While Trump himself has been quiet on psychedelics, he demonstrated a ‘personal interest’ in fast-tracking Johnson & Johnson’s esketamine nasal spray product (Spravato) for use within the VA during his first term.
Trump’s enthusiasm was so ardent that the agency “shoved aside usual protocols, even though experts inside and outside the government [had] serious concerns”, according to The Guardian, which also reported that VA staffers “were told by a senior official to drop everything in March [2019] and accelerate the drug’s availability because the president had expressed enthusiasm for the drug, Spravato, as a possible treatment for depressed veterans.”
ProPublica and The Center for Public Integrity led on the reporting of the matter, which led to a House Democrats investigation into potential outside influence at the VA in the push to have Spravato added to its formulary despite skepticism from its own Medical Advisory Panel (the ‘formulary committee’). That built on earlier reporting that detailed a trio of those in Trump’s Mar-a-Lago set were having an outside influence on VA policy. J&J had also been partnering with the VA on a suicide awareness campaign while developing Spravato, which included the company inviting then-VA Secretary David Shulkin to ring the closing bell at the New York Stock Exchange on Veterans Day back in 2017.
Nothing seems to have come of that House Democrats investigation or the associated reporting, which may imply a green light for similar efforts by today’s drug developers, even as questions remain around its cost/risk-benefit profile, especially given that it’s much more expensive than IV ketamine.
Anyhow, might this example inform what we might expect to happen, if anything, with psychedelics?
Well, Trump showed little substantive knowledge of the drug itself back then, which might suggest that the lack of scientific knowledge among his present posse won’t be a blocker to garnering a special interest from Trump and co. next year. (“I guess it’s a form of a stimulant”, he said of esketamine, the S-enantiomer of the dissociative anaesthetic ketamine… a downer, not an upper.) And, given that it seems it was Trump’s Mar-a-Lago pals that set his sights on Spravato, might we expect him to take a similar interest in psychedelics, given an increasingly psychedelic MAGA milieu?
But, crucially, Trump didn’t get Spravato approved: FDA did so in March 2019 on its own accord. He simply instructed VA to get it online… kicking them into overdrive to have it rolled out. Within days of its approval, according to reporting, Trump urged VA officials to buy “truckloads” of the new product, with a J&J contract signed within 48 hours and a statement issued just two weeks after approval. (According to STAT, however, only 15 veterans had been treated with Spravato by mid-December 2019.)
So, hoping for Trump or one of his appointees to put his thumb on the FDA approval scales is more than he did in the case of Spravato. But, given that FDA Advisory Committee (AdComm) members had expressed some concern about Spravato and that this didn’t temper Trump’s bullishness on the roll-out of the drug at the VA, could we see a similar attitude with MDMA?
But it’s also unclear whether a lack of political will within the VA would be a blocker to MDMA’s uptake: It already has prominent internal champions. Perhaps the most obvious of those is VA Under Secretary of Health Shereef Elnahal, who has repeatedly supported efforts to get psychedelic research underway in the organisation and to prepare for a potential roll-out.
***
So, it is at least plausible that Lykos’ MDMA for PTSD could face a smoother route to resubmission, or even some alternative route altogether, under a Trump administration.
But what about the broader crop of psychedelic drug developers? Compass Pathways, for example, is in the throes of its Phase 3 program. It’s hard to imagine a Trump administration calling off the remainder of those trials, for example.
So why, then, are certain psychedelic stocks rallying (above and beyond the broader market rise) since the election? Shares in atai are up over 30%, MindMed is up a similar amount, and the small MDMA supplier Pharmala is up nearly 50%. Compass, meanwhile, is up less than 5% and remains down on the month following its news of a delay to its first Phase 3 readout and lay-offs.