We guess the federal government can’t do one good deed without doing a bad one to even things out. Only a little more than a month ago the Food and Drug Administration approved, for the first time ever, a marijuana-derived medicine. The law was even changed to allow for the drug Epidiolex to be classified as a Schedule II drug, making it the first cannabis drug in decades to be legal at the federal level.
So seemingly as the result of some pact with the devil, the FDA has also approved a synthetic opioid even more potent than Fentanyl, the drug which has rightfully become a boogeyman in the opioid crisis that claimed more than 72,000 drug overdose deaths in the United States last year alone.
Dsuvia is a tablet which dissolves under the tongue to release opioids in an emergency setting. It is, incredibly, ten times as potent as fentanyl, a drug which has caused overdoses in part because it was already 50 times stronger than heroin.
In a statement released after Dsuvia was approved, FDA Commissioner Dr. Scott Gottlieb offered the agency’s reasoning behind the controversial move. Gottlieb acknowledged the opioid crisis and the need for caution in releasing new drugs into the market, writing, “Looking beyond this particular drug approval, I believe that we should consider whether we should be doing more to evaluate each candidate opioid, not just as an independent review decision, but rather also to consider each novel opioid drug in the context of the overall therapeutic armamentarium that’s available to patients and providers.”
However, in Gottlieb’s opinion Dsuvia is a “novel” drug which meets medical needs to currently being addressed by available pharmaceuticals. “The medicine is restricted to use in certified medically-supervised health care settings ‒ such as hospitals, surgical centers and emergency departments,” he wrote, adding that the Dsuvia “has some unique features in that the drug is delivered in a stable form that makes it ideally suited for certain special circumstances where patients may not be able to swallow oral medication, and where access to intravenous pain relief is not possible. This includes potential uses on the battlefield.”
Many critics are not as enthusiastic about the release of a new uber-powerful opioid on the market. As reported by the Huffington Post, the chairman of the FDA advisory committee that approved the new drug, Dr. Raeford Brown, wrote a letter to Gottlieb in October warning of the dangers of the new opioid. Dsuvia, he said, was an “extremely divertible drug” which could easily end up mixed in with street drugs such as heroin.
“I predict that we will encounter diversion, abuse, and death within the early months of its availability on the market,” Brown wrote.
“There is no need for another opioid on the market, particularly one as potentially lethal as Dsuvia,” Dr. Anna Lembke, chief of the Stanford University Addiction Medicine Dual Diagnosis Clinic, told the Huffington Post.
“There is no need for another opioid on the market, particularly one as potentially lethal as Dsuvia,” Lembke said. “In the midst of the worst opioid epidemic in U.S. history, the FDA seems to be operating in a vacuum, without regard for optics or public health.”
Cannabis has been shown to be a useful alternative to opioids in many cases, though Epidiolex, the only medical marijuana product currently legal under federal law, is prescribed only for certain forms of epilepsy, not for pain.
Photo via Flickr user U.S. Department of Agriculture