[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]





         U.S. DEPARTMENT OF VETERANS AFFAIRS RESEARCH PROGRAMS

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

                                HEARING

                               before the

                         SUBCOMMITTEE ON HEALTH

                                 of the

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

                       ONE HUNDRED TENTH CONGRESS

                             FIRST SESSION

                               __________

                            OCTOBER 4, 2007

                               __________

                           Serial No. 110-50

                               __________

       Printed for the use of the Committee on Veterans' Affairs








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                     COMMITTEE ON VETERANS' AFFAIRS

                    BOB FILNER, California, Chairman

CORRINE BROWN, Florida               STEVE BUYER, Indiana, Ranking
VIC SNYDER, Arkansas                 CLIFF STEARNS, Florida
MICHAEL H. MICHAUD, Maine            JERRY MORAN, Kansas
STEPHANIE HERSETH SANDLIN, South     RICHARD H. BAKER, Louisiana
Dakota                               HENRY E. BROWN, Jr., South 
HARRY E. MITCHELL, Arizona           Carolina
JOHN J. HALL, New York               JEFF MILLER, Florida
PHIL HARE, Illinois                  JOHN BOOZMAN, Arkansas
MICHAEL F. DOYLE, Pennsylvania       GINNY BROWN-WAITE, Florida
SHELLEY BERKLEY, Nevada              MICHAEL R. TURNER, Ohio
JOHN T. SALAZAR, Colorado            BRIAN P. BILBRAY, California
CIRO D. RODRIGUEZ, Texas             DOUG LAMBORN, Colorado
JOE DONNELLY, Indiana                GUS M. BILIRAKIS, Florida
JERRY McNERNEY, California           VERN BUCHANAN, Florida
ZACHARY T. SPACE, Ohio
TIMOTHY J. WALZ, Minnesota

                   Malcom A. Shorter, Staff Director

                         SUBCOMMITTEE ON HEALTH

                  MICHAEL H. MICHAUD, Maine, Chairman

CORRINE BROWN, Florida               JEFF MILLER, Florida, Ranking
VIC SNYDER, Arkansas                 CLIFF STEARNS, Florida
PHIL HARE, Illinois                  JERRY MORAN, Kansas
MICHAEL F. DOYLE, Pennsylvania       RICHARD H. BAKER, Louisiana
SHELLEY BERKLEY, Nevada              HENRY E. BROWN, JR., South 
JOHN T. SALAZAR, Colorado            Carolina

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

                               __________

                            October 4, 2007

                                                                   Page
U.S. Department of Veterans Affairs Research Programs............     1

                           OPENING STATEMENTS

Chairman Michael Michaud.........................................     1
    Prepared statement of Chairman Michaud.......................    28
Hon. Jeff Miller, Ranking Republican Member......................     2
    Prepared statement of Congressman Miller.....................    28
Hon. Henry E. Brown, Jr..........................................    13

                               WITNESSES

U.S. Department of Defense, Department of the Army, Major David 
  Rozelle, Administrative Officer, Military Advanced Training 
  Center, Walter Reed Army Medical Center........................     5
    Prepared statement of Major Rozelle..........................    31
U.S. Department of Veterans Affairs, Joel Kupersmith, M.D., Chief 
  Research and Development Officer, Veterans Health 
  Administration.................................................    24
    Prepared statement of Dr. Kupersmith.........................    55

                                 ______

Blinded Veterans Association, Thomas Zampieri, Ph.D., Director of 
  Government Relations...........................................    14
    Prepared statement of Dr. Zampieri...........................    38
Disabled American Veterans, Joy J. Ilem, Assistant National 
  Legislative Director...........................................    17
    Prepared statement of Ms. Ilem...............................    48
Friends of VA Medical Care and Health Research, John R. Feussner, 
  M.D., MPH, Professor and Chairman, Department of Medicine, 
  Medical University of South Carolina, Charleston, SC, and 
  Volunteer Staff Physician, Ralph H. Johnson Veterans Affairs 
  Medical Center.................................................     3
    Prepared statement of Dr. Feussner...........................    29
Pain Care Coalition, Mark J. Lema, M.D, Ph.D, Chair, Department 
  of Anesthesiology, Critical Care and Pain Medicine, Roswell 
  Park Cancer Institute, Buffalo, NY, and Professor and Chair, 
  Department of Anesthesiology, University of Buffalo, State 
  University of New York, School of Medicine and Biomedical 
  Sciences, and President, American Society of Anesthesiologists.     7
    Prepared statement of Dr. Lema...............................    34
Paralyzed Veterans of America, Carl Blake, National Legislative 
  Director.......................................................    15
    Prepared statement of Mr. Blake..............................    46

                       SUBMISSIONS FOR THE RECORD

National Association of Veterans' Research and Education 
  Foundations, statement.........................................    65
Orthotic and Prosthetic Alliance, statement......................    67
Pike, Alvin C., CP, Lead Prosthetist, Minneapolis, MN, Veterans 
  Affairs Medical Center, Veterans Health Administration, U.S. 
  Department of Veterans Affairs, statement on his own behalf....    69
Salazar, Hon. John T., a Representative in Congress from the 
  State of Colorado, statement...................................    70

                   MATERIAL SUBMITTED FOR THE RECORD

Post Hearing Questions and Responses for the Record:
Hon. Michael H. Michaud, Chairman, Subcommittee on Health, 
  Committee on Veterans' Affairs, to Joel Kupersmith, M.D., Chief 
  Research and Development Officer, Veterans Health 
  Administration, U.S. Department of Veterans Affairs, letter 
  dated October 11, 2007.........................................    71
Hon. Jeff Miller, Ranking Republican Member, Subcommittee on 
  Health, Committee on Veterans' Affairs, to Hon. Gordon 
  Mansfield, Acting Secretary, U.S. Department of Veterans 
  Affairs, letter dated October 5, 2007..........................    76

 
         U.S. DEPARTMENT OF VETERANS AFFAIRS RESEARCH PROGRAMS

                              ----------                              


                       THURSDAY, OCTOBER 4, 2007

            U. S. House of Representatives,
                            Subcommittee on Health,
                            Committee on Veterans' Affairs,
                                                    Washington, DC.

    The Subcommittee met, pursuant to notice, at 10:02 a.m., in 
Room 334, Cannon House Office Building, Hon. Michael Michaud 
[Chairman of the Subcommittee] presiding.
    Present: Representatives Michaud, Snyder, Miller, and Brown 
of South Carolina.

             OPENING STATEMENT OF CHAIRMAN MICHAUD

    Mr. Michaud. The Subcommittee on Health will come to order. 
I would like to thank everyone for coming here today.
    At this hearing, we will examine the U.S. Department of 
Veterans Affairs (VA) Research Program. Research is one of the 
core missions of the Veterans Health Administration (VHA). VA 
is unique in that it has the capability to provide clinical 
services and conduct research within the same organization.
    As a result, the VA has done ground-breaking research on 
topics ranging from post traumatic stress disorder (PTSD), 
prosthetics, smoking cessation, and treatment of heart disease.
    The purpose of this hearing is to examine VA research 
programs, particularly in light of the current conflict. As we 
all know, Operation Enduring Freedom (OEF) and Operation Iraqi 
Freedom (OIF) have presented us with some new challenges in 
caring for and treating injured soldiers.
    In recent years, we have seen a dramatic increase in the 
number of returning veterans with conditions such as post 
traumatic stress disorder, traumatic brain injury (TBI), and 
traumatic amputation. These conflicts have produced nearly 
28,000 severely injured veterans, over 700 of which have had 
traumatic amputations.
    It is vital that VA continue to push the edge of research 
in order to provide these brave men and women with the most up-
to-date care available whether they need prosthetics, pain 
management, eye care, or any number of other services.
    It is also important that VA work in collaboration with the 
U.S. Department of Defense (DoD), academic partners, and other 
public and private entities to leverage their resources and 
knowledge and to produce the best possible results out of their 
research.
    I would like to send a special welcome to one of our 
witnesses today. On June 21, 2003, Major David Rozelle was 
leading a convoy west of Baghdad when his vehicle struck a land 
mine which resulted in the loss of his right foot.
    After spending 8 months recovering at Fort Carson, 
Colorado, Major Rozelle returned to Iraq as a troop commander 
conducting operations in Baghdad and Tel Afar. He was the first 
troop commander to redeploy in the same battlefield as an 
amputee in recent military history.
    Major Rozelle is currently serving as an Administrative 
Officer at the Military Advanced Training Center (MATC) at 
Walter Reed Army Medical Center. Drawing on his personal and 
professional experience, Major Rozelle helped plan and design 
this brand new facility using the most state-of-the-art 
research available.
    I would like to welcome you, Major.
    Continuing research is vital to improving healthcare, 
saving lives, and improving the quality of life for our sick 
and injured.
    I look forward to hearing from our witnesses today about 
what VA is doing and what VA should be doing to advance that 
core mission, research.
    I would now like to recognize a good colleague and friend, 
Ranking Member Miller, for an opening statement.
    [The prepared statement of Chairman Michaud appears on
p. 28.]

             OPENING STATEMENT OF HON. JEFF MILLER

    Mr. Miller. Thank you very much, Mr. Chairman.
    We all know that research is necessary to generate new 
knowledge and achieve both scientific and clinical excellence. 
VA is world renowned for its medical research. VA's Research 
Program has a strong history of success and is credited with 
pioneering life-saving therapies and treatments that have 
improved healthcare not only for veterans, but for patients as 
a whole.
    This year, for example, the first vaccine for shingles was 
approved as a result of VA research.
    Modern molecular medicine and rapidly advancing medical 
technology make a strong research enterprise more important to 
veterans now more so than ever.
    As we map out the future of VA and the research that they 
do, we must work to ensure that the VA's goals are aligned with 
the special healthcare needs of both our new generation of 
veterans from the Global War on Terror and our older veterans 
of previous wars.
    Recognizing the value of VA research, we must also be aware 
that nothing is more important than translating research from 
the bench to the bedside.
    I am pleased to see that we will hear from the 
Administrative Officer from the Military Advanced Training 
Center and have the opportunity to discuss collaborative 
efforts on Federal research for the benefit of our military and 
veterans.
    Mr. Chairman, I appreciate the opportunity to participate 
in this hearing today and yield back the balance of my time.
    [The prepared statement of Congressman Miller appears on
p. 28.]
    Mr. Michaud. I thank the gentleman.
    On our first panel today is Dr. John Feussner, who is 
Professor and Chairman of the Department of Medicine, Medical 
University of South Carolina in Charleston, South Carolina. He 
is testifying on behalf of Friends of VA Medical Care and 
Research (FOVA).
    Major Rozelle, who is the Administrative Officer from the 
Military Advanced Training Center (MATC) at Walter Reed Army 
Medical Center.
    And Dr. Mark Lema, who is Chair of the Department of 
Anesthesiology, who is testifying today on behalf of the Pain 
Care Coalition (PCC).
    So I would like to start off first with Dr. Feussner.

STATEMENTS JOHN R. FEUSSNER, M.D., MPH, PROFESSOR AND CHAIRMAN, 
 DEPARTMENT OF MEDICINE, MEDICAL UNIVERSITY OF SOUTH CAROLINA, 
CHARLESTON, SC, AND VOLUNTEER STAFF PHYSICIAN, RALPH H. JOHNSON 
  VETERANS AFFAIRS MEDICAL CENTER, ON BEHALF OF FRIENDS OF VA 
    MEDICAL CARE AND HEALTH RESEARCH; MAJOR DAVID ROZELLE, 
  ADMINISTRATIVE OFFICER, MILITARY ADVANCED TRAINING CENTER, 
 WALTER REED ARMY MEDICAL CENTER, DEPARTMENT OF THE ARMY, U.S. 
 DEPARTMENT OF DEFENSE; AND MARK J. LEMA, M.D., PH.D., CHAIR, 
DEPARTMENT OF ANESTHESIOLOGY, CRITICAL CARE AND PAIN MEDICINE, 
 ROSWELL PARK CANCER INSTITUTE, BUFFALO, NY, AND PROFESSOR AND 
  CHAIR, DEPARTMENT OF ANESTHESIOLOGY, UNIVERSITY OF BUFFALO, 
STATE UNIVERSITY OF NEW YORK, SCHOOL OF MEDICINE AND BIOMEDICAL 
SCIENCES, AND PRESIDENT, AMERICAN SOCIETY OF ANESTHESIOLOGISTS, 
                ON BEHALF OF PAIN CARE COALITION

            STATEMENT OF JOHN R. FEUSSNER, M.D., MPH

    Dr. Feussner. Good morning, Mr. Chairman, other Members of 
the Committee. My name is John Feussner.
    As you alluded to, I am Professor and Chairman of the 
Department of Medicine at the Medical University of South 
Carolina in Charleston. I am also a volunteer staff physician 
at the Ralph Johnson VA Medical Center in Charleston. 
Previously I served VA in Washington, D.C., as its Chief 
Research and Development Officer from 1996 to 2002.
    I would be remiss if I did not thank the Committee straight 
away for its support of VA research as evidenced by your 
recommendation for a $480 million appropriation for fiscal year 
2008.
    As you already stated, VA research is one of the Nation's 
premier biomedical research programs attracting high caliber 
clinicians who both do research and deliver medical care in 
VA's healthcare facilities. These physician researchers 
represent a scarce national resource and one that VA has 
sustained over several decades.
    Recall also that the VA Research Program is an intramural 
program, only supporting physician researchers and other 
scientists who are VA employees. These investigators are at the 
forefront of research that impacts newly returning veterans 
from Iraq and Afghanistan, especially concerning traumatic 
blast injuries, burns, and post traumatic stress disorder.
    And as it has done historically, VA is taking the lead on 
research issues affecting aging veterans who constitute the 
largest portion of veterans seeking treatment in the VA health 
system.
    The VA research enterprise continues to be veteran centric 
focusing its resources on illnesses either unique to or highly 
prevalent among veterans. The support and commitment for VA 
research from this Subcommittee really is the good news.
    However, and there are always many howevers, the current 
$480 million appropriation only provides a starting point for a 
more sustained future investment. New funding is necessary not 
only to sustain current research but to fund new research 
initiatives, to support career development for new physicians 
and other scientists, and to improve VA's aging research 
infrastructure.
    New funding can enhance research in such areas as traumatic 
brain injury, the effects of limb loss from our recent military 
conflicts and on the physical and psychological well-being of 
veterans.
    Because of past severe budget constraints, even approved 
and meritorious, VA research projects were either underfunded 
at a low dollar amount or unfunded entirely in part because of 
the inflationary and other escalating costs of doing high-
quality research.
    The FOVA Coalition encourages Congress to consider an 
orderly and predictable growth strategy for the VA research 
budget for the foreseeable future. Otherwise, gains made by 
this current Congressional appropriation may be lost without 
adequate attention paid to the future year research 
expenditures.
    However, even with sustained growth, Congress must begin to 
invest in VA's aging research infrastructure. In 2001, the VA 
research evaluation project assessed the state of the research 
infrastructure by surveying sites on the quality of the 
physical infrastructure, the organizational structure 
supporting research, and the availability of state-of-the-art 
research equipment.
    We estimated then that a dedicated funding allocation of 
approximately $40 million per year would be necessary to 
maintain and upgrade VA research facilities. Unfortunately, the 
events of September 11, 2001, intervened and attention to this 
crucial need for VA research waned.
    We all applaud the Committee's recommendation for a $15 
million construction funding stream for VA research facilities 
in its views and estimates for the 2008 fiscal year budget. 
This is certainly a very, very positive first step.
    However, at least $45 million needs to be allocated for 
research facilities improvement under this minor construction 
account each year for the foreseeable future. Such an annual 
allocation could improve VA's research infrastructure in as 
many as a dozen facilities each year.
    Finally, I would like to leave the Committee with several 
thoughts. First, our sincere gratitude for your support of this 
critical national resource, the VA Research Program.
    Second, please consider a strategic commitment to sustain 
this growth for the foreseeable future so that present gains 
are simultaneously sustained.
    And, finally, embrace the challenge and commitment to make 
the quality of VA research infrastructure match the quality of 
VA researchers. We should not expect world-class physicians and 
scientists to work in deteriorating research facilities. VA 
cannot afford to lose its best and brightest in this way.
    Again, Mr. Chairman, Members of the Committee, thank you 
for the opportunity to present FOVA's views on the Research 
Program. I will make every effort to answer your questions.
    [The prepared statement of Dr. Feussner appears on p. 29.]
    Mr. Michaud. Thank you very much.
    Major Rozelle.

                STATEMENT OF MAJOR DAVID ROZELLE

    Major Rozelle. Chairman Michaud and Congressman Miller, 
thank you for inviting me to participate in this hearing 
alongside my colleagues from the Department of Veterans 
Affairs.
    I am Major David Rozelle, an Armor Officer and 
Administrative Officer of the Military Advanced Training Center 
or MATC at Walter Reed Medical Center.
    I am excited to talk to you today about the use of advanced 
technology at the MATC and at the Center for the Intrepid, CFI, 
at Brooke Army Medical Center in San Antonio, Texas.
    The openings of the CFI on the 29th of January 2007, and 
the MATC on September 13th, 2007, demonstrate the tremendous 
support of American people for our wounded warriors. These 
facilities are symbolic of the significant advances that are 
being made in the care provided to our courageous 
servicemembers.
    Within the walls of the MATC, one recent patient described 
it as where the magic happens. It is a mix of technology and 
philosophy that allows our warriors to return to a lifetime of 
the highest physical activity, psychological and emotional 
function. Each servicemember is treated as a tactical athlete 
bringing the latest advances in sports medicine to bear.
    Within the walls of the MATC, there is a multidisciplinary 
health professional team that works together to seamlessly 
bring the patient from recently wounded status to return to 
warrior status. This team includes representatives from the 
Veterans Benefits Administration, the VA social workers, and VA 
vocation, education, and rehabilitation counselors.
    While the team includes those thought to be part of the 
traditional rehab team, the physical therapists, occupational 
therapists, physiatrists, and nurse case managers, it also 
includes psychological liaison providers, biomechanics, the 
patients, and the patient's family, among others.
    The facilities boast many state-of-the-art capabilities. 
These capabilities include the firearms training simulator 
which includes a Blue Tooth technology which replicates the 
weight, feel, and responsiveness of the actual weapons, an M16, 
M14, rifles, and the nine millimeter pistol.
    Also included is one of the most sophisticated gait labs in 
the world with a 23 camera capture system, a dual force plate 
treadmill, and six force plates in the floor to analyze gait 
patterns for adjustments to both prosthetics and for treatment 
plans.
    The best example of both centers' one-of-a-kind capability 
would be the computer-assisted rehabilitation environment or 
CAREN system. Imagine a helicopter simulator and replace the 
helicopter with a platform placed in front of a virtual reality 
screen. Imbedded in this is a treadmill with dual force plates 
underneath the treadmill.
    There are a number of scenarios that patients react to as 
part of the therapy and the future programming capabilities are 
indeed limitless.
    The facility offers a variety of opportunities which 
include a climbing wall, tread wall, an indoor walking and 
running track with a static harness system called the solo 
step. This support system frees the therapist to watch the 
patient and to make immediate corrections to their gait and 
patients the freedom of walking on their own.
    The elevating parallel bars were developed specifically for 
our military amputee population. This allows the patients to 
train for community obstacles that they frequently encounter 
such as sloping streets, sidewalks, or ramps.
    Technology has played a significant role in prosthetic 
restoration. New methods of measurement have resulted in more 
efficient methods of measuring the servicemember's amputated 
limb with better precision, efficiency, and quality.
    These methods include the computer-aided design, computer-
aided manufacturing, or CAD CAM, the optical digitizing and 
stereo lithography where CT scans are digitized and used to 
print an accurate three-dimensional model of the residual limb 
including existing heterotrophic ossification.
    The program pioneered and implemented the concept of early 
custom postoperative prostheses and coupled for the first time 
with a policy of utilizing externally powered prostheses 
components.
    Under this philosophy, the prosthetic sockets are rapidly 
produced with extremely durable and temporary materials and are 
coupled with the most technologically advanced components.
    The patient receives multiple and frequent sockets to 
accommodate the volume and shape changes common during the 
early postoperative phases.
    The use of myoelectric upper prosthetic components instead 
of body powered components places much less stress on the 
residual limb and permits the patient to begin to train much 
earlier in the rehabilitation process.
    The innovative use of current state-of-the-art technology 
has attracted many manufacturers to our program who are seeking 
to provide new technology to program prior to release to the 
general population.
    The resulting collaboration between the DoD and the 
Veterans Health Administration is ongoing and has already led 
to several significant successful projects. Among these is the 
development of the VA/DoD clinical practice guidelines (CPG) 
for patient care. The CPG sets in place the clinical pathway 
for both pre- and post-amputation patient care.
    Additionally, partnership between the DoD experts and 
industry recently resulted in the development of the newest 
generation of sea leg, which is a microprocessor controlled 
prosthetic and even allows instantaneous adjustment to variable 
walking speeds for amputees.
    As of September 2007, there have been 700 servicemembers 
who have sustained a major limb amputation in support of the 
Global War on Terror. Twenty-three percent of these individuals 
have lost an upper limb and over 20 percent have lost more than 
one limb. Nearly 90 percent of these servicemembers have been 
under the age of 35 and as a result, have unique psychosocial 
needs and generally seek to return to a more active lifestyle 
than older individuals.
    Additionally, the majority of combat-related amputations do 
not occur in isolation. Over 50 percent have documented 
traumatic brain injury, some with vision and/or hearing loss, 
and many have significant remote fractures and significant soft 
tissue wounds, others with comorbid paralysis from peripheral 
nerve injury or central cord injury, and nearly all with 
contaminated wounds requiring frequent surgical wash-outs and 
extensive antibiotic use.
    These complex medical, surgical, and rehabilitative 
challenges require unique approach treatment and warrant 
dedicated research programs to optimize care.
    The advanced training centers have proven to be an ideal 
setting for training and advanced techniques related to amputee 
care and prosthetics.
    In addition to VA/DoD Clinical Rotation Program, we have 
held a number of courses attended by military therapists, 
Veterans Affairs therapists, and prosthetists from around the 
country.
    One example of our collaborative efforts was a recent 
conference that brought together internationally recognized 
experts in amputee care from the DoD, VA, and academia to 
outline state-of-the-art care and set a road map for future 
research needed for this population.
    The findings of this conference are scheduled to be 
published in a textbook which will be disseminated 
internationally.
    The combination of advanced technologies, innovative 
clinical practices, caring providers, and an amazing group of 
warriors in transition with strength and courage to seek the 
high ground and continuing to move forward has led to 
revolutionary changes in our understanding of capabilities of 
individuals with limb loss.
    I thank you for inviting me to talk to you today about the 
capabilities and the magic at the Military Advanced Training 
Center at Walter Reed and the Center for the Intrepid.
    Your continued support for our wounded, ill, and injured is 
very much appreciated by the soldiers and staff at Walter Reed 
and throughout the Army.
    [The prepared statement of Major Rozelle appears on p. 31.]
    Mr. Michaud. Thank you very much, Major.
    Doctor Lema.

             STATEMENT OF MARK J. LEMA, M.D., PH.D.

    Dr. Lema. Mr. Chairman, Congressman Miller, my name is Dr. 
Mark Lema. I Chair the Department of Anesthesiology, Critical 
Care and Pain Medicine at the University at Buffalo and the 
Roswell Park Cancer Institute.
    Today I represent the Pain Care Coalition, a national 
advocacy effort of the American Academy of Pain Medicine, the 
American Pain Society, the American Headache Society, and the 
American Society of Anesthesiologists or ASA. I currently serve 
as President of the ASA and I am also a pain physician.
    Collectively the PCC represents over 50,000 physicians, 
clinicians, researchers, and educators who serve in leading 
clinical roles in the specialized field of pain management. 
Some of these specialists work in the VA healthcare systems and 
others are involved in collaborative relationships with 
research and clinical care programs through the VA system.
    Briefly, I would like to discuss the complex problem of 
pain, especially for the men and women of our military. While 
we have made great advances, much more research needs to be 
done.
    Mr. Chairman, pain is a very large public health problem in 
this country. Over 80 percent of patients seeking a doctor have 
pain as their primary complaint. The pain problem is even more 
prevalent in our military and veteran populations.
    If miners, movers, and construction workers suffer low back 
pain from heavy lifting, imagine the toll on the spine of those 
active combat duty soldiers in full battle gear.
    If truckers develop back pain from long hauls, imagine the 
toll of those soldiers inside armored vehicles going long 
distances on poor or nonexistent roads.
    If life's daily stresses serve as triggers for those 
suffering migraine headaches, imagine the impact of battlefield 
conditions on the military personnel's stress.
    Over 90 percent of the severely injured veterans enrolled 
in the VA polytrauma centers are suffering from chronic pain 
with most of these veterans having pain at more than one site. 
Eighty-five percent have traumatic brain injury.
    As professionals in the pain care field, we must ensure 
that the brave military men and women who serve or have served 
our country get the very best care in pain management possible. 
However, many of these injuries have no cure.
    I applaud the VA for its leadership in focusing resources 
on the assessment and treatment of pain. We are particularly 
supportive of the national pain management strategy initiated 
in November 1998. There is still much work to be done.
    The Pain Care Coalition believes VA's pain research effort 
can and must be significantly enhanced. We urge this 
Subcommittee to develop targeted legislation with three basic 
components.
    First, Congress should require VA to establish a focused 
research and training program directed at both acute and 
chronic pain within its medical and prosthetic research 
programs at VA headquarters.
    Second, Congress should authorize, and VA should designate, 
cooperative centers throughout the country for research and 
education on pain.
    Third, Congress should authorize these newly created pain 
research centers to compete on an equal basis with other 
priority research areas.
    Mr. Chairman and Members of this Subcommittee, pain is 
often characterized as the invisible disease. Unlike cancer, 
diabetes, and heart disease, there are no reliable tests to 
confirm the presence and severity of pain. But that is no 
excuse for letting research efforts lag behind those of other 
VA research priorities.
    In closing, I would like to quote U.S. Army Deputy Surgeon 
General, Joseph G. Webb, Jr. In October 2005, he said, 
``Wounded soldiers in Iraq and Afghanistan benefit from 
receiving some of the most advanced technologies and techniques 
in medicine today. The benefits of advanced pain management are 
improved postoperative outcomes and the potential to eliminate 
chronic pain, particularly in amputees.''
    Mr. Chairman and Members of this Subcommittee, please help 
ensure adequate funding for pain management research. We must 
join together so that our brave men and women returning from 
combat continue to receive the best care possible by developing 
cures for traumatic, painful conditions.
    Thank you. I would be glad to answer any questions.
    [The prepared statement of Dr. Lema appears on p. 34.]
    Mr. Michaud. Thank you very much. And we thank the other 
two panelists also.
    A couple of questions. Major, my first question will be to 
you. You have played a very large role in the design process at 
MATC. Could you give us a brief description of how the MATC was 
designed with the wounded warrior in mind and what are the 
lessons that we and VA might be able to learn from that 
process?
    Major Rozelle. Well, I think the key, Mr. Chairman, was 
that we got together the entire team, so we looked at this 
center and who was going to be in it first. And then we went to 
those agencies. Rather than letting engineers design it for us, 
we brought a team together to say what do we need.
    We were then able to sit down and review through a number 
of different sets and see what space we needed and what was 
required based on what the Health Facility and Planning Agency 
would allow us to have space-wise. And we continued to 
reconfigure it in the process.
    Another successful approach we used with the Military 
Advanced Training Center was we did what is called a design 
build. Basically we were able to sit down as a team with the 
engineers that were designing it for us as they did their 10, 
30, 50, 75, and 90 percent drawings and continue to make 
adjustments based off our teamwork where we would get together 
and virtually walk through the building and continue to do 
business.
    We actually continued to make changes in design to include 
walls and room space and room function up until the 90 percent. 
It was a very successful tool rather than walking into a 
building that was designed by someone else and then having to 
occupy and then make changes.
    There were two systems that we actually had to build the 
building around. One is the gait lab that I talked about 
specifically because it required an isolated slab. That is 
something you cannot post engineer into a building. The second, 
of course, would be the computer-assisted rehab environment, 
the CAREN, which is the simulation room. It is another isolated 
slab and literally had to have the building built around it.
    And to answer your second question, how can we move forward 
on this, we continue to get our teams together to look at the 
future of the Walter Reed at Bethesda, for instance. Everything 
from our building will be moved from MATC to Bethesda. That is 
a very unique characteristic.
    And then, of course, when it is at Bethesda, we will be 
able to test it and it will be tested and we can make changes 
as we move forward.
    We would like to think that our building is the model that 
people already have come to study on what does this advanced 
facility look like and are very proud of it.
    Mr. Michaud. Thank you very much. That was very helpful.
    Dr. Feussner, as you know, there are going to be several 
new VA hospitals built over the next few years. As the VA moves 
forward with these new hospitals, what type of infrastructure 
would you like them to consider incorporating into these 
facilities in order to support research activities?
    Dr. Feussner. Well, with new hospitals, we are beyond the 
point of any remodeling issues. So new hospitals should be 
built with new research facilities.
    I think you know, you were in the building in Charleston, 
the Strom Thurmond Medical Research Building in Charleston, 
which was a joint venture between the Federal Government, State 
government in South Carolina, and the Medical University, it is 
state-of-the-art research facility, about 120,000 square feet.
    The kind of collaboration and integration of research 
disciplines that the Major has referred to occur commonly in 
these state-of-the-art facilities. And the price back when our 
facility was built in 1996, the price was about $45 million. It 
is probably substantially more than that, but also 
substantially less than building a brand new hospital facility. 
It would be unfortunate if the building of hospitals, if it did 
not occur simultaneously with the build-out of new research 
facilities.
    Mr. Michaud. Thank you.
    Another question for the Major. You have worked hard when 
you look at the collaboration with VA on patient care. Can you 
go in a little more detail about the collaboration between DoD 
and VA in your facilities in terms of patient care, resources, 
and research?
    Major Rozelle. Well, Mr. Chairman, specifically to 
integrating the VA into our building, now we for the first time 
have all three offices represented within our building. The 
idea is that this seamless transition should occur at the 
building. And we are very proud to have them there inside our 
walls. And that is a large step forward from where we were when 
I was injured in 2003.
    As far as collaborative research, it seems that we at least 
quarterly have either training or conference where we bring 
together our partners which we consider VA to be one and, of 
course, academia another where we reach out and bring people 
together whether it is something simple as, you know, say, a 
running clinic where we bring in whether it is VA prosthetists 
or therapists in to observe this young special population on 
these very unique prostheses or whether it is a conference 
where we are getting together to write textbooks.
    And we continue to look at the future of, you know, 
specifically gait analysis and the future protocols that will 
come out of that room are endless as well as the CAREN system, 
you know, another great collaborative opportunity for DoD and 
VA to work together.
    Mr. Michaud. Thank you very much.
    My last question is for Dr. Lema. You talked about 
amputees' experience with phantom limb and stump pains. Can you 
be more specific as to what these pains are and do you think 
part of it is because of where the joints are for these limbs? 
Is that part of the reason--we just really have not done enough 
research in that particular area?
    Dr. Lema. Thank you, Mr. Chairman.
    Phantom limb pain is a very complex pain problem because it 
is a central pain problem. The brain is actually wired to 
understand that it has fingers regardless of whether fingers 
develop. And, likewise, when an organ such as an arm or a leg 
is removed, the body still has imprinted in the brain the 
capability of sensing the nerve fibers that would have gone to 
that area but were avulsed during the trauma.
    So that is how pain can often be recognized by a person who 
no longer has a limb. And oftentimes a person will remember the 
last thing before the nerve has been destroyed. So many times, 
it is a painful avulsion and that could be the last thing that 
our military personnel remember.
    So there are number of different phantom limb pains, three 
in particular. One is through chronic disease which is actually 
different than phantom limb pain from traumatic avulsion. In 
other words, losing a limb as a result of a blast.
    And, finally, there is also stump pain and stump pain 
oftentimes can be a result of poor surgical technique in a 
controlled environment or the inability to actually approximate 
avulsed tissue because of the blast. And that puts stress and 
strain on the blood vessels and the nerves as the surgeons try 
and approximate the skin around the stump. And, of course, 
anytime pressure is placed on the prosthetic device, intense 
pain can be experienced by the patient.
    So we are talking about all of those. But in particular, we 
are talking about coordinating pain management into these areas 
to the point where you recognize that pain management is a 
discreet entity.
    Currently if you look at all of the programs that the VA 
has and you envision each one of those programs as a pebble in 
a bowl, pain medicine is the water that touches all of those 
pebbles. We would like to make it a discreet entity so that it 
does not lose its focus when the other research efforts are 
being focused, as the Major said, on very important advances in 
prosthetic therapy.
    Mr. Michaud. Great. Thank you very much.
    Mr. Miller.
    Mr. Miller. Continuing with the pain issue, in the research 
that VA is doing now with returning veterans from OEF/OIF, is 
that research that can be utilized with older veterans? Or are 
some of these issues more directly related to new wounds or 
issues that we are seeing in the battlefield today?
    Dr. Lema. Your best chance of success is usually addressing 
pain aggressively at the first opportunity. Oftentimes 
effectively treating acute pain will prevent the changes that 
actually go on. These are changes that actually occur in nerve 
cell remodeling. In other words, the nerves change their 
personalities. And oftentimes, once that happens, it is more 
difficult to treat.
    So people who have actually had chronic pain that is more 
longstanding have to actually undergo different types of 
treatment that is oftentimes more difficult.
    We have an opportunity with this war to address the 
transition between the effectiveness of what we see in our 
military hospitals to then what we see for our veterans around 
the country. We believe that that transition is not as seamless 
as it could be and especially in the area of pain medicine 
where 90 percent have unrelieved pain. It is incapacitating.
    Imagine if you had a headache right now, you could not 
focus on this hearing. But imagine if that headache persisted 
every day of your life. How would you be able to function as a 
normal human being? And that is what we are trying to address.
    Mr. Miller. Major, when the MATC was being designed and 
built, was cost an issue or were you hopefully provided an 
opportunity to put in there what you needed?
    Major Rozelle. Well, the cost is always a consideration, 
Congressman. But, you know, we had guidelines for the building. 
You know, we had $10 million to spend on the facility. But I 
never felt limited. I never felt strapped by that amount. If I 
needed something, I knew that I could go back and request it. 
So thank you for that.
    But also, you know, we had great support within the 
Department of Defense as well. We had lots of visitors who came 
and said what else can we put into the facility. And after a 
tour, they realized that we pretty much had put everything in 
there that we needed.
    So we would never turn down money certainly, but we had 
enough for the mission and we actually ended up coming in under 
budget. So we are very proud of that. The $10 million was the 
right amount for that facility.
    Mr. Miller. You may have already addressed this in your 
testimony, but as far as replicating the MATC around the 
country, is it being done? Where is it being done? Others 
obviously are looking to what you are doing; what does the 
future hold?
    Major Rozelle. Well, sir, you know, I think that we have 
had a lot of visitors from around the world. You know, we 
looked to our partners in this war. We had the Canadians come 
take a look at what we are doing. The Israelis are interested 
in what we are doing.
    The Colombians have also come and taken a close look at, 
you know, treating our soldiers together, you know, the idea 
that we have clinically proven that, you know, if you have a 
peer group, people heal better together. And, you know, that is 
something that is unique to what we are doing. You know, when 
you are newly injured and you spread those units across the 
country, they are finding themselves healing by themselves.
    So this package that we have created is certainly 
exportable, but we also do not want to say we should build a 
Center of Excellence or ten more Centers of Excellence across 
the country. We are satisfied with what we have now.
    Mr. Miller. That is all, Mr. Chairman.
    Mr. Michaud. Mr. Brown.

         OPENING STATEMENT OF HON. HENRY E. BROWN, JR.

    Mr. Brown of South Carolina. Thank you, Mr. Chairman. And I 
am sorry I was late. I had to be in a markup in another 
Committee.
    But it is a real pleasure to welcome my good friend from 
Charleston, Dr. Feussner, and we are grateful for his 
involvement in healthcare delivery not only just in the private 
sector in Charleston but also in the VA community.
    And, of course, you know we have been working with you, Mr. 
Chairman, and other Members of the Committee to try to explore 
some areas of possibility that we might be able to share some 
of the research and some of the expertise that we find between 
the VA and the Medical University.
    And we are grateful that you would come. You know, we have 
been on the cutting edge, I guess, of the Strom Thurmond Gazes, 
you know, Heart Research Center. And as we do, I guess, an 
expansion program there at the Medical University that, you 
know, it gives us more opportunity to combine some of our 
resources between the VA and the Medical University.
    So we are grateful to have you here today. I am sorry I 
missed your testimony, but I am sorry I missed the testimony of 
the rest of you gentlemen, too. But, anyway, thank you.
    It is a concerted effort that we are trying to combine as 
many of the resources of the taxpayers' dollars to not have 
duplications but to find the best of both worlds and combine 
those, you know, intellectual capitals to try to be sure that 
our young men and women that are coming back from harm's way in 
terrible physical condition, that their needs will be met.
    And I think it is absolutely a great idea that when those 
guys come back, they need the, I guess, support of their group. 
And so I think being in a group kind of a setting gives a 
little more of, I think, encouragement in their healing 
process.
    But it has been a real pleasure, Mr. Chairman, to serve on 
this Committee to try to find and meet the needs of our 
veterans. And we are grateful for the Charleston model as we 
try to not only save the taxpayers money but to bring the best, 
brightest minds together to be sure that we have a broad front 
to attack the needs of our veterans.
    And thank you, John, for being here.
    Dr. Feussner. Thank you, Congressman Brown.
    Mr. Michaud. Thank you once again. I would like to thank 
the panel for your outstanding testimony this morning and look 
forward to working with you.
    And it goes without saying, Major, we really appreciate all 
that you have given to this great Nation of ours. We are all 
extremely proud of you and the other men and women who proudly 
wear the uniform of the United States. So thank you very much.
    Major Rozelle. It is an honor. Thank you.
    Mr. Michaud. This panel is dismissed, and we will set up 
for our second panel.
    I would like to welcome the second panel here: Dr. Tom 
Zampieri, who is the Director of Government Relations for the 
Blinded Veterans Association (BVA); Carl Blake, who is the 
National Legislative Director for the Paralyzed Veterans of 
America (PVA); and Joy Ilem, who is the Assistant National 
Legislative Director for the Disabled American Veterans (DAV).
    I would like to thank all three of you for joining us 
today. And we will start with Dr. Zampieri and work down. Thank 
you.

 STATEMENTS OF THOMAS ZAMPIERI, PH.D., DIRECTOR OF GOVERNMENT 
 RELATIONS, BLINDED VETERANS ASSOCIATION; CARL BLAKE, NATIONAL 
LEGISLATIVE DIRECTOR, PARALYZED VETERANS OF AMERICA; AND JOY J. 
    ILEM, ASSISTANT NATIONAL LEGISLATIVE DIRECTOR, DISABLED 
                       AMERICAN VETERANS

              STATEMENT OF THOMAS ZAMPIERI, PH.D.

    Mr. Zampieri. Chairman Michaud and Ranking Member Miller 
and Members of the House Veterans' Affairs Subcommittee on 
Health, on behalf of the Blinded Veterans Association, we thank 
you for this opportunity to present our testimony today on 
important research programs.
    BVA is the only Congressionally chartered veteran service 
organization exclusively dedicated to serving the needs of our 
Nation's blinded veterans and their families. And we have 
worked for over 62 years with the VA closely in developing 
special rehabilitative programs, both outpatient and inpatient 
rehabilitative programs for our Nation's blinded veterans.
    Our testimony includes a great deal of data and statistics 
that hopefully will not overwhelm anybody, but I thought it was 
important that people understand that the prevalence and the 
incidence of blindness and low vision in the United States is 
one out of every 28 Americans over the age of 40, which amounts 
to 3.3 million Americans are either blind or have low vision.
    This figure is from 2004 and when broken down, it separates 
to 2.3 million with low vision and about a million who are 
legally blind. However, each year, 200,000 more Americans 
develop age-related macular degeneration, which is the most 
common cause of blindness in our older veterans over age 65. 
Diabetic retinopathy is another frequent cause of blindness in 
younger veterans between the ages of 40 and 65.
    The take-away from some of this is that the employment rate 
of those individuals of working age between age 19 and age 65 
who have a vision-related disability remains still only at half 
of the nondisabled workforce, 38 percent, and that figure is at 
the end of a lot of the other employment data that I put in 
there.
    And I think that is a statement on the importance of 
research in regards to not only medical research but advanced 
prosthetic devices and new technologies to assist individuals 
in their recovery from vision loss and being able to enter the 
workforce.
    The economic and social impacts of this is just tremendous, 
$68 billion annually. One figure I read was there are currently 
over 400,000 older Americans who are in nursing homes strictly 
because of blindness, which is costing Medicare $11 billion a 
year for those individuals to be in nursing homes. And a lot of 
those could function independently if they were able to have 
rehabilitation.
    One of the most common causes of individuals being admitted 
to nursing homes is actually falls.
    The other thing is that as of September 25th, 2007, this 
number constantly changes, there have been 27,767 
servicemembers wounded in Iraq and Afghanistan. The number of 
men and women requiring air and medical evacuation from Iraq 
between March 19th, 2003, and September 17th, 2007, was 8,298 
of which 1,162 or 13 percent had sustained combat eye trauma. 
Thirteen percent of all those wounded evacuated from OIF and 
OEF have sustained serious combat eye wounds.
    This is the highest percentage of eye wounded evacuated in 
any war in 100 years. This is a staggering number and, in fact, 
the previous witness who testified about pain being the silent 
aspect of the injuries, Bob Woodruff from ABC News who attended 
our convention said that eye injuries apparently is the silent 
epidemic of war casualties in the sense that these numbers, you 
never hear about them.
    And I am alarmed. And even in our previous testimonies, we 
found, you know, difficulty in getting any accurate numbers.
    The other aspect of this is the traumatic brain injuries 
which are associated with a large percentage of vision-related 
complications. Of the 3,900 TBI patients, it is estimated that 
80 percent of those complain of visual-related symptoms. And at 
the polytrauma centers, 62 percent of the patients are 
diagnosed as having a TBI-related diagnosis with dysfunction of 
diplopia, convergence disorders, photophobia, ocular motor 
dysfunction, inability to read.
    We are proud of the fact that the VA has devoted a lot of 
new resources into expansion of low vision outpatient services 
and the support that this Committee has given that effort. We 
are also pleased that one of their research projects is on 
retinal research up in Boston on development of an artificial 
retinal implant.
    But what concerns us is that the amount of funding that is 
dedicated toward both DoD and VA vision research, we feel, is 
far too low.
    I would be happy to answer questions about all that. We 
appreciate the ability to present our testimony today.
    The one thing that would help us tremendously, we feel, is 
passage of H.R. 3558 which was introduced by a couple Members 
of this Committee. The ``Military Eye Trauma Treatment Act of 
2007'' would create a Military Eye Trauma Center of Excellence 
and eye trauma registry.
    And this is vital, we feel, because until there is an 
accurate accounting of these eye casualties and this 
information is shared with the VA, then what we hope will come 
out of this is new best practices like they are doing with 
prosthetics and new research geared toward the experiences that 
the DoD ophthalmologists and the VA ophthalmologists are now 
having to cope with.
    And so, again, I appreciate this opportunity to present our 
testimony and look forward to your questions.
    [The prepared statement of Dr. Zampieri appears on p. 38.]
    Mr. Michaud. Mr. Blake.

                    STATEMENT OF CARL BLAKE

    Mr. Blake. Mr. Chairman, Mr. Miller, and Mr. Brown, on 
behalf of PVA, I would like to thank you for the opportunity to 
testify today on the research programs administered by the VA.
    As you know, research is a vital part of veterans' 
healthcare and an essential mission for our National healthcare 
system.
    In testimony during the 109th Congress, PVA supported 
legislation that would create Amputation and Prosthetic 
Rehabilitation Centers of Excellence similar to those that are 
done for Multiple Sclerosis and for Parkinson's Disease. The 
need for these centers is amplified by the number of veterans 
of OIF and OEF who have amputations.
    We believe these centers could partner with the new 
Military Advanced Training Center that was just spoken about in 
some detail that recently opened at Walter Reed. This 
partnership could enhance the long-term provision of these 
services to veterans as it would allow the VA to remain on the 
cutting edge of amputation and prosthetic research in 
conjunction with DoD.
    This is particularly important as the VA will likely be 
responsible for caring for these men and women throughout the 
course of their lives.
    Additionally, VHA should be required to partner with 
manufacturers, dealers, payers, and advocates to develop 
performance test standards for amputee and prosthetic devices.
    An example of these types of test standards is the American 
National Standards Institute, ANSI, and Rehabilitation 
Engineering and Assistive Technology Society of North America, 
REATSNA, wheelchair performance standards. These standards are 
a collaborative effort with specific impacts on wheelchair 
research and development, consumer disclosure, and payer 
decisions.
    PVA believes that these centers could be the spearhead for 
development of evidence-based performance test standards for 
amputee and prosthetic devices within the VA.
    PVA also has a particular interest in research projects 
that the VA administers as it continues to address neurotrauma 
and sensory loss primarily as a result of spinal cord injury or 
disease or traumatic brain injury.
    As you are well aware, TBI is recognized as the signature 
injury of combat in Iraq and Afghanistan. According to the VA's 
estimates, TBI and various degrees of spinal cord injury 
account for nearly 25 percent of the combat casualties 
sustained by servicemembers in OIF and OEF.
    Despite the positive gains by advancements in body armor, 
the head as well as the cervical spine are exposed to 
significantly more trauma. This has not only led to specific 
injuries related to TBI and paralysis, but also vision loss, 
psychological problems, and the larger polytrauma aspect. As 
such, it is absolutely essential that continued research in the 
areas of TBI and SCI continue to advance.
    Likewise, PVA believes more research must be conducted to 
evaluate symptoms and treatment methods of veterans who have 
experienced TBI. This is essential to allow VA to deal with 
both the medical and mental health aspects of TBI including 
research into the long-term consequences of mild TBI in OEF/OIF 
veterans.
    Furthermore, TBI symptoms and treatments can be better 
assessed for previous generations of veterans who have 
experienced similar injuries.
    PVA is particularly interested in the VA's special research 
project that focuses on genomic medicine. The thrust of this 
project is to link veterans' genetic information with the VA 
electronic health record. The program will ultimately allow 
clinicians to make better decisions for veterans based on their 
genetic information.
    Furthermore, it will address patients' rights, informed 
consent, privacy, and ownership of genetic material involved 
with genetic tissue banking.
    However, despite the expectations of this exciting field, 
we must reiterate that additional new funding will be 
necessary. Genomic medicine cannot be advanced by simply 
reshuffling funding priorities within existing VHA research and 
development funding. If it is placed into a stream where it 
will compete with current VA projects, the sheer scope and cost 
of genomic medicine alone will overrun all other ongoing 
projects.
    Finally I must emphasize our concern about funding for the 
overall Medical and Prosthetic Research Program. We certainly 
appreciate the fact that the appropriations bills passed by the 
House and Senate meet or exceed the $480 million recommended by 
the Independent Budget for fiscal year 2008 and we appreciate 
this Committee's support for those measures.
    However, with the outcome of the appropriations still 
hanging in limbo and the fact that no appropriation has been 
provided even as the start of the new fiscal year has already 
passed, we remain concerned about the ongoing viability of the 
VA Research Program.
    Mr. Chairman and Members of the Subcommittee, again I would 
like to thank you for the opportunity to testify and I would be 
happy to answer any questions that you might have.
    [The prepared statement of Mr. Blake appears on p. 46.]
    Mr. Michaud. Thank you very much, Mr. Blake.
    Ms. Ilem.

                    STATEMENT OF JOY J. ILEM

    Ms. Ilem. Thank you, Mr. Chairman and Members of the 
Subcommittee, for inviting the Disabled American Veterans to 
provide testimony on VA research programs.
    There are a number of research areas we believe warrant 
special attention including prosthetics, traumatic brain 
injury, mental health, women veterans, the aging veteran 
population, Gulf War, and minority veterans.
    A significant number of young servicemembers are returning 
from Iraq and Afghanistan with complex polytraumatic injuries. 
VA will be responsible for the health maintenance of this 
population for decades. Therefore, it is essential that VA 
remains the leader in advancing new technologies in prosthetic 
and orthotic items while refining rehabilitation models and 
promoting good health outcomes for veterans with amputations 
and other trauma.
    Traumatic brain injury or TBI is another area of particular 
concern for DAV. While severe brain injuries are more easily 
recognized, some servicemembers exposed to explosive blasts 
have no obvious or visible injury. It is believed that many 
OEF/OIF veterans have suffered mild brain injuries or 
concussions that have gone undetected.
    Emerging literature strongly suggests that even mild TBI 
injuries may have long-term mental health consequences. With 
the influx of servicemembers returning with mild or moderate 
TBI, research should be expanded on the evaluation and 
treatment of this injury in new veterans. However, studies 
undertaken by VA should also include older veterans of past 
military conflicts who have suffered similar injuries that were 
undetected, undiagnosed, or misdiagnosed and untreated.
    Combat-related mental health readjustment issues should 
also be a critical research priority for VA. Veterans of these 
current wars have a wide range of possible mental health 
conditions such as readjustment disorder, anxiety, depression, 
PTSD, and substance abuse.
    Early studies suggest that substance abuse is a growing 
problem in a large number of returning war veterans. Therefore, 
we urge VA to continue research into this critical area as well 
and to identify the best treatment strategies to address 
substance abuse and associated mental health and readjustment 
issues while continuing to address the needs of older veterans 
with these problems.
    We urge Congress to remain vigilant to ensure that mental 
health research and appropriate treatment programs are 
authorized and sufficiently funded.
    With increasing numbers of women serving in the military 
today and with more women veterans seeking VA healthcare 
following military service, VA must be prepared to meet their 
unique physical and mental health needs. Women's health 
research is essential to fully understand the healthcare needs 
of this population and to develop high-quality services and 
treatments.
    While many of the health problems of male and female 
veterans returning from combat operations will be similar, VA 
must address the health issues that pose special challenges for 
women.
    DAV has recommended that VA focus its women health research 
on finding the healthcare delivery model that demonstrates the 
best clinical outcomes for women veterans, assesses the 
barriers that women perceive or have experienced in seeking VA 
healthcare services, conduct a long-term health study of women 
who served in combat theaters, and conduct research to fully 
understand the dual burden of military sexual trauma and 
combat-related PTSD.
    While additional research and resources must be provided to 
better treat our newest generation of combat veterans, VA still 
has a large number of aging veterans. In that respect, research 
focused on diabetes, hypertension, heart disease, dementia, and 
other chronic illnesses affecting older populations must 
continue.
    Likewise, additional research is needed to explore and 
develop systematic methods for efficacious treatments for Gulf 
War veterans with unexplained medical symptoms and illnesses so 
that a collection of best practices becomes available to all VA 
clinicians in the field.
    A June 2007 VA study found that racial and ethnic 
disparities appear to exist in all clinical areas. Researchers 
noted that this finding was especially troubling since it may 
indicate that disparities in healthcare delivery contribute to 
disparities in health outcomes. It is clear from this study 
that VA needs to continue this important research and find 
solutions to this problem.
    From its earliest days, biomedical rehabilitation and 
health services research has been an integral part of VA's 
overall mission. Today the VA system offers veterans the best 
care anywhere as confirmed by numerous health industry experts. 
But millions of sick and disabled veterans depend on the VA 
healthcare system to help them overcome severely disabling 
injuries.
    We urge VA to press forward and to remain on the cutting 
edge of healthcare through its esteemed research program and we 
encourage this Subcommittee to maintain necessary oversight of 
VA research programs and to provide sufficient funding to help 
VA improve service and health outcomes for disabled veterans.
    Mr. Chairman, that concludes my testimony and I will be 
happy to answer any questions you may have. Thank you.
    [The prepared statement of Ms. Ilem appears on p. 48.]
    Mr. Michaud. Thank you very much. And I thank the other two 
panelists as well.
    Everyone on this panel agrees that VA should continue to 
put money and resources into research and development, although 
money is limited, so we have to sometimes make priorities.
    I would like to ask all three of you what should the VA's 
top three priorities be as they relate to research and 
development? We will start with Dr. Zampieri.
    Mr. Zampieri. I think that from our perspective, you know, 
one of the unique aspects of the war and the injured coming 
back is that when you look at all the different types of 
research, you are not going to find in the private sector a 
thousand severe, you know, eye trauma cases.
    I mean, you talk to private university ophthalmologists who 
do emergency room work and you look at national eye registry 
data, you know, like three percent of all Americans who go in 
the emergency rooms suffer from a severe type of industrial eye 
injury.
    And, you know, we feel that there are certain types of 
military injuries that should be a priority as far as whether 
it is amputation, prosthetics research, vision research, spinal 
cord injury (SCI), you know, speaking for my friends here, 
because you cannot just go out in the private sector and find 
those dollars.
    I mean, you know, these are unprecedented. One of our 
attachments shows you pictures of what we are talking about. 
And, you know, I was upset that in the Congressionally directed 
DoD research, there is $4.9 million for eye research. And I am 
saying to myself, you know, is something wrong with this 
picture in regards to--you know, there are certain things that 
we have a responsibility for and I just think that anything 
related to combat trauma, the Blinded Veterans Association 
thinks should be a priority.
    The other aspect of this is one of the difficulties is 
technology. Everybody is overwhelmed. The good news is there 
are lots of new adaptive technology equipment that is out there 
and sorting through those and testing those and finding out 
which ones really work the best is actually overwhelming for 
some of the staff that I talk to.
    So it is a good news, bad news story. You have so much 
emphasis nowadays on technology research, but, you know, how do 
you sort that out within the VA and Department of Defense as to 
which really work well? And if you are going to invest money 
into those, is your return going to be, you know, valuable?
    Anyway, thank you.
    Mr. Blake. Well, Mr. Chairman, I would say first that I do 
not think that is a fair question because the scope of research 
programs conducted by the VA is so broad that I do not know 
that we could pinpoint certain ones.
    As an advocate for Paralyzed Veterans of America, I do not 
think I would be doing my job if I did not say that we believe 
neurosensory loss and trauma associated with spinal cord 
injuries should be at the top of the list, but I think that 
falls into a broader category in some fashion.
    Like Tom mentioned about combat-related traumas and injury, 
I do not think that you can tailor research to that because 
there are so many avenues under that whether it be TBI, 
psychological disorders and research associated with that, 
those sorts of things. But I think there is probably a broader 
field associated with it.
    I believe that the genomic medicine research is going to be 
a growing field. It is a massive scope in that program, but I 
think a lot of focus is going to be placed there because of the 
potential for it. But outside of that, I do not know that I 
could give you one, two, or three items that would be the way 
to go.
    Ms. Ilem. I think I would have to concur with my colleagues 
that it is a difficult question to try to pinpoint if you had 
to pick the top three. And I think probably VA is grappling 
with that as well. They have, you know, a limited amount of 
funding and they have to choose the areas that they feel are 
the most critical. And I would assume they are looking at 
issues that they think they are going to have the largest 
problem in those populations.
    And obviously they want to, I am sure, remain on the 
cutting edge with prosthetic technology that is coming out and 
make sure that this small group, relatively small group 
maintains, you know, to continue to have these really 
incredible prosthetic items available to them throughout their 
lifetime.
    And the traumatic brain injury, obviously everyone is very 
concerned about it in the mild and moderate category, not just 
the most severe, and what are the long-term consequences for 
that population.
    And I think mental health too. Everybody is very concerned 
about that because of the long-term chronic consequences that 
can lead to a lot of other issues.
    So it is a difficult question, but I think that we all 
agree that anything related to military service, VA should have 
the funding available to do the research necessary to make sure 
that the appropriate programs and services are available and 
the best treatments in the world for these veterans.
    Mr. Michaud. Well, you all did a very good job answering 
the question and part of it, I expected your answer to be what 
it was. So I appreciate it.
    I will give you an easy one to answer. What ideas do you 
have on how VA and DoD and other government agencies can 
improve on how to conduct research in a collaborative manner? 
What works best?
    Mr. Blake. What works best?
    Mr. Michaud. Yes. I mean, can VA and DoD and other agencies 
do a better job on collaborative research and development?
    Mr. Blake. Well, I would say the key is to ensure that as 
we move forward, at least particularly with the newest 
generation of veterans, that DoD and the VA do not operate 
their own programs within a vacuum. That is not saying that 
they do. The VA does an outstanding job of working with 
academic affiliates, the private sector, and within the VA. The 
DoD has done some degree of research, particularly with the 
newest related casualties from Iraq and Afghanistan and it is 
important to ensure that some kind of link is established in 
all of these areas.
    I think the prosthetics issue is going to be a big issue 
because a lot of the men and women out at Walter Reed, 
Bethesda, and certain other locations are getting the most 
advanced prosthetics and it is important to ensure that the VA 
is tied in to what is going on there so that they understand 
this ever-evolving technology because they will be the ones in 
the long term responsible for meeting the needs of these men 
and women.
    Ms. Ilem. Yeah. I would agree with that. And I think that 
VA and DoD, you know, we hear about some of these collaborative 
projects and things that they are working on. And it is great 
to hear that VA is being allowed to, you know, bring their 
prosthetists and other folks out there, you know.
    But I think we would like to see more of that right from 
the get-go in terms of, you know, they are both interested in 
what is happening with this population and it crosses over. 
And, you know, however they can work together to make sure that 
all of these treatments and best practices are both developed 
in both, you know, agencies as a collaborative effort, I think, 
is in the best interest of our veterans.
    Mr. Michaud. Great. Thank you.
    Mr. Miller.
    Mr. Miller. Thank you, Mr. Chairman.
    Let the record reflect I will not ask the panel a difficult 
question that they cannot answer. It is very unfair of you to 
do that.
    One question because our time is running short, I know we 
have a vote coming up shortly. One thing that we find in the 
Federal bureaucracy is that there are many agencies doing 
duplicative work, research. There is such a competition for 
research dollars.
    Do you feel, and this could go to any or all of you, and 
TBI a perfect example, that there should be a single Federal 
clearinghouse agency for medical research? Would that aid in 
what we are trying to accomplish, providing the best care to 
those who need it?
    Mr. Blake. Well, that is not an easy one either.
    Ms. Ilem. I know. That is not easy either.
    Mr. Miller. I did not say it was easy.
    Mr. Zampieri. That is sort of like, you know, can we reform 
the Tax Code.
    Mr. Miller. Yes, we can.
    Mr. Zampieri. You know, I guess you could, but it is not 
going to be easy. Speaking as a person who is a clinical 
provider as a physician assistant for 25 years, you know, the 
universe of Federal research and university research and 
private foundations is complex.
    And I guess, you know, my way of approaching this is that, 
again, that, you know, I think that DoD and VA should look at a 
way to partner even more on the specific research again with 
these different types of injuries and stuff from the war.
    And, you know, like I mentioned, one of the things that we 
would like to see is whether it is associated with this Eye 
Center of Excellence, but a joint technology sort of research 
center, you know, where they work together on all this, you 
know, advanced technology development, similar to what they are 
doing now in regards to amputee prosthetics, you know, and just 
build on that.
    I think the problem once you get off into the world of the 
National Institutes of Health (NIH) and all that is the 
complexities of the competitive research that goes on outside. 
I do not think one ``Federal research czar'' could handle this.
    Mr. Blake. I think it is certainly an idea worth 
consideration. I think the problem that you run into is 
although the vast majority of research programs benefit a broad 
cross-section of the general population maybe in different 
ways, one type of research does not necessarily benefit the 
other type of group.
    And we would certainly hate to see any kind of a national 
management of research where a program is managed that does not 
benefit veterans in some fashion. That is not to say that even 
research conducted with the VA benefits all of a society, but 
we believe it does. But we need to ensure that the VA has that 
directed expertise as it relates to the issues surrounding 
veterans and their own experiences.
    So I am not sure that a single agency could manage research 
in that fashion and ensure that it is universally applicable 
and would benefit everyone.
    I would say that NIH maybe on some level does a little bit 
of that now because a lot of research in some fashion passes 
through the doors of NIH before it comes back out to wherever 
it goes. Even the VA has its own partnerships in most cases 
with research through NIH.
    Ms. Ilem. I mean, I would not have much more to add than I 
think what both my colleagues have said other than, you know, I 
think it is an idea worth exploring or looking at. However, I 
think I would need more time to really think about that and the 
implications.
    And the thing that first came to mind was thinking about, 
you know, making sure not just about the duplication but make 
sure there is not stunting of creativity and thoughts and ideas 
and different avenues of approaching things.
    But certainly it is something that we could, you know, 
further explore and get back to you or your staff with.
    Mr. Miller. That is it.
    Mr. Michaud. Mr. Brown.
    Mr. Brown of South Carolina. Mr. Chairman, I am going to be 
pretty easy on the panel. I have a yes or no answer.
    I know down in Charleston, I think we mentioned with the 
other panel that we do have, you know, combined with heart, 
with the Strom Thurmond Gazes Research, you know, Clinic.
    And so I would ask the question if you do not think in 
order to be able to utilize the best taxpayers' dollars is to 
combine some kind of oversight to all of these agencies and 
also include in the private sector because I think there is a 
lot of duplication of effort out there and I know competition 
is always good for the funds.
    But would you agree that by including the private sector 
that that gives us another dimension of intellectual capital 
that we probably would not have just within our own bounds?
    Mr. Zampieri. I would agree that, you know, that there is 
obviously, so I do not get misquoted, I think that there should 
be effective coordinated private-sector research, you know, 
from the VA perspective.
    You know, a lot of the physicians that I worked with, for 
example, in Houston, Texas, at the VA Medical Center, we did a 
lot of prostate cancer research in association with Baylor 
University. And, in fact, most of the VA urologists would have 
said that we would not have been able to do some of that 
research without the support of the, you know, outside 
universities.
    And so, you know, my background gives me that, you know, 
that this is very important. I guess, you know, my concern, 
though, is that there is again sometimes specific military and 
VA types of research that it would be difficult to find that 
type of private university research going on.
    While I do know that there is a lot of retinal research 
going on in private university driven programs and retinal 
implants and optic nerve and things like that, so there is a 
relationship there that they could draw upon.
    Mr. Brown of South Carolina. I was just hoping that you 
would just say yes and we would not have to reinvent the wheel. 
And I know a lot of times, there is a lot of research being 
focused on, you know, the same issue in many different areas. 
And if they could combine those resources, it seems like it 
would be better utilization of our taxpayers' dollars.
    And I know that buzzer just went off and that means that we 
are going to have to go vote pretty shortly, so I will just 
leave the other two panelists an option to say yes or no.
    Mr. Blake. How about maybe?
    Ms. Ilem. Same.
    Mr. Brown of South Carolina. Thank you very much.
    Thank you, Mr. Chairman.
    Mr. Michaud. Thank you.
    And, Dr. Snyder.
    Mr. Snyder. Thank you, Mr. Chairman. I will not ask any 
questions because we have votes going on.
    But I appreciate your all's advocacy on funding for medical 
research and proper funding and the detail in your written 
statements that you go on about what that means for the folks 
that are members of your organizations. I think your advocacy 
is absolutely vital and I appreciate your doing it year after 
year. Thank you.
    Thank you, Mr. Chairman.
    Mr. Michaud. I would like to thank this panel.
    And I do not know if we can fit the third panel in within 
the next 5 minutes. The third panel is Dr. Joel Kupersmith, who 
is an M.D. He is the Chief Research and Development Officer 
from the VHA. He is accompanied by Dr. Tim O'Leary and Dr. 
Michael Selzer.
    I would like to thank you very much, Dr. Kupersmith, and 
look forward to hearing your testimony.

    STATEMENT OF JOEL KUPERSMITH, M.D., CHIEF RESEARCH AND 
   DEVELOPMENT OFFICER, VETERANS HEALTH ADMINISTRATION, U.S. 
DEPARTMENT OF VETERANS AFFAIRS; ACCOMPANIED BY TIMOTHY O'LEARY, 
   M.D., PH.D., DIRECTOR, BIOMEDICAL LABORATORY AND CLINICAL 
       SCIENCE RESEARCH AND DEVELOPMENT, VETERANS HEALTH 
   ADMINISTRATION, U.S. DEPARTMENT OF VETERANS AFFAIRS; AND 
   MICHAEL E. SELZER, M.D., PH.D., DIRECTOR, REHABILITATION 
RESEARCH AND DEVELOPMENT, VETERANS HEALTH ADMINISTRATION, U.S. 
                 DEPARTMENT OF VETERANS AFFAIRS

    Dr. Kupersmith. Thank you very much, Mr. Chairman.
    Mr. Chairman and Members of the Subcommittee, thank you for 
the opportunity to discuss the Department of Veterans Affairs 
Medical and Prosthetic Research Program.
    With me are Dr. Timothy O'Leary, Director of Biomedical 
Laboratory and Clinical Science Research, and Dr. Michael 
Selzer, Director of Rehabilitation Research and Development.
    For more than 80 years, VA research has been a valuable 
investment with remarkable and lasting returns. The history of 
VA research is filled with examples of how it has improved care 
including developing numerous advances in prosthetics, 
developing a system that allows tetraplegics' brain waves to 
turn on lights and open e-mails, pioneering, understanding, and 
treatment of post traumatic stress disorder or PTSD, 
identifying genes associated with Alzheimer's disease, 
premature aging, schizophrenia, and diabetes.
    In recognition of their innovative work, VA researchers 
have received three Nobel Prizes and six Lasker Awards.
    VA research is an intramural program where clinical care 
and research occur under one roof. This unique advantage allows 
VA investigators to bring scientific discovery from the 
laboratory bench to the patient's bedside making this program a 
most effective tool to improve veterans' care.
    All our veterans from those who served in World War II to 
those returning from current conflicts in Iraq and Afghanistan 
deserve the very best care possible. Therefore, VA has a 
comprehensive research agenda using all the tools of modern 
science to develop new treatments for physical injuries, 
illnesses, and mental health disorders, to improve access to 
healthcare, and to address long-term needs.
    A priority area for VA research is health issues of 
veterans of Operation Iraq and Enduring Freedom or OIF/OEF such 
as prosthetics healthcare, pain, traumatic brain injury, spinal 
cord injury, sensory loss, mental health, and polytrauma.
    Let me provide a few examples of exciting research in these 
areas. VA researchers are developing improved materials and 
designs for prostheses. One project under way involves building 
a new flexible prosthetic wrist to allow upper arm amputees to 
interact with objects in a more life-like fashion and with 
fewer mechanical failures.
    In addition, VA recently unveiled a computer-driven ankle 
foot prostheses that helps restore amputees' ability to walk 
normally. In a preliminary study of the prototype, patients 
used less energy during walking, had fewer balance problems, 
and walked 15 percent faster.
    To learn more about combat-related mental health, VA 
researchers are collaborating with DoD to collect risk factors 
and health information from military personnel prior to the 
deployments to Iraq. These soldiers will be reassessed upon 
their return and several times afterward to identify changes 
that occurred following combat duty and to identify risk 
factors for PTSD and other health conditions.
    An additional goal is to examine whether and how PTSD and 
traumatic brain injury are related.
    Excruciating pain is experienced by more than 50 percent of 
patients after spinal cord injury. VA investigators have 
identified a particular mechanism responsible for conveying 
pain signals to the brain and are now using that discovery to 
develop a new pain treatment. This research has the potential 
to benefit the general public as well as veterans.
    Other priority research areas include treating and 
preventing chronic diseases such as diabetes, obesity, HIV/
AIDS, and heart disease, understanding healthcare needs and 
service utilization of women veterans, treating conditions 
including substance abuse, adjustment and anxiety disorders, 
psychotic disorders, dementia and memory disorders, and related 
brain damage and providing personalized medicine.
    VA is at the forefront of developing treatment that is 
tailored specifically to an individual based on genetic 
medicine also known as personalized medicine. It will increase 
the effectiveness and safety of healthcare, drug treatments, 
and disease prevention efforts. Personalized medicine is 
considered the direction for healthcare in the 21st century.
    VA research supports a broad initiative examining access to 
healthcare aimed at identifying system-wide gaps in care, 
assessing specific access issues and barriers for special 
populations, assessing the impact of new programs, practice 
structures, and organizations, and developing and evaluating 
quality improvement efforts, organizational and management 
interventions, implementation initiatives, and new 
technologies.
    Further, meeting the long-term care needs of the aging 
veteran population continues to be a high priority for VA 
research. A major focus is on research that will enhance care 
coordination to improve quality of life for long-term care 
patients.
    Other projects include those aimed at caregivers and a new 
initiative focused on developing approaches to community-based 
long-term care.
    In conclusion, VA research with its distinguished history 
of discovery and innovation today remains an essential part of 
VA's efforts to ensure the health and well-being of our 
Nation's veterans. VA takes great pride in research that keeps 
it at the forefront of modern medicine and healthcare and 
expects to see further remarkable discoveries in the future.
    Mr. Chairman, that concludes my statement and I will be 
pleased to respond to any questions you or the Subcommittee 
Members may have. Thank you.
    [The prepared statement of Dr. Kupersmith appears on p. 
55.]
    Mr. Michaud. Thank you very much, Dr. Kupersmith. You are 
actually saved by the bell. So I will be submitting my 
questions for the record as will Ranking Member Miller as well.
    Dr. Snyder.
    Mr. Snyder. I am sure other Members may have questions for 
the record also.
    Dr. Kupersmith, the issue of the funding has been kind of a 
nod at some of us over the last several years because I thought 
the President's budgets have always been grossly inadequate. 
They do not keep up with the medical inflation rate or whatever 
that term is, the research inflation rate. They include funding 
that, you know, they just anticipate that there is going to be 
robust funding from NIH and other agencies or private funding. 
Those budgets were inadequate also.
    So we have a catch-up phenomenon going on. But I mean, do 
we not still have some more work to do in terms of overall 
funding and what could be done given all the things that you 
just outlined, the challenges that our veterans and our new 
generation of veterans are facing? Would you all not benefit 
from additional funding?
    Dr. Kupersmith. Well, as you know, I support the 
President's budget. I can certainly tell you----
    Mr. Snyder. My question was, will you not benefit from 
additional funding?
    Dr. Kupersmith. I am sorry?
    Mr. Snyder. My question, though, was, I understand you are 
supporting the budget, but my question was, would you all not 
be able to do additional good things if you had additional 
funding?
    Dr. Kupersmith. Yes. Yes. The answer is yes. Certainly I 
think our portfolio is moving certain directions which I think 
will be very beneficial to veterans and others in the future. 
We are obviously moving more toward conditions related to OIF/
OEF and research on that level.
    We always balance our portfolio between the newer veterans 
coming back or we have in the past few years and the chronic 
diseases that veterans have. And genomic medicine actually 
bridges both of those. Some of our first projects in genomics 
will be on PTSD and TBI.
    And so some of the things that were mentioned today, pain, 
for example, we have been increasing our portfolio on that and 
we are very interested in that. We even have it as part of our 
Research Career Development Award Program.
    So the answer is, yes, we do have a number of things that 
we would do.
    Mr. Snyder. Is it not a question not just of projects? I 
mean, I assume that you have a good system for sorting through, 
okay, we have this many research projects from around the 
country that we could fund. We think we are going to come up 
with our list of ones that we think are good. We have adequate 
funding for this many. There are still some we would like to 
fund. I mean, that is part of it.
    But is not another part of it, unless we have robust 
funding, researchers are going to find other places to go to 
and other countries to go to and private sector places to go 
to? Is that not an issue, too, that we need to have robust, 
reliable funding so that to keep the kind of personnel that you 
want at the VA?
    Dr. Kupersmith. Surely it is. And I think that, you know, 
it is both. And I will answer that if we had more money, we 
would--you know, the retention of physicians is a very 
important part or research is a very important part of 
retention of physicians in the VA and our research program in 
general. Obviously researchers go where there is funding. And, 
you know, again, we support the President's budget. If we had 
more funding, those are some of the things that we would think 
about certainly.
    Mr. Snyder. Thank you, Mr. Chairman.
    Mr. Michaud. I would like to thank this panel as well and 
the two previous panels for your testimony today. And we will 
submit additional questions for the record.
    Dr. Kupersmith. Can I just ask one? May we respond to some 
of the questions that were asked to the other panelists? We 
would appreciate that opportunity also.
    Mr. Michaud. In writing, yes.
    Dr. Kupersmith. Yes.
    Mr. Michaud. Yes, absolutely.
    Dr. Kupersmith. Thank you very much. I appreciate that.
    Mr. Michaud. This hearing is adjourned. Thank you.
    [Whereupon at 11:27 a.m., the Subcommittee was adjourned.]



                            A P P E N D I X

                              ----------                              

             Prepared Statement of Hon. Michael H. Michaud,
                    Chairman, Subcommittee on Health
    At this hearing, we will examine the Department of Veterans Affairs 
Research Programs.
    Research is one of the core missions of the Veterans Health 
Administration (VHA). The VA is unique, in that it has the capability 
to provide clinical services and conduct research within the same 
organization. As a result, the VA has done ground-breaking research on 
topics ranging from post-traumatic stress disorder, prosthetics, 
smoking cessation and treatment of heart disease.
    The purpose of this hearing is to examine VA research programs, 
particularly in light of the current conflict. As we all know, 
Operations Enduring and Iraqi Freedom have presented us with some new 
challenges in caring for and treating injured soldiers. In recent 
years, we have seen a dramatic increase in the number of returning 
veterans with conditions such as PTSD, TBI, and traumatic amputations.
    These conflicts have produced nearly 28,000 severely injured 
veterans, over 700 of which have had traumatic amputations. It is vital 
that the VA continue to push the edge of research in order to provide 
these brave men and women with the most up-to-date care available--
whether they need prosthetics, pain-management, eye-care, or any number 
of other services.
    It is also important that the VA work in collaboration with the 
Department of Defense, academic partners and other public and private 
entities to leverage their resources and knowledge--and to produce the 
best research possible.
    I would like to send a special welcome to one of our witnesses 
today.
    On the 21st of June, 2003, Major David Rozelle was leading a convoy 
west of Baghdad when his vehicle struck a landmine, which resulted in 
the loss of his right foot. After spending 8 months recovering at Fort 
Carson, Colorado, Major Rozelle returned to Iraq as a Troop Commander 
conducting operations in Baghdad and Tal Afar--he was the first troop 
commander to redeploy to the same battlefield as an amputee in recent 
military history.
    Major Rozelle is currently serving as an Administrative Officer at 
the Military Advanced Training Center at Walter Reed Army Medical 
Center. Drawing on his personal and professional experience, Major 
Rozelle helped plan and design this brand new facility--using the most 
state-of-the-art research available.
    Welcome, Major Rozelle.
    Continued research is vital to improving healthcare, saving lives 
and improving the quality of life for our sick and injured. I look 
forward to hearing from our witnesses about what the VA is doing--and 
what the VA should be doing--to advance their core mission of research.

                                 
   Prepared Statement of Hon. Jeff Miller, Ranking Republican Member,
                         Subcommittee on Health
    Research is necessary to generate new knowledge and achieve 
scientific and clinical excellence.
    The Department of Veterans Affairs (VA) is world renowned for its 
medical research, and VA's research program has a strong history of 
success and is credited with pioneering life saving therapies and 
treatments that have improved health care not only for veterans but for 
patients as a whole. This year, for example, the first vaccine for 
shingles was approved as a result of VA research.
    Modern molecular medicine and rapidly advancing medical technology 
make a strong research enterprise more important to veterans than ever.
    As we map the future of VA research, we must work to ensure that 
VA's research goals align with the special health care needs of both 
our new generation of veterans from the Global War on Terror and our 
older veterans of previous wars.
    Recognizing the value of VA research, we must also be aware that 
nothing is more important than translating research from the ``bench'' 
to the ``bedside''.
    I am pleased to see that we will hear from the Administrative 
Officer from the Military Advanced Training Center and have the 
opportunity to discuss collaborative efforts on federal research for 
the benefit of our military and veterans.
    Thank you, Mr. Chairman, and I yield back the balance of my time.

                                 
           Prepared Statement of John R. Feussner, M.D., MPH
             Professor and Chairman, Department of Medicine
          Medical University of South Carolina, Charleston, SC
   and Volunteer Staff Physician, Ralph H. Johnson Veterans Affairs 
   Medical Center on behalf of Friends of VA Medical Care and Health 
                                Research
    Good morning Mr. Chairman and members of the committee. My name is 
John Feussner, and I am Professor and Chairman of the Department of 
Medicine at the Medical University of South Carolina in Charleston. I 
am also a volunteer staff physician at the Ralph H. Johnson VA Medical 
Center and was the Department of Veterans Affairs Chief Research and 
Development Officer from 1996 until 2002. I am testifying on behalf of 
the Friends of VA Medical Care and Health Research (FOVA), a coalition 
of over 80 organizations dedicated to ensuring that America's veterans 
receive the highest quality health care by promoting the long-term 
sustainability of the VA Medical and Prosthetics Research Program.
    On behalf of FOVA, I want to thank the members of the committee for 
the opportunity to present the coalition's views on the importance of 
the VA research program and the challenges the program faces in the 
upcoming years. In addition, I wish to thank the Committee for its 
support of the VA Medical and Prosthetics Research program, as 
evidenced by your recommendation of a $480 million appropriation for VA 
research for fiscal year (FY) 2008. The support for this program across 
party lines is indicative of its success and the common understanding 
of the importance of the program for America's veterans. FOVA 
encourages Congress to deliver the appropriations bill funding the VA 
medical care and research programs to President Bush quickly so 
veterans and researchers will not have to wait for access to 
appropriate resources.
    The VA Medical and Prosthetics Research Program is one of the 
nation's premier research endeavors, attracting high-caliber clinicians 
to deliver care and conduct research in VA health care facilities. The 
success of the VA program--which can be seen in the array of 
achievements attributed to VA researchers, such as the invention of the 
implantable cardiac pacemaker, the creation of a new vaccine for 
shingles, and the development of state-of-the-art prosthetics, 
including a new bionic ankle--is a function of its structure, 
leadership, and the secured availability of resources.
    The VA research program is an intramural program; grantees must be 
VA employees with at least a five-eighths appointment to the VA. The 
program, therefore, offers a dedicated funding source to attract and 
retain high-quality physicians and clinical investigators to the VA 
health care system, who in turn provide first-class health care to our 
Nation's veterans. With this effective mechanism for attracting top 
researchers, VA has been able to make significant advances in areas of 
research that benefit the veteran population. VA investigators have 
been at the forefront of research that impacts newly returning veterans 
from Operation Iraqi Freedom and Operation Enduring Freedom, including 
research on post-traumatic stress disorder, polytraumatic blast 
injuries, and massive burns. In addition, VA has taken the lead on 
issues affecting the aging population of veterans who continue to 
constitute the largest portion of veterans seeking treatment in the VA 
system. Investigators in the VA research program have contributed to 
significant advances in pain management, substance abuse treatment, 
mental health disorders, respiratory medicine, diabetes, and 
Alzheimer's disease.
    FOVA would like to stress the importance and value of the VA 
program's peer review system in articulating the agency's research 
portfolio. Congress may encourage VA to consider new research areas; 
however, it is vital to the integrity of the program that scientific 
merit remains the predominant criteria for funding. Peer review of 
proposals ensures that VA's limited resources support the most 
meritorious research. Additionally, centralized VA administration 
provides coordination of VA's national research priorities, aids in 
moving new discoveries into clinical practice, and instills confidence 
in overall oversight of VA research, including human subject 
protections, while preventing costly duplication of effort and 
infrastructure.
    While VA has been effective in its mission to provide the best 
possible care to the nation's veterans, veterans from the current wars 
in Iraq and Afghanistan are returning with injuries and conditions that 
will require treatment over many years. Additionally, veterans are 
returning with injuries never before experienced in such severity, 
which require additional research, and in turn, additional resources. 
FOVA greatly appreciates this Committee's support for the program in FY 
2008; however, the $480 million appropriation only provides a starting 
point when consideration is given to long-term inflationary pressures.
    To fund new research while still supporting traditional research 
areas that benefit the majority of veteran patients, FOVA encourages 
Congress to support significant increases to the program over the next 
three years. Additional funding can support research into such issues 
as traumatic brain injury (TBI), mental health treatment of veterans, 
and the effects of limb loss on other co-morbid conditions. Research is 
needed to understand the physical and psychological effects of TBI 
injuries and long-term funding is required to conduct post-deployment 
surveillance for TBI. Research into the potential long-term effects of 
exposures and risk factors among veterans of hazardous deployments can 
offer potential treatments for returning veterans while leading to the 
development of preventative medicine for future deployments. Advances 
in VA's rehabilitative research portfolio can improve treatment for 
paralysis and lead to greater limb function in injured veterans.
    Additional funds could also restore previous funding levels for 
scientific awards. Due to previous years of inadequate funding, VA 
capped scientific awards at $125,000 annually. This level of grant 
support--which is barely enough to hire one laboratory technician and 
purchase necessary supplies--is significantly lower than the average 
grant awarded by other federal granting agencies. The amount diminishes 
productivity, slows the translation of research from the bench to the 
bedside, and hinders recruitment to the VA program.
    Moreover, while the promise of medical research lies in the 
potential to create new treatments and cures for diseases and injuries, 
these efforts are not achieved by one grant or project. Research is a 
long-term ambition that cannot be fully successful in one funding cycle 
but must be sustained if treatments are to be discovered. FOVA 
encourages the Committee to consider the long-term needs of VA 
investigators when promoting future funding allocations for the 
program. As most VA research awards are three years in duration, the 
coalition encourages Congress to consider a planned growth for the VA 
research budget over the course of the next three years to continue the 
upward trajectory of the program in an orderly fashion.
    However, even with sustained growth, VA will be ineffectual in 
advancing new treatments if it does not have the appropriate 
infrastructure in place. For years, VA has been aware of the 
inadequacies of its research infrastructure. An internal review of the 
infrastructure of VA laboratories was implemented in 2001 when I was at 
Central Office. The Research Evaluation Project assessed the state of 
the research infrastructure by surveying sites on the quality of the 
physical infrastructure, the organization structure in place to support 
research, and the availability of biomedical equipment. Based on that 
evaluation and the list of necessary improvements subsequently 
compiled, your predecessors and I reached an understanding that a 
dedicated funding allocation of $40 million a year was required to 
maintain VA research facilities. In May 2004, then Secretary of 
Veterans Affairs Anthony J. Principi approved the Capital Asset 
Realignment for Enhanced Services (CARES) Commission report that called 
for enhancement of VA research space, and this Committee and 
appropriators have called on VA to update these studies.
    Under the current system for funding infrastructure improvements, 
research must compete in the minor construction budget with other 
facility needs. This system has led to an even greater accumulation of 
necessary research facility upgrades including improved ventilation, 
electrical supply, plumbing, and space configuration. FOVA applauds the 
Committee for recommending a $15 million minor construction funding 
stream for research facilities in its views and estimates for the FY 
2008 budget. This step certainly brings needed attention to this 
matter. FOVA recommends at least a $45 million allocation for research 
facilities improvements under the minor construction account. 
Considering the significant needs recognized in 2001, this level of 
funding would just begin to address the agency's infrastructure 
problems.
    While VA can take advantage of its relationships with affiliated 
medical schools and non-profit foundations to garner additional funding 
for infrastructure improvements, these funds are limited and VA must 
assume responsibility for the cost of its own research facilities. 
Based on preliminary accounts of yet another survey assessing VA 
research facilities, FOVA is under the impression that at least half of 
the facilities received failing grades, which signifies that dedicated 
minor construction funding is vital to sustainability of the program.
    There are a number of examples of the poor state of research 
laboratories in the VA system. When an animal facility is too small, 
investigators bring the animals into their regular laboratories, 
exposing themselves and staff to occupational illnesses. Occupational 
Safety and Health Administration (OSHA) inspectors have expressed 
concerns about VA research facilities and, in one case, said that if it 
was up to OSHA, the building would be shut down. Meanwhile, a 
researcher in Seattle, Washington, received a grant that required 
storing tissue samples in sub-zero freezers. Space was allocated, but 
the facility was unable to provide $30,000 to upgrade the electrical 
system to support the freezers. VA researchers in Gainesville were 
unable to conduct certain types of research because their ``wet lab'' 
countertops are made of particleboard and Formica, rather than the 
standard stone, and are easily burned and stained from exposure to heat 
and chemicals.
    Substandard facilities make VA a less attractive partner in 
research collaborations with affiliated universities, reduce VA's 
ability to leverage the research and development appropriation with 
other federal and private sector funding, and make it difficult to 
attract cutting edge researchers to pursue careers in VA. Facility R&D 
Committees regularly disapprove projects for funding consideration 
because the facility does not have the necessary infrastructure and has 
little prospect of acquiring it. Upgrading facilities should proceed 
hand-in-hand with increasing funding for the VA research program to 
yield successful outcomes important to veterans and all patients.
    Again, thank you for the opportunity to present FOVA's views on the 
VA research program. I look forward to your questions.

                                 
               Prepared Statement of Major David Rozelle,
       Administrative Officer, Military Advanced Training Center,
                    Walter Reed Army Medical Center
           Department of the Army, U.S. Department of Defense
    Chairman Michaud, Congressman Miller, and distinguished Members of 
the subcommittee, thank you for inviting me to participate in this 
hearing alongside my colleagues from the Department of Veterans Affairs 
(VA). I am Major David Rozelle, an Armor Officer and Administrative 
Officer of the Military Advanced Training Center at Walter Reed Army 
Medical Center. I am excited to talk with you today about the use of 
advanced technology at the MATC and at the Center For the Intrepid 
(CFI) at Brooke Army Medical Center in San Antonio, Texas. The openings 
of the CFI on the 29th of January 2007 and the MATC on September 13, 
2007, were noteworthy events that demonstrated the tremendous support 
of the American people for our wounded warriors. These facilities are 
also representative of the significant advances that are being made in 
the care provided to our courageous servicemembers. Although the two 
centers mirror each other in capabilities, the CFI is monumental in 
appearance while the MATC is strictly utilitarian. The MATC, however, 
will eventually move its capabilities to a more permanent home once 
Walter Reed closes.
    One patient recently described the interior of the MATC as ``where 
the magic happens.'' It is a mix of technology and philosophy that 
allows our warriors to return to a lifetime of the highest physical, 
psychological and emotional function. Each servicemember is treated as 
a ``tactical athlete''--the MATC brings the latest advances in sports 
medicine to bear on their treatment. Within the walls of the MATC there 
is a multidisciplinary health professional team that works together to 
seamlessly bring the patient from recently wounded status to a return 
to warrior status. This team includes representatives from the Veterans 
Benefits Administration, VA Social Workers, and VA Vocation Education 
and Rehabilitation counselors. While the team includes those thought to 
be part of the traditional rehabilitation team--the physical 
therapists, occupational therapists, physiatrists, and nurse case 
managers--it also includes psychological liaison providers, 
biomechanists, the patients, the patients' family members, and others.
    The facilities boast many ``state-of-the-world'' or ``state-of-the-
art'' capabilities:

      The fire arms training simulation room utilizes Blue 
Tooth technology to replicate the weight, feel and response of actual 
weapons, the M16 and M14 rifles and the 9mm pistol. This allows the 
servicemember to regain confidence in their ability to carry out the 
roles of a combat Soldier. It is also utilized to clear individuals 
prior to their participation in some of the outdoor recreational 
activities like skeet shooting and hunting.
      The gait labs are among the largest and most 
sophisticated in the world. With a 23 camera capture system, a dual 
force plate treadmill, and force plates of different sizes arranged in 
an array in the floor, the gait lab is able to analyze the gait 
patterns of our clients while they utilize a variety of prosthetic 
components and apply the results to both prosthetic adjustments and to 
physical therapy and occupational therapy treatment plans.
      The Computer Assisted Rehabilitation Environment or CAREN 
System is another ``state-of-the-art'' technology that provides 
tremendous potential for our clients. Imagine a helicopter simulator 
and replace the helicopter with a platform and an imbedded treadmill 
with dual force plates under the treadmill. Now link this through a 
computer system to a screen that projects an image which is linked to 
your actions as you move on the platform. We can have you walking up 
and down a hilly trail with the platform shifting to mirror the changes 
on the screen, if you speed up the system detects it and speeds up both 
the projection and the treadmill, if you slow down the system responds 
accordingly. It can generate a city street scenario, beginning with 
walking down a quiet street, then adding in stressors, additional 
people, cars backfiring, trash on the side of the road, pedestrian 
tunnels, and allow our psych staff to work with you as you approach 
these stressors. This is a new and exciting technology that is 
applicable not only to our patients with limb loss, but also those with 
traumatic brain injury or combat stress.
      The facility offers a variety of opportunities to work on 
advanced skills that are applicable to both leisure activity and 
military skills. This includes both a climbing wall and a treadwall--
the climbing wall adds the challenge of functioning at height while the 
treadwall challenges the patient cardiovascularly.
      The SoloStep is an overhead support system that permits 
the patients to be supported as they progress from walking to running. 
The MATC offers the only Solostep system in the world that goes in a 
continual loop. Rather than a 20 foot straight run where the patient 
has to continually stop and turn around, ours goes around the entire 
length of our track. This support system frees the therapist from 
having to hold the patient as they ambulate and allows the therapist to 
watch the patient and make immediate corrections to their gait.
      Elevating parallel bars were developed specifically for 
the military amputee patient population. The Army Medical Department 
has the only three sets in the world. This allows the patients to train 
for community obstacles which they will frequently encounter such as 
sloping streets, sidewalks, or ramps. These also will play a 
significant role in research efforts to provide our warriors with more 
functional prosthetic devices.
      A vehicle simulator is available to provide the initial 
training with hand controls. We collaborate with the VA, who will 
provide the follow on training out on the street in actual vehicles. 
One of our staff members, a VA employee, has developed software 
programs for the simulator to specifically address driving issues 
related to deployment. Known as combat driving, it includes such 
practices as rolling stops and wide lane changes to avoid obstacles in 
the road. While these are potentially life saving measures in theater, 
they may be extremely dangerous if practiced stateside. By working on 
modifying these behaviors on the simulator we are able to better 
prepare our patients for a return to driving.

    A very active community reintegration program has been developed 
which includes a variety of activities from field trips to a museum or 
a mall or a wide range of sports activities to include skiing, 
kayaking, scuba, cycling, mountain climbing, and surfing. This was a 
lesson learned during the Viet Nam war as the military worked to help 
patients return to the civilian community. The success of that program 
has kept it an integral part of the military amputee rehabilitation 
process. Another program that has been very successful is our running 
program, training our clients for a range of distance races, biathlons, 
and triathlons.
    As mentioned earlier, much of our success is due not to the 
technology advances, but to the philosophy and approach to patient 
care. Again, during the Viet Nam war it was identified that having the 
patients work in larger cohort groups appeared to have greater benefit 
than working independently, close to home. Many veterans with limb loss 
from previous wars have volunteered to be peer visitors for our 
patients. This ability to see the future, whether it is seeing a 
recently injured warrior who is one or two months ahead of you, or 
seeing the more distant future provided by the peer visitors, provides 
a sense of purpose and focus for our patients to strive toward.
    Technology has played a significant role in prosthetic restoration. 
New methods of measurement have resulted in more efficient methods of 
measuring the servicemember's amputated limb with better precision, 
efficiency, and quality. These methods include Computer Aided Design 
Computer Aided Manufacturing (CADCAM), optical digitizing and stereo 
lithography where CT Scans are digitized and used to print an accurate 
3 dimensional model of the residual limb including any existing 
heterotopic ossification. Additionally, the treatment for 
servicemembers in the Global War on Terror has resulted in current 
technology being utilized in new ways. The U.S. Armed Forces Amputee 
Patient Care Program at WRAMC was the first in the world to utilize the 
micro-processor prosthetic knee as an early rehabilitation knee unit, 
providing newly injured servicemembers increased stability, safety and 
confidence in the use of a prosthetic limb.
    The Program pioneered and implemented the use of the Military 
Ambulatory Diagnostic Prosthesis philosophy for the lower limb amputee. 
Under this philosophy, the prosthetic sockets are rapidly produced with 
extremely durable temporary materials and coupled with the most 
technologically advanced components. The patients receive multiple and 
frequent sockets to accommodate the volume and shape changes common 
during the early post-operative phases.
    Similarly, with upper extremity limb loss, the concept of Early 
Post-Operative Prosthesis was resurrected and coupled for the first 
time with a policy of utilizing external powered prosthetic components. 
The use of myo-electric prosthetic components instead of body powered 
components places much less stress on the residual limb and permits the 
patient to begin to train much earlier in the rehabilitation process. 
The ability to rapidly manufacture and change sockets to accommodate 
upper extremity residual limb changes has permitted our patients to 
continue to use a prosthesis throughout the early stages of 
rehabilitation and makes them much less likely than their civilian 
counterparts to reject prosthetic use.
    The innovative use of current state of the art technology has 
attracted many manufacturers to the program. These manufacturers are 
seeking to provide new technology to the program prior to release to 
the general population. The early release of this technology allows the 
military prosthetists to obtain critical knowledge of the technology 
and provide expert feedback to the manufacturer.
    The current emphasis on care of the military amputee patient has 
stimulated the application of a wide range of advanced technologies 
into the development of enhanced prostheses, which can much more 
closely simulate the human body.
    Collaboration between the DoD and the VA is ongoing and has already 
led to several significant successful projects. Among these is the 
development of the VA/DoD Clinical Practice Guidelines (CPG) for Care 
of the Amputee. This CPG sets in place the clinical pathway for both 
pre and post amputation patient care. Additionally, the establishment 
of a VA/DoD Clinical Rotations Program allows for rehabilitation 
practitioners (physical therapist, occupational therapist and 
prosthetist) all from the same Veteran Integrated Service Network 
(VISN) to train as a team simultaneously with counterparts at MATC and 
the CFI. This unique program bridges the span between the VA and DoD 
practitioners and provides an understanding of operations at the 
varying installations which ultimately leads to better care of the 
injured servicemember.
    With the financial support of Congress, we have been able to 
develop a research program that has already provided some exciting 
developments and, with the advanced care centers, promises to 
significantly change how we provide warrior care in the future.
    Over 82% of amputations in the U.S. occur as the result from 
complications of diabetes and dysvacular disease, with a greater 
prevalence rate of individuals over the age of 65. Data obtained from 
OEF and OIF reveal a much different patient population. As of September 
2007, there have been over 700 servicemembers, who have sustained a 
major limb amputation in support of GWOT. Twenty-three percent (23%) of 
these individuals have lost an upper limb and over 20% have lost more 
than one limb. Nearly 90% of these servicemembers have been under the 
age of 35 and as a result have unique psychosocial needs and generally 
seek to return to a more active lifestyle than older individuals. 
Additionally the majority of combat related amputations do not occur in 
isolation. Over 50% have had a documented traumatic brain injury (TBI), 
some with vision and/or hearing loss, many have significant remote 
fractures and significant soft tissue wounds, others with co-morbid 
paralysis from peripheral nerve injury or central cord injury and 
nearly all with contaminated wounds requiring frequent surgical 
washouts and extensive antibiotic use. These complex medical, surgical 
and rehabilitation challenges require a unique approach to treatment 
and warrant dedicated research programs to optimize care.
    The advanced training centers have proven to be an ideal setting 
for training in advanced techniques related to amputee care and 
prosthetics. In addition to the VA/DoD Clinical Rotation Program, we 
have held a number of courses attended by military therapists and 
Veterans Affairs therapists and prosthetists from around the country.
    The combination of advanced technologies, innovative clinical 
practices, caring providers and an amazing group of warriors in 
transition with the strength and courage to seek the high ground and 
continually move forward has led to revolutionary changes in our 
understanding of the capabilities of individuals with limb loss.
    I thank you for inviting me to talk with you today about the 
capabilities and the magic of the Military Advanced Training Center at 
Walter Reed and the Center for the Intrepid in San Antonio. Your 
continued support for our wounded, ill, and injured is very much 
appreciated by the Soldiers and staff at Walter Reed and throughout the 
Army.

                                 
            Prepared Statement of Mark J. Lema, M.D., Ph.D.
  Chair, Department of Anesthesiology, Critical Care and Pain Medicine
    Roswell Park Cancer Institute, Buffalo, NY, Professor and Chair,
 Department of Anesthesiology, University of Buffalo, State University 
      of New York, School of Medicine and Biomedical Sciences, and
           President, American Society of Anesthesiologists,
                    on behalf of Pain Care Coalition
    Mr. Chairman and members of the Subcommittee, my name is Mark J. 
Lema, M.D., Ph.D. I am Chair of the Department of Anesthesiology, 
Critical Care and Pain Medicine at the Roswell Park Cancer Institute in 
Buffalo, New York, and Professor and Chair of the Department of 
Anesthesiology at the University of Buffalo, State University of New 
York, School of Medicine and Biomedical Sciences. I also serve as the 
current President of the American Society of Anesthesiologists.
    I am pleased to testify today on behalf of the Pain Care Coalition, 
a national advocacy effort of the American Academy of Pain Medicine, 
American Pain Society, American Headache Society and American Society 
of Anesthesiologists. Collectively, these organizations represent more 
than 50,000 physicians and other clinicians, researchers, and educators 
who provide clinical leadership in the increasingly specialized field 
of pain management. Some of these individuals work either full or part 
time in the VA health system, and many others are involved in 
collaborative relationships with research and clinical care programs 
throughout the VA system.
    We appreciate the opportunity to appear today and present our views 
on the state of pain research at the VA. As professionals in the pain 
care field, nothing we do is more important than assuring that those 
who serve our country in times of war get the very best pain care 
possible during all stages of their service, and in all settings of the 
military and veteran health and medical systems. These settings range 
from the battlefield to the clinics, hospitals, rehabilitation centers 
and long term care facilities of the VA. As a complement to these 
clinical care responsibilities, those of us in pain medicine have a 
continuing interest and responsibility in pain care research within the 
VA's Medical and Prosthetic Research Program, as well as other public 
and private research efforts with which the VA collaborates.
THE SCOPE OF THE PAIN PROBLEM
    Pain is a very large public health problem in this country. It is 
the most common reason people access the medical care system, a major 
cause of lost productivity in the workplace, and a substantial 
contributor to short and long term disability. It affects Americans at 
all stages of life and in all walks of life. For example, 26 million 
Americans of working age have frequent back pain, and chronic back pain 
is the leading cause of disability for those under 45 years of age. 
Twenty-five million suffer from migraine headaches. Four million, 
mostly women, suffer from a complex pain syndrome known as 
fibromyalgia. Forty million have arthritis pain.
    Pain imposes a terrible burden on those who suffer and on their 
families, and it imposes large costs on the health care and disability 
income systems. Medical costs and lost productivity alone are estimated 
to top $100 billion annually. Pain is often poorly understood by those 
who suffer and by those around them. It is often undiagnosed or 
misdiagnosed, and under-treated or mistreated. Sometimes pain is the 
symptom of other diseases as in the case of cancer, arthritis, heart 
disease, and diabetes. Other times, pain is the disease itself as with 
migraine, chronic back pain and various diseases associated with damage 
to the nervous system, such as post-herpetic neuralgia, diabetic 
neuropathy, or injuries to the nervous system such as commonly occur in 
combat, including phantom limb pain, post-injury or post-surgery 
neuralgias, and traumatic brain injury.
    The most recent complete study of soldiers enrolled in VA 
Polytrauma Centers show that more than 90% have chronic pain, that most 
have pain from more than one part of the body, and that pain is the 
most common symptom in returning soldiers. Advances in neuroscience, 
such as neuroimaging, now demonstrate that unrelieved pain, regardless 
of its initial cause, can be an aggressive disease that damages the 
nervous system, causing permanent pathological changes in sensory 
neurons and in the tissues of the spinal cord and brain.
    Pain can be acute and effectively treated by short term 
interventions, or it can be chronic, often without effective ``cures'' 
and sometimes without consistent and effective means of alleviation. 
Those who suffer severe chronic pain see their daily lives disrupted--
sometimes forever. Their pain and their constant search for relief 
affects their function, their relationships with those they love, their 
ability to do their work effectively, and often their self esteem. 
Chronic pain is often accompanied by or leads to sleep disorders, 
emotional distress, anxiety, depression, and even suicide.
    If these facts are true in the general population, which we know 
them to be, then they are doubly true in the military and veteran 
populations. The physical and emotional stresses of military service 
make inevitable the disproportionate incidence of both acute and 
chronic pain among active duty personnel. If miners, movers and 
construction workers suffer low back pain from heavy lifting, imagine 
the toll on the spine of those in active duty combat situations. If 
truckers develop back pain from long hauls, imagine the toll of armored 
vehicles going long distances on poor or non-existent roads. If the 
stresses of daily civilian life serve as triggers for those suffering 
severe migraine, imagine the impact of battlefield conditions.
    The incidence of acute pain among those injured in current 
conflicts will be virtually 100%, and for far too many, the original 
short term trauma will be followed by chronic pain of significant 
dimension and duration. For example, virtually all of those suffering 
the loss of one or more limbs in combat will suffer from phantom limb 
pain. While this can be managed with varying degrees of effectiveness, 
there is no known ``cure.'' Virtually all veterans fitted with 
prostheses will suffer some degree of pain at the device/body 
``interface.'' Again, this can be managed to some degree, but it is 
rarely eliminated.
    Far less visible, but even more prevalent, is the extensive damage 
to the central and peripheral nervous systems resulting from the 
horrific explosive devices deployed in the current conflicts. Unlike 
broken bones, flesh wounds and burns, many of which will eventually 
heal after aggressive treatment, extensive nerve damage may only be 
manageable, not curable, given the current state of science and 
clinical practice. Most returning veterans with extensive nerve damage 
will be chronic pain sufferers and will require long term pain 
management, with varying prognoses for success. Ironically, the 
proportion of these chronic pain sufferers among returning wounded 
servicemen and women will be far greater in the current conflicts than 
in previous wars because of the remarkable successes of military 
medicine which now keep so many of the very severely injured alive.
PCC'S INVOLVEMENT IN PAIN MANAGEMENT FOR VETERANS
    On the battlefield and upon returning home from service, critically 
wounded men and women must receive the best, most advanced pain 
management interventions available. Members of the Pain Care Coalition 
have made significant contributions toward efforts to alleviate the 
suffering of our brave soldiers.
    For example, Lt. Col. Chester ``Trip'' Buckenmaier III, an Army 
anesthesiologist and member of the American Society of 
Anesthesiologists, has been at the forefront of providing revolutionary 
pain care to wounded veterans. During a deployment to Iraq several 
years ago, Dr. Buckenmaier used portable infusion pumps to alleviate 
the pain of soldiers with grave injuries to their arms and legs. In a 
recent Wall Street Journal article, Dr. Buckenmaier described a 
situation in which a soldier changed his evaluation of his pain from 10 
on a 10 point scale--``the worst pain imaginable''--to zero, after 
being treated with a portable infusion pump.
    This example underscores the life-saving, life-changing pain 
management techniques increasingly used in military medicine. In fact, 
during an October 2005 hearing of the House Committee on Armed 
Services, Deputy Surgeon General Joseph G. Webb, Jr., highlighted the 
advances of pain medicine benefiting our soldiers. He said, ``Wounded 
soldiers in Iraq and Afghanistan benefit from receiving some of the 
most advanced technologies and techniques in medicine today . . . The 
benefits of advanced pain management, during and after surgery, are 
improved postoperative outcomes and the potential to eliminate chronic 
pain, particularly in amputees.''
    Dr. Buckenmaier's story and Major General Webb's testimony 
illustrate the potential and the challenge of deploying innovative and 
advanced pain management techniques to treat our veterans.
THE VA'S CURRENT PAIN RESEARCH EFFORT
    Perhaps more than any other federal agency, the VA has been a 
leader in focusing institutional resources on the assessment and 
treatment of pain. Under a ``National Pain Management Strategy'' 
initiated in November 1998 (``Strategy''), and pursuant to VHA 
Directive 2003-021, the Veterans Health Administration has made pain 
management a national priority. Among the specific objectives of the 
Strategy are:

      providing a system-wide standard of care to reduce 
suffering from ``preventable'' pain;
      ensuring consistency in the assessment of pain;
      ensuring prompt and appropriate treatment for pain;
      promoting an inter-disciplinary approach to pain 
management; and
      providing adequate training to and resources for 
clinicians in VA healthcare to achieve these objectives.

    The Pain Care Coalition applauds the Strategy and generally 
supports its specific goals and objectives. At the same time, the 
Coalition has significant concerns with the current VA effort:

      Directive 2003-021 is only a five-year plan. It is 
scheduled to expire in May of 2008;
      there has been, to the Coalition's knowledge, no 
comprehensive assessment of the Strategy's strengths, weaknesses and 
accomplishments; and
      reports from the field suggest that implementation has 
been far from consistent. Some VA facilities have made great strides in 
improving pain care, while for others it is more an aspirational goal 
than an operating reality. As a result, veterans get widely different 
treatment for pain depending on the expertise and resources of the 
particular VA facility at which they receive their care.

    Significantly, and directly germane to the Subcommittee's current 
inquiry, the Pain Care Coalition believes that, in order to ensure 
effectiveness, the VA's pain management Strategy must be accompanied by 
and integrated with a significant research commitment to advancing the 
science of pain care, and to translating developments in the science to 
improved clinical care throughout the system.
    The VA has had a long and continuing research interest in the 
phenomenon of phantom limb pain, with current work focused at the 
molecular level. It also has current research efforts in neural repair, 
which might someday lead to improvements in therapy for those veterans 
currently returning with significant damage to the nervous system. And 
it recently completed a successful study of the effectiveness of a 
shingles vaccine in older veterans which validated research findings 
elsewhere, and will improve care in the general population. Other 
important pain research initiatives are scattered amongst NIH research 
institutes.
    In 2006, through an initial grant funded privately, the VA brought 
together research investigators with interests in pain as part of a VA 
sponsored conference on pain and palliative care. That meeting 
identified several research interest groups including post-deployment 
pain, primary care pain programs, and opioid analgesics. These groups 
generated a number of new research projects, several of which have 
earned Merit Award funding through the peer-review process of the VA's 
Office of Research Development (``ORD''). Work from these groups also 
spawned important articles in major journals and a special issue of the 
Journal of Rehabilitation Research and Development devoted to pain 
research. Based on this success, the VA's ORD funded a second meeting 
of pain researchers just held in September of 2007. At this meeting, 
researchers identified other important projects which demonstrated the 
breadth and depth of research that is possible if a focused effort is 
made to organize and promote a VA research agenda dedicated to the 
basic and clinical sciences of pain medicine. I look forward to making 
the results of this most recent meeting available to the Subcommittee 
in the near future.
    It is imperative that pain research be placed high on the list of 
current VA research priorities. Alarmingly, the VA's justification 
accompanying the Administration's proposed FY 2008 budget for the 
Medical and Prosthetic Research Program barely mentions pain. The 
Coalition is aware of no VA data to show what proportion of the 
research budget is devoted to pain, but we suspect it is a very small 
percentage.
    The VA has identified four research priorities related to the 
current conflicts:

      polytrauma;
      neurotrauma;
      burns; and
      chronic illness generally.

    Three others are considered continuing priorities relevant to these 
and all preceding conflicts:

      prosthetics;
      PTSD; and
      vocational rehabilitation.

    Pain is central to each of these seven priorities, and effective 
pain management is crucial to the restoration of a reasonable quality 
of life for all of these conditions, but there is little indication 
that pain research has been integrated with other research efforts in 
these seven areas, or coordinated across these and other research 
programs.
    Unfortunately, pain is not an area where the VA's leveraged 
research approach can rely on leadership from research partners at the 
NIH or in private industry. For example, despite the documentation that 
chronic pain is one of the most costly of all health problems to the 
U.S. economy, a recently conducted review of the NIH pain research 
portfolio showed that only 1% of NIH's annual research funding is 
devoted to projects with a primary focus on pain. If projects where 
pain is a secondary concern are added, it only rises to 2%. There is no 
Institute or Center at NIH to provide a central home for pain research, 
and efforts to coordinate pain research across the various institutes 
and centers are in the very early stages of development.
    While private industry has significantly advanced drug and device 
therapies for particular types of pain or classes of pain patients, 
industry alone can not be expected to carry the load of long term basic 
science research needed to better understand the mechanisms of pain, 
and in particular how chronic pain syndromes develop despite successful 
treatment of the original trauma.
RECOMMENDATIONS OF THE PAIN CARE COALITION
    The Pain Care Coalition believes the VA's pain research effort can 
and must be significantly enhanced. We urge the Subcommittee to develop 
targeted legislation with several basic components.
    First, the Congress should require the VA to establish within the 
Medical and Prosthetic Research program at VA headquarters a focused 
program of research and training directed at acute and chronic pain. 
That program should identify research priorities in pain most relevant 
to veterans returning from the current conflicts, and should promote 
and coordinate basic and applied research on these priorities both 
within the VA, and with its research partners. The same centralized 
pain research program should boost education and training of VA 
personnel to ensure that research advances are rapidly disseminated 
throughout the VA care system.
    Second, Congress should authorize and the VA should designate an 
appropriate number of cooperative centers throughout the country for 
research and education on pain. Each such center should take the lead 
on a priority area of basic science research on pain, or an aspect of 
acute or chronic pain most relevant to veterans returning from the 
current conflicts. At least one of the centers should be designated as 
the lead center for research on pain attributable to central and 
peripheral nervous system damage, and one such center shall be 
designated as the lead center to coordinate the work of all the 
centers.
    Third, Congress should authorize these newly created pain research 
centers to compete on an equal basis with other priority research areas 
(TBI, PTSD, polytrauma, prosthetics and others) for funds appropriated 
each year to the Department's overall medical and prosthetic research 
budget.
CONCLUSION
    Mr. Chairman and members of the Subcommittee, pain is often 
characterized as an invisible disease--we can not see it, and unlike 
such diseases as cancer, diabetes, and heart disease, there are no 
affordable and widely available lab or imaging tests to confirm its 
presence and quantify its severity. But that's no excuse for letting 
research efforts lag behind those of other priorities. The Pain Care 
Coalition is committed to advancing the practice of pain management. We 
strongly support new and increased efforts within the VA's research, 
education and clinical care programs to ensure that our brave men and 
women returning from combat receive the best pain care possible. The 
Coalition, along with each of the organization's it represents, stands 
ready to work with the Subcommittee and the VA toward that end.

                                 
             Prepared Statement of Thomas Zampieri, Ph.D.,
     Director of Government Relations, Blinded Veterans Association
INTRODUCTION
    Chairman Michaud, Ranking Member Miller, and Members of the House 
Veterans Affairs Subcommittee on Health, on behalf of the Blinded 
Veterans Association (BVA), thank you for this opportunity to submit 
our testimony on VA Research Programs. BVA is the only congressionally 
chartered Veterans Service Organization exclusively dedicated to 
serving the needs of our Nation's blinded veterans and their families. 
BVA has now worked for more than 62 years with VA Blind Rehabilitation 
Service in order to improve VA's ability to provide high quality 
outpatient and inpatient rehabilitation training for blinded veterans.
    BVA appreciated the approval granted earlier this year by former 
Secretary Nicholson and Under Secretary of Health Dr. Kussman for a 
three-year, $40 million expansion of the full continuum of blind and 
low vision outpatient rehabilitation services. With the now growing 
numbers of wounded entering the VA health care and benefits system from 
both Operation Iraq Freedom (OIF) and Operation Enduring Freedom (OEF), 
along with the large numbers of aging veterans with degenerative eye 
diseases, this expansion of clinical services is vital.
    As of September 25, 2007, a total of 27,767 servicemen and women 
had been wounded in Iraq. The number of men and women requiring air 
medical evacuation from Iraq between March 19, 2003 and September 17, 
2007 was 8,298, of which 1,162, or 13 percent, had sustained combat eye 
trauma. The 13 percent figure represents the highest percentage of eye 
wounded for any of the American wars of the past 100 years.
    The staggering nature of these numbers reflects the probability 
that young veterans will, in the very near future, depend on VA blind 
and low-vision services in order to live independently in their own 
homes and, hopefully, enter the workforce once they have fully 
recovered from their injuries. According to the Defense Veterans Brain 
Injury Center (DVBIC), some 3,900 of the Traumatic Brain Injured 
personnel have sustained injuries sufficiently severe that they are 
experiencing neurosensory complications. Epidemiological Traumatic 
Brain Injury (TBI) studies have found that 80 percent of the these 
3,900 complain of visual symptoms related to their TBI while 62 percent 
have associated neurological visual disorders of diplopia, convergence 
disorder, photophobia, ocular-motor dysfunction, and an inability to 
interpret print. Some TBIs result in visual field loss with enough loss 
to meet the standard for legal blindness. Like other generations of 
disabled veterans who have desired to live independently, the current 
generation of OIF and OEF veterans deserves the same opportunity.
PREVALENCE AND INCIDENCE OF BLINDNESS
    Low vision or blindness affects one in 28 Americans over the age of 
40, which amounts to approximately 3.3 million Americans. This 2004 
figure, when broken down, consists of 2.3 million Americans with low 
vision and about one million being legally blind. Every year, 200,000 
Americans develop age-related macular degeneration, which is the most 
common cause of blindness in people over age 65. Diabetic retinopathy 
is the most frequent cause of new blindness in individuals between 40 
and 65. People who move from visual impairment to blindness have a 50 
percent greater chance of becoming injured or depressed and a 2.5 to 3 
times greater chance of needing skilled nursing or a long-term care 
facility.
    Approximately 648,000 Americans age 80 and older are blind. While 
only 4.3 percent of the 65 and older population live in nursing homes, 
16 percent of those who are visually impaired and 40 percent of those 
who are legally blind reside in nursing homes with an estimated cost of 
close to $11 billion in direct nonmedical costs for seniors with visual 
disorders. By 2020, the number of Americans age 40 and over with low 
vision or blindness is projected to reach 10.5 million, almost three 
times what it was in 2004.
    VA estimates that there are currently 169,000 legally blinded 
veterans throughout the country, of which 47,450 are enrolled in 
Veterans Health Administration (VHA) services. The number is projected 
to reach 55,000 within 10 years. In addition, blindness within the 
total veteran population of 24 million is expected to increase over the 
next two decades, just as it is increasing within the general American 
population from glaucoma, macular degeneration, diabetic retinopathy, 
and cataracts.
    It should be clear to Members of this Committee that a new 
generation of OIF and OEF blinded and impaired low vision veterans will 
require specialized research programs to meet their needs. The older 
veterans who are now beginning to lose their sight have equally 
important needs. Rehabilitation research programs for both groups and 
their families must be individualized.
ECONOMIC AND SOCIAL IMPACT
      Of the $68 billion annual cost of vision impairment and 
eye disease as estimated by the National Eye Institute, the annual 
financial burden to the American economy of blindness and low vision in 
adults age 40 and over--driven in large part to advanced macular 
degeneration, cataracts, diabetic retinopathy, and glaucoma--is 
estimated at $51.4 billion. This includes $16.2 billion in direct 
medical costs, $11.2 billion to other direct costs, and $8 billion in 
lost wages and productivity, as well as $16 billion in excess monetary 
impact due to vision loss. The following points illustrate the 
potential importance of vision rehabilitation research in reversing the 
negative consequences of loss of sight in our veteran population. It is 
seven times more expensive to provide nursing home care for a blind 
individual than for one that is trained and able to function 
independently at home. Falls associated with vision loss is the sixth 
leading cause of nursing home admissions.
      ``The Employment Experience of Persons with Limitations 
in Physical Functioning,'' a University of California study published 
in 1999, found that even after adjusting for age and gender 
differences, persons reporting functional limitations are less than 
half as likely to be in the labor force as those with no functional 
limitations. Part-time employment and job loss are also more common 
among persons with functional limitations. Three quarters of those 
experiencing a job loss reported that the loss created a major problem 
in their lives. Only half of those with no limitations reported that 
the problem created by the loss was a major one.
      Literature reviews on employment among persons with 
disabilities indicate that such persons experience lower labor force 
participation rates, higher unemployment rates, and higher rates of 
part-time employment than persons without disabilities (Yelin, 1997; 
Bennefield & McNeil, 1989). These findings are consistent across 
numerous national surveys, including the Current Population Survey 
(CPS), Survey of Income and Program Participation (SIPP), the National 
Health Interview Survey (NHIS), a survey of Trupin and Armstrong in 
1998, and a survey of Trupin, Sebesta, Yelin, and LaPlante in 1997. 
Disabilities in these studies are defined as factors that limit work 
capacity and functional activity (McNeil, 1993).
      The National Health Interview Survey (NHIS), conducted by 
the National Center for Health Statistics (NCHS) and reported in a 
March 2003 article, revealed that working age individuals with visual 
impairments had lower employment rates and lower mean household incomes 
than those without visual impairments. The employment rate was 54 
percent for the severely visually impaired age 18-54 in statistics 
compiled in 1994-95.
      The National Organization on Disability Research found 
that, despite improvements in transportation during the past decade, 
inadequate or inaccessible transportation was reported by 30 percent of 
the disabled. The lack of transportation made employment, social 
participation, and commercial activities less likely, causing increased 
depression and medical costs.
      In the aforementioned study, lower mean household incomes 
and lower employment rates were found among those with disabilities 
related to mobility (43.3-percent rate of employment), agility (46.0-
percent rate of employment), speaking (41.7 percent employment), mental 
function or ability to learn (47.5 percent employment), hearing loss 
disability (62.7 percent employment).
      A study by Hendricks, Schiro-Geist, and Broadbent (1997) 
at the University of Illinois showed a link between disability and 
employment outcomes for those who had, from 1948 to 1993, completed 
both a university education and rehabilitation services. Using a 
regression analysis for those disabled with a degree, the study 
revealed a salary gap of 8.3 percent between disabled and nondisabled 
workers. While this and similar other studies have found that the 
disabled with higher education and rehabilitation earn more than the 
disabled without this level of education and training, the income 
levels and earning capacity are still lower in all comparisons with 
working age non-disabled individuals.
      National Council on Disability (NCD) today October 1, 
2007, on the first day of National Disability Employment Awareness 
month, released a report that presents the best practices in the public 
and private sectors and the promising public policies and initiatives 
that increase employment opportunities for people with disabilities. 
However, the employment rate of working age people with disabilities 
remains still only half that of people without disabilities (38 percent 
compared with 78 percent in 2005).
NEUROLOGICAL IMPACT OF TBI DYSFUNCTION
    Perception plays a significant role in our ability to live life. It 
aids in providing information about the properties in our environment 
and allows us to act in relation to those properties. In other words, 
our perceptions provide us with the means to experience our environment 
and live within it. We perceive what is in our environment by a 
filtered process that occurs through our complex neurological visual 
system. Although all senses play a significant role, the visual system 
is one of the most important, providing more than 70 percent of our 
sensory awareness. With various degrees of visual loss, we are no 
longer able to clearly adjust and see our environment, resulting in 
increased risk of injuries, loss of functional ability, and 
unemployment. Impairments range from an inability to successfully 
navigate one's visual field to loss of visual acuity, loss of color 
vision, photophobia, and difficulty in recognizing faces.
    Among the numerous ways one can acquire visual deficits, and a 
leading one at that, is injury to the brain. Damaging various parts of 
the brain can lead to specific visual deficits. Although some cases 
have reported spontaneous recovery, complete recovery is unlikely and 
early intervention is critical. Currently complex TBI-visual research 
is being examined in an attempt to improve the likelihood of recovery. 
The training of certain areas of the brain has been found to improve 
vision deficits in some disorders. Nevertheless, researchers have 
stressed that the extent of recovery can be limited and will usually 
require long term follow-up often with specialized adaptive devices and 
prescriptive equipment.
    The brain is the most intricate organ in the human body. Visual 
pathways within this vital organ are also very complex. Due to the 
interconnections between the brain and visual system, damage to the 
brain can bring about various cerebral visual disorders. The visual 
cortex has its own specialized organization, causing the likelihood of 
specific visual disorders if damaged. The occipitotemporal area is 
connected with the ``what'' pathway. Thus, injury to this ventral 
pathway leading to the temporal area of the brain is expected to affect 
the processing of shape and color. This can make perceiving and 
identifying objects difficult. The occipitoparietal area (posterior 
portion of head), on the other hand, relates to the ``where,'' or 
``action'' pathway. Injury to this dorsal pathway leading to the 
parietal lobe will increase the likelihood of difficulties in position 
(depth perception) and/or spatial relationships. In cases of injury, 
one will find it hard to determine an object's location and may also 
discover impaired visual navigation. It is also highly unlikely that a 
person with TBI will have only one visual deficit. He/she will usually 
experience a combination of deficits due to the complexity of the 
organization between the visual pathway and the brain. The most common 
cerebral visual disorder after brain injury involves visual field loss. 
The loss of peripheral vision can be mild to severe enough to result in 
legal blindness. It requires specific visual field testing to be 
correctly diagnosed and different prescribed devices to adapt to this 
loss. While the DVBIC reports about 10% as severe open head injuries, 
most TBI cases are closed head injuries that can result in a variety of 
visual deficits from overt to subtle.
    In addition to considering these complex neurological effects on 
the patient, BVA would ask Members of this Subcommittee to consider the 
huge emotional effects of TBI on the servicemember or veteran when 
deciding what level of support should be given to research in this 
area. These emotional effects may be equaled or even surpassed by those 
inflicted on the patient's family. Brain injuries are known for causing 
extreme distress on family members who must take on the role of 
caregiver in addition to facing the many other challenges associated 
with this type of injury to a son, daughter, father, mother, brother, 
sister, or even an extended family member.
VA MEDICAL AND PROSTHETICS RESEARCH
    BVA has supported investments in veteran-centered research projects 
within VHA. Such projects in the past have led to an explosion of 
knowledge that has advanced the understanding of many different 
diseases and unlocked strategies for prevention, treatment, and cures. 
Additional funding is needed to take advantage of the burgeoning 
opportunities to improve the quality of life for our blinded and low 
vision veterans and for the Nation as a whole. VA must concurrently 
address the needs of its longstanding patient base as well as the 
evolving challenges being presented by our newest war-wounded veterans. 
With increased directed vision research funds, it is expected that VA 
will begin pursuing the following in Fiscal Year 2008: new adaptive 
prosthetics, aging vision diseases, and specialized vision research. 
This funding increase should also allow for an increase in funding for 
Rehabilitation Research & Development (RR&D), now so desperately needed 
with the ever-increasing numbers of combat eye injuries. BVA points to 
the success of new retinal research of great importance, the 
continuation of RR&D initiatives in Boston, where investigators are 
working on the development of artificial retinal implants for those 
with vision loss due to retinal trauma.
RECOMMENDATIONS
    Examples of four separate categories identified by the National 
Alliance for Eye and Vision Research (NAEVR) as vital vision research 
are listed below. NAEVR believes that such research is sufficiently 
significant that it be supported by Members of Congress and utilized by 
both DoD and VHA.
Eye Trauma, Healing, Infection/Inflammation Control, and Rehabilitation
    This research relates to acute and chronic implications of corneal 
and retinal eye trauma, healing, infection/inflammation control, and 
associated vision rehabilitation.

      Treatment of eye trauma caused by a physical, chemical, 
or biological agent insult; associated healing; and infection/
inflammation control (including infections associated with skin around 
the eye, the corneal surface, or within the ocular globe, and the 
impact of environmental conditions that promote infection).
      Ocular surface reconstruction and treatment of corneal 
damage by corneal transplantation or through corneal stem cell 
transplantation.
      Retinal and optic nerve regeneration (through 
identification of the genes involved and associated gene therapy, or 
through other biomedical processes).
Visual Function/Visual Acuity
    This research relates to the metabolic and physiological processes 
that relate to visual clarity, contrast sensitivity, and spatial 
orientation.

      Impact of metabolic modulation or stress on visual acuity 
and contrast sensitivity (i.e. effect of lowered blood glucose levels 
on central vision).
      Visual image processing (better understanding of the 
biological/electrochemical interface in the vision process to improve 
acuity and advance ``artificial vision'' and other assistive 
technology).
      Sensory dysfunction associated with TBI, such as extreme 
light sensitivity (photophobia).
      Spatial orientation processing (relation of motor control 
and perception, especially relating to depth perception of objects in a 
visual field) to enhance peripheral vision.
      Next-generation refractive error correction and vision 
augmentation research (i.e. LASIK, visual implants/prostheses, and 
associated corneal healing issues).
Vision Health Disparities
    This research relates to characterization of visual disparities 
based upon gender, race, or age, and determination of the underlying 
physiological basis to develop treatments and therapies.

      Epidemiological studies of military populations to 
determine extent/physiological basis of vision health disparities (i.e. 
greater incidence of glaucoma, cataracts, and diabetic retinopathy in 
the African American/Native American/Hispanic populations).
      Research into low vision caused by traumatic eye injury 
or chronic eye diseases such as age-related macular degeneration or 
glaucoma.
      Age-related macular degeneration research (leading cause 
of blindness in the United States and the leading cause of blindness in 
Americans age 60 and over).
Emerging Adaptive Technology Research
      Optimal vision rehabilitation management after acute 
injury, facilitating the advancement of evidence-based best practices 
for blind and low vision rehabilitation. This could become possible by 
the joint funding of RR&D and HSR&D projects that target the 
development of rigorous, solid best practices guidelines with a strong 
emphasis on vision loss resulting from neuro-trauma. It would also 
address visual impairment concerns of minority veterans, rural 
veterans, and other key target groups.
      Establishment of a Blind Rehabilitation Service-focused 
technology evaluation and assessment center in conjunction with 
experienced blind agencies charged with identifying the highest quality 
of vision rehabilitation through independent, scientific testing on 
both devices and training. Emphasis would be on quick, timely turn 
around of results so veterans can access these newly proven adaptive 
technologies.
CONCLUSIONS
    Serious combat eye trauma occurring in Operation Iraq Freedom and 
Operation Enduring Freedom has become the third most common injury in 
both of these conflicts. Only PTSD and TBI are now more common. We urge 
all members of this Subcommittee to support H.R. 3558, the Military Eye 
Trauma Treatment Act of 2007. The Act creates a Center of Excellence 
and Eye Trauma Registry. Already having included the provisions for the 
establishment of PTSD and TBI Centers of Excellence in the Wounded 
Warrior Act, Congress could now, with this critical legislation, 
substantially improve the multidisciplinary coordination, treatment, 
rehabilitation, and research of eye trauma as it relates to TBI. 
Visually impaired servicemembers and veterans within both the DoD and 
VA systems are depending on passage of this bill. We respectfully 
request that it be passed soon.
    BVA supports specialized, directed research programs in the area of 
vision that will benefit the aging population of blinded and visually 
impaired veterans. The Association also strongly supports language in 
the House Armed Services appropriations that includes recommendations 
for more research for traumatic vision injuries. Together with NAEVR's 
advocacy, BVA strongly requests that ``Eye and Vision Research'' 
maintain its eligibility for funding within the Congressionally 
Directed Medical Research Program (CDMRP) in FY 2008 Department of 
Defense (DoD) appropriations. BVA also believes that such funding must 
be significantly increased from the limited $4.8 million appropriated 
in FY 2007.
    Chairman Michaud and Ranking Member Miller, BVA expresses thanks to 
both of you again for this opportunity to present our testimony. The 
current need to increase VA research is tremendous when considering the 
overwhelming numbers of veterans suffering from traumatic visual 
injuries, traumatic brain injury dysfunction, and age-related causes of 
blindness. The future strength of our Nation depends on the willingness 
of young men and women to serve in our military. This willingness 
depends, in turn and at least in part, on the willingness of our 
government to meet its full obligation to them as veterans.

                               __________
                              Attachments
                       Clinical Update: Cataract
     Wounds of War: Part One: Eye Surgeons in Iraq and Afghanistan
By Denny Smith, Senior Editor*
Eyenet Magazine
May 2006 Edition
---------------------------------------------------------------------------
    *EDITOR'S NOTE: As the conflict in Iraq enters its fourth year, 
Army ophthalmologists continue treating wounded troops there and in 
Afghanistan. EyeNet presents the first of two reports on the 
experiences of Eye M.D.s confronting combat-related ocular injuries. 
NEXT MONTH: Soldiers Journey Home for Recovery.

American Academy of Ophthalmology Web Site: www.aao.org
Original URL: http://www.aao.org/aao/publications/eyenet/200605/
comprehensive.cfm

    The cost of war is often counted in fallen soldiers. But war's 
survivors, both soldier and civilian, may also pay a tremendous price, 
by enduring traumatic, disfiguring and life-altering injuries. 
Ophthalmologists, like many other physicians and medical workers, have 
been tending the wounded in Afghanistan and Iraq for over three years 
now. More than 17,000 American servicemen and women have been wounded 
since the U.S.-led invasions began.\1\
---------------------------------------------------------------------------
    \1\ www.dior.whs.mil/mmid/casualty/castop.htm.
---------------------------------------------------------------------------
    ``The survivors often have very bad injuries, and there's no way to 
completely repair many of them,'' said Thomas H. Mader, MD, a retired 
U.S. Army colonel who served in Iraq in 2004 and who is the primary 
author of a recent report in Ophthalmology describing ocular and 
adnexal injuries treated by U.S. Army ophthalmologists.\2\ 
``Occasionally you treat a patient with a relatively minor injury, 
which can be repaired in 10 minutes and the prognosis is excellent. But 
then there are explosive globe injuries, and other terribly mutilating 
trauma, where there is absolutely no chance at all of salvaging the 
eye.'' Dr. Mader is now practicing ophthalmology at the Alaska Native 
Medical Center in Anchorage.
---------------------------------------------------------------------------
    \2\ Mader, T. H. et al. Ophthalmology 2006; 113(1):97-104.
---------------------------------------------------------------------------
    Eye and brain injuries appear to be more frequent in Afghanistan 
and Iraq compared with previous U.S. conflicts, even though the number 
of deaths per injured troops has decreased. This apparent spike in head 
injuries is partly a statistical illusion: The body armor of troops in 
Iraq and Afghanistan, much improved over what soldiers had in World War 
II, Korea and Vietnam, protects internal organs but not faces and 
limbs. So, ironically, doctors now confront profoundly injured troops 
who once would have died of massive thoracic or abdominal wounds before 
nonfatal injuries to eyes and extremities got medical attention.
For Every War, a Dread Weapon
    Many of the injuries logged in Iraq result from disastrously 
effective improvised explosive devices (IEDs). These are simple, 
homemade bombs, such as artillery shells filled with glass or rocks, 
that are detonated remotely as troop convoys pass by. The sheer 
concussive force of IEDs is dangerous in itself, but most injuries are 
related to debris propelled by the blast. ``These fragments can range 
in size from a grain of sand to something the size of your fist,'' said 
Dr. Mader.
    Sean M. Blaydon, MD, is a former lieutenant colonel who commanded 
the Army's first eye surgical team to be deployed in the Iraq conflict, 
in 2003 and 2004. ``Roadside bombs became more common as the conflict 
dragged on,'' said Dr. Blaydon. ``Many of the injuries were 
devastating, including large areas of the face or both eyes. It's very 
troubling to see young kids with both eyes missing. I don't know 
anybody who didn't get personally affected by it.'' Prior to his 
service in Iraq, Dr. Blaydon was director of ophthalmic plastic, 
orbital and reconstructive surgery and the ocular trauma service at 
Brooke Army Medical Center in San Antonio. He is now a clinical 
assistant professor at the University of Texas, San Antonio, and in 
private practice in Austin.
    A different, but just as troubling, injury profile was described by 
Lt. Col. Mark F. Torres, MD, who served in Afghanistan in 2003 at 
Bagram Air Base, north of Kabul. ``In Afghanistan there are fewer IED-
related injuries and more wounds related to land mines. This is a 
country with 20 years of recent war, and so there are many, many land 
mines planted throughout the country. Now, thanks to better armor, they 
cause fewer injuries to the thorax or abdomen. But that doesn't save 
the extremities, head and neck. And the majority of victims are 
children, who often approach the mines out of curiosity, like they 
would a toy. These typically cause a lot of damage to the face and 
limbs.'' Dr. Torres is now assistant chief of ophthalmology at Madigan 
Army Medical Center in Tacoma.
Care for the Globe
    Physicians witnessing modern warfare are standing at a frontier of 
visually appalling and medically daunting trauma. But the goal for 
treating a battle-related ocular wound is the same as it would be for 
any big-city ER trauma: Save the globe and preserve vision.
    ``We always erred on the side of attempting to preserve badly 
damaged globes,'' said Dr. Mader. ``Even when it looked like an injury 
was so severe that the chance of the eye's survival was minimal, we 
always brought them into the OR and tried to do the best repair 
possible. There are times when an injury is so drastic that you just 
cannot anatomically put the eye back together. When that happens you 
have to know when to call it quits. But we always tried to salvage the 
eye even if the prognosis for useful vision seemed poor.''
    Dr. Blaydon concurred. ``The philosophy of my team was to do as 
much as we could to salvage the globe. No matter how severe the injury, 
if we could put the globe together somehow, we did. We knew that in a 
good 50 percent of severely injured eyes there was little chance that 
vision was going to be saved, and very likely the eyes would eventually 
be enucleated. But these soldiers were badly injured, and sedated, and 
not able to give consent. If they were enucleated right then, they 
might later second-guess what was done. They may wonder, `I came in 
with 10 other guys and maybe they just didn't have time to save my 
eye.' We wanted them to be able, later on, to understand how serious 
the injury was and how every effort was made to save the eye. After 
that, psychologically, they do better if they have an enucleation.''
    Working shoulder to shoulder. The care given in the first minutes 
and hours after an injury must be intensely organized even in the 
middle of chaos. Dr. Mader described a typical scene. ``Our team worked 
in Baghdad in the heavily fortified Green Zone. We had a general 
ophthalmologist, an oculoplastics specialist, neurosurgeons and 
maxillofacial surgeons. We all worked together, often on the same 
patients, because so many troops with eye injuries had other wounds of 
the face and brain.''
    Dr. Blaydon shared a similar picture. ``These soldiers often had 
multiple injuries. On top of a wounded eye, a guy could have had 
traumatic amputation below the knee on one side, lost a foot on the 
other, and they're still trying to save one arm. Many times we had to 
delay our surgery because the orthopedic surgeons were trying to save 
arms and legs.''
    When assessing a newly injured soldier, Dr. Mader hoped to be able 
to communicate with him or her. ``Some were unconscious, suffering from 
horrible head wounds. For others, it was helpful if they were still 
conscious, because you could question them, assess their visual loss, 
ask if they could see light or moving fingers.'' Sometimes, grimly, the 
prognosis was obvious, even to the patient. ``One young fellow who had 
lost both eyes in a blast came in fully conscious and was talking 
clearly to me. He knew what had happened to him.''
    Dr. Blaydon described wounds that seemed almost impossible to 
approach. ``You may see ruptured globes in civilian practice, but in 
combat trauma it could be hard even to distinguish pieces of sclera. In 
everyday urban trauma, a bad rupture is usually stellate, with sharp 
edges, and it's straightforward to repair. In combat-related, high-
velocity injuries, not only do you have complex cornea and sclera 
lacerations and intraocular contents coming out, but the edges are so 
necrotic it's hard to even sew them back together.''
    Neither bombs nor balm discriminated. Army ophthalmologists have 
been treating soldiers and civilians in almost equal numbers. ``We 
treated both American and allied troops, as well as Afghan military and 
enemy combatants. The majority of casualties we saw were actually 
Afghan civilians,'' said Dr. Torres.
    The same was true for Dr. Mader. ``An injured person could randomly 
be an American or an Iraqi, soldier or civilian. When someone was 
brought into the hospital, we treated everybody the same, whether a 
civilian, a child or enemy combatant.''

                               __________
              Clinical Update: The Wounds of War: Part Two
                   Soldiers Journey Home for Recovery
By Denny Smith, Senior Editor*
Eyenet Magazine
June 2006 Edition
---------------------------------------------------------------------------
    *At the Joint Meeting in November, Herbert P. Fechter, MD, will 
moderate a panel of military ophthalmologists who will share their 
experiences in Afghanistan and Iraq. Photos and videos will demonstrate 
the special considerations of ophthalmic war surgery and will address a 
variety of combat-related injuries (Instruction Course #590).

American Academy of Ophthalmology Web Site: www.aao.org
Original URL: http://www.aao.org/aao/publications/eyenet/200606/
comprehensive.cfm

    Even as the conflicts in Afghanistan and Iraq roll on, wounded 
servicemen and women are returning home with injuries that may require 
years of medical and psychological rehabilitation. Last month EyeNet 
featured the experiences of Thomas H. Mader, MD, Sean M. Blaydon, MD, 
and Mark F. Torres, MD, each of whom served on Army surgical teams 
close to combat zones. The soldiers they treated are now filling 
polytrauma facilities in the United States.
Whisked Away From War
    Troops wounded in Iraq or Afghanistan undergo emergent primary 
repairs to life- and sight-threatening injuries often within minutes of 
sustaining the injury. When stable enough, they are transported several 
times to various levels of care.
    The first stop is Landstuhl Army Medical Center in Germany, then on 
to Walter Reed Army Medical Center in Washington, D.C., or Brooke Army 
Medical Center in San Antonio, and finally on to tertiary-care 
hospitals around the country.
    These later stages of care can be the hardest part for both doctors 
and patients. ``It's one thing to sew somebody up as best we could do, 
and it's another thing to provide the follow-up care,'' said Dr. Mader. 
``That is a very, very difficult job, both professionally and 
emotionally. As you can imagine, the psychological impact of a young 
man losing one or both eyes has to be dealt with by both patient and 
physician.''
    Physicians and families take a long view. The community 
ophthalmologist may be seeing more such veterans, and they will need 
multiple levels of care for many years, according to Glenn C. 
Cockerham, MD, chief of ophthalmology at the VA Palo Alto Health Care 
System and clinical associate professor of ophthalmology at Stanford 
University.
    ``When they come to us they are entering a period in which late 
complications, including retinal detachments, corneal decompensation, 
traumatic cataracts or posterior capsular opacifications, may 
present,'' said Dr. Cockerham. ``If one eye, usually on the side of the 
blast, is severely damaged, it is extremely important to take special 
care of their better-seeing eye. But many of them have head injuries 
and resulting memory problems, so we include families in the 
rehabilitation process to watch over their loved one and make sure they 
get to appointments. Their families are usually very supportive, having 
been there for them throughout.''
    Collaborative care is key. Dr. Torres explained how the community 
ophthalmologist can offer veterans care. ``There are a lot of joint 
arrangements between military hospitals and the VA, and between the VA 
and civilian academic medical centers. The average comprehensive 
ophthalmologist offering long-term management of a combat-related 
trauma should, pretty easily, be able to consult with combat-
experienced ophthalmologists.''
    Dr. Blaydon agreed. ``The general ophthalmologists can manage these 
returning vets, but they might be seeing a different trauma than they 
would in an emergency room. Much of it is explosive, high-velocity, 
blunt trauma to the face, which means there's a lot of soft-tissue 
damage and underlying skeletal damage. Many had globe ruptures that 
were severe and complex, and there are often fine, foreign bodies 
embedded in the cornea. Even if the rupture is repaired perfectly, the 
patient remains corneally blind. Many of these will go on to corneal 
transplant. Some of them have bad retinal injuries from just blunt 
trauma.''
Courage and Candor Beyond the War
    Most returning veterans are very young, between their late teens 
and early twenties. Dr. Blaydon maintains a deep regard for their 
emotional well-being. ``I am in awe of the attitude and the motivation 
of these young guys. Before you address their specific injury, it's 
important to consider the psychology of the veteran. They went over 
there to serve their country and to serve alongside their comrades, and 
they want us to respect the fact that they were doing their job when 
they got their injury. These patients need a lot of physical and 
emotional therapy to get back into society.''
    Americans are deeply divided over the Iraq conflict. And yet, Dr. 
Blaydon has observed that the soldiers are coming home to a country 
that cares for them. ``This war is as divisive as any we've had in the 
past. The difference now is that returning vets are receiving support 
from both sides of the fence. That's an important part of welcoming 
these soldiers home.''
    Hope for vision preempted. Conceivably, some of these soldiers 
could benefit from research into artificial retinas, research that has 
received significant funding from the Department of Energy. But Dr. 
Blaydon said the devastating nature of many injuries means that few of 
these veterans would be good artificial retina candidates. ``The 
anterior visual camera, the optic nerve and visual pathway must all be 
intact for an artificial retina to be considered.'' These crucial 
structures are obliterated in many vets.
    Precautions slow to appear. One of the questions now haunting the 
military is whether U.S. troops were provided adequate protection for 
battle. Since the Afghanistan and Iraq conflicts began, Army 
ophthalmologists have repeatedly asked for troops to be given better 
eyewear. While no form of protection can eliminate all injuries, many 
could have been prevented or lessened in severity. In fact, Dr. Mader 
writes in Ophthalmology, ``Polycarbonate ballistic eyewear could have 
prevented many, but not all of the ocular injuries we report.'' \1\
---------------------------------------------------------------------------
    \1\ Mader, T. H. et al. Ophthalmology 2006;113(1):97-104.
---------------------------------------------------------------------------
    Dr. Blaydon noted that ophthalmologists had long lobbied the Army 
for the type of ballistic eyewear that protects against low-velocity 
projectiles. The Army had developed eye armor known as Ballistic/Laser 
Protective Spectacles, but almost none of the soldiers had them. ``The 
Army, as far as we could tell, did not issue them. Eye armor just was 
not part of the issue,'' Dr. Blaydon said.
    The Army did issue Sun, Wind and Dust Goggles, which can protect 
the eye against some minor injuries. But they are cumbersome, and can 
often impair clear, full peripheral vision. ``Soldiers just do not like 
to wear them. What they do like to wear are Wiley X ballistic goggles 
that fit closely to the face. But the soldiers had to purchase these on 
their own. The Army soon realized how severe and frequent the eye 
injuries were and began purchasing these goggles and mandating that 
they be worn,'' Dr. Blaydon said. Even these goggles cannot protect 
against the most potent improvised explosive devices, but, he noted, 
``The incidence of injuries has since gone down, depending on the tempo 
of operations.'' \2\
---------------------------------------------------------------------------
    \2\ Gawande, A. N Engl J Med 2004;351(24):2471-2475.
---------------------------------------------------------------------------
    From a distance. These physicians tend to deflect credit for their 
own heroic service into recognition of others still working in the 
combat zones. ``Many soldiers would have died had it not been for the 
premier care they got in Baghdad. The surgeons there are the top-of-
the-line and that care is as good as you're going to get in a critical 
care hospital,'' said Dr. Blaydon.
    Dr. Mader regards his experience with equanimity. ``If there was 
any positive thing about being there, I would say I worked with some of 
the finest young people I've ever met in my life. Had I been wounded 
and brought to that 31st Combat Support Hospital, I would have had 
complete faith in the medical personnel working there.''
    Dr. Torres shared a similar sentiment. ``It's a rewarding 
experience in unfortunate circumstances. You feel like you're doing 
something positive, even if the world around you is not.''

                                 
                    Prepared Statement of Carl Blake
      National Legislative Director, Paralyzed Veterans of America
    Mr. Chairman and members of the Subcommittee, Paralyzed Veterans of 
America (PVA) would like to thank you for the opportunity to testify 
today on the research programs conducted by the Department of Veterans 
Affairs (VA). Research is a vital part of veterans' health care, and an 
essential mission for our National health care system. PVA is very 
involved in many aspects of medical and prosthetic research because of 
the long-term impact that these initiatives can have on our members.
    The VA health care system is a unique environment combining 
clinical care, education, and research. VA currently supports 
approximately 3,800 researchers at 115 VA medical centers. The research 
program serves as an excellent recruitment tool for young doctors as 
well as scientists because it gives them an opportunity to develop 
skills as clinical researchers. According to the VA, nearly 83 percent 
of VA researchers are practicing physicians. Because of this dual role, 
VA research often immediately benefits patients. For example, 
functional electrical stimulation, a technology using controlled 
electrical currents to activate paralyzed muscles, is being developed 
at VA clinical facilities and laboratories throughout the country. This 
technology is now being applied to many PVA members receiving health 
care service and rehabilitation therapy at spinal cord injury centers. 
Through this technology, tetraplegic patients have been able to grasp 
objects, stand and pivot to assist transfers, and control bladder 
function. We anticipate greater capacity for even walking short 
distances.
    PVA interacts a great deal with the VA's Office of Research and 
Development. Most of our attention is focused on the Rehabilitation 
Research and Development (RR&D) and Health Services Research and 
Development Service (HSR&D). RR&D projects involve technologies such as 
wheelchair development and testing, seating systems, functional 
electrical stimulation (FES), audiology, prosthetics and orthotics, and 
other components. HSR&D projects are multidisciplinary activities that 
involve expertise in a combination of clinical fields--physicians, 
nurses, therapists--as well as social sciences--psychology, sociology. 
It involves delivery system research and application. This particularly 
involves the Quality Enhance Research Initiative (QUERI), which 
includes spinal cord injury (SCI). PVA's Research Department has been a 
direct participant in the QUERI executive group as well as the SCI 
QUERI since their inception.
    Meanwhile, the Clinical Sciences Research and Development Service 
(CSR&D) conducts clinical trials and epidemiological research on key 
diseases that impact veterans. CSR&D research project accomplishments 
include key research findings across a range of diseases and definitive 
evidence for clinical practice.
    Through the system's scope of primary, secondary, and tertiary 
care, as well as long-term care, with multi-disciplinary academic 
affiliations, the VA brings validation and innovation to the delivery 
of the best care for today's veterans. Perfect examples of this idea 
are the Parkinson's Disease Research Education and Clinical Centers 
(PADRECC) and Multiple Sclerosis (MS) Centers of Excellence. These 
centers represent a successful strategy to focus the Veterans Health 
Administration's (VHA) system-wide service and research expertise to 
address two critical care segments of the veteran population. They 
integrate direct health care services, education, and research to the 
benefit of veterans in the system.
    In testimony during the 109th Congress, PVA supported legislation 
that would create Amputation and Prosthetic Rehabilitation Centers of 
Excellence (similar to those for MS and Parkison's disease). The need 
for these centers is amplified by the number of veterans of Operation 
Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) who have 
amputations. As we stated with regards to the Parkinson's disease and 
MS Centers of Excellence, the VA has the essential expertise to focus 
dedicated services on a wide range of medical conditions. It then 
transfers learned approaches for specific care to the broader VA health 
care system. However, the Veterans Health Administration (VHA) often 
times lacks the financial wherewithal to create a needed focal point or 
center. This legislation calls for the creation of these focal points 
and the need for resources to actuate that goal. We must emphasize, 
however, that additional real dollars will likely be needed to 
establish these centers.
    Furthermore, these centers could partner with the new Amputation 
and Prosthetic clinic recently opened at Walter Reed Army Medical 
Center. This partnership could enhance the long-term provision of these 
services to veterans as it would allow the VA to remain on the cutting 
edge of amputation and prosthetic research in conjunction with DoD. 
This is particularly important as the VA will likely be responsible for 
caring for the men and women with prosthetic needs over the course of 
their lives.
    Additionally, VHA should be required to partner with manufacturers, 
dealers, payers, and advocates to develop performance test standards 
for amputee and prosthetic devices. An example of these types of test 
standards is the American National Standards Institute (ANSI) and 
Rehabilitation Engineering and Assistive Technology Society of North 
American (RESNA) Wheelchair Performance Standards. These standards are 
a collaborative effort with specific impacts on wheelchair research and 
development, consumer disclosure, and payer decisions. PVA believes 
that these centers could be the spearhead for development of evidence-
based performance test standards for amputee and prosthetic devices. 
Furthermore, expertise on these matters could be drawn from such 
projects as the VA's Human Engineering Research Laboratories (HERL), a 
project being conducted in collaboration with the University of 
Pittsburg and supported by PVA's Research Foundation, and focused on 
mobility technologies.
    PVA has a particular interest in research projects that the VA 
administers as it continues to address neurotrauma and sensory loss, 
primarily as a result of spinal cord injury or disease (SCI/D) or 
traumatic brain injury (TBI). As you are well aware, traumatic brain 
injury is recognized as the signature injury of combat in Iraq and 
Afghanistan. According to the VA's estimates, TBI and various degrees 
of SCI account for nearly 25 percent of the combat casualties sustained 
by servicemembers in OIF/OEF. Despite the positive gains by 
advancements in body armor, the head (and by extension the brain), as 
well as the cervical spine, are exposed to significantly more trauma. 
This has not only lead to specific injuries related to TBI and 
paralysis, but also vision loss, psychological problems, and the larger 
polytrauma aspect.
    As such, it is absolutely essential that continued research in the 
areas of TBI and SCI continue to advance. PVA has long been a leader in 
the field of spinal cord research. Through the PVA Research Foundation, 
we continue to work to find a cure for SCI/D and alleviate the effects 
of similar conditions. Through the PVA Education Foundation, we develop 
tools to share the broad-based knowledge for SCI/D care with all types 
of health care professionals. Finally, PVA, as a partner in the 
Consortium for Spinal Cord Medicine, promotes the use of evidence-based 
clinical practice guidelines and consumer guides. PVA also supports 
numerous efforts in the field. For example, at the Center for 
Neuroscience and Regeneration Research at Yale University, scientists 
study nerve regeneration that may ultimately lead to better treatments 
for SCI or possibly even a cure. This work is conducted in conjunction 
with the VA.
    Likewise, PVA believes more research must be conducted to evaluate 
the symptoms and treatment methods of veterans who have experienced 
TBI. This is essential to allow VA to deal with both the medical and 
mental health aspects of TBI, including research into the long term 
consequences of mild TBI in OEF/OIF veterans. Furthermore, TBI symptoms 
and treatments can be better assessed for previous generations of 
veterans who have experienced similar injuries.
    PVA also supports a couple of specific research projects that the 
VA instituted during FY 2007. The first project focuses on the special 
needs of service personnel returning from Operation Iraqi Freedom (OIF) 
and Operation Enduring Freedom (OEF). The project will develop new 
treatments and tools for clinicians to ease the physical and 
psychological pain of men and women returning from the combat theaters, 
improve access to VA healthcare services, and accelerate discoveries 
and applications, especially for neurotrauma, sensory loss, amputation, 
polytrauma, and related prosthetic needs. We appreciate that even as 
the VA begins to move forward with this project, it is already 
collecting data to determine if the health care needs of amputees and 
severely injured veterans from OIF and OEF are being met and to 
identify areas where improvement is needed. These data will help focus 
the project on additional areas that need to be studied.
    This project directly supports the important role that research 
plays in the clinical setting. Through this project clinicians can 
learn and apply new tools to the treatment of physical and 
psychological conditions experienced by the men and women returning 
from the Global War on Terror. Furthermore, findings from this research 
project can be shared with Department of Defense (DoD) treatment 
facilities, particularly Walter Reed Army Medical Center and Brook Army 
Medical Center, as well as the Defense Advanced Research Projects 
Agency. This collaboration will be absolutely essential as it will 
provide for new screening tools, clinical applications, and long-term 
follow-up.
    As a member of the Friends of VA Research (FOVA) coalition, we 
wholeheartedly support the vision to expand the VA research program to 
encompass the needs of service personnel returning from current 
conflicts, whether they include polytrauma, massive burn injury, or 
mental health conditions. Such expansion of the program requires new 
resources so that VA's other research areas, which are equally 
important to the long-term care of veterans, do not suffer.
    The second special research project focuses on genomic medicine. 
The thrust of this project is to link veterans' genetic information 
with the VA electronic health record. The program will ultimately allow 
clinicians to make better decisions for veterans based on their genetic 
information. Furthermore, it will address patients' rights, informed 
consent, privacy, and ownership of genetic material involved with 
genetic tissue banking. We believe that the human genome reports of 
recent years have provided a strategy to integrate clinical 
symptomology with genetic testing to create a predictive model that 
could extend health care delivery to a truly preventive service.
    However, despite the expectations of this exciting field, we must 
reiterate that additional new funding will be necessary. Genomic 
medicine cannot be advanced by simply reshuffling funding priorities 
within existing VHA R&D funding. If it is placed into a stream where it 
will compete with current VA projects, the sheer scope and cost of 
genomic medicine will overrun all other ongoing projects. This will 
simply not be a cheap field to study, so the burden should be shared by 
the Veterans Health Administration (VHA) and DoD. Moreover, the genomic 
priorities of NIH should be marshaled with VHA.
    PVA also believes that one particular change should be made that 
would allow the VA to invest additional resources into its 
infrastructure. Currently, many VA researchers are primary grantees 
from the National Institutes of Health (NIH). However, these 
researchers do not receive any funding to support management and 
physical plant costs of their projects. Their physical infrastructure 
and administrative costs (also called indirect costs), which are vital 
to the support of the research enterprise, are not funded by NIH to VA 
researchers. However, if that same VA researcher carries that same 
grant through an academic affiliate, then NIH would provide full 
indirect support. If the VA is going to attract clinician researchers, 
they must provide the best environment; otherwise, they are placed at a 
significant competitive disadvantage. Simply put, Congress must provide 
funding for capital improvement and support the VA research enterprise 
or NIH should be required to pay fair indirect costs to the VA.
    Finally, I must emphasize our concern about funding for the overall 
Medical and Prosthetic Research program. We certainly appreciate the 
fact that the appropriations bills passed by the House and Senate meet 
or exceed the $480 million that The Independent Budget calls for in FY 
2008. However, with the outcome of the appropriations still hanging in 
limbo, and the fact that no appropriation has been provided even as the 
start of the new fiscal year has passed, we remain concerned about the 
ongoing viability of the VA research program. It is time to put the 
games aside and complete the appropriations work that these programs so 
vitally rely upon.
    Mr. Chairman, PVA appreciates your continued interest in 
maintaining a viable research program. We look forward to working with 
the Subcommittee to ensure that adequate resources are provided for 
Medical and Prosthetic Research. Quality research outcomes can only 
lead to better patient care for veterans.
    Thank you again. I would be happy to answer any questions that you 
might have.

                                 
                   Prepared Statement of Joy J. Ilem
  Assistant National Legislative Director, Disabled American Veterans
    Mr. Chairman and Members of the Subcommittee:
    Thank you for inviting the Disabled American Veterans (DAV) to 
provide testimony on Department of Veterans Affairs (VA) research 
programs. As an organization of more than one million service-disabled 
veterans, DAV has a genuine concern about the health and well-being of 
the men and women who are serving today or who have served our country 
and suffered physical and mental disabilities as a result of military 
service.
    VA's research program, developed following World War II, has a rich 
and robust history with a clear mission, ``To discover knowledge and 
create innovations that advance the health and care of veterans and the 
nation.'' The program is distinguished by three Nobel Laureates, six 
Lasker Prize winners, and a number of important discoveries and 
inventions. Today, VA's offices of Health Services Research and 
Development and Rehabilitation Research and Development are focusing on 
a number of important areas including: posttraumatic stress disorder 
(PTSD); mental health and substance abuse; spinal cord injury; genomic 
medicine; and women's health. The complex and unique injuries sustained 
by troops serving in Iraq and Afghanistan have created the need for new 
research and treatment strategies focused on addressing the unique 
needs of the newest generation of combat disabled veterans who have 
traumatic brain injury (TBI); polytrauma; spinal cord injury; burns; 
amputations; and hearing and vision loss. Although VA has been the 
leader in conducting research on many war-related injuries in the past, 
it is critically important that proper funding be made available for VA 
to expeditiously conduct research and effectively implement related 
advances in treatment for all of these devastating injuries. My 
testimony will focus on several of these areas in more detail.
Prosthetics
    Many veterans who served in Operations Enduring and Iraqi Freedom 
(OEF/OIF) have sustained catastrophic or polytraumatic injuries during 
their military service to include severe brain injury, spinal cord 
injury and traumatic amputation. Most servicemembers begin the recovery 
and rehabilitation process at Walter Reed Army Medical Center (WRAMC) 
or other specialty military treatment facilities. ``Warrior Rehab'' as 
it is known is an extraordinary example of the incredible journey many 
severely injured veterans travel as they are rehabilitated, fitted and 
trained to use state-of-the-art prosthetics. The new rehabilitation 
center at WRAMC and the extraordinary Center for the Intrepid (which 
was sponsored by DAV and our contributors), are two of the world's most 
technologically advanced rehabilitation centers for amputees. As 
servicemembers transition to veteran status and into VA care, we 
encourage VA to significantly increase research on amputation, 
prosthetics, and orthotics to help improve health outcomes and make 
available the newest technologies for this unique patient population. A 
significant number of servicemembers and veterans returning from OEF/
OIF today are young--and aggressive rehabilitation programs are helping 
them return to very active lifestyles. VA will be responsible for the 
long-term health maintenance of this population for decades; therefore, 
it is appropriate that VA develop research initiatives that ensure VA 
is the leader in advancing new technologies and prosthetic and orthotic 
items, and rehabilitation models that promote good health outcomes for 
veterans with amputations. Any research should also include older 
veterans from previous generations who could benefit from these 
studies.
Traumatic Brain Injury
    Mr. Chairman, Traumatic Brain Injury (TBI) and spinal cord injury 
account for almost 25% of the combat casualties sustained by our 
soldiers in OEF/OIF. Blast injuries that violently shake or compress 
the brain within the closed skull cause devastating and often permanent 
damage to the brain--and veterans with severe TBI will likely need a 
lifetime of care for their injuries.
    Military service personnel who sustain catastrophic physical 
injuries, and suffer severe TBI, are easily recognized and the 
treatment regimen is well-established. However, VA experts note that 
TBI can also be caused without any apparent physical injuries when a 
veteran is in the near vicinity of improvised explosive device (IED) 
detonation. Veterans suffering a milder form of TBI may not be detected 
so readily, but symptoms can include chronic headaches; irritability; 
disinhibition sleep disorders; confusion; memory problems; and 
depression. With nearly 15,000 IEDs now reported in Iraq alone, it is 
believed that many OEF/OIF servicemembers have suffered mild brain 
injuries or concussions that have gone undiagnosed, and that symptoms 
may only be detected later, when these veterans return home.
    We are concerned about emerging literature that strongly suggests 
that even ``mild'' TBI patients may have long-term mental health and 
other health consequences. According to VA's mental health experts, 
mild TBI can produce behavioral manifestations that mimic PTSD or other 
symptoms. TBI and PTSD can also be co-existing conditions. Much is 
still unknown about the long-term impact of these injuries and the best 
treatment for mild/moderate TBI. The influx of OEF/OIF servicemembers 
returning with brain injury and trauma has increased opportunities for 
research into the evaluation and treatment of such injuries in newer 
veterans; however, we suggest that any studies undertaken by VA include 
older veterans of past military conflicts who may have suffered similar 
injuries that thus far have gone undetected, undiagnosed, and 
untreated. Their experiences could be of enormous value to researchers 
interested in the progression of these injuries on a long-term basis. 
Likewise, such knowledge of historic experience could help both 
Department of Defense (DoD) and VA better understand the procedures and 
policies needed to improve screening, diagnosis and treatment of mild 
TBI in the newest generation of combat veterans.
    We are pleased that VA has designated TBI as one of its special 
emphasis programs, and is committed to working with DoD to provide 
comprehensive acute and long-term rehabilitative care for veterans with 
brain injuries. We urge Congress to remain vigilant to ensure that VA 
research programs are sufficiently funded and are adapted to meet the 
unique needs of the newest generation of combat service personnel and 
veterans with TBI, while they continue to address the needs of older 
veterans with severe physical disabilities, as well as posttraumatic 
stress disorder (PTSD) and other combat-related mental health 
challenges.
Mental Health
    Current research findings indicate that OEF/OIF combat veterans are 
at higher risk for PTSD and other mental health problems caused by 
their experiences and exposure in these wars.
    VA reports that veterans of these current wars have sought care for 
a wide range of possible medical and psychological conditions, 
including mental health conditions, such as adjustment disorder, 
anxiety, depression, PTSD, and the effects of substance abuse. Through 
July 2007, VA reported that of the 252,095 separated OEF/OIF veterans 
who have sought VA health care since fiscal year 2002, a total of 
94,921 unique patients had received a diagnosis of a possible mental 
health disorder. Over 45,000 of the enrolled OEF/OIF veterans had a 
probable diagnosis of PTSD, and almost 38,000 reported nondependent 
abuse of drugs. Also, critically, 31,000 OEF/OIF veterans have been 
diagnosed with depression.
    In a recent study, VA New Jersey-based researchers examined 
substance abuse and mental health problems in returning veterans of the 
war in Iraq. Researchers noted that although increasing attention is 
being paid to combat stress disorders in veterans of the Iraq and 
Afghanistan conflicts, there has been little systemic focus on 
substance abuse problems in this cohort. In the group studied (292 New 
Jersey National Guard members who had returned from Iraq within the 
past 12 months) there was a 39.4 percent prevalence of a substance 
abuse problem; 37.1 percent reported problem drinking; and a 21.2 
percent prevalence of alcohol abuse or dependence. Highlights of the 
study included the following findings: nearly 47 percent of veterans 
studied had reported a mental health and/or substance abuse problem. 
Substance use problems were found to be higher among veterans with 
mental health problems; access to treatment both during and after 
deployment was especially low for those needing substance abuse 
treatment (among veterans with dual disorders--41 percent received 
mental health treatment but only 9 percent received treatment for 
substance abuse). We urge VA to continue research into this critical 
area and to identify the best treatment strategies to address substance 
abuse and other mental health and readjustment issues collectively.
    We urge VA to continue research that is veteran-centered and 
specifically focused on rehabilitation of veterans with physical and 
cognitive impairments related to military service and studies to 
identify and promote effective and efficient strategies to improve the 
delivery of healthcare to veterans. We believe VA's research priorities 
should include:

      A study to objectively and systematically measure the 
expectations of OEF/OIF veterans to help VA better serve this 
population. These veterans are younger, have family and community 
support systems in place, and are frequently dealing with complicated 
post-service readjustment, employment, education and other issues. VA 
should conduct health services and other research to identify services 
to meet their mental health needs.
      Studies to address access issues for this new population 
including tracking of OEF/OIF veterans to learn what services they 
utilize. VA should also examine barriers to care, especially those that 
relate to attitudes of veterans and their families toward being treated 
in the VA, and any breakdown in access this may cause.

    The DoD and VA share a unique obligation to meet the health care--
including mental health care--and rehabilitation needs of veterans who 
are suffering from readjustment difficulties and various injuries as a 
result of combat service. Both agencies need to ensure that appropriate 
research is conducted and that federal mental health programs are 
adapted to meet the unique needs of the newest generation of combat 
service personnel and veterans, while continuing to address the needs 
of older veterans with substance abuse problems, PTSD and other combat-
related readjustment issues and other mental health challenges. 
Congress must remain vigilant to ensure that research and treatment 
programs are authorized and sufficiently funded.
Women Veterans
    With increasing numbers of women serving in the military, and with 
more women veterans seeking VA health care following military service, 
it is essential that the VA be responsive to the unique demographics of 
this veteran population cohort. In addition, VA must ensure that its 
special rehabilitation programs are tailored to meet the unique health 
concerns of women who have served in combat theaters and those who have 
suffered catastrophic disabilities as a result of military service. 
Women's health research is essential to achieving these objectives--
specifically to fully understand the healthcare needs of this 
population and to develop high quality services and treatments.
    In 2004, VHA's Office of Research and Development held a 
groundbreaking conference, ``Toward a VA Women's Health Research 
Agenda: Setting Evidence-Based Research Priorities for Improving the 
Health and Care of Women Veterans.'' The participants of the conference 
were tasked with identifying gaps in understanding women veterans' 
health and health care, and with identifying the research priorities 
and infrastructure required to fill these gaps. In April 2005, a 
special solicitation was issued for intramural VA research proposals to 
assess health care needs of women veterans and demands on the VA health 
care system in targeted areas, such as mental health and combat stress, 
military sexual trauma (MST), PTSD, homeless women veterans, and 
differences in era of service (e.g., Iraq vs. Gulf War service 
periods). An entire issue of the Journal of General Internal Medicine 
was dedicated to VA research and women's health in March 2006. 
Published findings included articles on why women veterans choose VA 
health care; barriers to VA health care for women veterans; the health 
status of women veterans; PTSD and increased use in certain VA medical 
care services; and MST.
    We have strongly encouraged VA, as it takes steps to advance this 
agenda, to focus on research and programs that enhance VA's 
understanding of women veterans' health issues and discover new ways to 
optimize health care delivery and improve health outcomes for this 
special VA patient population.
    Mr. Chairman, one area of particular interest to DAV is the 
incidental impact of VA's primary care model on women's health. There 
has been a trend in the Veterans Health Administration (VHA) to move 
away from dedicated women's health clinics, to general primary care, 
for the purpose of providing both primary and gender-specific health 
care to women veterans within unified clinics. According to VA, less 
than half of its facilities surveyed provide care to women through 
mixed gender primary care teams, referring women to specialized women's 
health clinics for gender-specific care. In the mid-1990s, VA 
reorganized from a predominantly hospital-based delivery care model, to 
an outpatient health care delivery model, focused on preventative and 
health maintenance care. While we believe that shift was appropriate, 
we are concerned about the incidental impact of the primary care model 
on the quality of health care delivered to women. VA's 2000 conference 
report, ``The Health Status of Women Veterans Using Department of 
Veterans Affairs' Ambulatory Care Services,'' noted that with the 
advent of primary care in VA, many women's clinics were being 
dismantled and that women veterans were assigned to primary care teams 
on a rotating basis, without regard to gender. Findings from that 
report indicated that this practice further reduced the ratio of women 
to men in any one practitioner's caseload, making it increasingly 
unlikely that an individual clinician would gain the clinical exposure 
necessary to develop and maintain expertise in women veterans' health. 
We understand that a follow-up study is currently being conducted and 
that VA researchers will study the impact of the practice structure on 
the quality of care for women veterans, and the fragmentation of care 
including unmet health care needs of those with chronic physical and 
mental health conditions.
    VA acknowledges that full-service women's primary care clinics that 
provide comprehensive care, including gender-specific care, are the 
optimal milieu for providing care to women veterans. Or, in cases where 
there are relatively low numbers of women being treated at a given 
facility, it is preferable to assign all women to one primary care 
team, or provider, in order to facilitate the development and 
maintenance of provider clinical skills in women's health. VA also 
notes that the health care environment directly affects the quality of 
care provided to women veterans and has a significant impact on a 
patient's comfort, privacy, feeling of safety, and sense of welcome.
    According to VA researchers, although women veterans surveyed 
reported that they prefer receiving primary and gender-specific health 
care from the same provider or clinic, in actuality, their care is 
often fragmented, with different components of care being provided by 
different clinicians with variable degrees of coordination and 
expertise in caring for women. Additionally, researchers have found a 
number of barriers to delivering high quality health care to women 
veterans. Specifically, insufficient funding for women's health 
programs; competing local or network priorities; limited resources for 
outreach; inability to recruit specialists; lower numbers of women 
veterans' caseloads; limited availability of after-hours emergency 
health services; and an insufficient number of clinicians skilled in 
women's health, have been identified as current barriers to care for 
women veterans.
    VA Researchers made several recommendations to address these 
barriers, including concentrating women's primary care delivery to 
designated providers with women's health expertise within primary care 
or women's health clinics; enhancing provider skills in women's health; 
providing telemedicine-based access to experts to aid in emergency 
health care decisionmaking; and increasing communication and 
coordination of care for women veterans using fee-basis or contract 
care services. We urge this Subcommittee to provide oversight and to 
monitor VA's progress in this area. We also encourage VA to continue to 
make women's health a research priority and to develop new knowledge 
about how to best provide for the health and care of women veterans.
Addressing the Needs of Women Veterans Who Served in OEF/OIF
    The challenge of addressing the health care needs of the growing 
number of women veterans exposed to combat with and without obvious 
injury is daunting. In the future, the needs will likely be 
significantly greater with more women seeking access to care, increased 
health care utilization, and a more diverse range of medical 
conditions. It is unlikely the past experience of women veterans in the 
VA will serve as an accurate guide because of the unique experiences 
and exposures of women veterans who served in OEF/OIF.
    Given the increasing role of women in combat deployments, and with 
more than 70,000 women now having served in the OEF/OIF combat 
theaters, we are pleased that the Women's Health Science Division of 
VA's National Center for PTSD (hereinafter Center) is evaluating the 
health impact of combat service on women veterans, including the dual 
burden of exposure to traumatic events in the combat theater and the 
potential of MST. According to the Center, although there is no current 
empirical data to verify MST is occurring in Iraq at a higher rate than 
expected, there have been numerous reports in the popular press citing 
cases of sexual misconduct in theater. In the Center's Women's Stress 
Disorder Treatment Team, of 49 returning female veterans, 20 (41 
percent) reported MST. This is very disturbing to DAV and we believe it 
warrants greater attention by VA in its research portfolio.
    Additionally, the Center notes that anecdotal reports from OEF/OIF 
veterans suggest a number of unique concerns that have a more direct 
impact on women than on their male counterparts returning from combat 
theaters, including lack of privacy in living conditions; sleeping and 
showering areas; limited gynecological healthcare in theater; 
healthcare impact of women choosing to stop their menstrual cycle; and 
health consequences of dehydration and chronic urinary tract infection. 
Findings also suggest distinct differences occur in homecoming, 
including that women may be less likely to have their military service 
recognized or appreciated by their communities; possible differential 
access to VA treatment services; and increased parenting and financial 
stress that they must endure.
    DAV is pleased that the Center is examining gender differences in 
mental health; MST in the combat theater; gender differences and other 
stressors associated with OEF/OIF service and homecoming, including 
treatment of PTSD in women; enhancing sensitivity toward, and knowledge 
of, women veterans and their healthcare needs among VA staff; and MST 
among reserve components of the armed services.
    We also understand a number of VA research projects are focused on 
evaluation of the VA's MST screening and treatment programs including 
identifying the prevalence of MST and the associated mental and 
physical health conditions (especially among all VA users and OEF/OIF 
veterans), establishing the association between MST screening and later 
use of MST-related treatments, and identifying key characteristics of 
VA facilities that influence successful implementation of MST screening 
and treatment practices.
    Some women suffer from severe PTSD and will require intensive 
evidence-based treatment. VA has conducted ground-breaking research on 
evidence-based treatment for PTSD, including a recent study that 
established its efficacy for women. While these developments are an 
important first step, they will only have an impact on the thousands of 
women veterans affected when these techniques are fully deployed 
throughout the VA system and easily accessible to providers and 
patients. This is not currently the case, as acknowledged by the 
National Center representative in recent testimony before the 
President's Commission on Care for America's Returning Wounded 
Warriors.
    We acknowledge that VA is attempting to address the needs of women 
veterans returning from combat theaters in a variety of ways, and has 
provided guidance for medical facilities to evaluate the adequacy of 
programs and services for returning OEF/OIF women veterans in 
anticipation of gender-specific health issues. However, additional 
research including improvement in sharing data and health information 
between DoD and VA is essential to understanding and best addressing 
the health concerns of women veterans. At this time we do not fully 
understand the barriers that may prevent OEF/OIF women from accessing 
VA care. We do know from recent studies of OEF/OIF active duty and 
reserve component personnel that stigma is a major barrier in accessing 
mental health services; with over 40% reporting that stigma would 
impact their decision to seek care. We believe further research is 
necessary that looks at the barriers that women veterans perceive or 
have experienced in seeking VA health care.
    VA needs to ensure priority is given to women veterans' programs so 
quality health care and specialized services are made available equally 
for women and men. VA must continue to work to provide an appropriate 
clinical environment for treatment, even where there is a disparity. 
Given the changing roles of women in the military, VA must also be 
prepared to anticipate the specialized needs of women veterans who were 
sexually assaulted in military service and/or catastrophically wounded 
in combat theaters. Although it is anticipated that many of the health 
problems of male and female veterans returning from combat operations 
will be similar, VA facilities must address the health issues that pose 
special challenges for women. DAV has recommended that VA focus its 
women's health research on finding the health care delivery model that 
demonstrates the best clinical outcomes for women veterans. Likewise, 
VA should develop a strategic plan, in conjunction with DoD, to collect 
critical information about the health status and continuing care needs 
of women veterans with a focus on evidence-based practices to identify 
other strategic priorities for a woman's health research agenda.
    DAV makes the following research recommendations to better serve 
women veterans returning from combat theaters.

      VA should conduct research involving recently discharged 
active duty women and recently demobilized female Reserve component 
members to assess the barriers that they perceive, or have experienced, 
to seeking health care through VA. Research should include assessments 
of the effect of stigma, driving distance to the nearest source of 
care, lack of child care, understanding of VA eligibility and services, 
user friendliness of VA services for those who have attempted to access 
care, cultural sensitivities that differentially affect women, and 
other key potential barriers.
      VA should quickly disseminate and deploy resources to 
make evidence-based PTSD treatment easily accessible for women veterans 
across the country, and explore options for providing child care for 
those needing it to enable them to achieve access to treatment.
      DoD should fund a prospective, population-based health 
study of women who served in OEF/OIF. An epidemiologic study with at 
least a 10-year follow-up period is needed. This study should be 
carried out by DoD, VA, and University researchers collaboratively.
      VA should conduct a comprehensive assessment of its Women 
Veterans' Health Programs, including specialized programs for women who 
are homeless or have substance-use and/or mental health challenges, and 
develop an action plan to improve services for this population and 
projected future needs of OEF/OIF women veterans.
      VA should conduct research to fully understand the dual 
burden of military sexual trauma and combat-related PTSD, and develop 
the best treatment practices and programs for this population.

    Other areas relevant to MST that could benefit from additional 
research resources:

      Expand evidence-based treatment for mental health 
conditions associated with MST, beyond PTSD (e.g., depression, 
substance abuse, eating disorders, and difficulties with sexual 
functioning).
      Increase research into the physical health co-morbidities 
associated with MST and how to more effectively work with MST and 
veterans in the primary care setting.
      Focus on ways in which existing MST treatments can be 
adapted to for men (In general, men are an understudied population when 
it comes to MST.)
      More research into barriers both male and female veterans 
face when trying to access MST-related treatment services.
      Research into the prevalence and consequences of MST 
during OEF/OIF combat deployments.
      Greater understanding of the phenomenology and dimensions 
of MST within VA (e.g., what specific harassment and assault 
experiences are captured by the existing MST screening mechanism.)
      Program evaluation research focused on demonstrating the 
effectiveness of innovative treatment programs prior to exporting the 
programs to additional facilities and programs.
Aging Veteran Population
    While additional research and resources must be provided to better 
treat our newest generation of combat veterans, VA stills has a large 
cohort of aging veterans who served in earlier periods. In that 
respect, research focused on diabetes, hypertension, heart disease and 
other chronic illnesses affecting older populations must continue. 
Also, we are concerned that VA research address the needs of elderly 
veterans with co-morbid mental health and substance-use disorder 
problems.
    DAV recommends that VA consider research for this population that:

      Addresses the health care needs of aging veterans with 
traumatic injuries (spinal cord injury, amputations, sensory loss), who 
now also must cope with the diseases of old age (such as heart disease, 
diabetes, chronic obstructive pulmonary disease, hypertension, etc.). 
Clinicians report they are seeing Vietnam veteran population cohorts 
who are already beginning to experience these problems;
      Develops innovative interventions to aid family 
caregivers who are providing home-based care for service-injured 
veterans. This caregiver burden needs to be evaluated to look at ways 
that the VA can best support them--from the perspective of caregivers 
who are elderly themselves to our newest generation of family 
caregivers of severely injured OEF/OIF veterans (e.g., parents, 
siblings, grandparents and spouses); and
      Supports genomic medicine--additional resources should be 
provided for VA to expand its new Genomic Medicine Program. VA's 
electronic medical record system allows VA to longitudinally follow its 
patient population and is uniquely positioned to develop this new 
science. Genomics offers the possibility of new, highly targeted 
patient treatments in the areas of mental health and chronic disease 
that minimize the effect of adverse reactions to clinical 
interventions.
Gulf War Veterans
    Studies indicate about 30 percent of veterans who served in the 
Gulf War suffer from unexplained medical symptoms and illnesses termed 
Gulf War Illnesses. In 2004, then VA Secretary Principi committed up to 
$15 million per year for 5 years for Gulf War Illnesses research. The 
following year VA Secretary Nicholson announced a funding increase and 
establishment of a research treatment center and a pilot program to 
further study and treat veterans suffering with Gulf War Illnesses. 
Additionally, the Fiscal Year 2006 Defense Appropriations Act provided 
$5 million to DoD's Gulf War Veterans' Illnesses Research Program 
administered through the Office of Congressionally Directed Medical 
Research Program. The seed money for this program attracted a 
remarkable number of proposals (80) indicating significant interest to 
find effective and immediate treatment for Gulf War illnesses; however, 
DoD has excluded additional funding for the program from its proposed 
2008 budget.
    VA's own Research Advisory Committee for Gulf War Veterans 
Illnesses notes little effort has been made to utilize VA's heralded 
group of research clinicians currently treating Gulf War veterans. No 
mechanism is currently in place for compiling data on treatments and 
outcomes documented in the medical records of ill veterans seen by 
these VA clinicians. Additional research is needed to explore and 
compile good health outcomes related to efficacious treatments that are 
used in treating ill Gulf War veterans and to share best practices with 
other VA facilities.
    We believe that while research into causative factors should 
continue, efforts should be made toward more research into treatments 
and interventions that take into account all effective treatments being 
used by VA clinicians for this population, since roughly 200,000 
veterans have been suffering from Gulf War illnesses for over 16 years.
Minority Veterans
    For many years, the VA has expressed its commitment to eliminating 
ethnic and racial disparities in health care to ensure equal access and 
quality health care for all veterans using VA services. In June 2007 
the VA Health Services Research and Development Service (HSR&D) 
released a new report, Racial and Ethnic Disparities in the VA 
Healthcare System: A Systematic Review. This research examined a number 
of clinical interests including: arthritis and pain management; cancer; 
cardiovascular diseases; diabetes; HIV and Hepatitis C; mental health 
and substance abuse; preventative and ambulatory care; and 
rehabilitative and palliative care. The study concluded that 
disparities appear to exist in all clinical arenas, and a number of 
hypotheses were suggested to explain why disparities exist. More 
notably, researchers commented in nearly each case that the underlying 
causes of disparities in care and outcomes were not fully explored or 
remained unclear. One key finding was that in studies examining quality 
indicators representing immediate health outcomes--such as control of 
blood sugar, blood pressure, or cholesterol--minority veterans 
generally fared worse than Caucasians. The researchers noted that this 
finding was especially troubling since it may indicate that disparities 
in health care delivery contribute to disparities in health outcomes. 
It was also noted that fewer studies examined Hispanics, American 
Indians, and Asians and that in general, disparities in the VA appear 
to impact African American and Hispanic veterans most significantly.
    The study relates specific sources of disparities and offers a 
number of future research recommendations to further elucidate and 
reduce or eliminate racial disparities in VA health care. It is clear 
from this study that much more needs to done in this area; therefore, 
we encourage VA to continue this important research.
Conclusion
    In closing, the Veterans Health Administration is a unique health 
care system with much to offer its large and diverse patient 
population. And from its earliest days, research has been an integral 
part of VA's overall mission, while maintaining a veteran-centric 
focus. Today, the VA system offers veterans the ``best care anywhere'' 
as reported by independent researchers, the Institute of Medicine, 
health industry experts and numerous media outlets. Millions of the 
nation's sick and disabled veterans need and depend on the VA health 
care system to help them overcome severely disabling injuries suffered 
during their military service. We urge VA to press forward and to 
remain on the cutting edge of health care through its esteemed research 
program, and we encourage this Subcommittee to maintain necessary 
oversight of VA's research and to provide sufficient funding so that VA 
can improve services and health outcomes for sick and disabled veterans 
as it continues its quest for excellence.
    Mr. Chairman, this concludes my testimony and I will be happy to 
address questions from you or other Members of the Subcommittee.

                                 
              Prepared Statement of Joel Kupersmith, M.D.
                 Chief Research and Development Officer
  Veterans Health Administration, U.S. Department of Veterans Affairs
    Mr. Chairman and members of the Subcommittee, thank you for the 
invitation to appear before you today to discuss the Department of 
Veterans Affairs (VA) medical and prosthetic research program. I 
appreciate this opportunity to discuss the vital role VA research and 
development has in ensuring the health and well-being of our Nation's 
veterans. With me are Dr. Timothy O'Leary, Director of Biomedical 
Laboratory and Clinical Science Research and Development, and Dr. 
Michael Selzer, Director of Rehabilitation Research and Development.
Introduction
    Let me first say that the future of medicine is determined by 
research. Just as the advances in medicine that save and improve lives 
today would not have occurred without yesterday's research, the 
advances in medicine that we have all grown to expect will not occur 
without today's and tomorrow's research.
    Dating back more than 80 years, VA research has been a valuable 
investment with remarkable and lasting returns for veterans and the 
Nation as a whole. I am sure that you are familiar with the many awards 
won by VA investigators--3 Nobel prizes, 6 Lasker awards, and many 
others. But what is more important is the large number of treatments 
and procedures that have been developed and effectively proven by VA 
investigators. VA research has taken special advantage of its 
connection to clinical care and is replete with examples of how it has 
improved care, including:

      Developing numerous advances in prosthetics, including 
better-fitting and lighter artificial limbs, prosthetics that can 
sense, artificial hands that are capable of very fine motion, a 
biomechanical foot, and the Seattle foot--a great early example of 
these advances;
      Pioneering understanding of and treatment for post-
traumatic stress disorder (PTSD), including exciting new treatment 
advances proving the effectiveness of prolonged exposure therapy and a 
drug to significantly reduce trauma nightmares and other sleep 
disturbances in PTSD;
      Identifying genes associated with Alzheimer's disease and 
premature aging;
      Laying the groundwork for the development of the 
computerized axial tomography (CAT) scan;
      Pioneering research efforts leading to new home dialysis 
techniques;
      Developing the nicotine patch and other therapies to help 
smokers quit;
      Developing the cardiac pacemaker and many other advances 
for abnormalities of heart rhythm, high blood pressure, and coronary 
artery disease; and
      Developing a system that decodes brain waves and 
translates them into computer commands that allow tetraplegics to 
perform simple tasks like turning on lights and opening e-mails by 
using only their minds.

    VA's Cooperative Studies Program deserves special mention. It has 
received national media attention for its groundbreaking work improving 
treatment for a host of critical medical conditions, including:

      A series of studies that established the cornerstone for 
treatment of hypertension;
      One of the first studies to ascertain the long-term 
effects of coronary artery bypass surgery;
      An investigative study on the use of cortisone to treat 
patients with septic shock;
      A landmark study that showed aspirin reduces deaths and 
heart attacks in patient with unstable chest pain;
      A vaccine for shingles;
      New innovative drugs and therapies to treat PTSD; and
      A study that showed balloon angioplasty plus stenting did 
little to improve outcomes for patients with stable coronary artery 
disease who also received optimal drug therapy and underwent lifestyle 
changes.

    But past success is never enough. Research must be future-oriented. 
VA's research program builds on its past by identifying and confronting 
the important questions and challenges of today and conducting the hard 
work to find solutions for the future.
VA Research as a Unique Laboratory
    A particular advantage of VA research is that it is an intramural 
program where clinical care and research occur together under one roof. 
For this reason, VA has the capacity to bring scientific discovery from 
the patient's bedside to the laboratory bench and then back to the care 
of patients, making this program one of VA's most effective tools to 
improve the care of veterans. Embedding research within an integrated 
health care system with a state-of-the-art electronic health record 
creates a national laboratory for the discovery of new medical 
knowledge and the translation of that knowledge into improved health. 
Furthermore, the opportunity to conduct research assists VA in 
recruiting outstanding clinicians and creates a culture of continuous 
learning and innovation ensuring VA's continued leadership in health 
care.
    Additionally, VA research has a unique program, the Quality 
Enhancement Research Initiative (QUERI), which creates durable 
partnerships between VA researchers, clinicians, and policy-makers to 
accelerate the implementation of research evidence into routine 
practice. Allow me to give you one example of this innovative program--
administration of influenza and pneumococcal vaccine to individuals 
with spinal cord injury. People with spinal cord injury are at higher 
risk for influenza and pneumonia. To increase these patients' rates of 
vaccination, VA QUERI investigators partnered with VA clinical leaders 
in spinal cord injury. Working together, they increased the rate of 
influenza vaccination from 28 to 61 percent, and the rate of pneumonia 
vaccination from 40 to 79 percent. These improvements continued even 
after the initiative ended, with the vaccination rates reaching 72 and 
86 percent, respectively, when last measured.
    This advance for veterans with spinal cord injury can be attributed 
to researchers working within VA's health delivery system to improve 
the process of care. I think this exemplifies the value of having 
research and clinical care ``under one roof'', working together to 
improve the delivery of care.
Priorities of VA Research
    Each year we re-evaluate our priorities based on the changing needs 
of the veterans we serve, and strive to fund the highest quality 
science that meets those priorities. The following are some of the 
current priority areas for VA research:

      Research related to Operation Enduring Freedom and 
Operation Iraqi Freedom (OEF/OIF) veterans and deployment health;
      Mental health;
      Personalized medicine;
      Chronic diseases;
      Access to care;
      Long-term care; and
      Women's health.

    Details about these priority areas are given below.
Research Related to Operation Enduring Freedom and Operation Iraqi 
        Freedom (OEF/OIF) Veterans and Deployment Health
    VA has implemented a comprehensive research agenda to develop new 
treatments and tools for clinicians to ease physical and psychological 
pain, improve access to VA health care services, and address the full 
range of health issues of OEF/OIF veterans. This research also has 
direct relevance for veterans of other conflicts, as well as for 
civilians suffering from disability due to injury or disease.
    Specific areas of focus in OEF/OIF and deployment health related 
research include:
    Traumatic Brain Injury (TBI) and Other Neurotrauma
    Although Kevlar helmets and improved body armor save lives, they do 
not protect against blasts and impacts to the head, face, and cervical 
region of the spinal cord. Those that survive blast force and impacts 
may suffer injuries to internal organs, limb loss, sensory loss, 
paralysis, cognitive loss, chronic pain, and psychological disorders.
    To advance the treatment and rehabilitation of soldiers returning 
with these types of injuries, VA issued a request for research 
proposals that focus on TBI; cervical spinal cord injury (SCI); co-
morbid conditions such as PTSD and trauma to extremities; screening and 
diagnostic tools related to mild TBI, especially field-based; and 
continuity of care between the Department of Defense (DoD) and VA. 
Applicants were asked to pay special attention to cooperative projects 
with DoD.
    Many exciting projects have emerged from this solicitation and 
other funding mechanisms to help veterans suffering from TBI, 
including: (1) studying neural repair after brain injury to build a 
better understanding of cognitive rehabilitation, as well as find 
potential targets for practical treatments that enhance quality of 
life; (2) developing a project exploring community re-integration for 
servicemembers with TBI (to promote seamless transition between 
servicemembers currently being treated, or who will one day be treated, 
in both DoD and VA medical facilities); and (3) several studies 
assessing the relationship between TBI and PTSD and their impact on 
health outcomes.
    In addition, several VA scientists with expertise in neuroimaging 
and neuropsychology are turning their efforts to further understanding 
the brain changes that occur in TBI. This is important because 
following TBI there may be subtle or distinct brain damage that results 
in memory, attention, thinking, and personality changes that are 
difficult to diagnose and treat with current knowledge. A new study 
will start this year combining state-of-the-art imaging techniques 
(e.g., three-dimensional brain imaging and diffuser tensor imaging to 
examine white matter changes) with comprehensive neuropsychological 
assessments to fully characterize patients with TBI compared to other 
types of brain damage such as stroke. Knowledge from this study will 
help inform rehabilitation and diagnostic strategies.
    VA researchers are also studying many ways to help veterans with 
SCI. Investigators are developing practical functional electrical 
stimulation systems that may allow individuals with incomplete SCI to 
walk. VA researchers are also preparing to conduct clinical studies of 
a neuroprosthetic system for restoration of hand-arm function in 
veterans with a cervical level SCI. It is hypothesized that users will 
demonstrate significant improvements in their pinch strength, range of 
motion, and their ability to perform grasp-release tasks with their 
hands and also show better control of their forearms and elbows. VA 
investigators are also testing microstimulators to recreate breathing 
and coughing patterns that will avoid respiratory complications which 
are currently the leading cause of death in SCI patients. Further, VA 
researchers are continuing to improve the mobility and function of 
veterans with SCI and other disabilities through innovative engineering 
for wheelchairs and other assistive technologies.
    In one exciting study, VA researchers and others recently 
demonstrated that a neuromotor prosthesis (NMP) could enable a 
tetraplegic to operate an artificial hand, robotic arm, computer, or 
television by using only his thoughts (Nature. 2006; 442(7099):164-
171). A NMP is a brain-computer interface that helps replace or restore 
lost movement in paralyzed patients. This technology uses an electrode 
that picks up brain signals and sends them to a computer for decoding. 
The brain signals are translated into commands to power electronic or 
robotic devices, including prosthetics.
    One of the most common conditions in returning OEF/OIF veterans due 
to blast exposure is tinnitus (ringing noise in the ear). VA 
researchers are developing a diagnostic test to identify this 
condition, which is currently done by self-report. In collaboration 
with DoD, VA investigators are planning a study to determine which 
auditory processing disorders are more often associated with exposure 
to high-explosive blasts, whether there is spontaneous recovery of 
auditory function after blast exposure, how much recovery may be 
expected, and how rapidly it occurs.
    In addition, VA investigators are developing behavioral strategies 
to cope with conditions of low vision and blindness. VA researchers 
also continue to make progress on the development of an artificial 
retina for those who have lost vision due to retinal damage. As 
reported in one recent publication, the threshold electrical current 
needed to stimulate the retina of a rabbit in which the device was 
implanted was very low (Journal of Neural Engineering. 2005; 2(1):S48-
S56). This was encouraging because using lower currents would reduce 
the chance of damage to surrounding eye tissue. Analogous approaches 
may prove useful in combat-related vision loss.
    Combat-related Mental Health
    Among active duty Army and Marine Corps personnel who participated 
in combat during OEF/OIF, 11.2--17 percent reportedly met screening 
criteria for major depression, generalized anxiety disorder, or PTSD. 
These areas of readjustment mental health disorders are actively being 
pursued in ongoing VA research.
    In a landmark ongoing study, VA researchers, collaborating with 
DoD, are collecting risk factor and health information from military 
personnel prior to their deployments to Iraq. These soldiers will be 
reassessed upon their return, and several times afterward, to identify 
possible changes that occurred in emotions or thinking following their 
combat duty in Iraq and to identify predisposing factors to PTSD as 
well as other health conditions. To date, researchers have already 
reported that troops who had served in Iraq showed mild deficits in 
some tasks of learning, memory, and attention, but scored better on a 
test of reaction time, compared with non-deployed troops. The 
researchers have proposed longitudinal follow-up studies to determine 
if these neuropsychological effects might fade over time, or be a 
precursor to PTSD (Journal of the American Medical Association. 2006; 
296(5):519-529). An additional goal for this research is to examine the 
neuropsychological associations of TBI with the development of PTSD at 
long-term follow-up.
    Veterans with PTSD commonly experience nightmares and sleep 
disturbances, which can seriously impair their mood, daytime 
functioning, relationships, and overall quality of life. In an exciting 
new treatment development, VA investigators have found that prazosin, 
an inexpensive generic drug already used by millions of Americans for 
high blood pressure and prostate problems, improved sleep and reduced 
trauma nightmares in a small number of veterans with PTSD (Biological 
Psychiatry. 2007; 61(8):928-934). Plans are under way for a large, 
multi-site trial to confirm the drug's effectiveness.
    One of the more interesting recent findings in PTSD research being 
pursued in the field now is the idea that traumatic memories may be 
``extinguished'' or weakened with a medication administered as the 
memory is ``replayed'' or reactivated under controlled circumstances. A 
small clinical trial is being conducted to determine whether the drug, 
propranolol, is more effective than a placebo in reducing PTSD symptoms 
such as hyper-arousal, re-experiencing, or avoidance when a distressing 
memory is reactivated. Research participants will be veterans of the 
Iraq or Afghanistan conflicts.
    In addition, VA investigators are currently conducting the first 
ever clinical trial of a medication to treat military service-related 
chronic PTSD. It will also be the largest placebo controlled, double-
blind study of its kind ever conducted, meaning that it is the most 
rigorous type of clinical trial. It will involve 400 veterans diagnosed 
with military-related chronic PTSD from 20 VA medical centers (VAMCs) 
nationwide. The main objective of the study is to determine if 
risperidone is effective in veterans with chronic PTSD who continue to 
have symptoms despite receiving standard medications used for this 
disorder.
    Risperidone is being studied since it has been shown to be safe and 
has received the most study in the treatment of PTSD patients.
    Pain
    Veterans from all eras may experience chronic pain related to 
traumatic injuries. Accordingly, VA has issued a solicitation for 
research proposals that seek to develop novel approaches for the 
treatment and management of chronic pain associated with TBI, SCI, 
amputation, and burn injury that may result from OEF/OIF deployment as 
well as multiple sclerosis and other disorders.
    Excruciating pain is experienced by more than 50 percent of 
patients after SCI. VA investigators have identified a particular form 
of sodium channel (of which there are more than 10) responsible for 
conveying pain signals to the brain (Nature. 2006; 444(7121):831-832). 
VA researchers are now exploiting this finding to develop a new pain 
treatment.
    In addition, VA and DoD are jointly funding a study to examine the 
short- and long-term benefits of implementing early advanced regional 
anesthesia techniques for pain control following major traumatic 
injuries to extremities encountered during OEF/OIF combat. It is hoped 
that these techniques will result in a significant reduction in pain 
disability as well as in the incidence and severity of mental health 
disorders due to early pain intervention on the battlefield.
    It is well-known that limb trauma causing fractures and/or nerve 
injuries can lead to the development of a disorder called complex 
regional pain syndrome (CRPS). To address this issue, VA researchers 
have developed a rat fracture model resembling CRPS. Using molecular 
approaches, the investigators will attempt to characterize chronic 
changes in key mediators such as cytokine signaling after limb trauma, 
which will demonstrate the feasibility of promising new treatments for 
post-traumatic pain and inflammation. This work could potentially be an 
important step toward the ultimate goal of improving clinical efficacy 
and safety in the pharmacologic management of CRPS.
    Prosthetics and Amputation Health Care
    While nearly two-thirds of adult amputations may arise due to 
peripheral vascular disease of the lower extremity, they are 
complemented by those necessitated by trauma, in the present case, the 
trauma related to high explosive blasts or through other combat 
scenarios. High-impact explosive trauma from improvised explosive 
devices has become the signature injury of the OEF/OIF theaters.
    Tendon losses are common in military trauma and in degenerative 
diseases such as rheumatoid arthritis and osteoarthritis. In mutilating 
injuries, a tendon grafted from another part of the individual's body 
may improve function; however, only a limited supply of these tendon 
grafts exists. VA investigators are working to create biocompatible 
tissue-engineered tendon grafts, which will have wide applicability in 
improved reconstruction of extremities for veterans.
    In addition, joint cartilage may be lost or degenerated as a result 
of trauma, disease, or aging, which leads to reduction in mobility and 
quality of life. VA investigators are using tissue engineering methods 
to develop an implant that can help regenerate cartilage.
    The care of the wounds following amputations has been the subject 
of extensive research. This type of wound care is particularly 
challenging, owing more to the conditions surrounding the original 
injury than those of the surgery. VA researchers are investigating 
three management strategies in current standard of care for residual 
limbs after surgery: (1) soft dressings, (2) rigid plaster dressing, 
and (3) commercial prefabricated rigid prostheses. Studies of this 
nature are critical to a better understanding of wound care in a 
variety of settings extending from the ``dirty'' wound characteristic 
of a roadside bombing all the way to the healing capacities in an 
elderly diabetic veteran. These kinds of studies can potentially 
improve outcomes of amputations and burns. Most critically, improved 
wound healing methodologies actually have the potential to minimize the 
need for amputation itself.
    VA researchers are also developing improved materials and designs 
of prostheses. In addition, VA investigators are gathering information 
about how prosthetic devices are used, amputee satisfaction, 
comparisons of selected prosthetic devices, associated costs, and 
various prosthetic procurement alternatives, so VA can better match 
technology to an individual veteran's needs.
    Another project that is under way involves building a new flexible 
externally powered two-degree-of-freedom prosthetic wrist for use in 
upper-extremity prostheses. This will provide prosthetic users with 
electric-powered prosthetic components that interact with objects in a 
more lifelike fashion and devices that will be more robust and less 
prone to mechanical failure.
    Currently available prostheses for trans-tibial (below the knee) 
amputees do not help promote normal walking; in fact, their ``passive'' 
design can result in balance difficulties and slow walking speed. VA 
has funded research that addresses this problem by developing a powered 
ankle-foot prosthesis that promises to help restore amputees' ability 
to walk normally. A preliminary study involving three trans-tibial 
amputees confirmed the benefits of the new prototype: the patients 
expended less energy during walking, had fewer balance problems, and 
walked 15 percent faster. This device has recently received significant 
media attention.
    Polytrauma
    As a result of new modes of injury (improvised explosive devices), 
improved body armor, and surgical stabilization at the frontline of 
combat, more soldiers are returning with complex, multiple injuries 
(``polytrauma''), including amputations, brain and spinal cord 
injuries, eye injuries, musculoskeletal injuries, vision and hearing 
loss, burns, nerve damage, infections, and emotional adjustment 
problems.
    In response, VA has established a Polytrauma and Blast-Related 
Injury (PT/BRI) QUERI coordinating center to promote the successful 
rehabilitation, psychological adjustment, and community reintegration 
of these veterans. Two priorities have been identified: (1) TBI with 
polytrauma, and (2) traumatic amputation with polytrauma. The primary 
target is OEF/OIF VA patients, many of whom remain on active duty 
during their initial course of treatment in VA. However, the center's 
activities will benefit all VA patients with complex injuries, 
regardless of service era and mechanism of injury.
    The PT/BRI QUERI is working closely with VA Polytrauma 
Rehabilitation Centers (PRCs) to identify needs and gaps in care, as 
well as best practices. For example, one needs assessment study found 
that PRC patients are demographically and clinically different from 
inpatient rehabilitation patients treated before OEF/OIF. The systems 
of care, facilities, and individual health care teams are rapidly 
changing to meet the needs of these unique patients.
    VA also recently issued a special solicitation for research 
projects on the long-term care and management, including family and 
community reintegration, of veterans with polytrauma, blast-related 
injuries, or TBI.
    Gulf War Veterans' Illnesses
    While there were few visible casualties associated with the 1990-
1991 Gulf War, many individuals returned from this conflict with 
unexplained medical symptoms and illnesses. Nonspecific symptoms such 
as fatigue, weakness, gastrointestinal difficulties, cognitive 
dysfunction, sleep disturbances, headaches, skin rashes, respiratory 
problems, and mood changes that often occur together in a constellation 
have been termed Gulf War veterans' illnesses (GWVI). Despite a large 
number of studies and considerable funding over the past decade, the 
causes and successful treatment of GWVI remain illusive. VA continues 
to expand its efforts to understand and treat GWVI.
    There is also persistent concern that Gulf War veterans may be at 
increased risk for amyotrophic lateral sclerosis (ALS, also known as 
Lou Gehrig's disease), multiple sclerosis (MS), and brain cancer, as a 
result of their service. In addition to the studies that examine the 
causes and treatment of these diseases in the general veteran 
population, VA is funding studies to examine them specifically in Gulf 
War veterans. Accordingly, VA is supporting a broad research portfolio 
composed of studies dedicated to understanding chronic multi-symptom 
illnesses, long-term health effects of potentially hazardous substances 
to which Gulf War veterans may have been exposed to during deployment, 
and conditions or symptoms that may be occurring with higher prevalence 
in Gulf War veterans.
    Beyond OEF/OIF and deployment health related research, VA's 
research priorities include several areas affecting the larger veteran 
population, including:
Mental Health Research
    In addition to combat-related mental health, VA continues to 
support a strong behavioral and psychiatric disorders research 
portfolio focused on further understanding and treating mental health 
problems in veterans. Investigations are directed toward substance 
abuse, PTSD, adjustment and anxiety disorders, psychotic disorders, 
dementia and memory disorders, and related brain damage. Many 
laboratory studies are being conducted to better understand the changes 
that take place when someone is suffering from adjustment problems or 
mental illness. Clinical trials are under way to test novel drug and 
therapy treatments specifically targeted to help veterans. 
Additionally, VA has a strong program for developing and implementing 
better mental health care, including enhancing collaborative care 
models, improving access to mental health care through innovations such 
as telemedicine and the Internet, and reducing barriers to veterans 
seeking mental health care. Several ongoing projects are investigating 
how veterans with mental illness might benefit from rehabilitation 
approaches, including vocational rehabilitation, skills training, and 
cognitive therapy to improve everyday functioning and work performance. 
Future research will enable VA to determine how to care for veterans 
with mental illness so that they can return to their highest level of 
functioning.
Personalized Medicine
    Personalized medicine means tailoring care to the individual, in 
this case the veteran. In 2006, VA launched the Genomic Medicine 
Program as part of its Personalized Medicine Initiative. Genomic 
medicine is the direction for health care in the twenty-first century. 
It could allow VA to provide care that is tailored specifically to the 
genetic makeup of individual veterans, increasing the effectiveness and 
safety of health care and disease prevention efforts. Currently, VA is 
funding over 140 research projects related to genomics. These include 
studying the complete set of DNA of many people to determine what 
genetic changes are associated with a certain disease (genome-wide 
scans), the role of specific genes, and genetic determinants of 
variable responses to drugs (pharmacogenomics). These studies are 
investigating the role of genetics in many diseases of importance to 
veterans--including psychiatric disorders (e.g., schizophrenia, 
depression, PTSD, and anxiety); cancers of the prostate, breast, colon, 
lung, and bladder; heart disease; diabetes; Alzheimer's disease; 
stroke; Parkinson's disease; autoimmune disorders, including rheumatoid 
arthritis and lupus; GWVI; and chronic viral infections such as HIV.
    VA investigators recently conducted a genome-wide search for 
schizophrenia susceptibility genes. The study included 166 families 
with more than two affected individuals, from seven VAMCs. There are 
216 affected sibling pairs in these families, comprising the largest 
North American sample of schizophrenic sibling pairs to date. 
Preliminary data from the researchers' genome scan suggest the 
involvement of a small region on chromosome 18. The team will continue 
to narrow the search by fine-mapping this region and seeking specific 
genes.
    VA has established a Genomic Medicine Program Advisory Committee 
(GMPAC) comprised of the nation's leading clinicians, scientists, 
administrators, as well as veteran representatives. The Committee has 
recommended the establishment of several working groups. It has also 
discussed issues such as who should have access to data generated by 
this program, assessment of veterans' attitudes toward genomic 
medicine, and establishing veterans' trust.
    An Ethics Advisory Working Group, which will report through the 
GMPAC, has also been established. Members of this working group include 
bioethicists, a member of the clergy, and veterans. The first meeting 
of this group was in May 2007. Topics of discussion included the ethics 
of the informed consent document, special populations (e.g., those with 
mental illness), and the role of group vs. one-on-one discussions for 
educating veterans about the program.
    In addition, last week VA held the first meeting of its PTSD 
Genetics Working Group to explore and define a research program to 
identify the genes that are important in how an individual responds to 
the experience of deployment, especially their response following 
combat exposure. By carefully characterizing those affected by combat-
related PTSD and conducting genetic analyses, VA will be in a position 
to identify genetic variants that contribute to PTSD and other post-
deployment adjustment disorders such as major depression. Once this 
program is established, this resource will be available for continued 
research including studying the genetic relationship to treatment 
response.
Chronic Diseases
    Promoting good health and managing chronic conditions remain high 
priorities for VA health care and VA research, especially in the aging 
veteran population. The following are examples of efforts by VA 
investigators to discover how to prevent and treat chronic diseases.
    Diabetes
    Nearly a quarter of the veterans receiving care from VA have 
diabetes, and a far greater number (73 percent) are at risk due to 
overweight or obesity. VA researchers are studying innovative 
strategies and technologies--including group visits, telemedicine, peer 
counseling, and Internet-based education and case management--to 
improve access to effective diabetes care and outcomes. In addition, VA 
investigators have initiated studies to identify and define the impact 
of traditional rehabilitation treatment for veterans who have diabetes, 
and to develop innovative treatments to prevent and improve diabetes 
outcomes in special populations such as the elderly, amputees, 
minorities, and spinal cord injured veterans. VA is also supporting 
major clinical trials on treating kidney disease and coronary artery 
disease in diabetic patients.
    It has been long known that type 2 diabetes runs in families and 
that certain populations are at a higher risk than others (e.g., 
Hispanic veterans and American Indian veterans). However, it was not 
until the recent advances in genetic technologies that researchers 
began to investigate associations between specific genes and diabetes.
    VA investigators have been honing in on genes that boost the risk 
for type 2 diabetes and obesity. Working with Mexican-American families 
enrolled in the Veterans Administration Genetic Epidemiology Study, VA 
investigators have compared small differences in the DNA of people with 
and without the disease. Earlier work by members of the group had 
suggested that a specific region of chromosome 6 was involved. This 
region contained several hundred genes, and initially it was not clear 
which gene played a role in causing disease. But using recent advances 
in genome-sequencing, the researchers have combed through the region 
and narrowed their search to seven genes. The precise functions of 
these genes are still unknown. Two are involved in metabolic pathways 
not previously connected with diabetes or obesity. The remaining five 
appear to be ``master regulators'' that can alter the expression of 
hundreds of other genes. Ongoing research is aimed at determining how 
these genes raise the risk of diabetes and obesity.
    Obesity
    The VA patient population, like that of the U.S. in general, is 
experiencing an epidemic of overweight and obesity. In terms of 
treatment options, recent findings from VA investigators indicate that 
surgical treatment is more effective than diet and medications for 
weight loss in severely obese patients. Weight loss was maintained for 
up to 10 years or longer, and it was accompanied by significant 
improvements in diabetes, hypertension, and high cholesterol (Annals of 
Internal Medicine. 2005; 142(7):547-559; Annals of Internal Medicine. 
2005; 142(7):532-546).
    Ongoing VA studies are seeking to identify and define the impact of 
traditional rehabilitation treatment for overweight and obese veterans, 
and also to develop unique treatment measures to prevent and improve 
obesity outcomes. In addition, VA researchers are investigating the 
influence of obesity on the quality of care that veteran patients 
receive. VA investigators are also focusing on unique populations at 
risk for obesity, such as patients with spinal cord injury.
    Human Immunodeficiency Virus/Acquired Immune Deficiency 
        Syndrome (HIV/AIDS)
    VA is the largest single provider of HIV care in the U.S., with 
nearly 20,000 patients with the disorder treated annually. Accordingly, 
VA funds a full range of studies from bench research aimed at 
elucidating the underlying mechanisms of HIV to implementation projects 
that improve VA's effectiveness in caring for this population.
    VA investigators recently showed that people with a below-average 
number of copies of a particular immune-response gene have a greater 
likelihood of acquiring HIV and, once infected, of progressing to full-
blown AIDS. Researchers examined blood samples from 4,308 HIV-positive 
and HIV-negative volunteers of various geographical ancestries. 
Depending on the study sub-population, each copy of the gene CCL3L1 
decreased the risk of HIV infection by 4.5 to 10.5 percent. These 
findings, cited as one of the top articles published in the eminent 
journal Science in 2005, have important implications for the treatment 
and prevention of HIV infection and AIDS, and possibly other infectious 
diseases as well (Science. 2005; 307:1434-1440).
    The same group has gone on to show that a person's genetic makeup--
in this case, the genes CCL3L1 and CCR5--could be a more accurate 
predictor of disease progression than currently used laboratory 
markers, such as CD4+ T cell counts and viral loads. The researchers 
also demonstrated that the combination of laboratory and genetic 
markers captures a broader spectrum of AIDS risk than either set of 
markers alone (Journal of Immunology. 2007; 178:5668-5681).
    Heart Disease
    Heart failure is the most common diagnosis causing hospitalization 
of veterans, with resulting high costs and resource utilization over 
time. VA researchers recently found that the use of an implanted 
defibrillator reduced the risk of dying and improved quality of life 
for veterans with heart failure (Journal of the American College of 
Cardiology. 2005; 45(9):1474-1481). VA researchers are also studying 
non-invasive care for heart failure. In addition, nurse researchers are 
preparing to link biochemical markers of heart failure with patterns of 
depression to aid in earlier screening and treatment for depression in 
patients with heart failure. Nurse researchers are also exploring the 
role patients can play in their own heart failure care.
    Coronary artery disease, a narrowing of the arteries that supply 
blood to the heart muscle, is the leading cause of death in both men 
and women. More than half a million Americans die each year from 
coronary artery disease.
    A U.S.-Canadian trial sponsored in part by VA's Cooperative Studies 
Program found that balloon angioplasty plus stenting did little to 
improve outcomes for patients with stable coronary artery disease who 
also received optimal drug therapy and underwent lifestyle changes. The 
researchers concluded that if a patient with heart disease is doing 
well on medical therapy alone, there is no added preventive benefit to 
angioplasty and stenting (New England Journal of Medicine. 2007; 
356:1503-1516).
Access to Care
    VA has a prominent and unique role in meeting the health care needs 
of veterans and ensuring equitable access to quality care for the most 
recent veterans, veterans from previous service eras, vulnerable 
populations who rely on VA for health care, and future veterans. The VA 
health care system continues to strengthen efforts to improve health 
care to veterans by identifying barriers to care and assessing and 
implementing system improvements to improve access to quality care. VA 
research supports and guides these system improvements through a 
diverse range of studies that analyze factors and interventions 
impacting access to the VA health care system. VA research identifies 
system-wide gaps in care to veterans; assesses specific access issues 
and barriers to care for special populations; assesses the impact of 
new programs, practice structures, and organizations of care on access 
and quality of care; and develops and evaluates the impact of quality 
improvement efforts, organizational and management interventions, 
implementation initiatives, and new technologies on improved access and 
health care to veterans.
    Over the past decade, VA has added to the number of Community-Based 
Outpatient Clinics (CBOCs) to increase access to primary care for 
veterans. CBOCs have been an integral part of VA's transition from an 
inpatient-oriented system to an outpatient-oriented system. A VA study 
compared inpatient and outpatient utilization and expenditures of 
veterans seeking primary care in 108 CBOCs and 72 affiliated VAMCs in 
fiscal years 2000 and 2001. Findings show that CBOCs provided veterans 
with improved access to primary care and other services, but costs were 
contained because they had fewer health care visits and hospital stays 
than veterans receiving care at VAMCs. These results held even after 
adjusting for demographics, patient risk, and distance from care. CBOC 
patients had significantly lower odds of having specialty, mental 
health, or ancillary (e.g., radiology, laboratory, other outpatient) 
visits than VAMC patients. CBOC patients also were less likely to be 
hospitalized (BioMed Central Health Services Research; 7(1):56).
    Evidence-based practices designed for large urban clinics are not 
necessarily transportable into small rural practices. Implementing 
collaborative care for depression in small rural primary care clinics 
presents unique challenges because often on-site mental health 
specialists cannot be hired. The Telemedicine-Enhanced Antidepressant 
Management (TEAM) study evaluated a collaborative care model adapted 
for small rural VA CBOCs using telemedicine technologies (interactive 
video equipment for mental health and no on-site psychiatrists/
psychologists). Participants in the intervention had better medication 
adherence, were more likely to respond to treatment, and were more 
likely to experience a remission than those with usual care. Patients 
also had better quality of life and higher satisfaction. These findings 
suggest that collaborative care models can be successfully adapted 
using telemedicine to address rural disparities (General Hospital 
Psychiatry. 2006; 28(1):18-26; Psychiatric Services. 2006; 57(12):1731-
7).
    In addition, VA is beginning a new access to care research 
initiative for OEF/OIF veterans that will build on the body of VA 
research examining access to care issues and innovations. This research 
is expected to enhance OEF/OIF veterans' access to practices that 
improve well-being and function after physical injury sustained in war, 
that mitigate suffering due to chronic medical conditions, and that are 
effective for the treatment needed by veterans returning from the wars 
in Iraq and Afghanistan. It is hoped that VA's OEF/OIF access research 
initiative will help facilitate improved access to care for eligible 
veterans and more efficient and effective systems of care that meet the 
health care needs of the OEF/OIF veteran population.
Long-term Care
    Meeting the long-term care needs of veterans is growing in 
importance as the number of veterans most in need of these services--
those 85 years old and older--is expected to reach 1.3 million by 2012. 
In addition, a younger population of veterans with different long-term 
and care coordination needs is emerging as a result of the OEF/OIF 
conflicts.
    Many veterans prefer to receive long-term care in non-institutional 
settings, so they can stay connected with their community and loved 
ones. However, the success of such long-term care is critically 
dependent on the ability of veterans' family and friends to assist in 
their care. Caregiver burden is common and frequently limits the 
ability of family and friends to provide assistance. Caregiving can 
also have significant negative consequences on the health and well-
being of caregivers, yet little is known about how to ameliorate the 
impact of the burden of care. VA has initiated several efforts to 
understand and support the needs of caregivers. These include special 
efforts to survey the needs of caregivers of blast injury and TBI 
patients, as well as a research initiative focused on developing new 
approaches to community-based long-term care.
    In addition, VA is funding several projects to assess the 
effectiveness of telemedicine technologies for rehabilitation of 
veterans who are older, disabled, and/or in difficult to reach, rural 
areas as compared to home visits by health care personnel and usual 
care. Tele-rehabilitation may be particularly useful for older and 
disabled veterans with long-term care needs because it empowers them to 
take responsibility for their own health by providing ongoing 
communication with the VA health care system and may allow them to 
remain independent in their homes as long as possible.
Women's Health
    In response to the increasing number of women veterans, documented 
expansion of the number of women in the military, and special health 
care needs of female veterans, VA has focused additional attention on 
women's health research. VA research efforts are aimed at better 
understanding the general health care needs and service utilization of 
women veterans; examining the unique experiences of women veterans 
regarding risks, treatment, and health care outcomes related to 
military traumas; and assessing VA's organization of care for women 
veterans and the implications for improved quality of care.
    Examples of VA research studies relevant to women veterans' health 
include further understanding the cellular mechanisms underlying breast 
and cervical cancers, the role of hormones in stroke and aging, further 
characterizing basic neurobiological changes in women who have 
undergone severe trauma, and specific prosthetic designs for women.
    In the largest randomized clinical trial to date involving women 
veterans with PTSD, VA investigators and colleagues found that 
prolonged-exposure therapy--a type of cognitive behavioral therapy--was 
effective in reducing PTSD symptoms and that such reductions remained 
stable over time. Women who received prolonged-exposure therapy--in 
which therapists helped them recall their trauma memories under safe, 
controlled conditions--had greater reductions of PTSD symptoms than 
women who received only emotional support and counseling focused on 
current problems (Journal of the American Medical Association. 2007; 
297(8):820-830). Together with a strong mental health research program, 
VA research is well positioned to continue to enhance health care for 
women veterans.
Conclusion
    Because more than 70 percent of VA researchers are also clinicians 
caring for veterans, VA is uniquely positioned to move scientific 
discoveries from investigators' laboratories into patient care. In 
turn, VA clinician investigators can identify new research questions 
for the laboratory at the patient's bedside, making research one of 
VA's most effective tools to continue improving the care of veterans. 
The fundamental goal is to address the concerns of the entire veteran 
population from the youngest soldier who returns with injuries from 
recent conflicts to the aging veteran, and to use research findings 
proactively to benefit the future veteran. VA takes great pride in the 
research that keeps it at the forefront of modern medicine and health 
care and expects to see further remarkable discoveries in the coming 
decades.
    Mr. Chairman, that concludes my statement. I am pleased to respond 
to any questions you or the Subcommittee members may have.
    Thank you.

                                 
 Statement of National Association of Veterans' Research and Education
    The National Association of Veterans' Research and Education 
Foundations (NAVREF) appreciates the opportunity to submit a statement 
for the record of the hearing being conducted on October 4, 2007, by 
the Health Subcommittee of the House Committee on Veterans Affairs 
regarding the Department of Veterans Affairs (VA) Medical and 
Prosthetic Research program.
    NAVREF is the voluntary membership association of the VA-affiliated 
nonprofit research and education corporations (NPCs) established and 
operated in accordance with 38 U.S.C. Sec. Sec. 73617368. NAVREF's 
mission is to promote high quality management and communication among 
the NPCs, and to pursue issues at the government level that are of 
interest to its members. NAVREF accomplishes this mission through 
education, interactions with agency and congressional officials, and 
advocacy. Additional information about NAVREF is available on its Web 
site at www.navref.org.
Background About the NPCs
    In 1988, Congress allowed the secretary of the Department of 
Veterans Affairs to authorize ``the establishment at any Department 
medical center of a nonprofit corporation to provide a flexible funding 
mechanism for the conduct of approved research and education at the 
medical center.'' [38 U.S.C. Sec. 7361(a)] At this time, 85 facilities 
are taking advantage of this authority, providing each VAMC with a 
highly valued means for administering non-VA federal and private sector 
funds in support of VA research and education.
    We encourage the Subcommittee to review the VA's most recent report 
on the NPCs which VA submitted to Congress in accordance with 
requirements stated at 38 U.S.C. Sec. 7366(b) through (d). This 
compilation of information provided by NPCs presents a comprehensive 
overview of NPC revenues and expenditures, the activities they support 
and the oversight provided by VA through the VA NPC Program Office and 
the VA NPC Oversight Board as well as annual audits by independent 
auditors. This report demonstrates that NPCs have become an integral 
component of VA facility research programs, administering $227 in non-
VA federal and private sector revenues and approximately 5000 projects 
at any one time during the last year.
    NPCs are fully dedicated to serving the needs of VA research and VA 
investigators. In the course of administering research, they support a 
variety of project-related costs such as salaries for research 
personnel, supplies, equipment and travel for scientific conferences 
and training. Additionally, they support a number of activities that 
foster a vibrant research environment at VA medical centers across the 
nation. Such activities include supporting institutional review boards 
(IRB) and other compliance measures, core research equipment and 
services, seed and bridge funding and VA staff recruitment. NPCs also 
donate to VA the services of approximately 2500 NPC research employees 
who work under VA without compensation (WOC) appointments with the 
background, security and training requirements such appointments 
entail--side-by-side with VA-salaried employees.
Current Reviews of NPCs and Oversight
    Internal control failures experienced by three NPCs in 2006 
prompted the VHA Office of Finance and the Office of the Inspector 
General (IG) to undertake separate reviews of the NPCs that were 
performed during 2007. Although we believe that NPC boards and 
employees are for the most part conscientious stewards of NPC funds, 
NAVREF applauds VA for acting forthrightly to confront NPC management 
deficiencies that do come to light, and we consider the results of 
these reviews to be learning opportunities for NPCs. We have invited 
both the VHA and IG auditors to present their objectives, 
methodologies, findings and recommendations during the NAVREF 2007 
Annual Conference in November so that all of the NPCs may learn from 
VA's substantial investment in conducting the reviews. The IG report, 
which originally was scheduled for completion in August, is not yet 
complete, but we remain hopeful that it will be published in time for 
discussion during the conference. Additionally, eight hours of the 
NAVREF conference program will be devoted to internal controls training 
for both large and small organizations, and VA is planning separate 
training specifically for members of NPC boards. NAVREF anticipates 
using the IG's recommendations to focus its own future educational 
programs on areas identified to be in need of improvement.
    To improve VA oversight of NPCs, we encourage the Subcommittee to 
support the Office of Research and Development's plan to recruit as 
director of the VA Nonprofit Program Office a fully dedicated GS-15 
with expertise in nonprofit management, accounting and governance. This 
office is tasked with providing NPC oversight and when staffed with the 
appropriate level of expertise will be a welcome partner in ensuring 
high standards of NPC management.
Proposal to Update and Clarify the NPC Authorizing Statute
    Nearly two decades after enactment of Public Law 100-322, the 
success of the NPCs in supporting VA research and education 
demonstrates that the NPC authorizing statute has been effective in 
accomplishing Congress's purpose of providing VA with flexible funding 
mechanisms for the conduct of VA-approved research and education. Its 
authors successfully crafted a unique private-public partnership that 
has served VA facility research programs and investigators well. 
However, during the intervening years, VA health care delivery systems, 
the VA research program and the NPCs have evolved. Prompted in part by 
the upcoming twentieth anniversary of the authority to establish NPCs, 
during the last twelve months the NAVREF board conducted a 
comprehensive review of the NPC authorizing statute in light of 
accumulated years of experience working within its terms.
    After much deliberation, and discussions with the Office of 
Research and Development and the VA Office of General Counsel as well 
as Paralyzed Veterans of America and staff of the House and Senate 
Committees on Veterans Affairs, NAVREF concluded that it would be of 
benefit to VA and the NPCs to update and clarify the NPC authorizing 
statute. This will also benefit veterans by helping NPCs meet their 
full potential in supporting VA research and education that ultimately 
results in improved treatments and high quality care for veterans. 
Guided by these discussions, early this year NAVREF began developing a 
statutory proposal that is nearing completion and that we expect to 
submit to Congress in December for consideration and enactment during 
the second session of the 110th Congress.
    NAVREF's primary objective in proposing statutory revisions is to 
allow ``multi-site'' NPCs. That is, voluntary sharing of one NPC among 
two or more VAMCs while still preserving their fundamental nature as 
medical facility-based organizations. We have two purposes for seeing 
this objective. First, it would allow VAMCs with small research 
programs to join with larger ones or for several small programs to join 
together to pool their resources for purposes of efficiency and 
ensuring sound management. Second, it would allow reasonable, but not 
overly burdensome, board composition by requiring the medical center 
director of each facility to serve on the board to ensure local 
accountability. Otherwise the board of a multi-site NPC would be 
required to have as VA members just one Chief of Staff, Associate Chief 
of Staff for Research and Associate Chief of Staff for Education. 
Beyond this proposed statutory minimum, our proposal would leave it up 
to each multi-site NPC board to determine the combination of VA and 
non-VA members best suited to its own needs. In our view, requiring all 
of these personnel from each facility to serve on the board is not a 
good use of their valuable time and results in an unnecessarily large 
and logistically cumbersome board.
    This change in the NPC statute would benefit VA by reducing the 
number of NPCs that VA is required to oversee and would eliminate the 
need for duplicative local effort at the same time as it would increase 
the resources each NPC would have available for management. NAVREF 
anticipates that as many as twenty low-revenue VA research programs may 
welcome the opportunity to partner with other nearby facilities to 
share NPCs.
    NAVREF's other proposed revisions in the NPC authorizing statute 
are designed to clarify--not change--the legal status of the NPCs as 
independent organizations, exempt from taxation under Section 501(c)(3) 
of the Internal Revenue Service (IRS) code and subject to VA oversight 
and regulation. Additionally, proposed revisions clarify the NPCs' 
purposes as well as their funds acceptance and expenditure authorities. 
Our objective in making these changes is to resolve longstanding 
uncertainty and sometimes outright confusion and disagreement among VA 
officials, internal VA and external overseers, funding organizations 
and NPC personnel. NAVREF is also suggesting a general re-organization 
of the statute to pull together in separate sections the various 
provisions addressing status, purposes and powers.
    As NAVREF considered statutory revisions, it also identified a 
number of issues that while not requiring legislation, could benefit 
from discussion in congressional report language or inclusion in an 
updated version of VHA Handbook 1200.17 which contains VA's 
interpretation of the NPC statute and VA policy pertaining to NPCs. For 
example, NAVREF has included a recommendation for requiring VA to 
approve the establishment of a new NPC on the basis of an assessment of 
the ability of the

facility's research or education program to generate a revenue stream 
sufficient to support the NPC infrastructure, and assurance that 
qualified staff will be available to manage the NPC. The NPC statute 
already states, ``The Secretary may authorize the establishment at any 
Department medical center of a nonprofit corporation . . .'' Therefore, 
no explicit statutory language is needed to give VA the ability to 
determine which facilities may establish new NPCs. However, it may be 
useful to include in report language a sense that there should be some 
minimum expectations of research programs contemplating establishing an 
NPC and then more specific policy guidance regarding the process of 
applying for VA approval could be provided in the handbook. This and a 
number of other recommendations will be provided to Congress as an 
addendum to NAVREF's statutory proposal. We would be pleased to work 
with the Subcommittee to determine which the Subcommittee may wish to 
address in report language.
Conclusion
    The NPCs represent a unique means for VA to maximize the benefits 
of externally funded research conducted in VA facilities. The NPCs are 
performing as Congress intended, serving as flexible funding mechanisms 
for the conduct of VA-approved research and education. NPCs facilitate 
research that benefits veterans, and they foster vibrant research 
environments at VA medical centers, enhancing VA's ability to recruit 
and retain clinician-investigators and other staff who in turn apply 
their knowledge to state-of-the-art care for veterans. Some even 
contend that their NPCs and the contributions of services, personnel 
and equipment they provide in support of VA research have become an 
essential component of successful research programs.
    However, NAVREF recommends that in 2008, 20 years after the VA-NPC 
public-private partnership was first authorized, and co-incident with 
expiration of authority to establish new NPCs, it is time to update and 
clarify the NPCs' enabling legislation. Experience working within the 
statute has brought to light its many strengths, but also areas that 
could benefit from updating and clarification, particularly in light of 
continuing evolution of VA health care and the increasing complexity of 
both research and nonprofit compliance. NAVREF would be pleased to work 
with the Subcommittee toward revisions in the statute that will allow 
NPCs to meet their full potential in supporting VA research and 
education while ensuring VA and congressional confidence in their 
management.
    Thank you for the opportunity to submit a statement for the record. 
If you have questions, please do not hesitate to contact NAVREF 
Executive Director Barbara West.

                                 
             Statement of Orthotic and Prosthetic Alliance
    Mr. Chairman, thank you for the opportunity to submit this 
testimony on behalf of the Orthotic and Prosthetic Alliance (``O&P 
Alliance''). The O&P Alliance is a coalition of four of the primary 
organizations representing the field of orthotics (orthopedic braces) 
and prosthetics (artificial limbs). The four organizations include the 
American Academy of Orthotists and Prosthetists (``AAOP''), the 
National Association for the Advancement of Orthotics and Prosthetics 
(``NAAOP''), the American Orthotic & Prosthetic Association (``AOPA''), 
and the American Board for Certification in Orthotics, Prosthetics, and 
Pedorthics (``ABC''). The O&P Alliance represents the professional, 
scientific, research, business, and quality improvement aspects within 
the fields of orthotics and prosthetics.
    Professional orthotic and prosthetic care combined with appropriate 
medical, surgical, and rehabilitative management provides the Veteran 
with limb loss and/or limb dysfunction the opportunity to live a highly 
functional life. The O&P Alliance would like to stress the importance 
of funding prosthetic and orthotic research and development. The past 
30 years has seen great clinical and technological advancements in the 
orthotic and prosthetic fields. We have amputees and others with limb 
impairments to achieve unprecedented levels of function with the 
assistance of artificial limbs and orthopedic braces. The orthotic and 
prosthetic field must continue to advance in several areas to more 
accurately replicate human function and develop better measurement 
tools to assess quality and compare the relative effectiveness of 
orthotic and prosthetic interventions.
    Historically, the Department of Veterans Affairs (``VA'') has 
realized considerable success in conducting orthotic and prosthetic 
research. For example, the VA developed a method of fabricating a 
transparent plastic to assess the quality of prosthetic

socket fit in lower-limb amputees; the VA was among the first to design 
an energy-storing and releasing prosthetic foot that spawned a new 
generation of far more responsive prosthetic feet for application to 
lower limb amputees with extensive mobility needs. The functional 
benefit of prosthetic feet of this design has been shown to reduce the 
walking fatigue and create a more fluid gait. The VA has also supported 
the adaptation of Computer Aided Design/Computer Aided Manufacture 
(CAD-CAM) to the field of prosthetics and orthotics, yielding 
significant new advancements and efficiencies in measurement, fitting, 
and fabrication of orthotics and prosthetics.
    Within the private sector of the organized field of orthotics and 
prosthetics we have seen many technological advancements that have 
become the standard of care for amputees and those with orthopedic 
impairments. The 1980's and 1990's were a time of significant industry 
investment in orthotic and prosthetic development that yielded many new 
advances achieving greater comfort, lighter weight, improved 
durability, and especially, increased function. It should be noted that 
the VA Prosthetic and Sensory Aids Service has adopted many of these 
advancements in O&P technology and routinely cover these technologies 
for veterans with orthotic and prosthetic needs.
    While technology has come a long way since the days of wooden legs 
and heavy metal braces, much remains to be done. To help plot a 
research agenda, the American Academy of Orthotists and Prosthetists 
has recently conducted a series of consensus conferences designed to 
prioritize such research. In addition, significant efforts have been 
undertaken in this area by the National Center for Medical 
Rehabilitation Research at the NIH. O&P technology research has also 
been supported by at least three other federal agencies, including the 
National Institute on Disability and Rehabilitation Research within the 
Department of Education, the National Science Foundation, and the 
Department of Defense.
    The pace of technological research and development has not been 
matched by the pace of outcomes research in the O&P field. The VA 
amputee population alone is widely disparate. It includes both aging 
and geriatric veterans who have become accustomed to more traditional 
technology, and newer, younger amputees returning from conflict abroad 
whose expectations for prosthetic rehabilitation are extremely high. In 
order to build on the successes the VA and the O&P field has had to 
date, it is necessary that the VA take into consideration that the 
patient population they serve is both growing and changing. We believe 
that these factors will make it vital for the VA to work more closely 
with the private sector to help lead the way for all users of orthotics 
and prosthetics, veterans and non-veterans, to benefit from continued 
research and quality care in this field.
    The demand for orthotic and prosthetic services continues to 
increase, not only from the influx of amputees and those with 
musculoskeletal injuries returning from combat abroad, but also from 
chronic disease at home. There are nearly 200,000 members of the armed 
forces now in war zones who will be eligible for VA services as they 
leave the military. Young men and women returning from Iraq and 
Afghanistan may need VA services for the rest of their life. Diabetes, 
and the precursor to this chronic illness, obesity, are on the rise and 
are major contributors to amputation rates and other orthopedic 
conditions in this country. As the ``baby boom'' generation continues 
to age, the incidence and prevalence rates of orthopedic conditions 
will continue to increase significantly.
    For these reasons, there is a national need to improve the evidence 
base of prosthetic and orthotic care. Research is needed to develop 
better measurement instruments that will assist an orthotist or 
prosthetist with clinical decisionmaking and verify whether an orthotic 
or prosthetic intervention achieves a particular clinical goal. The 
ability to quantify functional outcomes will result in more accurate 
and clinically relevant cost-benefit analyses. These analyses, in turn, 
will enable more reliable quality of life studies as related to the 
application of new technologies currently being marketed directly to 
the public.
    Furthermore, research is needed to provide measurement tools for 
the practitioner to be able to assess performance of the orthosis and/
or prosthesis and measure outcomes in environments outside the 
traditional clinic setting. It is difficult to utilize multi-center 
studies for orthotics and prosthetics due to the problems inherent in 
the inter-laboratory reliability of measurements involving gait 
laboratories. Research is needed to improve multi-center measurement 
reliability. In order to be statistically significant, this research 
should involve studies of sufficient size.
    The practice of orthotics and prosthetics is a very personal 
relationship between the patient and the practitioner. It is highly 
clinical and technical, and is for the remainder of the person's life. 
The process of creating a complex treatment plan, coordinating 
treatment with the various medical and ancillary disciplines necessary 
for successful outcome is necessarily protracted. There are many steps 
in the process requiring many appointments to achieve comfort, 
stability, and function. The end result is a melding of human flesh and 
man-made/designed hardware that is uniquely fit to meet the medical and 
functional needs of the patient, affording the Veteran the maximum 
degree of independence. The entire process is purely customized to the 
particular individual. As such, the practice of quality orthotics and 
prosthetics demands practitioner expertise and skilled technique which 
can vary considerably from practitioner to practitioner. There is a 
need for systems which can capture scientifically the subjective 
decisionmaking skills of practitioners recognized for their high level 
of expertise so that these skills can be shared more widely. When fully 
realized, the development of these tools and measurements will improve 
patient care across a broad spectrum of the public at a lower cost.
    To conduct effective evidence-based research, we believe it is 
imperative that there be a strong partnering between the VA and private 
sector O&P professionals who have potentially more current experience 
with such patients. Currently, many of the O&P services provided by the 
VA are performed under contract though private O&P practitioners. By 
teaming with the private sector on a comprehensive research agenda, the 
VA will be able to conduct more reliable research and serve all 
orthotic and prosthetic patients more effectively in the future. 
Considering the interests of the Department of Defense in providing 
quality orthotic and prosthetic care to wounded service men and woman, 
it stands to reason that DoD would also be a logical partner in this 
joint enterprise.
    We therefore propose that the VA and DoD fund a joint initiative 
with active involvement from the private sector to create a Prosthetic 
and Orthotic Outcomes Research and Treatment Center. Such a center 
would enable the military and VA health care systems to work with and 
alongside the civilian O&P profession to further develop the evidence 
base in the field. Such a center or network of centers could work 
cooperatively to further define common terms, refine functional 
measurement tools, conduct comparative studies of various technologies, 
and measure outcomes of prosthetic and orthotic interventions to 
clearly identify which treatment protocols are most effective.
    In this manner, patients would benefit from improved, evidence-
based approaches to maximize their functional capacity. Health care 
payers (both military and civilian) would have additional data in which 
to base their coverage decisions and maximize their investment in 
prosthetic and orthotic services and the prosthetic and orthotic 
research community would be spurred into developments that are still on 
the horizon and improve education and training or O&P clinicians.
Conclusion:
    The O&P Alliance appreciates the opportunity to testify on this 
very important issue. We urge the members of the Committee to continue 
to fund and conduct research in the areas of orthotics and prosthetics, 
and to work with the private sector to ensure that this research 
investment is optimized. We stand ready to work with this Committee to 
address these critical issues. Thank you for your consideration of our 
views. If you wish to discuss these issues further, please contact 
Peter W. Thomas, counsel to the O&P Alliance, at 202-466-6550.

                                 
            Statement of Alvin C. Pike, CP, Lead Prosthetist
            Minneapolis, MN, Veterans Affairs Medical Center
  Veterans Health Administration, U.S. Department of Veterans Affairs
    Congressman Michaud and members of the Subcommittee on Health, 
thank you for this opportunity to allow my statement to be a part of 
your proceedings.
    The views and opinions expressed are my own, and do not necessarily 
represent those of my current employer, the Department of Veterans 
Affairs, or those of the VA research community. They do however 
represent my 43 years as a prosthetist with a portion of that time in 
upper management with the world's largest manufacturer of components 
for artificial limbs, and leadership offices within the prosthetics and 
orthotics profession.
    Today we see in the news media--brought about by the coverage given 
to amputees from Operation Enduring Freedom/Operation Iraqi Freedom--
new high tech components for prostheses. An essential component to the 
success of this new technology is the man/machine interface that is 
called the socket. Although there have been numerous variations on 
socket design over the intervening half century, there have been no 
significant biomechanical studies of this integral portion of the 
prosthesis since research done at University of California Los Angeles 
in the fifties. Any variations on basic designs have primarily come 
from the work of independent clinical prosthetists in private 
practices.
    In addition to socket design, I believe more research is needed on 
how the alignment of the components effect function, on socket 
suspension methods, and on the development of evidence based practice.
    In 2006, Northwestern University Rehabilitation Engineering 
Research Center in Orthotics and Prosthetics conducted an online forum 
followed by a meeting of prosthetists, orthotists, research engineers, 
and users of artificial limbs and braces. The report generated by this 
forum/meeting (attached) corroborates the pressing need for the type of 
research I have listed above. In fact, though virtually all 
participants agreed on the importance of research, most believed the 
current quantity of research to be insufficient. I believe this must be 
rectified to appropriately serve our veterans.
    The following is taken from: Prosthetics/Orthotics Research for the 
Twenty-first Century: Summary 1992 Conference Proceedings--John W. 
Michael, MEd, CPO, John H. Bowker, MD.

          ``The period from 1945-1965 is now viewed as a time of 
        unparalleled scientific and technical advances in O&P. Key 
        findings from this era still provide the conceptual basis for 
        virtually all contemporary techniques. Although many factors 
        have contributed to the long-term successes of this era, two 
        key aspects were the coordination of research and evaluation 
        efforts and the long-term commitment of significant 
        governmental funding.''
          ``Although the field is currently in a relatively high state 
        of clinical development, most advances in recent decades have 
        been technical. Little or no advances in fundamental principles 
        have occurred since the termination of significant governmental 
        funding for O&P research and development in the sixties.''

    In closing I would like to quote the Hon. Anthony J. Principi from 
a speech given on November 17, 2003, in Arlington, Virginia.

          ``Good afternoon, and thank you for inviting me to help 
        launch a new beginning for both VA's orthopedic and prosthetics 
        research and development, and for a brighter future for 
        America's disabled servicemembers and veterans, men and women 
        who now bear the burdens of mid-20th century technology even as 
        they live surrounded by the envelope pushing technologies of 
        the 21st century.''

            Respectively submitted,
                                                  Alvin C. Pike, CP
                                      (Board Certified Prosthetist)
    Past President--American Academy of Orthotists and Prosthetists

Attachments: NU State of the Science Report [The attachment is being 
retained in the Committee files.]

                                 
                   Statement of Hon. John T. Salazar
        a Representative in Congress from the State of Colorado
    Thank you Mr. Chairman for an opportunity to discuss the important 
issues of VA Research programs.
    I would like to especially thank our witnesses this morning for 
their commitment to our troops.
    We have made such advancements in the field of medicine that the 
likelihood of dying on the battlefields today is less than in previous 
wars.
    This is the reality. However we'll never be able to turn those 
advancements into real life benefits for our men and women in uniform 
without the proper funding.
    Earlier this year during the budget process, the Administration 
requested $411 million for FY 2008, a decrease of $2.7 million below FY 
2007 levels.
    This Committee recommended $452 million, a $38.3 million increase 
above FY 2007 levels, and $41 million above the VA's request.
    Research is one of the core missions of the Veterans Health 
Administration, and we're committed to providing the resources 
necessary to accomplish that mission.
    This Committee, and this Congress, have made a promise to care for 
our veterans, and fighting for proper funding is part of that promise.

                                 

          POST HEARING QUESTIONS AND RESPONSES FOR THE RECORD:
                                     Committee on Veterans' Affairs
                                             Subcommittee on Health
                                                    Washington, DC.
                                                   October 11, 2007

Joel Kupersmith, M.D.
Chief Research and Development Officer
Veterans Health Administration
U.S. Department of Veterans Affairs
810 Vermont Avenue, NW
Washington, DC 20420

Dear Dr. Kupersmith:

     Thank you for testifying before the U.S. House of Representatives 
Committee on Veterans Affairs Subcommittee on Health at the hearing on 
``VA Research Programs'' held on October 4, 2007.
     Please provide answers to the following questions by November 26, 
2007.

    1.  Infrastructure

         As the VA moves forward with construction of new 
hospitals, what types of infrastructure should be incorporated into 
these facilities in order to support research activities?
         How specifically does aging infrastructure impact the 
VA's ability to conduct research?

    2.  Collaboration With Other Departments

         How does the VA partner with other agencies (DoD, HHS) 
in research?
         What can the VA do to work more effectively with other 
agencies to do research and to share resources and information--to 
ultimately benefit veterans?

    3.  Phantom Limb and Stump Pain

         What specific research projects does the VA have to 
address the issue of phantom limb and stump pain? What future plans 
does the VA have to conduct research on this issue?

    4.  Eye Trauma

         How many OEF/OIF veterans are returning with eye 
problems?
         What is the VA currently doing in terms of eye 
research? What types of research is planned for the future to help 
these veterans?

    5.  Research Priorities

         What should be the VA's top 3 research priorities?
         Do you see these priorities changing over the next 10 
years? 20 years? If so, how?

    6.  Barriers to Collaboration

        We have heard from several sources that there are barriers to 
the VA getting research money agencies such as NIH and NIMH.

         Can you please comment on this issue? What is the 
nature of these barriers?
         What can the VA do to make it easier for it to get 
research money from these agencies?

    7.  Intellectual Property

        There has been some discussion recently about VA research and 
intellectual property--who owns the research.

         Can you please comment on this issue?
         How does the intellectual property issue affect the 
availability of the most current medical treatment to veterans?

    Again, thank you for your testimony. The Subcommittee looks forward 
to receiving your responses by November 26, 2007.

            Sincerely,
                                                 MICHAEL H. MICHAUD
                                                           Chairman

                               __________
                        Questions for the Record
                     Hon. Michael Michaud, Chairman
        Subcommittee on Health House Veterans' Affairs Committee
                            October 4, 2007
                      VA Research Programs Hearing
Infrastructure
    Question 1: As the VA moves forward with construction of new 
hospitals, what types of infrastructure should be incorporated into 
these facilities in order to support research activities?

    Response: Most research within the Department of Veterans Affairs 
(VA) is carried out by researchers who are affiliated with medical 
schools or other institutions of higher learning. In general, a 
decision to include research space within a new VA facility depends 
upon the strength of the current VA and academic affiliate research 
efforts (in the case of replacement facilities), or on the research 
potential of the academic affiliate (in the case of new facilities). In 
general, it is not a prudent use of resources to build research 
infrastructure at a VA hospital in the absence of a strong academic 
affiliate or nearby Federal laboratory.
    In those facilities where establishment of a research program is 
appropriate, such as those affiliated with top medical schools, it is 
critical that it be built for flexible long-term use. Current 
laboratory research requires laboratories which are readily 
reconfigured to meet new research demands. This generally requires more 
electrical power, better ventilation and more plumbing than are found 
in older laboratories or in less expensive ``fixed'' laboratory 
designs. Such laboratories are likely to be appropriate for state-of-
the-art genomic and physiologic research. Facilities may need specially 
configured rooms for modern human and animal imaging equipment, 
including magnetic resonance imaging systems and microscopes, computed 
tomographic scanners and the like. Similarly, construction of flexible 
animal facilities that are capable of providing humane care for a 
variety of species ranging from rodents to primates is advisable. 
Engineering laboratories that are capable of fabricating prosthetic 
devices as well as microelectromechanical systems facilitate research 
efforts to restore function to veterans suffering traumatic injuries in 
war. State-of-the-art clinical research units facilitate the 
translation of basic research findings into life-saving and life-
enhancing medical treatments. All require information technology 
support which is both state-of-the-art and specific to the research 
undertaken in an individual facility.

    Question 2: How specifically does aging infrastructure impact the 
VA's ability to conduct research?

    Response: Aging infrastructure at some VA facilities negatively 
impacts VA's ability to conduct research by impeding the recruitment of 
new investigators, who are often put-off by aging facilities. 
Inadequate electrical supplies and ventilation makes it difficult to 
support state-of-the-art research equipment, making it both more 
difficult for investigators to compete for scarce VA and National 
Institutes of Health (NIH) research funding, and more difficult to 
carry out uniquely VA research aimed at improving the physical and 
mental health of those suffering injury during military service. In 
spite of these limitations, however, VA researchers continue to carry 
out world-class laboratory and clinical research which is published in 
top journals such as Science, Nature and The New England Journal of 
Medicine. This research improves the health of veterans and often that 
of the general public and is America's most cost-effective medical 
research investment.
Collaborations With Other Departments
    Question 3: How does the VA partner with other agencies (DoD, HHS) 
in research?

    Response: Through VA's academic affiliations and collaborations 
with other entities, VA research is fully integrated with the larger 
biomedical research community. VA scientists partner with colleagues 
from other Federal agencies [e.g., the Department of Defense (DoD) and 
the National Institutes of Health (NIH)], academic medical centers, 
non-profit organizations and commercial entities nationwide to further 
expand the reach and scope of VA research. Partnering and coordinating 
is accomplished at both the national and local levels. At the national 
level, VA scientific program managers work closely with their 
colleagues in other agencies to develop joint solicitations, identify 
partnering opportunities, review programs to eliminate redundancy and 
establish mechanisms such as joint scientific conferences to keep our 
research at the cutting edge. Additionally, national program staff 
enlist scientists from DoD, NIH, other Federal agencies and academia to 
participate on peer review panels of VA research, and assist in finding 
VA scientists to serve on the peer review panels of other agencies. On 
the local level, VA scientists collaborate extensively with other 
agencies through collaborative research projects, intergovernmental 
personnel agreements, memoranda of understanding, interagency 
workgroups and other mechanisms.

    Question 4: What can the VA do to work more effectively with other 
agencies to do research and to share resources and information--to 
ultimately benefit veterans?

    Response: VA is currently implementing NIH's electronic research 
administration (eRA) system for the submission, review and tracking of 
research proposals submitted by VA investigators. By sharing a common 
platform and database for research, scientific program managers in VA 
and other agencies can better coordinate scientific efforts. 
Additionally, VA's Office of Research and Development (ORD) is working 
with VA's Office of Information and Technology and other Federal 
agencies to develop secure systems for data sharing and exchange.
Phantom Pain and Stump Pain
    Question 5: What specific research projects does the VA have to 
address the issue of phantom limb and stump pain? What future plans 
does the VA have to conduct research on this issue?

    Response: VA's ORD supports a growing portfolio in pain-related 
research. VA investigators are examining the complexities of pain and 
how best to ameliorate its disabling effects among veterans, including 
those with phantom limb pain, as well as pain related to the residual 
limb, spinal cord injury, multiple sclerosis, osteoarthritis, back 
disorders and other conditions.
    Basic research is aimed at understanding the underlying molecular 
basis for pain, while applied work is examining traditional 
pharmacologic means and interventions such as cognitive behavioral 
therapy. It is anticipated that discoveries from these projects will 
provide information in pain management and underlying sources of pain.
    In one exciting recent study, VA investigators identified specific 
channels responsible for conveying pain signals to the brain (Nature. 
2006; 444(7121):831-832). VA researchers are exploiting this finding to 
develop new pain treatments.
    In other ongoing projects, VA researchers are conducting imaging 
studies to identify and examine sources of pain; investigating 
enhancements to pain control from conservative therapy, including oral 
and topical analgesics, to corticosteroid injections, electrical 
stimulation and socket reshaping; and examining the effectiveness of 
exercise (e.g., strengthening, flexibility-enhancing and cardiovascular 
enhancements) to ameliorate pain.
    VA's research program plans to expand on its current pain research 
initiatives to develop novel therapies to address pain, develop new 
ways to improve coping strategies and rehabilitative outcomes and test 
new paradigms of pain assessment, management and treatment.
Eye Trauma
    Question 6: How many Operation Enduring Freedom/Operation Iraqi 
Freedom (OEF/OIF) veterans are returning with eye problems?

    Response: Since the majority of the eye injuries requiring eye 
surgery are cared for by military (DoD) ophthalmologists prior to 
release from active duty, DoD would be the appropriate source for 
comprehensive data related to eye injuries or traumatic brain injury 
(TBI) suffered in OEF/OIF combat and any vision loss resulting from 
those injuries. VA Eye Care Services is collaborating with DoD to 
develop a database related to eye injuries and TBI related vision loss.
    VA does have data on OEF/OIF patients who have received 
rehabilitation services in the VA blind rehabilitation centers. In July 
2007, data from President's Commission on Care for America's Returning 
Wounded Warriors indicated that 48 OEF/OIF veterans had been treated by 
VA blind rehabilitation centers; as of October 2007, 53 OEF/OIF 
veterans were admitted for treatment.

    Question 7: What is the VA currently doing in terms of eye 
research? What types of research are planned for the future to help 
these veterans?

    Response: VA's ORD supports a broad portfolio of vision-related 
research seeking to improve everyday function and quality of life among 
veterans suffering from vision loss, whether from acute trauma or due 
to age-related changes. Research extends from practical aspects of way-
finding (i.e., maneuvering in the environment) to the development of 
advanced intraocular transplants. Several individual research projects 
and two centers of excellence (Aging Veterans with Vision Loss; 
Innovative Visual Rehabilitation) focus on the rehabilitation of low-
vision and blind veterans.
    VA supported research has led to measurement tools such as the VA 
Low Vision Visual Functioning Questionnaire (long and short form) that 
is used in clinical practice to measure functional ability of low 
vision patients and to measure patient-centered outcomes of low vision 
rehabilitation. This questionnaire is used in both VA and non-VA 
clinics.
    Current work involves advanced orientation and way-finding 
technologies for low vision and blind veterans to allow them to 
navigate independently in various environments. This includes the use 
of talking Braille signs, global positioning systems and virtual 
reality training systems to use in rehabilitation activities. Work is 
also under way to develop a retinal implant (type of neuroprosthesis) 
to restore vision to the blind.
    Future planned research includes visual robots for orientation and 
way-finding of low vision and blind veterans; further development of 
retinal implant technology; and rehabilitation strategies for veterans 
with dual sensory impairment (vision and hearing), which is occurring 
due to trauma, as well as age-related phenomena.
Research Priorities
    Question 8: What should be the VA's top 3 research priorities?

    Response: It is crucial that VA's research programs remain focused 
on veterans' high priority healthcare needs. The quality of the 
research and relevance to the veteran population remain the determining 
factors in deciding what studies to fund.
    The top three priority areas for VA research include:

      The needs of returning OEF/OIF veterans, including TBI 
and other neurotrauma, such as sensory loss and spinal cord injury; 
post-deployment mental health, including post-traumatic stress disorder 
and depression; prosthetics and amputation healthcare; pain; polytrauma 
(i.e., complex, multiple traumas); and access to care for OEF/OIF 
veterans;
      The needs of the aging veteran population, particularly 
treatments for chronic diseases; and
      Personalized medicine, meaning increasing our 
understanding of the role of genetics and other individual issues in 
diagnosis and treatment of illnesses to allow VA to provide care that 
is tailored specifically to the makeup of individual veterans. VA is 
uniquely positioned to lead in this area because of its large patient 
population that is stable, diverse and treated in a variety of 
settings, care system with outstanding investigators and an integrated 
research network and unrivaled electronic health record.

    Question 9: Do you see these priorities changing over the next 10 
years? 20 years? If so, how?

    Response: Because the mission of VA research is to improve 
veterans' lives, our priorities will adapt as the needs of veterans 
change. Although we cannot predict all those needs for the future, we 
do rely on projections in the veteran population as well as trends in 
medical research and medical care. It is certain that VA research will 
need to increasingly address the needs of OEF/OIF veterans, including 
the long-term outcomes of post-traumatic stress disorder (PTSD), TBI 
and other blast injuries, which are creating the types of complex co-
occurring illnesses previously limited to elderly. OEF/OIF TBI veterans 
may have a life expectancy of 50 years or more, so their health and 
care-giving needs are considerable. Additionally, as the demographics 
of the military change (e.g., increased women veterans and minority 
veterans) our research will adapt to address their unique issues.
    We also anticipate by changing the expectation of veterans and 
their caregivers, VA research will be prompted to create innovations 
that promote more personalized, community-based options for care. Rapid 
learning and needs assessment using improved tools for ``data mining'' 
the personalized health record is a critical strategy for the next 10 
years and beyond.
    Finally, based on recent and projected advances in our 
understanding of biological systems underlying illness, we anticipate 
that genomics and related research will play an increasingly larger 
role in VA's research portfolio. Genomic medicine has the potential to 
significantly improve the quality of care for veterans, especially in 
the treatment of chronic diseases. Recent research findings have shown 
that genomic medicine shows great promise to prevent adverse drug 
reactions, personalize clinical care, customize drug treatments and 
improve outcomes.
Barriers to Collaboration
    We have heard from several sources that there are barriers to the 
VA getting research money from agencies such as NIH and NIMH.

    Question 10: Can you please comment on this issue? What is the 
nature of these barriers?

    Response: VA investigators have, in fact, been successful in 
competing for and receiving increased funding from the NIH and other 
Federal research sponsors over the past several years. Much of this 
funding is administered by academic affiliates or by VA-affiliated 
nonprofit research and education corporations (NPC) which provide a 
flexible funding mechanism for the administration of non-VA funds.
    While there are no statutory or regulatory barriers to VA obtaining 
research funds from NIH and other Federal agencies and administering 
them through academic affiliates or NPCs, there are some administrative 
barriers. Currently, a limited number of NPCs administer Federal funds, 
and many lack the resources and expertise needed to do so. Dual-
appointment researchers (i.e., VA and academic affiliate) generally 
have its Federal funds administered through the university, but the few 
VA researchers without university appointments do not have this option.

    Question 11: What can the VA do to make it easier for it to get 
research money from these agencies?

    Response: VA is currently working on solutions regarding the 
administration of federal funds by NPCs, including consolidation and 
training.
Intellectual Property
    There has been some discussion recently about VA research and 
intellectual property--who owns the research.

    Question 12: Can you please comment on this issue?

    Response: If intellectual property (IP) is created in the course of 
VA research, VA may assert ownership of the IP and file patent 
applications, as appropriate, or pursue other means of protecting and 
encouraging the development of the research discovery. The decision to 
assert ownership depends on the presence and degree of VA contribution, 
including facilities, funds, information, equipment, materials and 
employee time.
    Because most VA investigators have dual appointments with an 
academic affiliate, one or more university partners may also assert 
ownership to VA intellectual property. To address this unique 
relationship and to facilitate cooperation between the VA and academic 
affiliates, VA developed a Cooperative Technology Administration 
Agreement (CTAA). This legal agreement outlines relevant definitions, 
terms and conditions for managing the intellectual property, and allows 
the joint owners to work as one decisionmaking body in the best 
interest of technology transfer and development. The CTAA preserves VA 
ownership, while granting the university the necessary authority to 
protect and market the IP.
    If IP is created in the course of privately sponsored VA research, 
VA maintains ownership of all data and IP emerging from these 
agreements. The sponsor often is granted an up front, non-exclusive 
license to IP resulting from the study.

    Question 13: How does the intellectual property issue affect the 
availability of the most current medical treatment to veterans?

    Response: It generally has no effect because discoveries that 
emerge from VA research are typically in an early stage of development, 
requiring further reduction to practice, validation and scale-up before 
they can provide any benefit to veterans. This development work is 
generally beyond the scope and mission of VA, so a commercial partner 
who is willing to commit considerable resources and assume significant 
risk is needed. Patents allow the commercial partner to take the 
development risk with some promise of financial return.
    The VA currently is reviewing several allegations of patent 
infringement in which the patent owners allege that their inventions 
are used or manufactured by or for VA without license of the owner 
thereof. The technologies range from cardiovascular stents to hearing 
aids. If the allegations are proven, the ultimate costs of providing 
such devices to veterans may increase. However, a perfected government 
use license acquired in consideration of VA contributions may be 
offered as a defense.

                                 

                                     Committee on Veterans' Affairs
                                             Subcommittee on Health
                                                    Washington, DC.
                                                    October 5, 2007

Honorable Gordon Mansfield
Acting Secretary
U.S. Department of Veterans Affairs
810 Vermont Avenue, NW
Washington, DC 20420

Dear Secretary Mansfield:

    On Thursday, October 4, 2007, Dr. Joel Kupersmith, MD, Chief 
Research and Development Officer, Veterans Health Administration, 
testified before the Subcommittee on Health on the U.S. Department of 
Veterans Affairs Research Programs. As a follow-up to the hearing, I 
request that Dr. Kupersmith respond to the following questions in 
written form for the record:

    1.  Please list the number of invention patents VA has processed, 
retained ownership rights, and retained sole ownership rights since 
VA's Technology Transfer Program was established in 2000. Additionally, 
provide an estimate of the number of ``lost opportunities'' and the 
reason the Department did not pursue these opportunities.
    2.  Please explain the mechanisms of joint patents filed by VA with 
its academic partners. Specifically, how are respective ``contributing 
shares'' determined? Assuming the subsequent licensing of those 
patents, how are royalty distributions between partners determined? Are 
royalty distributions received by the VA under those circumstances, in 
force over the life of the patent, or are VA's royalties received in 
one lump sum?
    3.  What are some challenges VA faces in deploying the latest 
state-of-the art prosthetics research into prosthetic care for 
veterans?
    4.  What collaborative activities are VA and the U.S. Department of 
Defense (DoD) currently conducting? Is there a Memorandum of Agreement 
or Memorandum of Understanding between VA and DoD for collaborative 
research? What about for other federal departments?
    5.  How do VERA funds support VA research? Are such funds actually 
received by the medical center, and in the research laboratory? How 
does VA know this to be the case? What monitors does VA use to ensure 
these funds are allocated to research?
    6.  Has VA completed its study to identify deficiencies in VA's 
research infrastructure? Has VA developed a prioritized plan to 
renovate and modernize VA research infrastructure? If so, please 
provide a list of the prioritized research facility projects and 
include the cost of the project and implementation timeline.
    7.  What training does VA provide researchers on VA Data Security 
and Privacy policies? How is this training verified and tracked? How 
many VA researchers have not received the training? Does VA require 
encryption for all researchers accessing VA data?
    8.  The Office of Inspector General has released a number of 
reports recently on problems with researchers operating outside the 
scope of practice. What steps is VA taking to ensure that researchers 
are acting within their scope of practice? Does VA believe that a 
researcher operating outside their scope of practice constitutes a 
violation of human subjects protections? How are researchers trained on 
human subjects protections? Is this training documented? How often is 
this training provided?

    The attention to these questions by the witnesses is much 
appreciated, and I request that they be returned to the Subcommittee on 
Health no later than close of business, 5:00 p.m., Friday, November 2, 
2007. If you or your staff have any questions, please call Dolores 
Dunn, Republican Staff Director for the Subcommittee on Health, at 202-
225-3527.

            Sincerely,
                                                        Jeff Miller
                                                     Ranking Member

                               __________

                        Questions for the Record
          The Honorable Jeff Miller, Ranking Republican Member
                         Subcommittee on Health
                  House Committee on Veterans' Affairs
                            October 4, 2007
                          VA Research Programs
    Question 1: Please list the number of invention patents VA has 
processed, retained ownership rights, and retained sole ownership 
rights since VA's Technology Transfer Program was established in 2000. 
Additionally, provide an estimate of the number of ``lost 
opportunities'' and the reason the Department did not pursue these 
opportunities.

    Response: Since 2000, the Department of Veterans Affairs' (VA) 
Technology Transfer Program (TTP) has received 1,226 invention 
disclosures. VA retained rights to 744 of these inventions. Of those 
inventions, 69 are solely owned by VA.
    Each of VA's inventions has undergone a commercial and 
patentability assessment by either VA or the academic affiliate. As 
such, VA's TTP has taken advantage of all opportunities on those 
inventions disclosed since the program was established in 2000. The 
commercial and patentability assessment can include discussions with 
the VA inventor, patentability opinions from VA contract patent 
attorneys and technology assessments from marketing contractors. VA has 
marketed all its inventions in hopes of finding a licensee or a 
cooperative research and development partner to advance the technology 
and bring it to market.

    Question 2: Please explain the mechanism of joint patents filed by 
VA with its academic partners. Specifically, how are respective 
``contributing shares'' determined? Assuming the subsequent licensing 
of those patents, how are royalty distributions between partners 
determined? Are royalty distributions received by the VA under those 
circumstances, in force over the life of the patent, or are VA's 
royalties received in one lump sum?

    Response: Most VA investigators have dual appointments with an 
academic affiliate. This often results in co-ownership of an invention 
between VA and the academic affiliate. To address this unique 
relationship and facilitate and enhance the cooperation between VA and 
academic affiliates, VA developed a cooperative technology 
administration agreement (CTAA). This agreement outlines relevant 
definitions, terms and conditions for handling co-owned intellectual 
property (IP). Using the CTAA preserves VA ownership while providing 
the university the needed authority to effectively patent and market 
the IP. The ClM also has a provision that if the university chooses not 
to patent or market an invention VA has the right to do so. Currently, 
VA has executed 76 ClMs with some of the leading research institutions 
in the country, including Harvard, Yale, Stanford and the entire 
University of California system.
    VA's ``contributing shares'' are calculated in terms of the number 
of VA inventors as a proportion of the total number of inventors. For 
example, if an invention has two inventors, one full-time VA staff and 
one non-VA university staff, the ``net revenue'' split would be 50 
percent to VA and 50 percent to the university.
    ``Net revenue'' is defined as total revenue, minus royalties paid 
to the inventors, expenses (e.g., patent filing costs) and a 15 percent 
administrative fee. All net revenues are to be paid annually over the 
life of the patent or for the term specified in the license.

    Question 3: What are some challenges VA faces in deploying the 
latest state-of-the-art prosthetics research into prosthetic care for 
veterans?

    Response: New and emerging technology (e.g., bionics, 
microprocessors and electric and myoelectric components) is becoming 
commercially available at a very quick pace. In addition, manufacturers 
make claims and develop criteria about new products for which there is 
very little scientific or clinical evidence. We have in the past worked 
with researchers and developers on new and emerging technologies in 
clinical settings, where we have fit a variety of new devices over the 
years. Some examples include: Advanced Body Powered Arm; Synergetic 
Prehensor; Modular Electronic Locking/Unlocking Actuator (for elbow); 
and the Hypobaric Lower Limb Suspension Systems. It is critical that VA 
continue to evaluate these new products in the process, and develop 
criteria by consulting with clinicians and researchers specializing in 
new and emerging technology.

    Question 4: What collaborative activities are VA and the U.S. 
Department of Defense (DoD) currently conducting? Is there a Memorandum 
of Agreement or Memorandum of Understanding between VA and DoD for 
collaborative research? What about for other federal departments?

    Response: In the context of research, VA's Office of Research and 
Development (ORD) has a long history of collaboration with DoD and 
collaboration has substantially increased over the last 2 years. 
Individual research projects currently under way are examining a wide 
range of topics, including traumatic brain injury (TBI), polytrauma, 
prosthetics and amputation healthcare, post-traumatic stress disorder 
(PTSD) and other post-deployment mental health, burns and pain.
    High-level planning and coordination of research efforts in 
response to the needs of Operation Enduring Freedom/Operation Iraqi 
Freedom (OEF/OIF) veterans began in May 2006, with an interagency 
workgroup planning conference that mapped the landscape of post-
deployment mental health issues. The conference report is available at: 
www.research.va.gov/news/announcements/deployment-meeting.cfm. This 
planning conference led to an inter-agency solicitation for research 
proposals.
    A subsequent senior leadership meeting held at Fort Detrick, MD, on 
November 13, 2006, articulated further principles for collaboration and 
identified TBI and PTSD as key topics for coordinated effort.
    ORD scientific leadership participated June 11-13, 2007, in a DoD-
sponsored PTSD/TBI vision setting meeting, in which plans were 
articulated for the use of the $300 million supplemental appropriation 
received by Defense Health Programs for PTSD and TBI research. Senior 
ORD scientific staff continues to work closely with the DoD's 
Congressionally mandated medical research programs to implement the 
$300 million supplemental appropriation in support of PTSD and TBI 
research. It is anticipated that VA researchers will submit proposals 
and collaborate extensively with their DoD counterparts in this 
Congressionally directed initiative.
    In addition, ORD is currently planning, in collaboration with DoD 
investigators, a state-of-the-art conference on OEF/OIF-relevant 
research, which will be presented to a joint VA/DoD audience in the 
spring of 2008.
    Furthermore, VA and DoD regularly involve each other in the 
evaluation of research proposals and funding selections.
    Memoranda of Understanding exist between VA and DoD, as well as 
other Federal departments, for specific research projects.

    Question 5: How do VERA funds support VA research? Are such funds 
actually received by the medical center, and in the research 
laboratory? How does VA know this to be the case? What monitors does VA 
use to ensure these funds are allocated to research?

    Response: The Veterans Equitable Resource Allocation (VERA) 
allocates research support funds based on the total expenditures of 
funded research at each medical center. These expenditures are weighted 
based on whether the research is administered by VA or is peer 
reviewed. The total amount allocated in VERA is based on the estimates 
for medical care support to research as submitted in the President's 
medical programs budget request.
    Networks distribute to medical centers research support funds as 
they are computed for each medical center, care line or product line. 
Each medical center, care line or product line explicitly accounts for, 
and obligates, research support funds to support the salaries of 
clinician-researchers, and research facilities and administrative 
costs. Research support expenditures are monitored on the local level 
by administrative officers for research, working in partnership with 
facility fiscal staff.

    Question 6: Has VA completed its study to identify deficiencies in 
VA's research infrastructure? Has VA developed a prioritized plan to 
renovate and modernize VA research infrastructure? If so, please 
provide a list of the prioritized research facility projects and 
include the cost of the project and implementation timeline.

    Response: VA's Office of Research and Development has established a 
research infrastructure evaluation and improvement project to review 
VA's research facilities and identify deficiencies.
    A detailed questionnaire regarding current research space 
allocation and condition was disseminated to all field sites to gather 
preliminary information. Preliminary results showed a need for research 
infrastructure corrections across the system. To better document and 
prioritize issues identified in the preliminary assessment, a 
comprehensive evaluation instrument designed to ensure a thorough and 
consistent system-wide review of research space was developed and 
tested at three pilot sites. A summary of the three pilot surveys 
completed will be provided in a report to Congress in the near future.
    In addition, VA recently selected a contractor to complete the 
research facility site visits. Three site visits were conducted in 
September 2007. Over the next 3 years, approximately 70 more site 
visits will be conducted. VA plans to issue reports to Congress 
periodically, as appropriate, describing the efforts undertaken.
    Because the research infrastructure evaluation and improvement 
project is still under way, a prioritized list of research facility 
projects is not available.

    Question 7: What training does VA provide researchers on VA Data 
Security and Privacy policies? How is this training verified and 
tracked? How many VA researchers have not received the training? Does 
VA require encryption for all researchers accessing VA data?

    Response: All staff involved in VA research, not just researchers, 
are required to take the course VA Research Data Security and Privacy. 
This includes all VA research office personnel, researchers, study 
coordinators, research assistants, trainees such as house officers and 
students, administrative support staff (including secretaries and 
clerks) and members of the Institutional Review Board (IRB) and 
Research and Development Committee. Personnel includes compensated and 
without compensation employees and those on Intergovernmental personnel 
agreements (IPAs). Local VA facilities must maintain documentation that 
training requirements have been met.
    As of October 12, 2007, 20,929 people have taken the course since 
VA began offering it in February 2007. Data does not exist on how many 
researchers have not taken the course.
    In addition, all Veterans Health Administration (VHA) staff are 
required to take the VA Cyber Security Awareness Training Course and 
the VHA Privacy Policy Training Course.
    VA Handbook 6500 requires that VA sensitive information, including 
sensitive research data, must be in a VA protected environment at all 
times or it must be encrypted. All portable media (e.g., laptops, 
portable drives, thumb drives, compact discs) that contain VA sensitive 
information must be encrypted.

    Question 8: The Office of the Inspector General has released a 
number of reports recently on problems with researchers operating 
outside the scope of practice. What steps is VA taking to ensure that 
researchers are acting within their scope of practice? Does VA believe 
that a researcher operating outside their scope practice constitutes a 
violation of human subjects protections? How are researchers trained on 
human subjects protections? Is this training documented? How often is 
this training provided?

    Response: VA's Office of Research and Development (ORD) requires a 
scope of practice for researchers and staff working on human subjects 
research protocols. The scope of practice is based on the occupational 
category under which the person is hired and the person's 
qualifications, including licensure and training. In addition, the 
scope of practice is agreed upon by the person's immediate supervisor 
and the associate chief of staff for research and development.
    Each VA facility is responsible for the credentialing of all 
research employees and the local research office ensures that this is 
done and that a scope of practice has been developed. The principal 
investigator for each protocol is responsible for all aspects of that 
research and, as such, ensures that the research staff is qualified to 
perform their duties and that the duties are consistent with the scope 
of practice.
    Working outside of a scope of practice may or may not represent 
harm to subjects. It depends on the specific task or procedure that was 
conducted and the specific research protocol. Working outside the scope 
of practice may also violate other Federal and State laws such as 
practicing medicine without a license.
    All staff involved in VA human research (except secretarial support 
staff) is required to have annual training in good clinical practices 
and the ethical principles of human research protection. Most 
individuals meet this requirement by taking the same online 
Collaborative Institutional Review Board Training Initiatives (CITI) 
course used by many academic institutions. If VA facilities obtain 
permission from ORD, they may substitute other comparable training 
(e.g., in person courses that cover the material). CITI keeps 
electronic records of everyone who completes the course. This is an 
annual training requirement.

                                  
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