We now have a word to summarize the absurdity of America's drug laws. That word is Dsuvia - the name of a new opioid painkiller that is 10 times more powerful than fentanyl, a highly addictive opioid that caused nearly 30,000 fatal overdoses in America last year. And yet the FDA says Dsuvia is safer than cannabis, even though marijuana has never killed anyone—ever.
Last month, the FDA made the controversial move to approve Dsuvia over numerous objections from high-ranking policymakers. Those opposed included four US senators and Dr. Raeford Brown - Chair of the FDA's Advisory Panel, who noted that there are actually no distinct medical benefits or application for the drug right now. So Dsuvia is basically a highly dangerous substance that does not need to be circulated at a time when the illegal diversion of opioids to the black market is fuelling the worst overdose crisis America has ever seen.
"The lack of efficacy data and the [manufacturer’s] inadequate response to safety concerns have not been addressed since the FDA’s complete response letter was sent in 2017," said Dr. Brown, who is also a professor of anesthesiology and pediatrics at the College of Medicine at the University of Kentucky. "Clearly the issue of the safety of the public is not important to the commissioner, despite his attempts to obfuscate and misdirect."
But FDA Commissioner Scott Gottlieb pressed ahead with approving the drug produced by AcelRx because he thinks battlefield medics should have it, just in case the need for it arises in a war zone.
"The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds," Gottlieb said in a statement. "The military application for this new medicine was carefully considered in this case."
Shortly after releasing that statement, medical experts scoffed at Gottlieb's dubious rationale.
"There is absolutely no need for this product," said Dr. Andrew Kolodny - Executive Director of the advocacy group Physicians for Responsible Opioid Prescribing. "Claiming we need it on the market to help soldiers on the battlefield is ridiculous. We already have sublingual fentanyl product available for use on the battlefield."
Dr. Kolodny might have also called out Gottlieb for flagrant hypocrisy in allowing a double-standard for opioid medications. The FDA commissioner claims that battlefield medics need every tool available at their disposal to treat wounded veterans, but the FDA still refuses to approve medical marijuana, even though 33 states have approved medicinal cannabis and various veterans groups are clamoring for it to be approved as a safer and more effective treatment for conditions that they developed as a result of active combat.
But the FDA and the rest of the federal government still define cannabis as a substance that has no accepted medical use and is as dangerous as heroin. Yet the same government is fine with approving Dsuvia even though it also has no accepted medical use and is 10 times more potent than fentanyl, which is 50 times more potent than heroin.
h/t Scientific American