[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]




 
        INNOVATIVE TECHNOLOGIES AND TREATMENTS HELPING VETERANS

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

                                HEARING

                               before the

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

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                               __________

                              MAY 13, 2009

                               __________

                           Serial No. 111-18

                               __________

       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     HENRY E. BROWN, Jr., South 
Dakota                               Carolina
HARRY E. MITCHELL, Arizona           JEFF MILLER, Florida
JOHN J. HALL, New York               JOHN BOOZMAN, Arkansas
DEBORAH L. HALVORSON, Illinois       BRIAN P. BILBRAY, California
THOMAS S.P. PERRIELLO, Virginia      DOUG LAMBORN, Colorado
HARRY TEAGUE, New Mexico             GUS M. BILIRAKIS, Florida
CIRO D. RODRIGUEZ, Texas             VERN BUCHANAN, Florida
JOE DONNELLY, Indiana                DAVID P. ROE, Tennessee
JERRY McNERNEY, California
ZACHARY T. SPACE, Ohio
TIMOTHY J. WALZ, Minnesota
JOHN H. ADLER, New Jersey
ANN KIRKPATRICK, Arizona
GLENN C. NYE, Virginia

                   Malcom A. Shorter, Staff Director

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

                               __________

                              May 13, 2009

                                                                   Page
Innovative Technologies and Treatments Helping Veterans..........     1

                           OPENING STATEMENTS

Chairman Bob Filner..............................................     1
    Prepared statement of Chairman Filner........................    36
Hon. Harry E. Mitchell, prepared statement of....................    36

                               WITNESSES

Alkermes, Inc., Cambridge, MA, David A. Broecker, President and 
  Chief Executive Officer........................................     6
    Prepared statement of Mr. Broecker...........................    50
BrainCells Inc., San Diego, CA, James A. Schoeneck, Chief 
  Executive Officer..............................................    29
    Prepared statement of Mr. Schoeneck..........................    71
Brainport Technologies, Wicab, Inc., Middleton, WI, Robert A. 
  Beckman, President and Chief Executive Officer.................     5
    Prepared statement of Mr. Beckman............................    41
Fate Therapeutics, Inc., La Jolla, CA, David Scadden, M.D., 
  Scientific Founder.............................................    12
    Prepared statement of Dr. Scadden............................    59
Federoff, Howard J., M.D., Ph.D., Executive Vice President for 
  Health Sciences, Executive Dean of the School of Medicine, 
  Georgetown University Medical Center, Washington, DC...........    25
    Prepared statement of Dr. Federoff...........................    68
Harmonex, Inc., CliniCom, Atlanta, GA, Nelson M. Handal, M.D., 
  FAPA, Founder, Chairman, and Medical Director, Board Certified 
  Child, Adolescent and Adult Psychiatrist, and Fellow, American 
  Psychiatric Association........................................    27
    Prepared statement of Dr. Handal.............................    69
Mobile Medical International Corporation, St. Johnsbury, VT, Mark 
  Munroe, Senior Vice President, Sales and Marketing.............     8
    Prepared statement of Mr. Munroe.............................    55
Sidransky, David, M.D., Director, Head and Neck Cancer Research 
  Division, Johns Hopkins University School of Medicine, and 
  Professor of Oncology, Otolaryngology-Head and Neck Surgery, 
  Cellular and Molecular Medicine, Urology, Genetics, and 
  Pathology, Johns Hopkins University and Hospital, Baltimore, MD     4
    Prepared statement of Dr. Sidransky..........................    39
TeleMed Network, Ross, CA, Stanley Stern, President..............    10
    Prepared statement of Mr. Stern..............................    56
Zila, Inc., Scottsdale, AZ, David R. Bethune, Executive Chairman 
  and Chief Executive Officer....................................     2
    Prepared statement of Mr. Bethune............................    36

                       SUBMISSIONS FOR THE RECORD

Balanoff, William L., DDS, MS, FICD, SmilePerfect, Fort 
  Lauderdale, FL, statement......................................    73
Califano, Joseph, III, M.D., Professor, Department of 
  Otolaryngology-Head and Neck Surgery and Oncology, Johns 
  Hopkins Medical Institutions, Baltimore, MD, statement.........    75
Epstein, Joel, DMD, MSD, FRCD(C), FDS RCS, Director, 
  Interdisciplinary Program in Oral Cancer Biology, Prevention 
  and Treatment, College of Medicine, Chicago Cancer Center, 
  University of Illinois, Chicago, IL, statement.................    77

                   MATERIAL SUBMITTED FOR THE RECORD

Post-Hearing Questions and Responses for the Record:

    Hon. Bob Filner, Chairman, Committee on Veterans' Affairs to 
      Hon. Eric K. Shinseki, Secretary, U.S. Department of 
      Veterans Affairs, letter dated May 14, 2009, and VA 
      responses..................................................    79


        INNOVATIVE TECHNOLOGIES AND TREATMENTS HELPING VETERANS

                              ----------                              


                        WEDNESDAY, MAY 13, 2009

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

    The Committee met, pursuant to notice, at 10:00 a.m., in 
Room 334, Cannon House Office Building, Hon. Bob Filner 
[Chairman of the Committee] presiding.
    Present: Representatives Filner, Mitchell, Hall, Perriello, 
Teague, Donnelly, McNerney, Walz, and Adler.

              OPENING STATEMENT OF CHAIRMAN FILNER

    The Chairman. Good morning. I apologize for being late. I 
call this hearing of the House Veterans' Affairs Committee to 
order.
    If the first panel can take their seats while I am just 
doing a little introduction, that would be great.
    I ask unanimous consent that all Members have 5 legislative 
days in which to revise and extend their remarks. Without 
objection, so ordered.
    I want to thank you all for being here. The purpose of this 
hearing is very simple. In my job, and I am sure every one of 
my colleagues has the same experience, we meet constituents who 
have had contact, have invented, or have manufactured 
instruments, technologies, or treatments which would seem to 
have a great benefit for our veterans.
    Yet, many have had a frustrating experience of dealing with 
a bureaucracy that just does not seem to react very quickly to 
new ideas and new treatments, and people are frustrated. They 
have things to help, whether it is a device for early detection 
of oral cancer, for example, or correction of vision for those 
who are brain injured.
    You would think the U.S. Department of Veterans Affairs 
(VA) would jump on these inventions and, yet, for some reason 
that is the law of bureaucracies, it is easier to say no.
    What I wanted to do today is highlight a series of 
different medical technologies, treatments, inventions, and 
discoveries that would seem to me, and to many people that I 
have talked to, to have great relevance for our veterans. Yet, 
somehow, they do not seem to have been introduced into the VA 
system.
    I would ask each of our panelists to summarize the medical 
situation for a layman as succinctly as possible and talk about 
some of the frustration you have had with trying to get it 
introduced into the VA system.
    I think people are going to be really startled by some of 
the things that we can do as a Nation which our veterans can, 
in fact, increase the quality of their lives and the degree of 
their health care. Yet, we seem not to have done it and I just 
want to highlight the fact that there are so many of these 
around.
    I have no special interest in any company per se. I am not 
trying to get anybody a job or a contract. I just feel it is 
imperative that the ingenuity of our Nation be more recognized 
and that the sense that we can do better for our veterans comes 
out. Somehow, maybe we can change things by having all of you 
here together showing what we can do as a Nation and hopefully 
encourage the more quick acceptance of this for treatments.
    I thank you for being here. I would welcome panel number 
one. It is comprised of companies that will discuss a wide 
range of technologies and treatments that are either ready for 
use or are currently in development.
    [The prepared statement of Chairman Filner appears on p. 
36.]
    Are you in the same order that I have here? Mr. Bethune, we 
thank you. You are Chairman and Chief Executive Officer of 
Zila, Incorporated. Dr. Sidransky is the Director of the Head 
and Neck Cancer Research Division of Johns Hopkins University 
School of Medicine joining him. Mr. Beckman is the President 
and Chief Executive Officer for BrainPort Technologies, Wicab, 
Incorporated. Mr. Broecker is the President and Chief Executive 
Officer for Alkermes, Incorporated. Mr. Munroe is the Senior 
Vice President of Mobile Medical International Corporation. Mr. 
Stern is the President of TeleMed Network. And, Dr. Scadden is 
the Founder of Fate Therapeutics, Incorporated.
    I would like you to try to summarize the medical knowledge 
for a layman. Be as dramatic as you would like and give us some 
sense of what happened when you brought this to the VA's 
attention, either locally or nationally.
    We will start with Mr. Bethune. Thank you.

 STATEMENTS OF DAVID R. BETHUNE, EXECUTIVE CHAIRMAN AND CHIEF 
EXECUTIVE OFFICER, ZILA, INC., SCOTTSDALE, AZ; DAVID SIDRANSKY, 
 M.D., DIRECTOR, HEAD AND NECK CANCER RESEARCH DIVISION, JOHNS 
    HOPKINS UNIVERSITY SCHOOL OF MEDICINE, AND PROFESSOR OF 
 ONCOLOGY, OTOLARYNGOLOGY-HEAD AND NECK SURGERY, CELLULAR AND 
  MOLECULAR MEDICINE, UROLOGY, GENETICS, AND PATHOLOGY, JOHNS 
   HOPKINS UNIVERSITY AND HOSPITAL, BALTIMORE, MD; ROBERT A. 
   BECKMAN, PRESIDENT AND CHIEF EXECUTIVE OFFICER, BRAINPORT 
 TECHNOLOGIES, WICAB, INC., MIDDLETON, WI; DAVID A. BROECKER, 
    PRESIDENT AND CHIEF EXECUTIVE OFFICER, ALKERMES, INC., 
 CAMBRIDGE, MA; MARK MUNROE, SENIOR VICE PRESIDENT, SALES AND 
   MARKETING, MOBILE MEDICAL INTERNATIONAL CORPORATION, ST. 
JOHNSBURY, VT; STANLEY STERN, PRESIDENT, TELEMED NETWORK, ROSS, 
     CA; AND DAVID SCADDEN, M.D., SCIENTIFIC FOUNDER, FATE 
                THERAPEUTICS, INC., LA JOLLA, CA

                 STATEMENT OF DAVID R. BETHUNE

    Mr. Bethune. Thank you, Mr. Chairman.
    I am a proud U.S. Navy veteran and I am Chairman and CEO of 
Zila, developer and marketer of the innovative ViziLite Plus 
technology for the early detection of oral cancer and 
precancerous abnormalities.
    Private citizens around the world and even prisoners in our 
Federal prisons enjoy the life-saving benefits of ViziLite Plus 
screening.
    The VA has repeatedly resisted efforts to understand the 
great value of ViziLite Plus.
    Oral cancer kills one American every hour, but veterans are 
2.8 times more likely to get oral cancer than the general 
public, partly due to the higher rates of smoking, chewing, and 
drinking.
    In 2006, the VA diagnosed 1,704 oral cancers, 5 percent of 
all U.S. cases. Surviving this disease depends upon detection.
    In the VA, their own data shows that 70 percent of oral 
cancers are diagnosed at late stage when the 5-year survival 
rate is just 26 percent, which is worse than our general 
population results.
    ViziLite Plus has received FDA clearance to aid in the 
detection of early stage oral abnormalities including precancer 
and cancer.
    Some clinical studies on oral cancer screening, which when 
dentists use their unaided eyes and fingertips have shown that 
up to one-third of serious cancers and lesions are missed.
    Supplementing the exam with ViziLite Plus has shown to 
produce 100 percent screening effectiveness. ViziLite Plus is 
an adjunctive screening technology similar to the mammogram, 
PAP smear, or PSA test. They all promote early detection, 
leading to fewer deaths, enhanced quality of life, and 
significantly lower health care costs.
    The treatment of late-stage oral cancer typically costs 
$200,000 per patient and while treating a precancerous lesion, 
it costs less than $1,500.
    Zila provides the VA with ViziLite Plus at a deeply 
discounted $12 per test. Screening all veterans seen in VA 
facilities yearly would cost about $60 million, a sum that 
would easily be recouped by the reduction in surgeries, long-
term care, suffering and death.
    ViziLite Plus is backed by eight published studies, 
recognized by the American Dental Association through their 
Dental Procedure Code, adopted by the Federal Bureau of 
Prisons, used by dentists worldwide, and covered by numerous 
health insurance plans.
    The decision to implement ViziLite Plus exams should be 
universal in all VA facilities. Congress should urge the 
Secretary of Veterans Affairs to immediately implement annual 
ViziLite plus oral cancer screening of all veterans who are 
seen at VA facilities nationwide. This is the best way to 
assure the consistent delivery of quality life-saving care to 
our veterans.
    Thank you.
    [The prepared statement of Mr. Bethune appears on p. 36.]
    The Chairman. I would now like to introduce Dr. David 
Sidransky. He is the Director of the Head and Neck Cancer 
Research Division at Johns Hopkins University, School of 
Medicine and Professor of Oncology, Otolaryngology-Head and 
Neck Surgery, Cellular and Molecular Medicine, Urology, 
Genetics, and Pathology at Johns Hopkins University and 
Hospital. He is also one of the world's most cited cancer 
researchers and author of over 340 peer-reviewed publications.
    Dr. Sidransky.

               STATEMENT OF DAVID SIDRANSKY, M.D.

    Dr. Sidransky. Thank you.
    The mission is to try and identify and treat oral cancer 
and its precursors as early as possible. Historically this has 
put a premium on the thorough and meticulous initial 
examination.
    However, clinical studies designed to test the 
effectiveness of visual examination in identifying dysplasia, 
the earliest cells that turn or can turn into cancer and cancer 
itself, say otherwise.
    In the meta-analysis of six worldwide studies, it was 
reported that the weighted sensitivity of visual examination in 
identifying oral cancer and precancerous lesions was under 80 
percent.
    Visual examination by untrained examiners often misses the 
earliest more curable lesions. These results demonstrate that 
disease remained undiagnosed by conventional examination.
    By contrast, published studies reporting sensitivity values 
from ViziLite are consistent. To date, the sensitivity of 
ViziLite examination in identifying dysplasia and cancer is 
nearly perfect.
    According to published literature, pharmaceutical-grade 
toluide blue, such as that included in the ViziLite Plus test 
kit, preferentially stains lesions consistent with severe 
dysplasia, carcinoma in situ and cancer.
    In one study, we find that a TBlue application correlated 
to a reduction of false positives by more than 50 percent. As 
such, ViziLite Plus has adequate sensitivity to find the 
meaningful number of individuals with disease while having 
sufficient specificity to not falsely identify individuals 
without disease as being positive for cancer.
    It is within this framework that ViziLite Plus fits into 
clinical practice. No other medical device has sufficient 
sensitivity and specificity to meet the requirement of early 
detection of oral cancer among veterans.
    Other dyes and devices cannot precisely identify 
precancerous lesions and early invasive cancers while excluding 
healthy patients who need no further intervention.
    Indeed ease of use makes ViziLite appropriate for use by 
all oral disease health care professionals including dentists, 
periodontists, oral surgeons, otolaryngologists, and even 
primary care physicians.
    In conclusion, ViziLite Plus is an easy-to-use, sensitive, 
and specific medical device to help both relatively untrained 
and expert examiners both identify oral lesions in their 
patients who are in the high risk group for oral cancer.
    Additionally, in an aging patient population, this product 
can bring diagnostic power to physicians outside the dental 
specialties for greater value and potentially more savings in 
hospitalization.
    Inclusion in VA oral cancer screening protocols would 
improve screening efficacy for lesions suspicious for both 
precancer and cancer and ultimately reduce the terrible 
morbidity and mortality of this disease that our veterans 
suffer.
    Thank you.
    [The prepared statement of Dr. Sidransky appears on p. 39.]
    The Chairman. Thank you so much.
    Mr. Beckman.

                 STATEMENT OF ROBERT A. BECKMAN

    Mr. Beckman. Good morning. I am Robert Beckman, the CEO of 
Wicab, Inc., a medical device company based in Madison, 
Wisconsin.
    I want to thank the Committee for inviting me to present 
information on two innovative medical devices we are 
developing. Both devices are available today for further 
clinical testing that could ultimately lead to unique benefits 
for some of our wounded or disabled veterans.
    We are developing sensory substitution technology invented 
by Dr. Paul Bach-y-Rita at the University of Wisconsin. Before 
he passed away, Paul famously said, ``We see with our brains 
and not with our eyes and the brain is not hardwired.''
    What he meant is that if your eye is not functional, an 
alternate sensor such as a digital camera can be used. And 
because the brain is not hardwired, alternative neuro channels 
such as the tongue can transmit the impulses.
    Wicab is developing and testing two unique medical devices 
based on this invention, one for balance and one for vision.
    First, the BrainPort vision device, which I brought with me 
today, consists of a small digital camera with zoom capability. 
The user controls the intensity of the stimulation on their 
tongue and the zoom feature. The image is transmitted real time 
and displayed on the user's tongue through this 20-by-20 array 
of stainless steel pins.
    So our device provides a streaming video image on the 
tongue for blind people. With the BrainPort vision device, 
users are able to identify and navigate complex paths, 
doorways, and objects.
    For example, one blind user with two glass eyes was able to 
successfully shoot a basketball and another used the BrainPort 
vision device at an indoor rock climbing gym to see the next 
rock holds and at home with his daughter to play tic-tac-toe.
    The BrainPort vision device will not replace the cane or 
the sight dog, but it will become an important additional tool 
to improve the safety, mobility, and quality of life for blind 
users.
    Some examples, finding the open seat on a crowded bus or 
train, identifying the direction to the target building in a 
confusing parking lot, finding the handle in order to remove a 
hot pot from the stove.
    Wicab recently sponsored clinical testing of the BrainPort 
vision device at the Atlanta VA. Dr. Michael Williams, the PI, 
``concluded bottom line the device performs remarkably well for 
the tasks that we looked at in phase one.''
    To optimize the device, we need feedback from a much larger 
pool of users who are blind. We would welcome the opportunity 
to further test the BrainPort vision device at VA sites. 
Perhaps those willing soldiers who are blind as a result of a 
blast injury should be first inline to test this new 
technology.
    Now I would like to turn your attention to the BrainPort 
balance device. This devise uses an accelerometer mounted 
within the intra-oral device to sense head position 
information. An accelerometer is like a digital carpenter's 
level which senses tilt information as the patient's head 
moves.
    This tilt information is displayed on the patient's tongue 
in the form of an electrical signal which feels like a bubble 
moving on their tongue.
    We trained patients with chronic balance disorders to 
maintain their balance by keeping the bubble on the center of 
their tongue. This training is intuitive. On day one, patients 
learn to maintain their balance simply by keeping the signal in 
the center of their tongue. More importantly, within 3 to 5 
days after patients start training, they start to experience 
improved balance even after the device is removed.
    Patients perform most of the training at home during two 
20-minute sessions per day. This is an important feature 
because patients with chronic balance disorders cannot easily 
travel to a clinic.
    Early patient results after BrainPort balance device 
training are very promising. For instance, a traumatic brain 
injury (TBI) patient in Madison, Wisconsin, has now used our 
device for 2 and a 1/2 years. His physician, his mother, and 
the patient all agree that his recent improvement dramatically 
exceeds the gains he achieved in the first 13 years after his 
injury.
    University of Wisconsin investigators recently analyzed 
data from 26 stroke patients, all of whom continued to 
experience significant balance disorders despite extensive 
vestibular rehabilitation. The results of the training with the 
BrainPort balance device over 8 weeks were quite promising both 
statistically and clinically according to the PI, Dr. Mary Beth 
Badke.
    The BrainPort vision device and the BrainPort balance 
device have both been hindered by limited funding available to 
run clinical studies necessary to demonstrate the efficacy to 
the standards of the medical community.
    The VA could help accelerate adoption of both devices into 
standard medical care by prioritizing and sponsoring further 
clinical studies within the VA system, especially in cases 
where the overall target populations are relatively small such 
as people who are blind or have a balance disorder related to a 
traumatic brain injury. VA funding could make the difference 
for those deserving veterans.
    Mr. Chairman, thank you for inviting me to make this 
presentation to the Committee Members today.
    [The prepared statement of Mr. Beckman appears on p. 41.]
    The Chairman. Thank you so much.
    I have to get my list here. Next, we will have, Mr. 
Broecker.

                 STATEMENT OF DAVID A. BROECKER

    Mr. Broecker. Thank you, Chairman Filner. I really 
appreciate you inviting me here today to address the Committee.
    My name is David Broecker and I am the President and CEO of 
a small biotechnology company in Cambridge, Massachusetts, 
called Alkermes. At Alkermes, we are dedicated to developing 
medicines that make a difference in patients' lives.
    I am pleased to be with you here today and appreciate the 
time you have given me to share the story of a breakthrough 
medicine that we believe can make a tremendous difference in 
the lives of numerous veterans suffering from alcohol 
dependence.
    The medicine is call VIVITROL. But before telling you about 
VIVITROL and how it might benefit veterans, I would first like 
to highlight the problem of alcohol dependence.
    As you are well aware, alcohol dependence is a huge public 
health problem, especially among people who have served in the 
military. It is a disease that not only hurts the patient but 
also affects the lives of family and friends. Unlike other 
illnesses, most alcohol dependent people do not seek treatment 
unless confronted by family or friends and many times treatment 
only occurs after a patient is in some sort of crisis 
situation.
    Nationally, there are approximately 20 million people who 
abuse or have become dependent on alcohol. Of these, fewer than 
10 percent are actually in treatment for their disease.
    Today treatment consists almost exclusively of counseling 
or talk therapy aimed at changing the behaviors of alcohol 
dependent patients. Fewer than ten percent of these people in 
treatment are actually offered any sort of addiction medicine 
in the ongoing treatment of their disease.
    Unfortunately, without medication-assisted therapy, the 
relapse rates of 1 year of treatment are extremely high. 
Tragically the problem of alcohol dependence is intensified in 
military personnel, particularly combat personnel who are often 
subjected to extremely difficult circumstances.
    According to estimates from the Substance Abuse and Mental 
Health Services Administration, approximately 650,000 veterans 
suffer from alcohol dependence. When you combine the diagnosis 
of alcohol abuse with alcohol dependence, the number jumps to 
approximately seven and a half percent of all veterans or 
nearly 1.9 million people.
    Despite these challenges, there are ways to dramatically 
improve care for our alcohol dependent veterans. Current 
treatment guidelines issued by the National Institute on 
Alcohol Abuse and Alcoholism call on providers to consider 
medically assisted treatment in addition to counseling on an 
ongoing basis for all patients.
    Currently there are only four medicines approved by the FDA 
for the treatment of alcohol dependence, Antabuse, ReVia, 
Campral, and our product called VIVITROL.
    Unlike the other medicines which must be taken on a daily 
basis to have a clinically significant effect, VIVITROL is 
unique in that it is an injection that delivers medicine over 
an entire month.
    For alcohol dependent patients struggling with their 
addiction and trying to change their behaviors in profound 
ways, the challenges associated with adhering to daily 
medications are significant, and this is what often leads to 
relapse.
    These are fragile patients, particularly in the early 
stages of treatment. This is why VIVITROL represents a 
breakthrough in the treatment of this disease.
    With VIVITROL, patients receive medicine for an entire 
month allowing them to focus on changing their behavior through 
counseling and other psychosocial support.
    VIVITROL was developed in conjunction with support from the 
National Institutes of Health (NIH) and was approved by the FDA 
in 2006 for the treatment of alcohol dependence. It was shown 
in a large, multi-center, placebo-controlled study to 
dramatically reduce drinking among dependent patients. It has 
also been shown to prolong abstinence and prevent relapse, 
especially among severely dependent patients.
    Since launch, we have heard numerous stories that tell us 
that this medicine does indeed make a difference in patients' 
lives.
    In addition, we know of large managed care organizations 
that have done their own assessments and concluded that 
VIVITROL works well and reduces the utilization of other health 
care services within their system.
    Our belief is that veterans would benefit significantly 
from widespread adoption of VIVITROL within the VA for the 
treatment of alcohol dependence.
    The utilizations of medicines in general, and VIVITROL in 
particular, within the VA has been extremely limited. I believe 
there are several reasons for this.
    First, the current VA/U.S. Department of Defense (DoD) 
guidelines for the use of medically assisted treatment for 
alcohol dependence were written in 2001. VIVITROL was launched 
after these guidelines were developed. These guidelines need to 
be updated and disseminated throughout the VA.
    Second, metrics and targets need to be established and 
tracked for the screening and treatment of alcohol dependence. 
Make the metrics simple so that no one can argue with them. I 
believe that the systems are in place to do this.
    And, finally, make the treatment of alcohol dependence 
within the VA, and with our current service personnel, a real 
priority. The benefits for patients and their families will be 
dramatic.
    And we look forward to working collaboratively to see that 
these goals are achieved.
    Again, I would like to thank the Committee for letting me 
share the story of Alkermes and VIVITROL and, at the 
appropriate time, I would like to answer any questions you 
might have.
    [The prepared statement of Mr. Broecker appears on p. 50.]
    The Chairman. Thank you.
    Mr. Munroe.

                    STATEMENT OF MARK MUNROE

    Mr. Munroe. Good morning. First I want to thank Chairman 
Filner and the Committee for allowing me to testify here today 
on behalf of my employer, Mobile Medical International 
Corporation of St. Johnsbury, Vermont.
    My name is Mark Munroe, Senior Vice President of Mobile 
Medical. My sole purpose here today is to explain how Mobile 
Medical is using an innovative approach to help Veterans Health 
Administration (VHA) medical centers provide top-flight 
surgical care, keep VA surgeons engaged with their patients, 
and save a significant amount of time and money associated with 
the refurbishment of VA operating rooms.
    It is important to note that this is not a new concept. We 
have been engaged with the private sector over 14 years and our 
solutions with VA medical centers for more than 3.
    Mobile Medical is an international company that develops 
and manufactures commercial and military mobile surgical 
hospitals which meet all U.S. health care standards. These 
mobile health care solutions are rapidly deployable, fully 
integrated, self-contained, and present innovative solutions 
for today's health care delivery needs.
    To illustrate the versatility of this technology in various 
markets, please note that Mobile Medical has responded to a 
Federal Emergency Management Agency (FEMA) request to support 
the University of Texas medical branch in Galveston after 
Hurricane Ike.
    We provide on-site surgery at a maximum security prison in 
North Carolina with a Mobile Medical staffed unit and have 
delivered eye care and surgical care units to Armenia, Saudi 
Arabia, Oman, and Iraq.
    As a point of reference, about 6 weeks ago, Mobile Medical 
was featured on the international television program Little 
People, Big World where Iraqi dwarf children were shown 
receiving care on the mobile unit in southern Iraq.
    Our flagship product, the mobile surgery unit, can be 
driven to any VA hospital location and upon deployment, triples 
in size to become a mobile surgical hospital that meets all 
U.S. health care standards.
    These standards include those required for State licensure, 
Medicare certification, and Joint Commission on the 
Accreditation of Health care Organizations. Mobile Medical 
units meet all three of these standards.
    Mobile Medical has provided mobile surgical capability to 
private, nonprofit, and university medical centers for over 12 
years from California to Virginia, and beyond. This service has 
most often been provided on a rental basis and contract periods 
last anywhere from 6 months to several years.
    The primary reasons hospitals opt for this mobile solution 
are that it eliminates the cost of contracting out surgical 
cases to other hospitals and saves additional resources by 
trimming months from the duration of the project.
    Over the past 18 months, Mobile Medical has successfully 
brought this cost-saving innovation to VA medical centers which 
are undergoing hospital operating room renovations.
    Our conservative estimates indicate that VA medical centers 
can save on average $12,000 per surgical case by maintaining 
control of their cases rather than contracting them out to 
local or regional hospitals. This approach also assures VA 
management that VA surgeons are handling the cases and 
maintaining their skills.
    Mobile Medical has successfully utilized this approach at 
the VA medical center in White River Junction, Vermont, and has 
a unit actively working on endoscopic cases at the VA medical 
center in Martinsburg, West Virginia.
    Mobile Medical is preparing to provide several units to 
cover a major operating room renovation project at the Miami VA 
and is currently working on similar opportunities at VA 
facilities in New Orleans, Kansas City, San Diego, Clarksburg, 
and Fayetteville.
    Many facility leaders have indicated interest in utilizing 
our units for the purpose I have described in a streamlined 
contractual process administered by the VA headquarters.
    In order to address these concerns, Mobile Medical 
submitted an unsolicited proposal to VA's National Acquisition 
Center in 2008. This submission proposed a pilot project using 
three mobile surgery units over 3 years, saving $90 million. 
Those savings are summarized in the attached two page executive 
summary I have provided. This request was ultimately denied.
    Mobile Medical estimates that a more robust project using 
20 mobile surgery units for currently scheduled operating room 
projects could result in a total cost avoidance of nearly $700 
million over a 5-year period. We have also attached a document 
that supports that information as well.
    Mobile Medical continues to attempt a dialog with the 
National Acquisition Center (NAC) in order to emphasize the 
significance of the cost savings this approach offers. The 
benefits of keeping patients and staff inside the VA system for 
their surgeries and the difficulties VA medical center 
contracting officers face as they attempt to fashion 
appropriate contract vehicles for this service.
    Mobile Medical stands ready to provide the VA and the 
veterans it serves with cost-effective solutions for complex 
health care delivery concerns. We would be happy to provide 
private sector references as well as VA references if so 
desired.
    Thank you for taking the time to learn about our innovative 
work. It has been a pleasure being here today.
    [The prepared statement of Mr. Munroe appears on p. 55.]
    The Chairman. Thank you so much.
    Mr. Stern.

                   STATEMENT OF STANLEY STERN

    Mr. Stern. Chairman Filner, Members of the Committee, thank 
you for the opportunity to testify today on behalf of TeleMed 
Network.
    My name is Stanley Stern. I am the President of TeleMed 
Network.
    Our team has the singular goal to reduce the shocking rate 
of veteran suicides. As you know, suicide is a solitary and 
misguided act. Our technology addresses this issue directly, 
confronting isolation with connectivity to both the VA and 
other veterans, especially those who are isolated because of 
geography or health status.
    Further, our technology can provide direct and indirect 
guidance to avert these misguided decisions. Our technology 
team is led by Ed Yoon, the former Engineer of the Year for 
Microsoft, and Dr. Mervyn Silverman, an internationally 
recognized leader in the fight against AIDS, provides public 
health guidance.
    Our technology provides veterans with video 
teleconferencing capability in their home. Teleconferencing is 
not new, but it is expensive and complicated to install, 
costing boardrooms hundreds of thousands of dollars per room, a 
cost that can be justified, but cannot be done on a large 
scale.
    Our TeleMed Internet Endpoint known as a TIE costs less 
than $1,000. It is designed to scale. It is small, three 
pounds, portable, mailable, and provides a brilliant 
videoconferencing image on a veteran's home television display.
    The TIE and its secure network are mutually optimized for 
video. There is no installation. It is plug and play. Just plug 
it into the TV, connect it to the Internet, and turn it on. In 
order to scale, it has to be simple.
    Let me explain how being visually connected benefits a 
veteran. First, with just one touch on a wireless keyboard, a 
veteran sees and speaks with a VA health care service provider 
whenever he or she needs help. The health care worker 
immediately appears full screen and the call can be initiated 
by the VA or the veteran.
    A second button connects the veteran to a 24/7 group 
therapy session. The caller can participate or simply observe 
his peers speaking about issues he also confronts. It is an 
ever-accessible confirmation that he is not alone and that 
there are solutions available.
    With this technology, these benefits can be available 
without an appointment, without travel, and, most important, 
without stigma because these conversations do not need to be 
part of a medical record. They just need to help the veteran.
    TIE provides many other communication benefits. After an 
18-month deployment, close friends are dispersed across the 
country. TIEs allow veterans to see and converse with each 
other again.
    For example, squad or platoon meetings every Tuesday night. 
Local veterans can meet on Wednesday nights and there can be 
various interest group meetings as well. TIE connects vets from 
their homes to their veteran peers and professionals at the VA. 
It directly confronts isolation and misguided decisions.
    Help is the least accessible for our rural veterans who 
must often drive hours to receive care. Inaccessibility 
compounds the medical problem and many choose just not to get 
the needed attention.
    Our focus remains suicide prevention, but a TIE unit is 
also an excellent vehicle for medical checkups, evaluation, 
counseling, and eliminating the driving, the waiting, and the 
mileage expense to the VA.
    The TIE can benefit spouses left at home who will be able 
to communicate with each other for support and learn from the 
successes of those who have already had these experiences 
themselves.
    Accessible marriage counseling is just another benefit. Job 
training, classes, even interviews will be available to provide 
new directions, possibilities, and hope for returning veterans.
    The network also creates cost-saving efficiencies. An 
available health care provider in Nevada can answer an urgent 
call from busy New York.
    TIE is a conduit that connects the VA to its veterans, 
allowing the VA to provide its best Post Traumatic Stress 
Disorder (PTSD) remedies 24/7 to a veteran's home.
    Our technology provides the quality, simplicity, and cost 
that allow these advantages to be scalable, benefiting both 
rural and urban veterans.
    We will measure these improvements with independent 
research that will quantitatively demonstrate reduced suicide 
rates and intentions, improved medical benefits and access, and 
lower costs all within 1 year.
    Mr. Chairman, that completes my statement. I will be happy 
to answer any questions. Thank you.
    [The prepared statement of Mr. Stern appears on p. 56.]
    The Chairman. Thank you.
    Dr. Scadden.

                STATEMENT OF DAVID SCADDEN, M.D.

    Dr. Scadden. Mr. Chairman, Members of the Committee, thank 
you very much for the opportunity to speak with you today.
    I am here as a representative and scientific founder of 
Fate Therapeutics, which is a new biotech company started in 
San Diego, California.
    My day job is as a physician. I am a hematologist/
oncologist. I run the Center for Regenerative Medicine at the 
Massachusetts General Hospital. I am the Jordan Professor of 
Medicine at Harvard, where I co-founded and co-direct the 
Harvard Stem Cell Institute and the Department for Stem Cell 
and Regenerative Biology.
    Fate Therapeutics is a company that is dedicated to taking 
advantage of the explosive new information about stem cell 
biology as a way to induce regeneration and thereby reduce 
disability.
    The technology of stem cells is something that has become 
available now as a modality by which we can approach problems 
of chronic disability as a means to try to reverse, not simply 
forestall, the development of disease.
    Stem cells that we are approaching are really of two types. 
The first is the adult stem cell population that resides in all 
of us, that is in most of our tissues. And our approach is to 
identify compounds that have the capacity to turn these cells 
on as a means to enhance the body's ability to repair itself.
    We have identified drugs that are capable of doing this, 
and are entering into clinical trials to do so, and have, as a 
number of different opportunities, ways in which we can take 
advantage of learning about the stem cells that, for example, 
make up our musculoskeletal system and turn them on with 
medications as a way to improve the outcome of blast injury to 
limbs, an important aspect of veteran care.
    In addition, another stem cell technology that we focus on 
is the ability to take cells from any one of us simply by 
plucking a hair, exposing them to particular compounds in a 
laboratory, and reversing the history of those cells so that 
they become essentially an embryonic-like cell.
    They are clearly not derived from an embryo. They can be 
derived from any of us, but they have the full capability of 
being able to serve as a source of any cell type.
    The advantage of this cell is that it then becomes 
essentially an identical reproduction of the cells that we all 
have and, therefore, it could be potentially used as a tool kit 
for each of us as a way to potentially replace injured tissue. 
That would be accomplished without the potential for 
immunologic rejection.
    These cells also have the capacity to be used as a model 
for the development of new medications. Again, an emphasis of 
our company is to try to design ways in which we can identify 
molecules that could be used as a way to enhance regeneration, 
to induce an ability to restore function of damaged tissues.
    So we are an early stage company that has focused on the 
two different types of stem cells using essentially the 
strength of the pharmaceutical approach to now develop 
strategies to improve the ability of regenerative capabilities 
in settings that are particularly relevant for veterans 
including those of limb injury, with blasts to musculoskeletal 
tissues, as well as neurologic regeneration in the setting of 
hearing loss and visual loss.
    So our company is one that tries to take advantage of the 
necessary need for the innovations in the academic setting, 
coupled with the commercial enterprise, and we hope with 
government partnership.
    Thank you for your attention.
    [The prepared statement of Dr. Scadden appears on p. 59.]
    The Chairman. Thank you so much.
    In a conversation with the Secretary of the Department of 
Veterans Affairs, I asked him to send somebody to this hearing. 
Is there a representative from the VA here? Thank you so much, 
we have a representative. I appreciate you being here.
    Both the Secretary, in his use of the word transformative, 
and the Deputy Secretary's understanding of innovation bode 
well for the future, but we wanted to make sure people were all 
aware of this.
    Mr. Mitchell, do you have any questions?
    Mr. Mitchell. Thank you, Mr. Chairman. I would like to ask 
a couple questions of Mr. Bethune.
    What makes the use of ViziLite Plus by the VA such a high 
priority?
    Mr. Bethune. Well, I would ask Dr. Sidransky to answer that 
if you do not mind.
    Dr. Sidransky. Yes. The bottom line is that veterans are at 
great risk for oral cancer. And while we all accept screening 
for various types of cancer like cervical cancer, colon cancer, 
et cetera, we sometimes neglect this important disease which is 
really a plague for veterans.
    By using this technology, lesions that are curable, 
resectable, and would impact these veterans. It would be 
available to them, and that is the main reason to really 
approach and use this technology with the veterans.
    Mr. Mitchell. I have one other question of Mr. Bethune.
    In your prepared testimony, you argue that this Committee 
should call upon the VA's headquarters to implement ViziLite 
Plus exams across the VA system despite objections raised by 
senior VA dental officers. However, you also mention six 
facilities in the VA system are already using ViziLite.
    What feedback have you received from those VA offices who 
have decided to utilize your product and does it square with 
the assessments of the senior VA officials?
    Mr. Bethune. Congressman, I believe that they do agree that 
it is a very worthwhile test to be performed routinely. We 
have----
    The Chairman. I am sorry. Can you put the microphone in 
front of you?
    Mr. Bethune. Yes. Those that we have contacted and talked 
to about this product found it very important to implement.
    Our problem is as a very small company, we do not have the 
resources to call on all of the many VA hospitals and clinics 
around the United States and it would take us years to have 
each of these institutions look at this technology and then 
make the decision. That is why we are urging the head of the VA 
here, General Shinseki, to look at it as a universal program 
for all of the VA hospitals.
    Mr. Mitchell. But the feedback you have gotten from the six 
VA hospitals so far has been very positive?
    Mr. Bethune. Pretty much so, yes, sir.
    Mr. Mitchell. Thank you, Mr. Chairman.
    The Chairman. Thank you, Mr. Mitchell.
    Mr. McNerney.
    Mr. McNerney. Thank you, Mr. Chairman.
    Well, I have to say I found all of your testimony very 
exciting. And this is the kind of thing I want to see happen.
    Mr. Bethune, the ViziLite Plus, how intrusive is it to 
administer this test? Is it just a swab or how is the test 
administered?
    Mr. Bethune. We have a person out here. Dr. Balanoff is a 
practicing dentist and he uses this routinely in his practice.
    Dr. Balanoff, could you answer that question, please?
    Dr. Balanoff. Yes. It is a very simple test. You have a 
patient rinse with an acetic acid rinse----
    The Chairman. Sir, we have a microphone at the end of the 
dais. If you could use that one? Thank you.
    Dr. Balanoff [continuing]. You have the patient rinse with 
an acetic acid rinse which has kind of a vinegar taste to it. 
And the most important thing is to use a light. And this light 
will identify all abnormalities. And this is really important 
for the general dentist, which is going to be screening the VA 
population.
    So it is just a very simple, easy test that takes less than 
2 minutes to do and is noninvasive and is 100 percent accurate 
to all leukoplakias, white lesions, inside the mouth.
    And then the follow-up to that would be if you found 
something abnormal to use the blue, the tolonium chloride that 
we have as part of our kit and, again, noninvasive.
    Mr. McNerney. So you rinse out the mouth and then look at 
it with a light or something?
    Dr. Balanoff. That is correct. That light is a special 
wavelength. White light which will allow the dentist to find 
something abnormal and then once they find something abnormal 
to refer it off to the appropriate specialist. And what this 
light does, it is an adjunctive test, which just makes it 
easier.
    It would be kind of equivalent to going to a medical doctor 
and not allowing the medical doctor to use a stethoscope or a 
blood pressure cuff. You want something adjunctive to help you 
diagnose the health of the patient and that is what the light 
does.
    Mr. McNerney. All right. Thank you. Thank you.
    Mr. Beckman, the BrainPort vision device, this sounds 
very--how intrusive is the device that is on the tongue? Are 
you able to eat? Do you have to remove it for different 
activities or how intrusive is this?
    Mr. Beckman. Well, for vision, the device does rest on top 
of the tongue. And so, yes, indeed, in its current form, you 
would have to remove the device when you were eating, talking, 
et cetera.
    However, with additional funding, there are no 
technological barriers to making this device totally wireless 
so that the intra-oral device could be mounted on the upper 
palate. And blind people using wireless technology would be 
able to use the device without anybody even knowing that they 
actually have the technology available to them.
    Mr. McNerney. Well, that is pretty exciting. I am kind of 
thrilled by the technical aspect of this rather than the 
administrative aspect, if you cannot tell.
    Mr. Broecker, the drug that you are talking about, how does 
it work? Does it make you nauseous when you have alcohol or how 
does it work?
    Mr. Broecker. No. You know, one of the very first medicines 
that was developed was a drug called Antabuse and that is the 
one that if you take it and you drink alcohol, it makes you 
sick.
    Our drug, VIVITROL, is a monthly injection. And what is 
thought is that this diminishes the cravings that occur in 
alcohol dependent patients by blocking your opiate receptors. 
And so that is how the drug works.
    Mr. McNerney. Are there any side effects?
    Mr. Broecker. Some minor nausea, but that quickly goes away 
after a couple days.
    Mr. McNerney. And do you have to continue the usage of 
VIVITROL for a long period of time or is a couple months 
sufficient?
    Mr. Broecker. Well, in the studies that we have done, we 
have monitored patients over a 6-month period of time. So the 
clinical studies we have done have been over 6 months of time. 
However, we do know of patients that have been on it for, you 
know, 2, 3 years.
    But it is very important that, you know, the patient not 
only get the drug but they are engaged in an active counseling, 
you know, a program to deal with the behavioral aspects of 
alcohol dependence. So the medicine addresses the biological 
urge and craving to drink while the counseling addresses the 
behavioral change that is required.
    Mr. McNerney. Well, thanks.
    Again, I want to thank the panel for their testimony and 
for the Chairman for the insight to bring this panel together.
    The Chairman. Thank you.
    Mr. Walz.
    Mr. Walz. Thank you, Mr. Chairman.
    And thank you to each of you for coming in and, as my 
colleague from California said, sharing with us some very 
exciting and innovative technology.
    Obviously the goal of this Committee and I would say the 
goal of all Americans is to provide for the highest quality of 
life for our veterans after they serve our Nation. It is an 
honorable goal and also if it is done right, and we have heard 
many of you say this, it is not only doing morally the right 
thing, it is going to save us money in the long run.
    So my question to you, and I am with Mr. McNerney, I like 
the technology side, too, but I also know that it is not the 
technology that stops this from happening, it is bureaucracy 
that stops it from happening in many cases.
    So that is the part I want to talk about a little bit, 
about acquisition reform and contracting reform because we 
heard the President talk last week, just in cost overruns at 
DoD, if we do this right in acquisition reform, we can save up 
to $300 billion.
    I do not think people realize what we are talking about. 
That is the entire pay of our entire military and the health 
care for their families for 2\1/2\ years in cost overruns, not 
cutting weapon system, just cost overruns.
    So my issue on this is, I wanted to ask each of you, we all 
understand that the reason we have a lot of these things in 
place is to prevent fraud, waste, and abuse. Obviously it is 
not totally doing that, at least from an efficiency standpoint 
in DoD. The same might be true of the VA. Those procedures were 
never put into place to stop innovative and life-saving 
technologies from getting to our veterans.
    So I would like each of you to just take, you know, a few 
seconds or whatever. What has been your experience? And some of 
you, you are obviously coming from the private sector, too, so 
you are dealing with private institutions.
    I say this because I always ask all of my questions against 
a backdrop that I represent the Mayo Clinic and I ask them how 
does it work for you as opposed to the VA. And we all agree the 
VA does many, many, many things as well as anybody in the world 
in terms of the care.
    This is the part I want to understand: are we nimble enough 
to innovate or are we behind the curve in that? So why don't 
each of you just give your input as you see this. Are we 
inhibiting it and not really protecting the taxpayer dollars in 
the right way?
    So if we just start with Mr. Beckman and go around, that 
would be great.
    Mr. Beckman. Neither the BrainPort balance device nor the 
BrainPort vision device are cleared by the Food and Drug 
Administration (FDA) at this time. So we are not in the process 
of attempting to commercialize or market our devices to the VA.
    On the other hand, I think that the VA could take a 
leadership role, especially when you consider that people with 
traumatic brain injury represent a very small population 
overall and within the military. And, secondly, people that are 
blind, especially people that are totally blind with no better 
than light perception are also a very small population.
    So, again, it would, I think, make sense for the Veterans 
Affairs to take a leadership role so that the people, for 
instance, who have been blinded or who have suffered traumatic 
brain injury as a result of the most recent conflicts would be 
the first in position to be able to test these technologies 
rather than being the last.
    Mr. Broecker. When it comes to alcohol dependence, as I 
mentioned in my testimony, the latest guidelines that have been 
adopted by the VA were in 2001. And, since that time, not only 
has our drug been approved by the FDA, but there has been 
another drug called Campral that has been approved by the FDA.
    So, as it relates to adoption of innovative treatments for 
a disease like alcohol dependence, these guidelines need, you 
know, continued to be updated and then disseminated within the 
VA system.
    My understanding is that there were recent guidelines that 
were developed last spring that still have not been 
disseminated. So, I think something that they need to do is 
clearly, you know, the expert groups and the key opinion 
leaders within the VA should see to it that these things get 
adopted and get put into practice within the VA system.
    I think the other thing is, you get the results you 
measure. And, I know that the VA is a big, complex system, but 
if you could, develop very simple measures that could be 
adopted across the VA about things like alcohol dependence or, 
the variety of the diseases that are represented up here with 
all the various technologies and hold the people accountable 
for implementing some of these new technologies.
    And then the final thing I would say is, make funding 
available. If there are certain funding pools that could be 
allocated to the adoption of certain technologies, as you 
mentioned about sight and things like that, there is no better 
testing ground than the VA for some of these innovative 
therapies.
    Mr. Munroe. Congressman, we are in a little bit of a 
different category here with Mobile Medical in that we 
currently work with the VA. We are on an innovative technology 
track, which is answering a question that exists today and that 
is that with the current state of the VA facilities and the 
need for operating room renovation, the facilities really have 
two options when it comes to doing that.
    The first is they close their operating rooms altogether 
and they send their patients outside into the private health 
care sector. When you do that, you lose all control. And 
certainly from a cost perspective, now you are in the 
commercial setting paying commercial rates. You are not in the 
existing setting which is really health care at cost.
    The second option that they have is they can close a 
portion of their operating rooms and essentially phase a 
renovation project. If they do that, two major things happen. 
One is the construction and renovation of that project doubles 
and sometimes triples in length, i.e., it triples in cost.
    The second thing that happens is you are always concerned 
about infection control. And we have seen some of that very 
recently in the VA setting because when you are doing 
construction in an operating room theater on one side of a wall 
and you are treating a patient on another side of a wall, I am 
sure some of the surgeons here could say, you know, that is not 
the most conducive environment.
    Additionally you have staff that now have to work different 
shifts, overtime, double time in order to cover that type of 
schedule.
    So to answer your question of the bureaucracy component of 
this, just today we received an e-mail from one of the VA 
facilities that says our renovation project is approved. It is 
part of the stimulus bill. We forgot how we are going to treat 
our patients when we close our operating rooms.
    We did not put that on the front end of our project plan. 
We just said we need to fix the hardware, the operating room. 
So now the contracting officer has to scramble and they have to 
scramble to take operating dollars to solve that problem. That 
issue is apparent at every VA facility I go to and visit when 
they talk to us about operating room renovations.
    So as you can see in some of the numbers we have presented, 
our objective and our goal with our unsolicited proposal was to 
show the VA that the request is there. The contracting 
officers, the chiefs of surgery, have the need for this 
solution. The projects are scheduled. The facilities need to be 
renovated.
    If there was a pool of units such as ours that they could 
now say, okay, this project now receives two, three, four 
mobile surgery units, all that bureaucracy goes away because 
now they have access to the tool that they need, no different 
than having access to the drug that they need or anything else 
to help the veterans in that setting.
    Mr. Walz. I appreciate it. I went over my time. I will wait 
if we get a chance to come back around again to let the four of 
you take that on too.
    So, Mr. Chairman, I yield back.
    The Chairman. Mr. Walz, why don't we just try to finish?
    Mr. Walz. Thank you, Mr. Chairman. I appreciate that.
    Mr. Stern, go ahead.
    Mr. Stern. Well, I will be brief. In our case, this is a 
dramatic reduction in cost for communication and communicating 
with veterans about their real psychological needs early will 
truncate many years of therapy thereafter. So it has to stand 
up to the cost benefits and I am sure that it does.
    That said, for many of the technologies we have heard about 
today, there is also a social benefit that often transcends the 
economic parts. And I think that somehow, even though it cannot 
be quantitative, has to be measured.
    Dr. Scadden. I will just say that in the setting of 
rehabilitation, the VA is clearly very strong, but its emphasis 
is largely on device and engineering-based approaches.
    And one of the things that I think stem cell biology 
represents is a way to try to take advantage of cellular 
components that may enhance the ability of such devices to be 
functional.
    And to have the VA be involved in bringing together teams 
of individuals who have the perspective and expertise that the 
VA system represents coupled with those who have the expertise 
in cell biology, I think, could actually be a very productive 
area of developing new approaches to rehabilitation 
regeneration.
    Mr. Bethune. Yes, sir, Congressman. Our product, ViziLite 
Plus, has been approved by the FDA. It has been awarded a 
special government award contract for use in any Government 
Federal facility. So there is no impediment for this product to 
be used.
    The impediment, I believe, is that we do not have a 
universal requirement that this be administered around all of 
the VAs. It is a decentralized decision now being made where 
the local VA can make the decision.
    And most of the VAs, you asked this morning, Congressman 
Mitchell, about what do they think about this product is that 
many of them say, well, we do not have the funds earmarked for 
this product.
    So many VAs report that they don't have available money to 
spend, although they tell me they do have the funding for other 
projects, but they do not have a special earmark fund for 
ViziLite Plus to administer this oral cancer screening exam.
    Mr. Walz. Thank you, Mr. Chairman.
    The Chairman. Thank you, Mr. Walz.
    Mr. Donnelly.
    Mr. Donnelly. Thank you, Mr. Chairman.
    Dr. Scadden, this area of stem cells is really interesting. 
What can it be rewound to do? There are a couple of specifics 
that you mentioned, but what is the overall feel that is out 
there?
    Dr. Scadden. So right now we have the ability to take a 
cell that is defined as being something like a skin cell or a 
blood cell and essentially have it be able to forget all of its 
history. It no longer identifies itself as such and it can 
become any one of the different cell fates. There are over 200 
cell types that make up our body.
    So the potential is to be able to now say, well, maybe from 
this population of cells that we derived from here, we could 
now make a cell population that makes insulin and that could be 
used for individuals with diabetes or we could make things like 
muscle and potentially have it be useful in that context.
    So I think the range of possibilities is quite enormous. 
The technology is obviously very, very early and the question 
of how to do it in a way that gets predictable outcomes, that 
is safe, all of these things are still in need of development.
    But it is, I think, something that we should frankly be 
driving full speed ahead because this is really a very 
transformative technology and the ability to potentially 
reverse, not just forestall, the outcome of injury and disease.
    Mr. Donnelly. So while you talk in the documents we 
received about three specific applications, the applications 
are basically limitless?
    Dr. Scadden. Yeah. I mean, we do not know now whether or 
not we will be able to create all of the different cell types 
of the body, but certainly this potential is something that 
when tested has been possible to achieve. And I think a lot of 
it is more technical than it is in biologic terms.
    Mr. Donnelly. And this is simply just one of our skin cells 
from our hand?
    Dr. Scadden. Right. So what is done now is either biopsy 
from the arm, for example, you can literally pluck a hair, you 
can take a blood sample.
    Mr. Donnelly. Thank you.
    Thank you, Mr. Chairman.
    The Chairman. Mr. Hall.
    Mr. Hall. Thank you, Mr. Chairman.
    And thank you to all of our panelists. I am sorry to have 
missed the first part of the testimony, but I have a couple 
questions.
    Mr. Beckman, I wonder if you could tell us why BrainPort 
devices are not implantable and is that something that could 
change?
    Mr. Beckman. I think one of the key advantages of the 
BrainPort device is the fact that it is not implantable. In 
fact, it is a portable device where there is no need to implant 
the technology.
    Other technologies for vision such as retinal implants are 
being developed, but I think the fact that they involve 
surgery, that they are invasive means that those technologies 
will likely not be available for probably 10 years or more. Our 
technology is available today.
    Mr. Hall. I understand that. And I can see the advantages 
to either, or both. But cochlear implants, for instance, have 
been and are being used by large numbers of people with some 
success.
    Is it because of the location in the brain of the nerves 
that one would need to get at, the nerve centers one would need 
to get at, that it is more difficult or is this something that 
you see happening in the future?
    Mr. Beckman. That goes back to my testimony. One of Dr. 
Paul Bach-y-Rita's main hypotheses is that the brain is not 
hardwired. So, in other words, you can use an alternate sensor 
and also an alternate path to send that signal to the brain.
    And we have demonstrated that, for instance, people who are 
blind who perform a certain task with our device and while they 
are performing that task, they are analyzed with PET imaging, 
we have demonstrated that those people process the visual 
information in the visual cortex of their brain.
    On the other hand, people who are sighted that perform the 
exact same task process that same information in the 
somatoesensory region of their brain. So, in other words, the 
brain is masterful in the way that it can process the 
information in the appropriate area.
    Mr. Hall. And it can change, it can switch and adapt from 
one pathway to another?
    Mr. Beckman. Yes.
    Mr. Hall. What is the typical training, you may have said 
this in response to a question before I got here, what is the 
typical training time for someone to be able to use, to adapt 
to the BrainPort?
    Mr. Beckman. I think that is also an amazing part about 
this technology. We train blind people, literally in hours they 
start to recognize symbols, pathways, doorways, et cetera. We 
have not so far had anybody except for one blind person, Eric 
Weihenmayer, use the device for more than 10 hours.
    We have videos on our Web site that show some of the 
benefits. All of those people are performing the tasks with 
less than 10 hours of training.
    And I think what is most interesting is what will happen 
when we get this technology into the hands of many, many 
adults, letting them take it home, use it on their own, explore 
the potential benefits of the technology on their own. That is 
where we will start to really discover what the advantages and 
possibilities are for this technology.
    Mr. Hall. Thank you.
    Regarding the use of, I believe it is Mobile Medical and 
TeleMed, well, certainly, you know, having just come back from 
Afghanistan and Iraq as many of us did on our so-called break 
at the end of last month, we are all very much in favor of and 
encouraged by the work that you are doing to make the treatment 
of our wounded service men and women faster and more effective. 
And we realize the conundrum of battlefield medicine saving 
more lives but then leaving more grievously wounded people for 
us to treat when they get home.
    I read something here, I believe it was Mr. Stern, the 
TeleMed testimony, about remote computer provided sessions for 
group therapy counseling, et cetera.
    What are the limitations of that? I mean, there are 
inherent, I believe there are inherent limits to what a soldier 
will diagnose him or herself with or how--the interpersonal 
reaction between therapists and patient or a room full of 
participants face to face is different. There is body language. 
Well, it is harder to just get up and walk out the door. It is 
easier to log off. How do you address that or can you address 
that problem?
    Mr. Stern. Yes, Congressman.
    Mr. Hall. Would you push your microphone there, please. 
Thank you.
    Mr. Stern. How is it now?
    Mr. Hall. That is fine. Thank you.
    Mr. Stern. The idea behind a group session is, there are a 
number of types. I only had 5 minutes to explain there and so I 
welcome the question.
    There is absolutely room for private group therapy session 
where somebody can be there as an individual or anonymously. 
That is all right, too, because the stigma is a big part of 
this.
    But I think the thing that will benefit most people is 
having the ability for, with the knowledge of those 
participating, with their full knowledge, having others observe 
them passively.
    You know, it is not unlike what we see in talk radio where 
you will have a psychologist or a doctor explaining a problem 
to one person who knows they are being heard nationally, but 
many of us just listen in the car and listen and think, well, 
that relates to me. I have had those problems and I like 
hearing that solution.
    But we would not have gone to a psychologist or a doctor to 
get that solution. This offers that benefit, but it has to 
always be very clear. You need to know if it is public or 
private and it is easy to do both.
    I hope that answers your question, sir.
    Mr. Hall. It does. Thank you.
    I yield back, Mr. Chairman.
    The Chairman. Mr. Perriello.
    Mr. Perriello. Just quickly. Thank you very much, Mr. 
Chairman, for holding this hearing.
    I think this intersection of innovative technologies and 
treatment of our veterans is a very exciting area and obviously 
in many ways, the VA system itself is in a great position to 
deal with this given the issues that we face. But we also know 
so many independent private-sector groups are at the cutting 
edge of this.
    So not only helping us to understand where the technology 
is and where it can go, but also addressing some of these 
issues of the dynamic relationship between the VA system itself 
and independent companies is very important.
    So I enjoyed reading your statements even though I missed 
many of them here. I really just want to say how important this 
is as an issue and something we want to push on.
    There are not many questions I have. I just wanted quickly 
to understand a little bit more from you, Mr. Bethune, about 
what some of the real world experiences have been with doctors 
and health care providers with the ViziLite Plus innovative 
technology. It is just something I wanted to understand a 
little more about how that has played out in the real world 
applications.
    Mr. Bethune. Well, thank you for that question. I have a 
person here in the audience who would be great for that 
question, Dr. Joel Epstein. He is Professor of Oral Medicine 
and also Oral Cancer at the University of Illinois. So he might 
be able to answer that question more.
    Dr. Epstein. Thank you for your question. It is nice to be 
here with you.
    The real world utilization requires increasing education 
for utilization of detection adjuncts based upon the principle 
that early detection of any cancer is critical. It is critical 
more from the standpoint of diagnosis and preventing reducing 
the morbidity of more intensive therapy that is required for 
advanced disease management.
    In addition, there are the cost savings in terms of quality 
of life impact which is dramatic for head, neck and oral cancer 
and from the standpoint of cost of care.
    Early detection that is being promoted on an ongoing basis 
in the community and to a large degree the dental community 
because currently we see earlier stage disease being diagnosed 
by dental providers rather than medical providers. This relates 
in part to the way in which patients present.
    For example, if it is weight loss or voice changes occur, 
those patients may present at a late stage to a physician's 
office rather than a dentist's office.
    But certainly, all health care providers should be involved 
in early detection procedures and this can and has been shown 
to enhance the early detection of oral cancers.
    Mr. Perriello. Let me ask one other question that is 
hypothetical. It came up anecdotally talking to some of the 
doctors, but more the troops when I was over in Afghanistan, 
was this issue about whether we are sufficiently prescreening 
folks. And it was all anecdotal in terms of a propensity for 
PTSD.
    And there was no evidence, and I am not claiming that there 
is such a thing, but do we think that down the road, there may 
be some way to look at this from the front end of being able to 
identify more accurately potential predisposition in some of 
these directions before we send people into conflict or is that 
really something that will continue to play out as sort of myth 
among folks at the battlefront but not real medicine?
    Dr. Sidransky. Hi. Yeah. So this probably goes away from 
the area of expertise of the people that are here. I am 
actually also a geneticist.
    And I think that in general, that is the way the medicine 
is going, but it will be a period of time. We will understand 
more the makeup of individuals as well as some of the risk 
factors perhaps with questionnaires and other things that they 
fill out.
    And I think for any type of disease, whether it be cancer, 
post-traumatic stress or anything else, I think there will be 
an interaction between the genetic information that the veteran 
comes with as well as some of the environment that can be 
related and the questionnaire is some sort of intake.
    And I think it can. I think for many of these diseases that 
interaction, if you can actually take it out and implement some 
way of actually looking at it, we will be able to identify some 
of these individuals, to identify them as being potentially at 
risk or basically, you know, for therapy or something else or 
actually not able to be able to participate because of that.
    We are not quite there yet, I think, for a lot of the 
mental and the psychiatric issues, but I think there is a lot 
of movement in that direction.
    Mr. Stern. And I agree with Dr. Sidransky on this point, 
that this is solvable. And right now it is being done in a very 
crude way, I am afraid.
    I mean, I know an anecdote that was told to me by the 
person in charge of suicide prevention at the Palo Alto VA. She 
was telling me the story of a sergeant who on the day they were 
being deployed had questions about one of his troops and his 
behaviors and really did not know how to diagnose it.
    And it was happening at that level and clearly it could be 
done before that by professionals, not the sergeant ready to 
board the plane, but by professionals before that, as long as 
you have the communication ability or some other mode to get 
people in and diagnose them. So I think it is very solvable.
    The Chairman. We need to go for votes. We have been called 
for votes and we are going to have to take a recess for about 
15 minutes. I will dismiss the first panel after I just ask 
some quick questions.
    I want to thank you all, I think everybody who has heard 
you was blown away by the excitement of what new technology can 
really do. You represent just a slice of what is happening in 
America with new innovations.
    I am confident that our new Administration will be more 
open on the various levels you talked about, not only in 
testing, but if you need a centralized decision, for example, 
or more openness.
    I had a long talk with Secretary Shinseki and Mr. Gould, 
the Deputy Secretary, and they are very aware of how an agency 
needs to have a way to innovate. I think we are going to have a 
much more flexible, nimble VA to make use of some of the 
innovations very much more quickly. We will be testing that by 
your experiences.
    I just again want to make it clear for the record, you see 
that none of our Republican colleagues are here. They decided 
that somehow special interests were invited, somehow that we 
were promoting this or that company. That was not the 
intention. We are trying to take a cross-section of what is 
available. Nobody here is pushing for a contract, just a sense 
of ideas that are available and how we might respond as an 
institution.
    I just want to make sure, since this always comes up, that 
none of the witnesses have ever given me or anybody else up 
here a campaign contribution.
    This is a hearing to talk about the excitement and the 
possibilities of new innovations. I see someone who might want 
to say a few words, from the Blinded Veterans Association, of 
what this might mean for someone who is blind.
    The opening up of fields of vision for people who have eye 
injuries, or brain injuries is exciting. It is a tool where 
people can read, with a non-invasive technology that has been 
shown to us and, yet, the VA does not have it for some reason.
    I want to thank you all for helping us generate that 
excitement and to make sure the new Administration understands 
that we have to look at this in a much more nimble fashion.
    We have the second biggest bureaucracy in the government, 
but it has to move faster because it affects our patients' care 
and their quality of life. Every one of you talked about how we 
could save hundreds of millions, if not billions, of dollars. 
This is not rocket science to say if it works, let us use it.
    Just one quick question. Mr. Munroe, you talked about the 
mobile surgical unit to help when there are problems, for 
example, refurbishing a VA facility.
    How about access into rural areas? That is one of the 
biggest problems faced by the VA. I assume we can adapt this 
and take that to the veterans in rural areas as opposed to 
forcing them to go 200, 300, 400, 500 miles.
    Mr. Munroe. Mr. Chairman, understanding one thing. The 
genesis of Mobile Medical was exactly that, was that there are 
patients in the private sector and in the VA setting that spend 
hours traveling for procedures and having a mobile solution 
that can go to a community, draw from that pool while it is 
there, and then travel to another community is exactly the 
reason that the mobile surgery unit was created in the first 
place.
    The Chairman. Thank you.
    Mr. Munroe. You are welcome.
    The Chairman. Again, we have to run for some votes. We will 
be back in 15 minutes. I will dismiss the first panel. Ask the 
second panel to approach the witness table.
    Again, thank you so much for sharing these innovations. 
Some of this is proprietary, but I really appreciate you 
sharing with us the excitement and to demonstrate the kinds of 
changes that we can make to better serve our veterans. We will 
start panel two in 15 minutes.
    [Recess.]
    The Chairman. I apologize again for the interruption, we 
have no control over when votes are held. We thank you for your 
patience and look forward to panel number two. I hope that in 
your presentation you answer the question that Mr. Walz asked, 
which is, ``What do you need from the VA to make this a reality 
for the veterans we are responsible for?''
    I appreciate your being here. Dr. Howard Federoff is the 
Executive Vice President for Health Sciences at Georgetown 
University, Dr. Nelson Handal is the Founder and Medical 
Director of Harmonex, Inc., Clinicom, and James Schoeneck is 
the Chief Executive Officer of Braincells Inc.
    Dr. Federoff.

 STATEMENTS OF HOWARD J. FEDEROFF, M.D., PH.D., EXECUTIVE VICE 
PRESIDENT FOR HEALTH SCIENCES, EXECUTIVE DEAN OF THE SCHOOL OF 
MEDICINE, GEORGETOWN UNIVERSITY MEDICAL CENTER, WASHINGTON, DC; 
 NELSON M. HANDAL, M.D., FAPA, FOUNDER, CHAIRMAN, AND MEDICAL 
    DIRECTOR, HARMONEX, INC., CLINICOM, ATLANTA, GA, BOARD 
CERTIFIED CHILD, ADOLESCENT AND ADULT PSYCHIATRIST, AND FELLOW, 
AMERICAN PSYCHIATRIC ASSOCIATION; AND JAMES A. SCHOENECK, CHIEF 
       EXECUTIVE OFFICER, BRAINCELLS INC., SAN DIEGO, CA

          STATEMENT OF HOWARD J. FEDEROFF, M.D., PH.D.

    Dr. Federoff. Good afternoon Chairman Filner and Members of 
the Committee, thank you for holding this hearing, for the work 
you are doing on behalf of America's brave veterans, and for 
allowing me to testify this morning.
    I will be focusing on innovative work that from my 
perspective is critically important to addressing the long-term 
implications of traumatic brain injury both to ensure that we 
are serving the long-term needs of returning veterans who have 
experienced TBI and also to do so in ways that are wise for the 
Department of Veterans Affairs Health Care Programs.
    The Defense in Veterans Brain Injury Center makes the point 
on its Web site that America's armed forces are sustaining a 
tax from explosions or blasts almost daily in Iraq and 
Afghanistan. It also notes that screenings at Walter Reed have 
found that 32 percent of servicemembers evacuated from theater 
had traumatic brain injury. Those statistics obscure the 
reality.
    Also referenced on that Web page that sometimes in the 
setting of mild traumatic brain injury there may be no outward 
sign of injury. Over 90 percent of combat-related TBIs are 
close brain injuries.
    Indeed, TBI has been termed the silent epidemic. While 1.4 
million Americans suffer from TBI from a variety of sources 
each year, many of these injuries with potential long-term 
consequences are not reported. Even in mild cases of trauma the 
central nervous system can suffer permanent, often debilitating 
damage.
    There can be no dispute that our military is moving 
aggressively to respond as best as they can to the flood of 
very visible and tragic traumatic brain injuries that our men 
and women in uniform are experiencing in these 21st century 
conflicts.
    Just as the nature of these injuries has changed from shell 
shock suffered by those serving in earlier conflicts, medical 
science has made significant strides. But we owe it to those 
who are serving and those who have served our Nation in uniform 
to act on the important realization that notwithstanding the 
attention they are receiving, there are all too many who have 
suffered mild to moderate traumatic brain injuries that pose 
serious but hidden threats to their long-term well-being. We 
need to act.
    Developing methodologies for more rapid and accurate 
diagnosis of traumatic brain injury and its associated risk 
determine the most effective approaches to triaging patients 
with traumatic brain injury.
    Pursue the rational design and screening of new therapies, 
including novel drug discovery and development targeting the 
prevention or minimizing of cognitive impairments which can 
impact learning capabilities, the ability to hold down a job, 
and to predispose to post-traumatic stress disorders.
    Years of neurologic research has taught us a great deal 
about the human brain, and therefore there is information that 
is relevant to TBI victims.
    First, the plasticity of the human brain permits unique 
recuperative responses to trauma. We must fully understand 
these responses to better understand when to intervene and when 
to allow the body to heal itself.
    Second, research to date indicates that unlike in the case 
of stroke in at least some forms of TBI there is a longer time 
frame from the time of injury for possible therapeutic 
intervention before permanent loss of brain function.
    And third, research in other areas. Alzheimer's and 
Parkinson's disease makes clear that blood in its circulating 
cells may serve as an important window into the human brain 
helping us to better understand the impact of neurologic 
disease and injury.
    For example, understanding the neuropathology of brain 
inflammation through the analysis of blood-based proteins and 
distinct populations of white blood cells called leukocytes may 
help us to determine the extent to which the brain has been 
injured and the degree to which the body is responding and 
possibly recovering.
    These observations are generally invisible, absent a 
molecular analysis of the blood of an injured person, but they 
potentially hold the key to effective and timely interventions.
    Recently the Department of Defense, through its Neurotoxin 
Exposure Treatment Program, NETRP, has awarded a 5-year grant 
to Georgetown University Medical Center neuroscientists to 
perform systematic and extensive biomolecular profiling of 
brain tissues and peripheral blood to identify and validate 
robust and sensitive and specific markers for traumatic brain 
injury. These signatures can be read from the blood, and early 
on may aid in the diagnosis of a variety and severity of brain 
injuries and guide therapeutic responses.
    Indeed this research I am confident will inform the 
rational design of new drugs and therapies to prevent both 
short-term and lasting brain damage.
    Our work will be carried out in conjunction with the 
Seattle-based Institute of Systems Biology and researches at 
the University of Rochester.
    As someone who believes in the tremendous benefits of 
possible collaboration, I am pleased that we are working with 
the Uniform Services Universities of the Health Sciences as 
they pursue their direction from Congress to focus on TBI, as 
well as the National Institute for Nursing Research, the 
National Institute of Neurologic Disorders and Stroke, and the 
Washington Hospital Center.
    Our research for the Department of Defense will rely 
critically on first the civilian-sector TBI patients for our 
initial studies in recognition of the reality that we will be 
able to recruit these individuals without delays that are 
inherent in working with patients injured in combat.
    However, I am following up with the recommendations from 
Chairman Filner that we reach out to the DC VA Medical Center 
to pursue approaches to ensure longitudinal followup between 
the care received in these cases from the military and the 
ongoing Department of Veterans Affairs military care.
    Given the ongoing work of traumatic brain injury at the 
Washington VA Medical Center, as well as over 30 Georgetown 
Medical Center faculty who hold appointments there, I am 
confident that we will actively engage the Washington VA 
Medical Center in this research to provide the best possible 
care for traumatic brain injury patients now relying on the 
Department of Veterans Affair for medical services. Ongoing 
monitoring of their conditions and well documented longitudinal 
followup will be critical; it will likewise enrich our 
research.
    Members of the Committee know very well that the vast 
majority of military personnel who are returning from the field 
who have experienced TBI are very young. God willing, they have 
long lives ahead, therefore it is incumbent upon us to ensure 
that we are aggressive in this kind of research endeavor that 
looks beyond the immediate consequences of even mild TBI. With 
this type of research we can address the silent epidemic before 
it takes a toll on the long-term quality of life of those 
serving our country.
    I urge the Department of Veterans Affairs, in close concert 
with the Department of Defense and Department of Health and 
Human Services, to remain vigilant in pursuing the 
identification of both these biomolecular signatures and of 
effective therapeutic responses to traumatic brain injury.
    Again, thank you for giving me this opportunity.
    [The prepared statement of Dr. Federoff appears on p. 68.]
    The Chairman. Thank you. Dr. Handal.

           STATEMENT OF NELSON M. HANDAL, M.D., FAPA

    Dr. Handal. Mr. Chairman, Members of the Committee, thank 
you for the opportunity to share information about innovative 
treatments and technologies that are serving to enhance quality 
of care, especially in our area of mental health. I am a board 
certified psychiatrist.
    As you know, information, and the way it is used, is at the 
core of psychiatrist assessment and diagnosis. Typically 
patients requiring mental health care are interviewed in what 
is commonly referred to as a traditional face-to-face 
psychiatric interview. Practicing medical health clinicians 
know that too often time constraints, volume and complexity of 
the information, limited access to care, and other factors, if 
not properly identified and addressed, end up limiting the 
accuracy of their face-to-face interview.
    The key question is how to gather information 
comprehensively in a reasonable amount of time utilizing an 
easy to use tool that generates a valuable report to facilitate 
disposition and the clinician's initial face-to-face interview?
    Our organization, Harmonex, is the developer of a patient 
self-administered and computer-based assessment tool known as 
CliniCom. CliniCom is comprehensive, easy to use, and allows 
the clinician to verify suggested diagnosis. The technology 
resides in a secure platform that comprehensively screens for 
56 mental illnesses and traumatic brain injury. CliniCom also 
includes a powerful suicide alert. CliniCom is based on the 
DSM-IV standard and incorporates clinical research and widely 
accepted community standards of care.
    CliniCom is being used successfully across our Nation at 
private outpatient clinics and hospital settings alike. The 
technology can be equipped to run in most clinical environments 
using tablets, desktops, and kiosks. CliniCom evokes the 
appropriate question sets based on the user type and the 
patient's age. It does not replace the mental health 
professional, it simply allows them to significantly enhance 
the face-to-face interview, its outcomes, and quality of care.
    CliniCom does not forget to ask pertinent mental health 
questions each and every time. It gathers complete medical, 
social, and family histories and can also identify concerns 
associated with suicide, violence, and traumatic events. 
CliniCom will also quantify severity of symptoms and severity 
of conditions automatically. It allows for secure and uniform 
documentation by organizing clinical information in the 
standard history and physical format.
    Once patients complete the assessment, clinicians can 
devote much of their interview toward building rapport, 
validating the clinical report, and helping patients understand 
the nature of their condition. It is very difficult to gather 
all of this information during a single traditional face-to-
face psychiatric interview. Our technology can gather 
clinically relevant and necessary information in a reasonable 
and quantifiable manner.
    The clinical decisionmaking process overall is 
significantly enhanced by allowing CliniCom to identify 
individuals that may have co-morbid conditions, meaning the 
presence of one or more disorders or diseases in addition to a 
primary disease or disorder. An example would be an individual 
with depression, in addition to PTSD and substance abuse. With 
CliniCom clinicians can better ensure that both primary and 
comorbid problems are identified simultaneously, leaving no 
stone unturned.
    A recent independent survey of 1,109 CliniCom users 
identified that 92 percent of users reported that CliniCom was 
very easy to use. In addition, survey results indicate that 87 
percent of the users found CliniCom to be very easy to 
understand, while 88 percent found it to be very thorough. 
Seventy percent of users completed the assessment in 60 minutes 
or less. This is a function of the severity of their case.
    While CliniCom has served to enhance care to the private 
sector, we have confidence that the technology can also serve 
to enhance care within military mental health. CliniCom has 
unique characteristics that make it well suited for use both as 
pre- and post-deployment screening tool and also as a 
comprehensive mental health assessment tool.
    By implementing a technology like CliniCom, DoD and the VA 
can use this valuable clinical resource to help mitigate the 
overarching issues of stigma and access to care, an issue that 
every member of our armed forces is given a complete 
comprehensive and responsible mental health assessment.
    In summary, CliniCom is a unique information gathering tool 
designed to assess mental health conditions, TBI, and 
suicidality. The technology is comprehensive, easy to use, and 
its conclusions can be easily verified by mental health 
professionals.
    In addition, what is learned from these cases can be used 
to conduct research that could lead to even greater advantages 
in mental health care. Truly modernizing the way we help people 
of all walks of life, who today suffer from mental illness.
    We are grateful to the Members of this Committee for the 
work you do on behalf of our veterans and soldiers. Thank you 
for your time and the opportunity to introduce to you CliniCom. 
We look forward to answering your questions and are prepared to 
help in any way we can.
    [The prepared statement of Dr. Handal appears on p. 69.]
    The Chairman. Thank you very much. Mr. Schoeneck.

                STATEMENT OF JAMES A. SCHOENECK

    Mr. Schoeneck. Chairman Filner and Members of the 
Committee, thank you for your opportunity and the honor of 
being able to appear before this distinguished Committee today. 
And I wish to commend you for your attention to the compelling 
issues surrounding military post-traumatic stress disorder or 
PTSD.
    I have served as CEO of BrainCells since 2005 and have 
worked on successful drugs in both the biotech and 
pharmaceutical industry for almost 30 years. BrainCells is a 
San Diego based biotech founded on the discovery made only 10 
years ago that new nerve cells grow in certain parts of the 
human brain. In fact, new neuron production, a process known as 
neurogenesis, is a requirement for the normal emotional 
responses that mentally healthy people take for granted.
    By way of ground breaking studies from our founding 
scientists from Columbia University and the Salk Institute, we 
have demonstrated that stress can arrest the formation of these 
new cells resulting in immeasurably shrunken site within the 
brain called the hippocampus.
    We now have the first physical understanding of the 
biologic processes that are involved in psychiatric diseases. 
Image studies performed on PTSD patients confirm that they also 
suffer abnormal changes in the hippocampus. And although these 
methods are not yet available to diagnose and study progress of 
all clinical PTSD patients, they may some day soon be 
available.
    Importantly, BrainCells has designed a drug screening 
platform to search for new classes of drugs that will help this 
nerve cell growth function return to normal, restoring 
neurogenesis with the intention of improving emotional 
integration with fewer side effects. BrainCells believes that 
its compounds provide alternatives to the traditional anti-
depressant and anti-anxiety drugs by directly increasing 
neurogenesis.
    Expanded screening and treatment for PTSD and depression 
and new efforts to reduce the stigma surrounding mental illness 
among servicemembers are to be commended. But since October 
2001, approximately 1.6 million U.S. troops have been deployed 
for Operations Enduring Freedom and Iraqi Freedom, and 
according to last year's Rand Study, one in seven 
servicemembers is returned from deployments with symptoms of 
PTSD.
    PTSD can be regarded parenthetically as a chronic wounding 
of the brain just as traumatic brain injury bruises the brain. 
Violence, divorce, domestic abuse have skyrocketed among 
returnees and suicide rates in the military now exceed those in 
the civilian population; unheard of as a historic suicide rate 
has always been much lower among soldiers, sailors, Marines, 
and airmen.
    PTSD is classified as an anxiety disorder with symptoms of 
chronic anxiety and fear that serve no purpose. It is often 
accompanied by typical or atypical depression. Non-drug 
treatment is regarded as the first line option for PTSD and is 
routinely incorporated in the management plans for patients. 
Many do not achieve a response from this non-drug therapy.
    The selective serotonin reuptake inhibitors, or SSRIs, are 
used as first line pharmacological treatments. These are 
familiar classes of anti-depressants like Prozac and Paxil. 
Response rates for these medications rarely exceed 20 to 30 
percent of PTSD patients. In fact, this class of drug routinely 
causes side effects like insomnia, weight gain, and most 
significantly for young returnees, sexual dysfunction. This is 
because of the increased serotonin resulting from the 
medication that can affect many parts of the brain and the 
body, many of which do not need to extra serotonin.
    Less than 40 percent of servicemembers diagnosed with PTSD 
receive mental health care, and some of those voluntarily forgo 
treatment or compliance because of sexual functional effects or 
those worries. Many soldiers use alcohol and illegal drugs to 
deal with the symptoms rather than take their SSRIs.
    Combat veterans are now thought to suffer a more severe 
form of PTSDs than civilian victims of trauma. Military stress 
is generally associated with greater depression, more anger, 
irritability, more aggression, and a far greater tendency 
toward suicide or violence as illustrated by the deaths in Iraq 
this week. Additional studies are needed, but experts are 
moving to the conclusion that military PTSD is both different 
from civilian trauma and also it is more difficult to treat.
    Methods used to treat civilian PTSD are at times inadequate 
to address military syndromes. It is disturbing to realize that 
we still have thousands of Vietnam veterans in the full throws 
of chronic PTSD and simultaneously we are being advised by the 
military that currently deployed troops are experiencing severe 
problems in record numbers, and if left untreated PTSD is a 
lifetime disorder.
    Probably because of the nature of this unique physiological 
insult, combats for PTSD is different than the mental syndrome 
that civilians suffer. It has its own symptoms that require 
medications designed and tested for military and veteran 
populations.
    It is unlikely that the civilian pharmaceutical industry 
can or will invest resources to address this as it is a 
specialized orphan-like condition that suffers from anxiety, 
depression, memory, and memory processing disorders.
    The investors at BrainCells, for example, anticipate that 
we will use our resources to develop drugs for large civilian 
populations, like major depressive disorder. This market may 
provide investors with their anticipated return on the 
investment in exchange for the high financial risks taken in 
drug development.
    Unless the government provides collaboration incentives and 
funding directly to biotech and pharmaceutical industry to 
deliver to the FDA-approved drugs labeled for military post-
traumatic stress disorder, clinicians will be left with a 
combination of existing drugs tested and approved for people 
with a different medical condition.
    Members of our military who voluntarily protect our Nation 
from harm are deserving of well funded pharmaceuticals that are 
directly and specifically directed to the disease of military 
PTSD.
    Congress has generously funded significant amounts into the 
research of determining the organic causes and best practices 
for treating PTSD, but its yet to fully engage those of us who 
are singularly and professionally dedicated to identifying and 
testing safe new compounds.
    Members of the Committee are undoubtedly aware of the 
myriad of ways that private enterprise can be provided 
incentives as exemplified by orphan drug laws that offer tax 
credits and patent extensions to illnesses affected by small 
populations. Tragically, military PTSD has already exceeded the 
statutory 200,000 patients that define orphan drug laws, but 
surely our war fighters are deserving of the best that our 
creative laboratories can provide.
    In closing, I wish to summarize the following thoughts and 
recommendations.
    PTSD is a disease that dramatically impacts the lives of 
our troops and returning veterans and their families. There are 
wonderful new developments in the field of neuropharmacology 
that could make a huge difference to sufferers of PTSD with 
fewer side effects. We must respond with a sense of urgency 
around testing new classes of drugs to treat the patients with 
military PTSD. Our collective goal should be to have new 
medications for the veterans of these conflicts, not the next. 
And a public private pathway to drug development is necessary, 
including regulatory and financial incentives for orphan-like 
drug development, including supporting clinical trials.
    Thank you once again for the opportunity to speak before 
the Committee.
    [The prepared statement of Mr. Schoeneck appears on p. 71.]
    The Chairman. I thank you all and appreciate all the 
thought that has gone into this.
    If I can just go back. Mr. Schoeneck, have you brought up 
these suggestions directly with the VA or have you been in 
contact with the VA Central Office?
    Mr. Schoeneck. We have not talked directly with the VA 
Central Office. We have previously spoken more with the DoD 
than with the VA around these problems.
    The Chairman. You want direct support, either money or some 
of the other incentives you talked about for research into 
these areas?
    Mr. Schoeneck. That is correct, that is correct.
    The Chairman. Just for the layman here, I know it in 
general, but give me a more specific definition of the orphan-
drug incentive. What is an orphan-drug incentive?
    Mr. Schoeneck. When you are designated as an orphan drug 
you get 7 years of market exclusivity on the back end of the 
approval for the drug. And particularly if we are using drugs 
that may have already exhausted some of their normal patent 
life that becomes very important in terms of having a time that 
the risk for the investment can be paid back for those that 
have taken that risk.
    The Chairman. What is the criteria?
    Mr. Schoeneck. It is 200,000.
    The Chairman. Is it a small population?
    Mr. Schoeneck. Yes, small populations that are 200,000 or 
less.
    The Chairman. So that number needs to be revisited as one 
of the things you are suggesting.
    Mr. Schoeneck. Exactly.
    The Chairman. Is the VA research process big enough? Is 
there enough money? Is it open enough? Are you aware of what is 
available now and how they go about that?
    Mr. Schoeneck. The dollars that are available now tend to 
be more toward treatment or exploring treatments with existing 
medications, not things that are novel and in development. And 
the drug development process and the requirements that are 
there from the FDA, which should be there in terms of 
protecting the safety of Americans, those are not things in 
general that the VA pays for. Those are generally paid for by 
some outside source or by a more specific funding source.
    The Chairman. Does NIH do any of this?
    Mr. Schoeneck. The NIH, to my knowledge, is not doing 
anything directly on PTSD. There is a Congressionally directed 
consortium that is working on PTSD, but they are looking more 
at the currently available compounds and how they may be able 
to be used together rather than looking at things that are 
truly novel.
    The Chairman. Could the VA use the NIH as an agent to make 
sure there is specific granting authority or amounts of money 
available for things that the VA wants? Is that a model that we 
could use?
    Mr. Schoeneck. I think it is possible. I would have to 
think about it more, but I think it is possible.
    The Chairman. If the NIH system works, and I don't know if 
it does, but let us assume it does, some of the money from VA 
could be put in NIH or NIH money could be targeted to the areas 
of research that the VA needs as opposed to forming a 
bureaucracy within the VA to deal with it. If you think it is a 
good idea, let me know.
    Dr. Handal, have you dealt with the VA in trying to get 
CliniCom used or have you dealt with the Department of Defense?
    Dr. Handal. I have talked with several people.
    The Chairman. I assume this is a computer program?
    Dr. Handal. Yes. It is software that has been developed 
over the past 5 years, and we have implemented the technology 
in 13 States.
    The issue with DoD or the VA is, I think, the same as what 
we heard this morning. It is very difficult, I think, for--
specially for innovative technologies to, you know, have some 
audience, and that is why I really appreciate the opportunity 
today.
    The Chairman. Are the people you deal with afraid that it 
is not proven or that they are going to buy something that is 
not worth it or proves to be wrong or what is the problem?
    Dr. Handal. No. I think everybody gets very, very 
interested and very excited about it. I think part of it is the 
bureaucracy.
    Now you were mentioning, you know, the fact that there are 
ways to probably get application, and those ways we have tried, 
many of those ways, and still I think we have had difficulty. I 
would like to have Ms. Sharon Allred, she is our CEO, and maybe 
she can give you a little bit more information about how that 
pathway went.
    The Chairman. If you can just use that microphone there? 
Whom do you go to in the VA and what occurs when you get there? 
Give me a sense of what is going on.
    Ms. Allred. Well we have tried a lot of local approaches 
working with chief of psychiatry at Walter Reed and we have 
worked with Fort Rucker and several of the places where we have 
actually gone to where the psychiatrists themselves and the 
medical professionals believe very strongly in what we have 
developed and built. But when you start trying to put it into 
place, then you start hitting some of the red tape type issues. 
You know, they have to get approval and they can't necessarily 
get approval at the local level, and they have to, you know, it 
has to be a top down type process.
    You know, we have tried to look for solicitations and other 
things that actually deal directly with this, but again those 
are very difficult to find. And as we were talking with the 
gentlemen here earlier that represent the VA, a lot of times it 
is just difficulty in trying to find who the right person to 
talk to within the VA that handles the type of technology that 
we are dealing with.
    We are tried, true, and proven in the private sector. We 
have definitely done our research on the security. We have 
actually had it analyzed by personnel from the military. So we 
feel like we are ahead of the curve, we are just not exactly 
sure how to get directly into the right people.
    The Chairman. Okay, thank you.
    Ms. Allred. Uh-huh.
    The Chairman. You need a little revolutionary cadre on the 
side that is working constantly at subversive activities. Of 
course, I will chair that.
    I am only being half facetious. Any big bureaucracy needs 
to institutionalize a way to undermine it to institutionalize 
change. That is to find ways that somehow don't get through the 
normal processes.
    As I said, I had a long conversation with the Secretary and 
the Deputy Secretary, and they seem to understand that. As the 
Deputy Secretary said, you want to have openness, but you have 
to have some constraint on it as well.
    There has been FDA approval of a lot of innovations we have 
heard and there has been other peer reviewed innovations. It 
seems to me that risk is minimized with all these other things 
that are going on.
    We have, as everybody pointed out, many cases of PTSD and 
TBI. We need all the help we can get and I will look at 
anything. Particularly with PTSD as you point out--as everybody 
has pointed out--it would be good to have pre-deployment and 
post-deployment data to see what kinds of differences there 
are. If you have a tool to do that, I don't know why we don't 
use it.
    The numbers are so high, and I think that the numbers that 
we have used here tend to underestimate it. As policy makers, 
we should say prove to me you don't have TBI or PTSD before you 
leave, rather than us having to prove you have it. Make a 
mandatory physical evaluation for everybody. Whether you are 
using something like CliniCom, or a personal interview with a 
psychiatrist or other medical professional. We don't do that. 
We have all these self-administered questionnaires that are 
gained, and they are not comprehensive anyway.
    We are letting servicemembers who can explode at any time, 
and it is up to us to minimize that. You all have given us some 
ways to help them. It seems that the military and the VA should 
be looking at all these innovations. By not doing so, we get 
two statistics. Half of the homeless on the street tonight are 
Vietnam veterans, because we did not look at PTSD, and the 
suicide rate of Vietnam veterans now outnumber those killed on 
the battlefield.
    We have done something wrong there. We can't keep repeating 
that mistake, and yet it seems that we are. We have far less 
numbers in Iraq and Afghanistan, but the percentages are as 
high or higher in all the things we don't want to happen.
    As we proceed as a Committee and as a VA with new 
leadership, what is the first thing each of you would like to 
see happen? What is the key thing that you would like--a new 
VA, a transformed VA, an innovated VA, how could it help what 
you all are thinking? If each of you would take a turn at that? 
Give me one thing.
    Dr. Federoff. In the current context being able to engage 
the spectrum of health care professionals in longitudinal 
follow up. Particularly now that it is clear that there is some 
elements of blast-related head injury that distinguishes itself 
from other forms of head injury.
    Without that natural history work and a commitment to 
support it long term, some of the answers that are needed will 
not be known, and it may well be the case in citing the Vietnam 
example that some of those answers may not be known for 
decades. But commitment long term for follow up--careful follow 
up is, I think, warranted.
    The Chairman. And, the VA is about the only institution 
that can do that?
    Dr. Federoff. Yes.
    The Chairman. Or, can provide you with the subjects for 
such research?
    Dr. Federoff. Correct.
    The Chairman. Yes.
    Dr. Handal. One idea would be the creation of an office for 
innovative technology, and that would basically be where people 
who develop technology, especially in health care, would 
approach that office and present to them whatever claims they 
have, and then that office probably should be responsible for 
carrying this information through the VA and DoD, and then 
replying back to whoever is interested in working with the VA.
    I think it sounds to me, and I am not a businessman in the 
true sense, I am a physician, but it really sounds to me that 
there are so many ways that you can try to approach the VA and 
the DoD, but there really is no one door where you can go and 
say okay I have this technology and I want you to look at it 
and talk to me about it and I can describe it and then you can 
carry it forward and see who is interested in the VA.
    And we can claim for instance that we have a hospital in 
our area that could use it. The director for instance of the 
program, with the Behavioral Health Program, Dr. Barry 
Frankhauser, he told me I want to use it. And he wanted to use 
it at that particular military hospital. And you know, it was 
very difficult to convince other people to do it, despite the 
fact that they thought it was a very appropriate thing to do.
    The Chairman. Yes, you are getting back to my revolutionary 
cadre of subversives. I put it a little differently than you.
    Of course, setting up that office will go through a 
bureaucratic process which will take 7 years and which will 
only be staffed by those who have given adherence to the 
bureaucracy.
    You have to almost institutionalize a revolutionary part of 
your--I mean, how does IBM or how does Microsoft innovate? They 
are big bureaucracies. Our new Deputy Secretary of the VA comes 
from IBM, so I think he can give us some help on that. How do 
those big bureaucracies constantly innovate? There is probably 
a secret little room with a lot of young geeks in jeans, who 
are thinking things through all the time to undermine 
Microsoft, then they adopt them, and then they make another 
$500 billion. It seems to me we have to do that if you want to 
carry back that message somewhere. Of course, that will go 
through your bureaucratic process and may never get to the 
Secretary.
    I am sorry, am I pronouncing your name right by the way?
    Mr. Schoeneck. Schoeneck.
    The Chairman. Schoeneck. Okay, thank you.
    Mr. Schoeneck. So I think just two brief things. One is 
access to VA populations with PTSD and funding to look at and 
examine truly novel medications in this area.
    We have been stuck in the same cycle of medications coming 
off of the Prozac-like spins for the last 25 years and it is 
time for this population to have an opportunity to get 
something truly novel that might be able to treat the disease 
in a different way.
    I think the other one is to potentially think about an 
orphan-drug exception that designates military PTSD as an 
orphan drug. You would definitely get the attention of more an 
industry by doing that.
    The Chairman. So just by doing that, that makes incentive 
to----
    Mr. Schoeneck. Absolutely.
    The Chairman. Well, I appreciate all of your thoughts. We 
look forward to working with you in the future. We will follow 
up on all this and hope that we can make the quality of life 
for our veterans a lot better, quicker and cheaper.
    Thank you so much. This hearing is adjourned.
    [Whereupon, at 12:40 p.m., the Committee was adjourned.]



                            A P P E N D I X

                              ----------                              

                 Prepared Statement of Hon. Bob Filner,
             Chairman, Full Committee on Veterans' Affairs

    I would like to thank everyone for attending this hearing today. 
The purpose of today's hearing is to be made aware of, and learn about, 
the innovative technologies and treatments which are currently 
available or are in development to help veterans.
    We will hear from companies that have devoted many resources into 
researching the unique maladies that affect veterans of all conflicts.
    While I applaud the VA for being the leader in research and 
treatment of such conditions as Traumatic Brain Injury and Post 
Traumatic Stress Disorder, it is important that our veterans have 
access to other ground-breaking treatment modalities which have been 
developed in the private sector.
    As the Chairman of the Veterans' Affairs Committee, I have learned 
about many exciting developments in technology and treatments that can 
help our deserving veterans. However, it has come to my attention that 
the developers of these new technologies and treatments face many 
barriers. For example, it is a challenge to add a new treatment tool to 
the VA's supply schedule and there is yet another obstacle of the VA 
not making active use of the treatment tool on the supply schedule.
    In the end, this affects veterans who cannot access the best 
technologies and treatments that are available in the market. Just as 
our veterans bravely risked their lives for our country, it is our duty 
to ensure that they have access to the latest and the most effective 
treatments.

                                 
              Prepared Statement of Hon. Harry E. Mitchell

    Thank you, Mr. Chairman, for calling this hearing. We live in the 
most innovative country in the world and at a time of unprecedented 
technological advancement. I am pleased that we will have the 
opportunity to review a number of cutting-edge products and treatments 
that can help save lives--and improve the quality of life--of many of 
our veterans.
    Before I yield back my time, I'd like to thank David Bethune--the 
Chairman of Scottsdale's Zila, Inc.--for appearing before the Committee 
today. Zila develops and markets the ViziLite Plus Technology, which 
provides a method for detecting oral cancer. This product is already in 
use at a number of VA facilities, and I look forward to learning about 
its results at the VA.
    Thanks also to Vomaris Innovations--who produces a bio-electric 
wound care product in Chandler, Arizona--for submitting testimony to 
the Committee. And finally, thank you to the rest of our panelists. I 
look forward to hearing about new tools and methods we may use in the 
care of America's veterans. I yield back.

                                 
       Prepared Statement of David R. Bethune, Executive Chairman
        and Chief Executive Officer, Zila, Inc., Scottsdale, AZ

    Thank you, Mr. Chairman and Members of the Committee, for inviting 
us to participate in today's important hearing on Innovative Technology 
and Treatments Helping Veterans. I am David R. Bethune, a proud navy 
Veteran and Chairman and Chief Executive Officer of Zila, Inc., the 
developer and marketer of the ViziLite Plus technology for the early 
detection of oral abnormalities that could lead to cancer.
    It has been said that without change, there is no innovation. With 
respect to the Department of Veterans Affairs, I would modify that: 
Without change, our Nation's Veterans will not enjoy the life-saving 
benefits of innovation.
    Innovation has already brought an effective, fast and low-cost 
screening technology to dental offices throughout America and the 
world. And yet our Veterans, who are among the most in need and most 
deserving of this technology, are being denied its benefits. In this 
respect, our Veterans receive inferior care to the inmates in our 
Federal prisons. Why? Because the VA has not added a 5-minute procedure 
to routine dental check-ups, that could save lives, improve the quality 
of life, and prevent costly surgeries and long-term care.

The Tragedy of Oral Cancer
    Oral cancer is a killer. Yet while it claims one American life 
every hour, it flies under the radar for most Americans. In times past, 
oral cancer was thought to be a disease of old men who had smoked all 
their lives. Today, with oral cancer rates increasing among women, and 
striking both women and men in their 20's and 30's, we know that 
virtually everyone is at risk. Tobacco and alcohol are confirmed 
causes, and now, thanks to Johns Hopkins research, it is becoming clear 
that the HPV virus, long known as the primary cause of cervical cancer, 
is emerging as a leading cause of mouth cancer. Seventy-five percent of 
all people carry the HPV virus at some point in their lives, and it is 
easily spread to the mouth through oral sex.
    Oral cancer is the eighth most common type of cancer among males in 
the United States. 34,000 new cases are reported yearly, and 
regrettably, most are discovered at later stages, when the outlook is 
most grim. This helps explain the surprisingly high death rate 
associated with this disease. The tragedy is that because oral cancer 
occurs in the mouth, which is totally accessible to the eyes of 
dentists and physicians, it should be one of the most avoidable and 
manageable forms of cancer.
    Based on available statistics, Veterans are especially susceptible 
to oral cancer. In 2006, 1,704 cases of oral cancer were diagnosed 
within the VA. That's 5 percent of all annual cases in the U.S. Given 
that the VA treats about 5.5 million patients per year, Veterans are 
almost 3 times more likely to be diagnosed with oral cancer than are 
members of the general public. And now we know that the conflicts in 
Iraq and Afghanistan are producing another generation of tobacco-using 
Veterans. A survey of Marines and sailors shows they are using tobacco 
at more than twice the rate of other Americans--64 percent vs. 30 
percent.\1\ If there was any doubt that oral cancer is a real and 
growing threat for vets, this should put it to rest.
---------------------------------------------------------------------------
    \1\ Tobacco use in Iraq vets--http://www.medpagetoday.com/
MeetingCoverage/CHEST/11520 accessed 5/4/09.
---------------------------------------------------------------------------
    As with most other types of cancer, chances of surviving this 
disease depend largely on how early it is detected. In the VA system, 
the record for detection and survival is dismal. Seventy percent of VA 
oral cancers are diagnosed at late stage, when the 5-year survival rate 
is just 26 percent. Early stage detection occurs only 30 percent of the 
time; those lucky patients have an 82 percent 5-year rate of survival. 
The goal, however, should be detection of pre-cancerous tissue--cells 
on the pathway to cancer. Identifying these abnormalities offers the 
best chance of avoiding the often horrific or fatal consequences of 
oral cancer itself. And this--the early detection of oral abnormalities 
that could lead to cancer--is exactly what ViziLite Plus was cleared by 
the FDA to do.
    The hardworking and highly professional dentists of the VA should 
not be faulted for these poor cancer detection statistics; after all, 
their record closely aligns with that of the historical record of 
dentists who serve the public. A primary reason that so many cancers go 
undetected for so long is that the conventional examination method is 
far from perfect. Dentists have long been taught to use their trained 
eyes and fingertips to conduct a conventional visual exam. Yet studies 
to date of the conventional visual exam have demonstrated that it is 
only effective in identifying suspicious lesions about two-thirds of 
the time; in other words, it misses suspicious lesions one-third of the 
time. When you supplement the conventional visual exam with ViziLite 
Plus, you increase screening effectiveness to 100 percent.

Adjunctive Screening Technology Makes Sense: Fewer Deaths, Enhanced 
        Quality of Life, Lower Healthcare Costs
    ViziLite Plus falls into a category of medical devices called 
adjunctive screening technologies. It is similar in function to 
(although less expensive than) the mammogram for breast cancer; the Pap 
smear for cervical cancer; and the PSA test for prostate cancer. The 
rationale for adjunctive screening technologies comes down to this: 
They promote early detection, which leads to fewer deaths, enhanced 
quality of life, and significantly lower healthcare costs.
    There is ample evidence that adjunctive screening technologies save 
lives. From 1972-1992, breast cancer deaths declined 45 percent with 
mammograms. From 1950-1990, the Pap smear helped reduce cervical cancer 
deaths by over 70 percent. And from 1993-2002, prostate cancer deaths 
declined 18 percent, thanks to the PSA test.
    It's hard to put a valuation on the dramatic reduction in pain and 
suffering that is achieved through early detection, especially with 
oral cancer. When a pre-cancerous lesion is identified, it and the 
threat of imminent cancer can be eliminated in a quick out-patient 
procedure. That contrasts with gross surgical removal of large segments 
of the tongue, cheek or jaw bone for patients with late-detected mouth 
cancer. With such extensive surgery, and accompanying radiation and 
chemotherapy, quality of life plummets as simple, everyday tasks like 
talking, eating and sleeping are made near-impossible.
    As for cost savings, we have solid evidence that early detection of 
oral cancer dramatically reduces the need for expensive surgery, 
chemotherapy and long-term care. Analysis by the Delta Dental insurance 
company shows that treatment of late stage oral cancer typically 
exceeds $200,000 per patient, while treatment of pre-cancerous lesions 
costs only $500-$1,500. For patients, early detection means a faster 
return to the workplace, which reduces lost wages and improves 
productivity.
    Even in these challenging economic times, the VA can afford wide-
scale implementation of ViziLite-assisted oral cancer screening exams. 
Zila Pharmaceuticals has contracted to provide ViziLite Plus to the 
government at a deeply discounted price of approximately $12 per test. 
If the VA were to provide a potentially life-saving ViziLite Plus exam 
to every Veteran receiving VA services (5.5 million in 2007), the cost 
would total only $66 million--a meager amount compared to the agency's 
$41.2 billion budget \2\, and a sum that would be totally eclipsed in 
cost by the reduction in surgeries and long-term care.
---------------------------------------------------------------------------
    \2\ VA budget--http://www.whitehouse.gov/omb/budget/fy2009/
Veterans.html accessed 5/4/09.
---------------------------------------------------------------------------
    The military should also provide ViziLite Plus-assisted oral cancer 
exams to all personnel undergoing medical exams as they end their 
active duty.

Adjunctive Technology for Oral Cancer Screening is Widely Utilized
    ViziLite Plus screening is gaining wide acceptance as an adjunctive 
technology, advancing the standard of care. This is confirmed by: 
American Dental Association recognition (through their dental procedure 
code); adoption by the Federal Bureau of Prisons; acceptance by 
dentists; approval for reimbursement coverage by numerous commercial 
health insurance carriers; and contractual inclusion in the Federal 
Supply Schedule.
    Recognizing the need for an adjunctive screening technology to 
fight oral cancer, the American Dental Association in 2005 created a 
new procedure code for this type of screening. ViziLite clinical 
evidence was the sole data supporting the ADA's decision to create the 
Code, which facilitates insurance billing.
    The Federal Bureau of Prisons (BOP) has embraced ViziLite Plus. The 
BOP strongly encourages every Federal prison facility to incorporate 
ViziLite into their care protocols, both for new prisoners at intake 
and for those already incarcerated. The BOP recognizes the economic 
benefits of early detection and treatment, and ultimately, the 
importance of being fiscally responsible with moneys provided to it.
    Dentists across the United States and the world are incorporating 
ViziLite Plus into their oral cancer screening protocols. Patients are 
benefiting from the technology in Canada, the UK, France, Germany, 
Spain, Portugal and beyond.
    A growing number of health insurance carriers provide coverage for 
the ViziLite Plus screening exam. These include Guardian, UnitedHealth 
care Dental, Humana Dental, Northeast Delta Dental, Essex Dental 
Benefits, SafeGuard and many self-insured employer and union groups. 
Altogether, some 24 million people are enrolled in plans that offer 
ViziLite Plus coverage.
    ViziLite Plus is available to all VA facilities through a Federal 
Supply Schedule (FSS) contract (V797P-3158M) administered by the VA 
National Acquisition Center (VA NAC).

Zila's Experience Encouraging Use of ViziLite Plus in the Veteran's 
        Administration
    ViziLite Plus has been or is currently being utilized at six 
facilities out of the entire national VA system. Other than these 
facilities the VA has been slow in their response to our wanting to 
describe the system and its potential benefits to the Veteran. Given 
the ability of all facilities to readily purchase ViziLite Plus through 
the Federal Supply Schedule contract, I strongly recommend that this 
technology be made available to all that visit the VA clinics.
    One of the unique aspects of oral cancer is that screening and 
detection are typically performed by a dental professional, while 
treatment is administered by a medical professional. As a result, a 
simple budgetary fact may be undercutting care: The VA's dental budget 
bears the cost of using innovative technology to help identify oral 
cancer, but the economic benefit of early detection is shifted to the 
medical budget.
    To underscore this, our company has had far greater success in 
securing coverage for ViziLite Plus from those national insurance 
carriers that provide both dental as well as medical coverage, because 
they take a comprehensive look at costs and have come to the conclusion 
that ViziLite Plus saves money.
    Some dentists say, ``Your technology is not proven,'' or ``We'll 
consider using ViziLite Plus when it has matured.'' Rejecting 
innovation this way endangers lives. The ViziLite technology has been 
cleared by FDA and thoroughly vetted by scientists, regulators and 
private practitioners. Eight peer reviewed papers have been published 
demonstrating the efficacy of ViziLite and ViziLite Plus. This 
extensive research supports sensitivity of 100 percent--where oral 
cancer was present, ViziLite Plus detected it every time. A clinical 
study published in the journal Oral Oncology (using a high-risk patient 
population similar to that served by the VA) demonstrated a reduction 
of false positives by 55 percent--suggesting the potential of reducing 
unnecessary biopsies by half.
    We have been told by senior VA dental officers, ``My dentists don't 
have time to do a ViziLite exam,'' and ``We don't have the budget to 
purchase it.'' The exam takes only 5 minutes, so that should not be an 
issue. The cost savings of early detection vs. late detection have 
already been explained.
    Innovative technologies like ViziLite Plus are sometimes resisted 
by professionals who are set in their ways. VA leaders need to break 
through such resistance and bring this important and economical 
technology to our Veterans. Allow me to emphasize: The decision to 
implement ViziLite Plus exams should not be left to individual VA 
hospitals; it should be directed by VA's headquarters here in 
Washington.
    Without ViziLite Plus screening, cancers could grow, metastasize 
and wind up costing the VA extraordinary amounts of money, and could 
subject Veterans to gross physical distress, for no good reason.
    This Committee should urge the Secretary of Veterans Affairs to 
immediately implement annual ViziLite Plus oral cancer screening of all 
Veterans who are seen at VA facilities nationwide. This is the best way 
to assure the consistent delivery of quality life-saving care to our 
Veterans.
    In accepting the nomination to be Secretary of Veterans Affairs, 
General Eric Shinseki said, ``I can think of no higher responsibility 
than ensuring that the men and women who have served our Nation in 
uniform are treated with the care and respect that they have earned.'' 
Mr. Chairman, our Veterans deserve state-of-the-art innovative 
technologies like ViziLite Plus.
    On behalf of all the employees of Zila, Inc., I thank you and the 
Committee for your concern about this important matter, and I urge you 
to exercise continuing close oversight of this issue going forward.
    Thank you.

                                 
  Prepared Statement of David Sidransky, M.D., Director, Head and Neck
 Cancer Research Division, Johns Hopkins University School of Medicine,
    and Professor of Oncology, Otolaryngology-Head and Neck Surgery,
   Cellular and Molecular Medicine, Urology, Genetics, and Pathology,
          Johns Hopkins University and Hospital, Baltimore, MD

    Mr. Chairman and Members of the Committee, I am Dr. David 
Sidransky, M.D.:
    Oral cancer (squamous cell carcinoma of the head and neck, SCCHN) 
remains a significant cause of morbidity and mortality among Americans. 
While the death rate for many other cancers has improved, the mortality 
from advanced head and neck cancer has not changed in decades. Although 
90 percent of patients with SCCHN are often diagnosed over the age of 
40, the diagnosis of SCCHN is often delayed at all ages and the even 
with the best treatment, death in advanced cases of oral cancer does 
not spare any age group. Specific risk factors have been linked to the 
development of this cancer, including the use of tobacco products and 
excessive alcohol intake. However, about 25 percent of those diagnosed 
do not share any of these behaviors. A portion of these cancers are 
also associated with a virus, called the human papilloma virus or HPV. 
These cancers often strike the young in our society and their treatment 
leads to severe deformity, impairment of swallowing and drinking, and 
death. There is little hope of this society abandoning the major 
behavioral risks, specifically smoking or drinking. Moreover, HPV 
infection will not be controlled for decades even with the advent of 
new vaccines. Thus, oral cancer will continue to cause significant 
morbidity and mortality in our population.
    Most cancers, including SCCHN develop over a long period of time 
and arise from early precursor lesions. Most cancers in the oral cavity 
are not found at this precursor stage and are already invasive at the 
time of diagnosis. Clinical outcomes in advanced cancers depend on the 
histological type of cancer, the size of the tumor at presentation, 
spread to local draining lymph nodes and how aggressively the tumor is 
attacking the body and spreading throughout other organs as metastases. 
When cancers are small and have not spread the chances of cure are much 
higher. Thus, morbidity and mortality can be impacted by effective 
identification of cancer at early enough stages to be more easily 
cured, or at least halted, and by use of effective therapeutic 
modalities to remove or kill the cancer cells. Today, these 
interventional options depend on surgery to remove as much of a tumor 
as possible, and then radiation therapy or chemotherapy to attempt to 
prevent the smaller tumor foci from seeding distant locations and 
enabling metastatic disease. These latter approaches are fairly 
burdensome interventions, which are most effective before cancer cells 
spread to multiple, more distant sites in the body.
    Doctors have now known for decades that early detection is the best 
chance to impact the death rate from this disease (50-60 percent over 5 
years). A cancer that is caught early enough is often curable. The 
problem is that patients with oral cancer do not present to their 
health care professional with readily visible signs or symptoms of 
their cancer until the disease has advanced to a late stage. Thus, 
clinicians strive to identify and treat individuals with SCCHN as early 
as possible. This puts a premium on identification tools that can be 
easily integrated into clinical practice, that are relatively non-
invasive and also inexpensive, so they can be applied to large 
populations. Perhaps most importantly, early detection tools must have 
adequate sensitivity to find a meaningful number of such individuals 
while having sufficient specificity to not falsely identify individuals 
without disease as being positive for cancer.
    In a meta-analysis of six worldwide studies it was reported that 
the weighted sensitivity of visual examination in identifying oral 
cancer and precancerous lesions was 79.6 percent. Visual examination by 
untrained examiners often misses the earliest more curable lesions. 
These results demonstrate that disease remained undiagnosed by 
conventional examination. By contrast, published studies reporting 
sensitivity values for ViziLite are consistent. To date, the 
sensitivity of ViziLite examination in identifying dysplasia and cancer 
is reported as 100 percent.
    According to published literature, pharmaceutical-grade toluidine 
blue, such as that included in the ViziLite Plus test kit, 
preferentially stains lesions consistent with severe dysplasia, 
carcinoma in situ and cancer. In one study we find that a TBlue 
application correlated to a reduction in False Positives by 55 percent. 
As such, ViziLite Plus has adequate sensitivity to find a meaningful 
number of individuals with disease while having sufficient specificity 
to not falsely identify individuals without disease as being positive 
for cancer.
    It is within this framework--early identification in high-risk 
populations; use of accessible, inexpensive yet effective diagnostics; 
demonstrated clinically relevant diagnostic sensitivity and acceptable 
specificity--that the ViziLite Plus by Zila finds its niche. No other 
medical device has sufficient sensitivity and specificity to meet the 
requirement of early detection in oral cancer. Other dyes and device 
can not precisely identify precancerous lesions and early invasive 
cancers while excluding healthy patients that need no further 
intervention. Indeed, the ease of use of the ViziLite product makes it 
appropriate for use by dentists, periodontists, oral surgeons, 
otolaryngologists, and primary-care physicians.
    Considering the demographics of the U.S. military, past and 
present, one can see that risk factors such as alcohol consumption, 
cigarette smoking and advancing age imply that military members and 
veterans of military service are at elevated risk of developing SCCHN 
whether they are young or old. Clearly, having a product that can be 
used to screen for oral cancer by any number of physician or dental 
specialists as well as generalists, makes this a valuable and necessary 
tool in the early diagnosis of oral cancer among military Veterans.
    The FDA has cleared this combination device with an indication for 
use to assist in the evaluation of oral mucosal lesions for patients at 
increased risk for oral cancer. This is the intended use of the 
product, which has been studied in clinical trials in the United States 
and abroad and data reviewed by FDA. Interestingly, research and 
clinical studies by oral surgeons and dental research scientists has 
shown that this product is capable of much more. While it is not proper 
for any FDA-regulated company to make references to claims for which 
the product is not cleared, it is interesting to note the publications 
regarding the tolonium chloride component of ViziLite Plus.
    There is a great deal published in the literature which suggests 
that the identification of oral premalignant lesions by this product, 
in conjunction with use of ViziLite, may identify lesions that are a 
greater risk to the patient, perhaps by virtue of identifying specific 
changes in the DNA of the tumor cells that indicate a more aggressive 
cancer. The tolonium chloride dye has demonstrated relatively high 
values for sensitivity and specificity. Thus, arrays of intriguing 
molecular studies have shown that the lesions that tolonium chloride 
(TBlue) detects are those that will become or are already aggressive 
cancers.
    Probably at least partially because of the strength of the 
literature in support of tolonium chloride (TBlue) and the use of 
chemiluminescence (ViziLite), the ViziLite Plus system was selected to 
assist in the identification of precancerous lesions in a National 
Institutes of Health-funded, Phase II study of Cetuximab 
(Erbitux', ImClone Systems Inc.) in upper aerodigestive 
precancer. Its inclusion is to identify those patients meeting the 
eligibility requirements of molecular changes consistent with oral 
lesion likely to progress to cancer. Because of unique characteristics, 
ViziLite use in this trial also allows the physician to clearly mark 
the boundaries of the lesion to determine the efficacy of the tested 
drug.
    In conclusion, ViziLite Plus is an easy to use, sensitive and 
specific medical device to help both relatively untrained and expert 
examiners to identify oral lesions in their patients, who by virtue of 
their lifestyle choices regarding tobacco smoking and alcohol use, are 
in a high risk group for oral cancer. Additionally, in an aging patient 
population similarly at high risk of developing this cancer, use of 
this product can bring diagnostic power to physicians outside the 
dental specialties for greater value and potentially more savings in 
hospitalization. It is anticipated that inclusion into oral cancer 
screening protocols within the VA clinics would help to improve 
screening efficacy for lesions suspicious for precancer and cancer, and 
ultimately reduce the morbidity and mortality of this disease.

                                 
 Prepared Statement of Robert A. Beckman, President and Chief Executive
      Officer, Brainport Technologies, Wicab, Inc., Middleton, WI

Purpose of this Testimony
    The BrainPort vision device and the BrainPort balance device 
represent novel technologies with the potential to address certain 
needs of soldiers who have suffered vision loss due to eye trauma or 
balance disorders related to traumatic brain injuries, as well as those 
veterans who experience chronic balance disorders after a stroke. Both 
devices are available today for further clinical testing. VA 
participation and sponsorship of such studies would accelerate the 
introduction of these devices into standard rehabilitation practices.
Background on Sensory Substitution
    Sensory substitution is based on the premise that the input sensors 
for the human senses can be augmented or substituted by alternate 
sensors. Cochlear implants are an early example of sensory 
substitution. Miniature electrical components attached to an external 
microphone are implanted in people who are totally deaf. With training, 
people learn to interpret the electrical impulses as sound, which 
enables them to hear. Wicab, Inc., founded by the late Dr. Paul Bach-y-
Rita, is developing sensory substitution technology for patients with 
chronic balance disorders and people who are blind or vision impaired. 
Unlike cochlear implants, BrainPort devices are not implantable. 
Instead, the electrical signals are effectively transmitted from the 
sensor to the brain through the tongue. The tongue is a uniquely 
qualified target for electrical impulses because of 1) the density and 
sensitivity of nerve fibers 2) the suitability of the tongue's chemical 
environment to receive and maintain contact and 3) the rapid transfer 
of information from the tongue to the brain.
    For people with balance disorders, the BrainPort balance device 
uses an accelerometer to provide accurate head position information. 
For people who are blind or vision impaired, the BrainPort vision 
device uses a digital camera to provide visual images. In both cases, 
the sensory information is provided via a substitute channel, an 
electrical impulse on the surface of the tongue.

BRAINPORT VISION DEVICE
Description of Vision Device Technology
    The BrainPort vision device provides information to blind 
individuals via a neuro-stimulating array placed on the tongue. This 
unique device provides immediate benefits to its blind users in areas 
of safety, mobility, and recreation and opens a new world of sensory 
experience and exploration.
    The BrainPort vision device operates by acquiring an image stream 
from a camera, similar to a camcorder. Like a camcorder, the moving 
images are sent to a display, which, in this case, is the electrode 
array on the tongue. The image stream is displayed on the tongue by 
converting light information to electrical stimulation, which feels 
like microscopic bubbles to the user. With minimal training, users 
learn to interpret the images on their tongue as information about the 
scene in front of them.
    The BrainPort vision device includes an imaging system capable of 
working both indoors and outdoors, with a field of view spanning 3-75 
degrees (magnified versus wide angle views). The tongue array contains 
400 electrodes and is connected to the controller via a flexible cable. 
The control system is approximately the size of a PDA and runs for 
about 3 hours per charge, with swappable batteries.
    An artist's concept of the tongue array (or Intra-Oral Device, IOD) 
and camera mounting is shown below alongside the device. The IOD is 
attached to a flexible boom by a thin wire. The camera unit is mounted 
on a pair of eyeglasses frames. The user controls and the power supply 
are connected to a belt-worn, pager-style, controller.

[GRAPHIC] [TIFF OMITTED] T9916A.001

[GRAPHIC] [TIFF OMITTED] T9916A.002


Who would benefit from the BrainPort Vision Device?
    According to the American Federation for the Blind, there are 1.3 
million people in the U.S. who are legally blind, of which 20 percent, 
or 260,000 have no better than light perception. Considering the 
current resolution of the tongue display, the BrainPort vision device 
is most applicable to this subset of people who are blind, with no 
better than light perception. The BrainPort vision device is not 
intended as a replacement for the guide dog or the cane. However, blind 
users can use the BrainPort vision device independently--at home, at 
work, and in public spaces indoors and out as a tool for improved 
safety, mobility and object recognition. Secondary benefits include 
applying the technology toward specific hobbies and recreational 
situations. These benefits enable greater independence at home, school 
and in business, greatly improving quality of life.
    The following list of product benefits was compiled from survey 
responses gathered from blind individuals who have used and know the 
capabilities of BrainPort technology.
Safety
     Navigating difficult environments, such as parking lots, traffic 
circles, complex intersections
     Recognizing quiet moving objects like hybrid cars or bicycles
     Crossing the street and staying within the lines of a crosswalk
     Avoiding unexpected overhead obstacles like tree branches, low 
signs, doorways, and holiday decorations
Mobility
     Finding doorways, hall intersections, lobby or restaurant in an 
office or hotel
     Finding continuous sidewalks, sidewalk intersections and curbs
     Finding and navigating to buildings in school or business campus 
environment
     Avoiding obstacles on sidewalks and in hallways
     Finding stairwells and recognizing if they go up or down
Object Recognition
     Spot reading signs, mail, book titles, etc
     Locating people
     Locating known objects such as shoes, cane, coffee mug, keys
     Discriminating between empty and occupied chairs on a bus or in a 
conference room
     Finding the trash can, the restroom, kitchen
     Orienting oneself in a new environment, finding where objects are 
within a room
     Recognizing graphics: web pages, mathematical graphs, photos
     Signing documents such as checks and legal documents
Recreation
     Playing off-the-shelf board and card games
     Walking in the woods
     Finding a wayward basketball
     Running a road race
     Cross-country skiing
     Rock climbing
     Computer games

Current Status of Vision Device Product Development
    The development of the BrainPort vision device to its current state 
has been enabled by funding provided from the National Eye Institute 
and DARPA. The technology has evolved dramatically as a result of this 
funding and accomplishments by our engineering and neuroscience teams. 
Four years ago, the vision device required a desktop computer, employed 
a camera that had no zoom capability, a limited field of view and was 
only functional indoors. Today the device for the first time is small, 
versatile and user-friendly enough to enable blind users to explore the 
capabilities of the device both indoors and outdoors, without active 
supervision.
    Although the BrainPort vision device is not yet commercially 
available, Wicab plans to file for FDA clearance shortly. Nevertheless, 
the BrainPort vision device is nowhere near optimized. The current 
resolution on the tongue is limited by the density of the electrical 
tactors on the tongue array. The current density is 20 times 20 pixels, 
effectively 20 DPI resolution. Wicab projects users would experience 
increased perception by increasing the resolution, up to a limit of 
approximately 150 DPI. With technology adapted from high definition 
television displays, this improved resolution is feasible today, but 
would cost approximately $1 million to implement. Wireless technology 
could eliminate the current requirement for cables running from the 
control unit to the user's mouth--another advance that is feasible 
today, but expensive to implement.
    Beyond the physical aspects of BrainPort device design, there are 
more effective methods for information transfer (luminance or 
otherwise) through the tongue. These techniques include: Advanced Image 
Processing (pattern recognition, image stabilization, optical flow, 
etc); Context aware computing--adaptive algorithms to automatically 
adjust for visual task, reading a book versus walking down the street, 
for example; Proactive guidance--providing attentive signaling to 
important items in a scene (a `do not walk' sign is flashing); Directed 
guidance--to allow a blind user to query about items in a scene--`are 
my shoes in this room' (and highlight everything in the scene that 
looks like a shoe); and Information Stream Synergy--Integration of 
image data with external data, to overlay or interleave data from 
multiple sensors or data sources (the Internet, for example), with the 
image data.

BrainPort Vision Device Preliminary Clinical Results
    Over the past 2 years, Wicab has developed clinical tests to 
understand the capabilities of blind individuals while using the 
BrainPort device, and to develop product features based upon user 
performance and requests. Two years ago, the BrainPort vision device 
consisted of a 100-pixel tongue display and a narrow fixed field of 
view webcam. During testing, we noticed that subjects moved closer or 
farther away from an object for recognition. Based on this observation 
and suggestions from users, we incorporated user controlled zoom 
magnification. With this feature, users could magnify small 
characteristics (like letters on a page) or reduce large objects like 
buildings for appropriate recognition. In mobile situations, we noticed 
that users made repeated head movements to gather enough information to 
avoid obstacles, make turns, judge distance, etc. We found that 
expanding the camera's effective field of view enabled more comfortable 
use and better judgment of distance. In the last year, we have improved 
the resolution of the tongue display, from 100 pixels to 611 pixels. 
User feedback and performance confirms that more resolution provides 
crisper and clearer information to the user, especially when conveying 
curves and diagonal line features. Moreover, it enables object 
identification without reducing the field of view due to magnification.
    During studies with the 100-pixel tongue display, 10 participants 
accurately reported the orientation of a 10-inch line presented on a 
wall 2 feet in front of them, approximately 80 percent of the time. 
Participants also accurately sorted cards with squares and circles of 
varying sizes into their respective categories, again >80 percent 
correct performance. From a distance of 5 feet and utilizing the 
BrainPort zoom magnification features, participants could report the 
orientation of the `gap' in a rotating letter C, a controlled visual 
acuity test with a mean ``acuity'' of 20/135. To test orientation and 
mobility with the device, participants were placed in a large room, 15-
20 feet away from a wall that displayed a variety of shapes. 
Participants could accurately identify shapes from a distance, using 
zoom, as well as navigate to the targeted shape (85 percent and 95 
percent success rates, respectively). These high success rates 
demonstrate that with as little as 100 points of information, the 
BrainPort device enabled both identification of key features and the 
formation of a spatial reference for that information.
    The next experiments represent more recent work with five subjects 
and a higher resolution tongue display of 611-pixel, identifying moving 
balls. One hundred four-alternative forced choice (4AFC) trials were 
presented on a LCD computer display. In each trial, a filled in circle/
ball of three different sizes (small, medium and large) traveled in one 
of four directions (up, down, left, right). The subjects were to 
indicate with a button press on a numeric keypad which direction they 
perceived the motion of the circle or ball. As the graph below 
illustrates, all subject performed with greater than 90 percent 
accuracy within 3-4 seconds of trial presentation. This indicates that 
in the absence of other sensory input, participants using the BrainPort 
are quite sensitive to motion.

[GRAPHIC] [TIFF OMITTED] T9916A.003

    Another computerized experiment focused on object recognition, 
specifically letter matching. Fifty two-alternative forced choice 
(2AFC) letter stimuli were presented to all participants with a high 
resolution LCD video display system. Participants were instructed to 
respond, as quickly and accurately as possible, which of two letters 
matched the target item above the pair. Difficulty was manipulated by 
making the incorrect foil either visually similar to the correct answer 
in the hard condition, or dissimilar in the easy condition.

[GRAPHIC] [TIFF OMITTED] T9916A.004

    As the graph below illustrates, all subjects responded with greater 
than 90 percent accuracy, regardless of difficulty level within 25-35 
seconds. Participants responded faster to ``easy'' letter matches than 
for the ``difficult'' matching, while maintaining accuracy. With 
practice and experience, we expect response times would decrease.

[GRAPHIC] [TIFF OMITTED] T9916A.005

    Wicab is also conducting clinical studies of the BrainPort vision 
device at the Atlanta VA under the direction of Dr. Michael Williams. 
According to a recent preliminary report, Dr. Williams concluded 
``Bottom line, the device performs remarkably well for the tasks we 
looked at in Phase I, and substantially enhances subjects' ability to 
accurately identify a variety of shapes at varying distances, this is 
statistically significant at the .001 level, and not a random or chance 
finding.''

Recommendations
    The BrainPort vision device is now available for the next phase of 
clinical testing. One of the populations that may benefit from 
participating in these studies are soldiers who are blind, including 
those soldiers that lost their vision due to a traumatic injury. Wicab 
is very interested in obtaining further user feedback regarding the 
overall usefulness of the device in performing everyday tasks.

BRAINPORT BALANCE DEVICE
    The BrainPort balance device provides change in head position 
information to the brain through electrical impulses directed to the 
tongue. The device consists of: (1) an intraoral device, which contains 
an accelerometer for sensing head tilt and an electrode array for 
transmitting the signal to the tongue; and (2) a control unit, which 
contains the micro controller, signal processors, memory, battery, user 
controls and associated driver electronics. The signal on the tongue 
moves in relation to the patient's head position. Patients are trained 
to maintain their balance while standing with their eyes closed by 
focusing on keeping the signal in the center of their tongue. As the 
patient feels the stimulus move on their tongue, they can adjust their 
body to move the stimulation toward the center of the tongue.
    Training protocols typically require the patient to use the device 
during two 20-minute sessions each day. Within a few days, most 
subjects learn to use the signal on their tongue to help maintain their 
balance and, more importantly, start to experience retention of the 
therapeutic effect, improved balance, after the training session ends. 
Preliminary clinical data has demonstrated impressive results in 
treating the symptoms in a wide range of subjects with central or 
peripheral vestibular balance disorders.

[GRAPHIC] [TIFF OMITTED] T9916A.006

Who would benefit from the BrainPort Balance Device
    The prevalence of balance and/or vestibular disorders is 
significant:

      At least half of the overall U.S. population is affected 
by a balance or vestibular disorder sometime during their lives.
      Vestibular disorders (or dizziness) affect about 20 
percent of the general population. Prevalence increases with age: 
approximately \1/4\ to \1/3\ of the elderly complain of some form of 
dizziness, and by age 75 this proportion approaches 50 percent.
      Approximately 12.5 million Americans over the age of 65 
and 6 million under age 65 experience balance or dizziness problems 
that significantly interfere with their lives.
      Fifty percent of falls suffered by the elderly are 
associated with vestibular problems.
      The annual cost of medical care for U.S. patients with 
balance disorders exceeds $1 billion.
      Each year, over 700,000 people suffer a new or recurring 
stroke in the U.S.
      About 5.7 million U.S. stroke survivors are alive today, 
many of them with permanent stroke-related disabilities.
      Over 70 percent of military individuals involved in blast 
injuries have a resultant balance disorder.

    The conventional treatment for individuals with vestibular 
dysfunction is vestibular rehabilitation. Vestibular rehabilitation is 
effective for many vestibular disorders, however, approximately 30 
percent of all vestibular patients do not derive meaningful benefit 
from vestibular rehabilitation; instead, they rely solely on 
compensatory strategies. Furthermore, most vestibular disorders are not 
amenable to surgical treatment. Pharmacological management of these 
conditions with vestibular suppressants often retards the recovery 
process or is associated with adverse side effects such as drowsiness. 
Consequently, many people are left to manage their lives with 
inadequate therapeutic intervention. These people represent the target 
market for the BrainPort balance device.
    Chronic balance disorders can dramatically alter a person's ability 
to engage in daily activities, greatly diminishing their quality of 
life. Because both vestibular and visual cues for postural control are 
compromised, patients with chronic balance disorders are often at 
greater risk of falling, and must rely on constant vigilance and 
restricted physical activity to avoid instability and falls.
    Preliminary patient results indicate the BrainPort balance device 
will be useful in treating a broad population of patients that suffer 
balance disorders related to vestibular dysfunction. Target etiologies 
are both unilateral and bilateral vestibular dysfunction, including 
such specific vestibular disorders as ototoxicity, vestibular neuritis, 
and perilymphatic fistula, as well as a wide variety of disorders that 
affect vestibular function, such as balance deficits due to stroke or 
brain injury.

Current Status of Device Development and Regulatory Process
    The development of the BrainPort balance device and preliminary 
clinical studies have been funded by the National Institute of Deafness 
and other Communicative Disorders and private investors. Wicab received 
the CE Mark for the balance device in January 2006, and has commenced 
limited commercial activities in Europe, Canada, Brazil and Russia. 
Wicab expects initial sales will be modest, because most people in 
these countries rely on government reimbursement to cover the cost of 
medical devices such as the BrainPort balance device.
    Wicab is currently conducting a controlled clinical study in an 
effort to secure FDA 510(k) clearance. Wicab anticipates study 
completion by March 2010.
    Medical devices intended for commercialization in the United States 
must be designed under established Design Control procedures that meet 
the FDA Quality System Regulations. Wicab quality system includes 
design controls, supplier controls, manufacturing and post-market 
surveillance in accordance with FDA's QSR and the European standard ISO 
13485. The BrainPort balance device also complies with national 
standards such as Underwriters Laboratory and the EU Medical Device 
Directive.

BrainPort Balance Device Preliminary Clinical Results
Peripheral and Central Vestibular Dysfunction Study
    Wicab studied the benefits of training with the BrainPort balance 
device in 112 subjects with vestibular dysfunction at 17 clinical 
sites. Etiologies of the subjects include peripheral vestibular 
dysfunction (bilateral vestibular dysfunction, unilateral vestibular 
dysfunction, post acoustic neuroma resection), central vestibular 
dysfunction (stroke, brain injury and age related changes), and mixed 
etiologies. These prospective studies designed to measure short-term 
and long-term balance-related changes that resulted from training with 
the BrainPort balance device. The BrainPort device training procedure 
was consistent across all sites.
    Subjects received clinical training for 3-5 consecutive days (2 1-
hour sessions each day) with the BrainPort balance device. Subjects 
then continued training at home for two 20-minute sessions each day for 
the duration of the study and were assessed at the end of the at-home 
period. Subjects did not use the BrainPort device during the 
assessments.
    Changes in balance were measured using clinically accepted 
standardized outcome measures including Computerized Dynamic 
Posturography Sensory Organization Test, Dynamic Gait Index, 
Activities-specific Balance Confidence Scale and the Dizziness Handicap 
Inventory.
    Subjects showed statistically significant improvement in all 
measures. Almost all of the study subjects had received prior 
conventional rehabilitation and had reached a plateau. This improvement 
is in addition to that reached by traditional rehabilitation.

Atlanta VA Pilot Traumatic Brain Injury Study Summary
    Patients with traumatic brain injury (TBI) frequently have problems 
with balance and walking due to problems of integration of sensory 
inputs. Under sponsorship from Wicab, the Atlanta VAMC Rehab R&D Center 
is conducting a study to investigate the effects of the BrainPort 
balance device with patients with a traumatic brain injury and balance 
deficits.
    Standard physical therapy tests of balance and walking, including 
Computerized Posturography testing, and Dynamic Gait Index are used to 
measure of fall risk. After completing the testing, subject are trained 
to use the device while trying to maintain balance while standing with 
eyes closed and feet in a challenging position (such as together or 
heel-to-toe) and on altered surfaces, such as a foam cushion. Training 
occurs over 5 days. Subjects then take the device home to use twice 
daily for 20 minutes. Subjects return to the Atlanta VAMC for follow up 
testing to see if balance and walking improve after a 12-week period of 
home training.
    This project is still in the very early stages. Measures of balance 
confidence, computerized posturography and fall risk improved in the 
three subjects trained thus far. These data, while preliminary, 
suggests a positive effect of the BrainPort balance device on balance 
in individuals with TBI.

Traumatic Brain Injury Case Study
    One of the patients participating in a study with the device is a 
39-year-old male who sustained a severe traumatic brain injury due to a 
motor vehicle accident in 1993. Following his accident, he completed 
the full range of conventional rehabilitation including inpatient and 
outpatient physical therapy, occupational therapy and speech therapy. 
His balance and walking improved to where he could walk using a walker, 
but required supervision to navigate outside of his home and 
occasionally fell when walking or trying to do an activity. His 
cognitive function improved to the point where he was able to live 
independently and work part-time, but he felt like his head was never 
quite clear. He continued to have difficulty with balance, walking, and 
daily activities due to ataxia and impaired motor control on his right 
side, caused by damage to the left midbrain and cerebellum. After 
extensive rehabilitation, he had reached a plateau in his recovery. In 
2006, 13 years after his injury, he began using the BrainPort balance 
device.
    He has been training with the BrainPort balance device consistently 
for the past 2\1/2\ years. After the initial week of clinic training 
sessions, the majority of his training is completed in his home. He 
returns to the clinic for modifications to his training approximately 
every 3 months. He has demonstrated ongoing improvements in his balance 
since enrolling in the BrainPort study. His score on a standardized 
balance confidence scale improved from 74 percent confidence to 94 
percent confidence at 1 year, where it remains. Though he continues to 
use his walker, he demonstrates a much more upright posture with 
decreased dependence on the walker. He no longer falls and does not 
require supervision to walk in the community. He is transitioning to 
walking with a quad cane, which is much less cumbersome for daily use. 
He is able to walk longer distances both with and without his assistive 
devices. When he has a loss of balance, he is able to regain his 
equilibrium independently. He reports that he is more confident in his 
balance, and his activities do not require as much effort, which 
results in an increase in his energy level. The patient, his mother and 
his doctor attribute the improvements in his posture, standing balance, 
ataxia, and gait over the last 2\1/2\ years to training with the 
BrainPort balance device.

Stroke Pilot Study Summary
    A pilot study with 26 patients who have a balance problem due to 
stroke was conducted at 5 clinical sites. Participants learned to use 
the BrainPort device over a 5 day (10 hours total) clinic training 
period. Following clinic training, each participant continued their 
training in their home, independently for 8 weeks. Participants were 
assessed at baseline and at 8 weeks to compare their balance and 
mobility before and after training.
    Training with the BrainPort device for 8 weeks, seven of which were 
at home, yielded statistically significant (p values less than .05) 
improvements on the Dynamic Gait Index (DGI), Berg Balance Scale (BBS) 
and the Timed Up and Go Test (TUG), three valid objective measures used 
to assess balance and ambulation. With the BBS, this statistically 
significant change was over two times the minimal criteria established 
for clinically significant improvement. For the TUG, the degree of 
improvement also exceeded the minimal difference for clinical 
significance.
    Consistent with these objective findings, participants showed 
statistically significant improvement on the Activities-Specific 
Balance Confidence Scale, a self-report measure. This improvement was 
over two times the minimal criteria established for clinically 
significant improvement. Similarly, on the Stroke Impact Scale, 
patients demonstrated statistically significant improvement on their 
ratings of mobility, activities of daily living, social participation 
and overall rating of stroke recovery. Importantly, no statistically 
significant changes were obtained with measures of memory, 
communication and emotions, all subjective measures that were not 
anticipated to be affected by BrainPort training.
    Taken together, these data provide both objective and participant 
endorsement of the BrainPort device in the treatment of balance, 
mobility and function among individuals with stroke.
    Early studies with the BrainPort balance device demonstrate the 
potential for helping patients with stroke and traumatic brain injury 
improve their balance and motor control. Ultimately, the device could 
become a key component of a comprehensive rehabilitation program.

Recommendations
    The medical community requires rigorously planned controlled 
clinical data prior to adopting new technologies such as the BrainPort 
balance device. Wicab is sponsoring such a study in patients with 
peripheral vestibular dysfunction. Based on the early promising results 
in traumatic brain injury, we would welcome the opportunity to work 
with soldiers who have a balance disorder related to a blast injury to 
incorporate BrainPort balance training as a part of their 
rehabilitation regimen. VA leadership is appropriate, given the 
relatively small patient population with traumatic brain injuries, 
which hinders funding by commercial entities. Finally, the preliminary 
results in stroke warrant the initiation of a controlled clinical study 
in that target patient population, and Wicab would similarly welcome VA 
participation in this patient study.

                                 
         Prepared Statement of David A. Broecker, President and
         Chief Executive Officer, Alkermes, Inc., Cambridge, MA

    Mr. Chairman, Ranking Member Buyer and Members of the Committee, 
thank you for inviting me to testify here today on behalf of Alkermes.
Overview
    Alkermes is pleased to have the opportunity to submit testimony on 
innovative technologies and treatments for veterans. Given the personal 
sacrifice that our brave service men and women have made, we believe 
that it is important to give them access to the best medicines and 
treatments currently available to help them get the care they need to 
live happy, healthy and productive lives. Using innovative drug 
delivery technology, Alkermes has developed a unique medicine for the 
treatment of alcohol dependence, called VIVITROL' 
(naltrexone for extended-release injectable suspension). VIVITROL is a 
breakthrough medicine that, when combined with counseling, has the 
potential to greatly reduce the human and financial toll associated 
with alcohol dependence.

Alkermes
    Alkermes is a small biotechnology company located in Cambridge, 
Massachusetts. As a company, we are committed to developing medicines 
that make a difference in patients' lives. Our products, which use 
novel molecules and innovative drug delivery technologies, target the 
unmet medical needs of patients suffering from diseases like 
schizophrenia, bipolar disorder, addiction and diabetes. We approach 
the drug development process with patients as our top priority, 
beginning with a thorough understanding of the challenges they face on 
a day-to-day basis. Our products are designed with patient needs and 
behaviors in mind, with the goal of dramatically improving therapeutic 
outcomes.

Substance Use Disorders Among OEF/OIF Veterans
    Alcohol dependence is a major problem among military veterans. In 
2003, a survey conducted by the Substance Abuse and Mental Health 
Services Administration (SAMHSA) estimated the veteran population in 
the United States to be 25 million, or roughly 11.5 percent of the 
entire non-institutionalized civilian population.\1\ Approximately 7.5 
percent, or nearly 1.9 million, of these veterans reported drinking 
heavily in the month prior to being surveyed (compared to 6.5 percent 
of comparable nonveterans). SAMHSA estimated that approximately 650,000 
veterans (2.6 percent) were alcohol dependent. By 2006, the VA's own 
data showed that only 175,268 veterans were actually receiving 
treatment for their alcohol abuse or alcohol dependence within the VA 
system.\2\ In addition to post-traumatic stress disorder (PTSD), 
alcohol abuse and alcohol dependence are consistently among the most 
prevalent psychological disorders in male veterans of the Vietnam 
era.\3\ In female veterans of Vietnam, alcohol abuse and dependence are 
second only to depression and generalized anxiety.
---------------------------------------------------------------------------
    \1\ U.S. Department of Health and Human Services, Substance Abuse 
and Mental Health Services Administration, National Survey on Drug Use 
and Health, November 10, 2005.
    \2\ U.S. Department of Veterans Affairs, Health Services for VA 
Substance Use Disorder Patients--Comparison of Utilization in Fiscal 
Years 2005, 2004, 2003, and 2002, June 2006.
    \3\ U.S. Department of Veterans Affairs, National Center for 
Posttraumatic Stress Disorder, Findings from the National Vietnam 
Veterans' Readjustment Study, available at http://www.ncptsd.va.gov/
ncmain/ncdocs/fact_shts/fs_nvvrs.html?opm=1&rr=rr45&srt=d&echorr=true.
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    Since the start of Operations Enduring Freedom (OEF) and Iraqi 
Freedom (OIF), over 1.8 million American military personnel have been 
deployed, with nearly a third coming from the National Guard and 
Reserves.\4\
---------------------------------------------------------------------------
    \4\ Legal residence/home address for servicemembers currently 
deployed as of December 31, 2008. (2009) Defense manpower data center. 
Retrieved April 8, 2009 from: dva.state.wi.us/WebForms/Data_Factsheets/
ResDistribution_Dec08.pdf
---------------------------------------------------------------------------
    In 2006, the New Jersey Department of Military and Veterans 
Affairs, in conjunction with the University of Medicine and Dentistry 
of New Jersey and the Bloustein Center for Survey Research at Rutgers 
University, surveyed New Jersey National Guard members who had returned 
from Iraq within the past year. The results of the study were 
striking--37 percent of those surveyed reported problem drinking in the 
year following their deployment. Even more troubling, 55.3 percent of 
the veterans with PTSD reported problem drinking.\5\
---------------------------------------------------------------------------
    \5\ Kline, A. & Falca-Dodson, M. (2007) Presentation on substance 
abuse and mental health problem in returning Iraqi veterans.
---------------------------------------------------------------------------
    In a study published in the Journal of the American Medical 
Association, Hoge et al. of the Walter Reed Military Research Institute 
administered anonymous surveys and assessed 2,530 U.S. combat duty 
personnel before their deployment to Iraq and 3,671 troops three to 4 
months after their return from combat duty in Iraq or Afghanistan. Over 
35 percent of Marines reported experiencing at least one symptom of 
alcohol dependence (drinking more than intended) after deployment, and 
over 29 percent reported that they felt they needed to cut down on 
their drinking.\6\
---------------------------------------------------------------------------
    \6\ Hoge, C., Auchterlonie, J. & Milliken, C. (2006). Military 
mental health problems: Use of mental health services, and attrition 
from military services after returning from deployment to Iraq or 
Afghanistan. Journal of the American Medical Association, 295(9), 1023-
1032.
---------------------------------------------------------------------------
    To put the seriousness of these alcohol problems in perspective, 
Hoge et al. found substantially lower rates for depression (7.1 
percent), anxiety (6.6 percent) and PTSD (12.2 percent). Only PTSD 
showed a comparable rate of increase (pre-deployment to post-
deployment)--an expected finding given that over 90 percent of the 
combat duty personnel had been directly involved in gun battle and/or 
handling the bodies of fellow service men and women, killed in the line 
of duty.\7\
---------------------------------------------------------------------------
    \7\ Hoge, C.W., Castro, C.A., Messer, S.C., McGurk, D., Cotting, 
D.I. & Koffman, R.L. (2004). Combat duty in Iraq and Afghanistan, 
Mental Health Problems, and Barriers to Care. New England Journal of 
Medicine, 351(1), 13-22.
---------------------------------------------------------------------------
    The incidence of alcohol dependence symptoms appears to be the most 
common problem facing returning combat duty personnel. Alcohol 
dependence exacerbates other psychiatric and medical problems and 
undermines treatment. Combat duty personnel may be particularly likely 
to use alcohol to self-medicate their psychiatric problems, resulting 
in worsened overall mental health and alcohol dependence. The strong 
reluctance to seek professional help may be a particularly important 
factor contributing to the misuse and ultimate dependence on alcohol.
    While the incidence of mental health and alcohol problems within a 
few months of returning from combat is high, alcohol problems in 
particular often take years to manifest. For this reason it is 
important to consider research from past military conflicts. 
Specifically, the National Vietnam Veterans Adjustment Survey found 40 
percent of male veterans reported lifetime alcohol problems post-
deployment. In 2000, the Department of Defense's Alcohol Abuse and 
Tobacco Use Reduction Committee reported that, even prior to the start 
of the conflict, 21 percent of servicemembers admitted to drinking 
heavily, costing the Department of Defense more than $600 million each 
year in terms of medical care and lost productivity.\8\
---------------------------------------------------------------------------
    \8\ Rhem, K. (2000, June 6) Alcohol abuse costs DoD Dearly. 
American Forces Press Service. Retrieved May 7, 2009 from: http://
www.defenselink.mil/news/newsarticle.aspx?id=45284.
---------------------------------------------------------------------------
    A February 2007 report by the American Psychological Association on 
the mental health needs of returning veterans found a variety of 
barriers are preventing military personnel from accessing much needed 
mental health and alcohol treatment. The report cited stigma and a lack 
of availability of services as the primary reasons why personnel and 
their families are not accessing care.\9\ Shortages of trained 
uniformed personnel, high burn out rates among providers and 
difficulties in referring military personnel to civilian providers 
often mean long waits for care. Moreover, in other reports and 
testimony before this Committee, providers have reported significant 
recent decreases in the availability of inpatient beds for alcohol 
dependence treatment. During these high service utilization periods, 
medication assisted treatment for alcohol dependence may improve VA 
care delivery by integrating primary care and behavioral health care 
and providing immediate help upon substance use disorder diagnosis 
during high volume periods.
---------------------------------------------------------------------------
    \9\ Johnson, S. et al (2007) The psychological needs of U.S. 
military servicemembers and their families: a preliminary report. 
Retrieved May 7, 2009 from: http://www.apa.org/releases/
MilitaryDeploymentTaskForceReport.pdf.
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Vivitrol
    As researchers have gained a deeper understanding of the complex 
brain mechanisms that trigger alcohol dependence, medications are 
increasingly considered to be important treatment options for this 
disease. In 2005, the National Institute on Alcohol Abuse and 
Alcoholism (NIAAA) issued guidelines, recommending the combination of 
medications and psychosocial support as part of an integrated treatment 
program.\10\
---------------------------------------------------------------------------
    \10\ U.S. Department of Health and Human Services, National 
Institutes of Health, Helping Patients Who Drink too Much: A 
Clinician's Guide, 2005.
---------------------------------------------------------------------------
    One of the products currently approved by the U.S. Food and Drug 
Administration (FDA) for the treatment of alcoholism is VIVITROL, an 
extended-release naltrexone product developed and manufactured by 
Alkermes. Naltrexone is a non-addictive, non-aversive agent that binds 
to opioid receptors in the brain. In people with alcohol dependence, it 
is believed that this blockade diminishes craving for alcohol and leads 
to a greater ability to resist urges to drink excessively.\11\ 
Eliminating the urge to drink allows patients the stability they need 
to focus on the psychosocial therapy component of their recovery.\12\
---------------------------------------------------------------------------
    \11\ Oswald LK, Wand GS. Opioids and Alcoholism. Physiology & 
Behavior 2004; 81: 339-358.
    \12\ Vivitrol [prescribing information]. Cambridge, MA: Alkermes, 
Inc; 2007.
---------------------------------------------------------------------------
    Approved by the FDA in April 2006, VIVITROL is the first and only 
once-monthly injectable medication for the treatment for alcohol 
dependence. It is intended for patients who are able to abstain from 
drinking in an outpatient setting in the week prior to initiation of 
treatment with VIVITROL; patients using VIVITROL in combination with 
psychosocial support have demonstrated significantly increased 
abstinence and decreased both drinking and heavy drinking days beyond 
what was achieved with counseling and placebo alone.\13\
---------------------------------------------------------------------------
    \13\ Garbutt JC, Kranzler H, O'Malley S, Gastfriend D, Pettinati H, 
Silverman BL, et. al. Efficacy and Tolerability of Long-Acting 
Injectable Naltrexone for Alcohol Dependence: A Randomized Controlled 
Trial. Journal of the American Medical Association; 2005; 293:1617-
1625.
---------------------------------------------------------------------------
    In a 2005 study in the Journal of the American Medical Association, 
authors reported on the results of a 6-month phase III clinical trial 
on extended-release naltrexone. When extended-release naltrexone was 
added to counseling alone, the average patient experienced a 48-percent 
reduction in heavy drinking days compared to counseling plus placebo 
alone.\14\ For those who had abstained from alcohol in the week prior 
to receiving their first dose of medication, there was a 90 percent or 
better reduction in heavy drinking, a two to three times greater 
likelihood of maintaining continuous abstinence and a 90-percent 
reduction in drinking days compared to the counseling plus placebo 
group over the 6-month period. VIVITROL is the only pharmacologic 
treatment for alcohol dependence that extends a medication's release 
over 30 days, which assures that measurable blood plasma concentrations 
are present in the patient's bloodstream every day during the expected 
treatment period.
---------------------------------------------------------------------------
    \14\ Garbutt, J. et al (2005). Efficacy and tolerability of long-
acting injectable naltrexone for alcohol dependence: a randomized 
controlled trial. Journal of the American Medical Association; 293: 
1617-1625.
---------------------------------------------------------------------------
    In fact, studies show that VIVITROL, when combined with 
psychosocial therapy, triples the duration of initial abstinence and 
nearly triples the proportion of patients who maintain total abstinence 
over 6 months.\15\ Even at times when alcoholics are most at risk for 
drinking--for example, the ten deadliest U.S. national holidays due to 
drunk driving--this once-monthly medication has been found to reduce 
the median level of drinking to virtually zero.16,17
---------------------------------------------------------------------------
    \15\ O'Malley SS, Garbutt JC, Gastfriend DR, Dong Q, Kranzler H.R. 
Efficacy of extended-release naltrexone in alcohol-dependent patients 
who are abstinent before treatment. J Clin Psychopharmacol 2007 
Oct;27(5):507-12.
    \16\ Lapham S, Forman R, Alexander M, Illeperuma A, Bohn MJ. The 
effects of extended-release naltrexone on holiday drinking in alcohol-
dependent patients. J Subst Abuse Treat 2009 Jan;36(1):1-6.
    \17\ Rosenbloom DL. Holidays, triggers, and willpower--is there a 
role for medications? A commentary on ``The effects of extended-release 
naltrexone on holiday drinking in alcohol-dependent patients''. J Subst 
Abuse Treat 2009 Jan;36(1):7.
---------------------------------------------------------------------------
    While there are other pharmacologic treatments for alcohol 
dependence, a SAMHSA study found that the vast majority of patients 
with this disease have difficulty adhering to an alcohol 
pharmacotherapy that requires them to take a pill every 
day.18,19 Anticipating this challenge, the National 
Institute on Drug Abuse (NIDA) issued two reports in 1976 and 1981 
calling for the development of sustained-release 
preparations.20,21 The VIVITROL clinical development program 
was funded in part with a Small Business Innovation Research Program 
grant from NIAAA. The proprietary Medisorb' drug delivery 
technology in VIVITROL allows the medication to be gradually released 
into the body at a controlled rate, delivering the naltrexone 
throughout the bloodstream and to the brain for 30 days after each 
injection. It provides patients the convenience of monthly dosing, 
which alleviates the difficulty of adhering to a daily medication 
regimen.
---------------------------------------------------------------------------
    \18\ Other pharmacologic interventions to treat alcohol dependence 
include: oral naltrexone, acamprosate, and disulfuram.
    \19\ Harris KM, DeVries A, Dimidjian K (2004). Trends in naltrexone 
use among members of a large private health plan. Psychiatric Services. 
http://ps.psychiatryonline.org. 55(3):221.
    \20\ Willette R, Barnett G, editors (1976). Narcotic Antagonists: 
The Search for Long-Acting Preparations. NIDA Res Monogr DHEW 
Publication No. (ADM) 76-296. http://www.drugabuse.gov/pdf/monographs/
04.pdf.
    \21\ Willette R, Barnett G, editors (1981). Narcotic antagonists: 
naltrexone pharmacochemistry and sustained-release preparations. NIDA 
Res Monogr 28:1-273. http://www.drugabuse.gov/pdf/monographs/28.pdf.
---------------------------------------------------------------------------
Veterans Access to Vivitrol
    While Alkermes is pleased that many top tier addiction treatment 
centers have now adopted Vivitrol on their formularies as a first-line 
treatment for patients with alcohol dependence, the Committee should be 
aware that our Nation's veterans do not have the same access to the 
latest alcohol pharmacotherapies.\22\
---------------------------------------------------------------------------
    \22\ Alcoholism and Drug Abuse Weekly; 2007; 19(23).
---------------------------------------------------------------------------
    The VA conducted a clinical review of VIVITROL from January 2007 
through February 2008 and declined to grant the product formulary 
status. Although VA providers may prescribe non-formulary products for 
their patients, significant barriers may prevent VA patients from 
receiving treatment with VIVITROL. A longstanding VA directive limits 
the interaction that companies can have with VA physicians to discuss 
non-formulary products. This type of restriction may limit provider 
education and hamper patient access to novel therapies. Although some 
providers within the VA have fought for access to VIVITROL and have 
prescribed it for their patients with great success, the usage rate for 
VIVITROL within the VA is effectively zero.
    To the credit of the VA, the agency published policy guidance, 
Uniform Mental Health Services in VA Medical Centers and Clinics, in 
June 2008. This document promotes the use of medication assisted 
treatment for alcohol dependent individuals; however, to date, few 
veterans have been able to obtain access to VIVITROL. While there are 
approximately 650,000 veterans who meet the criteria for alcohol 
dependence, only about one quarter of those individuals actually 
receive SUD treatment within the VA system.\23\ In 2008, our estimates 
suggest that fewer than 125 patients in the entire VA system (less than 
0.07 percent) have received VIVITROL.
---------------------------------------------------------------------------
    \23\ U.S. Department of Veterans Affairs, supra note 2.
---------------------------------------------------------------------------
    In March 2008, the VA testified before this Committee that the VA/
DoD Clinical Practice Guidelines for Substance Use Disorders would be 
published within 6 months.\24\ These guidelines are a necessary element 
of educating providers about SUD treatment, which is key to broadening 
patient access and eliminating the stigma associated with this 
devastating disease. The guidelines were last updated in 2001 and, 
since their initial release, new medications for the treatment of 
alcohol dependence have been approved by the FDA. Nevertheless, in the 
absence of updated guidelines, our veterans appear to have enormous 
difficulty accessing these newer agents.25,26
---------------------------------------------------------------------------
    \24\ John Paul Allen, Ph.D., Associate Chief Consultant for 
Addictive Disorders, Veterans Health Administration, U.S. Department of 
Veterans Affairs, in testimony before the House Committee on Veterans' 
Affairs Subcommittee on Health, March 11, 2008, available at http://
veterans.house.gov/hearings/transcript.aspx?newsid=187.
    \25\ CAMPRAL' (acamprosate calcium) Delayed-Release 
Tablets were approved by the FDA on July 29, 2004.
    \26\ VIVITROL' (naltrexone for extended-release 
injectable suspension) was approved by the FDA on April 13, 2006.
---------------------------------------------------------------------------
    The VA has outlined a performance measure to assess its success in 
continuity of care for veterans in treatment for SUD; however, by the 
VA's own admission, ``Many VA SUD programs have found it difficult to 
meet the Office of Quality and Performance's Continuity of Care 
performance measure. The measure requires that patients entering a new 
episode of specialty SUD treatment receive at least two VA substance 
abuse clinic visits for each of three successive 30-day periods after 
qualifying as a new patient.'' \27\ VIVITROL is a powerful tool that 
could improve continuity of care for veterans being treated for SUD and 
bring VA closer to meeting this performance measure.
---------------------------------------------------------------------------
    \27\ Schaefer J et al. (2007). Program and Patient Factors that 
Influence Continuity of Care Performance Measure Outcomes in VA 
Substance Use Disorder Treatment Programs, available at http://
www.chce.research.va.gov/docs/pdfs/CoC_Providers_Survey.pdf.
---------------------------------------------------------------------------
    Many people outside of the VA have had access to VIVITROL for some 
time. Beneficial results have been reported in state public treatment 
systems, in many other community-based treatment programs throughout 
the U.S., in primary care settings, in DUI and drug courts and in 
private commercial insurance patients.28-32 In these 
privately insured patients, this medicine was associated with the 
greatest reduction in hospitalization and emergency room visits while 
simultaneously increasing patients' utilization of counseling--leading 
Aetna Behavioral Health to introduce disease management with the 
medicine before patients even leave alcohol rehabilitation programs. 
Similar cost benefits were reported by a major state-wide Blue Cross 
Blue Shield health plan--a 49-percent reduction in hospital and 
pharmacy costs after VIVITROL treatment.\33\ Improved outcomes and 
reduced costs are significant and attainable, but the VA must make SUD 
treatment a priority--both in policy and in funding.
---------------------------------------------------------------------------
    \28\ Colston S. Florida Advancing Recovery Project Implementing 
Medication Assisted Treatment using Vivitrol: November 2006-October 
2008 Preliminary Results. Available from: Florida Substance Abuse 
Program Office, [email protected].
    \29\ Abraham AJ, Roman PM. Early Adoption and Implementation of 
Vivitrol. Addiction Health Services Research Annual Conference, Boston 
MA, Oct 21, 2008.
    \30\ Un H. Medication Assisted Treatment for Alcohol Use Disorder. 
SAMHSA/CSAT Invitational Conference on Economic Access to Treatment, 
Washington DC, Nov 3, 2008.
    \31\ Lee JD, Grossman E, DiRocco D, Truncalil A, Rotrosen J, Hanley 
K, Stevens D, Gourevitch MN. Extended-release Naltrexone Injectable 
Suspension for Treatment of Alcohol Dependence in Urban Primary Care--A 
Feasibility Study: Preliminary Analysis. Addiction Health Services 
Research Annual Conference, Boston MA, Oct 21, 2008.
    \32\ Hon J Kandrevas, Hon D Gruenburg. Testimony on Use of 
Medication in Selected Michigan DUI Courts to State of Michigan House 
Subcommittee on Corrections, March 6, 2008.
    \33\ Borawala AS, Gill P, Jan S. Utilization Patters of 
Vivitrol' (naltrexone for extended-release injectable 
suspension) for Alcohol Dependence. Horizon Blue Cross Blue Shield of 
New Jersey, Newark NJ and Rutgers U. Poster presented at Academy of 
Managed Care Pharmacy 21st Annual Meeting, April 17, 2009, Orlando FL.
---------------------------------------------------------------------------
Real Patients, Real Success
    I would like to share with you a story, told to me by a physician, 
about the success one patient realized with VIVITROL. The patient's 
name is Chris, and he is currently 26 years old. Chris started drinking 
when he was in high school, on Friday nights after football games with 
his friends and fellow band members. After graduating from high school, 
Chris enrolled as a college freshman and soon found himself drinking 
more and more. Pretty soon, he started skipping classes and instead 
spent all his time drinking with his new friends. Unfortunately, Chris 
dropped out of school before the end of his freshman year and moved 
back to his father's home in Nashville, Tennessee.
    Chris enrolled in a local community college, but his drinking 
continued to get out of control. Every day, he would take a cooler of 
beer with him to school in the back of his car, drinking between 
classes and later showing up to work drunk. During the summers, he 
would visit his mother and stepfather in Dallas, Texas, where his 
drinking led to arguments and a concern that he might assault his 
mother. His anger and drinking led to a total of six arrests for 
driving under the influence (DUI)--three in Texas and three in 
Tennessee--and one arrest for aggravated assault. Chris would get sober 
during his times in jail, and he attempted to get longer-term treatment 
through the Salvation Army and numerous half-way houses. Each time he 
would ``dust himself off'' and try to stay sober, but, unfortunately, 
he relapsed every time. Finally, someone he knew convinced him to try 
VIVITROL.
    Chris was hesitant at first, but he quickly saw the benefits of the 
medicine. He liked being able to see a doctor once a month to receive 
his injection, without having to worry about taking his medicine every 
day. He was able to get into and stay in counseling. Currently, he is 
back in school. He was recently invited to his family reunion for the 
first time in 4 years, and he has re-established good relationships 
with both his parents. He has a new girlfriend, is holding down a job 
and has remained sober for more than a year. Chris says that VIVITROL 
really helped him get back on the right track, and now he can't wait to 
get up and enjoy each day. The reason this physician's story means so 
much to me is because Chris is his son.

Conclusion
    Alkermes and its investors took a risk in pursuing a difficult 
manufacturing process to produce medicines with innovative delivery 
systems in order to treat the unmet needs of patients with devastating 
diseases. If the company's work were assuredly profitable, companies 
much larger than ours would pursue the same approach. Patients, not 
profits, are the driving force behind what we do. Since 1987, Alkermes 
has continually focused on one goal--improving the lives of patients by 
developing therapies that improve outcomes. What started as a small 
research company is now a company that develops and manufactures 
treatments for diseases that others in the industry have largely 
ignored. The Federal Government, through NIH and NIDA, partnered with 
Alkermes in development of VIVITROL many years ago, but the government 
must remain an active partner, following through on its commitment to 
assist patients with accessible, affordable SUD pharmacotherapy. Our 
company is focused on the devastating problem of alcohol dependence 
among our veterans, and we believe that the VA must be equally 
committed. Meaningful clinical guidelines must be published and 
regularly updated to reflect emerging therapies; performance measures 
must be developed, communicated and enforced in order to promote 
accountability; and the VA must make treatment of addiction among our 
Nation's veterans a real priority before we lose even one more veteran 
to the disease. In closing, thank you again for the opportunity to 
testify here today about the Alkermes story. We believe we offer a 
product that can dramatically improve the lives of our Nation's 
veterans; they deserve no less than the very best innovative 
technologies and treatments available.

                                 
    Prepared Statement of Mark Munroe, Senior Vice President, Sales
        and Marketing, Mobile Medical International Corporation,
                           St. Johnsbury, VT

    Good day. First, I want to thank Chairman Filner and Congressman 
Buyer for allowing me to testify here today on behalf of my employer, 
Mobile Medical International Corporation, Inc. (MMIC) of St. Johnsbury, 
Vermont. My name is Mark Munroe, Senior Vice President of MMIC. My sole 
purpose here today is to explain how MMIC is using an innovative 
approach to help Veterans Health Administration Medical Centers provide 
top-flight surgical care, keep VHA surgeons engaged with their patients 
and save significant amounts of time and money associated with the 
refurbishment of VHA operating rooms.
    Mobile Medical is an international company that develops and 
manufactures commercial and military mobile surgical hospitals which 
meet U.S. health care standards. These mobile health care solutions are 
rapidly deployable, fully integrated, self-contained and present 
innovative solutions for today's health care delivery needs. To 
illustrate the versatility of this technology in various markets, note 
that MMIC has responded to a FEMA request to support the University of 
Texas Medical Branch (UTMB) in Galveston Texas after Hurricane IKE; 
provides on-site surgery at a maximum security prison in North Carolina 
with an MMIC staffed mobile unit; and has delivered eye-care and 
surgical care units to Armenia, Saudi Arabia, Oman and Iraq. As a point 
of reference, about 6 weeks ago Mobile Medical was featured on the 
international television program, Little People, Big World, where Iraqi 
dwarf children were shown receiving care on the MMIC mobile surgical 
unit in Southern Iraq.
    Our flagship product, the Mobile Surgery Unit, can be driven to any 
VHA location and upon deployment triples in size to become a mobile 
surgical hospital that meets U.S. health care standards. These 
standards include those required for State licensure, Medicare 
Certification and Joint Commission on the Accreditation of Healthcare 
Organizations (JCAHO). MMIC's units meet all three of these standards. 
MMIC has provided mobile surgical capability to private, non-profit and 
university medical centers for over 12 years from California to 
Virginia and beyond. This service has most often been provided on a 
rental basis, and contract periods last anywhere from 6 months to 
several years. The primary reasons hospitals opt for this mobile 
solution are that it eliminates the cost of contracting out surgical 
cases to other hospitals and saves additional resources by trimming 
months from the duration of the project.
    Over the past 18 months MMIC has successfully brought this cost-
saving innovation to VHA medical centers which are undergoing hospital 
operating room renovations. Our conservative estimates indicate that 
VHA Medical Centers can save on average $12,000 per surgical case by 
maintaining control of these cases rather than contracting them out to 
local or regional hospitals. This approach also assures VHA management 
that VHA surgeons are handling the cases and maintaining their skills.
    MMIC has successfully utilized this approach at the VAMC in White 
River Junction, Vermont, and has a unit actively working on endoscopic 
cases at the VAMC in Martinsburg, WV. MMIC is preparing to provide 
several units to cover a major operating room renovation project in 
Miami and is currently working on similar opportunities at VHA 
facilities in New Orleans, LA, Kansas City, MO, San Diego, CA, 
Clarksburg, WV and Fayetteville, NC. Many VHA facility leaders that 
have indicated interest in utilizing our units for this purpose have 
expressed a desire for a streamlined contractual process administered 
by VHA headquarters.
    In order to address these expressed concerns, MMIC submitted an 
``Unsolicited Proposal'' to the VA's National Acquisition Center in 
2008. This submission proposed a pilot project utilizing 5 MSU's over 3 
years saving $90 million. Those savings are summarized in the attached 
two-page executive summary. This request was ultimately denied. MMIC 
estimates that a more robust project utilizing 20 MSUs for currently 
scheduled operating room projects could result in total cost avoidance 
of nearly $700M over a 5-year period. (See one-pager also attached).
    MMIC continues to attempt a dialog with the National Acquisition 
Center in order to emphasize the significance of the cost savings this 
approach offers, the benefits of keeping patients and staff inside the 
VHA system for their surgeries and the difficulties VHA Medical Center 
contract officers face as they attempt to fashion appropriate contract 
vehicles for this service.
    Mobile Medical International Corporation stands ready to provide 
the Veterans Health Administration and its patients/clients with cost 
effective solutions for complex health care delivery concerns.
    Thank you for taking the time to learn about MMIC's innovative work 
within the VHA system. It has been a pleasure being here today and an 
honor to testify before the Committee. Thank you.

                                 
            Prepared Statement of Stanley Stern, President,
                       TeleMed Network, Ross, CA

    Chairman Filner, Ranking Member Buyer, and Members of the 
Committee, thank you for the opportunity to testify today on behalf of 
TeleMed Network. My name is Stanley Stern; I am President of TeleMed 
Network.
    I want to outline for you today a technology that my company 
believes can significantly improve the treatment of behavioral health 
problems among veterans by better connecting them to the medical and 
community support they deserve.
    A recent study by RAND estimated that 18.5 percent of troops 
returning from the wars in Iraq and Afghanistan--about 300,000 people--
suffered symptoms of post-traumatic stress disorder.\1\ Other studies 
have suggested that similarly large numbers of veterans show signs of 
depression, often in conjunction with PTSD.\2\
---------------------------------------------------------------------------
    \1\ T. Tanielian and L. Jaycox, eds, Invisible Wounds of War: 
Psychological and Cognitive Injuries, The Consequences, and Services to 
Assist Recovery, 2008.
    \2\ D.G. Campbell et al., ``Prevalence of Depression-PTSD 
Comorbidity; Implications for Clinical Practice Guidelines and Primary 
Care-Based Interventions,'' Journal of General Internal Medicine 22. 
no. 6 (2006); N. Breslau et al., ``A Second Look at Comorbidity in 
Victims of Trauma: The Postraumatic Disorder-Major Depress 
Connection,'' Biological Psychiatry, 48, no. 9 (200), as referenced in 
M. Audrey Burnam et al., ``Mental Health Care for Iraq and Afghanistan 
War Veterans,'' Health Affairs, 28, no. 3, (2009), p. 773.
---------------------------------------------------------------------------
    The Departments of Defense and Veterans Affairs, with the 
consistent support of this Committee, have dramatically increased 
efforts to restore our wounded, regardless of whether they were damaged 
in body or mind. Sometimes it has taken bad news to spur a response, 
but ultimately, I and most Americans believe, this Country does do the 
right thing for our veterans.
    Unfortunately, the challenges to treating those warriors who are 
now fighting their own private battles against mental health conditions 
are complicated by culture, demographics, and geography.
    Mental illness encourages isolation and flourishes in it, and the 
internal and external forces that drive troubled veterans into 
isolation are very strong. This is particularly sad when their illness 
is something like PTSD, which may respond better to personal therapy 
and interaction with veterans' groups than to drugs.\3\
---------------------------------------------------------------------------
    \3\ Institute of Medicine, Crossing the Quality Chasm: A New Health 
System for the Twenty-first Century (Washington: National Academies 
Press, 2001), as referenced in M. Audrey Burnam et al., ``Mental Health 
Care for Iraq and Afghanistan War Veterans,'' Health Affairs, 28, no. 
3, (2009), p. 776.
---------------------------------------------------------------------------
    Nationwide, relatively few Americans, compared with past 
generations, have been exposed to military life and its shared 
experiences, both good and bad. That's an unfortunate side effect of 
America's all-volunteer military. So when soldiers go home after 
battle, fewer and fewer people understand what they've been through. 
That goes for psychological counselors as much as anybody.
    After being steeped in the pride and self-reliant ethos of 
America's Services, many veterans are understandably reluctant to admit 
their need for help, particularly when the wounds are invisible. They 
may even think, albeit incorrectly, that VA hospitals exist mainly for 
those graying veterans of past wars, not for otherwise healthy young 
men and women.\4\
---------------------------------------------------------------------------
    \4\ Tanielian and Jaycox, eds., Invisible Wounds of War, referenced 
in M. Audrey Burnam et al., ``Mental Health Care for Iraq and 
Afghanistan War Veterans,'' Health Affairs, 28, no. 3, (2009), p. 774.
---------------------------------------------------------------------------
    The isolation can be even worse for those who served with the 
Reserves or National Guard, particularly when they go home to a small 
town or a community that's isolated by geography or culture. Qualified 
help, where caregivers understand what happens to men and women in war, 
may be miles away, compounding the self-protecting urge to stick it 
out, go it alone, to be a ``soldier.''
    Two years ago, the Department of Defense Task Force on Mental 
Health took a broad look at psychological care for veterans and 
candidly admitted that ``the Military Health System lacks the fiscal 
resources and the fully trained personnel to fulfill its mission to 
support psychological health in peacetime or fulfill the enhanced 
requirements imposed during times of conflict.'' \5\
---------------------------------------------------------------------------
    \5\ Report of the Department of Defense Task Force on Mental 
Health, June (2007), Executive Summary, Findings.
---------------------------------------------------------------------------
    The Task Force reported that about one-third of the 686,306 
veterans discharged between 2002 and 2006 who were eligible sought care 
at a VA facility. Of those, more than one-third were diagnosed or 
evaluated for mental disorders (17 percent PTSD, 14 percent drug 
problems, and 12 percent depression).
    Among the specific failures in mental health care were an inability 
to overcome the stigma that veterans attach to reaching out for mental 
health care, the inaccessibility of qualified service providers, 
insufficient collaboration among providers, and other problems having 
to do with communication.
    Indeed, the crux of many of the problems in dealing with military 
mental health problems is communication. So, why not use modern 
technology to relink the suffering veteran back into a supportive 
community that understands his or her problems and has the proper tools 
to solve them?
    Simply put, TeleMed's system can provide veterans with a video 
teleconferencing capability in their homes, using a simple, scaleable, 
and affordable version of the technology common in corporate business.
    Our TeleMed Internet Endpoint, what we call ``TIE,'' currently 
costs less than $1,000, with the price expected to drop significantly. 
It is small, just three pounds, so it is portable and can be mailed. 
Yet, it provides a brilliant video conferencing image on a home 
television. The TIE and its secure network are mutually optimized for 
video. Simply plug it into a TV, connect it to the Internet and an 
inexpensive digital camera, and turn it on.
    I invite you to imagine how this two-way visual and audio 
communication could be used.
    First, with just one touch on a wireless keyboard, the veteran sees 
and speaks with a VA health care service provider whenever he or she 
needs help. The health care worker immediately appears full screen. The 
contact could be initiated by the veteran or the VA.
    A second button could connect the veteran to an ongoing group 
therapy session, say on substance abuse or suicide prevention, perhaps 
one operating 24/7 with participants from around the globe. The caller 
might choose to participate, or simply observe his peers speaking about 
issues he also confronts. Imagine the psychological reassurance of this 
always-accessible confirmation that he is not alone. Help is available 
without an appointment, without travel, and most without stigma.
    In recent months, increased attention has been paid to suicide 
among veterans. I have no way of knowing if the rates of suicide have 
gone up because of our wars in Afghanistan and Iraq and the increased 
deployments associated with them, but I do know that a functioning TIE 
Network could be ready when a potentially suicidal patient needs help 
most, at the moment of crisis, in the middle of the night.
    Such group therapy conversations need not become part of a 
permanent medical record, and we know for certain that a major reason 
some military people are reluctant to seek help is because they fear a 
record of their outreach could damage their careers.
    At the same time, the Obama Administration has placed a major 
emphasis on systematized electronic medical records as a way to improve 
care and drive down health costs. The VA has already taken the lead in 
this field, and the TIE Network takes this initiative even further. 
Doctors could record sessions with patients for later review and 
consultation. Patients could access medical records, receive reminders 
on medications, see instructional or inspirational videos. TIE is 
secure, encrypted, and data transmission is fully compliant with HIPAA. 
The system is ready to interface with VA electronic medical records.
    Help, of course, is least accessible for our rural veterans who 
often must drive for hours to receive care. But studies have shown that 
mental health professionals in general are not distributed evenly 
across the county.\6\ TIE offers a chance to link those best qualified 
to provide evidence-based quality therapy to those who need it most. 
Concurrently, it offers a chance for the government to use cost-
effective treatment and not be tied to caregivers in specific areas.
---------------------------------------------------------------------------
    \6\ IOM, ``Increasing Workforce Capacity for Quality Improvement,'' 
in Improving the Quality of Health Care for Mental and Substance-Use 
Conditions, Quality Chasm Services (Washington: National Academies 
Press, 2006), and President's New Freedom Commission on Mental health, 
``Subcommittee on Rural Issues: Background Paper'' (Rockville, Md.: 
U.S. HHS, June 2004), as referenced in M. Audrey Burnam et al., 
``Mental Health Care for Iraq and Afghanistan War Veterans,'' Health 
Affairs, 28, no. 3, (2009), p. 775.
---------------------------------------------------------------------------
    My emphasis here today is on the many ways that the TIE Network can 
solve the difficult problems of treating the psychological problems of 
veterans, but TIE units are excellent vehicles for many other uses. 
They could be used for medical check-ups, evaluations, and counseling, 
while eliminating the driving, the waiting, and the mileage expense to 
the VA.
    TIE is a conduit that connects the VA to its veterans, allowing the 
VA to provide its best treatments for PTSD, depression, and other 
problems directly to the vet's home. Our technology provides the 
quality and simplicity at a cost that allows these advantages to be 
scalable, benefiting both rural and urban veterans. We will measure 
these improvements with independent research that I am confident will 
quantitatively demonstrate improved medical benefits and access, and 
lower costs--all within 1 year.

                               __________

                       TeleMed Network is led by:
                           The Executive Team

    Stanley Stern-President

      Founder of two companies:
        Cobalt Communications-video conferencing integration
        PRN-largest in-store advertising network

    Janette Gitler-COO

      Senior Program Director-Gordon and Betty Moore Foundation
        Responsible for $300M Environmental Fund
      Director of Programming-KRON & KQED (2 largest media in 
SF Bay Area)

    Dr. Mervyn Silverman-SVP & Medical Director

      Director of Health, City of San Francisco
      President, American Foundation for Aids Research
      Director Consumer Affairs, U.S. FDA
      Awarded: Public Health Hero, ``Heroes in Medicine Award, 
Award of Courage''

    David Wellstone-Director

      National spokesperson on health care & mental health
                           The Technical Team
    Ed Yoon-CTO

      Chief Technology Officer-Gordon & Betty Moore Foundation 
(Intel)
      Senior Technology Evangelist for Microsoft
      Developed/installed communication systems for Congress, 
FBI, CIA, DoD, NATO
      Microsoft-Senior Consultant to CINCPACFLT (Commander-in-
Chief, U.S. Pacific Fleet)-developed technology road-map for next 
decade
      Awarded: Architectural Engineer of the Year from 
Microsoft's executive Committee

    Ken Novak

      25 years of experience in Wide Area Network (WAN) design 
and implementation
      Digital Vision Fellow at Stanford University
      Chief Technology Officer at CGNET-IT services to non-
profits around the globe

    Bill Lattin

      Chief Technology Officer, Certicom Corporation
      Managing Director of SecureField, an information security 
consultancy that specializes in cryptographic design and network 
security.
      Chair of the Standards for Efficient Cryptography Group 
(SECG)
                             Advisory Board
    Jim Omura

      Professor of electrical engineering at UCLA for 15 years
      Designer of a number of spread spectrum communications 
systems, and the Massey-Omura cryptosystem
      Fellow of the IEEE and a member of the National Academy 
of Engineering
      Awarded the IEEE Alexander Graham Bell Medal

    Scott Minick

      Board Chairman-California Pacific Medical Center
      Board Member of approx. 12 biotech companies

    Susan Porth

      20 years with Kaiser Permanente
      10 years as SVP & CFO for 10 years

                                 
     Prepared Statement of David Scadden, M.D., Scientific Founder,
                 Fate Therapeutics, Inc., La Jolla, CA

    Mr. Chairman, ladies and gentlemen of the Committee, on behalf of 
Fate Therapeutics, I would like to thank all of the Members for 
inviting Fate Therapeutics to testify today. We would like to ask that 
this document be considered our formal testimony and have it submitted 
into the record through David Scadden, Founder, Fate Therapeutics.

           CREATING TOMORROW'S MEDICINES FOR WOUNDED SOLDIERS
              USING THE MOST ADVANCED STEM CELL TECHNOLOGY

Executive Summary:
    Many diseases and injuries involve the death of cells that the body 
cannot naturally replace. Sometimes cell death can occur suddenly, as 
when a soldier sustains traumatic injuries in the battlefield. Other 
times it is slow and inexorable, as in Parkinson's disease; a 
consequence that can be attributed to the exposure to chemical agents 
used in warfare. The great promise of stem cells--the body's equivalent 
of renewable energy--is that they could be coaxed into becoming and 
then replacing cells lost to disease or injury. While initial efforts 
centered on the use of embryonic stem cells, we believe the 
breakthrough creation of induced pluripotent stem cells (known as iPS 
cells) and deeper understandings in adult stem cell biology have 
enabled us to create and develop tomorrow's medicines for veterans.
    The transformative discoveries that led to the creation of iPS 
cells occurred in parallel with new understandings of adult stem cells 
and their roles in developmental and regenerative biology. iPS cells 
are created by using technologies that can turn a mature adult cell--
like a skin cell--into a cell that has similar properties of self-
renewal and pluripotency as embryonic stem cells, without using human 
embryos. Adult stem cells are found in almost all the tissues or organs 
in the body and are primarily responsible for maintaining and repairing 
the tissue in which they reside. Specifically, it was found that adult 
stem cells essentially lie in a reactive state; triggered into action 
by disease or injury. These remarkable discoveries were the basis for 
Fate Therapeutics' drug discovery and development strategy to create 
new medicines.
    Scientists at Fate Therapeutics are working to quickly unlock the 
true potential of iPS and adult stem cells by using a two-prong 
approach. Fate is establishing technologies to ensure safe, efficient 
methods to create iPS cells to enable disease modeling, drug discovery 
and development and personalized cell replacement therapy. The second 
approach is to apply conventional drug approaches, whether in the form 
of pills or by injection, to activate specific mature adult cells to 
restore health. By leading this area of research, Fate is answering the 
underlying questions of how cells in the body activate and transform in 
normal, disease or injured states and then applying these 
understandings to develop tomorrow's medicines for veterans and the 
general public.
    For veterans, we believe the near term applications for such a 
strategy to generate wound healing therapies are especially applicable. 
While improved technological advances in armor have increased the 
survivability of our soldiers, it has come with the unintended cost of 
our armed service men and women sustaining more severe injuries. 
Traumatic brain injury, non-union bone fractures, deafness and 
blindness are unfortunately injuries that are found to be commonplace 
in today's battlefields and unfortunately have limited to no treatment 
options. Programs underway at Fate Therapeutics have indicated that 
cells in the areas of the body that suffer damage from such wounds, can 
be activated through the traditional applications of medicines to guide 
the body to heal itself. While these initiatives are in the early 
stages, we continue to strive to fully realize the potential of the 
discoveries in stem cell biology and develop them as safe and curative 
therapies for our wounded soldiers who so honorably deserve them.

Fate Therapeutics:
    Founded in 2007 on the leading stem cell and developmental biology 
research, Fate Therapeutics is using the fundamental biological 
mechanisms that guide cell fate to develop regenerative medicines. The 
company has brought together the foremost scientists from the Nation's 
research hotbeds (Boston, San Francisco, San Diego and Seattle) who 
have demonstrated the potential to create and modulate stem cells to 
restore health. While embryonic stem cells opened the possibility for 
regenerative medicine, Fate Therapeutics is focusing on adult stem 
cells and induced pluripotent stem cells (iPSCs). Adult stem cells 
naturally exist in tissues or organs and are responsible for 
maintaining and repairing the tissue in which they are found. iPSCs are 
stem cells created from fully mature differentiated cells, like a skin 
cell, and are being developed as personalized cell replacement 
therapies (See Background on Stem Cell Research below for more on stem 
cell types and applications). Fate is using conventional drug discovery 
and iPSC technology to identify small molecules that can specifically 
activate these stem cells to repair and regenerate tissue for veterans' 
health.

Scientific Founders of Fate Therapeutics:
    Fate's scientific founders are working with the company to 
collaboratively research and develop innovative therapeutics to 
modulate cell fate. By partnering with the leading academic labs in 
stem cell and developmental biology, Fate has exclusive access to the 
most advanced biological assays, models and research to illuminate the 
biology of stem cells and deliver on the promise of regenerative 
medicine.

      Philip Beachy, Ph.D.-Ernest and Amelia Gallo Professor of 
Developmental Biology at Stanford University School of Medicine and an 
Howard Hughes Medical Institute (HHMI) Investigator

      Randall Moon, Ph.D.-William and Marilyn Connor Chair and 
director of the Institute for Stem Cell and Regenerative Medicine at 
University of Washington and an HHMI investigator

      David Scadden, M.D.-Gerald and Darlene Jordan Professor 
at Harvard Medical School, co-director of Harvard Stem Cell Institute, 
and director of Massachusetts General Hospital Center for Regenerative 
Medicine

      Leonard Zon, M.D.-Grousbeck Professor of Pediatric 
Medicine at Harvard Medical School, director of the Stem Cell Program 
at Children's Hospital Boston, and an HHMI Investigator

      Sheng Ding, Ph.D.-Associate professor in the departments 
of chemistry and cell biology at The Scripps Research Institute

      Rudolf Jaenisch, M.D.-Founding member of the Whitehead 
Institute, professor of biology at MIT, and member of the National 
Academy of the Sciences

    Drs. Beachy and Moon are leading developmental biologists who 
understand how to activate specific stem cell pathways to differentiate 
stem cells in vivo and in vitro. Drs. Scadden and Zon are renowned 
scientists and doctors who are researching ways to guide cells to treat 
various diseases and identifying means to explore the adult stem cell 
niche, locations where naturally occurring stem cells are found in the 
body. Drs. Ding and Jaenisch are the foremost investigators finding 
small molecules and other non-genetic methods to guide cell fate.

DIRECTING CELLS TO RESTORE HEALTH:
FATE THERAPEUTICS' REGENERATIVE MEDICINE PROGRAMS
FOR SOLDIERS AND VETERANS
Hearing Restoration
    Among veterans, hearing loss is the most common service-connected 
disability.\1\ A 2004 survey showed that 28 percent of troops coming 
home from a war zone have diminished hearing.\2\ In 2004, the Veterans 
Administration (VA) paid $633.8 million to 378,982 veterans whose main 
disability was hearing loss, according to the Army's Center for Health 
Promotion and Preventive Medicine (Figure 1). That number has since 
grown to more than $1.2 billion annually in compensation costs for 
hearing loss and hearing related injuries.
---------------------------------------------------------------------------
    \1\ Fausti SA, et al. Hearing health and care: The need for 
improved hearing loss prevention and hearing conservation practices. J 
Rehabil Res Dev. 2005 Jul-Aug; 42(4 Suppl 2):45-62.
    \2\ Schulz, TY. Troops Return with Alarming Rates of Hearing Loss. 
Hearing Health vol 20:3; Fall 2004.
---------------------------------------------------------------------------
    In a 2005 study, the Center for Naval Analyses found that permanent 
hearing loss is one of the most common disabilities among sailors and 
recommended expansion of active military hearing-conservation programs 
that work to reduce noise exposure.\3\ In 2005, it may have not seemed 
possible to recommend funding research to restore hearing, but today 
stem cell research and its applications in regenerative medicine offer 
that opportunity. Fate Therapeutics, a private biotechnology company, 
has converged the leading scientific expertise and research in stem 
cell and developmental biology to discover and develop regenerative 
medicines to treat a number of diseases and conditions that currently 
have little to no therapeutic options, including acute hearing loss.
---------------------------------------------------------------------------
    \3\ Geoffrey B. Shaw and Robert P. Trost. ``Statistical Analysis of 
Hearing Loss Among Navy Personnel.'' February 2005. CRM D0011228.A2.
---------------------------------------------------------------------------
Fate's Program to Cure Acute Deafness:
    Hair cells in the ear are specialized cells responsible for sensing 
sound and transmitting those signals to the brain. Once damaged, 
usually due to loud or sustained noise exposure, these specialized 
cells die and are not replaced, causing deafness; however, stem cells 
have been identified in the adult ear (Figure 3).

[GRAPHIC] [TIFF OMITTED] T9916A.007

    Figure 3a: Cross section through the ear anatomy; 3b: Expanded 
depiction of red box in 3a to show cochlear structure and hair cells 
(orange cell), the specialized sensory cell for hearing; 3c: Supporting 
cells upon activation can divide and differentiate into hair cells 
(blue cells); 3d: Supporting cells have also been seen to change form 
or transdifferentiate into hair cells (Images: University of 
Washington).

    Research in cell culture and animal models has shown that upon 
activation these stem cells can differentiate into the specialized 
cells needed to restore hearing. Fate Therapeutics has proprietary 
research around the pathways that modulate stem cell activation and 
differentiation and is evaluating the company's library of drug 
candidates to identify ways to efficiently activate these pathways. We 
are currently performing preclinical validation experiments in cochlear 
explant cultures to confirm our small molecule drug candidates activate 
progenitor cells in the inner ear to grow and differentiate into hair 
cells. We hope to advance the development of therapeutics to regenerate 
cochlear hair cells, which are lost as a result of noise damage 
sustained during military service.

Vision Restoration
    One in 10 veterans from military operations in Iraq and Afghanistan 
have sustained serious traumatic eye injuries, which is the highest 
percentage for eye wounds among any other major conflict dating to 
World War I.\4\ In 2007, it was reported that more than 1,100 veterans 
from these two military conflicts have undergone surgery for damaged 
eyes.\5\ While body armor improvements are saving more lives, eyes, 
limbs and heads still remain extremely vulnerable. In fact, eye wounds 
occur at almost twice the rate as wounds that require amputations. 
Moreover, troops who sustain combat injuries leading to sudden 
blindness lose a greater degree of independence and have a much longer 
rehabilitation time to regain the ability to perform simple life tasks.
---------------------------------------------------------------------------
    \4\ Wong, TY, et al. ``Eye Injuries In Twentieth Century Warfare: A 
Historical Perspective.'' (1997) Survey of Ophthalmology. (1997) 
41:433-459.
    \5\ Zoroya, G. ``Blinded by War: Injuries Send Troops into 
Darkness.'' USA Today. November 14, 2007.
---------------------------------------------------------------------------
    While science is still a long way from regrowing new limbs, stem 
cell research and its applications in regenerative medicine can now 
offer an opportunity to restore sight. Fate Therapeutics, a private 
biotechnology company, has converged the world's leading scientific 
expertise and research in stem cell and developmental biology to 
discover and develop regenerative medicines to treat a number of 
diseases and conditions that currently have little to no therapeutic 
options, including acute blindness.

Fate's Program to Cure Acute Blindness:
    Rods and cones in the eye are specialized cells responsible for 
sensing light and transmitting those signals to the brain. Once 
damaged, these specialized cells die and are not replaced, causing 
blindness; however, stem cells have been identified in the adult eye 
(Figure 2).

       a.  
    [GRAPHIC] [TIFF OMITTED] T9916A.008
    
       b.  
    [GRAPHIC] [TIFF OMITTED] T9916A.009
    
    Figure 2a: Location of stem cells in the eye; 2b: Expanded 
depiction of red box in 2a to show a Muller glial cell (arrow: orange 
cell), a type of stem cell in the eye that can upon activation divide 
and differentiate into rods (light blue cells) (Images: Nature).
    Research in cell culture and animal models has shown that upon 
activation of the Wnt or Hedgehog pathway these stem cells can 
differentiate into the specialized cells needed to restore sight. Fate 
Therapeutics has proprietary research around the pathways that modulate 
these stem cells and is evaluating the company's library of drug 
candidates to identify ways to efficiently activate these pathways. We 
are currently performing preclinical validation experiments in retinal 
explant cultures to confirm our small molecule drug candidates activate 
progenitor cells in the eye to grow and differentiate into rods and 
cones. We hope to advance the development of therapeutics to regenerate 
photoreceptors lost as a result of choroidal hemorrhage and retinal 
detachment consequent to traumatic eye injury sustained in combat.

Bone Regeneration
    Advances in medical care and improvements in both body and vehicle 
armor have resulted in increased soldier survival, from 76.4 percent 
during the Vietnam War to 90.4 percent in Iraq. However, the price of 
this survival has led to the rise in soldiers sustaining more severe, 
traumatic injuries: orthopedic musculoskeletal injuries account for 
approximately 70 percent of war wounds; fractures account for 26 
percent of combat injuries; and 82 percent of all fractures are open 
fractures.\6\ Most civilian orthopaedic treatment approaches cannot be 
applied to battlefield medicine because combat injuries often involve 
high-velocity shells or explosives, which injuries are generally very 
different from low velocity bullet wounds more often seen in civilian 
trauma centers. The challenge in these battlefield injuries is the high 
degree of tissue loss and contamination combined with limited treatment 
resources. The specific treatment protocol includes surgical 
debridement, leaving all wounds open, early fracture stabilization, 
broad-spectrum antibiotics, and rapid evacuation to higher levels of 
care.
---------------------------------------------------------------------------
    \6\ Peter Pollack and Carolyn Rogers. ``A brief background of 
combat injuries.'' AAOS NOW. March/April 2007. American Association of 
Orthopaedic Surgeons.
---------------------------------------------------------------------------
    While science is still a long way from regrowing new limbs, stem 
cell research and its applications in regenerative medicine can now 
offer an opportunity to develop therapeutics that can activate the 
body's own stem cells to advance healing and repair of bone and 
cartilage. A regenerative medicine treatment supplement to support 
orthopedic medicine at either battlefield or surgical care level could 
provide quicker healing times and better overall recovery. Fate 
Therapeutics, a private biotechnology company, has converged the 
leading scientific expertise and research in stem cell and 
developmental biology to discover and develop regenerative medicines to 
treat a number of diseases and conditions that currently have little to 
no therapeutic options, including traumatic orthopedic injuries.
Fate's Program for Non-Union Fracture:
    Non-union bone fractures are large breaks in the bone that cannot 
heal without further intervention. These fractures represent a major 
challenge for battlefield medicine because treatment often requires 
multiple surgeries and medical procedures (Figure 2a).
       a.
    [GRAPHIC] [TIFF OMITTED] T9916A.010
    
       b.
    [GRAPHIC] [TIFF OMITTED] T9916A.011
    

    Figure 2a: Except for oblique, these different types of fractures 
take longer to heal and often need surgeries and other medical 
interventions to heal properly. 2b: A schematic of bone graft.
    The most common means of fixing a non-union fracture is to add a 
bone graft taken from the patient's own pelvis (Figure 2b). However, 
this increases pain, medical procedures, hospital time and potential 
complications, such as donor site wound infection, bleeding or 
numbness. The most advanced FDA-approved product, a bone growth factor, 
reduces the usage of bone graft but does not reduce healing time. 
Developing small molecule drugs that can selectively activate and guide 
stem cells in the body will be the best chance at a successful solution 
to reduce non-union fracture healing time. We hope to advance the 
development of therapeutics to regenerate bone in cases of high energy 
weapon injuries and blast injuries. These combat injuries are often 
associated with highly fragmented fractures and infection that increase 
the failure rate of bone to heal.
Background on Stem Cell Research
Embryonic Stem Cells:
    In 1998, the first human embryonic stem cell (hESC) line was 
created from a fertilized egg. This was a significant milestone in 
regenerative medicine because hESCs are pluripotent, meaning they can 
become any cell in the body, and stem cells could conceivably be grown 
and differentiated into replacement cells for any applicable 
therapeutic need (Figure 1).

[GRAPHIC] [TIFF OMITTED] T9916A.012

    All the Cells in the Body to Restore Health

    Figure 1: The promise of regenerative medicine

    However, the seemingly unlimited therapeutic potential associated 
with hESCs were tempered with the sobering safety issues that hESCs 
presented. Specifically, because of the limited population source from 
which hESCs are derived, potential patients would be exposed to similar 
immune rejection risks as those of organ transplant recipients when 
receiving organs from donors of not identical genetic matches. 
Moreover, hESC recipients would face increased risks to potentially 
unknown genetic diseases of the donor. Accordingly, the ability to 
generate patient-specific replacement cells with pluripotent 
capabilities became the next sought after milestone to fully realize 
the therapeutic potential of regenerative medicine.
    Scientists tried to address this hurdle with a technique that 
replaces an egg cell's nucleus with the nucleus from a patient's skin 
cell (Figure 2). Since the nucleus of an adult skin cell has a full set 
of chromosomes, the egg cell would in a sense be fertilized with an 
exact copy of the patient's DNA. The embryonic stem cell line derived 
from this ``fertilized'' egg cell would be a genetic match to the 
patient and likely to not be rejected. However, this technique was 
highly inefficient and relied on donated egg cells, which are from a 
limited population source and difficult to obtain.

[GRAPHIC] [TIFF OMITTED] T9916A.013

    2Figure 2: Schematic of nuclear transfer, a previously explored 
method to generate genetically matched stem cells.
Induced Pluripotent Stem Cells (iPS cells):
    In 2007, in separate publications Drs. Yamanaka and Jaenisch, the 
later a scientific founder of Fate Therapeutics, reported that fully 
differentiated adult cells, such as a skin cell, could be 
``reprogrammed'' to become embryonic-like stem cells by forcing 
expression of four transcription factors (Figure 3). Called induced 
pluripotent stem cells (iPS cells), as iPS cells were derived from the 
potential patient's own cells, the issue of creating patient specific 
cells was addressed. Furthermore, ethical issues involving the use of 
embryos or eggs had been avoided.

[GRAPHIC] [TIFF OMITTED] T9916A.014


    Figure 3: A schematic of creating iPS cells, a more efficient and 
reproducible process for generating personalized cell replacement 
therapies.

    iPS cells were first created by genetic manipulation using viruses, 
which carry risks from insertion and makes the cells unsuitable for 
clinical use. Fate Therapeutics and the company's scientific founders 
have found safer and more efficient ways to create iPS cells using non-
genetic methods, such as small molecules and biologics. As iPS cells 
can potentially be made from any adult cell and differentiate into any 
cell type, iPS cells are considered to be the best means to create 
personalized cells for regenerative medicine. Beyond cell therapy, Fate 
Therapeutics believes iPS cells are of essential importance to research 
how to control cell fate with small molecules to develop conventional 
therapeutics.\7\ These small molecules could potentially be applied to 
modulating adult stem cells to stimulate the body's own healing process 
to repair and regenerate tissues.
---------------------------------------------------------------------------
    \7\ All drugs in pill form, like aspirin, are composed of small 
molecules. Small molecules are easier to turn into drugs because they 
can be tested for safety and efficacy. Thus, they follow a conventional 
pharmaceutical drug development approach with a well-defined regulatory 
and commercialization path.
---------------------------------------------------------------------------
Adult Stem Cells Are Naturally Found in the Body:
    While ESCs and iPS cells are types of stem cells made in the lab, 
adult stem cells naturally occur in the human body. Adult stem cells 
are found in tissues or organs and primarily maintain and repair the 
tissue in which they are found. Some populations of adult stem cells 
are also thought to remain quiescent (non-dividing) in areas of the 
body called ``niches'' until they are activated by disease or tissue 
injury. Adult stem cells can renew themselves and can differentiate to 
yield the major specialized cell types of the tissue or organ. Some 
researchers are trying to grow adult stem cells in the laboratory for 
cell replacement therapy; however Fate Therapeutics is taking a 
different approach. Fate is using conventional drug discovery\8\ and 
iPS cell technology to identify small molecules that can specifically 
activate these adult stem cells in the body to repair and regenerate 
tissue.
---------------------------------------------------------------------------
    \8\ Conventional drug discovery relies on a deep understanding of 
the biological pathways and mechanisms which control a specific cell or 
cellular process. Small molecules and biologics are developed into 
drugs based on their selectivity to modulate these cellular processes 
in a way that has therapeutic benefit.

                                 
 Prepared Statement of Howard J. Federoff, M.D., Ph.D., Executive Vice
      President for Health Sciences, Executive Dean of the School
   of Medicine, Georgetown University Medical Center, Washington, DC

    Chairman Filner, Ranking Member Buyer and Members of the Committee. 
Thank you for holding this hearing, for the work you are doing on 
behalf of America's brave veterans, and for allowing me to testify this 
morning. I will be focusing on innovative work that from my perspective 
is critically important to addressing the long term implications of 
traumatic brain injury (TBI) both to ensure that we are serving the 
long term needs of returning veterans who have experienced TBI and to 
do so in ways that are wise for the Department of Veterans Affairs 
health care programs.
    The Defense and Veterans Brain Injury Center makes the point on its 
Web site that ``America's armed forces are sustaining attacks from 
explosions or blasts . . . almost daily in Iraq and Afghanistan.'' It 
also notes that screenings at Walter Reed have found that 32 percent of 
servicemembers evacuated from theater had TBI. Those statistics obscure 
the reality, also referenced on that webpage, that ``Sometimes, in the 
case of mild TBI, there may be no outward sign of injury. Over 90 
percent of combat-related TBI's are closed brain injuries.''
    Indeed, TBI has been termed ``the silent epidemic.'' While 1.4 
million Americans suffer from TBI from a variety of sources each year, 
many of these injuries--with potential long term consequences--are not 
reported. Even in mild cases of trauma, the central nervous system can 
suffer permanent, often debilitating damage.
    There can be no dispute that our military is moving aggressively to 
respond as best they can to the flood of very visible and tragic 
traumatic brain injuries that our men and women in uniform are 
experiencing in these 21st century conflicts. Just as the nature of 
these injuries has changed from the ``shell shock'' suffered by those 
serving in earlier conflicts, medical science has made significant 
strides. But we owe it to those who are serving and have served our 
Nation in uniform to act on the important realization that, 
notwithstanding the attention they are receiving, there are all too 
many who have suffered mild to moderate traumatic brain injuries that 
pose serious, but hidden threats to their long term well-being. We need 
to act to:

      Develop methodologies for more rapid and accurate 
diagnosis of TBI and its associated risks;
      Determine the most effective approaches to triaging TBI 
patients; and
      Pursue the rational design and screening of new 
therapies, including novel drug discovery and development targeting the 
prevention or minimizing of cognitive impairments which can impact 
learning capabilities, the ability to hold down a job, and predispose 
to post-traumatic stress disorders.

    Years of neurological research have taught us a great deal about 
the human brain, and, therefore, there is information relevant for TBI 
victims:

      First, the plasticity of the human brain permits unique 
recuperative responses to trauma. We must fully understand these 
responses to better understand when to intervene and when to allow the 
body to heal itself.
      Second, research to date indicates that, unlike in the 
case of a stroke, in at least some types of TBI, there is a longer 
timeframe from the time of injury for a possible therapeutic 
intervention before permanent loss of brain function.
      And, third, research on Alzheimer's and Parkinson's 
diseases makes clear that blood and its circulating cells may serve as 
an important window into the human brain, helping us better understand 
the impact of neurological disease and injury. For example, 
understanding the neuropathology of brain inflammation through analysis 
of blood based proteins and distinct populations of leukocytes may help 
us better determine the extent to which the brain has been injured and 
the degree to which the body is responding and possibly recovering. 
These observations are generally invisible absent a molecular analysis 
of the blood of an injured person, but they potentially hold the key to 
effective and timely interventions.

    Recently, the Department of Defense through its Neurotoxin Exposure 
Treatment Program (NETRP) has awarded a 5-year grant to Georgetown 
University Medical Center neuroscientists to perform systematic and 
extensive bio-molecular profiling of brain tissues and peripheral blood 
to identify and validate robust, specific and sensitive biomarkers for 
TBI. Those bio-molecular ``signatures'' can be read from the blood and, 
early on, may aid in diagnosis of the variety and severity of brain 
injuries and guide therapeutic responses. Indeed, this research, I am 
confident, will inform the rational design of new drugs and therapies 
to prevent both short-term and lasting brain damage. Our work will be 
carried out in conjunction with the Seattle-based Institute for Systems 
Biology and researchers at the University of Rochester. As someone who 
believes in the tremendous benefits that are possible through broad 
collaborations, I am pleased that we are planning to work with the 
Uniformed Services University of the Health Sciences as they pursue 
their direction from Congress to focus on TBI, as well as with the 
National Institute for Nursing Research, the National Institute of 
Neurological Disorders and Stroke, and the Washington Hospital Center.
    Our research for the Department of Defense will initially rely on 
civilian sector TBI patients for our clinical studies in recognition of 
the reality that we will be able to recruit civilian patients without 
the delays that are inherent in working with patients injured in 
combat. However, I am following up on a recommendation from Chairman 
Filner that we reach out to the DC VA Medical Center (WVAMC), to pursue 
approaches to ensure longitudinal follow up between the care received 
in the cases from the military and ongoing DVA medical care. Given the 
on-going work on traumatic brain injury at WVAMC, as well as the over 
30 Georgetown Medical Center faculty who hold joint appointments with 
WVAMC, I am confident that we will actively engage WVAMC in this 
research. To provide the best possible care for TBI victims now relying 
on the Department of Veterans Affairs for medical services, ongoing 
monitoring of their conditions and well-documented longitudinal follow 
up will be critical. It will likewise enrich our research.
    Members of this Committee know very well that the vast majority of 
military personnel who are returning from the field having experienced 
TBI are very young. God willing, they have long lives ahead. Therefore 
it is incumbent upon us to ensure that we are aggressive in just this 
kind of research endeavor that looks beyond the immediate consequences 
of even mild TBI. With this kind of research, we can address the 
``silent epidemic'' before it takes a toll on the long-term quality of 
life of those who are serving our country. I urge you to ensure that 
the Department of Veterans Affairs, in close concert with both the 
Department of Defense and the Department of Health and Human Services, 
remain vigilant in pursuing the identification both of these bio-
molecular signatures and of effective therapeutic responses to TBI.
    Again, thank you for giving me this opportunity to testify before 
you.

                                 
 Prepared Statement of Nelson M. Handal, M.D., FAPA, Founder, Chairman,
      and Medical Director, Harmonex, Inc., CliniCom, Atlanta, GA,
       Board Certified Child, Adolescent and Adult Psychiatrist,
              and Fellow, American Psychiatric Association

    [Good Morning.] Mr. Chairman, Members of the Committee, thank you 
for the opportunity to share information about innovative treatments 
and technologies that are today serving to enhance quality of care in 
mental health.
    As you know, information and the way it is used is at the core of 
psychiatric assessment and diagnosis. Typically patients requiring 
mental health care are interviewed in what is commonly referred to as a 
traditional face-to-face psychiatric interview. Practicing mental 
health clinicians know that too often, time constraints, volume and 
complexity of the information, limited access to care, and other 
factors, if not properly identified and addressed, often end up 
limiting the accuracy of their face-to-face assessments.
    The key question is how to gather information comprehensively, in a 
reasonable amount of time, utilizing an easy to use tool that generates 
a valuable report to facilitate disposition and the clinician's initial 
face-to-face interview.
    Our organization, Harmonex is the developer of a patient self 
administered and computer based assessment tool known as CliniCom. 
CliniCom is comprehensive, easy to use and allows the clinician to 
verify suggested diagnoses. The technology resides in a secure platform 
that comprehensively screens for 56 possible mental illnesses and 
Traumatic Brain Injury (TBI). CliniCom also includes a powerful suicide 
alert that is unlike anything available in mental health today. 
CliniCom is based on the DSM-IV standard and incorporates clinical 
research and widely accepted community standards of care.
    CliniCom is being used successfully across our Nation at private 
outpatient clinics and hospital settings alike. The technology can be 
equipped to run in most clinical environments using tablets, desktops 
or kiosks. CliniCom evokes the appropriate question sets based on the 
user type and the patient's age. It does not replace the mental health 
professional. It simply allows them to significantly enhance the face-
to-face interview, its outcomes, and quality of care.
    CliniCom does not forget to ask pertinent mental health questions 
each and every time. It gathers complete medical, social, and family 
histories and can also identify concerns associated with suicide, 
violence, and traumatic events. CliniCom will also quantify severity of 
symptoms and conditions automatically. It allows for secure and 
uniformed documentation by organizing clinical information in a 
standard History and Physical (H&P) format.
    Once patients complete the assessment, clinicians can devote much 
of their initial interview toward validating the CliniCom report and 
helping patients understand the nature of their condition. It is very 
difficult to gather all of this information during a single, 
traditional face-to-face psychiatric interview. Our technology can 
gather all clinically relevant and necessary information in a 
responsible and quantifiable manner.
    The ``Clinical Decision Making Process'' overall is significantly 
enhanced by allowing CliniCom to identify individuals that may have 
``co-morbid conditions,'' meaning the presence of one or more disorders 
(or diseases) in addition to a primary disease or disorder. An example 
would be an individual with depression in addition to PTSD and 
Substance Abuse. With CliniCom, clinicians can better ensure that both 
primary and co-morbid problems are identified simultaneously, leaving 
no stone unturned.
    A recent independent survey of 1109 CliniCom users indicated that 
92 percent of users reported that CliniCom was very easy to use. In 
addition, survey results indicated that 87 percent of users found 
CliniCom to be very easy to understand, while 88 percent found it to be 
extremely thorough. Seventy percent of users completed the assessment 
in 60 minutes or less. This is a function of the severity of their 
case.
    While CliniCom has served to enhance care in the private sector, we 
have confidence that the technology can also serve to enhance care 
within military mental health. CliniCom has unique characteristics that 
make it well suited for use both as a pre- and post-deployment 
screening tool and also as a comprehensive mental health assessment 
tool.
    Soldiers can effectively be screened with CliniCom prior to 
deployment to establish a mental health base-line. The technology can 
then be used in-theatre, to address any changes to that base-line or 
post-deployment in an effort to identify any changes in mental health 
status. As a post-deployment screening measure, CliniCom's methodology 
offsets some of the drawbacks inherent in screening methods currently 
in use; most of which are simply paper or online checklists consisting 
of only a few questions. We believe CliniCom would also assist the 
clinical assessment and care of soldiers in outpatient and inpatient 
behavioral health settings.
    CliniCom works to identify individuals with possible Post Traumatic 
Stress Disorder (PTSD), Traumatic Brain Injury (TBI) or suicidality in 
a thorough manner. Certain algorithms are triggered if the individual 
endorses trauma of any sort in the social history items; so for 
example, PTSD is identified not just by combat related trauma but also 
trauma that may have existed prior to deployment, even traumas 
occurring earlier in life.
    Another very important benefit of CliniCom is its suicide alert 
capabilities. When an individual endorses suicide presenting complaints 
or screening items, a complex algorithm for suicide assessment is 
automatically engaged.
    By implementing a technology like CliniCom, DoD and VA can use this 
valuable clinical resource to help mitigate the overarching issues of 
stigma and access to care and ensure that every member of our armed 
forces is given a complete, comprehensive and responsible mental health 
assessment.
    In summary, CliniCom is a unique, information gathering tool 
designed to assess mental health conditions, TBI and suicidality. The 
technology is comprehensive, easy to use and its conclusions can easily 
be verified by mental health professionals. In addition, what is 
learned from these cases can be used to conduct research that could 
lead to even greater advances in mental health care, truly modernizing 
the way we help people of all walks of life, who today suffer with 
illness.
    We are grateful to the Members of this Committee for the work you 
do on behalf of our veterans and soldiers. Thank you for your time and 
for the opportunity to introduce you to CliniCom. We look forward to 
answering your questions and are prepared to help in any way we can.

                                 
   Prepared Statement of James A. Schoeneck, Chief Executive Officer,
                     BrainCells Inc., San Diego, CA

    Chairman Filner, Ranking Member Buyer, Ladies and Gentlemen of the 
Committee:
    Thank you for the opportunity and the honor of appearing before 
this distinguished Committee today. I wish to commend you for your 
attention to the compelling issues surrounding Military Post Traumatic 
Stress Disorder, or PTSD.
    I have served as Chief Executive Officer of BrainCells Inc since 
2005, and have worked on successful drugs in the biotech and 
pharmaceutical industry for almost 30 years. BrainCells is a San Diego 
biotech founded on the discovery made only 10 years ago that new nerve 
cells, specifically neurons, grow in certain parts of the human brain. 
This new science of neurogenesis has linked emotional disorders to the 
failure to create and develop new cells located in a specialized part 
of the brain. In fact, new neuron production is a requirement for 
normal emotional responses that mentally healthy people take for 
granted. By way of groundbreaking studies, the founding scientists of 
BrainCells from Columbia University and the Salk Institute have 
demonstrated that stress can arrest the formation of these new cells 
(neurogenesis) resulting in a measurably shrunken site within the brain 
called the hippocampus. We now have the first physical understanding of 
biologic processes involved in psychiatric diseases. Image studies 
performed on PTSD patients confirm that they, also suffer from abnormal 
changes in the hippocampus. Although these methods are not yet 
available to diagnose and study the progress of all clinical PTSD 
patients, they will be someday soon.
    Importantly, BrainCells has designed a drug screening platform to 
search for new classes of drugs that will help this nerve cell growth 
function return to normal--restoring neurogenesis with the intention of 
improving emotional integration with few side effects. BrainCells 
believes that its compounds provide alternatives to traditional anti-
depressants and anti-anxiety drugs by directly increasing neurogenesis. 
BrainCells believes we have excellent drug candidates to treat PTSD.
    Over the past few years, the U.S. Department of Defense and the 
Veterans Health Administration have taken steps to improve mental 
health services for personnel returning from deployments and veterans. 
Expanded screening and treatment for PTSD and depression and new 
efforts to reduce the stigma surrounding mental illness among 
servicemembers are to be commended. But since October 2001, 
approximately 1.6 million U.S. troops have been deployed for Operations 
Enduring Freedom and Iraqi Freedom in Afghanistan and Iraq, and 
according to last year's Rand Study one in seven servicemembers has 
returned from deployments with symptoms of PTSD. That leaves us 230,000 
service men and women and veterans known to be suffering from mental 
injuries. (PTSD can be regarded parenthetically as a chronic wounding 
of the brain just as Traumatic Brain Injury bruises the brain.) Recent 
reports published in the Journal of the American Medical Association 
placed numbers even higher.i The radiating social effects of 
so many PTSD sufferers are mind-boggling when one considers that 
families also must experience the impact of their loved ones returning 
with mental illness. Violence, divorce, and domestic abuse have 
skyrocketed among returnees and suicide rates in the military now 
exceed those in the civilian population--unheard of as historic suicide 
rates have always been lower among soldiers, sailors, marines, and 
airmen.
---------------------------------------------------------------------------
    \i\ Bridget M. Keuhn, ``Soldier Suicide Rates Continue to Rise'' 
JAMA March 18, 2009 301 (11): 1111-1113.
---------------------------------------------------------------------------
    PTSD is classified as an anxiety disorder with symptoms of chronic 
anxiety and fear that serve no purpose. It is often accompanied by 
typical or atypical depression. Treatments for PTSD have had mixed 
results. Non-drug treatment is regarded as the first-line option for 
PTSD and is routinely incorporated into management plans for patients 
with PTSD. Many patients do not achieve a sufficient response to non-
drug therapy or are left with disabling residual symptoms.ii 
The selective serotonin reuptake inhibitors (SSRIs) are considered the 
first-line pharmacological treatments. These are the familiar class of 
anti-depressants like Prozac or Paxil. Response rates for these 
medications rarely meet 60 percent in the general population, and less 
than 20-30 percent of PTSD patients achieve remission.iii 
This class of drugs routinely causes side effects like insomnia, weight 
gain, and most significantly for young returning servicemembers, sexual 
dysfunction. This is because the increased serotonin resulting from 
this medicine affects many tissues in the brain and body--most of which 
do not need extra serotonin. Less than 40 percent of servicemembers 
diagnosed with PTSD receive mental health care--and some of those 
voluntarily forego treatment or compliance because of sexual function 
effects or worries. Many soldiers use alcohol or illegal drugs to deal 
with symptoms rather than take SSRI anti-depressants.
---------------------------------------------------------------------------
    \ii\ Expert Review of Clinical Pharmacology January 2009, Vol. 2, 
No. 1, Pages 77-86.
    \iii\ William Berger et al., ``Pharmacologic alternatives to 
antidepressants in posttraumatic stress disorder: A systematic 
review'', Dec. 24, 2008, Progress in Neuro-Psychopharmacology and 
Biological Psychiatry Volume 33, Issue 2, 17 March 2009, Pages 169-180.
---------------------------------------------------------------------------
    Combat veterans are now shown to suffer a more severe form of PTSD 
than civilian victims of trauma. Military trauma is generally 
associated with greater depression, more anger and irritability, more 
aggression, more problems with one's sense of personal identity, and a 
far greater tendency toward suicide or violence.iv 
Additional studies are needed, but experts are moving to the conclusion 
that military PTSD is both different from civilian trauma, and it is 
also more difficult to treat. Methods used to treat civilian PTSD are 
at times inadequate to address military syndromes. The numbers of 
refractory or resistant cases are rising. It is disturbing to realize 
that we still have thousands of Viet Nam veterans in the full throws of 
chronic PTSD and simultaneously we are being advised by the military 
that currently deployed troops are experiencing unprecedented severity 
and incidence of the condition. Often if left untreated, PTSD is a 
lifetime disorder.
---------------------------------------------------------------------------
    \iv\ Naifeh, James et al., ``Clinical Profile Differences Between 
PTSD-Diagnosed Military Veterans and Crime Victims,'' Journal of Trauma 
and Dissociation, 9(3): 321-334.
---------------------------------------------------------------------------
    Probably because of the nature of the unique psychological insult, 
military PTSD is a different mental syndrome than civilian trauma 
induced PTSD. It is not just depression and anxiety combined, but has 
its own set of symptoms that require medicines designed for and tested 
in the affected population. Presently, it is unlikely that the civilian 
pharmaceutical industry can or will invest resources to address this 
specialized ``orphan-like'' condition of military PTSD that includes 
suffering from extreme anxiety, depression and memory processing 
disorders. Our investors at BCI, for example, anticipate that we will 
use our resources to develop drugs to treat the large civilian market 
for major depressive disorder. This market may provide investors with 
their anticipated return on investment in exchange for the high 
financial risks taken in the development of new drugs. Unless the 
government provides collaboration, incentives and funding directly to 
the biotech and pharmaceutical industry to deliver FDA approved drugs 
labeled for military Post Traumatic Stress Disorder, clinicians will be 
left with combinations of existing drugs tested in and approved for 
people with different medical conditions. I wish to respectfully 
suggest to the Committee that the members of our military who 
voluntarily protect the Nation from harm are deserving of a well-funded 
pharmaceuticals development program directed specifically to military 
derived PTSD. The Congress has generously funded significant amounts 
for research into determining organic causes and best existing 
practices for treating PTSD, but has yet to fully engage those of us 
who are singularly and professionally dedicated to identifying and 
testing safe new compounds that treat tough diseases.
    Members of the Committee are undoubtedly aware of the myriad ways 
that private enterprise can be provided incentives, as exemplified by 
the orphan drug laws that offer tax credits and patent extensions to 
illnesses affecting small populations. Tragically, military PTSD has 
already exceeded the statutory 200 thousand patients that define the 
orphan drug laws, but surely our warfighters are deserving of the best 
that our creative laboratories can provide.
    I am deeply grateful for this opportunity to share my views with 
the Committee. In closing I wish to summarize with the following 
thoughts and recommendations:

    1.  PTSD is a disease with great personal and social cost that 
dramatically impacts the lives of our troops and returning veterans, 
their families and the society around them. Unfortunately, current 
therapies fail to sufficiently treat a large proportion of those 
afflicted with the disorder.
    2.  There are wonderful new developments in the field of 
neurobiology and neuropharmaceuticals that may make a huge difference 
to sufferers of PTSD and other mental disorders without some of the 
side effects that dissuade veterans and military personnel from seeking 
treatment.
    3.  We must respond with a sense of urgency around testing new 
classes of drugs to treat the patients who do not respond to existing 
therapies for military PTSD. Our collective goal should be to have new 
medicines for the veterans of these conflicts, not future ones.
    4.  A clear pathway to new drug development engaging the 
pharmaceutical industry as a full partner, including regulatory and 
financial incentives for orphan-like drug development, including 
clinical trials is required.
    5.  Improved screening of patients for early diagnosis and 
treatment must continue and expand since early diagnosis predicts far 
better outcomes.
    6.  We must also invest time and resources in improved tools to 
diagnose and differentiate PTSD from TBI, and the creation of tools 
that evaluate treatment effectiveness, thereby reducing treatment 
failures and suicides.

    Once again, my thanks for the opportunity to speak before you.

                                 
            Statement of William L. Balanoff, DDS, MS, FICD,
                   SmilePerfect, Fort Lauderdale, FL

    Mr. Chairman and Members of the Committee, I am William L. 
Balanoff, DDS, MS, FICD.
    Visual examination has often been referred to as the ``Gold 
Standard'' examination for oral cancer screening, but has not been 
successful at achieving early detection rates of pre-cancerous and 
cancerous lesions to the point of reducing incidence and death. As 
such, the incidence rate of oral cancer remains virtually unchanged and 
mortality rates have not significantly decreased over the same time 
period. I like to think that dental practitioners are not remiss and 
don't want to do a thorough job of screening patients at increased risk 
for oral cancer, but rather that it's just that we haven't had the 
benefits of adjunctive screening technologies to help us identify early 
cancers and precancerous lesions such as those used by our colleagues 
in the medical community for other cancer types.
    The reality is that the general practitioner is charged with the 
responsibility of identifying potentially harmful lesions and referring 
that patient to a specialist in oral diseases for further evaluation 
and possible treatment. Whether it is private practice dentistry or VA 
dentistry, the demands and complexities are great. Given the inherent 
difficulties associated with oral soft tissue examination (patient's 
ability to provide adequate access, pooling of saliva, multiple 
structures of varying color and working knowledge of oral pathology), 
the inclusion of a diagnostic adjunct is critical to ensure that all 
abnormalities have been visually captured.
    The idea of not using diagnostic adjuncts to screen patients for 
oral abnormalities is the equivalent to a philosophy of a medical 
doctor using only his eyes and hands to assess a patient's health when 
diagnostic adjuncts are available. All patients expect their doctors to 
use every tool and test available to assess their health. Much is the 
same for the practicing dentist and the availability of medical devices 
to assist in the screening for oral lesions which can be missed during 
visual examination. Rates of death associated with cancers encountered 
by my MD counterparts were not adequately reduced until adjuvant 
screening devices were introduced. Cancer death rates from prostate, 
breast and cervical cancer did not begin to show substantive decreases 
until adjunctive screening technology allowed physicians to see or feel 
things they could not see or feel with their unaided eyes or hands. 
Mammograms, PAP smears and PSA tests have reduced death rates by 40 
percent, 80 percent and 17 percent respectively. These dramatic 
improvements in lives saved was only realized when physicians were 
given scientifically based technological advancements to aid in the 
discovery of these diseases.
    Since leaving dental school, I have performed thousands of head and 
neck examinations to detect the presence of disease which requires 
treatment. Disease states such as periodontal disease and dental caries 
(cavities) are diagnosed with the aid of adjunctive technology. 
Periodontal probing, X-rays, and microbiology are standard regimens for 
the diagnosis of periodontal disease and X-rays are at the heart of 
diagnosing dental caries. As a dental professional, my decisions have 
been grounded in science and research to help detect and treat these 
disease states. Oral cancer and premalignancies can now be addressed in 
the same manner with the advent of devices for improving the efficacy 
of visual soft tissue examination.
    Of concern to me are those professing to be pundits of oral cancer 
screening and accepting the status quo as acceptable care. Of even 
greater concern is during my routine research of new products available 
to a practitioner that I read articles or reviews recommending that 
diagnostic adjuncts not be used and that visual examinations remain the 
only test required. Unfortunately, too often these recommendations are 
made by those who have never tried oral cancer screening adjuncts and 
are making recommendations based upon another's opinion or by those who 
do not see patients and only write about that which they themselves are 
inexperienced.
    For the past 5 years, the use of chemiluminescence (ViziLite) has 
allowed me to identify lesions that were otherwise missed during 
previous conventional oral examination. This adjunctive screening 
device is now the standard of care, along with conventional visual 
examination, in my conduct of dentistry and its use is ideally suited 
for patients identified at being at increased risk for oral cancer.
    The technology was first tested on thousands of women in worldwide 
clinical studies and was shown to significantly improve the sensitivity 
for identifying cervical intraepithelial neoplasias, the precancerous 
lesions of the female cervix. In four studies it was shown to improve 
the sensitivity of identifying cervical pathology from 92 percent to 
99.1 percent. The FDA cleared the light technology for dentistry in 
2001 because the visual response to lesions treated with a mild acetic 
acid followed by chemiluminescent illumination was nearly identical for 
the same kind of cells making up both areas. More recently, a medical 
grade toluidine blue (TBlue') was added to the ViziLite 
light source and cleared by the FDA for use as the combination device 
ViziLite Blue Oral Lesion Identification and Marking System (ViziLite 
Plus)by Zila Pharmaceuticals, Inc.
    Toluidine blue has been used clinically for many years and is well 
documented in its utility for use in identifying high grade dysplasia. 
It has been reported that toluidine blue may be preferentially retained 
by nuclear and mitochondrial DNA associated with oral premalignant 
lesions (OPLs) and ``frank'' cancer. It is because of this that 
staining suspicious lesions differentially identified during ViziLite 
examination is of great benefit to higher risk patients, such as those 
found in the VA hospitals. It allows me to refer patients with a 
greater likelihood of pathology present.

[GRAPHIC] [TIFF OMITTED] T9916A.015

[GRAPHIC] [TIFF OMITTED] T9916A.016

    My job as a general dentist is to find everything ``abnormal'' in 
my patients and to refer to specialists those conditions presenting 
with a great deal of clinical suspicion. Primarily, clinical suspicion 
is determined by direct visualization under normal patient lighting. As 
an adjunct, ViziLite Plus is critical for 1) initial identification of 
a lesion missed during visual examination and/or 2) to provide me with 
additional information to make an informed referral.
    General dentists, including those who treat our Nation's Veterans, 
are responsible for the detection of abnormalities that present as 
pathosis. And because there is a screening adjunct that has helped me 
to identify precancerous lesions that I missed during visual 
examination, I strongly recommend the ViziLite Plus system for use 
within the Veterans Administration system.

                                 
           Statement of Joseph Califano III, M.D., Professor,
    Department of Otolaryngology-Head and Neck Surgery and Oncology,
           Johns Hopkins Medical Institutions, Baltimore, MD

    Mr. Chairman and Members of the Committee, I am Dr. Joseph 
Califano, MD.:
    As a Professor of Otolaryngology-Head and Neck Surgery and 
Oncology, a researcher in Molecular Biology, and a practicing head and 
neck surgeon, I routinely see patients who present at their initial 
consultation with advanced head and neck cancers. Many head and neck 
cancers are already at an advanced stage in the disease process before 
the lesion is discovered during examination or the patient presents 
with a specific complaint. As an example, 50 percent of cancers of the 
tongue have already metastasized before they are diagnosed. It is 
typically only at relatively advanced stages that most patients become 
aware of any signs or symptoms associated with oral malignancies 
(except for lip cancer, which is usually obvious because any change in 
appearance is in a visually prominent area). While the survival rates 
for breast, lung and prostate cancers have improved over the last three 
decades, this is not true for oral cancer overall. Recurring and second 
primary tumors contribute to the devastating mortality and morbidity 
associated with oral cancers.
    Late diagnosis contributes to the low 5-year relative survival 
rates for all oral and oropharyngeal cancers, even as treatment 
modalities have improved. For example, the 5-year relative survival 
rate for localized cancer of the lip is 97 percent, but only 35.3 
percent when distant metastases are present at the time of diagnosis. 
For cancer of the tongue, the corresponding 5-year relative survival 
rates are 73.6 percent and 25.9 percent. It is also difficult to 
diagnose recurrent malignancies or second tumors close to a treated 
site, since irradiation and surgery each result in changes to the 
mucosa that could result in observed early pre-malignant and malignant 
abnormalities being dismissed as scarring or radiation-induced changes. 
For all types of oral cancers, the more localized the lesion at the 
time of diagnosis the better the patient's chance of survival and the 
less invasive and destructive treatment will be, leading to better 
quality of life. A recent pilot study at the University of Washington 
involving specialists trained to identify oral cancer found that their 
sensitivity in detecting lesions with atypical cellular changes using 
an unaided visual examination was just 21 percent, and 50 percent for 
lesions with moderate or greater dysplasia or carcinoma. Techniques 
with high sensitivity and specificity that aid earlier diagnosis of 
oral cancer have the potential to reduce both mortality and morbidity.

Carcinogenesis: a molecular process characterized by genotypic changes 
        followed by phenotypic change
    Malignancies develop through molecular changes at the cellular 
level. Cell cycles become deregulated, with genetic changes and tissue 
dysplasia of varying severity occurring. Loss of heterozygocity in pre-
malignant lesions, with chromosomal abnormalities and allelic loss on 
specific arms of chromosomes, is predictive of malignant 
transformation. Loss of heterozygocity in the 3p, 9p and 17p arms of 
chromosomes in particular is predictive for malignant transformation, 
and secondary malignancies are more likely in cases where multiple 
chromosomal arms are affected.

ViziLite Plus
    Adjunctive technology aids the detection of lesions at an early 
stage. ViziLite Plus is used to help identify pre-malignant and 
malignant lesions by differentially staining the tissues and has been 
found to offer high sensitivity and specificity. The stain used is 
pharmaceutical-grade toluidine blue (TBlue) which binds to a pre-
malignant or malignant lesion. Recent studies have shown that the 
differential uptake of TBlue in lesions is associated with chromosomal 
changes and loss of heterozygocity, and predictive of malignant 
transformation. In addition to aiding the detection of lesions 
requiring biopsy for histopathology and diagnosis, T-blue staining has 
been shown to delineate the margins of lesions such that the area of 
resection at the time of surgery encompasses the full extent of the 
lesion and all identified abnormal tissue.

Use of ViziLite Plus in the Erbitux study
    The ViziLite Plus system is currently being utilized as part of an 
ongoing Phase II clinical trial at multiple cancer sites for 
determining the efficacy of the head and neck cancer drug, Cetuximab 
(trade name Erbitux). ViziLite Plus was selected as part of the 
inclusion criteria for patient admittance into the study to identify 
lesions consistent with specific chromosomal deletions in patients with 
previous histories of oral and oropharyngeal cancer. Previous work with 
this pharmaceutical-grade toluidine blue has demonstrated an affinity 
for the dye to bind to sites of allelic loss that are consistent with 
cancer progression of low-grade epithelial dysplasia. To be admitted, 
positive differential staining must occur followed by histological and 
molecular analyses. The role of the blue dye is to identify those 
lesions with the greatest likelihood of presenting the necessary 
allelic loss for progression.

The value of adjunctive screening technologies in the VA
    Specific behaviors, and advancing age, increase an individual's 
risk for oral cancer. Smoking tobacco or drinking alcohol increases an 
individual's risk by up to 600 percent. Tobacco use is by far the 
single greatest risk factor, with over 75 percent of all cases 
occurring in tobacco users (smoking, spit, and chew tobacco). The 
combination of smoking and drinking further increases risk, as 
demonstrated by Mashberg's study on Veterans. The prevalence of tobacco 
smoking has historically been higher among Veterans than in the general 
population, and alcohol abuse is one of the most common mental health 
problems Veterans experience. Veterans are therefore a high-risk 
population for oral and oropharyngeal cancers.
    Since earlier detection aids earlier treatment and would improve 
patient outcomes and quality of life, adjunctive technology that 
improves the rate of detection and that helps predict which lesions 
will undergo malignant transformation is warranted. Screening 
technologies such as ViziLite Plus help the examiner detect lesions 
that would otherwise be missed, and help predict which lesions will 
undergo transformation. It is strongly suggested that ViziLite Plus be 
considered for inclusion into clinics examining high-risk populations, 
such as the Veterans Administration, so that more effective examination 
and biopsy procedures may be performed to diagnose disease earlier.
    Thank you for the opportunity of sharing my views on this important 
subject. I will be pleased to respond to any questions you may have.

                                 
        Statement of Joel Epstein, DMD, MSD, FRCD(C), FDS, RCS,
      Director, Interdisciplinary Program in Oral Cancer Biology,
 Prevention and Treatment, College of Medicine, Chicago Cancer Center,
                  University of Illinois, Chicago, IL

    Mr. Chairman and Members of the Committee, I am Dr. Joel Epstein, 
DMD:
    Over the past few years dentistry has been introduced to visual 
diagnostic adjuncts to the conventional head and neck and oral 
examination for oral cancers. Light-based technologies have been 
developed with the goal of assisting practitioners in identification 
and evaluation of mucosal changes that include premalignant lesions and 
cancer. Health care providers have been and continue to be challenged 
with identifying abnormal oral conditions, which may represent 
premalignant and malignant disease. Until recently we have had to rely 
solely on visual examination in order to identify these abnormal 
changes and only through meticulous and time consuming oral 
examination. The result has been that the majority of oral cancer is 
not diagnosed until symptomatic and with advanced stage of disease, 
when extensive treatment is required and prognosis is guarded. While 
conventional visual examination remains the cornerstone for the oral 
cancer screening process, adjuvants are available that may facilitate 
lesion identification and guide subsequent testing for diagnosis and 
may be of assistance to experienced health care providers and patients 
such as those found in the VA system.
    Worldwide clinical trials have been conducted to determine the 
sensitivity of the visual examination in identifying neoplasias 
presenting with precancerous dysplasia or invasive carcinoma. 
Sensitivity is determined by number of true positive (dysplasias and 
cancers identified) results and the number of false negative 
(dysplasias and cancer missed) results recorded during visual 
examination. A large general population in India was studied where an 
oral examination was conducted and early detection of cancers was 
shown, and reduced mortality was seen at 2 year follow-up. However, 
oral lesions at early stage are subtle and may appear benign and have 
few symptoms thereby limiting the attention of the examining health 
care worker. The advanced stage of cancer at diagnosis in \2/3\ of the 
population in studies in developed countries including the USA, 
demonstrates the difficulty in detection and diagnosis of premalignant 
lesions or early stage cancer.
    The most widely used light technology available and supported with 
the most peer-reviewed literature is chemiluminescence. Tissue 
reflectance using a chemiluminescent light source 
(ViziLite') emitting low-intensity, diffuse wavelengths of 
light may provide additional information. The light is reflected off of 
tissue surface and sub-layers, and is affected by keratin and tissues 
that contain cells with nuclei that take up a larger volume of the cell 
than normal (hallmark of dysplasia and cancer). Normal tissue absorbs 
this light and abnormal tissues will reflect the light. 
Chemiluminescent light is non-discriminatory and will be reflected by 
nearly all abnormalities. Clinical studies to date conducted at 
different centers show that approximately 60 percent of lesions will 
show enhanced contrast, brightness and surface texture with 
chemiluminescent light compared to standard white light illumination. 
To date, the literature has demonstrated a sensitivity of 100 percent 
for this type of technology in the detection of pathologic lesions. It 
has been further demonstrated that increased brightness may reduce the 
potential for not identifying a potentially significant mucosal lesion. 
These studies were conducted in patient populations likely comparable 
to those which are found in the VA to assess visibility and increased 
visual characteristics that may increase detection, but were not 
studies where identified lesions were biopsied to assess cellular 
change (histopathology).
    In studies involving oral chemiluminescence, lesions meeting the 
definitions of `clinically suspicious' for dysplasia or cancer were 
captured in lieu of biopsy and histological analyses, with the 
exception of two studies, i,ii which had histological 
outcomes. Additionally, all published studies have been conducted by 
specialists in Oral Medicine, Oral Pathology and/or Oral Surgery. In 
the majority of studies, chemiluminescence (ViziLite) examination 
identified lesions suspicious for pathology that remained unidentified 
after conventional visual examination. In four (4) studies involving 
885 patients, thirteen (13) lesions in thirteen different patients 
(1.46 percent) were not identified during visual examination and 
categorized as clinically suspicious for dysplasia or worse. Further, 
in one these studies iii an occult lesion detected by 
ViziLite alone was later biopsied post-study during routine patient 
care and proved to be squamous cell carcinoma of the lateral tongue.
---------------------------------------------------------------------------
    \i\ Ram S, Siar CH. Chemiluminescence as a diagnostic aid in the 
detection of oral cancer and potentially malignant epithelial lesions. 
Int J Oral Maxillofac Surg. 2005 Jul;34(5):521-7. Epub 2005 Jan 26.
    ii Epstein JB et al. Analysis of oral lesion biopsies 
identified and evaluated by visual examination, chemiluminescence and 
toluidine blue. Oral Oncol. 2008 Jun;44(6):538-44.
    \iii\ Epstein JB, et al. The Efficacy of Oral Lumenoscopy 
(ViziLite) in Visualizing Oral Mucosal Lesions. Spec Care Dentist. 2006 
Jul-Aug;26(4):171-4.
---------------------------------------------------------------------------
    Another adjunct for visualization and clinical assessment is vital 
tissue staining, where a product is applied to the oral surface in 
patients and evaluated. Toluidine blue has a long history of study. 
More recently, a medical grade toluidine blue has been developed and 
the more recent studies have used this product as a single agent for 
detection and evaluation or in combination with chemiluminescence. As a 
clinical researcher with experience in conducting research and 
publishing study results on diagnostic aids for the detection of oral 
cancer and its precursor lesions, it is clear from the literature that 
the use of toluidine blue is the most reliable adjunct we employ to 
assist in a differential diagnosis, biopsy site selection, to 
accelerate the decision for biopsy, and to assist in detection of 
lesion margins. Without performing tissue biopsy for H&E analysis, 
toluidine blue and it's preferential staining of nucleic acids (DNA) 
helps to identify lesions with the likelihood of presenting pathology. 
Cross-sectional studies iv,v and a prospective study 
vi have shown that toluidine blue binds to sites of genetic 
change that predicts progression of premalignant lesions to cancer and 
in lesions that already represent cancer at first diagnostic biopsy. 
Toluidine blue has been shown to assist in clinical evaluation, biopsy 
site selection and to provide guidance of the risk of progression of 
premalignant lesions to cancer.
---------------------------------------------------------------------------
    \iv\ Epstein JB, Zhang L, Poh C, Nakamura H, Berean K, Rosin M. 
Increased allelic loss in toluidine blue-positive oral premalignant 
lesions. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 
Jan;95(1):45-50.
    v Guo Z, Yamaguchi K, Sanchez-Cespedes M, Westra WH, 
Koch WM, Sidransky D. Allelic losses in OraTest-directed biopsies of 
patients with prior upper aerodigestive tract malignancy. Clin Cancer 
Res 2001;7(7):1963-1968.
    \vi\ Zhang L, Williams M, Poh CF, et al. Toluidine blue staining 
identifies high-risk primary oral premalignant lesions with poor 
outcome. Cancer Res 2005;65(17):8017-8021.
---------------------------------------------------------------------------
    The screening technology utilizing chemiluminescence and 
pharmaceutical-grade toluidine blue (TBlue) is ViziLite Plus. This 
device has been studied in patient populations similar to those found 
in the VA system. The combination device utilizes chemiluminescence for 
the identification of abnormalities in patient populations at increased 
risk for oral cancer (its FDA intended use). The ViziLite examination 
is performed only after conventional visual examination. ViziLite Plus 
also contains TBlue and is applied to those lesions differentially 
identified by the ViziLite light source and present with clinical 
suspicion.
    Based upon the body of evidence in the peer-reviewed literature it 
can be recommended that ViziLite Plus be used in a higher risk patient 
population by experienced providers, as seen in VA clinics. ViziLite 
Plus technology should be considered for clinical use in the evaluation 
of lesions previously identified during conventional head and neck 
examinations. Although this type of application may not realize the 
full potential of the combination device, the Veteran population could 
be well-served by reducing the number of false positive findings 
associated with visual examination thus potentially reducing the number 
of unnecessary biopsies. This outcome has been shown in a multicenter 
study ii, in a risk population similar to the VA population, 
where a reduction in the number of biopsies by approximately half would 
have still identified clinically significant lesions. Additionally, the 
system may be used in conjunction with clinical suspicion, for the 
monitoring of pathologic lesions over time as an indicator for repeat 
biopsy and histologic examination.
    Thank you for the opportunity of sharing my views on this important 
subject. I will be pleased to respond to any questions you may have.

                                 
                   MATERIAL SUBMITTED FOR THE RECORD

                                     Committee on Veterans' Affairs
                                                    Washington, DC.
                                                       May 14, 2009

Honorable Eric K. Shinseki
Secretary
U.S. Department of Veterans Affairs
810 Vermont Avenue, NW
Washington, DC 20420

Dear Mr. Secretary:

    In reference to our Full Committee hearing entitled ``Innovative 
Technologies and Treatments Helping Veterans'' on May 13, 2009, I would 
appreciate it if you could answer the enclosed hearing questions by the 
close of business on June 27, 2009.
    In an effort to reduce printing costs, the Committee on Veterans' 
Affairs, in cooperation with the Joint Committee on Printing, is 
implementing some formatting changes for materials for all full 
Committee and Subcommittee hearings. Therefore, it would be appreciated 
if you could provide your answers consecutively and single-spaced. In 
addition, please restate the question in its entirety before the 
answer.
    Due to the delay in receiving mail, please provide your response to 
Debbie Smith by fax at 202-225-2034. If you have any questions, please 
call 202-225-9756.

            Sincerely,

                                                         BOB FILNER
                                                           Chairman

                               __________

                        Questions for the Record
                   The Honorable Bob Filner, Chairman
                  House Committee on Veterans' Affairs
        Innovative Technologies and Treatments Helping Veterans
                              May 13, 2009

    During the Full Committee hearing on May 13, 2009, I received 
testimony from Alkermes, a small biotechnology company that 
manufactures a drug called VIVITROL. VIVITROL is an extended-release 
naltrexone product. It is a non-addictive, non-aversive agent that 
binds to opioid receptors in the brain. It was recently approved by the 
U.S. Food and Drug Administration (FDA). It is my understanding the 
drug VIVITROL was used on a limited basis in the Veterans Integrated 
Service Network 8, particularly in the Gainesville facility. Please 
provide answers to the following questions:
    Context of Response: Vivitrol' is not on the Department 
of Veterans Affairs (VA) formulary. Its use is very limited and VA does 
not systematically collect patient data that would definitively respond 
to several of the questions you raise. In these instances, we are 
summarizing peer reviewed literature on Vivitrol'. At 
present, no VA medical centers in the Veterans Integrated Service 
Network (VISN) 8 are performing research on Vivitrol'.
    Scientific Evidence: When the Food and Drug Administration (FDA) 
approved Vivitrol', the Veterans Health Administration (VHA) 
Pharmacy Benefits Management Service (PBM) initiated a review of the 
scientific evidence to evaluate its efficacy and safety compared to 
other standard therapies available to VA patients. VA formulary 
committees, the PBM medical advisory panel (MAP) and VISN pharmacy 
executives reviewed the scientific evidence supporting the use of 
Vivitrol'. There are limited data showing better medication 
adherence with injectable naltrexone relative to orally administered 
naltrexone. Unfortunately, there is no definitive evidence showing that 
injectable naltrexone is safer or results in better patient outcomes 
compared with oral naltrexone. Very limited data suggest a possibility 
that injectable naltrexone might be less safe than oral naltrexone. VA 
also recognizes that patients must be amenable to traveling to a VA 
clinic to receive intramuscular injections of naltrexone every month. 
Overall, there is a lack of definitive evidence that injectable 
naltrexone improves patient outcomes relative to oral naltrexone.
    Availability: Vivitrol' is available for non-formulary 
use and VHA PBM and the MAP/VISN pharmacist executives committee have 
issued guidance for the non-formulary use of injectable naltrexone. VA 
and Department of Defense (DoD) guidelines for the management of 
substance use disorders provide recommendations for the use of both 
oral and injectable naltrexone. Prior trials of oral naltrexone or 
other anti-alcoholic agents (e.g., acamprosate or disulfiram) are not 
required before injectable naltrexone can be considered. Further, 
clinical guidelines recommend that addiction-focused counseling be 
offered in addition to naltrexone, regardless of route of 
administration.
    The responses to the questions below reflect information based on 
VA prescription data and a thorough literature review. As noted, there 
are no systematically collected data available specific to VISN 8 that 
can be used to respond to the questions.
    Question 1: What is the total number of patients in your network 
receiving VIVITROL as part of their treatment for alcohol dependence?
    Response: Within VISN 8 the total number of patients receiving 
Vivitrol' is 45. The James A. Haley Veterans' Hospital in 
Tampa, Florida currently has one patient and the North Florida/South 
Georgia Veterans Health System currently has 44 patients receiving 
Vivitrol'. In fiscal year (FY) 2008, VA-wide, 71 Veterans 
were prescribed Vivitrol'. Oral naltrexone is more widely 
used, with 5,827 unique patients receiving it in FY 2008.
    Question 2: Does VIVITROL improve the patients' urges to drink?
    Response: Based on review of the available literature, both oral 
naltrexone and Vivitrol' result in decreased urges to drink 
for some patients.
    Question 3: What percentage of patients experienced a decrease in 
their urge to drink?
    Response: The FDA approved labeling for Vivitrol' 
suggests that it decreases heavy drinking (and, presumably, urges to 
drink) in those patients who were able to achieve abstinence for at 
least 1 week prior to starting treatment.
    Question 4: Does VIVITROL decrease drinking?
    Response: Review of the existing literature suggests that both oral 
naltrexone and Vivitrol' are effective at decreasing rates 
of heavy drinking among patients.
    Question 5: Does VIVITROL promote abstinence from drinking?
    Response: Both oral naltrexone and Vivitrol' are shown 
to significantly reduce use of alcohol. Both medications are 
appropriate for use in treatment programs that promote abstinence or 
programs that promote decreased use of alcohol.
    Question 6: What percentage of patients remain abstinent during 
treatment?
    Response: Based on findings from a small post-hoc subgroup analysis 
of individuals included in an industry-sponsored clinical trial who 
were able to achieve abstinence prior to drug treatment, 
Vivitrol' treatment was associated with approximately 32 
percent abstinence at 6 months, compared to 11 percent for those who 
received placebo.
    Question 7: What is the average duration of persistence on 
VIVITROL?
    Response: Vivitrol' is administered on a monthly basis. 
Review of utilization data for FY 2007 indicates that approximately 50 
percent of those Veterans who were prescribed Vivitrol' 
received no more than 1 injection. We are not aware of any direct 
research data on the average duration of persistence on 
Vivitrol'.
    Question 8: Do patients engage in behavioral counseling while 
receiving VIVITROL? If so, what percentage of patients are receiving 
counseling?
    Response: Vivitrol is currently prescribed and administered within 
VA specialty care for alcohol use disorders. Given that this treatment 
is provided within a specialty care program, Veterans who have been 
prescribed Vivitrol' would also receive counseling.
    Question 9: What happens to hospital utilization (specifically 
emergency department visits and inpatient admissions) in patients using 
VIVITROL?
    Response: We are not aware of any studies that have evaluated 
emergency department visits and rates of hospital utilization among 
patients using Vivitrol'.

                                  
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