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




 
   FROM MOLECULES TO MINDS: THE FUTURE OF NEUROSCIENCE RESEARCH AND 
                              DEVELOPMENT

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

                                HEARING

                               before the

                    SUBCOMMITTEE ON DOMESTIC POLICY

                                 of the

                         COMMITTEE ON OVERSIGHT
                         AND GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             SECOND SESSION

                               __________

                           SEPTEMBER 29, 2010

                               __________

                           Serial No. 111-159

                               __________

Printed for the use of the Committee on Oversight and Government Reform


         Available via the World Wide Web: http://www.fdsys.gov
                     http://www.oversight.house.gov



                  U.S. GOVERNMENT PRINTING OFFICE
65-562                    WASHINGTON : 2011
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing Office, 
http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center, U.S. Government Printing Office. Phone 202ï¿½09512ï¿½091800, or 866ï¿½09512ï¿½091800 (toll-free). E-mail, [email protected].  

              COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM

                   EDOLPHUS TOWNS, New York, Chairman
PAUL E. KANJORSKI, Pennsylvania      DARRELL E. ISSA, California
CAROLYN B. MALONEY, New York         DAN BURTON, Indiana
ELIJAH E. CUMMINGS, Maryland         JOHN L. MICA, Florida
DENNIS J. KUCINICH, Ohio             JOHN J. DUNCAN, Jr., Tennessee
JOHN F. TIERNEY, Massachusetts       MICHAEL R. TURNER, Ohio
WM. LACY CLAY, Missouri              LYNN A. WESTMORELAND, Georgia
DIANE E. WATSON, California          PATRICK T. McHENRY, North Carolina
STEPHEN F. LYNCH, Massachusetts      BRIAN P. BILBRAY, California
JIM COOPER, Tennessee                JIM JORDAN, Ohio
GERALD E. CONNOLLY, Virginia         JEFF FLAKE, Arizona
MIKE QUIGLEY, Illinois               JEFF FORTENBERRY, Nebraska
MARCY KAPTUR, Ohio                   JASON CHAFFETZ, Utah
ELEANOR HOLMES NORTON, District of   AARON SCHOCK, Illinois
    Columbia                         BLAINE LUETKEMEYER, Missouri
PATRICK J. KENNEDY, Rhode Island     ANH ``JOSEPH'' CAO, Louisiana
DANNY K. DAVIS, Illinois             BILL SHUSTER, Pennsylvania
CHRIS VAN HOLLEN, Maryland
HENRY CUELLAR, Texas
PAUL W. HODES, New Hampshire
CHRISTOPHER S. MURPHY, Connecticut
PETER WELCH, Vermont
BILL FOSTER, Illinois
JACKIE SPEIER, California
STEVE DRIEHAUS, Ohio
JUDY CHU, California

                      Ron Stroman, Staff Director
                Michael McCarthy, Deputy Staff Director
                      Carla Hultberg, Chief Clerk
                  Larry Brady, Minority Staff Director

                    Subcommittee on Domestic Policy

                   DENNIS J. KUCINICH, Ohio, Chairman
ELIJAH E. CUMMINGS, Maryland         JIM JORDAN, Ohio
JOHN F. TIERNEY, Massachusetts       DAN BURTON, Indiana
DIANE E. WATSON, California          MICHAEL R. TURNER, Ohio
JIM COOPER, Tennessee                JEFF FORTENBERRY, Nebraska
PATRICK J. KENNEDY, Rhode Island     AARON SCHOCK, Illinois
PETER WELCH, Vermont                 ------ ------
BILL FOSTER, Illinois
MARCY KAPTUR, Ohio
                    Jaron R. Bourke, Staff Director


                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on September 29, 2010...............................     1
Statement of:
    Akil, Huda, Ph.D., co-director and research professor, the 
      Molecular & Behavioral Neuroscience Institute, University 
      of Michigan; William Z. Potter, M.D., Ph.D., former vice 
      president of transactional neuroscience, Merck Research 
      Laboratories; Tim Coetzee, Ph.D., executive director, Fast 
      Forward, LLC; Kevin Kit Parker, Ph.D., associate professor 
      of applied science and biomedical engineering, Harvard 
      University; and John Morrison, Ph.D., dean, basic sciences 
      and the Graduate School of Biological Sciences, Mount Sinai 
      Medical Center.............................................    84
        Akil, Huda, Ph.D.........................................    84
        Coetzee, Tim, Ph.D.......................................   102
        Morrison, John, Ph.D.....................................   126
        Parker, Kevin Kit, Ph.D..................................   113
        Potter, William Z., Ph.D.................................    93
    Insel, Thomas R., M.D., Director, National Institute of 
      Mental Health; Walter J. Koroshetz, M.D., Deputy Director, 
      National Institute for Neurological Disorders and Stroke; 
      Joel Kupersmith, M.D., Chief Research and Development 
      Officer, Veterans Health Administration, U.S. Department of 
      Veterans Affairs; and Terry Rauch, Ph.D., Director, Defense 
      Medical Research and Development Program, Office of the 
      Assistant Secretary of Defense for Health Affairs, 
      Department of Defense......................................    10
        Insel, Thomas R., M.D....................................    10
        Koroshetz, Walter J., M.D................................    22
        Kupersmith, Joel, M.D....................................    41
        Rauch, Terry, Ph.D.......................................    55
Letters, statements, etc., submitted for the record by:
    Akil, Huda, Ph.D., co-director and research professor, the 
      Molecular & Behavioral Neuroscience Institute, University 
      of Michigan, prepared statement of.........................    87
    Coetzee, Tim, Ph.D., executive director, Fast Forward, LLC, 
      prepared statement of......................................   104
    Insel, Thomas R., M.D., Director, National Institute of 
      Mental Health, prepared statement of.......................    14
    Koroshetz, Walter J., M.D., Deputy Director, National 
      Institute for Neurological Disorders and Stroke, prepared 
      statement of...............................................    26
    Kucinich, Hon. Dennis J., a Representative in Congress from 
      the State of Ohio, prepared statement of...................     4
    Kupersmith, Joel, M.D., Chief Research and Development 
      Officer, Veterans Health Administration, U.S. Department of 
      Veterans Affairs, prepared statement of....................    43
    Morrison, John, Ph.D., dean, basic sciences and the Graduate 
      School of Biological Sciences, Mount Sinai Medical Center, 
      prepared statement of......................................   128
    Parker, Kevin Kit, Ph.D., associate professor of applied 
      science and biomedical engineering, Harvard University, 
      prepared statement of......................................   116
    Potter, William Z., M.D., Ph.D., former vice president of 
      transactional neuroscience, Merck Research Laboratories, 
      prepared statement of......................................    95
    Rauch, Terry, Ph.D., Director, Defense Medical Research and 
      Development Program, Office of the Assistant Secretary of 
      Defense for Health Affairs, Department of Defense, prepared 
      statement of...............................................    57


   FROM MOLECULES TO MINDS: THE FUTURE OF NEUROSCIENCE RESEARCH AND 
                              DEVELOPMENT

                              ----------                              


                     WEDNESDAY, SEPTEMBER 29, 2010

                  House of Representatives,
                   Subcommittee on Domestic Policy,
              Committee on Oversight and Government Reform,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 2 p.m. in room 
2203, Rayburn House Office Building, Hon. Dennis Kucinich 
(chairman of the subcommittee) presiding.
    Present: Representatives Kucinich, Kennedy, Foster, and 
Jordan.
    Also present: Representatives Thompson and Jones.
    Staff present: Claire Coleman, counsel; Justin Baker, 
clerk/policy analyst; and Molly Boyl, minority professional 
staff member.
    Mr. Kucinich. Good afternoon. The Domestic Policy 
Subcommittee of the Oversight and Government Reform Committee 
will now come to order.
    This hearing will explore efforts to expand knowledge and 
treatments to help individuals afflicted with neurological and 
mental health disorders. Without objection, the Chair and 
ranking minority member will have 5 minutes to make opening 
statements, prior to opening statements not to exceed 3 minutes 
by any other Member who seeks recognition.
    Without objection, Members and witnesses may have 5 
legislative days to submit a written statement or extraneous 
materials for the record. And without objection, for the 
purposes of participation in today's hearing, we welcome 
Congressman Mike Thompson to the subcommittee.
    Today's hearing will address the critical needs for better 
treatment for neurologic and psychiatric disorders, and how the 
neuroscience community can best facilitate research to advance 
and accelerate discovery of treatments and cures. Every year, 
the more than 1,000 disorders of the brain and nervous system 
result in more hospitalizations than any other disease group, 
even more than heart disease and cancer. Neurological illnesses 
affect more than 50 million Americans annually at costs 
exceeding $460 billion.
    Neuropsychiatric illnesses, like schizophrenia, mood 
disorders and autism are the leading cause of disability in 
North America and Europe. In the United States, the cost in 
lost earnings due to psychiatric disease is estimated 
conservatively to be $200 billion per year. The toll of brain-
related disorders is enormous for individuals and for families. 
Veterans returning from wars in Iraq and Afghanistan have been 
particularly hard hit by neurologic disorders. Traumatic brain 
injury, defined as a disruption in brain function as caused by 
head injury, has become known as one of the signature wounds of 
the wars in Iraq and Afghanistan, because of the insurgents' 
heavy use of explosive devices and armor which has better 
protected soldiers' lives from life-threatening injuries. That 
is despite the fact that we have better-protected soldiers.
    A disproportionately high number of returning military 
personnel also struggle with psychological health issues like 
post-traumatic stress disorder, clinical depression, anxiety 
disorder, sleep disturbances and substance abuse. The 
psychological toll of these wars has been particularly harsh 
because of long exposure to combat-related stress over multiple 
rotations. Unlike the physical wounds of war that maim or 
disfigure, these conditions remain invisible to other service 
members, to family members and to society in general.
    But emblematic of the great tragedy of war, especially this 
war, the toll these invisible wounds take on lives is great. 
Treatments to reverse or delay these injuries and disorders are 
critical and would benefit both the military and civilian 
populations alike, as approximately 1.7 million civilians 
sustain a traumatic brain injury as a result of car accidents, 
falls or other blows to the head every year.
    The field of neuroscience, which is the study of the 
nervous system, has made significant advances in the last 
decade, providing new insights into the functioning of the 
brain and underlying disease mechanisms. Yet many questions 
remain, spanning the most fundamental, such as how to keep our 
brains healthy to the specific challenges of finding diagnostic 
tools for diseases like Alzheimer's or schizophrenia and 
determining ways to effectively treat TBI and PTSD.
    The Federal Government has a vast array of research 
initiatives devoted to advances in neuroscience, and our 
ability to treat brain injuries and mental health disorders 
affecting both military and civilian populations. Many of these 
Federal initiatives involve extensive coordination with 
civilian and non-governmental sectors, including multi-
disciplinary, multi-sector research programs and centers. We 
will hear about these efforts today.
    Likewise, private foundations have played an increasingly 
important role in expediting the drug development process by 
bridging the gap between promising scientific discoveries and 
entrepreneurial expertise and funding needed to move them 
forward. The role of Government and private foundations has 
become especially critical to progress, because unfortunately, 
despite their immense profits, the pharmaceutical industry has 
been cutting back the research and development of central 
nervous system medications due to the high cost and high risk. 
As we will hear today, this could have a devastating impact on 
the drug development pipeline for neurologic disorders.
    Without collaboration across all sectors--Government, 
industry and non-profit--neuroscience breakthroughs will stall 
and much-needed treatments for all Americans, especially for 
our men and women in uniform, who have endured injuries in 
service to their country, will not materialize. I hope this 
hearing will raise awareness about the critical role 
neuroscience has in developing treatments to reverse or delay 
some of the impacts of neurologic or psychiatric disorders that 
millions of Americans are afflicted with, and will stimulate 
creative thinking about how to best advance discoveries and 
treatments for the broad spectrum of devastating brain-related 
injuries and disorders that continue to impose a heavy burden 
on individuals and society today.
    Before I recognize our ranking member, Mr. Jordan, I want 
to say that the reason why this hearing came about is because 
Representative Kennedy, who has throughout a great period of 
time communicated to me his concern that we delve into this 
subject in a methodical way, that we contact all sectors, and 
we try to find ways of creating benefits for people through 
either recognizing the synergies that exist, or where there may 
be insufficient numbers, helping to make sure that resources at 
some point will be available to help facilitate greater 
coordination.
    Representative Patrick Kennedy has been a tireless advocate 
for innovative, cross-disciplinary, collaborative biomedical 
research and has provided unwavering support to those with 
psychiatric disorders as well as returning veterans suffering 
from signature war injuries affecting the nervous system. So 
Pat, I want to thank you, not just on behalf of this committee, 
but on behalf of Members of Congress for your assistance in 
this vital area. You have made so many contributions to this 
Congress, but I think that as life goes on, this is going to be 
an area where you are leaving an enduring mark for your wisdom, 
your compassion and your sharing of your own experience with 
all of us. You are a person of great integrity and courage. I 
am honored to have served with you.
    At this point, I would recognize the ranking member, Mr. 
Jordan.
    [The prepared statement of Hon. Dennis J. Kucinich 
follows:]

[GRAPHIC] [TIFF OMITTED] T5562.001

[GRAPHIC] [TIFF OMITTED] T5562.002

    Mr. Jordan. Thank you, Mr. Chairman. Let me too thank you 
for having this important hearing and for the work that 
Congressman Kennedy has done on this subject.
    I have a meeting I have to get to in a few minutes, so in 
the interest of time I will ask the chairman if I can just 
submit my opening statement for the record.
    Mr. Kucinich. Without objection, so ordered.
    Mr. Jordan. Thank you.
    Mr. Kucinich. Thank you, Mr. Jordan, for your presence.
    Mr. Kennedy, the Chair recognizes Mr. Kennedy.
    Mr. Kennedy. Thank you, Mr. Chairman. I really appreciate 
those very generous and kind remarks. And of course, Ranking 
Member Jordan, thank you for your being here to help kick this 
important hearing off.
    And to my other colleagues, Mike Thompson, whose work in 
this area but also whose service today is highlighted because 
of his service to our country as a veteran in our military and 
that perspective that he brings and his work in this area. It 
is so appreciated. And Mr. Foster, thank you very much both for 
your being here and your efforts.
    I want to thank you, Mr. Chairman, for putting this hearing 
together, and also your staff, who have been so instrumental. 
Jaron Bourke and Claire Coleman, who have been helpful, and 
Justin Baker, and all those who have been so critical in 
putting this event together. And my own staff, I want to thank 
Dan Murphy and Laurel Havis and my whole office for the work 
that they did in putting up with my aggravation at trying to 
get all this pulled together. They have just been the best and 
I want to thank them tremendously for this.
    I have Chris Cann, who does all my veterans events in Rhode 
Island, I want to acknowledge he has put together a veterans 
diversion program for those ending up in our criminal justice 
system because of their wounds on this war, which are at ever-
higher rates. We are doing that on October 25th in Rhode 
Island. I thank Chris for his work on that. And I want to thank 
John Sack for all the efforts that he put in as well.
    Mr. Chairman, I also want to acknowledge some real other 
heroes here in this audience, not the least of which has been 
the former Secretary of Veterans Affairs, former U.S. Senator, 
but most important to all of us, an American hero in the true 
sense of the word, and that is Max Cleland.
    [Applause.]
    Mr. Kennedy. We have an amazing lineup of people who have 
come to testify today. I want to thank all of them for being 
here, and say we are really at a point today when we are going 
to examine where we are today in neuroscience. And most 
importantly, what the stage is for us to set for us to really 
move forward much faster, more effectively and certainly to 
deliver the answers to neurological disorders and disability. 
Now more than ever, because of how it affects our American 
heroes, our Nation's veterans, the signature wounds of this 
war, brain injury and PTSD. We have the biggest burden of 
illness amongst the civilian population, but the civilian 
population today is going to be looking to the fact that our 
heroes are going to be the catalyst to bring us to one mind on 
brain research. No more divisiveness; let's unify, let's get 
behind our veterans. When they win it, we all win it, as is 
always the case with our Nation's heroes, and in this case 
especially.
    So we have a bunch of great testimony today. We will learn 
from those in the civilian sector how they can be helpful in 
their research to help our veterans, which should be our No. 1 
priority.
    So thank you, Mr. Chairman. I appreciate the opportunity to 
have an opening statement. I look forward to the questions.
    Mr. Kucinich. Thank you. The Chair recognizes Mr. Foster.
    Mr. Foster. I yield back.
    Mr. Kucinich. The Chair recognizes Mr. Thompson.
    Mr. Thompson. Thank you, Chairman Kucinich. Thank you for 
having the hearing and thanks to you and Representative Kennedy 
for inviting me to provide testimony today. My thanks to 
everyone who is here who recognizes this as not only a huge 
problem, but one that we can really get ahead of the curve on.
    Mental illness impacts us all a great deal. The chairman 
pointed out the financial cost. While staggering, I think those 
dollar costs really pale in comparison to the heartbreak and 
the pain that families go through because of mental illness. 
With one in six of our adults in the country with diagnosable 
mental illness, it is really hard to find a family that isn't 
somehow touched by mental illness. As Patrick Kennedy said, our 
veterans are certainly a cause that we call can rally around. I 
am pleased to be able to say something on their behalf, and 
honored to be in the same hearing room with Senator Cleland, 
who is in fact a true hero.
    We see more of our military personnel returning from Iraq 
and Afghanistan not with physical injuries, although they are a 
huge issue, important issue as well, but with mental injuries 
including PTSD, anxiety disorder or depression. So the call for 
research and support for a cure for brain illness grows louder 
and louder each time one of these veterans returns home. 
Reports indicate that 19 percent of Iraq war veterans and 11 
percent of Afghanistan veterans suffer from mental illness.
    The brain has been called the last frontier for medicine. 
And the time for that to end, I believe, is right now. It is 
time to bring together all of the different groups, including 
the Federal Government, the Congress, private industry, 
academia, everyone who has an interest in brain illness, to 
fully explore and to tackle this problem once and for all.
    Every year in my congressional district, they hold the 
single largest fundraiser for mental health. It is called the 
Staglin Music Festival for Mental Health. And the proceeds from 
this fundraiser, the annual fundraiser, has now reached over 
$94 million. It is used to find research, to find better 
treatments and cures for schizophrenia, bipolar disorder and 
depression.
    Another great hero who is with us today is Garen Staglin, 
in the front row. I don't know where his wonderful wife, Shari, 
is, if she is here or not. But the two of them work tirelessly 
for mental health and to raise the money to provide research 
funding for mental health. Their work to find a cure and to 
improve treatment for brain illness is inspired, and it is 
driven by a very personal story. In 1990, their son was 
diagnosed with schizophrenia. It was heartbreaking, it was a 
scary time for them and for their son.
    But they took that heartbreak and they turned it into a 
benefit for everyone who cares about the advancement of mental 
health. In 1995, they started the International Mental Health 
Research Organization, which raises money for mental health 
research, collaborates and affiliates with organizations, and 
works to build awareness of scientific achievements in the 
field of mental health research.
    The Staglins are very fond of saying the rewards are much 
greater if you run toward the problem, not away from it. We are 
fortunate that both Garen and Shari are running toward the 
problem of mental health and not away from it. The rewards, as 
I mentioned, have been great. So I want to make sure we 
recognize that they are making an immediate difference in the 
lives of millions of people. And I am really proud that you are 
here, Garen, and of the work that you are doing.
    I too would like to join the chairman in recognizing our 
friend and colleague, Congressman Kennedy, for his work on 
mental health issues. He has been tireless, the entire 12 years 
that I have been in Congress, I don't know anyone who has 
worked any harder on any single subject than Patrick has worked 
on this. He has done so much good for so many people.
    It really saddens me that you are leaving Congress, because 
so many people are going to lose, in Congress, a great 
advocate. I know you will always been working on this stuff, 
but he is just a tireless fighter. So I want to pledge to you, 
Patrick, that I will keep doing everything you tell me to do to 
make sure that we can get ahead of this. Everything you tell me 
to do in regard to working on mental illness.
    Mr. Kennedy. Good thing you made that distinction. 
[Laughter.]
    Mr. Thompson. Everyone that has said it is right on, now is 
the time, and the emphasis on our veterans, I think it just 
punctuates the need to really double down and get this done. I 
thank you very much and I yield back and thank you for letting 
me testify.
    Mr. Kucinich. I thank the gentleman. Any other Members who 
appear will be given 5 legislative days to be able to make an 
opening statement.
    Mr. Kennedy. Mr. Chairman, Congressman Walter Jones has 
arrived.
    Mr. Kucinich. Congressman Jones, do you have a statement 
that you want to make?
    Mr. Jones. Yes, Mr. Chairman.
    Mr. Kucinich. Without objection, come on up here, have a 
seat. This is Congressman Walter Jones from North Carolina, 
Republican Member. Have a seat.
    Mr. Jones. Thank you, Mr. Chairman. Nothing like being 
late. Thank you.
    I have Camp LeJeune Marine Base in my district. We have had 
a number of suicides of Marines who have been frequently 
deployed. We are having more problems with families staying 
together. I want to thank Patrick Kennedy for taking the lead 
on this and asking me to join you, Mr. Chairman, and the other 
Members here.
    My biggest concern is that at some point in time in the 
very near future, we are not going to be able to do what we 
should do for those who are suffering from PTSD and TBI. So I 
wanted to be here today to listen, to learn and to also be very 
proactive with my friends.
    Thank you.
    Mr. Kucinich. I thank the gentleman. Members who appear 
once the testimony begins will be given five legislative days 
to submit statements for the record.
    Before I begin introducing our panel of witnesses, I 
apologize for being a few minutes late, but I ran right into 
the room and focused on my script and getting the hearing off 
and running. Had I noticed Max Cleland in the room, I would 
have spoken as some of my colleagues have to his exemplary 
service to our country in so many ways.
    When I came into Congress, Max was one of the first people 
I consulted with on that other side of the Capitol. And I have 
to say, Max, you honor us by your presence in this room. I am 
so grateful that you continue to serve in other capacities. You 
know how I feel about you and when I saw you, I thought, wow, 
Cleland is in the audience. So thank you.
    Our first panel: Dr. Thomas R. Insel, M.D., is the Director 
of the National Institute of Mental Health. His tenure at NIMH 
has been distinguished by groundbreaking findings in the areas 
of practical clinical trials, autism research and the role of 
genetics in mental illnesses. Prior to his appointment as NIMH 
Director in fall 2002, Dr. Insel was professor of psychiatry at 
Emory University.
    Next, Dr. Walter J. Koroshetz, who is Deputy Director of 
the National Institute for Neurological Disorders and Stroke. 
Before joining NINDS, Dr. Koroshetz served as vice chair of the 
neurology service and director of stroke and neurointensive 
care services at Massachusetts General Hospital. He is also 
professor of neurology at Harvard Medical.
    Joel Kupersmith, M.D., Dr. Kupersmith is Chief Research and 
Development Officer for the Veterans Health Administration, 
U.S. Department of Veterans Affairs. Prior to joining VA, Dr. 
Kupersmith was dean of the School of Medicine and Graduate 
School of Biomedical Sciences and vice president for clinical 
affairs at Tech University.
    Finally, Terry Rauch, Ph.D., currently serves as the 
Director of the Defense Medical Research and Development 
Program within the Office of the Assistant Secretary of Defense 
for Health Affairs. He has responsibility for the defense 
health program R&D portfolio. He has over 30 years of 
experience in many facets of the military health system and has 
held numerous senior level positions in the Army and the Office 
of the Secretary of Defense.
    I want to thank each and every one of the distinguished 
panelists for their presence here today. It is a policy of the 
Committee on Oversight and Government Reform to swear in our 
witnesses before they testify. I would now ask that each of the 
witnesses rise, raise your right hands.
    [Witnesses sworn.]
    Mr. Kucinich. Thank you very much.
    Let the record reflect that each of the witnesses answered 
in the affirmative. I would now ask that each witness give a 
brief summary of your testimony, keep the summary under 5 
minutes in duration if you can. Your complete written statement 
will be in the hearing record.
    I don't know if you can see the clock there, there is a, 
you have an even better view, but we have a little box there 
with colored lights. Let's begin with Dr. Insel. And thank you 
for being here, sir. Please start.

    STATEMENTS OF THOMAS R. INSEL, M.D., DIRECTOR, NATIONAL 
 INSTITUTE OF MENTAL HEALTH; WALTER J. KOROSHETZ, M.D., DEPUTY 
  DIRECTOR, NATIONAL INSTITUTE FOR NEUROLOGICAL DISORDERS AND 
 STROKE; JOEL KUPERSMITH, M.D., CHIEF RESEARCH AND DEVELOPMENT 
  OFFICER, VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF 
  VETERANS AFFAIRS; AND TERRY RAUCH, PH.D., DIRECTOR, DEFENSE 
    MEDICAL RESEARCH AND DEVELOPMENT PROGRAM, OFFICE OF THE 
 ASSISTANT SECRETARY OF DEFENSE FOR HEALTH AFFAIRS, DEPARTMENT 
                           OF DEFENSE

               STATEMENT OF THOMAS R. INSEL, M.D.

    Dr. Insel. Thank you, Mr. Chairman. I really appreciate the 
committee's interest in this issue, and I also want to thank 
Congressman Kennedy for what has been a very long period of 
passionate leadership. We are going to miss you tremendously as 
you move to your next post. I can only hope that you will come 
work for us at some point.
    Mr. Kennedy. I thought I already was. [Laughter.]
    What do you think all those appropriations were over there?
    Mr. Kucinich. Regular order. Go ahead.
    Dr. Insel. The National Institute of Mental Health is part 
of the National Institute of Health, part of the Department of 
Health and Human Services. And Dr. Koroshetz and I will talk 
about this perspective on these disorders and the urgent needs 
we have from the NIH side both for NINDS and NIMH. I think 
rather than go into the details of my testimony, which you have 
in front of you, I would like to just take you through pictures 
that may be more helpful for you to expand on some of the 
things, Chairman Kucinich, you already mentioned in your 
opening statements.
    So if I can have the next slide, let me talk a little bit 
about what it is when we talk about this burden of illness that 
people refer to. When we think about this in numerical terms, 
we use something called the disability adjusted life years, an 
unfortunate term, that has to do with how many years are lost 
to disability. You can see from this graph, I hope, from the 
World Health Organization, numbers put together in 2008, that 
neuropsychiatric illnesses broadly represent almost 30 percent 
of all the disability form all medical causes for non-
communicable diseases. So that ranks them well above heart 
disease, cancer and many of the things that many of us often 
think about as the big killers.
    Part of the reason why the disability rate is so high is 
that some of these actually become chronic diseases, and they 
begin early, and as was already mentioned, common. So the high 
prevalence also drives these kinds of numbers.
    In the next slide, you'll see that if you break this down, 
the next slide, please, I am sorry, we skipped one. Can we go 
back one? That the actual disorders within this category 
include depression, alcohol, Alzheimer's disease and many 
others, with depression being really the No. 1 driver for the 
sources of disability.
    It is really a powerful statement that so much of medical 
disability is driven by this one group of illnesses, all of 
which occur quite early in life. We tend to think of these as 
the chronic disorders of young people. But it is not just that 
they are chronic. They are also, not only that they cause 
morbidity, they also are a source or mortality.
    You will see in the next slide that suicide, which 90 
percent of the time involves a mental illness, accounts for 
over 34,000 deaths each year in this country, which is an 
extraordinary number when you put this in context. As you will 
see in the next bullet, that is almost double the number of 
homicides. And at this point, based on the numbers released 
about a week ago from the National Safety Transportation Board, 
more than the number of deaths from traffic fatalities, which 
is just extraordinary.
    Now, we have a whole criminal justice system to deal with 
the homicides and a whole transportation safety system to deal 
with traffic fatalities. One might ask, what do we have by 
comparison to handle this growing issue of suicides in America. 
It is not only suicides that are driving mortality, but lots of 
other sources of medical illness.
    You can see in the next bullet that in fact, in the United 
States, the life expectancy today for someone with a serious 
mental illness is about 56 years, which according to what I 
looked at on Google about a week ago is about the life 
expectancy today in Bangladesh. So this is not where we want to 
be in 2010.
    It was already mentioned before about the economic costs 
involved here. In the next slide, you will have a picture of 
that. Maybe this will be difficult for you to see, but the last 
column over shows that, if you will hit the next bullet, that 
it is about $57\1/2\ billion in health care costs that go to 
mental illnesses, which is just about what we are spending each 
year for cancer in the United States. What is dramatic about 
that are two things: first, that is a huge increase from where 
we were a decade ago, so these are really now driving upwards 
relative to many other medical sources. And maybe second, even 
more importantly, this barely captures the real costs, 
economically. Because most of the costs of mental illnesses are 
outside of the health care system.
    Next bullet, you will see, the costs of lost earnings, of 
welfare, next, incarceration, homelessness, school and home 
care, all the places where most care or failure of care from 
mental illnesses really play out. Next, so we estimate that the 
actual total comes to about $1,000 per American per year that 
we are spending, the way we do this now, to provide what is 
obviously mediocre help to people with these very disabling and 
chronic illnesses.
    Next, if that is the bad news, I need to tell you that we 
are not just facing huge challenges, but really unprecedented 
opportunities. And I wanted to take just a couple of minutes, 
if I can, to flesh those out. There are two that I will speak 
of very quickly. The first has to do with the recognition in 
the next bullet that these are indeed brain disorders, they are 
not brain disorders in the way stroke or Alzheimer's might be, 
but they are disorders of brain circuits. We have been able now 
to define those with the help of genetics and with the help of 
new technologies.
    We also now recognize, in the next bullet, that these are 
developmental disorders. I mentioned that they start early in 
childhood most of the time, at a time when the brain is still 
developing. But this gives us a real opportunity for thinking 
about how to intervene. We will see in the next slide that we 
have a whole range of technologies that have been developed 
over the last 5 to 10 years that are real game-changers here. 
For the first time, we can study brain circuits with the kind 
of precision that we can only dream about 15 to 20 years ago. 
And that has made this a tractable problem, where we should 
expect to see tremendous progress over the next decade.
    You will see in the next slide, and we will just run 
through these very quickly, that we have already begun to 
describe the circuit basis of most of the major disorders. This 
is depression. Next is obsessive compulsive disorder. Next, 
PTSD, one that we are going to talk much more about this 
afternoon.
    But in each case, we have begun to identify the major nodes 
in the brain, the importance of the pre-frontal cortex, which 
is really the kind of great last frontier for neuroscience. It 
has begun to open up real opportunities for new therapeutics.
    Let me finish up by saying that this is an enormous 
challenge. I don't want to give you for a moment the sense that 
we have mastered this problem. I would like to say that we know 
about 2 percent of what we need to know. But we need to do this 
in a way that as Congressman Kennedy said will be collaborative 
and will be a joint effort.
    There is an old African proverb that says if you need to go 
fast, go alone, if you need to go far, go together. And we will 
need to do both.
    So I will show you in the next couple of slides how we are 
thinking about that. In the next slide, you will see, let's go 
ahead and run through this. We have a number of projects with 
the VA, with a total of about nearly 100 grants across 23 
States with about $41 million in investments that we are now 
doing. And just keep hitting the bullets, because we don't have 
time to go through much of this. But I want to make sure you 
understand that this is by no means a siloed effort. We are not 
balkanized any longer. There is a lot of effort going on, both 
intellectually and practically, to make sure that we are 
working very closely together.
    And finally, in the last slide, let me just say that 
probably the largest effort that we have mounted at the NIMH in 
the past 18 months has been the Army Stars initiative, which we 
are doing very closely with the Department of Defense. This 
really responds to the increase in suicide, which you have 
heard a little bit about already, the increase has gone to 160 
in 2009, and 239 if you include reserve forces as well. In a 
recent publication, Vice Chief of Staff Pete Corelli mentioned 
that from his perspective, it appears that we may be losing 
more soldiers to suicide and to high risk behaviors than we are 
to combat. This has to be the highest priority.
    We have now entered in with them a very large study. We 
call it a Framingham-like study, because it is really looking 
at the entire Army and trying to understand risk and resilience 
for the forces, and providing information back as quickly as we 
can to promote resilience and to reduce risk.
    So if we can just put up the last slide. I want to thank 
you for your leadership in this area, Mr. Chairman, and I look 
forward to having a chance to discuss any of this much further 
with you.
    [The prepared statement of Dr. Insel follows:]

    [GRAPHIC] [TIFF OMITTED] T5562.003
    
    [GRAPHIC] [TIFF OMITTED] T5562.004
    
    [GRAPHIC] [TIFF OMITTED] T5562.005
    
    [GRAPHIC] [TIFF OMITTED] T5562.006
    
    [GRAPHIC] [TIFF OMITTED] T5562.007
    
    [GRAPHIC] [TIFF OMITTED] T5562.008
    
    [GRAPHIC] [TIFF OMITTED] T5562.009
    
    [GRAPHIC] [TIFF OMITTED] T5562.010
    
    Mr. Kucinich. Thank you very much.
    Dr. Koroshetz, please.

             STATEMENT OF WALTER J. KOROSHETZ, M.D.

    Dr. Koroshetz. Thank you very much, Chairman. I am going to 
talk a little bit maybe deeper in the weeds than Tom went. But 
I think a lot of the things are very complementary. I am going 
to talk about what we are doing to try to understand how the 
brain works and how we are working together, actually stressing 
the collaborative piece on developing treatments for brain 
disorders.
    Next slide. So our problem is that we have a lot of 
disorders. There are, some people count 600 neurological 
disorders that our institute is trying to attack. But the 
message here is that we have to go one by one to get a drug. 
But to make real progress, we need basic science discoveries 
that are going to cut across multiple, as opposed, because one-
by-one is going to take such a long time.
    Next slide. So this slide basically gets away from the 
numbers and just reminds you of the real tragedy that occurs 
when you lose part of your nervous system function. It really 
defines what is a human being and what makes us different from 
the next person. And so there is real personal tragedy behind 
all of these diseases, unfortunately.
    For people who are interested, I refer you to the Web site. 
We actually did a very kind of in-depth, bare bones, look at 
how the NINDS works, where we need to improve. We got experts 
from the extramural community, different Government agencies, 
industry, academia, disease organization leaders, to look at 
it. We brought them in, we bared ourselves, showed them how the 
Institute works. We got very good recommendations to move 
forward.
    And out of this, you can see the details on the Web site, 
but the mission is reaffirmed, which is to reduce the burden of 
neurological disorders through research. We think there are two 
main pillars on which this is going to stand. Firstly, we need 
to understand how the normal brain and nervous system develop. 
Much of what we think happens in repair when there is a brain 
injury is just beginning that developmental program all over 
again. So the more we learn about how the brain develops, we 
think the more we are going to know about how to effect repair 
once it is injured.
    We need to know what goes wrong in diseases, and then we 
need to be able to translate this knowledge from basic and 
clinical discoveries into better ways to prevent and treat 
neurologic disorders. There are a number of other points here 
which you could read more about, but I am going to hit some of 
them as we go along.
    Next slide, please. This point has come up already in the 
chairman's statements and hopefully will come up again. It is 
the fact that when push comes to shove, if you have a 
neurological disease, you need a particular treatment, a 
particular drug, a particular type of treatment that is going 
to help you. And it has to be specific. We eventually have to 
go from our basic knowledge to a very specific treatment.
    If we don't do that, if we don't take advantage of our 
preeminence in biological sciences to translate to really what 
are commercial products at the end, the patients see no 
benefit, needless to say the economy sees no benefit from the 
Government's investment. And it has been said, major pharma is 
now shunning neurological disorders as unacceptable, risky 
investments. They have very high development costs. They have a 
high failure rate when they go into the clinic. And the more 
and more we know about the diseases, we get smaller and smaller 
markets for them to make profits on. So we have to try and 
solve this problem.
    And the word that is used around NIH now is the word de-
risk. So what NIH sees is that their role currently is to try 
to take basic knowledge, try and actually develop molecules 
that will be treatments and bring them as far along the 
pipeline as we can until the risk is so low that industry will 
pick them up. That is kind of the general idea.
    The big problem, well, there are a lot of problems, but one 
of the big problems that we have hit is that if the sad but 
true statement that if you are a mouse and have disease X, 
don't worry about it, we can fix you. But if you are a human 
with disease X, you had better worry, because we don't have 
something.
    So we have been able to do really well for the mice. The 
problem is, when we go from the mouse to the human, we are 
missing something. We need a bridge. And we talk about 
biomarkers, and maybe this will come up later. A biomarker in 
my mind is a way to bridge what we know from the animal disease 
to the human disease, so that we know when we go into the 
human, we hit this biomarker, it is going to give a high chance 
of success. If we just go into the human and treat the brain as 
a black box, then there is a lot of guesswork, a lot of things 
can go wrong.
    That is the idea of this bridging biomarker. So there is a 
big emphasis now. You will hear about it particularly with 
regard to Alzheimer's disease, and this big ADNI project that 
is a public-private partnership to develop biomarkers for 
Alzheimer's disease drug development.
    Next slide. NINDS does not work alone. We have so many 
disorders, we need everybody working together. We basically 
work very closely with tremendous numbers of really innovative 
neuroscientists that, most belong to the Society for 
Neuroscience, the professionals in neurology, surgical, 
psychiatry, emergency medicine. Many different professional 
societies. And these private organizations, these organizations 
that are disease related that have real motivation and 
dedication and persistence to galvanize communities are 
essential for us to carry out our mission and perform 
tremendous, really tremendous research now.
    Next slide. Now, this is a really busy slide. And this is 
basically a slide of how we conceive of the pipeline going 
from, on the left, the basic science R01 investigative grants, 
which are the mainstream of the NIH investment, to really make 
the most of the innovation in the American scientist pool, to 
bring out new basic knowledge. And that is really the critical 
thing that everything is based upon.
    But once you have that knowledge, someone who is interested 
in this other area has to go in and try to pick out from that 
knowledge something that is going to be a useful treatment. 
Then there are a number of steps one has to go through until 
you get to the proof of principle, and the animal model, show 
it working, and go into the human. So this is not rocket 
science, but it is a process. It is well known to the 
pharmaceutical companies and now NIH is really getting 
interested in how we can move this further to the left, taking 
the risk out of drug development.
    What I have listed here is a number of the programs that 
NINDS has in this arena. The ones in green are ones that we do 
with many institutes at NIH. The ones in blue are ones that we 
generally have disease organizations as our partners. And the 
ones in red are the ones we usually have industry as our 
partners.
    And just a couple of points, just yesterday we announced 
that we will be working on a public-private partnership much 
like Alzheimer's disease, develop biomarkers for Parkinson's 
disease drug development. We have a network that we are going 
to set up that will be nimble, be able to move from disease to 
disease, to test the best therapies available coming out of 
neuroscience and biomarker informed trials. The NIH blueprint, 
important to know about the blueprint, it is all the institutes 
at NIH, they come together and they decide what they can do 
together as a group. Here they put together this 
neurotherapeutic grant challenge, which is trying to really 
fill the pipeline with really creative agents that can help 
many different neuroscience diseases, not just NINDS diseases 
or NIMH diseases, any neuroscience disease.
    Next slide. In terms of brain injury research, we have been 
working really hard with our DOD and VA collaborators to try 
and make a dent in trying to do something that will improve the 
recovery of our soldiers and protect them potentially in the 
future.
    So NINDS is a leading funding agency and has been for 
traumatic brain injury research. TBI is the leading killer of 
young adults. One of the couple of things we have done recently 
is we have set up, and I am the co-director of this, with Dr. 
Armstrong at the Uniformed Services University across the 
street, a center for TBI research. This is investigators at 
Walter Reed, National Navy Medical Center, Uniformed Services 
University and NIH. It is about 56 investigators working with a 
fairly good budget, trying to make a dent in many different 
areas of traumatic brain injury research. It is an intramural 
program at NIH and USU.
    We have a common data elements project that has been done 
with a Federal interagency group that has members from almost 
any Federal agency that works in the area of TBI. What they 
have been working on most recently is standard ways of 
collecting data, so that no matter who is doing the study, what 
agency is funding it, they are collecting the same type of 
data, so this data can be combined and mined, and the value of 
the data goes up substantially.
    We also are working on projects with DARPA. They have an 
amazing prosthetic arm. I don't know if anybody has seen it, 
but if you haven't, it is really worth it. Tremendous new 
prosthetic arm for upper extremity amputees. And we are funding 
projects so that soldiers will be able to control this from 
brain activity.
    The NIH also participates in DOD grant review. We are 
working now with Uniformed Services and some of the other DOD 
groups to develop an MRI scanner that will just do brains, but 
can be small enough to be taken far afield into the military.
    Finally, we do again have another phase three trial on 
progesterone ongoing in acute TBI. We are working with a 
military site to bring them into San Antonio TBI Level I trauma 
center.
    Next slide. I am going to end really where the beginning 
is, and that is kind of in the basic science. I just want to 
tell this one story. There are lots of stories like this and 
the details change. But this is an example of how really basic 
science that you had no idea was going to be helpful to brain 
diseases, turns out that it really is.
    So basically, these little pictures here are microbes. They 
are not even real bacteria, that is how primitive they are. But 
they have these channels in their membranes that when light is 
shined upon the membrane, the channels open. And really 
innovative scientists have been able to take this gene from 
these microbes, put it into viruses, transfect brain cells. Now 
the brain cells have these channels.
    And they can go in with laser lights and with amazing 
temporal and spatial accuracy, they can then shine the light, 
the channels will open. Some of them will shut the cells off, 
depending on what channels, some will turn the cells on. And 
for the first time, with this technology, you can actually 
activate circuits in the brain, as opposed to what we did 
before, which was sent electricity in with a wire and nobody 
knew where the electrons went. This is really specific, really 
tremendous.
    It has only been out a couple of years, you can see from 
these papers, that there is real disease-related work that has 
come from this stuff that started with microbes. So for 
instance, they have been able to show that when someone has a 
spinal cord injury, they lose their ability to breathe. They 
can now put these channels into mice with a spinal cord injury, 
activate the breathing circuits and the mice start breathing 
again.
    So just a great example, lots of stories like this where 
the basic science, you can't tell where the advances are coming 
from. But a tool that comes out of this that you didn't have 
before and really allows a lot of breakthroughs.
    Next slide. And that is basically what I wanted to say, it 
is short but I hope it was interesting and I would be happy to 
answer any questions. Thanks.
    [The prepared statement of Dr. Koroshetz follows:]

    [GRAPHIC] [TIFF OMITTED] T5562.011
    
    [GRAPHIC] [TIFF OMITTED] T5562.012
    
    [GRAPHIC] [TIFF OMITTED] T5562.013
    
    [GRAPHIC] [TIFF OMITTED] T5562.014
    
    [GRAPHIC] [TIFF OMITTED] T5562.015
    
    [GRAPHIC] [TIFF OMITTED] T5562.016
    
    [GRAPHIC] [TIFF OMITTED] T5562.017
    
    [GRAPHIC] [TIFF OMITTED] T5562.018
    
    [GRAPHIC] [TIFF OMITTED] T5562.019
    
    [GRAPHIC] [TIFF OMITTED] T5562.020
    
    [GRAPHIC] [TIFF OMITTED] T5562.021
    
    [GRAPHIC] [TIFF OMITTED] T5562.022
    
    [GRAPHIC] [TIFF OMITTED] T5562.023
    
    [GRAPHIC] [TIFF OMITTED] T5562.024
    
    [GRAPHIC] [TIFF OMITTED] T5562.025
    
    Mr. Kucinich. Thank you very much.
    Dr. Kupersmith, you may proceed.

               STATEMENT OF JOEL KUPERSMITH, M.D.

    Dr. Kupersmith. I want to also thank the committee for 
inviting us, for having this hearing. I want to thank Dr. Insel 
and Dr. Koroshetz for their slide shows, which also act as a 
basis for what we have to say.
    VA is one of the largest medical programs in the country, 
one of the largest research programs. And it includes close 
academic affiliations with major universities and medical 
schools.
    We have over 3,400 researchers working on 2,300 projects 
and supported by approximately $1.9 billion in funding from all 
sources. We are widely supported by the Department of Defense 
and National Institutes of Health grants, our pharmacy 
coordinating center that is part of our nationwide clinical 
trials program, recently won the Baldridge Award, and has 
worked closely with NIH and DOD on projects.
    Our collaborations with relative partners are extensive and 
essential to our advancement of research.
    Our cutting-edge neuroscience research has extended from 
seminal studies on how memory is organized to the only 
evidence-based treatment for PTSD to Nobel Prize work on 
neuropeptides to a variety of genomic advances. I will 
highlight some of our findings and some of our research on 
PTSD, traumatic brain injury, spinal cord injuries and our work 
on the DEKA DARPA arm that was just mentioned.
    We are a leader in PTSD research, currently supporting over 
10 studies and spearheading the national dissemination of two 
evidence-based psychotherapies that we have proven to be most 
effective for PTSD, cognitive processing therapy and prolonged 
exposure therapy. We are also undertaking three large studies 
in the long-term assessment of PTSD and associated health 
conditions in Vietnam veterans. We have other studies which 
include genetic assessment of PTSD, genetic assessment of 
resilience to PTSD, treatment for sleep-related disturbances 
and strategies to engage veterans in early PTSD treatment.
    Our research directly affects our PTSD guidelines and our 
guidelines are developed jointly with the Department of 
Defense. We have increased our research funding in traumatic 
brain injury, and at the beginning of fiscal year 2010, started 
three research centers dedicated to detecting and treating TBI. 
These include one that is going to specialize in PTSD and TBI 
and how to distinguish one in basic science, and one that is 
going to deal with other aspects of TBI.
    VA is at the cutting edge of methods for detecting mild TBI 
through the use of biomarkers imaging and eye tracking 
assessments and is investigating, as I said, the links between 
TBI and PTSD and how to improve diagnosis of each.
    We are also studying repetitive brain injuries combined 
with aging to determine whether these injuries can lead to 
neurodegenerative diseases. And there are some initial findings 
in that.
    We have also and have always invested substantially in 
spinal cord injury research and recently started a spinal cord 
injury consortium to better address the needs of veterans with 
these conditions. One project involves combination therapy 
using bioscaffolds to implant stem cells with growth factors to 
repair and restore function. This approach, as Dr. Koroshetz 
intimated, is successful in rodents so far. But we are testing 
it in non-human primates. And it does hold promise to restore 
spinal cord function over the long haul.
    Another group of studies we are doing is on functional 
electrical stimulation that applies low-level currents to 
nerves of spinal cord injured patients to stimulate muscle 
activity for movement of limbs, as well as for bladder 
function.
    Now, our work on the new generation prosthetic arm, I 
think, is an example of mutual beneficial results of 
collaboration. This is the arm that Dr. Koroshetz mentioned. It 
was developed by DARPA. We are doing the clinical trials and 
optimization of it. And we have completed studies in 22 male 
and female veterans and military personnel and others.
    We are testing the prototype, which has flexible socket 
design and innovative control features. And one of the 
important developments that has also been mentioned is that we 
will add the addition of brain computer interface technology. 
This is a group that is working at the Providence VA with a 
number of associated medical schools funded by us and also 
funded by the National Institute of Health. Right now, the DEKA 
arm is controlled by sensors that are in the feet. So it can 
only be used while sitting or standing, not while walking. But 
with this brain computer interface, we will enable individuals 
to walk and to command this prosthesis through thoughts in the 
brain.
    Time does not permit me to discuss other VA neuroscience 
studies, but these are included in my written statement and I 
am happy to answer your questions. Thank you.
    [The prepared statement of Dr. Kupersmith follows:]

    [GRAPHIC] [TIFF OMITTED] T5562.026
    
    [GRAPHIC] [TIFF OMITTED] T5562.027
    
    [GRAPHIC] [TIFF OMITTED] T5562.028
    
    [GRAPHIC] [TIFF OMITTED] T5562.029
    
    [GRAPHIC] [TIFF OMITTED] T5562.030
    
    [GRAPHIC] [TIFF OMITTED] T5562.031
    
    [GRAPHIC] [TIFF OMITTED] T5562.032
    
    [GRAPHIC] [TIFF OMITTED] T5562.033
    
    [GRAPHIC] [TIFF OMITTED] T5562.034
    
    [GRAPHIC] [TIFF OMITTED] T5562.035
    
    [GRAPHIC] [TIFF OMITTED] T5562.036
    
    [GRAPHIC] [TIFF OMITTED] T5562.037
    
    Mr. Kucinich. Dr. Rauch, you may proceed.

               STATEMENT OF TERRY M. RAUCH, PH.D.

    Mr. Rauch. Mr. Chairman, before I give my statement, I 
would like to thank Mr. Kennedy for his hard work in this area. 
This old retired soldier very much appreciates your effort in 
this critical area.
    Mr. Chairman, members of the committee, thank you for the 
opportunity to discuss Department of Defense research efforts 
to advance our understanding of neurological and psychological 
trauma. We greatly appreciate the committee's support of our 
efforts to discover and develop diagnostic treatment and 
prevention strategies to help the many brave men and women who 
have been afflicted with these debilitating disorders.
    Mr. Chairman, without a doubt, the devastating nature of 
neurological and psychological trauma is one of the most 
difficult challenges we face with respect to research and 
development and translation of discoveries in clinical care. 
The central nervous system allows us to interact with the world 
around us. Therefore, any neurological or psychological injury 
can be devastating, not only to the service member but also to 
the family members as well.
    Psychological trauma in many cases has proven responsive to 
various therapies, but it remains a difficult challenge to 
identify and effectively treat. Recovery from psychological 
trauma is often complicated by co-occurring physical injury, 
depression, substance abuse and the threat of suicide. Even 
mild cases of neurological and psychological trauma can have 
devastating effects on lives, careers and families.
    The Department of Defense has developed a comprehensive 
research and development program for the study of neurotrauma 
and psychological health. The programs focus on basic 
mechanisms of disease and applied and clinical research that 
address prevention, diagnosis, treatment and rehab. This 
research and development is conducted by investigators within 
DOD, within the VA, within NIH and within leading academic 
institutions and also in industry partners.
    Psychological trauma has posed a significant threat to 
service members. During Operations Iraqi Freedom, now Operation 
New Dawn, and Enduring Freedom, an estimated 20 to 40 percent 
of service members experienced behavioral health problems post-
deployment, most often PTSD, depression, and interpersonal 
conflicts. Studies have also shown evidence of increased strain 
on families.
    Our highest priority in neurotrauma research is the 
diagnosis of TBI, specifically mild TBI. While moderate and 
severe TBI are relatively straightforward, to diagnose mild TBI 
can be difficult to assess, particularly if the service member 
has an injury that wasn't witnessed. Our goal in diagnostics 
has been to identify the unique biological effects of TBI and 
to leverage that knowledge to identify or develop more 
effective, objective diagnostic tools that will determine the 
presence and severity of brain injury.
    To meet this challenge, we have funded research on more 
than 60 different technologies over the past 4 years. These 
include blood biomarkers of TBI, identifying unique electrical 
paterns of the brain, indicative of injury and the severity of 
that injury, and more valid and reliable neurocognitive 
diagnositc tests.
    With regard to treatment and rehab research on neurotrauma, 
we currently sponsor more than 70 projbects investigating drug 
and drug combinations, nutritional compounds with therapeutic 
potential, cell and gene therapies used in regenerative 
medicine, deep brain stimulation and rehab methods and devices.
    We sponsor a significant amount of work to better 
understand neurobiological basis of PTSD. Significant research 
is underway to discover objective techniques to distinguish 
between PTSD and TBI. These efforts are focused on neuroimaging 
techniques, as well as biomarkers specific to PTSD and mild 
TBI.
    We have also invested significantly in research to identify 
the most promising drugs to treat various PTSD symptoms and to 
use in combination with different psychtherapies.
    Last, suicide is a significant public health problem. It 
has been identified as the third leading cause of death of 
young people and the eleventh overall leading cause of death in 
the U.S. population. Until recently, military suicide rates 
have been significantly lower than general population rates. 
However, in 2004, military suicide rates began to climb, and 
today, exceed the age-adjusted civilian rate.
    In order to better understand the factors related to 
suicide, the DOD and NIH are invoolved in an ongoing 
collaboration, as my colleagues described before, to conduct 
the largest scale study of suicide in the military. The project 
is the largest epidemiologic study of mental health, 
psychological resilience, suicide risk, suicide-related 
behaviors and suicide deaths in the U.S. Army.
    Drug, including prescription drugs and alcohol abuse, is a 
significant health problem in the military. Almost 30 percent 
of the Army's suicide deaths from 2003 to 2009 and more than 45 
percent of the non-fatal suicide behavior from 2005 to 2009 
involved the use of drugs or alcohol. Increased prescription 
use among the military has led to heightened concern with 
overdoses. We have sponsored a significant amount of substance 
abuse research that includes epidemiologic studies as well as 
studies investigating prevention and treatment interventions. 
Further epidemiologic research is needed to accurately 
characterize drug use and mis-use to include risk factors and 
to identify potential barriers to treatment-seeking behavior.
    Mr. Chairman, the Department of Defense continues to 
perform and manage exceptional medical research and development 
for the population that demands and deserves the finest care 
available. I am proud to be here today to represent the men and 
women who conduct these programs. And I thank them for their 
service. I thank you, Mr. Chairman, for the opportunity to be 
with you today and I look forward to your questions.
    [The prepared statement of Mr. Rauch follows:]

    [GRAPHIC] [TIFF OMITTED] T5562.038
    
    [GRAPHIC] [TIFF OMITTED] T5562.039
    
    [GRAPHIC] [TIFF OMITTED] T5562.040
    
    [GRAPHIC] [TIFF OMITTED] T5562.041
    
    [GRAPHIC] [TIFF OMITTED] T5562.042
    
    [GRAPHIC] [TIFF OMITTED] T5562.043
    
    [GRAPHIC] [TIFF OMITTED] T5562.044
    
    [GRAPHIC] [TIFF OMITTED] T5562.045
    
    [GRAPHIC] [TIFF OMITTED] T5562.046
    
    [GRAPHIC] [TIFF OMITTED] T5562.047
    
    [GRAPHIC] [TIFF OMITTED] T5562.048
    
    [GRAPHIC] [TIFF OMITTED] T5562.049
    
    [GRAPHIC] [TIFF OMITTED] T5562.050
    
    [GRAPHIC] [TIFF OMITTED] T5562.051
    
    [GRAPHIC] [TIFF OMITTED] T5562.052
    
    Mr. Kucinich. Thank you very much, Mr. Rauch.
    We have a vote on. We are going to go for another 5 
minutes. What I would like to do is, in deference to Mr. 
Kennedy, I am going to give him the first question here. After 
he concludes with his questions, we are going to go vote. Then 
we will come back here at 4 p.m., because five votes will take 
up about an hour.
    So Mr. Kennedy, why don't you start.
    Mr. Kennedy. Thank you, Mr. Chairman.
    First, I appreciate your contributions to this hearing 
enormously, and the testimony submitted and the points that you 
have made, and the questions that we will get into over the 
course of time when we come back I think will really bring some 
more illumination to all that and will be very useful.
    But I want to take this opportunity in response to Dr. 
Rauch's point, first thank him for his service to our country 
in the military.
    To hit one point home that I believe needs to get hit home 
hard, and that is, there is no difference between psychological 
and neurological. And if you want to know there is the highest 
suicide rates now against military, they are not supposed to 
have problems. But when we have a military that is talking 
about their problems in terms of 30 percent of the suicides are 
caused by alcohol, alcohol is caused by their combat wound. 
That 30 percent isn't alcohol, that 30 percent is a result of 
their combat wound.
    And the last word about drug-seeking behaviors, no, self-
medicating because they got a combat wound. Physical. We have a 
dual track, one, objective diagnostic tools for TBI as like a 
separate track from objective diagnostic tools from what you 
said, behavioral. It is not behavioral. It is physiological. Do 
you want to know why there is a stigma? Because the military 
refuses to talk about this as a combat wound, PTSD, physical 
changes in the brain as a result of prolonged exposure to 
cortisol.
    We still have the leading medical experts coming up here 
and testifying, in spite of the report that was just released 
last week, which I would like to submit for the record, if it 
is all right with the chairman.
    Mr. Kucinich. Without objection.
    Mr. Kennedy. I think you were right, Dr. Rauch, about it 
being neurotrauma. But that doesn't apply to TBI, it applies to 
PTSD and TBI. I only can't hit this point home enough, because 
if we don't get to the stigma of mental illness, we are never 
going to get to the science. This notion that there is a dual 
track between the psychological versus the neurological, no 
way, wait a second. Let me just say, psychological is 
neurological. That is what we just learned on the board from 
the Director of the National Institutes of Mental Health. It is 
neurological. Stop calling it psychological. Stop calling it 
mental health and you will have less veterans feeling 
stigmatized by it, because we are the biggest stigmatizers, 
with that nomenclature.
    When you have, and it is a fact, more veterans killing 
themselves in active service than are being killed in combat, 
there should be a wake-up as to what we are doing. The last 
commission report just released, no mention of the 
physiological impact of the trauma of war impacting suicide. 
All that we heard was psychological, behavioral, mental health. 
We re-stigmatized it.
    That suicide commission was an utter disaster, in my 
opinion. Because all it ended up doing was laying on top to 
these veterans that somehow they have something that happens to 
them after war. No. This happened to them while they were 
serving, it is a combat wound. It is not alcoholic, it is not 
drug-seeking. It is a combat wound that ends up manifesting 
itself in these symptoms that then ultimately ends up as a 
suicide. And if we refer to it as alcohol-seeking behavior, 
drug-seeking behavior, something else, we do injustice to the 
fact that these veterans are stigmatized by their behavior 
because it is a result of their neurological changes that their 
service incurred on their brains.
    And we can talk all day about science. But if we don't get 
this issue of stigma out on the table, we are never going to 
get anywhere, as far as I am concerned, Mr. Chairman. Thank you 
for allowing me the time.
    Mr. Kucinich. Thank you very much, Mr. Kennedy. We are 
going to recess until 4 p.m., at which time I will come back 
and I have questions for the panelists. Then we will go to the 
next panel after that.
    I appreciate your patience and we will come back, and if 
the other members, Mr. Jones, Mr. Foster, if you are able to 
make it back, we would be very grateful.
    Thank you, Mr. Kennedy. We are recessed until 4.
    [Recess.]
    Mr. Kucinich. Thank you very much for your patience. We are 
going to resume the hearing.
    Dr. Koroshetz had to leave due to a previously scheduled 
engagement, so we excused him from the panel of witnesses 
during the break.
    We are going to resume with questions. Mr. Jones, we will 
go to you and then when all Members have had a chance to ask 
questions during the first round, I will ask mine.
    Mr. Jones. Mr. Chairman, thank you for holding the hearing, 
and Mr. Kennedy, thank you for your leadership on this issue 
regarding mental health, but also the mental health of our 
soldiers and our families.
    I want to very briefly, again, I talked about Camp LeJeune. 
A year ago, Dr. Kernan Manion, a psychiatrist, was released 
from his contract at Camp LeJeune. Because of that I asked for 
an investigation. And the IG is investigating his situation, 
but also from that situation, it has kind of expanded. Tom 
Bagosy was a sergeant, Marine sergeant that had been overseas 
twice. He was in the mental health counseling at Camp LeJeune, 
it was PTSD. Three months ago, he left the clinic at Camp 
LeJeune, and on McHugh Boulevard, he stopped his car and 
committed suicide at 11:30 a.m.
    I want to ask you experts a little bit from the 
neurosciences to this point. Do you believe that the military 
mental health system could be helped if there was a national 
committee set up to evaluate military mental health, to make 
recommendations to the Department of Defense and to the 
Congress? The reason I bring this up is I have been very 
impressed with you. You are professionals, you are experts into 
an area that I am not.
    But as a layman who has a military base in his district, 
and seeing the pain and the hurt that I have seen over the last 
few years, last story, and I would appreciate your answer about 
what can we do to strengthen military health. Can you imagine 
being able to speak at an elementary school at Camp LeJeune, 
Johnson Elementary School, National Reading Day, we are home 
because of the Easter break, I am reading Dr. Seuss to 12 kids 
sitting on the floor. And as I take questions at the end of, I 
say, you can ask me anything. The questions went, have you seen 
the President, do you have a wife, do you have a dog, those 
kinds of things. The last child, these are 6-year-old children, 
the last child, I said, this is my last question. He looked up 
at me and he said, my daddy's not dead yet. My daddy's not dead 
yet. Out of the mouth of a 6-year-old child.
    Now I want to come back to what would be my only question 
of you. Are we at a point that the Congress needs to say to the 
President, whomever he is or maybe 1 day she, we need to put 
together a mental health commission of experts like yourself at 
the table to help our military develop a strong mental health 
program, whether we be at war or we be at peace? Does this have 
any validity?
    Because what I am hearing, I know the hyperbaric oxygen 
treatment, we finally got it down at Camp LeJeune. They don't 
have the staff yet. But it seems like we are doing everything 
we can to deal with the mental health of our military, 
particularly those at war. But yet, it just seems like there 
are so many different aspects of it that somebody has to kind 
of bring it together and have it focus.
    Does it make sense to have a commission to recommend to the 
military, to the Congress, to the President, of what we need to 
do to make the mental health program in our military stronger 
and better for the families?
    Mr. Rauch. Sir, I will start off. I think we need to work 
hard to leverage our existing collaborations right now that we 
have. They are very strong and they are very robust, with the 
VA and NIH. I have tried in my statement to focus on some 
examples. In my written statement, I have more examples.
    But I think from my professional point of view, as a 
psychologist, I think the place to start is to work hard to 
leverage the existing relationships and collaborations that we 
have thus far with NIH and the VA on this issue of family 
studies, specific to the military.
    Mr. Kennedy. Walter, could I interject here?
    Mr. Jones. Yes, sir.
    Mr. Kennedy. Do we have standard data points for TBI so 
that we can collaborate, so that a scientist from Rhode Island 
can talk to a scientist in his district on neuroscience? 
Because apparently in the second testimony that we heard, we 
don't, from Dr. Koroshetz's statement there is no standard TBI 
data input. So how can you talk about collaboration?
    Mr. Rauch. Sir, that is a good point. Remember that when we 
talk about traumatic brain injury, we are talking about a 
pretty broad spectrum. So that can range from mild, in 
concussion, to severe and penetrating and everything in 
between. There are a lot of differences in there. So it is a 
very, very broad spectrum.
    I will turn it over to my colleagues, if they have a 
different view of the range of TBI.
    Mr. Kennedy. I think the whole purpose here, as Walter is 
saying, is that we are all in it together. Civilian research 
can benefit veteran research.
    Mr. Rauch. Absolutely.
    Mr. Kennedy. But if we don't have common data points and 
there are TBIs every night of the week from car accidents, and 
we can't collect anything that is useful to the veteran in 
terms of recovery, response, function, how can we be saying we 
are in it to win it for the vets? Tom, you have the blueprint 
at the NIH for a collaboration.
    Dr. Insel. Right. The blueprint has developed these 
programs for collaboration. As Walter Koroshetz mentioned, 
there is a real interest in what they are calling common data 
elements, which the neurology institute is putting out for all 
investigators to use for each of the disorders that they 
support. So that I think will be an important resource.
    But if I may, could I go back to your original question? I 
think the perspective that you are describing is just very 
different from the personal experience I have had as a civilian 
representing a Government agency dealing with the leadership of 
the Pentagon. I have to say this, as clearly as I can, that the 
level of commitment to reducing suicide, to ensuring that 
resilience is supported, and to changing culture is greater 
amongst the leadership in the Pentagon than anything I have 
ever seen in the civilian sector.
    These people really believe that this is their highest 
priority right now. They are very concerned about this issue. I 
have never seen that level of concern from anyone in the 
civilian sector, where in fact the suicide rate continues to 
take 34,000 lives a year.
    So I think, I understand your wish to be helpful. But I do 
think that it underestimates what is already happening from an 
administration that really wants to make a difference here and 
is looking for answers quickly, and is trying out things 
quickly to try to bring this rate down and to try to make life 
better for soldiers in active duty.
    Mr. Jones. Mr. Chairman, can I speak just very quick and I 
will finish?
    Mr. Kucinich. Go ahead.
    Mr. Jones. I have great respect for the military. I didn't 
serve, but I have great respect. But this hyperbaric oxygen 
treatment that has been studied for years and years and years 
by the military, that is why they put a chamber down at Camp 
LeJeune, they are going to continue to study, I found out, 
talked to two people the other day, one was awarded the Medal 
of Honor in Vietnam for this country. He was so distraught 
about his grandson who had been severely injured, TBI, that he 
paid for him to go to the hyperbaric oxygen program at LSU.
    I called him. He said, my son is just remarkably recovered. 
He can function now. He is not on drugs. So your point, I don't 
disagree with you. But this still, I am not saying it is the 
only treatment. You are the scientists. I am not. But I have 
talked to three different individuals, including a General 
Manny down at Florida, do you know him? Yes, you are smiling, 
so you do know who I am talking about. He was under the 
treatment at Walter Reed for months and months and months, saw 
no improvement. His wife talked to the doctor at Walter Reed 
and she went to I think it was George Washington Med School. 
The doctor actually gave a prescription for him to be in the 
hyperbaric treatment program there.
    This man has been in my office. He has been elected a State 
judge. He is functioning 110 percent. But if he would have 
stayed in the military, they would have kept him probably 
drugged for quite a bit of his life with no real improvement. 
So that is my concern. I don't fault anybody in the military. I 
think they do a magnificent job. But when you talk about 
working together, when you are talking about bringing people 
together, I just wonder if, as Patrick was saying, is there a 
formula that we can have for the military to know what is 
available without having people trying to duplicate other 
studies?
    I just don't know, and that is the reason I wanted to sit 
here today. With that, I yield back.
    Mr. Kennedy. Well, Walter, you hit the nail, there isn't, 
to answer your question. Because there aren't common data 
points on TBI, which is the signature wound in the war, to help 
us instruct on whether those are injuries that affect and 
increase suicide rates. Just as of September 24th, I appreciate 
Tom standing up for his compatriots who are working hard, but 
Walter Reed Amy Hospital's chief of psychiatry, Colonel John 
Bradley, said shoddy training and coordination has left us a 
failure on taking on suicides in the military. From his own 
words.
    So I appreciate your standing up for him. But when don't 
have the lead expert on mental health and suicides different 
psychological from neurological, after your testimony saying it 
is all neurological, you have a big problem here.
    Mr. Kucinich. I am going to ask the gentleman to hold some 
of that for the next round of questions. I have some questions, 
then we are going to have one more round, which the gentleman 
may lead off again.
    Dr. Insel, I want to talk to you about the nature of 
stress. Stress produces chemicals which affect the brain, isn't 
that right?
    Dr. Insel. Correct.
    Mr. Kucinich. Can an abundance of stress in certain 
individuals bring about organic brain changes?
    Dr. Insel. We know that some of the stress hormones alter 
the way in which cells are born and cells die within the brain. 
So there is every reason to think that stress does have direct 
effects on the health of the brain. You will be able to hear a 
lot more about this from Dr. Akil, who is in the next panel, 
who is really one of the world's experts on this.
    Mr. Kucinich. Is there an area of the brain where frequent 
stress breaks down inhibition toward suicide?
    Dr. Insel. A lot of the research is focused on the effect 
of stress on an area called the hippocampus, which is certainly 
very important for higher cortical function, for memory, for 
the way in which memories get encoded in the brain. But the 
relationship of stress to brain anatomy or brain morphology and 
suicide remains now a very vague one. There are a lot of gaps 
in our understanding of how these things connect.
    Mr. Kucinich. I ask this question because, if it is not 
site-specific, then the work of someone like Karl Pribram, his 
holonomic theory, comes into play. I am sure you are familiar 
with his theories.
    Dr. Insel. The places where stress is likely to have the 
greatest impact is where the receptors for hormones like 
cortisol, are found in the brain. And they are not everywhere. 
There are areas that are highly enriched. Those are places that 
we look, and in fact, those are the places where we see 
changes.
    But again, there is a gap here between our understanding of 
the cellular effects of stress and our understanding of what 
causes suicide. It is a very complicated area when you try to 
predict, for instance, who is likely to take their own life. We 
know some of the factors from a population, but within an 
individual person, we are not very good yet at being able to 
have high levels of prediction.
    Mr. Kucinich. I heard you in response to an observation by 
my friend from North Carolina indicate work that is being done 
in the Department of Defense on matters relating to suicide. 
You did say that, correct?
    Dr. Insel. This is a joint project between NIMH and DOD.
    Mr. Kucinich. What is ironic about that, if I may, is that 
the stressor in this case is war. There is a ``duh'' factor 
about this. The latest book about President Obama and the 
Afghanistan war indicates the tension between the 
administration and the Pentagon, and the difficulty that the 
administration was having in having the Pentagon produce a plan 
to exit the war.
    I think that my friend from North Carolina would agree, you 
can study the nature of suicide all you want. But if you have 
increased suicide that is coming from people who are in combat 
under horrendous conditions where there are all kinds of 
atrocities being committed, how smart do you have to be to 
figure this out?
    So I appreciate that you are studying it. But it would be 
more productive, I think, if a group of scientists would come 
forward and have the opportunity to do some real tests on how 
stress breaks down people and how it puts them in that soft 
circumference of suicidal ideation, which then may lead to 
people acting and taking their own life. So you can't really 
speak to that, because that is not your area of decisionmaking.
    But no matter how caring the people in the Pentagon are 
about the troops, as long as you are sending people into this 
mix-master of war, you are going to end up with suicides. 
Again, I don't think you have to be a neurophysiologist to 
understand this. I don't think you have to be a cognitive 
psychologist or cognitive neuroscientist to understand this. We 
put these young people into an impossible situation, they are 
killing themselves. I don't deserve a Ph.D. for that 
observation.
    Now, is it true, Dr. Insel, that certain approaches to 
neuroscience necessarily depend on a mechanistic view of human 
beings?
    Dr. Insel. I am not sure I understand your question.
    Mr. Kucinich. Well, like Skinner, Skinnerian approach, 
stimulus-response. Behaviorism, if you induce certain stimuli, 
you get a certain effect. Are you a student of that particular 
type of neuroscience?
    Dr. Insel. That actually falls into a category of what 
would be called behavioral science. That really has to do with 
predicting behavior based on stimulus and response. One of the 
things that is perhaps most conspicuous about that is that it 
leaves out the brain. So neuroscientists tend to think more 
about the mechanisms by which behavior gets regulated, and they 
tend to be a little more complicated than just the simple----
    Mr. Kucinich. Complicated. That is a good word. Tell me 
about it.
    Dr. Insel. The complications of how we predict behavior. 
Again, I need a little help here in terms of what it is you are 
looking for.
    Mr. Kucinich. When you talk about neuroscience, you could 
take an almost linear view. I am interested as compared with 
cognitive neuroscience, which encompasses the possibilities of 
quantum physics interfacing with neuroscience, where you 
actually create the potential of change that cannot necessarily 
be explained by the more linear progression of a more 
mechanical approach. Does that not register with you at all? If 
it doesn't, I will withdraw the question.
    Dr. Insel. Well, I am not sure I heard the question. But if 
the question is, does neuroscience provide a basis for 
approaching that complexity and trying to understand that 
complexity, I think the answer is yes. I think we have the 
tools now, many of which come from very different fields, such 
as higher math or from physics, from dealing with large amounts 
of information that we are able to actually begin to make sense 
of the complexity of how the brain works with models that 
become predictive.
    We have a long way to go, but I would say that we have come 
a very long way from a simple Skinnerian model of stimulus and 
response.
    Mr. Kucinich. That is good to hear. Every component of the 
philosophy of science carries with it part of the headlong 
momentum of some of the early thinking within those 
disciplines. So I just wondered where a Skinnerian view fits 
in.
    Dr. Insel. In the testimony that I gave, Mr. Chairman, I 
used the term disruptive innovations. From my perspective, this 
last decade has been a series of truly disruptive innovations, 
as we have begun to understand, to go back to Congressman 
Kennedy's point, that the brain really is the gateway to 
understanding the mind. I don't believe that we had fully 
appreciated that in previous decades.
    Mr. Kucinich. I want to conclude by saying that, it may 
have been in, I don't think it was in your testimony, but maybe 
your colleague who just had to leave, spoke of the light 
shining on microbial membranes that opened up new channels. Is 
that what you are talking about?
    Dr. Insel. That is a technique that has been used to be 
able to study circuitry in the brain in a very precise way.
    Mr. Kucinich. I think you understand the comparison I am 
making, and that is that if you use light as a metaphor here, 
shining itself on certain membranes, opening up new channels, 
it is a metaphor for the possibilities of neuroscience to go 
into areas which would make the work that you are working out 
right now seem primitive in years to come, with all due 
respect. I am a fan of neuroscience's capabilities. So I 
appreciate your presence here.
    Dr. Insel. Thank you. If I may, just as a final comment 
about this, I think it needs to be said, we are in the middle 
of a revolution. In 20 to 30 years we will look back on this 
period to realize how little we knew. But the tools are there 
to transform the way we think about the brain. As someone said 
in the opening comments, this is really the last great frontier 
of science. For the first time, I think we have the discovery 
tools that we have needed to really explore and to colonize 
that frontier in a different way.
    Mr. Kucinich. Just one other question occurs to me. I don't 
know if you are able to answer this. But the phenomenon of 
fear, the emotion of fear. I have seen some studies that 
suggest that it originates in the limbic system, is that right?
    Dr. Insel. We use the term mediated.
    Mr. Kucinich. Mediated by the limbic system.
    Dr. Insel. Yes.
    Mr. Kucinich. And is that really, on an evolutionary 
standpoint, part of what some might call part of the reptilian 
brain, the flight or fight syndrome?
    Dr. Insel. Sir, those are models that we have kind of given 
up a few years ago.
    Mr. Kucinich. Well, I am talking about the archaeology of 
your discipline.
    Dr. Insel. The core, ancient part of the brain which feeds 
into those kinds of flight or fight impulses.
    Mr. Kucinich. Since you work with, since people in the 
neuroscience discipline work with the Department of Defense, is 
anyone doing any studies about the potential of transformation 
beyond fear, which often puts people into this fight or flight, 
which is a precursor for, inevitably, on a macrocosmic level, 
the precursor of war? Does anybody ever think about that?
    Dr. Insel. I am not sure that we are where you are on this 
idea. There is a tremendous amount of research right now on the 
fundamental neurobiology of fear and fear responses. And 
particularly what we call extinction, the ability to overcome 
fear.
    But the relationship of that to war is a place where I 
think most neuroscientists haven't gone.
    Mr. Kucinich. Thank you.
    Mr. Kennedy, second round.
    Mr. Kennedy. Thank you.
    I think the most significant issue is how to do the 
research, so we make the most of what we know. It is not what 
we know, it is how much we don't know that we know. And that 
gets back to the common data points for TBI. But we can't do 
the data mining or find out what is working or what isn't, if 
there isn't common language and nomenclature.
    You have a blueprint at NIMH. Does that blueprint include 
DOD and VA? And if not, why not? And to Dr. Kupersmith, do you 
have, along with the DOD and Terry, the ability to have a 
common program, computer program to input these data points or 
not?
    Dr. Insel. Just very quickly, we do have a blueprint, which 
is a consortium of I think 15 institutes and centers at NIH for 
some common projects. It is a fairly limited effort, it is 
identifying areas of common need and pushing ahead on a few of 
those. It does not involve DOD, VA or many of the other 
institutes at NIH, even. So it is truly a kind of homegrown 
project.
    It has not in any way inhibited many of the institutes, my 
own included, NIMH, from these very large collaborations. As I 
said, the biggest project we are doing is the collaboration 
with DOD. And it has really become our signature project for 
2010, and probably will be for the next few years. So the 
blueprint is not part of that. But it almost doesn't need to 
be. We have a lot going on just out of the institute itself.
    Mr. Kennedy. We don't have a program that allows for all 
this data to be put in so the scientists in one area of the 
country can find out what the scientists in the other areas of 
the country are doing, so we can work to greater effect, to 
everybody's advantage. We don't have that.
    Dr. Insel. We don't have a single data repository at this 
point for, other than for autism. I don't think that exists for 
any other area that our institute is working in.
    Mr. Kennedy. Would it be useful to everybody? I know you 
have these collaborations and it is helpful. But could we 
dedicate funding that would leverage what the institutes do by 
giving a little money to help bring them and their work 
together, to help and maximize each other in a coordinated way?
    Dr. Insel. We have done that in autism, and I think it has 
been transformative. We have an opportunity now for virtually 
every project to flow into the same data base called the 
National Data Base for Autism Research. That is a model that 
could be followed in a number of areas.
    Mr. Kennedy. That is terrific. Dr. Kupersmith.
    Dr. Kupersmith. Our computers have not merged yet with DOD, 
but there is a tremendous amount of work on that. And that is a 
goal, certainly, of this administration. Our computer system 
evolved out of a clinical computer system sort of from the 
ground up with investigators creating software, merging into a 
large system. So that is clearly a goal of this administration, 
it is not a research topic, per se. Although research will 
benefit greatly from it. We are looking forward to being able 
to do that.
    Mr. Kennedy. Because if we don't know what we know, we are 
just doomed to repeat the science.
    Dr. Kupersmith. Absolutely. And I think that quotes Albert 
Einstein, actually.
    Mr. Kennedy. Well, I am often confused for him in my 
intellectual passion for things. [Laughter.]
    Dr. Kupersmith. There is very hard work, as many know, that 
is going on, very important.
    Mr. Kennedy. Thank you. And Terry, what would you say, Dr. 
Rauch, about the need to get DOD to help open what Tom has in 
his NIH and the VA, make it all, so everybody is helping to a 
common effort, both soldiers benefiting, and civilians 
benefiting from the soldier and vice versa.
    Mr. Rauch. You make a very good point, sir. We are working 
on it. We have a collaborative effort with VA, NIH, DOD, 
Department of Education. It is called the Common Data Elements 
project. And its purpose is to do exactly what you charged us 
to do, and that is to standardize terminology within TBI and 
the psych health portfolio. It is in development, it is in 
progress. But it has started.
    I think I probably need to take this for the record and 
give you some more information. Your question really deserves a 
more detailed answer, and I would like to provide more detail 
on the Common Data Elements project for TBI and psych health.
    Mr. Kennedy. Super. Thank you. That is what the hearing is 
about: what can we do in Congress to help leverage what you are 
already doing and what the science shows us out there already.
    Mr. Kucinich. Congressman Kennedy, there is a person by the 
name of George Farre who was a physicist and is a philosopher. 
And he spoke to science as a structure-specific language, 
constructed for the representation of what there is. So 
semantics do count. Because they link through their expression 
to specific structures that help either to confirm pre-existing 
notions of a science or dis-confirm them.
    So the point that you raised about the nomenclature is not 
a small matter. It is actually quite significant, not just for 
the subject of a particular type of behavior, but there are 
implications, broader social implications.
    Mr. Kennedy. I just want to repeat, Tom, what you said, to 
go fast, go alone, but to go far, you go together. But we need 
to go far together, but we need to go faster. If you can 
provide us some recommendations from your point of view as to 
what FDA can do, since they are integral in whatever comes up, 
your researchers, together if we can it right into the field 
for our soldier and our veteran. That would be very useful, if 
you can give us some ideas on regulatory science. Again, this 
is a process issue, as you have just said, Dr. Kupersmith. It 
doesn't involve the science, but the science can't be maximized 
unless you get the process right.
    So if you could provide us some input on that, as you have 
already in your testimony, it helps us make a better case 
politically, that if we just put some dollars here, we leverage 
a whole bunch. If we work as a team, we get further. And your 
blueprint is a perfect, how do we institutionalize that more, 
get the common data sets and standardized terminology together. 
So that would be useful.
    Mr. Kucinich. Thank you, Congressman Kennedy. I just have a 
couple brief questions and we will go to our next panel. One of 
you gentleman brought up nutrition, was it you, Mr. Rauch? In 
what context did you bring that up?
    Mr. Rauch. I brought that up in the context of nutritional 
interventions in the whole psych health/TBI/PTSD portfolio, to 
include looking at nutriceuticals. That is an area in which we 
have a number of projects that we are funding.
    Mr. Kucinich. John Robbins, the author, has written 
extensively about the impact, adverse impact on human health of 
certain types of foods. There has been plenty of research about 
the adverse impact on physical and mental states in consuming 
large amounts of sugar. We know it is true of large amounts of 
salt. There have been studies done on prison populations whose 
diets have changed and it has, a change in diet produced 
changes in their emotional states, made them actually less 
aggressive.
    I think that the potential for neuroscience making a great 
contribution is there, there is no question about it. It is 
really urgent that we use whatever means we have available to 
help fulfill its potential.
    So I want to thank the members of the first panel for your 
commitment in your respective disciplines, for your thoughtful 
testimony and question answering that you provided. This is an 
area which Congressman Kennedy, I think that in the next 
Congress, we ought to think about doing some followup hearings. 
We ought to think about----
    Mr. Kennedy. I will be sitting back there, Mr. Chairman, 
looking up at you.
    Mr. Kucinich. You will always be welcomed. I think what you 
have done is you have, through your becoming involved in this, 
we have become aware there are examples of research 
collaboration between and among Federal agencies. What you have 
done is to remind the people in the community that it is 
important to collaborate with each other. Whether it is done on 
ad hoc process or on a regular basis, I think that it is and 
can be productive because of the synergy that always comes from 
interdisciplinary thinking.
    So I would urge that an approach of interdisciplinary 
thinking to continue through encouraging all the parties to 
this to keep talking, if they are, and to start talking 
together if they are not. I think it is a good idea to work 
collaboratively with your friends in Congress who will advocate 
on your behalf in the appropriate venues.
    Thank you for being here, and good luck with your work, and 
we are going to call the second panel.
    While the second panel is getting into place, I want to 
thank them and the members of the audience for your patience. 
Because of the congressional voting schedule, we have had kind 
of a prolonged hearing here. Your willingness to come here to 
offer testimony and answer questions is much appreciated.
    I am going to introduce our second panel. Dr. Huda Akil, 
Ph.D., is the Gardner Quarton distinguished University 
professor of neuroscience and psychiatry and the co-director of 
the molecular and behavioral neuroscience institute at the 
University of Michigan. Dr. Akil has made seminal contributions 
to the understanding of brain biology, of emotions, including 
pain, anxiety, depression and substance abuse. Dr. Akil has 
received several awards for her research and is past president 
of the Society for Neuroscience. Thank you, Dr. Akil, for your 
presence.
    William Z. Potter, M.D., and Ph.D., spent 25 years at the 
National Institutes of Health focused on translational 
neuroscience. While at the NIH, Dr. Potter developed a wide 
reputation as an expert in psychopharmacological sciences and 
championed the development of novel treatments for CNS 
disorders. In 2004, Dr. Potter joined Merck Research Labs as VP 
of Clinical Neuroscience and assumed the newly created position 
of VP of Transactional Neuroscience in 2006, a position from 
which he retired in January of this year. Thank you very much, 
Doctor.
    Timothy Coetzee, Ph.D., is the executive director of Fast 
Forward, LLC, the National Multiple Sclerosis Society's drug 
discovery and development affiliate. In this capacity, Dr. 
Coetzee is responsible for the Society's strategic funding of 
early stage biotechnology and pharmaceutical companies engaged 
in the discovery and development of new treatments and 
diagnostic tools for multiple sclerosis. Thank you, sir.
    Kevin Kit Parker, Ph.D., is the Thomas D. Cabot associate 
professor of applied sciences and associate professor of 
biomedical engineering at the School of Engineering and Applied 
Sciences at Harvard. Professor Parker is the director of the 
Disease Biophysics Group and a member of the Systems Biology 
Department at Harvard Medical School, Harvard Stem Cell 
Institute and the Harvard-MIT Health Sciences and Technology 
program.
    He is also a major in the Rhode Island Army National Guard 
and has completed two combat tours in Afghanistan with the 82nd 
Airborne and the 10th Mountain Division. Thank you for being 
here, sir.
    John H. Morrison, Ph.D., is the dean of basic sciences and 
the Graduate School of Biological Sciences at Mount Sinai 
School of Medicine. Before becoming Dean, he served as the 
Chair of neuroscience. Dr. Morrison is also professor of 
neuroscience and the Willard T.C. Johnson professor of 
geriatrics and adult development in neurobiology of aging. 
Thank you.
    This is a distinguished panel, as was the last one. It is 
our policy in this Committee on Government Oversight and Reform 
to swear in all witnesses before they testify. I would ask that 
the witnesses stand, raise your right hands.
    [Witnesses sworn.]
    Mr. Kucinich. Thank you. Let the record reflect that each 
of the witnesses has answered in the affirmative.
    As with the members of the first panel, I would ask you to 
try to keep your remarks to 5 minutes. And as with the members 
of the first panel, I let them go on, because they had some 
things to say that were very important.
    Mr. Kennedy. In that regard, Mr. Chairman, I just want to 
thank everybody who showed up today. All of you represent 
different organizations, groups and have been very useful in 
helping put this hearing together. I want to thank Zach Lynch 
from the Neurotechnology Organization who has been very useful 
in helping put together some very helpful statistics and points 
for us in the hearing, and just say, we wish we could get 
everybody up here. Because everybody in this audience, from 
looking out on this audience, I am familiar with in this field. 
But just appreciate that we understand and have incorporated a 
lot of your recommendations and suggestions into the hearing. 
And thank everybody for being here today.
    Mr. Kucinich. Thank you.
    Dr. Akil, you may begin. Thank you.

   STATEMENTS OF HUDA AKIL, PH.D., CO-DIRECTOR AND RESEARCH 
 PROFESSOR, THE MOLECULAR & BEHAVIORAL NEUROSCIENCE INSTITUTE, 
UNIVERSITY OF MICHIGAN; WILLIAM Z. POTTER, M.D., PH.D., FORMER 
 VICE PRESIDENT OF TRANSACTIONAL NEUROSCIENCE, MERCK RESEARCH 
  LABORATORIES; TIM COETZEE, PH.D., EXECUTIVE DIRECTOR, FAST 
 FORWARD, LLC; KEVIN KIT PARKER, PH.D., ASSOCIATE PROFESSOR OF 
APPLIED SCIENCE AND BIOMEDICAL ENGINEERING, HARVARD UNIVERSITY; 
AND JOHN MORRISON, PH.D., DEAN, BASIC SCIENCES AND THE GRADUATE 
   SCHOOL OF BIOLOGICAL SCIENCES, MOUNT SINAI MEDICAL CENTER

                 STATEMENT OF HUDA AKIL, PH.D.

    Ms. Akil. Mr. Chairman, Mr. Kennedy, members of the 
committee, thank you for this opportunity to testify here 
today.
    I wanted to mention that beyond my service as the past 
president of the Society for Neuroscience, I am a member of the 
Council of the Institute of Medicine and its forum on 
neuroscience. I am also a co-chair of the steering committee of 
the Biomarkers Consortium at the Foundation for NIH.
    I currently hold funding from the NIH, the Office of Naval 
Research and the Pritzker Foundation to conduct work on the 
biology of stress, emotions, addiction and mood disorder. As an 
aside, given the discussion in the earlier period, we are 
studying in the Consortium the brains of people who were 
depressed and committed suicide versus the brains of people who 
did not and whether they were being treated or not. We are 
beginning to get some insights to your question about where in 
the brain the changes might happen. That is not the focus of my 
testimony today, but I am happy to answer questions about it.
    So as we have heard, the global burden of brain disease is 
staggering. The challenge of understanding, preventing and 
curing brain disorders is still very much before us. Today, 
what I wanted to do is outline what I believe to be the central 
grand challenge of neuroscience, one that is relevant to all 
the brain disorders that we have been talking about. I would 
like to suggest a couple of strategies for meeting it.
    Our brain contains 100 billion cells that communicate via 
500 trillion connections or synapses. The point of all this 
communication is to orchestrate brain activity. Each brain cell 
is a breathtaking piece of biological machinery. But a single 
cell can never perceive beauty or feel sadness or solve a 
mathematical problem. Through the magic of integration, 
completely new capabilities emerge. When networks of brain 
cells come together to form brain circuits, each of which 
perform specific functions, such as vision, hunger, cognition, 
emotions.
    I call this neural choreography. By the time a brain 
disorder is evident, it has affected not a single group of 
cells, but the entire circuit. It is the disruption of the 
whole network that leads to the symptoms of the illnesses that 
we are concerned about. The problem is not that a ballerina has 
stumbled, but that the choreography of the whole ensemble has 
fallen apart.
    So when we are thinking about the impact of brain injury on 
movement, the exaggerated response to a threat signal in a 
soldier with PTSD, the drug compulsion in an addict, the 
confusion about reality in a psychotic patient, we have to 
think about disrupted brain circuits, neural choreography gone 
awry.
    And our grand challenge is to understand the workings of a 
brain circuit and learn how it controls itself. As Dr. Insel 
has indicated, we know the elements of many of these circuits. 
But we need to watch them perform in real life, in real time, 
and discover how their choreography fails and how that causes 
disease.
    The idea that brain disorders are the result of faulty 
brain circuits also explains why it has been so hard to uncover 
genetic causes of some disorders that we know to be very 
heritable, like bipolar illness. It is because the symptoms 
that clinicians diagnose are manifestations of a disrupted 
brain circuit and there are countless ways to screw that up. So 
different families can suffer from completely different genetic 
problems and still share the same medical diagnosis. It is like 
any given dancer in the troop can fail and disrupt the whole 
dance.
    But the choreography idea also means that there are 
multiple ways to repair the problem. We don't need to devise a 
new treatment for each family. We need to learn how to retune 
the circuits, the networks.
    So how do we take on the neural choreography challenge? My 
inspiration for tackling it comes from the brain itself, the 
creation of well-orchestrated networks of scientists who work 
together to achieve what can never be achieved separately. This 
effort needs to be grounded in some hard-earned realities. In 
the words of President Kennedy, we need to be idealists without 
illusions. Understanding the brain and mind is hard. And we 
need help, not only from each other, but from our colleagues in 
math, physics, chemistry and engineering. We also need to 
engage our friends in the social sciences, since our brains are 
constantly being remodeled by our social environment.
    But the knowledge that can emerge from such networks can be 
transformative, and the discoveries unimaginable. I have 
suggested in my written testimony three types of integration: 
horizontal integration, where a large number of investigators 
with the same general expertise focus on a given slice of a 
problem, for example, validating biomarkers over disrupted 
brain circuits, say in PTSD. Vertical integration among 
different scientists who are focusing on a scientific question 
or disorder and trying to solve it from molecule to mind and 
back. Neural choreography is right in the middle of that path.
    And finally, two-dimensional integration that represents 
special large-scale projects that combine vertical and 
horizontal efforts. The goal would be to advance our 
fundamental knowledge of neural circuitry and relate the 
discoveries not to one disease but to several disorders.
    But whatever the model, rather than being entirely 
investigator-driven or agency-driven, I believe that this 
process needs to arise from a partnership between the 
scientific community and the Federal agencies, to get buy-in 
and to define the specific approaches that would be most 
fruitful.
    So in summary, understanding the brain and healing it when 
it is sick may well be the most difficult challenge that 
humanity has ever undertaken. We need to give this amazing 
organ its due by bringing together every tool we have at our 
disposal and working together to probe its mysteries. Thank 
you.
    [The prepared statement of Ms. Akil follows:]

    [GRAPHIC] [TIFF OMITTED] T5562.053
    
    [GRAPHIC] [TIFF OMITTED] T5562.054
    
    [GRAPHIC] [TIFF OMITTED] T5562.055
    
    [GRAPHIC] [TIFF OMITTED] T5562.056
    
    [GRAPHIC] [TIFF OMITTED] T5562.057
    
    [GRAPHIC] [TIFF OMITTED] T5562.058
    
    Mr. Kucinich. Thank you.
    Dr. Potter.

             STATEMENT OF WILLIAM Z. POTTER, PH.D.

    Dr. Potter. Mr. Chairman, Mr. Kennedy and members of the 
committee, I am speaking from the perspective of a retired 
officer in the Public Health Service and a practicing 
psychiatrist. I served in intramural programs of the National 
Institute of Mental Health for 25 years, and I have just 
retired from the pharmaceutical industry, where for the last 15 
years, I worked with a couple of big companies, Eli Lilly and 
Merck, which had big investments in CNS drugs.
    Despite the sensational advances in neuroscience during 
this period, and the explosion of sophisticated technologies 
you have been hearing about, we have not delivered truly novel 
drugs for diseases of the brain. Arguably, the current 
generation of psychiatric medications for treating 
schizophrenia, depression and severe anxiety are no more 
effective than the first generation of medications discovered 
over 50 years ago, and those by accident.
    The assumption back in the 1980's at all levels of 
Government and industry was that scientific explosion would 
rapidly lead to more scientific treatments. But that was overly 
optimistic. If anything, the opposite has been the case. It has 
become much more difficult to develop the novel targets that 
were identified, and to bring a single new entity to market now 
costs on average $1.8 billion, which is actually a pretty 
conservative estimate of the real costs.
    The new drugs, and this is for all drugs, new drugs for 
brain diseases emerge at even a lower rate and prove more 
expensive to develop and carry extremely high risks.
    So what went wrong with our predictions from the 1980's? 
And as Dr. Insel has pointed out, we have a new revolution to 
incorporate into our future thinking.
    So what went wrong was the assumptions were too simple, as 
Dr. Akil has currently addressed. So the complexity at both the 
genetic and physiological level was much greater than we ever 
anticipated, and we did not have the maps or navigational tools 
to go through all this data and pick out the right targets.
    So what we are up against is this wall of what we call 
target validation, what are the right things to make drugs for. 
Instead of a few drug targets, we have hundreds now that we 
need to sort through. And it requires us to sort through a 
single one that we think might be valid, which takes us over 13 
to 14 years and get it through regulatory review and to the 
market, if you are in the business of the industry. For the 
central nervous system area, at best, 1 in 20 of the things we 
that into this expensive and long development actually deliver.
    So obviously, with that sort of numbers, it is not possible 
for the pharmaceutical industry to survive by investing in the 
CNS field, without a huge paradigm shift. Given long 
development times under the current laws, most drugs will have 
10 years or less of patent protection by the time you have been 
through this. And ironically, the ``me-too'' drugs, which are 
easier to develop, are actually the ones that enjoy the longer 
patent protection. So the incentive structure actually rewards 
coming up with ``me-too'' drugs, and says, don't waste your 
money on coming up with novel, better drugs. But this is 
basically why many companies have reduced their investment.
    So in one area we have an exception, fortunately, and that 
is around the field of Alzheimer's. And there, both the NIH, 
clinical scientists, patient advocacy groups, philanthropies, 
FDA and industry joined together under this remarkable effort 
sponsored by the National Institute of Aging called the 
Alzheimer's Disease Neuroimaging Initiative.
    In keeping with some of what Mr. Kennedy has already 
discussed, the findings become available on computer, available 
all in the public domain, as soon as the data is gathered and 
processed. This ADNI model has taken hold worldwide and is 
currently trying to be implemented in the European Union, 
Japan, Australia and Korea. Fundamentally, their governments 
have said, this area of translational medicine and the tools 
and the data sharing necessary to support it are national 
priorities.
    We use this term translational medicine to cover all the 
science and technology to help us translate the basic science 
that Dr. Akil was talking about into something that might be 
useful for patients. But to realize the promise of these 
scientific advances, we have to invest a great deal more in the 
tools of translational medicine, an area which sort of falls in 
the middle and gets less support than the basic science at one 
end, or the large clinical trials of the drug companies at 
others.
    So the right balance of resources across the domains of 
basic research, translational medicine, clinical trials, has 
yet to be achieved. We need to expand this open source model, 
which Mr. Kennedy has already been referring to. So the first 
major recommendation of what can we do better is get more open 
sharing of all relevant clinical data on the characterization 
of the disease state and drug response. Obviously you need to 
protect individual privacy.
    And the second big push would be to put the research tools 
and compounds held by both commercial entities and universities 
and private and funded investigators into the public domain, 
into what we call pre-competitive space, get that out there as 
quickly as possible. And to make that possible, we probably do 
need innovative approaches to the intellectual property issues 
which currently impede this sharing of technology and data.
    I will stop there, but I can go into much greater detail of 
how this might work.
    [The prepared statement of Dr. Potter follows:]

    [GRAPHIC] [TIFF OMITTED] T5562.059
    
    [GRAPHIC] [TIFF OMITTED] T5562.060
    
    [GRAPHIC] [TIFF OMITTED] T5562.061
    
    [GRAPHIC] [TIFF OMITTED] T5562.062
    
    [GRAPHIC] [TIFF OMITTED] T5562.063
    
    [GRAPHIC] [TIFF OMITTED] T5562.064
    
    [GRAPHIC] [TIFF OMITTED] T5562.065
    
    Mr. Kucinich. Your entire statement will be in the record, 
Dr. Potter.
    Dr. Potter. I would like to mention one thing. We do have 
an initiative, which Dr. Akil has already referred to, the 
Foundation of the National Institutes of Health, where we are 
beginning to try to bring us all together to work in this pre-
competitive manner. I want to emphasize that the funding and 
infrastructure and degree of support to really do it at a 
proper national scale is simply not great enough.
    Mr. Kucinich. Thank you.
    Dr. Coetzee.

                STATEMENT OF TIM COETZEE, PH.D.

    Mr. Coetzee. Thank you, Mr. Chairman and Mr. Kennedy, for 
inviting us to speak here. I am honored to be here with these 
distinguished panelists.
    My name is Timothy Coetzee. I am the President of Fast 
Forward, the venture philanthropy arm of the National Multiple 
Sclerosis Society.
    I am here today on behalf of the estimated 400,000 
Americans and the many thousands of veterans who live with MS 
every day. Together, we ask you to help us advance MS research 
and really neurological research across the board for all of 
our colleagues who are affected by neurological disease. We 
need your help in providing resources and policies to expand 
collaboration and networks between Government, patient 
advocates, private foundations and the pharmaceutical and 
biotechnology industries, and of course, academic 
investigators.
    While my remarks focus on MS, really they can be applied 
across the board. Multiple sclerosis is a chronic, 
unpredictable, often disabling disease of the central nervous 
system. It interrupts the flow of information from the brain to 
the body and stops people from moving.
    MS is the most common neurological disease leading to 
disability in young adults. But despite many decades of 
research, its cause remains unclear and there is indeed no 
cure. While we are grateful for the availability of a number of 
FDA approved disease modifying therapies, we still need more 
and better cost-effective therapies. Finding these new 
therapies hinges on the research and the kinds of collaborative 
efforts that we are talking about today amongst all the 
stakeholders.
    It has been our experience that research discoveries can 
happen in a lot of different ways, as you have heard today. 
Some require lots of careful years of shepherding, while a lot 
can happen overnight. Whether it is a molecule or a tool, they 
all need a number of steps to be taken in order to translate 
those discoveries into actual applications that can be used in 
people with MS, as well as other neurological diseases. This 
involves collaborators, commercial development, access to 
clinical trial participants and a lot of money.
    We were created as an organization by the National MS 
Society specifically to drive commercial development for MS 
therapies. We have made a commitment to ensure that potential 
new therapies actually make it into the clinic and are 
developed and are able to be used for people with all forms of 
MS.
    We have found that all too often, promising drug treatments 
languish because companies lack the funding, focus to conduct 
pivotal research that will break through barriers and move a 
compound through the development pipeline and ultimately into 
clinical trials. We fill the gap that is often called the 
valley of death by creating a collaborative environment between 
scientists, clinicians, academic researchers and of course, 
commercial visionaries. By creating these vital networks, Fast 
Forward increases the focus on MS and speeds the process of 
bringing drugs to market.
    Today we join with our patient advocacy colleagues in 
calling for more investments and policies to sustain innovation 
in neuroscience research and development. In our view, 
expanding and sustaining innovation in neuroscience R&D really 
requires three critical elements. As you have heard today, we 
need to sustain a large and vibrant medical research community 
in the United States. Medical innovation doesn't happen in 
isolation, it happens amongst a community of scientists and 
physicians actively involved in understanding knowledge and 
disease about biology and human disease. It is vital that we 
continue to expand our commitment to the National Institutes of 
Health and work also funded through the Department of Defense 
and the Veterans Administration.
    Second, we also believe that we have to create an 
environment conducive to the formation of what we call fluid 
networks of scientists engaged in translational research. We 
know that research and innovation happens faster when 
scientists work together across networks, fields, institutions, 
and borders, for that matter. Coordination by the Government 
agencies, private foundations and patient advocates is critical 
to ensuring these networks.
    And last, we believe that Government, foundations and 
patient advocates have to use their influence and financial 
resources to connect people together across sectors. We know 
from our own experience that young companies and innovators 
work smarter and faster when you have experts in the private 
sector working with experts in the academic sector. We need to 
do more of this, so that all the stakeholders can enhance 
neuroscience R&D.
    In conclusion, Mr. Chairman, the United States has a long 
history of being a leader and driver of neuroscience research 
and development. Unfortunately, we do find ourselves in the 
environment where economic challenges are beginning to threaten 
this leadership. As patient advocates, we urge action to ensure 
that there is greater coordination amongst the stakeholders. 
Every day, Americans receive the diagnosis that they have a 
neurological disease. These individuals do not have the luxury 
of time. They need our help to create a research and 
development environment where they can have access to the best 
treatments to stop their disease and restore lost function. 
Thank you for helping us move closer to that world and thank 
you for your time.
    [The prepared statement of Mr. Coetzee follows:]

    [GRAPHIC] [TIFF OMITTED] T5562.066
    
    [GRAPHIC] [TIFF OMITTED] T5562.067
    
    [GRAPHIC] [TIFF OMITTED] T5562.068
    
    [GRAPHIC] [TIFF OMITTED] T5562.069
    
    [GRAPHIC] [TIFF OMITTED] T5562.070
    
    [GRAPHIC] [TIFF OMITTED] T5562.071
    
    [GRAPHIC] [TIFF OMITTED] T5562.072
    
    [GRAPHIC] [TIFF OMITTED] T5562.073
    
    [GRAPHIC] [TIFF OMITTED] T5562.074
    
    Mr. Kucinich. Thank you very much.
    Dr. Parker.

              STATEMENT OF KEVIN KIT PARKER, PH.D.

    Mr. Parker. Chairman Kucinich, Congressman Kennedy, thanks 
a lot for inviting me here.
    I am going to tell you the story of TBI through a rather 
uncommon lens, because I am a soldier and a scientist. I am 
going to start last year, last March in the Tangi Valley in 
Afghanistan. You will see it up there. We ran a patrol and the 
lead vehicle, we had been fighting since off and on since about 
8 a.m., we hit an IED. We flipped over the MRAP and there you 
see us running up to check the soldiers.
    About 30 seconds after this photograph was taken, an RPG 
hit that cliff right above our heads, when we were trying to 
pull the wounded soldiers out of there. And then the day got a 
lot worse.
    That just kind of illustrates the situation you were 
talking about, combat stress. There is a lot to that, and we 
could talk more about that later. But this kind of illustrates 
what is happening out there in the battlefield. This is the 
ignition event for TBI, and it is the ignition event for those 
neurodegenerative diseases that can result on down the road.
    So if you will move to the next slide, please. I want to 
just teach you a little bit about TBI, and I can only teach you 
a little bit, because I am not a neuroscientist. I was doing 
the heart when someone started to kill my friends with IEDs, 
and I figured I had better get a piece of this fight.
    So if you take a look, you imagine that the whole patient, 
the soldier, the behavior, those functional behaviors that can 
arise from neurodegenerative diseases, that is a meter link 
scale. What happens when that IED goes off? The brain, listed 
up there at the top of that scale gets slammed forward into 
that skull because that shock wave couples into the body. And 
it starts a cascade of injuries that goes from the centimeter 
scale of this brain through the neural networks that allow you 
to recognize a friend, speak to a loved one, count your change 
at the Burger King. It disrupts the neurons, breaks the 
synapses, all the way down to the nanometer scale at the 
bottom, where you see endocrine bonding, cellular matrix, this 
is where mechanical forces get transduced into physiological 
signals called mechanical transduction pathways. In this case, 
it is a pathophysiological signal, because we are activitating 
signal pathways that we don't necessarily want to activate.
    This is the temporal scale of TBI. I am going to look 
mostly on this time line to the right of the blast, what we 
call right of the boom. You can assume that prior to the blast, 
we assume we get stable neural structures, stable vascular 
structures and a stable gene expression. There is a big 
asterisk next to that, because these guys are in combat, they 
are facing physical danger, moral jeopardy. There is a lot of 
stress hormones there. We don't know exactly how they might be 
impacting all those structures.
    Once that boom happens, things start happening on a 
nanometer scale. Proteins undergo conformational changes that 
turn on those signaling pathways that cause excitotoxicity that 
cause these neurons to have their membranes torn, to activate 
signaling pathways in mild cases of TBI that you might not see 
for some time. You can't diagnose them currently.
    If you follow that time line going all the way across to 
the right, spanning out through the rest of the epidemiological 
life span of that soldier, you are going to see a variety of 
problems emerge. They might not emerge right away, but 
eventually they might. And when they do emerge, every time they 
emerge, if it is 20, 30 years on down the road, that is one 
more victory for the opponents that we are facing on the 
battlefield. When they take another soldier down with 
Parkinson's disease or Alzheimer's or dementia on down the 
road, they are still winning that fight.
    We talk about counterinsurgency as a long war. Taking care 
of these casualties is the longer war. What we need to do is 
develop a cohesive plan to address this longer war. It is 
interagency, just like we have on the battlefield right now. 
But interagency, just like you heard from the first panel, is 
the only way we are going to solve this problem.
    I want to make a couple of recommendations before I close 
here. When you start taking a look at putting people onto this 
problem, I think as an outsider coming in, there is a need to 
evangelize the scientific community about TBI. We talk about 
job retraining for people that have been in textiles, that have 
been in the automotive industry that need a new job, we need 
retraining for scientists who want to come into this field, who 
want to make that jump, it is very difficult for them.
    So this might be as simple as running courses at the Marine 
Biological Lab at Woods Hole, MA, or Cold Spring Harbor Labs in 
New York. It could be as simple as that. It could be something 
more complex, where NINDS, VA, DOD and NIMH get together and 
start talking about that kind of job retraining. That is 
literally what it is.
    We need funding mechanisms for a long, sustained 
interdisciplinary effort. Earlier you heard about the 
prosthetics programs being run out at DARPA. The program 
manager for that is Geoffrey Ling, who is the only 
neurointensive care doc in the Army. He is also the program 
manager for my DARPA funding, the TBI program called PREVENT, 
Prevent an Explosive, Violent Neurological Trauma. You have one 
guy doing this thing all by himself over there at DARPA.
    But these kind of interdisciplinary fights, where you need 
people that understand shock physics, cell and tissue 
mechanics, molecular biology, neural biology, psychiatry, that 
is very complex. And you probably won't find an instance in 
American or scientific history where all those scientists have 
been represented in the same room at one time. About the only 
people that can pull that together is DARPA.
    But DARPA does short-term funding. They come in, they 
impact a field and they move on and let another agency pick it 
up. We need a longer term, more sustained effort at bringing 
these people together for a long time.
    I think that two things need to happen in terms of 
establishing goals for this field. One is, I am not going to 
surrender that turf that you see just to the right of boom. 
Right now, if you get a mild TBI on the battlefield, you might 
get treated, you might get evaluated, you might get pushed back 
into the fight. And one of the soldiers that was in that 
photograph I showed you earlier in that photograph has been 
blown up 10 times between tours in Iraq and Afghanistan. What 
is going to happen when he goes home 1 day and he suddenly 
can't remember his son's name? That is a victory for the enemy.
    I am not going to surrender that turf to the enemy. If you 
take a look, just to the right of boom, when I run up there and 
I take care of that soldier, when I pull open that MRAP door to 
see if he is OK, the treatment for that TBI needs to start 
right now. So one of the goals that we need to have for this 
interdisciplinary research program is to develop a technique or 
a means of treating prophylactically the neurodegenerative 
diseases that might not emerge until 20 or 30 years on down the 
road.
    The second thing we need, and this is something that was 
mentioned previously, is we need a Framingham heart study on 
TBI. It might be PTSD, too. But the DOD and the VA keep great 
medical records. I live in Massachusetts. The Framingham heart 
study run by Boston University has revealed all kinds of great 
things about heart disease that scientists like me, who 
traditionally work in the cardiac field--now I split my time 
between TBI and the heart--have used to guide our scientific 
studies. We currently don't have that data base. We need that 
data base.
    A Framingham heart study, and short-term goals, so that 
over entire timeframe of the disease, and that is what TBI is, 
it is a disease, we need opportunities, we need funding, we 
need organization and we need leadership to do that.
    In conclusion, I would like to thank you again for the 
opportunity to testify.
    [The prepared statement of Mr. Parker follows:]

    [GRAPHIC] [TIFF OMITTED] T5562.075
    
    [GRAPHIC] [TIFF OMITTED] T5562.076
    
    [GRAPHIC] [TIFF OMITTED] T5562.077
    
    [GRAPHIC] [TIFF OMITTED] T5562.078
    
    [GRAPHIC] [TIFF OMITTED] T5562.079
    
    [GRAPHIC] [TIFF OMITTED] T5562.080
    
    [GRAPHIC] [TIFF OMITTED] T5562.081
    
    [GRAPHIC] [TIFF OMITTED] T5562.082
    
    [GRAPHIC] [TIFF OMITTED] T5562.083
    
    [GRAPHIC] [TIFF OMITTED] T5562.084
    
    Mr. Kennedy. We need your leadership. Kevin, awesome. Thank 
you for your service, every which way.
    Mr. Kucinich. Dr. Morrison.

               STATEMENT OF JOHN MORRISON, PH.D.

    Mr. Morrison. I would also like to thank the chairman and 
Mr. Kennedy for the opportunity to be here today to discuss the 
potential and promise of neuroscience.
    I am here today on behalf of the Society for Neuroscience, 
which is a non-profit membership organization of more than 
40,000 basic scientists and clinicians from around the world 
who study the brain and central nervous system. Our members 
work across the entire research spectrum to advance basic 
understanding of brain function and to translate basic science 
discoveries into treatment strategies for more than 1,000 brain 
illnesses.
    Exciting achievements in scientific discovery have fueled 
tremendous progress over the last decades, positioning the 
neuroscience community for transformational progress, thanks to 
new tools and technologies that enable us to study the brain as 
never before. You have heard about some of those today.
    Today I would just like to offer two brief examples of 
emerging discoveries that hold promise for research and the 
American people. First, neuroscientists are making great 
strides in understanding the brain circuits involved in PTSD 
and how these circuits are altered by stress. We know now of a 
number of altered brain chemicals and systems associated with 
PTSD and the part of the brain that links learning and memory 
to emotion is smaller in people with PTSD. As Mr. Kennedy 
pointed out earlier, PTSD is circuit-based, specific circuits 
are malfunctioning.
    Neuroscientists are also making tremendous progress in 
understanding the neurobiology of aging. We know that a part of 
brain cells called spines in the prefrontal cortex are depleted 
as we age, and this leads to cognitive decline. These basic 
research findings have already provided scientists and 
clinicians with new therapeutic targets to prevent the loss of 
spines and retain cognitive health. These same observations 
will help form a new approach to therapeutics for Alzheimer's 
disease.
    The importance of neuroscience research is reflected, and 
you have heard about this already today, in the fact that brain 
and nervous system disorders result in more hospitalizations 
than any other group, affecting more than 50 million Americans 
a year at costs exceeding $460 billion.
    A strong investment in basic science innovation is also 
critical to our national economy. It creates thousands of high-
wage jobs at a critical time.
    Biomedical research must be seen as one primary solution 
for diseases and disorders that already cost society hundreds 
of billions of dollars a year, several of which increasingly 
threaten our social fabric, including my area of expertise, 
Alzheimer's disease. Two years ago, the bipartisan Alzheimer's 
Study Group, co-chaired by Newt Gingrich and Bob Kerry, painted 
a very troubling picture of the social impact of Alzheimer's 
disease, if we don't do more to delay or prevent progression of 
the disease.
    The outlook for Alzheimer's is not morally sustainable for 
those millions who we know will suffer terribly or for their 
families. Nor is it economically sustainable for our Nation. 
The situation is repeated for a thousand other brain disorders. 
At a time of economic challenge for our Nation, the economic 
question is not, how can we afford to invest in research, 
rather, it is how can we afford not to invest in research that 
has the potential to save many times the dollars invested.
    The issue discussed today remind us that scientists and 
medical practitioners must be much more engaged in a two-way 
dialog if we are to ensure that discoveries translate into 
treatments and clinical observations are integrated into 
research development. We have seen this referred to several 
times today.
    Neuroscience research that benefits one condition or 
disorder has broad potential applications for many conditions, 
making it critical that we encourage more collaboration that 
crosses traditional scientific boundaries. One of the most 
critical collaborations is across what has traditionally been 
thought of as two largely independent enterprises: basic 
science and clinical research. In fact, we must recognize that 
both endeavors are necessary components of a continuum that 
leads to translation. We must encourage and facilitate 
scientists and clinicians to work together as a team to 
translate scientific knowledge and discoveries into specific 
personalized approaches to diagnosis, treatment and prevention 
of disease.
    One example of the importance of practical scientific 
application and translation is our increased understanding of 
synaptic plasticity, which is in essence the brain's ability to 
modify neural circuits to better cope with new circumstances. 
This incredible capacity for adaptation is a fundamental 
property of the synapse and our understanding of it emerged 
from basic science. Yet it is already having a revolutionary 
impact on therapeutic strategies for multiple brain disorders.
    In closing, we live on the forefront of an era of 
breathtaking potential to advance biological knowledge and 
human health. Our future success will depend in large measure 
on sustaining the strong investment in basic neuroscience 
discovery as well as team-oriented, collaborative approaches 
between the basic researchers and the clinical researcher.
    I look forward to the road ahead in this exciting field and 
what our success stories will mean to the American people.
    [The prepared statement of Mr. Morrison follows:]

    [GRAPHIC] [TIFF OMITTED] T5562.085
    
    [GRAPHIC] [TIFF OMITTED] T5562.086
    
    [GRAPHIC] [TIFF OMITTED] T5562.087
    
    [GRAPHIC] [TIFF OMITTED] T5562.088
    
    [GRAPHIC] [TIFF OMITTED] T5562.089
    
    Mr. Kucinich. Thank you very much.
    We have another series of votes. Mr. Kennedy and I have 
conferred and we are each going to take 3 minutes for questions 
or comments, and then we are going to adjourn this.
    But I would just say that there will be followup questions 
that myself and others will submit to you, and we will ask for 
your thoughtful consideration on the questions members of the 
committee submit.
    Mr. Kennedy, you are recognized for 3 minutes, and then I 
will wrap it up.
    Mr. Kennedy. Thank you very much, Mr. Chairman.
    As we are speaking today, a Rhode Islander in Fort Hood 
committed suicide, as we were conducting this hearing. He is 
from Middletown, Rhode Island, in my district. He committed 
suicide and murdered his wife. He leaves behind two children, 
one six and one is two. Dr. Parker, Kit Parker, who could very 
well have served alongside of this Rhode Islander in his 
service as a Rhode Island Guard, pointed out most poignantly, 
these are combat deaths. And they are part of the enemy's 
strategy. Whether they are killed in action or they are killed 
over here because of their wounds of that action that they saw, 
it is a death as a result of this war. And if we don't take it 
as such, we are not going to approach it as such. Because we 
will think of it as something else, other than part of our war 
effort.
    So the urgency that you gave us, Kit, in terms of fighting 
this fight as if it were fighting the enemy, because this is 
the enemy's fight that they are taking to us, we have to take 
it back to them. And that kind of call to action that you gave 
us, so poignant, so powerful, serves to act as a catalyst for 
all of the things that Dr. Potter was saying about the need for 
a national priority to be put on this, that is going to return 
the science in short order on the emergency level that it is 
demanded, because we are not turning it around fast enough.
    So for everybody here, that open source need for sharing of 
science, because we are all in it together, and the need for us 
to do it fast and furious for the benefit of the people who 
will come to benefit from this, and to bring it to a national 
scale is so welcome. I thank you all for that. That image, Tim, 
of the valley of death, the valley of death in translational 
research, from moving that research in the lab to the bedside 
to benefit people, that is the valley of death. That is the 
word you used, it is a valley of death. Every day longer we 
leave these veterans in that valley, we are shirking our 
responsibility to go in and set them free.
    Thank you for your comments. Dr. Potter, if you could keep 
submitting for us the kinds of regulatory science reform you 
think would be necessary at the FDA to give Dr. Hamburg her 
support along with what we ask the NIH and other directors to 
talk about, so that when they come up with something, we can 
move it right into practice. If you could just close by 
commenting a little bit about where that is just such a lacking 
part of our FDA. No offense to them, they need the support from 
us.
    Mr. Kucinich. What we will do is ask if you will respond in 
a letter on that.
    Mr. Morrison. Certainly.
    Mr. Kucinich. If I may, I am going to try to make sure that 
we can get to vote here.
    I want to thank Pat Kennedy again for being instrumental in 
creating this hearing.
    Dr. Morrison, can high levels of stress impair synaptic 
plasticity?
    Mr. Morrison. Absolutely. Well, let me qualify that. 
Absolutely in animal models, there is no question about it.
    Mr. Kucinich. Dr. Akil, you said something that I thought 
was, everything you said, all the witnesses, is very important. 
But you said our brains are modeled by the social environment. 
That parallels the studies of David Bohm, the quantum 
physicist, who said that the world is a hologram of the brain, 
which is a hologram of the world. He was really looking at the 
holonomic theories of Karl Pribram. They got together and 
addressed the issue of the brain in a more global way, which is 
what your testimony, I assume, is advocating. When you talk 
about the choreography of the brain, you are speaking of the 
brain in a much broader sense, instead of things that are site-
specific, you are looking at the brain in terms of its 
vastness?
    Dr. Akil. Yes. I think the idea is that things are 
integrated both in space and in time in the brain. That is how 
new functions emerge that we cannot comprehend by looking too 
molecularly. And the brain is the place where nature and 
nurture meet. So the social environment is just as important as 
the genes that we are born with.
    Mr. Kucinich. The work, then, of let's say a Maslow becomes 
relevant?
    Dr. Akil. Right.
    Mr. Kucinich. The work of Carl Rogers becomes relevant.
    Dr. Akil. Exactly, yes.
    Mr. Kucinich. I would just like conclude by saying one 
other thing. That is, we have spent time talking about 
soldiers, and Dr. Parker, thank you for bringing this very 
specific study of the impact of war, the physical impact of war 
and the long-term impact of war. We also need to look at post-
9/11 America, when you talk about the social environment, the 
brain being modeled by social environment. We have an America 
that has been filled with fear and violence, whether it is 
vicarious through the media. That has to have an effect, it 
just does. I would like that to be a subject of perhaps another 
hearing in which maybe we can ask some of you to come.
    We have 2 minutes to vote, Representative Kennedy.
    Thank you for your dedication. As Chair, I can promise you 
that our subcommittee is going to stay in touch with each and 
every one of you. I think the work that you are doing is 
important to the future of the world. Thank you.
    [Whereupon, at 5:35 p.m., the subcommittee was adjourned.]

                                 
