In this Issue
Lykos Insiders, Affiliates, Respond to Critics
Might FDA Miss Its August 11th Goal Date?
FDA-Affiliated Workshop Discusses Ketamine’s Use In Mental Health Treatment
Colorado’s Regulated Psychedelics System Takes Shape; Last Chance for Public Comment
EMA Reps Recap Psychedelics Workshop
Other Stories
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I’m opening this Issue with a review of some of the alternative views I have heard since my last missive which, broadly, criticised conspiratorial theories and personal attacks that have taken hold in the wake of negative verdicts by both ICER and FDA’s Psychopharmacologic Drugs AdComm.
In response to that piece, I have received various ‘You got it wrong this time, Josh!’, or ‘You missed this angle’ views. Here, I focus on views expressed by Lykos insiders, allies or other sympathetic individuals, which includes employees of the company but also practitioners who may or may not have worked on Lykos’ studies, other operators in the psychedelic drug development field, and so on. All requested anonymity when speaking with me, so I’m paraphrasing their comments here.
Psymposia did have a big effect on ICER and the FDA AdComm, according to some I spoke with. In my commentary, I said: “If your drug development process has been entirely derailed by a small, poorly funded group of individuals, you really have to ask yourself whether that’s the truth or whether you’re looking for a scapegoat.” However, I have since heard from several individuals who believe I missed the mark, here, and argue that Psymposia and its team members’ critiques had a wrecking effect on these deliberations.
Many individuals I spoke with claimed that the number of discrete cases of abuse/misconduct is small. They point out that there are only one or two clear-cut, publicised cases of abuse or serious misconduct from Lykos’ Phase 2 and 3 programs.
A subset of individuals who expressed the above message claimed that this has been deliberately obscured by the anonymisation of certain reports of misconduct, in order to make it seem like there are more discrete cases than there really are or were. Of course, it’s difficult to determine one’s intent when anonymising such reports, as the alternative (to name the individual involved in each discrete incident) would likely have a chilling effect. So, whether it’s a deliberate effort to make it seem there are more instances of misconduct than there are, or whether it’s a byproduct of protecting those brave enough to speak out, is a tricky thing to parse out. Journalists, too, might also emphasise these stories of harm, given their editors’ presumed desire for shock-factor stories—a point I made in last week’s commentary. Further complicating matters is the fact that the details of how these cases are being/have been investigated and handled are not generally public… especially when it comes to the FDA’s inspections of, and interactions with, Lykos.
Another angle of defence, or attack, was to suggest that at least some of the most prominent critics of Lykos fundamentally misunderstand key tenets of clinical studies and protocols. These individuals highlighted imprecise discussion of things like the reporting threshold for suicidal ideation and thus the point at which it’s considered an adverse event, for example.
Others suggested that critics are deliberately conflating MAPS and Lykos, so as to maximise their scare tactics in drawing on both MAPS’ woo and Lykos’ status as a pharma co.
While almost all of the individuals I spoke to were fairly level-headed and certainly not interested in personal attacks or derision, at least a couple expressed contempt for certain prominent critics. (And, while I was preparing this piece, I caught wind of a particularly nasty email sent by a Director of Heroic Hearts Canada to one such critical voice, Neşe Devenot.)
In terms of the path ahead for Lykos, some people I spoke with emphasised the fact that the company’s MDMA-assisted therapy protocol calls for limited administrations of MDMA, i.e. several sessions, as opposed to chronic dosing. As such, they expressed optimism that apparent deficiencies in the safety dataset can be addressed via a Phase 4 study or other postmarketing requirements, as opposed to representing a blocker to approval.
Almost all of the individuals I have spoken with acknowledge that Lykos’ lack of engagement with ICER was a mistake. While getting ICER to appreciate the economic value of MDMA-assisted therapy was surely a non-starter, those I spoke with didn’t expect ICER to rip into their trial design and conduct to the extent it did, or for it to set the tone for such widespread criticism in the media ahead of PDAC’s meeting.
While I was fortunate to bend the ear of many individuals close to the company and related ventures, some declined to speak and instead pointed me to a Consensus Statement coordinated by Bob Jesse. Unsurprisingly, critics picked up on the fact that around half of the twenty-odd signatories have received support or funding from Lykos for research, or served as researchers/clinicians in Lykos-sponsored studies.
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