In an unassuming lab on the B.C. Institute of Technology’s Burnaby campus, two psychedelics startups have just crafted their first batch of pharmaceutical-grade MDMA – also known as the party drug ecstasy, or molly – which they plan on donating to a handful of patients with treatment-resistant PTSD. That is, if Ottawa decides to open up compassionate access to the drug through a federal program already granting roughly 100 Canadians the right to legally use psilocybin, one of the psychoactive compounds found in “magic mushrooms.”
In October, Filament Health added coca leaf, cocaine and MDMA, its first synthetic drug, to its federal licence to supply researchers with psilocybin as well as other illegal drugs it can extract from flora. Last week, the publicly traded company encapsulated its first pills for PharmAla Biotech Holdings Inc., which plans on soon supplying patients through Health Canada’s Special Access Program.
The pair of companies are part of a wave of Canadian firms looking to open up medical access to psychedelics using the SAP. Ottawa decided to funnel requests to use these drugs through this program at the start of last year, and is now facing a Federal Court challenge by patients who argue it’s too hard to get their psilocybin under the current regime. The program was started decades ago to grant patients compassionate access to unauthorized drugs made abroad, but in 2013 then-health minister Rona Ambrose banned physicians from using it to prescribe heroin, magic mushrooms and other illegal drugs.
Over the past year and a half, Health Canada has approved psilocybin to be given by 90 or so health care professionals to patients grappling with the end of their lives or treatment-resistant depression. Filament has supplied the drugs for 84 of these special prescriptions for free.
But more than a dozen licensed clinicians have applied for their patients to use MDMA under the federal program, with nascent research showing its promise in improving post-traumatic stress disorder. Government staff have reviewed their applications, but told them there isn’t a supply of the controlled drug produced to Ottawa’s strict manufacturing standard, according to Ben Lightburn, co-founder of Filament. Until now.
“I don’t think there’s a broad conspiracy to hold back psychedelics – not any more,” Mr. Lightburn said recently from his tiny lab, which Filament leases in a BCIT space that housed a cannabis firm before it failed. “We’re seeing that Health Canada is paying attention to the growing body of evidence in support of the clinical effectiveness of these substances.”
Filament is also licensed to supply researchers and clinical trials with a host of other natural hallucinogens, including DMT (a mind-altering ingredient found in a variety of plants), mescaline (which the company says it can cull from cactuses bought at a local nursery) and cathinone (a stimulant commonly consumed in East Africa and the Arabian Peninsula by chewing khat leaves).
Health Canada spokesperson Charlaine Sleiman said her agency cannot comment on individual requests made for MDMA through the SAP, which provides access to patients with serious or life-threatening conditions for whom “conventional therapies have failed, are unsuitable or unavailable.” But people in the field are hopeful the drug’s approval is imminent: At the end of February, Health Canada issued a public notice recognizing the growing interest in psychedelic-assisted psychotherapy and gave detailed instructions to health care practitioners seeking psilocybin or MDMA for their patients.
Nick Kadysh, chair of the trade association Psychedelics Canada and founding chief executive officer and president of PharmAla, says federal bureaucrats have signalled they are keen to have a supply of the compound in place.
“They have been calling us once every couple of weeks for the past six months saying, ‘Hey, when are you going to be online? We’d like this to be online as fast as possible,” Mr. Kadysh said.
He added that his company has focused so far on making MDMA for clinical trials and academic studies.
Tashia Petker, an addiction researcher completing her clinical psychology PhD at the University of B.C., said more funding is needed for psychedelics research so that ailing Canadians can find new therapies, but also to codify best practices in their medical use and educate more clinicians on when and how to deploy them.
“We need really well-qualified practitioners to be trained in this approach so we can have benefits while minimizing harms because these medicines are powerful,” she said. “And they should be provided in the context of psychotherapy that is grounded in evidence and is also subject to regulation and oversight to protect patients, as well as the providers.”
Mr. Lightburn, who led a plant extract company then helped raise $6-million in private capital before going public with Filament, said executives who exited the cannabis industry before its bubble popped and who are now working or investing in the psychedelics sector are learning that the drugs appeal to a much smaller market and face tougher regulatory hurdles. Rising interest rates and dampening enthusiasm for speculative investments have also hit Canada’s psychedelics sector hard since its value exploded during the first waves of the pandemic.
As it stands, the research underpinning the efforts of advocates and companies to medicalize psychedelics just isn’t solid enough to justify prescriptions, said David Nickles, managing editor of non-profit Psymposia magazine and co-creator of a New York Magazine podcast examining the institutions and groups pushing for wider societal acceptance of these substances.
Mr. Nickles said his interviews with medical ethicists and experts in clinical trials revealed major methodological flaws in the landmark Phase 3 study Mr. Lightburn and Mr. Kadysh both herald as showing MDMA’s potential to help those with PTSD. It is troubling, he said, that the trials to date have only involved a tiny number of people and have not fully mapped out the various risks posed by psychedelics. These drugs should definitely not be criminalized, he added, but they also should not be prescribed until the medical establishment has a keen understanding of their benefits and drawbacks.
“What’s going to happen when – instead of 90 participants – you have 90,000 patients?” he said in a phone interview from Los Angeles.
Mr. Lighburn said pharmaceutical approval of MDMA will not result in North America’s streets being flooded with the drug, which was first invented by the German drug giant Merck in 1912 as it searched for a compound to better control bleeding.
“We want to show Health Canada, the politicians and the general population at large – outside of Vancouver – that there are responsible people here,” he said, dressed in a white gown, beard and hair nets while holding a large clump of finger-length “blue meanie” magic mushrooms.