[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
U.S. GOVERNMENT PRINTING OFFICE
55-230 WASHINGTON : 2011
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing
Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; DC
area (202) 512-1800 Fax: (202) 512-2104 Mail: Stop IDCC, Washington, DC
20402-0001
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.
X. Bibliography
American Psychiatric Association. (2000). Diagnostic and
statistical manual of mental disorders, fourth edition, text revision
[DSM-IV-TR]. Washington, DC: American Psychiatric Association.
Aursnes, I., Tvete, I., Gassemyr, J. & Natvig, G. (2005). Suicide
attempts in clinical trials with paroxetine randomized against placebo.
BMC Medicine, 3, 1-5.
Bailey, L., Gordis, L. & Green, M. (1994). Reference guide on
epidemiology. In Federal Judicial Center's reference manual on
scientific evidence (pp. 122-179). St. Paul, MN. West.
Biswas A, Bhaumik, S., and Branford, D. (2001). Treatment-emergent
behavioural side effects with selective serotonin re-uptake inhibitors
in adults with learning disabilities. Human Psychopharmacology, 16,
133-137.
Breggin, P. (2003). Suicidality, violence and mania caused by
selective serotonin reuptake inhibitors (SSRIs): A review and analysis.
Ethical Human Sciences and Services, 5, 225-246.
Breggin, P. (2006). Intoxication anosognosia: The spellbinding
effect of psychiatric drugs. Ethical Human Psychology and Psychiatry,
8, 201-215, 2006. Simultaneously published in the International Journal
of Risk and Safety and Medicine, 19, 3-15, 2007.
Breggin, P. (2008a). Medication Madness: The Role of Psychiatric
Drugs in Cases of Violence, Suicide, and Crime. New York: St. Martin's
Press.
Breggin, P. (2008b). Brain-Disabling Treatments in Psychiatry:
Drugs, Electroshock and the Psychopharmaceutical Complex, Second
Edition. New York: Springer Publishing Company.
Breggin, P. (2009, May 2). Does psychiatric medication increase the
risk and prevalence of suicide? Paper presented at The 17th Annual
International Military & Combat Stress Conference, Los Angeles,
California.
Breggin, P. and Breggin, G. (2004). Talking Back to Prozac. New
York: St. Martin's Press.
Code of Federal Regulations, Title 21, Volume 4, [21CFR201.57]
Warnings and precautions. Revised as of April 1, 2008, From the U.S.
Government Printing Office via GPO Access.
Constantino, J., Liberman, M., & Kincaid, M. (1997). Effects of
serotonin reuptake inhibitors on aggressive behavior in psychiatric
hospitalized adolescents: Results of an open trial. Journal of Child
and Adolescent Psychopharmacology, 7, 31-44.
Donovan, S., Clayton, A., Beeharry, M., Jones, S., Kirk, C.,
Waters, K., Gardner, Faulding, D. & Madeley, R. (2000). Deliberate
self-harm and antidepressant drugs: Investigationable link, British
Journal of Psychiatry, 177, 551-556.
Donovan, S., Kelleher, M., Lambourn, J. and Foster, T. (1999). The
occurrence of suicide following the prescription of antidepressant
drugs, Archives of Suicide Research, 5, 181-192.
Ebert, D., Albert, R., May, A., Merz, A., Murata, H., Stosiek, I.,
and Zahner, B. (1997). The serotonin syndrome and psychosis-like side
effects of fluvoxamine in clinical use--An estimation of incidence.
European Neuro-Pharmacology, 7, 71-74.
Emslie, G.J., Rush, A.J., Weinberg, W.A., Kowatch, R.A., Hughes,
C.W., Carmody, T. and Rintelmann, J. (1997). A double-blind,
randomized, placebo-controlled trial of fluoxetine in children and
adolescents with depression. Archives of General Psychiatry, 54, 1031-
1037.
Fergusson, D., Doucette, S., Glass, Kathleen, Shapiro, Stan, Healy,
David, Hebert, Paul and Hutton, Brian. (2005, February 13). BMJ, 330,
396-403.
Fisher, S., Kent, T. and Bryant, S. (1995). Postmarketing
surveillance by patient self-monitoring: Preliminary data for
sertraline versus fluoxetine, Journal of Clinical Psychiatry 56, 288-
296.
Fisher, S., Bryant, S. and Kent, T. (1993). Postmarketing
surveillance by patient self-monitoring: Trazodone versus fluoxetine,
Journal of Clinical Psychopharmacology 13, 235-242.
Food and Drug Administration (FDA). (1993, September). Monitoring
adverse drug reactions: The FDA's new MEDWatch Program. Rockville,
Maryland.
Food and Drug Administration (FDA). (1996, June). The clinical
impact of adverse event reporting. Rockville, Maryland: Center for Drug
Evaluation and Research.
Food and Drug Administration (FDA). (2004a, October 15). FDA Public
Health Advisory. Suicidality in children and adolescents being treated
with antidepressant medication. Rockville, Maryland, www.fda.gov.
Food and Drug Administration (FDA). (2004b, October 15). Label
change request letter for antidepressant medications. www.fda.gov.
Food and Drug Administration (FDA). (2004c, September 13-14).
Summary minutes of the CDER Psychopharmacologic Drugs Advisory
Committee and the FDA Pediatric Advisory Committee. Center for Drug
Evaluation and Research. Rockville, Maryland. Unnumbered pages.
Food and Drug Administration (FDA). (2004d, March 22). FDA issues
Public Health Advisory on cautions for use of antidepressants in adults
and children. Rockville, Maryland. www.fda.gov.
Frankenfield, D., Baker, S., Lange, W., Caplan, Y. & Smialek, J.
(1994). Fluoxetine and violent death in Maryland, Forensic Science
International 64, 107-117.
Ghaemi, S., Boiman, E., & Goodwin, F. (2002). Diagnosing bipolar
disorder and the effect of antidepressants: A naturalistic study.
Journal of Clinical Psychiatry, 61, 804-808.
GlaxoSmithKline (2006, May). Dear Healthcare Professional:
Important Prescribing Information [regarding Paxil-induced
suicidality]. Philadelphia, Pennsylvania: GSK.
Go, F., Malley, E., Birmaher, B., & Rosenberg, D. (1998). Manic
behaviors associated with fluoxetine in three 12-18-year-olds with
obsessive-compulsive disorder. Journal of Child and Adolescent
Psychopharmacology, 8, 73-80.
Government Accounting Office. (1990, April). FDA drug review:
Postapproval risks 1976-1985 (Report to the Chairman No. GAO/PEMD900-
15). Washington, DC: Subcommittee on Human Resources and
Intergovernmental Relations.
Grewal, R. (2008, August 14). Email from Renmeet Grewal, Regulatory
Project Manager, Division of Psychiatric Products, Center for Drug
Evaluation and Research, Office of Drug Evaluation, Food and Drug
Administration to Donald Farber, attorney, San Rafael, California.
Hammad, T. (2004, September 13). Results of analysis of suicidality
in pediatric trials in newer antidepressants. Delivered at the Center
for Drug Evaluation and Research. Joint meeting of the CDER
Psychopharmacologic Drugs Advisory Committee and the FDA Pediatric
Advisory Committee. Bethesda, Maryland.
Harding, C., & Zahniser, J. (1994). Empirical correction of seven
myths about schizophrenia with implications for treatment. Acta
Psychiatrica Scandinavica, 90 (Suppl. 384), 140-146.
Health Canada Online. (2004, June 3). Advisory: Health Canada
advises Canadians of stronger warnings for SSRIs and other newer
antidepressants. www.hc-sc.ca/English/protection/warnings/2004/
2004_31.htm.
Healy, D. (2000). Emergence of antidepressant induced suicidality.
Primary Care Psychiatry, 6, 23-28.
Healy, D., Herxheimer, A. & Menkes, D. (2006). Antidepressants and
violence: Problems at the interface of medicine and law. PloS Medicine,
3, 1478-1487.
Healy, D. and Whitaker, C. (2003). Antidepressants and suicide:
Risk-benefit conundrums. Journal of Psychiatry and Neuroscience, 28,
331-339.
Howland, R. (1996). Induction of mania with serotonin reuptake
inhibitors. Journal of Clinical Psychopharmacology, 16, 425-427.
Henry, C., Sorbara, F., Lacoste, J., Gindre, C., & Leboyer, M.
(2001). Antidepressant-induced mania in bipolar patients:
Identification of risk factors. Journal of Clinical Psychiatry, 62,
249-255.
Hoehn-Saric, R., Lipsey, J., & McLeod, D. (1990). Apathy and
indifference in patients on fluvoxamine and fluoxetine. Journal of
Clinical Psychopharmacology, 10, 343-345.
Jain, J., Birmaher, B., Garcia, M., Al-Shabbout, M. and Ryan, N.
(1992). Fluoxetine in children and adolescents with mood disorders: A
chart review of efficacy and adverse reactions. Journal of Child and
Adolescent Psychopharmacology, 2, 259-265.
Jick, S., A. Dean, A., & Jick, H. (1995). Antidepressants and
suicide, British Medical Journal 310, 215-218.
Joint Meeting of the Peripheral Nervous System Drugs Advisory
Committee (PCNS) and the Pharmacologic Drugs Advisory Committee (PDAC)
(2008, July 10). Minutes. Food and Drug Administration, Center for Drug
Evaluation and Research. Rockville, Maryland.
Jureidini, J., Doecke, C., Mansfield, P., Haby, M., Menkes, D., and
Tonkin A. Efficacy and safety of antidepressants for children and
adolescents. (2004). British Medical Journal 328: 879-883.
Jurrlink, D., Mamdani, M., Kopp, A., & Redeimeier, D. (2006). The
risk of suicide with selective serotonin reuptake inhibitors in the
elderly. American Journal of Psychiatry, 163, 813-821.
King, R.A., Riddle, M.A., Chappell, P.B., Hardin, M.T., Anderson,
G.M., Lombroso, P., et al. (1991). Emergence of self-destructive
phenomena in children and adolescents during fluoxetine treatment.
Journal of the American Academy of Child and Adolescent Psychiatry, 30,
179-186.
Kirsch, I., Deacon, B.J., Huedo-Medina, T.B., Scoboria, A., Moore,
T.J., & Johnson, B.T. (2008). Initial severity and antidepressant
benefits: a meta-analysis of data submitted to the Food and Drug
Administration. PloS Medicine, 5(2), e45 EP.
Laughren, T. (2006, November 16). Overview for December 13 meeting
of Psychopharmacology Drugs Advisory Committee (PDAC) (Memo from the
Director, Division of Psychiatric Products to members of PDAC).
Rockville, Maryland.
Leslie, L., Newman, T., Chesney, J., and Perrin, J. (2005). The
Food and Drug Administration's deliberations on antidepressant use in
pediatric patients. Pediatrics, 116, 195-204.
Levy, D., Kimhi, R., Barak, Y., Aviv, A., & Elizur, A. (1998).
Antidepressant-associated mania: A study of anxiety disorder patients.
Psychopharmacology, 136, 243-246.
Ljung, R., Bjorkenstam, C., and Bjorkenstam, E. (2008). Ethic
differences in antidepressant treatment preceding suicide in Sweden.
Psychiatric Services, 59, 116-117.
Lorge, E. (2008, January 31). Army responds to rising suicide
rates. http://www. army.mil / -news / 2008 / 01 / 31 / 7222 - army -
responds - to - rising - suicide - rates. Retrieved February 9, 2010.
Marangell, L., Yudofsky, S. and Silver, J. (1999).
Psychopharmacology and electroconvulsive therapy. Chapter 27 in Hales,
R., Yudofsky, S. and Talbott, J. (Eds.). The American Psychiatric Press
Textbook of Psychiatry (pp. 1025-1132). Washington, DC: American
Psychiatric Press.
Marangell, L., Silver, J., Goff, D., & Yudofsky, S. (2003).
Pharmacology and electroconvulsive therapy. In R. Hales & S. Yudofsky
(Eds.), The American Psychiatric Publishing Textbook of Clinical
Psychiatry (4th ed., pp. 1047-1149). Washington, DC: American
Psychiatric Press.
Martin, A., Young, C., Leckman, J., Mukonoweshuro, C., Rosenheck,
R., & Leslie, D. (2004). Age effects on antidepressant-induced manic
conversion. Archives of Pediatric and Adolescent Medicine, 158, 773-
780.
Moncrieff, J. and Kirsch, I. (2005). Efficacy of antidepressants in
adults. BMJ, 331, 155-157.
Newman, A black-box warning for antidepressants in children? New
England Journal of Medicine, 351, 1595-1598.
Olfson, M., Marcus, S., and Shaffer, D. (2006). Antidepressant drug
therapy and suicide in severe depressed children and adults. Archives
of General Psychiatry, 63, 865-872.
Pfeffer, C. (2007). Editorial: The FDA pediatric advisories and
changes in diagnosis and treatment of pediatric depression. American
Journal of Psychiatry, 164, 843-846.
Pfizer Canada Inc. (2004, May 26). Stronger WARNING for SSRIs and
other new antidepressants regarding the potential for behavioral and
emotional changes including risk of self harm. www.hc-sc.gc.ca/hpfb-
dgpsa/tpd-dpt/Zoloft.
Preda, A., MacLean, R., Mazure, C., and Bowers, M. (2001).
Antidepressant-associated mania and psychosis resulting in psychiatric
admission. Journal of Clinical Psychiatry, 62, 30-33.
Raja, M., Azzoni, A., & Koukopoulos, A. (2009).
Psychopharmacological treatment before suicide attempt among patients
admitted to a psychiatric intensive care unit. Journal of Affective
Disorders, 113, 37-44.
Riddle, M., King, R., Hardin, M., Scahill, L., Ort, S., Chappell,
P., et al. (1990-1991). Behavioral side effects of fluoxetine in
children and adolescents. Journal of Child and Adolescent
Psychopharmacology, 1, 193-198.
Standardization of definitions and criteria of causality assessment
of adverse drug reactions: Drug-induced liver disorders: Report of an
international consensus meeting. International Journal of Clinical
Pharmacology, Therapy and Toxicology, 28, 317-322.
Teicher, M., Glod, C., & Cole, J. (1990, February). Emergence of
intense suicidal preoccupations during fluoxetine treatment. American
Journal of Psychiatry, 147, 207-210.
Teicher, M., Glod, C., & Cole, J. (1993). Antidepressant drugs and
the emergence of suicidal tendencies. Drug Safety, 8(3), 186-212.
Thompson, M. (2009, June 5). America's Medicated Army. Time. http:/
/www.time.com/time/nation/article/0,8599,1811858,00.html. Retrieved
February 9, 2010.
Tonkin, A., and Jureidini, J. (2005). Editorial: Wishful thinking:
Antidepressant drugs in childhood depression. British Journal of
Psychiatry, 187, 304-305.
Valenstein, M., Kim, H., Ganoczy, D., McCarthy, J., Zivin, K.,
Austin, K., Hoggatt, K., Eisenberg, D., Piette, J., Blow, F., and
Olfson, M. (2009). Higher-risk periods of suicide among VA patients
receiving depression treatment: Prioritizing suicide prevention
efforts. Journal of Affective Disorders, 112, 50-58.
van Reekum, R., Streiner, D., and Conn, D. (2001). Applying
Bradford Hill's criteria for causation to neuropsychiatry. Journal of
Neuropsychiatry and Clinical Science, 13, 318-325.
Whittington, C., Kendall, T., Fonagy, P., Cottrell, D., and
Boddington, E. (2004). Selective serotonin reuptake inhibitors in
childhood depression: Systematic review of published versus unpublished
data. Lancet, 363, 1341-1345.
Wilens, T., Biederman, J., Kwon, A., Chase R., Greenberg, L., Mick,
E., et al. (2003). A systematic chart review of the nature of
psychiatric adverse events in children and adolescents treated with
selective serotonin reuptake inhibitors. Journal of Child and
Adolescent Psychopharmacology, 13, 143-152.
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.