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“Absurd” rules are hampering research into controlled drugs, says former drugs adviser

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f2210 (Published 08 April 2013) Cite this as: BMJ 2013;346:f2210
  1. Krishna Chinthapalli
  1. 1BMJ

All NHS hospitals should be allowed to hold all controlled drugs and use them for clinical research, according to the former chair of the government’s Advisory Council on the Misuse of Drugs.

David Nutt, who is now professor of neuropsychopharmacology at Imperial College London and president of the British Neuroscience Association, spoke about barriers to research into illicit drugs, following on from his criticisms last year.1 At a press briefing on 5 April, ahead of the British Neuroscience Association Festival of Neuroscience on 7-10 April, he said that currently only four hospitals in the UK may hold and administer Schedule 1 controlled drugs.

Under the Misuse of Drugs Act 1971 and subsequent regulations, Schedule 1 drugs are presumed to have no therapeutic value, and a special Home Office licence is needed to use them in any research. Such drugs include cannabis, psilocybin, and ecstasy. Nutt alleged that this definition was absurd and restrictive. “To research cannabis, you have to have a special licence. To research heroin, you need no licence at all. No one can conceivably argue that cannabis is more harmful than heroin,” he said.

He also cited the example of sativex, a cannabinoid medicine licensed for spasticity in multiple sclerosis. “It should be a Schedule 1 drug, because all cannabis was listed in Schedule 1, but [the Home Office] said that because it’s a special formulation of cannabis in a special solution that you spray into your mouth, that exempts it,” he said.

“One way forward is to exempt all hospitals from the Schedule 1 licence. All hospitals in this country are exempted from having to hold Schedule 2, 3, and 4 licences.” Schedules 2, 3, and 4 are medicinal drugs that are tightly controlled and cannot be lawfully possessed without a prescription. Schedule 2 includes amfetamine, cocaine, and most opioids.

He suggested that Schedule 1 restrictions were hampering clinical research not only into cannabinoid therapy for cancer, pain syndromes, and psychiatric disorders, but also ketamine analogues for depression and mephedrone for substance dependence.

Nutt went on to talk about other barriers to his own research. Last year, he injected psilocybin, the hallucinogenic ingredient in magic mushrooms, into healthy volunteers and found an improvement in mood. “We noted that in some of our normal volunteers that they felt better for a period of weeks afterwards. There is a vast literature out on the internet of people self medicating and some of it is quite compelling,” he said.

His team at Imperial College has Medical Research Council funding and ethical approval for a clinical trial of psilocybin for people with depression. However, he said that Home Office and EU regulations would delay his trial for at least a year and add hundreds of thousands of pounds in costs because any pharmaceutical company seeking to produce psilocybin must apply for an “unnecessary” special licence and then comply with “arcane and disruptive” EU standards on good manufacturing practice.

Nutt also criticised the government in 2009 when he was chair of the Advisory Council on the Misuse of Drugs and was subsequently dismissed from his post. At the time, he said that alcohol and tobacco caused more harm than cannabis and opposed the government’s stricter classification of cannabis.2

Notes

Cite this as: BMJ 2013;346:f2210

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