Health written question – answered on 22nd June 2011.

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Photo of Paul Flynn Paul Flynn Labour, Newport West

To ask the Secretary of State for Health for what reasons pharmaceutical companies have been licensed to develop cannabis-based medicines to be dispensed in the UK; and what consideration he has given to licensing the dispensation of similar medicines in naturally-grown formats.

Photo of Simon Burns Simon Burns The Minister of State, Department of Health

The Government accepted that there was a need to explore whether cannabinoids had therapeutic properties and could be developed as an approved medicine for multiple sclerosis sufferers.

We are advised that the issue of licences to companies to manufacture, using controlled substances on specific premises, is the responsibility of the Home Office.

The Medicines and Healthcare products Regulatory Agency (MHRA), an Executive Agency of the Department of Health, is responsible for ensuring that medicines available in the United Kingdom are efficacious and acceptably safe. The MHRA will only grant a marketing authorisation for any given product once it is satisfied that the product is safe, efficacious and of an acceptable quality for use in specific medical treatments in the defined patient population and it can only do so in response to the submission of an application to market a product.

At this time, no application has been made to the MHRA in relation to ‘naturally-grown formats’ of cannabis. The only cannabis-based medicine to be licensed in the UK is Sativex, a product licensed for use as an add-on treatment for multiple sclerosis-related spasticity when people have shown inadequate response to other symptomatic treatments or found their side effects intolerable. It is based on extracts of two specific varieties of cannabis and controlled so as to produce a product with consistent properties.

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Posted on 24 Jun 2011 9:18 am (Report this annotation)

The approval of Sativex by the MHRA raises a few questions about the UK's current drug control policy for cannabis. Simon Burns' line that the consistent standardization of Sativex differentiates it from products that can be produced in the typical illicit cannabis grow operations now prevalent across the UK is questionable.

Sativex has a 1:1 ratio of THC to CBD. (Incidentally, this also broadly true of most hashish smuggled into in the UK. See "Potency of D9-THC and Other Cannabinoids in Cannabis in England in 2005: Implications for Psychoactivity and Pharmacology" by Potter, Clark and Brown.) Standardized herbal cannabis with a consistent ratio of both THC and CBD could in fact be produced by an amateur breeder through using cuttings of the right parent plant. The technique is known colloquially as "cloning" among indoor cannabis growers.

Cannabis plants with the desired 1:1 THC:CBD ratio make up about 50% of plants in a typical crop of the types of plants cultivated for hashish in countries such as Morocco, Lebanon and Afghanistan. Another 25% of plants are typically pure THC, and the rest pure CBD. For this reason, most imported hashish has broadly the same 1:1 THC to CBD ratio as Sativex does. This is somewhat ironic, given the MHRA's approval of Sativex.

Interestingly, any quick assumption that the presence of CBD in Sativex accounts for its being a safe medicine - i.e. the prevailing assumption that CBD, an anti-psychotic, might combat THC's potential dangers - has shown to be wrong by a well-known piece of research from Keele University in 2007, commissioned by the ACMD. This is "Assessing the impact of cannabis use on trends in diagnosed schizophrenia in the United Kingdom from 1996 to 2005."
Frisher M, Crome I, Martino O, Croft P.

Before the Keele Study, the earlier paper from Potter, Clark and Brown had voiced a widespread concern that a possible psychosis epidemic may on the cards in the UK due to new intensively bred "skunk" strains of cannabis eclipsing traditional imported Moroccan hashish. This was the line taken by The Independent and Robin Murray. Potter's team had found that between 1996 - 2005 the typical potency of UK cannabis had roughly doubled to a level of about 13.9% THC. CBD, an anti-psychotic, had likewise disappeared as hashish vanished from the market to be replaced by high THC- no CBD "skunk". (Ironically, this development of the cannabis market appeared to be being driven by the very prohibitionist laws that The Independent changed its editorial stance to back.)

But contrary to the fears voiced by Potter's team and by Robin Murray, the Keel University study "did not find any evidence of increasing schizophrenia or psychoses in the general population from 1996 to 2005."

The Keele team examined the "trends in the annual prevalence and incidence of schizophrenia and psychoses, as measured by diagnosed cases from 1996 to 2005. Retrospective analysis of the General Practice Research Database (GPRD) was conducted for 183 practices in England, Wales, Scotland and Northern Ireland. The study cohort comprised almost 600,000 patients each year, representing approximately 2.3% of the UK population aged 16 to 44. Between 1996 and 2005 the incidence and prevalence of schizophrenia and psychoses were either stable or declining. Explanations other than a genuine stability or decline were considered, but appeared less plausible. In conclusion, this study did not find any evidence of increasing schizophrenia or psychoses in the general population from 1996 to 2005."

Over the same period that typical potency of typical UK cannabis doubled, and CBD content disappeared, the levels of psychosis and schizophrenia in the UK were either stable or declining.

I hope that Simon Burns will consider the very real possibility that the "skunk psychosis" fears being voiced by The Independent, Robin Murray, Charles Walker MP and Mary Brett of Cannabis Skunk Sense are, however well-intentioned, without sound scientific foundation. The UK desperately needs a rational and compassionate drug control policy.