The Guardian reports:
Personal interest from Donald Trump appears to have put a controversial antidepressant on a fast track at the Department of Veterans Affairs (VA) that shoved aside usual protocols, even though experts inside and outside the government have serious concerns the drug is effective and say it may be dangerous.
Sources inside the Department of Veterans Affairs say staffers were essentially told by a senior official to drop everything in March and accelerate the drug’s availability because the president had expressed enthusiasm for the drug, Spravato, as a possible treatment for depressed veterans.
In the midst of a rapidly convened series of VA meetings early that month, another official said the president wanted the VA to buy “truckloads” of the drug, according to sources. Trump also touted the drug’s benefits to the veterans affairs secretary, Robert Wilkie, in a White House meeting just last week, offering to help negotiate the VA’s purchase of the drug.
From the Center For Public Integrity:
The drug’s heightened profile has unleashed a storm of questions from academics, psychiatrists, and health researchers who have concerns about Spravato: how it was approved, how well it works, whether it is safe, how much it costs, and whether it’s right for veterans. The discussion has surfaced some unsettling concerns:
The FDA abandoned a longstanding procedure of requiring two successful short-term trials before approving anti-depression drugs. Instead, when this drug showed itself to be no better than placebo in two of three short-term trials, the FDA accepted the one successful trial, adding on another and different type of trial that some say was deeply flawed.
Even though the drug is being hurried into use by the VA, some psychiatrists and researchers say the evidence from trials does not demonstrate that the drug is effective on people over 65 — or possibly even on males. The VA’s patient population is 90 percent male and 52 percent over 65.
Spravato’s formal name is esketamine. The medication is chemically similar to the veterinary tranquilizer Ketamine, which is also used as a club drug.