Sunday, 29 June 2014

The real life effect of Sativex

Flachenecker P, Henze T, Zettl UK. Long-Term Effectiveness and Safety of Nabiximols (Tetrahydrocannabinol/Cannabidiol Oromucosal Spray) in Clinical Practice. Eur Neurol. 2014 Jun 18;72(1-2):95-102. [Epub ahead of print]

Background: Nabiximols (Sativex®), in a cannabinoid-based oromucosal spray, is an add-on therapy option for patients with moderate to severemultiple sclerosis spasticity (MSS) resistant to other medications. The study objective was to provide long-term data on clinical outcomes, tolerability, quality of life and treatment satisfaction for MSS patients receiving nabiximols in routine care. Methods: This was the 12-month prolongation of the MOVE 2 study, an observational, prospective, multi-centre 3-month non-interventional study conducted in a routine care setting across Germany. Structured documentation forms, questionnaires and validated instruments were used for data collection. 

Results: In total, 52 patients were included in the effectiveness analysis after 12 months. The mean spasticity numerical rating scale (NRS, 0-10) score decreased significantly from 6.0 ± 1.8 points at MOVE 2 baseline to 4.8 ± 1.9 points after 1 month and remained on this level after 12 months (4.5 ± 2.0 points); in patients classified as 'initial responders' (≥20% NRS improvement after 1 month) similar results were found (baseline: 6.3 ± 1.4 points; after 1 month: 4.0 ± 1.0 points; after 12 months: 4.3 ± 1.9 points). The majority of patients (84%) did not report adverse events. 
Conclusion: Real-life data confirm the long-term effectiveness and tolerability of nabiximols for the treatment of resistant MSS in everyday clinical practice.
Yet more evidence for some effect of Sativex in the people hat respond to the drug. There were 16% reporting adverse events. The central problem for the UK is not the benefit that needs to be shown but that the drug is cost effectiveness, otherwise it will always have problems in UK PLC. 

Furthermore maybe this cost will be the problem in North America...because of cheaper "unregulated" competition


There are numerous Hemp growing operations springing up especially in Canada and Colorado where the possession/growing is becoming accepted. 


Unlike pharma cartels, there is market competition apparently going on and the cost of medicinal pot is tumbling. 

Add to this the lack of requirement to demonstrate real efficacy for medicinal purposes,like other nutricienticals, then real pharma is going to have their work cut out to get their foot in to the medicinal cannabis market. 


The number of pot growers stating that they know it works because they use it themselves (say no more) and the effects are always remarkable....Much of it sounds however frankly unbelievable. There are millions of people using cannabis and if cannabis could really reverse (I am not saying their is no benefit..but cures?) disease conditions...the proof would be there or easy to come by. They sound like (bad) used car salesmen, who would sell their gran for a quick buck. 

The failures of academic neuros to show benefits from THC in progression (CUPID) may have probably killed off interest in research in this area room a pharmaceutical perspective. 

However because of the wide availability and use of marijuana, outside of pharma, suggests that it would be worth further investigating the effects on progression, where the majority of research suggests a neuroprotective potential.


It is clear that some components of cannabis can compete to stop this benefit being realised. Would you want to know which mix of components offer benefit...This needs real data not the hear say from pot shops. 


What is the merit say of a 1:1 mix of Cannabidiol over tetrahydrocannabinol say compared to 20:1 or no cannadidiol. It is claimed that CBD reduces the side effects of THC...so why therefore would it not reduce the therapeutic effects? Where's the data, where's the biology.


CoI: We are developing in a competing product.

8 comments:

  1. Sativex is cannabis. Surely we are now past the disinformation campaign which tried to portray it as some sort specialist pharmaceutical preparation containing only THC and CBD? Dr Geoffrey Guy acknowledges openly that it contains all 400+ compounds found in the plants from which it is made.

    GW grows cannabis to the very highest standards and uses a very sophisticated CO2 extraction technique that maximises yield and results in thoroughly decarboxylated cannabinoids but all this come at a massive cost.

    Here an analysis of comparative costs of Sativex, street cannabis and Bedrocan, the Dutch government's approved producer of medicinal cannabis: http://www.clear-uk.org/fascinating-facts-about-the-sativex-rip-off/

    Your dismissal of the vast amount of evidence of the therapeutic effects of cannabis is best skipped over to save your embarrassment.

    Sativex is a fantastically expensive version of what is a very inexpensive medicine. It's an excellent product but it has been constrained by ridiculous, paranoid, over-regulation of a substance that is less harmful than coffee.

    The difference between Sativex and other medicinal cannabis options is like the difference between growing your own tomatoes, buying them from a supermarket, a farm shop or as a processed puree or passata.

    GW has developed fantastic expertise in cannabinoid medicine. You only have to look at its product pipeline to realise how misplaced and inappropriate your remarks about used car salesmen are. Certainly there are evangelists but that's hardly surprising when for 80 years people have been denied access to a medicine that we know had been used safely and effectively for 10,000 years beforehand.

    The price of Sativex must be cut at least by three-quarters. Then we will see its true potential and worth.

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    1. What we dismiss is pseudo science. What we need to see if hard experimental data, rather that here say. I believe cannabinoids have many therapeutic actions. Could it be the Aspirin of the 21st century, however if we believe rheotoric the stoners it does everything..fine but lets see the evidence.

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    2. "Your dismissal of the vast amount of evidence of the therapeutic effects of cannabis is best skipped over to save your embarrassment."
      No embarrassment here, we were the first to definitively prove the therapeutic effects of cannabis on spasticity and subsequently neurodegeneration. We go with data rather than anecdote, which is no data.
      GW came up with the 1:1 THC/CBD gimmick so that Sativex could be patented, simple as.
      They've priced it too high for it to be widely prescribed so they've now moved onto CBD for epilepsy.
      The now increasingly widespread availability of medicinal cannabis in the US and increasingly other countries will in my opinion shove Sativex further onto the sidelines. There will be better agents coming on stream (hopefully including our own, which will be efficacious but with none of the side effects associated with either cannabis or Baclofen.

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  2. I agree that cannabis offers great potential to reduce symptoms. I want to be free to explore what works for me without threat of being criminalized (UK). It was reported in Medical News Today that cannabis is anti-inflammatory. Please research this!

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    1. We have researched this and while it is true that at very high doses (in mice) cannabis can be anti-inflammatory the bad news is that you would be permanently in a coma (mice are rather more resilient than we are) at these doses.
      On a positive note we have also found that at much lower doses cannabis is neuroprotective (again in mice). This wasn't shown in the UK CUPID clinical trial but it was done badly (too many of the wrong patients too advanced in their EDSS were studied) so still think this is correct. Sadly the prospects of another trial repeating this and being done properly are remote.

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    2. It may well be that cannabis requires high dosing to be anti-inflammatory in mice but that is certainly not the case in humans. Many people who suffer from rheumatoid arthritis have found very small doses of cannabidiol (CBD) rich strains of cannabis to be very effective in reducing RA pain and inflammation. These are the same very small doses that are so effective against neuropathic pain.

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    3. We are mixing messages, you are talking about symptomatic control and this is different from immunosuppression and disease modifying activity MD2 is talking about and it is different from neuroprotection. Anti-inflammatory can mean different things and we can't lump it all together.

      Yes there are reports of cannabis affecting pain in arthritis (e.g.http://www.2ndchance.info/marijuana-Blake2006.pdf) but where is the hard evidence that CBD is the mediator of the effect. Many so called CBD rich varieties still contain massive amounts of THC.

      We have a paper showing that CBD is not inert.

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  3. Thanks for the info & doing what you can.

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