The U.S. Food and Drug Administration (FDA) approved the drug application for Syndros, a liquid drug produced by Insys Therapeutics on July 1, 2016. Dronabinol, the main ingredient in Syndros, is a synthetic form of THC, the most abundant cannabinoid in the cannabis plant. To be absolutely clear, dronabinol is not naturally-derived THC. It is a chemical imitation of that compound.
As of today, natural derivatives of the cannabis plant, including solutions containing THC (the compound Syndros imitates) are federally illegal. Cannabis is classified as a Schedule I drug as defined by the Controlled Substances Act. That means that it is federally illegal to produce, distribute, or consume.
But that law doesn’t apply to synthetic THC.
Pill forms of dronabinol have been legal for medicinal use since 1985, so the fact that synthetic THC is legal while natural THC has been the target of a decades-long prohibitionist campaign isn’t news. The reason the topic received more attention in the past couple of years is because Syndros is a liquid form of the drug, and the FDA’s July 2016 approval led to the DEA’sNovember 22, 2017 ruling to classify this variation of dronabinol as a Schedule II substance as well. Schedule II substances are legal for medicinal use.
Legal Dronabinol is Not a Win for the Cannabis Movement
A commenter’s statement opposing the DEA’s ruling pointed out the two reasons that the legality of synthetic weed is more like a slap in the face than a victory for the cannabis movement: the ruling benefits the large pharmaceutical companies in a way that could threaten the cannabis industry’s growth and the lines it draws between synthetic and natural cannabis prop up scientifically inaccurate narratives about the alleged dangers of weed.
The two opposing commenters “expressed concern that pharmaceutical companies are making a profit from approved drugs containing marijuana constituents [and] the FDA should not approve drugs containing constituents of marijuana because […] of the lethality of those drugs.”
It’s clear from the statement that the opponents of the ruling are cannabis prohibitionists, and given their worry about cannabis’ “lethality,” uninformed ones for that matter. It is impossible to overdose from weed the way one can overdose from legal drugs like fentanyl or oxycodone. However, their point about pharmaceutical companies profiting off of cannabis is a valid one.
The DEA’s response is an astounding demonstration of a sidestep justified by circular reasoning:
“The DEA notes that FDA-approved products of oral solutions containing dronabinol have an approved medical use, whereas marijuana does not have an approved medical use and therefore remains in schedule I.”
In short, marijuana is illegal because it is illegal and dronabinol is legal because it is. So there.
The DEA continues:
“Regarding the comments related to pharmaceutical companies and the approval of FDA drugs, these comments are outside the scope of this rulemaking because they do not relate to the factors determinative of control of a substance or the criteria for placement of a substance in a particular schedule.”
In other words, we don’t care who is control of this whole enterprise (even if the people in control are also largely responsible for the prescription abuse epidemic bringing entire communities to a halt), so don’t ask us the tough questions.
How Insys Therapeutics, the Driving Factor in Arizona’s Failure to Legalize Pot, Got Fake Weed Legalized
Insys Therapeutics is the primary benefactor of the DEA’s ruling because it means that they can continue to distribute Syndros without fear of federal prosecution. But it’s the fact that Insys is the victor that illuminates the irony behind the DEA’s decision.
The 2016 general election saw eight out of nine states legalize cannabis for either medical or recreational use. The only state that failed to approve its cannabis initiative was Arizona. Insys played an important role in funding the state’s anti-pot campaign. The pharmaceutical company donated half a million dollars to ensuring cannabis remained illegal. The painful irony is that the FDA approved of Syndros, a synthetic cannabis product, only a few months before the November election. That means that Insys was campaigning with the FDA to get its synthetic weed legal while funding cannabis opposition groups to ensure that the real thing remained inaccessible.
Insys’ intentions to stymie the legal cannabis movement have been public since they submitted a 2007 investor filing with this statement:
“Legalization of marijuana or non-synthetic cannabinoids in the United States could significantly limit the commercial success of any dronabinol [synthetic THC] product candidate…If marijuana or non-synthetic cannabinoids were legalized in the United States, the market for dronabinol product sales would likely be significantly reduced and our ability to generate revenue and our business prospects would be materially adversely affected.”
Cannabis VS Dronabinol
A large body of evidence documenting the medical efficacy of whole plant cannabis has been growing for the past several decades. Despite this, the FDA has continued to deny cannabis-derived drugs approval, a critical step in the rescheduling of cannabis. However, synthetic cannabis has been legal since 1985. The reason for this disparity isn’t clear.
One theory is that pharmaceutical companies have the money that the FDA needs to review applications for drug approval and that statesmen and women need to fund their campaigns. Big Pharma accumulates billions upon billions of dollars each year. In donating to congressional campaigns and directly paying the FDA to ensure that approval for their drugs is expedited, they have an ethically suspect amount of power in the regulation of drugs.
This is where the most essential difference between cannabis and dronabinol becomes especially relevant.
Dronabinol is synthesized in a laboratory owned by the pharmaceutical companies producing it. These companies have a huge amount of clout when it comes to determining the price and accessibility of these drugs. Additionally, dronabinol lacks the whole plant benefits that come with consuming actual cannabis products. While the drug does seem to be effective at reducing nausea and vomiting, it isn’t as effective as whole plant cannabis. It also isn’t nearly as versatile.
On the other hand, a small home garden of cannabis plants can provide a patient with all the medicine they need, and it has absolutely nothing to do with Big Pharma. According to the National Academies of Sciences, Engineering, and Medicine, there is conclusive evidence that cannabis is an effective treatment for chronic pain in adults, chemotherapy-induced nausea and vomiting, and multiple sclerosis spasticity symptoms.
Imagine if patients experiencing any of these illnesses could access their medicine without having to take any synthetic drugs. Pharmaceutical companies would probably lose some money, sure, but a whole lot of people would be healthier and less likely to fall into opioid addiction.
The purpose of medicine is simple: to help people feel better. If there is a way to achieve that goal without bankrupting patients or elevating their risks of adverse reactions including addiction and overdose, it is unethical to block that avenue for the sole purpose of making Big Pharma even bigger.