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.

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.

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.

First, let me state the obvious. Big Pharma is busily applying for — and has already received — multiple patents for the medical properties of pot. (The US government has too, but that’s a different story all together.) These include patents for synthetic pot derivatives (such as the oral THC pill Marinol), cannabinoid agonists (synthetic agents that bind to the brain’s endocannabinoid receptors) like HU-210 and cannabis antagonists such as Rimonabant. This trend was most recently summarized in the NIH paper, “The endocannabinoid system as an emerging target of pharmacotherapy,” which concluded, “The growing interest in the underlying science has been matched by a growth in the number of cannabinoid drugs in pharmaceutical development from two in 1995 to 27 in 2004.”

In other words, at the same time the American Medical Association is proclaiming that pot has no established medical value, Big Pharma is in a frenzy to bring dozens of new, cannabis-based medicines to market.

Not all of these medicines will be synthetic pills either. Most notably, GW Pharmaceutical’s oral marijuana spray, Sativex, is a patented standardized dose of natural cannabis extracts. (The extracts, primarily THC and the non-psychoactive, anxiolytic compound CBD, are taken directly from marijuana plants grown at an undisclosed, company warehouse.)

Does Big Pharma’s sudden and growing interest in the research and development of pot-based medicines mean that the industry is proactively supporting marijuana prohibition? Not if they know what’s good for them.

First, any and all cannabis-based medicines must be granted approval from federal regulatory bodies such as the US Food and Drug Administration — a process that remains as much based on politics as it is on scientific merit. Chances are that a government that is unreasonably hostile toward the marijuana plant will also be unreasonably hostile toward sanctioning cannabis-based pharmaceuticals.

A recent example of this may be found in the Medicine and Health Products Regulatory Agency’s recent denial of Sativex as a prescription drug in the United Kingdom. (Sativex’s parent company, GW Pharmaceuticals, is based in London.) In recent years, British politicians have taken an atypically hard-line against the recreational use of marijuana — culminating in Prime Minister Gordon Brown’s declaration that today’s pot is now of “lethal quality.” (Shortly thereafter, Parliament elected to stiffen criminal penalties on the possession of the drug from a verbal warning to up to five years in jail.)

In such an environment is it any wonder that British regulators have steadfastly refused to legalize a pot-based medicine, even one with an impeccable safety record like Sativex? Conversely, Canadian health regulators — who take a much more liberal view toward the use of natural cannabis and oversee its distribution to authorized patients — recently approved Sativex as a prescription drug.

Of course, gaining regulatory approval is only half the battle. The real hurdle for Big Pharma is finding customers for its product. Here again, a culture that is familiar with and educated to the use therapeutic cannabis is likely going to be far more open to the use of pot-based medicines than a population still stuck in the grip of “Reefer Madness.” (For example, Marinol, despite having been approved by the FDA in 1986, was rescheduled so that doctors might prescribe it more liberally in 1999 — three years after California and other states began approving medical marijuana use legislation. Coincidence? I doubt it.)

Will those patients who already have first-hand experience with the use of medical pot switch to a cannabis-based pharmaceutical if one becomes legally available? Maybe not, but these individuals comprise only a fraction of the US population. Certainly many others will — including many older patients who would never the desire to try or the access to obtain natural cannabis. Bottom line: regardless of whether pot is legal or not, cannabis-based pharmaceuticals will no doubt have a broad appeal.

That said, many argue that the legal availability of pot would encourage patients to use fewer pharmaceuticals overall and significantly undercut Big Pharma’s profits. To a minor degree this may be a possibility, though likely not to an extent that adversely impacts the industry’s bottom line. Certainly most individuals in the Netherlands, Canada, and in California — three regions where medical pot is both legal and easily accessible on the open market — use prescription drugs, not cannabis, for their ailments. Further, despite the availability of numerous legal healing herbs and traditional medicines such as Echinacea, Witch Hazel, and Eastern hemlock most Americans continue to turn to pharmaceutical preparations as their remedies of choice.

Should the advent of legal, alternative pot-based medicines ever warrant or justify the criminalization of patients who find superior relief from natural cannabis? Certainly not. But, as the private sector continues to move forward with research into the safety and efficacy of marijuana-based pharmaceuticals, it will become harder and harder for the government and law enforcement to maintain their absurd and illogical policy of total pot prohibition.

Needless to say, were it not for advocates having worked for four decades to legalize medical cannabis, it’s unlikely that anyone — most especially the pharmaceutical industry — would be turning their attention toward the development and marketing of cannabis-based therapeutics. That said, I won’t be holding my breath waiting for any royalty checks.

So, if Big Pharma isn’t a significant player in the ongoing prohibition of the personal use of cannabis, then who is responsible? Based on my experience, the answer is obvious. First and most importantly, there’s federal government — as represented not only by the lawmakers who continue to vote in favor of America’s Draconian drug policies, but also the numerous acronymn ladened bureaucracies (such as the ONDCP, NIDA, etc.) who actively lobby against any change in direction.

The second most powerful player in maintaining pot prohibition? That’s easy: law enforcement, as represented by bigwigs like the US Drug Enforcement Administration and the California Narcotics Officers Association, all the way down the line to small-town police forces — all of whom consistently finance efforts to derail any relaxation of federal, state, or local marijuana policies.

The third and final primary player responsible for maintaining modern-day pot prohibition? Unfortunately, that would be us, the general public — a majority of whom have repeatedly voiced disapproval for legalizing the use personal use of pot by adults in both national polls and on statewide ballot initiatives, most recently in Colorado and in Nevada in 2006. (By contrast, more than half of Americans do support — and have consistently voted for — legislation in support of the qualified medical use of cannabis by authorized patients.)

In short, until there is a significant sea-change in the attitudes and actions of the Feds, cops, and the general public, expect prohibition — particularly the broader prohibition on the recreational use of cannabis — to continue.