The future of neuropsychiatric drug research in Europe is in jeopardy, as low levels of public funding are exacerbated by waning industry commitment to the field, a new report has warned.
Both AstraZeneca and GlaxoSmithKline have recently announced moves to scale down neuroscience research as they overhaul their R&D infrastructure in search of better productivity, efficiency and financial returns.
In February, GSK said it was reducing investment in the neuroscience field and ceasing discovery research in areas such as pain and depression. The next month, AstraZeneca revealed an R&D restructuring plan that included withdrawing from discovery research in 10 disease areas, among them schizophrenia, bipolar disorder, depression and anxiety.
“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,” commented David Nutt of Imperial College, London, who co-organised a European College of Neuropsychopharmacology (ECNP) summit in March on the future of drug research focused on the central nervous system.
“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,” Nutt warned.
Leading healthcare challenge
The report from the ENCP summit, called to consider the “implications and consequences of the abrupt withdrawal of a number of major pharmaceutical companies from key areas of neuroscience research and development in brain disorders and psychopharmacology in particular”, says this trend is particularly critical for mental health at a time when neuropsychiatric illness “has become the healthcare challenge of the 21st century in Europe”.
Every year, around one third of the EU’s population has to cope with one or more mental or neurological disorders, the ENCP notes. With “currently imperfect” treatment options and only one new antidepressant (agomelatine – Valdoxan, Servier) licensed in Europe over the last 10 years, conditions such as depression, dementia and addiction now account for around 35% of the continent’s total disease burden – higher than cancer or heart disease, it adds.
The ECNP identifies a number of challenges facing neuropsychiatric research in Europe and makes several recommendations for urgent action to get R&D in the field back on track.
Complexity and risks
At the heart of the problem are the complexity and risks associated with identifying reliable targets for better pharmacological treatment in psychiatry and neurology, it observes. As a result, “the costs of drug discovery and development no longer easily translate into returns from the market for prescription medicines”.
For example, the report says, neuropsychiatric medicines tend to require longer development times than other treatments (13 years on average) and involve higher failure rates, often late in the development cycle.
Tougher licensing barriers are coupled with a growing threat of litigation over adverse effects once new drugs reach the market. Moreover, residual prejudice against mental illness and suspicion of neuropsychiatric treatments makes healthcare systems less willing to pay for available medicines, the ECNP claims.
There is also pressure from capital markets for shorter investment cycles, plus continuing deficits in the science underpinning neuropsychiatric drug discovery, such as reliable biomarkers.
Among the report’s recommendations for action are:
– Working on ways to boost public and private investment in brain science. This might include incentives for companies and other researchers investigating novel drugs in the field, such as “extending patent life for the first in a new class and removing the six-month efficacy data requirement until after the drug is licensed to make Europe equivalent to the USA”.
– Enhancing the research effort through initiatives such as setting up and/or recognising centres of excellence in experimental CNS research; developing ‘open-source’ databases of compounds pruned from company R&D pipelines; and hosting a ‘medicine chest’ network for psychopharmacology research, including databases of tool research compounds for human studies.
– Reviewing regulatory processes to encourage more and better clinical trials in psychiatry – for example, exploring alternatives to placebo-controlled designs and improved signal detection, or optimising requirements for studies in children and adolescents.
– Working with patient organisations to address stigma around mental illnesses, outcome measures in clinical trials and alternative funding sources.
