor giving them access to all the 
resources at Baylor including core laboratory facilities, 
oversight committees, dedicated IRB to the VA clinical trials, 
accreditation for human and animal research, and pre-award 
management for all non-VA grants. And these resources can be 
prohibitively expensive for VA medical centers and their not-
for-profit corporations to support if they were independent of 
the affiliate. Sharing with academic affiliates reduces 
unnecessary redundances and maximizes the use of Federal 
dollars.
    Each VA academic partnership is unique. For example, about 
20 years ago Baylor and the DeBakey VA consulted with the VA, 
our non-for-profit organization, and HHS, and agreed that we 
should be reimbursed by NIH grants for the on-campus facility 
FNA. Baylor provides complete research oversight support and 
provides annual contributions to the non-for-profit corporation 
to support VA research. So money is flowing to the VA from us.
    All other medical schools--at other medical schools, NIH 
grants are administered via VA researchers vary based on the 
amount of infrastructure provided by the VA. Due to this 
variation in support that various VAs have for the research 
enterprise, the AAMC believes that administration of NIH grants 
should be determined at the local level by each VA medical 
center. A one-size fits all approach could hurt VA research 
programs as well as the collaborations with affiliates.
    The DeBakey VA relationship with Baylor and the joint 
appointment of researchers also is an important tool for 
recruiting physicians and scientists to the VA and retaining 
high quality researchers. The VA affiliation also enhances the 
training quality of our programs, the Baylor programs. Our 
students and residents have the opportunity to work with 
veterans and learn about military health, which makes them 
better doctors.
    There are additional recommendations in the written 
testimony, but if I leave you with one message today, it is 
without the synergistic 70-year partnership with academic 
medicine, the VA's ability to fulfil its mission of patient 
care, education, research would be limited.
    I appreciate this opportunity again, and I look forward to 
answering any questions that you have.
    Mr. Dunn. Thank you very much, Dr. Klotman.
    Dr. Clancy, you are now recognized for five minutes.

                  STATEMENT OF CAROLYN CLANCY

    Dr. Clancy. Good morning, Chairman Dunn, Chairman Bergman, 
Ranking Members Brownley and Kuster, Members of the 
Subcommittee. I appreciate the opportunity to discuss VA's 
medical and prosthetic research program, and I am accompanied 
by Dr. Rachel Ramoni our chief research and development 
officer.
    VA's Office of Research and Development has been improving 
the lives of veterans through health care innovation and 
discovery for more than 90 years. And in so doing, civilians 
have also benefitted from groundbreaking advances including the 
first successful liver transplant, and, as mentioned by the 
Chairman, the pacemaker, and the first shingles vaccine.
    We continue to conduct cutting-edge research such as the 
development of a bionic ankle that helps propel users forward, 
the creation of the Million Veteran Precision Medicine 
Initiative, and groundbreaking work to repair severed spinal 
cords. In addition to the scientific merit of VA research, VA 
is also recognized for its ability to translate research 
findings into real-world benefits for our veterans.
    I want to thank the Committee for the additional resources 
you provided in the omnibus. And, in fact, we have created a 
one-page summary of how we will prioritize that unexpected but 
very welcome investment of resources, which I would like to ask 
be entered into the record.
    Mr. Dunn. Without objection, it is entered.
    Dr. Clancy. The non-profit research and education 
corporations, or NPCs, are an important part of the VA research 
partnership ecosystem, established in 1988 to serve as a 
flexible vehicle to receive the external funds that help drive 
VA innovation. For example, a recently announced multi-million-
dollar interagency agreement with the National Cancer Institute 
will be administered by the not-for-profit corporations.
    VA's affiliations with our Nation's medical schools go back 
to 1946 when General Omar Bradley forged this pioneering 
partnership. Seventy-two years later, we are affiliated with 
well over 90 percent of medical and osteopathic schools, so 
these partnerships give us access to cutting-edge technology, 
expertise, and national research networks that would be 
difficult, costly, and wasteful to duplicate within VA. For 
example, the spinal cord repair program previously mentioned is 
the product of a very strong collaboration with the University 
of California system.
    VA research is committed to supporting activities that 
improve the health and well-being of our veterans. Our office 
of research and development evaluates proposed research 
projects by conducting rigorous scientific peer review. 
Projects that are not veteran focused do not receive funding.
    In addition, our research portfolio is continually 
rebalanced over time to meet our veterans most pressing needs. 
So, today, our five clinical priorities are post-traumatic 
stress disorder, traumatic brain injury, suicide prevention, 
opioids, and Gulf War illness.
    While VA's medical and prosthetic research program focuses 
on benefitting current and future veterans, the output of our 
research ultimately benefits the Nation. For example, in 2017 
VA launched a nationwide study of the health benefits of a 
robotic exoskeleton for veterans with spinal cord injury. VA 
research also has an impressive track record of transforming VA 
health care by bringing new evidence-based treatments and 
technologies into everyday clinical care.
    Two key examples recently. First is the implementation of a 
new suicide prevention clinical initiative, this has been 
defused across our system. Based on predictive modeling and 
existing medical record data to identify veterans at the very 
highest risk of suicide so we can provide them with more 
intensive services and follow-up.
    Veterans are now using the bionic LUKE arm as the result of 
our Office of Research's partnerships. The approval and 
delivery to veterans of the most advanced prosthetic arm ever 
created. This is an area upper limb prosthesis that has not 
seen advances in about 50 years.
    VA's medical and prosthetic and research program has 
significantly improved the care and well-being of our veterans. 
These gains have been possible because of consistent 
congressional commitment in both the form of attention and 
financial resources. And we believe it is critical to continue 
to move forward with the current momentum and preserve the 
gains made thus far.
    This concludes my testimony. My colleague and I are 
prepared to answer any questions.
    Mr. Dunn. Thank you very much, Dr. Clancy.
    We are going to take--go around the dais and have everybody 
five minutes to ask you questions. I am going to ask the panel 
to try to answer concisely. I know that it is hard sometimes, 
we ask vague questions. But since we each only have five 
minutes, it is a plus if we can be concise.
    So I am going to yield myself five minutes now. And start 
with Dr. Clancy a question. Given the prevalence of the PTSD 
and TBI among veterans, I would like to know a little bit more 
about this. These are prioritized treatments you have and 
technologies, what do we--what can we offer our veterans that 
we hadn't been offering?
    Dr. Clancy. To some extent we are looking at different and 
can offer now new medical treatments, and we are also looking 
at ways of how to delivery those treatments. For example, I am 
going to guess that you are aware that one-third of the 
veterans we serve live in rural areas, so they have got a 
pretty substantial distance to travel to get care. And we have 
recently tested and developed a telehealth approach so that 
veterans can get this care virtually. And as nearly as we can 
tell from published studies, this is just as effective as 
traveling that distance and coming in person.
    Mr. Dunn. So you have got metrics on that?
    Dr. Clancy. Yes.
    Mr. Dunn. We would love to have you share that with us.
    Dr. Clancy. Sure.
    Mr. Dunn. Not right this minute, but that is something that 
would be of keen interest, I think, to everybody in this 
Committee.
    Dr. Klotman, you mentioned not one size fits all, and one 
of the areas that we have had some interactive with, which IRB 
do we use?
    Dr. Klotman. So it depends on what institution. In our 
case, we have seven independent IRBs, but one of them is 
dedicated to the VA. So we can get very quick IRB approval for 
any clinical protocol.
    Mr. Dunn. Is the VA IRB quick for you? Is it easy to use?
    Dr. Klotman. It is because it is run by Baylor.
    Mr. Dunn. Oh, okay.
    Dr. Klotman. So we man--it is sort of outsourced to us, so 
we do it for--
    Mr. Dunn. Do you think that that translates across the 
country to all the researchers, because we get the sense that 
maybe it isn't?
    Dr. Klotman. I would say one of the big problems, when 
talking to academic institutions, with their VA affiliate is 
getting clinical trials approved. And I think it would--it is 
worth exploring how to improve the IRBs to facilitate clinical 
research for veterans. Absolutely important.
    Mr. Dunn. Okay. While I have got you there, Dr. Klotman, I 
am going to ask you about translation of VA research to the vet 
side. So that if a clinical translation, do you think that that 
is happening well? Do you think it is happening rapidly, or 
enough?
    Dr. Klotman. I think it is happening terrifically well. We 
respond, you know, scientists respond to funding opportunities. 
When you list five priorities, our scientists are focused on 
mental health, on opioid addiction, on PTSD, traumatic brain 
injury. We are trying to do AI, run facial recognition to pick 
up depression by tele-medicine. So we are very focused on 
trying to translate our work directly to patient care. But that 
is a mission, you know, of the--you look at the top 30 or 40 
medical schools that are into research, it is--we do 
translation research, that is what we are trying to do, and the 
VA does it very well.
    Mr. Dunn. So if I am a medical student--I am not going to 
go back to medical school--if I was a medical student--
    Dr. Klotman. I would feel sorry for you.
    Mr. Dunn [continued]. --you could have a--you have a 
syllabus for --and I think these three would fit--or four, top 
four priorities, or five, would fit together very neatly; PTSD, 
TBI, suicide, and opioids. I mean, that sounds like one 
chapter, get this, and read it twice. Is that--we have a 
syllabus for that?
    Dr. Klotman. Well, we don't have a syllabus per se, but we 
do encourage our students to do research with these 
investigators. One of the--we have a specialized center called 
iQuest, which is really around health and human services 
research, it is one of the biggest in the country. And we have 
25 faculty and probably 40 trainees in that group all doing 
research appropriate for veterans. It is actually funded by the 
VA and the NIH, and it is a tremendous center. So we have 
direct access for our trainees and learners to get into issues 
related to veterans.
    Mr. Dunn. Great.
    Dr. Clancy, so the same question on translation. Can you 
address that from your point of view, or maybe Dr. Ramoni? You 
choose.
    Dr. Clancy. Well, research that we publish, and support is 
highly publicized within our own system. The next step is 
obviously to make sure that that is tightly linked with 
clinical operations. And I have to say that under Dr. Ramoni's 
leadership, there has been a much, much stronger partnership 
there between the research enterprise and the people who have 
got to worry every day about how to get this done.
    We literally had all of our network leaders in town this 
week, and to say--and Dr. Ramoni was not actually there for the 
conversation--but to say they were excited about research, and 
to hear where they have taken money out of their own budgets to 
make sure that their veterans have access to the findings so 
that they can put them into practice was quite--
    Mr. Dunn. I am running short on time--
    Dr. Clancy [continued]. --wonderful.
    Mr. Dunn. --here, so I--and I want to be--I want to observe 
the limits so that I will be a good role model here. The ORIEN, 
Dr. Ramoni, are you using ORIEN for the total cancer care? Is 
that something that is?
    Dr. Ramoni. We are not--sorry--we are not yet participating 
in ORIEN, and that is in part because ORIEN and APOLLO in which 
we are participating, both are seeking the same types of 
samples.
    Mr. Dunn. Okay. You and I are going to talk offline. And I 
recognize my time has run out. I will yield to Ms. Brownley. 
Representative Brownley.
    Dr. Ramoni. I look forward to that. Thank you.
    Ms. Brownley. Thank you very much. I have just sort of a 
general overall question as it relates to the research that VA 
is undertaking. So where does one go to find out where all of 
the research, you know, what are all of the research projects, 
you know, across the country, and where is that happening? You 
know, what are sort of the subject areas? Dr. Dunn just 
mentioned a couple in terms of opioid abuse or brain injuries, 
post-traumatic stress, et cetera. But where--I don't know kind 
of what is happening on a global sense in terms of the 
research.
    Dr. Clancy. It is a great, great question, and I am so glad 
you asked. We put out a lot of information in the form of 
quarterly updates and newsletters. And I will tell you if you 
run an organization, as I did for a number of years outside VA 
that funds a lot of research, it is a bit challenging to figure 
how do you put these into buckets together in a way that is 
very, very accessible.
    I think we could do a better job. I think that in many ways 
some of the phenomenal research we are funding has become one 
of the world's best kept secrets, and we are working very hard 
to try to overcome that. Do you want to add to that?
    We also have an external research advisory committee that 
meets four times a year. So they become a very important source 
of spreading our research. But we have a lot more to do.
    Ms. Brownley. Are they like an overseer, or?
    Dr. Clancy. They are an advisory group. I think it is fair 
to say that they do give a lot of advice. And one person's 
advice might feel like someone else's oversight. But four times 
a year I think is a pretty good rhythm, and they are pretty 
current on what is going on.
    Dr. Ramoni. Hi. Thank you for your question. I would just 
like to add that all of the research we fund is available 
through ERA Commons, which is NIH reporter. So if you go to the 
NIH reporter Web site and you select VA, you can get a list of 
all the projects we fund.
    Now, as Dr. Clancy said, I think we can do a better job of 
summarizing that because I doubt with your busy schedules that 
you have time to scroll through our 2,000 funded projects. But 
what we are--what our national research advisory committee has 
advised us is that we ought to, at least on a yearly basis, 
summarize the research impact so that we can share more broadly 
with others. And we do have a breakdown of where our funding is 
going in terms of types of research that we can certainly make 
available to you.
    Ms. Brownley. And is that found on a Web site somewhere as 
well in terms of the priorities and the amount of resources 
funding as priorities?
    Dr. Ramoni. We can certainly direct you to those. I am not 
certain if they are listed on the Web site because as Dr. 
Clancy said, it can sometimes be a challenge to clearly convey 
the distinct categories. For instance, if you were looking at 
suicide risk amongst people with opioid substance use disorder, 
they would be classified under two sections. And so that is 
sometimes a challenge for us to present. But we would be happy 
to walk you through that orally as well in a briefing.
    Ms. Brownley. Yeah. And just as a, you know, a layperson 
looking into this, it seems--it just seems very complicated and 
complex in trying to, you know, pull the layers apart to kind 
of see what is there. And once you start doing that, it tends 
to get more confusing--to me, anyway--and more complicated as 
opposed to sort of understanding, you know, what are the broad 
strokes, and are we all in agreement in terms of where--what 
our priorities are in the areas in which we want to continue to 
explore. And so, anyway, it just is a general statement. I 
think for a layperson and for people to understand that we are 
actually doing research and pursuing innovations when we really 
can't translate to the public and to the communities so that 
people know that their tax dollars are going to a good purpose, 
and that we do want to resolve and solve some of these issues 
that particularly veterans are experiencing when they come home 
from the battlefield, so.
    Dr. Clancy. So I am going to take that as a charge that we 
need a greatest hits. To use an old analogy. No, but I mean, I 
am saying that with the upmost respect. It takes some thought 
and so forth to do that. But we should.
    Ms. Brownley. Very good. I see my time is out, so I will 
yield back.
    Mr. Dunn. Thank you, Representative Brownley. And since you 
yield back ten seconds, I am going to say we would all like to 
see that list of, you know, sort of--not the all 2,000 but how 
you are prioritizing, where the resources are going, and sort 
of by subject matter what they are. So thank you very much for 
that.
    We will now recognize Mr. Poliquin for five minutes.
    Mr. Poliquin. Thank you, Mr. Chairman, I appreciate it. 
Thank you all very much. It is so important to make sure that 
our research goes on with our affiliates, our academic 
affiliates, in concert with VA to make sure that we do the best 
we can for our veterans. We owe them that responsibility to do 
that.
    Dr. Klotman, I want to ask you a question. You mentioned a 
minute ago some of your research dealt with diabetes, and what 
have you. Why wouldn't the VA--why wouldn't all the research on 
behalf of our veterans focus on ailments and maladies that are 
specific to veterans like PTSD, and traumatic brain injury, and 
exposure to toxins, and so forth, so on? If you have all these 
other institutions around the country doing great work on 
cancer and diabetes, why would we spend tax payer dollars to do 
that when we can get that already?
    Dr. Klotman. So I think you have to look at the broad 
health of veterans throughout their entire life span. Yet there 
are things that are very specific to veterans, but there are 
also things that impact veterans' lives. If you look at, you 
know, the vast number of veterans that we are taking care of, 
their day-to-day problems are often common illnesses.
    Mr. Poliquin. Yeah. We have research on most of those 
common ailments.
    Dr. Klotman. But breakthroughs come from all different 
places. It is really hard to, you know, to say, well, we are 
going to have a cure for diabetes that is NIH focused.
    Mr. Poliquin. So we might be doing--
    Dr. Klotman. Another big breakthrough might come from--
    Mr. Poliquin [continued]. --we might be spending tax 
payer--
    Dr. Klotman [continued]. --VA--
    Mr. Poliquin [continued]. --we might be spending tax payer 
dollars working on diabetes for veterans where we are doing it 
at other research facilities around the country, and you don't 
think that is duplicative and wasteful?
    Dr. Klotman. No, I actually don't. I will tell you the vast 
majority of research that we do at the VA is very specific to 
veterans' problems. But--
    Mr. Poliquin. The veterans--thank you, sir. Dr. Clancy--
    Dr. Klotman. Let me just say one thing, though. If you are 
taking care of a veterans for their entire life span and you 
are trying to have them have a, you know, good outcomes, you 
have to take care of all of their illnesses.
    Mr. Poliquin. No, of course not. I am not talking about 
specific to a veteran, I am saying a malady that is specific to 
the veteran population, that is what I am referring to.
    Dr. Clancy, the VBA, the Veterans Benefit Administration, 
collects mountains of data on the 7 million veterans we take 
care of now. Do we aggregate this data, and whiteout, of 
course, who the individuals are, but aggregate this data such 
that we can use it to determine where the research should go?
    Dr. Clancy. We have some people who are beginning to take a 
very hard look at that. I guess--
    Mr. Poliquin. Do we aggregate the data, and do we use it to 
make decisions on where the research dollars should go for our 
veterans? Because anybody that collects that amount of data on 
the veterans certainly know what their problems are.
    Dr. Clancy. Yes, and we are certainly aware of where the 
greatest opportunities are in terms of--
    Mr. Poliquin. Okay. So who is aggregating--
    Dr. Clancy [continued]. --how many people apply for 
benefits.
    Mr. Poliquin. So who is aggregating that data?
    Dr. Clancy. We can take that for the record, and I will 
follow-up. It is not a routine function that feeds right into 
research priorities, but I--which is what I think you are 
suggesting.
    Mr. Poliquin. If we are looking for research on veterans 
who have problems, and we have mountains of data on what their 
ailments are, it would make sense to me that we use that 
information. So our office will get back to you to see what a 
more complete answer would be, if that is okay.
    Dr. Clancy. Yes, that would be fine.
    Mr. Poliquin. Great. Thanks. Today, Mr. Chairman, there is 
about $600 million in the VA budget that is specifically 
earmarked for medical research that is conducted either at the 
VA medical facilities around the country, about 160 of them, 
but there is an additional $1.2 billion each year, roughly, for 
veterans--for research for veteran health, and it comes mostly 
from the NIH and the Department of Defense, and they are issued 
by grants.
    This research is either conducted at the VA or at medical 
institutions, affiliates, academic institutions, universities 
like Baylor, great universities like Baylor, across the 
country. Now there are, if I understand this correctly--and, 
Ms. Rusconi, you are going to correct me if I am wrong, I am 
sure--there are roughly 150 individuals across the country that 
make decisions where the administration of those research 
projects go.
    Either through you folks, through the NPCs, or they are 
administered actually through the research organization 
themselves. I think they are called investigators. And I think, 
Ms. Ramoni, you came to us several months ago, and you used to 
be an investigator. And, Mr. Klotman, you might be one now, I 
don't know.
    But my point being this. If an investigator is an employee 
of the VA, and also an employee of say Harvard--my alma mater, 
so I am not picking on Baylor--and they all of a sudden are an 
individual, he or she, whose career is dependent upon how much 
tax payer dollars they can come to that institution, whether 
you are Baylor or Harvard, or Yale or Stanford, whatever it 
might be, but they are also in a position to determine who gets 
the administration dollars for that project. Now, up in Maine, 
where I come from, that is a conflict of interest. And here is 
why that matters.
    Let's say you have a $10 million grant from the NIH. The 
administration cost is an add-on to that grant. Now if I am not 
mistaken, over at the NPCs that were formed 30 years ago 
specifically for this reason, your add-on cost is roughly 25, 
26 percent. So that is $2-and-a-half million on a $10 million 
grant to develop whatever it might be, a new prosthetic. 
However, now places like Harvard, my understanding--
    Mr. Dunn. Mr. Poliquin.
    Mr. Poliquin [continued]. --is that the add-on cost--
    Mr. Dunn. Mr. Poliquin.
    Mr. Poliquin [continued]. --is roughly 70 percent.
    Mr. Dunn. Mr. Poliquin?
    Mr. Poliquin. Yes, sir.
    Mr. Dunn. Your time is expired, but I like your line of 
questioning. I encourage you to pursue that.
    Mr. Poliquin. Great. Would you like to, or anybody else 
like to give their time to me? Mr. Chairman.
    Mr. Dunn. I will give them their opportunity when your time 
comes. All right. So that will be the next.
    Mr. Poliquin. Thank you, sir.
    Mr. Dunn. Representative Kuster, you are recognized for 
five minutes.
    Ms. Kuster. Thank you very much, Mr. Chairman, I appreciate 
it. And thank you to all of our witnesses for being with us. I 
want to also thank you for mentioning the LUKE arm in your 
testimony, Dr. Clancy. We are very proud in New Hampshire of 
the development of the LUKE arm, and I have had a chance to see 
it in action, and it is really very impressive.
    I wanted to hone in on the conversation about, our Chair 
today has mentioned PTSD, traumatic brain injury, opioid 
addiction. I am the Chair of a bipartisan task force in 
Congress, we now have 105 Members working together, Republicans 
and Democrats, on legislation to combat the opioid epidemic, 
and I know that there is research being conducted, Congressman 
Brownley referenced a study out of Minnesota. It would be very 
helpful for us, and I would even like to ask our Chairs of the 
Health Committee, and the Subcommittee, and the Oversight 
Subcommittee, if we could put together a session that I would 
be happy to organization with members from the task force to 
talk about lessons that can be learned to reduce the use of 
opioid medication.
    But in that regard, can you talk a little bit more about 
how this research is getting from the lab to use across the VA? 
And then what we would like to do, I am working on legislation 
about a center of excellence, so that we can then take those 
lessons learned into the civilian population.
    Dr. Clancy. So it is a great question, and, frankly, we use 
any vehicle that we can. So, for example, in terms of treating 
chronic pain and the use opioids, we have an evidence-base 
guideline that we develop in collaboration with the Department 
of Defense because it speaks to the unique injuries and 
experiences of active duty members as well as veterans.
    So that becomes one--because those guidelines are updated 
almost continuously to make sure that they have all the current 
evidence, that becomes one great vehicle to incorporate our 
latest research. I think that your idea of having such a 
session would be phenomenal because there is a lot going on in 
three areas.
    One is, what other alternatives do we have to opioids? A 
second is, what nonpharmacologic in terms of chronic pain 
management, which the whole country is struggling for, and a 
bigger problem for our veterans. And the third is, how do we 
help people who are addicted actually begin to return to a 
functional life?
    Ms. Kuster. And if I could just add to the list, a fourth 
would be the CDC has recognized that four out of five heroin 
users have co-occurring mental health issues--
    Dr. Clancy. Yes.
    Ms. Kuster [continued]. --and I think that veteran 
population, with the anxiety, depression, traumatic brain 
injury, we are finding in the civilian population trauma. For 
example, sexual assault, domestic violence trauma. So I think 
there is a lot to be learned, and you can tell from 105 Members 
of Congress coming and working together right now, this is very 
rare, and you can tell the urgency and the breadth of this 
problem across the country. So love to work with you on that.
    I guess my other question, I am very familiar, Dartmouth 
Medical School is my district, I work a lot with them, and they 
are the academic affiliate for White River Junction VA and 
hope--we are working on an affiliation, hopefully, with our 
Manchester VA that has had some troubles. I am familiar in the 
private sector in the civilian world that we have, for example, 
the New England Journal of Medicine, that physicians can stay 
current on research that is published. Is there a corollary 
from VA research where physicians can stay current based upon 
research results that are published?
    Dr. Clancy. So we have a terrific dissemination center that 
is part of the Office of Research and Development, and they 
will routinely put out surveys of research, which is--not 
surveys, I am sorry, summaries of research that has just been 
published and so forth which is extremely helpful, they will 
usually give you the electronic link. So if the journal makes a 
free access, right then you have got it. And I was literally 
looking at one on the way over here.
    Some of our work is also going to get into something at NIH 
called Medline Plus, which actually translates into something 
closer to plain language English, I don't want to over-state 
this, sort of abstracts of published studies and so forth. 
Whether we can and should do more, we share a lot of cutting-
edge findings with our veteran's service organizations and so 
forth. But I am sure that there is more that we could do.
    Ms. Kuster. So my time is, but I think I would join my 
colleagues in saying that we would be very interested in 
accessing those preferably plain English versions to understand 
so that we can share with the tax payers the incredible 
advances that are coming out of the VA. And I yield back.
    Mr. Dunn. I thank you very much, Ms. Kuster.
    Representative Higgins, we recognize you for five minutes.
    Mr. Higgins. Thank you, Mr. Chairman. I would like to yield 
a minute of my time to my colleague Mr. Poliquin.
    Mr. Dunn. You are recognized.
    Mr. Poliquin. Thank you, Mr. Higgins, very much, I 
appreciate it.
    We have already determined that at NPCs the add-on cost for 
administration is roughly 25, 26 percent. Mr. Klotman, what is 
the add-on cost of Baylor?
    Dr. Klotman. 56.5 cents.
    Mr. Poliquin. Say it again, sir.
    Dr. Klotman. 56.5 cents.
    Mr. Poliquin. 56.5. Ms. Rusconi, what is the difference 
between the administrative functions you provide for research 
down at the VA and the administrative that the folks at Baylor 
do, or at Harvard, or Yale, or anybody else? Is the service 
essentially the same? Does it include doing the paperwork, and 
paying the bills, and ordering supplies? Do I have that right?
    Ms. Rusconi. For the most part I would agree. At our VA, 
our VA actually has--takes care of all of the RIB and all of 
the services that were described.
    Mr. Poliquin. Thank you. Mr. Klotman, who determines 
whether it is 56 percent or 70 percent?
    Dr. Klotman. The NIH. The NIH comes--the HSS comes and does 
a very complete audit, which it is like everything--
    Mr. Poliquin. So it is NIH?
    Dr. Klotman. Yes, it does.
    Mr. Poliquin. Whoever awards the grant, they determine what 
you are going to get paid?
    Dr. Klotman. We negotiate with them every three years, and 
we show our costs. I mean, it is very rigorously reviewed, the 
costs of oversight and research. The differences are often what 
services you are providing. So we, you know, we provide IACUC, 
IRB, all those real--those are real costs that--
    Mr. Poliquin. Ms. Rusconi, do you provide the same services 
they do at the academic affiliates?
    Ms. Rusconi. Actually, at the Kansas City VA we provide the 
IACUC, the IRB, and the R&D for our facility as well as the 
facility in Wichita, Kansas, and we provide--
    Mr. Poliquin. Okay.
    Ms. Rusconi [continued]. --the IRB--
    Mr. Poliquin. Okay.
    Ms. Rusconi [continued]. --and for--
    Mr. Poliquin. Thank you. We are stewards of the tax payer 
dollars, we are $21 trillion in debt, the interest payments on 
that debt are about $240 billion a year, that exceeds our 
entire budget by the VA by about 40 percent. Every dollar 
counts.
    Mr. Dunn. Mr. Poliquin.
    Mr. Poliquin. What I am trying to determine is, we have got 
two folks--
    Mr. Dunn. Mr. Higgins--
    Mr. Poliquin [continued]. --providing the same service--
    Mr. Dunn [continued]. --will you yield another minute--
    Mr. Poliquin [continued]. --but one is--
    Mr. Dunn [continued]. --to Mr. Poliquin?
    Mr. Poliquin [continued]. --twice the cost of the other, 
and I am trying to figure out why.
    Mr. Higgins. I already have.
    Mr. Poliquin. Sorry, Clay. Thank you, Clay.
    Mr. Dunn. One more minute.
    Dr. Klotman. I would just say, you should look at the 
services provided. I mean, this is a real menu of costs, these 
are not fictitious costs, they are real overhead. Just in the 
same way you come to this building--
    Mr. Poliquin. And whoever issues the grant, NIH DoD, they 
determine what your costs will be in negotiate with you, 
correct?
    Dr. Klotman. Correct.
    Mr. Poliquin. Okay.
    Dr. Klotman. And the grants--a point you made before about, 
it is the individual and the conflict of interest. The grants 
are administered to the institution not to the individual.
    Mr. Poliquin. No, but the individual--
    Dr. Klotman. It is in the name of the institution.
    Mr. Poliquin [continued]. --who's the investigator at the 
institution can also award the administration to you.
    Dr. Klotman. The--
    Mr. Poliquin. Is that correct?
    Dr. Klotman. Well, that is not really accurate. For NIH it 
is the grant is awarded to the institution on behalf of the 
individual. The expectation is that the institution supervises 
and oversees the research, and that the spending is responsible 
within--
    Mr. Poliquin. And who determines where that 
administration--administrative dollars go? Does the NIH or does 
the investigator?
    Dr. Klotman. The NIH determines where it goes, it is not 
the individual investigator. With an individual--
    Mr. Poliquin. That is not what Dr. Clancy and Dr. Ramoni 
told me.
    Dr. Klotman. No, if there is an individual who has shared 
time, every two weeks they have to fill out their activities 
report, and if--the amount of time that is covered at the VA is 
covered by the VA, and the amount of time that is covered by 
the NIH is covered by the NIH. There is no overlap of the two.
    Mr. Poliquin. Okay. So you don't think it is a--
    Mr. Dunn. One moment, Mr. Poliquin. Representative Higgins, 
you have three minutes remaining. Do you--
    Mr. Higgins. (Inaudible).
    Mr. Dunn. Then you are recognized for three minutes, 
Representative Higgins.
    Mr. Higgins. Thank you, Mr. Chairman. And God bless you my 
colleague, Bruce.
    Dr. Clancy, you may recall, madam, we met in my office, and 
we briefly discussed inclusion of urgent care facilities as a 
means by which veterans could access care in their community. 
The VA mission act passed the House of Representatives 
yesterday. If signed into law, will this provision and the 
precedence set by the recent launch of urgent care access for 
veterans in Southern California, will that provide the VA 
adequate authority to expand access to these walk-in urgent 
care facilities in other regions? I have been advised that it 
would. Thank you for that answer.
    Dr. Clancy. Yes.
    Mr. Higgins. My larger question to you, Dr. Klotman, you 
mentioned some of the research being tele-medicine using facial 
recognition for depression. I have an overall concern about a 
culture of over prescription, of pharmaceuticals, for our 
veterans; opioids, anti-depressants. And when investing money 
that has been harvested from the people to pay for research, 
and I am a big supporter of tele-medicine, I think it is 
wonderful, I have large rural communities in my district, but 
facial recognition for depression, how would that determine the 
difference between temporary depression or normal moments of 
sadness, or reflection, a contemplative somber moment, how 
would that differentiate from the diagnosis of clinical 
depression which could lead to further over prescription of 
pharmaceuticals into our veterans population? I am very 
concerned--
    Dr. Klotman. No, I understand.
    Mr. Higgins [continued]. --about the culture we have 
created within our veteran populations that our goal should be 
to get them back into a state of productive--
    Dr. Klotman. I agree.
    Mr. Higgins [continued]. --participation in society, and 
yet we are building barriers for them to return to work, and 
return to society, as a productive citizen because of the 
pharmaceuticals that we prescribe.
    Dr. Klotman. Well, I think you have hit upon a national 
problem, you are absolutely right. The study that is currently 
ongoing is to do exactly what you said, can you sort out a 
situational--
    Mr. Higgins. Are we working on non-medicinal treatment--
    Dr. Klotman. Oh, yeah.
    Mr. Higgins [continued]. --research for PTSD, for instance?
    Dr. Klotman. Absolutely. Absolutely, yeah.
    Mr. Higgins. Service dogs--
    Dr. Klotman. And the other thing--
    Mr. Higgins [continued]. --exercise, group therapy, et 
cetera?
    Dr. Klotman. And it is hard for veterans sometimes to come 
to the VA. The whole purpose of this is getting more continuous 
follow-up so you can detect problems sooner. I mean, the idea 
is to improve their lives in ways that are not drug dependent. 
Absolutely.
    Mr. Higgins. Thank you for your answer. And I would also 
like response, perhaps in writing, from my colleague brought 
up, Mr. Chairman, regarding where exactly can we observe what 
research is taking place across the country and what the nature 
of that research is. I yield back.
    Mr. Dunn. Your question is noted, Representative Higgins.
    Representative Lamb, you are recognized for five minutes.
    Mr. Lamb. Thank you, Mr. Chairman.
    Dr. Clancy, by way of greatest hits, I just wanted to note 
back in Pittsburgh in a VA that is not actually in my district, 
but it is near it, and it takes care of many of veterans from 
our district, we had the development of a pneumatic wheelchair 
powered by an air motor, Dr. Rory Cooper, we are very proud of 
that.
    The chair only weighs 80 pounds, and it can be used--it is 
waterproof basically. So one of the things they have used it 
for is kids with disabilities go to water parks and they use 
it, veterans as well. So that was a great achievement by our VA 
research in Pittsburgh at the human engineering research lab. 
So I think that is a good one to highlight. It has made a big 
difference in people's lives. It is easier for family members 
to carry it around because it is so light.
    One concern that I have heard expressed from folks back in 
Pittsburgh is that in the Office of Research and Development, 
there tends to be a lot of resources behind the research side 
of it and less behind the development side of it. So I will 
just throw it open, maybe either Dr. Clancy or Dr. Ramoni, have 
you heard that concern before from people within the system?
    Dr. Ramoni. Thank you, Congressman Lamb. That is, as you 
heard, one of my three priorities is to increase the real-world 
impact of VA research. And, in fact, in collaboration with Dr. 
Rory Cooper's lab in Pittsburgh, and I had the pleasure of 
visiting it and using that pneumatic wheelchair which is really 
a remarkable invention, we are establishing a development 
pipeline with him.
    Often the first step is producing enough of a thing such 
that you can get buy in to produce it more broadly. For 
instance, to have enough versions of that pneumatic wheelchair 
such that a company might want to pick it up and produce it and 
distribute it. So we are entering currently into a partnership 
with Dr. Cooper's lab in order to do that.
    In addition, we are taking a number of other steps to 
ensure that we move from bench or lab to bedside more quickly. 
We are, in the basic science space, funding actual development 
dollars to conduct toxicology studies which are the gap between 
the bench research and moving into clinical trials. So we have 
a broad-based effort to take more of our in-lab developed 
innovations and move them out where veterans can benefit from 
them.
    Mr. Lamb. What is kind of the number one thing that we can 
do to support that to make it easier?
    Dr. Ramoni. Well, it is certainly companies--I would say 
one of our great challenges is that sometimes veterans have 
very specialized needs. And so, for instance, an upper limb 
prosthesis, some companies might not find it financially 
attractive to proceed in those spaces. And so any help that, 
frankly, and party can provide to us in helping to overcome 
that barrier would be wonderful.
    As an alternative, we are looking at, in those cases, could 
we as a department, and obviously this would be outside of 
research and development, could we actually produce those items 
for our veterans if no for-profit company is willing to step 
into that space.
    Mr. Lamb. In addition to just overall more funding for 
research, are there specific programs that could use a shot in 
the arm to improve that transition that you are talking about?
    Dr. Ramoni. So in technology transfer, and, of course, 
people know a GAO report came out recently, and that is an area 
of intense focus for us, we are doing a fantastic job on 
getting invention disclosures. The machinery to then actually 
market those inventions to producers is something that we are 
building. And so that area in particular will help us go from 
invention to actual real-world use by veterans.
    Mr. Lamb. Great. And I yield back the remainder of my time, 
Mr. Chairman. Thank you.
    Mr. Dunn. Thank you very much, Mr. Lamb.
    Mr. Arrington, you are recognized for five minutes.
    Mr. Arrington. Thank you, Mr. Chairman.
    I want to follow along the line of my colleague Mr. Lamb. I 
was former vice chancellor for research and technology 
commercialization at Texas Tech, believe it or not. It is 
complicated, and it is challenging to get an early-stage 
technology to market. It takes a lot of time, it takes a lot of 
capital, it takes an entrepreneurial team. Not many 
universities are culturally aligned with sort of this sort of 
entrepreneurial dynamics that exist in the marketplace. So you 
got to really wire it well. There are some sophisticated 
ecosystems at Stanford, and Boston, and some other places, but 
it is very, very difficult.
    Personally, my take on this is get it out, get it out of 
the VA, for God's sake. And I am just saying that because it is 
a big bureaucracy, and it is not entrepreneurial or innovative, 
but there could be some great discovers. I think relatively 
speaking, it is just universities don't have that very well. 
The best way to commercialize it is get it to a start-up 
company, get it to an established industry partner and let them 
run with it, and make sure that we take a piece of the action 
to evergreen the research.
    Speaking of that, what are the deals that we made? How 
many--you said disclosures have increase, so what about revenue 
from--what about license agreements? Are they going up or down? 
Sorry, you, Ms. Ramoni.
    Dr. Ramoni. Rachel. Yes. So thank you for your question. It 
is an area that is a very high interest to me not only for the 
revenues but also because this means that these products are 
out there where veterans can benefit--
    Mr. Arrington. Exactly.
    Dr. Ramoni [continued]. --from them.
    Mr. Arrington. But if there is no financial motive they 
won't do it. Just let's be clear.
    Dr. Ramoni. Absolutely.
    Mr. Arrington. So how many license agreements? Are they 
going up or down, or are they flat?
    Dr. Ramoni. They are going up. And I have the facts and 
figures in here. But I can tell you, in terms of royalties, and 
if you read the GAO report, it is a pretty stark description of 
where we are now, or where we were. Back in 2016, we just had 
$300,000 in royalties. And I have to say, historically that--
    Mr. Arrington. 300, how much?
    Dr. Ramoni. Thousand dollars in royalties.
    Mr. Arrington. That is it?
    Dr. Ramoni. Yes. And that is what I am saying. It is a 
pretty stark--
    Mr. Arrington. How many annual disclosures do you get of 
potential IP--
    Dr. Ramoni. We get hundreds--
    Mr. Arrington [continued]. --potential marketable product?
    Dr. Ramoni. Over 500 disclosures.
    Mr. Arrington. Over 500?
    Dr. Ramoni. That is right.
    Mr. Arrington. So I would say that is--
    Dr. Ramoni. Yes. And I do want to add that--
    Mr. Arrington. How long have you been in this space of 
technology transfer within the VA?
    Dr. Ramoni. Well, I have just been--
    Mr. Arrington. Not you personally, the VA in general.
    Dr. Ramoni. So the VA, I think the--certainly the attention 
that the VA receive from the House Veterans Affairs Committee 
surrounding the Shanaze hepatitis C treatment brought greater 
attention, and we are grateful for Mr. Bergman having written 
to the Secretary to increase our number of staff in tech 
transfer. So it has been a relatively recent growth in our tech 
transfer team, and we got a new head of tech transfer--
    Mr. Arrington. I would outsource it.
    Ms. Ramoni [continued]. --tech transfer team.
    Mr. Arrington. I would give it to a group that does that, 
that that is their core competency. They do that for a living. 
They have the connections with the money guys. They have the 
connections with the industry. They move at the speed of 
business. I just would do it.
    I mean, I must say, 500 disclosures--
    Ms. Ramoni. Yes.
    Mr. Arrington [continued]. --and $300,000 in revenue--
    Ms. Ramoni. Yeah, I know.
    Mr. Arrington [continued]. --is paltry.
    Ms. Ramoni. I--
    Mr. Arrington. And it is--I am not blaming you. I just 
don't think it is aligned with the core mission.
    Ms. Ramoni. Well--
    Mr. Arrington. We have got to have incentives to get 
these--this IP to--into the right hands, where they can raise 
the capital, take it to market, and make a difference. They 
will never make a difference, in my opinion, inside the VA 
culture. It is not wired for that. And it is--
    Ms. Ramoni. Right.
    Mr. Arrington [continued]. --not an indictment on your 
skills and competency. It is just a culture reality.
    Ms. Ramoni. I agree with you--
    Mr. Arrington. What is the--
    Ms. Ramoni [continued]. --entirely.
    Mr. Arrington [continued]. --let me just jump to Clancy--
for
    Dr. Clancy. What do you--how do you measure success? And I 
am not trying to be rude. I just--it is time. We don't have a 
lot of time. So what--how do you measure success among your--
the researchers that you give taxpayer money to, to discover?
    Dr. Clancy. Sure. So broadly, that would be publications, 
of course. It would be who else or what other entities have 
picked up those publications. So for example, if work published 
becomes part of a Medicare quality measure, that is going to 
have a big impact--
    Mr. Arrington. Does--
    Dr. Clancy [continued]. --and get out and so forth.
    Mr. Arrington [continued]. --transferring the technology, 
to commercializing the technology, is that a metric?
    Dr. Clancy. That has to be a metric.
    Mr. Arrington. Is it a metric of success? Do you--
    Dr. Clancy. Yes, yes.
    Mr. Arrington [continued]. --hold people accountable for 
that?
    Dr. Clancy. Do we hold them accountable? Not yet. I want to 
be clear. Under Rachel's leadership, just in the past two 
years, we are on an upward curved for sure. I would love to 
have the opportunity to follow up with you, your staff, about 
what might be some options for who else we could partner with 
to make this happen. Some parts of the government have small 
business innovation research, and a variety of mechanisms that 
we actually do not have.
    But that is just one that occurs to the top of my brain. I 
am sure there is a variety of other mechanisms, and given your 
experience, I think it would be a great--
    Mr. Arrington. I would love to--
    Dr. Clancy [continued]. --opportunity to follow up on.
    Mr. Arrington [continued]. --sit down with you. I want it 
to be successful, and I am over my time.
    If you have a second round, I am going to stick around.
    Mr. Dunn. And to that point, we will have time for a second 
round. I encourage you to stick around and take advantage of 
that.
    Mr. Arrington. Thank you, Mr. Chairman.
    Mr. Dunn. These are great questions.
    Mr. Arrington. Sorry to abuse my--
    Mr. Dunn. But I will recognize now, for five minutes, 
Representative Rice.
    Ms. Rice. Thank you, Mr. Chairman. The Vietnam Veterans of 
America's statement for the record raised an issue about 
limited VA funded research for certain health conditions that 
are of immediate consequence to veterans, citing the long-term 
effects of Agent Orange exposure as an example. That remains 
significant for Vietnam war veterans. And conditions stemming 
from military exposure, such as toxic substances from burn pits 
for Iraq and Afghanistan veterans.
    This point relates to an issue that has been raised by 
veterans in my district, in New York, on Long Island, regarding 
exposure to liver fluke in Vietnam which is a parasite 
prevalent in Southeast Asia known to cause a certain type of 
cancer that can take, literally, decades for--I mean, I am 
telling you. You guys know this--for symptoms to appear.
    The VAMC in Northport, which is further out on Long Island, 
conducted the first ever pilot study on liver fluke in Vietnam 
vets through a partnership with an academic medical center in 
South Korea, which was privately funded after the VA declined 
to fund the study. For veterans who are just starting to show 
the long-term effects of something that they were exposed to in 
Vietnam, this type of health condition, obviously, is of 
immediate concern.
    So to any of the panel Members, this concern that the VA is 
not funding research for certain health issues that are of 
immediate consequence to veterans--and now, while I may admit 
that this--the effects of liver fluke might relate to a small 
population of veterans, they still served this country, and are 
suffering this condition because of their service.
    So if anyone can answer that question as to why the VA is 
not funding research for certain health issues that are, right 
now--and for that matter, the Iraq and Afghanistan veterans, 
that are of immediate consequence to veterans?
    Dr. Clancy. Well, thanks to your support--that is of the 
Congress, right? We are funding a burn pits registry, and I 
have been really seriously impressed by the enthusiastic 
response from veterans in terms of their enrolling in this. And 
one of Dr. Ramoni's five priority areas for the additional 
support we got through the omnibus is actually to focus on 
exposure to Agent Organ and the impacts among Blue Water Navy 
veterans.
    The liver fluke issue is quite interesting. I would say it 
is fair to say that one can find lots of examples, not just at 
VA but elsewhere, where somebody turned down a very novel, kind 
of, research product at one point in time or in--what was 
something that in--overtime turned out to be very, very 
consequential.
    The word is out among veterans. One of the challenges we 
have is that we do not, at this moment in time, as I understand 
it, have a commercially available test to be able to test for 
that. So many veterans are coming in to see their docs, saying 
``I want this test because I read about this research.'' So we 
need to find out more about that, and we would be happy to 
follow up with you.
    Ms. Rice. Well, thank you. I would ask--
    Dr. Clancy. And I know that Rick is very interested.
    Ms. Rice. Yes, thank you. Final question, then I will give 
whatever time I have to Mr. Poliquin, if he wants it.
    What steps can the VA take to standardize and eliminate 
delays associated with the ISO reviews, to advance clinical 
trials, and support successful research partnerships?
    Dr. Clancy. ISO with you.
    Ms. Ramoni. Thank you for your question. As you might have 
heard, we held a summit on April 12th with a broad variety of 
stake holders to look at all the barriers that prevent us from 
starting up clinical trials, especially industry trials, 
efficiently.
    One of those was the information security officer review, 
and I am very happy and proud to say that we now have three 
research specific information security offers--officers in 
place, and I have been receiving e-mails from the field that 
say that this transforms everything, and this, when we 
announced it at the summit, received a standing ovation. So
    Ms. Rice. Well, that is great.
    Ms. Ramoni. --we are pleased to have addressed that.
    Ms. Rice. Great, great. That is great news. And I have 51 
seconds for my friend Mr. Poliquin--
    Mr. Poliquin. Thank you.
    Ms. Rice [continued]. --with the Chairman's approval.
    Mr. Dunn. You are recognized for 46 seconds.
    Mr. Poliquin. Thank you very much, Congressman. I have in 
front of me the May report of the Inspector General at HHS. Let 
me read this to you, if I may.
    ``The Department of Health and Human Services, which is the 
parent organization for the National Institute of Health, and 
under that is the Division of Financial Advisory Service, DFAS, 
is the Federal agency responsible for negotiating and 
establishing indirect cost rates, i.e. administrative rates, 
for non-profit organizations, our affiliates, academic 
affiliates, that receive the majority of the Federal awards 
from HHS.'' And their conclusion in part, ``DFAS did not always 
comply with Federal requirements for establishing indirect cost 
rates.''
    So I am very suspect that the process that is used to 
determine the rates between our affiliates in the Federal 
government is up to snuff. But with that, thank you very much 
Congressman Rice. I know we are going to have a second round, 
if I am not mistaken, Mr. Chairman.
    Mr. Dunn. There will be a second round.
    Mr. Poliquin. Thank you.
    Mr. Dunn. I now recognize General Bergman for five minutes.
    Mr. Bergman. Thank you, Mr. Chairman. You know, we are 
overloaded with acronyms around here. We would like to give you 
a new one; RTR, Research to Results.
    So having said that, as you look at where you are, because 
we see--I see a lot of familiar faces at the testimony table, 
and you see at the front end of the food chain with those doing 
the research, we see you all the time. Why don't we see them? 
That is okay. It is a rhetorical question. I can tell, stunned.
    No, the point is the--we have all played the game where you 
start the message around the room and by the time it gets 
back--and this Committee, you know, bipartisan, we want to get 
to the bottom line very quickly. Not that they have to come 
here and testify, but I would suggest to you that most of the 
Committee Members here would be more than willing to devote 
some time to walk right into a research lab because of the fact 
that we get to talk with the people right then, right there.
    So when front end, those literally in the labs doing the 
research, to this end where we are doing, you know, the 
testimony if you will, as far as the results--again, I will 
just speak for myself. I like to see the amount of layers that 
this goes through, and where it gets scrubbed, where it gets, 
you know, redirected. So the point is, we can do better.
    Dr. Clancy, do you think the VA, NIH, and possibly DoD are 
duplicating research?
    Dr. Clancy. Having run a research agency for a number of 
years, for HHS, I can assure that a very key part of all 
applications submissions is saying where else that you are 
funded, and if you are untruthful about that, that is fraud and 
a reason to withdraw support. So by and large--and we have 
people that check that all the time. So I don't think that they 
are duplicating research.
    What I worry about more is gaps, and that is where we have 
been reaching recently far more to the NIH, to Defense, and so 
forth, to figure out ``Okay. Here is all this great stuff''--
    Mr. Bergman. So the point is--
    Dr. Clancy. Yes.
    Mr. Bergman [continued]. --if we were to say, ``Okay. Can 
you give us an example over the last four or five years of 
where a--this review board or whoever the folks were, you could 
produce a list of said, ``Okay? You know, Houston and New York 
are doing this overlap, and we said no to one of them.'' I 
mean, is there some kind of data that we could get?
    Dr. Clancy. In general, that is almost always going to be 
handled before it even gets to peer review by a scientific 
committee. If it doesn't get handled then, it is going to get 
handled before--
    Mr. Bergman. Are there records? I mean, of the peer--I 
mean, the bottom line is, when someone is sitting at a desk, is 
asked to look at a couple different proposals and says, ``No, 
we are already doing it here,'' is there data that we can pull 
up that says that?
    Dr. Clancy. If it looks--I can't speak for NIH, but could 
find out for you, and I don't know if we have that kind of 
record. I know that in general, we feel like the opportunities 
greatly exceed available resources, which is not intended to 
sound ungrateful. But it also means that--
    Mr. Bergman. Well, that--but that is more of a reason--
    Dr. Clancy. Exactly.
    Mr. Bergman [continued]. --because if you have more 
opportunities than you do have resources, we have to ensure 
everything--
    Dr. Clancy. Yes.
    Mr. Bergman [continued]. --we do does not accidently 
overlap something that is already being done, because we are 
dealing with finite resources here that we have to focus on 
that research that is going to directly benefit our veterans in 
the long term.
    I would like to, just for a second here, to expand on Mr. 
Poliquin's line of questioning. You know, Dr. Clancy, in many 
instances, a researcher who decides which entity, the VA or the 
affiliate, will administer the NIH or DoD grants. Do you think 
allowing the researcher to make the decision creates a conflict 
of interest? And if so, what can the VA do to eliminate that?
    Dr. Clancy. I think that it may be perceived as a conflict 
of interest, which the distinction between those two, I think, 
is negligible. At--
    Mr. Bergman. A lot of cases, they have dual appointments. 
Do you think there is any pressure being put on, in some cases, 
because you have a dual appointment? You are basically working 
very hard, but you can only serve one master, but you might be 
serving two.
    Dr. Clancy. Whether people perceive that there is implicit 
pressure, for example in the form of promotions and tenure and 
things like that, I can't say. I think the study we are doing 
now will shed some light on that in terms of how those 
decisions are made.
    Mr. Bergman. When do you think that study will be done?
    Dr. Clancy. Rachel? When will the WESTAT study be done?
    Ms. Ramoni. The WESTAT study will be complete by the end of 
September, sir.
    Mr. Bergman. Great. I look forward to that. And I am going 
to give you back ten seconds, Mr. Chairman.
    Mr. Dunn. Thank you very much, General Bergman. So we have 
finished the first round of questions. We are blessed to have 
some time left on the clock. We would like to go about around 
and allow additional questions. So in--clearly, there are 
passionate and interested people here on the dais. 
Representative Brownley, I recognize you for five minutes.
    Ms. Brownley. Thank you. Dr. Clancy, I wanted to ask you a 
question. Congress authorized two major medical leases at Heinz 
and Albuquerque focused on research activities. To date, 
neither lease appears to have been executed by the department, 
and in fact, VA has told stake holders that it is engaged in 
procuring a contract to re-examine the requirements for the 
Heinz location.
    This is concerning because Heinz researchers are located, 
my understanding, in a century-old building. Additionally, in 
this year's President's Budget Submission, VA removed a request 
for a lease for a research facility in San Francisco. I am 
concerned that VA is not taking action to ensure that VA 
researchers and partners have access to modern facilities to 
conduct research which we know is a major plus in VA for 
recruiting clinicians.
    Can you tell me what the status of the three leases, and 
what assistance you might need from Congress to move forward on 
these leases for which you clearly identified a need as 
recently as a year ago?
    Dr. Clancy. I will take that for the record and get back to 
you promptly. I don't know the status of the current leases. I 
do know that the San Francisco VA is now engaged in a 
partnership to move major chunks of their facility. So I can 
imagine that might have led to a delay or pause in the 
additional research space, but for Heinz and Albuquerque, I do 
not know.
    I do note to Mr. Poliquin and the Chairman Bergman's 
questions that some of the issues around space and available 
research space have something to do, I believe, with where the 
indirect costs are actually administered on occasion. But we 
will get--
    Ms. Brownley. If you could get back--
    Dr. Clancy. Of course.
    Ms. Brownley [continued]. --to me on that, I would 
appreciate it very much.
    And Dr. Klotman, in your testimony, you said ``To duplicate 
services such as numerous oversight and review services, if NIH 
grants were to instead be managed by the NPC, would produce no 
additional value and be a wasteful use of tax dollars.'' Can 
you expound on that?
    Mr. Klotman. Well, I think it depends and, again, each 
institution is a little bit different. We do--and in part 
because we were--we have this long relationship with the VA 
dating back to the, you know, mid-40s. A lot of the research 
infrastructure was generated on the Baylor College of Medicine 
side.
    If, for some reason now, it was, ``Well, let's have it all 
administered by the not-for-profit entity,'' they would have to 
duplicate a lot of things that we are doing. They would have 
to--the Oversight Committees, the IRB, everything, including 
bringing on and recruiting faculty, and educating them as to, 
you know, ethical conduct of research. There is just a lot 
infrastructure that would have to be duplicated to do that, and 
that is why I think it is duplicative in our case, but not in 
all cases.
    Ms. Brownley. Yeah.
    Mr. Klotman. But in our case.
    Ms. Brownley. Ms. Rusconi, do you--would you like to 
comment?
    Ms. Rusconi. Yes, I would really like to respond to that. I 
applaud what they have going on down at Baylor. We absolutely 
would not ever want to upset a system that from all appearances 
is working very, very well, both for the VA, the non-profit, 
and for the affiliate. There is no reason to change that, but 
there are many, many other situations throughout the country 
where that is not happening, and that is part of our concern.
    There are also other models besides what is happening at 
Baylor, like in California, where some of those services are 
split between the VA and the affiliate, and also where there is 
a different format for the submission of grants. If the 
predominance of the work is occurring at the VA, then the non-
profit takes the lead. If the predominance of the work is 
taking place at the affiliate, then the affiliate takes the 
lead.
    And that has worked out very well, and honestly, the most 
profitable--for the most part, the most profitable NPCs are 
actually on the West Coast and they benefit greatly from that, 
and their VAs benefit greatly from that. For instance, they get 
infrastructure and many other things, like buildings and all 
those other pieces that the non-profit can contribute to that 
VA.
    Ms. Brownley. Thank you for that, and I yield back.
    Mr. Dunn. Thank you, Representative Brownley. 
Representative Poliquin, you are recognized for five minutes.
    Mr. Poliquin. Thank you very much, Mr. Chairman. Ms. 
Rusconi, if the NPC in your case is awarded the administrative 
work for research done at the VA, if you don't use all those 
dollars in the administration of that project, does that go 
back to the VA?
    Ms. Rusconi. I don't think I understand the question.
    Mr. Poliquin. If in the administration of the project or 
the project itself, the research project itself, if all the 
funds are not consumed for that project, where does the money 
go?
    Ms. Rusconi. If it is a Federal project, the way that it is 
done is we--the administrative body, whoever it is, whether--
    Mr. Poliquin. Yeah.
    Ms. Rusconi [continued]. --it would be the affiliate or the 
NPC, they have to expend those costs first before they get 
reimbursed. And so we would not be able to draw down those 
funds. So that is--
    Mr. Poliquin. So it stays in the VA?
    Ms. Rusconi. Well, it doesn't go to the VA. It would never 
leave the NIH. So if we had a researcher that had $50,000 
grant--
    Mr. Poliquin. Okay. Thank you.
    Ms. Rusconi [continued]. --that is what would happen, but 
if--
    Mr. Poliquin. Thank you. Dr. Clancy--and I don't want to be 
rude, Ms. Rusoni. We just have a limited amount of time.
    Dr. Clancy, if Harvard--to pick on Harvard a little bit, my 
Alma Mater. They are a great school. If they win a--they apply 
for and receive a $10 million grant from the NIH, they receive 
the money, they are doing the research, and they don't--and 
also, the investigator is working for the VA and for Harvard. 
So the investigator says, ``No, we are going to do the 
administration also,'' which I think is an inherent conflict of 
interest. We have already discussed. Is that if--and that is--
and their markup, I guess, is 70 percent. So you are talking 
about $10 million for the research, $7 million for the add-on, 
administrative add-on.
    If that money in either case is not used, does Harvard keep 
it? If the research project ends without spending the $10 
million, do they keep it, or do they return it to the VA, or to 
the NIH?
    Dr. Clancy. They do not keep it. I--
    Mr. Poliquin. Where does it go?
    Dr. Clancy [continued]. --don't believe they return it.
    Mr. Poliquin. They just don't draw it down; is that 
correct?
    Ms. Ramoni. They do not draw it down--
    Mr. Poliquin. Got it.
    Ms. Ramoni [continued]. --Mr. Poliquin.
    Mr. Poliquin. Thank you very much.
    Ms. Ramoni. Also, I would like to point out that the off-
site rate--so if the work were being done at the VA but run 
through Harvard, the off-site rate for that typically is around 
20 percent, 25 percent. So pretty close to that of the NPC.
    Mr. Poliquin. Ms. Rusconi?
    Ms. Rusconi. My question, when they are talking about the 
off-site rate for the affiliate, is if that work is happening 
at the VA, why would they be getting an indirect rate at that 
point? Because honestly, at that point, if the work is 
happening at the VA, there should be a subaward to the NPC.
    Mr. Poliquin. You know what I would like to see? And I am 
going--we have subpoena power here, don't we?
    Mr. Chairman? We have subpoena power here, don't we? Yeah, 
great. Okay. Here is what I would like to see.
    It is going to be very simple, and I think I asked for it 
last time Dr. Clancy and Dr. Ramoni were here. It is very 
simply. What I would like to see is going back--take five 
years. We could probably go back 50, but let's take five years.
    What I would like to see is every grant that was awarded by 
the VA, by the NIH, by the DoD, and any other large 
organizations that do that outside the VA. I think it is the 
NIH and DoD. Every grant, what it was used for, who it went to, 
what the amount was for, who did the administrative work, and 
what that amounted to? That would be really tell-tale. So we 
can see--and what--so we can determine what the rate is. So we 
can see where the taxpayer dollars are going.
    This is supposed to be used for care of veterans. I am all 
for research. I love it. I want to make sure the taxpayers 
aren't getting ripped off, and I want to make sure that our 
veterans get maximum bang for their buck. And when you have a 
delta between 25 percent and 56 percent, or 70 percent, which 
was what was told last time, last July, if I understand this 
correctly, then something is wrong. I am missing something.
    And so I want to get that data. So Dr. Clancy, how do we 
get that data?
    Dr. Clancy. We will take a first crack at assembling it for 
you.
    Mr. Poliquin. No, we already have a study that we went--we 
started back in July or September, whatever it was, we are six- 
or nine-months in. It will be a year before we get the study. 
Is it going to have this data?
    Dr. Clancy. Rachel?
    Ms. Ramoni. Mr. Poliquin, thank you for your question. As 
we discussed, both when you were kind enough to visit us, as 
well as with your staff--
    Mr. Poliquin. No, not to visit you. I paid an unannounced 
house call because you folks weren't responsive to our staff in 
getting the data. So it wasn't a scheduled visit. I just showed 
up.
    Ms. Ramoni. We appreciate that.
    Mr. Poliquin. Well, I appreciate getting--
    Ms. Ramoni. And--
    Mr. Poliquin [continued]. --us this data. How do we get 
this data?
    Ms. Ramoni. We explained to you at that point that that 
data currently is not in the VA's hands, that we had made 
efforts to--
    Mr. Poliquin. So how do we get this data?
    Ms. Ramoni. The NIH would have to cooperate with us in 
releasing those data which would require a Congressional 
request.
    Mr. Poliquin. Okay. Good. And that data can be released 
directly, I think, Mr. Bergman, can't it to this Committee? 
Thank you very much. I yield back my time. I don't have any.
    Mr. Dunn. Thank you Representative Poliquin. Representative 
Kuster.
    Ms. Kuster. Just a quick--
    Mr. Dunn. You have five minutes.
    Ms. Kuster [continued]. --question, if I could. This is for
    Dr. Ramoni. We have been talking about bridging the gap 
between basic research and clinical research, and my particular 
interest is brain health diagnostics.
    The Director of National Institute of Mental Health, in 
2013, stated ``We must set our sights higher than a 19th 
century approach for mental health diagnosis.'' So physicians 
need more than the current symptom-based categories. Symptoms 
alone rarely indicate the best choice of treatment. My question 
to you is can the VA support bio-marker discovery and 
validation, and pursue the deployment of at least two 
additional brain health diagnostic measurements before 2023?
    And if anyone else has any comment on that, I am happy to 
hear.
    Ms. Ramoni. Thank you for that question. As you heard, 
several of my priorities touch on mental health, with PTSD, 
suicide prevention, TBI, opioid use disorder, and it is a high 
priority of ours to move from symptom-based diagnostics to bio-
marker based diagnostics. Even our work in Gulf War illness, we 
are moving towards bio-marker based diagnostics.
    To that end, we are developing road maps for a set of 
projects that are intended to lead to objective bio-marker 
diagnostics for both PTSD and TBI, and we are not doing this 
alone. We are working in collaboration with NIH, with DoD, and 
with co-inveterate bioscience and industry partners in order--
that this should move forward as quickly as possible.
    Ms. Kuster. Great. Thank you very much, and I yield back.
    Mr. Dunn. Thank you very much, Representative Kuster. 
Representative Arrington--
    Mr. Arrington. Thank you.
    Mr. Dunn [continued]. --you are recognized for five 
minutes.
    Mr. Arrington. Thank you, Mr. Chairman. I, too, believe in 
research and the investment we make as a Federal government to 
discover, to solve problems, and I think that no place on 
planet Earth do we do that better than in the United States of 
America, and I think a part of that is the investment the 
Federal government makes.
    But we have got to do it in a smart way, in a strategic 
way, in a cost-effective way. We have to know what our core 
competencies are and what we are not as competent in, where 
there is greater expertise in the marketplace. So I think my 
colleague, Mr. Poliquin is--I appreciate his passion for making 
sure this is working the way it is supposed to, and we have an 
oversight roll, obviously in that.
    And I guess my first question is, what is the process by 
which we engage in the research agenda? When you set that 
agenda, and there have been questions about how do we prevent 
mission creep? How do we focus on our area of interest and 
impact, which is those things that affect the unique community 
of our veterans, as opposed to cancer and other areas of 
research that are important, but they affect everybody? But we 
are trying to get at those specific issues that plaque the 
veteran community.
    What is the process? Do you all bring that to the VA 
Committee or some Subcommittee prior to the concrete drying on 
that agenda so that we can provide some input and challenge you 
on why you are focused on area X, Y, or Z?
    Dr. Clancy?
    Dr. Clancy. In terms of setting priorities for the research 
overall, we have some broad frameworks, right, that this is 
important to veteran's health. We are not going to fund it 
unless it is a veteran focused project.
    I think the trickiest part is the one that you and a couple 
of your colleagues have keyed in on. The distinction between 
conditions that we know to be unique to veterans and what they 
are suffering right now, and conditions that are common, very 
prevalent--
    Mr. Arrington. Right.
    Dr. Clancy [continued]. --among veterans but also among 
other Americans as well. Creating that bright line is sometimes 
harder than you might think. For example, when Mr. Poliquin was 
asking about learning from VBA claims, which I think is a great 
idea, there are some exposures that have a very long latency 
and we might not know without having done research.
    In general, we are looking to our advisory committee, to 
researchers themselves, to lots and lots of stakeholders, 
veterans service organizations, and so forth. To the best of 
knowledge, we have not come to the Congress. We certainly give 
you reports on the other side. We could certainly make that 
part of a budget submission so that you would have a better 
sense, I think.
    I am not sure how close you want to get to that. Some 
people might think that was politicizing things too much, as 
opposed to substantive interest, which has been very much the 
theme of today's conversation.
    Mr. Arrington. I think it is part of our oversight role. I 
mean, I don't--I think it is too late after we see the work 
that you are doing to suggest that it is inside or outside the 
purview of the mission for research at the VA.
    But nevertheless, I think I am interested in how we can 
improve that process, so we are better engaged on the front 
end. How much--what percentage of the research at the VA is 
translational versus fundamental? Is it 50/50, Dr. Ramoni?
    Ms. Ramoni. So that is an area that I am, as you know, 
keenly focused on. Currently, the majority of our research is 
basic research, and some of that basic research, of course, is 
in veteran focused areas. For instance, a non-opioid pain 
medication is being researched in basic science, or traumatic 
brain injury--
    Mr. Arrington. Just in the interest of time--
    Ms. Ramoni. Yes.
    Mr. Arrington [continued]. --and I know I keep cutting you 
off, and I do apologize, but--
    Ms. Ramoni. But--
    Mr. Arrington [continued]. --I think it is an opportunity.
    Ms. Ramoni. Yes.
    Mr. Arrington. If I were there with you, I would say what--
where can we have a strategic--
    Ms. Ramoni. I agree.
    Mr. Arrington [continued]. --advantage and focus given our 
strengths, et cetera, sort of SWAT analysis. I would say--
    Ms. Ramoni. Right.
    Mr. Arrington [continued]. --we should be more 
translational, less basic. NIH can do basic, all these other 
institutes. Let's focus more on how we get at solving the 
problem, and a quicker way, and I would also say, ``Can we use 
the inside of the Veteran Hospital System, Health System?''
    Ms. Ramoni. Yes.
    Mr. Arrington. It is the largest in the country.
    Ms. Ramoni. Okay.
    Mr. Arrington. How do we tap into that, like you did with 
tele-medicine. That is why you are leading in tele-medicine. 
That is a leadership role for the VA. How to use the patient 
material and all that you have, but with some flexibility that 
you don't have on the outside, that my friend from Baylor 
College of Medicine doesn't have because of restrictions, how 
do you tap into that, so we can translate therapies and 
devices, so we can save lives?
    That is a question I have. I am out of time, but let's talk 
about that. Let--you all come over to the office. I will come 
see you, and let's see if we can't share some thoughts and 
ideas on how to--
    Ms. Ramoni. I would welcome that.
    Mr. Arrington [continued]. --have a--
    Dr. Clancy. Mr. Chairman, could I make one quick point? One 
area where we do take great advantage of our system, and this 
is just getting started but very, very exciting. You may be 
aware that clinical trials are unbelievably expensive because 
effectively every study creates a separate infrastructure which 
is then disbanded.
    Because of our integrated system and an electronic record, 
we are actually now funding some point-of-care studies where 
patients are randomized when they are being seen for care. We 
are collecting data from the electronic record which takes the 
cost of a clinical trial and reduces it by orders of magnitude. 
So we are with you, and we would love some follow-up.
    Mr. Arrington. Thank you for that. Mr. Chairman, I yield 
back.
    Mr. Bergman. [Presiding.] Thank you. I am going to yield 
myself five minutes. That will complete the second round. I 
think--Representatives Brownley and Kuster, you have no more 
questions. Mr. Poliquin, you would like one more round?
    Mr. Arrington, would you like any more time?
    Mr. Arrington. I am going to reserve mine for a meeting--
    Mr. Bergman. Okay.
    Mr. Arrington [continued]. --but then, I appreciate their 
comments.
    Mr. Bergman. All right.
    Dr. Clancy, just--if you could take for the record, I would 
really like to know how many dual appointment researchers we 
have across the spectrum. Okay? And if you can give me a 
number, I assume you can give us a name. Okay?
    So a by name, which then would therefore assume a by 
location list, because I sense across the Committee that there 
is keen interest in the how things are getting done, and not 
that all of you don't have--you know all your data, you know, 
because you do. But it is important for us to hear it from 
boots on the ground as well. So I think that is going to be an 
important step going forward.
    Dr. Ramoni, Mr. Poliquin brought up problems with data 
sharing between VHA and VBA. What are some of the impediments 
to working with VBA?
    Ms. Ramoni. Thank you for your question. So I think the 
first impediment is simply an historical inertia. We simply 
haven't worked that much with VBA in the past, although some of 
our researcher now are beginning to use VBA data, for instance 
in our suicide prevention work and also in our evidence-based 
policy group.
    What would need to happen is to have a data use agreement 
with VBA, and to have that prioritized in both on the ORD side, 
which it certainly would be, and also on the VBA side so that 
we can establish those relationships and also have that work 
properly staffed because sharing data takes curation. It takes 
explanations of the data. It takes having some understanding 
from the VBA side.
    Mr. Bergman. Is there any ongoing institutional resistance 
based on the, you know, old ``if not invented here'' syndrome 
type of thing? I mean, is there--do we have any cultural 
barriers that we need to break down between VHA and VBA?
    Dr. Clancy. I don't think so.
    Ms. Ramoni. I don't think there are cultural barriers. 
Again, it has been a sort of inertia that we both need--we need 
to work on both sides to break down, and I certainly am 
committed to do so. And as we proceed, we will, of course, keep 
this Subcommittee informed and should we encounter any of the 
barriers you mentioned, we are grateful for your support.
    Mr. Bergman. Oh, we know that human behavior is such that 
everyone in a, if you will, in a chain of command or a food 
chain, they look up to see the behavior above them. And if the 
leadership at all levels is not having cross-talks, cooperating 
across whatever boundaries might be there, the organization 
will emulate those qualities of their leadership, and that is 
why it is so important that--it is kind of like, I don't know 
if you any of you are parents, but you know, kids watch their 
parents. And if the parents are talking the kids pay attention. 
If the kids think the parents aren't talking, they are going to 
try to, you know, divide and conquer you.
    But we are here together in this, and you know, not to 
overblow the family analogy, but we are a family. We are a 
family that is dedicated to the results for veterans, and that 
is pure and simple the mission of the family.
    Dr. Ramoni, in NAVREF's testimony, you asked that the VA 
share the scope, criteria, and assessment for the Nonprofit 
Program Office's out brief reviews. Could you please provide 
those to the Committee as well? Second, are these out briefs 
something the VA is willing to share with NAVREF? I mean, 
again, in the spirit of sharing information?
    Ms. Ramoni. Would the out briefs that--excuse me, sir. The 
out briefs at each NPC?
    Mr. Bergman. At the reviews, at the review level?
    Ms. Ramoni. Yes. We would leave it to the discretion of the 
local NPC to share those because not every NPC has a 
relationship with NAVREF, but we have no desire to not make 
those publically available. We would certainly make those 
available to NAVREF if we were given the permission of the NPC.
    Mr. Bergman. Okay. Well, it is, you know, again it is going 
back to breaking down those barriers--
    Ms. Ramoni. Right.
    Mr. Bergman [continued]. --that inhibit the results and 
giving--
    Ms. Ramoni. Right.
    Mr. Bergman [continued]. --us the, you know, the outcomes 
that we all are striving for, and sometimes outcomes aren't--
isn't a strong enough work. It means results--
    Ms. Ramoni. That is right.
    Mr. Bergman [continued]. --related to the veteran. So with 
that, I am going to yield back. Mr. Poliquin, you get the third 
and final strike.
    Ms. Ramoni. Thank you, sir.
    Mr. Bergman. Round, I am sorry.
    Mr. Poliquin. Thank you, Mr. Chairman, very much. 
Appreciate if you set that clock to eight minutes, instead of 
five, but in any event.
    Dr. Clancy, who oversees the investigators? My--the reason 
I ask that question is my understanding--correct me if I am 
mistaken, is that the investigators or researchers--I am using 
investigators because that is what--Dr. Ramoni taught me that 
word.
    If these individuals, I believe, are hired by the local VA 
hospitals around the country, so they are employees of the VA, 
and at the same time they might work for a terrific medical 
institution like at Baylor, at Harvard, or at Case Western, 
whatever it might be. And they then have authority to apply for 
grants, get the grants, and then determine where the 
administrative dollars goes, notwithstanding what
    Dr. Klotman said earlier.
    So who is overseeing those investigators to make sure 
everything is going the way it should be?
    Dr. Clancy. Well, as Dr. Klotman pointed out earlier, there 
is a very careful time and attendance record. The VA-- actually 
from the time of my earliest training with--
    Mr. Poliquin. No, I am not really asking that,
    Dr. Clancy. Thank you for that. What I am asking is, is 
there anybody looking over the investigator's shoulders to say, 
``You know, every time you apply for a grant, and I know you 
work at XYU, University,'' that that grant money goes to XYU 
because you are applying for that and you have to put it on the 
grant, but the administration is also done by that university. 
Is anybody serve as a check and balance to that individual?
    Dr. Clancy. Well, to some--
    Mr. Poliquin. Or are we doing it now?
    Dr. Clancy [continued]. --extent, we would expect the NPCs 
to do that. I am going to guess that a fair amount of that is 
delegated to the discretion of the investigator--if I could 
just finish for a moment.
    Mr. Poliquin. Sure.
    Dr. Clancy. If I am splitting my time five-eighths, three-
eighths, that would be a very common break because you have to 
be five-eighths funded to get VA research funding. But if I can 
say on my three-eighths time ``I am applying for a grant from 
NIH,'' that would be okay the way we have been doing business.
    Mr. Poliquin. No, what I am looking for is if you have an 
investigator--and what Congressman Bergman asked is a really 
good one. Who are these people, where are they located? If you 
have 150--oh, I am just choosing a number. I think it is 
probably pretty close. Is that if you have 100 of them that are 
always doing the administrative work, where they work, not at 
the VA but at their research affiliate, their academic 
affiliation, that would be a concern of mine.
    Dr. Clancy. I would agree.
    Mr. Poliquin. Okay. Good. So there is no one that oversees 
that except us, correct?
    Dr. Clancy. I think you have brought a unique lens--
    Mr. Poliquin. Okay.
    Dr. Clancy [continued]. --and intensity to--
    Mr. Poliquin. Okay.
    Dr. Clancy [continued]. --our focus--
    Mr. Poliquin. Here is why this--
    Dr. Clancy [continued].--and we appreciate that.
    Mr. Poliquin. --matters, Dr. Clancy, and everybody here. Is 
that we have a situation where there is an inherent conflict of 
interest, and we are looking at very big amounts of dollars. A 
lot of bacon.
    You have $1.2 billion, roughly, of grants that are provided 
by NIH, and the DoD, and others, in one year. And if you say 
``roughly,'' if we use our low-cost provider over here, the 
NPCs, right, at roughly 25 percent, that is roughly $900 
million of research, roughly, and about $300 million in one 
year of administrative overhead and so forth and so on, to 
administrate those--oversee those grants, make sure that they 
get--research gets done.
    Well, what if you are overpaying? What if it is not 25 
percent, what if it is double that, like has been discussed 
here? What if it is more than that? That is another $300 
million a year. So you are getting less research and more 
overhead. We see that everywhere. Everywhere, frankly, in the 
non-profit sector. Not picking on anybody.
    That is why I want to see the data. I want to see what 
grants were issued, who did the research, how much money for 
the research, how much money for the overhead, who these 
investigators are, and what their record is of awarding that 
administrative work?
    And on top of that, you have the Inspector General's report 
that says, ``This ain't going well,'' and that just came out. 
So I am not trying to pick on anybody. We are all responsible 
for taking care of our veterans. Thank you. We are not 
clinicians, but it is our responsibility to make sure that the 
dollars are going to the right place, and we are not 
overpaying. It is that simple. Yes?
    Ms. Rusconi. I would like to make a point of clarification 
which is I understand what Dr. Clancy is talking about, that 
the NPC might have an input into where someone, a PI, would 
submit the grant, but the reality is that throughout the 
country, there are lots of times that the NPC isn't even aware 
that that grant is being submitted. So there is absolutely no 
way that the NPC could be part of it.
    Mr. Poliquin. But 30 years ago, you folks were created by 
Congress specifically to solve this problem, correct?
    Ms. Rusconi. Correct.
    Mr. Poliquin. Well, I would like to know how much of the 
business you are getting, because you are the low-cost 
provider.
    Ms. Rusconi. We would also like to know.
    Mr. Poliquin. Good. Pretty simple, Jack. Excuse me, Mr. 
Chairman. I yield back my time.
    Mr. Bergman. Am I now Chairman Jack? Is that what it is? I 
am no longer General Jack?
    Mr. Poliquin. It is whatever you would like, sir, as long 
as the--
    Ms. Kuster. I vote general.
    Mr. Poliquin [continued]. --this summer.
    Ms. Kuster. Just for the record.
    Mr. Bergman. Yeah, so. All right. Well, thank you to all 
the Committee Members for the--this has probably been one of 
the more focused and direct Subcommittee meetings and hearings 
that we have had. So I appreciate everybody's input, especially 
all of you at the testimony table, because together we do make 
a difference and we make a positive different. And if it was 
all easy, it would all have been done long time ago and we 
would all be doing other things.
    So I really appreciate your continued intellectual 
engagement here for our penchant for details now that big data 
allows us to get those details in a relatively expeditious and 
accurate manner. So our thanks to all the witnesses today. You 
are now excused. Ranking Member Kuster, would you like to make 
any comments before we close?
    Ms. Kuster. I have a brief closing statement, and one point 
I would like to leave the record open long enough for the VA to 
respond to the questions that have been asked today.
    The perspectives we heard today are important points of 
view to consider as we ultimately have a dramatic impact on the 
quality of care to our veterans in New Hampshire and all across 
the country, and to community providers, and indeed, civilians 
across this country. While I appreciate the hard work and 
dedication of the witnesses and organizations that you 
represent, the testimony today does concern me. I appreciate 
the great work that the VA Non-Profit Research and Education 
Corporations, or NPCs, conduct to oversee crucial VA research 
with frugality. However, it is concerning that the availability 
of NPCs at all VA medical centers may be limited.
    Likewise, I appreciate the robust academic affiliations the 
VA currently enjoys, and as I mentioned in my comments, 
Dartmouth College and Dartmouth Medical School has proven to be 
a wonderful partner in expanding and improving veterans' health 
care in rural New Hampshire. However, it concerns me that some 
academic institutions may charge more than necessary to 
administer Federal research grants, and insuring the most 
efficient system is crucial to maximizing resources this 
Congress provides to care for our veterans. And I think you 
have heard this as a bipartisan concern.
    I recognize the VA has been unable to provide clear 
guidance in an expeditious manner as to how this research money 
is to be distributed, and I encourage the VA to vitalize this 
guidance as quickly as possible, and share that with this 
Committee. I believe there is a great opportunity here for all 
stakeholders to work together and insure that VA's research 
regime is efficient and effective.
    To that end, I ask my colleagues to consider joining me in 
convening a roundtable of relevant stakeholders to further 
discuss these issues, and as I mentioned specifically, I would 
love to include the bipartisan Heroine Task Force, and both 
Committees to engage in this discussion.
    Our experience with the opioid epidemic has made effective 
medical research, especially into pain management and substance 
use disorder, an acute concern of members across this country. 
We know the importance of getting new research on pain, 
addiction, and mental health is important. Veterans are 
uniquely impacted by the opioid epidemic because over 50 
percent of veterans experience chronic pain. Our veterans need 
the latest in medical research to combat this problem, and I 
hope to advance legislation soon that would centralize and 
improve pain management at the VA by creating centers of 
excellence.
    Of course, this is hardly the only area in need of 
additional research. I know veterans with upper body prosthetic 
needs experience a limited suite of options. Creation of a 
center of excellence on bionics or upper prosthetics is needed 
to further meet the needs of veterans. There is emerging 
research and technology, and as I appreciate your mention in 
your opening remarks, about the Luke arm, but assuring that the 
VA is adequately able to deploy the latest technology is 
crucial to improving our veterans' quality of life.
    So this serves to underscore my commitment to delivering 
the highest quality of care to our veterans by ensuring that 
the VA remains a leader in medical research. I thank you for 
your time, and I yield back.
    Mr. Bergman. Thank you, Ranking Member Kuster. It has been 
nearly one year after our research hearing last June, and it 
quite frankly, does not appear that the VA has made any 
improvements on its utilization of the NPCs. Budgets are still 
tight, yet we continue to find examples of VA not utilizing the 
available options for additional funds.
    As we have heard, NPCs have contributed over two billion, 
that would be with a ``B,'' to VA research over the past decade 
and could contribute more if they were to administer the grants 
for research projects conducted within VA. VA should not be 
paying overhead costs without getting the benefit of 
reimbursement.
    It is also critical that the research office have access to 
VBA's data so that it may better meet its mission of veteran 
centric research. This data would be extremely beneficial in 
determining what diseases and disorders to examine and help 
guide ongoing projects.
    I hope that our discussion will open the door to better 
communications because quite frankly, I am pretty tired, and I 
think we all are, of hearing about missed opportunities within 
VA due to one office not communicating with another. VA's 
research budget exceeds $1 billion annually. So one would think 
that the accomplishments it has contributed to veterans and the 
American public would be many, but what we have heard here 
today is that that is not the case.
    Certainly, VA can tout some major accomplishments over the 
past several years, but unfortunately, they are not necessarily 
in areas significant to veterans or related to their service. 
Moreover, many of these results are being implemented at only 
one medical center or one VISN which limits the benefits 
received by veterans across the country.
    Simply put, VA research needs to be more focused on 
specific conditions prevalent among our Nation's veterans, and 
the department must follow through on projects so that there 
are actual clinical benefits to show for all of the funding the 
research program receives. So bang for the buck. It is past 
time to witness the urgency this long-standing problem 
deserves.
    I ask unanimous consent that all Members have five 
legislative days to revise and extend their remarks, and 
include extraneous material. Without objection, so order.
    I would once again like to thank all of our witnesses and 
audience members for joining in today's conversation. With 
that, this hearing is adjourned.

    [Whereupon, at 11:51 a.m., the Subcommittees were 
adjourned.]

                                 
                       Statements For The Record

          Submitted by the Coalition to Heal Invisible Wounds
    Roger Murry, Executive Director

    Chairman Wenstrup, Chairman Bergman, Ranking Member Brownley, 
Ranking Member Kuster, and Members of the Subcommittees:
    On behalf of the Coalition to Heal Invisible Wounds, thank you for 
this opportunity to provide written testimony regarding the VA's 
research partnerships, priorities and the extent to which the VA 
effectively translates research findings to the clinical setting to the 
benefit of Veteran patients. We commend the Subcommittees' leadership 
in addressing these critical issues.
    The Coalition to Heal Invisible Wounds was founded in February 2017 
to advance policy reforms that widen and expedite the pipeline for new 
therapies and diagnostics for post-traumatic stress disorder (PTSD) and 
traumatic brain injury (TBI). Coalition members innovate at all stages 
of the therapy development life-cycle and also serve Veterans who most 
urgently require mental health interventions. \1\
---------------------------------------------------------------------------
    \1\ The Coalition's members are Cohen Veterans Bioscience (co-
chair), the Military Veterans Project, NAMI Montana, Otsuka America 
Pharmaceutical Inc. (co-chair), and Tonix Pharmaceuticals.
---------------------------------------------------------------------------
    According to the VA PTSD Psychopharmacology Working Group: ``The 
urgent need to find effective pharmacologic treatments for PTSD should 
be considered a national mental health priority.'' \2\ Despite the 
``high prevalence and costly impact'' of PTSD in military personnel and 
Veterans, ``most patients are treated with medications or combinations 
for which there is little empirical guidance regarding benefits and 
risks,'' and there is ``no visible horizon for advancements in 
medications that treat symptoms or enhance outcomes in persons with a 
diagnosis of PTSD.'' The scenario is similar for TBI and these two 
conditions often coexist but may also occur independently in the VA 
population.
---------------------------------------------------------------------------
    \2\ John H. Krystal et al., It Is Time to Address the Crisis in the 
Pharmacotherapy of Posttraumatic Stress Disorder: A Consensus Statement 
of the PTSD Psychopharmacology Working Group, J. Biological Psychiatry 
(2017) http://www.biologicalpsychiatryjournal.com/article/S0006-
3223(17)31362-8/abstract
---------------------------------------------------------------------------
    The Coalition believes that better diagnostics and therapies will 
spur more Veterans to seek care. According to a 2017 survey of over 
4,000 Iraq and Afghanistan Veterans of America (IAVA) members, 46 
percent report having PTSD, while 19 percent report having TBI. \3\ 
Only 16 percent of IAVA members believe troops and Veterans are getting 
the care they need for mental health injuries and stigma remains the 
top reason Service members and Veterans are not seeking care. A major 
reason why IAVA members stop seeking care is that they do not think 
that the treatment will work.
---------------------------------------------------------------------------
    \3\ 2017 Member Survey; Iraq and Afghanistan Veterans of America.'' 
Accessed May 9, 2018. https://cultureondemand.github.io/iava-report/
---------------------------------------------------------------------------
    An implicit promise of world-class health care is a strong research 
function. Veterans have earned the right to world-class health care. 
Better research will lead to better care of our Veterans who suffer 
from PTSD, TBI, and other mental health conditions that are prevalent 
among the veteran population. We strongly believe that the VA can 
become a leading partner in delivering new therapies and diagnostics; 
it has many outstanding assets and institutional strengths, as well as 
the desire to overcome the institutional hurdles to establishing 
advanced research partnerships.
    The Coalition seeks to advance discrete reforms at the VA to 
support cutting-edge research partnerships. We focus on enhancing big-
data research partnerships, standardizing approval and oversight of 
multi-site clinical trials to accelerate the development of new 
therapies, and spurring the development of new brain health diagnostics 
for clinical use. Ultimately, the VA can align its management of 
clinical trials much closer to best practices, which will lead to 
increased clinical trial success rates and the accelerated development 
of new diagnostics and therapies for conditions that disproportionately 
impact Veterans. We believe that in 2018, with appropriate oversight 
from Congress, the VA can pursue several targeted reforms that would 
serve as significant first steps in this process:

    1.Permit sponsors to use commercial IRBs accredited by the 
Association for the Accreditation of Human Research Protection Programs 
(AAHRPP);

    2.Clarify that the Central Office has the authority to determine 
all information security requirements for a multi-site trial, direct 
the VA to develop a central list of compliant vendors and direct the VA 
to staff the office appropriately;

    3.Direct the VA to study the obstacles sponsors face in recruitment 
and develop a plan to support Veteran participation in clinical trials;

    4.Develop a master plan to support clinical research; and,

    5.Direct the VA to work with pertinent Federal and non-governmental 
partners to deploy at least two additional brain health diagnostic 
measurements for clinical use at VA facilities before 2023.

    We are grateful for the opportunity in this testimony to describe 
in more detail both these initial steps and the overall trajectory for 
reform.

A. Conduct and Support for VA's Research Partnerships

    We support the work of the Subcommittees and the VA to bridge the 
gap between basic research and clinical research. This work complements 
ongoing examinations within the Office of Research and Development, at 
NAVREF and their member Nonprofit Research and Education Corporations 
(NPC), and within the private-sector research community as to how the 
VA can help get more research into the clinic. Major stakeholders share 
an understanding that the current diagnostic and therapeutic options 
available to Veterans are not sufficient, and that creating a more 
predictable and streamlined research approval and oversight process at 
the VA will attract more investment to address conditions that are 
specific to or prevalent among the Veteran population. Enhancing 
research pathways also will help the VA deliver better care to 
Veterans.
    An important place to begin bridging the gap is to standardize 
clinical trial reviews. While some VA clinics have been able to 
participate in multi-site clinical trials, sponsors report a widespread 
lack of standardization in the approval and oversight of sponsored 
clinical research at the VA. This delays VA trial site start dates, 
increases research costs, and discourages research sponsors from 
partnering with the VA. We encourage the Subcommittees to 
comprehensively review how the VA can streamline the approval process, 
identify and propagate best practices, and develop true continuity in 
the approval and administration of clinical trials. For 2018, three 
reforms, described below, are close at hand and would immediately draw 
more clinical research to the VA.

1. Institutional Review Boards (IRBs)

    IRB reviews ensure that clinical trials abide by clear ethical 
guidelines and protect the well-being of research participants, but 
sponsors need the reviews to be prompt and consistent. Despite earnest 
efforts by many within the VA to standardize and improve the IRB 
process (namely, by standing up a central IRB), the IRB process 
continues to be a source of major delays for sponsors. In fact, despite 
a decade or more of work on the central IRB, some multi-site clinical 
research sponsors, due to frustrations with the central IRB, have 
reverted to using local IRBs. In light of the high-quality, private-
sector options available, we do not advise further efforts to enhance 
the current IRB process as it relates to sponsored research. Instead, 
we recommend that the Subcommittees move to permit sponsors to use 
commercial IRBs accredited by the AAHRPP. Stakeholders within the NPC, 
industry and non-profit communities broadly support this proposal.
    Allowing the use of accredited commercial IRBs would allow for 
predictable and frequent IRB review processes and timelines. In 
pursuing this reform, it is important to consider and account for, 
where relevant, how this step would impact the role of other review 
committees, VA requirements for education and training, VA-specific 
regulatory requirements related to human subjects research, and the 
workload for the local and NPC IRBs. We believe that each of these 
considerations can be adequately addressed.

2. Information Security Officer (ISO) Reviews

    ISO reviews seek to ensure the safety of patient data. The reviews 
are often lengthy and unpredictable, leading to security requirements 
for the same study that can differ by VA clinic. Local ISOs are 
extremely busy and have variable knowledge of clinical research data 
storage and transfer requirements. Guidelines for ISOs can be unclear 
and outdated, while many ISOs feel organizational pressure to pursue 
the most conservative approach, and constrain the VA from participating 
in cutting-edge research. Further, there is no central list of 
compliant research vendors, so vendors are vetted and re-vetted by 
local ISOs.
    A centralized information security review for multi-site clinical 
research would allow for a more thorough, standardized, and appropriate 
review process, while reducing delays that often occur at the local 
level. The VA has begun to move in this direction. The Central Office 
recently set up an office to assist local ISOs with reviews of multi-
site research. However, the Central Office does not have clear 
authority to manage all information security requirements for a multi-
site trial. Congress should clarify that the Central Office has the 
authority to determine all information security requirements for a 
multi-site trial, that it should develop a central list of compliant 
vendors and direct the VA to staff the office appropriately. These 
steps would standardize the scope and timing of the ISO review process, 
as well as send positive signals to potential research sponsors.

3. Clinical Trial Recruitment

    Veterans should have the right to be fully informed of all of their 
treatment options, including the potential benefits and risks of 
clinical trial participation. This allows Veterans the opportunity to 
benefit personally from cutting-edge research opportunities and assist 
the wider community as a whole through trial participation. In fact, in 
oncology and increasingly other areas of medicine, clinical trials are 
now the standard of care. Research sponsors report widely varying 
experiences recruiting research participants. Some VA sites, for 
example, maintain a database of VA patients that have indicated their 
desire to be contacted about new opportunities to participate in a 
study and allow sponsors to effectively recruit. Other VA sites do not 
offer this or other institutional supports for recruitment, leading to 
extended recruitment timelines and increased cost of the research. Some 
sponsors have been unable to fill the patient population needed for the 
trial, compromising the ability to understand the efficacy of the 
treatment being tested.
    Recruitment problems are not unique to the VA. According to 
researchers at Vanderbilt and Duke Universities, nearly 1 in 5 clinical 
trials are either terminated for failed participant accrual, or are 
completed with less than 85 percent of the expected enrollment. 
Recruitment challenges increase the cost and reduce the speed with 
which advances in medicine reach Veterans and the general population.
    VA research stakeholders have expressed an array of difficulties 
related to recruitment, but it is not yet clear what specific reforms 
the VA could undertake to best facilitate enrollment. We would advise 
that Congress direct the VA to study the obstacles sponsors face in 
recruitment and to develop a plan to support Veteran participation in 
clinical trials.

    B. Translating Research Findings to the Clinical Setting to the 
Benefit of Veteran Patients.

    1. Master Plan to Support Clinical Research

    While improving clinical trial management will spur more private 
sector activity, the VA should also play a direct role in bridging the 
gap between basic research and clinical research. Today, grant money is 
divided across too many different projects, leaving each with too 
little money to appropriately design and run a clinical trial, and 
unable to lead to the next step of investigation. The VA should assess 
how federal agencies and the private sector are supporting clinical 
research into new diagnostics and therapies for conditions that 
disproportionately impact Veterans. The VA should then develop a master 
plan that provides for strategic support of clinical research, 
including for private sector activity, to speed developments that 
address those conditions. The plan should include innovation grants for 
external research, such as the Industry Innovation Competition, in 
which the VA spurs activity in the private sector to help solve VA's 
most pressing challenges. The plan should complement the comprehensive 
plan for biomarker discovery and validation described blow.

2. Diagnostics Research Mandate

    As our members engage every day with Veterans suffering from PTSD 
and TBI, they see an urgent need for mechanism-based diagnostic tools 
to precisely diagnose those conditions. Using symptom-based diagnostic 
tools alone diminishes the ability of physicians to effectively 
diagnose these multi-faceted disorders as well as overcome the known 
challenges of diagnosis such as stigma and delays in qualified clinical 
assessment. In 2013, while still serving as Director of the National 
Institute of Mental Health, Dr. Tom Insel stated that ``the diagnostic 
system has to be based on the emerging research data, not on the 
current symptom-based categories,'' and that ``we must set our sights 
higher'' than a 19th century approach. \4\ ``Indeed, symptom-based 
diagnosis, once common in other areas of medicine, has been largely 
replaced in the past half century as we have understood that symptoms 
alone rarely indicate the best choice of treatment.'' Clinicians need 
new tools to more precisely diagnose those suffering from PTSD and TBI, 
which requires the VA to effectively translate research findings to the 
clinical setting for the benefit of Veteran patients.
---------------------------------------------------------------------------
    \4\ ``Post by Former NIMH Director Thomas Insel: Transforming 
Diagnosis.'' NIMB Director's blog. Posted April 29, 2013. Accessed May 
9, 2018. https://www.nimh.nih.gov/about/directors/thomas-insel/blog/
2013/transforming-diagnosis.shtml
---------------------------------------------------------------------------
    Diagnostics are objective, measurable predictive factors that help 
doctors improve care. For example, the FDA recently approved a blood 
test to improve the diagnosis of concussions, which could eliminate the 
use of unneeded CT scans in at least a third of those with suspected 
brain injuries. Writing in the VA's PTSD Research Quarterly, VA 
researchers determined that ``we appear to have reached a watershed in 
the development of biologically-based interventions for the prevention 
and treatment of PTSD.'' \5\ Further, understanding the multiple and 
interacting mechanisms of malfunction in each stress system will be 
critical to advance the diagnosis and treatment of trauma-related 
mental health disorders into the precision medicine era.
---------------------------------------------------------------------------
    \5\ ``Biomarkers for Treatment and Diagnosis.'' PTSD Research 
Quarterly. Accessed May 9, 2018. https://www.ptsd.va.gov/professional/
newsletters/research-quarterly/V26N1.pdf
---------------------------------------------------------------------------
    According to a recent literature search of PTSD biomarker discovery 
studies, researchers identified over 800 PTSD biomarker candidates, but 
none have been validated or approved by the FDA for clinical use. There 
are many reasons for the failure to validate PTSD candidate biomarkers 
to date, but most can be overcome by bringing together large data sets 
and standardization of research techniques. For example, targeted 
research based on big data analysis is more likely to direct 
researchers toward plausible candidates that can be replicated and 
validated. Given the state of the science, we believe this is not only 
possible but also probable by 2023.
    To bridge the gap between basic research and the needs of Veterans 
and their doctors, Congress should require the VA to work with 
pertinent Federal and non-governmental partners to build a 
comprehensive plan for biomarker discovery and validation including the 
deployment of at least two additional brain health diagnostic 
measurements before 2023 for clinical use at VA facilities, and funding 
a broader long-term biomarker study through the Department of Defense 
(DOD). The statutory objective would help VA leadership marshal 
sufficient resources and implement administrative reforms to boost 
public-private partnerships and power the discovery of biomarkers.

C. Conclusion

    The Coalition to Heal Invisible Wounds thanks the Subcommittees for 
its work to strengthen VA medical and prosthetic research program. We 
strongly believe that the VA has the potential to be a world-class 
research partner to the private sector, enabling better health care for 
Service members and Veterans, and the initiatives proposed above would 
provide significant initial progress toward that goal.
    . We encourage the Subcommittees to continue to engage with 
stakeholders to develop a multi-year plan that provides for continual 
improvements to data-sharing, clinical trials and therapy and 
diagnostics research. Comprehensive reforms would address the many 
other pacing limiters of clinical research, such as limitations on 
protected time for physician-researchers participating in sponsored 
research, and budget and Cooperative Research and Development Agreement 
(CRADA) negotiations. Comprehensive reform would also advance the best 
practices that have helped clinical trials succeed at the VA, such as 
the lead site model pioneered by several innovative NPCs.

                                 
                              Rick Weidman
    Executive Director for Policy & Government Affairs

    Regarding

    Department of Veterans Affairs Medical and Prosthetic Research 
Program

    Good morning, Dr. Wenstrup and General Bergman, and other 
distinguished members of these two very important Subcommittees. 
Vietnam Veterans of America (VVA) is pleased to have the opportunity to 
present for your consideration our Statement for the Record on the VA's 
medical and prosthetic research program. Also, for the record, we want 
you to know how much we appreciate the work you do for our nation's 
veterans.
    As we all know, VA research is different from research sponsored by 
other federal research agencies. According to the VA it is focused 
entirely on veterans' needs. It is intramural, and more than 60 percent 
of VA researchers are also clinicians who provide direct patient care.
    In your letter to VVA you requested that we address three issues 
related to VA research, which we do in this statement. However, we 
would like to emphasize that our biggest issue with the Department's 
research program is that it does not fulfill, in our minds, the purpose 
for which it was established. And that is to conduct research that is 
focused entirely on veterans' needs. We would, therefore, request that 
you do a few things:

      Request a Government Accountability Report (GAO) that 
takes a comprehensive look at the VA research program, including 
projects funded, the amount of funding expended, the source of the 
funding and bench-to-bedside focused treatments and the reality of that 
goal in as much as it is accomplished by the VA.
      We ask that this be a report that takes a retrospective 
look over the last 5 to 15 years of the program.

    Issue 1: Department of Veterans Affairs partnership with nonprofit 
research and education corporations, academic affiliates, and other 
entities regarding administration of research funding as well as to 
conduct and support research efforts.

    The VA's total actual budgetary resources for Research & 
Development for Fiscal Year 2017 was $1.8 billion, of which $673 
million was direct appropriations. VA's research program also relies on 
other sources of funding, non-federal as well as federal. For FY'17, in 
addition to the direct appropriations, the department received $535 
million for Medical Care Support, $425 million from other federal 
agencies, and $170 million in non-federal funding. Though this pales 
when measured against federal research dollars for the National 
Institutes of Health, the Congressionally Directed Medical Research 
Programs of the Department of Defense, and the Centers for Disease 
Control and Prevention, it is certainly not insignificant.
    VA proudly, and rightfully, points to some of the major 
accomplishments coming out of its research program, e.g., the heart 
pacemaker, the nicotine patch, the first successful liver transplant, 
improvements in wheelchair design. However, we must question: How much 
of what VA research has produced recently is of significant benefit to 
veterans?
    Conceptually, VVA has no argument with enlisting outside 
researchers from not-for-profit research and educational corporations 
and academic affiliates. For several years now, we have proposed the 
creation of an external entity, headed by a qualified individual who 
would be confirmed by the Senate, which would engage independent 
scientists and medical researchers to conduct research on specific 
health conditions of immediate consequence to veterans, conditions 
stemming from battlefield trauma, e.g., the ingestion of toxic 
substances from burn pits in Afghanistan and Iraq, and other military 
exposures such as oil well fire, sulfur fire, sand, dust, and 
particulate matter.
    We say this because for several years after the advent of the 21st 
century, it is our understanding that little or no research was 
conducted, for instance, on the long-term effects of exposure to Agent 
Orange and other toxins that were so liberally sprayed in South 
Vietnam. When the former head of the VA's Office of Research and 
Development was asked pointblank a few years ago if and when Agent 
Orange research would be funded, he replied with empty rhetoric and 
could not cite any specific research program then underway or being 
planned for the immediate future.
    We would urge you to investigate how much money was expended on 
just what specific, peer-reviewed research was conducted that has been 
of salient benefit to our wounded warriors.
    Finally, in brief response to the essence of the first question, 
VVA has no qualms about expanding and enhancing the universe of 
researchers who would respond to a Request for Proposal (RFP) for 
specific areas of research, as long as there is strict oversight by the 
appropriate staff at the VA and by you in Congress.

    Issue 2: The extent to which VA's research projects and priorities 
display a concentrated focus on issues and conditions that are specific 
to or prevalent among the veterans population.

    Much of our answer to this question is alluded to above. Basically, 
we have not seen any concentrated focus in this regard. Why? Because we 
believe VA researchers have been funded for the most part to conduct 
research in their individual areas of interest which are not always of 
relevance to specific health conditions unique to veterans exposed to 
the inherent dangers in a combat zone.

    Issue 3: The extent to which VA effectively translates research 
findings to clinical settings to the benefit of veteran patients.

    Again, the nugget of our comment here is in our responses to Issues 
1 and 2. This is not to say that all research projects funded by the VA 
are of little consequence to veterans. Important research has been 
conducted in improving prosthetic arms and legs, for instance. But this 
is the exception, not the rule.
    We thank you for the opportunity to submit for your consideration 
our Statement for the Record. Should you have any questions, we would 
of course be pleased to reply.

                                 
                       Whistleblowers of America
    Jacqueline Garrick, LCSW-C

    Dear Chairman Roe and Ranking Member Walz;

    Whistleblowers of America (WoA) is submitting this statement 
because we are concerned about priorities for further research and the 
proper management of research funds at the Department of Veterans 
Affairs (VA). We are grateful for this opportunity to share VA insider 
information with you and the rest of the Committee.

Sentinel Events:

    Sentinel events usually involve wrongful deaths, surgery on wrong 
patients or body part, loss of function, other surgical errors/
retention of foreign body, treatment delays or complications, 
medication mismanagement, falls/injuries, suicides or overdoses of a 
patient in or at a facility, assaults and other crime. According to a 
study conducted by Johns Hopkins University in 2016 \1\, medical errors 
would actually be the third leading cause of death in the United States 
accounting for 220,000 to 440,000 annual deaths if the Centers for 
Disease Control and Prevention tracked those deaths using the same 
coding as the study.
---------------------------------------------------------------------------
    \1\ Johns Hopkins Medicine, May 3, 2016 release
---------------------------------------------------------------------------
    VA does capture some data on sentinel events (also known as adverse 
events or medical errors) through its National Center for Patient 
Safety. However, VA insiders note that these events are supposed to 
undergo a root cause analysis (RCA) and other administrative reviews 
but are inconsistently conducted and can be more punitive in nature 
than corrective. Furthermore, these RCAs rarely generate adequate 
process improvement recommendations that can be monitored, shared and 
re-evaluated.

      Congress should require VA to replicate the study 
conducted by Johns Hopkins University and mandate that it provide an 
annual roll up report of its sentinel events and related research on 
the tools its uses to identify, manage, disclose, respond, remediate 
and re-evaluate these adversities that risk patient safety.

Opioids and Pain Management Research Translation:

    WoA has provided previous testimony on the problems it sees with 
opioid use and pain management for veterans seeking care at VA. Our 
belief is that care should be holistic and utilize multiple tools and 
interventions. It should be driven by medical decisions not 
administrative policies. Those medical decisions should be evidence 
based and informed, which requires VA to engage in veteran-centric 
research and translational activities to bring research into the 
patient care environment. However translational research is often 
lacking, and policies made by non-clinical managers drive outcomes. VA 
research and development funding must give veterans, Service members 
and their families priority. These research dollars must be aligned to 
population data-driven needs.
    WoA understands that pain cannot be managed to zero. However, pain 
as the 5th Vital Sign can be confusing to patients and needs research 
on alternative interventions to opioids to bridge gaps in prescribing 
practices. For example, Chronic Pain Syndrome can be managed with 
improved sleep hygiene, dietary changes, exercise (physical therapy, 
yoga, stretching), chiropractic therapy, orthotic intervention usage, 
as well as good calcium and Vitamin D levels. Strong occupational and 
physical therapy programs as well as dieticians are indicated in 
thorough pain management. However, these are all underfunded and under 
studied areas of intervention. The Department of Defense (DoD) has done 
some studies with Service members who have benefited from massage, 
Reiki, yoga, acupuncture, aqua therapy and the adaptive sports 
programs. In the private sector, pain management is an integral part of 
the care management team. This has not been the case with VA and 
military transitioning patients see the disparity in their treatment. 
VA needs to give more attention to these techniques to close the parity 
gap in pain management care.
    WoA has met with the Veterans Cannabis Coalition because of our 
shared concerns in addressing the opioid epidemic in America and 
prescription drug use among VA patients. Regarding cannabis research 
studies, the National Academies of Sciences (NAS) found, in a 2017 
review of 10,000 existing cannabis studies, conclusive or substantial 
evidence that cannabis is effective for the treatment of pain in adults 
and limited evidence that it can improve the symptoms of posttraumatic 
stress disorder (PTSD). The NAS report recommendations focus on the 
broad need for improvements to research processes and high-quality 
clinical trials. The VA is uniquely positioned to fully investigate the 
effects and potential applications of cannabis. The health care needs 
of veterans, particularly for alternatives to opioids for chronic pain 
management, should make cannabis research a top priority within the VA, 
and Congress should work to remove the existing barriers to research 
and stigma imposed by the National Institute for Drug Abuse (NIDA). As 
one physician noted to WoA, ``over the years, my practice has changed, 
based on the changes in the medical literature. Cannabis research could 
someday potentially change what the current medical literature states 
is standard of care regarding pain management.''
    As WoA has previously testified, the Federal Government has no 
Center Of Pain Management Excellence (COPE) but could greatly benefit 
from such a focus. Strategically located COPEs in partnership with DoD 
were recommended by a joint task force report issued by the Army 
Surgeon General in 2010 \2\. If this recommendation were instituted, VA 
and DoD could be leading the nation in responding to the opioid 
epidemic as required by President Trump. However, eight years later, we 
still do not have these Centers, proper toxicology or accountability 
for opioids, or standardized protocols for pain management that could 
come from the proper research. Congress should ask for an update on 
these recommendations, especially regarding the COPE.
---------------------------------------------------------------------------
    \2\ The Pain Management Task Force Report: Providing a Standardized 
DoD and VHA Vision and Approach to Pain Management to Optimize the Care 
for Warriors and their Families made 109 recommendations. The report 
was required by NDAA 2010.

      Congress should authorize VA to partner with DoD and 
other entities to establish a COPE.
      COPE should lead efforts to create, delegate, and 
integrate further studies on alternative to opioids for pain 
management, including cannabis.
      COPE should develop and institute plans and strategies to 
translate research into practice.

Mental Health, TBI, and Suicide Prevention:

    Mental health is the bailiwick of VA, especially related to (PTSD). 
The VA had led the nation in researching PTSD and its treatment. It 
houses a body of knowledge through the National Center for PTSD that is 
unexceed anywhere else. However, as reported by the AFGE, there is a 
high turnover rate among VA providers, so there is a constant need for 
new clinicians to be supported and trained with innovative approaches 
and techniques, such as with Virtual Environments (VE). For example, 
these VE can help train providers to deal with difficult subjects to 
discuss, such as Military Sexual Trauma (MST) or sexual dysfunction, or 
suicidal ideation. Social Work students are already being trained in 
these environments as well as military personnel in leadership courses. 
These tools need further research and development for application in a 
VA environment, but could expand training capabilities and reduce long-
term production costs.
    Although VA collaborates with DoD on issues related to Traumatic 
Brain Injury (TBI) there are still gaps in its ability to understand 
and treat this range of brain damage, especially when there are co-
morbid conditions present. For example, in accordance with the VA/DoD 
Treatment Practice Guidelines, ``For patients with PTSD, we recommend 
individual, manualized trauma focused psychotherapies that have a 
primary component of exposure and/or cognitive restructuring to include 
Prolonged Exposure (PE), Cognitive Processing Therapy (CPT), Eye 
Movement Desensitization and Reprocessing (EMDR), specific cognitive 
behavioral therapies for PTSD, Brief Eclectic Psychotherapy (BEP), 
Narrative Exposure Therapy (NET), and written narrative exposure.'' 
These are excellent standards of care but can be ineffective with 
patients who are cognitively impaired, such as those with TBI or 
Dementia. Thus, the above can leave veterans labeled ``treatment 
resistant'' as opposed to misdiagnosed. While VA spends on average $30 
million a year on brain research, DoD spends closer to $80 million. 
Each agency has different populations it needs to study, so researchers 
trying to deal with aging veterans find shortfalls in their 
capabilities, especially on brain studies involving women veterans, 
which is why Pink Concussion is seeking women veterans to donate their 
brains. In a 2018 OIG report, (15-01580-108) it found problems with 
providers who could not effectively diagnose TBI or differentiate it 
from PTSD, which negatively impacted veterans' ability to obtain proper 
service connection disability compensation and access medical care.
    Investments should be made in exploring and testing some of the 
innovative neurotechnologies that are available for identifying brain 
functioning and treating or mitigating TBI impacts. Tools coming to the 
market include brain performance trackers and wearables, 
neuromonitoring, brain-computer interfaces, neuro-biofeedback, and 
other cognitive aids that could also be explored for use in veteran 
populations.
    Research has also already correlated PTSD and TBI to increased 
risks for dementia. Dementia onset also can stimulate new symptoms or 
exacerbate existing mental disorders as cognitive capabilities 
degenerate. As the veteran population with these conditions continue to 
age, new protocols are needed to support a healthy aging process that 
enhances the independence and integrity of the veteran while developing 
and testing tools that can better assist caregivers to allow veterans 
to age in place.
    In 2013, VA, DoD and the Departments of Education and Health and 
Human Services issued a National Research Action Plan (NRAP) for Mental 
Health. Major commitments were made by all of the agencies and entities 
involved for enhanced research coordination and governance, 
prioritization, innovation and translational capabilities. However, 
over the last five years, there seems to be little reporting on the 
outcomes generated by the NRAP and its partners.
    In July 2017, VA released data on veterans who have died by 
suicide. Although compelling, the problem with the data release was 
that it is not tied to any VA program outcome data or funding execution 
information. There is no indication that VA uses this report in any 
meaningful way to target its interventions or other approaches. In 
fact, there have been several OIG investigations that recommend that VA 
do more targeted outreach at the local levels. However, VA continues to 
fund national awareness campaigns that have no evidence of 
effectiveness. There is growing research that awareness campaigns do 
not work or could even have an adverse impact because they normalize 
the behavior they are trying to mitigate. \3\ Yet, in the last few 
years, VA has awarded almost $100 million in contracts for ``Make the 
Connection'' and the ``Veterans Crisis Line'' campaigns instead of 
using those funds to address shortfalls at the call center, hire more 
mental health providers, expand peer support or conduct local outreach. 
Whistleblowers have noted that money gets spent on things like videos, 
posters, dashboards or SharePoint sites that could have been allocated 
for direct patient care, provider training or research.
---------------------------------------------------------------------------
    \3\ University of Michigan, School of Public Health
---------------------------------------------------------------------------
    Congress passed the Joshua Omvig, Clay Hunt, and the Chris 
Kirkpatrick Acts in attempts to mandate VA suicide prevention efforts. 
We lost Omvig, Hunt, and 20 other veterans a day, along with Dr. 
Kirkpatrick to suicide while VA has struggled to provide evidence-based 
interventions and support. Ongoing OIG and GAO investigations should 
prove fruitful in identifying suicide prevention improprieties and 
shortfalls along with recommendations for better practices.

      The Committee should hold a hearing to learn more about 
these mental health and brain treatment technologies to help prioritize 
their research value.
      Congress should require VA to lead an effort with its 
sister agencies to update the NRAP goals and objectives and document 
pertinent outcomes for veterans.
      Congress needs to hold VA accountable for how it uses the 
suicide population data it collects to inform the programs it creates 
and how it aligns appropriated funds for these purposes. The Committee 
should hold a hearing on suicide prevention funding to review OIG and 
GAO findings related to waste, fraud and abuse.

Research Treatment for Tinnitus:

    Tinnitus and hearing loss are the primary service connected 
conditions adjudicated by the Veterans Benefits Administration. There 
are double the number of veterans who are service connected for 
tinnitus than there are for PTSD, yet the research funding for 
audiology is minimal.
    Tinnitus, which is a constant ringing or buzzing in their ears, 
impacts so many aspects of a veterans' quality of life. It is often a 
side effect within the ear or brain from other conditions, 
environmental exposures (noise in a combat zone), or injury (TBI). 
Depression, anxiety, lack of sleep and difficulty focusing or 
concentrating are associated with tinnitus. Furthermore, tinnitus can 
exacerbate PTSD because of its sensory deprivation implications may 
impact memory imprints on the brain. A recent study \4\ looked at the 
relationship between Tinnitus and suicide.
---------------------------------------------------------------------------
    \4\ Martz et al. (2018)
---------------------------------------------------------------------------
    Although symptoms can be managed, there is no cure. The National 
Center for Rehabilitative Auditory Research (NCRAR) at the VA Portland 
Health Care System has been involved with researching transcranial 
magnetic stimulation (TMS) that involves using magnates to 
nonsurgically penetrate the brain and affect the activity of neurons as 
a new treatment.

      Congress should request an update from the NCRAR for a 
status on its research portfolio and potential translation capabilities 
for TMS.

Homeless Veteran Program Data:

    WoA is aware that VA administrators are intimidating VA employees 
to match homeless Veterans to housing that is grossly inadequate for 
the veteran and to underreport the number of homeless veterans who 
cannot maintain independent living. They are using the HUD vouchers to 
get homeless veterans into apartments, but then do not have the ability 
to furnish or provide supplies for them. Many of these veterans are 
chronically mentally ill and need more supervision than can be provided 
in an apartment. The veteran fails to conduct appropriate hygiene, so 
neighbors complain to landlords who evict these veterans. The VA case 
manager should be recording these veterans as homeless, but instead are 
told to document these veterans as transferring and not to report 
anything until they get the veteran into new housing. Additionally, 
over $1 billion has been provided to community organizations via 
Supportive Services to Veterans Families (SSVF) grants, with little to 
no performance data produced.

    There needs to be greater accountability for this highly vulnerable 
population.

      Congress should require VA to closely document the needs 
of each homeless veteran, match him or her with the appropriate type of 
facility, and enhance case manager assistance with ongoing issues while 
the veteran is transitioning from homelessness.
      VA should conduct a long-term ``lifecycle'' study on 
homeless veterans to identify challenges, complex medical/mental/dental 
needs and account for accurate touchpoints for interventions, services 
and outcomes of these engagements.
      VA should be required to report data regarding the number 
of veterans placed in transitional housing and the number who 
subsequently leave and the reasons why they left housing. It should 
also collect and report SSVF outcome data. Congress should authorize VA 
to conduct a comprehensive review of the Homeless Veteran population 
and a needs assessment.

    Toxic Exposures and Environmental Hazards Research and Presumption:

    Agent Orange: A primary source of concern for veterans that have 
contacted WoA has been related to toxic exposures and environmental 
hazards. There are still so many Vietnam-era Veterans with Agent Orange 
related issues that have not been appropriately recognized because of 
the shortfalls in the research, such as Blue Water Navy. For example, 
eye cancers are a continuous issue that lack research support. VA 
continues to deny claims for disability benefits, which in turn blocks 
veteran from accessing care. As the Vietnam generation ages and has 
more complex needs for care, the arguments over probable correlations 
need to be resolved before there is no one left for the science to 
help.

    Gulf War Illness: Although it has been more than 25 years since the 
US invaded Iraq, the mysteries of Gulf War Illnesses haunt veterans 
while perplexing VA. A July 2017 GAO report concluded that VA is still 
inappropriately denying veterans claims. It found an 80 percent denial 
rate, which is three times greater than any other type of claim 
denials. Plus, it also took VA longer to adjudicate these benefits. 
This delay means that sick veterans are not fully eligible for VA 
health care. VA has promised better training and to develop a new plan 
for research.

    Fort McClellan: When the Veterans Disability Benefits Commission 
(VDBC) issued its report, \5\ it included the Service members (mostly 
women) from Ft. McClellan, AL in its recommendation for a presumption 
framework. The VDBC made 20 recommendations for improvements to the VA 
presumption process, the creation of a scientific review board, and 
veteran health surveillance. Over 10 years later, the American Legion 
is still reporting on the ``unknown toxic legacy'' of Anniston and has 
resolutions that requires a toxic substance national research center, 
comprehensive examinations for environmental exposures, and improvement 
in these rules. \6\
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    \5\ VDBC. Honoring the Call to Duty: Veterans Disability Benefits 
in the 21st Century. October 2007.
    \6\ Olsen, K. the long shadow of Ft. McClellan. The American Legion 
Magazine. March 2018. Pgs. 22-28

    Camp LeJeune: Due to the water contamination at the Marine Corps 
Base, Camp LeJeune, NC, increased reports of cancers in veterans and 
their families have been document over the last several decades related 
to the cleaning solvents in the water. Referring to the previous notes 
on Ft. McClellan and the VDBC findings, VA would be better situated to 
address these issues if they were to have a standardized process and 
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scientific review board.

    Burn Pit Exposures: Similar to previous generations of veterans, 
those who have served in Afghanistan and Iraq since 9/11 were exposed 
to a concoction of burning substances on military installations that 
has caused them to raise health concerns from cancers to respiratory 
and gastrointestinal disorders. Although VA denies conclusive research 
for these conditions and does not have a presumption for burn pits, it 
has established a registry. However, this is an area yet again that the 
VDBC recommendation could be informative and assistive to veterans' 
wellness if implemented. A registry alone assists no one.

      Mandate VA to establish a Scientific Review Board as 
described by the VDBC for use in considering presumptions related to 
exposures. A standard should be adapted for ``causal effect'' based on 
more likely than not broad spectrum of evidence that is either 
Sufficient, Equipoise and above, Equipoise and below, Against. This 
calculation should include relative risk assessment, epidemiology, 
registries, surveillance data, predictive algorithms and interfaces 
with DoD.

Research Waste, Fraud and Abuse:

    WoA has reviewed complaints related to the waste, fraud and abuse 
of research program funds that have gone to universities and other 
private sector partners. In these cases, VA failed to provide proper 
oversight of government funds or property and could not account for 
items issued to non-government researchers or other staff. Property 
that should have been returned to the government was not and funds 
unexecuted were not returned.
    Much of the $1.9 billion of taxpayer funded VA Research falls 
outside of the realm of ``Direct Veteran Patient Care.'' There exist 
little or no oversight to monitor these VA funded research activities. 
VA Medical Centers Research dollars and facility resources are often 
redistributed towards gaps in Veteran care services, which leads to a 
disparaged and fractured research work environment. These are dedicated 
VA laboratory research spaces intended to support VA funded research 
that take place at more than 80 VA research facilities nationwide. The 
VA remedy is the wholesale issuance of ``100% Off Site Waivers'' to the 
Academic Affiliate.'' VA Rules and Regulations stipulate that ``All VA 
Funded Grant Activity must take place on VA owned property.'' Local VA 
``Nonprofit research Corporations'' (NPC's) no longer route Veteran-
centric research grant funding through VA and millions of dollars of 
research equipment and space are abandoned to sit fallow. As a result, 
a ``Boondoggle'' is created to support an illusion of ``Activity and 
Accountability'' as once noted by Congressman Mike Coffman. The end 
result is displaced VA equipment infrastructure, lost technology 
transfer opportunities, royalties and invention disclosure as reported 
in a recent GAO report. \7\
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    \7\ GAO-18-325: Published: Apr 25, 2018.
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    The OIG has conducted several investigations into VA research and 
development and has time and time again found mismanagement issues. For 
example, it investigated the development of a mobile application by VA 
and found that there were 80 potential contracts totaling over $1 
billion and VA did not ``pick and stick'' to the line item 
appropriation, thereby executing funds without the proper congressional 
authorities and confusing technology and patient care funds. In another 
investigation, the OIG found that VA did not have proper safeguards 
with its data when sharing information with external entities, such as 
universities.

      Considering these research deficits and the lack of VA's 
accountability for mismanagement and mishandling of equipment and space 
in its research program, VA should immediately put forth a plan for 
research oversight and its ability to report on executed research 
funds.

    Jacqueline Garrick is a former Army social work officer who has 
worked in the Departments of Veterans Affairs and Defense as well as 
for the House Veterans Affairs Committee. She is a subject matter 
expert in mental health and program evaluation. She is an advocate for 
disabled veterans and the use of peer support to improve resilience in 
traumatized populations. She founded Whistleblowers of America in 2017 
based on her experience reporting attempted fraud with DoD Suicide 
prevention funds.
    Whistleblowers of America is a 501C3, EIN 82-3989539. Its mission 
is to provide peer support to employees and veterans who have reported 
wrongdoing and experienced retaliation.

    Contact:
    Jacqueline Garrick
    [email protected]
    202-309-1870

                                 
 National Association of Veterans' Research and Education Foundations 
                                (NAVREF)

    May 23, 2018

    US House of Representatives
    House Committee on Veterans' Affairs
    335 Cannon House Office Building
    Washington, DC 20515

    To the Committee Staff:

    In regard to the hearing held May 17th on the Department of 
Veterans Affairs' medical and research prosthetic program, we would 
like to make an addition to the hearing record. Representative Poliquin 
asked Ms. Rusconi about the handling of unspent funds from an NIH 
research award. We would like to add the following statement to Ms. 
Rusconi's response:

    It should be noted that funds drawn from an NIH or other federal 
grant by an NPC include the federally negotiated indirect rate to 
administer those funds. Those administrative funds are used to support 
the NPC, whose sole mission is to support VA research.

    Thank you for holding this important hearing and giving NAVREF the 
opportunity to represent the perspective of the VA-affiliated nonprofit 
corporations.

    Respectfully,

    Richard P. Starrs
    Chief Executive Officer

    Robin Rusconi
    Chairperson

                                 [all]
```