Urgent action is needed over new drugs for mental illness

The abrupt withdrawal by major pharmaceutical companies from research into mental disorders and diseases of the brain in Europe, coupled with low levels of EU research funding is tantamount to, “the withdrawal of hope for patients and their families,” according to a report published earlier this month by the European College of Neuropsychopharmacology (ECNP).

Urgent action is needed to pull more funding in the field, which encompass a wide range of mental disorders and conditions, such as depression, schizophrenia, anxiety, sleep disorders and addiction, as well as neurological disorders, such as Parkinson’s disease and Alzheimer’s, says the co-author of the report, David Nutt, a neuropsychopharmacologist at Imperial College London.

Unmet medical need

There is a huge unmet medical need: in any given year almost 80 million Europeans, or 27 per cent of Europe’s population are affected by disorders of the brain. Diseases of the brain and central nervous system constitute 35 per cent of Europe’s total disease burden. Throughout Europe, 23 per cent of the years of healthy life are lost due to brain diseases and 50 per cent of the years of life are lived with disability - at a total cost to the region of €386 billion per annum.

And yet, says Nutt, only 8 per cent or €465 million of the EU Seventh Framework Programme health research budget of €6,050 million has so far been invested in research on the causes and treatment of disorders of the brain.

Since the beginning of 2010 nearly all of Europe’s major pharmaceutical companies have announced significant cut-backs in their investment in central nervous system drug research. As many as 3,000 jobs are expected to disappear across the region as a result, along with hundreds of millions of euros of funding. Nutt wrote the report with co-author Guy Goodwin following a summit which ECNP convened in March 2011 to discuss how to deal with these cutbacks.

The summit was attended by 60 key representatives from academia, government, the pharmaceutical industry, the biotechnology sector, regulatory agencies and patients’ organisations.

Reliable targets

Nutt says the crux of the problem is that the identification of reliable targets for drug treatments in psychiatry and neurology is particularly complex and challenging. This is making drug development in the field uneconomic.

It’s also the case that drugs for mental illnesses take longer to develop than other treatments, at an average of 13 years  average 13 years. And this is compounded by higher failure rates, often late in the development cycle, incurring (even) greater financial loss.

Nutt calls for an effort to increase investment, especially to redress Europe’s historically low levels of public investment in neuroscience. There need to be new ways of working with industry to make data and compounds that have failed clinical trials available to the academic research community. This would make it possible to carry out metanalyses of the pooled data, to get a better idea of why drugs have failed in clinical trials and to inform the design of future trials.

There should also be a review of the regulatory process with the aim of encourageing more and better trials in psychiatry.

Nutt said, “Despite the public health imperative, not only has EU research funding remained very low, but – even worse – big pharma is increasingly coming to see research into better neuropsychiatric drug targets as economically non-viable. With Europe’s extraordinary tradition in neuroscience innovation relying so heavily on private-sector investment, the consequences for the region’s research base and public health agenda are of major concern.”

A very key part of Europe’s knowledge economy is under serious threat, and the withdrawal of research resources means the slow down in new treatments being developed, will inevitably affect patient well-being.

In short, 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 report is available online.

David Nutt is the Edmond J Safra chair in Neuropsychopharmacology at Imperial College, London and a former member of the UK government’s Committee on Safety of Medicines, and a past President of the European College of Neuropsychopharmacology.