January 4, 2012
Despite death and overdose, therapeutic Ecstasy shows promise
By: David P. Ball
MAPS researchers share their frustrations getting our planned Canadian study of MDMA-assisted psychotherapy for PTSD up and running. After three inspections of the Vancouver pharmacy that will be used to store the MDMA to be used in the study, Health Canada has changed the requirements for receiving a Controlled Substances license and requested that additional changes be made. The Vancouver Observer speaks with lead investigators Ingrid Pacey, M.D., and Andrew Feldmår, Ph.D., about the challenges of initiating psychedelic psychotherapy research in Canada.
Originally appearing here.
Three recent overdoses from the illegal drug Ecstasy in the Lower Mainland have police issuing warnings to users – but a local psychologist worries that misconceptions about the drug are causing the government to stall important research into treating trauma.
With two deaths and a 24-year old Abbotsford woman in critical condition since New Years Eve after ingesting eight tablets of the drug commonly associated with raves – its official name is methylenedioxymethamphetamine (MDMA) – police said the drug is not safe in any quantity.
Meanwhile, a ground-breaking study into using MDMA in psychotherapy to treat post-traumatic stress disorder (PTSD) has hit a bureaucratic wall after Health Canada inspectors changed security requirements, delaying an already-approved research study from proceeding, one of the study’s researchers alleged.
“It looks like ... Health Canada is okay with the study, but there are higher-up politics involved,” said Andrew Feldmár, a psychologist approved three years ago to study the effects of MDMA on trauma patients. “Basically, they tied (Health Canada’s) hands and want to frustrate the project.
“Because of the prejudice of politicians, thousands of people are deprived of the benefits (of MDMA). Who is putting pressure on Health Canada not to get this going?”
The drug, which was invented in 1912 by German chemist Anton Köllisch, produces what Feldmár called “empathogenic” effects: it increases feelings of empathy and trust. Treatment of patients with PTSD is often difficult, he explained, because trauma can cause a sense of isolation and loss of trust. Studies conducted with soldiers in the U.S., Israel and Switzerland suggest MDMA assists patients to develop a connection with their therapist, as well as to relieve feelings of shame associated with PTSD.
The history PTSD, like MDMA, has been controversial. Previously labelled “shell-shock” after World War One, until recently many have been reluctant to accept that experiencing violence such as war might have long-term psychological effects. Today, however, researchers are discovering trauma can cause physical changes to the brain. The majority of people with PTSD, in fact are civilians, not soldiers.
“Many people coming back from war are deeply traumatized,” Feldmár said. “The use of MDMA is the most effective and best method for freeing them of the effects of trauma.
“For people who have had trauma, it allows them to get back in touch with the terror or the horror of the original experience, and to be able to mourn and grieve it – and leave it behind. There are people who have been traumatized and no other therapy helps them.”
Approved by Health Canada more than three years ago, the study – titled “MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD)”—required the drug to be imported from Switzerland, where it is produced, and stored securely at a Vancouver pharmacy.
Feldmár, along with study co-author Dr. Ingrid Pacey, enlisted a pharmacist in Kerrisdale neighbourhood to apply for an import permit. In May, inspectors flew from Ottawa to inspect the site, and said security improvements were required to ensure the MDMA would not be stolen.
After two Health Canada inspections and numerous safety upgrades – including an alarmed, locked safe secured to the floor inside a locked wooden box and an alarmed door to a back room – inspectors continue to increase the requirements, said pharmacist Colin Holyk, at Kerrisdale Pharmacy.
“The requirements they gave me initially are now outdated and they have a new set of requirements,” Holyk alleged in a video released in October by the study’s U.S. backers, the Multidisciplinary Association for Psychedelic Studies (MAPS). “My gut feeling is they’re going to come back and say we’ve got to do something else.
“A lot of this seems to be such overkill for security measures for the small amount of medicine we’re doing for the trial. It is a very, very, very small amount for a drug trial in Canada – I think they’ve lost sight of that.”
Health Canada could not be reached by press time for comment.
In the meantime, researchers are unable to seek patients and funding for the trials until the project gets the green light from Ottawa – delays that Feldmár said are depriving medicines to victims of trauma.
“It definitely causes unnecessary suffering,” he said. “It’s really unconscionable to have this helpful substance banned.
“Neither Ingrid (Pacey) or I have given up. We know it’s a worthwhile project—more and more studies are being published around world showing that MDMA and other psychoactive drugs are extremely effective for people with PTSD, depression or other psychiatrically categorized problems. I don’t know how long we’ll wait, but we’re not going to give up.”
Feldmár said that there is a significant difference between controlled, supervised use of MDMA with a therapist and the street drugs which recently caused a series of hospitalizations in Abbotsford. In those cases, he said, the drugs may have been cut (mixed) with other, more dangerous chemicals. Ingesting many tablets of any medicine – even Aspirin, he added – would be harmful to a user.
“Very few ecstasy tablets that have been tested are pure MDMA,” said Const. Ian MacDonald, with the Abbotsford Police Department. “They’re usually cut with other products, whether amphetamines or household cleaning products.
“Different chemicals are poured into process. It’s not done under scrutiny of any corporation or Health Canada – it’s done in people’s basements. They’re throwing in whatever junk they want. It’s definitely a bit of a crapshoot.”
MacDonald said police were shocked when 17-year-old Cheryl McCormack died on December 17 in Abbotsford after having taken only “one or two” ecstasy tablets – allegedly in an attempt to lose weight with her friends. He said after the New Years hospitalization, the force decided to go public about the problem, issuing a press release warning of the dangers of MDMA use.
“When we first received word ... we had young high school-aged girls taking ecstasy tablets for weight loss, we all sat up and went, ‘What?!’ MacDonald told the Vancouver Observer. “We assume it’s used more frequently as the party type of drug.
“But that was part of the reason we went out as strongly as we did. In a high school environment, with urban myths, you have to put it down quickly or you have others using and falling victim.”
With Lower Mainland hospitals reporting several ecstasy-related overdoses every week, the drug’s use may be becoming more common. And though toxicology results from recent cases – as well as four deaths over the past month in Calgary – are not known, MacDonald said that whether deaths were caused by the quantity consumed or other chemicals mixed in is beside the point.
“People have asked me, “Is it a bad batch of illicit drugs?” he said. “My response is there’s no such things as a good batch.
“Based on our recent experience, I don’t like those odds. If you’ve got a one-in-four chance of taking something to go to the hospital – and two-thirds of those have died – I’m hoping that’s enough of a message right there.”
The way Feldmár sees it, however, is that while there are dangers associated with abusing the street drug, MDMA itself is not the problem. He suggested that some recreational users are in fact self-prescribing it as medication for their mental health.
“Nobody’s stupid,” he said. “It’s a very frequently used medicine.
“People know that it has very positive effects, that’s why they use it. I think what we’re tyring to prove in a scientific way what everybody already knows. There has been an underground network of people already using it.”
Feldmár was featured in a Vancouver Observer news story which was carried worldwide in 2007, after he was permanently banned from entering the U.S. for publishing his own 1960s experiences with drugs in an academic journal.
U.S. Border guards discovered an thesis he had published in which he acknowledged having used psychoactive drugs decades prior. This year, he was issued a temporary visa to attend his son’s wedding in the U.S, but that exemption expires this month.
“It’s grossly unfair,” he said.
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