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.

When the White House commissioned this report in response to the passage of California’s Compassionate Use Act of 1996, many in the mainstream media, and many more lawmakers, were still skeptical about marijuana’s potential therapeutic value.  The publication of the Institute of Medicine’s findings — which concluded that cannabis possessed medicinal properties to control pain and nausea, and to stimulate appetite — provided the issue with long-overdue credibility, and began in earnest a political discourse that continues today.

So what have we learned in the ten years following the release of this groundbreaking study? As I write today in both Reason Magazine online and in The Hill.com’s influential Congress blog (post your feedback here):

In Ten Years, Medical Marijuana Has Gone From Fringe to Mainstream — So Why Is It Still Against The Law?
via The Hill.com

We’ve affirmed that the use of medical marijuana can be used remarkably safely and effectively.

We’ve learned that cannabis possesses therapeutic value beyond symptom management, and that it can, in some cases, moderate disease progression.

We’ve discovered alternative methods to safely, effectively, and rapidly deliver marijuana’s therapeutic properties to patients that don’t involve smoking.

We’ve learned that restricted patient access to medicinal cannabis will not necessarily result in higher use rates among young people or among the general public.

And finally we’ve learned — much to the chagrin of medical marijuana opponents — that in fact the sky will not fall if we grant patients the right to use it.

Today, the only practical impediments prohibiting the legal use of medical marijuana are political ones.  The Obama administration should heed the advice of the Institute of Medicine and initiate clinical trials regarding the medical use of cannabis, and it should remove federal legal restrictions so that states can regulate marijuana like other accepted prescription medicines.

Antihyperalgesic effect of a Cannabis sativa extract in a rat model of neuropathic pain: mechanisms involved
via PubMed

This study aimed to give a rationale for the employment of phytocannabinoid formulations to treat neuropathic pain. It was found that a controlled cannabis extract, containing multiple cannabinoids, in a defined ratio, and other non-cannabinoid fractions (terpenes and flavonoids) provided better antinociceptive efficacy than the single cannabinoid given alone, when tested in a rat model of neuropathic pain.

On a separate but related note, am I the only one offended that most scientists appear to be more inclined to document pot’s healing powers in rats and mice than in, say, human beings?

Of course, if you want to enroll in clinical trials intent on documenting so-called “marijuana abuse,” you can take your pick here.

A funny thing happens when the US government begrudgingly allows for double-blind, placebo-controlled clinical trials evaluating the therapeutic efficacy of inhaled cannabis.  

Investigators discover time after time that it works! 

Here are the results from the latest study, conducted at California’s Center for Medical Cannabis Research.   

Low-dose pot eases pain while keeping mind clear
via Reuters News Wire

NEW YORK (Reuters Health) — Giving carefully calibrated doses of smoked marijuana to people with neuropathic pain, which can be difficult-to-treat and extremely painful, can ease their pain without clouding their minds, California researchers report.

Read the full story here. 

Unfortunately, according to recently released legal filings, fewer than 20 investigators in the United States currently possess federal approval to conduct legal clinical research on whole smoked cannabis. (Not surprisingly, most of these researchers are conducting trials that seek to assess the potential physical and mental harms allegedly associated with the drug.) In addition, state funding for the CMCR — which has backed virtually all of the medical cannabis research conducted over the past several years — has dried up and no new appropriations are likely.

Of course, federal officials could readily step in with grant money to keep this important clinical research going — after all, just last month the US National Institute on Drug Abuse announced that it would be spending millions to establish the first-ever ‘Center on Cannabis Addiction‘ — but, needless to say, I’m not holding my breath.