Cannabis Clinical Trials for Multiple Sclerosis to Begin

The long awaited clinical trial of cannabinoids for treatment of spasticity from Multiple Sclerosis were announced on Monday 13th December 1999.

The clinical trials, funded by a £950,000 grant from the Medical Research Council, will involve 660 MS patients aged between 18 and 65 who are being recruited from MS clinics at hospitals all over the UK. The study is to be conducted by Dr Zajicek, Consultant Neurologist at Derriford Hospital, Plymouth.

The research protocols were agreed between the Medical Research Council and Royal Pharmaceutical Society. Patients will be assigned to a double-blind regime whereby they will be given capsules containing THC, cannabis oil (extract), or placebo (vegetable oil), and researchers will study the effects on severe muscle stiffness (spasticity) in the legs. Neither the patients nor their doctors will be told which treatment they are given until after the study.

Dr Zajicek, who leads the study, commented "We hope the study will provide definite scientific evidence about whether or not taking cannabis is helpful to people with multiple sclerosis... If cannabis alone is found to offer the best relief for patients then we will have to publish that evidence and the Government will have to make its own decision about whether the drug should be legalised."

Peter Cardy, chief executive of the MS Society, stated: "For years we have pressed for proper medical research to assess the clinical effectiveness and safety of these substances.í "Thousands of people with MS suffer from the often very painful symptoms of spasticity [spasms]. It is clearly an unacceptable state of affairs when many people suffering from a serious medical condition feel driven to break the law.í "The trial will provide us with the evidence we need to know whether cannabis or cannabinoids [extracts of the drug] are a safe and effective treatment of spasticity in MS."

There are about 85,000 people in Britain suffering from multiple sclerosis, one of the most common diseases of the nervous system affecting younger people.

One notable MS sufferer is mother of two Clare Hodges, who has been using cannabis for 8 years to alleviate muscle spasms arising, and founded of the Alliance for Cannabis Therapeutics after being forced to give up work as a TV producer because of the disease. While welcoming the the announcement of clinical trials, Clare was not wholly impressed with the medical establishment's reaction to calls for cannabis to be legalised for patients like her. "Of course any research is welcome, but we need help now", she said

In a Commons Written Answer on 2nd December, Patricia Hewitt, Trade & Industry Minister, had outlined the research proposals approved to date:

"The Medical Research Council (MRC) has invited a number of research proposals on the potential therapeutic uses of cannabinoids. A funding decision is expected in December on a clinical trial concerning the therapeutic uses of cannabinoids/cannabis in the treatment of spasticity in multiple sclerosis. Two further trials of its use in post-operative pain will be considered next year. The MRC currently co-funds a "Realising Our Potential Awards" (ROPA) grant with Zeneca at the University of Manchester. This study investigates the effects of cannabinoids on brain cell degeneration. MRC have contributed £97,260.

Also, the Biotechnology and Biological Sciences Research Council (BBSRC) supports two individual projects/grants investigating the medicinal effects of cannabis.í

Matthew Atha, IDMU director, commented (17-12-99).

"IDMU welcomes these clinical trials which should establish whether the anecdotal evidence of hundreds of MS patients is backed up by scientific and clinical evidence.í

We are however concerned that oral cannabis preparations may, by virtue of slow absorption and first-pass metabolism by the liver, may differ markedly in medical effects from smoked cannabis both in terms of qualitative nature of the effects, and in the dosage and controllability of symptomatic relief and avoidance of side-effects.

We look forward to the results of parallel clinical trials to be conducted by GW pharmaceuticals which may distinguish between the effects of different cannabinoids using an inhaler which may mimic the rapid onset of smoking cannabis whilst minimising the health risks associated with smoking raw plant material.

We urge that the study be completed and published as soon as reasonably practicable, in order to avoid unneccesary delays in bringing safe and effective cannabinoid-based medicines to the patients who need them.