cannabisnews.com: Bayer Bids To Market Pot-Based MS Drug in Canada





Bayer Bids To Market Pot-Based MS Drug in Canada
Posted by CN Staff on May 11, 2004 at 17:09:18 PT
By The Canadian Press 
Source: Canadian Press 
Pharmaceutical giant Bayer HealthCare has applied to market a marijuana-based drug in Canada. If approved, it would be the first cannabis-based drug legally available in this country for the relief of debilitating symptoms of multiple sclerosis and severe neuropathic pain.Bayer and GW Pharmaceuticals of Britain announced Tuesday they had filed a new drug submission to Health Canada for Sativex, an oral spray developed by GW Pharmaceuticals and licensed to Bayer.
A spokesperson for Health Canada said it typically takes about 18 months for the department's therapeutic products directorate to review and rule on a submission. Bayer's vice-president for public policy and communication said the companies are confident, based on early discussions with the department, that the submission will be approved."It's our belief through our initial discussions that we hope to get it through the regulatory process, and in as quick time as possible," Doug Grant said Tuesday. "You can never tell with any drug once it gets into the regulatory process, but they have been quite open in discussing this with us."The companies describe the product as a whole plant medicinal cannabis extract containing tetrahydrocannabinol, or THC, and cannabidiol as its principal components. There are other cannabis-based drugs available in this country. They are used by cancer and AIDS patients to control nausea and vomiting and to restore appetite as a means of combating the wasting effect of those diseases.But Sativex would be the first cannabis-derived drug aimed at MS sufferers.The head of the MS clinic at St. Michael's Hospital in Toronto said if the drug is approved, it would be a welcome addition to the arsenal of drugs available to alleviate the pain and spasticity experienced by many patients with MS.While there are other, non-cannabis based drugs on the market to treat those symptoms of the disease, "there remains a subgroup of MS patients who don't respond well or at all to the anti-pain, anti-spasticity drugs. And that group would want to try this," said Dr. Paul O'Connor, a neurologist."If it became an approved medication by the federal government, I would certainly want to try it in certain patients and get some first-hand experience as to how it works."O'Connor said some of his patients use marijuana to control these debilitating symptoms. But users of medicinal marijuana complain the product available by prescription from the federal government is of poor quality. And O'Connor said many patients don't want to smoke."A lot of the patients that do smoke it wish that there was a more convenient and non-smokeable but effective form of a cannabinoid available," he said.Approximately 50,000 people in Canada are diagnosed with MS.British regulatory authorities are already working on a drug approval submission for Sativex. Grant said the companies hope to have approval shortly and to have the product on the market there by the end of this year.Source: Canadian PressPublished: May 11, 2004Copyright: 2004 The Canadian PressRelated 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 #7 posted by ekim on May 12, 2004 at 12:49:33 PT
not the America i no
Here's a reality check for you. Click on:
http://www.alternet.org/story.html?StoryID=18659
http://www.mmdetroit.org
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Comment #6 posted by Jose Melendez on May 12, 2004 at 07:18:56 PT
Systemic waste, fraud and abuse: The antitrust.
"The attorney general of California is very unhappy about the state's energy crisis, and he has come up with the perfect solution. It involves a creative type of punishment for Kenneth Lay, chairman of the Houston-based energy company Enron. Though Lay has not been convicted of any crime, Bill Lockyer says, "I would love to personally escort Lay to an 8-by-10 cell that he could share with a tattooed dude who says, 'Hi, my name is Spike, honey.'" Let the record show that the chief law enforcement officer for the nation's biggest state regards prison rape as a valuable feature of his correctional system. Soft-hearted souls may lament the sexual victimization of jail and prison inmates by violent sociopaths, but Lockyer's chief concern is that there are some people who have yet to experience this form of justice.  It used to be that prison was feared because it meant a prolonged loss of freedom, hard labor, separation from family and friends and, sometimes, violence by guards. But somewhere along the line, Americans got used to the idea that it also involves sadistic sexual abuse, with no one doing anything to stop it. Why are we so nonchalant? We might be outraged that anti-social thugs are getting away with horrific new crimes every day, under the very noses of law enforcement. Instead, many people -- Lockyer among them -- have embraced the proposition that the victims are getting only what they deserve. "from: http://www.townhall.com/columnists/stevechapman/sc20010607.shtmlSee also: Who needs elections?"If a single Florida incumbent loses in November it would be an upset, a national story."http://www.news-journalonline.com/NewsJournalOnline/News/Local/03AreaEASTCOL051204.htm - - -YES! You can help:see:Mirror campaign:http://rxpot.com/sayNoWay/vs.http://www.house.gov/mica/welcome.htmthank you kindly,Jose Melendez, DeLand, FLfounder, http://Rxpot.comWage peace.
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Comment #5 posted by kaptinemo on May 12, 2004 at 06:33:20 PT:
The first click of the ratchet begins
with 'possession'. From there, it gets progressively worse.Because DuPont and the other antis - just as nearly all opportunistic businessmen seeking to get fat off the DrugWar - have carefully cultivated a media presence that doesn't *dare* point out his logical fallacies for fear of being cut off from future 'scoops'...which have turned out to be nothing more than predigested pap. That the man is engaged in a conflict of interest - selling drug testing kits to dimwitted parents frightened by his and other antis' 'public service' pronouncements - is obvious. Yet few journos will have the stones to point this out.So his bald-facedly disingenuous claim that people are not arrested and imprisoned for simple possession never gets exposed to the cold, merciless light of rationality. The Emperor continues to parade around, bare-*** naked and covered with sores and no one points out this fact lest they be decried as being 'partisan'. 
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Comment #4 posted by BigDawg on May 12, 2004 at 04:22:38 PT
Jose
There are many points to be made... but I will toss in the part that bothers me the most."The image of millions of people being incarcerated for long periods of time for smoking marijuana (or using any drug) in the privacy of their homes is a modern myth."^^^This is simply untrue. And, if for the sake of argument we accept that premise, WHY must we have such laws if they are not being enforced? If the argument is that simple users are not being incarcerated, why is there such a big fight to keep those laws? Having such laws means that it is inevitable that there ARE at least some who are being arrested as users. Is this not injustice?
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Comment #3 posted by Jose Melendez on May 12, 2004 at 03:41:25 PT
A note
I am writing an extensive article out of the three questions I asked (in Comment #2) of Dr. Robert L. DuPont, based on his sworn testimony under oath before Congress, and taking into account conflicts of interest:See also:http://adrugwarcarol.com/news/viewtopic.php?forum=1&topic=763 http://www.ibhinc.org/pdfs/MedicalMarijuanaTestimony.pdfhttp://www.ibhinc.org/whatsnew.html
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Comment #2 posted by Jose Melendez on May 12, 2004 at 03:35:57 PT
3rd draft, NOT FINAL FORM
OK, here we go, and I think I already spot further backpedaling. Any hints, ideas or suggestions before I run with this?-Jose Melendez
rxpot.comfrom: From: "Audrey Bumanis" abumanis ibhinc.org
Date: Mon May 3, 2004 16:57:40 US/Eastern
To: 
Cc: BobDuPont aol.com, "'Jackie Mazza'" JMazza ibhinc.org, Helen DuPont HDuPont ibhinc.org, SWiggins ibhinc.org
Subject: Robert DuPont Cannabisnews.com Response
Return-Path: abumanis ibhinc.org
Delivered-To: jose xxxxxxx.comAttached is the response you have been waiting for!Thank you for your patience.  vvvvvvvvvvvvvvvvAudrey BumanisResearch AssistantInstitute for Behavior and Health6191 Executive BoulevardRockville,MD20852Voice: 301.231.9010Fax: 301.770.6876www.ibhinc.org1. Youíve made it clear in your April 1 testimony to Congress that smoking crude plant matter is a serious threat to health and safety, and that legitimizing smoked marijuana as a ìmedicineî, even under limited and doctor-supervised use, is against the public interest.What, if any, are the dangers or undesirable side effects from other methods of marijuana ingestion such as food preparations, teas, tinctures or vaporization?Smoking is a toxic drug delivery system that is incompatible with any medicine.I am enthusiastic about the therapeutic potential for the purified chemicals found in marijuana smoke. It is likely that any medicine based on these chemicals will use synthetic analogs rather than plant-derived chemicals but the distinction between plant-derived and synthetic chemicals in medicines is not a policy issue.With respect to the non-smoked delivery of marijuana such as in foods or teas, I have no objection if such treatments were shown to be safe and effective by the usual FDA tests for medicines. At the testimony before the Subcommittee on Criminal Justice, Drug Policy and Human Resources on April 1, 2004, the representative of the Food and Drug Administration went out of his way to say that ìbotanicalsî such as crude marijuana can be approved by the FDA but that they must meet the same high standards as other medicines for both safety and efficacy. I agree with this opinion.2. The sublingual whole cannabis extract Sativex, developed by U.K. firm GW Pharm is currently licensed for European sales by Bayer A.G.Do you have any reservations about F.D.A. approval of such extracts, and what do you see as the best medical indications for cannabinoid based medications?Sativex is an intriguing new product. I am interested in seeing if Sativex can pass muster with the US FDA. If it does, and if its release into the medical marketplace is accompanied by a comprehensive plan of post-marketing surveillance of abuse of the product, I will be happy to see where Sativex finds a place in the contemporary medical arsenal.3. Many hundreds of thousands of American lives are lost each year due to complications from the use of far more harmful but legally taxed and consumed drugs and their associated delivery devices.How is society served by incarcerating people who choose raw, generic cannabis as their medication or intoxicant?One of the more remarkable arguments for decriminalizing or even legalizing marijuana smoking is that alcohol and tobacco cause more death and more illness than does marijuana. This popular argument has perverse public health implications. The high health costs rung up by alcohol and tobacco are reasons to curtail their use in society, they are not reasons to encourage greater use of marijuana. I am committed to reducing the use, especially, by youth, of all three of these drugs. The high health costs of alcohol and tobacco use are powerful warnings about the dangers of legalization.With respect to incarceration of ìpeople who choose raw, generic cannabis,î the Controlled Substances Act of 1970 distinguished penalties for possession from those for distribution with the possession penalties. For all illegal drugs the penalty for use is limited to a misdemeanor status punishable by a fine and imprisonment of less than 1 year. Incarceration for simple possession, absent a situation in which the charge is part of a plea-bargain from a more serious offense and/or repeated criminal offenses is exceedingly rare. The image of millions of people being incarcerated for long periods of time for smoking marijuana (or using any drug) in the privacy of their homes is a modern myth.The important frontier for the criminal justice system with respect to illegal drug use is the potential for the criminal justice system to facilitate recovery. Drug courts and other alternatives-to-incarceration programs plus linking drug abuse treatment to parole and probation are hopeful new areas of > development.A Comment: I welcome debate on drug policy. I respect those who disagree with me and I respect their arguments. Sound public policy depends on civil debate and mutual respect. I appreciate this opportunity to express my views in cannabisnews.com
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Comment #1 posted by FoM on May 11, 2004 at 21:37:56 PT
Press Release: Drug Policy Forum Trust 
Medical Marijuana Experts to Visit New ZealandWednesday, May 12, 2004International Medical Marijuana Experts to Visit New Zealand
Experts and officials from government-sanctioned medical marijuana programmes in The Netherlands, Canada, and the United States will be visiting New Zealand 26-30 May. In recent years, governments around the world have begun re-legalising the use of marijuana (cannabis) by patients with chronic pain and other forms of suffering, such as muscle spasms due to multiple sclerosis, appetite enhancement in patients with terminal conditions, and nausea due to chemotherapy. A parliamentary health select committee recently recommended that New Zealand consider making cannabis-based medicines available to suffering patients. However, no consensus yet exists on how to proceed.The Drug Policy Forum Trust (DPFT) has invited overseas experts from leading international programmes to provide a private briefing to its trustees concerning the detailed workings of these programmes. The DPFT will then write a report containing recommendations for a medical marijuana programme in New Zealand.The visiting experts are: Willem Scholten, PharmD, MPA 
Head, Office of Medicinal Cannabis 
Ministry of Health, Welfare and Sports
The Hague, The Netherlands 
Peer Neeleman, M.D. Head, Pain Center Sub-Department Department of Anesthesia University Hospital
Rotterdam, The Netherlands 
Robin O’Brien, D.Pharm Member, Advisory Committee to Health Canada’s Office of Cannabis Medical Access Formerly with BC Cancer Association Vancouver, BC, CanadaHilary Black
Director, British Columbia Compassion Club Society
Vancouver, BC, Canada
Valerie and Mike Corral
Wo/men’s Alliance for Medical Marijuana
Consultants, San Francisco Medical Cannabis Initiative
Santa Cruz, CA, USAIn addition to the private briefing, to be held in Kaikoura, the visiting experts will give two presentations in Wellington, on Wednesday and Thursday evenings, 26-27 May. The time and place for both sessions is 7:30pm at the Old Government Buildings, Room LT3, 3 Lambton Quay. These presentations are free and open to the public. The speakers will be available for private briefings and press interviews on the above days.For more information contact Drug Policy Forum Trust on 083 275 557 www.drugpolicy.org.nz email: admin nzdpft.orgThe Drug Policy Forum Trust is an independent group of doctors and other professionals who support evidence-based drug policies. They have published reports see: http://www.drugpolicy.org.nz/cannabis-policy.htm testified at parliamentary select committee hearings, held educational seminars for MPs, and engaged in many similar activities. Current trustees are Prof Fred Fastier, D.Sc., D.Phil., Dr Robin Briant, MD, FRACP, Dr John McPartland, D.O., and Dr David Hadorn, M.D., Ph.D. (director). Copyright (c) Scoop Media 
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