Over 2,500 Subjects Since 2005 Have Used Marijuana-Based Medicines In Controlled Clinical Trials

[Editor's note: This post is excerpted from this week'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.]

Researchers worldwide have performed 37 separate clinical trials assessing the therapeutic safety and efficacy of inhaled cannabis and marijuana-based medicines since 2005, according to a review published online last week in the journal Cannabinoids: The Journal of the International Association for Cannabinoid Medicines (IACM).

Investigators from Leiden University in the Netherlands and the nova-Institut in Germany conducted a systematic review of recent clinical trial data pertaining to the medical use of whole smoked marijuana and cannabinoids.

Authors identified 37 controlled studies since 2005 evaluating the therapeutic effects of cannabinoids. The trials involved a total of 2,563 subjects.

Of the 37 clinical trials that have been recently conducted, eleven assessed the drug’s impact on chronic neuropathic pain – a difficult to treat type of pain resulting from nerve damage. Other studies assessed the efficacy of cannabinoids to treat multiple sclerosis-associated spasticity (nine separate studies); HIV/AIDS (four); experimental pain (four); intestinal dysfunction (two); nausea/vomiting/appetite (two); schizophrenia (two); glaucoma (one); and ‘other indications (two).

Authors concluded, “Based on the clinical results, cannabinoids present an interesting therapeutic potential mainly as analgesics in chronic neuropathic pain, appetite stimulants in debilitating diseases (cancer and AIDS), as well as in the treatment of multiple sclerosis.”

Last Wednesday investigators from the California Center for Medicinal Cannabis Research released the results of a series of double-blind, placebo-controlled trials that determined that cannabinoids could be “a first-line treatment” for patients suffering from neuropathy.

Commenting on the review, NORML Deputy Director Paul Armentano said: “The safety and efficacy of marijuana as a medicine has now been established by the ‘gold standard’ of clinical study. Further, over 2,500 patients have used cannabinoids in controlled clinical trials over the past five years alone. This is a far greater total than the number of subjects that would likely be administered any other new drug pending United States FDA approval, and is a large enough population to once and for all establish marijuana’s objective value as a medicine.”

Nature’s (Legal) Cannabinoids

“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.

The Feds’ Position On Medical Pot: Organic = Bad, Organix = Good; Any Questions?

Marijuana chemical may slow multiple sclerosis
via insciences.org

Armed with a $1.5 million National Institutes of Health grant, Temple researchers are studying more effective ways to treat multiple sclerosis. And their research utilizes synthetic cannabinoids based on chemicals derived from the marijuana plant.

… Using a compound (O-1996) synthesized by scientists at the Medical College of Virginia and the company Organix, Tuma and Ganea performed animal studies and found that the synthesized chemical affected cannabinoid receptors present primarily on immune cells.

… “This is a totally new approach to treating this disease, “says Adler, director emeritus and senior advisor for CSAR and Laura H. Carnell professor of pharmacology research. “These cannabinoids hold enormous potential, and that’s encouraging since we’re limited in options when it comes to preventing or reversing MS.”

Okay, follow along with me if you can.

The U.S. National Institutes of Health appropriates over one million dollars to fund medical research — not to investigate the therapeutic effects of natural cannabinoids (bad!), but rather to investigate the therapeutic effects of synthetic chemicals (good!) that are designed to mimic the effects of natural cannabinoids.

Equally ironically, the research is taking place at Temple University in Pennsylvania — where any use of natural cannabis (bad!) as a medicine is criminally illegal, but where research into the use  faux cannabis (good!) is embraced.

Makes sense, right? Well about as much sense as the federal government claiming that pot (bad!) has no medical utility while simultaneously patenting certain natural occurring chemicals in the plant — those that the Feds hope to one day profit from (good!) — as, you guessed it, a medicine.

Any questions?