In June, the Department of Veterans Affairs chose to approve the use of a new, expensive anti-depressant despite concerns about the drug’s effectiveness, and a backdrop of political speculation about the president’s involvement.
The drug, called esketamine (brand-name Spravato), is intended to offer the same kinds of effects as a mental health tool that ketamine, a popular recreational drug, veterinary anesthetic, and “darling of combat medics,” has been found to offer in clinical studies.
However, recent reporting by Kaiser Health News and others have raised some serious concerns about the drug’s adoption, including its effectiveness, its risks, and even its FDA approval. KHN explained:
[Though] Spravato’s appearance on the market was greeted with public applause, some deep misgivings were expressed at its day-long review meeting and in the agency’s own briefing materials, according to public recordings, documents and interviews with participants, KHN found. Dr. Jess Fiedorowicz, director of the Mood Disorders Center at the University of Iowa and a member of the FDA advisory committee that reviewed the drug, described its benefit as “almost certainly exaggerated” after hearing the evidence.
As the New York Times reported last month, questions have also been raised about President Trump’s involvement in the drug’s speedy adoption and approval:
The decision to endorse [Spravato —] manufactured by Janssen, a unit of Johnson & Johnson — came days after President Trump offered to negotiate a deal between the drug maker and the agency. Johnson & Johnson reportedly was working with associates at Trump’s Mar-a-Lago club, and the company has been supporting V.A. suicide-prevention efforts. A spokesman for the V.A. said that the decision to approve the drug, which would cover its use by doctors in its nearly 1,000 clinics nationwide, was a medical one.
Though Veterans Affairs has approved the drug, the agency has not yet added Spravato to its medical formulary. According to The Guardian, one estimate puts Spravato’s potential earnings for Johnson & Johnson at around $600 million by 2022.