Exclusive license for medical marijuana treamtent?

December 21, 2011 2:11 PM

The US National Insitutes of Health recently filed notice of a prospective grant to give an exclusive license to New York based Kannalife for Development of Cannabinoid(s) and Cannabidiol(s) (i.e. marijuana) Based Therapeutics To Treat Hepatic Encephalopathy in Humans. Toke of The Town covers the issue, including an interview with Kannalife CEO Dean Pethanas.
posted by Brandon Blatcher (15 comments total)

Cannabis is not a panacea. It is not absolutely safe. It comes about as close as a medicine can on both counts. It is much safer than cigarettes, alcohol, fast food or tv. It is also interesting that even if you smoke a lot, you are not at increased risk for lung cancer. All smoke, whether it is BBQ or wood or any product of combustion is full of carcingenic benzpyrenes. There is probably something anti-carcinogenic in cannabis.
Novel hexahydrocannabinol analogs as potential anti-cancer agents inhibit cell proliferation and tumor angiogenesis.




IACM
posted by sensi63 at 2:28 PM on December 21, 2011 [1 favorite]

Exclusive license for medical marijuana treamtent?

No, an exclusive license for one particular patent that the U.S. government owns, which claims "A method of treating diseases caused by oxidative stress, comprising administering a therapeutically effective amount of a cannabinoid that has substantially no binding to the NMDA receptor to a subject who has a disease caused by oxidative stress."
posted by grouse at 2:33 PM on December 21, 2011

Meanwhile, the FDA recently refused (once again) to move marijuana out of Schedule II ("no accepted medical use"), against the recommendations of the American Medical Association.
posted by vorfeed at 2:34 PM on December 21, 2011 [2 favorites]

In a rational world, Cannabis is schedule III at most.
posted by mullingitover at 2:37 PM on December 21, 2011

In a rational world, there are no prohibitions on drugs and data driven education.
posted by Burhanistan at 2:39 PM on December 21, 2011 [3 favorites]

my suspicion is that once the drug is patented, magically Kannalife gets bought out by a major drug company with plenty of lobbyists. like he says, marijuana is untouchable by the mainstream right now, but when it's proven drug with profit involved..

and it will still be illegal to possess without a prescription from your friendly doctor. that only accepts private insurance.

and when was anything that happens in this world on a large scale rational?
posted by ninjew at 2:41 PM on December 21, 2011

Also, since THC is believed to bind to the NMDA receptor, this patent specifically does not apply to the use of THC, but only cannabinoids that don't bind to NMDA, such as cannabidiol. The patent stresses that cannabidiol as a therapeutic is particularly attractive because it does not have psychotropic effects. So, even if this effort is successful, I don't think this will open the door to the medical use of whole marijuana.
posted by grouse at 2:55 PM on December 21, 2011

Question: why is the US goverent taking out patents in the first place?
posted by ook at 4:36 PM on December 21, 2011

Alternative question: why does my iPhone autocorrect "government" as "goverent"?
posted by ook at 4:38 PM on December 21, 2011

Question: why is the US goverent taking out patents in the first place?

Good question. Here's a description of the Public Health Service's patent policy:

PHS generally seeks to patent biomedical technologies when a patent will facilitate and attract investment by commercial partners for further research and commercial development of the technology. Patent protection generally will not be sought by the PHS where further research and development is not necessary to realize the technology's primary use and future therapeutic, diagnostic, or preventive uses are not reasonably anticipated. For example, PHS generally will not seek patent protection for commercially valuable research tools (knock-out mice, receptors, cell lines) for the sole purpose of excluding others from using the patentable subject matter without a license. Such materials can be licensed under biological materials licenses or distributed to the research community without further compensation…

When commercialization and technology transfer can best be accomplished without patent protection, such protection will not be sought. For example, some technologies may be commercialized through non-patent licensing, and some technologies are transferred to the private sector most expeditiously through publication. For those best transferred through publication, patenting and licensing are unnecessary and could inhibit broad dissemination and application of the technology. Methods of performing surgical procedures, for example, could fall within this category.

In essence, if an invention requires a large commercial investment before it can be used on patients, commercial entities are likely to want exclusive rights to its use before putting in that investment. Drug companies won't spend hundreds of millions of dollars refining and clinically testing a new drug if a free rider can follow them and produce the new drug without making these expenditures.
posted by grouse at 5:00 PM on December 21, 2011

I see. Thank you for that.

So basically the plan here is to spend hundreds of millions of dollars refining and clinically testing an existing drug which is already in widespread use, so they can make sure it isn't fun anymore.

Have I got that more or less right?
posted by ook at 7:10 PM on December 21, 2011 [3 favorites]

Have I got that more or less right?

Well, no. As far as I know, no one's conducted a randomized controlled trial that verifies the effectiveness of marijuana against hepatic encephalopathy. Someone has to make sure it works. Whether it's fun is another matter altogether.
posted by grouse at 9:32 PM on December 21, 2011

As far as I know, no one's conducted a randomized controlled trial that verifies the effectiveness of marijuana against hepatic encephalopathy.

This is primarily because the same government that's handing out patents for synthetic marijuana refuses to provide whole marijuana for FDA-approved trials. NIDA controls the sole legal source of marijuana for research, and they've gone so far as to state that they "do not fund research focused on the potential medical benefits of marijuana".

In short: whether it's fun is not another matter altogether, because it's almost certainly a large part of why Kannalife was awarded this patent. A non-psychoactive cannabis derivative would give the US government a perfect excuse to shut medical marijuana down, even though it's unlikely to be as effective a medicine as marijuana itself is.
posted by vorfeed at 11:44 PM on December 21, 2011

even though it's unlikely to be as effective a medicine as marijuana itself is.

Well, let's not go that far; we don't know have any evidence that the psychoactive components are either more or less likely to be effective than the non-psychoactive components, because (as grouse points out) there hasn't been a randomized, controlled study. I mean, one could theorize that since the proposed basis of the effectiveness of this as medicine is that it can easily cross the blood-brain barrier, that the psychoactive components might be the first ones you'd want to look closely at, but that's just a hypothesis. Good science would be to study each component individually to see which is the effective medicine.

Of course, science that would be both good and cost-effective would be to start by studying the whole plant first, just as a confirmation that any of the components are effective, before you go to the trouble and expense of synthesizing or isolating the individual cannabinoids.

But apparently they're instead going to just start with the assumption that the psychoactive components are the least desirable:

Nonpsychoactive cannabinoids, such as Cannabidiol (CBD), are particularly advantageous since they avoid toxicity that is encountered with psychoactive cannabinoids at high doses.

Because of course it's well-known that THC has an extremely high LD₅₀ oh wait that's extremely low I guess they mean something other than toxicity by their use of the word "toxicity" here.
posted by ook at 9:49 AM on December 22, 2011

Well, let's not go that far; we don't know have any evidence that the psychoactive components are either more or less likely to be effective than the non-psychoactive components, because (as grouse points out) there hasn't been a randomized, controlled study.

There's plenty of evidence that both THC (psychoactive) and CBD (non-psychoactive) are medically useful. In fact, the vast majority of medical research on marijuana has been done on THC. The only currently-legal marijuana-derived medicines in the United States are psychoactive, and contain synthetic THC (Marinol, Cesamet). I think it's obvious that whole marijuana, which contains both THC and CBD along with many other compounds, is more likely to be effective (in overall terms) than a synthetic medicine which contains just one compound.

Anecdotal evidence backs this up; the THC/CBD ratio largely determines the effects of the plant, both psychoactive and medical, and there's evidence of a synergistic effect between these and other cannabis compounds. The idea that whole marijuana can (or should) be replaced by a single synthetic really only exists due to politics.

Note that Sativex -- a whole-marijuana tincture approved for medical use in the UK and Canada -- contains both THC and CBD, though it's still just one THC/CBD ratio. It's also no different from a tincture one could make at home or buy at a dispensary, other than having been standardized for composition and dose...
posted by vorfeed at 11:08 PM on December 22, 2011