Witness Testimony of Ira Katz, M.D., Ph.D., Veterans Health Administration, U.S. Department of Veterans Affairs, Deputy Chief Officer, Mental Health Services, Office of Patient Care Services
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 service members alike. Since October 2009, VA and DoD have held two major conferences related to the mental health needs of Veterans and service members. 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 US 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 life span, 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 the 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 multidisciplinary 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 service members, a little more than one 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 Substance Use Disorder, and behavioral strategies for managing both pain and 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 follow-up 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.
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 follow up 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.