The FDA Has Demolished All Scientific Standards: Untested Covid Boosters For 6-Month-Olds But No Decades-Long-Tested MDMA Therapy For Veterans
Over the past few weeks, the FDA has created this glaring asymmetry: you can get your healthy 5-year-old a 4th mRNA vaccine, but a veteran suffering from severe PTSD can't get access to MDMA therapy.
It is not provocative to state that the FDA is now widely perceived to be corrupt, unethical, and politically influenced in large segments of the American public. Their commissioner regularly spews vaccine misinformation, they swimmingly approve suspect “weight-loss” drugs (as one arbitrary example), they continue to recommend experimental mRNA vaccines to healthy populations, and their senior officials frequently leave the agency to join lucrative pharmaceutical companies.
To name just a few problems.
The reasons to distrust the FDA abound, feeding into the 40% decline in trust in medicine since 2020.
If anyone needs a jarring refresher, the FDA’s self-stated role is “protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs.” If the FDA “determines that the research, data, and evidence shows that the drug is safe and effective for the intended use, the FDA approves the drug.”
Does the FDA really do that?
Increasingly, the public doesn’t believe such absurd mythologies. I certainly don’t. But if you put a gun to my head (and almost all of you reading this) in 2020 — having zero opinions on the regulation of drugs and vaccines — I’ve would naively assumed the FDA is uncompromising in its duties as the world’s leading drug regulatory body. This is one of the biggest socio-medical shifts of the past few decades — whole books ought to be written on its devastating implications.
Over the past 10 days, the FDA has made two separate regulatory decisions that render their stated role of ensuring drug “safety, efficacy, and security” nearly implausible.
Firstly, the FDA rejected the approval of MDMA-assisted therapy for PTSD.
Why is that?
We don’t exactly know. FDA’s letter to Lykos Therapeutics is private, but Lykos predictably stated they were very disappointed in response:
"Our heart breaks for the millions of military veterans, first responders, victims of sexual and domestic abuse and countless others suffering from PTSD who may now face more years without access to new treatment options. We intend to work tirelessly and use all available regulatory pathways to find a reasonable and expeditious path forward for patients who deserve access to midomafetamine-assisted therapy for PTSD."
- Lykos CEO Amy Emerson
Lykos Therapeutics’ phase 3 MDMA-assisted psychotherapy study submitted to the FDA found 71.2% who underwent the MDMA treatment went into complete remission, compared to 47.6% of those in the placebo with therapy arm (high-quality therapy is what leads to meaningful changes in the end!). Moreover, 86.5% of participants in the MDMA arm experienced a “clinically meaningful improvement” in PTSD symptoms (“defined as a ≥10-point reduction in CAPS-5 total severity score”).
In conjunction with rigorous psychotherapy, MDMA offers particular utility in treating PTSD because it lowers activity in the amygdala (fear centre of the brain) and heightens memory, commonly resulting in a self-compassionate, fearless exploration of previously unapproachable traumas.
As honest psychiatrists admit, current treatments are failing. Opening up painful traumas — ranging from sexual abuse, encounters with violence while serving in law enforcement or the military to being bullied in middle school or reeling from a heartbreaking breakup — in conventional talk therapy settings have lead to a 50% drop-out rate, causing a widespread crisis of PTSD patients who are too afraid to open pandora’s box in a standard therapy session, but are looking for effective alternatives. Meanwhile, psychopharmacological interventions such as SSRIs only drive 20 to 30% of PTSD patients into remission, while merely masking symptoms, not addressing root-cause traumas.
As echoed by the CEO of Lykos, many of the issues likely factoring into the decision — which were brought up in the June Advisory Committee meeting (I covered here) — were already known by the FDA as they had approved Lykos’ study design. This has understandably caused immense frustration among psychedelic advocates who hoped to finally break the bureaucratic ice and open the doors to at least one promising psychedelic treatment.
For instance, in the June Advisory Committee, panel members raised functional unblinding as a major issue. Study participants were blinded — they didn’t know whether they received MDMA or placebo — but the acute “heart-opening” effects characteristic of MDMA are so palpable, the vast majority of patients correctly guessed which group they were in. As Dr. Matt Johnson stated in the recent 4-hour debate I moderated on this topic, this problem is extremely difficult to solve in this study design greenlit by the FDA and there are no good solutions. For instance, using low-dose MDMA as an active placebo confers other problems such as increased difficulty to detect safety signals in the treatment group since low-dose MDMA can often pose greater psychological challenges (“not being fully sober or altered”) than high-dose MDMA.
Another issue brought up by the panel was 40% of participants in the study had used in MDMA previously in their life, thereby biasing the results in the MDMA group. However, this concern is refuted by the study itself as the response rate was roughly equal in both MDMA-naive and MDMA-experienced groups. Besides, the vast majority of those with prior MDMA experience had likely used the drug in a party or rave setting, not in the confines of a therapeutic endeavour.
PTSD is an urgent mental health problem in the United States and its consequences are devastating. Twenty veterans die of suicide everyday, though newer estimates suggest the true number is at least double that. In a bipartisan letter to president Biden, Republican and Democrat lawmakers highlight the “150,000 [veterans who have taken their life] since 9/11,” which is “more than 21 times as many American lives lost in warzones over that same time” and the “billions of federal dollars spent on addressing PTSD and mental health” failing to lower the tragic count of veteran suicides.
It’s not that the MDMA trials were perfect. There were some valid concerns (My interview with Rick Doblin on the allegations of potential under-counting of suicidal ideation is coming out soon. You don’t wanna miss it. Subscribe below to get it straight to your inbox).
The FDA does not deem PTSD to be a national emergency requiring swift, efficient approval of a provably effective treatment. And perhaps rightly so, especially if one’s bar of safety and efficacy data is so high that Lykos Therapeutics must replicate their results to larger sample sizes and demonstrate safety on a much bigger scale.
However, that is not the bar FDA has ever maintained — at least not recently.
In contrast to the rejection of MDMA-assisted therapy, the FDA just rammed through, yet again, a new updated Covid booster. As if they want to further undermine trust and generate more conspiracy theories, they’ve committed another irrecoverable scientific travesty by exploiting the “emergency use authorization” pathway:
The FDA states, "A product authorized for emergency use has not undergone the same type of review by the FDA as an FDA-approved product." What conceivable Covid emergency is there in 2024? Pro-vaccine doctors in Canada aren’t seeing it:
As Dr. Vinay Prasad highlighted on his Substack, the KP.2 variants the booster is targeted towards is dying rapidly:
The number of kids now dying of Covid is so small, there are no good estimates.
Yet, the CDC recommends the new booster to all kids as young as 6 months old. An infant born this year is eligible for a new untested shot (there is no randomized study on the booster) and you can line up your 5-year-old child for his 4th or 5th shot total? What is the compounded risk of myocarditis? Does anyone know?
Then why is it recommended by the state?
Countries such as Australia, Denmark, Germany, Hong Kong, and others don’t recommend new boosters for children.
To make matters worst, a group of FDA-supported scientists published a study earlier this year in JAMA Pediatrics finding an undiscovered 1 in 5,000 elevated risk of seizures in kids 2 to 5 years old:
New FDA Study Reports Elevated Post-Vaccination Seizure Risk In Toddlers
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Of course the media did not cover this. I was one of the only people to dissect this story and contact the FDA about their continued mRNA vaccine recommendation in the face of this new safety signal. They responded in a predictably dogmatic manner, stating:
The FDA is confident in the safety and effectiveness of the COVID-19 vaccines approved or authorized for use in the U.S. The vaccines’ benefit-risk profiles are well understood and demonstrate that the known and potential benefits for individuals 6 months of age and older outweigh their risks.
The FDA simply has no consistent, principled standards.
They have utterly failed to regulate and assess the safety and efficacy of drugs and biologics in the U.S.
A complex matrix of regulatory, political, financial, and pharmaceutical forces are at play here — everything from the war on drugs to perverse financial incentives at the FDA — but this glaring asymmetry is impossible to exaggerate:
The FDA does not deem it is safe and/or effective for a 45-year-old veteran suffering from PTSD to undergo MDMA therapy, but a healthy 5-year-old is eligible for his 4th booster dose to combat the (nonexistent) threat of COVID-19.
And they wonder why trust in institutions is dead.
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The FDA does not exist regarding anything COVID... the operation is still a military operation and the FDA is just a front for the DoD, which is still running its culling operation against the American people and no one seems to notice.
FDA and CDC paid off big time by big pharma. Either that or they hate humanity.