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



 
                       EXPLORING THE RELATIONSHIP

                 BETWEEN MEDICATION AND VETERAN SUICIDE

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


                                HEARING

                               before the

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

                     ONE HUNDRED ELEVENTH CONGRESS

                             SECOND SESSION

                               __________

                           FEBRUARY 24, 2010

                               __________

                           Serial No. 111-62

                               __________

       Printed for the use of the Committee on Veterans' Affairs




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                     COMMITTEE ON VETERANS' AFFAIRS

                    BOB FILNER, California, Chairman

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

                   Malcom A. Shorter, Staff Director

Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public 
hearing records of the Committee on Veterans' Affairs are also 
published in electronic form. The printed hearing record remains the 
official version. Because electronic submissions are used to prepare 
both printed and electronic versions of the hearing record, the process 
of converting between various electronic formats may introduce 
unintentional errors or omissions. Such occurrences are inherent in the 
current publication process and should diminish as the process is 
further refined.


                            C O N T E N T S

                               __________

                           February 24, 2010

                                                                   Page
Exploring the Relationship Between Medication and Veteran Suicide     1

                           OPENING STATEMENTS

Chairman Bob Filner..............................................     1
    Prepared statement of Chairman Filner........................    51
Hon. David P. Roe................................................     2
    Prepared statement of Congressman Roe........................    51
Hon. Harry E. Mitchell, prepared statement of....................    52

                               WITNESSES

U.S. Department of Veterans Affairs, Ira Katz, M.D., Ph.D., 
  Deputy Chief Officer, Mental Health Services, Office of Patient 
  Care Services, Veterans Health Administration..................    39
    Prepared statement of Dr. Katz...............................    79
U.S. Department of Defense, Brigadier General Loree K. Sutton, 
  M.D., Director, Defense Centers of Excellence for Psychological 
  Health and Traumatic Brain Injury, Special Assistant to the 
  Assistant Secretary of Defense for Health Affairs..............    41
    Prepared statement of General Sutton.........................    86

                                 ______

American Psychiatric Association, Annelle Primm, M.D., MPH, 
  Deputy Medical Director for Minority Affairs, and Associate 
  Professor of Psychiatry, Johns Hopkins School of Medicine, 
  Baltimore, MD..................................................    30
    Prepared statement of Dr. Primm..............................    69
American Psychological Association, M. David Rudd, Ph.D., ABPP, 
  Dean, College of Social and Behavioral Science, The University 
  of Utah, Salt Lake City, UT....................................    28
    Prepared statement of Dr. Rudd...............................    67
Breggin, Peter R., M.D., Ithaca, NY..............................     3
    Prepared statement of Dr. Breggin............................    52
Farber, Commander Donald J., Esq., USN (Ret.), San Rafael, CA....    32
    Prepared statement of Commander Farber.......................    72
Leon, Andrew C., Ph.D., Professor of Biostatistics in Psychiatry 
  and Public Health, Weill Cornell Medical College, New York, NY.    10
    Prepared statement of Dr. Leon...............................    66

                       SUBMISSION FOR THE RECORD

Billings, Bart P., Ph.D., Carlsbad, CA...........................    91


                       EXPLORING THE RELATIONSHIP



                 BETWEEN MEDICATION AND VETERAN SUICIDE

                              ----------                              


                      WEDNESDAY, FEBRUARY 24, 2010

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

    The Committee met, pursuant to notice, at 10:00 a.m., in 
Room 334, Cannon House Office Building, Hon. Bob Filner 
[Chairman of the Committee] presiding.

    Present: Representatives Filner, Michaud, Herseth Sandlin, 
Mitchell, Halvorson, Perriello, Teague, Rodriguez, Donnelly, 
Space, Walz, Adler, Bilirakis, and Roe.

              OPENING STATEMENT OF CHAIRMAN FILNER

    The Chairman. Good morning. The Committee on Veterans' 
Affairs will come to order.
    I ask unanimous consent that all Members may have 5 
legislative days in which to revise and extend their remarks. 
Hearing no objection, so ordered.
    Thank you all for attending today's hearing. I think it is 
an important hearing to look at the potential relationship 
between psychiatric medications and suicides. Not an attractive 
topic, but one that I think we have to address.
    Certainly, we know with post traumatic stress disorder 
(PTSD) and traumatic brain injury (TBI) being so prevalent in 
the current wars in Iraq and Afghanistan, mental health issues 
have taken and should take center stage.
    Research has shown that mental disorders and substance 
abuse disorders are linked to more than 90 percent of people 
who die by suicide. Today, as you know, suicides among 
servicemembers and veterans continue to increase at an alarming 
rate, far exceeding the comparable suicide rates among the 
general population, and I think higher than we had during the 
Vietnam War.
    It is a tragedy that our servicemembers and veterans 
survive the battle abroad only to return home from the theater 
of war to fall by suicide.
    We know there is a widespread availability and use of 
psychiatric medications to address mental health disorders, but 
there is apparently some dispute about whether these drugs 
prevent or lend a hand in suicide. Some doctors are convinced 
by their clinical experience that psychiatric drugs often 
adversely impact the individual's better judgment and lead 
people to lose control over their emotions and actions.
    Suicides may be driven by so-called drug-induced adverse 
reactions and intoxications. There are, on the other hand, some 
studies that show suicide attempts were lower among patients 
who are treated with antidepressants than those who are not.
    Through this hearing, we will explore the two opposing 
schools of thought on the relationship with psychiatric 
medicine and suicide. In this process, we will also seek to 
better understand the reasons why more and more servicemembers 
and veterans are taking their own lives and what the U.S. 
Department of Veterans Affairs (VA) and U.S. Department of 
Defense (DoD) are doing to prevent such deaths.
    Before we hear from our first witnesses, I will recognize 
Dr. Roe for an opening statement.
    [The prepared statement of Chairman Filner appears on p. 
51.]

             OPENING STATEMENT OF HON. DAVID P. ROE

    Mr. Roe. Thank you, Mr. Chairman, and thank you for holding 
this hearing.
    I think those of us who are gathered here today would be 
hard pressed to find a topic more heart breaking than when a 
servicemember makes the decision to end his or her own life. 
This hearing is one of the many hearings and meetings this 
Committee has had in an effort to combat veteran suicide and I 
can tell you that the stories we hear in these proceedings much 
like those in Dr. Breggin's book always raise difficult 
questions.
    As painful as such anecdotal accounts are, we must take 
heed not to be so quick to point out to a single cause or 
mistaken theory for a solution. It is sound research that is 
critical to our efforts to put an end to these tragedies and 
understand the entire story.
    On that front, there are many encouraging signs. In 2008, 
the Army and the National Institutes of Mental Health (NIMH) 
began a 5-year study into the factors that contribute to 
suicide in the Armed Forces and how to prevent them. Called the 
ARRM Study to Assess Risk and Resilience in Servicemembers, 
this is the largest study of suicide and mental health among 
military members ever conducted.
    In addition, there is a great deal of ongoing public and 
private research into the causes of suicide and treatment 
options, including medication, to prevent it.
    I am hopeful that with this research, practitioners will be 
able to better identify risk factors for veteran suicide and 
design prevention, outreach, and treatment options that are 
effective and practical within the VA setting.
    The psychology behind why a person may see death as the 
only way out is more complex than any of us have the ability to 
fully comprehend and it is the interaction of a number of 
factors that may lead to this catastrophe.
    In addressing these issues, one cannot simply place blame 
on the veteran, their military service, their illness, or their 
chosen treatment option. As the research goes on, we must allow 
our veterans and servicemembers to have the full range of 
approved treatment options that they decide upon with their 
doctors.
    I want to thank our witnesses for being here this morning 
and I look forward to hearing and learning from each of you. It 
is only by working together that we can convince every 
courageous yet struggling American veteran and their country 
that supports them that hope and help are out there.
    I yield back the balance of my time.
    [The prepared statement of Congressman Roe appears on p. 
51.]
    The Chairman. Thank you, Dr. Roe.
    I want to introduce the first panel. We have Dr. Peter 
Breggin, Psychiatrist and Author from Ithaca, New York, and Dr. 
Andrew C. Leon, Professor of Biostatistics in Psychiatry and 
Public Health at Weill Cornell Medical College.
    Thank you for being with us.
    Dr. Breggin, I just have one question to start off with, to 
test your mental state--do you willingly live in Ithaca, New 
York?
    Dr. Breggin. I lived here most of my life, DC.
    The Chairman. I spent 10 years at Cornell, so I know 
something about the background.
    Dr. Breggin. That is right.
    The Chairman. Okay, test passed. Please enlighten us. You 
have the floor.

STATEMENTS OF PETER R. BREGGIN, M.D., ITHACA, NY (PSYCHIATRIST 
     AND AUTHOR); AND ANDREW C. LEON, PH.D., PROFESSOR OF 
 BIOSTATISTICS IN PSYCHIATRY AND PUBLIC HEALTH, WEILL CORNELL 
                 MEDICAL COLLEGE, NEW YORK, NY

                 STATEMENT OF PETER R. BREGGIN

    Dr. Breggin. Well, I am Peter R. Breggin, M.D. I am a 
psychiatrist. And I was in this area of DC for most of my 
career and then we moved to Ithaca, New York, to be in the 
country.
    In the early 1990s, I became the first psychiatrist to 
speak and write extensively about violence and suicide caused 
by the newer antidepressants beginning with Prozac, later going 
on to Paxil, Zoloft, Celexa, and other drugs.
    I also, as a result of that early research, became a 
scientific expert for more than 100, I think it was like 170 
product liability cases against Eli Lilly, the manufacturer of 
Prozac, that were combined by a court to provide the 
opportunity for one person to research the data and look into 
the company files for all of the suits. And I was chosen to be 
that one medical expert.
    This ended up giving me experience that literally no one 
else in the world has had in terms of looking at the basic data 
from Eli Lilly concerning the development and marketing and 
then from some other drug companies.
    I was shocked at what I found inside the company. For 
example, the German equivalent of our Food and Drug 
Administration (FDA) had become concerned that they were 
finding an increased suicide rate on studies of Prozac. So they 
asked Eli Lilly, and this is back now in the late 1980s, to go 
back and look at all of their clinical trials and report to 
them on the rate of suicide attempts in the con- 
trolled clinical trials of Prozac compared to another drug or pl
acebo.
    Lilly found, depending on how you count it, a 6 to 12 to 1 
ratio of suicide attempts, not just thinking, attempts in the 
control or comparison group compared to placebo. Lilly never 
made the results public. They never gave this report that I 
found to the Germans. They never made it available to the FDA.
    I also found memos inside Lilly explaining guilt and shame 
on the part of some German investigators working for Lilly that 
the company was classifying suicides and suicide attempts 
reported by doctors to them as no drug effect or other harmless 
kinds of entities, thereby disguising the suicide attempts and 
the completed suicides.
    And one of these memos, the gentleman declared, how am I 
going to explain this to my family. He expressed a genuine 
feeling of shame.
    At the same time, the FDA conducted a study comparing 
Prozac to an older antidepressant, Trazodone. After factoring 
in the increased number of prescriptions for Prozac and also 
factoring in the controversy because the controversy had not 
broken out yet, there were far more reports of suicidality and 
violence and other mental adverse effects on Prozac.
    I worked on these issues for many, many years, as you know, 
and then testified before the FDA in 2004 on a couple of 
occasions and the agency distributed one of my papers written 
in 2003 to the panel, the FDA panel. And a lot of the language 
in the current label virtually reads actually very, very 
similar to what I had to say in my papers and books.
    Now, my conclusions in this testimony are based not only on 
these very early studies that I discovered inside of Eli Lilly, 
which, by the way, you can find on my Web site, the Lilly 
documents I am describing, and I also described them in a 
couple of my books.
    But my conclusions are based in part on the many citations 
in the paper I wrote specifically for this Committee. I 
actually sat down and wrote you a paper, Antidepressant Induced 
Suicide and Violence: Risks for Military Personnel, and in the 
hundreds of citations in my book.
    My recent book, which Mr. Roe was kind to mention and which 
I know that you have read, Mr. Chairman, Medication Madness, 
gives an overview of my clinical experience, which now included 
in the book more than 50 cases of violence, suicide and crime, 
most of them on antidepressants.
    And I actually interviewed survivors. I actually went to 
crime scenes, read all the medical records, police records, and 
clearly documented in Medication Madness from a clinical 
viewpoint that there are many, many cases like this. I actually 
have over 100 that are mentioned in the book and 50 documented 
in detail.
    In 2004, after the various hearings, the FDA actually 
before them, required the antidepressant manufacturers to 
review their clinical trials. The FDA itself concluded that the 
newer antidepressants doubled the rate of suicidal thoughts and 
behaviors in children, youth, and young adults up to age 24, 
which, of course, is very menacing for the soldier population, 
the military population.
    Now, you get a doubling of rates. Well, what does this 
mean? Well, the clinical trials are very short. Most of them 
average about 6 weeks. Some of the Prozac trials were 4 weeks. 
Suicidal patients are excluded from clinical trials.
    The patient is monitored every week by experts and informed 
of all the dangers presumably and the patient is given huge 
hope. You are in this wonderful research setting where you are 
getting something new and wonderful. And, furthermore, there is 
no attempt to look for suicide attempts and to categorize them.
    Now, when you get a doubling of suicide attempts and 
ideation under those conditions, you can assume that in the 
military or clinical practice it is going to be multiples, 
unknown multiples because there it is given for months, there 
it is not monitored, their psychotic patients are included, 
their suicidal patients are included, and all of that is 
excluded from the clinical trials.
    Now, one of the questions that may come up today is that 
there were in this particular batch of trials no completed 
suicides. The shock is how many attempts there were because the 
best way to treat suicide, if there were one, would be to 
simply put somebody in a clinical trial and give hope because 
suicide is loss of hope. That is why when you get all the 
doctors looking at you and testing you and working with you, 
you almost never get suicides in any kind of clinical trial of 
that kind.
    Now, the FDA warnings that came out of these hearings are 
identical for all antidepressants. The Zoloft label is the 
model I am going to use. And it begins with a huge black box, 
huge black box, very rare thing, with the title Suicidality and 
Antidepressant Drugs. And I will read you just the first line 
of it.

          ``Antidepressants increase the risk compared to 
        placebo of suicidal thinking and behavior, parentheses, 
        suicidality in children, adolescents, and young adults 
        in short-term studies of major depressive disorder and 
        other psychiatric disorders.'' And later in the label, 
        they will say that a lot of the adverse effects occur 
        in nonpsychiatric patients.

    This black box is very lengthy and many of the items are 
repeated over and over again in the warnings and further on. It 
is the only label like that that I know of. The black box is 
followed by a very ominous section, still in the warnings, 
entitled ``Clinical Worsening and Suicide.'' This idea of 
clinical worsening that is repeated in the label has not been 
given enough attention.
    It states in this section that the following symptoms I am 
going to list, quote ``have been reported in children and 
adults taking antidepressants both for psychiatric and 
nonpsychiatric purposes.'' And the list includes ``anxiety, 
agitation, panic attacks, insomnia, irritability, hostility, 
aggressiveness, impulsivity, akathisia,'' which is psychomotor 
restlessness, and the DSM-IV, our major document, points out 
that akathisia leads to violence and suicide.
    So I interrupted. ``Akathisia, hypomania, and mania.'' And 
mania is an out of control state that increases vastly the risk 
of violence and suicide. This is the list that is virtually 
taken from several of my earlier publications and note the 
mention of irritability, hostility, aggressiveness, and 
impulsivity.
    Imagine causing that in young men and women who are heavily 
armed and under a great deal of stress. And irritability, 
hostility, aggressiveness, impulsivity not only lead to 
violence but to suicide. Many suicides are out of anger and 
irritability and resentments.
    The Chairman. Dr. Breggin, I do not mean to interrupt. I 
just want to ask a specific question. If an active-duty soldier 
is given these medications, they may not even see that warning, 
right? I mean----
    Dr. Breggin. Well, my experience, last year, I spoke at the 
oldest military stress conference given. Bart Billings, whom 
you know, retired Army officer and psychologist, runs that. And 
I talked to Generals and I talked to mental health 
professionals and they all agreed that these warnings were 
hardly ever presented to the soldiers and that the Army was in 
a sense acting as if it was unaware.
    And some of these people gave me estimates not of the 15 
percent of active-duty soldiers on psychiatric drugs that we 
often hear but up to 30 percent of soldiers in some sections. 
Marines in particular was one that was mentioned to me.
    The Chairman. So they are not even informed of the risks?
    Dr. Breggin. No, no. And as we go on further, we will see 
that the FDA tells doctors you should, and the word ``should'' 
is in the label, you should share this information with the 
patient and the family and make sure they understand it. It is 
not just you repeat it to them. You sort of, you know, ``hey, I 
want you to understand this is what may happen to you.''
    That is what I do in my clinical practice. I do not say by 
the way, the drug may cause this or that, you know. I just make 
sure over a period of many sessions that the person understands 
the risks.
    Did I answer your question, sir?
    In addition to this list that is associated with the drug 
itself, the antidepressants, and this is mentioned in the label 
and mentioned in the medication guide I will tell you about, 
the antidepressants often cause severe withdrawal reactions in 
which all of those symptoms, all of those adverse reactions can 
develop.
    In fact, I spend probably half my practice even in remote 
Ithaca treating people who come to me to try to get off of 
these drugs and are suffering violent feelings, suicidal 
feelings when they try to stop. And, in fact, in the last 3 
weeks, I have had at least three or four patients who as we 
went down lower on their doses developed really, really 
frightening reactions and then I had to treat those, usually by 
raising the dose back up for a while.
    Let me mention some of the science more specifically at 
this point. This list of mania and hypomania and agitation and 
aggression and so on, that list in one FDA document is stated 
to be a ``known'' effect, this whole series that I read to you, 
are known effects of the drugs.
    And what I am going to read to you now involved mostly 
controlled clinical trials or epidemiological studies. No one 
should be able to say that causality has not been demonstrated. 
The gold standard for causality is the controlled clinical 
trial and it shows a doubling of the rate of suicidality. That 
is the gold standard.
    And I have a discussion that is documented between the top 
members of the FDA agreeing at the hearings that unless 
somebody is cheating or there is some other malfeasance going 
on when you have a causal association in controlled clinical 
trials. I would add epidemiological studies that demonstrates 
causality.
    In addition, Federal regulations say that the warning 
labels must have a reasonable degree of certainty about 
causality before it gets put into the label.
    An overview of some of the studies that are involved, 
because I want you to know this is not merely my personal 
opinion. This is what the science has overwhelmingly taught me 
starting with my looking inside the drug companies.
    In addition to the studies done under the auspices of FDA, 
we have, and this is for children and adults, we have a study 
by Aursnes, A-U-R-S-N-E-S, in 2005. He looked at 16 placebo 
controlled clinical trials in which Paxil was randomized 
against placebo and found increased suicidal behavior.
    The references are in the article that I gave to you, 
attached to my testimony, as well as my books and paper.
    Ferguson in 2005 searched the adult literature, found 702 
randomized clinical trials of 87,000 patients and found a 
significant increase in suicidality on antidepressants.
    Donovan in 1999, in a large British study involving 229 
completed suicides, it is a big study in England, found a 
higher suicide rate in patients treated with the newer 
antidepressants.
    Donovan in 2000 examined 2,776 consecutive cases of 
deliberate harm in individuals age 17 and older, not children, 
17 and older, like soldiers, seen at the emergency department 
of a British infirmary. Again, the suicide rates were increased 
in people taking the newer antidepressants.
    A fellow named Jick, J-I-C-K, in 1995 conducted an 
epidemiological study in the United Kingdom involving 172,000 
adult patients and Prozac was associated with more suicides 
than the older antidepressants.
    In my home State, for many years, of Maryland, Frankenfeld 
and some very respected researchers at the University of 
Maryland studied coroners' cases in Maryland and found that 
suicides were more violent, which is my clinical experience, in 
patients taking Prozac compared to older antidepressants.
    Now, GlaxoSmithKline in 2006, the manufacturer of Paxil, 
conducted a new meta-analysis of all its adult trials, the FDA 
said you have to do a meta-analysis of all the adult trials, 
and found a statistical increase in the rate of suicidality in 
depressed patients of all ages, an increased rate from the 
clinical studies, their own, which were not oriented toward 
this, an increased statistically significant rate, all ages in 
patients with major depressive disorder. It is in a Dear Doctor 
letter that they sent out to all the health care, it is really 
now called Healthcare Letter, to all the health care 
professionals in the country.
    A study of 1,255 suicides in 2006 in Sweden found that, 
which was 95 percent of all the suicides in Sweden, by Ljung, 
et al, L-J-U-N-G, published in 2009, found there was a greatly 
increased number of completed suicides exposed to the 
antidepressant drugs. In fact, 52 percent of the Scandinavian 
women who killed themselves had filled a prescription for these 
drugs.
    Now, this is not as causal as the clinical trials. It could 
be other factors. But it is just part of this mountain, 
mountain of evidence.
    A retrospective study examined the suicide rate in the VA 
involving a cohort, a group of people that were 887,000, that 
is 6 digits, 887,000 VA patients treated for depression and 
found, quote, ``completed suicide rates were approximately 
twice the base rate following antidepressant starts in VA 
clinical settings.'' That is Valenstein, et al, in 2009.
    Now, again, you can look at something like this and say, 
well, maybe the worst patients were put on the antidepressants 
and that is the correlation. That is not what they concluded. 
And, of course, this now comes against the backdrop of the 
clinical trials which show causality.
    Juurlink, J-U-U-R-L-I-N-K, et al, in 2006 reviewed more 
than a thousand cases of actual suicide in the elderly and 
found that during the 1st month of treatment with selective 
serotonin reuptake inhibitors (SSRIs) there was a fivefold 
increase in risk in the elderly. This is no surprise because 
the elderly are more susceptible to adverse effects.
    Fisher, et al, in a really interesting study did a phone 
survey of people who went to a pharmacy and got drugs, 
medications, and found that there was a higher rate of 
suicidality in people who got the SSRIs compared to other 
antidepressants.
    I do not think there is a question about causality, 
although some people will raise questions of causality today, I 
am sure.
    Finally, just to look at the literature on mania, because 
mania, if you read the DSM-IV, is caused by antidepressants. 
This is in our diagnostic manual, that all of the phenomena of 
mania are caused by antidepressants as well as by just simply 
bipolar disorder. And mania results in suicide, violence, 
crime. I have had a whole bunch of just dreadful cases like 
that.
    Well, in 2001, Preda, P-R-E-D-A, found that 8.1 percent of 
adult psychiatric admissions could be attributed to 
antidepressant induced mania and psychosis, 8 percent of 
hospital admissions.
    Another group found that 8 percent of patients treated with 
Paxil developed mania. In other words, they are not even 
looking for it. They go back and they look at records and they 
find that 8 percent of the patients got mania when the drug was 
started. Causality has been definitely established in studies 
like this.
    Howland in 1996 again found a 6 percent rate. Look at these 
rates, six, eight. Very, very consistent of SSRI induced mania. 
To induce mania in a soldier, in an armed young man or woman is 
an incredibly risky affair.
    Ebert, et al, in 1997 found a 17-percent rate of hypomania 
in patients on SSRIs. Some were suicidal or dangerous.
    Martin used a national database of 7 million privately 
insured individuals and he found that if you look at people 
given antidepressants, all of a sudden, they are getting 
bipolar disorder diagnoses afterward, after the 
antidepressants.
    I could go on and on, but I will not. I want to tell you 
one more study because this one comes out of the heart of the 
advocacy group for psychiatric drugs. It comes from Harvard 
Medical School where most of what they do is financed or much 
of it by the drug companies and where some of the prominent 
doctors were recently under investigation by Senator Grassley 
for taking money from the drug companies and not informing 
people.
    Well, they did a study, this is Wilens, et al, 2003, of 
adverse psychiatric events on children taking these drugs, 
children and adolescents, and they are just more susceptible 
than adults, but it is the same phenomena. And they found that 
22 percent had adverse psychiatric events, quote, ``most 
commonly related to disturbance of mood.''
    Then they did something that is called a re-challenge. We 
have a few studies like this. A re-challenge is where somebody 
develops a symptom like suicidality. You stop the drug, the 
symptom goes away. You restart the drug, the suicidality comes 
back. You stop the drug, it goes away.
    Rothschild did a study like this, not even in this paper, 
but you can find it my books and scientific papers. The FDA 
says this is a very, very good thing to do. Well, in this case, 
when they re-exposed the children to an SSRI, 44 percent of 
that group again became disturbed. And what drug-induced 
symptoms did they develop? The things we have been hearing 
about. They became irritable, anxious, manic. They developed 
insomnia. Four percent of the children became aggressive.
    The Chairman. Dr. Breggin, I need you to----
    Dr. Breggin. I will finish up now.
    The Chairman [continuing]. Finish up right now. Okay. Thank 
you.
    Dr. Breggin. I really appreciate this time to share with 
you my work and the literature.
    Now, under FDA regulations, I want to talk about efficacy 
very briefly, the pharmaceutical companies can cherry pick 
their studies. They can do six or eight studies and just 
provide two that are marginally effective, statistically 
significant to the FDA for the purpose of pricing efficacy. It 
is not hard when you are purchasing the investigators and 
writing the protocols for them and then analyzing the data 
inside the drug company for the companies to develop positive 
studies, but it is still hard.
    And when all of the antidepressant studies that are done, 
not just the cherry picked ones, are combined in a meta-
analysis, the antidepressants are no better than placebo.
    Now, as you may discover today, psychiatric associations 
and other groups that rely heavily on financial support are 
going to try to reject and deny all this.
    In conclusion, there is overwhelming evidence that the 
newer antidepressants commonly prescribed in the military can 
cause or worsen suicidality, aggression, and other dangerous 
mental states. The documented increase of suicides in the 
military as well as any discovered, and I hope you will look 
into this, Mr. Chairman, any discovered increase in random 
violence among soldiers is in part caused or exacerbated by the 
widespread use of prescriptions for antidepressants.
    Finally, little will be lost and much will be gained by 
curtailing the prescription of antidepressants in the military. 
The military instead should rely upon newly developed 
psychological and educational programs, many of which are being 
implemented and which Dr. Bart Billings, who is familiar to 
this Committee, has written about in his report to the 
Committee, including his Human Assistance Rapid Response Team 
(HARRT) program.
    Thank you very, very much for the time.
    [The prepared statement of Dr. Breggin appears on p. 52.]
    The Chairman. Thank you so much for that, rather chilling 
testimony.
    Dr. Leon, you are recognized.

                  STATEMENT OF ANDREW C. LEON

    Dr. Leon. Thank you for the opportunity, Mr. Chairman and 
distinguished Committee Members, to discuss this topic.
    My name is Dr. Andrew Leon. I know this is clearly an 
emotional issue. My family has been profoundly impacted by 
mental illness, so much so that I devoted my career to the 
field of psychiatry.
    I am Professor of Biostatistics in Psychiatry and Public 
Health at Weill Cornell Medical College where I have been on 
the faculty for over 20 years. I have published over 200 peer-
reviewed scientific manuscripts. Nearly all of my research has 
been funded by the National Institutes of Health (NIH).
    I have served as a consultant to FDA, to the NIMH, and to 
industry primarily to monitor the safety of patients who are 
enrolled in clinical trials on data and safety monitoring 
boards.
    All of us here in this room share a common goal and that is 
to do the very best for our veterans. My perspective is that 
doing the best requires the discipline to use empirical methods 
to understand optimal mental health care and suicide 
prevention.
    I was a biostatistician on the FDA's Psychopharmacologic 
Drug Advisory Committee from 2003 to 2008 and participated in 
the FDA hearings on antidepressants and suicide, 
antidepressants and suicidality, I should say, not suicide 
deaths.
    The class of medications that I will discuss is 
antidepressants. First, depression is a life-threatening 
illness. Suicidality is a symptom of depression, whether 
treated or untreated. My main points that I will make today are 
depression increases the risk of suicide. Antidepressants 
reduce suffering from depression that has been demonstrated in 
several hundred randomized controlled clinical trials where the 
investigators and the assessors were blinded to the treatment 
received by the subjects in the trial. There is not a way that 
it can be manipulated by a pharmaceutical company when they are 
blinded to the treatment received when the ratings are done.
    The Chairman. I do not mean to interrupt, but I do not 
think the issue was whether somebody is cheating on a study. It 
is the selection of studies when they are finished.
    Dr. Leon. Oh, no. Absolutely. That is a very important 
point.
    The Chairman. You cannot say that cherry picking cannot 
result from this.
    Dr. Leon. I will address that in just 1 minute.
    So my three points that I want to make, then I will 
address, Mr. Chairman, your point, is depression increases the 
risk of suicide. Antidepressants, antidepressant medication can 
reduce the suffering from depression. And to reduce risk of 
suicide, clinicians must carefully monitor veterans with 
depression, whether treated or untreated.
    Now, with regard to the clinical trials, Mr. Chairman, that 
you are referring to, all clinical trials conducted by a 
pharmaceutical company for a particular drug must be submitted 
to the FDA. They cannot cherry pick. They submit all. The point 
Dr. Breggin was making that the FDA regulations require at 
least two positive trials where the medication meets another 
cell, typically placebo.
    So the cherry picking that Dr. Breggin was referring to, 
whether it was submitting just part of the results or 
manipulating the data that come in, is simply not true. I have 
reviewed those data. I reviewed the data from many hearings at 
clinical in the FDA, not just on suicidality, but for many 
other indications that were being sought for other psychiatric 
medications.
    Today I am going to discuss three different types of 
studies, randomized controlled clinical trials where 
antidepressants are typically compared to placebo, 
observational studies, and postmortem studies.
    Three types of suicidality are reported in these studies, 
suicidal thinking, suicide attempts, and suicide deaths.
    In 2004, the FDA reviewed 25 pediatric clinical trials for 
antidepressants involving over 4,400 subjects and found that 
patients randomized to antidepressants were about twice as 
likely to report suicidality. Nearly all of that was suicidal 
thinking. These were for pediatric clinical trials, children 
and adolescents under the age of 18.
    There were about 3 percent of those on medication or 
placebo. Three percent reported feelings of suicidality. And 
that was mostly suicidal thinking. About 80 to 90 percent of 
that was suicidal thinking. There were no suicide deaths in 
those clinical trials, no suicide deaths.
    In 2006, we reviewed 295 clinical trials of antidepressants 
for adults involving over 77,000 participants. Less than 1 
percent of those participants reported suicidality, most 
suicidal thinking.
    Unlike the pediatric trials, adults randomized to 
antidepressants were not more likely to report suicidality. In 
fact, antidepressants conveyed significant protection for 
adults over the age of 65. For the age group that was referred 
to earlier, ages 18 to 25, there was not a significant increase 
in the risk of suicidality. I mean, I reviewed the data. I 
wrote five papers on this topic. I have one of them here. The 
rate was not elevated more than we would expect by chance.
    So we have clinical trials here, say maybe nearly 300 
clinical trials. From those, the 11 new antidepressants, new 
meaning starting in 1985, a newer class, a newer generation of 
antidepressants, was being developed and approved. All of those 
antidepressants had demonstrated efficacy, that is clinical 
benefit for treating the symptoms of depression in more than 
one trial. So the efficacy, the clinical value of these was 
very clearly presented empirically.
    Now, I am involved in the NIMH collaborative depression 
study, which just ended last year. It was a 31-year followup 
study of patients who presented with mood disorders, bipolar 
disorder, and depression starting in the late 1970s. And we 
continued to assess as many as we could follow until 2009.
    One relevant paper from that is, I was able to look at 
those subjects during the course of the study, and, actually, 
this was before the 2009 data came in, so we had at the time up 
to 28 years of followup data, in order to examine the risk of 
suicidality and antidepressants.
    And what is not included in the clinical trial is those who 
received no treatment and those subjects who were not quite 
severely ill enough to qualify to be enrolled in a randomized 
trial and those subjects who were too severely ill to be 
enrolled in a randomized trial. We included subjects who were 
suicidal. We included subjects who had co-morbidity, both 
psychiatric co-morbidity, substance abuse, alcohol abuse, and 
other medical co-morbidity. We included subjects who were 
taking other medications.
    And during the course of this from 757 subjects, we had 
over 6,700 intervals during which they either received or did 
not receive antidepressants. We found from that that 
antidepressants significantly reduced the risk of suicide 
attempts and suicide deaths. We did not assess suicidal 
thinking, but there was a significant reduction in the risk of 
suicidal behavior, that is attempts and deaths.
    The data from our observational study are much more 
generalizable than a randomized controlled trial because we 
include much more the subjects and the situations they are in 
more typically reflects those who are receiving antidepressants 
in the United States.
    Our research group at Cornell has conducted several 
postmortem studies of suicide deaths in New York City. In fact, 
we examined all suicide deaths in New York City. We looked at 
the autopsy records over a 10-year period for youth suicides, 
children and adolescents under the age of 18. We looked at the 
toxicology to determine whether or not antidepressants were 
taken before their suicide death.
    There were 105 adolescents and children who killed 
themselves in New York City over a 10-year period. Ninety-five 
percent of those deaths had not, of the suicides, had not taken 
antidepressants. Only 5 percent had been treated with 
antidepressants. It is a tragic story.
    We repeated it again in adults. We looked at a 4-year 
period and there we had over 1,400 suicides. We had autopsy 
records of 1,400 suicides. Seventy-seven percent of those 
suicide deaths had not received antidepressants prior to their 
suicide.
    This suggests that prevention of suicide requires 
intervention primarily among patients who are not receiving 
antidepressants.
    A cause and effect relationship has not been established 
between antidepressants and suicide. This is one of the most 
controversial issues in the field of psychiatry. It is an issue 
about which many people write and speak without access to the 
proper data. The randomized controlled clinical trial data that 
the FDA reviewed is the most comprehensive database about 
antidepressant exposure ever assembled in the field of 
psychiatry.
    Antidepressants have clearly been shown to reduce the 
suffering from depression and suffering from depression is 
accompanied by significant functional impairment, job loss, 
family disruption, and inability to get out of bed in the 
morning. And a great deal of that can be reduced by taking 
antidepressants.
    However, there is a risk-benefit ratio we have to look at 
as with any medication. As with any medication, they are not 
going to be perfect. But a great deal of those patients who 
take the medications will get better and a very tiny percentage 
will have thoughts of suicidality. They may have had those 
thoughts before they started.
    Okay. Let me wind up by saying, so the cause and effect 
relationship has not been established. However, antidepressants 
do successfully reduce symptoms of depression.
    In light of the suicide risk in depression, a prudent 
recommendation is that veterans, whether treated or untreated, 
must be appropriately monitored by clinicians.
    In conclusion, I would like the Committee to recognize that 
depression is itself a risk factor for suicide. To leave these 
men and women untreated is to accept suffering from the 
disorder itself.
    I thank the Committee for the opportunity to speak here 
today on this critically important issue.
    [The prepared statement of Mr. Leon appears on p. 66.]
    The Chairman. I thank both of you for your testimony.
    In your last sentence, Dr. Leon, I do not think anybody was 
ever suggesting not to treat people.
    Dr. Leon. Good. I am glad to hear that.
    The Chairman. You are setting up a false straw man there, 
but we will get to that.
    Mr. Teague, do you have any questions?
    Mr. Teague. No. For the second time, I will pass for right 
now.
    The Chairman. Mr. Rodriguez.
    Mr. Rodriguez. I was listening to the comments and I 
thought I heard that you indicated that the FDA looks at the 
top two studies to determine if they are positive.
    Is there a review of the literature before deciding on 
anything or is it just the two top positive studies? I guess 
both of you all can comment.
    Dr. Leon. Well, there will be very little literature on 
medication that has not been approved for sale in the United 
States. I mean, the literature is presented.
    And just as a clarification, the FDA does not just review 
the top two studies. They review all of the studies. But what 
is required for approval, it is one of the many criteria 
requirement, is that they have at least two positive studies.
    But when I was on the Advisory Committee, we reviewed data 
from all of the studies that were conducted with a particular 
medication.
    Dr. Breggin. Yes. The drug company can do as many studies 
as it wants. And, again, they are very heavily programmed by 
the drug company. And then it only has to submit for efficacy 
to get the drug approved only two studies that are marginal.
    When you put all those studies together, including the ones 
that were not cherry picked, say the five or six or seven 
others that each of the drug companies is doing, the most 
recent meta-analysis shows that, in fact, the drugs do not 
work.
    It is easy to pick a study that says the drugs are 
efficacious. We are looking at a mountain of evidence that they 
cause suicidality.
    I am very surprised at Dr. Leon's comments that suicidality 
has not been proven. He is willing to use two of the cherry 
picked studies to say there is efficacy and it has been 
approved by the FDA, but he is not willing to use the FDA's own 
studies, which the drug companies were forced to reevaluate, to 
use the FDA studies to show causality for suicidality. What is 
good for the goose is good for the gander. And this, I believe, 
is an extraordinary omission.
    And also he is contradicting the FDA's basic conclusion 
that the risk goes to age 24. It is in the Black Box Warning. 
Federal regulations require that there be evidence for 
causality before you have a Black Box Warning.
    Dr. Leon. Well, that is incorrect. Okay. The Federal 
regulations do not require evidence of causality. I have been 
involved----
    Dr. Breggin. The warnings.
    Dr. Leon. That is not correct.
    Dr. Breggin. I can get them for you.
    Dr. Leon. Dr. Breggin, you do not know what you are talking 
about. There are many things you have said that are incorrect 
and that was the most blatant error you have made today.
    Dr. Breggin. I think----
    Dr. Leon. I am speaking right now, Dr. Breggin. Thank you.
    Dr. Breggin. Mr. Chairman, I think you actually have the 
regulation.
    Mr. Rodriguez. I think if I have time, I would like to ask 
another question.
    Now that you are talking about suicides, one of the things 
you mentioned was that medication was reducing the deaths and 
attempts of suicides, however, that the suicidal thinking was 
still there.
    And so, how do you determine a situation such as that? 
Because I know that if you are working with an individual and 
he is suicidal during the period of time when you are engaged 
with them, a lot of times if they still have the suicidal 
thinking, as soon as you let them go, the possibility of 
committing suicide or attempts will probably come back, but 
when you continue to be engaged with them in the studies, 
closer the monitoring the less they are likely to do it?
    I think that is common sense. If I want to commit suicide 
and I am in a study, and you are watching me a lot closer, it 
is less likely I am going to kill myself or less likely to make 
an attempt; however, I still would have the suicidal thinking 
which you have indicated stays with them.
    So what did the medication actually do?
    Dr. Leon. Okay. Congressman, apparently I was not clear. I 
was talking about two different studies. The one study, that 
large observational study funded by the National Institute of 
Mental Health, we only evaluated, we only asked questions 
about--recorded information about suicide attempts and suicide 
deaths. We did not ask about suicidal thinking.
    So in that, we did not----
    Dr. Breggin. Why not?
    Dr. Leon. Why not?
    Dr. Breggin. Yeah. Why not?
    Dr. Leon. Well, we had to----
    Dr. Breggin. It is a very important clinical practice. It 
is a much more----
    Dr. Leon. Thank you.
    Okay. We had 28 years of followup at the time. We developed 
our assessment criteria back in the 1970s and the assessment 
criteria served as the standard for psychiatric research that 
is conducted today.
    We actually did ask about suicidal thinking once every 5 
years, but our weekly assessment records recorded suicide 
attempts, suicide deaths, all medications taken and----
    Mr. Rodriguez. But you said you only did it every 5 years?
    Dr. Leon. No, no. The suicidal thinking question was once 
only every 5 years.
    Mr. Rodriguez. Because I know that as soon as a person 
indicates any kind of tendency for suicide, a flag goes up. And 
so in the studies, you would think that would be accounted for 
because then the family is engaged also and thus it would be 
less likely for the attempt to occur. If other factors are also 
there, then it is less likely to occur without even any 
medication. And that just makes sense.
    But, you know, I guess we would have to see which 
prescription and which item because if the suicidal thinking is 
there, then it is still there. And as soon as you maybe take 
them off the support in terms of the family or anything else, 
whether they are taking medication or not, they might commit 
suicide.
    Dr. Leon. It is not like a clinical trial where a 
comprehensive assessment battery is administered every week or 
2 weeks and the medication received is controlled by the 
investigator. An observational study is very different.
    A randomized controlled clinical trial has very strict 
inclusion and exclusion criteria. Typically for 
antidepressants, it excludes about 80 or 90 percent of the 
patients who want to become subjects in the trial.
    An observational study on the other hand observes the 
treatment and the responses to treatment that subjects and the 
patients have and it also observes responses and the clinical 
course among people who are not treated. But in an 
observational study, the investigator does not have any control 
over the treatment. They receive the treatments that their 
clinicians choose to give them.
    Mr. Rodriguez. I ran out of my time. I do not know if you 
will allow Dr. Breggin to answer.
    The Chairman. Go ahead, Doctor.
    Dr. Breggin. Notice that Dr. Leon is using a noncontrolled 
study, a naturalistic study, which allows for multiple 
interpretations, multiple variables, all kinds of things going 
on in the practice, but is rejecting the gold standard that 
gentlemen like Dr. Leon always said was the gold standard which 
are the controlled clinical trials.
    Every single study, save maybe two that I read to you 
today, the epidemiological studies and the clinical trials, 
were all controlled. He is basing his rebuttal or his argument 
on uncontrolled data. And that is notoriously not good for 
determining causation.
    Mr. Rodriguez. Now, how do you determine uncontrolled data?
    Dr. Breggin. There is no control group to the work he is 
doing. He is just looking at collaborative unity.
    Dr. Leon. That is incorrect, Dr. Breggin.
    Dr. Breggin. But it is not a controlled clinical trial.
    Dr. Leon. No. The difference as a researcher, as a----
    Dr. Breggin. For causation, it is not as good, period.
    The Chairman. Let Dr. Leon answer, please.
    Dr. Breggin. Sir, you are an epidemiologist.
    Dr. Leon. I am a biostatistician. I have designed dozens, 
hundreds of trials, Dr. Breggin. And the difference is we did 
have a control in our observational----
    Mr. Rodriguez. In layman's term, control means you have a 
group on one side and a group on the other? Is that correct?
    Dr. Breggin. That are identical but receiving different 
treatments and you do not know which one is which.
    Mr. Rodriguez. Okay. I understand.
    Dr. Breggin. You did not have that.
    Dr. Leon. The investigator and the subject do not know, the 
patients do not know which one is which. But we did have a 
control in our study and that was the control that we see out 
in the general population, subjects either--I mean, those with 
depression in the general population, those veterans with 
depression are either treated or they are not treated. Our 
control in our observational study was some subjects received 
antidepressants, the other subjects did not receive 
antidepressants.
    The Chairman. Is an observational study just based on data 
or are you looking at people in real time?
    Dr. Leon. Oh, no. We are watching them over time and this 
was 28 years of followup. It is called observational because we 
observe but manipulate the treatment that is received.
    The Chairman. Are you familiar with Heisenberg's 
Uncertainty Principle?
    Dr. Leon. Well, it applies if assessing the subjects has a 
therapeutic benefit.
    Dr. Breggin. The Heisenberg----
    The Chairman. Right. That is the point that Mr. Rodriguez 
raised, who has a lot of mental health background, that is if 
you are studying people and showing an interest in them, that 
affects----
    Dr. Leon. Wait, wait.
    The Chairman [continuing]. In and of itself----
    Dr. Leon. Absolutely, and that is----
    The Chairman [continuing]. Affects the outcome. That is, as 
Mr. Rodriguez said, if they are being watched and followed and 
advised----
    Dr. Leon. Yeah. That is----
    The Chairman [continuing]. That may be the effect of your 
observation, not of whether they are receiving or not receiving 
treatment.
    Dr. Leon. Yeah, absolutely. And that is the reason we 
included a control group in this, because they were also 
receiving those same assessments. So the change in 
psychopathology, the change in suicide risk that might be 
brought about by conducting the assessments would be held 
constant across the treated and the untreated groups.
    The Chairman. Okay. We will get back to that. Thank you.
    Mr. Rodriguez. Mr. Chairman.
    The Chairman. Mr. Walz.
    Mr. Rodriguez. I am sorry. I really need to add one 
additional question.
    The Chairman. Sure. Go ahead.
    Mr. Rodriguez. I know we are talking about veterans right 
now, but as it deals with kids, because I am really concerned 
about the medication given to kids that has never been tested 
on kids. And now I just wanted to see if you care to comment on 
medication for kids.
    Dr. Leon. Oh, absolutely. And I will tell you I was at 
several hearings on this topic at the FDA. And when we reviewed 
the antidepressants and suicidality in children and 
adolescents, those under age 18, there was a very big 
difference between the data that were available because with 
children and adolescents, we reviewed those data and there were 
only a few clinical trials that ever showed efficacy in 
children with antidepressants.
    Now, the one medication that showed efficacy in children in 
more than one trial was fluoxetine, Prozac. That is the one. 
And they did get an indication or approval from the FDA. So the 
risk-benefit ratio when we look at most medications, in most 
antidepressants in children, there is not a well-established 
benefit.
    So a very small risk really raises alarm. However, in 
looking at adult data, there is a great deal of data showing a 
benefit of antidepressants. There is several decades of data 
available showing us that there is a benefit.
    So then when we look at a very small risk and a very large 
benefit, the risk-benefit ratio is much less alarming. It 
cannot be ignored completely. Instead what we need to do and 
what we insisted on when we were helping the FDA, advising the 
FDA in putting together the Black Box Warning, we, and I have 
looked at the transcripts of our meetings to confirm this, 
those of us who voted for a Black Box Warning, and I voted for 
the Black Box Warning, for antidepressants both in kids and in 
adults, and it is because I saw from these data, no, I cannot 
say there is no risk at all. I want the clinician to be aware 
of the risk. I want the patient to be aware of the risk and I 
want the family members to be aware. There is a very small 
risk. If we see any hint of agitation, hostility, akathisia, or 
suicidality, contact the physician immediately so we can deal 
with that problem.
    The Chairman. Thank you.
    Mr. Walz.
    Mr. Walz. Well, thank you, Mr. Chairman, for holding this 
hearing. As usual, you are a strong advocate for making sure we 
get things right as we care for our veterans.
    And I want to thank both of you for coming.
    Dr. Leon, you did mention that our ultimate goal here is to 
make sure we provide the ultimate care to our veterans and I am 
appreciative of that statement.
    Just a couple things. And it might either be the 
schoolteacher in me or the parent of a small child, I want to 
bring us back to something we can agree on on this. And I 
appreciate listening to both sides of this. Just a couple 
things.
    Am I right, in the Black Box Warning on this, I am trying 
to get this side of it, then bring it back to the veterans' 
care, the Black Box Warning just it may increase the risk of 
suicidal thinking? That is where it came from. If I am right, 
there was about a 4 percent rate amongst those children who 
were looked at?
    Dr. Leon. Well, yeah. In children, I think it was at 3 
percent.
    Mr. Walz. And it was amongst children is where it was put 
out on that. Okay.
    Dr. Leon. Okay.
    Mr. Walz. And NIH does go on to say SSRIs can be beneficial 
and FDA says the benefits far outweigh the risk.
    Now, my question to you, Dr. Breggin, and I am very 
appreciative of this on interactions and how things come 
together, do you believe there are any benefits or places where 
antidepressants should be prescribed?
    Dr. Breggin. I think they do more harm than good. In this I 
am certainly in a position that is different than most 
psychiatrists who practice psychiatry and I do not want that to 
influence all the science I am presenting, the controlled 
clinical trials, on the viewpoint on the suicidality.
    In my experience the way antidepressants work, if they do 
work, is they cause either apathy or a mild euphoria. We are 
now seeing patients who have been on these drugs for 5 or 10 
years and they have lost their interest in life. It is an 
incredible tragedy. They do not love anymore. They do not care 
as much. They have lost their musical abilities. The drugs do 
not have a magic way of fixing depression, which is basically a 
loss of hope. Depression is where a person feels so bound down 
in choices, or----
    Mr. Walz. You do not think there is any physical evidence 
on serotonin, and----
    Dr. Breggin. Oh no, sir. There is not. There is not. The 
way that----
    Mr. Walz. I say this coming from Minnesota, where the sun 
does not shine much.
    Dr. Breggin. Well certainly I get a little more depressed 
myself in the wintertime, sir. I turn to my wife for solace 
rather than to an antidepressant. But no, the way that the 
imbalance theory came about is that even before Prozac was 
approved by the FDA, Eli Lilly sent doctors that they paid out 
to talk about serotonin imbalances. But now that the SSRIs are 
sort of running out the market, overwhelming the market, now 
they are talking about drugs like Effexor and other drugs, 
Cymbalta, that affect more than one neurotransmitter.
    Mr. Walz. I am going to go to two questions, then, for both 
of you. I was going to, and it might be for the next panel I 
will ask on this issue of I represent the Mayo Clinic area so 
some of the research I try and stay up on, and some of the 
drugs that are purported to stimulate neuron growth and some of 
those things. I would be interested at some point, maybe I will 
save that for the next panel but to plant this for both of you. 
Here is what I want to see is, if we can agree on this. And I 
heard Dr. Leon say it, and he ended his testimony with it. And 
I think this is a critical point. We must be monitoring people. 
And I am going to come back to people in this room who know I 
am a broken record on this.
    The key, as we transition these soldiers who we are talking 
about and these veterans, is the coordination of their care 
from DoD to VA. And the, am I hearing from both of you, whether 
you believe that there is an issue for pharmaceuticals, or an 
issue for psychotherapy, or whichever a combination of them, or 
what is best, the real issue here is, and the real threat on 
suicides and mental health, mood, depression, PTSD, or whatever 
it is, is if there is not monitoring. If there is not a clean 
hand off of care. If there is a veteran who is not getting a 
coordinated care on this, and may or may not be on 
antidepressants but his new physician may not know about that, 
or she may not be seeing someone. Is it fair for me to say that 
the both of you would agree that there may be the greatest risk 
of suicide in that lack of attention to them during this 
handoff period, or lack of coordination?
    Dr. Leon. I would say that there, the risk of suicide would 
be elevated if clinical attention is not paid to the patient as 
they are switching from one source of mental health care to 
another. As a point of clarification, I do want to point out 
that I also support the use of psychotherapeutic interventions 
for many psychiatric disorders, including depression. And I 
have published many clinical trial results----
    Mr. Walz. It is not an either/or.
    Dr. Leon. Oh, it is not an either/or. And we have published 
combination studies, medication and psychotherapy.
    Mr. Walz. But Dr. Breggin, you do not take that same 
position? Is it an either/or for you that----
    Dr. Breggin. I think the antidepressants are ineffective, 
but I do not think it is the key here to the hearing. It is not 
what I am here to talk about.
    Mr. Walz. Is this care issue important? This handoff?
    Dr. Breggin. Well, first about the monitoring. Remember 
that all of the controlled clinical trials where they got the 
doubling of the suicidality were heavily controlled and 
monitored, much more so than anything the military could ever 
produce in routine clinical practice. So while monitoring 
helps, that we agree on, in fact the best data we have on 
suicidality are from very heavily monitored control groups and, 
you know, clinical studies with placebo control groups. So I 
would say yes, we have to increase the monitoring if the drugs 
are going to be used. You always have to monitor people who are 
suicidal. The reason I have never had a suicide in my practice 
is because when somebody is suicidal I monitor them. They get 
my home and cell phone, they get all my phone numbers, they get 
whatever they need. You have to monitor in order to help people 
not be suicidal, not harm themselves.
    Mr. Walz. I will yield back my time, Dr. Leon, and it may 
come back up again. But I will let the rest of the Members ask. 
But I appreciate both of you coming today.
    The Chairman. Thank you. Mrs. Halvorson.
    Mrs. Halvorson. Thank you, Mr. Chairman. And thank you, Dr. 
Leon, and thank you, Dr. Breggin. First of all, Dr. Breggin you 
said, and I came in late so I apologize for not hearing the 
entire testimony. But you said, ``They don't work.'' Well, 
according to your testimony you said that they need to be 
curtailed. I hate to throw the baby out with the bath water 
but, you know, my whole remarks were going to be exactly what 
Congressman Walz said.
    This is not about the two of you arguing over whether we 
need them or we do not. This is about our veterans. This is 
about the fact that they are not getting the care that they 
deserve. This is about the fact that while they are in theater, 
or while they are under the care of the Department of Defense 
and then they are turned over to the VA, that the way that they 
are taken care of and the way that they are decided on how 
their disabilities are calculated, that they are different. And 
so when they go into the VA system they feel like they have 
been shafted somehow. And I hear it everyday. And I just think 
that we, I know you are here to discuss about the 
pharmaceuticals, and whether that, but we have lost more of our 
young men and women due to suicide than combat. And we need to 
do something about taking care of our veterans so that we are 
monitoring them, we are taking care of them, that they do not 
feel like there is a loss out there, that they do not feel good 
about themselves.
    It is not about the fact that there are the medications 
that do not work, or that they are on medications versus should 
they or not. And it is not directed at you personally. However, 
I think the debate that we need to be having here, and the 
debate that we need to continue to be having, the bottom line 
being we are not taking care of our veterans the way that they 
deserve to be taken care of. And it is not about whether they 
are on medication or not. It is whether when they leave the 
service and go into the Department of Veterans Affairs that we 
need to be doing a better job of monitoring and taking care of 
them so that they feel a part of society again. That we give 
them the best hope, that we give them the health care and the 
best economic opportunities.
    So we can argue everyday until the cows come home that we 
either curtail the medication, that it does work or it does 
not, but we cannot paint every medication with the same brush. 
We cannot throw them all out because you say that they do not 
work, because I know plenty of people that need them. So we 
have to monitor people. We have to do it the right way. But the 
bottom line here is we need to take care of our veterans the 
way that they deserve to be taken care of.
    Dr. Breggin. I am in total agreement with you. One of my 
major concerns is that one of the major, if not the major, 
reason that soldiers and vets are disappointed with the 
treatment they get is that they get medication automatically 
pretty much when they go to a VA clinic or when they go and 
report to a corpsman or somebody else, and express that they 
have depression. Literally, they are staying away from 
treatment because they do not want the stigma of the diagnosis 
and they do not want to be on the meds. So I think that the 
government, that the military is moving in the right direction 
with a whole bunch of new education programs where they are 
encouraging the sergeants, and the corporals, to be able to 
talk to the enlisted men. And they are encouraging screening, 
and they are encouraging education on self-empowerment. You 
have some studies going on overcoming learned helplessness and 
learning to handle your emotions. I, you know, that was not my 
subject for today. That was going to be Bart Billings' 
subject----
    Mrs. Halvorson. Well so, in other words, diversity in your 
portfolio. You cannot throw out drugs completely but we need to 
add a few other things to go along with that. Dr. Leon, I do 
not know if you want to add anything to that?
    Dr. Leon. Yes, I agree with you. What is important 
particularly, since we are talking about medication today I 
will focus on medication in responding to your question. What 
is most important is those first few weeks that a patient 
starts on an antidepressant. Monitoring is critically 
important.
    Mrs. Halvorson. Right.
    Dr. Leon. I mean, they have to be in touch with the, a 
physician has to follow up with the patient maybe more than 
once a week, a couple of times a week, and continue to do that 
perhaps for the first 4 or 5 weeks. But definitely stay in 
touch. It cannot be that, ``Here are 90 pills. Come back in 3 
months.'' That is thoroughly irresponsible and it is very----
    Mrs. Halvorson. Which, the people I talk to they are not 
even just handed medications automatically anyway. But, and I 
know I am running out of time. But I just want it to be known 
that it is not as easy as everybody thinks, that automatically 
they claim they have depression and they are handed a pill. 
From what I see, and from, what I hear from my advisory 
Committee, from the people who come in, because I have a full-
time veterans caseworker. You know? And I have more people who 
come in to say that they are not getting the help that they 
need with regards to their depression than the people who say 
that they are just given a pill and told, ``Take this and all 
your worries will go away.'' So I yield back. And hopefully as 
we move along through this I would love to continue that 
discussion.
    The Chairman. Thank you. Mr. Donnelly. Passes. Dr. Roe.
    Mr. Roe. Thank you, Mr. Chairman. And thank both of you for 
being here today. I was, Dr. Breggin, enthralled, but just a 
quick question on neurobiology. Not something I want to go back 
and study very much, but a very complicated subject. But you do 
not subscribe to any neurobiology? Any chemical changes in your 
brain that might have something to do with depression?
    Dr. Breggin. Well we know----
    Mr. Roe. Do I understand that right?
    Dr. Breggin. Sorry, I interrupted you. Yes, sir?
    Mr. Roe. No, go ahead.
    Dr. Breggin. We know that some diseases and disorders, 
dementia, can lead to depression. We know that diabetes can 
lead to depression. But we do not know that any routinely 
treated psychiatric disorder has a specific biochemical 
component. Now the human brain, sir, is, literally each one of 
our brains is more complicated than the total physical 
universe. In other words, there is more going on inside our 
brain than a physicist is looking at when he is looking at the 
whole of the universe. That is how complicated neurochemistry 
is. To think that the five or six neurotransmitters that have 
been partially studied, we do not even have their subtypes----
    Mr. Roe. Not to interrupt, but I agree with you that it is 
an extremely complicated subject. But I do believe there is 
some neurochemistry going on. Dr. Leon, do you have a comment?
    Dr. Leon. I am not a psychiatrist. I am a biostatistician. 
But I do understand from my colleagues that the neurobiology of 
depression and the neurobiology of suicidality has been fairly 
well studied. And although it is, not all components of the 
brain that are implicated in depression might not have been 
identified, there is clearly some systems that have been well 
implicated to trigger depression.
    Mr. Roe. A couple of things. I want to go back to, so you 
can clarify, because I have dealt with this as a practicing 
physician for over 30 years on the black box warning. And 
second, Dr. Breggin it was a little bit, your discussion about 
how the FDA approves a drug was a little misleading to a non-
medical person, I think. Assuming that a drug company goes out 
and performs some studies and then they can just pick which 
ones they send to the FDA. And Dr. Leon you are carrying, that 
is the impression I got. And can you carry on with that? And 
then you can answer, Dr. Breggin.
    Dr. Leon. Yes, certainly. Well, if we take a hypothetical 
situation where a pharmaceutical company has a program for a 
new molecular entity, that they want to see if this drug might 
work with this depression, they might conduct four or five 
clinical trials. And they will collect all of those data, 
submit all of the results from all of those data to the FDA. 
All of the data. I mean, that is required by law, to submit all 
of those data to the FDA. Now, the FDA does not, has standards. 
At least two of those trials have to be positive but also they 
have to show a clinical meaningful effect. So a trivial effect, 
or as Dr. Breggin said a marginal effect, would not be 
approved. The FDA, I can only speak for psychopharmacologic 
agents but I have seen it many times. They want to see that the 
magnitude of the effect is clinically meaningful.
    Mr. Roe. Dr. Breggin.
    Dr. Breggin. I certainly did not mean to give a 
misimpression. My point was very simple, that the drug 
companies can conduct as many studies as they want. They do get 
submitted to the FDA, of course. But they only need to cherry 
pick two that show efficacy. Now, it is not quite, I believe, 
the way Dr. Leon says. I have cited in my book a discussion 
within the FDA between Paul Lieber, who was the head of the 
psychiatry section at the time, and his boss Rob Temple about 
how the approval of Zoloft was so marginal they were 
embarrassed to do it, and how it had not been approved in 
Europe.
    And secondly, Dr. Leon is incorrect, giving an incorrect 
impression when he says they send all the data to the FDA. The 
data if it were, let us say, in boxes would fill this room. 
Now, I have gone through that kind of data. And I have said to 
the FDA, ``Hey, I have gone through the Prozac data. I can show 
you the suicidality.'' All of that data is not looked at by the 
FDA. The FDA looks at generally the summaries and the reviews 
sent into them. They do not have the manpower or the interest 
to look at all of the data or to go back and find it.
    Mr. Roe. I want to go ahead with my question because my 
time is short. We are here to talk about veterans and treatment 
of veterans. And we had 400 and something veterans last year in 
America commit suicide. And I think what we need to do, as an 
observational study, is to see the ages of those veterans. 
Whether they had or had not been in the VA, whether they had or 
had not had treatment. To me that is pertinent information. 
Were they older veterans? I am a Vietnam Era veteran. Is it 
Vietnam Era? Are they new veterans? Where are these suicides 
occurring?
    And I also, and I will leave it at that because my time is 
expired. But I had two cases of, in my 31 years of suicide, in 
patients of mine. One I did not see coming from anywhere. It 
was absolutely none whatsoever. The other patient, after 20 
years of treating with you it was not a surprise to me. I am 
astonished that in all of your years of practice that not even 
a single patient ever committed suicide. And of course, some 
may have been lost to follow up. I understand how that goes.
    Dr. Breggin. Oh, of course. Well sir, I think I am lucky. I 
think I am blessed. And I really, really care about my 
patients. And I really, really work hard. And I did not even 
have a serious suicide attempt from 1968 to the present until 
this year in a young man who was new to my practice and who was 
having serious difficulties.
    I believe that as a professional if you really get involved 
with your patients, if you really care about them, they can 
call you any time of the day or night, you are willing to even 
see them for free for an extra time if they do not have the 
money. You want to see their moms, their dads, their kids, and 
bring the family together to help them care about each other. 
And you have blessings, that suicide becomes extraordinarily 
rare in my experience.
    Mr. Roe. I had even read studies, Dr. Breggin, though, that 
when psychiatrists interfered with a patient, the suicide rate 
went up. So you can read anything in a study. I yield back my 
time.
    Dr. Breggin. Well, I believe that, sir. That is maybe the 
drug effect, sir. And the demeaning experience of getting a 
label rather than being told there is hope, that you can master 
the issues that are overwhelming you, that the doctor can work 
with your wife and you, or your husband and you, over the 
issues that are demoralizing you. That the, what has happened 
to you in the service can really be dealt with, you can get 
that support and hope. And that is what really matters. It is 
the hope and guidance you get toward a better life when you are 
depressed, how to find your way out of it.
    And by the way, I could not make, I am a public figure. If 
I made these claims falsely about no suicides, people would 
line up.
    Dr. Leon. Not the suicide deaths.
    Dr. Breggin. No, their families would. They would be suing 
me. A public figure like me? It would be on the front pages of 
the American Psychiatrist Association newspaper, Doctor sued 
for suicide in his practice.
    The Chairman. Okay. Thank you both. Dr. Leon, you mentioned 
in your opening statement that you had mostly been funded by 
NIH, and served as a consultant to FDA, NIMH, and to industry. 
I am just wondering which industries you were consulting to?
    Dr. Leon. I have worked with, which company?
    The Chairman. Yes.
    Dr. Leon. Pharmaceutical company? I have worked with quite 
a few of them. Right now, as a matter of fact, I monitor the 
safety of subjects who are enrolled in trials by, conducted by 
Pfizer and by Astra Zeneca.
    The Chairman. I mean, how about some of the common 
antidepressants. Have you been consultants on those?
    Dr. Leon. Most of the common antidepressants were approved 
in the late, well Prozac was the late 1980s. No I did not work 
on any of the Prozac. And most of the SSRIs were approved in 
the early to mid-1990s. I did not work on any of those. The 
safety and monitoring work I have done maybe the last 4 or 5 
years.
    The Chairman. A couple of things--yes, please, Dr. Breggin.
    Dr. Breggin. I am concerned that Dr. Leon implied that I am 
not always telling the exact facts. The Federal regulations are 
cited per page in the report I gave you that say you have to 
have reasonable evidence of causation. And I believe that you 
can find them there. And I think that Don Farber, the attorney, 
will draw your attention as well to those Federal regulations.
    The Chairman. Okay, thank you. The thing that struck me 
getting into this subject was that there was a lot of media 
hype, there was a cover story on Newsweek, for example, that 
said the way we were treating these issues in active duty was 
basically to just throw pills at them, getting them back onto 
the front lines, or getting them back into battle. We did not 
want to lose them from the battlefield, basically. From reading 
your books, and seeing and hearing what you said, even hearing 
what Dr. Leon said, that is very, very dangerous in that they 
are not being monitored. They are being thrown some pills, at 
least this is my sense, and I do not know how true it is. If we 
had commanders here testifying I do not know what they would 
say.
    It appears from testimony we get from our own constituents, 
that when given pills, you are not going to read the black box 
and you are not being monitored. And guess what? We have 
incredible numbers of suicides. I think it was Dr. Breggin who 
stressed that there is other violence besides suicide. You 
cannot just study suicide. The last time I saw this, and it has 
probably been updated, the New York Times reported that a third 
of our young men and women who have been diagnosed with PTSD 
had already committed felonies of which several hundred were 
homicides. That is often their own spouse or their kids. These 
kids did not come home to kill their spouse or their children, 
but something happened, whether it is the PTSD, or the 
treatment. It seems to me that these servicemembers may not 
show up at the VA anyway and may not get any treatment 
whatsoever. They may be taking these pills without being 
monitored. It looks to me that that is what is happening. We 
are throwing pills at them, they commit suicide, and they 
commit homicide. It is not everyone but there is so much of it 
that as a policymaker I have to be concerned. Dr. Leon, 
although you guys had differences in some fundamental things 
you would not advocate that active-duty servicemembers are 
given these pills without further monitoring. I think that is 
what is happening. I am sure you would not be in favor of that?
    Dr. Leon. Oh, absolutely.
    The Chairman. But I do not think it can happen. In the 
nature of what war is, it is hard to monitor. If the 
psychiatrists or the commanding officers who are with these 
troops think that you can just throw the pills at them, that is 
a pretty dangerous solution. That is what I am trying to get 
at. When they become veterans we may not even see them until it 
is too late and we do not even know about all of their records, 
as Mr. Walz pointed out.
    Dr. Leon. Well as the black box warning says, there are two 
or three main points----
    The Chairman. I know, but they do not see the black box.
    Dr. Leon. No, no, no. But I just want to paraphrase from 
the black box to respond to you. The concern is, one is the 
depression itself is life threatening. So some kind of 
treatment, some type of intervention is needed.
    The Chairman. You said, here you wrote, ``Depression 
increases risk of suicide and antidepressants decrease 
suffering from depression.'' It seems you have not included the 
problems, and the probability of the problems. That is, I read 
all the baldness side effects because, and it says, ``We will 
treat the baldness but you are going to be sexually impotent.''
    I do not see where the following of depression reduces the 
risk of suicide, and drugs decrease suffering, therefore, you 
argue, you have to take the drugs. I would argue, therefore, 
you have to explain the risks. You have not judged those risks, 
so I will have less depression but I will go out and commit 
suicide. It sounds to me like that is what you are saying.
    Dr. Leon. All right, no. I agree with the first two points 
you made, but I did not say, therefore, drugs have to be used. 
I said, my third point was to reduce the risk of suicide 
clinicians must carefully monitor our veterans whether they are 
treated or untreated. And the ones who are treated, I mean, 
some might have mild enough depression they just need a 
watchful eye. Some of them might need psychotherapy. Others, a 
short-term psychotherapy, I am not talking about 10 years on 
the couch, but a short-term psychotherapy like cognitive 
behavioral therapy which has been shown to work for depression. 
But others with more severe depression will probably do better 
by taking antidepressants. And that is----
    The Chairman. Well I would be afraid to go to you if I was 
depressed. Because you are telling me that it is most important 
to get rid of the symptoms of depression. You will tell me that 
maybe suicidality will occur. What Dr. Breggin is saying is 
this is the fundamental distinction. You say in your testimony 
the cause and effect relationship has not been established. Dr. 
Breggin says it has been established. Why the difference? 
Obviously that affects the therefores, right? It seems to me he 
established it. Why do you not think he has?
    Dr. Leon. Well, Dr. Breggin is not a scientist and he does 
not primarily rely on----
    Dr. Breggin. Wait, wait, wait, wait, wait. I have written 
dozens of articles----
    The Chairman. He is a psychiatrist.
    Dr. Breggin. I am the editor of----
    Dr. Leon. Dr. Breggin is not an empirical scientist. I want 
to make a couple of points.
    The Chairman. Well that may be a compliment, by the way. 
Empiricism in and of itself is not science either, frankly.
    Dr. Leon. Okay. A couple of points----
    The Chairman. Because of the uncertainty principle and 
other things.
    Dr. Leon. A couple of, a couple of----
    Dr. Breggin. See the desperation----
    The Chairman. Let him talk.
    Dr. Leon. A couple of points of clarification. Please do 
not come to me for treatment of depression. I am a Ph.D., I am 
not an M.D. I am a biostatistician, I am not a psychologist. I 
do not have a clinical practice, I do not have a license.
    The Chairman. You are saying he is not a scientist and you 
are not a doctor. Why should I listen to you?
    Dr. Leon. I am not a physician, that is correct, but I am a 
biostatistician with over 20----
    The Chairman. I would say you lie with statistics. You seem 
to be saying empiricism, he is not an empirical guy. I would 
say empiricism is a lie. So how do you respond to that?
    Dr. Leon. Well respectfully, Congressman, I disagree with 
you. Statistics used appropriately with methods that are 
defined before seeing results are, can be used to help guide us 
to help treat veterans in the most important----
    The Chairman. Only if you have some judgment there with it.
    Dr. Leon. Right. I do want to make another point of 
clarification. We do hear about these tragic deaths. And each 
one of them is a terrible tragedy, and a great deal of 
suffering for any family. But I do want to make a point that 
the number I have in front of me is from 2005, but there were 
180 million antidepressant prescriptions filled in the United 
States. One hundred eighty million, that might translate to, 
what, 20 million, 25 million took antidepressants in 2005. And 
we hear about, so that is the group at risk of, those exposed 
to antidepressants are the group at risk of treatment induced 
suicidality. We do not hear about those 180 million, or 20 
million patients. We hear about the handful of tragic cases 
that destroyed families. And those, that is why----
    The Chairman. When you say a handful, it is out of a 
controlled study. We have not done a controlled study of those 
25 million, right?
    Dr. Leon. The 25 million? No, no. No, that is the data from 
antidepressant prescriptions----
    The Chairman. Right. That is how many people are taking it. 
But you have said, we cannot study 25 million people. So we do 
a controlled study of several thousand.
    Dr. Leon. Oh yeah, absolutely.
    The Chairman. His conclusions come from that, those 
controlled studies. Why do you dispute that it is not a 
causality?
    Dr. Leon. Oh, because the controlled studies do not provide 
definitive evidence of a causal link, particularly in adults. 
There is no association of an, there is no evidence of an 
increase in risk of suicidality when an adult takes an 
antidepressant. The data are very clear. For the older 
patients, it actually protects them. I imagine quite a few 
veterans in the United States are 65 years of age and older. 
The data are very clear, the risk of suicidality is absolutely 
reduced. For those between 18 and 65, we do not see an 
elevation in the risk of suicidality. For those under 18, the 
evidence is very different, and I am not advocating the use of 
antidepressants for those patients.
    The Chairman. Okay. Just to conclude the panel, do you want 
to respond to that?
    Dr. Breggin. Yes, just briefly. First, let me indulge 
myself and describe my scientific credentials briefly since he 
has literally said I am not a scientist. For example, I was the 
scientific presenter at the Federal NIMH Consensus Conference 
on ADHD and Its Treatment on the subject of adverse effects of 
psychiatric drugs. I was the only scientist on that issue. I 
was the scientist at the Consensus Conference by NIMH on 
Electric Shock on the specifics of the biochemical and 
biological injuries from electric shock. I have been a 
consultant to the Federal Aviation Administration on whether 
fliers should be allowed to use drugs like Zoloft. I am an 
editor on the International Journal on Risk and Safety in 
Medicine, which is the scientific journal that does risk and 
safety. And I founded a journal called Ethical Human, well now 
called Ethical Human Psychology and Psychiatry, with 50 board 
members, many of them renowned scientists. And I have published 
dozens of scientific peer-reviewed articles. And finally, I 
have written a very scientific tome called Brain Disabling 
Treatments in Psychiatry, which is in its second edition, but 
really its third or fourth, by Springer Publishing Company, a 
premier scientific publisher.
    I would like to point your attention to one last thing. 
Which is the Veterans Administration has done one study, and I 
think that it provides you an opening for looking more deeply 
into this issue. And it is the study by Valenstein in 2009, 
which involved a group of 887,000 vets and found this increased 
rate of suicides and suicide attempts in vets soon after they 
were started on the newer antidepressants. That gives you a 
beginning of how you might sponsor or encourage research in 
this area and I would be happy to contribute to any thinking 
that you do in that area.
    The Chairman. Thank you. Dr. Roe.
    Mr. Roe. Just one brief comment. I do want to stand in 
defense of the Department of Defense. I have been a battalion 
surgeon in an infantry battalion, in an infantry division 
overseas. And we do not just write prescriptions and throw them 
at patients and let them walk out the door, I can tell you 
that.
    The Chairman. Where were you?
    Mr. Roe. In Korea. And at the demilitarized zone in Korea, 
Second Medical Battalion, Second Infantry Division.
    The Chairman. What year was this?
    Mr. Roe. 1973 and 1974.
    The Chairman. So you were not there during the Korean War.
    Mr. Roe. It was not during the Korean War, no. It was a 
little after that. But the point is, is that I think we have 
some very fine physicians and medical people in the Department 
of Defense. And I do not know whether they are going to, if 
that is part of the next panel, and it probably is. But anyway, 
I just want to make that clarification, that that is not the 
way I saw patients treated.
    The Chairman. I would not argue with you based on your 
experience. During combat situations when you are suffering 
because of the volunteer Army and there is a shortage of 
people, you are not doing anything to get people off of active 
duty, you want to keep them there. All of the testimony that I 
have read, and all of the talking to soldiers, and young 
veterans, is that clearly there are some ethical things that 
any doctor should address. Basically, they want to get them 
back onto the front lines as soon as possible and psychiatry or 
counseling is not the quickest way. We give them a pill, they 
will feel better, and go back. The problem is when they get 
finished with battle or go home, they do not feel good.
    We thank both of you for your testimony. You have obviously 
started an important discussion, and we will continue it with 
Panel Two. Thank you again, you will be excused.
    Dr. David Rudd is Dean of the College of Social and 
Behavioral Science at the University of Utah, who is here on 
behalf of the American Psychological Association; Annelle Primm 
is the Deputy Medical Director for Minority Affairs at the 
American Psychiatric Association (APA); and Commander Donald 
Farber, Retired, comes to us from the U.S. Navy in San Rafael, 
California. Thank you all for being here. Dr. Rudd, if you will 
begin and because we have votes coming up we want to limit your 
oral testimony to 5 minutes. We have your written testimony for 
the record.

  STATEMENTS OF M. DAVID RUDD, PH.D., ABPP, DEAN, COLLEGE OF 
  SOCIAL AND BEHAVIORAL SCIENCE, THE UNIVERSITY OF UTAH, SALT 
LAKE CITY, UT, ON BEHALF OF AMERICAN PSYCHOLOGICAL ASSOCIATION; 
ANNELLE PRIMM, M.D., MPH, DEPUTY MEDICAL DIRECTOR FOR MINORITY 
   AFFAIRS, AMERICAN PSYCHIATRIC ASSOCIATION, AND ASSOCIATE 
  PROFESSOR OF PSYCHIATRY, JOHNS HOPKINS SCHOOL OF MEDICINE, 
   BALTIMORE, MD; AND COMMANDER DONALD J. FARBER, ESQ., USN 
                     (RET.), SAN RAFAEL, CA

            STATEMENT OF M. DAVID RUDD, PH.D., ABPP

    Mr. Rudd. Yes, thank you, Chairman Filner and Members of 
the Committee. I want to express my appreciation for the 
opportunity to testify here on behalf of the 152,000 members 
and affiliates of the American Psychological Association 
regarding the relationship between veterans suicide and 
medication.
    I do not want to repeat some of the previous testimony, and 
so I am going to summarize a number of points and emphasize a 
few additional points regarding this issue. Confusion following 
the warning label has been shared among both practitioners and 
the general public, and I think that is a critical issue, is 
that the warning label has created considerable confusion. I 
think it is confusion that was evidence when you looked at some 
of the previous testimony. There are a number of facts as a 
part of this that are oftentimes overlooked.
    First, that there were no suicides in the original 
pediatric and adolescent clinical trials, and that is a total 
of 4,400 patients. There simply were no suicides in those 
original trials that drove the warning label. Although there 
were suicides in the adult trials, as was stated previously, 
the number was not sufficient to reach any conclusion about 
drug effect on suicide. They were comparable across both the 
clinical arm of the trial as well as the placebo arm of the 
trial.
    Given the failure to demonstrate any clear relationship 
between medications and death by suicide the warning label 
focuses broadly on the issue of suicidality and that includes 
suicidal thinking as well as suicidal behaviors. And I think it 
is important to recognize that when we talk about suicidality 
in terms of these findings it is defined as present or absent. 
So we do not know the severity of the suicidal thinking. There 
is something very different between having suicidal thoughts 
and having suicidal thoughts with definitive plans and intent 
to act on those thoughts. That is something that gets lost in 
this discussion and I think it is a critical part of that 
discussion. It is one thing for an adolescent to have a thought 
about suicide. It is another to have a definitive plan, 
motivation, and intent to act on that thought. And you can say 
the same thing about suicidal behaviors. When we look at the 
frequency and occurrence of suicidal behaviors in this 
literature there is not a distinction between lethality of 
behavior. So we are simply talking about the presence of a 
suicide attempt, what is defined as a suicide attempt, what is 
defined as a suicide attempt in the absence of that. So we do 
not have any understanding of those suicide attempts, the 
lethality, the potential lethality of those attempts. And those 
are a couple of critical variables that would really help us 
understand the nature of this risk much more clearly.
    There are a couple of other points to make about the 
confusion that has been created among both practitioners and 
the general public, including the follow up periods for these 
various drugs are very short. We are talking about a period of 
a few weeks to several months. So we simply do not know the 
duration of the effect. We do not know if in fact the increase, 
the increase in suicidality, does it endure for more than a few 
weeks? What are the recovery curves? Do people experience this 
only in the initial phase? How long does it endure over the 
long haul? And ultimately, how does that impact treatment and 
eventual recovery, which is very much a critical variable.
    Another point, neither the warning label nor the medication 
guide provides any specific information about age-related data. 
A point that was made earlier is that there is no risk for 
adults, that that evidence is fairly clear in terms of an 
escalation of risk for adults. And in fact in the elderly, 
there is good evidence, and I would tell you very compelling 
evidence, that antidepressants actually reduce risk for the 
elderly population and that is the group in which suicide risk 
is the greatest. And that is by a fairly significant margin.
    And then a final point to make is that as evidence of the 
confusion that has been created by the warning label in some of 
this literature, we did a small study that looked at general 
practitioners, and looked at the issue of whether or not 
general practitioners, who prescribe the overwhelming majority 
of antidepressants in this country, understand the warning 
label. Ninety-one percent of the general practitioners made 
errors in their understanding of the warning label, believing 
that the risk was actually for death. The worry is that they 
communicate that to patients and that we are not accurately 
communicating to patients the nature of risk, and as a result 
can reduce the likelihood that people will actually pursue care 
and be willing to receive care during these periods of high 
risk.
    Given that as high as 75 percent of depressed adults 
looking for treatment receive medication and an estimated 50 
percent of adults receive both psychotherapy and medication, it 
is a critical issue for veterans. I would tell you that it is 
more likely than not that the majority of depressed, anxious 
individuals, those suffering PTSD, that receive care are likely 
to look at medications as well as psychotherapy as an 
alternative. Unintended consequences of the warning label are 
something that we really need to guard against.
    A few points that I would like to make about the 
effectiveness of behavioral treatments. I think it is important 
to recognize, and I understand my time is passing fairly fast 
here. But I wanted to make a few points about the efficacy of 
psychotherapy. We now have a number of studies, as has been 
mentioned previously, in terms of cognitive behavioral therapy, 
cognitive processing therapy, prolonged exposure, that are very 
effective for depression, that are very effective for post 
traumatic stress disorder, as well as a range of anxiety 
disorders that emerge following combat experience and they are 
relatively simple to do. The behavioral treatments that are 
available today are manualized treatments. We know how to do 
them well. We can train individuals to provide that care and do 
it with very high fidelity. And we now know that they are very 
effective in reducing the rates of suicide attempts following 
treatment. And I would tell you currently the data I think is 
fairly overwhelming, fairly compelling, that the best approach 
is the combination of medicine as well as behavior therapies 
for these kinds of problems. There are periods of acute risk in 
which medications are essential. And I think that is another 
issue that gets lost in this conversation. When a soldier comes 
in, when a veteran comes in and is acutely distressed and 
acutely disturbed, and having significant sleep disturbance, 
significant anxiety symptoms, during those periods we need to 
do something quickly in order to resolve those symptoms and to 
help them adjust during these periods of acute and imminent 
risk. Medicines do that. They do that far more effectively in 
terms of short term gain than psychotherapies. One of the 
problems with psychotherapies is that they are essentially 
skill based treatments. You can see that in my testimony. And 
as a result, we are targeting the developing of skills, the 
development of abilities, that have essentially been deficient 
in those individuals for any number of reasons. But over time, 
we have demonstrated the ability to help them develop those 
skills. And I think as Dr. Briggen so nicely put it, to develop 
hope. That is essentially what provides suicide, is the 
establishment and the maintenance of hope over time.
    Medicines in the early phase of that process I have found 
essential. I do a fair amount of treatment in this area. I am 
going to tell you about 60 percent of the people that I treat 
are on medications. A high number of those individuals have 
simply had their lives saved because they have had symptom 
reduction during these early phases of psychotherapy. Thank you 
very much.
    [The prepared statement of Dr. Rudd appears on p. 67.]
    The Chairman. Thank you. Dr. Primm.

             STATEMENT OF ANNELLE PRIMM, M.D., MPH

    Dr. Primm. Thank you for the opportunity to speak before 
the Committee today on behalf of the American Psychiatric 
Association, APA, the medical specialty organization 
representing 37,000 psychiatric physicians nationwide. APA's 
critical goals and activities include advocating for patients 
and the profession; ending discrimination against Americans who 
need treatment for mental illness, including substance 
disorders; supporting education, training, and career 
development of psychiatrists; enhancing the scientific basis of 
psychiatric care; and defining and supporting professional 
values and ethics.
    The APA vigorously advocates for immediate and seamless 
access to care for psychiatric and substance disorders for 
America's military personnel and their families. We continue to 
staunchly support increased Federal funding of psychiatric and 
brain injury research. We remain concerned that despite 
concerted efforts of the VA and the DoD, stigma still 
discourages from seeking care those who need help for PTSD and 
other disorders. We also note with increasing concern the 
reported increase in suicide attempts and completed suicides by 
veterans and those currently serving, and strongly urge direct 
and effective action to address this serious problem.
    Today's invitation by the Committee requested that the APA 
provide its position on the effectiveness and safety of 
psychiatric medication. I know that many of the most dramatic 
improvements in the effective treatment of mental illness have 
come as a result of newer and better medications, especially a 
class of antidepressants called SSRIs which can be utilized to 
help manage PTSD symptoms. These medications have meant 
remarkably positive changes in the lives of tens of millions of 
Americans. Simply put, it is the position of the APA that a 
patient's decision to take a psychiatric medication should be 
based on the best medical advice and scientific evidence 
available. Medications, when utilized, should be used in 
conjunction with supportive therapies, such as cognitive 
behavioral therapy. The prescribing and monitoring of brain 
medications should, however, be overseen by those with medical 
education, training, and clinical experience.
    First, I want to emphasize the importance of access to data 
from clinical trials, including data from negative trials, 
unpublished research, and post-market studies for physicians, 
other health personnel, and researchers. Patients need to be 
sure that their treatment is based on the best information in 
order to make fully informed decisions about treatment options.
    Next, let me address medication in general, and the SSRI 
antidepressants in particular, which are a class of medications 
often used to help treat PTSD symptoms. Research has clearly 
demonstrated that medication can be helpful, and even 
lifesaving, for many people with psychiatric disorders. 
Contrary to frequent reports in the popular media, there is 
little or no evidence that confirms that SSRIs increase the 
risk of actual suicide. It does appear that these medications 
may increase the likelihood that some patients will actually 
tell someone about their suicidal thoughts or even about a 
suicide attempt. From my perspective as a psychiatrist, this is 
actually a good thing because it means you have the opportunity 
to intervene and keep the person safe.
    Since the early 1990s the teenage suicide rate in the 
country had actually declined by over 25 percent, consistent 
with the increased use of SSRI antidepressants. That trend 
continued until 2004, when the FDA issued a black box warning 
about an increased risk of suicidal thoughts or behavior in 
children and adolescents treated with SSRIs. This was based on 
a data review in which no completed suicides occurred. In 2006, 
the black box warning was extended to include young adults up 
to age 25. The APA was concerned then, and remains so now, that 
the warning has in fact had a chilling effect on the use of 
SSRI medication in this population. Unfortunately, in the years 
since the FDA black box warning was issued, the rate of 
completed suicides for young people has increased dramatically 
according to the Centers for Disease Control and Prevention. 
This data is detailed in my written statement.
    As noted, we believe it is crucial for patients and family 
members to have access to current information on all issues 
related to recognized treatment options. To this end, the APA 
and other physicians and patient groups have jointly developed 
www.healthyminds.org to provide patients, families, and 
physicians with as much information as possible about the 
evaluation and treatment of depression, PTSD, and substance use 
disorders. APA is also a proud partner of Give An Hour, a 
volunteer program that provides mental health and substance use 
disorder treatment services through a network of mental health 
professionals who volunteer their services for an hour a week 
to active and returning military, National Guard, veterans and 
their families.
    We hope today's hearing will promote better information, 
encourage expanded support for research, and enhance the 
ability of returning military personnel and their families to 
advocate effectively for the treatment they deserve. Thank you 
for the opportunity to testify, and I would be pleased to 
answer your questions.
    [The prepared statement of Dr. Primm appears on p. 69.]
    The Chairman. Thank you so much. Commander Farber.

    STATEMENT OF COMMANDER DONALD J. FARBER, ESQ, USN (RET.)

    Commander Farber. Thank you, Mr. Chairman. I am Don Farber. 
I practice law in San Rafael, California. And since 1999, a 
majority of my cases have been antidepressant suicide, either 
representing the heirs or the family themselves. I am also a 
25-year Navy veteran, half that time at sea. I was not a lawyer 
in the Navy.
    In 2010, the Committee asks a compelling question. Do 
antidepressants cause suicide or don't they? This 20-year 
question has to be asked because those expected to know have 
not sought an answer. Who is most credible in this debate? If 
the year were 1530 and the Committee asked whether the Earth 
was flat or round, one would ask Magellan's map makers rather 
than the flat Earth advocates. Similarly, in 1940, one asking 
how to deal with Hitler would ask Churchill, not Neville 
Chamberlain.
    Individual psychiatrists like Peter Breggin, David Healy, 
and Joseph Glenmullen were citing the antidepressant risk in 
the 1990s, as Dr. Breggin has testified. In contrast, 
antidepressants enthusiasts assured us antidepressants were 
safe with no evidence linking to suicide. They did not say, 
``Well, antidepressants are safe in adults but not in kids.'' 
They did not say, ``Antidepressants are safe after the 7th day 
but not in the first few days.'' Antidepressants manufacturers 
and organized psychiatry staked out their absolute positions in 
1990 and have not wavered since.
    The shock came in 2004, when the FDA issued the 
antidepressant suicide warnings that many witnesses have 
discussed. Most of organized psychiatry has been on the wrong 
side of antidepressant history as it has unfolded. The American 
Psychiatric Association would not only have denied patients of 
the public awareness of the suicide risk on the labels, but to 
primary care physicians as well who prescribe a majority of the 
antidepressants. In 1991 at the original Prozac hearing, when 
there were 350 completed Prozac suicides reported, APA 
persuaded the FDA to forego the warning, stating at that time, 
``We feel that labeling must be based on sound science and not 
sensationalism.''
    In 2004, pediatric suicide events from antidepressants were 
excessive and the FDA scheduled another hearing. Rather than 
support the FDA's inquiry, the APA, declining to make a 
labeling recommendation, admonished the FDA for the fuss, 
stating, ``We are concerned that the publicity surrounding this 
issue may frighten some parents and discourage them from 
seeking help for their children.'' The FDA did issue the 
generalized suicide warnings and ordered additional evaluations 
of the pediatric data. After reevaluation confirmed suicidality 
causation in children, another hearing was held to vote on the 
black box, the highest form of warning.
    APA suddenly found religion with the old warning, stating 
at the hearing, ``We support the continuation of the current 
FDA warnings with respect to SSRI antidepressants. We believe 
the language is appropriate and consistent with our current 
knowledge and understanding of scientific data.''
    In 2006, APA repeated the cycle with young adults. The data 
did show a beneficial effect of antidepressants in the elderly, 
as Dr. Rudd has pointed out. But again opposing the black box 
and a lost cause, APA could not bring itself to acknowledge the 
FDA's young adult data, claiming instead, ``data showed that 
adults collectively show no increased suicide risk although 
there was some variation by age, including a protective effect 
for people 65 and above.'' This heralding the positive and 
suppressing the negative on antidepressants has been organized 
psychiatry's 20-year pattern.
    Most telling in this debate, antidepressant enthusiasts 
have sat silent for 20 years as the antidepressant 
manufacturers have refused to test for suicidality. There has 
never been a prospective trial designed to test the link 
between antidepressants and suicide. This should be a big deal. 
I leave with the Committee 27 sources confirming this fact from 
all varieties, mostly pro-antidepressant enthusiasts I might 
add. And Chief Executive Officers I left, it is not in my 
prepared statement, but I left with the staff a 10-page, 27 
sources of quotes, and there is no dispute about this fact.
    FDA officials conducting their suicide reviews reported 
last year in the British Medical Journal, ``Antidepressant 
drugs can have two separate effects. An undesirable effect in 
some patients to promote suicidal ideation or suicidal 
behavior, and a therapeutic effect in others.''
    So, do antidepressants cause suicide? Of course they do. 
Antidepressant manufacturers would not secretly settle the 
suicide lawsuits for the large sums they do if these were 
merely nuisance lawsuits. Going forward it would be responsible 
for VA, or DoD, to investigate rising suicides by dismissing 
FDA's antidepressant suicide warnings. Thank you, sir.
    [The prepared statement of Commander Farber appears on 
p. 72.]
    The Chairman. Thank you, sir. We thank you all. We have a 
series of three votes going on right now. We must recess for 
about 15 to 20 minutes, and when we return we will have 
questions from the panel. I need a certification that nobody is 
on these drugs so there will be no violence until we return.
    [Recess.]
    The Chairman. I apologize for the forced recess. The only 
thing that trumps a Committee hearing is votes on the floor, so 
we have to get there.
    Again, I thank the panelists for being here. Thank you for 
waiting. Let me just ask before my colleagues get here. 
Commander Farber, on the issue of causality it seems to me that 
you are saying it is basically defacto settled by the 
settlements that the drug companies have made. Would that be 
fair?
    Commander Farber. That is a fair statement. The causality--
I heard the exchange between Dr. Breggin and Dr. Leon. And Dr. 
Breggin is mostly correct. But Dr. Leon is not totally 
incorrect.
    The law says there shall be reasonable evidence of a causal 
association before you can put out the warning label. And that 
is up to the sponsors that these labels are voluntarily 
submitted. Yes, the FDA has a heavy hand. But it is a voluntary 
thing. So all the manufacturers agree by definition that these 
drugs have a causal association between the two.
    The Chairman. What would you say to your co-panelists who 
said it can't be either or? There are situations, especially 
with acute circumstances and short term treatment. You have to 
be closely monitored and there is room for these 
antidepressants.
    Commander Farber. Well, I'm not for banning them. In my 
testimony, and I think maybe Dr. Breggin probably disagrees 
with me, but antidepressants both cause and prevent suicides. 
The data I have seen on the statistical both are possible. And 
that is what the FDA, in fact, said.
    And the problem is when you do a 30-year medical analysis 
and you look at everything, if it is true that they both cause 
and prevent suicide, you are going to get for a long period of 
time a statistical dead heat that is insignificant therefore.
    But that doesn't change the fact that there are a lot of 
caused suicides, and you have to deal with it.
    The Chairman. In the legal arena, you said there have been 
lots of settlements that the drug companies have made.
    Commander Farber. I have made many settlements, large 
settlements. I can't talk about them. I am sworn to secrecy.
    The Chairman. Oh, tell me one. Come on.
    Commander Farber. I have lost a few, too. But lawyers on 
both sides see this similarly. When I go in with a 
pharmaceutical lawyer and we talk about settlement, we all talk 
the same language. We are not at each other's throats, because 
we see what all the damages are and the facts.
    There are bad cases. And when I get referred to a case, I 
take only a select, probably less than 20 percent of them. But 
there is definite causation. And if you don't believe that, you 
can go back to the early 1980s when you see all these clinical 
trials that are not submitted to the FDA. And I won't say most, 
but five, 10 percent of the cases on suicidality the provider, 
the investigator, will say in his opinion that this suicidal 
act was caused by the antidepressant. They know all this thing 
about statistical, there is no proof, and all that. But if you 
go into the inside papers, they will say that.
    One other thing. Back in 2004, when big Pharmaceutical 
Research and Manufacturers of America (PhRMA) was getting all 
this static about openness and published studies and whatnot, 
they came out and said, oh, we are going to publish everything 
on the Internet, whether it is successful, or positive, or 
negative. They did. GlaxoSmithKline was very good at publishing 
all their studies on the Internet.
    The problem is, they based it on efficacy. If it is a 
failed study, they published it on their Internet on efficacy. 
But they screened out all the suicidal events. They screened 
out all the causation assessments by the principal 
investigators. I don't want to call it hiding. I think the 
pharmaceutical industry does what Toyota does. They all do it. 
They are not going to put forward unfavorable data. But 
suicidal causation is definitely in there.
    The Chairman. Dr. Leon mentioned that there are 180 million 
prescriptions to 25 million families who have taken these 
drugs. Nobody has ever studied it, but those are the positive. 
Those who think that there is a relationship are focusing on 
just a few dramatic cases. What would you say to that?
    Commander Farber. Well, if you turn it over to a 
statistician, and I have no doubt the statisticians do a proper 
job, and I have no doubt that statisticians do a proper job. 
They are honest people. They are technicians and they look.
    The Chairman. But they are not scientists.
    Commander Farber. And if you don't focus on the suicidal 
cause, you are going to miss it. The statistics for suicide are 
buried in the haystack.
    In 1990, a Harvard psychiatrist did this explosive article. 
He came out with this. He said 3.5 percent were suicidal. 
Nobody knows. Nobody knows whether it is 1 percent, 10 percent, 
3 percent, or whatever.
    So you have to do the study. And no studies have been done 
simply because the Food, Drug, and Cosmetic Act really doesn't 
require it per se. All, as Dr. Breggin pointed out, it requires 
to get the drug on the market is two successful, well-
controlled studies on efficacy.
    So if nobody is pushing the drug companies, and I have it 
in my paper why the FDA has backed off of that, they are not 
going to do the studies. So we are going to continue this 20-
year debate another 20 years until somebody in Congress or 
somebody--a university says we are going to do the studies with 
a focus of trying to link antidepressants and suicide.
    But all these studies, these 4,000 studies, they have never 
looked at it. And as I said, look at my work product. And I 
cite those 27 sources.
    The Chairman. Thank you. Do either of the representatives--
they are both APA. You both are APA, right?
    Mr. Rudd. That is correct.
    The Chairman. Do you want to respond to anything that you 
have heard today before we adjourn the panel?
    Oh, I'm sorry, Mr. Roe will have the last question.
    Mr. Roe. Well I think two points need to be made. I think, 
one, the issue about causation. It is important I think about 
relative risk that is embedded in the use of a medicine.
    That if you look at relative risk, you think--you can take 
the child and adolescent trials as an example of that. Four 
thousand four hundred patients in the combined aggregated 
trials. Out of those, the difference in terms of people that 
experience suicidality in the clinical arm versus the placebo 
arm was 176 to 88. We are talking about a difference of 88 
patients out of 4,400. The relative risk is marginal at best.
    And now for those 88 patients, that is a significant risk. 
And there are certainly lives that can be disrupted because of 
the suicidality and the potential for loss of life. But 88 
patients out of 4,400 is a very marginal risk. And I would tell 
you that the efficacy of the medicines far outweigh the risk. 
And this is something critical for us to always consider and 
think about.
    And when you talk about active-duty personnel and you talk 
about veterans, that the relative risk is far greater to limit 
their access to medicine than to somehow have a message that is 
unclear and confusing as to what the nature of that risk is. I 
think that is a critical variable that oftentimes gets lost in 
this discussion.
    The Chairman. Dr. Primm.
    Dr. Primm. I wanted to say two things. One is that 
suicidality is associated with depression in the first place. 
And really the watchword is monitoring.
    The second point I wanted to make is about some of the 
comments that Mr. Farber made before, namely that he was 
quoting selectively from our 2004 and 2006 testimony. And if 
you are interested, we would be happy to provide you with the 
full documents.
    The Chairman. Thank you. I appreciate that.
    Dr. Roe.
    Mr. Roe. Thank you, Mr. Chairman.
    Mr. Farber, you made the comment. I just heard the tail end 
of your testimony. But you made the comment that 
antidepressants cause suicide.
    Commander Farber. Yes.
    Mr. Roe. Did you say that?
    Commander Farber. Yes.
    Mr. Roe. How can you say that?
    Commander Farber. Well, when you see the evidence. I am not 
a scientist. But we are all asked to look at evidence. As jury 
members----
    Mr. Roe. I think we have been--excuse me a minute. We have 
been doing that all morning. To make a statement that 
antidepressants cause suicide is ridiculous.
    Commander Farber. Why?
    Mr. Roe. With all due respect.
    Commander Farber. Why is it ridiculous?
    Mr. Roe. There is no evidence to prove that whatsoever.
    Commander Farber. I have been hearing that for 20 years. 
Let us find out the evidence.
    Mr. Roe. That I don't----
    Commander Farber. But my answer----
    Mr. Roe [continuing]. That I don't disagree with.
    Commander Farber. My answer is if the drug companies think 
there is evidence, if we see in the pediatric population and 
the young adult population, that FDA notice of October 15, 
2004, stated we have established evidence of causation. I am 
paraphrasing.
    At that time, the FDA did not have authority to order label 
changes, so they didn't like that. They protested at the FDA 
and said we don't like the causal association, because these 
are all short-term trials that we didn't focus on it, and so on 
and so forth. So the FDA changed the wording to make it 
acceptable.
    Mr. Roe. One of the things--excuse me. I don't have a lot 
of time. But one of the things that we do in medicine and it 
was born out by Dr. Rudd is that there is a risk-benefit ratio 
for everything we do.
    If you take an antibiotic, if you take penicillin, a 
certain percentage of those people are going to have 
anaphylaxis and a very rare patient will die. But there is a 
benefit to that also.
    And that is what we as physicians try to do is to balance 
the risk and the benefit to any particular treatment. And this 
one is very difficult to treat, depression. Obviously, I mean, 
you are not a clinician, and nor do I expect you to be able to 
answer this, but in the clinical setting with patients, it is 
very, very hard to know what is in between somebody's ears.
    And you are correct in saying we need to study these things 
and use best practices. And we don't--I have never relied on, 
in my 30-plus years of practice, I have never relied on the 
drug companies to continue the studies that we do afterward.
    What happens when there is a particular medication that 
comes out, it is studied by many others by what we do, by other 
studies that come out funded by NIH, or whomever. So it is not 
just drug studies that look at drugs and the effect of those, 
because I agree with you.
    Look, good people can make--can draw the wrong conclusion. 
We have had two people here today who are both educated, both 
with the same information drew different opinions. That 
happens. Good people do that. It doesn't mean one is dishonest 
or the other.
    Commander Farber. But, Mr. Roe, I never said 
antidepressants had no value. I never said there was--in fact, 
I said they prevent suicide. You can have both.
    Mr. Roe. Well you just said they cause suicides.
    Commander Farber. They do.
    The Chairman. If you will yield? Before you came in we were 
discussing something similar. Would you explain what leads to 
that warning on a black box?
    Commander Farber. Well, first of all, causation. All right. 
If you go the FDA hearings, they talk about statistical 
significance on suicidal safety information. The 4 percent to 2 
percent in the pediatric community was causation. It was 
determined by the Board on September 14th, 2004, to be 
causation.
    Mr. Roe. Not suicide. No one in that study committed 
suicide.
    Commander Farber. I said suicidality.
    Mr. Roe. I thought you--well, maybe I misunderstood.
    Commander Farber. I make another point about completed 
suicides. I think that is a bogus argument. If Toyota came in 
here or Goodyear and said, you know, we have 20,000 accidents 
on the freeway due to bad tires, and we make bad tires. But you 
know they are really safe, because not very many people are 
killed in those accidents, that witness would be laughed off 
the stand on the Washington Post and so forth. Because if you 
commit suicide, okay, it is not a completed suicide. But it is 
a very dangerous situation. And these are short-term trials. 
But that is true. There were 4,400 patients and there were no 
completed suicides.
    But when you get out into the general population where 
there is very little monitoring and so forth, I am not 
disagreeing that they have benefit, Mr. Roe.
    Mr. Roe. Thank you.
    Mr. Rudd. But equally--I need to respond to that. The other 
thing you are assuming though is that all of the suicidality in 
those trials was severe. You have absolutely no evidence to 
suggest that all of the suicidality, either the ideation or the 
attempts, was of significant lethality, duration, or frequency. 
You have no data to make that argument. I have looked at that 
data.
    And so the assumption that is embedded in this is that any 
emergence of suicidality is very severe. Now I would take a 
serious clinical issue that you can't make an assumption that 
it is severe and significant without data.
    Mr. Roe. I am running short of time. But, Dr. Primm, you 
made a statement. And this was--I hadn't connected this and 
didn't know the data until I listened to your testimony and 
read some of it about teenage suicide rates going down. And I 
don't know that you can make a cause and effect as you may have 
tried to do, or maybe I misunderstood you about when the black 
box labeling and doctors then became reluctant to prescribe 
SSRIs to the teenage group. But the suicide rate then went up 
after that. Are you saying that there was a cause and effect 
because less young folks were treated?
    Dr. Primm. Yes. There appears to be a chilling effect that 
occurred after that 2004 FDA black box warning. And I believe 
1994 to 2003 we saw a steady decline in teenage suicides. So 
the chilling effect of the black box warning has led to an 
increase in suicides because of people being fearful of 
prescribing these medications.
    Mr. Roe. So what you are saying is that maybe--not that 
there could be a cause and effect, because again that is 
observational what we are doing after this occurred. But other 
things may have occurred too. But you are saying that maybe it 
cost--do you have any number of lives or young people?
    Dr. Primm. You know, I would refer--we would be happy to 
provide more detailed information after the hearing to give you 
more specifics on those statistics.
    Mr. Rudd. It is around 1,700, whether it was the number of 
deaths that actually were increased during that interim after 
the warning label.
    And there is clear data to indicate several things. One, a 
lack of willingness for general practitioners, non-psychiatric 
physicians, general practitioners to prescribe medications and 
a decrease in the willingness of families to even pursue care 
for treatment as well as take medications. Those are all 
consequences of the warning label.
    Commander Farber. I agree with the statement that after the 
initial warnings that there was a decrease in prescriptions. I 
mean that was one of the reasons for opposing the warning is 
because these are so casually prescribed. So I would agree. It 
is the logical product of that.
    But I would go beyond that. What if it is true? What if it 
is true that these warnings have cost lives? That does not at 
all affect informed consent. When I go to the doctor I am 
entitled to his best estimate on the warning and so forth. And 
even if it causes a societal increase, that doesn't affect 
individual consent. And we are entitled to that as Americans.
    Mr. Roe. I agree with that. I yield back.
    The Chairman. I thank you all. Although I would interpret 
the decrease over--what did you say 1994 to 2003? I mean, there 
was a Democratic President. Then you had a Republican 
President. Obviously more suicides. It is scientific. You are 
looking at me as if you don't agree with me.
    All right. We thank you for helping us out here in this 
very complex situation.
    Our Panel Three is Dr. Ira Katz, the Deputy Chief Officer 
of Mental Health Services in the Department of Veterans 
Affairs, accompanied by Dr. Janet Kemp, who is the National 
Suicide Prevention Coordinator for the VA, and Brigadier 
General Loree Sutton, Director of Defense Centers of Excellence 
for Psychological Health and Traumatic Brain Injury.
    We also have accompanying Dr. Katz, Michael Valentino, 
Chief Consultant for Pharmacy Benefits Management Services.
    Dr. Katz, you have the floor.

   STATEMENT OF IRA KATZ, M.D., PH.D., DEPUTY CHIEF OFFICER, 
   MENTAL HEALTH SERVICES, OFFICE OF PATIENT CARE SERVICES, 
  VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF VETERANS 
  AFFAIRS; ACCOMPANIED BY JANET E. KEMP, RN, PH.D., ASSOCIATE 
  DIRECTOR, EDUCATION AND TRAINING, VETERANS AFFAIRS NATIONAL 
  SUICIDE PREVENTION COORDINATOR, U.S. DEPARTMENT OF VETERANS 
 AFFAIRS; MICHAEL A. VALENTINO, R.PH., MHSA, CHIEF CONSULTANT, 
    PHARMACY BENEFITS MANAGEMENT SERVICES, VETERANS HEALTH 
   ADMINISTRATION, U.S. DEPARTMENT OF VETERANS AFFAIRS; AND 
  BRIGADIER GENERAL LOREE K. SUTTON, M.D., DIRECTOR, DEFENSE 
 CENTERS OF EXCELLENCE FOR PSYCHOLOGICAL HEALTH AND TRAUMATIC 
 BRAIN INJURY, SPECIAL ASSISTANT TO THE ASSISTANT SECRETARY OF 
     DEFENSE FOR HEALTH AFFAIRS, U.S. DEPARTMENT OF DEFENSE

               STATEMENT OF IRA KATZ, M.D., PH.D.

    Dr. Katz. Thank you. Chairman Filner, Ranking Member Roe, 
and Members of the Committee, thank you for the opportunity to 
appear here today to discuss VA's response to the mental health 
needs of America's veterans.
    I would like to request that my written testimony be 
included in the record.
    The Chairman. Yes. It will be done for everybody. Thank 
you.
    Dr. Katz. Thank you. My testimony makes four points. First, 
the appropriate use of psychotherapeutic medications is a key 
component of overall mental health care. But medications, like 
all treatments, can be associated with risks as well as 
benefits.
    Second, VA has systems in place to monitor for adverse 
effects associated with medication use and programs to enhance 
the safety of pharmacological treatments.
    Third, VA's mental health programs have been designed to 
optimize the safety of psychopharmacological treatment and to 
provide effective alternatives.
    And fourth, young adult veterans, those who may be most 
vulnerable to suicidality as an adverse effect of 
antidepressant medications, have lower suicide rates when they 
come to VA for health care.
    It has been more than 50 years since clinical research 
began to establish the benefits of psychopharmacological 
treatments for serious mental illness. Over the last half 
century, there has been a steady accumulation of scientific 
evidence further supporting their effectiveness.
    In fact, substantial components of the evidence has come 
from VA research. Today, the effectiveness of the medications 
as key components of mental health care is as well established 
as the use of antibiotics for infectious disease or 
chemotherapy for cancer. However, all of these treatments can 
be associated with risks as well as benefits. As we have been 
discussing, the Food and Drug Administration has required a 
black box warning for all antidepressant medications, noting 
increases in suicidality in children, adolescents, and young 
adults.
    The warning emphasizes the use of antidepressants can be 
associated with both benefits and risks. And the patients 
receiving antidepressants should be monitored for adverse 
effects. VA has programs in place to ensure that this occurs.
    VA recognizes that the use of any medication can be 
associated with adverse effects. Accordingly, VA has developed 
comprehensive systems to identify potential adverse drug 
effects and to provide information about them to providers as 
quickly as possible.
    VA's electronic medical record has allowed it to develop 
the only national system for electronic reporting of adverse 
drug effects. By analyzing computerized databases, VA is able 
to identify drug safety signals, assess the significance of 
external drug safety issues in its patient population, and 
rapidly track trends of known safety issues.
    Using these programs, the VA has provided guidance to its 
facilities and FDA, addressing suicidality and other potential 
mental health side effects for a number of medications, and 
these have been listed in my written testimony.
    VA has enhanced access to mental health care by requiring 
that mental health services are integrated with primary care. 
To ensure that veterans are monitored appropriately while they 
are receiving mental health services, VA requires that these 
programs include evidence-based care management, providing 
repeated contacts with patients to educate them about their 
conditions, about medications, and about other treatments, as 
well as ongoing evaluations of both therapeutic outcomes and 
adverse effects.
    Research has demonstrated that these care management 
interventions can decrease depression and other conditions and 
that they can reduce suicidal ideation.
    VA offers veterans a number of alternatives for mental 
health care. For over a generation, VA has offered problem 
focused readjustment counseling for combat vets in its Vet 
Centers, as well as evidence-based mental health services in 
its medical centers and clinics.
    For several years, VA has provided training to clinical 
mental health staff to ensure that therapists in each facility 
are able to provide evidence-based psychotherapies for the 
treatment of PTSD, depression, and other conditions as 
alternatives or adjuncts to pharmacologic treatment.
    VA implemented the broad use of specific psychotherapies in 
response to evidence that, for many patients, they are the most 
effective of all treatments. Our goal is to make meaningful 
choices between effective treatments available to those who 
come to us for care.
    Working with the National Violent Death Reporting System, 
VA recently calculated rates of suicide for all veterans from 
16 States, including those who use VA health care services and 
those who don't.
    Among the youngest veterans, those aged 18-24, those who 
came to VA were 56 percent less likely to die from suicide in 
2005, 73 percent less likely in 2006, and 67 percent less 
likely in 2007.
    VA recognizes concerns about the use of antidepressant 
medications among young adults as a potentially vulnerable 
population. But it has found that the risk of suicide is lower 
among the young adults who come to VA for care and that the 
rates appear to be dropping. In sum, VA's care works.
    Thank you again for the opportunity to appear. My 
colleagues and I are available to address any questions.
    [The prepared statement of Dr. Katz appears on p. 79.]
    The Chairman. Thank you so much.
    Doctor/General, which one do you prefer by the way, General 
or Doctor in this setting?
    Dr. Sutton. Thank you. Dr. Sutton is fine.
    The Chairman. Thank you. Dr. Sutton.
    I must say that wherever I go to discuss this subject Loree 
Sutton always comes up, so you must be doing very good work and 
you have a visible job. So thank you for what you are doing.

      STATEMENT OF BRIGADIER GENERAL LOREE K. SUTTON, M.D.

    Dr. Sutton. Well, thank you, Mr. Chairman. It is a great 
team effort. And I am privileged to sit at the table here with 
our colleagues from the VA.
    In my over 20 years in uniform, there has never been such a 
collaborative, close partnership. And I echo what Dr. Katz has 
said in terms of laying out the essential role of medication, 
antidepressants as one tool in our tool kit.
    I would like to thank you first of all for certainly 
inviting me. My formal remarks lay out the many actions that 
are going on across the Department of Defense within each of 
the services and in collaboration with our Federal partners as 
well as with organizations, institutions, and communities 
across the country and around the world.
    Perhaps I could then use my allotted time to provide a 
perspective that has not yet been represented this morning. And 
that is of those whom I represent, the soldiers, sailors, 
airmen, Marines, Coast Guardsmen in uniform; yes, and the 
veterans; yes, the retirees; the mothers, the fathers, the 
sisters, the brothers, the widows, the widowers. We are all in 
this together.
    And there could not be a more important topic, Mr. 
Chairman. Thank you so much for calling this session together, 
because when it comes to suicide, this is not an academic or a 
scientific discussion.
    These are our brothers. These are our sisters. We are a 
family. And it takes the efforts of all of us in the cross 
generations, individuals like Sergeant Andy Brandi, a Marine 
Corps Sergeant who is writing extensively, working with 
individuals and families across the country to bring hope, to 
keep it alive.
    So where is the hope? Let me just highlight three brief 
areas, one of which Dr. Roe you mentioned at the beginning, the 
STARRS Study. This pioneering study, landmark study, the study 
to assess risk and resilience in servicemembers.
    The Army has reached out to the National Institute of 
Mental Health. This 5-year study promises to revolutionize the 
way that we benchmark our practices, the way that we bring 
applications to the field, gain the evidence, bring them back 
to apply and improve as we go.
    This study will certainly benefit all of our servicemembers 
and their families. The data collection starts in March and 
April of this year. And so we are very heartened and very 
hopeful about what this will find.
    There will be quarterly reports going back to the services, 
particularly the Army who sponsored this study, so more to 
follow.
    But second, what has not been mentioned today, I think 
really bears mentioning, is that we are on the frontlines of a 
revolution. And that is a revolution in pharmacogenomics. I 
would refer you to Dr. Francis Collins' recent book, The 
Language of Life, where he talks about all that we are learning 
now about what our personal human genetic code means in terms 
of how we respond to medications.
    We know that depression, for example, carries a strong 
genetic component. When you look at the twin studies, the 
concordance rates are approximately 40 percent in identical 
twins. And so I think that this is certainly going to 
revolutionize the way in coming years that we talk about 
medication, that we personalize our medical care. And I look 
forward to developing that concept with our partners at the NIH 
and within the VA.
    Third, the revolution in neuroscience. It has been said 
today that the brain is the most complex organ. Indeed it is. 
We all thought the human genome project was complex in itself, 
which it was. Three billion DNA-based pairs, part of the double 
helix ladder, yielding 20,000 genes that code proteins. That 
make us the human beings that we are.
    But think of the brain. Fifty to 100 million neurons with 
over 100 trillion connections all here within the confines of 
our brain. So is it any surprise that this is such a complex 
challenge that the human being mind, body and spirit? It is not 
subject to command and control. And there is much that we are 
learning.
    And there is much reason for hope, whether it be the 
neuroplasticity, the stories of neurogenesis and leading 
research that, for example, Dr. Norman Doidge in his book, The 
Brain That Changed Itself, tells that story like a gripping 
novel. And it is one that I would commend to each of us as 
citizens of this great country.
    Let me just conclude my remarks with what is fundamentally 
underlying everything that we do. That is to say, that we are 
in the middle of a cultural transformation. One that takes us 
in which DoD and the services, I would say in combination with 
our VA partners, is leading the country from what has been a 
very narrow medically focused culture in the military, suck it 
up and drive on, which has served us well in some ways for 
years. It is no longer at year 9 in this conflict sufficient.
    We are moving to a public health model, one that emphasizes 
resilience and strength. This cultural revolution is being led 
at leadership by leaders at all levels. From the Secretary of 
Defense who has said repeatedly how other than the war itself, 
there is no higher priority. To the Chairman of the Joint 
Chiefs of Staff, Admiral Mullen, who has repeatedly said that 
these wounds that are unseen, the spiritual, the psychological 
wounds of war, which we have come to understand, can be the 
most deadly of all. They are just as important as the 
psychological wounds.
    I would say to you, to anyone who wonders if those of us in 
uniform care about this issue. One only has to sit at the 
Army's monthly suicide review meeting led by the Vice Chief of 
Staff of the Army, General Corelli, while commands around the 
entire Army, the entire world, every command who has had a 
suicide event during that last month, reports on that event. 
Every command in the Army listens, and learns, and takes action 
so that we can make a difference and stem this tide.
    And so the message at all levels of leadership, which of 
course it is not enough to have it at the top levels, now our 
challenge is to drive these messages, this hope to the deck 
plate, to the foxhole, to the flight line, and to the kitchen 
table. These messages are simple but powerful.
    One, you are not alone. Second, the unseen wounds of war 
are real. Third, treatment works, and the sooner we can 
intervene, the better. And finally, reaching out is an act of 
courage and strength.
    I look forward to your questions, Mr. Chairman.
    [The prepared statement of General Sutton appears on p. 
86.]
    The Chairman. Thank you, thank you all. I don't think 
anyone doubts, Dr. Sutton, the concern of the people up the 
line.
    But there is a fact that suicides have increased and I 
guess I was going along with some of the statistical data that 
I heard that when the black box appeared, we had more suicides. 
As the concern went up, you had more suicides. Well, I wouldn't 
make that association, but that is what some people were doing 
earlier.
    That is, the suicides have increased. They are at a higher 
rate than they were during Vietnam. So something is going on 
that your concern is not meeting.
    I would just like you respond specifically about the fact 
that a lot of pills are given out under battlefield conditions. 
There have been a lot of popular articles, testimony from 
individual soldiers, et cetera, that there is still the 
pressure to get back into the--pull yourself together, kid. Get 
back up. Here are a couple of pills to do it.
    Also what has concerned me most about the increase of PTSD, 
the increase of suicide, and other manifestations is that tens 
of thousands of our young people leave Iraq or Afghanistan 
without having a competent medical professional address PTSD 
and/or brain injury. There are self-administered 
questionnaires. There are only a few questions, and if people 
want to get home, they know how to check them off. There is not 
sufficient personnel to handle it.
    Yet it seems that would be the first step. With all this 
concern, with all this strength and courage, let everybody be 
forced to have an hour with a competent medical professional 
before they leave. That is not happening as far as I have 
understood.
    So we still have lots of these pills being given out. We 
have lots of suicides. We have lots of PTSD, lots of brain 
injury, and we are not really dealing with it either in DoD or 
the VA.
    Dr. Katz gave some statistics about how they come to the VA 
and they reduce those odds. Well, we wait for them to come. If 
that is the case and you so are passionate about it, what about 
the outreach to get them first? Everybody has to come to the VA 
after they leave. You are the Army, and the Marines, and the 
Navy--get everybody.
    If we have all this evidence that it cuts down on suicides, 
have everybody come in. I think we have tens of thousands of 
young people out there, whether they are on the medication or 
not, capable of suicide, homicide, and other violent behaviors. 
We simply have not come to grips with the intensity of this 
issue.
    Dr. Sutton. Mr. Chairman, I share your concern. Certainly 
on this journey----
    The Chairman. I always say that to constituents.
    Dr. Sutton [continuing]. I share your concern, Mr. 
Chairman. We are all on this journey together. And we recognize 
that for as many improvements as we have made, certainly 
screening it is important. But it is not enough, which is why 
you may be interested to know of some of the current 
initiatives which I believe get to the heart of your concern. 
Certainly it is a concern that we share.
    First of all, under development right now is a Virtual 
Lifetime Electronic Record (VLER), which will allow individuals 
from the date of a session at the MEP Station to have a 
lifetime electronic health record that will then travel with 
them to the VA at whatever point they leave the service.
    We agree. Sharing medical information is critical. And so 
that is going to----
    The Chairman. I don't mean to be cynical, and I hope what 
you are saying is right, but we have been saying this for 30 
years. You have two different electronic records.
    We have the Secretaries of DoD and VA talking every week 
supposedly about how to integrate them but they have not been 
done. To say that we can do that is just not the fact.
    Dr. Sutton. Well actually, Mr. Chairman, you might be 
interested in knowing that, in fact, increasingly there is the 
ability to interoperate between the two systems of Armed Forces 
Health Longitudinal Technology Application (AHLTA) and VistA. 
For example----
    The Chairman. I understand that. But when----
    Dr. Sutton. What we are able to share----
    The Chairman. But we are still not sharing all the data.
    Dr. Sutton. Not all of the data yet. No, that is correct, 
sir. But we are sharing the screening data. We are sharing the 
periodic health assessment data, which contains a wealth of 
information. And it is given to every troop every year 
regardless of their deployment status.
    We are also sharing the personal and social data that 
includes risk factors, family history. And as I mentioned, we 
are moving toward a Virtual Lifetime Electronic Record.
    The Chairman. Maybe we could talk about it further because 
the people out in the field that I talk to don't have that same 
sense of comprehensiveness or optimism.
    Dr. Sutton. Well, we are not there yet, Mr. Chairman. I 
will give you that.
    The Chairman. Thank you.
    Dr. Sutton. But this is where we are going. Let me give 
you----
    The Chairman. Oh, it sounded like we were there.
    Dr. Sutton. Let me give you a couple of other examples. 
First of all, we are, as we speak, piloting a mandatory event 
driven protocol for the management of concussions in theater. 
There is a brigade from Fort Campbell, which is currently on 
its way to Afghanistan. This is a protocol that has been pulled 
together with the best expertise across the Federal Government 
and around the country.
    Mr. Chairman, what this will do is in the event of an 
improvised explosive device explosion, whether it be in a 
vehicle, whether it be a dismounted troop, whether it be in a 
building, or if a leader sees something is not quite right with 
the troop, there is a mandated protocol now that doesn't depend 
upon the knowledge of the medic on the ground or the leader who 
is closest by.
    The Chairman. That is great. People have been calling on 
this for a decade and you are just doing it with one--what did 
you call it, brigade, or I didn't hear what the----
    Dr. Sutton. This is the pilot study.
    The Chairman. So you got to a pilot study 10 years after 
everybody said why aren't we doing this. I am glad you are 
doing it and you are very impressive as a witness, but I would 
say you are at least a decade behind and the kids are 
suffering.
    Dr. Sutton. Mr. Chairman----
    The Chairman. You are just piloting it--why don't you do it 
for everybody? I mean, we know we have to do this.
    Dr. Sutton. Mr. Chairman, we are moving this out rapidly. 
We are following with a post traumatic stress and psychological 
health protocol, which will absolutely----
    The Chairman. And what about the tens of thousands who have 
already been discharged? What are we doing about them?
    Dr. Sutton. Oh, sir, first of all, the VA has contacted 
several hundred thousand individuals, everyone that they could 
possibly contact. And I really would ask Dr. Katz to perhaps--
--
    The Chairman. I would be a little bit----
    Dr. Sutton [continuing]. Provide detail.
    The Chairman. I would be a little bit more skeptical about 
those claims, but go ahead.
    Dr. Sutton. Okay.
    The Chairman. Look, they say they have these outreach 
programs, but they don't outreach. They simply do not get the 
people in. So I don't know what they are doing or if they are 
doing it completely but I will tell you, it is not working.
    Dr. Sutton. Well, and Mr.----
    The Chairman. As the Army or the Navy you can order these 
folks in if you want to. The fact is, I don't care what they 
are doing, they have not come in.
    Dr. Sutton. Well, and here is what we have----
    The Chairman. The folks who need it most come least, right, 
or at least----
    Dr. Sutton. That is one of the challenges, sir. You are 
right. Within the services, Special Operations Command, the 
Marine Corps, the Army, Navy, and Air Force have reached out to 
all of those individuals, those servicemembers who were not 
part of the screening process, not part of the improvements 
that are currently with us at this time.
    But we know that that is not sufficient. So we have 
partnered with the USO, and the Red Cross, and the Vet Centers. 
And we have just completed a pilot of training the USO staff 
members in over 140 airport facilities around the world. We are 
working to develop a kiosk and a far forward USO site that will 
bring together green bean coffee, Vet Center peer-to-peer 
counselors, Bonnie Carroll and her Transition Assistance 
Program for Survivors personnel, the Red Cross. And be able to 
reach out to individuals who are at risk in our airports, in 
our hospitals.
    The Chairman. I am glad you are doing all that and I don't 
want to argue that it is not effective because it is.
    On the one hand you are doing this outreach and you have 
this small pilot study but you are still putting tens of 
thousands of kids in jeopardy without being adequately 
evaluated for mental illness or brain injury.
    You want to catch up here, but you are pouring more into 
the ocean so you will always be behind.
    Dr. Sutton. Mr. Chairman, we are working this at all 
levels. We understand that we are in unchartered territory. 
Never in the history of our republic have we ever placed so 
much trauma on the shoulders of so few, on behalf of so many, 
for so long. So this is----
    The Chairman. Vietnam was a good case study by the way.
    Dr. Sutton. And hope, I guess as I sat here this morning, 
Mr. Chairman, it has concerned me. We can talk about this issue 
of medication, and safety, and efficacy as well as suicide 
prevention in the safety and the confines of this great Capitol 
building.
    But what if I am a young troop or a family member and I am 
watching this Web streamed around the country and around the 
world? And I am wondering. I am on antidepressants right now. 
Does that mean that I am going to die, that I am going to go 
crazy, that I am going to kill my spouse? If I am feeling 
depressed, feeling despair, maybe my buddy died in my arms last 
week, and I am thinking I need help. I am not sure that I would 
have the courage or the hope to get help after what I have 
heard here today.
    The Chairman. Well, you should have more confidence, 
because they haven't heard it yet. They don't get those 
warnings.
    I would rather that if my kid was in that situation to be 
fully informed than to say----
    Dr. Sutton. I would----
    The Chairman [continuing]. Oh, I guess I am going to be 
crazy, and I won't take that. That is not what information 
does.
    Dr. Sutton. No, that is correct, sir. The black box 
warnings that the FDA put out were never designed to decrease 
the number of antidepressant prescriptions. What they were 
meant to do was to inform providers and consumers of the 
known----
    The Chairman. Right.
    Dr. Sutton [continuing]. Association with increased 
suicidality so that providers, family members, patients alike 
could monitor themselves, monitor----
    The Chairman. But you didn't answer my question about the--
all the literature about kids just getting lots of pills. 
Obviously, they are not going to read the warning because they 
are not going to get the black box. Is that just media hype, or 
is that going on?
    Dr. Sutton. Sir, this is one of our challenges. We know 
that medication in and of itself is not enough. It is one of 
the tools. And it is not always the primary tool by any means. 
There are other evidence-based therapies, whether it be 
cognitive behavioral therapy, cognitive processing therapy, 
whether it be prolonged exposure therapy that are very 
effective and in combination.
    There are also complimentary therapies, which we----
    The Chairman. I agree with you, but why is it that we hear 
that they are just doing one in the battlefield conditions?
    Dr. Sutton. Sir----
    The Chairman. People don't have time to really think about 
that.
    Dr. Sutton [continuing]. We are on a journey. We are not 
where we want to be yet. But we are putting the investment into 
learning about the----
    The Chairman. Okay.
    Dr. Sutton [continuing]. Effects of acupuncture, tai chi, 
chi-gong, other mindfulness----
    The Chairman. Okay.
    Dr. Sutton [continuing]. Mediation techniques.
    The Chairman. No, I appreciate that, and we want to help 
you in that process, certainly.
    Dr. Sutton. Thank you so much, Mr. Chairman.
    The Chairman. We will be partners with you on that journey.
    Dr. Sutton. That is great.
    The Chairman. Thank you. One question before I get to Mr. 
Roe.
    Dr. Katz, you heard Dr. Breggin's testimony. And he 
mentioned several times this Valenstein study, which he quotes, 
``Completed suicide rates were approximately twice the base 
rate following antidepressant starts in VA clinical settings.''
    Is that what was done in 2009? You never mentioned it in 
your study. Is it relevant? Why didn't you talk about it?
    Dr. Katz. The issue is the need for monitoring when 
antidepressants are started, when doses are changed, or when 
medications are stopped. The balance between the benefits and 
the risks are enhanced with appropriate monitoring. That is why 
VA has implemented requirements for care management, for----
    The Chairman. I didn't understand a word you said.
    Dr. Katz. You can make the increase----
    The Chairman. There was a study that says of 887,000 plus 
VA patients treated for depression, it found that, and I am 
quoting Dr. Breggin's testimony. ``Completed suicide rates were 
approximately twice the base rate following antidepressant 
starts in VA clinical setting.'' Is that true or not?
    I don't know what you are talking about when you talk about 
monitoring stuff. This is a conclusion looking at almost a 
million people. Doesn't that tell you something?
    Dr. Katz. Yes, sir.
    The Chairman. What does it tell you?
    Dr. Katz. This is what it tells me. Let me draw an analogy. 
Dr. Roe talked about the risk of anaphylaxis when penicillin is 
given. You don't not give penicillin. But you watch people like 
a hawk when you do give it to catch early signs of side effects 
and then do what you can to reduce them.
    The Chairman. Does that mean we weren't doing that from the 
VA for these million patients?
    Dr. Katz. The time covered in Dr. Valenstein's study was a 
number of years, sometime ago. I will get back to you.
    [The VA subsequently provided the following information:]
                 Statement of Marcia Valenstein, MD, MS
          Respectfully, I would like to clarify the message of my 
        paper, ``Higher Risk Periods for Suicide Among VA Patients 
        Receiving Depression Treatment: Prioritizing Suicide Prevention 
        Efforts,'' which was cited during testimony before the House 
        Committee on Veterans' Affairs on February 24, 2010, on 
        ``Exploring the Relationship Between Medication and Veteran 
        Suicide.''
          The purpose of this research was to identify the periods 
        during treatment for depression that are high risk for suicide 
        to help physicians prioritize suicide prevention efforts. In 
        this observational study, we did not attempt to causally link 
        antidepressant use to suicide death. The purpose of our paper 
        was to alert clinicians and policy makers about high risk 
        periods in regular, ongoing clinical care--and to note that all 
        age groups (not just younger patients) were at higher risk 
        during these treatment periods. Randomized, clinical trials 
        would be necessary to appropriately address causality regarding 
        antidepressants and suicide, and any inference of such an 
        association is unsupported by this research.
          This study calculated suicide rates for five sequential 12-
        week periods following different treatment events: psychiatric 
        hospitalizations, new antidepressant starts (more than 6 months 
        without fills), ``other'' antidepressant starts, and dose 
        changes. We found that suicide rates were highest for patients 
        immediately following psychiatric hospitalizations at 568 per 
        100,000 person-years, compared to a base rate of 114 per 
        100,000 person-years in the overall population of Department of 
        Veterans Affairs (VA) patients in depression treatment. Suicide 
        rates were also higher than the base rate at 210 per 100,000 
        person-years following new antidepressant starts. Adults aged 
        61-80 years were at highest risk for suicide in the first 12-
        weeks periods following these treatment events. Although 
        suicide rates were higher following antidepressant starts, we 
        did not indicate that antidepressants were the cause of suicide 
        deaths--just as we did not indicate that the hospitalizations 
        were the cause of suicide deaths following hospital discharge. 
        Instead, patients who are hospitalized or who start a new 
        antidepressant are likely more symptomatic, and the increased 
        risk of suicide death likely ensues from the issues and 
        symptoms that prompted the treatment intervention.
          The research recommended that health systems should 
        prioritize prevention efforts following psychiatric 
        hospitalizations to have the greatest impact on suicide. VA has 
        done just this, instituting mandatory weekly followups for all 
        veterans leaving an inpatient mental health program. The study 
        further noted that close monitoring was also warranted in the 
        first 12 weeks following antidepressant starts, across all age-
        groups. As VA's testimony indicated, physicians and patients 
        alike are advised about the potential for adverse effects and 
        are closely monitored during the period immediately following 
        any new prescription for antidepressant medications.

    The Chairman. I hope so. Dr. Roe.
    Mr. Roe. Thank you, Mr. Chairman.
    Not to understate the obvious, but the least way to get 
your anxiety raised is not get shot at. That helps a lot when 
you are not being fired at and what Dr. Sutton said.
    We can't forget why we are here. When I leave--what the 
military does--when I leave here today I am going to Arlington 
to bury one of our soldiers who was killed in Afghanistan 
recently. So I will leave this hearing and go to Arlington to 
do just that.
    And you are right. And we can't thank our young men and 
women enough for what they do every single day so we can sit 
here. As you just pointed out, General, in this nice, warm, 
safe building, so thank you. We thank them. And we will be 
going to Afghanistan in a few weeks to visit the troops again.
    A couple of points. Unseen wounds are real. And to dovetail 
to what the Chairman was saying, when I ETS'd from the 
military, it was basically a--you can be out in 48 or 72 hours. 
You go this, this, and this. And I hit the door. And then that 
was the last anybody ever heard of me, saw me.
    That really wasn't the way to do it. And what he is saying 
I think he is right is you don't--you can't command an ex-
veteran to do anything. They will point that out right quickly. 
They are not going to follow any orders after that that they 
don't want to. They have been doing that for however long they 
have been doing that.
    So if you are going to do it, it has to be done while they 
are still in the military. And I think certainly having a very 
good evaluation, seeing this uptick in suicide, is a very, very 
good idea. And then be able to hand that off, because Dr. Katz 
makes some good points.
    Whether you use antidepressants, or don't, or whether you 
use just therapy, whatever, in the 18-24 year olds that was 
from 2005 through 2007. That was some pretty significant 
reductions in suicides when you get to treatment. I think what 
the Chairman is saying is what about those that never get to 
treatment. We don't identify those.
    I think that is what he is--if we can identify those or 
have markers on the way out, hand them off to the VA. I think 
that is what this Committee wants to do. In a nutshell I think 
in how do we treat them. Best practices will determine that.
    Certainly there is a difference of opinion about that. And 
we are not here to decide that today. But, Dr. Katz, I think 
your data that you gave, the 18-20 year olds, is impressive 
that therapy works. Whether it is just a psychotherapy, or 
medication, or whatever the therapy you use, it is working. So 
I think we have determined that.
    And the question, Dr. Sutton, you may not have an answer 
for 
this, but what percent of the troops that we have now are on SSR
Is?
    Dr. Sutton. Yes, sir. The utilization data we have, and by 
the way let me just say that this is one of the questions that 
we know that the STARRS Study will help us answer with more 
precision.
    But here is what we know now. We know that across the force 
our utilization rates for SSRIs, for example, is approximately 
17 percent, which as you heard earlier, closely approximates 
what you see in the general population. I think the number was 
closer to 20 percent before. But that is what we know in terms 
of our utilization data across the force.
    Now what we also know we have had electronic health records 
in theater for the last 2, now going on 3 years. We know that 
the prescription rate in theater varies from 3 to 6 percent.
    So in other words, you have individuals who deployed at 
theater with perhaps a 6-month supply, which is routine. And 
then we have 3 to 6 percent who then get resupplied in theater. 
It is an imprecise estimate. But I would say that our--given 
the 17 percent that we know from utilization data across the 
force, 3 to 6 percent in theater or roughly at about 20 percent 
of the force are using 
antidepressants. The majority of those, as you mentioned, the SS
RIs.
    Mr. Roe. Well there is no question that the force, as you 
pointed out, I mean I have known people now that have been 
deployed four and five times, is under tremendous stress. No 
doubt about that.
    So I agree with the Chairman completely. We need to make 
this work. Also we have been to great lengths. Chairman 
Mitchell in our Oversight and Investigations Subcommittee, I 
guess a month or so, 6 weeks ago, and I don't think that 
seamless transition is going to work by the October date. It 
didn't look like that is. So there is a great hurdle yet to 
where the DoD and VA can speak to each other in an intelligible 
language.
    So that has got to happen, or either we got to scrap it and 
start over after a 20-year start. And I don't want to be 
sitting here 10 years from now and then have the same answers, 
well, we are still working on it. We think we are going to get 
it to work. And I know that is not your bailiwick. That is an 
IT problem. But it is a practical problem for the medical 
personnel.
    I want to thank the Chairman for having this meeting. And I 
want to thank all of the witnesses today. I didn't get a chance 
to thank the first panel and the second panel for being here.
    Thank you, Mr. Chairman.
    The Chairman. Thank you, Dr. Roe.
    We thank you all for being here. We appreciate your passion 
and your commitment to our Nation's active duty and our 
veterans. I think we all want to do a better job, because they 
are our children.
    Thank you so much.
    [Whereupon, at 1:24 p.m. the hearing was adjourned.]



                            A P P E N D I X

                              ----------                              

                 Prepared Statement of Hon. Bob Filner,
             Chairman, Full Committee on Veterans' Affairs
    I would like to thank everyone for attending today's hearing. The 
purpose of today's hearing is to explore the potential relationship, if 
any, between psychiatric medications and suicides.
    With PTSD and TBI being the signature wounds of the current war in 
Iraq and Afghanistan, mental health issues have naturally taken center 
stage.
    Research has shown that mental disorders and substance abuse 
disorders are linked to more than 90 percent of people who die by 
suicide. Today, suicides among servicemembers and veterans continue to 
increase at an alarming rate, far exceeding the comparable suicide 
rates among the general population. It is a tragedy that our 
servicemembers and veterans survived the battle abroad only to return 
home and fall to suicide.
    With the widespread availability and use of psychiatric medications 
to address mental health disorders, it begs the question of whether 
these drugs prevent or lend a hand in suicides.
    There are some doctors who are convinced by their clinical 
experience that psychiatric drugs often adversely impact the 
individuals' better judgment and lead people to lose control over their 
emotions and actions. Suicides may be driven by so-called drug-induced 
adverse reactions and intoxications.
    On the other hand, there are research studies that show suicide 
attempts were lower among patients who were treated with 
antidepressants than those who were not. In other words, 
antidepressants had a protective effect and did not support the 
hypothesis that antidepressants place patients at greater risk of 
suicide.
    Through this hearing, we will explore the two opposing schools of 
thought on the relationship with psychiatric medication and suicides. 
In this process, we will also seek to better understand the reasons why 
more and more servicemembers and veterans are taking their own lives 
and what the Department of Veterans Affairs and the Department of 
Defense are implementing in this struggle to prevent more suicides.

                                 
                Prepared Statement of Hon. David P. Roe,
        a Representative in Congress from the State of Tennessee
    Thank you, Mr. Chairman.
    I think those of us gathered here today would be hard pressed to 
find a topic more heartbreaking than when a servicemember makes the 
decision to end his or her own life. This hearing is one of many 
hearings and meetings this Committee has had in an effort to combat 
veteran suicide and I can tell you that the stories we hear in these 
proceedings--much like those in Mr. Breggin's book--always raise 
difficult questions.
    As painful as such anecdotal accounts are, we must take heed not to 
be so quick to point to a single cause or mistake theory for solution. 
It is sound research that is critical to our efforts to put an end to 
these tragedies and understand the whole story.
    On that front, there are many encouraging signs. In 2008 the Army 
and the National Institute of Mental Health began a 5-year study into 
the factors that contribute to suicide in the armed forces and how to 
prevent them. Called the Army Study to Assess Risk and Resilience in 
Servicemembers (or, Army STARRS), this is the largest study of suicide 
and mental health among military members ever conducted.
    In addition, there is a great deal of ongoing public and private 
research into the causes of suicide and treatment options, including 
medication, to prevent it.
    I am hopeful that with this research, practitioners will be able to 
better identify risk factors for veteran suicide and design prevention, 
outreach, and treatment options that are effective and practical within 
the VA setting.
    The psychology behind why a person may see death as the only way 
out is more complex than any of us have the ability to fully comprehend 
and it is the interaction of a number of factors that may lead to this 
catastrophe. In addressing these issues, one cannot simply place blame 
on the veteran, their military service, their illness, or their chosen 
treatment option.
    As the research goes on, we must allow our veterans and 
servicemembers to have the full range of approved treatment options 
that they decide upon with their doctors.
    I want to thank our witnesses for being here this morning. I look 
forward to hearing and learning from each of you. It is only by working 
together that we can convince every courageous yet struggling American 
veteran that their country supports them and that hope--and help--are 
out there.
    I yield back the balance of my time.

                                 
             Prepared Statement of Hon. Harry E. Mitchell,
         a Representative in Congress from the State of Arizona
    Thank you, Mr. Chairman, for calling this hearing today. I commend 
your leadership for addressing suicide prevention and treatment for 
returning soldiers and our veterans.
    Among the many important issues that this Congress and 
Administration must address in the 111th Congress, I firmly believe we 
need to do more to prevent veteran suicide.
    As we all know, many of our newest generation of veterans, as well 
as those who served previously, bear wounds that cannot be seen and are 
hard to diagnose.
    There are over 20 million veterans in our country, and only a 
fraction of them are directly connected to the VA. We must continue to 
be proactive and innovative to reach those who may need help but may 
not know where to turn.
    Proactively bringing the VA to our veterans, as opposed to waiting 
for veterans to find the VA, is a critical part of delivering the care 
they have earned in exchange for their brave service.
    We persuaded the VA to overturn its self-imposed ban on television 
advertising as a method of outreach. The VA then produced a public 
service announcement and began an outreach campaign to inform veterans 
and their families about the suicide prevention hotline.
    What began as a limited DC area pilot program has been expanded 
nationally, and it has been effective. Since its inception in July of 
2007, nearly 225,000 calls were received from veterans. And the hotline 
has been credited with saving 7,000 lives.
    Through measures like the hotline, the VA is able to reach out to 
many more veterans that it might otherwise be unable to help.
    While I applaud the VA and Secretary Shinseki for expanding and 
extending outreach, I believe we need to do more. We need to expand and 
extend outreach efforts, including the use of e-mail, Twitter, Facebook 
and new media, to let veterans know where they can get help.
    As I told a group of Iraq and Afghanistan veterans who visited with 
me recently, we need to ``have the back'' of every veteran.
    Thank you again to all of our witnesses. I look forward to hearing 
your perspectives.
    I yield back.
                                 
        Prepared Statement of Peter R. Breggin, M.D., Ithaca, NY
                       (Psychiatrist and Author)
    I am Peter R. Breggin, M.D., a psychiatrist in private practice in 
Washington, DC, for several decades and now in Ithaca, New York. In the 
early 1990s I became the first physician to speak and write extensively 
about the new antidepressants causing violence, suicide and other 
abnormal behavioral reactions. I became the scientific expert for more 
than 100 combined cases against Eli Lilly concerning Prozac-induced 
violence and suicide, and wrote many related books and scientific 
articles. In 2004 the FDA finally upgraded the warnings for all 
antidepressant drugs. The FDA's language was virtually borrowed from 
one of my scientific publications (Breggin, 2003), which the agency had 
provided to each member of its review committee.
    My conclusions in this testimony are based on dozens of citations 
listed in the scientific paper I have written specifically for this 
hearing, ``Antidepressant-Induced Suicide and Violence: Risks for 
Military Personnel.'' My conclusions are further based on hundreds of 
scientific citations in my published papers and in chapters 6 and 7 of 
my 2008 medical book, Brain-Disabling Treatments in Psychiatry, Second 
Edition (New York: Springer Publishing Company).
    My other recent book, Medication Madness (2008, New York: St. 
Martin's Press) presents more than 50 cases in which I have personally 
evaluated the medical and police records, and interviewed perpetrators 
and survivors. Based on voluminous scientific data and clinical 
experience, individuals with no prior tendencies toward suicide, 
violence or mania can be driven into these states by antidepressants.
    In 2004 the FDA required the antidepressant manufacturers to review 
their previous clinical trials in regard to suicidality. The FDA 
concluded that the newer antidepressants double the rate of suicidal 
thoughts and behaviors in children, youth, and young adults up to age 
24. The actual rates will be much more than doubled in routine clinical 
practice in the military and elsewhere. In routine practice the 
medications are administered for longer periods of time than a mere few 
weeks, monitoring is much more casual, drug cocktails are common, and 
suicidal and more disturbed patients are not excluded as they were in 
the clinical trials.
    The FDA's new warnings provide a consensus of FDA-appointed 
experts. For convenience, I will cite the October 2008 FDA-approved 
label for Zoloft. The warnings are similar or identical to the other 
antidepressants. The Zoloft label begins at the top with the following 
Black Box bold warning:


----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------

Suicidality and Antidepressant Drugs

  Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in
children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other
psychiatric disorders. Anyone considering the use of Zoloft or any other antidepressant in a child, adolescent,
or young adult must balance this risk with the clinical need. . . .

----------------------------------------------------------------------------------------------------------------


    The black box is followed by a lengthy warning section ominously 
entitled Clinical Worsening and Suicide Risk. It states:

          The following symptoms, anxiety, agitation, panic attacks, 
        insomnia, irritability, hostility, aggressiveness, impulsivity, 
        akathisia (psychomotor restlessness), hypomania, and mania, 
        have been reported in adult and pediatric patients being 
        treated with antidepressants for major depressive disorder as 
        well as for other indications, both psychiatric and 
        nonpsychiatric.

    For emphasis, the FDA repeats this array of dangerous symptoms 
throughout the label. Note the specific mention of irritability, 
hostility, aggressiveness, and impulsivity--a prescription for violence 
as well as suicide, especially in already stressed and heavily armed 
soldiers.
    Federal regulations require that these warnings must be based on 
``reasonable evidence of a causal association with a drug.''
    The FDA-approved label concludes with a Medication Guide that 
prescribers are advised to give and discuss with patients and their 
families. The guide lists the following risks associated with the 
drugs.

      thoughts about suicide or dying
      attempts to commit suicide
      new or worse depression
      new or worse anxiety
      feeling very agitated or restless
      panic attacks
      trouble sleeping (insomnia)
      new or worse irritability
      acting aggressive, being angry, or violent
      acting on dangerous impulses
      an extreme increase in activity and talking (mania)
      other unusual changes in behavior or mood

    Meanwhile, the efficacy of these drugs is in doubt for both 
children and adults. Under FDA regulations, pharmaceutical companies 
can cherry pick their studies to find only two that show minimal 
effectiveness. However, antidepressants do not prove effective compared 
to placebo when all controlled clinical trials conducted for the FDA 
are included in a meta-analysis.
    As you may discover today, medical and psychiatric organizations 
that rely very heavily on financial support from the pharmaceutical 
industry have unconscionably resisted and even dismissed the FDA's 
warnings, and all the science behind them.
    In conclusion, there is overwhelming evidence that the newer 
antidepressants commonly prescribed in the military can cause or worsen 
suicidality, aggression, and other dangerous mental states. There is a 
strong probability that the documented increase in suicides in the 
military, as well as any increase in random violence among soldiers, is 
caused or exacerbated by the widespread prescription of antidepressant 
medication.
    Little will be lost and much will be gained by curtailing the 
prescription of antidepressants in the military. The military instead 
should rely upon the newly developed psychological and educational 
programs described by Dr. Bart Billings at today's hearing.
                               __________
    Antidepressant-Induced Suicide and Violence: Risks for Military 
                               Personnel
                       By Peter R. Breggin, M.D.*
                            Ithaca, New York
I. Introduction
    Evidence pertaining to violence and suicide induced by the newer 
antidepressants has been growing for years (Breggin and Breggin, 1994; 
Teicher et al., 2003). Recently public concern has been expressed about 
the increased prescription of psychiatric medications, especially 
antidepressants, to military personnel (Thompson, 2008). At the same 
time, the military has voiced concern about escalating rates of suicide 
among active duty soldiers (Lorge, 2008). At a military conference on 
combat stress, this author pointed to an association between increasing 
rates of antidepressant prescription and increasing rates of suicide in 
the military (Breggin, 2009).
---------------------------------------------------------------------------
    * Peter R. Breggin, M.D., 101 East State Street, Ithaca, New York, 
14850. Phone 607-272-5328. www.breggin.com. This paper was written as 
background for Dr. Breggin's testimony before the U.S. House of 
Representatives, Veterans' Affairs Committee, Hearings on ``Exploring 
the Relationship Between Medication and Veteran Suicide,'' February 24, 
2010.
---------------------------------------------------------------------------
    This paper focuses on evidence that antidepressants frequently 
cause suicide, violence and manic-like symptoms of over-stimulation--
and therefore present a serious hazard when given to military 
personnel. Studies with children will be included, because they 
commonly involve youth up to age 17 or 18 and because medication risks 
for all age groups often show up first or most obviously among 
children.

II. Research Leads to FDA Label Changes for the Newer Antidepressants
A. FDA Label Changes
    Because of concerns about reported cases of suicide in association 
with the newer antidepressants, the FDA required a re-evaluation of all 
controlled clinical trials conducted on children and youth during the 
FDA approval process. The selective serotonin reuptake inhibitor (SSRI) 
antidepressants were re-evaluated including fluoxetine (Prozac), 
fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), 
citalopram (Celexa) and escitalopram (Lexapro). In reports issued by 
the FDA (e.g., Food and Drug Administration, March 22, 2004d) four 
other potentially stimulating antidepressants were found to produce 
similar adverse behavioral and mental effects and were included in the 
group: venlafaxine (Effexor), mirtazapine (Remeron), bupropion 
(Wellbutrin or Zyban) and nefazodone (Serzone). The study included 
4,582 patients in 24 trials (Hammad et al., 2006). The meta-analysis 
found that the risk of suicidal ideation and behaviors was doubled for 
children and youth taking the antidepressants compared to placebo (4 
percent versus 2 percent) (Food and Drug Administration, October 15, 
2004a). The eventual label changes, however, were applied to all 
antidepressants, including older ones where no new evidence was 
available.
    To illustrate the FDA-mandated label changes, the following 
excerpts are taken from the Zoloft (sertraline) label as of October 
2008 (see attachments for complete label). Identical or nearly 
identical warnings and information can be found in all antidepressants 
labels, most of which appear in the Physicians' Desk Reference. A Black 
Box at the top of the label warns about the increased risk of suicidal 
behavior in children and youth, and also young adults ages 18-24, which 
includes many young soldiers.
    The Zoloft label begins with the following Black Box 
Warning:
---------------------------------------------------------------------------
     Bold emphases also appear in the label.


----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------

Suicidality and Antidepressant Drugs

  Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in
children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other
psychiatric disorders. Anyone considering the use of Zoloft or any other antidepressant in a child, adolescent,
or young adult must balance this risk with the clinical need. . . .

----------------------------------------------------------------------------------------------------------------


    The Black Box Warning provides additional information. Then the 
label continues with an elaborate WARNINGS section subtitled, Clinical 
Worsening and Suicide Risk, which contains the following statement:

          There has been a longstanding concern, however, that 
        antidepressants may have a role in inducing worsening of 
        depression and the emergence of suicidality in certain patients 
        during the early phases of treatment. Pooled analyses of short-
        term placebo-controlled trials of antidepressant drugs (SSRIs 
        and others) showed that these drugs increase the risk of 
        suicidal thinking and behavior (suicidality) in children, 
        adolescents, and young adults (ages 18-24) with major 
        depressive disorder (MDD) and other psychiatric disorders.

    This section continues with a specific warning about the increased 
risk of medication-induced suicidality during ``the initial few months 
of a course of drug therapy, or at times of doses changes, either 
increases or decreases.'' It then describes an activation or stimulant-
like array of adverse effects:

          The following symptoms, anxiety, agitation, panic attacks, 
        insomnia, irritability, hostility, aggressiveness, impulsivity, 
        akathisia (psychomotor restlessness), hypomania, and mania, 
        have been reported in adult and pediatric patients being 
        treated with antidepressants for major depressive disorder as 
        well as for other indications, both psychiatric and 
        nonpsychiatric.

    Note the specific mention of ``irritability, hostility, 
aggressiveness, impulsivity''--a virtual prescription for causing 
suicide and violence, especially in already stressed individuals, 
including soldiers.
    Further in the section on Clinical Worsening and Suicide Risk, this 
FDA-approved label recommends information that the prescriber should 
share with patients and caregivers. It repeats the array of dangerous 
stimulant or activation symptoms described above.
    A section titled Discontinuation of Treatment with Zoloft describes 
similar dangers associated with stopping or withdrawing from Zoloft and 
the other newer antidepressants, including ``dysphoric mood, 
irritability, agitation . . . anxiety, confusion . . . lethargy, 
emotional lability, insomnia, and hypomania.''
    Under the heading Information for Patients the label addresses the 
importance of informing patients about all of these risks. In this 
section, the FDA-approved label once again warns about Clinical 
Worsening and Suicide Risk and again describes the activation syndrome, 
including ``the emergence of anxiety, agitation, panic attacks, 
insomnia, irritability, hostility, aggressiveness, impulsivity, 
akathisia (psychomotor restlessness), hypomania, mania, other unusual 
changes in behavior, worsening of depression, and suicidal ideation, 
especially early during antidepressant treatment and when the dose is 
adjusted up or down.'' It warns ``families and caregivers of patients 
should be advised to look for the emergence of such symptoms on a day-
to-day basis, since changes may be abrupt. Such symptoms should be 
reported to the patient's prescriber or health professional, especially 
if they are severe, abrupt in onset, or were not part of the patient's 
presenting symptoms. Symptoms such as these may be associated with an 
increased risk for suicidal thinking and behavior and indicate a need 
for very close monitoring and possibly changes in the medication.''
    The probability that these warnings will be given to military 
personnel is not high, and of course their families will often be 
unavailable to monitor them.
    A Medication Guide appears at the end of the label. The label 
states, ``The prescriber or health professional should instruct 
patients, their families, and their caregivers to read the Medication 
Guide and should assist them in understanding its contents.'' The 
Medication Guide is not restricted to any age group. Its application to 
all ages was confirmed in a communication from the FDA's Senior 
Regulatory Project Manager, Division of Psychiatric Products to 
attorney Don Farber in 2008, which stated, ``In 2007, FDA revised the 
MG [Medication Guide] to expand the age range to all patients. . . . 
The revised MG was approved for all antidepressants in July and August 
2007'' (Grewal, 2008).
    The Medication Guide gives specific guidance about identifying 
danger signs associated with the use of antidepressants:

          Call a health care provider right away if you or your family 
        member has any of the following symptoms especially if they are 
        new, worse, or worry you:

      thoughts about suicide or dying
      attempts to commit suicide
      new or worse depression
      new or worse anxiety
      feeling very agitated or restless
      panic attacks
      trouble sleeping (insomnia)
      new or worse irritability
      acting aggressive, being angry, or violent
      acting on dangerous impulses
      an extreme increase in activity and talking (mania)
      other unusual changes in behavior or mood

    To add to the risks, all of the above symptoms can occur when the 
dose is reduced or stopped. Withdrawal from antidepressants is very 
dangerous and must be done carefully and with supervision (Zoloft 
label; Breggin, 2008a&b).
    Once again note the array of dangerous adverse reactions, including 
not only suicide but many emotional and behavior reactions that would 
be especially hazardous in a soldier, including, ``feeling very 
agitated or restless,'' ``new or worse irritability,'' ``acting 
aggressive, being angry, or violent,'' and ``acting on dangerous 
impulses.''
B. Canadian Drug Regulatory Changes
    On June 3, 2004, before the FDA issued its formal label changes, 
Health Canada (the Canadian drug regulatory agency) issued an Advisory 
for all of the newer antidepressants, including Zoloft, emphasizing the 
risk of both ``harm to self'' and ``harm to others'' in children and 
adults taking these drugs.
   After consultations with Health Canada, Pfizer also upgraded its 
  warnings for Antidepressant-Induced Suicide and Violence: Risks for 
                           Military Personnel
    Zoloft on May 26, 2004. In a black boxed warning under the rubric 
``Adult and Pediatrics: Additional data,'' the company warns about the 
risk of ``self-harm or harm to others.'' It too describes an activation 
or stimulant like array of drug-induced symptoms: ``The agitation-type 
events include: akathisia, agitation, disinhibition, emotional 
lability, hostility, aggression, depersonalization. In some cases, the 
events occurred within several weeks of starting treatment.''
III. Confirmation from the Diagnostic and Statistical Manual of Mental 
        Disorders
    The official American Psychiatric Association Diagnostic and 
Statistical Manual of Mental Disorders (2000) is considered a consensus 
document drawing on current expertise in psychiatry. It is the most 
commonly used authority in the field and provides the official 
diagnostic system. In the section on mania and elsewhere, it makes 
clear that antidepressants can cause all the symptoms and behaviors 
associated with mania: ``Symptoms like those seen in a Manic Episode 
may also be precipitated by antidepressant treatment such as medication 
. . .'' (p. 361). Symptoms and behaviors associated with mania, 
including the medication-induced disorder, emphasize high-risk 
behaviors: ``criminal'' behavior, ``antisocial'' behavior, 
``irritability, particularly when the person's wishes are thwarted,'' 
``assaultive behavior,'' ``physically assaultive'' behavior, 
``physically threatening'' behavior, ``suicidal'' behavior, and shifts 
from anger to depression (pp. 359-261). By causing mild to severe 
degrees of manic behavior, antidepressants can cause suicide, violence 
and a wide variety of antisocial behaviors.
    The official diagnostic manual also makes clear that SSRI 
antidepressants can cause akathisia, including suicide, aggression, and 
worsening of psychosis or behavioral dyscontrol (American Psychiatric 
Association, 2000, p. 801).

IV. Overview of Scientific Studies
A. Antidepressant-Induced Suicidality in Children and Adults
    In addition to the studies done under the auspices of the FDA 
(above), a large body of research confirms an increased risk of 
suicidality in children and adults (of all ages) when taking 
antidepressants. Aursnes et al. (2005) located unpublished data on 
adult controlled clinical trials not previously available for a total 
of 16 studies in which Paxil had been randomized against placebo. They 
found a statistically significant 7 suicide attempts among patients 
taking Paxil and 1 among patients receiving placebo. They concluded, 
``Our findings support the results of recent meta-analyses. Patients 
and doctors should be warned that the increased suicidal activities 
observed in children and adolescents taking certain antidepressant 
drugs may also be present in adults.''
    Fergusson et al. (2005) searched the adult literature and found 702 
randomized clinical trials (87,650 patients) comparing an SSRI to 
placebo or an active non-SSRI control medication. They found a 
statistically significant increased risk of suicide attempts on SSRIs 
compared to placebo.
    Donovan, Kelleher, Lambourn, and Foster (1999) found a 
significantly increased rate of suicide among adult patients treated 
with SSRIs compared to those treated with tricyclic and other 
antidepressants. The large British study involved 222 suicides.
    Donovan, Clayton, Beeharry, Jones, Kirk, Waters, et al. (2000) 
conducted a prospective study of 2,776 consecutive cases of deliberate 
self-harm in individuals age 17 and older who were seen at the 
emergency department of a British infirmary. The relative incidence of 
deliberate self-harm was significantly higher (P<0.001) in patients who 
were prescribed the SSRIs fluoxetine, paroxetine, and sertraline 
compared to patients who were prescribed older more sedating 
antidepressants.
    Jick, Dean and Jick (1995) conducted an epidemiological study of 
reports from general practices (primary care) in the United Kingdom 
involving 172,598 adult patients who had been given at least one 
prescription for antidepressants. Even after taking into account a past 
history of suicidal behavior and other variables, fluoxetine remained 
twice as likely to be associated with suicide as older more sedating 
antidepressants.
    Frankenfield, Baker, Lange, Caplan and Smialek (1994) conducted a 
retrospective case review of all deaths in Maryland where either 
fluoxetine or tricyclic antidepressants were forensically detected. The 
study covered a 3\1/2\ year period of time and found a statistically 
significant increase in violent suicides in association with fluoxetine 
(65 percent versus 23 percent).
    Under guidance from the FDA, GlaxoSmithKline conducted ``a new 
meta-analysis . . . of suicidal behavior and ideation in placebo-
controlled clinical trials of paroxetine in adult patients with 
psychiatric disorders . . .'' (GlaxoSmithKline, 2006, p. 1). The 
company found a statistically significant increase in suicidal behavior 
in adults of all ages treated with Paxil for Major Depressive Disorder.
    In a non-controlled study of suicide attempt cases admitted to a 
psychiatric unit in a general hospital, suicide attempt cases were more 
likely to have received antidepressants and benzodiazepines than non-
suicide cases. The study noted the possibility that antidepressants and 
benzodiazepines ``can induce, worsen or precipitate suicidal behavior 
in some patients . . .'' (Raja et al., 2009, p. 37). It advised warning 
patients of the risk.
    A study of 1,255 suicides in 2006 in Sweden (95 percent of all 
suicides in the country) examined the frequency of psychiatric 
medication usage up to 180 days before death (Ljung et al., 2009). The 
study reported that 32 percent of Scandinavian men and 52 percent of 
Scandinavian women filled a prescription for antidepressants in the 180 
days prior to death by suicide.
    A retrospective study examined the suicide rates among 887,859 VA 
patients treated for depression between April 1, 1999, and September 
30, 2004. It focused on 12-week periods after various events including 
hospitalization and antidepressant starts or dose changes. The authors 
found that ``completed suicide rates were approximately twice the base 
rate following antidepressant starts in VA clinical settings'' 
(Valenstein et al., 2009).
    Juurlink et al. (2006) reviewed more than 1,000 cases of actual 
suicides in the elderly and found that during the first month of 
treatment the SSRI antidepressants were associated with nearly a five-
fold higher risk compared to other antidepressants.
    Fisher, Kent and Bryant (1995) conducted a phone survey of pharmacy 
patients taking various antidepressants and found a higher rate of 
suicidality on SSRIs.
    The studies in this section confirm that the risk of antidepressant 
suicidality is not limited to children, youth, and young adults, but 
encompasses all ages.
B. Antidepressant-Induced Mania in Adults
    A considerable body of research demonstrates that the newer 
antidepressants frequently cause mania. Preda, MacLean, Mazure, and 
Bowers (2001) carried out a retrospective study of 533 adult 
psychiatric hospital admissions over a 14-month period and found that 
43 (8.1 percent) could be attributed to antidepressant-induced mania 
and/or psychosis. Morishita and Arita (2003) carried out a 
retrospective review of 79 patients treated for depression with 
paroxetine and found that 7 (8.6 percent) developed hypomania or mania.
    Howland (1996) examined approximately 184 adult patients treated at 
a university clinic and hospital with SSRIs, including fluoxetine, 
paroxetine, and sertraline. He identified 11 cases (6 percent) of SSRI-
induced mania, mostly severe.
    Ebert et al. (1997) carried out a prospective study of 200 adult 
inpatients over a total of 8,200 treatment days with the SSRI Luvox. 
Fourteen patients (17 percent) developed hypomania and some became 
potentially suicidal or dangerous.
    Levy et al. (1998) carried out a blind retrospective chart 
assessment of 167 adult patients with anxiety disorders. They reported, 
``Five patients (2.99 percent) were identified as having an episode of 
antidepressant-associated mania within 3 months of initiation of 
treatment.''
    Martin et al. (2004) used a national database of more than 7 
million privately insured individuals, aged 5-29 years, to find new 
diagnoses of bipolar illness made in association of antidepressant 
treatment. They found a statistically significant correlation between 
exposure to antidepressants and a subsequent diagnosis of bipolar 
disorder.
    Individuals who already have a tendency to become manic have vastly 
increased risk of mania when exposed to SSRI antidepressants (Henry et 
al., 2001; Ghaemi et al., 2000) with rates that exceed 20 percent.
    The SSRI antidepressants pose a very serious, indeed an extreme, 
risk of causing mania in patients with and without a prior history of 
manic-like symptoms. This alone should contraindicate their use among 
active duty soldiers.
C. Antidepressant-Induced Aggression in Adults
    Studies of antidepressant-induced mania often cite cases of 
violence. In addition, Healy et al. (2006) evaluated controlled 
clinical trial data produced by GlaxoSmithKline (2006a) concerning 
Paxil and found an increased rate of hostility for children and adults 
taking the medication. Healy (2000) conducted a randomized double-blind 
crossover study comparing the effects of sertraline (Zoloft) to a non-
SSRI antidepressant (reboxetine) in a group of healthy volunteers. Many 
of the 20 individuals developed adverse mental and neurological effects 
while taking the sertraline and two became severely disturbed with 
tendencies toward suicidal and violent behavior.
    The FDA conducted an unpublished epidemiological study comparing 
fluoxetine to trazodone in regard to spontaneous reports concerning 
hostility and intentional injury (Food and Drug Administration, 1991; 
available on www.breggin.com). Ever after the greater number of 
prescriptions for fluoxetine were factored in, fluoxetine had a higher 
frequency of reports for aggressive and violent behavior.
    In a phone survey of pharmacy patients taking antidepressants, 
Fisher, Bryant and Kent (1993) compared fluoxetine with a more sedating 
antidepressant, trazodone. They concluded that fluoxetine caused ``a 
higher incidence of psychologic/psychiatric adverse clinical events, 
including delusions and hallucinations, aggression, and suicidal 
ideation'' (p. 235).
D. SSRI-Induced Apathy Syndrome in Adults
    The mixture of apathy and disinhibited aggressiveness reported by 
Healy and others is found in a portion of patients who act 
uncharacteristically violent as a result of taking SSRIs (Breggin, 
2008a&b). Hoehn-Saric, Lipsey and McLeod (1990) describe ``Apathy and 
Indifference in Patients on Fluvoxamine and Fluoxetine,'' including 
apathy, indifference, loss of initiative and disinhibition with and 
without hypomania in five patients.
    Antidepressant-induced apathy has become sufficiently common to be 
described in the American Psychiatric Press Textbook of Psychiatry 
(Marangell et al., 2003; also see Marangell et al., 1999). Patients who 
become apathetic lose their ability to care about others and may have 
an increased tendency toward both suicide and violent (Breggin, 2008b).
E. A Broad Range of Adverse Behavioral Effects in Children and Youth
    Studies of children often include youth as old as age 17 or 18. 
There are many studies confirming suicidality and aggression in 
children and youth (see earlier in this report and Breggin, 2008b). 
Also, children are often more sensitive to drugs and are more likely to 
display adverse effects that will also appear with less frequency in 
adults.
    Researchers at Clinical and Research Program in Pediatric 
Psychopharmacology at the Massachusetts General Hospital and Harvard 
Medical School systematically evaluated 82 charts of children and 
adolescents treated with SSRIs for depressive or OCD symptoms over a 
mean period of 26.9 months (Wilens et al., 2003). Psychiatric Adverse 
Events (PAEs) were found in 22 percent, ``most commonly related to 
disturbances in mood.'' Remarkably, ``Re-exposure to an SSRI resulted 
in another PAE in 44 percent (n=13) of the group.'' Of the 82 children, 
21 percent developed mood disorders, including 15 percent who became 
irritable, 10 percent who became anxious, 9 percent who became 
depressed, and 6 percent who became manic. In addition, 4 percent of 
the children became aggressive. Sleep disorders afflicted 35 percent of 
the children, including 23 percent drowsy and 17 percent insomnia. 
Finally, 10 percent became psychotic!
    Go et al. (1998) reviewed the cases of 40 youths, ages 12-18, 
treated with antidepressants for OCD. Thirty percent (6 of 20) 
developed hypomanic or manic symptoms. Jain, Birmaher, Garcia, Al-
Shabbout and Ryan (1992) made a retrospective examination of the 
medical charts of children and young men age 9-18, who had taken 
fluoxetine at university clinic. The researchers found that 23 percent 
of fluoxetine-treated young people developed mania or manic-like 
symptoms. Another 19 percent developed drug-induced hostility and 
aggression, including a grinding anger with short temper and increasing 
oppositional behavior.
    Constantino, Liberman and Kincaid (1997) prospectively studied the 
course of aggressive behavior in 19 SSRI-treated psychiatrically 
hospitalized adolescents, age 13-17. The group was not pre-selected for 
potential aggressiveness. They found symptoms of physical aggression 
toward self or others in 12 of 19 patients on SSRIs.
    Another study of children and youth age 8-16 in a university 
setting found that 50 percent developed two or more abnormal behavioral 
reactions to fluoxetine, including aggression, loss of impulse control, 
agitation, and manic-like symptoms (Riddle, King, Hardin, et al, 1990/
1991). The effects lasted until the fluoxetine was stopped.
    A second research study from the same university setting described 
a number of youngsters (6 of 42 or 14 percent in their cohort) age 10-
17 who became aggressive and even violent while taking fluoxetine 
(King, Riddle, Chappell, et al., 1991).
    A controlled clinical trial found that fluoxetine caused a 6-
percent rate of mania in depressed children and youngsters age 7-17 
(Emslie et al. 1997), causing the youngsters to be removed from the 
study.
    As already mentioned, Martin et al. (2004) studied a national 
database for more than 7 million privately insured individuals, aged 5-
29 years, and found that exposure to antidepressants increases the 
probability of a subsequent diagnosis of bipolar disorder.
    In combination with the FDA's suicide warnings in regard to 
children, youth, and young adults, the studies in this section should 
lead to the discontinuation of antidepressants in the treatment of 
children and youth.

V. Determining Causation for Drug Research
A. Bradford Hill Criteria for Causation
    The nine Bradford Hill criteria for causation (Reekum, et al., 
2001; Bailey et al., 1994) were easily met by the FDA studies on 
antidepressant-induced pediatric suicidality as well by the great 
majority of studies reviewed in this report concerning antidepressant-
induced suicidality, mania, aggression, and other behavioral 
disturbances both in children and in adults. The one exception was the 
Bradford Hill criterion called ``Specificity,'' which is described by 
the authors as outmoded. Although not all of the criteria must be met 
to confirm causality, each of the studies do fulfill all or most of 
criteria, including Strength of the Association, Consistency of 
Evidence, Temporal Sequence, Biological Gradient, Biologic Rationale, 
Coherence, Experimental Evidence, and Analogous Evidence.
    Although it is a rare occurrence in psychiatry, the research on 
antidepressant-induced suicidality and mania in children and adults 
even meet the most stringent and convincing Bradford Hill criteron--
Experimental Evidence (Reekum, et al., 2001):

          Experimental evidence is the most compelling evidence of 
        causation. If it can be shown that experimentally (ideally 
        randomly) inducing the causative agent consistently produces 
        the outcome, at greater rates than in a nonexposed control 
        sample, this is clear and compelling evidence of causation. 
        However, it is obvious that such evidence will be rare in 
        neuropsychiatry. . . . P. 8.

    The capacity of controlled clinical trials to establish causality 
was confirmed in a discussion between FDA officials Russell Katz, MD, 
Director of Neurological Products, and Ralph Temple, MD, Director of 
Medical Policy, the Center for Drug Evaluation and Research. The verbal 
exchange took place during an FDA Advisory Committee Meeting (Joint 
Meeting of the Peripheral Nervous and Central Nervous System Drugs 
Advisory Committee . . . 2006, pp. 274 and 275). Katz and Temple agreed 
that when ``controlled clinical trials'' demonstrate a statistically 
significant difference from placebo, then ``that is operationally 
defined as causality.''
B. Causation in Regard to the FDA Suicide Studies of Children and Youth
    The FDA-mandated review of all placebo-controlled antidepressant 
clinical trials for children, youth and young adults strongly 
established the causal relationship between the newer antidepressants 
and suicidality. Thomas Laughren, at the time the Director, Division of 
Psychiatric Products of the FDA, wrote, ``The pediatric data presented 
at the September 2004 PDAC meeting represented the first systematic 
demonstration of a causal link'' (Laughren, 2006, emphasis added). 
Cynthia Pfeffer (2007), a physician and consultant at the FDA meetings, 
stated in regard to the pediatric trials, ``The Committee concluded 
that a causal link exists between antidepressant treatment and 
pediatric suicidality . . .'' (p. 844). Thomas Newman (2004), a 
physician and epidemiology on the FDA Advisory Committee further 
observed, ``The fact that an association emerged from the meta-analysis 
with a P value of 0.00005, for an outcome that the sponsors of the 
trails [pharmaceutical companies] were not looking for, and presumably 
did not wish to find, was quite convincing'' (p. 1598).
    The FDA Advisory Committee voted 25-1 with 1 abstention for ``Yes'' 
in response to the question, ``Do the suicidality data from these 
trials support the conclusion that any or all of these drugs increase 
the risk of suicidality in pediatric patients?'' It then voted 27-0 
that ``we are unable to conclude that any single antidepressant agent 
is free of risk at this time'' (Food and Drug Administration, 2004c, 
``Questions to the Committee,'' unnumbered).
    Five members of the Advisory Committee wrote a review of the FDA's 
deliberations concerning antidepressant-induced suicidality in children 
and youth (0 up to age 18), and made clear that causation had been 
established (Leslie et al., 2005). They stated, ``the causal link 
demonstrated in the FDA analyses therefore focused entirely on suicidal 
ideation and behavior'' (p. 200) and that ``there was an increased risk 
for suicidality causally related to the use of the SSRIs and related 
antidepressants'' (p. 200).
    The FDA originally required the pharmaceutical companies to state 
in their antidepressant labels that ``A causal role for antidepressants 
in inducing suicidality has been established in pediatric patients'' 
(Food and Drug Administration, October 15, 2004b). Later this wording 
was modified to an ``increased the risk,'' which is substantially the 
same. The FDA's definitive publication on its findings speaks directly 
of ``the absolute increase in the risk of the event of interest due to 
treatment'' (Hammad et al., 2006). The FDA report concluded, ``when 
considering 100 treated patients, we might expect 1 to 3 patients to 
have an increase in suicidality beyond the risk that occurs with 
depression itself owing to short-term treatment with an 
antidepressant'' (p. 336).
    Under clinical conditions in the real world rather than in 
controlled clinical trials, the rates of suicidality would be much 
higher than those in the clinical trials. Controlled clinical trials 
educate and inform the patients in detail, involve weekly monitoring, 
last no more than several weeks, avoid drug combinations, and exclude 
suicidal patients. In addition, they provide great hope and inspiration 
to the subjects and their families who seek to find a ``new cure'' for 
their emotional problems by participating in the experimental clinical 
trials (Breggin, 2008b). Because of these factors it is very rare for a 
patient to actually commit suicide during a trial, and none occurred in 
FDA's pediatric trials.
C. FDA Warnings for Children, Youth and All Adults
    We have seen that the FDA-approved labels for Zoloft and all other 
antidepressants contain elaborate warnings about medication-induced 
suicidality in children, youth and young adults, as well as warnings 
for a wide array of other symptoms including impulsivity, hostility, 
aggressiveness, and mania. The Federal regulations that govern the 
warnings sections in drug labels dictate that the inclusion of these 
adverse reactions must be based on ``reasonable evidence of a causal 
association with a drug.'' According to the Code of Federal Regulations 
(2008):

          In accordance with Sec. 314.70 and 601.12 of this chapter, 
        the labeling must be revised to include a warning about a 
        clinically significant hazard as soon as there is reasonable 
        evidence of a causal association with a drug; a causal 
        relationship need not have been definitely established. P. 29.

    In a Talk Paper, the FDA confirmed that the array of stimulant-like 
or activation symptoms associated with the antidepressants was in fact 
caused by the drugs when it referred to ``certain behaviors known to be 
associated with these drugs, such as anxiety, agitation, panic attacks, 
insomnia, irritability, hostility, impulsivity, akathisia (severe 
restlessness), hypomania, and mania . . .'' (FDA, 2004d, p. 1, emphasis 
added).
    This array of activation or stimulant-like symptoms is described in 
the antidepressant labels as occurring in children and adults. 
Consistent with this, the Talk Paper stated, ``The agency is advising 
clinicians, patients, families and caregivers of adults and children 
that they should closely monitor all patients being placed on therapy 
with these drugs for worsening depression and suicidal thinking, which 
can occur during the early period of treatment'' (FDA, 2004d, p. 1, 
emphasis added).

VI. Case Examples
A. Causation Established by Clinical Case Reports
    The pharmaceutical industry has attempted to discredit case reports 
as evidence for causation. However, case reports have led to most FDA 
changes in labels and to most withdrawals of psychiatric drugs from the 
market, and are a mainstay in the FDA for evaluating adverse drug 
reactions (Food and Drug Administration, 1993 & 1996; Government 
Accounting Office, 1990; Breggin, 2008b, pp. 263-269). The FDA itself 
described principles for determining causation from clinical reports 
(now called adverse event reports) in a table titled ``Useful Factors 
for Assessing Causal Relationship Between Drug and Reported Adverse 
Event'' (Food and Drug Administration, 1996, p. 6, emphasis added). 
Drawing on an international consensus meeting on the subject 
(Standardization of Definitions and Criteria of Causality Assessment of 
Adverse Drug Reactions, 1990), the FDA listed six potential criteria: 
chronology or temporal relationship, course of event when agent stopped 
(dechallenge), known etiological roles of agents in regard to the 
event, response to readministration of the agent (rechallenge), 
laboratory test results, and ``previously known toxicity of agent.''
    Because clinical trial, epidemiological and other research evidence 
is so strong in regard to the antidepressant-induced mental and 
behavioral abnormalities, the following clinical cases are included 
mainly for illustrative purposes.
B. Clinical Cases
    In my clinical and forensic practice I have evaluated more than 50 
cases of violence, suicide, mania and crime induced by psychiatric 
medications, especially the newer antidepressants (Breggin, 2008a). In 
the cases that I reviewed, the suicidal, violent or criminal behaviors 
were unprecedented and seemed in retrospect to be very alien and 
inexplicable to the individuals. Recidivism was zero when the 
medications were stopped. In evaluating the cases, I interviewed 
surviving victims and their families and acquaintances. In all but one 
of the cases I had complete access to medical, educational, 
occupational and police records. In all cases I interviewed the 
individuals if they survived, as well as witnesses and family members. 
In many cases my expert reports lead to acquittal on the basis of 
involuntary intoxication, reduced charges, shortened sentences, or 
release from incarceration. Most of the cases were evaluated for legal 
purposes and some were clinical consultations or treatment cases.
    As the patterns emerged from re-examining these cases, I was struck 
by the fact that victims of drug-induced abnormal mental states and 
behavior almost never had an inkling that they were acting irrationally 
or that they were under the influence of their psychiatric drugs. This 
led me to formulate the concept of medication spellbinding 
(intoxication anosognosia)--the concept that psychoactive substances 
reduce the individual's capacity to appreciate mental and behavioral 
adverse reactions (Breggin, 2006, 2008a&b).
    Case A: A gentle 37-year-old man with previously mild depressive 
symptoms and no history of violence became psychotic shortly after 
starting the SSRI antidepressant sertraline (Zoloft) and believed that 
his wife had been taken over by a dangerous alien from another world. 
In order to destroy the alien inside her, he undid her safety belt and 
drove their car into a barrier, nearly killing her. In a legal case in 
which I played no role, he was found Not Guilty by Reason of Insanity. 
Only after he began to recover over the subsequent weeks of psychiatric 
incarceration did he begin to suspect that medications might have 
caused his psychosis. He was released after several months of 
commitment to a mental hospital whereupon he was referred to me to 
gradually remove him from a cocktail of medications. He has done very 
well after more than a decade of drug-free followup.
    Case B: Without using a disguise, a 20-year-old college man with no 
history of crime committed a series of eight knifepoint robberies of 
his local gas stations, including those he and his family frequented, 
and was easily identified and caught. He had been recently started on 
the SSRI antidepressant paroxetine (Paxil) which was continued during 
his trial and sentencing. He was allowed to return home briefly before 
serving a lengthy incarceration and immediately robbed another local 
gas station using an identical knife and the same automobile, and was 
easily apprehended. My report on the effects of Paxil on his behavior 
convinced the court to give him a considerably reduced sentence.
    The above cases had manic features. In other cases, compulsive 
suicidal or violent behaviors developed without associated manic-like 
features.
    Case C: A 16-year-old girl was begun on fluoxetine (Prozac) to 
relieve the stress associated with an undiagnosed gastrointestinal 
disorder. Although there were no serious conflicts in the family, 
shortly after starting on the fluoxetine, she began to feel intensely 
compelled to stab her mother in the back. As the urge peaked, she 
confessed her intentions to her mother, and completely recovered when 
removed from the antidepressant.
    Case D: A 38-year-old highly responsible man with minimal symptoms 
of depression and no history of crime or violence was prescribed 
sertraline (Paxil). Within weeks the medication caused him to suffer 
from akathisia (extreme restlessness and agitation) and obsessive 
suicidality. He drove his car into a policeman in order to knock him 
down to obtain his gun to shoot himself. The officer was seriously 
injured but with the help of a bystander he managed to subdue his 
assailant. After my expert report in the case, the police officer 
agreed that drugs must have caused the assault, and a plea agreement 
was reached that led to only a brief incarceration. On followup he has 
done well for several years.
    Familiarity with medication effects does not necessarily protect 
the individual from abnormal emotional and behavior reactions. In 
several of my cases (Breggin, 2008a), the victims of drug-induced 
abnormal behaviors were physicians.
    Case E: A sophisticated psychiatrist with no history of violence 
gradually became manic while taking the SSRI antidepressant fluvoxamine 
(Luvox). He violently assaulted a female colleague with a tack hammer 
and then made a bizarre suicide attempt. He was convicted of assault 
and continued on the antidepressant in prison. He remained in a 
medication-induced mildly manic-like condition in prison and did not 
realize that the drug had caused his violent behavior until he was 
removed from it several months later. While still incarcerated, he 
asked me for a consultation to clarify what had occurred.
VII. Antidepressant-Induced Reactions that Result in Suicide and 
        Violence
    The various antidepressant-induced clinical syndromes and reactions 
associated with suicide and violence have been reviewed elsewhere 
(e.g., Teicher et al., 1990, 1993; Breggin, 1993 and 2008a&b). Almost 
all are now described in the FDA-mandated label changes under Clinical 
Worsening and Suicide Risk, including 
the activation or stimulation spectrum of adverse drug effects: ``the 
emergence of anxiety, agitation, panic attacks, insomnia, irritability, 
hostility, aggressiveness, impulsivity, akathisia (psychomotor 
restlessness), hypomania, mania, other unusual changes in behavior, 
worsening of depression, and suicidal ideation, especially early during 
antidepressant treatment and when the dose is adjusted up or down.''
    All of the above adverse reactions are associated with suicide and 
violence. The antidepressant labels confirm that these can occur when 
the drug is given for ``both psychiatric and nonpsychiatric'' purposes. 
In a study of patients treated with fluoxetine and paroxetine, and 
suffering from nothing more than learning disabilities, 31 percent 
suffered from stimulant symptoms including elevated mood, 
hyperactivity, overtalkativeness, agitation, and aggression (Biswas et 
al., 2001).
    Individually, some of the causal syndromes or adverse reactions 
include: (1) anxiety and agitation with or without hyperactivity 
(akathisia); (2) worsening depression; (3) compulsive suicidality; (4) 
irritability, hostility, and aggressiveness; (5) apathy and 
indifference; (6) behavioral dyscontrol or impulsivity; and (7) mania 
and psychosis.
VIII. Lack of Efficacy
    It is relatively easy to prove that antidepressants frequently 
cause serious and even life-threatening harm, while it remains 
difficult to prove that they are helpful. In order to obtain FDA-
approval, pharmaceutical companies cherry pick their studies in order 
to find two that show some effectiveness. However, when all adult 
controlled clinical trials, including the unsuccessful ones, are pooled 
in a meta-analysis, antidepressants do not prove effective (Kirsch et 
al., 2008; Moncrief and Kirsch, 2005). Meanwhile, studies of children 
and youth almost uniformly fail to show effectiveness (Whittington et 
al., 2004, ages 5-18; Jureidini et al., 2004, Tonkin and Jureidini, 
2005; studies reviewed in Breggin, 2008b).
IX. Conclusion
    There is overwhelming evidence that the SSRIs and other stimulating 
antidepressants cause suicidality and aggression in children and adults 
of all ages. The evidence suggests that young adults aged 18-24 (the 
age of many soldiers) are especially at risk for antidepressant-induced 
suicidality. There is a strong probability that the increasing suicide 
rates among active duty soldiers are in part caused or exacerbated by 
the widespread prescription of antidepressant medication. In addition, 
antidepressants frequently cause manic-like reactions, including loss 
of impulse control and violence, posing potentially grave risks among 
military personnel. Little will be lost and much will be gained by 
stopping the prescription of antidepressants to military personnel. The 
military should rely upon the psychological and educational programs 
that are currently under development for preventing suicide and 
ameliorating other psychiatric disorders among servicemembers. 
Antidepressants should be avoided in the treatment of military 
personnel.
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              Prepared Statement of Andrew C. Leon, Ph.D.,
      Professor of Biostatistics in Psychiatry and Public Health,
              Weill Cornell Medical College, New York, NY
    My name is Dr. Andrew C. Leon. I know that this is clearly an 
emotional issue. My family has been profoundly impacted by mental 
illness--so much so, that I have devoted my career to the field of 
psychiatry. I am Professor of Biostatistics in Psychiatry and Public 
Health at Weill Cornell Medical College, where I have been on the 
faculty for over 20 years. I have published over 200 peer-reviewed 
scientific manuscripts. Nearly all of my research has been funded by 
NIH. I have served as a consultant to FDA, NIMH and to industry, 
primarily to monitor the safety of participants in clinical trials.
    All of us here today share a common goal: to do the very best for 
our veterans. My perspective is that doing the best requires the 
discipline to use empirical methods to understand optimal mental heath 
care and prevention of suicide.
    I was the biostatistician on the FDA's Psychopharmacologic Drug 
Advisory Committee from 2003-2008 and participated in FDA hearings on 
the topic of antidepressants and suicidality. The class of medications 
that I will discuss is antidepressants. Depression is a life 
threatening illness. Suicidality is a symptom of depression, whether 
treated or untreated.
    My main points today are paraphrased from the FDA Black Box Warning 
on all antidepressants: (1) Depression increases risk of suicide (2) To 
reduce suicide risk, clinicians must carefully monitor veterans with 
depression, whether treated or untreated.
    I will discuss three types of scientific studies: randomized 
controlled clinical trials (comparing antidepressants and placebo), 
observational studies, and post-mortem studies. Three types of 
suicidality are reported in these studies: suicidal thinking, suicide 
attempts and suicide deaths.
    In 2004, the FDA reviewed 25 pediatric clinical trials for 
antidepressants involving over 4,400 subjects and found that patients 
randomized to antidepressants were about twice as likely to report 
suicidality. However only 3 percent reported suicidality--mostly 
suicidal thinking. There were no suicide deaths.
    In 2006 the FDA reviewed 295 clinical trials of antidepressants for 
adults involving over 75,000 participants. Less than 1 percent reported 
suicidality, mostly suicidal thinking. Unlike pediatric trials, adults 
randomized to antidepressants were NOT more likely to report 
suicidality. In fact, antidepressants conveyed significant protection 
from suicidality for ages 65 and higher.
    At least one, large longitudinal observational study of mood 
disorders, funded by the NIMH, extended the clinical trial conclusions, 
finding that antidepressants significantly reduced risk of suicide 
attempts and suicide deaths in adults.
    Our research group at Cornell conducted post-mortem studies of 
suicide deaths in New York City. Ninety-five percent of the youth 
suicides and 77 percent of adult suicides had NOT taken antidepressants 
immediately before their deaths. This suggests that prevention of 
suicide requires intervention primarily among patients who are not 
receiving antidepressants.
    A cause and effect relationship has not been established between 
antidepressants and suicide. In light of the suicide risk in 
depression, a prudent recommendation is that veterans, whether treated 
or untreated, must be appropriately monitored by clinicians. In 
conclusion, I would like the Committee to recognize that depression is 
itself a risk factor for suicide. To leave these men and women 
untreated is to accept suffering from the disorder itself.

                                 
        Prepared Statement of M. David Rudd, Ph.D., ABPP, Dean,
   College of Social and Behavioral Science, The University of Utah,
  Salt Lake City, UT, on behalf of American Psychological Association
    Chairman Filner, Ranking Member Buyer, and Members of the 
Committee, I want to express my appreciation for the opportunity to 
testify on behalf of the 152,000 members and affiliates of the American 
Psychological Association (APA) regarding the relationship between 
medication and veteran suicide. Attention to this issue is particularly 
timely given the considerable confusion about medications and suicide 
risk since the 2004 Food and Drug Administration (FDA) black box 
warning label was placed on certain antidepressants being prescribed 
for children and adolescents. As you know, the label was subsequently 
updated in 2007 and expanded to include young adults up to 24 years of 
age. Since then, there has been a ``spillover effect'' for adults 
beyond this age. In 2008, the FDA also issued an alert that 
antiepileptic drugs include a warning in their labeling to inform 
patients about the possible risk for suicidality.
    Given the confusion that has followed the warning label and more 
recent FDA alert, along with its potential impact on direct clinical 
care, the field of psychology can make a significant difference in 
helping to inform the discussion regarding the actual nature of risk, 
the role of medications in the treatment of suicidality, and the 
utility of psychotherapeutic treatment approaches as a primary 
treatment option or in combination with medications. While the vast 
majority of the data are not specific to the veteran population there 
is no reason to believe the observable trends for adults in the general 
population would be different.
    Confusion following the warning label has been shared among both 
practitioners and the general public. Among the facts frequently 
overlooked are the following: (1) there were no suicides in the 
original pediatric and adolescent trials (a total of 4,400 patients), 
(2) although there were suicides in the adult trials, the ``number was 
not sufficient to reach any conclusion about drug effect on suicide'' 
with comparable numbers across the placebo and clinical components of 
the studies, (3) given the failure to demonstrate any clear 
relationship between medications and death by suicide, the warning 
label focuses on ``suicidality'' defined as ``suicidal thoughts'' of 
unknown frequency, severity and duration and ``suicidal behaviors'' of 
unknown lethality, (4) the rates of suicidality in the clinical trials 
were low and in terms of actual numbers, very small differences were 
significant and resulted in a warning label, (5) the followup periods 
for the various drug trials were quite short (i.e., several months), 
and we do not have much needed data to understand potential recovery 
curves and treatment effectiveness after the initial 4-8 week window of 
the trials, (6) neither the warning label nor the medication guide 
provides any age-related data regarding suicide risk, with little 
context to understand the implications of the findings (particularly 
since suicide risk increases with age), and (7) practicing general and 
family physicians have demonstrated error rates as high as 91 percent 
in terms of an accurate understanding of the nature of the risk for 
suicidality communicated in the FDA warning label, with most believing 
the warning label communicates a risk for death by suicide.
    Given that as high as 75 percent of depressed adult patients 
looking for treatment receive medications and that an estimated 50 
percent receive both psychotherapy and medications, this is a very 
critical issue for our veterans. Not only have there been unintended 
consequences of the warning label and widespread media coverage of the 
link between medications and suicidality, but also the effectiveness of 
behavioral treatments has often not been considered.
    Acute and chronic suicidality is a particularly difficult clinical 
problem. It is one that requires an accurate understanding of the role 
and effectiveness of medications, along with behavioral treatments. 
There is evidence available to suggest that not only have practitioners 
been hesitant to diagnose and treat problems like depression since the 
FDA warning label, but also that patients have been less willing to 
pursue treatment, with both groups inappropriately believing 
medications raise the risk for death by suicide. It is not surprising 
that our efforts to reach veterans in serious need of care are hampered 
when death by suicide is inappropriately considered a significant risk 
of treatment. This concern extends to the family members of veterans as 
well.
    The reality is that the efficacy of treatment (both psychotherapy 
and medications) far outweighs the observed risk for suicidal thoughts 
and behaviors. There have been a number of well designed, rigorous 
studies demonstrating a marked reduction in suicide risk associated 
with selective serotonin reuptake inhibitor (SSRI) use, cutting across 
the full spectrum from early to late adulthood. For high-risk suicidal 
individuals, medications can be very effective in managing symptom 
severity (e.g., sleep disturbance, agitation, anxiety) during periods 
of imminent risk and prove an important complement to behavioral 
treatments. During periods of acute risk, patients often experience 
difficulty fully participating in psychotherapy because symptoms limit 
their ability to concentrate, engage, and most importantly, learn.
    Since many, arguably all, suicidal patients consider suicide as an 
option in an effort to reduce or eliminate their emotional suffering, 
medications can play an important and strategic role. They provide a 
treatment option that can more quickly target symptoms facilitating a 
patient's feeling of hopelessness. Behavioral treatments take time, 
with patients gradually building critical skills and resolving traumas. 
Until adequate skills are established and refined, medications can help 
fill the gap, buying what is oftentimes lifesaving time.
    Despite the concerns about medications and suicide, we now know 
scientifically that a number of behavioral treatments help reduce the 
risk of death by suicide. There are a number of reviews of 
psychotherapies that have proven effective in the treatment of suicidal 
behavior. I completed a recent review driven by a simple question, what 
are the common elements of treatments that work? There are a handful of 
treatments proven to be effective at reducing suicide attempts after 
treatment, with considerable overlap in the nature and type of 
treatment. In the case of behavioral treatment, simple interventions 
can help save lives.
    First, all of the effective treatments have simple and 
understandable models that are shared with patients. Patients need to 
understand why they have become suicidal and the benefits of the 
treatment in order to fully invest in care. When a patient understands 
why they have been suicidal and how treatment will help, the net result 
is hope, improved motivation, less shame, better compliance and more 
effective care. This is a simple step and can be carried out in any 
setting and by a range of health professionals. Second, effective 
treatments target identified skill deficits. Patients that consider 
suicide evidence skill deficits that can be identified, targeted and 
improved. Third, effective treatments emphasize self-reliance, self-
awareness and personal responsibility in a number of concrete ways. 
Patients are encouraged to assume a considerable degree of personal 
responsibility for their own care by use of commitment to treatment 
agreements and safety plans. As might be apparent, the ability to take 
personal responsibility for one's care is very much an identified 
skill. Fourth, effective treatments emphasize the importance of crisis 
management, removal of available lethal methods, and access to care 
during and after treatment, with written and accessible treatment 
plans. This includes the involvement of family and friends. Finally, 
effective treatments incorporate compliance protocols. When a patient 
drops out of treatment, specific steps are taken to try to engage the 
patient in care, with a concerted effort to identify and target the 
reasons the patient withdrew. It is critical to keep at-risk patients 
engaged in treatment.
    These are very simple actions that can save the lives of our 
veterans who are experiencing thoughts of suicide. They can be 
accomplished across the full range of settings and by a variety of 
providers. Especially for those hesitant to consider medications as an 
alternative, behavioral treatments have much to offer, either as an 
independent treatment or in combination with medications. We owe it to 
our veterans to ensure that they have the mental and behavioral health 
care that they need and deserve and the psychology community remains 
committed to assisting in this effort.
    Thank you. I appreciate the opportunity to speak with you today and 
welcome the chance to respond to questions.

                                 
     Prepared Statement of Annelle Primm, M.D., MPH, Deputy Medical
  Director for Minority Affairs, American Psychiatric Association, and
 Associate Professor of Psychiatry, Johns Hopkins School of Medicine, 
                             Baltimore, MD
    My name is Annelle Primm. I am the Deputy Medical Director for 
Minority Affairs of the American Psychiatric Association and an 
Associate Professor of Psychiatry at the Johns Hopkins School of 
Medicine. Thank you for the opportunity to speak before the Committee 
today on behalf of the American Psychiatric Association (APA), a 
medical specialty organization which represents 37,000 psychiatric 
physicians nationwide.
    APA also promotes the highest standards of care for our patients 
and their families, and to that end we strive for standards of 
excellence in psychiatric research and in the education and training of 
our psychiatrist workforce. Critical goals and activities of the 
American Psychiatric Association include:

      Advocating for patients and for the profession, and 
fighting discrimination against people suffering from mental illnesses, 
including substance use disorders.
      Supporting education, training and career development of 
psychiatrists and other physicians.
      Enhancing the scientific basis of psychiatric care.
      Defining and supporting professional values and ethics.

    The APA vigorously advocates for immediate and seamless access to 
care for psychiatric and substance use disorders for America's military 
and their families. We continue to staunchly support increased Federal 
funding of psychiatric and brain injury research. We remain concerned 
that despite concerted efforts of the VA and DoD, stigma still shadows 
those who seek psychiatric care and discourages those who need care 
from seeking it. The unprecedented length and number of deployments of 
U.S. military personnel, as well as the nature of our current military 
engagements, have placed an enormous strain on those serving in all 
facets of the military as well as their families. As physicians, 
researchers and family members, the APA has noted with increasing 
concern the increase in suicide attempts and completed suicides by 
veterans and those currently serving, and has advocated for direct 
action to address this major problem.
    Beginning in 2002, the suicide rate among soldiers rose 
significantly, reaching record levels in 2007 and again in 2008 despite 
the Army's major prevention and intervention efforts. In response, the 
Army and NIMH partnered to develop and implement ``STARRS'' (Study To 
Assess Risk and Resilience in Servicemembers) the largest study of 
suicide and mental health among military personnel ever undertaken. 
Many APA members are involved in the NIMH-Army study which will 
identify--as rapidly as possible--modifiable risk and protective 
factors related to mental health and suicide. It also will support the 
Army's ongoing efforts to prevent suicide and improve soldiers' overall 
wellbeing. The length and scope of the study will provide vast amounts 
of data and allow investigators to focus on periods in a military 
career that are known to be high-risk for psychological problems. The 
information gathered throughout the study will help researchers 
identify not only potentially relevant risk factors but potential 
protective factors as well. Study investigators will move quickly to 
provide information that the Army can use immediately in its suicide 
prevention efforts and use to address psychological health issues.
Medication Safety
    Today's invitation from the Committee requested that the APA 
provide its position on the effectiveness and safety of psychiatric 
medications. I note that many of the most dramatic improvements in the 
effective treatment of mental illness have come as a result of newer 
and better medications, especially a class of antidepressants called 
SSRIs which can be utilized to help manage PTSD symptoms. These 
medications have meant remarkably positive changes in the lives of tens 
of millions of Americans and would not have been possible without the 
resources of the pharmaceutical industry to research and development.
    Simply put, it is the position of the American Psychiatric 
Association that a patient's decision to take a psychiatric medication 
should be based on the best medical advice and scientific evidence 
available. Medications, when utilized, should be in conjunction with 
supportive therapies such as cognitive behavioral therapy. The 
prescribing and monitoring of brain medication should, however, be 
overseen by those with medical education, training and clinical 
experience.
    First, the APA would like to emphasize the importance of open 
access to non-individually identifiable data from clinical trials, 
including data from negative trials, unpublished research and post-
market studies. Physicians and patients clearly need access to this 
kind of information in order to make fully informed decisions about 
treatment options. For this reason, the APA has been in the forefront 
of the call for the development of a national registry of clinical 
trials. Such a registry should be comprised of non-individually 
identifiable data for those with an approved need, such as physicians, 
researchers and clinicians. This registry needs to be carefully 
designed in order to avoid a huge `data dump' which can lead well-
intentioned reviewers to erroneous conclusions. The data in such a 
registry needs to be meticulously coded in the same manner across many 
domains in order to be truly useful.
    Next, let me address medication, in general, and the SSRI 
antidepressants, in particular, which are a class of medications often 
used to help manage PTSD symptoms. Research has clearly demonstrated 
that medication can be helpful and even lifesaving, for many people 
with psychiatric disorders, but medication is most effective when used 
as a key component of a comprehensive treatment plan, individualized to 
the needs of the patient.
    Let me take a minute to address the complex issue of whether or not 
the SSRIs increase the risk of suicidal thinking or behavior. At this 
point, here's what we actually know, from a scientific perspective: 
Contrary to frequent reports in the popular media, there is no evidence 
to suggest that these medications increase the risk of actual suicide. 
It does appear that these medications may increase the likelihood that 
some patients will actually tell someone about their suicidal thoughts 
or even about a suicide attempt. From my perspective, as a 
psychiatrist, this is actually a good thing, because it means you have 
the opportunity to intervene and to keep the person safe. The teenage 
suicide rate in the country had actually declined by over 25 percent 
since the early 1990s, in a manner consistent with the increased use of 
SSRI antidepressants.
    In October of 2004, following a review of clinical trial data, the 
U.S. Food and Drug Administration (FDA) issued a public warning about 
an increased risk of suicidal thoughts or behavior in children and 
adolescents treated with SSRI antidepressant medications. In 2006, an 
advisory committee to the FDA recommended that the agency extend the 
warning to include young adults up to age 25, given that brain 
development continues well into a person's 20s.
    In the 2004 FDA review, the data showed that no completed suicides 
occurred among nearly 2,200 children treated with SSRI medications. 
However, about 4 percent of those taking SSRI medications experienced 
suicidal thinking or behavior, including actual suicide attempts--twice 
the rate of those taking placebo, or sugar pills. In response, the FDA 
adopted a ``black box'' label warning indicating that antidepressants 
may increase the risk of suicidal thinking and behavior in some 
children and adolescents with major depression. A black box warning is 
the most serious type of warning in prescription drug labeling.
    The warning notes that children and adolescents taking SSRI 
medications should be closely monitored for any worsening in 
depression, emergence of suicidal thinking or behavior, or unusual 
changes in behavior, such as sleeplessness, agitation, or withdrawal 
from normal social situations. Close monitoring is especially important 
during the first 4 weeks of treatment. SSRI medications usually have 
few side effects in children and adolescents, but for unknown reasons, 
they may trigger agitation and abnormal behavior in certain 
individuals.
    Following the notable 2004 black box warning there was a decrease 
in initial prescribing of antidepressants. The APA was concerned then 
and remains so that the warning has the unintended consequence of a 
`chilling effect' on people and their families considering treatment 
for depression.
    According to data from the Center for Disease Control and 
Prevention, the suicide rate for 25-34-year-olds declined an average of 
0.9 percent annually, or about 17 percent when comparing 1985 with 
2004. The suicide rate for teens began declining sharply in the mid-
90s. During the 10 years 1994-2003, suicides dropped an average of 3.8 
percent annually, or 33 percent when comparing 1994 with 2003. Rates 
rose in 2004: the rate of suicide in young people under 20 increased 18 
percent over 2003--the first increase in 12 years. The rate decreased 
somewhat from 2004 levels over the past 3 years but has remained above 
the 2003 level.
    Recently, results of a comprehensive review of pediatric trials 
conducted between 1988 and 2006 suggested that the benefits of 
antidepressant medications outweigh their risks to children and 
adolescents with major depression and anxiety disorders. The study, 
partially funded by the National Institute on Mental Health, was 
published in the April 18, 2007, issue of the Journal of the American 
Medical Association. In the meantime, the increase in suicides 
following the FDA action should serve as a very strong caution against 
reaching conclusion and taking action too quickly.
    APA welcomes more information about how to best use these 
medications in the treatment of our patients. In particular, we support 
long-term followup studies on both safety and efficacy. Fortunately, 
several such studies are currently underway, with funding from the 
National Institutes of Mental Health.
    Finally, let me emphasize the importance of advocacy for returning 
military with psychiatric and substance use disorders. Families, in 
particular, need to be advocates for their loved ones. They need to 
make sure their family members has a comprehensive evaluation by a 
trained and qualified mental health professional and that they have 
access to necessary and appropriate ongoing treatment services. They 
should also ask lots of questions about any proposed diagnosis or 
treatment plan. To this end, the APA has jointly developed a Web site, 
www.Healthyminds.org to provide patients, families and physicians with 
as much information as possible about the evaluation and treatment of 
depression, PTSD and substance use disorders. Over a dozen major 
medical, family and patient advocacy organizations have already 
endorsed this collaborative effort. In addition, the APA is a proud 
founding partner of ``Give an Hour.'' This volunteer organization 
provides professional mental health and substance use disorder services 
through a network of professionals who volunteer their services for an 
hour a week to active and returning military, National Guard, veterans 
and their families. ``Give an Hour'' has been utilized as a portal for 
care for those who fear the stigma of seeking services within the VA or 
DoD structure.
Scientific Data and Information Available to Physicians
    Over the past decade, the relationship between medicine and 
industry, including pharmaceutical manufacturers and medical device 
companies, has been under increased public scrutiny. Patients need to 
be able to rely on the objective recommendations of their physicians. 
In turn, physicians must be able to rely on the objectivity of research 
as it pertains to the safe and effective use of medications and medical 
devices.
    Recognizing the necessity of managing potential conflicts of 
interest, the APA has been proactive in examining our relationships 
with the pharmaceutical industry. We have taken considerable pains to 
implement safeguards to reduce the risk of a conflict of interest 
between the industry and the provision of Continuing Medical Education. 
In fact, the APA received a commendation and a 6 year accreditation for 
outstanding compliance with accreditations rules and regulations--2004-
2010 from the Accreditation Council for Continuing Medical Education.
    The APA also has a Scientific Program Committee (SPC) which is 
responsible for all decisions concerning the content and format of the 
APA Annual Meeting, including editorial responsibility for the peer 
review, selection and presentation of the scientific and clinical 
content of the Annual Meeting. The committee reviews all submissions 
for scientific and clinical merit, including those symposia seeking 
industry support. Members of this committee must also submit disclosure 
forms and recuse themselves from discussions that might involve a 
perceived conflict.
    In March 2009, the APA's Board of Trustees voted to phase out 
industry-supported education programs and industry-supported meals 
served at the APA scientific meetings. As far as we know, the APA is 
the first professional medical specialty to end industry-sponsored 
symposia. As a result of the Board action, at our 2009 scientific 
meeting, only 11 of over 500 programs offered were supported by the 
pharmaceutical industry. I do want the Committee to note that the 
overwhelming majority of our educational activities at our annual 
meetings are developed by APA members as well as the National 
Institutes of Mental Health, National Institute on Drug Abuse and the 
National Institute of Alcohol Abuse and Alcoholism.
    The American Psychiatric Association has long understood the need 
for a comprehensive disclosure policy based on clarity and 
transparency, particularly in the areas of publishing, research and 
education. APA recognizes that the ultimate success of its education 
enterprise rests on the public's (and its members') trust and 
confidence that the educational content is based on accepted scientific 
information free of any perceived marketing bias. Similarly, the 
success of our research enterprise rests on the public's trust and 
confidence that the research is conducted and presented in an unbiased 
manner.
    We at the APA are hopeful that today's hearing and testimony will 
help promote access to information, encourage expanded support for 
research, and enhance the ability of returning military and their 
families to advocate effectively for the treatment they need and 
deserve.
    Thank you for the opportunity to testify. I would be pleased to 
answer your questions.

                                 
   Prepared Statement of Commander Donald J. Farber, Esq., USN (Ret.)
                             San Rafael, CA
                      Introduction and Background
    Thank you, Mr. Chairman. My name is Don Farber. I am a Navy 
veteran, 25 years in the line; half that time sea duty. For the past 17 
years, I have practiced law in San Rafael, California--with a large 
portion of my practice representing victims of antidepressant suicide. 
I have gathered information on antidepressants and suicide over the 
years, including:

      Deposing pharmaceutical CEO's, FDA officials, 
pharmacists, industry psychiatrists, and treating physicians;
      Reviewing many of industry's so called ``trade secrets'' 
on antidepressants and suicide--documents the public and the FDA never 
see;
      Acting as a co-lead counsel from 2002-2006 in Federal 
court, Los Angeles, on the Plaintiffs' Steering Committee on a mass 
tort case involving Paxil and 3,000 plaintiffs who alleged addiction 
from the drug;
      Addressing the last three (3) advisory committee hearings 
on antidepressants and suicide convened by FDA.
                          A ``Religious War''
    The antidepressant suicide debate has been ongoing since Prozac 
entered the market in 1988--the FDA's having received 350 reports of 
completed suicides by Prozac patients by early 1991. The debate has 
always been intense, one medical historian quoted as calling it a 
``religious war.'' \1\ My testimony today excludes the related issue of 
third party violence which may relate from antidepressants, such as the 
rising number of unexplained school, workplace, and shopping mall 
massacres.
---------------------------------------------------------------------------
    \1\ Quoting University of Toronto medical historian Professor 
Edward Shorter, by Benedict Carey in New York Times, December 13, 2006 
article ``Panel to Debate Antidepressant Warnings.''
---------------------------------------------------------------------------
                          Of Course, They Do!
    Do antidepressants cause suicide? Of course they do! Antidepressant 
manufacturers would not secretly settle wrongful death lawsuits for 
large sums that they do if these were just nuisance suits. In 
antidepressant clinical trials going back to the 1980's, the 
manufacturers' own principal investigators have assessed several 
hundred suicide related adverse events as ``caused'' by the 
antidepressant.
    Antidepressant manufacturers cannot credibly deny their medications 
cause suicide. Their voluntarily adopted ``Warning'' labels entitled 
``Clinical Worsening and Suicide Risk,'' on their medications translate 
to a meaningful conclusion. By Federal regulation, the companies' 
cannot issue these ``Warnings'' unless there is reasonable evidence of 
a QUOTE causal association UNQUOTE between the drug and suicidality. In 
short, the companies--with their labels--legally acknowledge causation 
despite their continuing overtures to the contrary.
                No Clinical Trials on the Subject--Ever!
    Looking to this Committee's focus on hopeful solutions to the 
suicide problem, if there is one point I'd like to emphasize today, it 
is this. A major scientific gap exists in the 20 year antidepressant 
suicide debate. There has never been a prospective trial designed to 
test the link between the antidepressants and suicidality. Do not take 
my word for this. I leave with the Committee my work product in the 
packet--citing 27 sources affirming what I just reported (``Work 
Product''). The irony is that antidepressant enthusiasts, before the 
debate started going against them, criticized plaintiffs' experts as 
``junk scientists'' for opining on medication induced suicide. What is 
``junk science'' is the implication real science exists to deny 
antidepressant suicidality when nary a scientific trial has ever been 
conducted to make that determination.
             20 Years of ``Ethics''--or Self Preservation?
    Why no testing? One theory for the historical failure to test is 
because the companies fear the likely results. Documenting the 
scientific link between antidepressants and suicide would significantly 
erode consumer and provider confidence in the medications, even more so 
than the events of 2004 when the FDA first acted on the subject. It is 
noteworthy that the FDA has not invoked its powers under the Food, Drug 
& Cosmetic Act (``FDCA'') to require antidepressant manufacturers to 
specifically test for suicide. While safety is a threshold requirement 
for any drug approval, ``two well controlled trials'' demonstrating 
efficacy are all that is required under FDCA to get the drug on the 
market. Safety is more of a subjective call, and is a requirement the 
FDA can often satisfy by adequate labeling. Over the years industry has 
offered shifting explanations for it's ``no testing'' posture in 
antidepressant suicide:

    a.
       Early on they claimed was no reason to test because the 
preliminary data, through meta-analyses and the like, indicated there 
was no suicide problem. That excuse went away early last decade when 
data on pediatric and young adult populations showed a high suicidality 
rate.
    b.
       Then they claimed that a prospective randomized clinical trial 
(``RCT'') to test a suicide hypothesis was not practical because it 
would entail too large a test population. That excuse became 
questionable when it was shown that a ``challenge/dechallenge'' 
protocol could be designed with only a few hundred patients in each 
treatment arm, with only a slight decrease in the confidence interval 
to detect the problem.
    c.
       The next excuse was that it would be unethical to specifically 
test for suicide, given that placebo, or sugar pill treatment in a 
clinical trial for a patient known to be suicidal would breach medical 
ethics, such as the Nuremberg Code. That turned out questionable, as 
well, when it was pointed out that ``placebo'' is routinely used in 
psychotropic drug trials endorsed by the FDA, that European countries 
traditionally restricted placebo testing as a matter of course, and 
that in any case, a non-medication treatment arm involving therapy 
would avert any prohibition based upon non-treatment of an at risk 
patient.
    d.
       The final excuse is one from a manufacturer of a major SSRI who, 
having avoided testing for 20 years, simply claimed it was not QUOTE 
``methodologically possible to design and conduct a scientifically 
reliable clinical study that would yield greater scientific 
understanding between . . . (the drug) . . . and suicide than now 
exists.''

    In 1990 at the height of the initial Prozac controversy, the FDA, 
itself, requested Eli Lilly to perform such testing. (See 
``EliLillyFDAMemo''.) The FDA backed off after Lilly produced a 1991 
meta-analysis, an analysis later highly criticized for its gaps in the 
data, showing Prozac had no statistical significance with suicidality. 
In later times, a senior FDA official, contrary to its original 
persuasive powers to get Eli Lilly to agree to the testing, seemed to 
reverse itself. In a 2004 interview the FDA's Director of Medical 
Policy, Dr. Robert Temple, in charge in 1990 when his office persuaded 
Lilly to test, told PBS:

          ``Nobody is going to let you do a placebo control long-term 
        trial to see if there are more suicides in one group than 
        another because that would involve leaving people who are 
        grossly depressed off therapy. I don't think anybody would do 
        such a trial.'' \2\
---------------------------------------------------------------------------
    \2\ May 28, 2004 PBS Newshour, Interview Dr. Robert Temple by PBS 
Correspondent Susan Dentzer.

    Dr. Temple's gratuitous concession was as unnecessary as it was 
counter-productive. FDA has more than enough tools in its arsenal to 
ensure/persuade industry to do the testing. In 2003 the FDA banned the 
dietary supplement Ephedra, doing so only after the highly publicized 
death of Baltimore Orioles pitcher Steve Bechler who took the 
supplement before succumbing. Ephedra's 155 deaths reported to the FDA 
when the drug was banned were dwarfed by Prozac's 350 completed 
suicides reported a decade earlier--which the FDA summarily dismissed 
at the time as anecdotal. Another FDA legal enforcement tool short of 
banning, if the affected company does not participate in making its 
drug safe, is to declare the drug misbranded and prosecute. This could 
properly occur if the company refused to comply with an FDA labeling 
request to place in the labeling the high incidence of suicide events 
and the company's failure to have tested for suicidality. The essence 
is that the Federal Government has the power, indirectly if not 
directly, to compel companies wishing to market antidepressants to 
conduct specific suicide testing. While manufacturers can contest such 
FDA actions in court, the judiciary gives great deference to the FDA's 
mission of ensuring drug safety and enforcement actions in support. 
Since 2004 consensus in the research community, save the pharmaceutical 
industry, is that focused antidepressant suicide testing was long past 
due. Dr. Temple's interview notwithstanding, FDA officials themselves, 
including Dr. Janet Woodcock and Dr. Thomas Laughren, are on record 
stating prospective testing on the antidepressant suicide issue is 
needed.\3\
---------------------------------------------------------------------------
    \3\ FDA Transcript of Psychopharmacological Drugs Advisory 
Committee December 13, 2006, page 456 line 12 through 457 line 17, and 
Transcript of Hearing Subcommittee on Oversight & Investigations of 
Committee on Energy & Commerce, September 23, 2004, 2nd session, Serial 
No. 108-125 (``FDA's Role in Protecting the Public Health Examining 
FDA's Review of Safety and Efficacy Concerns in Antidepressant Use by 
Children'' Tab 38, page 368, 369. e.g. ``(At CDER meeting) . . . there 
was general agreement that more studies would be desirable. . . . `Dr. 
Woodcock suggested that a trial was needed to examine the emergence of 
behavioral toxicity in children and adolescents treated with 
antidepressants. She added that the focus of the trial should not be 
efficacy.''
---------------------------------------------------------------------------
      Antidepressant Suicide Reports--From Health Care Providers!
    Ephedra's adverse event data at the time of its banning were minor 
compared to antidepressants. Prozac, Zoloft, and Paxil, the first three 
(3) SSRIs (``selective serotonin reuptake inhibitor'') on the market 
combined for 638 reported deaths between the period November 1, 1997 
and the time FDA banned Ephedra on December 30, 2003.\4\ The FDA's 
``Adverse Event Data System'' (AERS) and its pre-1997 predecessor 
system recording ``MedWatch'' reports of adverse events constitute 
merely a drop in the bucket of the overall drug induced adverse events 
occurring in the general population. Except for pharmaceutical 
companies and other selective entities, reporters of ``MedWatch'' 
submissions do so voluntarily. Adverse events filed with AERS 
constitute, depending on what expert you talk to, from 1 percent to 10 
percent of the actual adverse events occurring throughout the country. 
AERS filing is not proof that the reported drug caused the adverse 
event, especially when consumers and lay people file the reports. 
However it is commonly accepted that health care providers, already 
burdened by substantial medical paperwork, file ``MedWatch'' 
submissions to the FDA because they believe there may be causation in 
the particular patient. Filings of antidepressant adverse events are 
voluminous. Prozac, Zoloft, and Paxil ``MedWatch'' reports constituted 
20,142 filings from 1997 to 2009. Fifty-five percent (55%) were 
originated by health care providers. Two thousand four hundred fifteen 
(2,415) suicide attempts by antidepressant patients were reported in 
that time frame, of which 64 percent were reported by health care 
providers. Of that total, eight hundred three (``803'') were completed 
suicides.
---------------------------------------------------------------------------
    \4\ On November 1, 1997, FDA commenced AERS recording in a new 
computer system. All reported adverse events to the FDA prior to that 
date were accounted for in a separate system, and remain segregated. 
The ``350'' Prozac completed suicides reported earlier are thus not 
compiled in AERS.
---------------------------------------------------------------------------
               FDA Issued First Suicide Warnings in 2004
    After many years of dismissing the antidepressant suicide problem, 
the Food & Drug Administration, confronted the issue anew in 2004. That 
year the Agency, after advisory committee hearings, directed the 
issuance of generalized suicide warnings for adults taking 
antidepressants, and ``black box'' warnings for patients under 25. The 
FDA's database did not show statistical significance in suicidality 
causation for adults between 25-64 years of age. That, however, is not 
proof antidepressants do not cause suicides in that group. The FDA's 
data comprising 100,000 adult patients from placebo controlled trials 
only going back to the early 1980's is hampered by the significant 
vacuum I referred to earlier--incomplete data from old trials never 
designed to link antidepressants and suicidality. An ``either or'' 
approach on antidepressant suicide causation, which antidepressant 
advocates selectively now apply to the 25-64 age group, is misleading 
as well as simplistic.
   ``Statistical Significance''--As Used in the Debate--Is Not Very 
                                Helpful
    Industry traditionally has relied upon the concept of ``statistical 
significance'' to debunk causation. The fact that the pediatric and 
young adult patient pools shows statistical significance between 
antidepressants and suicidality despite the limited scope of nature of 
data for all populations suggests, according to experts of all stripes, 
the increased sensitivity of youth to antidepressants. The 
antidepressant suicide risk, when and where it presents itself, cannot 
be accurately detected and measured with the swoop of the broad brush. 
The FDA's suicide warning highlights what are believed to be the 
medication's high risk periods, stating that close observation for 
suicidality should occur ``during the initial few months of a course of 
drug therapy, or at times of dose changes, either increases or 
decreases.'' Suicidality can then abate, giving way to what 
antidepressants advocates call the ``therapeutic'' effect of the 
medications. Most experts testifying for plaintiffs in antidepressant 
suicide cases do not contend they are per se opposed to the medications 
or wish them banned. On the contrary, they prescribe antidepressants 
for carefully screened patients and monitor them for suicidality in 
accordance with the FDA warning.
            Antidepressants Both Cause and Prevent Suicides
    Just last August, seven (7) FDA authors, including the Director of 
Medical Policy, published in the British Medical Journal their 
conclusion, a correct one in my view, stating ``Antidepressant drugs 
can have two separate effects: an undesirable effect in some patients 
that promotes suicidal ideation or suicidal behavior and a therapeutic 
effect in others.'' \5\ Stated succinctly, and I paraphrase: 
Antidepressants both cause and prevent suicides!
---------------------------------------------------------------------------
    \5\ BMJ (British Medical Journal) 2009; 339:b2880 Published 11 
August 2009.
---------------------------------------------------------------------------
    Most of my plaintiff experts in antidepressant suicide lawsuits 
agree with this in terms of the short term trials that the databases 
reflect. Long term adverse side effects are another issue. With some 
patients driven to suicide by antidepressant inducement, other 
patients, including those suffering from Major Depressive Disorder 
(``MDD'') and otherwise statistically bound for suicide, yet saved by 
the effect of antidepressants at least in the short term, the effect is 
a statistical dead heat when viewed in the large numbers of these many, 
short term trials.
                Saturated Propaganda and True Believers!

    Then why are we still debating this? Because of twenty (20) years 
of saturated propaganda. Antidepressant suicide risk has been and 
remains suppressed by basically two factions: (1) the pharmaceutical 
industry and (2) organized psychiatry. No ``conspiracies'' here--it is 
pure self interest.
    In industry's case, the products sell. Reuters reports 
antidepressant use doubled in a decade, to $9.6 billion in U.S. sales 
in 2008. Any loss of consumer and provider confidence due to a 
documented suicide risk cuts directly into sales. Universities and 
professors depending on outside research money take pharmaceutical 
funds to test antidepressants--and other drugs--executing non-
disclosure agreements to obtain the pharmaceutical contracts. And ghost 
writing! The favorable results of the drug trials get written up by the 
drug company--while the negative trials are quelled. The draft to 
report the favorable results is turned over to the professor who, after 
a few minor changes, becomes the lead author on the article which is 
submitted to a prominent medical journal. After publication, the next 
day the news of this effective drug is published in the New York Times 
or Wall Street Journal. The net result of what was implied to the 
public as credible science by independent academics was actually 
carefully choreographed data by a drug company. Stung by criticism, 
companies have attempted to defuse the issue by claiming they have 
posted on their Web sites, the results of all their clinical trials, 
``whether positive or negative.'' While these postings have accurately 
represented whether efficacy results were ``positive or negative,'' 
they continue to suppress overall suicidal data. The ``causation'' 
assessments by the principal investigators mentioned above are censured 
out of the Web sites. Nowhere, for example, on GlaxoSmithKline's Web 
site does it disclose that 42 patients out of the 2,963 patients taking 
the drug during pre-marketing clinical trials attempted suicide, a 
``frequent'' occurrence of this serious event.
                    ``America is not Maoist China''
    Organized psychiatry suppresses awareness of the antidepressant 
suicide risk for another reason. They are true believers. Organizations 
like the American Psychiatric Association (``APA'') and the American 
College of Neuropsychopharmacology (``ACNP'') \6\ are examples. I also 
include the National Institute of Mental Health (``NIMH'') in this 
grouping. Organized psychiatry is very professional, does a lot of 
superb work in mental health, and cares for their patients. Their 
opposition to suicide warnings while in good faith, is misguided. The 
true believers insist antidepressant suicide Warnings scare patients 
away from their medications--causing more suicides in the long run. One 
industry sponsored statistician echoing this concern, writing in 2007 
stated: ``If the intent of the pediatric black box warning was to save 
lives, the warning failed, and in fact it may have had the opposite 
effect; more children and adolescents have committed suicide since it 
was introduced.'' A medical commentator for the American Enterprise 
Institute criticizing the FDA's implementation of the ``black box'' was 
surprisingly candid in asserting that societal impact of the warning 
trumped all, and that individual suicides are not the question.'' \7\ 
The Committee should take note of the invidious nature of this 
rationale, which lurks throughout the pro-antidepressant lexicon. Even 
if it were true that Warnings add to the Nation's suicides, which I 
doubt, the notion that keeping individual patients in the dark about 
antidepressant suicide risk for the overall good of society is Maoist 
China, not the United States of America where individual informed 
consent is central to medical ethics. More frightening than organized 
psychiatry's opposition to warnings out of patient concern is that the 
attitude, if it carried the day, would have denied risk information to 
fellow physicians. It is here, e.g. primary care, where the majority of 
antidepressants are prescribed and label information counts. No 
rationale can justify withholding medical risk information from fellow 
providers. While the ``Warnings'' issue is settled history, its core 
issue addresses us once again as the Veterans Administration (``VA'') 
and Department of Defense (``DoD'') deal with rising suicides in their 
constituent populations.
---------------------------------------------------------------------------
    \6\ On January 21, 2004, ACNP (www.ACNP.org) . . . attempted a 
preemptive strike against the FDA and the Agency's plan to review 
pediatric antidepressant suicide data February 2, 2004. Not in 
possession of the FDA's then newly obtained antidepressant data showing 
an association with pediatric suicidality, the ACNP in its 22 page 
release highlighted sections in its report entitled ``Weak Evidence 
Links SSRIs to Suicidal Behavior in Youth'' and ``No Significant 
Increase in Suicidal Behavior in Clinical Trials of Youth.'' ACNP's 
lack of updated data was hardly of concern to the organization. The 
report acknowledges ``because the Task Force did not have access to a 
substantial amount of unpublished data, including detailed findings 
held by drug sponsors, this report is preliminary.'' ACNP's attempt to 
ward off FDA action failed with the Agency's imposition of suicide 
warnings based on the Feb. 2nd hearing. Additionally, the FDA's 
ultimate determination of the data showed serious lapses in the ACNP's 
proclamation. (Source: ``Preliminary Report of the Task Force on SSRIs 
and Suicidal Behavior in Youth.'' January 21, 2004. The ten (10) 
authors of the preliminary report had substantial ties to industry. One 
author of this report is an Investigator assisting the U.S. Army in its 
current study to assess rising Army suicides.
    \7\ ``Is it possible, then, that SSRIs have precipitated some 
actual suicides? Yes . . . But the larger question the FDA must answer 
for the public is whether these medications have prevented more 
suicidal activity than they have caused. Almost surely they have.'' 
``The Rush to Black Label (or blackball) SSRIs.'' September 30, 2004, 
by Sally Satel, MD, http://www.aei.org/article/21316. . . .''
---------------------------------------------------------------------------
        Lack of ``Completed Suicides'' Is Nothing to Brag About
    A retort now universally put forth by antidepressant advocates who 
opposed the FDA's warnings is that there were no ``completed suicides'' 
within the 4,100 pediatric patients comprising the clinical trials that 
spurred the ``black box'' warning. Taken from a controlled clinical 
trial environment of psychiatric monitoring, the absence of completed 
suicides gives little solace when, with 109 \8\ ``possibly suicide 
related'' events out of the 4,100, causation of suicidality from the 
medication is established. Downplaying the fact of no ``completed 
suicides'' in the short term pediatric trials is revealing as one notes 
how far industry has moved the goalposts as more and more revelations 
on the adverse effects of the medications have surfaced with each 
passing year. The claim itself manifests a degree of desperation. One 
can imagine the ridicule a tire manufacturer would receive testifying 
before Congress if acknowledging his company's deficient tires have 
caused a large number of highway accidents, but he didn't view it as a 
big problem because most of the accidents were not fatal. This 
Committee should treat the ``no suicides'' claim in these short term 
trials with the same curiosity.
---------------------------------------------------------------------------
    \8\ See page 157, bottom line, FDA ``Psychopharmacological Drugs 
Advisory Committee'' transcript, September 13, 2004.
---------------------------------------------------------------------------
       Antidepressant Advocates--Playing ``Politics'' Themselves
    Industry and organized psychiatry claim, usually subtly, that the 
FDA caved in to politics and media, in issuing the warnings. One APA 
headline proclaimed ``The FDA May Have Overreacted.'' \9\ These swipes 
at the FDA have no basis in fact. The 15-8 advisory committee vote 
recommending the ``black box'' was cast entirely by independent 
experts. It should be pointed out that industry and organized 
psychiatry use politics and lobbying on the matter as much as anyone. 
That was demonstrated during the 2004 hearings. From 1990 onward both 
groups fought vigorously to dissuade the FDA from instituting any 
suicide warnings for antidepressants. In early 2004 when FDA's 
preliminary antidepressant data on children showed causality with 
suicidality, both groups continued their past argument that the sky 
would fall if the Agency imposed suicide warnings. This time, however, 
on March 22, 2004 the FDA went the other way, issuing the generalized 
suicide warnings for both children and adults. The Agency, at the same 
time, farmed the data out for a second opinion. It simultaneously 
announced it would convene additional hearings when the re-evaluation 
was complete. The re-evaluation was completed in the summer of 2004, 
confirming the causation in children. With verification of the risk now 
placed before the advisory committee, the FDA, among other options, 
placed the ``black box'' warning option, the highest form of drug risk 
warning, before the committee for a vote. Confronting the looming 
``black box,'' industry and organized psychiatry in preparing their 
presentations executed an about-face.\10\ Rather than decry the 
generalized suicide ``Warning'' issued March 23, 2004 as contrary to 
their long held views, both groups pivoted quickly to make it appear 
the recently instituted generalized suicide warning was something they 
always supported. The sky will fall argument was now directed to the 
``black box'' option. The tactic failed. The committee voted 15-8 to 
impose the ``black box'' in regard to the children's risk, and it was 
implemented by the FDA on October 15, 2004. The 2004 hearings further 
illustrated how Psychiatry differs from General Medicine on the matter 
of the antidepressant warnings. Non-psychiatrists on the advisory 
committee voted 10-3 in favor of the black box. Psychiatrists split 5-
5. Psychiatry's opposition flew in the face of the fact that non-
psychiatrists dispense the great majority of antidepressant 
prescriptions, about 70 percent by many accounts, with non-
psychiatrists generally supporting the warnings. Since the 
implementation of the ``black box'' in 2004, both industry and 
organized psychiatry have lobbied vigorously to remove the boxed label.
---------------------------------------------------------------------------
    \9\ ``Psychiatric News'' May 4, 2007, http://
pn.psychiatryonline.org/content/42/9/1.1.full.
    \10\ At the initial February 2, 2004 hearing, the APA 
representative declined to offer recommendations for labeling based on 
the new data and further admonished the FDA on the antidepressant 
suicide issue concerning children, stating ``we are concerned that the 
publicity surrounding this issue may frighten some parents and 
discourage them from seeking help for their children. . . .'' (FDA PDAC 
Transcript 2/2/04 Page 226 line 25 thru Page 227 line 3). After the FDA 
issued the generalized suicide warnings March 22, 2004 and the ``black 
box'' option was before the panel on September 13, 2004, the APA 
representative told panelists: ``(W)e support the continuation of the 
current FDA warnings with respect to antidepressants. We believe the 
language is appropriate and consistent with our current knowledge, 
understanding and scientific data.'' (FDA PDAC Transcript (FDA PDAC 
Transcript 9/13/04, bottom page 300, top of page 301).
---------------------------------------------------------------------------
                     In the Debate--Who to Believe?
    I do not contend that the antidepressant skeptics' voices should 
dominate this discussion. Both antidepressant benefit and risk 
information should be weighed proportionately for treatment, but when 
investigating suicides, it is a risk-driven inquiry only. For honest 
brokers pursuing the issue, such as this Committee, VA, and DoD--it is 
necessary that history and credibility of the voices speaking on the 
antidepressants be objectively evaluated. Going back centuries, one 
would not place great credence on the ``flat Earth'' advocates after 
Columbus and Magellan proved the world to be round. The same analogies 
might be drawn from the history of the antidepressant debate. There 
were those from the early and mid 90's, after Prozac came on the scene, 
calling attention to the antidepressant suicide issue--names in 
psychiatry like Peter Breggin, David Healy, and Joseph Glenmullen. 
There were others, the majority from industry and organized psychiatry, 
who vigorously promoted the medications and went out of their way to 
discredit these voices who were saying ``not so fast.'' The ``flat 
Earth'' advocates from the early 90's are still around--and still on 
the same side of the issue, now claiming, that the FDA's ``black box'' 
warnings have increased suicides nationally. I am not here to name 
names or criticize personally those who have a contrary view to mine. 
After all, I'm only a lawyer opining on what certainly involves medical 
and scientific issues. But lawyers, as well as the public, look at the 
evidence and make judgments--both in the jury docket and in our daily 
lives. It is thus more than fair to point out these antidepressant 
enthusiasts were wrong from the start, proven wrong by a demonstrated 
statistical significance in suicidality in pediatric populations 
determined in 2004, and wrong again in 2006 when statistical 
significance was shown with young adults. History has shown the 
skeptics were right from the beginning--and should in this search for 
truth command at least as much deference as those Investigators now 
participating in the process who were on the wrong side of events that 
the FDA decided.
            Lurking Beneath the Polite Exterior--NIMH v FDA
    Where does the strategic situation stand today? As much as the FDA 
has moved the ball since 2004, the antidepressant suicide issue remains 
stuck in the quicksand. Lurking beneath the surface of the 
antidepressant suicide debate are polar opposite positions of two 
Federal agencies: the Food & Drug Administration (``FDA''), and 
National Institute of Mental Health (``NIMH''). This opposition is not, 
for comity purposes, openly acknowledged and can be explained, in part, 
by the agencies' different statutory missions.
    This Committee should note the sharp distinction between the 
antidepressant suicide warnings emanating from the FDA, and the 
continued suppression of the antidepressant suicide risk by the NIMH. 
One would not expect NIMH to give medication induced suicide equal 
billing with a ``take your meds'' approach in psychotropic therapy. On 
the other hand, NIMH is obliged to be accurate in its public 
pronouncements. That has not always been the case in regard to 
antidepressants, and unfortunately remains so in some applications. 
Examples are useful. On September 20, 1991 NIMH was instrumental in the 
FDA's decision to deny suicide warnings to the public in regard to 
Prozac, erroneously framing the labeling issue in terms of banning 
antidepressants, urging the FDA voting panelists on that day ``instead 
of trying to withhold these drugs, there should be much more aggressive 
effort to make . . . (antidepressants) . . . even more widely available 
to the appropriate patients.'' \11\ Banning Prozac was never on the 
table, the FDA having rejected that option weeks earlier 
(``APANewsReleaseProzac''). NIMH should not suppress awareness of the 
risk as pointed out by the FDA, and should give representative 
information on the limited effectiveness of antidepressants, articles 
of which have increased substantially in the last few years. Today one 
is hard pressed to find existence of the FDA's suicide warnings on the 
NIMH Web site. One finds, instead, a skewed selection of literature on 
the Institute's Web site, mostly all strongly endorsing antidepressants 
and omitting mention of the articles in the scientific literature 
citing the drawbacks. In May 2008, I notified the Director, NIMH that 
the Institute's publication ``Depression,'' distributed to the public 
misrepresented, by under-statement, the breadth of the FDA's suicide 
warning by omitting the fact adults were included in the FDA's warning 
(FarberLtrtoNIMH). Responding to my letter, NIMH simply misstated the 
facts, again, by asserting its publication was issued before the FDA's 
issuance of the warning (NIMHLtrtoFarber). NIMH continues in 2010 to 
misrepresent the FDA's suicide warning (NIMHWebsite & NIMHLtrtoFarber).
---------------------------------------------------------------------------
    \11\ FDA Transcript of Psychopharmacological Drugs' Advisory 
Committee September 20, 1991, Page 177 Lines 1-7.
---------------------------------------------------------------------------
             FDA Suicide Warnings Are Detailed and Balanced
    Since 2004, FDA ``suicide warnings'' on antidepressants have been 
detailed and balanced. In 2007 the FDA was fair enough on the issue to 
ensure the labeling reflected that failure to treat depression, 
impliedly by antidepressants, could be hazardous as well. NIMH, by 
contrast, continues its longstanding policy of silence on the 
antidepressant suicide risk. NIMH further highlights articles 
criticizing the FDA's suicide warnings. I praised the Director for the 
good work the Institute does--but the skewed coverage of 
antidepressants has to be troubling for citizens expecting neutrality 
and objectivity from NIMH. The FDA's directed suicide warning is 
excellent, entailing monitoring of symptoms and followup, including 
advising monitoring by caretakers and family members to be alert for 
symptoms of suicidality (Feb2010FDAAntidepressantWarnings).
                   Antidepressant Suicide Monitoring
    For veterans and servicemembers, I fear this 3rd party monitoring 
is not being done--it certainly won't be unless the VA and the command 
structure recognize the value of the FDA warning, and implement it in a 
way appropriate to the veterans' setting. The setting of a VA clinic, 
and any combat zone, obviously poses unique issues for considering such 
3rd party monitoring. Patient privacy and the ``macho'' persona are 
also issues in mental health treatment that have to be confronted in 
treating veterans and active military. Whatever the difficulties, the 
Veterans Administration and DoD will be doing their members a 
disservice if risky drugs are administered to patients without the 
safeguards that patients in private practice receive at the 
recommendation of FDA. In medical malpractice cases, physicians who 
don't warn patients of the potential dangers of a drug as recommended 
by the FDA are generally considered to violate the standard of care.
                   NIMH Tags Along--But Still Silent
    When the turbulence of 2004 over pediatric data arose and the FDA 
had to change its policy and issue an antidepressant suicide warning, 
and again in 2006 when young adults were added to the ``black box,'' 
the NIMH was effectively forced to tag along. In November 2006, the 
NIMH issued five (5) grants to study the antidepressant suicide 
situation, including adult suicide (NIMHPressRelease061113). Presumably 
these grants were a byproduct of the numerous pleas heard during the 
2004 FDA hearings that the cited scientific vacuum be rectified. 
Notwithstanding what transpired before 2006--or since, this prolonged 
gap and NIMH silence continues to exist in an area which arguably it 
has responsibility to lead (NIMHEmail). The lack of progress in this 
20-year problem is unsatisfactory in public health, regardless of which 
agency or agencies have lagged.
            VA (and DoD) on ``Suicide''--Fish Out of Water?
    My current observation on the issue of veterans' and military 
suicides leaves me concerned. In dealing with rising numbers of 
suicides, VA and DoD appear to be relying on NIMH to lead them to 
enlightenment. Noted on the Institute's Web site is the Army's 
memorandum of agreement and frequent references to the issue of 
veterans' suicides. It is natural that NIMH would be a source of 
Federal assistance given that neither DoD nor VA, despite huge 
constituencies for treatment and certain specialties in research, e.g. 
combat stress and prosthetics, have never been institutional leaders in 
drug safety or suicide. Traditionally, the military has medically 
discharged members with serious mental health problems. In 2004, I 
learned from Navy Times of the large numbers of suicides in the Pacific 
Fleet. Stating the background and relevant facts on antidepressant 
suicide litigation, I wrote a letter to the Commander in Chief of the 
Pacific Fleet with specific recommendations (FarberCINCPACFLT). The 
issue was turned over to Navy medical bureaucrats in Washington, where 
it died a sudden death; at least no one ever followed up with me. While 
in theory a NIMH partnership is the correct call for VA and DoD to make 
in alleviating the very serious problem of rising veterans' and active 
duty suicides, for reasons I've stated I fear NIMH will not be robust 
in sufficiently highlighting antidepressant risk from benefit, and that 
investigative avenues to determine the full causes of the rising rates 
may be bypassed. Maybe antidepressants are responsible for half the 
suicides--or maybe just a few, or possibly none. Whatever it is, it is 
scientifically unacceptable and a breach of duty to approach this 
complicated problem pretending the issue of antidepressant induced 
suicide does not exist. Mr. Chairman, your leadership here today 
ensures that question won't be swept under the rug--as it was for so 
long.
                               Conclusion
    My two recommendations to the Committee are:

    1.  Direct the VA to conduct independent antidepressant suicide 
testing through one or more neutral, third parties, and
    2.  Direct the VA to ensure all psychotropic drug labeling warnings 
and precautions are made available to all patients.

    Thank you for the privilege of testifying before this Committee.

            Respectfully,

                                                   Donald J. Farber

                                 
   Prepared Statement of Ira Katz, M.D., Ph.D., Deputy Chief Officer,
        Mental Health Services, Office of Patient Care Services,
  Veterans Health Administration, U.S. Department of Veterans Affairs
    Mr. Chairman, Mr. Ranking Member, and Members of the Committee:
    Thank you for the opportunity to appear today to discuss the 
Department of Veterans Affairs' (VA) response to the mental health 
needs of America's veterans.
    VA has responded aggressively to address previously identified gaps 
in mental health care by expanding our mental health budgets 
significantly. In fiscal year (FY) 2010, VA's budget for mental health 
services reached $4.8 billion, while the amount included in the 
President's budget for FY 2011 is $5.2 billion. Both of these figures 
represent dramatic increases from the $2.04 billion obligated in FY 
2001. VA has increased the number of mental health staff in its system 
by more than 5,000 over the last 3 years. During the past 2 years, VA 
trained over 2,500 staff members to provide psychotherapies with the 
strongest evidence for successful outcomes for post traumatic stress 
disorder (PTSD), depression, and other conditions and we require that 
all facilities make these therapies available to any eligible veteran 
who may benefit.
    VA is working closely with our colleagues at the Department of 
Defense (DoD) to improve the quality of care for veterans and 
servicemembers alike. Since October 2009, VA and DoD have held two 
major conferences related to the mental health needs of veterans and 
servicemembers. In FY 2010 and FY 2011, we will expand inpatient, 
residential, and outpatient mental health programs with an emphasis on 
integrating mental health services with primary and specialty care.
    With its emphasis on providing care management for depression and 
making evidence-based psychotherapy available for all veterans who need 
it, VA is ensuring that planning for treatment of mental health 
conditions includes attention to the benefits as well as the risks of 
the full range of effective interventions. Making these treatments 
available responds to the principle that when there is evidence for the 
effectiveness of a number of different treatment strategies that can be 
effective, the choice of treatment should be based on the veteran's 
values and preferences, as well as the clinical judgment of the 
provider.
    My testimony makes four major points: first, appropriate use of 
psychotherapeutic medications is a key component of overall mental 
health care, but medications, like all treatments, can be associated 
with risks as well as benefits; second, VA has systems to monitor for 
adverse effects associated with medication use and programs to enhance 
the safety of pharmacological treatments; third, VA's mental health 
programs have been designed both to optimize the safety of 
psychopharmacological treatments and to provide effective alternative 
strategies for treatment; and fourth, VA's mental health and suicide 
prevention activities are effective and evidence-based. The data 
demonstrate that young adult veterans are coming to VA for their mental 
health needs, and those veterans who may be vulnerable to suicidality 
as an adverse effect of antidepressant medications have lower suicide 
rates when they come to VA for health care.
Effectiveness and Safety of Psychopharmacological Treatments
    It has been somewhat over 50 years since the benefits of 
psychopharmacological treatments for serious mental illnesses were 
established, and during that time there has been a steady accumulation 
of scientific evidence for the effectiveness of medications for the 
treatment of mental disorders, for limiting the severity and duration 
of episodes of illness, and for preventing relapses and recurrences. 
Reviews of the evidence have confirmed these findings, which have been 
translated into recommendations for clinicians in the VA-DoD Clinical 
Practice Guidelines for Major Depressive Disorder, Post Traumatic 
Stress Disorder, Psychoses, and Substance Use Disorder, as well as 
guidelines for the treatment of mental health conditions supported by 
other U.S. Government agencies, agencies of others nations, 
professional societies, and scientific organizations. Today, the use of 
medications as a key component of mental health care is as well 
established as treating infectious diseases with antibiotics, cancer 
with chemotherapy, or rheumatological conditions with anti-inflammatory 
agents; in sum, the effectiveness of this treatment modality has been 
established beyond any reasonable doubt. There are, of course, many 
questions that can and should be raised, to include: when medications 
should be used and when other therapies should be used instead or in 
addition; how decisions should be made about dosage and duration; how 
therapy should be monitored; and how treatment should be modified when 
adverse effects are observed.
    The accumulating evidence about the effectiveness of 
psychopharmacological treatment has been accompanied by increasing 
knowledge about side effects and adverse reactions. In recent years, 
there has been concern about suicidality as a possible adverse effect 
of approved medications used to treat conditions as diverse as 
depression, anxiety, bipolar disease, psychoses, attention deficit 
disorder, sleep disturbances, migraine, Parkinson's disease, and 
others. For each of these, the associations between suicide and 
medications have been difficult to evaluate because, for each, 
medications have been demonstrated to be effective for the treatment of 
conditions that are, themselves, risk factors for suicide. In most 
contexts, this can make it difficult to sort out what effects may be 
due to medication and what to the underlying condition. This is a 
phenomenon known as ``indication bias;'' it is a reflection of the 
principle that medications are prescribed for individuals who are 
already at increased risk for suicide. However, suggestions that 
antidepressant medications may lead to increased risks of suicide-
related behaviors in adolescents and young adults were derived from 
randomized clinical trials where the research design allows the 
separation of the effects of antidepressant medications from those of 
depression.
    Although findings from clinical trials on antidepressants and 
increased risks of suicide cannot be explained by indication bias, 
these relationships are complex. They are based on increases in 
suicidal ideation and related behaviors, rather than death. Moreover, 
when investigators looked across the lifespan, they found that 
increases in suicidal behaviors in younger individuals were offset by 
decreases in older adults. Finally, the findings from randomized 
clinical trials have not been reinforced through evidence from 
observations on the relationships between antidepressant prescribing 
and suicide rates across time or geographic areas. Although there is 
still debate about whether the available evidence demonstrates 
decreases in suicide rates with increased prescribing of newer 
antidepressants, there are no suggestions that increased medication use 
leads to increased risks of suicide.
    Nevertheless, the Food and Drug Administration (FDA) viewed the 
findings from randomized clinical trials as sufficient to require a 
boxed warning in the product labeling of all antidepressant 
medications. The warning includes language stating that:

          Antidepressants increased the risk compared to placebo of 
        suicidal thinking and behavior (suicidality) in children, 
        adolescents, and young adults in short term studies of major 
        depressive disorder (MDD) and other psychiatric disorders. 
        Anyone considering the use of [insert established name] or any 
        other antidepressant in a child, adolescent or young adult must 
        balance this risk with the clinical need. Short term studies 
        did not show an increase in the risk of suicidality with 
        antidepressant compared to placebo in adults beyond age 24; 
        there was a reduction in risk with antidepressant compared to 
        placebo in adults aged 65 and older. . . .

    The language in the boxed warning also notes that use of 
antidepressants is, in general, associated with both risks and 
benefits. The important clinical issue is not about whether these 
medications have a place in mental health care, but rather about how 
they should be used. The FDA's boxed warning states:

          Depression and certain other psychiatric disorders are 
        themselves associated with increases in the risk of suicide. 
        Patients of all ages who are started on antidepressant therapy 
        should be monitored appropriately and observed closely for 
        clinical worsening, suicidality, or unusual changes in behavior 
        . . .

    Other research provides evidence that certain medications may have 
specific effects decreasing the risk of suicide. A randomized clinical 
trial found that clozapine had a demonstrated impact reducing 
suicidality when compared with another atypical antipsychotic 
medication. This led FDA to approve the use of clozapine for reducing 
the risk of recurrent suicidal behavior in patients with schizophrenia 
or schizoaffective disorders. Findings from other research suggest that 
lithium, rather than mood-stabilizing anticonvulsants, may be 
associated with decreased rates of suicide for people with bipolar 
disorder. Still other research demonstrates decreased rates of suicide 
and death from accidental overdoses in people with opiate addiction who 
are treated with methadone. All of these findings represent important 
leads for guiding clinical practice.
    VA's research programs sponsor scientific investigations on the 
effect of medications for mental health conditions including 
depression, substance abuse, anxiety disorders, PTSD, sleep 
disturbances and psychotic disorders. In these studies of 
pharmacological treatments for mental health conditions, safety plans 
are in place to respond to patient needs emergently when suicide 
ideation arises during a research study. VA has well established 
reporting plans for adverse events in research to inform oversight 
bodies in a timely manner (VHA Handbook 1058.01), and VA's Pharmacy 
Benefits Management program keeps clinicians conducting research well 
informed about medication label changes. Effective February 1, 2010, 
VA's Office of Research and Development entered into a new Memorandum 
of Agreement with the VA National Suicide Prevention Hotline; this 
agreement delineates the exact procedure for research personnel to use 
when a veteran participating in a research program needs help for 
suicidal thoughts or actions. Studies are currently being evaluated to 
determine how this will complement research safety plans already in 
place.
    Although the issue raised in this hearing is a broad one, the 
importance of depression as a risk factor for suicide, and the high 
rates of utilization of serotonin-reuptake inhibitors and other 
antidepressant medications, makes questions about these medications a 
major public health concern. Moreover, with the ongoing wars in 
Afghanistan and Iraq, there are substantial numbers of young veterans 
returning home, many of whom may have mental health conditions. The 
effects of antidepressant medications are very relevant to this 
important component of the populations served by VA.
Monitoring Adverse Drug Events
    VA recognizes that the use of any medication can be associated with 
a risk for adverse events. In response to this basic principle, VA has 
developed a comprehensive system to identify potential adverse drug 
effects (ADEs), and to provide information as quickly as possible to 
clinicians and providers. An ADE is defined as an unintended effect of 
a drug that occurs secondary to drug administration.
    Post-marketing drug surveillance is vital for recognizing ADEs and 
reporting them to FDA. A cornerstone of post-marketing surveillance is 
collecting and evaluating reports of ADEs through voluntary reporting 
by health care professionals. The safety profile of any drug or 
pharmaceutical agent evolves over time as new information is discovered 
when health care providers offer it to larger populations and sub-
groups not previously studied during clinical trials. Because the 
electronic medical record is able to link prescription data to clinical 
outcomes at the patient level, VA is uniquely able to identify and 
track drug safety issues. VA has the only national system for 
electronic reporting of ADEs through its innovative VA Adverse Drug 
Event Reporting System (VA ADERS). By analyzing this computerized 
database, VA is able to identify drug safety signals, assess the 
significance of external drug safety issues in our own patients, and 
rapidly track trends of known drug safety issues.
    VA's Center for Medication Safety (VA MedSAFE) is a national, 
comprehensive pharmaco-vigilance program that emphasizes the safe and 
appropriate use of medications. VA MedSAFE utilizes various methods and 
tools, including passive and active surveillance, to continuously 
monitor for potential ADEs, including the use of VA ADERS as previously 
described. In many instances, VA MedSAFE directly and promptly notifies 
providers across VA's health care system if patients are at risk. VA, 
DoD and FDA have a memorandum of understanding (MOU) that allows close 
collaboration on specific post-marketing surveillance efforts and other 
drug and vaccine safety projects conducted through FDA's newly 
established Sentinel Initiative and its Office of Surveillance and 
Epidemiology.
    Evaluating preventable ADEs, providing interventions to decrease 
preventable ADEs, and educating the field on best practices all reduce 
the likelihood of ADEs. By conducting and promoting medication safety 
projects at the regional and national levels, VA provides safe and 
effective pharmaceutical care to veterans. Through the national roll-up 
system and data analysis provided by VA MedSAFE, each facility and VISN 
(Veterans Integrated Service Network) can benchmark themselves against 
national trends. We are unaware of any other health care system with as 
robust and well-developed a system for tracking, assessing, and acting 
on drug-related safety issues within their patient population.
    VA provides consumer medication information sheets on each new and 
renewed prescription. VA is highly engaged with patient education on 
medications with local VA medical centers developing policy for teams 
of clinicians to provide medication education, involving physicians, 
nurse practitioners, physician assistants, clinical pharmacy 
specialists, pharmacists, nurses, and other allied health care 
providers. Clinical Pharmacy Specialists and clinical pharmacists are 
key members of the health care team and can assist in optimizing drug 
therapy and improving medication safety for outpatients.
    Medication Reconciliation, a Joint Commission National Patient 
Safety Goal, is a process which mitigates the risk of ADEs that occur 
at transitions of care by addressing discrepancies between a patient's 
accounting of medication use and the medication lists in the medical 
record every time a medication is dispensed, changed, or added to the 
medication regiment. The VA Medication Reconciliation Initiative, 
launched in December 2008, is tasked with facilitating safe, high 
quality, effective, and above all, veteran-centered medication 
reconciliation throughout the VA system. This multi-disciplinary effort 
includes a VA Medication Reconciliation Toolkit, Educational Video, 
Facility Monitor, External Peer Review Process, and patient 
informational Web site called ``Medications: Play it Safe!'' on the My 
HealtheVet Web site. This initiative's workgroups continue to improve 
patient and staff resources and tools to improve documentation and 
monitoring of this process. In the coming months, VA will continue to 
bring together innovators from VA with those from DoD and the private 
sector to establish a world-class medication reconciliation program for 
veterans and to provide guidance for this challenging endeavor.
    As part of these programs, VA has been concerned about increases in 
suicidal ideation and other symptoms of suicidality as adverse drug 
effects. VA has provided guidance to its facilities addressing concerns 
about antidepressants, anticonvulsants, retinoids, propoxyphene, 
ziconotide, tetrabenazine, interferon, neuraminidase inhibitors, 
leukotriene inhibitors, aripiprazole, and paliperidone.
    Also, the Serious Mental Illness Treatment Research and Evaluation 
Center (SMITREC) conducts ongoing analyses of risk factors for 
veterans' suicides and shares its findings to the field. So far, VA has 
distributed new information on risks specifically in VA's population 
related to mental health conditions, traumatic brain injury, and pain. 
Currently, SMITREC is collaborating with VA MedSAFE to conduct a broad-
based, exploratory evaluation of the associations of medications with 
suicide. The goals of these analyses will be to generate hypotheses to 
guide further research about potential side effects; they are being 
conducted to ensure that the full resources of the VA as a national 
health care system are used to detect all possible risks to veterans. 
Still another activity, the PTSD Mentorship program, led by the 
National Center for PTSD, provides training for PTSD specialty care 
staff from all VA medical centers and includes an emphasis on evidence-
based pharmacological treatment for PTSD and a focus on avoiding poly-
pharmacy.
Safe Use of Psychopharmacological Agents and Available Alternative 
        Treatments
    VA has been making significant enhancements to its mental health 
services since 2005, through the VA Comprehensive Mental Health 
Strategic Plan and special purpose funds available through the Mental 
Health Enhancement Initiative. VA's enhanced mental health activities 
include outreach to help those in need to access services, a 
comprehensive program of treatment and rehabilitation for those with 
mental health conditions, and programs established specifically to care 
for those at high risk of suicide. To reduce the stigma of seeking care 
and to improve access, VA has integrated mental health into primary 
care settings to provide much of the care that is needed for those with 
the most common mental health conditions. In parallel with the 
implementation of these programs, VA has been modifying its specialty 
mental health care services to emphasize psychosocial as well as 
pharmacological treatments and to focus on principles of rehabilitation 
and recovery.
    In addition to the care offered in medical facilities and clinics, 
VA's Vet Centers provide outreach and readjustment counseling services 
to returning war veterans of all eras. It is well-established that 
rehabilitation for war-related PTSD, Substance Use Disorder, and other 
military-related readjustment problems, along with the treatment of the 
physical wounds of war, is central to VA's continuum of health care 
programs specific to the needs of war veterans. The Vet Center service 
mission goes beyond medical care in providing a holistic mix of 
services designed to treat the veteran as a whole person in his or her 
community setting. Vet Centers provide an alternative to traditional 
mental health care that helps many combat veterans overcome the stigma 
and fear related to accessing professional assistance for military-
related problems. Vet Centers are staffed by interdisciplinary teams 
that include psychologists, nurses and social workers, many of whom are 
veteran peers.
    Vet Centers provide professional readjustment counseling for war-
related psychological readjustment problems, including PTSD counseling. 
Other readjustment problems may include family relationship problems, 
lack of adequate employment, lack of educational achievement, social 
alienation and lack of career goals, homelessness and lack of adequate 
resources, and other psychological problems such as Depression and/or 
Substance Use Disorder. Vet Centers also provide military-related 
sexual trauma counseling, bereavement counseling, employment counseling 
and job referrals, preventive health care information, and referrals to 
other VA and non-VA medical and benefits facilities.
    To promote suicide prevention, VA established a strong partnership 
with the Department of Health and Human Services Substance Abuse and 
Mental Health Services Administration (SAMHSA) to operate a Veterans 
Call Center as part of the National Suicide Prevention Lifeline. VA 
also has appointed suicide prevention coordinators and care managers at 
each VAMC and the largest community-based outpatient clinics. 
Altogether, VA employs over 400 staff members who focus specifically on 
suicide prevention.
    During 2009, the VA Call Center received approximately 10,000 calls 
per month, approximately 20 percent of all calls to the National 
Suicide Prevention Lifeline. These calls led to 3,364 rescues of those 
determined to be at imminent risk for suicide and 12,403 referrals to 
VA Suicide Prevention Coordinators at local facilities. In 2009, the VA 
Call Center received calls from 1,429 active duty servicemembers, a 
little more than 1 percent of all calls. To address the needs of the 
active duty population, VA worked with SAMHSA to modify the 
introductory message for Lifeline, developed MOUs with DoD, and 
established processes for facilitating rescues, including 
collaborations with the armed services in Iraq. Also during 2009, the 
hotline services were supplemented with an Internet chat line that has 
been receiving more than 20 contacts a day.
    The Lifeline and VA Call Center may be the most visible components 
of VA's suicide prevention programs, but the Suicide Prevention 
Coordinators are equally important. Both the VA Call Center and 
providers at their own facilities notify the Suicide Prevention 
Coordinators about veterans at risk for suicide. The Coordinators then 
work to ensure the identified veterans receive appropriate care, 
coordinate services designed specifically to respond to the needs of 
veterans at high risk, provide education and training about suicide 
prevention to staff at their facilities, and conduct outreach and 
training in their communities. Other components of VA's programs 
include a panel to coordinate messaging to the public as well as two 
Centers of Excellence charged with conducting research on suicide 
prevention: one, in Canandaigua, focused on public health strategies, 
and one in Denver, focused on clinical approaches.
    In 2009, VA approved the Handbook on Uniform Mental Health Services 
in VA Medical Centers and Clinics to define what mental health services 
should be available to all enrolled veterans who need them, no matter 
where they receive care, and to sustain the enhancements made in recent 
years. One important set of requirements in the Handbook was designed 
to ensure that psychopharmacological treatment is conducted using 
evidence-based strategies to optimize effectiveness and safety. Another 
set was designed to ensure that evidence-based psychotherapies are 
available for veterans who could benefit from them and that meaningful 
choices between effective alternative treatments are available.
    VA has established programs to support the principle, specified in 
FDA's boxed warning, that ``(p)atients of all ages who are started on 
antidepressant therapy should be monitored appropriately and observed 
closely for clinical worsening, suicidality, or unusual changes in 
behavior.'' The purpose of the boxed warning is not to create barriers 
for the use of these medications for the treatment of depression or 
PTSD. Instead, it is to promote awareness that these medications are 
associated with risks, as well as benefits, and that treatment requires 
monitoring.
    Also, based on its Comprehensive Mental Health Strategic Plan, VA 
has enhanced access to mental health services by requiring that mental 
health services must be integrated into primary care services. To 
ensure veterans are monitored appropriately while they are receiving 
mental health services, including treatment with psychotherapeutic 
medications, VA requires that these integrated care programs include 
evidence-based care management.
    Care management for depression includes repeated contacts with 
patients to educate them about depression, medications, and other 
treatment, as well as to provide evaluations of both therapeutic 
outcomes and adverse effects. The benefits of the frequent contact 
program relate to increased patient-engagement in care. Also, 
information from patient monitoring is translated into decision-support 
for providers about when they should modify treatment. Two programs 
that are used frequently in VA primary care settings are Translating 
Initiatives in Depression into Effective Solutions (TIDES) and the 
Behavioral Health Laboratory (BHL), both of which are evidence-based 
interventions supported by extensive research. Studies on care 
management for depression in primary care settings have demonstrated 
that these interventions can decrease both depression and suicidal 
ideation in older adults. This led to recognition of care management 
for late life depression as a best practice for suicide prevention.
    For several years, VA has provided training to clinical mental 
health staff to ensure that there are therapists in each facility who 
are able to provide evidence-based psychotherapies for the treatment of 
depression and PTSD as alternatives to pharmacological treatment or as 
a course of combined treatment. The initiative to make these 
psychotherapies broadly available within VA is relevant to concerns 
about medication safety, but the program was not developed as a result 
of those concerns. VA implemented the broad use of evidence-based 
psychotherapies in response to evidence that for many patients, 
specific forms of psychotherapy are the most effective and evidence-
based of all treatments. Specifically, the Institute of Medicine report 
on treatment for PTSD emphasized findings that exposure-based 
psychotherapies, including Prolonged Exposure Therapy and Cognitive 
Processing Therapy, were the best-established of all treatments for 
PTSD. Other specific psychotherapies included in VA's programs include 
Cognitive Behavioral Therapy and Acceptance and Commitment Therapy for 
depression and Skills Training and Family Psycho-Education for 
schizophrenia. VA is adding other treatments such as Problem Solving 
for Depression, Cognitive Behavioral Therapy and Contingency Management 
for Sub- 
stance Use Disorder, and behavioral strategies for managing both pain an
d insomnia.
Focusing on the Evidence
    As stewards of the public interest and bearing the responsibility 
for caring for America's veterans, VA conducts ongoing analyses of its 
programs and continually asks itself how they can be improved. VA's 
mental health enhancements were designed to implement evidence-based 
practices. Early in this process, VA conducted exploratory analyses of 
the associations between the rates of suicide and the quality of mental 
health services, evaluating both on a facility-by-facility basis. The 
findings demonstrated statistically significant associations with two 
quality measures even after controlling for other differences between 
facilities. These findings led VA to adopt specific requirements for 
followup care after hospital discharge, and to require depression care 
management. Most generally, the findings support the conclusion that 
high quality mental health care can prevent suicide.
    One way to evaluate the impact of VA mental health care, with its 
use of medications as well as other forms of treatment, is to evaluate 
suicide rates. However, before addressing this issue, it is important 
to consider who accesses VA health care. For this, it is useful to 
refer to findings on those veterans returning from Afghanistan and Iraq 
who participated in the Post-Deployment Health Re-Assessment (PDHRA) 
program administered by DoD. Between February 2008 and September 2009, 
approximately 119,000 returning veterans completed PDHRA assessments 
using the most recent version of DoD's form. Of the more than 101,000 
who screened negative for PTSD, 43,681 came to VA for health care 
services and 57,476 did not. Translating this finding into statistical 
language, the odds of coming to VA for those who screened negative were 
about 0.8:1. Among 17,853 who screened positive for PTSD, 12,674 came 
to VA for health care services and 5,179 did not; in other words, the 
odds of coming to VA for those who screened positive were about 2.4:1. 
These findings demonstrate that veterans screening positive for PTSD 
were substantially more likely to come to VA for care. Findings about 
depression were similar. Both sets of findings support earlier evidence 
that those veterans who come to VA are those who are more likely to 
need care and to be at higher risk for suicide. The increased risk 
factors for suicide among those who came to VA is often referred to as 
a case mix difference.
    Working with the Centers for Disease Control and Prevention's 
National Violent Death Reporting System, SMITREC recently calculated 
rates of suicide for all veterans, including those using VA health care 
services and those who do not. This analysis included data from 16 
States for individuals aged 18-29, 30-64, and 65 and older for the 
years 2005, 2006, and 2007 (during the period of VA's mental health 
enhancement process). The year 2005 marked the beginning of 
enhancement, while the year 2007 is the most recent one for which data 
are available.
    Suicide rates for veterans using VA health care services aged 30-
64, and those 65 and above were higher than rates for non-users, and 
they remained higher from 2005 to 2007, probably a reflection of the 
case mix discussed above. However, findings for those aged 18-29 were 
quite different. In 2005, younger veterans who came to VA for health 
care services were 16 percent more likely to die from suicide than 
those who did not. However, by 2006, those younger veterans who came to 
VA were 27 percent less likely to die from suicide, and by 2007, they 
were 30 percent less likely. This difference appears to reflect a 
benefit of VA's enhancement of its mental health programs, specifically 
for those young veterans who are most likely to have returned from 
deployment and to be new to the system.
    It is particularly important to look at suicide rates among the 
youngest veterans (those aged 18-24) who are thought to be most 
vulnerable to suicidality as an adverse effect of antidepressant 
medications. Because the number of veterans from the 16 States in this 
group is relatively low, the rates are, for statistical reasons, 
variable. Nevertheless, they demonstrate important effects. In 2005, 
2006, and 2007, respectively, those who came to VA were 56, 73, and 67 
percent less likely to die from suicide. Those who utilized VA services 
were, to some extent, protected from suicide with an effect that 
appeared to increase during the time of VA's mental health 
enhancements.
Conclusion
    VA as a system is committed to detecting and decreasing adverse 
drug effects and improving the quality and availability of mental 
health care to veterans. VA's mental health enhancements have included 
major initiatives to increase the use of evidence-based psychotherapy 
for the treatment of PTSD and depression, as well as to enhance the 
safe use of psychotherapeutic medications. VA recognizes the concerns 
raised by FDA and others about the use of antidepressant medications 
among young adults as a potentially vulnerable population, but it has 
found that the risk of suicide is lower among the young adult veterans 
who come to VA for care and that the rates appear to be dropping. VA 
firmly believes that each veteran has earned an individual 
determination of the best treatment and routine followup for his or her 
specific condition, and its clinical guidelines support this endeavor.
    The concerns about risks of suicide are appropriate concerns. VA 
has conducted evaluations to determine whether they are reflected in 
increased rates of suicide in those young adult veterans who receive VA 
care. The answer is that these veterans are, in fact, at decreased risk 
for suicide. Thank you again for the opportunity to appear, and my 
colleagues and I are available to address any questions from the 
Committee.

                                 
     Prepared Statement of Brigadier General Loree K. Sutton, M.D.,
  Director, Defense Centers of Excellence for Psychological Health and
Traumatic Brain Injury, Special Assistant to the Assistant Secretary of
         Defense for Health Affairs, U.S. Department of Defense
Introduction
    Chairman Filner, Mr. Buyer, distinguished Members of the Committee; 
thank you for the opportunity to appear here today to talk to you about 
the Department of Defense's (DoD) efforts to reduce the number of 
suicides across our force.
    On behalf of DoD, I want to take this opportunity to thank you for 
your continued, strong support and demonstrated commitment to our 
servicemembers, veterans, and their families.
    Over the last 9 years, a new era of combat emerged, where 
counterinsurgency and asymmetric warfare are the norm. This shift 
continues to place a great amount of strain on our most important 
resource, our servicemembers. Despite the operational challenges facing 
them and their families, they remain incredibly resilient, motivated, 
and well-trained. The Department recognizes the need to provide the 
resources and programs necessary to maintain their resilience and 
motivation. Our core messages tell our servicemembers and their 
families that they are not alone; treatment works; the earlier the 
intervention the better; and reaching out is an act of courage and 
strength.
    The Department also recognizes that the total number and rate of 
suicides continue to rise and this is of deep concern at all leadership 
levels. Today, I will share with the Committee our current efforts to 
reduce the number of suicides across the force, and the role of 
medication and suicides.
    Suicide has a multitude of causes, and no simple solution. There 
are many potential areas for intervention, and it is difficult to 
pinpoint the best approach because each suicide is unique. Recognizing 
this, DoD is tackling the challenge using a multi-pronged strategy 
involving comprehensive prevention education, research, and outreach. 
We believe in fostering a holistic approach to treatment, leveraging 
primary care for early recognition and intervention, and when needed, 
providing innovative specialty care. The areas of focus to reduce risk 
include: (1) conducting data collection and analysis to detect 
contributing risk factors; (2) facilitating partnerships across DoD, 
Federal agencies, and civilian organizations to increase collaboration 
and communication; (3) reducing stigma and increasing access to 
resources to provide needed care; and (4) using research to close gaps 
and identify best practices.
Data Surveillance
    Quality data collection and analysis are critical components behind 
effective prevention efforts. The Department made great strides over 
the last 12 months on gathering critical information to understand the 
complexity of factors leading to suicide and ways to prevent such 
tragedies from occurring within our communities. Data collected by the 
DoD Suicide Event Report (DoDSER) tell us that we must continue to 
educate our population and build programs, as there continue to be 
multiple opportunities to intervene. For example, we are learning that 
30 percent of individuals who died by suicide communicated their 
potential self harm; 49 percent had been seen in a medical/support 
clinic/program within 30 days of suicide; and 26 percent sought broadly 
defined mental health resources.
    Historically, the Services used unique suicide surveillance 
systems. In January 2008, the National Center for Telehealth and 
Technology (T2), a Defense Centers of Excellence (DCoE) component 
center, launched the DoDSER Annual Report. The DoDSER Annual Report was 
developed to standardize data collection and reporting. Pulling data 
from all branches of the military, it captures over 250 data-points per 
suicide with details, summaries, and analyses of a wide range of 
potential contributing factors. DoDSER Annual Report data include 
specific demographics, suicide event details, treatment, and military 
history, among others. The variables are designed to map directly to 
the Centers for Disease Control and Prevention's National Violent Death 
Reporting System to support direct comparisons between military and 
civilian populations.
    By standardizing data and reporting, DoD tracks and analyzes 
suicide data and contributing risk factors proactively to inform and 
improve future prevention, intervention, and treatment services. The 
DoDSER Annual Report is revised annually based on input from the 
Services. The data facilitate the review and evaluation of the 
effectiveness of suicide prevention initiatives and their execution 
over time. DoDSER represents the strides DoD has taken to better 
understand what some of the underlying factors are for suicide. The 
Department uses this tool to inform current efforts and initiatives.
    According to the Armed Forces Medical Examiner System (AFMES), in 
January 2010 there were 24 confirmed suicides, all in Regular 
Components within the DoD. In calendar year 2009, AFMES reported that 
there were 312 confirmed suicides, with 286 confirmed in Regular 
Components and 26 confirmed in the Reserve Components. Demographic risk 
factors include: male, caucasian, E-1 to E-4, younger than 25 years 
old, GED or less than high school education, divorced, and in the 
Active Duty Component. Other factors associated with suicide, which are 
consistent with data from civilian populations, are: substance abuse, 
relationship issues, and legal, administrative (Article 15), and 
financial problems. Although the impact of deployment is still under 
investigation, a majority of suicides do not occur in the theaters of 
operation. Sixteen percent of suicides occurred in Iraq or Afghanistan. 
Despite the knowledge gained and data collected, it is important to 
resist oversimplifying or generalizing statistics. Each suicide is as 
different as a person is unique.
    According to AFMES, there were 26 confirmed suicides in calendar 
year 2009 among the Reserve Components, which include all active Guard 
and Reserves. Due to the unique nature of their service, there are 
challenges associated with capturing all suicide completions, 
preparatory behavior and self harm without intent to die among National 
Guard and Reserve populations when they are not on active or activated 
status. To address this issue, DoD is examining ways to utilize 
information gathered from existing tracking and reporting systems 
including, but not limited to, insurance and benefit data. The DoD 
continues to support National Guard and Reserve populations through 
numerous initiatives to increase outreach, care, and resources on all 
fronts.
    The numbers also tell us that prevention is not enough, as 36 
percent of military suicides had a history of a mental disorder. The 
integrated efforts of prevention, intervention, and treatment are 
essential to DoD's approach to tackle the challenge of suicide.
Facilitating Partnerships
    Continued collaboration with the Department of Veterans Affairs 
(VA) and other Federal, private, and academic organizations is a key 
part of DoD's overall strategy.
    Conferences serve as dissemination and outreach platforms by 
providing local and regional coordinators with innovative ideas to 
implement within their communities and providing DoD and VA with the 
opportunity to gather feedback on communities' needs. The annual DoD/VA 
Suicide Prevention Conference provides such a forum. With over 900 
attendees, the 2010 conference shared practical applications, results 
from research and pilot studies, guidance from senior DoD and VA 
leaders on the way forward, and testimonies emphasizing the importance 
of seeking help.
    We work closely with our partners at the VA to ensure that the 
transition out of service and into VA care is seamless and that 
servicemembers, veterans, and families receive the care they deserve. 
The DCoE coordinates information and resources with VA's National 
Suicide Prevention Lifeline (1-800-273-TALK), and National Resource 
Directory. As part of this partnership, DCoE worked with VA and the 
Substance Abuse and Mental Health Services Administration (SAMHSA) in 
December of 2009 to modify the introductory message on the Lifeline, so 
that callers are instructed to press ``1'' if they are a United States 
military veteran or Active Duty Servicemember (ADSM) or are calling 
about one. This expansion increases the scope of services that are 
available to ADSMs who may be in crisis.
    Collaborative care is an example of an immediate solution that DoD 
is aggressively implementing. According to DoDSER data, 36 percent of 
completed suicides had a history of a mental health condition. 
Providing mental health services in conjunction with primary care is an 
important part of our prevention strategy because early detection and 
intervention is a key to preventing suicide behaviors. Each Service is 
developing collaborative care models based on recommendations from a 
National Institute of Mental Health (NIMH) study. The DCoE collaborates 
with the Services to integrate the best practices from these models to 
develop consistent standards across DoD. DCoE is currently implementing 
a controlled trial study at 6 sites and 18 clinics of collaborative 
primary care to inform future efforts.
    In August 2009, the DoD Suicide Prevention Task Force was 
established under the purview of the Defense Health Board. The goal of 
the task force is to provide recommendations to legislative and 
administrative bodies on suicide prevention within the military.
Reducing Stigma
    The Department recognizes the importance of eliminating the toxic 
threat of stigma by transforming its culture from reactionary to a more 
proactive environment by engaging leadership to encourage transparency, 
accountability, candor, and respect. The DoD is promoting awareness 
among leaders and urging them to lead by example in matters related to 
health and well-being. In addition, changes in policies and messages to 
all levels help create a safe culture to seek help. One significant 
change was the revision of question 21 on the questionnaire for 
security clearances on whether a servicemember has sought mental or 
behavioral help in the past year. DoD believes that servicemembers 
should not have to deny themselves the care they need and deserve out 
of fear of repercussions. Our efforts to combat stigma will continue 
alongside our efforts to provide the best prevention, intervention and 
treatment options.
    Additionally, DoD is undergoing a cultural transformation to push 
care closer to the servicemembers and their families. An emphasis on 
early intervention for antecedent issues such as post traumatic stress, 
depression, and substance abuse can help address needs before they 
develop into bigger issues that could contribute to suicides. This 
population based approach enables DoD to engage multiple audiences 
including peers, families, units, and communities to support suicide 
prevention, risk reduction, and overall health promotion. The Services 
also have programs to address needs before they develop into issues 
that must be addressed in a specialty care setting.
    DCoE helps combat stigma through the Real Warriors Campaign, a 
public education initiative that reinforces the notion that reaching 
out is a sign of strength. Under the theme of ``Real Warriors, Real 
Battles, Real Strengths,'' this effort provides concrete examples of 
servicemembers who sought care for psychological health issues and are 
maintaining a successful military career. While primarily focused on 
stigma, the Real Warriors Campaign is actively engaged in the fight 
against military suicide in a number of ways:

      The Web site prominently displays the National Suicide 
Prevention Lifeline on every page;
      Two video profiles of servicemembers involved in the 
campaign openly discuss their struggles with suicidal ideation from a 
position of strength and optimism having reached out for care that is 
working; and
      The site allows servicemembers, veterans, families and 
health professionals to confidentially reach out to health consultants 
around the clock through the Real Warriors Live Chat feature or by 
calling the DCoE Outreach Center.

    The Campaign's message boards include numerous posts from 
servicemembers who share their coping strategies for dealing with 
suicidal ideation. The site includes content that focuses on suicide 
prevention and substance abuse. Short, documentary-style videos 
illustrate the resilience exhibited by servicemembers, their families, 
and caregivers.
    Since the Real Warriors Campaign launched in May 2009, the Web 
site, www.realwarriors.net, saw more than 45,500 unique visitors from 
127 countries, with more than 69,128 visits and 450,000 page views. The 
DoD believes that stigma can be defeated by encouraging and supporting 
servicemembers to reach out when help is needed.
Research
    A critical component of DoD's strategy is advancing research. As 
part of DoD's research portfolio, the RAND Center for Military Health 
Policy Research is reviewing and cataloging suicide prevention programs 
across the Services with recommendations for enhancements of current 
programs. The results will be released March 2010 and disseminated to 
inform future program development.
    A pilot study that showed promise in the civilian sector is the 
Caring Letters Program. In a randomized clinical trial, sending brief 
letters of concern and reminders of treatment to patients admitted for 
suicide attempt, ideation, or for a psychiatric condition was shown to 
dramatically reduce the risk of death by suicide. In an effort to 
determine the applicability to military populations, the National 
Center for TeleHealth and Technology (T2) is piloting a program at Ft. 
Lewis, Washington. The goals of the Caring Letters Pilot are to (1) 
test the feasibility of expanding the program to other military 
treatment facilities, (2) collect preliminary outcome data, and (3) 
evaluate the method of letter transmittal (email vs. postal mail). 
Since its inception in July 2009, 81 letters have been sent. Efforts 
are currently underway to plan a multi-site randomized control trial.
Department of Defense Initiatives
    Many programs are currently in place to raise awareness among 
servicemembers, train civilian providers supporting our servicemembers 
and communities, and increase leadership involvement in behavioral 
health efforts. The programs are on all levels, from the national level 
down into local communities. These initiatives, including programs that 
provide face-to-face support or online support, demonstrate DoD's 
multi-pronged approach and commitment to ensuring servicemembers and 
families have access to the best resources. Some examples of these 
efforts are detailed below:
    Each Service has its own suicide prevention initiatives tailored to 
its culture. In November 2007, DoD established the DCoE to offer a 
central coordinating point for activities related to psychological 
health concerns and traumatic brain injuries. DCoE focuses on the full 
continuum of care and prevention to enhance coordination among the 
Services, Federal agencies, and civilian organizations. DCoE works to 
identify best practices and disseminate practical resources to affected 
communities. In this effort, emphasis is placed on building resilience, 
supporting recovery, and promoting reintegration to ensure a 
comprehensive, multi-faceted, and proactive approach in promoting 
health and well-being.
    The Suicide Prevention and Risk Reduction Committee (SPARRC), 
chaired by DCoE, provides a forum for inter-Service and VA partnership 
and coordination. Members include Suicide Prevention Program Managers 
from the Services and representatives from the National Guard Bureau, 
Reserve Affairs, VA, Office of Armed Forces Medical Examiner, T2, 
Substance Abuse and Mental Health Services Administration, and others. 
This committee is the main venue for ensuring collaboration and 
consistency in systemwide communication related to suicide, risk 
reduction policy initiatives, and suicide surveillance metrics across 
the military. A SPARRC Web site is currently in development to serve as 
a ``clearinghouse'' for suicide prevention information, contacts, 
innovative approaches, and tools.
    Additionally, the DCoE Outreach Center coordinates with Military 
OneSource, accessible by phone at 1-800-342-9647. Licensed mental 
health consultants are available to listen, answer questions, and refer 
callers to a wide range of services 24 hours a day, 7 days a week, 365 
days a year. Military OneSource provides services on a range of other 
topics including education, relocation, and parenting.
    Another DoD program that encourages seeking care is inTransition, 
which provides a bridge of support for servicemembers while they are 
transitioning between health care systems or providers. The program 
assigns credentialed ``Supercoaches'' on a one-on-one basis to 
servicemembers in transition. These ``Supercoaches'' provide support, 
encouragement, and promote continued use of behavioral health services.
    In an effort to increase access to resources and align with modern 
commu- 
nication platforms, DoD is harnessing technology and social media 
tools. Afterdeployment.org, an interactive Web site developed by T2, 
provides servicemembers and families behavioral health information 
using an anonymous platform. This mental wellness resource is designed 
to help servicemembers and families manage the challenges faced after a 
deployment. In addition, Afterdeployment.org launched a series of free 
podcasts, available on iTunes, discussing a variety of mental health 
issues affecting servicemembers and families. Since the rollout in 
August 2008, Afterdeployment.org has seen 86,083 visits to its Web 
site. Afterdeployment.org is currently developing both a mobile version 
of the site and a mobile application. The portability will allow access 
to resources regardless of location.
    Telebehavioral health refers to use of telecommunications and 
information technology for clinical and non-clinical behavioral health 
care services. Telebehavioral health may include the use of 
videoconferencing, Web-based cameras, email and telephone. T2 is 
exploring ways to supply timely telebehavioral health services to 
servicemembers in theater and during health screenings immediately upon 
return to the continental United States. The use of technology provides 
servicemembers and their families access to psychological health care 
even in the most extreme and/or remote circumstances.
Medication and Suicide Risk
    The Department supports the use of psychopharmacological treatments 
as a key component of mental health care. Scientific evidence over the 
past several decades points to the role of medications in limiting the 
severity and duration of illness as well as for preventing relapses and 
recurrences. These findings have been translated into recommendations 
for clinicians in the VA-DoD Clinical Practice Guidelines for Major 
Depressive Disorder, Post Traumatic Stress Disorder, Psychoses and 
Substance Use Disorder. These guidelines are updated periodically as 
required to reflect the most current knowledge concerning each of these 
conditions. Recognizing that all medications carry potential risks as 
well as benefits, clinicians must exercise their judgment in applying 
these guidelines and determining the most effective use of medications, 
other therapies which include Cognitive Behavioral Therapy, Cognitive 
Processing Therapy and/or Prolonged Exposure treatment, or a 
combination of medication and therapy. Therapy must be monitored, with 
careful attention to diagnosis, dosing, clinical response and potential 
adverse events.
    In recent years, antidepressant medications, particularly the use 
of Selective Serotonin Reuptake Inhibitors (SSRIs), have been closely 
evaluated for the increased risk of suicide-related behaviors in 
adolescents and young adults associated with their use. In recognition 
of this risk, the FDA requires a ``black box'' warning in the product 
labeling of all antidepressant medications that advises clinicians to 
closely monitor any worsening in depression, emergence of suicidal 
thinking or behavior, or unusual changes in behavior, such as 
sleeplessness, agitation, or withdrawal from social situations. Close 
monitoring is especially important during the first 4 weeks of 
treatment. The FDA also recognizes that depression and other 
psychiatric disorders are themselves associated with increased risks 
for suicide.
    Accordingly, the Department uses multiple tools to address the 
identified risk for antidepressant as well as other medications, as 
scientific evidence reaches the threshold for action. These methods 
include dissemination of safety alerts to clinicians, patient 
information sheets, pharmacy monitoring for harmful combinations of 
prescribed medications, adherence to the Joint Commission standards 
governing medication reconciliation, compliance with the reporting of 
adverse events, increasingly sophisticated use pharmacotherapeutic 
analysis as well as training and education programs in evidence-based 
modalities reflecting the most current clinical practice guidelines.
    The DoDSER data base, while still maturing, provides an 
unprecedented repository of Service suicide surveillance data that will 
continue to inform our efforts. Further, we look forward to the payoff 
from continued research investments.
Way Forward
    Suicide is a problem that needs solutions now. DoD is focused on 
rapidly translating best practices into applicable tools for 
servicemembers and families. At the same time, DoD continues to improve 
on collaborative relationships across the Services and with national 
experts, collecting data, and in research efforts that will accelerate 
improvements in current services and programs as well as spur new 
innovations. In addition, DoD will also continue to evolve and leverage 
our population-based system to push innovations in prevention and care 
toward the servicemember and family.
    DoD's current initiatives to address the challenges placed on 
servicemembers and their families are progressing, but we recognize 
that there is still much to be done. In order to build on our current 
efforts and successfully shift to a model of population-based care, we 
identified the following areas of additional focus.
    An issue of increasing concern is suicides of military family 
members and how to support surviving families. At this point in time, 
DoD does not track suicides of military family members. However, DoD 
recognizes the importance of engaging and supporting this population, 
as their sacrifices deserve our recognition. The DoD Suicide Prevention 
Task Force met this year with surviving families at the Tragedy 
Assistance Program for Survivors (TAPS) Seminar. The DoD Task Force 
will provide recommendations to the Secretary of Defense and Congress. 
Efforts will be focused on increasing outreach to families; providing 
families with more education and training to recognize the signs of 
suicidal behavior and where to seek help; and supporting families after 
a suicide event. In addition, for calendar year 2010, SPARRC partnered 
with TAPS to form a subcommittee to identify additional needs of 
families and to recommend concrete solutions.
    Postvention, which refers to all activities and response after a 
suicide event, is another area of growing attention. The goals of 
postvention include: (1) promote healing, (2) reduce risk of contagion, 
and (3) identify those at risk and connect them to help. Postvention is 
also viewed as a form of prevention for survivors. This year, DoD will 
work with the Services to promote consistent postvention protocols 
across programs.
    Connect/Frameworks Suicide Postvention Program is a civilian 
program that utilizes evidence-supported protocols to promote an 
integrated community-based response to suicides. Postvention protocols 
and guidelines include topics such as discussing cause and method of 
death; how to address needs of families; memorial service activities; 
and media coverage and messaging.
    In addition to prevention, intervention, and treatment, DoD is 
shifting attention to increasing resilience. DoD promotes a holistic 
approach that optimizes the physical, psychological, and spiritual 
components of the human condition. The DoD is also piloting resilience 
programs in military settings to determine applicability and 
effectiveness within military populations. While the impact of 
deployment on suicide is still under investigation, it cannot be denied 
that an era of high operational tempo and persistent conflict increases 
pressure on our warriors. A comprehensive approach to enhancing 
resilience actively confronts the increasing stressors servicemembers 
face in this environment.
    2010 will also provide DoD further opportunities to demonstrate a 
public health model of prevention, by supporting peer-to-peer programs 
in the Services and continuing to increase the number of mental health 
providers in communities. DoD is actively engaged in hiring more mental 
health providers and providing them with quality and continued 
training.
Conclusion
    Through our united and concerted efforts, we can continue making a 
change for the better. DoD recognizes the need to provide the resources 
and programs necessary to maintain the resilience and motivation of our 
servicemembers and families. We will continue to emphasize education as 
we deliver our core messages. ``You are not alone; treatment works; the 
earlier the intervention the better; and reaching out is an act of 
courage and strength.''
    We are devoted to this effort and will continue to work 
aggressively to prevent the unnecessary loss of life.
    With the Committee's continued assistance and support, we will 
ensure our brave men and women in uniform and their families have 
access to the resources they require.
    On behalf of the DoD, thank you for the opportunity to highlight 
these vital issues. I look forward to your questions.

                                 
Statement of Bart P. Billings, Ph.D., Carlsbad, CA (Psychologist and Aut
                                  hor)
I. Role of Psychiatric Medications in Suicide
    If you were the parent of a son or daughter serving in the 
military, would you want your child being prescribed medication, on the 
battlefield or off, which contained a black box warning that states:


----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------

Suicidality and Antidepressant Drugs

  Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in
children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other
psychiatric disorders. Anyone considering the use of Zoloft or any other antidepressant in a child, adolescent,
or young adult must balance this risk with the clinical need. . . .

----------------------------------------------------------------------------------------------------------------


    A medication guide appears at the end of the label. The label 
states, ``The prescriber or health professional should instruct 
patients, their families, and their caregivers to read the medication 
guide and should assist them in understanding its contents.''
    The medication guide gives specific guidance about identifying 
danger signs:

          Call a health care provider right away if you or your family 
        member has any of the following symptoms especially if they are 
        new, worse, or worry you:

      Thoughts about suicide or dying
      attempts to commit suicide
      new or worsening depression
      new or worsening anxiety
      feeling very agitated or restless
      panic attacks
      trouble sleeping (insomnia)
      new or worsening irritability
      acting aggressive, being angry, or violent
      acting on dangerous impulses
      an extreme increase in activity and talking (mania)
      other unusual changes in behavior or mood

    Identical or nearly identical warnings and information can be found 
in all antidepressants labels. The strongest warning pertains to 
children and young adults up to age 24, which includes many young 
military personnel.
    From 2002 through 2008, there has been nearly a doubling of 
psychiatric medications prescribed to our military personnel and their 
families. At the same time, there has been a surge in the number of 
suicides among servicemembers and their family members that appears to 
correlate directly with the increased use of psychiatric medication.
    Stop and think about the fact that military personnel, who carry a 
weapon 24 hours a day, 7 days a week, for a year deployment, can be 
given a medication that has a black box warning, indicating a potential 
side effect can be suicide as well as aggressive, angry and violent 
behavior that can lead to homicide. If a medical practitioner 
prescribed this type of medication in the civilian community, to a 
patient who constantly carried a loaded weapon (had a permit to do so) 
and had extensive training on how to use this weapon, they could likely 
be charged with malpractice and possibly loose their license to 
practice medicine. If there was a suicide or homicide by this patient, 
directly related to this prescription, then the practitioner could be 
criminally charged.
    When discussing this issue with several civilian private practice 
physicians, they stated that they would not prescribe psychiatric 
medications to this type of patient but would refer the patient for 
counseling. This is not the case with many Veterans Administration (VA) 
psychiatrists, who in most cases prescribe psychiatric medications to 
the veterans they treat. I was recently at a professional conference at 
a local college where a VA psychiatrist admitted openly that he 
prescribed psychiatric medication to 98 percent of the patients who he 
treated at his clinic located in North County, San Diego.
    In 2008, the New York Times reported Dr. Ira Katz, head of mental 
health services in the VA, wrote an email to his staff stating: The VA 
should be quiet about the rate of suicide attempts with veterans 
receiving VA services. It should be noted that about 1,000 suicide 
attempts a month were reported in veterans seen at VA facilities. 
Again, one must look at the relationship between extensive numbers of 
psychiatric medication being prescribed at the VA and the large number 
of suicides and attempted suicides by veterans receiving services at 
the VA.
    For the past 27 years, I have been living within 15 minutes from 
Camp Pendleton Marine Base, which is a major staging area for marines 
sent into battle and returning from battle. My proximity to one of the 
largest marine bases in the world has allowed me to see firsthand what 
many young military personnel and their families experience. I have 
seen military personnel as patients, as an expert doing evaluations for 
legal cases involving marines and as a member of an advisory board at 
Palomar Community College providing scholarships to military personnel 
and their families. I have spoken with marines at various social 
functions as well as through service clubs and charity events. This 
exposure has helped me to conclude that one of the biggest fears that a 
marine has in discussing his personal combat stress reactions to others 
is that he will be medicated.
    In 2007, a reporter, Rick Rogers from the San Diego Union Tribune, 
published a story stating that more marines died at Camp Pendleton from 
suicide, homicide and motorcycle accidents (34 percent increase in 
motorcycle deaths between 2007 and 2008) than marines deployed from 
Camp Pendleton who died in combat.
    This same reporter, previous to this article, reported that marines 
and other military personnel were being sent into combat while on 
psychiatric medication. He was one of the first reporters in the 
country to report on this policy, developed by the chief psychiatrists 
in all military services. An article in Time magazine a few years ago 
discussed the medication of our military in depth and identified, by 
name, the leading proponents of endorsing the use of psychiatric 
medication on the battlefield. Principally Colonel Cameron Ritchie of 
the Army and Captain William Nash of the Navy.
    At a past educational conference that I was invited to 3 years ago, 
as a VIP at Camp Pendleton, I had an opportunity to ask the Commanding 
General of the Camp Pendleton Marine Base what he thought about Mr. 
Rogers article regarding marines being sent into combat while on 
psychiatric medication. His response was similar to many other combat 
commanders I have spoken with, who have been educated by military 
psychiatrists. He stated that mental health diseases should be treated 
like any physical disease, and that would be by administering 
medication. He stated that if you had an infectious disease, you would 
get an antibiotic and if you had a mental disease, psychiatric 
medication could be similarly administered. When I mentioned that the 
side effects of antibiotics had no black box warning of possible 
suicide and psychiatric medication did, he was quick to state he never 
took medication himself and wouldn't do so.
    The questions that need to be asked:

      How can medical practitioners in the military and the VA 
get away with what, in the civilian community, could be considered 
malpractice and in certain cases criminal?
      Why are military mental health psychiatrists or their 
disciples, who initially recommended the use of these types of 
medication to their mental health subordinates, who are located on the 
battlefield, still in positions of leadership and funded, with the 
responsibility to explain the causes of continued escalation of 
suicides in the military?
      Why hasn't there been a change in mental health 
leadership who has consistently failed to stop the drastic increase in 
suicides and homicides in the military?
      Why haven't there been widely published post-mortem 
reports on all suicides and homicides, both on the battlefield and at 
home, clearly identifying if the victim was on psychiatric medications?
      Does anyone believe that military mental health staff who 
advocated initially using psychiatric medication, will ever do research 
that demonstrates that the same medications they recommended be used on 
our military personnel has direct side effects that can lead to suicide 
and homicide?

    Hopefully some, if not all of these questions can be answered in 
testimony provided at these congressional hearings.
    I don't believe the current increase in suicides and homicides in 
the military is a coincidence, based on my personal observations, as 
well as other professionals' observations and writings on the subject. 
A recent text, ``Medication Madness,'' written by a world renowned 
psychiatrist, Peter Breggin, M.D., on adverse reactions to medications, 
discusses in depth the science and end results of adverse reactions to 
psychiatric medications. This text should be read by anyone taking or 
prescribing medication. I have personally spoken with psychiatrists, 
who work with military personnel, who have informed me they changed the 
way they currently treat their patients (reducing their use of 
medication) after hearing Dr. Breggin speak about adverse effects of 
psychiatric medication.
    At the 17th Annual International Military and Civilian Combat 
Stress Conference in May 2009, everyone attending the conference heard 
an Army social worker state that the use of psychiatric medication on 
the battlefield was rampant. She had completed two 1-year tours of duty 
in Iraq and Afghanistan and estimated that 90 percent of the U.S. 
combatants have used, at one time or other, psychiatric medications. 
She explained that they are being handed out, not only by physicians 
but also by physicians assistants, nurses, medics and even from soldier 
to soldier. She was told by various psychiatrists, while deployed, to 
support medicating troops and in one instance that her services on the 
battlefield were useless since she could not prescribe medication.
    At the same combat stress conference, an Army Lieutenant Colonel 
Commander described how some of his troops, after returning to Germany 
from Iraq, were given psychiatric medications and how their behavior 
deteriorated after receiving the medications.
    Prescriptions for all TRICARE beneficiaries, according to a 
Department of Defense (DoD) claims database (attachment 1 and 2), 
indicate that in 2002 a total of 3,739,914 prescriptions for 
antidepressants and antipsychotics were issued. In 2008 the number of 
these prescriptions rose to 6,413,035 (attachment 1 and 2).
    Figures for 2009 are not available at this time but based on the 
steady progression of increased amounts of medications prescribed, one 
would assume the total prescriptions, to date, would be over 7 million.
    In 2009, the number of suicides in the military surpassed the 
civilian death rate from suicide. The suicide death rate for military 
personnel was 20.2 per 100,000 while the civilian death rate was 19.2 
per 100,000. Veterans between the ages of 20 to 24 had a suicide death 
rate of 22.9 per 100,000, which is 4 times higher than non-vets the 
same age. It should also be noted that statistics indicate that there 
are 10 failed attempts at suicide for each actual completed suicide.
    This is the first time in decades that military suicides are at the 
current level. Presently we now have the highest level of suicides in 
the military that we have seen in three decades. Since 2001 there have 
been 2,100 suicides in the military, triple the number of troops that 
have died in Afghanistan and half of all U.S. deaths in Iraq. The 
correlation of increased suicides, as well as homicides, in the 
military, and the increased use of medications, with a side effect of 
suicide, irritability, hostility and aggressiveness does not appear to 
be a coincidence, but a direct link to adverse reactions a person may 
experience when taking these medications.
    A recent study was performed in Sweden (attachment 3):

          Rickard Ljung, M.D., Ph.D., Charlotte Bjorkenstam, M.Sc. and 
        Emma Bjorkenstam, B.Sc; Ethnic Differences in Antidepressant 
        Treatment Preceding Suicide in Sweden, Psychiatric Services 
        59:116-a-117, January 2008 http://ps.psychiatryonline.org/cgi/
        content/full/59/1/116-a Janne Larsson, reporter--investigating 
        psychiatry, Sweden mailto:janne.olov.larsson@telia. com.

    This study linked a direct relationship between people taking 
antidepressants or antipsychotic medications and suicide.

          ``Thus it can be said that 561 (45 percent) of ALL male and 
        female 1,255 persons (18-84) who committed suicide in Sweden 
        2006 had filled a prescription for antidepressant drugs OR 
        neuroleptics (not at all counting other psychiatric drugs) 
        within 180 days before their suicide.''

    Overall conclusions of the study indicated that approximately 46 
percent of people taking these medications committed suicide. The study 
found a direct link between the use of psychiatric medication as 
described above and suicide.
    There are many other studies that cite similar and even more 
significant findings, but since I don't consider myself an expert in 
the science of these medications, I will defer all questions in regard 
to the science behind these medications to Peter Breggin, M.D., who 
will provide extensive testimony in this area. Dr. Breggin has a 
prestigious background with the National Institute of Mental Health 
(NIMH) and elsewhere, where he researched the science of the 
medications we are discussing.
    Also information on the Internet Web site www.ssristories.com lists 
hundreds of civilian and military cases of death, suicide, attempted 
suicide, etc. that are linked to psychiatric medication. It identifies 
such cases of sudden death in soldiers taking a combination of 
psychiatric medications, the May 11th, 2009 Iraq mental health clinic 
shooting where 5 soldiers were killed by a soldier on psychiatric 
medication.
    On the other side of the coin, I have not observed significant 
long-term studies that have ever shown any psychiatric medication to be 
effective in treating Post Traumatic Stress Disorder (PTSD), for which 
significant prescriptions in the military are written. I am not saying 
that the FDA hasn't seen research presented to them by pharmaceutical 
companies, that allowed them to approve these medications for treating 
PTSD, but am concerned that these studies were less than one would 
desire to approve treating all our military as well as their families. 
When positive results are reported, they are typically short-term, not 
long-term effects.
II. National Tri-Service Combat Stress Conference
    As a retired military officer and founder and director of the 
longest running combat stress conference in the world, I have had the 
opportunity to talk with numerous active and reserve military personnel 
and their families. I have also heard presentations from experts from 
throughout the world on stress reactions to combat. As a clinical 
psychologist and mental health professional for over 42 years, I have 
had the opportunity to see patients while in the military (33 years, 9 
months in USAR), as well as in my civilian practice. These experiences 
have also allowed me to teach classes on combat stress reactions in the 
military as well as in the civilian community.
    I have been honored with military awards (attachment 4) and my work 
has been lauded by DoD officials for developing the International 
Military and Civilian Combat Stress Conference, as well as other 
programs (attachment 5, 6, 7 and 8).
    As a military and as a civilian psychologist, I have had an 
opportunity to develop firsthand opinions regarding, not only the 
relationship between psychiatric medications and suicide, but other 
adverse reactions our military personnel experiences that interfere 
with their performance on the battlefield and when returning home to 
their families.
    My overall observations and clinical experience leads me to state, 
emphatically, that integrative treatment approaches in treating combat 
stress and related problems is more effective in the long run, than 
prescribing drugs, both as a force multiplier and a money saver.
    Integrative approaches--such as individual counseling, bio-
feedback, guided imagery, progressive relaxation, peer counseling, 
cognitive-behavioral therapy, virtual reality therapy, implosive 
therapy, hypnosis, etc. have little or no adverse reactions and there 
is research that shows them to be effective both short-term and long-
term. It should be noted that during the first Persian Gulf War, combat 
stress chambers were successfully used to reduce stress. This is more 
that can be said currently of psychiatric medication. A recent book 
written in 2007 by a world-renowned psychologist, Stanley Krippner, 
Ph.D. and his associate, Daryl S. Paulson, Ph.D. titled ``Haunted by 
Combat,'' as well as an epilogue to this text presently being published 
in the 2010 paperback, gives extensive examples and findings as to the 
success of providing integrative mental health treatment protocols.
    If one considers that the average cost of a prescription for an 
antidepressant or antipsychotic can cost anywhere from $25 to $50 each, 
then the cost the DoD is billed for so-called mental health 
prescriptions should likely exceed $2 billion a year. This level of 
funding could pay for all the mental health professionals needed to 
provide the integrative treatment programs our military personnel and 
their families need, with no fear of adverse reactions and every 
expectation of success. If implemented, there are strong indications 
that the suicide rate would drop dramatically, as well as the 
increasing number of soldiers being diagnosed with PTSD and other 
reactions to combat stress.
    During the first Persian Gulf War, I was in a medical unit, the 
6252nd U.S. Army Reserve Hospital, which deployed most of its military 
personnel. Upon returning after the war ended, I observed many varied 
problems among the soldiers. These problems consisted of emotional 
difficulties, marital difficulties, financial problems, general health 
problems, legal problems, family problems, spiritual problems, etc.
    What was striking at the time was that most of these problems could 
have been minimized or completely avoided if the soldiers were better 
prepared prior to deployment. With the assistance of the Commanding 
General of the 6252nd and the staff of our Combat Stress Company, I 
developed a readiness protocol to address all of the issues one had to 
deal with prior to and when actually deployed, as well as when 
returning home. We came up with a 20-minute interviewing manual that, 
with minimal training, one could administer to each member of a 
military unit.
    The soldier would respond for themselves as well as for their 
family. The program was called the Human Assistance Rapid Response Team 
(HARRT--brochure attachment 9 and 10). Members of the Combat Stress 
Company administered the instrument to military units with significant 
success. Readiness problems improved and returning prematurely from 
deployment dropped. The HARRT program also identified Suicide Ideation 
and Homicide Ideation.
    Out of the HARRT program, a 2-day conference (attachment 11) was 
born to teach how the HARRT program could be utilized and improved. 
This conference led to an annual National Tri-Service Combat Stress 
Conference held for 15 years at Camp Pendleton Marine Base in 
California. Today this conference, which is held the first week of May, 
is going into its 18th year and has been re-named The Annual 
International Military and Civilian Combat Stress Conference.
    In December 1997, I was invited to the Pentagon by Brigadier 
General Richard Lynch to address the Army Reserve Forces Policy 
Committee's Mobilization Subcommittee in regard to the HARRT program. 
The committee was made up of seven Major Generals with command 
experience. After my presentation of the HARRT program, Major General 
Donald F. Campbell, chairman of the committee, stated that the total 
committee supported the implementation of the HARRT program (attachment 
12). Major General Campbell stated in his letter ``As chairman of that 
mobilization subcommittee, I am pleased that our decision to support 
your program has assisted you in your commitment to pursue your goal of 
fully implementing the HARRT program with all our military services, 
both Active and Reserve.''
    Major General Hennis, who was one of the committee members of the 
above-mentioned panel and a Commanding General for the National Guard 
in one of our southern States, requested at the committee meeting that 
the HARRT program be first fully implemented for all members of the 
National Guard in his State. Since there was no followup funding from 
the DoD to fully implement the HARRT program, this request could not be 
followed up on at the time. This lack of funding and followup from DoD 
was repeated on other occasions resulting in the underutilization of an 
admittedly viable program. In another instance, a National Guard 
Special Forces unit in California specifically contacted me to perform 
the HARRT interviews on all their members prior to deployment. Since 
there was no funding and orders to honor their request received from 
DoD, the request could not be implemented. The Special Forces commander 
was upset and disappointed his request could not be honored and had to 
deploy knowing his unit could have been better prepared to depart.
    On May 28, 1999, I was invited to visit the Department of the 
Army's Office of the Surgeon General. As a result of the visit, a 
letter was written (attachment 2) commentating favorably on the Combat 
Stress Conference, the Prisoner of War Conference and the HARRT 
program. A comment in the letter specific to the HARRT program is as 
follows: ``It is reasonable to expect that this program alone will 
directly benefit hundreds of thousands of servicemembers and their 
families.'' This comment was related to a then recent DoD directive 
6490.5, instructing all military organizations to implement Combat 
Stress programs.
    From 1997 and later in 1999, when the HARRT program and Combat 
Stress Conferences were initially supported by the above-mentioned DoD 
organizations at the Pentagon, there has been little followup by DoD to 
fully follow through and implement these viable Combat Stress 
educational and preventative programs. This lack of followup has 
predictably resulted in many hardships for military personnel as well 
as their families. No one knows how many suicides and homicides could 
have been averted if these, admittedly quality Combat Stress programs 
could have been fully implemented back in 1997 or 1999. Instead the DoD 
has supported the extensive use of psychiatric medication, which 
appears to have worsened the problems of combat stress, which can be 
readily measured by the increases in suicide and homicide in the 
military.
    In 2005, the military command, from the Tri-Service Combat Stress 
Conference founding organization (6252 USAH), stated it did not have 
the staff or funding to continue the Tri-Service Combat Stress 
Conference and asked myself and other retired officers if we could 
continue the conference privately, with no military funding or support. 
This request was shocking, due to the fact that the need for combat 
stress training was elevated since the beginning of the War on 
Terrorism. This lack of support for combat stress training was 
consistent with the lack of DoD followup mentioned above. This 
challenge to continue the training conference was taken up by a few 
dedicated retired officers and today the conference still continues and 
is now the longest running and in my mind, one of the best conferences 
held in the world on combat stress. It should be noted that in 1999, 
when I visited the DoD to discuss the conference, I suggested that the 
DoD take over the conference due to the important nature of the content 
and the fact that when I retired I was fearful the conference would not 
continue. I was told that I was doing a good job both verbally and in 
writing but that they were not interested in assuming leadership of the 
conference.
    To date, the International Civilian and Military Combat Stress 
Conference has trained thousands of military and civilian personnel on 
how to effectively deal with combat stress related problems. It has 
also motivated other military and civilian groups to start their own 
conferences on combat stress. It is considered by many to be the gold 
standard of all combat stress conferences, as demonstrated by the many 
world-renowned military and civilian instructors and Federal and State 
legislative people who have attended and have given presentations over 
the years.
    (For conference history and previous instructors see 
www.tservcsc.bizhosting.com).
    At the onset of the current War on Terrorism, many expert 
presenters at the Combat Stress Conference warned that military 
personnel should not be medicated when on the battlefields or when 
eventually returning home. The overall consensus of presenters, as well 
as people attending the conference, was that integrative treatment was 
the most effective way of dealing with combat stress issues. I would 
estimate that only 2 percent of people attending the conference 
advocated medicating soldiers. This 2 percent consisted primarily of 
psychiatrists. It should be noted that most psychiatrists are primarily 
trained to administer medication and generally don't have the training 
to provide integrative treatment. This lack of exposure to integrative 
treatment can be traced back to the medical schools that train 
psychiatrists. An example of this was when I recently questioned, at a 
conference where he was a presenter, a chief psychiatrist who worked in 
a VA clinic. He stated at this public forum that he medicates 98 
percent of the veterans he sees as patients. This is not an isolated 
instance based on common psychiatry practice standards.
    I have personally seen military personnel as patients, who 
explained that they were given antidepressants on the battlefield to 
simply try to stop smoking. One marine explained to me that when he 
returned back home, he could find no indication in his medical record 
that he was ever given psychiatric medication. He experienced cognitive 
problems from the first time he was given the medication and when he 
complained to the medical staff, he was given even more psychiatric 
medication. It wasn't until he, on his own, took himself off the 
medication after 2 years that he returned to normal functioning. This 
marine was interviewed by me and California Assemblyperson Mary Salas' 
(Chair of Assembly Veterans Committee) Chief of Staff, Francisco 
Estrada, to evaluate veteran's services in California. This is not an 
isolated case since I have encountered many military personnel with the 
same experiences. The use of the psychiatric medications is prevalent 
on the battlefield, where it is being dispensed not only by medical 
doctors but also by physician's assistants, medics, soldier to soldier, 
etc.
SUMMARY AND RECOMMENDATIONS
    Since the War on Terrorism began, there has been a steady increase 
in suicide and homicide in the military. There has also been a steady 
increase in the number of psychiatric medications purchased by DoD and 
prescribed to military personnel and their families. Research and the 
FDA (black box warning) have revealed that there is a direct 
relationship between the use of psychiatric medication and suicide. The 
black box warnings on the actual medication label also describe the 
link between the medication and suicide, as well as other cognitive 
effects, which can also trigger homicidal behavior.
    There have been integrative treatment training programs, as well as 
actual treatment protocols, available since the end of the first 
Persian Gulf War that have been effective in treating and identifying 
residual effects of combat stress, i.e. the Human Assistance Rapid 
Response Team (HARRT), Tri-Service Combat Stress Conference. These 
programs have been underutilized and underfunded in favor of widespread 
use of psychiatric medications with the result being increases in 
military suicide and homicide.
    A solution to the ongoing and increasing problems with suicide and 
homicide is not more medication but more integrative treatment programs 
administered by trained mental health providers, as well as military 
leadership personnel.
    The full implementation of the HARRT program as a readiness tool, 
as well as its use as an instrument to identify potential suicide and 
homicide ideation is advisable. The HARRT program was recognized by DoD 
personnel as a valuable tool, as far back as 1997 and 1999, with 
recommendations at that time to fully implement the program.
    Also DoD should recognize that all military personnel in combat 
experience Post Traumatic Stress (PTS)--notice there is not a ``D'' at 
the end. PTS for military personnel is a normal reaction to being in an 
abnormal environment, the battlefield. PTS becomes a disorder (D) when 
the soldier (term referring to individuals in all military 
organizations), does not learn ways of dealing with the PTS and how to 
normalize themselves. If this normalization process does not occur, 
then the soldier can develop a disorder and the PTS can become Post 
Traumatic Stress Disorder (PTSD).
    It is critical that the DoD become aware of the difference between 
PTS and PTSD. If DoD can recognize that psychiatric medication has not 
been effective in treating combat stress, than a natural conclusion 
would be to turn their focus and finances to methods that have been 
approved and worked in the past to various degrees and expanding these 
programs.
    One program that should be strongly considered for implementation 
by DoD should be a mandatory one (1) hour a day program for thirty (30) 
days for all military personnel returning from combat zones. This 
mandatory 1 hour a day, of structured mental training (MT), 
administered by trained staff, using a militarywide standardized 
approach, will help all returning soldiers realize that they are having 
normal reactions from being in an abnormal battlefield environment. By 
learning methods of dealing with abnormal experiences and developing 
coping approaches through integrative treatment methods, they can 
return to normal functioning. There will no longer be a need for 
soldiers to hide what they are experiencing since all individuals, by 
attending mandatory MT programs, will realize that they are all human 
beings, in a similar situation, subjected to the same stresses and 
similar experiences.
    Cutting back on the extensive use of psychiatric medication and 
implementing integrative programs such as the HARRT program, MT 
programs and similar programs throughout the military, could lead to 
strong expectations for significant decreases in PTSD, suicide and 
homicide in the military. This decrease would result in more soldiers 
being available for deployment, reduction in family and personal 
hardships and a reduction in psychiatric disability moneys being spent, 
while in the military as well as when the soldier returns to civilian 
life after discharge.

                                 
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