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Abilify Is Top-Selling U.S. Drug -- But New Reports Question Long-Term Antipsychotic Use, Cite Need for Personalized Services

The fresh attention to alternative and "evidence-based" therapeutic approaches, along with the new questions about the value of lifelong antipsychotic medications for people with schizophrenia, can potentially strengthen the way mental health providers respond to this often-devastating illness.
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Last month, the news broke that the anti-psychotic Abilify, thanks in part to direct marketing to consumers for depression, has become the best-selling drug in the United States, raking in roughly $7 billion a year. Yet as Jay Michaelson in The Daily Beast pointed out recently, no one's sure how it may achieve its purported effects as an "augmented" treatment for depression.

The alarms about the dangerous and sometimes deadly side-effects of antipsychotics affecting children and the elderly, among others, have been mounting for years. But only very recently have mainstream health officials in the United States and in Britain started to express concerns about these medications, with limited efforts, for example, to rein in their overuse in nursing homes. At the same time, there's a rethinking underway at the National Institute of Mental Health (NIMH), U.K.'s National Health Service and the British Psychological Society (BPS) over the way clinicians diagnose schizophrenia and treat the illness over the long term with antipsychotics. In late November, for instance, the respected BPS released an updated study, "Understanding Psychosis and Schizophrenia," that offers a sweeping challenge to conventional thinking and treatments for schizophrenia. The report argues:

Many people believe that schizophrenia is a frightening brain disease that makes people unpredictable and potentially violent, and can only be controlled by medication. However research conducted over the last 20 years and brought together in this report reveals that this view is false.

Despite these provocative critiques of traditional treatments for schizophrenia, there is still relatively little being done to crack down on off-label or irresponsible prescribing of the medications for a much broader -- and profitable -- array of conditions including insomnia, dementia and depression.

The rest of us should be concerned about these trends, too. Nearly one in four visits to a psychiatrist for anxiety will lead to a prescription for an antipsychotic, an "off-label" use not approved by the FDA. What's happened is that the risky anti-psychotics originally intended for schizophrenia, then later approved for bipolar disorder, have seen their use extend to bipolar grade-schoolers and adult depressives with the dubious blessing of a pro-Pharma FDA, often based on shaky science. Now about 85 percent of all antipsychotic prescriptions are for "off-label" uses still unapproved by the easygoing FDA, such as anxiety and insomnia.

Unfortunately, the debate over the appropriate use of antipsychotic medications has become deeply polarized. Proponents such as Dr. E. Fuller Torrey score political points by calling for forced medication of seriously mentally ill people deemed too dangerous or unstable -- while critics, led by the influential journalist and author Robert Whitaker at his website, Mad in America, have forcefully argued against involuntary treatment and contended that antipyschotics are widely overused. They've marshaled studies that show they have limited evidence of efficacy even for those for whom the drugs were first developed: people with schizophrenia.

What's too often downplayed in this either/or debate is the notion that the medications, if judiciously prescribed and coupled with proven therapies, caring therapists and social supports, can be quite helpful for those ravaged by the symptoms of schizophrenia. The harsh reality, though, is that few people suffering with the most severe and persistent forms of mental illnesses such as schizophrenia, bipolar disorder and major depression -- about 4 percent of the population -- will ever get the targeted, empathetic help shown at such programs such as The Village in Long Beach, even though they too often face the long-running calamities of homelessness, repeat incarceration and hospitalizations. Meanwhile millions more are needlessly exposed to antipsychotics they don't need and that pose real dangers to their health and possibly their lives, but neither influential reform organizations nor government agencies are doing much about it.

The commonly-hyped notion of an imbalance of chemicals -- especially serotonin -- causing depression, for instance, has largely been discredited in recent research. There is no single biological marker yet found for depression or other mental illnesses, but there are enough indicators showing that biology doubtless plays a key role -- although not yet precisely determined or quantified -- in mental illness. These include studies of identical twins; neural imaging studies highlighting malfunctioning brain activity; and research into abnormal brain development. That research has helped to spur a new federal "brain initiative."

In the meantime, clinicians and consumers hope for the best with the tools at hand. These can include evidence-based "psychosocial" treatments, such as "supported employment," that use clinical and social work teams to aid the most severely mentally ill people -- and that don't rely primarily on medications for their impact. Unfortunately, only 2 percent of people in the public mental health system struggling with serious mental illnesses have access to those services.

Now, important recent reports reinforce mounting concerns about the long-term use of antipsychotics and the potential benefits of at least considering using lower dosages. Even the director of NIMH, Dr. Tom Insel, citing recent research about long-term outcomes in JAMA Psychiatry and other journals, has raised questions about these medications:

Antipsychotic medication, which seemed so important in the early phase of psychosis, appeared to worsen prospects for recovery over the long-term ... Clearly, some individuals need to be on medication continually to avoid relapse. At the same time, we need to ask whether in the long-term, some individuals with a history of psychosis may do better off without medication.

That represents a sea change in attitude from the federal government's leading mental health official.

At the same time, the evidence for abandoning medication use altogether as advocated by groups such as MindFreedom, even for those in a psychiatric crisis, is much thinner and far more controversial. Even so, unorthodox alternative treatments that seek to avoid or downplay medication, such as Finland's Open Dialogue community-based approach to first psychotic breaks, are winning more attention, including a well-designed research project at the University of Massachusetts.

In the spirit of Open Dialogue's philosophy, the new British Psychological Society report rejects the notion of automatically classifying an assortment of symptoms -- such as hearing voices or seeing hallucinations -- as a particular mental illness needing a medical response, particularly medications. Instead, it argues for a far more personalized approach that doesn't potentially label or stigmatize people with an illness diagnosis, attacking what it and like-minded critics of psychiatry call the outdated "medical model." A co-author of the report, University of Liverpool psychology professor Peter Kinderman, and an author of the new book, Prescription for Psychiatry, bluntly proclaims, "We are saying in our report is that there is no good evidence that mental health problems, including problems such as psychosis, stem from or can be explained as biological illnesses or diseases."

The report also presented an ambivalent view of medication as "sometimes" useful for many in a crisis but potentially risky in the long run with only modest benefits compared to placebos, citing a British Journal of Psychiatry editorial and other studies. The new report, prepared largely by psychologists and edited by Anne Cooke, an influential psychologist at Canterbury Christ Church University, argues that what are called symptoms of schizophrenia are far more common than believed and may not pose a problem for the individual, noting that as many as 10 percent of the population sometimes hear strange voices inside them. The report also contends. "Services should not insist that people see themselves as ill. Some prefer to think of their problems as, for example, an aspect of their personality which sometimes gets them in trouble but which they would not want to be without."

In an interview, Cooke explains, "If they're not distressed and if they're not putting themselves in danger, there's no need to seek treatment," citing cultures where hearing voices is well-accepted, for example. Some critics argue, though, that this emphasis on self-perceived "distress" is too limited and old-fashioned: The report doesn't emphasize using objective new mental health measurements that look at an individual's quality of life and functioning, including engaging in work, relationships and meaningful activities.

The report strongly implies that if people feel fine lying in the street in a delusional state, so be it. To some, these views may also sound simply like updates of the radical, highly controversial views of mental illness held by R.D. Laing and Thomas Szasz in the 1960s; critics have contended that this philosophy helped spur a wave of heedless deinstutionalization and the laissez-faire neglect of the most seriously mentally ill in jails and on the streets. Cooke concedes philosophical common ground with those dissident thinkers, but says, "We're much more scientific and use far more data." Their primary goals are to encourage far more personalized therapies that don't stigmatize people; reduce over-use -- and in some cases, any use -- of medication; and to promote widespread adoption of what they say is an effective cognitive behavioral treatment (CBT) for schizophrenia, a treatment embraced by the U.K.'s National Institute for Health and Care Excellence (NICE).

Yet doubts remain about the potential for CBT to aid people with severe schizophrenia, especially if used without any medication at all. Still, this approach was hailed in a Lancet commentary headlined, "At last an alternative to antipsychotics?" describing a new small-scale study in The Lancet that even proponents noted essentially cherry-picked relatively stabilized subjects for the experiment and had a compromised experimental design.

Nevertheless, what's striking is how positively this radical new British Psychological Society report -- certainly compared to the perspective of mainstream psychiatry in the U.S. -- has been received by Britain's health establishment. The government's top mental health official, the Rt Hon. Norman Lamb, the Minister of State for Care and Support at the Department of Health, said, "I strongly welcome the publication of this report.... I am delighted, therefore, to add my voice in recommending this report, which explains in everyday language the psychological science of why people sometimes hear voices, believe things other people find strange, or appear out of touch with reality," borrowing the language of the report.

Although the report's unconventional perspective seems to be far afield from the biologically-based approach of NIMH's leaders, they share this in common: a distrust of the traditional diagnoses of schizophrenia and other mental illnesses as promoted in the disputed new American Psychiatric Association's diagnostic DSM-V manual. Both the British psychologists and NIMH's leadership see those diagnostic categories as neither useful nor scientific in guiding treatment. Tom Insel, the NIMH director, declared last year that those diagnostic categories lacked validity and weren't "based on any objective measures." Instead, the NIMH has begun a Research Domain Criteria (RDoC) initiative that aims to further explore brain, genetics and behavioral science to develop effective treatments.

In a presentation last year, Dr. Bruce Cuthbert, the director of the new RDoC program, said that one-size-fits all treatments for people classified with a primary diagnosis, such as PTSD, "borders on the unethical." Of course, NIMH isn't abandoning the research-based assumption that biological factors contribute to mental illness, but officials also acknowledge that there are now no clinical biological markers for mental illness and that current drug-based treatments are too often ineffective, especially over time.

As Debate Rages, Programs Do The Best They Can Now

In the meantime, psychiatrists in the field can't wait decades for new research to offer definitive solutions or the longstanding battles over the role of biology in mental illness to be finally resolved. Instead, for psychiatrists such as Dr. Mark Ragins, the medical director of Mental Health America's successful The Village program for the long-term mentally ill homeless in Long Beach, rigid ideological debates about medication and diagnoses don't help him and his staff aid people with severe mental illnesses. "This feels philosophical, an inside baseball debate that's quite removed from the everyday lives of people with schizophrenia," he says. "They've got concerns like: How do I get enough money to have a place to live? How do I find a primary care doctor and get him to take me seriously? How do I stop a policeman from shooting me?"

"This is so far from the trenches," he says of the BPS manifesto. He agrees with many of the report's underlying critiques of conventional, rushed, pill-dispensing psychiatry. He also shares the horror of anti-psychiatry critics at the legacy of abusive care for people with schizophrenia: "There is no other non-contagious illness in history where people are quarantined for life; or that you put ice picks into people's brains and chop them up. There's not even any other illness that the issue of non-compliance [on medication] has a legal structure of this magnitude to deal with it. My mother isn't put into a locked facility if she doesn't want to take her diabetes medication." Even so, he demurs, "I admire their efforts to decrease all these negative things, but by putting psychiatrists, medications and hospitals in with all these medical things in one pile, they've made it difficult for me to be a compassionate psychiatrist who uses medications in prescribing," he says. "They're not acknowledging the humanity of relieving that suffering."

There's little question that Dr. Ragins, his staff of clinicians and the teams of "personal service coordinators" available for 24/7 assistance have made a striking difference in people's lives. Guided by a "whatever it takes" philosophy, The Village, with Dr, Ragins as founding medical director, helped pioneer intensive, cost-effective services in California designed to reduce chronic homelessness, arrests and repeat hospitalizations that inspired a state-wide referendum that led to a specially-funded Mental Health Services Act in 2004. It spends about $1.5 billion annually on innovative and intensive services statewide, and its revenues derive, amazingly, from a tax on millionaires.

These days, The Village program has helped slash re-hospitalizations and re-arrests by rates ranging from over 80 percent up to 96 percent for incarceration -- and through direct housing programs and other assistance, to cut homelessness by over half, according to Mental Health America Los Angeles. During a visit there earlier this year, I saw how Dr. Ragins, a bearded, dedicated and easygoing psychiatrist radiating compassion, carried out his mission to offer individualized, helpful care . He seeks to promote "recovery" (i.e., managing mental illness successfully), hope and respect for individual rights by collaborating with his clients over their own goals, medications and personal views of their symptoms. (In fact, he questions the "guild self-promotion" behind the British psychologists' crusade for cognitive therapy for people with schizophrenia: "If they're for individualization, why do they think it's good for everybody?" wondering if this particular treatment is favored over others because only degreed psychologists are best trained to offer it.)

His approach brings the sort of personalized attention to his clients that a broad spectrum of critics, including psychiatrist Dr. Daniel Carlat in his book Unhinged, decry is generally missing from psychiatry today. Ragins spends enough time with them to learn what factors in their background and lives, including any history of abuse or rape, have contributed to their current crises -- and tailors his treatments towards their preferences and personal objectives. For example, he commonly asks those who are hearing voices, "Are they a blessing or a curse?" and then fashions his prescribing to fit their needs, including lowering dosages in a way that allows those who find their hallucinatory experiences comforting to hold on to them to some degree.

(That seems to be a response in part to to the burgeoning Hearing Voices Movement growing among some mental health "consumers," popularized by Eleanor Longden's TED talk with nearly 3 million views. What's gotten less attention is that she and other "peer" leaders in the movement also accept the role of medications as often helpful if collaboratively prescribed.)

To demonstrate the importance of fully understanding his clients' points of view, Dr. Ragin holds up his hand and tells the story of a patient who once held out his hand in front of Ragin's face, and asked the doctor, "What do you see?" Ragins proceeded to describe the inside of the palm and assorted life lines, but the patient soon interrupted him, offering a metaphor, "Until you can see the knuckles and hair on the back of my hands the way I see it, you won't really understand me."

That deeply-rooted empathy and understanding, shared by a social work staff hired primarily for their warmth and personal skills, not degrees or credentials, helps create remarkable breakthroughs for people who've long been tormented by mental illness. For instance, he describes the case of a disheveled man in his 40s who was first found by the Village's outreach staff on the street after being discharged from the hospital yet again. He was silent, sunburned, disoriented and angry, glaring up at the worker offering help, with a history of as many as 80 jailings and hospitalizations over 20 years. He never took medication on his own, and never could get it together to get disability payments -- and once beat up his mother so severely she ended up deaf. "His family was terrorized," Dr. Ragins notes, and he cycled between jails and hospitals and the streets of Long Beach.

The Village social workers knew he'd never come for a formal medical appointment, but they invited him to lunch to meet Dr. Ragins in the cafeteria. He could barely talk or even eat a sandwich: "He was like a wild animal," Ragins recalls. Even so, the outreach workers arranged for him to stay at a sober living facility whose kind-hearted manager tolerated odd behavior. Ragins learned from the hospital that he'd briefly improved on the antipsychotic, Risperdal that does pose serious side-effect risks, but he still prescribed it, and it helped the client make progress while he reconnected with his once-estranged sister who came by each day to bring a meal. A Village case manager eventually started taking him and a few other clients to go bowling, and while at first he still couldn't manage to tie his own shoes -- he did get up and bowl some impressive strikes, a sign that he was starting to engage with others. A few months later, Dr. Ragin says, "Now he is coherent, taking his medication regularly, and he has lunch with us. He can have a conversation, he's clean and he walks." Unfortunately, Dr. Ragins notes, "He has gained 35 pounds."

Dr. Ragins spotlights the dilemma he's facing as a psychiatrist: "When you talk about when to prescribe meds, here's a guy whose entire life has changed: he can have a conversation, his family's back, his mother is no longer in danger, he's living someplace, he's connected with people -- but he's got a dangerous side-effect of gaining weight."

"I can talk to his sister about giving him less burritos, but it comes down to: Do I lower the dosage and allow him to get sicker?" he says. "If the meds didn't do much of anything, then of course stop giving it or if he was functioning well before, you don't need it, either. But his life has been changed, so we have to ask: What are we balancing it against? If I continue to give him medication and his weight keeps going up, I'm worried about this." He's trying to bring a balanced way of assessing this thorny issue: "If the person is not going to be able to live in the community and be tolerated, the person is going to be incarcerated either in hospitals or jails. If the person is going to be rejected and homeless repeatedly, if a person is going to be isolated and not able to be in a relationship with any other human being or see their children taken away, it's not necessarily the height of [compassionate] philosophy to say, 'Good, let them be without meds.'"

He regrets in some ways that the broader community doesn't offer a more loving, tolerant response to madness. "We have to deal with the way the society and treaters are at present," he contends.

In fact, a largely forgotten radical alternative to such harshness was embodied in its purest form by experimental communities that emphasized what psychotherapist Michael Cornwall, the clinical director of the Bay Area Mandala Project, has called "loving receptivity." These were embodied by the much-debated '70s-era non-drug Soteria programs publicized by Robert Whitaker in his writings. Even though NIMH eventually stopped funding the Soteria project in the late 1970s, the failures and disputes surrounding conventional psychiatric treatments have spurred continuing interest in strikingly unconventional non-drug alternatives. For example, this weekend in Big Sur at Esalen, the legendary site for pioneering rebel thinkers like Gregory Bateson and Stanislav Grof, Cornwall is co-leading a conference attended by nurses, therapists and psychiatrists titled "Re-Visioning Madness: Compassionately Responding to People in Extreme States."

Yet while a psychiatrist such as Ragins likely shares some of the conference's values, he contends, unlike the impression left by the British Psychological Society report and the fiercest critics of antipsychotics, that the current debate posits a false choice: "It's not meds or individualization -- it's meds with individualization." Even so, only about 75 percent of the roughly 500 people being served at the Village are currently on psychiatric medications, and the therapists accept that clients can stop taking their medications after shared decision-making and being fully informed about the consequences -- with the door remaining open for help if they get in trouble again. As opposed to stern chastisements and threats about "going off their meds," David Pilon, the president of Mental Health America Los Angeles, points out, the program takes a relatively uncommon patient-centered, flexible approach to medication. That's because the cornerstone of the Village's success is building and maintaining a bond with their clients: "relationships, relationships, relationships," he says, paraphrasing the commonplace three-pronged maxim for retail success: "location."

Yet, as a last resort for the most extremely violent or endangered clients seen at The Village, even the liberal-minded staffers there sometimes seek, rarely, involuntary commitment. These people could be placed in treatment facilities although there are relatively few available beds or, under a hotly-disputed new Los Angeles County law, in expanded court-monitored outpatient commitment programs. But Village staffers generally avoid the mandatory commitment strategies that a UN official has called torture being touted by advocates such as Dr. E. Fuller Torrey and Rep. Tim Murphy (D-PA), sponsor of a controversial bill promoting forced medication while essentially stripping federal "Protection & Advocacy" attorneys of the legal tools needed to protect people with mental illness. In contrast, Village staff respect their rights, focus on voluntary engagement and maintain warm relations with their clients.

While most psychiatrist have yet to adopt the nuanced, thoughtful approach to prescribing that Dr. Ragins and the Village staff represent, critics of the long-term use of antipsychotics are getting an increasingly respectful hearing. Whitaker himself, whose books have been the primary catalyst for re-examining lifelong antipsychotic use, has been invited to lecture the psychiatry department at Massachusetts General and address the National Alliance on Mental Illness(NAMI) that has supported involuntary treatment and championed antipsychotics.

In November, spurred in part by Whitaker's writings, The Chicago Tribune highlighted the decades-long work of University of Illinois at Chicago emeritus professor Martin Harrow disputing long-term antipsychotic use. His 2007 study report tracking young people with schizophrenia for 20 years found that people not taking antipsychotics were doing better by the fifth year than those who were taking the medications. Those findings, though, aren't conclusive, because of considerable ongoing debate whether those doing without antipsychotics in the long run had less severe forms of the illness at the start of the studies. Even so, Harrow's research was reinforced last year when Dutch researchers reported in the mainstream JAMA Psychiatry journal that, as The Chicago Tribune summarized, "By the seventh year of their study of patients who had experienced episodes of severe mental illness, patients receiving low doses of antipsychotics were doing better than those on standard doses."

That study was important enough, but what was particularly striking was the praise for Harrow's research by one of the country's most eminent schizophrenia researchers, Dr. Anthony Lehman, a University of Marland psychiatry professor, who pioneered the Schizophrenia Psychiatric Outcomes Research Team (PORT) that strongly favors carefully prescribed antipsychotics along with psychosocial treatments. Lehman told the Tribune, "It's important work. I think he points out the need, really, to do more research, both in understanding how to identify the people who might do better without medication (and in not) throwing the baby out with the bathwater." The PORT collaboration of experts offers the most definitive review of evidence-based treatments for schizophrenia, including specifying which antipsychotics and dosages work best at different stages of the illness.

As the PORT research and the success of The Village demonstrates, , however, just doling out medications without other therapy and assistance simply doesn't work well, especially in the long run. And while a literature review in Psychopharmacology last year indicates that Abilify can actually increase psychosis, agitation and aggression, most prescribers and consumers are apparently unaware of those dangers. (Of course, none of these potential problems and side-effects mean that any consumer should stop taking Abilify or other antipsychotics on their own -- and all consumers should check with their doctors about their medications.)

The blockbuster sales for drugs such as Abilify and Seroquel, now rejiggered for depression, reflect a marketing strategy of going well beyond their original purposes of treating schizophrenia and bipolar disorder that affect just 1.1 percent and 2.6 percent of the population, respectively. The little-followed FDA-required black box warnings on Abilify warn about an increased risk of "suicidality" of young people 24 and under, and higher risk of cardiac deaths in older dementia patients prescribed the medication -- the latter warning a common danger with other antipsychotics as well.

The fresh attention to alternative and "evidence-based" therapeutic approaches, along with the new questions about the value of lifelong antipsychotic medications for people with schizophrenia, can potentially strengthen the way mental health providers respond to this often devastating illness. Programs such as The Village and the Threshold center in Chicago, which puts an even greater emphasis on gaining independent employment , show that severe mental illnesses can be managed in a way that promotes recovery. This includes a personalized, safe approach to taking -- or in some cases, not taking -- medications. And all this can be done with proven "psychosocial" strategies, such as Village-style Assertive Community Treatment outreach teams and supported employment programs that use a "job coach" working with a clinical team. As a result, people with severe mental illness don't have to be doomed to lifelong disability, homelessness, hospitalizations and unemployment. But these real-world solutions risk getting overlooked to the degree that the focus of reformers and intellectuals remains on philosophical debates over madness, biology and medications. Equally troubling, the ongoing ideological disputes over treating schizophrenia mean that there still won't be enough done to halt the day-to-day dangerous prescribing practices, fueled by drug industry fraud and greed costing billions, that threaten the safety and well-being of millions who shouldn't be taking antipsychotics at all.

Research for this article was supported in part by a grant from The Alicia Patterson Foundation.

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