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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

(II)

COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM

EDOLPHUS TOWNS, New York, Chairman

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

JOHN F. TIERNEY, Massachusetts

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

JIM COOPER, Tennessee

GERALD E. CONNOLLY, Virginia

MIKE QUIGLEY, Illinois

MARCY KAPTUR, Ohio

ELEANOR HOLMES NORTON, District of

Columbia

PATRICK J. KENNEDY, Rhode Island

DANNY K. DAVIS, Illinois

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

DARRELL E. ISSA, California

DAN BURTON, Indiana

JOHN L. MICA, Florida

JOHN J. DUNCAN, JR., Tennessee

MICHAEL R. TURNER, Ohio

LYNN A. WESTMORELAND, Georgia

PATRICK T. MCHENRY, North Carolina

BRIAN P. BILBRAY, California

JIM JORDAN, Ohio

JEFF FLAKE, Arizona

JEFF FORTENBERRY, Nebraska

JASON CHAFFETZ, Utah

AARON SCHOCK, Illinois

BLAINE LUETKEMEYER, Missouri

ANH ‘‘JOSEPH’’ CAO, Louisiana

BILL SHUSTER, Pennsylvania

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

JOHN F. TIERNEY, Massachusetts

DIANE E. WATSON, California

JIM COOPER, Tennessee

PATRICK J. KENNEDY, Rhode Island

PETER WELCH, Vermont

BILL FOSTER, Illinois

MARCY KAPTUR, Ohio

JIM JORDAN, Ohio

DAN BURTON, Indiana

MICHAEL R. TURNER, Ohio

JEFF FORTENBERRY, Nebraska

AARON SCHOCK, Illinois

——— ———

JARON R. BOURKE, Staff Director

(III)

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

(1)

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 AfVerDate 11-MAY-2000 16:11 Jun 29, 2011 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\65562.TXT KATIE PsN: KATIE
2

ghanistan 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 muchneeded 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 treatVerDate 11-MAY-2000 16:11 Jun 29, 2011 Jkt 000000 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\65562.TXT KATIE PsN: KATIE
3

ments 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 brainrelated 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:]

4

5

6

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

7

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.

8

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

9

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 duVerDate 11-MAY-2000 16:11 Jun 29, 2011 Jkt 000000 PO 00000 Frm 00013 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\65562.TXT KATIE PsN: KATIE
10

ration 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.

11

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 $571⁄2

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

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deed 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.

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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:]

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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 investVerDate 11-MAY-2000 16:11 Jun 29, 2011 Jkt 000000 PO 00000 Frm 00026 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\65562.TXT KATIE PsN: KATIE
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ment. 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.

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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.

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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:]

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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 longterm 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.

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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:]

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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

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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:]

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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.

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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.

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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.

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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

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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

77

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

78

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 revoluVerDate 11-MAY-2000 16:11 Jun 29, 2011 Jkt 000000 PO 00000 Frm 00082 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\65562.TXT KATIE PsN: KATIE
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tion. 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.

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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.

81

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

82

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 develVerDate 11-MAY-2000 16:11 Jun 29, 2011 Jkt 000000 PO 00000 Frm 00086 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\65562.TXT KATIE PsN: KATIE
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opment 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 HarvardMIT 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.

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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.

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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 investigatordriven 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.

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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:]

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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 incenVerDate 11-MAY-2000 16:11 Jun 29, 2011 Jkt 000000 PO 00000 Frm 00097 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\65562.TXT KATIE PsN: KATIE
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tive 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:]

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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

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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:]

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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

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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 evaluVerDate 11-MAY-2000 16:11 Jun 29, 2011 Jkt 000000 PO 00000 Frm 00118 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\65562.TXT KATIE PsN: KATIE
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ated, 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:]

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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.

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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:]

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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.

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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.]

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