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Research into treatments for mental illness is under threat

BMJ 2011; 342 doi: https://doi.org/10.1136/bmj.d3747 (Published 14 June 2011) Cite this as: BMJ 2011;342:d3747
  1. Jacqui Wise
  1. 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.”

Notes

Cite this as: BMJ 2011;342:d3747

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