Canada: Corporate Cannabis

by Brian Preston, (Source:Walrus)
01 Feb 2005
Will a New Marijuana Mist Become the Aspirin of the Twenty-First Century?

Philippe Lucas is apologizing for the quality of his cannabis. He is director of the Vancouver Island Compassion Society, which dispenses medicinal marijuana from behind an old storefront in Victoria. "This used to be a school of Chinese medicine," he says. "Can you feel the healing vibe?" Not at first. Apart from a comfy, well-worn couch in the waiting area, and a batik with yin-yang dolphins that you brush aside to enter the dispensing office, the place feels like a regular medical clinic. It reflects Lucas's personality: lean, clean-cut, and intense - there's nothing of the spacey stoner about him. If there's a "healing vibe," it emanates from the staff: the receptionist dressed in a fuzzy old sweater welcomes clients with "Hello, beautiful!" and "Can you use a hug?" Then she hugs.

In the dispensing office the cannabis is kept under lock and key. Today's strains for sale -- among them Sweet Tooth, Jack's Mix, and Other God -- according to a list handwritten in felt pen on a whiteboard-are grown primarily for recreational use, not medical. As he shows off a sample, Lucas apologizes again, because normally the Society grows and tests for purity the organic pot it supplies to its 400 members. But a recent rcmp bust destroyed their growing facility, forcing them onto the black market. There's no shortage for patients in need- in B.C. alone, the rcmp estimates 15,000 grow-ops contribute to a harvest that nationally is worth about $7 billion. The problem is that illegal growers don't hand out guarantees.

While Lucas struggles in the grey zone of legality to get better pot back on the menu, his patients could soon have an alternative: one that does not involve police raids and substandard cannabis. German pharmaceutical giant Bayer AG, and Cannasat Pharmaceuticals Inc. of Toronto, a firm backed by a number of prominent Canadian businessmen, including Citytv co-founder Moses Znaimer and Joseph Mimran, the former head of Club Monaco, want to start selling cannabis-based medicine. Their goal: produce medically approved devices, such as inhalers and sprays, that will deliver the healing powers of marijuana without the poisonous smoke and tar - or the threat of arrest that comes along with distributing it illegally.

In Canada alone there are nearly 50,000 people with multiple sclerosis ( MS ), many of whom could use such a device, and some estimates suggest another 400,000 Canadians could benefit from medical marijuana. At the moment, only 753 use cannabis legally.

And Alan Young, Cannasat's legal adviser, a loquacious Osgoode Hall law professor who has fought a decades-long battle to liberalize marijuana laws, says because cannabis-based drugs have the potential to help people in a number of critical areas yet to be discovered, it could become one of the biggest pharmaceutical sectors ever developed. "There is going to be a revolution in the next decade in treatment options," says Young, his voice rising to emphasize the point. "People are sick and tired of synthetic products that are constantly being pulled off the market for undisclosed side effects. The time is right for herbal products."

Bayer AG has already paid $60 million for the European rights and $14 million for the Canadian rights to market Sativex, a cannabis-based medicine developed in Britain by GW Pharmaceuticals. Health Canada has been asked to approve Sativex, a whole-plant cannabis extract, delivered in a sublingual spray, and a decision could come this year. It cost GW $100 million to develop Sativex, and while Cannasat vice-president Andrew Williams acknowledges the lead Bayer and GW have in the emerging sector, he believes the market will be large enough to support a number of companies. Cannasat is now putting together investors and a scientific team, which Williams says could lead to the creation of a suite of cannabis-based drugs over the next six to ten years.

Inhalers and sprays that provide the benefits of medical marijuana, but don't necessarily get you stoned, offer another advantage. Between 1999 and 2001, Ottawa gradually established the Medical Marihuana Access Regulations, and awarded Prairie Plant Systems of Saskatoon the right to produce and distribute cannabis to patients with authorization from their doctors. But many doctors are still reluctant to tell their patients to smoke medical marijuana because they believe inhaling it is harmful. Now many people advocating on behalf of patients fear that once the new cannabis-based medicines are on the market, Ottawa will favour them over medical marijuana. "There is legitimate fear that if GW gets approval," says Lucas, "Health Canada is going to say that's all we need to meet our obligations, we're shutting down the medical-marijuana program."

The Holy Grail for corporations trying to turn pot into a legitimate medicine is the vast U.S. market, which is ruled over by politicians who still see marijuana as an unspeakable menace. Euphoria masquerading as a medicine simply won't fly in the U.S. But GW may have found a solution. It has developed a tamper-proof dispensing system for the delivery of methadone that critics say could also be used for cannabis-based medicine. It looks like a cross between an asthma inhaler and a cellphone. The doctor keys in your allowable dose, and any attempt to spray a little more cuts you off cold turkey. Corporations see it as a way to profits; smokers call it a Big Brotherish apparatus designed to appease America's anti-pot paranoia - what they call "euphoriphobia." One such critic is Hilary Black, founder of the B.C. Compassion Club Society in Vancouver, who recently joined Cannasat. "The fact is,any pharmaceutical company using prohibition as a tool to market a product - that's wrong," says Black. "I have major ethical concerns with that."

In the mid-1990s, faced with mounting anecdotal evidence of marijuana's therapeutic value, the British government began funding scientific research into cannabinoids, the sixty constituent chemicals unique to the plant. Dr. Geoffrey Guy, chairman of the biotechnology company Ethical Holdings, made a case that doing pure research for its own sake was not enough. Guy wanted to grow cannabis and study it with a clear-cut goal: to produce a patentable, marketable, profitable prescription medicine.

To his surprise, Guy found the U.K. government highly receptive. In 1997, he formed GW Pharmaceuticals, where he now serves as executive director, and was granted permission to experiment with massive amounts of cannabis, eventually growing sixty tons a year in greenhouses in a secret location in the British countryside. In 2003, GW submitted the Sativex spray for regulatory approval in the U.K., to be used specifically for the relief of pain and muscle spasticity associated with MS.

The Vancouver Island Compassion Society also produces a cannabis spray, albeit a much simpler version. Unlike Sativex, which is a patented medicine, the Society's spray is a tincture of cannabis administered via a vapourizer called Cannamist. Last May, Lucas received a foretaste of possible legal battles to come with GW, Bayer AG, and its subsidiary Bayer Canada, when he described Cannamist at a medical marijuana conference held by a group called Patients Out of Time, at the University of Virginia. Geoffrey Guy happened to be in the audience, and afterward approached Lucas and asked him if he'd had a chance to look at the any of the many patent applications GW has for Sativex. "He said it with a twinkle in his eye," recalls Lucas, "but with firmness in his voice."

There is no question that GW plans to enforce its patents on Sativex, which is a precisely dosed medicine. Warns Guy: "To protect our extensive investment, we have sought to identify and patent certain inventions throughout the growing, extraction and manufacturing process. My comments to Mr. Lucas were made as a friendly and, hopefully, helpful gesture as I did not wish him to invest a great amount of effort into obtaining approval for a product as a prescription medicine only to find that he did not have the freedom to operate in the first place."

Guy's warning was reiterated shortly after I arrived in England to interview him, when Mark Rogerson, GW's grey-templed, elegantly dressed, public-relations man, met me at the Oxford train station. "Once it's approved and Sativex becomes a medicine under the law, there needs to be a minor change in legislation so it can be prescribed," he said, as he steered his Hyundai ( his Audi was in the shop ) into near-gridlock. "The Home Office has already said they will do that, and then patients will be taking a legal medicine. But if you are an MS sufferer, it would still be illegal for you to grow cannabis at the bottom of the garden to treat your symptoms. Our medicine will be legal, but anything else will not be."

We drove to a postmodern, science-oriented industrial park near Oxford, where GW operates a clinic to monitor patients taking part in medical trials. I was introduced to Gillian, a whispery little old lady with MS who has participated in a number of short-term trials and who is now using Sativex as part of a long-term study. She has suffered from intense and painful muscle spasms for thirty-four years. "I never slept through the night, I would wake up every fifteen minutes, and it made the night seem like a few years," she says. "I had my first lot of cannabis, and I slept right through. That really seemed like the most wonderful thing that ever happened."

Gillian shows me her little brown spray bottle of Sativex. "Do you get intoxicated? " I ask. "No," she replied. "I keep my dosage low so I don't. And I don't see why anybody should want to get intoxicated." Then she adds, "Intoxication isn't necessarily bad. If you fall in love, that's intoxication. But that's a chosen one."

According to GW, 95 percent of the patients in clinical trials are like Gillian. They want the medicine to work, but they don't want the high. And GW claims it has figured out a way to deliver cannabis in a spray in doses that are much lower than those needed for the desired highs of recreational use, but which are still medically effective. GW scientists are also doing research on specific strains of marijuana to develop a whole slate of medicines, including treatments for neuropathic pain involved in cancer, spinal-cord injuries and rheumatoid arthritis ; as well, there are indications that even psychological disorders such as schizophrenia could some day be treated with marijuana.

The active ingredients in Sativex are primarily two cannabinoids, thc, or delta9-tetrahydrocannabinol - the psychotropic ingredient appreciated by stoners around the world - and cbd, or cannabidiol, although all 400 constituent chemicals of the plant are present. In other words, Sativex is not a conventional pharmaceutical, which is usually a single molecule synthesized in a laboratory. It's a whole plant extract, a distillate of the best of the flowering female buds from those sixty tons of plants.

Dr. Philip Robson was senior lecturer in psychology at Oxford University before becoming clinical director of GW four years ago. If you were casting a tennis coach for a soap opera he would be your man: athletic and welcoming. "The bottom line is," he says in his office upstairs from the clinic, sitting beneath framed close-up photos of richly resinous marijuana buds, "if you take enough Sativex you will experience exactly the same effect you would if you were smoking a joint. But the delivery system is so different, the spike in the blood is so different - if you smoke a spliff you get this huge spike, and your plasma level of thc goes up to, say, 150 or 200 nanograms, which is quite a lot, whereas with Sativex we're operating at a level more like 4, 5, 6 nanograms. So people do avoid the high."

Using marijuana is still a social activity for many, and they will no doubt continue to grow their own rather than take it as a medicine. On the way to visit GW, I took a detour to a small town near the Scottish border to visit an illegal charity called thc4ms. The organization pretty much amounts to a shaggy-haired, amiable married couple named Mark and Lezley, who mix cannabis into chocolate bars, wrap them in foil, and ship them by mail to MS sufferers.

Lezley was diagnosed with a severe form of MS in 1984 after a stroke-like attack left half her body paralyzed. She was told that within five years she could expect to be in a wheelchair and incontinent. Then she met Mark, a rec-reational cannabis user. Today she smokes throughout the day, is mobile, active, and in control of her bowels. She's not cured: occasionally she will still have a spasm and drop a dish. "No MS household has a full set of crockery," says Mark.

Lezley decided to go public as a medical-marijuana activist after a nasty incident with a neighbour whose hunting dog had killed her cat. "I'm going to kill the dog," she told him.

"And I'll have you for smoking that pot," he shot back.

Soon after the altercation, she was watching Kilroy, the British television equivalent of Oprah. At the end of the show they asked anyone who smoked cannabis medicinally to contact them. "I rang up," she recalls, "and at the time Mark had quite the -"

"I had a good job, didn't I ? " says Mark, interrupting.

"He was management, in charge of a bakery," she continues. "And when I said to him what I was going to do, he said, 'Uh-oh, I'm gonna lose me job.' "

"And I did," he answers ruefully.

Later, Mark mixes up a batch of chocolate and cannabis at what they jokingly call their "lab" in the kitchen of a sympathizer's house in a nearby town. "We've come up with a new slogan for our literature: From Nature, Out Of Necessity." Adds Lezley, "We had a snappier one: 'Doing today for free what GW dreams of making millions from tomorrow.' "

Still, for everyone who wants to smoke their own, there are many more, believes Mark, who would prefer the prescription version. "I can't wait until GW gets its licence," he says. "I'll chuck all this kit and get my life back." Lezley immediately scolds him. "Those who want to press the button, take one spray, great. Those who want to use it herbally should be able to use it herbally. Freedom of choice."

Lezley describes herself as "a good girl. I never had a detention in school." Before using cannabis from necessity, she thought pot was for "druggies." Now, after twenty years of using it for pain management, she insists, "I'm still good," although she has changed in other ways. Once a stylish young hairdresser with "dyed-blond hair and high heels," she has become an almost stereotypical countercultural New Age earth mother who is into crystals, holistic remedies, and the legalization of marijuana for all purposes, not just medical. "Why are people so afraid of it? " she asks. "It opens your mind to a lot of things."

Later, Rogerson packed me back into the Hyundai and we travelled down to Salisbury to meet Guy. To get there Rogerson drove along the edge of a military firing range and parked outside the gates before registering at a small outbuilding. ( My Canadian passport seemed to make me suspect, and slowed the process. ) Then we walked through the checkpoint to a small building just inside the fence.

Guy is fifty, argumentative, short in stature and built like a fire hydrant. He shows little patience for marijuana activists who, he says, have "from time to time either latched onto, used, fed off of, or even hijacked the debate" on the therapeutic value of cannabis. Nor does he have time for those tinkering with cannabis as herbal medicine. "This is something that doesn't seem to be understood in North America," he says. "There is a massive, massive difference in being able to grow a plant, and being able to develop an approved medicine that can be prescribed by a doctor. There's a lot of people who will have a long discussion about what a medicine is, but I am a pharmaceutical physician, and my definition of a pharmaceutical [product] is a 'worthwhile medicine that makes money.' "

Ironically, some of the early research Guy used in developing Sativex came from America's National Institute on Drug Abuse. "The U.S. government has funded substantial research over the last twenty-five years," says Guy. "But it was all designed to prove that cannabinoids were the most terrible things on earth." He says it reminds him of the Soviet Union in the 1980s, the way the goals of many American studies - cannabis is bad - are at odds with the actual research presented. They've come up with remarkably little to show that the effects of the drug are adverse or dangerous, he asserts. "Had they spent twenty-five years looking at ibuprofen, they could have come up with a far worse profile."

By some estimates, 50 percent of prescribed medicines in the nineteenth century- designed to alleviate everything from migraines and menstrual cramps to the pain of childbirth - contained cannabis. Time will tell whether Bayer has latched on to the new Aspirin-whether Sativex will become the "take two and call me in the morning" drug of the twenty-first century.

Major research breakthroughs came in 1988, with the discovery of a cannabinoid receptor in the brain, and in 1992, when it was confirmed that humans, like all animals, possess endogenous cannabinoids in their bodies, in the same way that endorphins are endogenous opiates. Cannabinoids, Guy says, are "really one of the prime controllers of the body's systems." He com-pares the action of cannabis to the fine-tuning knob of a radio. Unlike modern synthetic chemical medicines, cannabinoids don't just show a simple effect in one direction, but can modulate up or down on the health dial, returning the body's systems to equilibrium. "We have combinations of receptors," he says, "that some of the materials in cannabis seem to be tailor-made for."

In fact, Guy believes there is evidence of an evolutionary link between cannabis and Homo sapiens. He argues that from the time plants and animals diverged in the primordial soup, they have remained in a co-evolutionary dance. Particularly noteworthy are the receptors humans have retained for chemicals found in opium and cannabis. He suggests that cannabinoid receptors, lying dormant for millennia, may have been reactivated when humans rediscovered cannabis 50,000 years ago, a time known as "the great leap forward," when our ancestors developed art, language, and new tools like boats, rope, and fishhooks.

Guy's rivals at Cannasat Pharmaceuticals in Toronto hope to build on the growing bank of scientific knowledge as to how cannabis interacts with those receptors. While Cannasat is trail-ing GW in the race to bring the first cannabis-based pharmaceutical to market, Cannasat's Williams says operating in Canada gives his firm an advantage. Potentially, Cannasat could tap into Prairie Plants' expertise and research-grade product, whereas GW had to build and operate their own growing facility. "Prairie Plant is almost there," he says, "and that will knock two years off the five-year head start that GW has."

Realistically, GW's head start is probably more like seven years, and they began with the most genetically pure cannabis in the world, the breeding stock of a Dutch firm called Hortapharm, whereas Prairie Plant was obliged by Health Canada to grow its plants from seeds confiscated by the rcmp.

Despite the fact that many MS sufferers might want to try Sativex, Cannasat's legal adviser, Alan Young, thinks Health Canada should delay approving the drug. He says GW has failed to look at enough strains of marijuana to guarantee that its product will substantially improve the lives of MS suffers. "The closer I looked at GW, the more distressed I was by the product," he says. "And all my fears are substantiated by the fact that GW has not received approval from its own government. So I've taken the position, 'Don't come to Canada until you get your business in order in the U.K.' "

Currently, patients trying to acquire medical marijuana approved by Health Canada find the process complex and bureaucratic. Approved applicants are allowed to either grow their own marijuana, have someone grow it for them in a strict one-to-one relationship, or buy their cannabis from the government. The strict regulations ( patients must submit a series of applications and one or more medical declarations, as well as a photograph of themselves signed by their doctor ) make cannabis far more difficult to obtain than even such sinister prescription drugs as Oxycontin, the morphine substitute better known as Hillbilly Heroin.

"People are contacting me daily from all parts of Canada, wanting to know how and where to purchase medical cannabis," says Barb St. Jean, editor of Cannabis Health Magazine, based in Grand Forks, B.C. "Their doctors tell them they will not sign the government approval forms." Currently the Canadian Medical Association ( cma ) and its insurer, the Canadian Medical Protective Association, counsel members not to sign. "But some doctors," says St. Jean, "tell their patients, 'Just go out and buy it if you want it.' This is insane."

The confusion could end if Bayer is allowed to distribute Sativex in Canada, where it will be strictly labelled for the treatment of MS only. But given compelling evidence of its efficacy in treating such conditions as arthritic pain and the nausea that often accompanies chemotherapy, it's likely that the market ( and profits ) will expand as "off-label prescribing" accelerates.

It's easy to foresee a scenario like this one: a person with chronic pain asks a doctor to sign the government paperwork allowing her to grow her own cannabis, or get it shipped in a packet from Flin Flon, already ground up like oregano. The doctor says, "I'm uncomfortable with that, because in fact the cma have advised me not to sign. However, I can write you a prescription for Sativex. It's for MS but it seems to work wonders for other chronic pain." And in one quick step, one more patient will be using Sativex for a condition that is completely unrelated to the MS that the drug was originally designed and licenced to treat.

Eventually Sativex could be introduced into the lucrative U.S. market. But with the war on illegal drugs going on, with much of it directed by the world's biggest consumer of illegal drugs, America, any substance that gets you giddy is guilty until proven innocent. GW and Bayer may be able to skirt that issue by emphasizing the fact that Sativex is taken in a dose so low that there's no high associated with it.

As Lucas points out, many patients at the Compassion Society in Victoria use the herb for chronic pain, and report that it doesn't trigger the euphoric high that a healthy person might experience using the same amounts of cannabis. Lucas himself, who contracted hepatitis C from tainted blood at the age of twelve and now uses cannabis for pain management and appetite enhancement, acknowledges that he does experience some euphoric effects. Then he mentions an ad he saw for a pharmaceutical on television the other night. "One of the long list of possible side effects was anal leaking," he says. "I'll take euphoria over anal leaking any day."

Perhaps the main selling point of Sativex, however, is that you don't have to smoke it to get the benefits. GW's Guy points out that Health Canada's Flin Flon operation distributes "herbal cannabis of only reasonably understood quality," which they dispense in the full knowledge that patients will smoke it, "therefore exposing them to an enormous raft of carcinogens." Guy then launches into a detailed rant about the sheer wastefulness of smoking. "We don't burn Sativex," he sneers. "Ninety-five percent of all the material of the joint is used to produce a heat source! Well, in this modern day and age we've got electricity and things like that if we want a heat source! We don't need to burn the actual drug to create a heat source."

Smoking, however, is exactly what many medical users want to do. And currently, compassion clubs, like Lucas's Vancouver Island Compassion Society in Victoria, are by far the leading providers of medical marijuana. Of the 750-plus patients now registered with Health Canada, only eighty-three have opted to use Flin Flon's finest. By contrast, Vancouver's B.C. Compassion Club Society, a non-profit society dedicated to supplying cannabis, has 3,000 members. Nearly a dozen such clubs across the country serve more than 8,000. Roughly 95 percent of these patients smoke their cannabis.

Health Canada's current attitude toward compassion clubs is that they are "illegal" and "a concern for the police and the justice system," says a Health Canada spokesperson. Ottawa is obligated by international treaties to "prevent diversion," meaning they worry compassion clubs could too easily become a front for illegal pot sales.

The problem with Health Canada, says Lynne Belle-Isle of the Canadian aids Society, who also sits on Health Canada's Stakeholders' Advisory Committee on Medical Marihuana, "is that they don't seem to know a lot about cannabis, and they're not in touch with the community of patients. We want the compassion clubs to be at the table, and there's a huge resistance on the part of Health Canada to that. Personally, I would prefer a person walking into a compassion club and getting their cannabis than getting it from Joe with a pager on the corner of the street."

Compassion clubs are the only organizations in Canada that have a ready-made client base for research pur-poses. Ottawa set aside $7.5 million for research in 1999, but only two studies were ever commissioned, although a third may be announced soon. One has been cancelled; the other, at McGill University's Pain Centre, is ongoing, and somehow Health Canada has spent $2 million of that original $7.5 million. Cannasat's Hilary Black believes Ottawa is delaying research in the face of U.S. pressure and potential pharmaceutical options on the horizon. "Health Canada has been dragging their heels just long enough for GW to hit the market," she says. "And after that point they could close down the Flin Flon operation."

When large foreign companies such as the drug manufacturer GW and its distributor Bayer arrive on the local medical marijuana scene, it's easy to see the conflict of interests as a case of hippies vs. suits, of the hippies being in the right, but inevitably losing to Big Bad Pharma. But this exasperates Guy. "Those people who you would have thought would be our biggest supporters are our most vociferous critics," he says. "We are offering virtually bottled cannabis, cannabis extract for patients who can get it from their doctor, reimbursed by the National Health Service or its equivalent, but here we are, the unacceptable face of pharmaceuticalization and profiteering."

In Victoria, Philippe Lucas concedes that the big drug companies will probably succeed. Ultimately, he says, the drug does deserve to be approved for ethical reasons: many of the MS sufferers in Canada are too timid or too ill to face the currently too-daunting task of arranging cannabis medicines for themselves. The arrival of Sativex will also help meet the needs of rural and small-town patients who live outside the reach of compassion clubs.

As for GW, let's leave the last word to Barb St. Jean of Cannabis Health. "They have dedicated experts, and hats off to them-they've done a great job," she says. "But I am perplexed at our own government's refusal to allow its own citizens to get in the game with alternatives."

[size=-1]Pubdate: Tue, 01 Feb 2005
Source: Walrus, The (Canada)
Copyright: 2005 The Walrus Magazine, Inc.
Contact: letters@walrusmagazine.com
Website: http://www.walrusmagazine.com
Details: http://www.mapinc.org/media/3657
Author: Brian Preston
Note: Brian Preston is an award-winning Victoria-based journalist and the author of Pot Planet.
Cited: Vancouver Island Compassion Society http://thevics.com/
Cited: GW Pharmaceuticals http://www.gwpharm.com/
Cited: Health Canada Office of Cannabis Medical Access http://www.hc-sc.gc.ca/hecs-sesc/ocma/index.htm
Cited: B.C. Compassion Club Society http://www.thecompassionclub.org/
Cited: Patients Out of Time http://www.medicalcannabis.com/
Cited: thc4ms http://www.thc4ms.org.uk/
Cited: Cannabis Health Magazine http://www.cannabishealth.com/
Bookmark: http://www.mapinc.org/people/Philippe+Lucas
Bookmark: http://www.mapinc.org/author/Alan+Young
Bookmark: http://www.mapinc.org/people/Hilary+Black
Bookmark: http://www.mapinc.org/people/Geoffrey+Guy
Bookmark: http://www.mapinc.org/mmjcn.htm (Cannabis - Medicinal - Canada)[/SIZE]