“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 intransient regulations, so that even if you have a good idea, you may never get it into the clinic.”
Professor Nutt said: “The law for the control of drugs like psilocybin as a Schedule 1 Class A drug makes it almost impossible to use them for research. The reason we haven’t started the study is because finding companies who could manufacture the drug and who are prepared to go through the regulatory hoops to get the licence, which can take up to a year and triple the price, is proving very difficult. The whole situation is bedevilled by this primitive, old-fashioned attitude that Schedule 1 drugs could never have therapeutic potential, and so they have to be made impossible to access.
Professor Nutt’s research has shown that psilocybin, the psychedelic ingredient in magic mushrooms, may have the potential to alleviate severe forms of depression in people who have failed to respond fully to other anti-depressant treatments. However, psilocybin is illegal in the UK. The United Nations 1971 Convention on Psychotropic Substances classifies it as a Schedule 1 drug, one that has a high potential for abuse with no recognised medical use, and the UK has classified it as a Class A drug, the classification used for the most dangerous drugs. This means that a special licence has to be obtained to use magic mushrooms in research in the UK, and the manufacture of a synthetic form of psilocybin for use in patients is tightly controlled by EU regulations.
Professor David Nutt, president of the British Neuroscience Association (BNA) and Edmond J Safra Professor of Neuropsychopharmacology at Imperial College London, told BNA’s Festival of Neuroscience yesterday that although the Medical Research Council has awarded a grant for the study, Government regulations controlling the licensing of illegal drugs in research and EU guidelines on Good Manufacturing Practice (GMP) have stalled the start of the trial, which was expected to start this year. He is calling for a change to the regulations.
The UK’s first clinical trial using the hallucinogenic ingredient in magic mushrooms for treating depression is being delayed due to UK and EU rules on the use of illegal drugs in research.