Clinical Topics

Political Issues Related to VA’s Limited Approval of Esketamine for Depression

by Stephen Spotswood

August 16, 2019

WASHINGTON—A VA panel this summer opted not to add the new depression medication esketamine, Spravato, to the department’s formulary in the usual way. This came despite strong support from President Donald Trump and an effort by VA officials to fast-track the drug for approved use at VA facilities. 

Instead,  the panel voted to allow VA physicians to prescribe the ketamine derivative on a pre-approved, case-by-case basis and also required physicians adhere to the Food and Drug Administration’s limited distribution requirements. According to those requirements, Spravato can only be prescribed following failure by at least two other medications. 

The drug will need to be administered by a physician who will be required to observe the patient after dosing. The patient also will need to be on another antidepressant medication while taking Spravato.

In the week prior to the VA panel’s vote, Trump met with VA Secretary Robert Wilkie and others to discuss the ongoing opioid abuse crisis, during which he brought up Spravato and its reported success in treating depression. 

Trump told those present that that he had previously spoken with Wilkie about the drug and told him to “Corner the market on it and give it to anybody that has the problem. You have people calling—and our folks do a great job on the phone, but it’s a telephone. You have people calling, looking for help. And if those people had that, I’m hearing like instantaneously they’re in much better shape,” according to a transcript of the meeting released by the White House.

Asked for an update on VA’s progress with Spravato, Wilkie told the president, “We are working with Johnson & Johnson to distribute it. We should have it in all our VA hospitals by the end of the year. But it’s in the purchasing process right now.”

Trump told Wilkie that he expected Johnson & Johnson, to be “very generous to you. And if you’d like, I’ll help you negotiate. Because, seriously, I just said ‘Corner the market.’”

Under Scrutiny

This support by the president and the fast-tracking of the drug through FDA approval is now coming under scrutiny by legislators and the press, with questions being asked about possible unethical influence being asserted on VA by the Mar-a-Lago Trio—a group of unofficial advisers to Trump who are at the center of a number of lawsuits.

The three men—Ike Perlmutter, CEO of Marvel Entertainment; Dr. Bruce Moskowitz, an internal medicine specialist; and Marc Sherman, a private attorney—reportedly had a hand in using their relationship to the president to direct policy and personnel decisions at VA. Questions have been raised about possible financial benefit to them.

Among their several contacts with VA officials, they reportedly pushed for the department to partner with Johnson & Johnson in 2017 on a campaign around veteran suicide awareness. This resulted in the #BeThere campaign in 2017, according to media reports. 

This connection between Spravato’s manufacturer and the ongoing Mar-a-Lago controversy was cited in an article in The Guardian in June. That article, along with questions raised by physicians and researchers about the trials FDA considered in approving Spravato has legislators demanding answers from VA.

“Already, 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,” House VA Committee Chair Mark Takano said in a statement the day the Guardian article was released. “Today’s reporting raises additional concerns that VA’s own process for objective review is being undercut by undue influences. 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. 

“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. Spravato should not be added to VA’s formulary until we have more answers about what this means for our nation’s veterans.”

Representatives from Janssen Pharmaceuticals—the subsidiary of Johnson & Johnson that developed Spravato—released a statement conveying their deep disappointment with “recent misleading media coverage” around the drug. 

“Treatment-resistant depression is a critical unmet health need that carries significant economic, emotional and functional burden. … Spravato offers significant and sustained improvement in symptoms of depression, bringing hope to patients who have cycled through multiple medicines without relief,” the company said in their statement. “We firmly believe that people suffering from TRD, including our nation’s veterans, deserve the opportunity to benefit from this breakthrough medicine.”

VA has estimated that 10-15% of the 20 million veterans has major depression requiring psychotherapy or antidepressants. About one-third of those are considered treatment-resistant, having tried multiple antidepressants without success. 

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