President Donald Trump said on Wednesday that the government will purchase “a lot” of the drug esketamine, a derivative of ketamine.
Though ketamine is known as a recreational hallucinogen, Trump asserted that a new nasal-spray derivative would be of great benefit to veterans with depression. As he left the White House for a veterans’ conference in Kentucky, he
told reporters that he had instructed the Department of Veterans Affairs to make a large purchase—overriding a
recent decision by the doctors who manage the hospitals’ formulary of which drugs are to be prescribed.
“There’s a product that’s made right now that just came out by Johnson & Johnson which has a tremendously positive—pretty short-term, but nevertheless positive—effect,” Trump
said. But that statement is contrary to the evidence. A review by the Food and Drug Administration of what limited studies have been done with esketamine found mixed results, leaving many scientists unsure if the drug is indeed effective and safe. Just last week, the agency published a
report that said the drug was not reliably better than placebo.
The problem, critics say, is that the drug’s manufacturer, Janssen, provided the FDA at best modest evidence it worked and then only in limited trials. It presented no information about the safety of Spravato for long-term use beyond 60 weeks. And three patients who received the drug died by suicide during clinical trials, compared with none in the control group, raising red flags Janssen and the FDA dismissed.
The FDA, under political pressure to rapidly greenlight drugs that treat life-threatening conditions, approved it anyway. And, 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.
