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BMJ 2011; 343:d4381 doi: 10.1136/bmj.d4381 (Published 12 July 2011)

Cite this as: BMJ 2011; 343:d4381

Letter

Mental illness treatments

Evidence for drugs in mental illness is flawed

Noel Thomas, general practitioner1

+Author Affiliations

1Maesteg, Bridgend, UK

nthomas@doctors.org.uk

The loss of research into drug treatments for mental illness is ironic when more doubt is being expressed about the reliability of research that has encouraged the prescription, or over-prescription, of psychotropics to countless people at huge cost.1

Marcia Angell, an editor of the New England Journal of Medicine for many years, recently reviewed three books that discuss the role of psychiatry and psychotropic drugs in the perceived "epidemic of mental illness" that has struck the United States.2 The book by Irving Kirsch contains information obtained from the Food and Drug Administration (FDA) under the Freedom of Information Act.3Angell writes:

Drug companies make very sure that that their positive studies are published in medical journals and doctors know about them, while the negative ones often languish unseen within the FDA . . . This practice greatly biases the medical literature, medical education, and treatment decisions.

Kirsch obtained details of 42 trials of the six most widely used antidepressants approved between 1987 and 1999:

Most of them were negative. Overall, placebos were 82% as effective as the drugs, as measured by the Hamilton Depression Scale (HAM-D), a widely used score of symptoms of depression. The average difference between drug and placebo was only 1.8 points on the HAM-D, a difference that, while statistically significant, was clinically meaningless. The results were much the same for all six drugs: they were all equally unimpressive. Yet because the positive studies were extensively publicised, while the negative ones were hidden, the public and medical profession came to believe that these drugs were highly effective antidepressants.3

These findings and comments will come as no surprise to the many doctors who have viewed these drugs with suspicion for decades, but the damage continues.

Notes

Cite this as: BMJ 2011;343:d4381

Footnotes

Competing interests: None declared.

References

1 Wise J. Research into treatments for mental illness is under threat.BMJ2011;342:d3747. (14 June.) [FREE Full text]

2 Angell M. The epidemic of mental illness. Why? New York Review of Books2011;58(11):20-3.

3 Kirsch I. The emperor's new drugs: exploding the antidepressant myth. Bodley Head, 2009

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BMJ 2011; 343:d4377 doi: 10.1136/bmj.d4377 (Published 12 July 2011)

Cite this as: BMJ 2011; 343:d4377

Letter

Mental illness treatments

Time to concentrate on human factors in mental illness

Sami Timimi, consultant child and adolescent psychiatrist1

+ Author Affiliations

1NHS Lincolnshire, Lincoln, UK

stimimi@talk21.com

Drug companies losing interest in psychiatry is great news for psychiatry and mental health services but most of all for patients.1 Other research funding sources may also recognise that a focus on the brain is not a credible, evidence based choice likely to contribute to better care for those who have mental distress. Drug companies have found mental health highly lucrative, with multibillion pound blockbuster drugs such as the misnamed (for marketing purposes) antidepressants and antipsychotics. Sooner or later it would become apparent that the evidence based cupboard was empty—that all of the drugs were of dubious effectiveness, had varying degrees of neurotoxicity, created abnormal mental states (which can be lifesaving for some at certain points in their distress) rather than corrected them, and were different from illicit drugs only through who provides them and how they are subsequently used rather than because of discoveries of some particular therapeutic potency.

In biological psychiatry a reliance on psychotropic drugs has encouraged some remarkable developments such as an increase in the numbers and a worsening of the long term prognosis for those categorised as mentally ill,2 and an increase in stigma that is associated with the model that mental illness is “an illness like any other illness.”3 Freed from the corrupting shackles of the pharmaceutical industry we can put money into better understanding the factors that have the biggest effects on outcome: social factors outside of treatment and the therapeutic relationship within treatment.4

Notes

Cite this as: BMJ 2011;343:d4377

Footnotes

Competing interests: None declared.

References

1 Wise J. Research into treatments for mental illness is under threat. BMJ2011;342:d3747. (14 June.) [FREE Full text]

2 Whitaker R. Anatomy of an epidemic. Crown, 2010.

3 Read J, Haslam N, Sayce L, Davies E. Prejudice and schizophrenia: a review of the ‘mental illness is an illness like any other’ approach. Acta Psychiatr Scand2006;114:303-18. [CrossRef][Medline][Web of Science]

4 Timimi S. Campaign to Abolish Psychiatric Diagnostic Systems such as ICD and DSM (CAPSID). 2011. Available at:www.criticalpsychiatry.net/?p=527

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BMJ 2011; 343:d4374 doi: 10.1136/bmj.d4374 (Published 12 July 2011)

Cite this as: BMJ 2011; 343:d4374

Letter

Mental illness treatments

Treat mental illness by addressing the causes

Woody Caan, professor of public health1

+ Author Affiliations

1Anglia Ruskin University, Cambridge CB1 1PT, UK

woody.caan@anglia.ac.uk

What lies behind the overt call for more money to fund research on psychotropic drugs?1 The sad reality is that across psychiatric practice there is no treatment, pharmacological or psychological, that suits all patients in all circumstances, even for the single, common diagnosis of depression used by Professor Nutt as an example.1 In other words, there are no “broad spectrum” treatments. For the foreseeable future, we will have to struggle to pick and mix for individuals some acceptable interventions that work for them, for now.

So what is really the critical shortage of research funding? The UK Clinical Research Collaboration found that the UK spends the tiniest proportion of its resources for health research on prevention.2 Prevention of mental illness is especially under-researched, even though the latest evidence suggests this type of “upstream” intervention could bring huge social and economic benefits to the UK.3 For example, from childhood to old age, we already know how to prevent many new cases of depression—if there was a political consensus on intervening. BMA members have taken a leading role in addressing the “causes of causes” that are antecedent to, for example, type 2 diabetes, coronary heart disease, and stroke. Can the health research community decide to address the determinants of mental illness, with determination?4

http://bjp.rpsych.org/cgi/eletters/198/6/417.

Notes

Cite this as: BMJ 2011;343:d4374

Footnotes

Competing interests: WC is editor of the Journal of Public Mental Health.

References

1 Wise J. Research into treatments for mental illness is under threat. BMJ2011;342:d3747. (14 June.) [FREE Full text]

2 UK Clinical Research Collaboration. UK health research analysis. UKCRC, 2006.

3 Knapp M, McDaid D, Parsonage M. Mental health promotion and mental illness prevention: the economic case. Department of Health, 2011.

4 Caan W. It is not enough ‘to remedy the consequences of adversity and vulnerabilities.’ 8 June. eLetter to: Bhui K, Dinos S. Preventive psychiatry: a paradigm to improve population mental health and well-being. Br J Psychiatry2011;198:417-9. [Abstract/FREE Full text]

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BMJ 2011; 342:d3747 doi: 10.1136/bmj.d3747 (Published 14 June 2011)

Cite this as: BMJ 2011; 342:d3747

News

Research into treatments for mental illness is under threat

Jacqui Wise

+ Author Affiliations

1London

Scientists have called for urgent action after the abrupt withdrawal by drug companies from research into treatments for brain disorders.

In the past year a number of drug companies, including GlaxoSmithKline and AstraZeneca, have pulled out of neuroscience research in Europe because they see it as economically unviable. Furthermore, levels of European Union research funding into mental disorders and diseases of the brain have been low in comparison with private sector funding.

A report from the European College of Neuropsychopharmacology, published this week, makes a number of recommendations.

It calls for the regulatory process to be reviewed to encourage more and better trials in psychiatry and for incentives to be offered to drug companies, such as extending the life of patents on new drugs for brain disorders. It is also setting up a “medicine chest” for data from industry studies about research compounds that companies are no longer working to develop.

The report, published in European Neuropsychopharmacology (www.ecnp.eu/publications/reports/report-summit2011.aspx), follows a summit in March attended by representatives from academia, governments, the drug industry, regulatory agencies, and patients’ organisations.

David Nutt, co-organiser of the summit and professor in neuropsychopharmacology at Imperial College London, said, “Developing drugs for brain disorders takes much longer than for other drugs—on average, 13 years—and is therefore more expensive.

“There are also higher failure rates, often later in the development cycle.”

Professor Nutt said another problem was that licensing barriers for psychiatric drugs are disproportionately high. “Many companies are deciding it’s too difficult to work in this area,” he said. Only one new antidepressant, agomelatine, has been licensed in Europe in the past 10 years, whereas 10 new antiepileptics have been licensed. The report says that this is because placebo controlled clinical trials of monotherapy continue to be required for registration of most new drugs in psychiatry.

And whereas new drugs for epilepsy are commonly accepted as add-on treatments, these are not encouraged in depression. In addition, the European Medicines Agency has increased its demands concerning studies involving children and adolescents, making it difficult to fulfil requirements for some rare disorders.

Professor Nutt said that more basic neuroscience research was needed. “Neuroscience is a complex discipline. We are still nowhere near understanding the fundamental targets for drugs.”

The report says that another challenge is the persistence of prejudice against mental illness. In particular, there is suspicion of drug treatments for mental illness, leading to a greater unwillingness by healthcare systems to pay for them.

Guy Goodwin, a summit co-organiser and president elect of the European College of Neuropsychopharmacology, said that the cost burden of psychiatric disorders is very high. But he said that drugs that improve the quality of life are often undervalued in comparison with those that increase the quantity of life: “More attention tends to be given to drugs which give small increases in life expectancy for a very high cost rather than drugs which improve quality of life.”

The report recommends incentives to encourage companies working on new drugs for brain disorders, especially those that act in radically new ways (novel drugs). For example, it suggests extending the patent life for novel drugs; and it proposes the removal of the requirement for a six month, placebo controlled trial before a drug can be licensed, to make Europe equivalent to the United States. The report also calls for a review of the regulatory process so that alternatives to placebo controlled trials are explored and for the requirements for child and adolescent studies to be reconsidered.

The executive director of the European Brain Council, Alastair Benbow, said, “If steps aren’t taken now to stimulate research and investment in both the public and private sector the field could really suffer lasting damage. The consequence of this for the region’s long term mental health will necessarily be negative.”

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Cite this as: BMJ 2011;342:d3747

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