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What monopoly is intent on dominating medical cannabis in the U.S.?

November 1, 2015

 

You’ve been duped by big pharma. Let me explain how. There is an observable political strategy that has voters in states like West Virginia and Kansas casting their ballots against their own self-interest by focusing on wedge issues that obscure the big picture. Such has been the case with Ohio Issue 3. Opponents are quick to point out the so-called monopoly, while a much larger, better established and more encompassing monopoly with enormous financial resources hangs in the background, eager to see medical marijuana in Ohio and elsewhere defeated.

 

Who is this monopoly and how does it work?

 

There is a strong push-pull, love-hate relationship between the pharmaceutical industry and grass roots, non-Western medicine that includes marijuana. The pharm industry is based on the single chemical entity, which is identified, tested, patented, approved and ultimately marketed as drug via the clinical trial process. Often, the end result differs from the hoped-for cure because of dire side effects. The millions of deaths and serious outcomes reported in the FDA’s own Adverse Events Reporting System testify to that. Millions upon millions of dollars are spent to arrive at the coveted approvals. These dollars are passed through to care providers and patients, escalating the cost of those cures. This system can only be enforced if less toxic medications like marijuana remain suppressed. 

 

By establishing 10 constitutionalized farms in Ohio on which marijuana can be grown in perpetuity challenges this system. Rather than formulating expensive FDA-approved oils through a single foreign-owned conglomerate or utilizing source product from a single federally-approved grow site, this model proposes 10 different protected locations where this processing can occur. Further, the International Cannabinoid Institute, with its observational research, could make great strides toward identifying the beneficial condition-to-plant cannabinoid ratios that would be impossible given the current clinical trial process.

 

However, the real monopoly begins with GW Pharmaceuticals, a British company that has developed and now markets an under-the-tongue whole cannabis extract spray called nabiximols via the tradename Sativex. It is approved for treating the spasticity associated with Multiple Sclerosis. GW Pharm also has Epidiolex®, basically the cannabinoid CBD (cannabidiol) under development as an Orphan Drug for the treatment of Dravet Syndrome. To some, GW is considered to be the antidote to marijuana legalization because it preserves the clinical trial process, concentrates manufacturing to a singular FDA approved source and has that all-important FDA-approved label to supposedly comfort doctors who wish to prescribe it.

 

The comfort level offered by regulators ignores the cost to patients, the time to market and already entrenched resistance to cannabis by those same regulators as well as pharmaceutical giants, to name a few. All of this is the province of big money … really big money. Consider these facts:

 

  • GW Pharm holds 30+ U.S. patents concerning various formulations of cannabinoids like THC, CBD and other extracted from the whole plant, as well as patents on the spray technology itself. It also owns 154 additional patents outside of the United States. International patents are enforced globally by treaty.

  • These patents include formulations and indications (uses) for cancer pain, epilepsy, nausea, vomiting, motion sickness, constipation, neuroprotection and more.

  • Patents represent a way for the pharmaceutical industry control their products during development and initial marketing. Patents last 20 years. In addition, the FDA can grant a time period for market exclusivity that can add years to the patent life. 

  • GW Pharm’s patents on Sativex will begin to expire in 2021, but new patents like that for cancer pain in 2014, would remain inforce until at least 2034.

  • Sativex has gained a reputation for being cost-prohibitive. A 2012 British study evaluated its cost effectiveness and found, “willingness-to-pay threshold of [$48,488 in equivalent U.S. Dollars], Sativex® appears unlikely to be considered cost effective.” A 2014 report out of New Zealand had the product priced at $16,000 per year. In addition, the Journal of the American Medical Association asserts that the price structure developing for novel orphan drugs such as Epidiolex is becoming unsustainable, with some of these drugs carring price tags as high as $300,000 per year.

  • Because GW’s Epidiolex has been authorized by the FDA for investigation as a new drug, CBD (cannabidiol) cannot legally be sold as a dietary supplement. Further, even if Sativex becomes widely available as a prescription drug, the prohibition on herbal marijuana can continue because the FDA, as a result of the patents, would consider them to be different and thus classify them differently. Most countries where Sativex is sold have used this approach to ban medical marijuana.

  • In 2007, GW Pharmaceuticals granted an exclusive license to the Japanese drug maker, Otsuka Pharmaceuticals, to develop and market Sativex in the US. Such a license would undoubtedly include development and enforcement of the patents and market exclusivity. GW Pharm, a British company, is responsible for the manufacture and supply of Sativex to Otsuka, a Japanese company. Under license, GW and Otsuka will also jointly oversee all US clinical development and regulatory activities to include collaboration on global cannabinoid research, with those activities carried out by GW, but funded by Otsuka.

  • Otsuka is the second leading pharmaceutical company in Japan and ranks number 21 among all such companies in the world. Otsuka’s annual sales approximate $11 billion. Much of this revenue is generated by its flagship product Abilify, which has been approved by the FDA for treatment of depression and schizophrenia. However, this $6.5 billion drug just lost its patent this year, impacting Otsuka with a drop 90% drop in revenue for the drug.

 

What you see in these points is a battle of the giants for control of cannabinoid-based treatments in the U.S., squeezing out the locally grown herbal plant. The mega-giant Otsuka would surely like to recoup its billion dollar loses from the patent expiration of Abilify, and what better way than domination of the exploding market for cannabinoid pharmaceuticals. These novel, in-demand drugs will command premium prices, particularly while the industry lobbies to continue prohibition and the exclusivity that will generate staggering profits for these monopolies, in the classic sense of the word.

 

You can now see how Issue 3 is not just about ten growers. The word “monopoly” has been thrown around as a damning label to conceal the true singular monopolization of the cannabis industry in its infancy. Tell me, what is a $20 million investment in legalizing marijuana in Ohio for everyone over age 21 compared to an $11 billion pharmaceutical industry giant? Surely, if big pharma has its way, prohibition of a simple therapeutic plant will continue in perpetuity, or at least until the expiration of its patents somewhere around 2036.

 

The FDA system may have its place in regulating dangerous single chemical entities – although it could be argued it isn’t doing its job – but this plant belongs to the Ohio people. It should be grown by people in Ohio, for the people of Ohio, to employ the people of Ohio, to fund the State of Ohio and to benefit Ohioans. Any other way, the true monopoly – Big Pharma –its foreign beneficiaries and local shills will be getting very rich, while patients continue to suffer. 

 

Don’t vote against your own self-interest. No on 2. Yes on 3.

 

 

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