News (Media Awareness Project) - Canada: Corporate Cannabis |
Title: | Canada: Corporate Cannabis |
Published On: | 2005-02-01 |
Source: | Walrus, The (Canada) |
Fetched On: | 2008-01-17 03:14:33 |
CORPORATE CANNABIS
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."
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."
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