Belfast Telegraph

Wednesday 16 April 2014

'Absurd' rules 'obstruct research'

Professor David Nutt says 'archaic' rules obstructing scientific progress should be abolished

A trial that could lead to radical magic mushroom treatments for depression has been stalled because of "absurd" regulations restricting the use of illegal drugs in research, it is claimed.

Study leader Professor David Nutt, controversially sacked from his role as the Government's chief drug adviser in 2009, argues that "archaic" rules obstructing scientific progress should be abolished.

His team at Imperial College London has uncovered evidence that the hallucinogen psilocybin may combat severe depression which resists conventional treatment. But psilocybin is the psychoactive ingredient in so-called "magic mushrooms", and banned as a Class A drug.

Although the Medical Research Council has awarded a £550,000 grant for the trial, Prof Nutt says the study has not yet been able to proceed.

Speaking on the eve of the British Neuroscience Association's Festival of Neuroscience in London, the professor said: "The trial hasn't started yet because the big problem is getting hold of the drug. We're not allowed to go and pick the mushrooms any more and finding a company to provide this illegal drug in a way that can be prepared for trial use as yet has proved impossible.

"We are between a rock and a hard place, and that's very unfortunate because if this is an effective treatment, as it may well be for some people, then they are obviously being denied that possibility."

Under the law, academic researchers are not allowed to manufacture their own Class A drugs and must obtain them from external sources. Companies that could supply the drugs have to go through "regulatory hoops" to obtain the necessary Home Office licence, said Prof Nutt. This could take up to a year and triple the cost, he maintained.

Other major hurdles were the EU guidelines on Good Manufacturing Practice (GMP), which set daunting standards for potential suppliers, and rules on storage.

Only four hospitals in the UK currently have a licence to hold psilocybin, making it difficult to roll the drug out as a prospective treatment, said Prof Nutt.

He added: "The knock-on effect is this profound impairment of research. We are the first people ever to have done a psilocybin study in the UK, but we are still hunting for a company that can manufacture the drug to GMP standards for the clinical trial, even though we've been trying for a year to find one. We live in a world of insanity in terms of regulating drugs at present. The whole field is so bogged down by these intransigent regulations, so that even if you have a good idea, you may never get it into the clinic. The rules are absurd. They just need to be abolished. There's no rationale to them at all. This is just a historical anomaly that we're chained to."

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