- While US research is well underway, research initiated by Supporting Wounded Veterans, is threatened by a funding shortfall, says the charity
- Warning follows highly successful MAPS Phase 3 trial in the US, in which 67% of participants who received three MDMA-assisted therapy sessions no longer qualified for a PTSD diagnosis
- Gilly Norton, CEO of Supporting Wounded Veterans, said: “It would be a national disgrace if veterans elsewhere in the world were able to access this treatment, and British veterans were not.”
A funding gap of £725,000 means that British veterans suffering from post-traumatic stress disorder (PTSD) could face years of delays in receiving MDMA-assisted therapy, a leading UK veterans’ charity has warned.
Its warning follows the recent announcement, on 3 May, of results from a highly successful US trial of the therapy, which treated 90 patients with severe, chronic PTSD. MAPS, the US-based non-profit body that ran the trial, revealed that 67% of participants who received three MDMA-assisted therapy sessions no longer qualified for a PTSD diagnosis and 88% experienced a clinically meaningful reduction in symptoms, among other positive findings (1).
MDMA-assisted therapy uses medical-grade MDMA produced by licenced pharmaceutical companies administered as one part of a carefully monitored therapy program. It is expected to be particularly effective in treating patients whose symptoms have not been alleviated by other, established treatments.
While research to inform a decision about regulatory approval for the therapy is underway and proving successful in the US – where it is designated as a ‘Breakthrough Therapy’ by the U.S. Food and Drug Administration similar work planned in the UK to gain regulatory approval, is under threat.
Military charity Supporting Wounded Veterans says that despite its own fundraising, and having secured contributions from the National Health Service England, and from MAPS, additional funding is needed to start the planned UK research this summer.
Without UK research results, regulatory approval here would likely be delayed, meaning UK veterans would continue to suffer for years whilst their counterparts in the US and elsewhere may be receiving treatment. Others suffering from PTSD, including victims of violent crime, rape, childhood sexual abuse, and those traumatised by accidents and disasters, would also be impacted by the delay.
Supporting Wounded Veterans in December 2020 launched its Pioneer Programme to raise money for the research. So far, it has raised £775,000, including commitments the charity has secured of £300,000 from NHS England and £350,000 from MAPS. A shortfall of £725,000 still needs to be found to meet the £1.5m required. The charity is determined to bridge the gap, and is inviting donations via www.supportingwoundedveterans.com/pioneerfund
The aim of MDMA-assisted therapy is to create ideal conditions for re-processing traumatic experiences, reducing an engrained overactivity of the ‘fight or flight’ response in the brain and working with participants through therapy to access their innate capacities for resilience and post-traumatic growth.
It involves administering carefully controlled doses of medical-grade MDMA under the guidance of qualified clinicians in a safe, comfortable and medically-controlled setting. The combination of therapy and medical doses of MDMA may make it easier for people with chronic, treatment-resistant PTSD to work through traumatic and distressing experiences, in an atmosphere of safety and acceptance, without becoming overwhelmed.
PTSD affects many people and is particularly common among those who have served in combat roles. Research by King’s College London’s Centre for Military Health suggests that 17% of veterans whose last deployment was in a combat role suffer from PTSD, including PTSD from other causes, compared with 6% of veterans whose last deployment was in a service role. The rate of PTSD for the civilian population is 4.4% (2).
It is estimated that between a third and a half of PTSD cases overall are resistant to established treatments (3), and veterans tend on average to be more resistant to treatment. Having sought to help numerous veterans with PTSD that proved resistant to other therapies, Supporting Wounded Veterans last year engaged with a research team at the Centre for Affective Disorders at the Institute of Psychiatry, Psychology & Neuroscience at King’s College London, to discuss undertaking the research here in the UK.
To assess the MDMA-assisted therapy’s ability to help those with PTSD that has proved resistant to other treatments, most veterans on a trial will have undergone a minimum of 10 years of other treatments with little effect.
Gilly Norton, Chief Executive of Supporting Wounded Veterans, said:
“We do not want to see British veterans miss out on a potentially invaluable treatment and suffer for even more years.
“An important opportunity lies before us, and we are asking the public to help us seize it. Together, we can make a tremendous difference to brave people who need our support. Many veterans with PTSD will have tried existing treatments for years – with determination, but without success. This new therapy has the potential to transform their lives, and those of their families.
“It would be a national disgrace if veterans elsewhere in the world were able to access this treatment, and British veterans were not. It is vital the research takes place this summer.
“Indeed, this programme could not just help British veterans, but also allow those taking part in the research to be a vanguard, pioneering therapy that could help civilian victims of trauma, too, if the results are positive – as they have been in the US so far.”
General Sir Nick Carter, Patron of Supporting Wounded Veterans, said:
“This initiative stems from a determined charity that provides a very personal, special service to veterans. It has seen first-hand the problems that veterans face, and the limitations of conventional treatments. Now it may have found a therapy that is likely to make a critical difference to many people suffering terrible effects of trauma, using outstanding British scientists at one of our top universities.”
Dr James Rucker, a Consultant Psychiatrist and a Senior Clinical Lecturer in mood disorders and psychopharmacology at the Centre for Affective Disorders at the Institute of Psychiatry, Psychology & Neuroscience at King’s College London (UK), who is an expert in this area, said:
“MDMA-assisted therapy is a novel, cutting-edge treatment for PTSD. The evidence suggests that it works by quietening the ‘fight or flight’ system in the brain, which we know is over-active in cases of PTSD. With this more general state of ‘relaxation’ that the drug brings, and in alliance with a specially trained therapist, patients with PTSD can start to reexperience their symptoms without feeling overwhelmed and resorting to the ‘avoidance’ that seem so often to make symptoms worse. The synergy of the MDMA plus the psychotherapy ‘sows a psychological seed’ of self-compassion that allows patients, often for the first time, to face their mental battle scars and the emotional struggles of returning to a civilian life; a life where oftentimes few can truly understand the emotional extent of what they have been through.
“With ongoing psychotherapy, this psychological ‘seed’ can be nurtured into a form of self-directed therapy (or ‘emotional toolbox’) that the patient can take away with them, into the real world. With time, this has the capacity to develop into a sense of resilience, post-traumatic growth and the rebuilding of a self-confidence that allows patients to move forward with their lives, with their mental battle scars a part of their own capacity for compassion and inner strength.”
Martin Hewitt, a former officer in the Parachute Regiment, who lost the use of his right arm leading an attack in Helmand Province, Afghanistan, and who is the Lead Ambassador for Supporting Wounded Veterans, said:
“I know many former servicemen and women who are extremely high-performing individuals, but whose mental health injury is preventing them from achieving what they want in life. PTSD can affect any rank or role in the military. We urgently need to conduct research on this new treatment, to maximise support for those who are suffering and encourage healing.”
Footnotes
1. https://maps.org/news/media/9122-maps-phase-3-trial-of-mdma-assisted-therapy-for-ptsd-achieves-successful-results-for-patients-with-severe-chronic-ptsd
2. https://www.kcl.ac.uk/kcmhr/publications/reports/files/Mental-Health-of-UK-Armed-Forces-Factsheet-Sept2018.pdf
3. https://www.ncbi.nlm.nih.gov/books/NBK224874/