DEA Approves Synthetic THC Drug Under Questionable Circumstances

By Britni de la Cretaz 03/31/17

The DEA has given the green light to a synthetic THC pill from a pharma company that led anti-marijuana legalization efforts.

Female scientist checking marijuana plant in a field.

Last fall, Arizona voters chose to defeat the marijuana legalization efforts of Prop 205. The proposition was ambitious, and would have given adults over the age of 21 the ability to possess up to one ounce of dried marijuana, up to six live plants (maximum 12 per household), and five grams of resin. It would have also set up a system of retail stores and dispensaries. But in the end, it was defeated 52-48. (Last week, two ballot initiatives were filed for the 2018 election, one that would legalize marijuana, and one that would legalize all other drugs.)

One of the biggest donors to the No on 205 campaign was the pharmaceutical company, Insys Therapeutics. It donated $500,000 to the campaign to defeat legalization—one of the largest contributions to an anti-legalization campaign ever. 

The company has also lobbied to keep the classification of marijuana as a Schedule I drug. Drugs in this category are said to have “no currently accepted medical use and a high potential for abuse.” In its plea to the DEA to keep marijuana in Schedule I, Insys cited "the abuse potential in terms of the need to grow and cultivate substantial crops of marijuana in the United States,” according to the Chicago Tribune.

Last year, a spokesman for Arizona's marijuana legalization campaign said of Insys, "It appears they are trying to kill a non-pharmaceutical market for marijuana in order to line their own pockets.” For their part, Insys said it opposed marijuana legalization because "it fails to protect the safety of Arizona's citizens, and particularly its children."

The company went on to say that it "firmly believes in the potential clinical benefits of cannabinoids," and that "we hope that patients will have the opportunity to benefit from these potential products once clinical trials demonstrate their safe and effective use."

Last week, Insys received preliminary approval from the DEA for a synthetic form of THC called Syndros. Syndros, a liquid, synthetic form of THC—the main psychoactive cannabinoid in marijuana plants—received FDA approval last summer for the treatment of nausea, vomiting, and weight loss in AIDS and cancer patients. The DEA has classified it as a Schedule II substance, defined as having “a high potential for abuse.”

Insys is also developing a synthetic version of CBD—another cannabinoid—to treat pediatric epilepsy, as well as a drug to treat opioid overdose.

Complicating matters further, the company is under criminal investigation at both the state and federal level, and is dealing with a shareholder lawsuit related to its marketing campaign of a product containing fentanyl. Several former executives, including its former chief executive, were arrested last year by the FBI for receiving paid kickbacks, as well as committing "fraud to sell a highly potent and addictive opioid that can lead to abuse and life threatening respiratory depression."

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Britni de la Cretaz is a freelance writer, baseball enthusiast, and recovered alcoholic living in Boston. Follow her on Twitter at @britnidlc.