Connect with us
marijuana drug approval marijuana drug approval

Global Affairs

What Marijuana Drug Approval Means for Legalisation

 7 min read / 

An epilepsy medicine for children is the first marijuana-derived drug to receive approval from the United States Food and Drug Administration (FDA). With federal and United Nations marijuana prohibitions wobbling (the UN World Health Organization’s Expert Committee on Drug Dependence met in June 2018 in part to reconsider cannabis), this may be the final push pro-legalisation forces need to get cannabis removed from the Controlled Substances Act.

Politicians in the United States like to speak of the slippery slope, the idea that a piece of legislation or a policy that seems innocuous might lead to unintended consequences, i.e. allowing same-sex marriage might lead to polygamy, child molesters marrying kids, or animal lovers marrying pets. A similar expression is the thin end of the wedge.

Marijuana legalisation has been resisted on similar grounds: it will lead to driving under the influence, shooting heroin on the streets or kids using LSD in school playgrounds. That marijuana was ruled by United Nations treaties to be in the first and worst class of drugs – those with no health benefits or safe usages and highly addictive – meant that even medical usages were off limits.

CBD from Hemp

As collateral damage, cannabidiol or CBD – a component of marijuana but one that does not produce a high and contains most of the elements that proponents say make medical marijuana useful, such as chronic pain control, anxiety, and stress reduction – was made illegal, as was hemp, a non-drug, non-intoxicating cousin of cannabis used to make textiles. Both hemp and marijuana are derived from the cannabis sativa plant.

Neither CBD or hemp can get you high. In fact, hemp has been described as “cannabis with the THC bred out”. CBD can be derived from hemp as well as cannabis, though some pro-marijuana experts claim there is or may be a qualitative difference, especially if the hemp in question was cultivated for fibre or seeds, not CBD.

Apparently, there is the possibility that CBD can be derived from other crops. ImmunAg is billed as the first “hops-derived cannabidiol product”, using the Humulus plant instead of hemp or marijuana. While marijuana has high levels of THC and hemp has trace amounts, Humulus has none.

One difference is that in dispensaries in states where marijuana is legal, the cannabis and CBD oil are better regulated. That means you can be reasonably sure of what you are getting, whether it contains THC or not. Hemp-derived CBD oil sold in states where cannabis is not legal are regulated as supplements, not drugs, and so may contain less CBD and more toxins.

Only four US states ban CBD completely. Last December the World Health Organization reversed itself and concluded that CBD had no abuse or dependence potential. Even US Senate Majority Leader Mitch McConnell, a staunch conservative, introduced legislation to legalise it this year.

Perhaps, as a result, hemp production is growing. Hemp cultivation and hemp producers doubled from 2016 to 2017, and the US hemp market is expected to increase six-fold to $1.65bn by 2021.

CBD from Cannabis

CBD is a cannabinoid, one of about 200 estimated to be found in cannabis. The most abundant is tetrahydrocannabinol or THC, which also is the main component that causes the euphoria or high. The amount of THC varies, and marijuana plants are bred specifically of high or low concentrations. How much is in CBD products depends. Some may contain no THC or negligible amounts, others might have equal parts CBD and THC.

Why have any THC? Because some research suggests that while CBD has the main medical benefits, it works better with a little THC, even if it is not enough to get high. Other research indicates that all of the components of cannabis work better together than separately because of what is called the entourage effect. If not the whole plant, then a two-to-one CBD-THC ratio has better results.

What Can CBD Treat?

On June 25 the FDA gave its approval for Epidiolex, a CBD-based drug specifically intended for the treatment of two rare forms of epilepsy that start in childhood. GW Pharmaceuticals, a United Kingdom firm, developed the drug, and because of that is a $4.1bn company.

Before it reaches the market, the US Drug Enforcement Agency must approve Epidiolex too (it has 90 days), which is likely but not guaranteed. The European Medicines Agency (EMA) likewise is expected to approve it next year for use in Britain and Europe probably in 2019.

While epilepsy is the only condition for which Epidiolex has FDA approval, it is not the only condition that CBD is believed to help alleviate. Others include Alzheimer’s disease; Parkinson’s, anxiety, depression, inflammation, and chronic pain. It may even be a source of antioxidants.

Other uses for CBD (not cures, but treatments that improve outcomes, if only temporarily) may include: smoking and other addictions; skin conditions such as acne, eczema, psoriasis; diabetes; fibromyalgia; Crohn’s disease; anxiety, depression, and post-traumatic stress disorder; schizophrenia; multiple sclerosis; autism; arthritis; migraines; loss of appetite and nausea; and insomnia.

If using an addictive substance to treat addiction seems crazy, consider that most experts believe marijuana has a low risk of addiction for most users. Recent research suggests that states with medical marijuana suffer fewer opioid drug overdose deaths. With its applications for treatment of mental illness and addiction, cannabis or CBD may be of use in a dual diagnosis treatment facility.

Potential of CBD Market

One drawback to Epidiolex’s financial prospects is that the two diseases it treats are rare. There only are an estimated 1,500 sufferers throughout the world. Even so, analysts expect GW Pharmaceuticals to have annual sales of more than £750m, which comes out to something like £500,000 per patient unless the FDA and EMA broaden the conditions for which it may be prescribed or it’s prescribed off-label.

Even if that fails to materialise, pro-legalisation forces will press harder for CBD and marijuana, in general, to be legalised, at least for medical use.

Hemp-derived CBD earned $190m in 2017, while the entire hemp industry could be a $1bn market in the US this year, $2.6bn by 2022.

In Canada, where full cannabis legality is a matter of weeks away, sales of CBD oil from distributor Diamond CBD have generated almost $700,000 since May 2017.

Around the world, CBD oil is much more accepted than dried marijuana.

Future of Cannabis Legalisation

In the US, direct democracy via the ballot box has been the usual path to legalisation. In 2016, the same year Donald Trump surprised many pundits and voters, seven states passed marijuana legalisation initiatives.

In its June 2018 primary, Oklahoma voters pushed the number of US states that allow medical marijuana to 30. Another six may vote on similar initiatives in November, three definitely, including Michigan (recreational), Utah, and Missouri (medical).

The hemp, cannabis and CBD laws are so complicated that it can be legal to grow marijuana in your home but illegal to grow hemp. And possession of CBD oil can make you liable for a $1,000 fine for possession of marijuana.

Already more than half the states, representing more than half the US population, have approved medical marijuana, and another ten have approved recreational use. Canada is soon to allow recreational use. Some Latin American countries are following. Uruguay has legalised marijuana at the national level, and Mexico now allows medical marijuana (though only 1% THC) nationwide.

While Europe, Asia, Africa, and Oceania do not seem too likely to follow immediately – France already is planning to close newly opened cannabis coffee shops selling low THC marijuana – the gravitational and financial pull of a cannabis-friendly Western hemisphere may be too strong to resist.

Sign up to Mogul News.

Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Send this to a friend