'Insane' rules block medical trial of fungus

Absurd and outdated laws on illegal drugs have prevented the start of a ground-breaking clinical trial into of a treatment for depression using the active ingredient of magic mushrooms, the leading pharmacologist Professor David Nutt will tell the British Neuroscience Association (BNA) festival in London today.

Professor Nutt, who was controversially sacked as the Labour government's drugs tsar for his outspoken views on illegal drugs in 2009, was awarded a £550,000 grant from the Medical Research Council to conduct the world's first attempt to see if the hallucinogenic substance psilocybin can be used to treat severe depression, but he has failed to find a drugs company prepared to seek the manufacturing licence required by law.

Professor Nutt, a neuropsycho-pharmacologist at Imperial College London and president of the BNA, said that he can only use psilocybin made synthetically by a company licensed under laws devised in the 1960s. The company also has to prove it conforms to 2005 European regulations known as good manufacturing practice (GMP). Professor Nutt said the rules make it cumbersome and uneconomical to manufacture psilocybin on a small scale, rasing the cost from about £300 to nearer £100,000.

"The rules are absurd and they need to be abolished. There is no rationale to them at all. They are an historic anomaly that we are chained to," Professor Nutt said.

"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," he said.

"We live in a world of insanity in terms of regulating drugs. The field is so bogged down by intransigent regulations that, even if you have a good idea, you may never get it into the clinic," he added.

Preliminary research suggests that psilocybin can reduce the nerve activity within a region of the brain called the anterior cingulate cortex, which is known to get over-stimulated in patients with depression, causing them to dwell on negative emotions and thoughts.

The trial, which was supposed to begin this year, will involve giving controlled doses of psilocybin to two groups of 30 patients with severe depression for whom at least two previous attempts at treatment have failed.

"We need a more rational debate over how the drugs laws are being implemented; if they are denying scientists access to these powerful tools for improving wellbeing then they are not actually doing what they should be doing," said Professor Nutt.