Soldiers: Veteran's Govt. Meeting: More Soldiers Kill Themselves Than Killed in Combat

Paragraphs 36 through 42 read:  "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 in varying degrees.  Mania is associated with loss of impulse control, violence and suicide.

Preda et al. (2001) found that 8.1 percent of adult psychiatric hospital admissions could be attributed to antidepressant-induced mania and/or psychosis.  Morishita and Arita (2003) found that 8.6 percent of patients treated with Paxil developed hypomania or mania.  Howland (1996) found a 6 percent rate of SSRI-induced mania, mostly severe.  Ebert et al. (1997) found a 17 percent rate of hypomania, some suicidal or dangerous.  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. Individual 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.  Studies also find an increased rate of hostility for children and adults taken Paxil (Healy et al, 2006, using data from GlaxoSmithKline, 2006a). Healy (2000) gave Zoloft to 20 volunteers, two of whom became aggressive and suicidal. The FDA conducted an epidemiological study comparing fluoxetine to trazodone in regard to spontaneous reports concerning hostility and intentional injury  and found increased hostility on Prozac. (Food and Drug Administration, 1991). In a phone survey of pharmacy patients newer and older antidepressants, Fisher et al. (1993) found Prozac caused a higher incidence of psychotic aggression, and suicidality.

http://www.veterans.house.gov/hearings/Testimony.aspx?TID=56906&Newsid=525&Name=%20Peter%20R.%20Breggin,%20M.D .

I am Peter R. Breggin, MD, 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 one hundred 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 impulsivity­a 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 sho
w 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.[*]

I. Introduction

This study focuses on evidence that antidepressants frequently cause suicide, violence and manic-like symptoms of over-stimulation­and therefore present a serious hazard when given to military personnel.  Research involving 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 (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 (Food and Drug Administration, October 15, 2004a).  Additional FDA-mandated studies extended the suicide warning to young adults age 18-24­the precise age of many soldiers..

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 following excerpts are taken from the Zoloft (sertraline) label as of October 2008.  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:[†]
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 with an elaborate WARNINGS section subtitled, Clinical Worsening and Suicide Risk, which contains the following statement:

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 an already stressed individuals, including soldiers.  In a rare display of emphasis by the FDA, this array of dangerous symptoms is described several times more in the label.

Under the heading Information for Patients the label addresses the importance of informing patients about all of these risks. 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 for all age groups 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 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

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 “

II. 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 16 placebo-controlled clinical trials in which Paxil had been randomized against placebo and found increased suicidal behavior. Fergusson et al. (2005) searched the adult literature and found 702 randomized clinical trials (87,650 patients) and found a significant increase in suicidality on antidepressants. Donovan et al. (1999) in a large British study involving 222 suicides found a higher rate of suicide on patients treated
with the newer antidepressants. Donovan et al. (2000) examined 2776 consecutive cases of deliberate self-harm in individuals age seventeen and older seen at the emergency department of a British infirmary. Again, suicide attempt rates were higher among patients treated with newer antidepressants. Jick et al. (1995) conducted an epidemiological study in the United Kingdom involving 172,598 adult patients and Prozac was associated with more suicides than the older antidepressants. Frankenfield et al. (1994) studied coroner’s cases in Maryland and found the suicides were more violent in patients taking Prozac compared to older antidepressants.

GlaxoSmithKline (2006) conducted a new meta-analysis of all of its adult trials of Paxil and found an increased rate of suicidality in depressed patients of all ages. .

A study of 1,255 suicides in 2006 in Sweden (95 percent of all suicides in the country)  reported that 32 percent of Scandinavian men and 52 percent of Scandinavian women filled a prescription for antidepressants in the 180 days prior to suicide ((Ljung et al., 2009).  A retrospective study examined the suicide rates among 887,859 VA patients treated for depression and 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 in varying degrees.  Mania is associated with loss of impulse control, violence and suicide.

Preda et al. (2001) found that 8.1 percent of adult psychiatric hospital admissions could be attributed to antidepressant-induced mania and/or psychosis.  Morishita and Arita (2003) found that 8.6 percent of patients treated with Paxil developed hypomania or mania.  Howland (1996) found a 6 percent rate of SSRI-induced mania, mostly severe.  Ebert et al. (1997) found a 17 percent rate of hypomania, some suicidal or dangerous.  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. Individual 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.  Studies also find an increased rate of hostility for children and adults taken Paxil (Healy et al, 2006, using data from GlaxoSmithKline, 2006a). Healy (2000) gave Zoloft to 20 volunteers, two of whom became aggressive and suicidal. The FDA conducted an epidemiological study comparing fluoxetine to trazodone in regard to spontaneous reports concerning hostility and intentional injury  and found increased hostility on Prozac. (Food and Drug Administration, 1991). In a phone survey of pharmacy patients newer and older antidepressants, Fisher et al. (1993) found Prozac caused a higher incidence of psychotic aggression, and suicidality.

D.  A Broad Range of Adverse Behavioral Effects in Children and Youth

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 et al. (1992) made a retrospective examination of the medical charts of children and young men age 9-18 and found that 23 percent of fluoxetine-treated young people developed mania or manic-like symptoms. Another 19 percent developed drug-induced hostility and aggression.

A study 8-16 year old in a university clinic 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 et al, 1990/1991).  A second research study found that 14 percent 10-17 year olds became aggressive and even violent while taking fluoxetine (King, 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).   As mentioned, Martin et al. (2004) found that exposure to antidepressants increases the probability of a subsequent diagnosis of bipolar disorder in 5-29 year olds.

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

According to the Code of Federal Regulations, WARNINGS are based on at least “reasonable evidence” for causation. (Code…, 2008). In a Talk Paper, the FDA also confirmed that the array of stimulant-like or activation symptoms associated with the antidepressants was in fact caused by the drugs. The FDA 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).  That these observations appear in the WARNINGS section confirms that “reasonable evidence” of causality because this is the standard set for WARNINGS by the Code of Federal Regulations (2008).

VI. Clinical Cases

In Medication Madness (2008a), I have evaluated more than fifty cases of violence, suicide, mania and crime induced by psychiatric medications, especially the newer antidepressants (Breggin, 2008a). The individuals had never before been suicidal, violent or criminal, and recidivism was zero when the medications were stopped.

VII.  Lack of Efficacy

To obtain FDA-approval, pharmaceutical companies can cherry pick their studies to find tw
o that show 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).

VIII. Conclusion

There is overwhelming evidence that the SSRIs and other stimulating antidepressants cause suicidality and aggression, sometimes as an aspect of highly dangerous states of mania.  All ages are susceptible but young adults aged 18-24 (the age of many soldiers) are especially at risk for antidepressant-induced suicidality.  There is a strong probability that increasing suicide and violence rates among active duty soldiers are in part caused or exacerbated by the widespread prescription of antidepressant medication.  Antidepressants should be avoided in the treatment of 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 newly developing psychological and educational programs described by Dr. Bart Billings at today’s panel.

For the bibliography and more detailed explanations, see the full-length paper.

[*] Peter R. Breggin, M.D., 101 East State Street, Ithaca, New York 14850.  Phone 607-272 5328.  www.breggin.com . This article was written specifically for the Committee on Veterans’ Affairs of the U. S. House of Representatives hearings of February 24, 2010 entitled “Exploring the relationships between medication and veteran suicide.”

[†] Bold emphases also appear in the label.