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DEA Gives Green Light to Drugs Containing Synthetic Cannabis

October 3, 2017
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The U.S. Drug Enforcement Agency (DEA) issued a new rule scheduling synthetic marijuana compounds under Schedule II of the Controlled Substances Act (CSA).

This means that while real cannabis remains placed firmly under Schedule I of the CSA due to the determination that it has no currently accepted medical use and a high potential for abuse, companies can now legally sell pharmaceutical drugs and products containing synthetic cannabis compounds.

Before marijuana legalization has been passed nationwide, synthetic marijuana has been effectively legalized.

Pharmaceutical-Grade Synthetic Marijuana Legalized

The U.S. Food and Drug Administration (FDA) approved a new pharmaceutical drug for the market known as “Syndros”, which is produced by Insys Therapeutics Inc. Syndros contains dronabinol, a synthetic cannabis compound. Dronabinol is the generic name for the delta-9-trans isomer of tetrahydrocannabinol (THC), the primary psychoactive substance in marijuana.

After gaining FDA approval, the U.S. Department of Health and Human Resources recommended to the DEA that synthetic cannabis products, specifically oral solutions containing dronabinol, be placed under Schedule II of the CSA. The DEA chose to do just that, and legalized synthetic marijuana by determining it had an acceptable medical use and placing it under Schedule II.

Syndros was legally approved for two uses. First, for the treatment of anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS), and second, for the treatment of nausea and vomiting resulting from cancer chemotherapy. Both ailments’ symptoms are well-known to be commonly treated by cannabis already.

Insys Other Wonder-Drug: Fentanyl-based Subsys

Insys Therapeutics currently only produces one other drug besides Syndros that’s available for purchase: Subsys. Subsys is a fentanyl-based sublingual spray. Fentanyl is responsible for many opioid-overdose deaths today, partly because it is a synthetic opioid that is among the most potent and addictive opioids currently available; it can be 50 to 100 times stronger than morphine.

Insys maintains that it is “committed to developing medications for potentially treating addiction to opioids, [and] opioid overdose.” If fentanyl is unnecessarily prescribed, it can certainly result in addiction, overdose and/or death; Subsys often has the opposite effect of what Insys claims it’s intended to treat when unsafe consumption causes opioid addiction and overdose.

Insys executives were arrested last December after leading a nationwide conspiracy to bribe medical practitioners to unnecessarily prescribe Subsys and defraud healthcare insurers. Insys set up an elaborate scheme involving both healthcare practitioners and insurance providers to sell as much Subsys as they could, even to people who didn’t need it.

According to the original indictment, in exchange for bribes and kickbacks from Insys executives, healthcare practitioners allegedly wrote large numbers of prescriptions for patients, most of whom were not even diagnosed with cancer. It’s also alleged that the executives conspired to mislead and defraud health insurance providers who were reluctant to approve payment for the drug when it was prescribed for non-cancer patients.

Insys Therapeutics Inc. Profiting from Prohibition

Back in 2007, Insys Therapeutics went on record in a U.S. Securities and Exchange Commission filing and stated that the nationwide legalization of marijuana would negatively affect their ability to generate revenue. Then, in 2011, Insys wrote a letter to the DEA urging the agency to keep marijuana firmly situated under Schedule I of the CSA.

Insys unsurprisingly supported anti-legalization efforts in Arizona last year during the election, donating half a million dollars to oppose Proposition 205, Arizona’s ballot initiative to legalize and regulate marijuana like alcohol. It ended up failing by a narrow margin, even though marijuana legalization is supported by 60% of Americans today.


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