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TX: 02.08.07 - Sativex

PRESENTER: SHEILA MCCLENNON
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 BBC CANNOT VOUCH FOR ITS COMPLETE ACCURACY.


MCCLENNON
An oral spray derived from cannabis which can alleviate some Multiple Sclerosis symptoms has again been turned down for a licence. Medicines and healthcare regulatory agency - the MHRA - has told the company doing trials on people with MS and similar conditions that it wants more data on the drug's effectiveness. Carolyn Atkinson joins me. Carolyn how did we reach this point?

ATKINSON
Well it's a decade since the Home Office first gave permission for cannabis plants to be grown across the UK under licence in secret locations but of course for years people have been talking anecdotally about the benefits of cannabis on pain caused by things like cancer or MS, for example, and on spasticity. Now in terms of MS it can relieve that terrible pain and the spasms which turn people's limbs completely rigid and other people completely shake violently. So the apparent arrival of this cannabis based drug, which is called Sativex, you spray it under your tongue, it has all the highs taken out of it so it leaves just the active ingredient, the arrival of that was seen as a breakthrough. So cut to the year 2001 and full blown trials started for people with a variety of conditions from MS to spinal cord injury and cancer. Now the owners of Sativex, which are called GW Pharmaceuticals, decided that they would try to get a licence for treating spasticity, they decided not to go for pain. Cut to 2005 and the MHRA refused to give a licence for Sativex and they told the company go off and do some more trials. So that's what they did. This time they involved people with very bad spasticity who actually stayed on any existing treatments they were on and then they added Sativex to those treatments. Now it's this evidence which has just been presented again to the MHRA by three eminent neurologists including Mike Barnes. He's a professor of neurological rehabilitation and he's a consultant neurologist at the University of Newcastle. He's an independent expert and he has told me that he thinks that the MHRA has made the wrong decision.

BARNES
Well I looked carefully through the data and I was really quite convinced that Sativex worked really quite well in this population of people with Multiple Sclerosis. And the reason I say that are these were people with quite marked problems with spasticity. In some people it's completely disabling, people simply cannot move full stop. Most people who have troublesome spasticity enough to need treatment then it is the factor that stops them doing what they want in life, it stops them managing at home, it may stop them dressing, it may stop them washing and it certainly may stop them working.

ATKINSON
So what is your reaction to the news that the MHRA have not accepted this data as being suitable to give this a licence?

BARNES
Well I think it's very disappointing indeed because I think the data was there, the evidence was there that it worked and the evidence was there that it's a very safe drug as well, which is of course an important point. They simply wanted more data to show that it worked. But I think the data is already there which quite well illustrates that it does work and it works well in a significant proportion of people.

ATKINSON
How many of these very badly affected people saw an improvement when they added Sativex to their existing drugs?

BARNES
They were measured on a scale and 20% improvement on that scale was deemed by the people involved to be a useful benefit and half achieved that level. And a 30% improvement in their spasticity was all - everyone agreed was much improved and about a third of people responded at that level.

ATKINSON
Part of the evidence shows that for people for whom it works it works in four weeks, they now want to get more evidence about that particular fact don't they.

BARNES
Yes. The good thing about Sativex is the great majority of people in whom it's going to work - 97% in fact - it will have worked within the first four weeks. So I think it's a very sensible suggestion that people try Sativex for four weeks, if it hasn't worked then they stop and if it has worked they continue. And the MHRA have said go away and do a study on people for four weeks and prove that's the case but I would suggest very strongly that actually the data that exists at the moment supports that case very well indeed.

MCCLENNON
Professor Mike Barnes. But Carolyn the MHRA is still not convinced, what do they say?

ATKINSON
Well they never actually comment on any decisions not least because of a lot of what they do is very commercially sensitive. As for the company involved, GW Pharmaceuticals, they think it's very frustrating for patients but they say they basically have to play by the MHRA rules, they won't criticise the ref they're just getting on with the game. They are positive though in the sense that they feel this could be the last piece in the jigsaw, they sort of know what shape it is, what colour it is, they've just got to find it. That could take maybe a couple of years to do the final set of trials but the company are also ending another trial at the moment - a pain trial - and if that data sort of comes through they may actually present that to the MHRA first, so Sativex could get a licence for pain instead of for spasticity.

MCCLENNON
Carolyn, thank you. And I'm joined by Chris Jones who's chief executive of the MS Trust. Chris the MHRA say the drug's company has failed to prove conclusively that Sativex relieves spasticity, I know you're disappointed but surely if the data isn't there it can't get a licence.

JONES
Yes, well I think the MS Trust's view with Professor Barnes is that the data is there, the evidence is there. Certainly we've already heard about the different symptoms of MS and the pain and the spasticity and I think one of the difficulties when you're looking at the effect of Sativex is that it's actually working in a number of ways. There's this sort of bundle of symptoms, it might be the pain of spasticity - the leg going into spasm in the night - that wakes you up, then you need to go to the loo because that frequency of going to the loo is another symptom of MS which again Sativex seems to have an effect on. Then you lie awake sleepless and the big MS symptom of fatigue – this overwhelming tiredness – obviously if the next day you’ve lost sleep is going again. But we have quite a lot of evidence from people with MS that this is effective. We did a study a couple of years ago with some researchers from Oxford University surveying 160 people with MS who’d been using Sativex for 12 months plus and 94 percent of them had improved symptoms across the board. And around a fifth, over the course of the 12 months, had actually stopped using some of the walking aids that they had been using: walking stick, wheelchair and so on. So we feel that is quite significant.

MCCLENNON
Chris Jones thank you for joining us we will return to this subject in the future – thank you.

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