freakoutcrazy

Blog des AK Psychiatriekritik der NFJ Berlin

Monat: November, 2011

Can Unethical Research Ever Lead to „Best Evidence?“

by Robert Whitaker

As readers of this blog know, in my book Anatomy of an Epidemic, I investigated what science has to say about how psychiatric medications shape the long-term outcomes of major mental disorders, and it’s fair to say that, given what I reported, some in the field of psychiatry are not happy with the book. Recently, Dr. William Glazer, a long-time consultant and advisor to Eli Lilly, penned a two-part „rebuttal“ of Anatomy of an Epidemic in Behavioral Healthcare journal. In turn, I posted a long response to his piece, inviting readers to assess whether Dr. Glazer, in his citation of studies, had done so honestly.

But there was one part of his rebuttal that, I have to confess, caused me to gasp in disbelief. It brings up an obvious ethical question.

In his rebuttal, Dr. Glazer stated that evidence that antipsychotics improve the long-term course of schizophrenia can be found in a 1999 study of 104 patients treated at Hillside Hospital in Queens during the late 1980s for a first episode of schizophrenia or schizoaffective disorder, who were then followed for five years. Dr. Glazer reported that those treated with „antipsychotics were five times less likely to relapse than were patients who stopped such medication,“ and thus this study „is one of the best demonstrations of the beneficial impact of long-term antipsychotic therapy.“

I happened to know that particular research well. I first wrote about it in 1998, when I co-wrote a series for the Boston Globe on abuse of patients in psychiatric research settings.

Here’s the background to that research. Starting in the 1970s, researchers investigating the „dopamine hypothesis“ of schizophrenia reasoned that if too much dopamine could cause psychosis, then a drug that caused brain neurons to release dopamine — amphetamine, methylphenidate, L-dopa — should make psychotic patients much worse. They began running experiments to see if that was so, and in the 1970s, David Janowsky, a physician at the University of California at San Diego School of Medicine, reported that dopamine-releasing drugs did indeed make psychotic patients much worse. Methylphenidate, which caused a doubling in the severity of symptoms, was the most potent of the dopamine-releasing agents when it came to making patients more psychotic.

In the late 1980s, psychiatrists at Hillside Hospital decided to repeat this experiment in first-episode patients who came to their emergency room for help. Rather than treat the patients with neuroleptics, they gave them methylphenidate, expecting taht this drug would exacerbate their psychotic symptoms. In two studies published in 1993, the researchers reported that methylphenidate caused 59 percent of them to become „much worse“ or „very much worse.“ The patients were then placed on neuroleptics, but they took longer than usual to stabilize. „We were surprised by the length of time required for patients to recover,“ the investigators reported.

The patients did not give their „informed consent“ to be in that study. The researchers, of course, did not tell the patients stumbling into their emergency room that they would be giving them a drug expected to worsen their symptoms, for of course nobody would agree to be in such a study.

The Hillside researchers then followed that patient group for another five years, and it is this follow-up data that they reported on in 1999. Eighty-two percent of the patients relapsed at least once during the five years (after recovering from their initial episode), and a significant percentage suffered several relapses during that period. Those patients who discontinued their medications and remained in the study — the study doesn’t state how many patients were in this category — relapsed at a five-fold higher rate than those who continued on the drugs. In Dr. Glazer’s view, this finding is one of the „best demonstrations“ that exists in the scientific literature of the long-term benefits of antipsychotics.

Now, quite apart from the unethical nature of the study, the findings in this study don’t reveal anything new. There is a long line of evidence that once patients are exposed to antipsychotics, they are at great risk of relapse when they withdraw from them, particularly if they do so abruptly. One presumed reason for that is that the drugs modify the brain in ways that increase a person’s biological vulnerability to psychosis. Furthermore, such drug-withdrawal studies don’t reveal anything about how well the drug-maintained patients are functioning; they don’t provide any information about how their long-term outcomes might compare to patients treated initially in a psychosocial manner but without antipsychotics; and they certainly don’t tell anything about how the drug-maintained patients fare physically, emotionally, and cognitively over a longer period of time. Finally, in this particular study, there were 13 patients who were stable off medication who then dropped out of the study, and the researchers didn’t know whether those patients subsequently stayed well or relapsed. Naturally, those who relapse after going off meds regularly return to the hospital, while those who stay well tend to disappear from the system, which may have been what happened in this study.

But that is not the important point here. The remarkable thing is that Dr. Glazer, when searching for evidence of the longer-term benefits of antipsychotics, could not find any study more compelling than this one, which involved initially treating the patients with a drug known to worsen psychotic symptoms.

And so now my question: Should an unethical study, one so clearly abusive, ever be incorporated into the evidence base for a drug therapy, and cited as one of the „best demonstrations“ of its efficacy?

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The Dr. Peter Breggin Hour – 11/28/11

Are you a victim of medical authoritarianism? My guest is Manhattan clinical psychologist Sarton Weinraub. He describes how he empowers patients to take control over their lives and their medical care, including how to manage their withdrawal from psychiatric medication. Empowering to clients and professionals alike.

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Madness Radio: Dignity of Elders Carole Hayes Collier

Why are nearly a third of all elders in nursing homes given anti-psychotic drugs, despite life threatening side effects? Are medications being used as chemical restraints? Can nursing homes be places of dignity — or should they be abolished? Carole Hayes-Collier was diagnosed schizophrenic at 19 and left to a lifetime of hospitalization. When she recovered, the abuses she witnessed inspired her to join the Gray Panthers and dedicate her life to elder rights and mental health.

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The history of ‘asylums’ in Australia

Over the course of this year at university, I’ve had to write a couple of essays for assessment. I’ve decided to add them to this blog, as I’m hoping to really expand it and add much more content over the coming months. Here is the first: an essay I wrote for a social policy course on the history of mental institutions in Australia. Given that it’s a research essay (and apparently one of the only ones done so far on the topic?), I’ve decided to keep all the references in it and leave it pretty much as written. If I get time in the near future, I may rewrite it a little to make it a bit easier and more enjoyable to read.

One of the biggest issues in mental health over the past 50 years or so has been the deinstitutionalisation of people with psychiatric disabilities. The use of the term ‘psychiatric disability’ refers to those whose “chronic and severe mental illness restricts their ability to cope with the demands of everyday living” (Keys Young, 1995). Many patients with disabilities such as these were kept in long-stay psychiatric hospitals, until the policy of deinstitutionalisation meant they would be moved into community-based care. This essay will examine the history of asylums in Australia and how community care, in its many different forms, became to be favoured over them in the process of deinstitutionalisation, which occurred from the 1950s onwards.

Lunatic asylums, as they were originally called, have existed for many centuries, originally as a means to keep mentally ill people off the streets – either to ‘protect’ the public or because there was no-one, or nowhere, else to care for them. In the very early 1900s, some areas of Australia also built ‘receiving houses’ for inmates with a chance of recovery, allowing them to be separated from other patients with more severe illnesses who were deemed ‘incurable’ (Meadows, 2007). Treatment in the very early days of asylums was practically non-existent, with very little funding or medical expertise, and inmates were treated cruelly and with little ‘care’. In the early 20th Century, institutions would suffer periods of government neglect, where facilities would become overcrowded and deteriorated, until a report or inquiry would surface about the inhumane conditions. Funding would be increased, facilities would improve, and then the cycle would eventually repeat (Meadows, 2007).

This began to change in the 1930s, with massive reforms of the mental health sector. The ‘medical model’ became more prominent, where mental illness was thought of as a disease or physical injury, instead of an incurable hereditary condition, or psychogenic condition. Physical treatment, using methods such as insulin and electro-convulsive therapy, allowed some patients to be sufficiently cured of their symptoms to leave the psychiatric hospitals (Smark, 2006). The Mental Hygiene Act of 1938 in Queensland, named after the mental hygiene movement which focused on preventative treatment of mental illness, was designed to reduce the stigma and attitudes around mental illness (Wilson, 2003). In the lead up to this legislation, the sterilisation and life-long separation of ‘mentally affected people’ was seriously debated by MPs and also some doctors (Meadows, 2007). Edward Hanlon, Queensland Labor Secretary for Health and Home Affairs, stated in his notes on the Bill that it represented “the efforts of the Government to provide a co-ordinated Health Service to all branches of the community, in all classes of illness whether mental or physical” (Wilson, 2003).

The deinstitutionalisation of psychiatric hospitals began in the 1950s in many Western countries (Keys Young, 1995; Mackinnon, 2003), though it could be argued that it did not begin because of policy but rather as a result of many other factors. At the time, drug technologies were rapidly advancing, which allowed some patients to have their symptoms of mental illness controlled enough to be deemed ‘safe’ to be amongst the public (Keys Young, 1995). The civil rights movement of people with disabilities was gathering steam, calling for disabled people to be given the same rights as other citizens, regarding quality of life, respect and life choices. Institutions were, and still are, incredibly expensive for governments to maintain, especially when compared to the alternative option of community care. Advocacy groups, such as parents of children with mental illnesses, proved to be a strong lobby force to governments, on both sides of the argument. The final main influencing factor in deinstitutionalisation was the anti-psychiatry movement, popular in the States at the time and the decades afterwards. This movement questioned the treatments, authority and diagnoses of psychiatrists, and caused many people to distrust these people who had so much influence in the institutions (Laffey, 2003).

The 1955 State Grants (Mental Institutions) Act provided large amounts money to institutions for capital works, showing that the policy of institutionalisation was still alive and well. Despite this, a Federal Inquiry released in the same year was damning of the ‘inadequate’ mental health system, highlighting low standards of care, abuse and overcrowding (Stoller, 1955). As a result of this, funding for additional beds was announced and there was a wider general interest in mental health. In what could be the beginnings of deinstitutionalisation in Australia, the report also called for an increase in community services.

The deinstitutionalisation movement gained momentum in the 1960s, and community care was an important issue in the 1972 Federal election, with Labor in support of community-based services (Smark, 2006). In 1973, the Mental Health and Related Services Assistance Act was passed, providing millions of dollars to community support networks and discharge centres. In the next year, Medibank was created, allowing universal access to specialist psychiatric services. This meant that all patients, not just the wealthy, could ‘shop around’ for the best and most suitable services, and get more support if it was needed. In the late 1970s, the Liberal-Country Party gained power and cut funding back from community care. However, the 1978 Review of Mental Health Care lists three past ‘revolutions’ in psychiatric care: the ‘open door’ policy, which has the objective of preventing institutionalisation, the ‘therapeutic community’, which reduces the possibility of institutionalisation, and the community health movement. It discusses and debates community care, short-stay hospitalisation and the inclusion of psychiatric hospitals amongst general hospitals, which indicates that it was written in a time of change, both in terms of thinking and policy, that was moving solidly towards deinstitutionalisation.

In 1983, the Richmond Report was release in New South Wales, which advocated strongly for further deinstitutionalisation and an increase in community services for people with psychiatric disabilities (Richmond, 1983). Although it was only a State-based inquiry and report, it was groundbreaking and set the tone for the upcoming Burdekin Report. Around 10 years of consultations and research during the 1980s culminated in the release of the Human Rights and Equal Opportunity Commission’s National Inquiry into the Human Rights of People with Mental Illness, known as the Burdekin Report. Released in 1993 after Australia became a signatory to the UN Principles on the Rights of the Mentally Ill, it detailed neglect, violations of human rights, and sub-optimal forms of community care. Despite beds being cut from institutions, community care was not receiving enough funding, which highlighted the two-way problem of deinstitutionalisation policies: funding can’t be taken from institutions without funds to community care being increased. Both Reports sparked huge changes and reforms in policy and legislation in the late 1980s and 1990s, and their effects are still felt today.

In the wake of the Burdekin Report, the ‘second wave’ of deinstitutionalisation came about in Australian social policy. The big changes were that the process of deinstitutionalisation quickened and that the human rights of patients became enshrined in the policy. The Federal Government, in conjunction with the States, quickly put out the National Mental Health Strategy, which included the National Mental Health Policy and National Mental Health Plan, amongst other things. These policies described a commitment to deinstitutionalisation and to the principles of mainstreaming and integration, where mental health services become part of general hospitals and health services. In Queensland specifically, the Ten Year Mental Health Strategy was released in 1996, also calling for significant reform and a desire for mainstreaming mental health services. It aimed to reduce psychiatric hospital facilities and increase the community support for people with psychiatric disabilities.

In conclusion, much has changed since the original asylums of Australia in the early years of settlement. The evolutions of medicine, social attitudes and public option have brought social policy along with them. After the initial moves towards deinstitutionalisation in the 1950s and the follow-up in the 1990s, it could be said that we are now in an era of post-institutionalisation, where most patients with psychiatric disabilities have never had long periods of care in institutions. Despite this, there is still much debate on the issue and almost unanimous agreement that it is not flawless. Australia is currently under the Fourth National Mental Health Plan, and there are documents such as the Queensland Plan for Mental Health 2007-2017 for the future, and it can only be hoped that these current and future frameworks will provide the care and support that people with psychiatric disabilities need.

References

Bordekin, B 1993, Human Rights and Mental Illness: Report of the National Inquiry into Human Rights of People with Mental Illness, Australian Government Publishing Service, Canberra.

Keys Young, Australian Housing Research Council, Australian Department of Human Services and Health & New South Wales Department of Housing Research and Policy Unit 1995, The needs of people with psychiatric disabilities living in public housing: issues and options, Australian Government Publishing Service, Canberra.

Laffey, P 2003, ‘Antipsychiatry in Australia: Sources for a Social and Intellectual History’, Journal of the Australian Society of the History of Medicine, vol. 5, no. 1, pp 17-36.

MacKinnon, D & Coleborne, C 2003, ‘Introduction: Deinstitutionalisation in Australia and New Zealand’, Journal of the Australian Society of the History of Medicine, vol. 5, no. 1, pp 1-16.

Meadows, G, Singh, B & Grigg, M (eds) 2007, Mental Health in Australia, 2nd edn, Oxford University Press, Melbourne.

Mental Health Council of Australia 2005, Not for Service: Experiences of injustice and despair in mental health care in Australia, Mental Health Council of Australia, Canberra.

Policy and Planning Division 1978, Review of mental health care: A discussion paper, Commonwealth Department of Health, Canberra.

Queensland Health, 1996, Ten Year Mental Health Strategy for Queensland, Queensland Health, Brisbane.

Richmond, D 1983, Inquiry into health services for the psychiatrically ill and developmentally disabled, New South Wales Department of Health, Division of Planning and Research, Haymarket.

Smark, C, & Deo, H 2006, ‘Social and Historical Power Plays: A Foucauldian Gaze on Mental Institutions’, College of Business Symposium, UWS 7-8th November, viewed 15th October,

Stoller, A & Arscott K 1955, Mental Health Facilities and Needs of Australia, Government Printing Office, Canberra.

Wilson, E 2003, ‘A “menace to the community”: Mental defectives in Queensland mental health legislation, 1938’, Journal of the Royal Australian Historical Society, vol. 89, no. 1, pp 72-85, viewed 15th October 2011,

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Marketing Risperdal: Part II

It would be tough to find a class of drugs prescribed for unapproved uses more frequently than antipsychotic drugs. The use of antipsychotics for unapproved conditions grew rapidly after Johnson & Johnson launched Risperdal in 1993. Johnson & Johnson invented the classification “atypical antipsychotic” to describe this new drug.

Soon after the launch of Risperdal, other pharmaceutical manufacturers, recognizing the huge off-label market potential, launched their own “atypical” antipsychotics. Ely Lilly came out with Zyprexa; AstraZeneca launched Seroquel; Glaxo came out with Geodon, and Bristol-Myers introduced Abilify, These drugs were all initially approved only to treat psychosis, but all were widely prescribed for conditions other than psychosis. Over time these new antipsychotics gained additional indications to treat conditions such manic episodes in Bipolar disorder, aggression, and, in the case of Abilify, depression.

In a previous post, Marketing Risperdal: Part I, I presented some of Johnson & Johnson’s data (gathered by IMS) showing the extensive off-label use of antipsychotics. The data in that post, and the data presented here, is from the period before atypical antipsychotics were approved for conditions other than psychosis.

As you can see from the graphic below, the antipsychotic market grew rapidly as the atypical antipsychotics came on the market. Total antipsychotic sales reached $6.7 Billion in 2002. Annual sales nearly doubled, to about $12 Billion,in 2006.

As a Johnson & Johnson employee who sold Risperdal for 3 1/2 years (1999-2003) and developed marketing programs for Risperdal for four years (2003-2007), I can tell you that the focus of Johnson & Johnson’s marketing strategy for Risperdal was to increase sales by promoting the drug for unapproved uses. J&J sales reps focused most of these off-label marketing efforts on promoting Risperdal for the treatment of anxiety, poor sleep (the so-called “soft symptoms” associated with schizophrenia), and to treat aggression in the elderly and aggression in children.

Big pharma has been very successful in marketing antipsychotics off-label. In 2002, 70% of all Antipsychotics were prescribed off-label.

In 2006, Risperdal (oral), was prescribed for conditions other than schizophrenia 81% of the time.

So who is paying for all of this off-label use of atypical antipsychotics? You are.

About 70% of Antipsychotic prescriptions are reimbursed by Medicaid or Medicare (By the way, it’s illegal to seek Medicaid or Medicare reimbursement for off-label use).

With the implementation of Medicare Part D in 2006, most antipsychotics previously covered my Medicaid, are now covered by Medicare.

Even when atypical antipsychotics are prescribed for the treatment of schizophrenia; they are not really achieving better outcomes for patients than the older, generic antipsychotics. But that fact has not stopped big pharma from marketing atypical antipsychotics as being safer and more efficacious than the much cheaper generic antipsychotics. The CATIE study, released in December 2005, refutes these claims of superiority.

CATIE was an 18-month, double-blind study, funded by the US National Institute of Mental Health (NIMH). It compared an older and much cheaper typical or first-generation antipsychotic, perphenazine (Trilafon), against several newer atypical or second-generation antipsychotic drugs – olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal) and ziprasidone (Geodon), among 1460 patients with established, but not refractory, schizophrenia.

CATIE was meant to reveal the truth as to how effective the different drugs were in the real world of everyday clinical practice. Effectiveness was judged by the length of time patients remained on treatment before discontinuing on account of a perceived lack of efficacy, intolerable side effects or for other reasons.

The CATIE results suggested the older cheaper antipsychotic perphenazine was, on balance, just as effective and tolerable as the rest.

For nearly two decades, Johnson & Johnson and other pharmaceutical manufacturers have been promoting atypical antipsychotics as safer, more effective alternatives to the older – much cheaper – conventional antipsychotics, when in fact, the atypical antipsychotics have not been shown to be safer of more effective than conventional antipsychotics.

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