Fentanyl & Marijuana … A Bad Combo

As I read the article, there were three "aha" moments for me:

• Syndros (an oral solution of dronabinol) has been classified by the DEA as Schedule II. That's the same level as Cesamet (nabilone capsules, a synthetic THC approved by the FDA in 1985 to treat nausea and vomiting). It's slightly different than Marinol (dronabinol capsules, a Schedule III synthetic THC, approved for nausea by the FDA in 1985 and for appetite stimulation in 1992). Those are all the same indications of usage for Syndros. Since "marijuana" remains Schedule I (illegal), there is obviously a difference in how the DEA views natural/organic "marijuana" and synthetic/manufactured marijuana. Taking that all into account, the less restrictive classification for Syndros than weed makes sense (with all due respect to the author of the story). As a sidebar, for those that don't feel that marijuana is medicinal, the FDA has said it is since 1985 (at least for Marinol and Cesamet).

• InSys Therapeutics, the maker of Syndros, is also the manufacturer of Fentanyl. If you've read any of my content, you'll recognize that name (either legitimately prescribed or sold on the street). InSys has gotten in trouble for their efforts around selling that product off-label (i.e. using fentanyl for non-cancer pain). An article on Monday at WorkCompCentral (subscription required), "Insys Hit With Wrongful Death Suit Over Off-Label Fentanyl Prescribing," documents the most recent lawsuit against InSys. Sarah Fuller died from an adverse reaction between Subsys and alprazolam. She did not have cancer. Her doctor prescribed Subsys (and Percocet and OxyContin) even though Sarah had struggled with narcotic addiction in the past. And it was pushed through, allegedly, by an InSys sales representative who told Sarah and her family that the drug would help with her pain. So sad - and so bad.

• InSys contributed $500k, along with other Big Pharma companies, to fight against legalizing marijuana in Arizona. It doesn't take a rocket scientist to figure out why - marijuana could be a competitor to their business. Especially after the National Academies of Sciences, Engineering and Medicine recently came out and said "the committee found evidence to support that patients who were treated with cannabis or cannabinoids were more likely to experience a significant reduction in pain symptoms" (I will be diving into their study more in a future blogpost). So is InSys hedging their bets by producing both?

If you add all that up, I'm not sure that Fentanyl and Marijuana are a good combination. Especially when the manufacturer involved with both is being sued for sales practices that literally killed people. Does the DEA take the manufacturer into consideration when approving drugs? If it doesn't, in this case, I think it should.