Thursday, April 12, 2012 -

    The Sativex Scam Becomes A Scandal

    Laurel Bush

    Laurel Bush,  a CLEAR member, is working diligently and courageously on exposing the truth about Sativex and the dishonest and corrupt relationship between GW Pharmaceuticals and the Home Office.  Now it seems that the Medicines and Healthcare products Regulatory Agency (MHRA) is becoming a co-conspirator.

    Having previously recognised Sativex as cannabis and therefore a schedule 1 drug “with no medicinal value”, it has now decided that Sativex isn’t cannabis at all!  See here for Laurel’s work with Freedom of Information requests which has exposed the dishonesty at the heart of government.  His tenacity is magnificent and he is owed a huge debt of gratitude from all those who need cannabis as medicine.

    What brings this issue to the fore again is the pressing need for the Home Office to re-schedule Sativex (also known by the non-proprietary  name of Nabiximols) under the Misuse of Drugs Act 1971 (MoDA).   Professor Les Iversen, chair of the Advisory Council on the Misuse of Drugs (ACMD), wrote to the Home Office in January 2011 advising that it be placed into schedule 4.  This hasn’t happened yet because the Home Office is desperately seeking a way falsely to distinguish Sativex from cannabis.  Now it seems it’s trying to inveigle more people into its deception.

    I have written to Professor Sir Kent Woods, chief executive of the MHRA, asking him to take action to protect the integrity of the agency and to ensure the truth about Sativex is made clear.

    Prof. Sir Kent Woods

    Dear Sir Kent,

    Sativex (Nabiximols)

    I am the elected leader of Cannabis Law Reform (CLEAR), a registered UK political party that seeks an end to the prohibition of cannabis, most urgently for those who need it as medicine.

    I am extremely concerned at the response by Sue Jones, your corporate policy official on 15th March 2012 to an FOI request concerning the ingredients of Sativex (your reference 12-065).

    Ms Jones wrote:

    “…the active elements of this drug are not cannabis, but two constituents found in the cannabis plant that have been found to have pharmacological properties for treating these specific indications. An “active constituent” means it has the pharmacological activity to treat the proposed indications. Since the product is derived from elements in the cannabis plant, rather than the cannabis plant itself, it should be clear therefore that Sativex is not “cannabis”.

    This is entirely false. It is nonsense.

    It is within the public domain that Sativex is an whole plant extract manufactured by blending two strains of herbal cannabis and using a CO2 extraction process to produce a tincture which also contains ethanol, propylene glycol and peppermint oil. Sativex is cannabis and contains all the cannabinoids, terpines and flavonoids present in the plants from which it is made.

    Dr David Potter

    David Potter, Director of Botanical Research and Cultivation at GW Pharmaceuticals, explains why the minor ingredients of cannabis are so important to the efficacy of Sativex in his thesis: http://www.gwpharm.com/uploads/phd_david_potter_jp.pdf

    Dr Geoffrey Guy

    Dr Geoffrey Guy, founder and executive chairman of GW, is on the record saying:

    “Most people in our industry said it was impossible to turn cannabis into a prescription medicine. We had to rewrite the rule book. We have the first approval of a plant extract drug in modern history. It has 420 molecules, whereas every other drug has just one.”

    GW Pharmaceuticals and the Home Office are presently engaged in an unlawful conspiracy falsely to distinguish Sativex from cannabis in order that the tincture can be re-scheduled into schedule 4 of the Misuse of Drugs Act 1971 leaving herbal cannabis in schedule 1. This is dishonest and corrupt.

    Please can you reassure me that the MHRA is not party to this attempted deception?

    I would ask that you issue a correction to Ms Jones’ response. The truth about Sativex and cannabis is of far more importance than any attempt at disinformation in order to support the government’s failed and dishonest policy of prohibition.

    The Home Office position that “there is no medicinal value in cannabis” is a lie and I call on you to ensure that the MHRA deals only in the truth.

    Kind regards,

    Yours sincerely,

     Peter Reynolds

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    Related news:

    1. The Truth About Sativex
    2. The Sativex Scam part 1
    3. BBC Taken In By The Sativex Scam.
    4. The Sativex Scam part 2.5
    5. The Sativex Scam part 2
    • a quiet man

      great work keep at it the truth will out

    • http://www.facebook.com/profile.php?id=550210336 Alex Walters

      420? coincidence? i think not.

    • http://www.facebook.com/people/Maharg-Smith/831904195 Maharg Smith

      i too applaud laurel bush and thank him for his terrier like ability to flush the lying rats out …i quote bob marley to the home office “if you are a big big tree we are a small axe”

    • http://www.facebook.com/people/Joshua-Riding/100000026569298 Joshua Riding

      WE A GUNNA CHOP THEM DOWN WE GUNNA CHOP THEM DOWN TUNEAGE

    • steve a

      I despair sometimes I really do.  Here you have a company with patent protected product all wrapped and ready to go and a world wide market opening up for it the week after next which they are set to make an absolute fortune from and they can’t even sing from the same hymn sheet. 

      Somebody should be telling their shareholders.
       

    • Focusonpeace

      It seems like an uphill battle…I guess Truth is treason in the Empire of lies

    • http://www.facebook.com/people/Maharg-Smith/831904195 Maharg Smith

       ready and sharp to cut you down.   as lord bob would say

    • 6_0_4

      420=fraud)

    • 6_0_4

      420=fraud)

    • http://www.facebook.com/people/Dan-Ford/1450969824 Dan Ford

      Superb work Laurel. This has set me thinking……. has anyone been arrested or cautioned or charged for possessing Sativex without a prescription? If there has already been such a case, what exactly was the charge?

    • stickybud

      Brilliant work, Peter and Laurel.

      Surely, this has got to break into the mainstream before long; then the brown stuff should start to impact the rapidly-spinning blades as the embargo on the truth about cannabis breaks down.

      Have you issued a press release?
      I reckon the Independent could make some reparations by picking this up.

    • stickybud

      Excellent articles on your site, Laurel.

    • cshaws

      I sent this a couple of weeks ago:  
      Sirs
      Whilst doing some research on a product called Sativex, which is a whole plant extract of the cannabis plant, I came across this quote from someone called Sue Jones, who I believe is an MHRA employee, in an answer to a recent FOI enquiry:”The details of the PAR show that the active elements of this drug are not cannabis, but two constituents found in the cannabis plant that have been found to have pharmacological properties for treating these specific indications. An “active constituent” means it has the pharmacological activity to treat the proposed indications. Since the product is derived from elements in the cannabis plant, rather than the cannabis plant itself, it should be clear therefore that Sativex is not “cannabis””This statement is wholly inaccurate and extremely misleading. Can you confirm that this comment does not reflect the official stance of MHRA on Sativex and that Ms Jones has been instructed to correct the statement.Dr Geoffrey Guy, founder of GW Pharmaceuticals who manufacture Sativex, is quoted as saying: “We have the first approval of a plant extract drug in modern history. It has 420 molecules, whereas every other drug has just one.” i.e. ALL the active molecular components of cannabis.I got this response today:

      Thank you for your email of 19 April 2012 concerning Sativex, and the statement made by Sue Jones in the MHRA’s internal review of FOI request 12/065.Firstly, just to be absolutely clear, when the term “cannabis” was used in the review document it was, of course, referring to Cannabis herb.With regard to the statement that Sativex is not the same as cannabis, the following observations can be made with regard to the licensing of Sativex. Sativex oromucosal spray contains the two cannabinoids, THC and CBD, as the major components of the active ingredients, in standardised amounts (i.e. each millilitre (ml) of Sativex oromucosal spray must contain 27 mg THC and 25 mg CBD, in line with the requirements of the marketing authorisation). It also contains other cannabinoids and plant constituents extracted from the Cannabis leaves and flowers, in minor amounts. The process is controlled to remove impurities to a level that assures the purity and safety of the final extract. The cannabinoid composition will be similar to Cannabis herb, but the actual quantities will be very different, as is the method of delivery (Cannabis herb is generally intended to be smoked and absorbed through the lungs, but Sativex is designed to be absorbed by the oromucosal area).Regarding statements from the marketing authorisation holder of Sativex, GW Pharma’s official website clearly states:- that Sativex “is composed primarily of a 1:1 ratio of two cannabinoids-CBD (cannabidiol-a non-psychoactive cannabinoid) and THC (delta-9-tetrahydrocannabinol)”In addition to the above, the MHRA has produced a public assessment report for Sativex, which was reviewed by the marketing authorisation holder (GW Pharma Limited). In the public assessment report, we make it clear that Sativex is composed of the above-mentioned two extracts of Cannabis sativa L. The MHRA’s clinical assessment of Sativex is also published in this public assessment report and clearly shows that the levels of effects typically observed with recreational use of herbal cannabis, including “euphoric mood”, “disorientation” and “anxiety”, occur in low frequencies with Sativex treatment. A copy of this public assessment report can be obtained at:http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con084961.pdfIt is for the above reasons that we do not consider Sativex to be the same as Cannabis herb…….

      Tosh. Now …… do I write back and ask what these ‘impurities’ are and what makes them think that ‘cannabis herb is generally intended to be smoked’.  Also does ‘minor amounts’ mean the same amounts that occur in the raw plant relative to the CBD / THC content?  

    • cshaws

      I was thinking about the reply from MHRA (previous post) in the early hours and it seems to me that the key phrase in their somewhat waffly reply is this single statement >> ”
      The process is controlled to remove impurities to a level that assures the purity and safety of the final extract.” .   So the difference between ‘harmful’ raw herb and a safe and pure extract, according to the MHRA, is solely down to these unidentified ‘impurities’.    Now, thus far, the government has maintained that the harmful effects of cannabis herb are, primarily, down to the high levels of THC present in ‘modern’ strains of skunk.  This government thinking is further evidenced by the 0.03% THC cut off point for industrial cannabis, anything containing higher than 0.03% THC is deemed Class B.  But now it seems that the blame for the alleged harms lies not with THC but with these mysterious ‘impurities’.   This danger must have been established as part of the R&D process for Sativex when these ‘impurities’ were identified as harmful compounds and a process developed to remove them.   The government therefore must know that these components are the real cause for concern – so why haven’t they announced this?  Surely they could quite easily and robustly defend their prohibitionist corner if it has been scientifically proven that these ‘impurities’ cause some, as yet, unannounced harm to the human organism. Moreover, surely they have an urgent duty of care to instruct all health centred organisations in these new found (since 1998) dangers so that the public at large can be properly informed of such dangers.  Especially in the case of children.  If these claims of ‘unsafe impurities’ are true it will have a dramatically negative effect on our cause and will negate thousands of man years of research into the benefits of cannabis, none of which, as far as I can ascertain, have identified any harmful impurities.   Where do I go from here?  

    • http://www.peter-reynolds.co.uk Peter Reynolds

      To be honest cshaws, I don’t think they know what they’re saying.  I think they’re just flapping about, trying to bluster their way out of a corner.  I think you’re absolutely right to go back and challenge them about these dangerous, psychosis-causing impurities.

      I chased up the MHRA about a reply from Sir Kent a week or so ago and it looks like one is on its way.

      I’m also talking to a forensic laboratory about an independent expert analysis of what Sativex is.

    • steve a

       I do feel a little sorry for GW, they know exactly what it is they are selling and to whom they want to sell it and are stopped by the stupidity of politicians trying very hard to be “wilfully ignorant”.

      You are not going to get the cannabis debate very far with what you are doing but it is worth continuing.  If only to send the message (like it needs sending) that in the internet age, every single word a politician and his cronies, speaks writes or signs is under close public scrutiny and if they cannot do accuracy then they will eventually get caught.

    • cshaws

      I have emailed MHRA again today asking them to identify these ‘impurities’ and pointing out to them that, based on their slogan “Safeguarding Public Health’ they have a duty of care and vicarious responsibility to all advocates of medicinal cannabis, all users of cannabis and all dispensers of medicinal cannabis around the world to reveal the nature of the impurities and what harms they are perceived or proven to cause. 

    • cshaws

      MHRA have opened a new FOI request based on my latest enquiry:  

      Dear SirThank you for your response.  I think you generally agree with me that Ms Jones’ original statement was inaccurate and that Sativex contains pure extracts of the cannabis plant and not constituents “derived from elements in the cannabis plant, rather than the cannabis plant itself” . In my view, however, your reasoning still does not differentiate herbal cannabis from the liquid extract based on known facts: 1 You say “ It also contains other cannabinoids and plant constituents extracted from the Cannabis leaves and flowers, in minor amounts…” – this is no different to any cannabis plant where the majority of cannabinoids, and other non-cannabinoid constituents, occur in lesser quantities than the primary constituents CBD and/or THC depending on the variety. 2.    ”The cannabinoid composition will be similar to Cannabis herb, but the actual quantities will be very different….” . Actual quantities will be different to what?  The Public Assessment Report that you reference states (Pg 29) that two plant varieties are grown – one high THC and one high CBD.  A blend of two extracts from two distinct cloned varieties of cannabis herb certainly makes the final blend different to either of the original two but blending does not alter the nature of the key constituents it merely alters the ratio in the final blend.The only statement that actually does make a differentiation, between the contents of the raw herb and the bottled extract, is contained in your response as follows:  ”…The process is controlled to remove impurities to a level that assures the purity and safety of the final extract. ” .  This would appear to be the key distinguishing feature, which renders Sativex a safer product than herbal cannabis, by chemically differentiating the final extract from the original source plant.  I have checked the GWP site and searched for the word impurity / impurities and can find no mention. However, on page 30 of the Public Assessment Report, that you kindly provided a link to, it states that “All potential impurities have been identified and characterised. Appropriate characterisation of the herbal preparation has been undertaken and appropriate specifications have been provided”.   As a keen advocate of the medicinal properties of herbal cannabis I would be very interested to know what these impurities are and, far more importantly, what harms they cause.  The PAR document implies that specifications of these impurities will have been provided to you as part of your safety assessment process.  As the first heading in the PAR report states your key departmental objective is ‘Safeguarding Public Health’.  I’m sure you will agree that you have a duty of care, and a vicarious responsibility, to all advocates of medicinal cannabis, all medicinal users of cannabis, all recreational users of cannabis and all medicinal cannabis dispensaries around the world , to reveal what these impurities are and what harms they cause.  Could you please send me copies of the documents characterising these impurities and their perceived and/or proven harms or advise me whether I need to raise a further FOI request in order to obtain this information. Thank you for your time.

    • http://www.peter-reynolds.co.uk Peter Reynolds

      You’re a terrier cshaws!  I’ve had a reply from Sir Kent, the MHRA CEO which I will post tomorrow.

    • http://www.facebook.com/people/Maharg-Smith/831904195 Maharg Smith

       Well done that man  bit of an OWZAT situation lol

    • cshaws

      I was thinking more ‘own goal’!  This one could run and run. Then, of course, they’ll pull out the ‘vexatious’ card. It’s all getting very predictable.  On the other hand they might tell the truth ………… Whichever way, my MP will be getting another epistle.  

    • cshaws

      A reply !  So having told me that the only apparent difference between Sativex and herb are some mysterious impurites that are removed in processing, they are now saying that Sativex still contains these ‘impurities’ and they have a list of them!  But it is commercial in confidence so I can’t have a copy.  Also their duty of care only extends to the approval of Sativex (cannabis extract + impurities) and not to herbal cannabis (cannabis + impurities) ????  Here’s the reply:  

      Our
      ref: FOI 12/207 – Identity of impurities and the harm they cause in
      Sativex
      Oromucosal
      Spray (PL 18024/0009).

      I
      am writing in response to the above request made under the Freedom of
      Information Act (FOIA)
      on 14 May 2012 for the above information.
      As
      we have stated in the Public Assessment Report, Sativex contains a
      combination of two
      extracts from Cannabis sativa L. leaves and flowers, equivalent to 27
      mg/ml
      delta-9-tetrahydrocannabinol
      (THC) and 25 mg/ml cannabidiol (CBD).
      Two
      plant varieties are grown; one that contains higher levels of THC and
      one that contains
      higher levels of CBD. Dried, milled herb from the high-THC and
      high-CBD plants
      are extracted with liquid carbon dioxide, and are further processed
      and controlled separately
      to yield the two distinct extracts needed to make the finished
      product.
      The
      resulting Cannabis extracts contain predominantly a major cannabinoid
      (THC or CBD),
      but also contain the other cannabinoids as well as other plant
      constituents extracted from
      the cannabis leaves and flowers, in minor amounts.
      In
      accordance with EU guidelines, the total extracts are considered as
      the ‘active ingredients’
      of the product. In addition, the extracts comply with the
      requirements for
      standardised
      extracts and the product complies with the guidelines for declaration
      of herbal
      extracts in the product information.
      With
      respect to impurities in herbal extracts this would generally refer
      to residual solvents,potential
      contaminants or degradation products. The Sativex product meets all
      current guidelines
      for potential impurities.
      EU
      guidelines for medicinal products can be found on the website of the
      European Medicines
      Agency (www.ema.europa.eu). The key guidelines for herbal medicinal
      products
      are included for ease below. The requirements of the European
      Pharmacopoeia apply
      to herbal medicinal products, and this includes controls and limits
      for contaminants
      -
      such as heavy metals, pesticides, microbial contamination, etc.
      http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/09/WC500113209.pdf
      http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003272.pdf
      http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/09/WC500113210.pdf
      http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/03/WC500104258.pdf
      The
      MHRA does hold a list of impurities contained in Sativex Oromucosal
      Spray
      (PL
      18024/0009). However, this information is exempt from release under
      Section 43 of the
      FOIA (Commercial interests). We believe that the release of this
      information into the public
      domain would aid a competitor company’s product development such
      that they
      would
      be able to get a similar product to market quicker and at less cost.
      Having
      considered the public interest, the Department’s decision is,
      therefore, to withhold the
      information. Regarding your statement concerning the MHRA’s duty of
      care, this duty of
      care is to safeguard public health with regard to licensed medicinal
      products. This
      includes
      Sativex Oromucosal Spray (PL 18024/0009), which is a licensed product
      in the UK.
      This does not include herbal cannabis, which is not licensed for use
      as a medicinal product
      in the UK. Further to this, cannabis in its raw form is a Class B
      drug under the
      Misuse
      of Drugs Act 1971 and listed under the Misuse of Drug Regulations
      2001 because its
      medicinal value is currently not recognised.
      I
      now consider this FOI request to be answered. If you have a query
      about this letter, please
      contact me using the email listed below. If you are unhappy with our
      decision, you
      may
      ask for it to be reviewed. That review will be undertaken by a senior
      member of staff at
      the Agency who has not previously been involved in your request. If
      you wish to pursue
      that option please write to the Communications Directorate, Area 4-T,
      Medicines
      and
      Healthcare products Regulatory Agency, at the above address quoting
      reference FOI
      12/207. After that, if you remain dissatisfied, you may ask the
      Information
      Commissioner at
      The
      Information Commissioner’s Office, Wycliffe House, Water Lane,
      Wilmslow,
      Cheshire,
      SK9 5AF………………   so there you go — utter garbage.

    • cshaws

      I asked if they could at least identify the nature of the impurities (i.e. naturally occurring or added during processing) and what is the current status of sativex under the MoDA.  This is the response (they don’t seem to realise that GW has no competitors !)  I’m giving up on this one now but they seem to have finally agreed that sativex is cannabis – period. 

      Our ref: FOI 12/248 – Two further questions concerning Sativex Oromucosal Spray(PL 18024/0009).I am writing in response to the above request made under the Freedom of Information Act (FOIA) on 29 June 2012 for the above information.Regarding your first question on the types of impurities contained within the aboveproduct, the MHRA does hold a list of impurities contained in Sativex Oromucosal Spray(PL 18024/0009). However, this information is exempt from release under Section 43 ofthe FOIA (Commercial interests). We believe that the release of this information or anindication of the types of substances listed therein would aid a competitor company’sproduct development such that they would be able to get a similar product to marketquicker and at less cost.Regarding your second question on its classification, Sativex is recognized as a Schedule 1 controlled drug, according to the Misuse of Drugs Regulations 2001. However, it should be noted that the Home Office has issued an open general licence for the product.This removes the legal requirement for doctors, pharmacists and patients to apply forindividual licences with the Home Office in order for it to be prescribed, dispensed andpossessed, respectively.It is worth noting that the scheduling of Sativex has been considered by the AdvisoryCouncil on the Misuse of Drugs (ACMD). For further information on this subject pleaserefer to the Home Office directly as this falls outside the remit of the MHRA.http://www.homeoffice.gov.uk/acmd1/sativex-letterI now consider this FOI request to be answered. If you have a query about this letter,please contact me using the email listed below. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of staff.  

    • ChristopherSawtell

      ” … It has 420 molecules, whereas every other drug has just one.”

      Four hundred and twenty molecules – fact is sometimes absolutely hilarious.

    • http://twitter.com/SkylonRow Ben Orrin

      This is an absolute shambles, they can’t even maintain the same story. We need to press our MP’s and officials and make our voices heard, failing that we need to raise the money to take this to the high court.

    • http://www.facebook.com/gavman289 Gavin O’Connell

      don’t hold your breath…the independent is little better than the daily mail these days