Mental Health is in Crisis. MDMA May Be the Prescription

How is the mental health of Canadians right now as we near the middle of 2024? Based on the latest data from Statistics Canada, it’s not good. From 2021 to 2022, the incidence of mental health disorders in Canada increased dramatically. The incidence of major depressive episodes nearly doubled. The impact of the COVID-10 pandemic on fear disorders was even more dramatic: social phobia more than doubled in one year, from 3.0% to 7.1%.

More concerning is the fact that people are not getting the help they require. 36.6% of people who were diagnosed as having a mental health disorder indicated that they were unable to access counselling, information, medication, or all three.

Partly, this reflects the fact that we have not made dramatic strides in the development of novel treatments for mental health disorders in decades. The last major development in the pharmaceutical field of neuropsychiatry occurred in 1987, almost 40 years ago, when Prozac—the first SSRI—hit the US market. Subsequent development of SNRIs and other derivative drugs provided significant benefits, but there has not been a true “revolution” in mental healthcare since then. The problems, meanwhile, have only gotten worse.

The Ongoing Mental Health Crisis in Canada

Today, the workhorse supporting mental healthcare in Canada (and around the world) remains talk therapy or counselling. While the number of therapists working in Canada today is significantly higher than it was 40 years ago, demand still exceeds supply. The Canadian Institute for Health Information (CIHI) suggests that most Canadians must wait weeks, if not months, to find a therapist.

Even when they do find a therapist, results can vary dramatically. A peer-reviewed analysis of therapist outcomes found that while the best therapists generated improvements at 10 times the speed of the average, the worst therapists in the sample actively increased mental illness symptoms among their patients. In short, they made their patients worse.

What can be done to tackle these two related and deeply important problems?

The Potential of MDMA

One approach, pioneered by the Multidisciplinary Association for Psychedelic Studies (MAPS, a US-based charity), has been the use of MDMA as an adjunct to psychotherapy. This is a dramatic departure from the traditional pharmaceutical model of drug discovery because the drug (in this case, MDMA) is not being used to improve the patient’s condition directly. Instead, the drug is utilized because it dramatically improves the outcomes of psychotherapy itself. MAPS’ first disease target has been treatment-resistant Post-Traumatic Stress Disorder (PTSD), partly because of the inherent difficulty in treating that disorder. 

The results have been impressive. In two published, double-blind multi-site phase 3 clinical trials, approximately 70% of patients were no longer diagnosed as having PTSD after 3 months of MDMA-assisted therapy. These results were positive enough that the US Food and Drug Administration designated MDMA a “Breakthrough Therapy.” In December, the successor to MAPS, Lykos Therapeutics, submitted their New Drug Application to the FDA. The agency will rule on the application by August 11^th, 2024.

The fact that MDMA—a drug most associated with rave culture—may be legal for use as a medicine in the USA this year is no doubt shocking to some, but not to those watching the neuropsychiatry space. Significant clinical results have been observed in the trial of Psilocybin (for Major Depression) and LSD (for Generalized Anxiety Disorder). Both are Breakthrough Therapies in their own right. The number of indications for these drugs has also proliferated wildly. There have now been clinical trials into a great number of mental health indications, with our own clinical research program currently focused on Social Anxiety in Autism.

Adopting Novel Therapies in Canada

In Canada, progress in adopting these therapies has been slow but not non-existent. In January 2022, the Government of Canada adopted regulatory changes allowing for the treatment of patients with all controlled substances through the Special Access Program. The first MDMA treatment under that regime occurred in May of 2023. 

However, considering the scale of the mental health crisis before us, critical observers have stated vocally that Canada is not moving nearly fast enough. In fact, in November 2023, the Senate of Canada sub-committee on Veterans Affairs published a report entitled The Time is Now, focusing on psychedelic-assisted therapies such as MDMA for the treatment of veterans. Their conclusion was that the government of Canada is not moving nearly fast enough, especially considering the shifts made by countries like Australia, which began licensing individual psychiatrists to prescribe MDMA and Psilocybin last year.

Compared to the current standard of care, a health economics model found that per 1,000 people with chronic PTSD, MDMA-AT generates discounted net healthcare savings of $132.9 million over 30 years, accruing 4,856 quality-adjusted life years and averting 61.4 premature deaths. MDMA-AT breaks even on cost at 3.8 years. In the US, where patients have a tendency to switch insurers around five years on average, this may be a more difficult model to accept. However, in Canada, where the provincial health insurer will have to cover the full cost of treatment in perpetuity, this represents a remarkable opportunity for cost savings.

The Future of Healthcare and Psychedelics

Just as critically, patients find the treatment incredibly positive and uplifting. MDMA-assisted therapies are toxicologically safe, and MDMA represents a low abuse liability as it is non-addictive. The treatments can be attempted relatively quickly. They only last three months, and only three days per month of active therapy is required. Even patients in the minority who don’t find full relief from their PTSD will usually see symptoms improve.

Today, the biggest issue for patients is not just regulatory access but also financial access. New modalities of care, such as assisted therapies, require new ways of thinking not just from regulators but also from providers, insurers, and health system operators. That means acting quickly: developing new billing codes as Quebec did, allowing providers to bill for psychedelic-assisted therapy, or developing new regulations for the act of psychedelic-assisted therapy as Alberta has.

It will require budget allocations from organizations that our first responders rely on, like Veterans Affairs Canada (VAC), which currently does not fund any assisted therapies (even with approved drugs like Ketamine). This will be challenging in the current cost-constrained environment, but as always in medicine, it is far more cost-effective in the long run to treat diseases, not symptoms. By comparison, VAC currently spends about $300 million per year to provide cannabis to veterans.

Recently, Blue Cross Alberta issued guidance to their healthcare partners that they will reimburse patients for psychedelic-assisted therapy, including MDMA-AT. Those, like Alberta Blue Cross, who can break through to these new ways of thinking and who can fight the urge to delay decisions will provide immeasurable benefits to patients and, crucially, for a single-payer system like Canada, to taxpayers. There is a cost to delaying making these types of critical changes, and those costs can be measured in human lives. The time truly is now.