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Plant Medicine and CBD Doesn’t Quite Fit Their Standard Operating Procedure

Plant MedicineThe randomized, double-blind controlled studies that became standard in the 1950s for drug clinical trials are not well suited for multi-compound natural products because having more than one bioactive phytocompound exponentially increases the variables that need to be controlled. In fact, the FDA has only approved several herbal prescription drugs and none involve hemp or cannabis.

The sole FDA approved cannabis plant-derived drug is a single, isolated and purified cannabinoid, CBD, in the drug called Epidiolex made by GW Pharmaceuticals that was approved in June 2018. The other FDA approved cannabinoid type drug is also a single molecule, a synthesized form of THC, marketed under the international generic name, Dronabinol.

The consistency of botanicals and plant extracts pose a challenge for the standard clinical trial protocol as potencies as well as the ratios of the bioactive compounds can vary.

The simple question that is difficult to answer is knowing which compound or combination of compounds in what proportions in a plant extract is effective as medicine.

Therapeutic effects become even more complex to understand because everybody is different. “One size fits all” does not apply in herbal medicine. Even with common drugs, some people find relief with ibuprofen while other folks use acetaminophen. Some people use one for headaches and the other for muscle aches. Is the natural sleep aid, melatonin, effective for you? It is an OTC drug in the US but a prescription drug in other countries – go figure! Does Benadryl knock you out or perk you up?

Each person reacts differently to treatment, whether it is with a FDA approved drug or a plant-based remedy. Cannabinoids and the other compounds in hemp act uniquely on a person’s endocannabinoid system, like a lock is specific to a key. Accordingly, the well recognized entourage effect of the various phytochemicals in the hemp plant is obviously a challenge for the FDA.

Another complexity the FDA has to address with all medicines is that clinical trials are not real world conditions. And most health problems don’t tend to be a single malady that can be alleviated by a single molecule.

The clinical trial process does work but has limitations. Even when a single molecule is approved for a single indication like pain, the FDA process is not fail-safe as with the case of opioids that were approved to be safe and effective based on parameters thought to be prudent but have led to widespread addiction.

The good news is that the FDA is committed to sorting out how to allow consumers access to hemp-derived and other plant based medicines.

Dietary supplements are regulated under the FDA’s DSHEA regulations established about 25 years ago. Food and cosmetics have their own regulatory framework. Both are different than the clinical trial framework for what the FDA defines as drugs. Another FDA pathway for approval of ingredients is named GRAS (Generally Regarded As Safe).

Coming back to hemp-derived bioactive phytochemicals like CBD, CBN, CBG, CBC, terpenes, terpenoids, and polyphenols that are non-addictive, non-toxic and non-psychotropic (i.e., non-intoxicating), in theory, GRAS surely would be the simplest pathway out of the maze we are in.

At some point, all of the regulatory confusion (or at least most) will be sorted out and even more people will be able to benefit from the hemp plant after almost 100 years of marginalization and illegal status.

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GW Suffers Major Blow as US Sinks Bid to Patent Cannabinoids for Epilepsy

British firm GW Pharmaceuticals (NASDAQ: GWPH) is licking its wounds after US judges tossed out its attempt to patent multiple cannabinoids for epilepsy treatment following an eight-year battle.

CBD is a PharmaceuticalsThe US Patent Trial and Appeal Board, an administrative law body of the national patent office, denied patent US9066920B2 on January 3, siding with petitioner Insys, a rival biotech firm.

The patent, which has been embroiled in dispute since 2010, is for “the use of one or more cannabinoids in the treatment of epilepsy”. More particularly, to the use of one or a combination of cannabinoids, CBD oil, in the treatment of generalized or partial seizures.

The invention covers a method of treating partial seizure comprising administering cannabidiol (CBD), to a patient wherein the CBD is present in an amount which provides a daily dose of at least 400 mg.

Administrative patent judges Erica Franklin, Susan Mitchell, and Zhenyu Yang, said claims 1 and 2 were “unpatentable” under US law, however the remaining 11 claims that were challenged survived and remain valid, and potentially enforceable should GW decide to appeal.

GW declined to offer comment when contacted by Cannabis Law Report, and declined to confirm or deny it would appeal.

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The Future of Hemp Engineering: Hempcrete, Supercapacitors, Bio-fuel and More

Despite a global prohibition still largely restricting the cultivation of cannabis, some scientists are still revolutionizing industries through engineering hemp buildings, supercapacitors, and more.

Preceding the 1900’s, cannabis was once one of the most significant crops for mankind. It was only in the past century when men forbid its cultivation, grinding cannabis production and all of its subsidiary parts to a halt.

The plant is rooted deep in humanity’s history and was likely the earliest cultivated plant for its textile fiber. Despite many countries’ recent regressions revoking the laws in which made cannabis illegal in the first place, it is largely recognized as a plant with no other use other than “getting people high”.

Hempcrete buildings

But cannabis is not one sole entity. It is rather a collection of a family of plants consisting of sativas, indicas, and ruderalis. Cannabis Sativa and indica plants are renowned for their psychoactive effects, but there is a variety of Cannabis Sativa which is grown specifically for its derived products.

The plant in question, otherwise known as hemp – or industrial hemp – is the seed or fibrous part of the Cannabis Sativa, whereas the flower of the plant is legally regarded as marijuana. Unlike marijuana, hemp does not possess a significant amount of psychoactive chemicals and as such, cannot be used to get “high”.

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Hemp In Space: Researchers Send Hemp Plants To International Space Station

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Hemp in space sounds like a science fiction dream. It will soon to be an exciting new reality thanks to a partnership of terrestrial firms hoping to learn about the effects of microgravity on the crop.

Space Tango, a start-up business from the heart of Kentucky seeks to harvest hemp in space. Co-founder and chairman, Kris Kimel, wants to lean about how the biology and quality of the crop will develop without the influence of gravity. The goal is to see if the medicinal value of cannabinoids prospers on this new frontier and to offer unique CBD products to the public.

Anavii Market is partnering with Space Tango on their journey into this new frontier. Anavii Market is an online CBD marketplace that seeks to improve quality reliability in the industry. Their goal is to provide a trusted source of CBD to the public.

WHAT WE KNOW ABOUT GROWING HEMP IN SPACE

Prior to Space Tango, Kimel was the founder and president of the Kentucky Science and Technology Corporation (KSTC), “which is where this notion of looking into space and microgravity kind of germinated.” As his interest grew, he left the company and moved over to Space Tango full time.

After nearly a decade of research on this new frontier, Kimel tells us there’s still so little they know and so much to learn when it comes to how plants develop in a gravity stress-free environment. Since hemp has had such little research within the last century and only recently has had its doors opened to scientists, Space Tango remains optimistic in breaking through new discoveries.

Kimel and his team are aware that principle biological systems (i.e. cells, organisms) become scrambled grown without gravity. In turn, this “opens up new pathways, new understandings, of those systems that you’d never see on earth.” Prior to their experiments with hemp, they’ve developed medical implants which can only be manufactured in space.

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Indiana is Well Positioned for Growing Hemp

Purdue Hemp Research
CNHI News Indiana/Scott L. MileyIn the field: A group of Indiana legislators and agricultural experts tour a hemp research farm operated by Purdue University. The tour accompanied a legislative meeting this week of the Interim Study Committee on Agriculture and Natural Resources.

Hemp likes living in Indiana, a Purdue agronomist told a committee of legislators examining ways to turn the plant into a Hoosier industry.

But Statehouse leaders haven’t been so sure they want to live with hemp.

Recent efforts to expand hemp production into private business have been met with skepticism, although many Indiana farmers are hoping to turn the green leafy plant into commodities ranging from salad toppings to auto parts.

Currently, hemp can be grown only for research at a farm operated by Purdue University.

“The Purdue hemp research group feels Indiana can be a leader,” Ronald Turco, department head of agronomy at Purdue, said.

“Indiana is well positioned for growing hemp in climate soils that support the crop. Most importantly we have an existing industry that needs vibrancy.”

He addressed the first meeting of the Interim Study Committee on Agriculture and Natural Resources. Seven of 14 members attended the Monday session in Lafayette.

The committee’s task is to determine how the state should regulate hemp production. The committee report is due by early November.

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