LONDON (Reuters) - The world's first clinical trial designed to explore using a hallucinogen from magic mushrooms to treat people with depression has stalled because of British and European rules on the use of illegal drugs in research.
David Nutt, president of the British Neuroscience Association and professor of neuropsychopharmacology at Imperial College London, said he had been granted an ethical green light and funding for the trial, but regulations were blocking it.
"We live in a world of insanity in terms of regulating drugs," he told a neuroscience conference in London on Sunday.
He has previously conducted small experiments on healthy volunteers and found that psilocybin, the psychedelic ingredient in magic mushrooms, has the potential to alleviate severe forms of depression in people who don't respond to other treatments.
Following these promising early results he was awarded a 550,000 pounds ($844,000) grant from the UK's Medical Research Council to conduct a full clinical trial in patients.
But psilocybin is illegal in Britain, and under the United Nations 1971 Convention on Psychotropic Substances it is classified as a Schedule 1 drug - one that has a high potential for abuse and no recognized medical use.
This, Nutt explained, means scientists need a special license to use magic mushrooms for trials in Britain, and the manufacture of a synthetic form of psilocybin for use in patients is tightly controlled by European Union regulations.
Together, this has meant he has so far been unable to find a company able to make and supply the drug for his trial, he said.
"Finding companies who could manufacture the drug and who are prepared to go through the regulatory hoops to get the license, which can take up to a year and triple the price, is proving very difficult," he said.
Nutt said regulatory authorities have a "primitive, old-fashioned attitude that Schedule 1 drugs could never have therapeutic potential", despite the fact that his research and the work done by other teams suggests such drugs may help treat some patients with psychiatric disorders.
Psilocybin - or "magic" - mushrooms grow naturally around the world and have been widely used since ancient times for religious rites and also for recreation.
Researchers in the United States have seen positive results in trials using MDMA, a pure form of the party drug ecstasy, in treating post-traumatic stress disorder.
"What we are trying to do is to tap into the reservoir of under-researched illegal drugs to see if we can find new and beneficial uses for them in people whose lives are often severely affected by illnesses such as depression," Nutt said.
The proposed trial would involve 60 patients with depression who have failed two previous treatments.
During two or three controlled sessions with a therapist, half would be given a synthetic form of psilocybin, and the other 30 a placebo. They would have guided talking therapy to explore negative thinking and issues troubling them, and doctors would follow them up for at least a year.
Nutt secured ethical approval for the trial in March.
In previous research, Nutt found that when healthy volunteers were injected with psilocybin, the drug switched off a part of the brain called the anterior cingulate cortex, which is known to be overactive in people with depression.
"Even in normal people, the more that part of the brain was switched off under the influence of the drug, the better they felt two weeks later. So there was a relationship between that transient switching off of the brain circuit and their subsequent mood,", he said. "This is the basis on which we want to run the trial."[Image from flicker user Electric Nerve]
(Reporting by Kate Kelland, editing by Richard Meares)
This is ridiculous, no realy. Most of those who are against these plants say so simply because they have not seen the grandiose benefits of them, or maybe because shades were put to cover their eyes. This is a law the United States pushed on UN and with it all it's 71 member countries. This stupid law was put forth by President Nixon in 1972' because he strongly felt the young generation with all their cannabis and psychedelic plant use, with all their shouts of love and peace severely hindered his attempt to slaughter hundreds of thousand people and even supporting the wrong side at that.
So i ask you why is this ridiculous law still within the lawbook? It is because when a law becomes a law is stays a law until someone changes it. Now, apparently some people still don't want that to happen. For many reasons that come to mind. Why should what is rightfully ours, be stolen away, kept hidden and with punishments harsh, hushed down, still continue to do so?
As far as i see what was hidden is now revealed to anyone whom possess the marvelous web called the internet. When scientific study is again allowed to be conducted you too will start to get a glimpse of what many of you have not yet seen. look up the research. The first two(?) studies has been preformed since the 40 year old ban on scientific research for psychedelics/entheogens.But that is by far not enough. More than one person one planet earth must be allowed to do research on this. It's almost suspicious, don't you think?
@Itisyou Well, it's transparent to anyone with common sense. It's not suspicious--the suspicions have already been confirmed. I actually don't care that much about the legal status of mushrooms or other psychedelics, in a way. I mean, apart from the fact that the scheduling system virtually prevents research, it doesn't bother me that much. If I wanted to do mushrooms, there's nothing really stopping me, and they aren't that difficult to obtain. If you have a handle on your shit and are a responsible person, there isn't much to worry about. That being said, it's not an ideal situation and I hope for a brighter future, but I'm not counting on it.
@christiandavidtoth @Itisyou The problem is this. With illegality comes factories of connotations or associations of fear. guilt, drug abuse, drug addictions implanted in minds young so as to keep them illegal and as to keep it mentally unavailable from us, so to speak. Their trumf card in the past was to point to mental diseases, but they were wrong, it appears it greatly aids in protection against and reperation of many such conditions. Their fear propaganda is extremely efficient and has worked for many centuries. However these days, it is not as easy, but still ridiculously easy if you're not a thinking person. You're are right in your writings, all i have to do is to go outside in the right season, in the right country and with the right knowledge. Yes i can do so because i know, but they do not. Should all not at least be given the choice? Be not selfish, instead share the esoteric knowledge to those kept ignorant. I choose to do so because it is the fastest and easiest way to a better world, for humanity, for all.
@DanBax76 I saw this on BBC news site and government appears to be getting it all wrong again ...
@lobophyllia @JPS_Dante @DanBax76 The effects are arguably similar to LSD. But how does that justify them being illegal? I don't follow. Is this why it's illegal: http://www.youtube.com/watch?feature=player_embedded&v=miCDPzJHvjk
Yes they do need synthetic psilocybin for the trials, which is the issue, and they can't get it because the manufacturers need to go through rigorous process to get licensed to make it.