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With ardent support from President Trump, the Department of Veteran Affairs is on the cusp of approving esketamine, a molecular derivative of ketamine, for the treatment of depression and suicide in US veterans.
Ketamine has been used both medically and recreationally since the 1970s, and as of the early 2000s, has been found by researchers to exhibit considerable antidepressant properties in clinical studies, especially in acutely suicidal patients.
While esketamine was originally developed to be administered intravenously, pharmaceutical/biotech conglomerate Johnson & Johnson repackaged the drug as a nasal spray called Spravato under their subsidiary, Janssen. On March 5 of 2019, President Trump announced his intent to assemble an aggressive task force, that would, as he put it, “mobilize every level of American society” to address veteran suicide. That same day, the Food and Drug Administration voted to approve Spravato for VA use.
Donned as a miracle drug for its ability to hit what experts call “a quick molecular reset button for brains impaired by stress or depression,” esketamine is expected to help address the staggering suicide rates among American veterans who haven’t responded to more orthodox, front-line antidepressant treatments. But the jury is still out for many authorities on the topic. Committee Chairman Rep. Mark Takano, D-Calif., joins the audible stream of officials who believe the clinical research on esketamine’s ability to stave off suicidal intent is still somewhat nebulous.
“Many concerns have been raised about the drug’s safety and efficacy, its suspicious fast-track approval through FDA review, and VA’s contracting process.
…Questions remain about the ultimate impact on the health and safety of veterans, who should not be made into a ‘test case’ while the clinical community continues to gather data about this treatment.”
While it’s often difficult to pinpoint and define an epidemic, veteran suicide rates are undoubtedly alarming. According to a 2016 report from the
Department of Veterans Affairs’ Office for Suicide Prevention, there are an estimated 20 suicide deaths every day among US veterans. With such high stakes, it’s easy to imagine why many consider the fast-acting Spravato a possible godsend. The FDA voting committee largely attributed their decision to approve the drug to data from Phase 3 clinical trial reports showing that Spravato demonstrated a “statistically significant effect compared to placebo on the severity of depression,” in patients.
The Department of Veteran Affairs is set to vote this week on whether or not Spravato will be prescribed to veterans.
H/T: The Guardian
Photo Credit: Associated Press