E. Fuller Torrey, MD

 an additional $98 million as part of the National Institutes of Health budget resolution in December 2019, which brings the NIMH budget to just under $2 billion and represents a 35% increase since 2015, one of the largest increases in the history of the NIMH. Yet, during the 5 years from 2015 through 2019, NIMH funded a total of 2 new drug treatment trials for schizophrenia and bipolar disorder, according to 

. This contrasts with the 5-year period from 2006 through 2010 when NIMH funded 48 such trials. NIMH has thus almost entirely given up its role of evaluating drugs for the treatment of 2 disorders.

Schizophrenia and bipolar disorder are among the most serious psychiatric disorders and play a disproportionate role among individuals who end up homeless, incarcerated, and who commit suicide. The cost of schizophrenia alone in the US was estimated to be $155.7 billion, based on a 2013 

 Traditionally, the pharmaceutical industry and NIMH have been the main developers of new psychiatric drugs. In recent years, the former has reduced its efforts to develop such drugs, at least in part because of the failure of genetic research to identify new targets for new drug development. Given the semi-withdrawal of the pharmaceutical industry, it would seem reasonable to expect the NIMH to increase, rather than decrease, its efforts.

A big part of the problem is the NIMH policy of requiring the identification of specific biological targets in the brain for treatment trials. This has been widely interpreted to mean that the NIMH is not really interested in supporting clinical trials at this time. Indeed, the NIMH has been widely criticized for focusing exclusively on basic brain research rather than clinical research that could help people currently affected by diseases such as schizophrenia and bipolar disorder. For example, in 2016, 20 current and former members of the NIMH National Advisory Mental Health Council published an editorial in the British Journal of Psychiatry criticizing the NIMH’s overemphasis on basic research.

 Joshua Gordon, MD, PhD, the current NIMH director, has “

that neither genetic research nor the study of complex circuits was likely to produce new treatments anytime soon.”

In fact, genetic findings relating to the immune system have been among the strongest genetic findings to date, and there is substantial genetic overlap between serious psychiatric disorders and a range of autoimmune diseases.

from small studies indicating that immune modulatory drugs have promise for the treatment of schizophrenia and bipolar disorder should be followed with larger scale studies.

 In addition, there are neuro-hormones such as estrogen that are promising as well as probiotics and other agents to modulate the microbiome and gut-brain axis.

 Given the fact that the last new psychiatric drug for psychosis was 

, which was approved 30 years ago, the time is long past due when the NIMH should undertake an aggressive search for better drugs. And now it has $2 billion in taxpayer funds to do so.

The opinions expressed here are those of the authors and do not necessarily reflect the opinions of 

 and Associate Director for Research at the Stanley Medical Research Institute; 

 is Theodore and Vada Stanley Distinguished Professor of Neurovirology in Pediatrics, Johns Hopkins University Medical School, Baltimore, MD.

1. Cloutier M, Aigbogun MS, Guerin A, et al. The economic burden of schizophrenia in the United States in 2013. 

2. Lewis-FernÃ¡ndez R, Rotheram-Borus Mj, Betts vt, et al. Rethinking funding priorities in mental health research. 

3. Heimer H. ICOSR 2017: The Prospects for New Drugs to Treat Schizophrenia. 

https://forum.schizophrenia.com/t/icosr-2017-the-prospects-for-new-drugs-to-treat-schizophrenia/78131

4. Hoeffding LK, Rosengren A, Thygesen JH, et al. Evaluation of shared genetic susceptibility loci between autoimmune diseases and schizophrenia based on genome-wide association studies. 

5. Severance EG, Dickerson F, Yolken RH. Autoimmune phenotypes in schizophrenia reveal novel treatment targets. 

6. Mueller N. Inflammation in schizophrenia: pathogenetic aspects and therapeutic considerations. 

7. Kulkarni J, Gavrilidis E, Wang W, et al. Estradiol for treatment-resistant schizophrenia: a large-scale randomized-controlled trial in women of childbearing age. 

8. Dickerson F, Adamos M, Katsafanas E, et al. Adjunctive probiotic microorganisms to prevent rehospitalization in patients with acute mania: a randomized controlled trial. 

Articles

Schizophrenia and bipolar disorder are among the most serious psychiatric disorders and play a disproportionate role among individuals who end up homeless, incarcerated, and who die by suicide. Why the lack of research?

Riches Abound, So Where Are the Trials for Schizophrenia and Bipolar Disorder?

Editor's note: This commentary is part of a 3-part collection

Introduction: Lies, Dam Lies, and Statistics

HOCUS POCUS: How the NIMH Made 2 Million People With Schizophrenia Disappear

, by E. Fuller Torrey, MD and Elizabeth Sinclair.

A RESPONSE FROM THE NIMH DIRECTOR: On the Prevalence of Schizophrenia and Transforming Care Through Research

is Founder of the Treatment Advocacy Center and Associate Director for Research at the Stanley Medical Research Institute. 

is a Research Associate at the Treatment Advocacy Center.

Although he has been the Director of the National Institute of Mental Health (NIMH) for less than 2 years, Dr. Joshua A. Gordon has made 2 million individuals with schizophrenia disappear. NIMH has not said where they went but officially, they no longer exist. This is a remarkable accomplishment, especially given the lack of attention NIMH has given serious mental illness

Until November 2017, NIMH had claimed that the 1-year prevalence of schizophrenia in adults in the US was 1.1%. In other words, in any given year approximately 11 out of every 1,000 adults would be diagnosed with this disease of the brain. The Bureau of the Census estimated in 2017 that there were 252.1 million adults in the US; thus approximately 2.8 million would have been diagnosed with schizophrenia.

This estimate was based on the last major epidemiological study of serious mental illness in the US, the Epidemiologic Catchment Area (ECA) study. This NIMH-funded study sampled 5 areas (Los Angeles, St. Louis, New Haven, Baltimore, and rural counties in North Carolina) in the early 1980s. At least 3,000 adults living in households and 500 individuals living in mental hospitals, prisons, nursing homes and other institutions were directly interviewed in each area, then surveyed by telephone 6-months later and re-interviewed another 6-months after that. The results are considered to be the most accurate mental illness prevalence data available for the US. In 1993, at the request of the US Senate Committee on Appropriations, the ECA data were given to the Senate so that they could be used to assess the costs of these disorders. The ECA data have thus been the standard in the US for the past 3 decades.

Inexplicably, in November 2017, NIMH changed its website and declared that the 1-year prevalence of schizophrenia is now 0.3%, or 3 cases in 1,000 adults. Based on the current census estimates, this means that there are now only approximately 750,000 adults with schizophrenia each year in the US. Since there were 2.8 million previously, just over 2 million have been made to disappear.

How does NIMH justify this remarkable feat? They no longer make any mention of the ECA study and instead cite as the basis of their estimate a National Comorbidity Survey carried out in 2001-2003. This survey was a sampling of 9,282 people living at home and specifically excluded individuals in institutions, including in psychiatric or other hospitals, nursing homes, jails, prisons, homeless shelters, or individuals living on the street. Thus the official count of individuals with schizophrenia in the US now excludes anyone not living at home. The refusal rate for participating in the survey was 29%, and the authors cite a study reporting that people with paranoid symptoms are more likely to refuse to participate in such surveys. For screening their original sample of 9,282 people living at home, the study used the Composite International Diagnostic Interview (CIDI), a screening tool known to be poor in identifying individuals with schizophrenia. Among the original 9,282 persons, 2,382 had some psychiatric symptoms and were then screened using an instrument for non-affective psychosis (schizophrenia, schizoaffective disorder, delusional disorder, non-affective psychosis not otherwise specified). The final psychiatric diagnoses for this survey were based on telephone interviews with 73 people.

NIMH then tries to justify the use of a schizophrenia adult prevalence rate of 0.3% per year by citing 2 summaries of a worldwide prevalence study. This study included 188 prevalence studies, including the ECA study, carried out in 46 countries, some as early as 1935. The main finding of this study was the very wide range of prevalence in different countries, with the US being among the highest. Many of the studies were carried out in developing and rural countries that have reported a low prevalence of schizophrenia until recent years. Taking the median prevalence from these 188 studies to justify a current estimate for the US is scientifically irresponsible.

The new estimates from NIMH are also egregiously inconsistent with the majority of other prevalence estimates, even within the federal government. The latest data from the Substance Abuse and Mental Health Services Administration (SAMHSA) state that schizophrenia accounts for 22% of people with serious mental illness, or about 2.3 million adults based on current estimates. The Centers for Medicare and Medicaid Services reports that 4% of all Medicare beneficiaries have schizophrenia, increasing to 11.2% all individuals who are dual-eligible for Medicare and Medicaid. In addition, widely-cited academic literature has prevalence estimates consistently between 0.9%–1.1%.

Why did NIMH wish to massively reduce the official prevalence of schizophrenia in the US? In the past 2 years, members of Congress have become much more interested in problems associated with untreated severe mental illness. With the passage of the 21st Century Cures Act and appointment of the nation’s first Assistant Secretary for Mental Health in the Department of Health and Human Services, it seems likely that federal mental health agencies like NIMH may be held accountable in a way that they have not been previously. Having to account for 750,000 people with schizophrenia is much easier than having to account for 2.8 million. In addition, NIMH has already been widely criticized for ignoring the needs of individuals with schizophrenia, specifically by failing to support research on the development of new medications and other effective treatments.

It should also be noted that NIMH has not funded a major study to determine the current prevalence of schizophrenia since the ECA study in the early 1980s-more than 30 years ago. Thus we really have no idea whether the prevalence of schizophrenia has increased, decreased, or stayed the same. The lack of data in the US on this question stands in sharp contrast to almost every European country. In England, for example, 7 major studies on the prevalence of schizophrenia were carried out between 1986 and 2009, including studies of whether the prevalence is increasing; why the prevalence is so high among certain immigrant groups; and whether there are regional differences in prevalence. A measure of England’s interest in these issues is a 258-page report, “Systematic Review of the Incidence and Prevalence of Schizophrenia and Other Psychoses in England,” prepared for the Department of Health in 2012. The Scandinavian countries, of course, have even more sophisticated prevalence studies based on their national case registers. Compared with these countries, the data available in the US on the prevalence of schizophrenia are equivalent to the data available in some developing countries.

The last major study of the prevalence of schizophrenia in the US was carried out in the early 1980s. The results from that study have been used for 3 decades to estimate the annual prevalence of schizophrenia at 1.1% (11 in 1,000 adults). For unknown reasons, NIMH decided in November 2017 to no longer use that data. Instead, it adopted a 2001–2003 study that only assessed schizophrenia in people living at home. Individuals who are hospitalized, in nursing homes, in jail or prison, or homeless are no longer included in the measure of prevalence, which NIMH claims to now be 0.3% (3 in 1,000 adults). This decreases the number of people estimated to have schizophrenia in the US from approximately 2.8 million to 750,000. The very fact that NIMH would make such a change is a measure of the institute’s lack of interest and expertise on this important issue.

We have 2 recommendations that the agency should take to address this major discrepancy. First, it should restore the previous estimate of the prevalence of schizophrenia (1.1% annual rate for adults) until more updated data become available. Second, NIMH, perhaps in collaboration with SAMHSA, should undertake a major new study of the prevalence of schizophrenia, including individuals in psychiatric hospitals, in jails or prisons, and who are homeless. When Dr. Gordon became the Director of NIMH, he stated that his highest priority was to support good science. Let us hope that making individuals disappear is not representative.

The last major study of the prevalence of schizophrenia in the US was carried out in the early 1980s. The results from that study have been used for 3 decades.

Individuals with serious mental illness who have committed major crimes pose a unique problem for balancing the clinical needs of the patient against the protection of the public. A 2011 summary of studies from 10 developed countries suggests that the US does a poor job in this task; recidivism for individuals with psychotic disorders was twice as high in the US compared with 9 other countries.

 We undertook a state survey of forensic practices to ascertain why the US does so poorly.

Treat or Repeat: A State Survey of Serious Mental Illness, Major Crimes and Community Treatment

, released September 19 by the Treatment Advocacy Center, is the result.

 In the first such study, surveys and interviews were conducted with mental health and correction officials in each state to determine what laws, policies, and programs are used to decrease recidivism for individuals with serious mental illnesses who are released from jails or prisons or discharged from hospitals. States were graded A, B, C, D, or F on their efforts. Overall grades reflect whether the state has adopted enumerated evidence-based laws or programs so that they are theoretically available for the target population. Analysis of implementation, either in the quality of the programming or the uniformity of service availability throughout a state, was beyond the scope of this report.

The results were less than encouraging and help to explain why the US lags behind other countries in this regard. No state received an A, but 4 states-Hawaii, Maine, Missouri, and Oregon-achieved a B+. On the other end of the spectrum, Alaska, Idaho, Indiana, Massachusetts, Mississippi, New Mexico, Texas, and Wyoming were graded F. It should be emphasized that the grades reflect states’ efforts only for this specific population of patients; for other patient populations, the state may do better or worse. We emphasize that the grade is a composite, since programs often vary widely among counties, especially in large states. The grade reflects what is theoretically available for a program within the state without the need for legislative or policy change.

The good news from this state survey is that programs were identified in many states that can be used as models to improve outcomes for this patient population. For individuals with serious mental illness who have committed major crimes, past studies have shown that if they do not continue treatment when they are placed in the community, their re-arrest rate is 40% to 60% within 5 years. However, if such individuals maintain treatment upon community reentry, their re-arrest rate can be reduced to 10% or lower.

The most widely used effective treatment is conditional release. This requires that individuals who live in the community follow a treatment plan or be subject to possible rehospitalization. The states with the largest number of individuals on conditional release per population are Hawaii, Arkansas, and Maryland. Follow-up studies of conditional release in California, Connecticut, Maryland, and Virginia have shown it to be highly effective in reducing recidivism. Conditional release is available in all states except Idaho, Indiana, Massachusetts, New Mexico, North Carolina, Pennsylvania, and Texas-all of which were graded D or F.

A second effective mechanism for reducing recidivism in individuals with serious mental illness living in the community is the creation of psychiatric security review boards (PSRBs). Pioneered in Oregon and Connecticut, these review boards centralize the authority for the release of and follow-up for forensic patients in a single small group of people. The Oregon PSRB, for example, consists of a psychiatrist, psychologist, lawyer, parole or probation officer, and member of the public appointed by the governor to 4-year terms. Virtually all individuals found not guilty by reason of insanity (NGRI) are assigned to the PSRB, which has full authority over the individual, including duration of inpatient care, conditional release, and discharge. Follow-up studies of PSRBs have shown them to be highly effective. Many states have a body that operates similarly, but the best results have been achieved where the legislature has created such a centralized authority.

A third effective mechanism for reducing the re-arrest rate is the use of Forensic Assertive Community Treatment (FACT) teams. The FACT team model for psychiatric patients in general has been in wide use since the 1970s and is highly effective. When it is used for forensic patients, a criminal justice professional is added to the treatment team. Such teams are responsible for the patients assigned to them 24/7 and also address the other needs of patients such as housing, job training, and money management. Studies of FACT teams have reported their effectiveness in significantly reducing convictions for new crimes, number of days in jail, and use of inpatient psychiatric services, compared with a control group.

Yet another mechanism for reducing recidivism in individuals with serious mental illness who have committed crimes is assisted outpatient treatment (AOT). While AOT is a civil remedy, its availability relates to maintaining treatment within the community both before and after criminal justice involvement. It is available in all states except Connecticut, Maryland, and Massachusetts but is underused in most states. AOT consists of a court order that allows the person to live in the community as long as he or she follows the treatment plan. Under Kendra’s Law (New York’s version of AOT), in follow-up studies for individuals with serious mental illness who had committed any crime, recidivism was reduced by 71%. In California, where AOT is called Laura’s Law, there was a 56% reduction in recidivism and a 75% reduction in days incarcerated.

Other recommendations for improving services

Treat or Repeat identified several other ways to improve the treatment of individuals with serious mental illness who have committed major crimes. It emphasizes that these individuals are a relatively small percentage of the total psychiatric case load. Based on studies discussed in the report, at any given time there is estimated to be approximately 200,000 individuals with serious mental illness who have committed a major crime living in the community; this is just 2% of all individuals with a serious mental illness. Because of their known high rate of reoffending if they are not being treated, such individuals should be given priority for psychiatric services.

Arkansas, for example, does so explicitly on the website of the Division of Behavioral Health Services, which lists “individuals found NGRI” and “individuals committed by the courts for dangerousness to others” as the top 2 priorities for treatment. Similarly, in Missouri the state contract with the regional community mental health centers explicitly states that forensic patients are a priority population for treatment. These are models for other states.

Another way to improve the treatment of this forensic subgroup of psychiatric patients is the greater use of clozapine, the only antipsychotic that has been demonstrated to decrease aggressive behavior. In an important 2001 article, Frankle and colleagues

 reported a reduction in re-arrest rates in psychotic patients with criminal histories who were treated with clozapine. Clozapine is grossly underutilized in this country compared with other developed countries, and this failure to utilize our most effective antipsychotic is another likely reason why our re-arrest rate is so high.

Finally, it is important to provide routine screening and discharge planning for seriously mentally ill individuals being released from jails and prisons. California’s mentally disordered offender designation enables screening and prioritization of services for those most in need of them in a corrections setting, including discharge planning. It is one of the only states to recognize the congruency of needs across departments, enabling enrollment of corrections inmates into its CONREP program (conditional release) and providing a model for other states to “de-silo” these 2 populations.

Ohio’s Department of Corrections utilizes a universal risk assessment tool to screen for potential dangerousness before release. Other notable corrections programs include Kentucky’s jail mental health crisis network, Kansas’s Sedgewick County Jail programming in Wichita, and Cook County’s successful discharge unit in Illinois.

Dr. Elinore McCance-Katz, the newly appointed Assistant Secretary for Mental Health and Substance Abuse, has explicitly stated that reducing the number of individuals with serious mental illness in the nation’s jails and prisons is a priority. Targeting individuals who have already been incarcerated by using programs proven to reduce recidivism is effectively going after the low-hanging fruit. Why would we not do that?

Dr. Torrey is a research psychiatrist who specializes in schizophrenia and bipolar disorder. He is Founder of the Treatment Advocacy Center, Associate Director of the Stanley Medical Research Institute, and the author of 

American Psychosis: How the Federal Government Destroyed the Mental Illness Treatment System

. Ms. Dailey is a legislative and policy counsel at the Treatment Advocacy Center. She is a lawyer and has a master’s degree in International Human Rights.

 Fazel S, Yu R. Psychotic disorders and repeat offending: systematic review and meta-analysis. 

 Torrey EF, Dailey L, Lamb HR, et al. Treat or Repeat: A State Survey of Serious Mental Illness, Major Crimes and Community Treatment. Treatment Advocacy Center. September 2017. 

http://www.treatmentadvocacycenter.org/treat-or-repeat

 Lamberti JS, Weisman RL, Cerulli C, et al. A randomized controlled trial of the Rochester Forensic Assertive Community Treatment Model. 

 Frankle WG, Shera D, Berger-Hershkowitz H, et al. Clozapine-associated reduction in arrest rates of psychotic patients with criminal histories. 

 Torrey EF, Knable MB, Quanbeck C, et al. Clozapine for Treating Schizophrenia: A Comparison of the States. Treatment Advocacy Center. November 2015. 

http://www.treatmentadvocacycenter.org/storage/documents/clozapine-for-treating-schizophrenia.pdf

How to decrease recidivism for individuals with serious mental illnesses who are released from jails or prisons or discharged from hospitals? Here are several effective mechanisms.

Treating the Sickest: Why Does the US Lag Behind?

Slideshows

After lounging on the doorstep of respectability for the past decade, assisted outpatient treatment is here to stay. But some still balk at the notion.

4 Myths About Assisted Outpatient Treatment

After lounging on the doorstep of respectability for the past decade, assisted outpatient treatment (AOT) has finally entered the mainstream.

In September, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced more than $13 million in federal funding for AOT demonstration grants (

). Three months later, as part of the 21st Century Cures Act, Congress extended the AOT grant program until 2022, increased the funding, and made AOT programs eligible for Department of Justice funding. This was part of a larger recognition by Congress that the US mental health system was in dire need of reform, led by Congressman Tim Murphy (R-PA) and Senator John Cornyn (R-TX). Thus, AOT has now been officially endorsed by SAMHSA and Congress, joining such groups as the National Sheriffs’ Association, the International Association of Chiefs of Police, the National Alliance on Mental Illness, and the American Psychiatric Association.

AOT is court-supervised treatment of severe mental illness within the community. It is a 2-way commitment that requires mental health systems to serve participants at the same time it commits participants to adhere to their treatment plans. It is similar in intent to conditional release, mental health courts, and conservatorship-all of which seek to improve the person’s adherence to a treatment plan and quality of life.

The specific procedures vary by state, but generally, to be a candidate for AOT, a person must meet clinical and legal criteria, such as a history of repeated hospitalizations or arrest resulting from nonadherence to treatment. For example, in New York the person must, among other factors, have a history of treatment nonadherence that has led to 2 or more psychiatric hospitalizations or incarcerations within the past 3 years or 1 or more acts of serious violence in the past 4 years; be unlikely to voluntarily participate in outpatient treatment; and be in need of treatment to prevent a relapse that would likely result in serious harm to self or others. Court petitions for AOT are usually filed by the county mental health department, which also arranges for development of a treatment plan and delivery of services (

Joy Torres illustrates the life-changing capabilities of AOT. Plagued by delusions and auditory hallucinations for years, she refused care, was hospitalized multiple times, jailed once, and lost her job and children. She recalls being “handcuffed and shackled on the cold, wet cement of a tiny (jail) cell with only a tin can for a bathroom,” “running around naked,” “sleeping in dumpsters to avoid being raped,” and “being treated like an animal because no one is willing to help you when you are too ill to help yourself.” Finally, she was court-ordered to adhere to a treatment plan under Laura’s Law-California’s AOT program. She says this gave her the right to “sleep on a bed, go to school, make friends, love my family, and to get and stay well.” She added, “Should I ever become sick again, please give me Laura’s Law.”

AOT was reportedly first used in 1972 at St. Elizabeth’s Hospital in Washington, DC, by an agreement between Dr. Roger Peele, a psychiatrist, and Harry Fulton, the chief public defender. A patient was ready for discharge but still needed medication supervision, so they decided to commit her to outpatient treatment in place of additional inpatient treatment. This was consistent with a previous court ruling that mandated patient placement in the “least restrictive alternative.” By 1984, AOT had been used at the hospital on 293 patients with very favorable results and had spread to a few other states. However, it was not widely known until 1999 when New York passed an AOT law called Kendra’s Law, named after Kendra Webdale, a young woman pushed under a subway train by a man with grossly undertreated schizophrenia.

AOT has spread in recent years but is still underutilized. New York, and more recently New Jersey, are using it most extensively. Ohio has excellent programs in Butler and Summit Counties and is extending it to other counties. In California, Laura’s Law was pioneered in Nevada County and has now been implemented in counties covering two-thirds of the state’s 38 million population. Seminole County in Florida and Oakland County in Michigan also have excellent programs. All states have laws permitting AOT except for Massachusetts, Connecticut, Maryland, and Tennessee, but in at least 15 states it is virtually never used.

The clinical effectiveness of AOT has been clearly established. Multiple studies have shown that it dramatically decreases the number of psychiatric admissions, hospital days, arrests, incarcerations, days of homelessness, and alcohol and drug abuse. People on AOT are more adherent to medication and, probably associated with this, are victimized less often.

 Four studies have also reported a decrease in violent behavior associated with the use of AOT (

Those who deny the effectiveness of AOT have offered 2 arguments. First, they claim that AOT’s effectiveness is based mostly on before-and-after studies of patients placed on AOT, rather than by studies that randomly assign patients to AOT or a control. But it can be argued that random assignment would be both unethical and legally impossible, as individuals eligible for AOT have already met criteria evidencing either dangerousness or need for treatment and a history of being unable to participate in such care voluntarily. Second, they claim that studies in other countries have not shown community treatment orders to be effective. However, community treatment orders are dissimilar to AOT because they fail to utilize a court order and thus cannot benefit from a judge’s authority-often deemed the “black robe effect.” The design of community treatment order studies themselves has also been subject to criticism.

These academic arguments diminish as data on AOT’s effectiveness accumulate. For example, in San Francisco where AOT was implemented in 2015 after 4 years of debate, the first-year report noted that almost everyone who met AOT criteria accepted voluntary treatment, leading to fewer emergency department visits and “a small but helpful step toward addressing” the problem of homelessness.

As impressive as the clinical effectiveness of AOT-and likely more salient to policymakers-is its demonstrated cost-effectiveness. In North Carolina, according to the researchers, “outpatient commitment [AOT] of six months or more, combined with provision of outpatient services, appeared to result in cost savings of 40%.”

 In New York, in the first year after AOT was implemented, costs declined 43% in New York City and 49% in 5 counties, and even more in the second year.

In a study in Summit County, Ohio, “annualized aggregate costs per participant in AOT were found by researchers to have declined 50% in the period before and after participation.”

 In a small study in Nevada County, California, the cost reduction for each AOT participant the first year was 80%-$1.81 saved for every $1.00 invested in the program.

Much of these cost savings come from improved medication adherence and decreased hospitalizations. In a separate study, researchers estimated that improved medication adherence for individuals with schizophrenia could save Medicaid $1580 per patient, or $3.3 billion per year.

Given the clearly established benefits of AOT, why has it taken so long for the program to gain mainstream acceptance? In some states, AOT statutes are poorly written or contain illogical criteria. In Pennsylvania, for example, eligibility criteria for AOT mirror the inpatient standard, requiring a judge to determine a person to be both a “clear and present danger” and eligible for community treatment.

In other communities, a lack of understanding may hinder its use. Judges are often surprised that AOT statutes do not allow for incarceration or direct placement into inpatient care as a noncompliance sanction. In many communities, the delay in adoption reflects the realities of a struggling mental health system, in which providers are reluctant or unable to address the upfront costs of program implementation, despite evidence that AOT saves money over time.

One source of AOT opposition is concerns about coercion or a restriction of individual liberties. AOT serves as a lightning rod for opposition to all forms of involuntary psychiatric treatment, despite AOT being no more coercive than conditional release or mental health courts-both of which are widely accepted.

 AOT is forced treatment infringing on civil liberties. This argument has been soundly rejected in the courts. In the 2004 case Matter of KL, the plaintiff challenged Kendra’s Law, arguing it authorized “forced treatment” without adequate due process. The New York Court of Appeals, widely regarded as a champion of civil liberties, unanimously held that AOT is not forced treatment. The court noted Kendra’s Law prohibits forcible administration of medicine and only allows re-hospitalization if the usual commitment criteria are met. Thus, the court found the law relies on “the compulsion generally felt by law abiding citizens to obey court directives,” not force.

People will voluntarily seek help if we make psychiatric services more widely available. This ignores the key factor addressed by AOT-anosognosia. Approximately half of individuals with serious mental illness experience anosognosia, damage to the parts of the brain used to think about ourselves, confirmed by at least 20 studies.

 People who think nothing is wrong with them-the signature symptom of anosognosia-have no reason to seek treatment. It is simply illogical to assume system improvements will draw in these patients, and the experience of many communities unfortunately bears this out.

 AOT drives patients away from seeking treatment. There is simply no defensible evidence that this is true. In fact, when individuals receiving AOT under Kendra’s Law in New York were asked, 81% said AOT had helped them get and stay well.

 Why spend resources on patients who don’t want to be treated when so many who do want to be treated are not getting services? Research shows that the population served by AOT disproportionately uses public resources. Consequently, research has found that mental health services, including voluntary services, can actually be expanded when AOT is used because of savings associated with decreased resource utilization by a small population.

 More broadly, addressing the outsized costs associated with high utilization is a growing concern for public health and policymakers.

AOT is here to stay, not as a cure-all but rather as another tool to help treat selected patients who are otherwise the most difficult to treat. Dr. Darold Treffert summarized the rationale for treatment approaches such as AOT nicely:

It is not “freedom” to be wandering the streets, severely mentally ill, deteriorating and getting warmth from a steam grate or food from a garbage can; that’s abandonment. And it is not “liberty” to be in a padded jail cell instead of a hospital, hallucinating and delusional, without treatment because that is all the law will allow.

Dr. Torrey is a research psychiatrist who specializes in schizophrenia and bipolar disorder. He is Founder of the Treatment Advocacy Center and Associate Director of the Stanley Medical Research Institute, and he is Professor of Psychiatry at the Uniformed Services University of the Health Sciences in Bethesda, MD. Mr. Snook is Executive Director of the Treatment Advocacy Center.

The authors report no conflicts of interest concerning the subject matter of this article.

 Treatment Advocacy Center. If I get sick again, please give me Laura’s Law. April 2014. 

http://www.treatmentadvocacycenter.org/fixing-the-system/features-and-news/2515-if-i-get-sick-again-please-give-me-lauras-law-personally-speaking

 Swanson JW, Swartz MS, Borum R, et al. Involuntary out-patient commitment and reduction of violent behavior in persons with severe mental illness. 

 New York State Office of Mental Health. Kendra’s Law: Final Report on the Status of Assisted Outpatient Treatment. March 2005. 

https://www.omh.ny.gov/omhweb/Kendra_web/finalreport/

 Phelan JC, Sinkewicz M, Castille DM, et al. Effectiveness and outcomes of assisted outpatient treatment in New York State. 

 Link BG, Epperson MW, Perron BE, et al. Arrest outcome associated with outpatient commitment in New York State. 

 Swanson JW, Swartz MS. Can states implement involuntary outpatient commitment within existing state budgets? 

 Swanson JW, Van Dorn RA, Swartz MS, et al. The cost of assisted outpatient treatment: can it save states money? 

 Health Management Associates. State and Community Considerations for Demonstrating the Cost Effectiveness of AOT Services: Final Report. February 2015. 

http://www.treatmentadvocacycenter.org/storage/documents/aot-cost-study.pdf

 Tsai G. Assisted outpatient treatment: preventive, recovery-based care for the most seriously mentally ill. 

 Predmore ZS, Mattke S, Horvitz-Lennon M. Improving antipsychotic adherence among patients with schizophrenia: savings for states. 

http://ps.psychiatryonline.org/doi/full/10.1176/appi.ps.201400506

 Treatment Advocacy Center. Serious Mental Illness and Anosognosia. 

http://www.treatmentadvocacycenter.org/evidence-and-research/learn-more-about/3628-serious-mental-illness-and-anosognosia

 Kendra’s Law: Final Report on the Status of Assisted Outpatient Treatment. Albany, NY: New York State Office of Mental Health; March 2005:20-21.

 Swanson JW, Van Dorn RA, Swartz MS, et al. Robbing Peter to pay Paul: did New York State’s outpatient commitment program crowd out voluntary service recipients? 

 Treffert DA. 1995 Wisconsin Act 292: finally, the fifth standard. Wisconsin Med J. 1996;95:537-540. â

Here: common misconceptions about assisted outpatient treatment--and how this tool can help selected mentally ill patients who are most difficult to treat. 

Assisted Outpatient Treatment Enters the Mainstream

Since Cain and Abel are depicted in the Bible as the first children of Adam and Eve, the killing of Abel by his brother can be said to have been the first homicide. Ever since, family homicides have infused the mythology of many cultures, including the work of Sigmund Freud in our own. Despite this, psychiatric aspects of family homicides have been inexplicably ignored. As Labrum and Solomon

 recently noted, “family violence perpetrated by persons with psychiatric disorders is a highly under-researched area, so much so that it is impossible to even approximately estimate the extent of the problem.” And among families of individuals with a serious mental illness the subject is rarely discussed, compared by one woman to “living in a closet within a closet.”

To assess the magnitude of this problem, the Treatment Advocacy Center undertook a study of family homicides. We utilized the FBI’s Supplementary Homicide Reports (SHR), a sampling of all homicides in the US; it is the only national database with information on the family relationship of offenders and victims. We supplemented this by collecting all 2015 media accounts of family homicides in which the offender was identified as having a serious mental illness. Finally, we reviewed the psychiatric literature, which is remarkably sparse in American studies, for estimates of the prevalence of serious mental illness among the perpetrators of family homicides.

According to the CDC’s National Vital Statistics System, there were 16,121 total homicides in the United States in 2013. Data from the FBI’s SHR sample suggests that 25% of these, or approximately 4000 homicides, were homicides in which one family member killed another. The largest number of these were spouse on spouse homicides (1433), followed by parents killing children (908); children killing parents (649); siblings killing siblings (301); and other family combinations (589).

A review of the existing psychiatric literature on each of these types of family homicides revealed major differences. Serious mental illness is estimated to play a major role in only 10% of spouse homicides; the majority are driven by infidelity, jealousy, alcohol, and other factors. By contrast, serious mental illness is estimated to play a major role in 67% of homicides in which children kill parents and 50% of homicides in which parents kill children. When such calculations are made for each type of family homicide and totaled, the number of family homicides associated with serious mental illness is approximately 1150. This is 29% of all family homicides and 7% of all homicides in the US.

Several aspects of these family homicides are of special interest. Although total homicides in the US have decreased progressively in recent years, there has been no decrease in the number of parents killing children or children killing parents, the 2 types of homicides strongly associated with mental illness. The weapons used were also somewhat surprising. In our media sample of family homicides associated with serious mental illness, guns and knives or other sharp objects were used equally-but each in less than one-third of homicides. Fatal beatings comprised the majority of the others, especially when the victims were very young or elderly. The beatings were done with fists but also with a variety of objects including baseball bats, golf clubs, hammers, and a tea kettle.

One of the most striking findings from this study was the number of elderly victims. Among all homicides in the US, only 5.1% of victims were age 65 or over and 2.2% were age 75 or over. By contrast, among our media sample, 17.7% of the victims were 65 or older and 9.2% were 75 or older. Thus, elderly parents and grandparents appear to be especially vulnerable victims in family homicides. This is presumably another result of the emptying of state psychiatric hospitals with the former patients forced to live with their families. In a small number of cases, this turns out tragically.

The failure to take prescribed psychiatric medication played a major role in family homicides in our study. In the vast majority of cases in which such information was available, the offender was noted to be not taking medication. This result is consistent with the literature. For example, a study of family violence found “compliance with medication” to be the most important variable that discriminated violent from nonviolent mentally ill relatives.

 Co-occurring substance abuse, especially alcohol abuse, in conjunction with serious mental illness also plays a major role in family homicides. In a study of family homicides by the Department of Justice, in 64% of cases the offender was using alcohol at the time of the killing.

The majority of family homicides are preceded by warnings and threats that are often ignored. In a study of parents who killed their children, “three-quarters of the parents showed psychotic symptoms prior to their filicide. Some mothers talked openly of suicide and even expressed concern about the future of their children.”

 In another study of 43 children who killed their mothers, “warnings of intended homicides or previous attacks on the mothers were identified in 24 cases.”

The fact that individuals with serious mental illness are responsible for more than 1100 family homicides each year-7% of the nation’s homicides-suggests that there is a serious problem. What can be done to decrease these numbers and reduce this deadly phenomenon? The following 6 recommendations would significantly improve the situation if implemented.

 Provide adequate psychiatric treatment. The linchpin for reducing the numbers of family homicides associated with serious mental illness is to provide adequate psychiatric treatment, especially for individuals who have risk factors that make it more likely that they will commit violent acts. Clozapine, the one antipsychotic demonstrated to decrease aggression and violent behavior in individuals with serious mental illness, is woefully underutilized by psychiatrists in the US.

Ensure that the prescribed antipsychotic medication is actually taken. A Swedish study of family homicides found that 48% of the mentally ill offenders had been prescribed antipsychotic medication, but only 4% of them were actually taking the medication.

 An obvious solution to the nonadherence problem is to switch the individual from oral medication to long-acting injectable preparations, which are now available for 6 antipsychotics.

Use assisted outpatient treatment. An individual with multiple risk factors for violent behavior against family members or a history of such behavior is an ideal candidate for assisted outpatient treatment (AOT). AOT requires the individual to be compliant with his or her prescribed treatment plan, including medication, as a condition for living in the community. AOT is available by law in all states except Massachusetts, Connecticut, Maryland, and Tennessee, but it is underutilized in most of the states where it is available. In a randomized trial in North Carolina, subjects with a history of serious violence had a reduction in violence from 42% to 27% when AOT was continued for at least 6 months.

 In New York, AOT reduced the proportion of individuals who “physically harmed others” from 15% to 8%, and the proportion who “threatened physical harm” from 28% to 16%.

Reform the federal HIPAA regulations. The federal Health Insurance Portability and Accountability Act (HIPAA) was passed by Congress in 1996 in an effort to safeguard the privacy of patients’ medical records. Unfortunately, it has been widely over-interpreted to severely restrict family access to basic medical information regarding family members over the age of 18. This has been especially problematic for those with a seriously mentally ill relative living with them, who often are not given basic information such as the person’s diagnosis or list of prescribed medication.

Focus on the individuals with the most risk factors. As noted previously, in the majority of cases of family homicides the offender has given clear warning signs. For example, in the review by Hillbrand and colleagues

 of 237 individuals who had killed their parents, “threats of harm and assaultiveness toward the victim prior to the crime were reported in most studies.” Too often, state laws regarding the involuntary commitment and treatment of psychiatric patients are interpreted very narrowly, with families being told, “We can’t do anything until he or she demonstrates dangerousness.”

Improve data collection and research. Given the magnitude of the family homicide problem and the fact that a subset of these homicides is preventable by treating the offenders’ mental illness, this would appear to be a promising area for better data collection and research. For example, better data should be collected on non-lethal assaults carried out by family members with a serious mental illness. Completed homicides are merely the tip of the iceberg. Longitudinal studies should also be done to assess possible relationships between family homicides and indicators of treatment availability, such as the number of available psychiatric beds.

In addition to saving lives, there is another important reason to try to decrease family homicides. A national survey reported that news stories about violent acts by mentally ill individuals “appear to play a critical role in influencing negative attitudes towards persons with serious mental illness.”

 Such negative public attitudes are at the core of stigma that affects all persons with any mental illness, making it more difficult for them to socialize, find employment, or obtain housing. Stigma against people with mental illness will not decrease until we decrease the number of mentally ill individuals who commit violent acts, including family homicides. And that will happen only when we begin to provide better treatment.

One of my most important life experiences

 was the 2 years I spent in Ethiopia as a Peace Corps physician. We had over 600 Peace Corps volunteers, mostly teachers, in the country at the time, and it was very rewarding to help move the country into the 20th century. My job included activities such as treating hepatitis in a volunteer and the consequences of a lion encounter in a Somali boy, and organizing a health education program for television-sometimes all on the same day. I return to Ethiopia regularly, and my wife and I are sponsoring a program for girls’ education in the economically poor southern region, where most girls go only to primary school. Currently, there are 130 girls in secondary school and university in the program. We are sponsoring a similar program in rural Tanzania in an area where my wife was a Peace Corps volunteer.

I also enjoy sports, classical music, and movies. I played competitive ice hockey, including organizing it as a club sport at Stanford, until age 61, when the warranty on my original hips expired. My wife and I regularly go to mostly baroque concerts and the opera, and this fall we will be returning to Italy for another Verdi opera tour. We also go to movies frequently. My all-time favorites are the classics of Ingmar Bergman, but recent movies I would recommend include 

Dr. Torrey is a Research Psychiatrist who specializes in schizophrenia and bipolar disorder. He is founder of the Treatment Advocacy Center and Associate Director of the Stanley Medical Research Institute, which supports research on schizophrenia and bipolar disorder, and he is Professor of Psychiatry at the Uniformed Services University of the Health Sciences in Bethesda, MD. He reports no conflicts of interest concerning the subject matter of this article.

 Labrum T, Solomon PL. Rates of victimization of violence committed by relatives with psychiatric disorders. 

 Anonymous. Letter to National Alliance on Mental Illness of Massachusetts. February 7, 1992.

 Swan RW, Lavitt M. Patterns of adjustment to violence in families of the mentally ill. 

. Special Report NCJ 143498. Washington, DC: Bureau of Justice Statistics.1994:3-38.

 Resnick PJ. Child murder by parents: a psychiatric review of filicide. 

 Nordstrom A, Dahlgren L, Kullgren G. Victim relations and factors triggering homicides committed by offenders with schizophrenia. 

 Swanson JW, Swartz MS, Borum R. Involuntary out-patient commitment and reduction of violent behavior in persons with severe mental illness. 

Kendra’s Law: Final Report on the Status of Assisted Outpatient Treatment

. Albany, NY: New York State Office of Mental Health. March 2005.

 Hillbrand M, Cipriano T. Commentary: parricides-unanswered questions, methodological obstacles, and legal considerations. 

 McGinty MS, Webster DW, Barry CL. Effects of news media messages about mass shootings on attitudes toward persons with serious mental illness and public support for gun control policies. 

Individuals with serious mental illness are responsible for more than 7% of the nation’s homicides. What can be done to reduce this deadly phenomenon? 

Raising Cain: The Problem of Family Homicides

 reported that clozapine use for individuals with schizophrenia continues to be very low in the US, compared with other Western countries. Equally concerning, however, was their finding that there is a 7-fold variation in clozapine use by state, from South Dakota, where 15.6% of Medicaid recipients with schizophrenia receive clozapine, to Louisiana, where only 2% receive clozapine. This report was subsequently enlarged 

Many reasons have been put forth for the overall low rate of clozapine use, including the administrative complexity of the monitoring program, the low Medicaid reimbursement, and the role of pharmaceutical companies who promote their patented antipsychotics. However, I am not aware of any study that has attempted to ascertain the reasons for the 7-fold difference in clozapine use among the states.

In my quest to understand the reasons for the differences, I found several factors that affect the numbers of prescriptions for clozapine. Because of its mandatory blood monitoring requirements, clozapine is usually prescribed by psychiatrists rather than by other medical practitioners. There is a more than 5-fold difference in the number of psychiatrists among states, which is reflected in the number of prescriptions for clozapine. For example, there are 3545 people per psychiatrist in Massachusetts and 18,997 people per psychiatrist in Idaho.

I compared the rank order of the states by clozapine use with the rank order by people per psychiatrist and found that the association was only slightly positive (Spearman’s nonparametric; rho = 0.26) and not statistically significant. Thus, the distribution of psychiatrists in the US explained very little of the differences in clozapine use among the states.

Next I looked at the urban-rural differences. It is easier to monitor clozapine use in urban areas, where patients can get to clinics relatively easily, than in rural areas, where patients may have to travel great distances. As seen in the 

, however, many of the states with the highest use of clozapine, such as South Dakota, Vermont, North Dakota, Wyoming, and Montana, are among the most rural of all the states. Urbanicity clearly is not the answer.

[[{"type":"media","view_mode":"media_crop","fid":"46743","attributes":{"alt":"NORMAN POGSON/SHUTTERSTOCK.COM","class":"media-image media-image-right","height":"181","id":"media_crop_3150874403786","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"5442","media_crop_rotate":"0","media_crop_scale_h":"217","media_crop_scale_w":"100","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"float: right;","title":"NORMAN POGSON/SHUTTERSTOCK.COM","typeof":"foaf:Image","width":"83"}}]]The next question that I examined was what organization has clinical responsibility for providing psychiatric care to each state’s Medicaid population. 

 34 states and the District of Columbia use for-profit managed care companies to manage medical care, including behavioral health, for at least some of the state’s Medicaid population. The other 16 states do not.

, the states that do not use for-profit companies are disproportionately represented at the top of the list of clozapine use. In fact, 8 of the 16 states that do not use for-profit managed care are included among the 13 states with the highest clozapine use. When the average clozapine use rate for the 34 states using for-profit managed care (4.7%) is compared with the 16 states not using for-profit managed care (6.9%), there is a strong association between lower clozapine use and for-profit managed care, although the association does not achieve statistical significance (Wilcoxon rank sum test; 

 = .08). To examine this association in greater detail would require a detailed analysis on the use of managed care for each state for 2006 to 2009, the same years as the clozapine use data.

What do states that do not use for-profit companies for psychiatric care of Medicaid enrollees use (eg, South Dakota, which has the highest rate of clozapine use of any state)? According to Cory Nelson, who was the chief executive officer of the state’s single state hospital (Human Service Center) during the period when these data were collected, most individuals with acute or chronic episodes of schizophrenia were admitted to the state hospital for a brief (average, 12- to 15-day) stay. Nelson reported that the hospital had “a full staff of board-certified psychiatrists” who were all clinical faculty associated with the medical school (personal communication, November 12, 2015). Major efforts were directed toward finding the most effective antipsychotic for each patient and reducing the use of multiple antipsychotics. An active “medical director and PharmD did constant review of this issue and held regular ‘difficult case conferences’ whenever challenges arose.” The patients were then discharged to 11 nonprofit community mental health centers that were accredited and largely funded by the state.

In North Dakota, which also ranked comparatively high in the survey (8.9% of individuals with schizophrenia on Medicaid were taking clozapine), the situation is similar. The state has a single state hospital and also owns and operates 8 community mental health centers. According to Andy McLean, MD, the Medical Director for the Department of Human Services and Chair of the Department of Psychiatry at the medical school, “we have been very active in our CMHCs in utilizing clozapine as a best practice [and] are in the process of adding a dedicated clozapine clinic to our psychiatry residency program” (personal communication, November 10, 2015).

A more detailed examination of each state’s administration of responsibility for providing psychiatric care to its Medicaid population may explain other apparent discrepancies. Washington is the only state among the top 6 clozapine users that uses for-profit managed care for behavioral health. In fact, it does so in only a single county (Optum Health, affiliated with UnitedHealth Group, has a contract for Pierce County). All the other counties have Medicaid psychiatric services administered by county-based Regional Support Networks operating as prepaid health plans, which may explain the state’s high ranking on clozapine use despite using for-profit managed care in one county.

The fact that states using for-profit managed care companies have lower use of clozapine for individuals with schizophrenia on Medicaid raises additional questions. Since clozapine is administratively more expensive to use initially but has proved to save money in the long run by decreasing re-hospitalization rates, are the for-profit managed care companies only interested in short-term profits? And are for-profit managed care companies associated with other indicators of inferior psychiatric care? Since for-profit managed care is spreading rapidly, these questions need answers.

Dr Torrey is a research psychiatrist who specializes in schizophrenia and bipolar disorder. He is founder of the Treatment Advocacy Center and Associate Director of the Stanley Medical Research Institute, which supports research on schizophrenia and bipolar disorder, and he is Professor of Psychiatry at the Uniformed Services University of the Health Sciences in Bethesda, MD. He reports no conflicts of interest concerning the subject matter of this article.

 Olfson M, Gerhard T, Crystal S, Stroup TS. Clozapine for schizophrenia: state variation in evidence-based practice. 

http://dx.doi.org/10.1176/appi.ps.201500324

 Torrey EF, Knable MB, Quanbeck C, Davis JM. Clozapine for treating schizophrenia: a comparison of the states. A report of the Treatment Advocacy Center. November 2015. 

http://www.tacreports.org/storage/documents/clozapine-for-treating-schizophrenia.pdf

 Kaiser Family Foundation. Medicaid managed care market tracker. 

http://kff.org/data-collection/medicaid-managed-care-market-tracker/

Reasons for the overall low rate of clozapine use brings to light questionable decisions on the part of policymakers

Why Clozapine Use Varies by State

The current shortage of psychiatric beds in the US is a major problem. Emergency departments (EDs) are crowded with acutely psychotic patients-some who wait for beds for up to a month. The pressure on existing beds is so intense that patients are discharged prematurely and often have to be readmitted or end up homeless or incarcerated. Nevertheless, many states continue to decrease the number of state hospital beds. One reason for such decisions by state officials is that there is no accepted standard regarding how many psychiatric beds are needed.

The recently published study of psychiatric bed needs by 

provides such a standard. The authors studied a 25-county region of North Carolina with a population of 3.4 million. The regions’ total psychiatric bed capacity consisted of 398 beds in a state hospital; 494 adult psychiatric beds in 14 general or private psychiatric hospitals; and 66 nonhospital crisis beds in 5 facilities. Combined, this totaled 958 psychiatric beds, or approximately 28 adult beds per 100,000 population. The average ED preadmission wait time for psychiatric beds in this region at the time of the study (2010 to 2012) was 3.3 days.

The authors used a computer simulation program to model different scenarios to ascertain how many additional psychiatric beds would be needed to achieve an average preadmission wait time of less than a day. The answer was 356 additional beds, bringing the total bed capacity to 1314 or about 39 adult beds per 100,000 population. This calculation included only adult patients (ages 18 to 64) and assumed a median duration of stay in the state hospital of 20 days, which existed in the hospital under study at that time. This calculation did not include psychiatric 

 or for forensic patients who usually stay for extended periods.

In 2008 a study was published by the Treatment Advocacy Center that estimated the minimum number of public beds necessary for adequate psychiatric services for a population of 100,000.

The current shortage of psychiatric beds in the US is a major problem. Patients are discharged prematurely and often have to be readmitted or end up homeless or incarcerated. 

Author | E. Fuller Torrey, MD

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