The Department of Veterans Affairs has fast-tracked approval for a drug that could be used to help veterans with treatment-resistant depression, but some say not enough testing has been completed to fully understand its effects.
Spravato, the brand name for the drug esketamine, is a derivative of ketamine, which has been used as a recreational drug and also to treat depression in some instances. Spravato is produced by a subsidiary of Johnson and Johnson. The drug is said to be so fast-acting the results can be felt in fewer than 24 hours.
“V.A. will closely monitor the use of esketamine in veterans to more fully understand its relative safety and effectiveness as compared to other available treatments. Based on this information, V.A. may revise its clinical guidance," a VA spokesperson said.
Reports last week cited critics who said President Donald Trump and others may have influenced the VA to fast-track incomplete clinical trials of the pricey medication, including meeting with VA Secretary Robert Wilkie, offering to help make a deal to get the drug. Patients who are prescribed Spravato must be monitored by medical staff, adding to the already expensive drug, which can cost thousands per course of treatment.
Spravato comes in two- and three-dose packages. For the VA, based on its contract with Johnson and Johnson, the cost per dose will be about $218.68, or $437.34 for the two-dose package and $656.03 for the three-dose package, VA spokesperson Ndidi Mojay told Connecting Vets.
VA and Congressional leaders' rhetoric has become increasingly desperate to move the needle on the rate of veteran suicide -- 20 per day, according to VA data -- but some were concerned about the quick approval of Spravato.
House Veterans Affairs Committee Chairman Rep. Mark Takano, D-Calif., said he was "incredibly alarmed" by the reports that Spravato was being "rushed through critical reviews and may be prescribed to veterans before fully vetting the potential risks and benefits." He called the fast-tracking "suspicious."
"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," Takano said. "We demand that VA provide documents and information about its review and contracting process to adequately address critical questions —including whether VA officials were pressured by the White House or the Mar-a-Lago 'three' to prescribe this drug to veterans."
An FDA joint advisory committee has already voted 14-2 to approve the drug for public release, defending the drug in The New England Journal of Medicine as a “novel treatment for a severe and life-threatening condition.” The drug is meant for adults with severe depression and suicidality that has not been responsive to other treatments.
But the drug has had controversial reactions from academics and health care professionals, who say its effects are not fully understood and side effects -- including suicidal ideation -- have been ignored.