cannabisnews.com: Canada To Approve UK Cannabis Drug





Canada To Approve UK Cannabis Drug
Posted by CN Staff on December 21, 2004 at 08:12:41 PT
By Reuters
Source: Reuters
London, England -- British biotech firm GW Pharmaceuticals' cannabis-based medicine has been tipped for approval for the first time, with Canadian regulators giving the go-ahead for its multiple sclerosis drug.The news comes just weeks after British regulators said they wanted more evidence about the benefits of the drug, which is used to treat the central nervous system disease, delaying its approval in the UK and battering GW Pharma's shares.
"As far as I'm aware, it's the first approval for a prescription cannabis medicine anywhere," a spokesman for the firm told Reuters on Tuesday.Shares in the firm jumped as much as 9.5 percent. They had lost about a third of their value since the start of December when UK regulators asked for more studies.Canada has confirmed that Sativex qualifies to be considered for approval. GW is required to respond and accept conditions within 30 days. If the response is acceptable, the regulator will proceed to finalize the marketing authorization.Analysts said the Canadian system for drug approval meant the rest of the process was little more than a formality. GW Pharma said it expected full approval by early next year."Under the Canadian system, full approval should be relatively straightforward from here," said Jon Senior, analyst at Evolution Beeson Gregory, who rates the stock an "add." He said the relatively modest gains in the wake of the Canadian news meant the stock looked good value at these levels.The medicine, administered by means of a spray into the mouth, will be exclusively marketed in Canada by Germany's Bayer, the firm said.GW grows thousands of marijuana plants at a secret location in the English countryside, having been granted a dispensation by the government to use the plant for medical research.The firm had hoped for UK approval to come through last year, but the drug has been held up by a series of regulatory delays. The latest UK delay could put back the launch of the drug in this country by at least six months. Source: Reuters (Wire)Published: Tuesday, December 21, 2004Copyright: Reuters 2004Related Articles & Web Site:GW Pharmaceuticalshttp://www.gwpharm.com/Cannabis Spray Could Get Canada Launchhttp://cannabisnews.com/news/thread18837.shtmlCanada: GW and Bayer Announce Agreement http://cannabisnews.com/news/thread17741.shtml
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Comment #38 posted by Max Flowers on December 22, 2004 at 09:33:39 PT
The Kubbys
That's very good news about the Kubbys, I had been worrying about them for like almost a year now. They are really good folks whom I hope to meet and be friends with someday.I find it very ironic that a guy with a beautiful wife and beautiful children can be ill and have a potentially fatal disease (glad he's doing well now though!), while I am in basically very good health, and have no wife, no children, etc. Same with a half brother of mine, he has a wife and kids and just recently had emergency bypass surgery.I wonder sometimes if I wouldn't take situations like theirs in trade for mine.
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Comment #37 posted by observer on December 22, 2004 at 04:18:45 PT
Marinol, Sativex
Like Marinol (read: NO MARIjuana), Sativex (weed out) will be a wonderful excuse that police and politicians will use to keep arresting pot smokers. Spray tinctures have been available for years at compassion clubs. I'm glad that some people find them useful.I'm not saying that Sativex doesn't have this or that chemical that pot has or hasn't; that's not my point.
http://drugpolicycentral.com/bot/pot
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Comment #36 posted by dr slider on December 21, 2004 at 22:40:23 PT:
re. comment 23 observer
You're wrong. While you're right that monideadic research into pharmacizing medcan could be problamatic, I have it on the word of the esteemed Dr. Russo that the work at GW is as open minded as you are. Phytocannabinoids, phytoterpinoids, and a partrige in an indica tree.Drink deep
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Comment #35 posted by afterburner on December 21, 2004 at 19:28:49 PT
December Update from the Kubbys
POWDER TO THE PEOPLE!
http://kubby.com/PowderToThePeople/
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Comment #34 posted by global_warming on December 21, 2004 at 15:32:00 PT
Who Ate The Starwberries?
Sounds like JP Walters is coming unglued..If Sativex is approved and the rest of the world is calling it medicine, how can this charade in the US continue?
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Comment #33 posted by FoM on December 21, 2004 at 14:18:20 PT
I Am Too Hope
Stick just got home from his trip. I just plugged in the trees. ( Artificial ones ) We are suppose to be getting a fairly good size snow storm and we are set in case it gets bad. Snow on Christmas is always nice. 
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Comment #32 posted by Hope on December 21, 2004 at 14:02:49 PT
I'm thankful for all of you.
May God grant us our heart's desire.
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Comment #31 posted by Hope on December 21, 2004 at 13:55:18 PT
this makes me feel a little better
From DPFT post online12/21/2004, Tom Angell wrote:Friends,This morning, I attended a press conference announcing the results of the 2004 Monitoring the Future study, at which Drug Czar John Walters was a featured speaker.Excitingly enough, I got to ask the first question during the question and answer period: "Mr. Walters, you frequently tout random student drug
testing as a silver bullet' a solution to our nation's drug problems. But
Dr. Johnston [the principal researcher of the MTF study and the guy sitting a
few seats down the table from Walters] and the rest of the Monitoring the
Future research team released the largest-ever study on the topic last
year, which found that school drug testing was not associated with either
the prevalence or frequency of student marijuana use, or of other illicit
drug use. Are you prepared to tell Dr. Johnston that his study was
methodologically flawed?"Dr. Johnston laughed out loud. Then, the mighty drug czar indeed
insinuated that the study is not as comprehensive as he would like. He
said that the study only looks at for-cause testing and not random drug
testing. (Does anyone know if this is wholly true?) Walters said that
he's sticking by random drug testing, and that we must diagnose those who
have drug problems while they're young, similar to the way we diagnose
young people who have tuberculosis. Dr. Johnston then got up and said
that although effective drug testing programs may be developed one day,
"as practiced up to the present, drug testing doesn't seem to be
effective."After my question, there were a number of other critical and pointed questions, ... 
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Comment #30 posted by Hope on December 21, 2004 at 13:35:00 PT
translation..."keep the money rollin in"
"These are sustained, broad and deep declines," John Walters, director of National Drug Control Policy, said at a news conference. "The challenge before us is to follow through."
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Comment #29 posted by Hope on December 21, 2004 at 13:26:54 PT
Yes, I know you are right
I'm no better than anyone else at carrying the weight of the world. I must shake it off and pretend it isn't happening just because I can't see it.More self congratulatory crap and pocket lining from the Bush Administrationhttp://abcnews.go.com/Health/wireStory?id=349572
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Comment #28 posted by Hope on December 21, 2004 at 13:22:59 PT
Yes, FoM!
The recommendation would be honored in whatever state that was that they were talking about the "loophole" the other day. The loophole is they forgot to put in only doctors in their state could recommend cannabis. But I think it's as hard to get a recommendation in Canada as it is anywhere.
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Comment #27 posted by FoM on December 21, 2004 at 13:22:44 PT
Hope
Enjoy your family and celebrate with them. That makes it easier to handle and they need you.
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Comment #26 posted by FoM on December 21, 2004 at 13:18:30 PT
A Question About Sativex
Would an American be able to go to a Doctor in Canada and get a prescription for Sativex if the Doctor thought it would help? If the answer is yes would the prescription be honored in the states then?
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Comment #25 posted by Hope on December 21, 2004 at 13:18:15 PT
Well...
before I'm accused of wallowing in misery...I must return to preparation of a joyous celebration, to celebrate the man of peace that tried...and was ignored as all men of peace are.
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Comment #24 posted by Hope on December 21, 2004 at 13:11:03 PT
listening to Cat
and looking at that photograph from the mess hall in Iraq. My heart is filled with doubt and pain.
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Comment #23 posted by observer on December 21, 2004 at 13:10:29 PT
Sativex = Weed Out
Sativa = weed, -ex = out
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Comment #22 posted by Hope on December 21, 2004 at 13:06:14 PT
Cat...easier to spell than Yusuf or Yusaf or...
he's more beautiful than ever. There is peace in him that wasn't there years ago.
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Comment #21 posted by FoM on December 21, 2004 at 12:38:21 PT
Peace On Earth
I don't know if we will ever see Peace again at least in my lifetime. Maybe if the world goes on for 50 more years or so peace might be attained.War makes more war. That's all it's good for.
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Comment #20 posted by Hope on December 21, 2004 at 12:23:40 PT
"our government"
Right now, FoM, those have to be the most grievous words in the world.We had power and we wasted it. George Bush, waving a banner with Jesus's name, who he obviously despises, raining death and terror on the earth in the name of vengence.Merry Christmas all you warmongers!Even Peace Train makes me sad. It reminds me what our government put Mr. Steven's through in the name of security. There is no justice or the warmongers would be criminals and peace would rule.
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Comment #19 posted by Hope on December 21, 2004 at 12:19:26 PT
We had the power
to do good for the world. There is no liberty. There is no peace. There is no joy. There is no justice. There is no love. Only sorrow, pain, death, screaming and crying.Thank you, George Bush and company. Thank you.
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Comment #18 posted by FoM on December 21, 2004 at 12:16:32 PT
Hope
This is just the beginning unfortunately. Bush has done us so wrong. If you can listen to this video of Peace Train it helped me. I hope our government will let him come back here to bring good music to those who really seek peace in the world.http://www.mountainoflight.co.uk/av/av.html
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Comment #17 posted by Hope on December 21, 2004 at 12:11:27 PT
Grief
My small irritant brought to me courtesy of our lovely government is nothing.This grief is hideous.http://apnews.myway.com/article/20041221/D87476VG0.html
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Comment #16 posted by Hope on December 21, 2004 at 11:45:21 PT
surely
the success of Sativex will loosen the bonds of hatred and fear enough to allow the medical use even in the U.S..Eventually.I really feel angry right now. I'm tired and worn out and frustrated and more than a bit overwhelmed. What irks me is I know there is a substance that would lift my spirits enough that I could see daylight...but I would have to risk my freedom to use it."Recreation is good medicine"..."a merry heart is good medicine"...I'm so angry my redneck is rising!
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Comment #15 posted by Hope on December 21, 2004 at 11:37:29 PT
Rimonabant
The prohibitionist's friend. They don't care who they hurt...just don't want anyone having any pleasure that they don't approve of.I really want to be forgiving...but it's hard.
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Comment #14 posted by FoM on December 21, 2004 at 11:36:15 PT
Hope
One word! Money! Think of all the companies that would lose.That's my opinion!
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Comment #13 posted by Hope on December 21, 2004 at 11:34:39 PT
I'm curious to know
why there have been no studies, that I'm aware of, that try to find out why cannabis can be such a huge relief to depressives.
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Comment #12 posted by FoM on December 21, 2004 at 11:34:31 PT
My Opinion
EJ that drug is one I would never touch with a ten foot pole. 
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Comment #11 posted by E_Johnson on December 21, 2004 at 11:31:56 PT
Aren't people concerned about Rimonabant?
Gee if cannabinoids influence all of these different systems, why aren't people more worried about the potential side effects of a cannabinoid blocker like Rimonabant? 
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Comment #10 posted by FoM on December 21, 2004 at 11:30:37 PT
More on Sativex from The BBC UK
Cannabis Hopes Bolster Drugs Firm: http://news.bbc.co.uk/1/hi/business/4114147.stm
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Comment #9 posted by Ethan Russo MD on December 21, 2004 at 11:02:59 PT
Yes, Perhaps
The endothelial cells of the blood vessels have cannabinoid receptors, perhaps different than CB1. They have been called CB3 or CBx. For more details, go to PubMed:http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=PubMedand plug in the search terms: endothelial endocannabinoid
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Comment #8 posted by E_Johnson on December 21, 2004 at 10:57:46 PT
Dr. Russo I have a question
Is there any chance that this effect could be from cannabinoids?http://story.news.yahoo.com/news?tmpl=story&u=/nm/20041220/hl_nm/exercise_fat_dc
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Comment #7 posted by FoM on December 21, 2004 at 10:35:28 PT
My Hope
Is that approval in Canada for a true Cannabis medicine will make our country re-schedule Cannabis because it does have medicinal properties. If it would be approved in the states and not hard to get from a doctor think how it would help with drug testing issues.
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Comment #6 posted by Max Flowers on December 21, 2004 at 10:21:58 PT
Excellent
Let's see what the bought-and-paid-for medical shills of the FDA/DEA have to say about this one. It will be VERY difficult for them to explain this away without looking like total asses (not that that has ever bothered them before). Still, there will now be an obvious schism between the medical reality in Canada and the line of bull that they (FDA/DEA flunkies) have been selling.
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Comment #5 posted by FoM on December 21, 2004 at 09:09:01 PT
Dr. Russo
I'm so very happy for you. Maybe with all the recalls on drugs here in the states Sativex might become available to fill the void. I'll keep my fingers crossed. I know that Sativex isn't toxic and hopefully approval will come quickly. 
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Comment #4 posted by Hope on December 21, 2004 at 09:06:31 PT
Dr. Russo
Congratulations!I know you're happy about all this...but probably sad as we all are that it's not being made available in your own country, too.Thank you for your work on this project.
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Comment #3 posted by Ethan Russo MD on December 21, 2004 at 09:03:43 PT
A Series of Stories
http://cgi.wn.com/?SearchString=Sativex&language=Any+Language&template=londonglobe%2Findex.txt&action=search&first=0available above under December 21.
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Comment #2 posted by FoM on December 21, 2004 at 08:55:06 PT
GW Pharmaceuticals Press Release
http://www.gwpharm.com/news_press_releases.asp?id=/gwp/pressreleases/currentpress/2004-12-21/
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Comment #1 posted by FoM on December 21, 2004 at 08:38:31 PT
Related Article from Times Online UK
Canada Poised To Back Cannabis PainkillerBy Mike Verdin, Times Online
 December 21, 2004 Canada is poised to become the first country to endorse a cannabis-based medicine after issuing final terms for the approval of a painkiller for multiple sclerosis patients. 
 
GW Pharmaceuticals said that it was poised to receive approval for its Sativex drug next year after receiving outline support from Health Canada, the country's healthcare regulator.Health Canada has issued a qualifying notice for Sativex, setting out terms on matters such as marketing, after which endorsement is considered a formality."Under the Canadian system, full approval should be relatively straightforward from here," Jon Senior, the Evolution analyst, said.Full consent would make Sativex, which is derived from thousands of marijuana plants grown at a secret location in England, the first cannabis-based medicine approved for prescription, GW said."This approval will be a major milestone for GW and for people with multiple sclerosis who have long awaited a prescription cannabis-based medicine for the treatment of neuropathic pain," Dr Geoffrey Guy, the GW chairman, said.He also praised the speed of the Canadian regulators, who have endorsed Sativex in seven months. "We are grateful to them for this rapid turnaround time," Dr Guy said."Health Canada in their review reflects a welcome recognition of the clinical need in MS patients for Sativex."The comments come amid a prolonged drive by GW to win UK approval for Sativex, which was first submitted to British authorities in March last year.The Committee on Safety of Medicines earlier this month said that further study was needed to confirm that the drug was sufficiently beneficial for patients, meaning that Sativex will not be launched in Britain for at least six months.GW shares surged 10 per cent to 116p in early trade before dropping back to 114p, up 9p on the day.
 Copyright: 2004 Times Newspapers Ltd.
 http://business.timesonline.co.uk/article/0,,9068-1411371,00.html
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