Summary of Hearings to consider the relationship between medication and veteran suicide — (US House of Reps Committee on Veterans’ Affairs)

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WEDNESDAY, FEBRUARY 24, 2010

The U.S. House of Representatives, Committee on Veterans’ Affairs, Washington,  DC. (members listed below), Chaired by Hon. Bob Filner, convened to consider the relationship between medication and veteran suicide.

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

COMMITTEE ON VETERANS’ AFFAIRS

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

The Chairman explained that presenters would have 5 days to ensure their remarks were correctly on record.

He introduced the topic, explaining that post traumatic stress disorder (PTSD)and traumatic brain injury (TBI) are prevalent in the current wars in Iraq and Afghanistan, resulting in “mental health issues”. He noted that:

“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 survive the battle abroad only to return home from the theater of war to fall by suicide.

We know there is a widespread… use of psychiatric medications, but there is apparently some dispute about whether these drugs prevent or (cause) suicide…

Through this hearing, we will explore the two opposing schools of thought on the relationship with psychiatric medicine and suicide.

Committee member Roe expressed the view that the issue of suicide is complex and raises difficult questions.  He expressed faith in National Institutes of Mental Health (NIMI) research to find the right answer to do the best for veterans.

The Chairman then introduced Dr. Peter Breggin, Psychiatrist and Author, and Dr. Andrew C. Leon, Professor of Biostatistics in Psychiatry and Public Health at Weill Cornell Medical College.

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 expressed the strong view that the newer antidepressants, SSRIs, cause violence and suicide in some people and are not safe and effective for anyone.

He noted that drug companies, particularly Eli Lilly, manipulate RCT data on drug safety and efficacy to make their drugs appear helpful and safe, when they are not.   He explained how as an expert witness he had observed this phenomenon first hand. Company insiders knew that their drugs caused suicide but they hid this fact from the general public. He noted that:

“In 2004, after (holding) hearings, the FDA… 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 military population…

…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…

…later in the label, they will say that a lot of the adverse effects occur in non-psychiatric patients.”

This black box is very lengthy, many of the items are repeated over and over again in the warnings and further on… The idea of clinical worsening that is repeated in the label has not been given enough attention.

The following symptoms are listed for children and adults taking antidepressants both for psychiatric and non-psychiatric purposes:”anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity,

Aggressiveness, akathisia hypomania, and mania.  Akathisia often leads to violence and suicide.

“Imagine young men and women who are heavily armed and under a great deal of stress (experiencing) irritability,hostility, aggressiveness,and impulsivity”.  These factors can lead to violence and to suicide. Many suicides are out of anger and irritability and resentments.

Often soldiers taking this medication are not even informed of the risks.

Dr. Leon noted that he had served as a consultant to FDA, to the NIMH, and to industry and stated that there is no evidence that SSRI antidepressants cause suicides, even if they may sometimes cause suicidal thinking. He  dragged out the old pharma argument that:

“depression is a life-threatening illness. Suicidality is a symptom of depression, whether treated or untreated… Antidepressants reduce suffering from depression that has been demonstrated in several hundred randomized controlled clinical trials…

…A cause and effect relationship has not been established between antidepressants and suicide.”

He went on in this vein at length, including responding to questions from the Chairman, Mr Teague, Mr. Rodriguez, Mr. Walz and Mrs. Halvorson.  He and Dr Breggin accused each other of being incorrect in a number of observations.  In each case it was Dr LKean who was in error.

Dr. Breggin pointed out that: “the way antidepressants 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… The drugs do not have a magic way of fixing depression, which is basically a loss of hope.”

Everyone agreed that treatment should be more than medication and that there should be adequate monitoring of the effect of prescriptions, acknowledging that this can sometimes be difficult in the field.

Mrs. Halvorson noted (bizarrely) that the hearings are not about whether the medications work or not, it is about taking care of veterans.  (As if giving  ineffective meds that cause suicide is not relevant to care).  She noted that:

“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.”

Mr. Roe asked Dr. Breggin if he subscribes any neurobiology theory of depression. Any chemical changes in your brain that might have something to do with depression?

Dr. Breggin responded that: “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.”

Dr. Leon noted that: “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 (sic)”.

The Chairman pointed out to all present that Dr Leon made his living fromj supporting the pharmaceutical company party line.

He noted that: “It seems you (Dr Leon) have not included the problems… 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…

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 replied that Dr. Breggin is not a scientist and there was some personal exchange about it.

M. David Rudd, PH.D., ABPP then offered the perspective of the American Psychological Association.  Most of the points he made had already been dealt with. He noted that cognitive behavioral therapy, cognitive processing therapy, prolonged exposure,that are very effective for depression, are also 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.

His position was that medication is essential for symptom reduction during these early phases of psychotherapy.

Dr. Annelle Primm, M.D., MPH then spoke on behalf of the American Psychiatric Association, APA.  Not surprisingly, she strongly advocated for maximum use of medication and supported the idea that: “stigma still discourages from seeking care those who need help for PTSD and other disorders”.

She “note(d) 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.”

In her opinion: “These medications have meant remarkably positive changes in the lives of tens of millions of Americans… 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.

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.”

Next to make a statement was Commander Donald J. Farber, ESQ, USN (RET.), who practises law in San Rafael California. Since 1999, a majority of his cases have been antidepressant suicide, either representing the heirs or the family themselves.

Commander Farber noted that: “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.

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 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 re-evaluation 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.”

…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.

[Recess.]

The Chairman. 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.

Dr. Katz. mades 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.

BRIGADIER GENERAL LOREE K. SUTTON, M.D. agreed with Dr. Katz about the essential role of medication, antidepressants.   She went on to make several points which included significant misinformation, probably because the Army works closely with NIMH.

She stated that “depression, for example, carries a strong genetic component”. She stated a belief that “the revolution in neuroscience” was relevant.  She said:   “we are in the middle of a cultural transformation… We are moving to a public health model that emphasizes resilience and strength…

Admiral Mullen, who has repeatedly said that these wounds that are unseen, the spiritual, the psychological wounds of war… can be the most deadly of all. They are just as important as the psychological wounds (sic).”

She concluded that the military needs to send these messages: you are not alone, the unseen wounds of war are real, and treatment works. The sooner we can intervene, the better (so)reaching out is an act of courage and strength.

The Chairman reminded Dr Sutton that (military) suicides have increased along with concern and treatment. He noted that “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 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.

…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.

The Chairman… you are very impressive as a witness, but I would say you are at least a decade behind and the kids are suffering… 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… 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-

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?

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 information about a study by Marcia Valenstein, MD, entitled “Higher Risk Periods for Suicide Among VA Patients Receiving Depression Treatment: Prioritizing Suicide Prevention Efforts,” which is summarized below]

The research was designed to identify the periods during treatment for depression where risk of suicide is highest in order to help physicians prioritize suicide prevention efforts. In this observational study, we did not attempt to causally link antidepressant use to suicide death.

…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 follow-ups 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. Dr. Sutton, what percent of the troops that we have now are on SSRIs?

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.

Mr. Roe. Well there is no question that the force is under tremendous stress. No doubt about that. So I agree with the Chairman completely. We need to make this work.

[At 1:24 p.m. the hearing was adjourned.]

SSRI Editor Comments:   Despite the strong testimony from Dr Peter Breggin and Commander Farber that SSRI antidepressants do cause violence and suicide in a small number of people, it is clear from the testimony of representatives from the decision-makers on military drug-use policy (Dr Ira Katz, Janet Kemp and Brigadier General Dr. Loree Sutton) that while they acknowledge there are risks, they are satisfied with the current approach to medicating troops.  They believe that overall use of psychoactive drugs at current levels is beneficial and just needs to be better supported with monitoring.   The issue of how officials can monitor impulsive acts, or acts that are the result of sustained distorted, secretive thinking and planning – the distortion being the result of drugs –  is not addressed.  It remains unacknowledged.