After the VA announced in March it would offer a highly anticipated ketamine-based medication for treatment-resistant depression, a Department of Veterans Affairs panel voted last week against widespread use, instead restricting the drug for pre-approved, case-by-case treatment.
The U.S. Food and Drug Administration on March 5 fast-tracked approval of Spravato, a nasal spray related to the anesthetic ketamine. Ketamine is also known in its illicit form as Special K, a party drug known for its disassociative effects, lending itself to abuse as a date rape drug.
In prescription form, however, Spravato, or esketamine, has been hailed as a breakthrough treatment in a field with relatively few new options for treating unmanaged depression. VA officials lauded its arrival two weeks after Spravato received FDA approval, saying the treatment would be available to patients based on individual medical need and physicians' assessments.
But the panel that decides which medications should be included among those readily accessible to VA physicians and patients -- known as the VA's formulary -- voted last week to leave Spravato off the list.
The decision means doctors will need prior approval before prescribing and buying the medication for patients.
A VA spokeswoman said Monday VA psychiatrists will still be allowed to offer Spravato "when clinically indicated" but "in keeping with the FDA-approved indications for esketamine use and safety requirements."
In addition, said Susan Carter, VA's director of media relations, VA has developed clinical and procedural guidance for prescribing Spravato, and "these evidence-based processes will ensure the medication is prioritized for use in veterans who have not previously responded to adequate trials of other available treatments for major depression."
The decision, by the VA's Medical Advisory Panel, came two days after a joint report by The Guardian and the Center for Public Integrity that raised considerable concerns over the drug's rapid FDA approval and the VA's quick endorsement.
According to the report, Spravato proved no better than a placebo in two of three short-term trials. The article also charged that during the trials, six people died, including three from suicide.
And it raised questions as to whether the medication is effective in males and patients ages 65 and over -- notable concerns at VA, where 90 percent of patients are men, with an average age of 63.
The media reports also charged that Johnson & Johnson, the parent company of Spravato maker Janssen, worked with the members of President Donald Trump's Mar-a-Lago club in what may have been an effort to influence the president and the VA to consider the medication.
House Veterans Affairs Committee Chairman Rep. Mark Takano, D-California, said Thursday he is alarmed that the "controversial new drug is being rushed through critical reviews and may be prescribed to veterans before fully vetting the potential risks and benefits."
"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.
FDA officials said they fast-tracked the medicine due to the limited availability of effective antidepressants for difficult-to-treat patients. Acknowledging its extensive side effects, FDA required Spravato to carry a boxed warning for symptoms that can include sedation and blood pressure spikes and disassociation, such as feelings of physical paralysis and out-of-body experiences, and suicidal thoughts and behaviors.
The FDA also decided to make the drug available only through a restricted distribution system, administered only by a medical provider who must monitor the patient after a dose.
Carter said VA will closely monitor the drug's use and effectiveness and compare it with other treatments. Based on the information received, it "may revise its clinical guidance and formulary status if warranted."
In the veteran population of 20 million, the estimated diagnosis rate of depression is 14 percent -- up to 2.8 million veterans. Between one-third to half of those veterans may be considered treatment-resistant.
Takano said he has asked the VA to provide documents and information about the process for reviewing and purchasing the drug and whether VA was "pressured by the White House or the Mar-a-Lago 'three' to prescribe this drug to veterans."
"Spravato should not be added to VA's formulary until we have more answers about what this means for our nation's veterans," Takano said.
Veterans who remain interested in the medication should speak with their VA physicians. Eligible veterans must have tried at least two antidepressant medications and continue having symptoms of major depressive disorder. Patients also must take an additional antidepressant while being treated with Spravato.