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

[Expat98]

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

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.

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.

Paul Armentano is the senior policy analyst for the NORML Foundation in Washington, DC.

---

http://www.alternet.org/drugreporter...c910b7af8ee862

[lulz]

I'm not entirely sure what to think of this.

Big pharma is a potential ally for cannabis smokers. If they have a big interest in developing medicinal uses for cannabis, it'll provide a lot of support for reclassifying cannabis from a Schedule I category (as Schedule I drugs are defined as having no medicinal use).

On the other hand, they'll probably fiercely oppose more extensive decriminalisation on the basis that if more people actually smoked cannabis itself, it would directly compete with a wide range of their own patented medications (nausea, insomnia, pain, etc).

If they can figure out how to relax the legal issues surrounding cannabinoids, while strengthening laws against cannabis itself, that's exactly what they'll do.

[Lunar Loops]

This from PharmaTimes (article link):

More positive data for GW Pharma's Sativex

08 September 2008

Shares in GW Pharmaceuticals have shot up almost 7% this morning after the firm presented data from a late study of its cannabis-based product Sativex which confirm the long-term efficacy of the drug in patients with neuropathic pain due to multiple sclerosis.

The study evaluated 42 MS patients with central neuropathic pain who had previously been in a Sativex (delta-9-tetrahydrocannabinol and cannabidiol)) Phase III MS neuropathic pain study and who continued to take the product for 12 weeks. They were then randomised to receive Sativex or placebo for a further four weeks. During the randomised period, patients were not permitted to adjust their dose. The purpose of this study was to assess the maintenance of pain control in patients who remain on Sativex versus those who switch to placebo.

GW says that the primary endpoint of the study - the time to treatment failure - was statistically significantly in favour of Sativex, which also performed better for mean pain score and sleep quality. The importance of the study lies in the fact that until now, all the evidence for long-term maintenance of efficacy of Sativex has come from long-term open-label exposure and the latest “confirm in the context of a placebo-controlled double-blind study that efficacy is indeed maintained in long-term use”, the firm said.

Stephen Wright, GW’s R&D director, said that the results “support the design of the ongoing Phase III trial in MS spasticity”. He added that it is encouraging to note that “if the difference between Sativex and placebo achieved in the results today are replicated in the ongoing Phase III MS spasticity study”, the latter will meet its objectives.

That study, which was requested by the UK regulator prior to granting approval for Sativex, is due to report in the first quarter of 2009 and a regulatory submission is planned for the first half of next year.

[Mutil]

Originally Posted by lulz

I'm not entirely sure what to think of this.

Big pharma is a potential ally for cannabis smokers. If they have a big interest in developing medicinal uses for cannabis, it'll provide a lot of support for reclassifying cannabis from a Schedule I category (as Schedule I drugs are defined as having no medicinal use).

On the other hand, they'll probably fiercely oppose more extensive decriminalisation on the basis that if more people actually smoked cannabis itself, it would directly compete with a wide range of their own patented medications (nausea, insomnia, pain, etc).

If they can figure out how to relax the legal issues surrounding cannabinoids, while strengthening laws against cannabis itself, that's exactly what they'll do.

i'm not so sure. if they had the ability to market recreational pot products, i have no doubt they would. maybe they won't need to, though...if there is potential for "abuse" of any of these new "patented" products, it may take in a chunk of the buyers of illegal street pot.

Swim would rather not rely on Monopoly to get high.