The Canadian government announced Tuesday that it has approved Sativex, a prescription pharmaceutical product derived from marijuana extracts, as a treatment for the relief of neuropathic pain in people with multiple sclerosis (MS). While Canada already has a medical marijuana program, Tuesday's step marks the first time any government in the Western Hemisphere has approved a natural, marijuana-based medicine since marijuana prohibition begun in the last century. Patients and advocates cheered the approval of the cannabis-based medicine, but some marijuana law reformers raised concerns about the potential political implications of the move.
Produced by the British company GW Pharmaceuticals and marketed in Canada by German pharmaceutical giant Bayer, Sativex is a spray administered under the tongue through a spray pump. A study of Sativex's efficacy in treating neuropathic pain related to MS found that the formulation provided significantly greater pain relief than a placebo and significantly reduced pain-related sleep disturbances.
GW Pharmaceuticals had originally hoped to win approval to introduce Sativex in Great Britain in 2003, when the British government granted the company a license to cultivate marijuana for medical research purposes. But last December, British authorities put the plan on hold, saying they wanted more evidence about its benefits. The company said this week it also plans to take "first steps" to seek approval in the United States. Sativex should be available in Canada by the beginning of summer, GW said.
"I think it's a good product and it is great to improve the options people have for accessing cannabis therapies," said Philippe Lucas, director of the Vancouver Island Compassion Society and head of the medical marijuana defense group Canadians for Safe Access. "The government's approval also serves to illustrate the hypocrisy of our drug laws," he told DRCNet. "You can have a plant-based medicine available through prescription, but medical marijuana is available only through an onerous bureaucracy and to not very many people. It's like having Vitamin C on the shelf, but outlawing oranges."
"Effective pain control and management are extremely important in a disease like MS," said Dr. Allan Gordon, Neurologist and Director of the Wasser Pain Management Centre, Mount Sinai Hospital, Toronto, Ontario. "The approval of Sativex in Canada reflects the urgent need for additional treatment options in the field of neuropathic pain in MS."
"We are very pleased that Health Canada did approve Sativex," said Deanna Groetzinger, vice-president for communications for the MS Society of Canada. "We think it is a good step forward for people with MS who have neuropathic pain. It provides another choice for people with MS and their physicians to treat pain that can be debilitating," she told DRCNet.
Many Canadian MS patients use or have used medical marijuana, said Groetzinger. "Some of the MS clinics have done studies to see how many patients use marijuana and how much. What they have found is that a good number try it, and some stay with it, but others stop because they don't like the side affects or they don't think it is helping or they're worried about the illegality. Now those patients will have one more option."
The decision also drew praise from south of the border. "This confirms that virtually everything the US government has told us about marijuana is wrong," said Rob Kampia, executive director of the Marijuana Policy Project. "GW Pharmaceuticals has proven -- and the Canadian government has acknowledged -- that marijuana is indeed a medicine, one that is both effective and remarkably safe. This natural plant extract is nothing like Marinol, the THC pill sold in the United States, and GW's research shows conclusively that marijuana's medical benefits go far beyond THC. The bottom line is that patients should have access to marijuana in whatever form they and their doctors find most useful. Sativex is to marijuana as a cup of coffee is to coffee beans, and there is simply no justification for arresting patients for using different varieties of the same medication."
But while there was much joy at the approval of Sativex and the validation of marijuana as medicine, there were also concerns, both practical and political. "We don't know how much it will cost," said Groetzinger, noting that GW and Bayer had yet to set a price. "That is a concern."
"How expensive will it be?" echoed Barb St. Jean, editor of Cannabis Health magazine and executive director of the Cannabis Health Foundation in Grand Forks, BC. "If we're talking Marinol prices, which are outrageous, how many will be able to afford it?"
That question will be answered soon enough, but questions about the political impact of the approval of a marijuana-based prescription drug will be more difficult to settle. Marijuana reform advocates on both sides of the border worried about whether governments will use Sativex as a wedge against smoked marijuana, medicinal or otherwise. GW Pharmaceutical's recent announcement that it had hired former deputy drug czar Dr. Andrea Barthwell as a consultant for campaign to win approval for Sativex in the US isn't helping them rest any easier. As recently as two months ago, Barthwell was campaigning against medical marijuana; now her job will be to help push a marijuana-based prescription drug.
"I just emailed GW with a bunch of questions about Barthwell," said St. Jean, "but in their reply, all they did was confirm that they had hired her. I asked them if they were alienating the herbal community. No reply."
"When we look at the recent hiring of Andrea Barthwell, we see the ruthlessness with which GW is charging at the American market," said Lucas. "We are right to have some concerns about the impact of this on drug reform in general. The fear is that this will be used as tool in the arsenal of prohibitionists to further restrict options of Canadians using medical marijuana. The fear is that Health Canada could use this as an excuse to either shut down or further restrict the already incredibly restrictive federal medical marijuana program. I am not suggesting that GW has nefarious intentions, but the product could lead to a shift in policy that could have a negative impact on medical marijuana users, cultivators, and distributors."
Those political implications could extend to the US, said Hilary McQuie of Americans for Safe Access. "It is really important we don't let them use Sativex against us," she told DRCNet. "We need to make sure they can't claim that this has the medical marijuana movement shaking in its boots because there is this pharmaceuticalized form out there now. Instead, we need to make sure our foes have to admit that marijuana is medicine now," she told DRCNet.
Meanwhile, shares of GW Pharmaceuticals climbed 10% this week on the news.