Loading

Sativex

  • by Paul Armentano, NORML Deputy Director November 7, 2013

    The results of a first-of-its-kind worldwide survey of nearly 1,000 medicinal cannabis consumers shows that most patients prefer their medicine in the way that nature, not Big Pharma, intended it to be.

    Investigators from Canada, Germany, the Netherlands, and the United States conducted a web-based survey consisting of 21 structured questions to assess patients’ perceptions of different types of cannabinoid-based medicininal products as well as their preferred modes of consumption. Over 950 subjects participated in the survey.

    The study’s findings appear in the Journal of Psychoactive Drugs.

    Overall, subjects said that herbal cannabis preparations were more cost-effective and posed fewer side-effects than cannabis-derived pharmaceuticals. Participants also reported greater satisfaction with inhaled (via either smoking or vaporizing) forms of cannabis products as compared to oral dosing.

    “In general, herbal non-pharmaceutical CBMs (cannabinoid-based medicines) received higher appreciation scores by participants than pharmaceutical products containing cannabinoids,” the study concluded. “[O]ur data suggest that overall there is good satisfaction with whole plant preparations that are affordable and administered in an inhaled manner, or in the form of a tincture.”

    An abstract of the study, “The Medicinal Use of Cannabis and Cannabinoids — An International Cross-Sectional Survey on Administration Forms,” appears online here.

  • by Paul Armentano, NORML Deputy Director July 24, 2012

    [Editor’s note: This post is excerpted from this week’s forthcoming NORML weekly media advisory. To have NORML’s news alerts and legislative advisories delivered straight to your in-box, sign up here.]

    The oral administration of cannabis extracts significantly reduces muscle stiffness in patients with multiple sclerosis (MS), according to just published clinical trial data published in the Journal of Neurology, Neurosurgery & Psychiatry.

    Investigators at the University of Plymouth, Clinical Neurology Research Group, in the United Kingdom assessed the use of cannabinoids versus placebo in 279 subjects with MS over a twelve-week period. Cannabis extracts in the study contained standardized doses of THC and cannabidiol (CBD), a non-psychoactive constituent in cannabis, contained in a soft, gelatin capsule.

    Investigators reported that oral cannabis extracts were “superior” over placebo in the treatment of MS-associated muscle stiffness and pain.

    Authors concluded: “Treatment with standardized oral extract of cannabis sativa relieved muscle stiffness. The proportion of participants experiencing relief was almost twice as large in the cannabis extract group as in the placebo group. … Effective pain relief is also achieved by cannabis extracts, especially in patients with a high baseline pain score. Our findings suggest that standardized cannabis extracts can be clinically useful in treating the highly complex phenomenon of spasticity in MS.”

    In May, clinical trial data published in the Journal of the Canadian Medical Association reported that cannabis inhalation significantly mitigates spasticity and pain in patients with treatment-resistant multiple sclerosis.

    Separate clinical trials assessing the administration of oral cannabis extracts on patients with MS have indicated that cannabinoids can alleviate symptoms of the disease long-term and may also act in ways to mitigate MS progression. Sativex, an oral spray containing plant cannabis extracts, is presently legal by prescription to treat MS-related symptoms in over a dozen countries, including Canada, Germany, Great Britain, New Zealand, and Spain. Nonetheless, the National MS Society of the United States shares little enthusiasm for cannabis as a potential treatment for multiple sclerosis, stating, “Studies completed thus far have not provided convincing evidence that marijuana or its derivatives provide substantiated benefits for symptoms of MS.”

    Full text of the study, “Multiple Sclerosis and Extract of Cannabis: results of the MUSEC trial,” appears in the Journal of Neurology, Neurosurgery & Psychiatry.

  • by Paul Armentano, NORML Deputy Director June 24, 2010

    [Editor’s note: This post is excerpted from this today’s forthcoming NORML weekly media advisory. To have NORML’s media advisories delivered straight to your in-box, sign up for NORML’s free e-zine here.]

    British health regulators have approved the sale and marketing of Sativex, an oral spray consisting of natural cannabis extracts (primarily the plant cannabinoids THC and cannabidiol aka CBD) as a treatment for symptoms of multiple sclerosis. (MS)

    The spray, which has been legally available to patients in Canada since 2005, went on sale in Britain on Monday. The drug will be marketed in the United Kingdom by the Bayer Corporation which estimates that Sativex will cost the country’s state-run National Health Service roughly £11, or about $16, a day for each patient.

    Commenting on the drug’s regulatory approval, NORML Deputy Director Paul Armentano said: “The approval of Sativex in the UK is newsworthy though hardly surprising, as the scientific evidence in support of marijuana’s medical safety and utility has been available for decades. However, the bigger question still remains. That is: ‘How can the US government continue to promote a policy that calls for the arrest and prosecution of patients who use a substance that fourteen states and much of the rest of the western world now acknowledges as a safe and legitimate medicine?’”

    In clinical trials, Sativex has been demonstrated to reduce MS-associated spasticity, pain, and incontinence. Long-term investigational trials indicate that consistent use of the cannabis-based medicine may also slow the progression of the disease.

    Surveys from the UK and elsewhere indicate that MS patients often report using cannabis therapeutically, with one study reporting that some four out of ten patients with the disease find relief from marijuana.

    GW Pharmaceuticals, makers of the Sativex, is expected later this year to seek separate regulatory approval for the spray in Spain, France, Germany, and Italy.

    In 2006, the US Food and Drug Administration authorized recruitment for the first-ever North American clinical trial of Sativex for cancer pain treatment. A Phase III trial is anticipated to begin the US later this year.

  • by Allen St. Pierre, Former NORML Executive Director February 21, 2010

    Where Do You Get ‘It’ From?

    Author: Publius*

    Most patients don’t get asked where they get their medicine. That’s because everyone knows people get their medicine from a pharmacy. But I have to get my medicine otherwise. I have to safeguard my “source” because my medicine is cannabinoid based – and that makes it almost illegal.  – But not today.  Today I can answer the source question openly because it is my local pharmacy – with drive-thru service and open to dispense medicine 24 hours a day. I drive up and push a big, yellow smiley-faced button to gain access – a soft automated voice comes over the speaker to verify that I am in the right place in order to pick up my prescription. Next, the typical professional looking person – white coat with badge – slides open the window asking my name and what I need.

    “I’m picking up a prescription for Publius.”

    They return with a baggie and bottle containing 30 synthetic cannabinoid capsules dosed at 5mg each – that’s right, legal cannabinoids!

    What are cannabinoids? Well, here is where things get interesting. As one learns in biology, the human body has many systems – the circulatory, respiratory, digestive, and nervous systems to name a few. Each system has parts: for example, the nervous system is made up of the brain, spinal cord, and nerves. By the late 1980s, science identified a new human system – the endocannabinoid system (ECS) – also referred to as the cannabinoid system. There is a cannabinoid system present in all mammals – to include humans and 15,000 other species.  A mammal is any vertebrate animal distinguished by self-regulating body temperature, hair, and milk-producing females – as mammal means “breast” or of the breast.

    The ECS has two main parts: cannabinoids, which are chemical neurotransmitters, and two receptors called “CB1” and “CB2.” Cannabinoids activate receptors found throughout the body – in all organs, for example. In fact, all systems in our bodies are modulated by the cannabinoid system. This means that as a body system changes, it uses the ECS to do so.

    Science and popular search sites like Wikipedia use three classifications of cannabinoids:

    1.  Endogenous cannabinoids (also referred to as endocannabinoids), which are produced by the human body

    2.  Herbal cannabinoids, the kind found in the cannabis sativa plant

    3.  Synthetic cannabinoids, produced and distributed by pharmaceutical companies

    The third kind is what I am picking up from the pharmacy – 30 Marinol (Dronabinol) capsules. Marinol is a prescribed cannabinoid from my doctor – and I am going to test it against the herbal cannabinoids I have been baking into my brownies for five years now.

    The pharmacist hands me a white paper bag containing the Marinol prescribed for my Multiple Sclerosis (MS). Stapled to the top is a typical handout with cautionary medical information. The small amount (150mg) of the synthetic cannabinoid THC costs $370 – or more than $69,000 per ounce!

    I sign my name on a distribution sheet and pay my $3 Medicare co-pay. The government, meaning our tax dollars, pays the other $367 for my medicine.  Now I am ready to go – but not before my ‘synthetic cannabinoid’ dealer informs me of possible side effects. She warns me to be on the lookout for – “dizziness, drowsiness, confusion, feeling ‘high,’ an exaggerated sense of well-being, lightheadedness, headache, red eyes, dry mouth, nausea, vomiting, stomach pain, clumsiness, or unsteadiness.”

    Geez – sounds like a lot of potential adversity on my chemically sensitive body.  From personal experience, I know that the herbal cannabinoids do not cause these side effects in my body. The pharmacist did mention one noticeable side effect that I have had with eating cannabis brownies: dry mouth – which is hardly a problem when considering the overall benefits of the medicine.

    When I get home I open the bag to take a look at the Marinol. The pills are a deep maroon color and perfectly round. They remind me of Boston Baked Beans – as they look exactly like those candies. One thing is for sure: synthetic cannabinoids do not look anything like herbal cannabinoids – the ones from the plant itself. The distinct medical difference of popping pills versus the variations and qualities of consuming natural cannabis cannot be understated – and surely won’t be by me. After a week of taking one pill a night before bed, as the doctor prescribed, I do not notice any positive effects from the Marinol. It makes me hungry – but that was never a problem in the first place. However, it is my first legal cannabinoid and that is what counts, right? – Not whether it works, just whether it is legal, right?

    Wrong.

    Here is what I know.  I have been self-medicating with herbal cannabinoids for five years to provide relief from MS, which I have had for 23 years.  During that time I went through the long list of prescribed pharmaceuticals.  The relief was minimal. The problem was (and is) the side effects, which became unbearable over time. I felt like a slave, dependent on a cycle of pharmaceutical use which abused my body and left me in the most depressed, hopeless, and flattened state.

    I finally said enough of the pharma-tinkering with my body and the MS and tried baking herbal cannabinoids into brownies. In doing so, my alternative treatment made me a criminal. I began to eat a small cube of cannabis brownie three times a day. Within the first month my insomnia disappeared, my bladder issues calmed, nerve tingles of the arms, legs, and feet stilled. I was no longer breaking out in upper body tremors after being out in the world of loud noises, traffic, and the everyday racing of life.  The MS was quieter. I found I wasn’t contemplating suicide and I felt hopeful about my life again – but realized I had become a chronic criminal.

    Cannabinoids are clearly medicinal to our bodies. But there is a strange distinction between which cannabinoids are effective and which ones are legal.  In the case of my MS, appetite stimulation has not been a problem – which is what the Marinol is usually prescribed for. Marinol simply did not work for me. There are other pharmaceutical cannabinoids – such as Nabilone and Sativex – available in other countries, but they remain expensive and less effective than herbal cannabinoids.  Nature created cannabis and the mammalian ECS, not you or me – and it was through the use of herbal cannabinoids that I was able to wean myself from a life of pharma-cocktails and move toward a healthier life. – Just as nature designed.

    This is the first chapter of book in progress titled The Cannabis Papers being published by Illinois NORML.

    More chapters are available for review here.

    *Publius is Bryan Brickner, Julie Falco, Dianna Lynn Meyer, Stephen Young, William Abens, Danielle Schumacher, Derek Rea (1954-2008), David Nott, Dan Linn, Dan S. Wang, Brian Allemana, and many others.

  • by Paul Armentano, NORML Deputy Director July 8, 2008

    REMINDER: NORML podcaster Russ Belville and I will be discussing this essay, as well as my previous blog post “US Government Patents Medical Pot,” later today on the NORML Daily Audio Stash. An abbreviated version of my essay appears on Alternet.org here.

    The US government’s longstanding denial of medical marijuana research and use is an irrational and morally bankrupt public policy. On this point, few Americans disagree. As for the question of “why” federal officials maintain this inflexible and inhumane policy, well that’s another story.

    One of the more popular theories seeking to explain the Feds’ seemingly inexplicable ban on medical pot — and the use of cannabis by adults in general — goes like this: Neither the US government nor the pharmaceutical industry will allow for the use of medical marijuana because they can’t patent it or profit from it. A related, yet equally common hypothesis argues: Big Pharma lobbies the federal government to keep pot illegal because it won’t be able to compete with patients growing their own medicine.

    They’re appealing theories, yet I’ve found neither to be accurate nor persuasive. Here’s why.

    (more…)