Financial Times: When Drugs Do Work

Summary: Financial Times investigates the momentum surrounding clinical research into treating medical conditions with psychedelics including MDMA, LSD, psilocybin, and ayahuasca. The article details the origins of psychedelic research, analyzes how the criminalization of psychedelics hinders research that could provide new treatments, and highlights the importance of continuing psychedelic research through interviews with MAPS Founder Rick Doblin, Ph.D., MDMA-assisted psychotherapy study participants Rachel Hope and Tony Macie, and others. “I have never been able to think so clearly or had so much peace in my life," explains Macie. “I’m not saying it’s for everyone. But our government wants to send us to war where they accept we could die, then when we get home they don’t want us to get treatment. It’s the least they owe us.”

Originally appearing here.

Rachel Hope is an unlikely ecstasy user. Brought up to be fiercely suspicious of recreational drugs, she now raves about the “party pill”. Abused from infancy, she repeatedly sought professional help in the US. “I spent 15 years in and out of clinics, on and off medications. I tried psychotherapy, hypnotherapy, yoga.” Doctors diagnosed her underlying condition as complex/chronic post-traumatic stress disorder – a state better known among soldiers returning from military conflict. “Whatever I did, it was getting worse. I was desperate,” she says.

But then Hope discovered a network of maverick scientists and doctors challenging the taboos around a number of drugs in small clinical trials. Ecstasy, LSD, psilocybin (the active ingredient in “magic mushrooms”) and cannabis are among the compounds beginning to make a cautious experimental comeback for conditions including trauma, depression, anxiety and pain relief. Hope stumbled across one such trial in South Carolina. It combined psychotherapy with 3,4-methylenedioxy-methamphetamine – better known as MDMA or ecstasy. In 2004, she became participant Number Seven.

She was suspicious at first. “I thought MDMA put holes in your brain,” she says. “I’m not uptight but I am a wholegrain, organic kind of person. I was very far away from believing this drug had anything for me.”

But after just two consultations following a small dose of MDMA, Hope felt a radical transformation. “It reduced anxiety, not numbing you but enhancing your awareness, giving you a feeling of connection,” she says. “It lit my head up like a Christmas tree, so I could see every single neurone . . . I could go inside my head, see the wiring and rewire it. It was as if I was born again, as though someone took me out of prison.” In 2012, she took the drug and therapy again as part of a follow-up study. She now considers herself cured.

Such results do not surprise Rick Doblin, founder and executive director of the Multidisciplinary Association for Psychedelic Studies (Maps), a non-profit group based in California. “MDMA brings back memories in a way [users] can deal with them,” he says. “We know that it reduces activity in the amygdala in the brain, where fear is processed, and enhances the prefrontal cortex, where we put things in context. When somebody is recalling a trauma while using the drug, their fear reaction is muted.”

Doblin has been at the centre of the revival of research. “I grew up in the 1960s and I believed in the anti-drug propaganda,” he recalls. “I thought one dose of LSD caused permanent brain damage and you would be screwed for life.” Then a friend introduced him to Ken Kesey’s cult novel One Flew Over the Cuckoo’s Nest and told him it was written under the influence of the drug. “In freshman year, I tried it. It really put me in touch with my emotions. I decided to dodge the draft [for Vietnam]. I thought I would be arrested and never able to practise as a doctor or lawyer, so I decided instead to be an underground psychedelic therapist.”

Like other psychoactive substances, LSD was first developed by European pharmaceutical companies looking for potential medical applications (Bayer originally patented heroin as a painkiller, and produced it commercially from 1898). It was synthesised by Albert Hofmann, a Swiss chemist at the pharmaceutical company Sandoz, now part of Novartis. In 1943, five years after he developed the drug, he accidentally absorbed some through his skin, leading to a “not unpleasant intoxicated-like condition”. He began lifelong research into LSD and related compounds as “medicine for the soul”.

In the early 1960s, to Hofmann’s intense frustration, the drug began to be popularised by Timothy Leary, then a lecturer in psychology at Harvard University, as part of his countercultural message to “turn on, tune in, drop out”. The backlash ultimately triggered bans around the world, and by the time Doblin began his medical experiments, LSD had already been outlawed in the US. He resolved to turn his attention to another promising psychoactive substance instead.

In 1912, Merck had filed a patent for methylsafrylamin, part of a programme to identify drugs to stop bleeding. The company carried out further research in the 1920s before abandoning it. But in the 1950s, the drug, a forerunner to MDMA, was re-examined by a very different group of specialists. During the cold war, the US army explored MDMA, LSD and other compounds for potential military applications including brainwashing. Its work was only declassified in 1977 – several years after drug enforcement agents first identified ecstasy on the streets.

Doblin recalls: “I only realised the medical potential with LSD after it was illegal. With MDMA, I thought I had a chance to get in and prepare before it was banned.” Just as ecstasy was exploding in youth culture, Doblin began to mobilise doctors, lawyers and politicians to protect medical research into the drug. He paid $4,000 for a 1kg batch of extremely pure MDMA, on which he continues to draw for his studies. Then, in 1984, as the US Drug Enforcement Agency pushed for a ban, Doblin successfully sued, arguing it should remain available to psychiatrists. He fought off two appeals before the agency tightly restricted its production, distribution and use.

Charles Grob, now professor of psychiatry at the University of California, Los Angeles, was given the first authorisation to administer MDMA alongside counselling for people with advanced cancer. “I had been aware of the psychiatric and medical literature from the 1950s, and was very impressed with reports on the treatment of patients who had otherwise not been responsive,” he says. “MDMA offered extraordinary potential but by the early 1970s everything was being shut down. The fear of the counterculture and compounds perceived as catalysts for change were very disconcerting to the authorities.”

Concerned about sensationalist media coverage, safety issues and finding the most suitable treatment for his patients, Grob ultimately abandoned MDMA and switched to experiments with psilocybin and ayahuasca (derived from various plants), both long used for religious ceremonies in traditional societies. He has since conducted tests on patients in Latin America, where local regulators have taken a more tolerant view than those in the US.

For specialists such as David Nutt, professor of neuropsychopharmacology at Imperial College London, the prejudice against psychoactive compounds has been far more dominant than scientific assessment of the risks and benefits. He cites research pointing to potential uses of MDMA not only for PTSD but also in autism, Parkinson’s disease and recovery of cognitive functions after brain trauma. Other studies suggest applications for psilocybin in the treatment of cluster headaches, obsessive compulsive disorder and depression; and LSD for pain and alcoholism. Yet these drugs have th
e toughest classification in the UK, stricter than heroin.

Such legal restrictions present researchers with major difficulties in finding funding and covering costs of procurement as well as meeting tight requirements on the drugs’ administration. “It’s beyond surreal,” Nutt says. “The scientific community is scared and ignorant. We are killing people by not allowing access to ecstasy. Half a million kids are taking it every week but scientists are considered criminals for using it in trials. I need taxi receipts to show we’ve delivered the drug to laboratories. It’s as if it’s plutonium.”

Despite the barriers, activity is on the rise. Ben Sessa, a psychiatrist in Taunton, Somerset, is currently seeking £42,000 to conduct brain scans on 24 military veterans to help understand how MDMA works. “We have a very twisted approach to drugs in today’s society,” he says. “We are prescribing amphetamine to six-year-olds for attention deficit disorder and giving out methadone by the bucketload to mentally ill patients. MDMA is far less toxic but is considered controversial. As a scientist, clinician and pharmacologist, I’m frustrated.”

Developing clinical trials is difficult for all drugs. For those designed to treat neurological and psychiatric conditions, the process is particularly tricky. The most convincing trials require a comparison between dozens or even hundreds of patients taking a drug and others unwittingly receiving a placebo. Yet given the easily detectable effects of MDMA, it is all but impossible to run such tests. Add hostility and the lack of official funding, and researchers have struggled to build an evidence base.

Doblin estimates that 500,000 patients used MDMA in combination with psychotherapy until the drug’s ban in the 1980s. Yet only three formal clinical trials have been conducted so far. The results are inconclusive, partly because the number of patients is so small. One in Spain in 2000 was designed to recruit 29 women diagnosed with PTSD after they were raped. A political outcry meant it was stopped after administration of the drug to just six patients. A second in Switzerland studied only 12 patients and a third in South Carolina – on which Hope was enrolled – a further 20.

Yet researchers point to a positive recent development. Cannabis was prescribed as a painkiller until bans began in the 1960s. In 2010, after a decade-long effort, a special strain without hallucinogenic side effects developed by GW Pharmaceuticals won regulatory approval in the UK and Spain for patients with multiple sclerosis. Nearly 30 countries have since approved it, with tests ongoing for its applications in cancer pain and epilepsy.

Doblin is optimistic that other drugs could follow suit and is aiming for approval for medical uses of MDMA by US regulators in 2021. He has had support from wealthy individuals including the late Richard Rockefeller, who helped develop links with the US Veterans Health Administration. The agency has agreed to co-operate with Maps in a fresh series of clinical trials.

Such progress cannot come too soon for Tony Macie, a former US soldier who suffered PTSD after his return from Iraq in 2008. Veterans Health Administration doctors prescribed him opiates and antidepressants but he feels “they didn’t look outside the box . . . they were just numbing me out, fixing the symptoms but not treating me”.

Through his own research, Macie came across a Maps-backed trial for MDMA and psychotherapy. “I just had such a good experience. I have never been able to think so clearly or had so much peace in my life.” He has since established a small business trying to help other war veterans. “I have had so many ask me privately if they can get hold of MDMA. I don’t recommend it. It needs to be done in a setting with a doctor. But there’s such a backlog for the trials,” he says. “I’m not saying it’s for everyone. But our government wants to send us to war where they accept we could die, then when we get home they don’t want us to get treatment. It’s the least they owe us.”

Grob cautions that MDMA is unlikely ever to be a “mainstream” medicine. But he too is preparing a fresh clinical trial to examine the drug’s potential in treating people on the autistic spectrum with severe social anxiety. “We were not ready to handle these compounds in the 1960s. Society was too immature,” he says. “Now we are almost 50 years from that point. The culture is far more mature.”