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If this is your first Z-Pack, welcome - I'm Zach.
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💊 Is ecstasy what’s next for me?
A few weeks ago, the Internet was going nuts about the FDA declining to approve the first MDMA-based PTSD treatment.
The law calls it MDMA and the kids call it ecstasy. Potato potato.
Lots of people, including famous ones like Tim Ferriss, were pissed about this.
But what doesn’t seem to be getting much attention is how it was probably good that the FDA did not approve this 👇
This is a good move.
The evidence that MDMA works for treating PTSD is flimsy, and the same day the FDA made this decision, it came to light that several MDMA studies involved protocol violations trial runners were aware of.
Result? Three retractions in one day.
— #Crémieux (#@cremieuxrecueil)
5:32 PM • Aug 11, 2024
Before we get into this mess, let’s be clear — I’m not kissing the boots of the FDA.
Like any government agency, they get (rightfully) criticized for a lot they get wrong:
Too slow to approve very beneficial drugs, even COVID boosters
Delaying approvals for several years for good things, like at-home testing for pregnancy and AIDS
Too pushy on opioids (a later post, but in the meantime, read this brick for all the nitty gritty)
But they’ve also done great things that you can’t deny!
All of the incredible meds and drugs they’ve approved that we use in our everyday lives (imagine the days before Advil and Pepto 😮💨)
Going war-mode, like with Operation Warp Speed (Donald Trump’s biggest [and only] accomplishment), which was the public-private partnership that cut bureaucratic red tape to deliver us COVID vaccines that helped save millions of lives around the world
So now that you know a bit more of where I stand, why does this one situation on denying approval for MDMA actually seem reasonable?
Lots of people think psychedelics are great for treating anxiety, depression, and especially PTSD. We’ve all heard this (or even experienced this first-hand) through college and causal conversation with the homies.
The problem with psychedelics is that they lack the gold-standard of medical legitimacy: solid clinical trials.
Currently, despite the hype, all MDMA and psychedelic drugs have are self-reports/anecdotal evidence from your sister and your brother.
The FDA, understandably, can’t rely on this.
I’ll cite some of Cremieux from above (I bolded below for emphasis):
“Sure, decriminalize, legalize, whatever. That's not the same as saying the FDA should approve any and every drug. Their approval has implications for insurers and doctors, and if they approve useless or harmful drugs, that's bad regardless of their legality.”
This gets to a point we don’t talk about much - the DOWNSIDES of approving a drug that’s useless or harmful.
Psychedelics have risks of harmful side-effects that don’t seem to ever be talked about, maybe because, culturally, we’re now on the other side of the War on Drugs, so there’s less stigma.
I’m guessing we also don’t hear much about harmful side effects because of survivorship bias, where we think the good stories we hear from our friends represent EVERYONE’S experience, or even the majority.
In this MDMA case, there apparently were a few red flags:
MAPS (Multidisciplinary Association for Psychedelic Studies), the organization that presented this data to the FDA for approval, seems to not be very open about sharing their methods.. sus.
After the FDA shared their decision to not move forward with it, MAPS literally asked to retract their data three times.. in one day, basically admitting they messed up the trials
The clinical trials didn’t end well because many of the patients in the test group and the control group knew which group they belonged to, which shouldn’t happen!
The trials should be “double-blind” — no one knows which group they’re in, so everything can be accurately measured. But it got “unblinded”.
MAPS was like:
What happens from here?
Not sure tbh, I guess they just run it back! I personally think the FDA should operate more in war-mode like they did during Operation Warp Speed days. They should quickly develop vaccines and drugs for malaria, bird-flu, and cancers. The good news is that some of this is already happening.
Still curious?
This post on cost-benefit analysis of FDA drug approval
This interview on lessons from the pandemic with the FDA
Thanks for taking the Pack,
Zach
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— #Work Retire Die (#@WorkRetireDie)
5:11 PM • Aug 15, 2024
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