Below is an extract of a post published on Guardian titled "The controversial ketamine-like drug that Trump is pushing on veterans"
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Via: Guardian
The president has touted the drug’s benefits and offered to help a senior Veterans Affairs official negotiate the purchase of the drug Personal interest from Donald Trump appears to have put a controversial anti-depressant 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. 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 third trial alone, adding on another and different type of trial that some say was deeply flawed. The FDA admitted it had not previously done this, but said it was not “unreasonable”. FDA committee member Erick Turner of the Oregon Health and Science University, who did not make the advisory committee meeting, called the FDA’s position “bull”. “It’s not a reason,” he said. “That’s like a parent saying, “Because I said so.’” 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 works on people over 65 – or, some say, even on males. The VA’s patient population is 90% male and 52% over 65. During several years of trials, six people who had been treated with the drug died, as opposed to none on placebos. Three of the deaths were suicides. Janssen said none were considered by investigators to be related to Spravato. The FDA concurred. Still, noted one professor and psychiatrist, “It’s not heading in the direction supporting protection from suicides.” Data from the drug’s trials shows it to be only marginally better than placebos in its performance, several researchers and psychiatrists said after looking at the data. The dangers of treatment – mainly dissociation, sleepiness, and blood-pressure hikes – are so significant that patients must stay in the doctor’s office for 2 hours after receiving their Spravato infusion. The office must be equipped with equipment to deal with hallucinatory, cardiac, and respiratory problems. The patient cannot drive for 24 hours after taking the drug. “A wonder drug? I think it’s a wonder that’s anybody thinks it’s a wonder drug,” said Diana Zuckerman, president of the National Center for Health Research in Washington DC. Continue reading…
