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Britain Poised to Approve Medicine Derived From Marijuana * 1
    #2276601 - 01/27/04 04:34 AM (14 years, 3 months ago)


Britain Poised to Approve Medicine Derived From Marijuana
Published: January 27, 2004

A marijuana-based medication for people suffering from multiple sclerosis and severe pain is expected to be approved for sale in Britain early this year, British officials say.

The drug, Sativex, developed by GW Pharmaceuticals, a British company, is a liquid extract from marijuana grown by the company under license from the government. Developed to be sprayed under the tongue, it would be the first drug in recent decades to include all the components of the cannabis plant, advocates of medical marijuana say.

The British agency that regulates pharmaceuticals does not like to discuss potential drugs before they are approved. The country's Home Office, which oversees laws and policies on controlled substances, has indicated that Sativex is likely to receive approval.

Alan Macfarlane, a chief inspector at the Home Office, said the results of the clinical trials for Sativex looked promising. "I'm hoping it will be dealt with in the next two to three months, and I will be surprised if it doesn't succeed," he said.

Bayer, the German pharmaceutical giant, signed a deal with GW last year to market Sativex in Britain and possibly other countries. "What's likely to happen is that the U.K. authorization will lead quite quickly to European Union authorization," Mr. Macfarlane said. "I think it's going to be a little troubling for the U.S. Drug Enforcement Administration, given the national climate about marijuana."

GW also hopes eventually to obtain regulatory approval from the Food and Drug Administration. But the review process in the United States is expected to take much longer, and the policy against marijuana use, in any form, is much more prohibitive.

Further, the Office of National Drug Control Policy says that marijuana abuse is associated with health problems as diverse as respiratory infections, impaired memory and learning, anxiety and panic attacks.

Marijuana proponents challenge these claims, saying the plant is far less toxic than many of the medicines it would replace. In any event, they say, approval of medical marijuana in Britain should lead to broader acceptance of the plant's therapeutic uses.

"If it turns out to be effective," said Dr. Jack Lewin, chief executive of the California Medical Association, "it's going to be a very positive development, akin in terms of medicine to moving from the crudeness of smoking opium to the use of Demerol and morphine."

The Food and Drug Administration has allowed people to import personal supplies of pharmaceutical drugs that are not approved in the United States, and medical marijuana advocates are already planning to pressure the authorities to allow patients to obtain Sativex.

But Will Glaspy, a spokesman for the Drug Enforcement Administration, said it was unlikely that someone could lawfully import an extract from a drug like marijuana, although he did not know specifically about Sativex. "If it's a controlled substance here, it would be illegal to bring it into the country," Mr. Glaspy said.

But some advocates for overhauling marijuana laws say the British approval of Sativex will bolster their case. Dr. Rick Doblin, president of the Multidisciplinary Association for Psychedelic Studies, a research and education organization in Sarasota, Fla., said, "To the extent that GW gets approval, it supports the credibility of what we have been saying about the medical benefits of marijuana, and it causes people to question the credibility of the government."

Others are concerned about the government's response.

Bruce Mirkin, a spokesman for the Marijuana Policy Project, an advocacy group in Washington, said, "The government could use this as an excuse to say, `See, we have this fabulous pharmaceutical substitute; you don't need this nasty weed anymore.' "

Drug companies have already developed a handful of drugs derived from isolated elements of the marijuana plant.

The most widely known marijuana drug now available is Marinol, which the F.D.A. approved in capsule form in 1985. Marinol is essentially a synthetic version of THC, or tetrahydrocannabinol, the psychoactive component of marijuana, and is used to treat chemotherapy-associated nausea and AIDS-related wasting and appetite loss.

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work in progress

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Re: Britain Poised to Approve Medicine Derived From Marijuana [Re: Anno] * 1
    #2276695 - 01/27/04 05:39 AM (14 years, 3 months ago)

good progress in britain :thumbup:

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Re: Britain Poised to Approve Medicine Derived From Marijuana [Re: Anno] * 1
    #2276911 - 01/27/04 09:22 AM (14 years, 3 months ago)

Good news, my little sister is a multiple sclerosis sufferer, so
anything that could help her out, is a step in the right direction :thumbup:

lets just hope america don't try to put a stop on it :frown:

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Trip'n Time

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Re: Britain Poised to Approve Medicine Derived From Marijuana [Re: G a n j a] * 1
    #2278596 - 01/27/04 07:59 PM (14 years, 3 months ago)

Wow, this is just liquid pot. If it get approved its only a mater of time, imo, before pot likewise get approved. And how long will britian approve of it before all of Europe does? Before all the world? :biggrin:

I think the US is going to be looking real stupid real soon...

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A Fun Guy
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Re: Britain Poised to Approve Medicine Derived From Marijuana [Re: DailyPot] * 1
    #2279153 - 01/27/04 11:35 PM (14 years, 3 months ago)

And if the Lib Dems overtake the Conservatives to Shadow Goverment, they'll push for full legalisation (if they live up to their current policy, anyway). I think legalising weed would show that a government *is* actually capable of doing what everyone wants, rather than just being a mother figure and telling them they're wrong, and get a lot more young people actively interested in politics again.

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mushroom mobster

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Re: Britain Poised to Approve Medicine Derived From Marijuana [Re: DailyPot] * 1
    #2282464 - 01/29/04 02:02 AM (14 years, 3 months ago)

Going to be? :-D


DailyPot said:
I think the US is going to be looking real stupid real soon...

"The business of America is business," - Calvin Coolidge

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Re: Britain Poised to Approve Medicine Derived From Marijuana [Re: Anno] * 1
    #2282928 - 01/29/04 06:16 AM (14 years, 3 months ago)

Comments by Lester Grinspoon MD on

Britain Poised to Approve Medicine Derived From Marijuana

January 27, 2004. New York Times

I am pleased that the New York Times carried the piece, "Britain Poised to Approve Medicine Derived from Marijuana" if for no other reason than it contributes to the growing understanding that cannabis has some remarkable medicinal utilities. However, I am disappointed that it did not address some of the concerns about Sativex and G. W. Pharmaceuticals.

GW Pharmaceuticals sold this product to the Home Office on the assertion that it will provide all of the medical benefits of cannabis without imposing on the patient the "two dangerous" effects -- those of smoking and getting high. There is very little to support the proposition that smoking marijuana represents a great risk to the pulmonary system. Although cannabis has been smoked widely in this country for four decades now, there are no reported cases of cancer or emphysema which can be attributed to marijuana. I suspect that breathing a day's worth of the air in Houston or any other city with poor air quality poses more of a threat than inhaling a day's dose of smoked marijuana. Furthermore, those who are, in today's antismoking climate, concerned about any toxic effects on the pulmonary system can now use a vaporizer, a device which frees the cannabinoid molecules from the plant material without the necessity of burning it and thereby producing smoke. As for the psychoactive effects, I am not convinced that the therapeutic benefits of cannabis can be separated from the psychoactive effects nor am I persuaded that that is always a desirable goal. For example, many patients with multiple sclerosis who use marijuana speak of mood elevation as well as the relief of muscle spasm and other symptoms. If cannabis contributes to this feeling better, should patients be deprived of this effect" The statement that, "The company maintains that Sativex, when taken properly, does not cause the kind of intoxication that people routinely experience from smoking marijuana" hinges on the phrase, "when taken properly". Properly here means taking a dose which is under the dose level required for intoxication. One has to question whether that dose is always therapeutic and whether cannabis taken sublingually can be so carefully titrated to find that precise dose. It is also true that people who want to use Sativex to get high will certainly be able to do so.

One of the most important characteristics of cannabis as a medicine is its capacity for self-titration when taken through the pulmonary system. Because the effects are achieved so rapidly through this means of administration, the patient can determine precisely the amount needed for symptom relief; the risk of underdosing or overdosing is minimized. While sublingual absorption of cannabis leads to faster relief than oral administration (which may take one and a half to two hours), it is not nearly as fast as pulmonary administration and therefore makes self-titration much more difficult if not impossible. Furthermore, many patients cannot hold the Sativex under the tongue long enough for it to be absorbed so as a consequence varying amounts trickle down the esophagus; it then behaves like orally administered cannabis with the consequent delay in the therapeutic effect.

Cannabis will one day be seen as a wonder drug as was penicillin in the 1940s. Like penicillin, cannabis is remarkably nontoxic, has a wide range of therapeutic applications, and will be quite inexpensive when it becomes free of the prohibition tariff. Even now illicit or homegrown marijuana, which is no less useful than Sativex, is less expensive than Sativex will be. This will be noted by people with medical insurance whose copayments are regularly increasing and it will be particularly important to the 43 million Americans who do not have health insurance.

While the pharmaceutical industry will undoubtedly produce analogs of cannabis which will be useful in ways that whole smoked cannabis is not, Sativex provides only one advantage over whole smoked (or vaporized) marijuana: its use will be legal. I have yet to see a patient who has used both dronabinol and smoked marijuana who has not found the latter more useful and manageable. The primary reason people use dronabinol rather than cannabis is a function of the law. Without the prohibition, few would use dronabinol. Similarly, the commercial success of Sativex will largely depend on the vigor with which the prohibition is enforced. It is not unreasonable to believe that as the pharmaceutical armamentarium of cannabinoids increases, so will the pharmaceutical industry's interest in sustaining the prohibition. Dr. Geoffrey Guy claims that he founded the company to keep people who find marijuana useful as a medicine out-of-court; there is, of course, a way to do this which would be much less expensive economically and in terms of human suffering.

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