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	TX: 13.06.05 - Cannabis - Drug licence refused PRESENTER: PETER WHITE

	Downloaded from www.bbc.co.uk/radio4 THE ATTACHED TRANSCRIPT WAS TYPED FROM A RECORDING AND NOT COPIED FROM AN ORIGINAL SCRIPT. BECAUSE OF THE RISK OF MISHEARING AND THE DIFFICULTY IN SOME CASES OF IDENTIFYING INDIVIDUAL SPEAKERS, THE 麻豆约拍 CANNOT VOUCH FOR ITS COMPLETE ACCURACY. WHITE Now thousands of people with multiple sclerosis who suffer spasticity, pain or spasms are angry at a decision not to licence a cannabis based drug which they say would ease some of their symptoms. Now two years after the licence application was first made the Medicines and Healthcare Products Regulatory Agency - a bit of a mouthful - that's the MHRA and that gives permission for drugs to be prescribed, has rejected an appeal by GW Pharmaceuticals who make Sativex. Now our reporter Carolyn Atkinson is here. Carolyn. ATKINSON Well this all began back in 1998 when the 麻豆约拍 Office first gave permission for cannabis plants to be grown in the UK under licence in secret locations and by 2001 the trials were started on people. Now more than a thousand patients have been taking part and let's be clear about this - this is nothing to do with smoking cannabis or eating cannabis cookies or cannabis chocolates or anything like that, this is a cannabis based spray. It's in a little bottle, you keep it in the fridge, you spray it on your tongue rather like you do with some of those breath fresheners that you can buy from the chemist. Now the drug company takes out the active bit, it's isolated it and consequently there are no highs and no side effects. Now last year I spoke to some people who've been on some of the trials taking place, which incidentally are not just for MS but they're also for pain from spinal cord injury or cancer, I spoke to Jane Shannon from Surrey who's had MS since 1992 and at the time she'd been on the trial for four months. SHANNON I've been spraying through the day once every now and again and it seems to just kill the pain because the thing with MS you get tension pain all down your leg and it relaxes them. ATKINSON So you're using it in a very sort of top up sort of way, you're deciding you've got pain and you take the cannabis and the effect is almost pretty immediate? SHANNON Yes, if I think it's the time of day that I'm going to actually have to do things and I know that I'm going to find it difficult to do it I take the cannabis. I can go round a supermarket and shop, before I was just so stiff and falling over everything, at the moment I'm not. In the last year or so I've basically stopped playing golf because I wasn't up to it or able to do it, but now I feel that I can play again, which to me is a great plus. WHITE Janet Shannon. Now the company making this drug Carolyn, GW Pharmaceuticals, they applied for a licence just on the grounds of spasticity or stiffness, which we now know has been refused, why did they choose that particular ground rather than the ground of pain, which is what a lot of people with MS actually talk about? ATKINSON Well it's very interesting how this process actually works because if you're a drug company you don't just turn up with your drug, knock on the door saying hello we'd like a licence please today, you keep the various organisations in the loop. So the company takes advice, it has suggestions, it has sort of behind-the-scenes chats and it felt at the end of all of this that its best chance was to apply for a licence for spasticity, not for pain, not for spasms. But as we now know it hasn't got it. Now the MHRA say the reason is that they're not happy with the efficacy of the drug, basically they don't think there's enough proof that it actually works. It admits that it is disappointing for many of those 85,000 people in fact in the UK with MS but they say their job is to look at the data, look at the results and the facts and nothing else. Now it says the quality of the drug and the safety of the drug are not problems but the risk benefit relationship is - how they call it - they call it - they say it's not favourable. Basically, there's too much risk for no improvement in symptoms. WHITE So what has been the reaction from the MS community? ATKINSON Well as you might imagine anger, dismay, disbelief - all of the above. The MS Society says that the way that people's symptoms are scientifically measured in a trial like this do not always detect the actual benefit that patients feel on a day-to-day basis as they go about their day. They point to recent figures which show that 43% of patients with MS are currently using cannabis illegally and they say those people say if it was available in a legalised form then 85% of people would do so. So the bottom line is they think, everyone thinks, that cannabis derived drugs, people with MS and the MS Society, they think that cannabis derived drugs improve the quality of life for people and they think the drugs should be licensed. And that is a view shared with Mike Barnes, who's professor of neurological rehabilitation at the University of Newcastle. BARNES I run a multiple sclerosis clinic and a spasticity clinic and I've asked people in the clinic and between 30-40% of those people take illegal cannabis because it helps their symptoms. And indeed that was the case in the Sativex studies themselves, they found that about a third of the people before they started on this study had taken illegal cannabis. So from those statistics I think it clearly shows that the drug works, it does help people with MS, it does alleviate their symptoms. WHITE Mike Barnes. So how long will people now have to wait before a new licence can be applied for? ATKINSON Well more trials are now being started by GW Pharmaceuticals, they need to get new data to present to the MHRA, that won't be finished till around about spring 2006, so it won't be presented to the MHRA until about summer 2006. And then of course it depends on how long the MHRA take to assess it, this time they took about 18 months to come back but of course no one knows how long it'll take second time around. WHITE And in the mean time, interestingly, there is one place in the world, isn't there, which does have the licence. ATKINSON It does yes, Canada has recently given a conditional licence, now that's something we don't have here but they've given a conditional licence, prescribing is imminent for patients in the next few weeks or so and there, interestingly, it's been given the go ahead for pain but not for spasticity. Now for the people in the UK who've been on the trials that have been taking place here there is some good news because they have been given special permission by the 麻豆约拍 Office to continue taking the drug. WHITE Carolyn Atkinson, thank you very much. Back to the Transcripts homepage Back to the You and Yours homepage The 麻豆约拍 is not responsible for external websites

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