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Friday, July 11, 2008

Big Pharma Is in a Frenzy to Bring Cannabis-Based Medicines to Market

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By Paul Armentano, AlterNet. Posted July 5, 2008.

While the the American Medical Association claims pot has no medical value, Big Pharma is busy getting patents for marijuana products.

Stop Arresting Smokers
The US government's longstanding denial of medical marijuana research and use is an irrational and morally bankrupt public policy. On this point, few Americans disagree. As for the question of "why" federal officials maintain this inflexible and inhumane policy, well that's another story

One of the more popular theories seeking to explain the Feds' seemingly inexplicable ban on medical pot goes like this: Neither the US government nor the pharmaceutical industry will allow for the use of medical marijuana because they can't patent it or profit from it.

It's an appealing theory, yet I've found it to be neither accurate nor persuasive. Here's why.

First, let me state the obvious. Big Pharma is busily applying for -- and has already received -- multiple patents for the medical properties of pot. These include patents for synthetic pot derivatives (such as the oral THC pill Marinol), cannabinoid agonists (synthetic agents that bind to the brain's endocannabinoid receptors) like HU-210 and cannabis antagonists such as Rimonabant. This trend was most recently summarized in the NIH paper (pdf), "The endocannabinoid system as an emerging target of pharmacotherapy," which concluded, "The growing interest in the underlying science has been matched by a growth in the number of cannabinoid drugs in pharmaceutical development from two in 1995 to 27 in 2004." In other words, at the same time the American Medical Association is proclaiming that pot has no medical value, Big Pharma is in a frenzy to bring dozens of new, cannabis-based medicines to market.

Not all of these medicines will be synthetic pills either. Most notably, GW Pharmaceutical's oral marijuana spray, Sativex, is a patented standardized dose of natural cannabis extracts. (The extracts, primarily THC and the non-psychoactive, anxiolytic compound CBD, are taken directly from marijuana plants grown at an undisclosed, company warehouse.)

Does Big Pharma's sudden and growing interest in the research and development of pot-based medicines mean that the industry is proactively supporting marijuana prohibition? Not if they know what's good for them. Let me explain.

First, any and all cannabis-based medicines must be granted approval from federal regulatory bodies such as the US Food and Drug Administration -- a process that remains as much based on politics as it is on scientific merit. Chances are that a government that is unreasonably hostile toward the marijuana plant will also be unreasonably hostile toward sanctioning cannabis-based pharmaceuticals.

A recent example of this may be found in the Medicine and Health Products Regulatory Agency's recent denial of Sativex as a prescription drug in the United Kingdom. (Sativex's parent company, GW Pharmaceuticals, is based in London.) In recent years, British politicians have taken an atypically hard-line against the recreational use of marijuana -- culminating in Prime Minister Gordon Brown's declaration that today's pot is now of "lethal quality." (Shortly thereafter, Parliament elected to stiffen criminal penalties on the possession of the drug from a verbal warning to up to five years in jail.) In such an environment is it any wonder that British regulators have steadfastly refused to legalize a pot-based medicine, even one with an impeccable safety record like Sativex? Conversely, Canadian health regulators -- who take a much more liberal view toward the use of natural cannabis and oversee its distribution to authorized patients -- recently approved Sativex as a prescription drug.

Of course, gaining regulatory approval is only half the battle. The real hurdle for Big Pharma is finding customers for its product. Here again, a culture that is familiar with and educated to the use therapeutic cannabis is likely going to be far more open to the use of pot-based medicines than a population still stuck in the grip of "Reefer Madness."

Will those patients who already have first-hand experience with the use of medical pot switch to a cannabis-based pharmaceutical if one becomes legally available? Maybe not, but these individuals comprise only a fraction of the US population. Certainly many others will -- including many older patients who would never the desire to try or the access to obtain natural cannabis. Bottom line: regardless of whether pot is legal or not, cannabis-based pharmaceuticals will no doubt have a broad appeal.

But wouldn't the legal availability of pot encourage patients to use fewer pharmaceuticals overall? Perhaps, though likely not to any degree that adversely impacts Big Pharma's bottom line. Certainly most individuals in the Netherlands, Canada, and in California -- three regions where medical pot is both legal and easily accessible on the open market -- use prescription drugs, not cannabis for their ailments. Further, despite the availability of numerous legal healing herbs and traditional medicines such as Echinacea, Witch Hazel, and Eastern hemlock most Americans continue to turn to pharmaceutical preparations as their remedies of choice.

Should the advent of legal, alternative pot-based medicines ever warrant or justify the criminalization of patients who find superior relief from natural cannabis? Certainly not. But, as the private sector continues to move forward with research into the safety and efficacy of marijuana-based pharmaceuticals, it will become harder and harder for the government and law enforcement to maintain their absurd and illogical policy of total pot prohibition.

Of course, were it not for advocates having worked for four decades to legalize medical cannabis, it's unlikely that anyone -- most especially the pharmaceutical industry -- would be turning their attention toward the development and marketing of cannabis-based therapeutics. That said, I won't be holding my breath waiting for any royalty checks.

Oh yeah, and as for those who claim that the US government can't patent medical pot, check out the assignee for US Patent #6630507.

__________________________________________________ _____


* Hampson, Aidan J.
* Axelrod, Julius
* Grimaldi, Maurizio


* The United States of America as represented by the Department of Health and Human Services

No. 09/674028 filed on 02/02/2001

Current US Class
514/454Tricyclo ring system having the hetero ring as one of the cyclos

Field of Search
514/454Tricyclo ring system having the hetero ring as one of the cyclos

Primary: Weddington, Kevin E.

Attorney, Agent or Firm

* Klarquist Sparkman, LLP

US Patent References
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Issued on: 10/24/1989
Inventor: Mechoulam, et al.5227537, Method for the production of 6,12-dihydro-6-hydroxy-cannabidiol and the use thereof for the production of trans-delta-9-tetrahydrocannabinol
Issued on: 07/13/1993
Inventor: Stoss, et al.5284867, NMDA-blocking pharmaceutical compositions
Issued on: 02/08/1994
Inventor: Kloog, et al.5434295, Neuroprotective pharmaceutical compositions of 4-phenylpinene derivatives and certain novel 4-phenylpinene compounds
Issued on: 07/18/1995
Inventor: Mechoulam, et al.5462946, Nitroxides as protectors against oxidative stress
Issued on: 10/31/1995
Inventor: Mitchell, et al.5512270, Method of inhibiting oxidants using alkylaryl polyether alcohol polymers
Issued on: 04/30/1996
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Issued on: 05/28/1996
Inventor: Mechoulam, et al.5538993, Certain tetrahydrocannabinol-7-oic acid derivatives
Issued on: 07/23/1996
Inventor: Mechoulam, et al.5635530, (3S,4S)-delta-6-tetrahydrocannabinol-7-oic acids and derivatives thereof, processors for their preparation and pharmaceutical compositions containing them
Issued on: 06/03/1997
Inventor: Mechoulam, et al.5696109, Synthetic catalytic free radical scavengers useful as antioxidants for prevention and therapy of disease
Issued on: 12/09/1997
Inventor: Malfroy-Camine, et al.6410588Use of cannabinoids as anti-inflammatory agents
Issued on: 06/25/2002
Inventor: Feldmann, et al.

International class
A61K 31/35 (20060101)




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