The biological life sciences industry is making great advances in physical health disorders, such as cancer and cardiovascular disease. But there has been a shift away from developing new drugs for mental health disorders, despite the massive health burden they create and the fact they are potentially growing even more prominent.
There has been a combination of commercial cautiousness and lack of political will to get involved. People think mental health disorders are somehow more difficult than other common conditions. But if we applied the type of science to mental health disorders that is currently being applied to the likes of cancer and heart disease, it would pay the same dividends.
By that, I mean a combination of basic and clinical research together with effort from pharmaceutical companies – that’s what we need to get the best new treatments.
Through the decades
In the Fifties, pharmaceutical companies began working with scientists and clinicians to develop a number of new drug treatments. By the mid-Eighties, they were tweaking antidepressants and antipsychotics to make them safer.
About 10 years ago, big pharma seemed to leave mental health. It means that even with the best possible use of current treatments, there is a great unmet need for new therapies.
New treatments in America
Fortunately, there is a suggestion that big pharma is now coming back to mental health. In America, we are finally seeing some genuinely new medicines developed to treat mental health disorders, such as esketamine, a new type of antidepressant and brexanolone, a new drug for postnatal depression.
These are exciting developments but at the moment they are not available in the UK and Europe.
Getting new mental health drugs in the UK and Europe
There is a whole list of drugs available in the US that have never made it to Europe because companies are required to do extra regulatory safety studies.
North America and China are often seen as the key target areas for pharmaceutical companies and some don’t follow through with Europe possibly because of the extra regulatory hurdles. The uncertainty over Brexit exacerbates this.
Certainly, for esketamine and brexanolone to come to Britain and Europe, there would need to be pharmacovigilance studies to monitor their safety.
One of the options for pharmaceutical companies is to use a new European Consortium for Observational Studies on Mental Health Products (ECHO), recently set up by the UK’s Drug Safety Research Unit to provide pharmacoepidemiological expertise with an experienced team of psychiatrists from across Europe for Post-Authorisation Safety Studies (PASS) and other observational studies on mental health products.
The aim of the Consortium is to ensure best practice in terms of monitoring drug safety and encouraging new treatments that benefit British and European patients.
Mental health drug safety post Brexit
The risk with Brexit is that if pharmaceutical companies come to Europe at all with their new drugs, they may well establish different pharmacovigilance studies in Europe and the UK. This could create a gap in capability, or possibly even risk that pharmacovigilance is not done properly in either place.
It’s essential we both encourage big pharma back to Europe with the latest mental health treatments but also that we ensure robust drug safety post Brexit.