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02-10-2005, 01:32 PM

Canada: Medical Marijuana Gets Backing in Canada

Jeanne Whalen

Wall Street Journal, US

Tuesday 08 Feb 2005
---

Mouth Spray Wins Preliminary Approval

U.K. and U.S. Tests Loom

As some popular painkillers come under fire for causing dangerous side
effects, an often-shunned alternative is gaining legitimacy in pain relief:
cannabis.

Medical marijuana has been winning legal endorsement through the efforts of
a British pharmaceutical firm. GW Pharmaceuticals of Salisbury, England,
has spent years developing and promoting a cannabis-based mouth spray that
the company claims eases severe pain and muscle stiffness without causing a
psychotropic high. Winning the backing of health authorities has been an
uphill battle, but Canadian officials recently gave it preliminary approval
for treatment of neuropathic pain in multiple sclerosis sufferers. Studies
concluded not long ago also showed the product effective at treating severe
cancer pain.

Now GW is aiming for approval in the United Kingdom, and longer-term, in
the U.S., where medical marijuana is likely to come up against greater
resistance. "The deepness and polarity of the [marijuana] debate in the
U.S. is unique," acknowledges Geoffrey Guy, executive chairman of GW. GW
hopes the Canadian approval "will force the U.S. to address this issue once
and for all and make a decision," says Managing Director Justin Gover. If
the product is approved in more markets, GW believes it one day could be
used by a million patients suffering from pain associated with MS, cancer
and other ailments.

The treatment, called Sativex, is an extract of a hybrid form of cannabis
grown by GW. The company says the plants are specially bred to remove most
of the psychotropic agents and to increase the presence of helpful
properties such as cannabidiol. The company, which won a special license
from the U.K. to breed cannabis and carry out research, grows 50,000 plants
every year in greenhouses in a location it keeps secret so as to avoid
curiosity seekers, protesters and potheads.

Founded in 1998 to research the medicinal uses of cannabis, GW is traded on
the London Stock Exchange. The company has a few other cannabis-derived
products in early development.

Richard Payne, a 56-year-old Briton with multiple sclerosis, began taking
Sativex three years ago as part of a clinical trial and says the medicine
helps relieve his muscle stiffness and gives him better bladder control. It
also has alleviated the violent muscle spasms that used to keep him awake
at night.

Finding the Right Dosage

"When I was finding a level that suited me I did get in an intoxicated
state once," he says, but he's since decreased the dosage, as he believes
most pain sufferers would. "If you took all your eight-week supply in a few
days you'd probably be very high," he says. "But I think people who suffer
MS would rather have a better quality of life for eight weeks than have a
couple of days where you don't know what's going on in the world."

In late December, Canada's health agency issued what it calls a "qualifying
notice" for the approval of Sativex to treat neuropathic pain in MS
patients. The de facto approval will become official once GW submits extra
forms agreeing to certain conditions, including an obligation to carry out
additional clinical trials with the product. GW says it expects its
partner, Bayer AG, to begin marketing Sativex within a few months in
Canada, where 50,000 people have MS.

Canadians, who legalized smoked marijuana for those with "grave and
debilitating illnesses" in 2001, have a fairly accepting attitude toward
the cannabis plant. The fact that British officials gave GW permission to
grow and test its product in Britain gives the company hope that it may win
approval there, too, possibly as soon as this summer.

The U.S. will be a harder sell. Under the classification system of the 1970
Controlled Substances Act, marijuana is listed as having "no currently
accepted medical use." That hasn't stopped gravely ill patients from
smoking it on the sly, and in recent years 11 states have defied federal
law by making marijuana legal for medicinal use. California was the first,
passing its 1996 Compassionate Use Act after heavy lobbying by AIDS
patients and others. Last year, Montana and Vermont became the latest
states to pass similar laws.

The Bush administration says the state laws interfere with federal efforts
to combat illegal drugs and has sought to overturn them. In 2002, Federal
Bureau of Investigation agents raided the home of a California woman who
was growing marijuana to treat her lower-back pain. The woman and a
colleague filed a lawsuit against the federal government, a case that has
worked its way up to the Supreme Court. The court began hearing the case,
Ashcroft v. Raich, last year, and is expected to rule in July.

Doesn't Give a High

GW hopes Sativex will avoid similar controversy because it isn't smoked
and, when used properly, doesn't give a high. The company has spent several
years explaining its product in meetings with key U.S. officials and says
it hopes to open discussions with the Food and Drug Administration in the
coming months. As a first step, GW is aiming to win FDA permission to carry
out a clinical trial of Sativex on American patients.

An FDA spokeswoman declined to comment on Sativex's prospects for approval.
Last summer, Robert J. Meyer, a director of the FDA's office of drug
evaluation, told a congressional committee that the FDA would "continue to
be receptive to sound, scientifically based research into the medicinal
uses of botanical marijuana and other cannabinoids" and would "facilitate
the work of manufacturers interested in bringing to the market safe and
effective products."

Sativex's approval in Canada won't make the product easily available to
Americans driving over the border. The medicine will be available only by
prescription in Canada and will be illegal back in the U.S.

Several years ago, the FDA approved a medicine called Marinol that is made
from a synthetic copy of a compound found in cannabis. The medicine, sold
by Solvay SA of Belgium, is used to treat appetite loss and weight loss in
AIDS patients. Other drug companies also are working on synthetic compounds
that mimic cannabis, including Indevus Pharmaceuticals, which is testing
such a product in late-stage human trials. Because Sativex is made from
pure cannabis extract, it will be a harder sell.

peace

Kaus · 02-15-2005, 06:19 AM

"The company, which won a special license
from the U.K. to breed cannabis and carry out research, grows 50,000 plants
every year in greenhouses in a location it keeps secret so as to avoid
curiosity seekers, protesters and potheads."

Anyone else wish they lived surrounded by 50,000 plants.. But seriously I hold reservation when it comes to this product. In some deep down gnawing feeling I think that "Large Buisness" getting rich off a god given plant is wrong. By rich I dont me hundreds or even thousands, rather millions/billions. IMHO I dont think it will help the struggle for legalization very much.

mrwags · 02-15-2005, 07:52 AM

I agree with you Kaus. But the only way cannabis is ever gonna come close to being legal in the USA is for the goverment to find a way to make money off of it. This sounds like it might be a first step a baby step mind you but a step indeed.

Mr.Wags

tragic1 · 02-15-2005, 07:54 AM

Sad but true Mrwags.

artdeco · 02-19-2005, 01:02 AM

Quote:

Originally Posted by mrwags

I agree with you Kaus. But the only way cannabis is ever gonna come close to being legal in the USA is for the goverment to find a way to make money off of it. This sounds like it might be a first step a baby step mind you but a step indeed.

Mr.Wags

The government could, right now, make huge sums of cash from taxation on MJ (medical or not).

What's holding things up is how are the big companies going to make money off legalization. But maybe this wouldn't be a bad step as it could be used to expose the lies against MJ...a self created crack in the prohibitions foundation that we could chip away at.

02-19-2005, 01:25 AM

The big honcho's , eat the little honcho's & the little honcho's eat us

commercially i think Sativex will be a big hit , and it will make thing's even worse for us grower's , pharmaceutical companies will make the profit

governments will get there taxes & will convince everyone that growing MJ is dangerous & we will be hunted down even more . this is what iam worried about

peace

artdeco · 02-20-2005, 01:57 AM

Quote:

will convince everyone that growing MJ is dangerous & we will be hunted down even more . this is what iam worried about

Uhhh, isn't that what they've been trying to do for the past 60 some odd years. They're just not very good at it. They're good at spending more and more money each year. They just try and get people to think that they will bust us all eventually. It's just not going to happen because the more pressure they put on a black market it just makes it more lucrative...so more people jump into the game.

Sure they bust some growers here and there...but by far most get away with it. You just have to have your place secured (no smell, no tell) and don't draw undue attention to yourself. Do this and the odds will be heavily on your side.

02-20-2005, 02:13 AM

It think it might be a step forward in terms of how the public percieves Cannabis and it's effects.

However, what I fear and what I think a lot of us know is that once the pharmaceutical companies get control of Cannabis it will definately have a negative impact on the legalization movement AND the medical marijuana movement. It will place the the pharmaceutical companies in control of who cultivates Cannabis and who is able to afford it and obtain it.

I'd sure like to stumble on one of those 50,000 plant wherehouses some day.

”Activate, actuate, and accelerate—Don't hesitate—concentrate, calibrate, and calculate. I'm here to educate you, so imitate what I dictate and integrate. Don't stop to speculate and do not deviate or you will deflate, degenerate, and deteriorate. Orientate your mind so you can escalate. Dedicate and delegate yourself to create and cultivate an animate brain state. Facilitate and formulate your focus to fixate your fate and open the floodgate. Always contemplate. Liberate. Don't frustrate—Meditate. Elevate yourself to penetrate that agitate irate state and celebrate.”

02-20-2005, 11:08 AM

Yeah because the Judges now have an excuse to convict you

they will say . oh well !! there is Sativex you broke the law , take a 100 euros city fine + 100 euros court expences & a 1000 euro for growing

but here where i am you can also buy your time for 15 euro a day

artdeco · 02-21-2005, 12:10 AM

I just don't see it going down like that. Right now here in Texas we've got a med bill being introduced with some 75% (from polls) of the population supporting MMJ here. The Gov has been sticking to it's hardline approach to MJ saying that it has no medical value what so ever. But the majority of the people are now seeing/experiencing that the Government line is a bunch of BS. Now you have pharmaceuticals coming online that are extracts of MJ and that will go a long way in exposing that lie on a whole other level.

What will be the publics opinion on MMJ be once they start seeing what a wonderful medicine it really is? Once they see their mother/father/sister/brother/son/daughter...etc get relief from their disease which in turn allows them to recover quicker or at helps easy their dying days...then we've won. Because once they know the true wonders of this plant, then no amount government lies can put that genie back in it's bottle.

Once the prohibition is over I'm sure that large multinationals will be getting into the game. We'll see ad campaigns trying to convince the sheepeople that brand-x MJ is better that brand-y...just like with beer. We are free to brew our own beer but only a tiny, tiny percentage of the beer drinkers ever try home brewing. Why not? It's much cheaper than buying corp-beer and it can be much, much better. It's just that people are busy and will (up to a price point) just as soon buy beer than to go through all the trouble to learn how to make it, then having to buy all the equipment and then spend the time making it. They'd just as soon plunk a few bucks on the counter and walk away with their intoxicant of choice.

So we need to keep taking the fight to the government with everything from political action to growing the herb until this prohibition is repealed.

02-10-2005, 01:32 PM	#1
Guest Guest Posts: n/a	Sativex is taking over Canada: Medical Marijuana Gets Backing in Canada Jeanne Whalen Wall Street Journal, US Tuesday 08 Feb 2005 --- Mouth Spray Wins Preliminary Approval U.K. and U.S. Tests Loom As some popular painkillers come under fire for causing dangerous side effects, an often-shunned alternative is gaining legitimacy in pain relief: cannabis. Medical marijuana has been winning legal endorsement through the efforts of a British pharmaceutical firm. GW Pharmaceuticals of Salisbury, England, has spent years developing and promoting a cannabis-based mouth spray that the company claims eases severe pain and muscle stiffness without causing a psychotropic high. Winning the backing of health authorities has been an uphill battle, but Canadian officials recently gave it preliminary approval for treatment of neuropathic pain in multiple sclerosis sufferers. Studies concluded not long ago also showed the product effective at treating severe cancer pain. Now GW is aiming for approval in the United Kingdom, and longer-term, in the U.S., where medical marijuana is likely to come up against greater resistance. "The deepness and polarity of the [marijuana] debate in the U.S. is unique," acknowledges Geoffrey Guy, executive chairman of GW. GW hopes the Canadian approval "will force the U.S. to address this issue once and for all and make a decision," says Managing Director Justin Gover. If the product is approved in more markets, GW believes it one day could be used by a million patients suffering from pain associated with MS, cancer and other ailments. The treatment, called Sativex, is an extract of a hybrid form of cannabis grown by GW. The company says the plants are specially bred to remove most of the psychotropic agents and to increase the presence of helpful properties such as cannabidiol. The company, which won a special license from the U.K. to breed cannabis and carry out research, grows 50,000 plants every year in greenhouses in a location it keeps secret so as to avoid curiosity seekers, protesters and potheads. Founded in 1998 to research the medicinal uses of cannabis, GW is traded on the London Stock Exchange. The company has a few other cannabis-derived products in early development. Richard Payne, a 56-year-old Briton with multiple sclerosis, began taking Sativex three years ago as part of a clinical trial and says the medicine helps relieve his muscle stiffness and gives him better bladder control. It also has alleviated the violent muscle spasms that used to keep him awake at night. Finding the Right Dosage "When I was finding a level that suited me I did get in an intoxicated state once," he says, but he's since decreased the dosage, as he believes most pain sufferers would. "If you took all your eight-week supply in a few days you'd probably be very high," he says. "But I think people who suffer MS would rather have a better quality of life for eight weeks than have a couple of days where you don't know what's going on in the world." In late December, Canada's health agency issued what it calls a "qualifying notice" for the approval of Sativex to treat neuropathic pain in MS patients. The de facto approval will become official once GW submits extra forms agreeing to certain conditions, including an obligation to carry out additional clinical trials with the product. GW says it expects its partner, Bayer AG, to begin marketing Sativex within a few months in Canada, where 50,000 people have MS. Canadians, who legalized smoked marijuana for those with "grave and debilitating illnesses" in 2001, have a fairly accepting attitude toward the cannabis plant. The fact that British officials gave GW permission to grow and test its product in Britain gives the company hope that it may win approval there, too, possibly as soon as this summer. The U.S. will be a harder sell. Under the classification system of the 1970 Controlled Substances Act, marijuana is listed as having "no currently accepted medical use." That hasn't stopped gravely ill patients from smoking it on the sly, and in recent years 11 states have defied federal law by making marijuana legal for medicinal use. California was the first, passing its 1996 Compassionate Use Act after heavy lobbying by AIDS patients and others. Last year, Montana and Vermont became the latest states to pass similar laws. The Bush administration says the state laws interfere with federal efforts to combat illegal drugs and has sought to overturn them. In 2002, Federal Bureau of Investigation agents raided the home of a California woman who was growing marijuana to treat her lower-back pain. The woman and a colleague filed a lawsuit against the federal government, a case that has worked its way up to the Supreme Court. The court began hearing the case, Ashcroft v. Raich, last year, and is expected to rule in July. Doesn't Give a High GW hopes Sativex will avoid similar controversy because it isn't smoked and, when used properly, doesn't give a high. The company has spent several years explaining its product in meetings with key U.S. officials and says it hopes to open discussions with the Food and Drug Administration in the coming months. As a first step, GW is aiming to win FDA permission to carry out a clinical trial of Sativex on American patients. An FDA spokeswoman declined to comment on Sativex's prospects for approval. Last summer, Robert J. Meyer, a director of the FDA's office of drug evaluation, told a congressional committee that the FDA would "continue to be receptive to sound, scientifically based research into the medicinal uses of botanical marijuana and other cannabinoids" and would "facilitate the work of manufacturers interested in bringing to the market safe and effective products." Sativex's approval in Canada won't make the product easily available to Americans driving over the border. The medicine will be available only by prescription in Canada and will be illegal back in the U.S. Several years ago, the FDA approved a medicine called Marinol that is made from a synthetic copy of a compound found in cannabis. The medicine, sold by Solvay SA of Belgium, is used to treat appetite loss and weight loss in AIDS patients. Other drug companies also are working on synthetic compounds that mimic cannabis, including Indevus Pharmaceuticals, which is testing such a product in late-stage human trials. Because Sativex is made from pure cannabis extract, it will be a harder sell. peace
	Quote

02-15-2005, 07:52 AM	#3
mrwags ********* Female Seeds Join Date: Jun 2004 Posts: 3,493	I agree with you Kaus. But the only way cannabis is ever gonna come close to being legal in the USA is for the goverment to find a way to make money off of it. This sounds like it might be a first step a baby step mind you but a step indeed. Mr.Wags __________________ Never Argue With The Ignorant Because They Will Simply Pull You Down To Their Level And Beat You With Experience So the idea of spreading the love is the disease and making sure it's done is the cure TY all for allowing me to get my treatment
	Quote

02-15-2005, 07:54 AM	#4
tragic1 Urban Gardner Join Date: Feb 2004 Location: Every where and nowhere at once Posts: 341	Sad but true Mrwags. __________________ "I don't have education, I have inspiration and if I was educated I'd be a damn fool." - Bob Marley
	Quote

02-15-2005, 06:19 AM	#2
Kaus Member Join Date: Jul 2004 Posts: 74	"The company, which won a special license from the U.K. to breed cannabis and carry out research, grows 50,000 plants every year in greenhouses in a location it keeps secret so as to avoid curiosity seekers, protesters and potheads." Anyone else wish they lived surrounded by 50,000 plants.. But seriously I hold reservation when it comes to this product. In some deep down gnawing feeling I think that "Large Buisness" getting rich off a god given plant is wrong. By rich I dont me hundreds or even thousands, rather millions/billions. IMHO I dont think it will help the struggle for legalization very much.
	Quote

02-19-2005, 01:25 AM	#6
Guest Guest Posts: n/a	The big honcho's , eat the little honcho's & the little honcho's eat us commercially i think Sativex will be a big hit , and it will make thing's even worse for us grower's , pharmaceutical companies will make the profit governments will get there taxes & will convince everyone that growing MJ is dangerous & we will be hunted down even more . this is what iam worried about peace
	Quote

02-20-2005, 02:13 AM	#8
Guest Guest Posts: n/a	It think it might be a step forward in terms of how the public percieves Cannabis and it's effects. However, what I fear and what I think a lot of us know is that once the pharmaceutical companies get control of Cannabis it will definately have a negative impact on the legalization movement AND the medical marijuana movement. It will place the the pharmaceutical companies in control of who cultivates Cannabis and who is able to afford it and obtain it. I'd sure like to stumble on one of those 50,000 plant wherehouses some day. ”Activate, actuate, and accelerate—Don't hesitate—concentrate, calibrate, and calculate. I'm here to educate you, so imitate what I dictate and integrate. Don't stop to speculate and do not deviate or you will deflate, degenerate, and deteriorate. Orientate your mind so you can escalate. Dedicate and delegate yourself to create and cultivate an animate brain state. Facilitate and formulate your focus to fixate your fate and open the floodgate. Always contemplate. Liberate. Don't frustrate—Meditate. Elevate yourself to penetrate that agitate irate state and celebrate.”
	Quote

02-20-2005, 11:08 AM	#9
Guest Guest Posts: n/a	Yeah because the Judges now have an excuse to convict you they will say . oh well !! there is Sativex you broke the law , take a 100 euros city fine + 100 euros court expences & a 1000 euro for growing but here where i am you can also buy your time for 15 euro a day
	Quote

02-21-2005, 12:10 AM	#10
artdeco New Member Join Date: Aug 2004 Posts: 19	I just don't see it going down like that. Right now here in Texas we've got a med bill being introduced with some 75% (from polls) of the population supporting MMJ here. The Gov has been sticking to it's hardline approach to MJ saying that it has no medical value what so ever. But the majority of the people are now seeing/experiencing that the Government line is a bunch of BS. Now you have pharmaceuticals coming online that are extracts of MJ and that will go a long way in exposing that lie on a whole other level. What will be the publics opinion on MMJ be once they start seeing what a wonderful medicine it really is? Once they see their mother/father/sister/brother/son/daughter...etc get relief from their disease which in turn allows them to recover quicker or at helps easy their dying days...then we've won. Because once they know the true wonders of this plant, then no amount government lies can put that genie back in it's bottle. Once the prohibition is over I'm sure that large multinationals will be getting into the game. We'll see ad campaigns trying to convince the sheepeople that brand-x MJ is better that brand-y...just like with beer. We are free to brew our own beer but only a tiny, tiny percentage of the beer drinkers ever try home brewing. Why not? It's much cheaper than buying corp-beer and it can be much, much better. It's just that people are busy and will (up to a price point) just as soon buy beer than to go through all the trouble to learn how to make it, then having to buy all the equipment and then spend the time making it. They'd just as soon plunk a few bucks on the counter and walk away with their intoxicant of choice. So we need to keep taking the fight to the government with everything from political action to growing the herb until this prohibition is repealed.
	Quote