What the FDA Approval of Epidiolex Means for the Medical Marijuana Market

What the FDA Approval of Epidiolex Means for the Medical Marijuana Market

Could the blatant contradictions of federal drug policies that categorize the cannabis plant as dangerous — but now consider the plant's most active compounds as safe — spur lasting change in federal cannabis policy?

Earlier this week, the U.S. Food and Drug Administration approved GW Pharmaceuticals’s Epidiolex (Cannabidiol), ushering in a new and controversial era of cannabis medicine. Unlike prior pharmaceutical drugs based on synthesized compounds in cannabis, Epidiolex is a standardized plant extract designed to deliver a consistent dose of the sought-after “no-high” cannabinoid CBD.

Epidiolex has not yet been scheduled, but has been approved for use in rare treatment-resistant epilepsy diagnoses such as Lennox-Gastaut syndrome and Dravet syndrome. In a press release announcing the approval, GW says it expects to be scheduled and available for prescription within 90 days. It is possible that in the future it could be prescribed for off-label use. The cost is still to be determined.

These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care,” Justin Gover, GW’s Chief Executive Officer said in the press statement.

A Long-Awaited Approval

This approval has been both anticipated and feared in the cannabis community. The anticipators include the epilepsy community — especially those in states where medical cannabis is illegal — as well as investors and speculators, who have been hyping GW’s stock as the approval has loomed on the horizon. The fearful include activists and West Coast patient communities that see the approval of these drugs as the true end of state compassion programs.

The decision also further highlights the federal government’s hypocritical cannabis policy, which views the whole cannabis plant as Schedule I with no accepted medical use yet has now approved a single plant derivative as medically efficacious. While much of the justification to prohibit cannabis has been the presence of the high-inducing THC, synthetic THC has actually been an FDA-approved Schedule III drug since 1985. The blatant contradictions of a policy that categorizes the plant as dangerous and its most active compounds, THC and CBD, as safe is already being used by advocates to push for federal change in cannabis policy.

In a pre-emptive statement, the FDA immediately rebutted that claim and used the opportunity instead to stress the importance of clinical trials on isolated compounds saying:

This product approval demonstrates that advancing sound scientific research to investigate ingredients derived from marijuana can lead to important therapies. …

This is an important medical advance. But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition. Moreover, this is a purified form of CBD. It’s being delivered to patients in a reliable dosage form and through reproducible route of delivery to ensure that patients derive the anticipated benefits. This is how sound medical science is advanced. …

It’s a path that is available to other product developers who want to bring forth marijuana-derived products through appropriate drug development programs.”

The cannabis plant, even when it contains high amounts of THC, is non-toxic and non-lethal. Educated use is incredibly safe and the worst side effect of uneducated or naive use is anxiety and paranoia. As far as deaths or long-term health damage, cannabis is safer than alcohol, cigarettes, sugar, food additives, and most over-the-counter and prescription medications. Further, researchers have already determined that genetically diverse botanical cannabis markets (such as those in Colorado or on the West Coast) provide better options for patients because of “the entourage effect” and how the plant works in the human body.

RelatedWhy It's Impossible to Test for Impairment by THC in Blood, Urine, or Saliva

Some commercial and home growers may be worrying about how this may impact them growing high-CBD varietals. While GW Pharmaceuticals holds a host of controversial patents on cannabinoid medicines, many farmers are not expressing concern, but those worried about plant patenting are saying now is a good time to protect common use genetics.

The more big pharmaceutical companies that we see coming on to the scene and the more patents that they hold, the harder it will be for everyone else,” says Beth Schecter.

Schecter is the executive director of the non-profit Open Cannabis Project, which is currently working to open-source cannabis varietal data to prevent predatory patenting that would threaten genetics farmers are already growing. She says the OCP is sequencing botanical varieties, so extracts and pharmaceutical isolates like Epidiolex fall outside the realm of what they are covering, but more of the industry should be working to open source data before the impending wave of drugs that will follow this approval. She also points to the unfair nature of the foreign research that allowed GW Pharmaceuticals to be the first.

In the United States, FDA drug approval costs anywhere from $500 million to billions of dollars. Naturally, only the best-financed firms can afford to research, develop, and market new drugs. In the U.S., in order to study cannabis, researchers must obtain the raw bud to study from the government itself. The government’s bud, grown on a single farm on the University of Mississippi, contains less than a third of the THC content found commercially in legal markets and is notoriously bad. Last year, researchers looking to study cannabis for the treatment of PTSD in war veterans were sent moldy samples to work with, stalling the project.

GW Pharmaceuticals, on the other hand, is located in Great Britain and enjoys government support and the exclusive legal right to grow large warehouses of botanical high quality cannabis to conduct its research and development.

[Epidiolex] was not subject to U.S. regulation in terms of testing and was able to do better testing than people in the U.S.,” Schecter says.

What Does This Mean for the Market?

Questions are mounting about the ramifications of the approval on the national CBD market.

For Realm of Caring, the company that rode the biggest wave of demand for its high-CBD variety “Charlotte’s Web” after it was featured on CNN in 2013, the approval of Epidiolex is a good thing, but they stress that it is not the same as botanical cannabis.

Many of you ask us what we think about this news,” the company wrote on its social media pages. “We are happy that families will have a pharmaceutical option. History has been made with the first cannabinoid-based pharmaceutical in the U.S. The administration of a whole plant botanical extract is very different than the protocols for an isolated CBD. We look forward to continuing to serve the community as we always have! This means more options for families who don’t have any!”

RelatedA Step Toward SAFE Banking for the Cannabis Industry?

The stories of children with treatment-resistant epilepsy that emerged in 2013 as a result of the CNN special generated an insatiable demand for “no-high medical marijuana” not just for epileptics, but for patients around the country still uncomfortable with the social stigmas of marijuana use but desperate to try it. Because of confusion and loopholes in federal law, international companies and unregulated small producers have capitalized on the demand for CBD medicines by selling “hemp-derived” CBD products. While there is no technical difference between “hemp” and “marijuana” because they refer to different uses of the same cannabis plant, “hemp” is legally classified as less than 0.3% THC allowing these companies to market their products as “legal.”

Not all CBD stakeholders are as positive as Realm of Caring, however. Longtime federal hemp lobbyist Ben Droz told HEMP Magazine, “The federal government could increase enforcement against CBD companies not approved by the FDA, which is to say, everyone besides GW Pharmaceuticals.”

The generic name of Epidiolex is simply “cannabidiol.” Whether or not having FDA-approved CBD will spur a crackdown on state-legal producers in medical and legal marijuana markets or ramp up crackdowns on underground producers remains to be seen.

The DEA has previously reinforced that CBD is, in fact, not legal federally, but so far they have not cracked down on licensed and regulated producers in medical, recreational, and CBD-only states. They have busted up unregulated oil producers, but not to the extent that it has even made a dent in the supplies of oils being marketed as “hemp CBD” still making their way to consumers around the nation.

Ideology, Not Science

It’s important to note that the federal government’s policies here are ideological, not scientific, in nature. Much of the current approach to drugs and medicine in the U.S. is still rooted in an ideological belief in “good” and “bad” substances, with little regard to science and actual practical use. Richard DeGrandpre labeled this ideology as “pharmacologicalism” in his book, The Cult of Pharmocology: How America Became the World’s Most Troubled Drug Culture.

Technically speaking, pharmacologicalism, like racism, is an ideological system rooted in a set of assumptions that, although false and exaggerated, govern a whole range of perceptions, understanding and actions,” DeGrandpre writes.

The idea that a single plant compound that has been tested in isolation is safer than a natural plant compound taken in the way other plants are consumed is an unproven theory, but one that remains incredibly profitable for pharmaceutical companies and the greater healthcare-industrial complex at large.