Why the FDA is not qualified to judge psychoactive medicine

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Why the FDA is not qualified to judge psychoactive medicine

by Brian Ballard Quass, the Drug War Philosopher

August 11, 2024

The FDA is incapable of fairly evaluating psychoactive medicine. This is because they ignore all obvious benefits, potential and actual, and insist that the drug be far safer than any other kinds of substances that they regularly approve. Take ECT shock therapy, for instance, a therapy for depression that knowingly damages the brain. That therapy is approved by the FDA and even encouraged!¹ Shock therapy! Why? Because the FDA believes in materialist theory and the testimony of microscopes, as opposed to COMMON SENSE... or even simple humanity for that matter. And yet MDMA, a non-addictive drug that does not damage the brain and has brought peace and love to dance floors for over 50 years, is considered unproven and dangerous. Only by completely ignoring common sense can the FDA make such a claim.

Anyone who agrees to shock therapy without trying entheogens first is a masochist - or else they are just understandably afraid of being arrested by our DEA. It seems our government, too, would prefer that you damage your brain rather than using godsend drugs. In fact, they are determined to ruin the life of any chronic depressive who does NOT opt for the "brain damage" option. This is not science, it is Christian Science -- with a vengeance.

But shock therapy is not some kind of weird exception: we have all seen prime-time ads for pharmaceuticals in which the rapidly announced side effects include death itself ² . Death! It makes you wonder if the FDA thinks that death itself is safe. This is the same FDA which looked on approvingly as Big Pharma turned 1 in 4 American women into patients for life with their dependence-causing pills, some of which are harder to kick than heroin ³.⁴ Was the FDA worried that a non-addictive drug like MDMA might help end that money-making status quo?

Materialist science is not qualified to investigate holistic cures in any case. The first step in their investigation of such substances is always to ignore all positive effects and to look for microscopic "gotchas" that will give them an excuse to say the drug is not proven efficacious - not proven efficacious despite the fact that entheogens have been used for positive purposes for millennia. THE PROOF OF EFFICACY IS EXTANT!!! IT'S RIGHT IN FRONT OF YOUR EYES!!! !" Check out the history of ancient peoples! As Al Sharpton used to say, "You better ask somebody." But the materialists claim that wonderful results of use do not mean anything. That's all anecdote, don't you see? According to the FDA, the fact that millions of people claim to have had positive experiences on MDMA means absolutely nothing. Scientists claim that THEY will be the judge of that. How? Not by cross-examining those satisfied customers but by looking under their blankety-blank microscopes to see what the molecules say.

It's so frustrating to write on this subject because it is hard to see what the scientists are missing. They are either ignorant or dedicated to the anti-scientific view of the Drug War, which says that a psychoactive drug that has even one potential downside must not be used for anyone, anywhere, ever. For that is the result when America outlaws such drugs - and even academic study of the drugs is stopped, except for cases where scientists risk their reputation while jumping through outrageous hoops established for them by the DEA, like buying thousand-dollar bank safes for the purpose of storing the blankety-blank plants and fungi of Mother Nature! Are these guys TRYING to go down in history as a byword for superstitious ignorance?

This applies to all psychoactive drugs, not just psychedelics and entheogens, though one hesitates to discuss this in connection to drugs like opium and cocaine because Americans are so thoroughly brainwashed to consider those drugs as pure evil. But from a holistic or shamanic point of view, no drugs are evil. The Kallawaya people of the Andes have a pharmacopoeia of over 800 substances and guess what: none of them are considered "drugs" in the evil sense of that word.⁵ Why not? Because the Kallawaya people are adults, not children. And they do not use drug law to marginalize minorities and win elections for totalitarians.

Take opium , for instance. It not only has positive uses, but it was considered a panacea by all the ancient western doctors, including Galen, Paracelsus and Avicenna.⁶ A blankety-blank panacea! And yet modern politicians insist that it has no positive uses whatsoever under any circumstances. Drug warriors insist dogmatically that it has no positive psychoactive properties whatsoever. Imagine all the unnecessary suffering in the world today because America has decided that the drug cannot be used wisely by anyone. Well, guess what, that is an anti-scientific lie, one which ignores psychological common sense, not to mention the testimony of millions, were we ever interested in talking to users rather than arresting them. Since when did we give up on the creativity of the human mind to find uses for psychoactive medicine? Since the Harrison Narcotics Act of 1914, perhaps? The simple fact is this: endless positive therapies come to the mind of an unbiased person for the positive use of drugs like opium and even cocaine , but the DEA forbids us from researching such things and tries to scare us into shutting up about them.⁷

One wants to cry in frustration with Friedrich Nietzsche at this point: Those who have ears, hear, damn it!⁸

What America does not understand is that freedom always has victims.⁹ Sure, if we re-legalize medicines, there will be people who will die because of their own stupidity - especially if we demonize drugs rather than teach safe use. But the fact that there are seemingly irreclaimable drunkards in the world does not make a case for liquor prohibition. We have to learn to accept victims of free activities - not just for freedom's sake and common sense, but because the number of people who will die from prohibition is far higher than the number who will die from freedom: it's just that the price of prohibition is being paid today by demographics that the American mainstream feels comfortable in ignoring: the disempowered, the poor, and minorities in general, not to mention the tens of thousands in Mexico killed because of the Drug War ¹⁰ - which our news media always blames on drug gangs, completely ignoring the fact that the Drug War created those drug gangs out of whole cloth by giving them a business opportunity to make extraordinary profits.¹¹

This is the same media that writes about the violence in cities today, pretending that it is completely inexplicable!¹² What? The Drug War armed the 'hoods in the first place and gave the poor incentive to make big money by selling desired products that the government had outlawed. The news media are equally clueless about the misnamed opioid crisis, which is really a prohibition crisis. They report that thousands of young people are dying from overdoses and contaminated drugs, but they never explain how prohibition naturally results in uncertain supply at uncertain doses.

These deaths are preventable and the Drug Warriors have the blood of young America on their hands.¹³

But the Drug War is the biggest case of mass denial in human history, and so these Drug Warriors, as always, blame these deaths on drugs. Well, guess what: millions of kids were not dying when opium was legal. People used the drug peaceably in their homes. Opiates were weaponized by prohibition.

But let's forget cocaine and opioids for now, since the hatred of that pair has been hammered into American kids since grade school.¹⁴

Let's think about entheogenic psychedelics, psychedelics that inspire peace, love and understanding. The FDA practices regulatory colonialism when they nix such drugs using a cost/benefit analysis that completely ignores their benefits. This is why the FDA is not qualified to recommend the outlawing of psychoactive drugs. Think about it. When they tell us that psychedelics are too dangerous, they are saying that 100% safety is more important than world peace. That's what it boils down to. And their rulings seem plausible because no one notices that they have totally ignored the benefits, or else they have downplayed them in a way that makes no common sense whatsoever.

The non-materialist looks at a drug like psilocybin and says, "Let's see: It turns many atheists into believers, it calms anxiety, it gives folks a reason to live... Gee, that works for ME!" The idea of outlawing the substance would never occur to them because the benefits are so overwhelming - and because the non-materialist knows the real costs of prohibition: the erosion of democratic freedoms, the endless deaths of minorities and foreigners, and the censorship of academia ¹⁵. All of these are factors that the FDA NEVER TAKES INTO ACCOUNT!¹⁶

The FDA no doubt has a crucial role to play in approving physical medicine, but when they opine on psychoactive medicine, they are always implicitly telling us what we should value in life. When they nix MDMA, they are telling us that 100% safety is better than peace, love and understanding - and that is a conclusion that should be hotly debated openly by humanists and philosophers - not decided implicitly by the rulings of a few FDA bureaucrats.

But convincing the FDA that a drug like MDMA is valuable is like trying to convince Dr. Spock of Star Trek that classical music is beautiful.

Captain Kirk:"Mahler's Second is a spiritual masterpiece, Spock."

Spock replies: "So you say, Captain, but you have not yet proven this to me."

At this point, the Captain says: "Spock, if you don't get it, you just don't get it."

And that's where we stand when it comes to the approval of entheogenic drugs today: the FDA just doesn't get it! As a shamanic medicine, drugs like psilocybin are to be judged not by their chemical structure but by their obvious results in the real world, and not just their effect on treating one single board-certified condition listed in the DSM but by their holistic effects in improving a user's life in general and the life of the community in which he or she lives. This is the shamanic vision, and it's the opposite of the reductive materialist approach to which the FDA slavishly adheres. And shamanic medicines should be judged on their own terms.¹⁷

cop car image courtesy ReiRever via tenor.com

cop car image courtesy ReiRever via tenor.com

Pull over to the side of the website!

Stop!

I guess you're wondering why I pulled you over. It seems you were trying to exit without first reading this related essay. But I'll let you go with a warning this time. By the way, you got any drugs in there? No? You sure?

Author's Follow-up: August 12, 2024

picture of clock metaphorically suggesting a follow-up

The surgeries and drugs that the FDA approves for psychiatric purposes all have something in common: they work by causing the depressed or anxious person to experience life less directly, less fully. Their aim is to make a good consumer, not a unique and self-actualized individual.

If MAPS ¹⁸ wants to make progress with MDMA they should start "calling out" the FDA for judging holistic medicines by materialist standards, which means ignoring all glaringly obvious benefits.¹⁹

Open Letter to Nicolas Langlitz

faculty member of The New School University, in response to his claim that there is "a very small place for psychedelics in philosophy."²⁰

I would argue that there is a huge place for psychedelics and entheogens in philosophy. These drugs remain outlawed because the FDA holds them to the standards of reductive materialism ²¹ when it comes to proving efficacy. This means, in practice, that the FDA ignores all glaringly obvious drug benefits and asks the metaphysical question, "Yes, but does it REALLY work," meaning does it work in a biochemical way that we can identify under a microscope. This is unfair. This is using materialism to normalize the disdainful views of Cortes and Pizarro with respect to holistic native medicines.

Also, almost every philosopher ignores "drugs" in general today and what they have to tell us about the elasticity of human behavior and human consciousness. This gives materialism a big boost in academia because no one dares to point out that, "Hey, wait a minute, MDMA brought peace and love to the dance floors in 1990s Britain. Why does it get no credit for that? Are there really no ways we can use opium ²² wisely, a drug that was considered a panacea by ancient doctors like Galen, Paracelsus and Avicenna? Is cocaine ²³ ²⁴ wrong even when the alternative to using it to cheer a patient up is shock therapy, i.e., knowingly damaging the human brain?" and endless questions of this kind that everyone's too afraid to ask in the age of the Drug War, or have become so used to prohibition and/or materialist assumptions that they no longer even think of asking them.

You've got to remember that these drugs are considered unsafe by an FDA that encourages Electroshock therapy. They have stood by while 1 in 4 American women became dependent for life on Big Pharma meds. And they allow ads for "meds" on TV in which death itself is listed as one potential side effect!

So there is plenty of grist for the mill for philosophers on the subject of psychedelics, and "drugs" in general: starting with, Is it not unfair to judge holistic drugs by materialist standards, when those standards dogmatically ignore all the obvious benefits of the drugs in question?

Also, I am the only philosopher I know who has complained about the ongoing attempts to criminalize laughing gas ²⁵ in the US and the UK, the substance whose use shaped William James' philosophy of reality. So in my view, the current disinterest in drugs in philosophic circles is self-interested and has nothing to do with a scarcity of topics upon which to opine. Plenty of books are written on all sorts of nonfiction subjects today that reckon without the Drug War, as for instance when they tell us that depression is an intractable problem, a claim that can only be made glibly like that by pretending that entheogenic indigenous medicines do not exist. The Drug War is also all about ignoring simple psychological common sense, which tells us the politically incorrect truth that any drug that inspires and elates can serve as an antidepressant -- unless we are using materialist standards that discount anecdote and history and insist on biochemical proof of efficacy. The materialist viewpoint also tells us that a drug must be studied for its ability to treat one specific illness rather than the entire person as shamanic holism maintains. In short, our drug approval system and the Drug War rest on western assumptions that have received very little critical scrutiny from philosophers, at least in the mainstream press.

If philosophers are onto these angles, I have yet to notice it. I do not know anyone who is making the connection between reductive materialism and the Drug War. So there are plenty of topics on which philosophers can dilate, if so many of them were not afraid to do so.

And since no one knows the true ontological status of the visions in altered states, or can say for certain what they are or are not telling us about the interconnectedness of nature and the potential omnipresence of consciousness, I would argue that philosophy has a wide field to study here, and that is, in fact, what William James himself told us in "The Varieties of Religious Experience" when he wrote:

"No account of the universe in its totality can be final which leaves these other forms of consciousness quite disregarded."²⁶

It's chic these days to dismiss the flower children of the '60s, but before we diss their philosophy of life, we should be honest about the philosophy that they were opposing, namely the attitude of militarism and distrust of "the other." The US was almost destroyed by nuclear weapons twice in the early '60s because of this aggressive status quo -- a fact that we should bear in mind before we yield to the temptation of condemning entheogenic drug use. Was Timothy Leary ²⁷ ²⁸ ²⁹ really the crazy one when he insisted that we all have a right to Mother Nature's bounty? Or was he not rather up against a corrupt system, determined to make him look like a lunatic? There is a whole world of topics like these on which most philosophers remain silent today for fear of vocational repercussions.

Author's Follow-up: August 15, 2024

The following is my email to Katie MacBride. She is writing articles for every magazine you can think of, pointing to the mote in the eye of enemies of the Drug War -- but failing to find the beam in the eye of the FDA and the government in general, which is constantly ignoring all obvious benefits of the drugs that they prefer to demonize instead.

Hi, Katie.

The FDA is so hugely biased that nobody notices it. They completely ignore the positive effects of MDMA. It brought peace and love to the dance floors in Britain and created their own Summer of Love. Then the Brits cracked down on the drug and alcohol was used instead. The result? Concert organizers had to use special forces police to keep the peace ³⁰.

The FDA approves shock therapy. They approve drugs that list the side effect of "death." And yet they do not approve a drug that could help stop school shootings and bring world peace.

Why not? Because they are hugely biased against any effects that are merely obvious. Why? Because as materialists, they think that all proof must be found under a microscope -- and, of course, they need to toe the line with the Drug War ³¹. This gives them an excuse for deep-sixing godsend meds without appearing to kowtow to Big Pharma -- but it is indirect kowtowing for all that.

And isn't it obvious, Katie, that there is huge pushback against a pill that would render much of Big Pharma 's pharmacopoeia irrelevant? Even if Big Pharma ³² ³³ is not at fault THIS time, this delay tactic has been going on for 45 damn years, leaving PTSD sufferers and folks like me in the lurch. Again why? Because we are not stakeholders, the depressed and the anxious. The stakeholders are Drug Warriors and the pharmaceutical companies and the whole government which is constantly trying to convince us that drugs are bad. It's Christian Science propaganda ³⁴.

Also, psychedelic hype is hurting no one as much as the outlawing of Mother Nature is. I had to pay $4000 to profit from a mushroom. It's insane.

With respect, Katie, the articles alluded to above are focused on TRIFLES compared to the huge injustice of the Drug War -- and the enormous bias of the FDA, which is so enormous that it is apparently invisible to most people.

Open Letters

Notes for essay entitled Why the FDA is not qualified to judge psychoactive medicine:

1: The FDA on ECT: Supporting a Vital Treatment Charles, Kellner MD, 2019 (up)
2: RINVOQ RX List (up)
3: Hall, Wayne, and Megan Weier. 2016. “Lee Robins’ Studies of Heroin Use among US Vietnam Veterans.” Addiction 112 (1): 176–80. https://doi.org/10.1111/add.13584. (up)
4: Richard Louis Miller. 2017. Psychedelic Medicine : The Healing Powers of LSD, MDMA, Psilocybin, and Ayahuasca. Rochester, Vermont: Park Street Press. (up)
5: Andean cosmovision of the Kallawaya UNESCO (up)
6: There is nothing to debate: the drug war is wrong, root and branch DWP (up)
7: Speaking Truth to Academia DWP (up)
8: Nietzsche and the Drug War DWP (up)
9: Partnership for a Death Free America DWP (up)
10: Scribd.com: The Fire Next Door: Mexico's Drug Violence and the Danger to America Carpenter, Ted Galen, Cato Institute, Washington, DC, 2012 (up)
11: Twenty-four hours of terror as cartel violence engulfs Mexican city The Guardian, 2023 (up)
12: The Racist Drug War killed George Floyd DWP (up)
13: The Problem is Prohibition, not Fentanyl DWP (up)
14: Why DARE should stop telling kids to say no DWP (up)
15: Coverup on Campus DWP (up)
16: The Mother of all Western Biases DWP (up)
17: The Andean cosmovision as a philosophical foundation of the rights of nature Suran, Ilona , Notre Affaire a Tous, 2021 (up)
18: Three Problems With Rick Doblin's MAPS DWP (up)
19: MAPS: Multidisciplinary Association for Psychedelic Studies (up)
20: Is There a Place for Psychedelics in Philosophy? Langlitz, Nicolas, 2016 (up)
21: How materialists lend a veneer of science to the lies of the drug warriors DWP (up)
22: The Truth About Opium by William H. Brereton DWP (up)
23: Sigmund Freud's real breakthrough was not psychoanalysis DWP (up)
24: “Freud on Cocaine : Freud, Sigmund, 1856-1939 : Free Download, Borrow, and Streaming : Internet Archive.” 2023. Internet Archive. 2023. https://archive.org/details/freudoncocaine0000freu/page/n5/mode/2up?view=theater. (up)
25: Forbes Magazine's Laughable Article about Nitrous Oxide DWP (up)
26: James, William. 2016. The Varieties of Religious Experience. Goodreads. https://www.goodreads.com/book/show/28820.The_Varieties_of_Religious_Experience. (up)
27: “Full Text of ‘the Politics of Ecstasy.’” 2026. Archive.org. 2026. https://archive.org/stream/ecstaspoliticsof00learrich/ecstaspoliticsof00learrich_djvu.txt. (up)
28: The One Thing that Timothy Leary Got Wrong: a philosophical review of The Politics of Ecstasy DWP (up)
29: Timothy Leary was Right DWP (up)
30: How the Drug War killed Leah Betts DWP (up)
31: Materialism and the Drug War Part II DWP (up)
32: Seife, Charles. 2012. “Is Drug Research Trustworthy?” Scientific American 307 (6): 56–63. https://doi.org/10.1038/scientificamerican1212-56. (up)
33: LaMattina, John. n.d. “Why Is Biopharma Paying 75% of the FDA’s Drug Division Budget?” Forbes. https://www.forbes.com/sites/johnlamattina/2022/09/22/why-is-biopharma-paying-75-of-the-fdas-drug-division-budget/. (up)
34: America's Imperialist Christian Science War on Drugs DWP (up)

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Richard Evans Schultes seems to have originated the harebrained idea (since used by the US Supreme Court to suppress new religions) that you have no right to use drugs in a religious ritual if you did not grow up in a society that had such practices. What tyrannical idiocy!

"In consciousness dwells the wondrous, with it man attains the realm beyond the material, and the peyote tells us where to find it." --Antonin Arnaud

It's funny to hear fans of sacred plants indignantly insisting that their meds are not "drugs." They're right in a way, but actually NO substances are "drugs." Calling substances "drugs" is like referring to striking workers as "scabs." It's biased terminology.

In "Psychedelic Refugee," Rosemary Leary writes: "Fueled by small doses of LSD, almost everything was amusing or weird." -- Rosemary Leary In a non-brainwashed world, such testimony would suggest obvious ways to help the depressed.

Rick Strassman reportedly stopped his DMT trials because some folks had bad experiences at high doses. That is like giving up on aspirin because high doses of NSAIDs can kill.

Immanuel Kant wrote that scientists are scornful about metaphysics yet they rely on it themselves without realizing it. This is a case in point, for the idea that euphoria and visions are unhelpful in life is a metaphysical viewpoint, not a scientific one.

Now the US is bashing the Honduran president for working with "drug cartels." Why don't we just be honest and say why we're REALLY upset with the guy? Drugs is just the excuse, as always, now what's the real reason? Stop using the drug war to disguise American foreign policy.

The government makes psychoactive drug approval as slow as possible by insisting that drugs be studied in relation to one single board-certified "illness." But the main benefits of such drugs are holistic in nature. Science should butt out if it can't recognize that fact.

I knew all along that Measure 110 in Oregon was going to be blamed for the problems that the drug war causes. Drug warriors never take responsibility, despite all the blood that they have on their hands.

Folks point to the seemingly endless drugs that can be synthesized today and say it's a reason for prohibition. To the contrary, it's the reason why prohibition is madness. It results in an endless game of militaristic whack-a-mole at the expense of democratic freedoms.

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Why the FDA is not qualified to judge psychoactive medicine

Author's Follow-up: August 12, 2024

Open Letter to Nicolas Langlitz

Author's Follow-up: August 15, 2024

Open Letters

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Diary of a Drug Fiend