when it comes to approving psychoactive substances
by Ballard Quass, the Drug War Philosopher
August 10, 2024
received a bulk email last night from Rick Doblin announcing that the FDA had raised technical objections to the approval of MDMA. The email confused me at first because the first paragraph did not make it clear whether this new development represented a huge problem for MDMA approval or whether it was just a bump in the road, something that MAPS and company were expecting all along and which was no real threat to the ultimate re-legalization of the substance. I kept reading, trying to determine whether Rick's message was good news, bad news or even indifferent news. Not until I came to the first sentence of paragraph seven did the answer become clear to me:
"While we are devastated to see the FDA's response, today's news shows us just how urgent our work is."
After reading that belated clarification, I cursed myself for having opened the email so late at night, because now I had to attempt to go to sleep while stewing over the idiocy of the FDA and the scam they call the drug approval process for psychoactive medicines.
If MAPS did not make a habit of studiously ignoring my comments12345, I would have called them up and shouted: "I told you so!" For I have written many essays over the last five years explaining why materialist science should have no role in approving psychoactive drugs. Their one and only relevant job as materialists is to highlight potential downsides to use of any given psychoactive substance. That's it. The real experts about use are people like philosophers, counselors, and artists: intelligent people who are personally familiar with the effect of the drugs in question and with a personal knowledge of the ways in which the substance may be used most safely and most powerfully for a variety of profound purposes, including but not limited to an increase in music appreciation, religiosity and creativity in general.
Instead, the FDA studies drugs outside of all context, failing to realize that the net effect of holistic drug use crucially depends on that context. They may say, for instance, that drug A causes downside B when studied outside of all context. This may be true. But what they do not tell you is that, when used in the proper context, drug A also causes upsides C and D, which either negate downside B entirely or make it a risk that's well worth taking from the user's point of view.
Here's another trick that the FDA uses to make their glacial approval process seem plausible to the average television-watching American. They imply that legalization will cause a sudden vast interest in and use of the drug in question, much of it irresponsible (as if MDMA is not being used as we speak, and in a dangerous way too, precisely because the FDA refuses to teach safe use and regulate the drug to prevent product contamination and overdose). But let us suppose for a moment that legalization would result in misuse. The question is, WHY is this so?
It is so because of PROHIBITION itself, which refuses to teach safe use. And it is prohibition which has outlawed almost all means of pharmacological mental improvement, and in such an unprecedentedly deprived world, folks will always be on the lookout for some legal means of feeling at peace with the world and with themselves. And whenever a new drug becomes available for this purpose, they will grab it just like a drowning swimmer will grab a lifesaver's buoy. And so fearmongers like Kevin Sabet will point to the widespread use of marijuana and cry out for more prohibition, failing to realize that the Drug War naturally leads to the use of whatever drugs finally slip through the sieve of the prohibitionist.6 If it's only marijuana, then please do not whine about the prevalence of marijuana use.
The prohibitionist's response, of course, is to "crack down" ever further, supposedly in the interests of our poor little young people: the same young people who are dying today by the tens of thousands because we refuse to teach safe use or to provide them with regulated product with regulated doses such that overdosing will not occur.
Besides, we know what your prohibition results in, Kevin, the proof is extant: the abolishment of the fourth amendment to the Constitution, the mass incarceration of minorities, and the seizure of entire multi-million-dollar properties based on the fact that a trace of psychoactive substances was found somewhere on the premises. Was not Thomas Jefferson rolling in his grave when the DEA stomped onto Monticello in 1987 and confiscated his poppy plants in violation of the natural law upon which he had founded America7?
The FDA operates via the Drug War criterion that a drug that is not 100% safe must not be used by anyone, anywhere, ever. That is as anti-scientific as it gets - and hypocritical beyond words, given the fact that this same organization continues to greenlight the purposeful damaging of the brain (i.e. ECT) as a valid therapy. Nor are they criticizing aspirin, which causes thousands of deaths every year8. And somebody needs to "call" the FDA on this mad bias of theirs. Yet by working within the system, MAPS is tacitly agreeing that this criterion makes sense. By working with materialists, MAPS is also playing along with the insane idea that a psychoactive drug has to be approved in bits and pieces, only for one specific board-certified "disease" at a time. And we wonder why psychoactive drug approval is so slow!
Here's the first step in the FDA process for evaluating a psychoactive drug:
1) Ignore all glaringly obvious benefits
Today's reductive materialism is all about ignoring common sense: for everyone knows that a drug that inspires people will work for far, far more than just PTSD. Besides, everyone has PTSD to some extent (or at least PTSD Lite) merely because they're human beings, since psychological problems often result (in whole or in part) from forgotten experiences and unexamined assumptions. Yet MAPS joins the FDA in pretending that their study findings for MDMA are relevant only to a narrow slice of patients who happen to fit a specific category agreed upon by insurance companies. This is not science: it is self-interested dissection of wholeness in the interest of corporations who are determined to make as much money out of treating human suffering as possible - and you cannot do that if one drug works for everybody, especially when said drug is so effective that it might render a whole swath of currently popular commercial medicines unnecessary. This go-slow approach also keeps the DEA relevant by letting them continue to crack down even on users of approved drugs, provided that these users have not been officially recognized as suffering from the narrowly defined conditions for legal use as specified by the FDA and the DSM.
Thus the FDA reins in psychoactive drugs by approving them only for specific uses and in specific cases. Only then can Big Liquor and Big Pharma heave a metaphorical sigh of relief.
I seldom delve into the details of the FDA's objections to psychoactive drugs because I deny their right to outlaw these substances in the first place. Besides, I know that their objections will be made out of context and that they will ignore any and all perfectly obvious benefits of the drugs in question. But in glimpsing the latest objections to MDMA approval, the FDA seems to be complaining about an inadequate study size by Lykos, the name of the MAPS organization working with the FDA. An inadequate study size? MDMA/Ecstasy has been used by hundreds of millions of young people over the last 50 years, and what was the result? Unprecedented peace, love and understanding. That was something that American capitalism could never forgive MDMA for9.
As noted above, the FDA has no expertise in approving psychoactive medicine. Such medicines only make sense from a holistic point of view. When you insist that the alleged curative powers show up for a board-certified condition under a microscope you are rejecting the holistic understanding of how illnesses work, and so your conclusions about the drugs in question are biased from the start.
Finally, the determination of safety is always based on a cost/benefit analysis. But the FDA does this analysis without considering many profound benefits.
The use of MDMA could help bring about world peace because the drug inspires compassion. Does the FDA believe that world peace is less important than 100% safety?
The use of MDMA could help prevent school shootings when used as therapy for hotheads. Does the FDA believe that ending school shootings is less important than 100% safety?
The use of MDMA could help prevent people from committing suicide? Does the FDA believe that preventing suicide is less important than 100% safety?
Here's where the materialists will say, "Yes, but MDMA has not been proven to prevent suicide and so forth."
Well, listen, the heart has its own reasons, as Pascal says. It is just common sense that a drug which increases compassion and provides temporary ecstasy could do these things under proper conditions. Whether humanity will ever be clever enough to use such drugs in this way may be uncertain, but don't expect me to ignore common sense just because materialists only except proof that can be quantified and viewed under a microscope. That reductionist preference is the whole problem. Why? Because entheogens like MDMA and psilocybin "work" according to an holistic understanding of that term. They produce obvious positive results, not just in one patient or for one "illness," but for the patient as a whole and for the community at large. To require that such substances be shown to work biochemically, under a microscope, is to impose western criteria on non-western treatments, which is just a kind of scientific colonialism. But these requirements are maintained for obvious reasons, namely, to keep these substances as illegal as possible for as long as possible. And everyone knows who benefits from that. Hint: it's not the depressed who will kill themselves because drug laws prevent them from legally experiencing drugs like psilocybin that tribal peoples have been using for millennia.
Irritating Journalism
When I googled "MDMA and the FDA" this morning, the first "hit" I encountered was an article by Sigal Samuel entitled "The biggest unknown in psychedelic therapy is not the psychedelics," recently published on the Vox website10. Although I was writing the above essay at the time, I had to stop what I was doing and write the following full-blown response to Sigal because just like the FDA, she ignores so many important considerations on this topic!
With respect, the FDA is completely biased in studying MDMA.
They say there is too little data -- but the drug has been used for half a century by hundreds of millions of young people. There is no big epidemic of liver failure today.
Also, the FDA completely ignores the benefits of the drug:
Its use brought UNPRECEDENTED peace, love and understanding to the dance floors of Britain in the 1990s -- until the Brits cracked down on the drug, and what was the result? Dancers started using alcohol and the dance floors became a battleground. Concert organizers had to hire special forces troops to keep the peace. Special forces!11 (No one was screaming for the outlawing of liquor, either.)
MDMA also inspires compassion. If Americans were not brainwashed to hate drugs, they would realize that MDMA could be a wonderful tool in preventing school shootings -- by letting hotheads experience what compassion is all about!
MDMA could also prevent suicides by giving someone a mental break -- without which they would give up on life.
But the FDA does not consider any of these benefits - nor any of the other benefits that will surely arise when human creativity is allowed to imagine new protocols for such godsend meds.
Moreover, they assume that criminalization will keep people safe. That is nonsense. Criminalization does not end drug use. Criminalization leads to drug gangs, it leads to adulterated product, it leads to ignorance about safe use. It leads to "no-go" zones in inner cities, which have become so prevalent these days that we take them for granted. We have seen this pattern for over 100 years now, for God's sake.
Plus, the outlawing of drugs like MDMA is based on a very anti-scientific principle: the idea that a drug that has one bad use at one set of dosages must not be used by anybody, anywhere, at any dose, for anything12. And because of America's influence in the world, we are actually outlawing drugs worldwide! This is the mad enforcement of a kind of Christian Science Sharia: harsh punishment for anyone who tries to improve their mental state without government approval.
Every activity has risks. (Free climbing is ridiculously risky, but it is perfectly legal. Why? Because we value freedom, except when it comes to drugs.)
But it is anti-scientific and unfair to judge a substance based only on those risks. We have to do a cost-benefit analysis.
Let's assume that MDMA (like alcohol) causes a risk to the liver for a certain percentage of users.
That's not the end of the story! We have to ask, how does that risk compare to the potential benefits of the drug for a specific person.
If a guy's about to jump off a roof because he has nothing to look forward to and always feels like crap, we should give him something like MDMA to teach him that there are other ways to see the world. But the Drug War makes us callously deny the guy anything that could help.
The FDA gets away with this because the chronically depressed people who sit at home alone and mope are NOT stakeholders in the approval process. Only Big Pharma, Big Liquor, and brainwashed Americans who have been taught to fear drugs rather than to understand them.
This same FDA greenlights the use of ECT SHOCK THERAPY—a procedure that knowingly damages the human brain13!!! And yet they have the nerve to tell us that MDMA is too dangerous and that it has no positive uses, for anybody, anywhere, ever? That's what they're saying, because their decision on MDMA is respected and enforced worldwide.
That's why chronic depressives like myself have been without godsends for a lifetime - because materialist science cannot wrap its mind around holistic cures, the same kinds of cures that Francisco Pizarro sought to root out in South America, for the Drug War is just the continuation of the western Christian disdain for holistic healing.
And let's not be naïve: there is huge money out there working behind the scenes to make us dislike MDMA: Big Liquor, Big Pharma and the DEA.
Finally, look: the world is on the brink of a nuclear Armageddon. Everyone knows it. It is madness that the number-one villains these days in the public mind are precisely those drugs which inspire peace, love and understanding.
Let the FDA come for psilocybin next: let them explain why they should be allowed to outlaw a substance that has been used religiously for millennia. The fact is, they have no right and no expertise in such topics.
The FDA wants to evaluate psychoactive substances in the same way that they evaluate aspirin - or rather, they want to study psychoactive substances more harshly, for aspirin causes thousands of deaths a year and the FDA is not issuing press releases denouncing the drug,
But the FDA has no expertise when it comes to psychoactive drugs: that's what holistic medicine tells us. In indigenous societies, you do not examine such drugs reductively but rather look at their results, in context, for real people, over time.
So for these reasons and many more, the FDA should butt out of the process of approving psychoactive drugs. Their only relevant role is to point out the generic risks that one might be taking with any particular drug. In other words, their role is education, but the Drug Warriors do not want to educate about safe use. On the contrary, they want to make safe use impossible by outlawing drugs and so make it difficult to find uncontaminated product at a known dosage. This insanity has resulted in tens of thousands of unnecessary deaths of young people in America, and continues to kill, as Drug Warriors double down in the greatest case of mass denial in human history. Now they simply blame all the downsides of prohibition on drugs themselves.
As someone who has been denied godsends for a lifetime now, I urge you to consider the FDA's latest actions in the context of the above concerns.
Sincerely,
abolishthedea.com
PS America is too brainwashed about drugs to evaluate these things rationally. Let's assume that MDMA was legalized and the next day there was a car accident that involved a driver "on" MDMA. Americans would consider that as a knock-down argument for criminalization. But that is so wrong. That is a conclusion we would never jump to in any other catastrophe. Should we have outlawed horses after Christopher Reeves had his accident? Should we outlaw cars after seeing a grisly crash on the highway? Should we outlaw rock climbing after seeing someone's dearly beloved son bleed out at the foot of Big Sur?14
We should treat the MDMA incident like anything else: as a call for education and a clear understanding of safety standards. We might also rationally respond with a crackdown on DUI offenses. But we should not crack down on MDMA itself - because in doing so we are making the drug unusable for a wide array of positive reasons - including avoiding shock therapy and preventing suicides.
The FDA materialists will say that MDMA has not been "proven" to do all these good things, but come on! It is common sense. A drug that helps build compassion and understanding in the human heart (as has been proven by countless anecdotes and the history of violence-free raves, etc...) can be used in ways to promote positive outcomes. But materialism ignores common sense. That's why materialist Dr. Robert Glatter wrote an article in Forbes magazine in 2021 questioning whether laughing gas could help the depressed. Laughing gas!15 "Um, yeah, Doc." It could even keep people from killing themselves, if they could look forward to use. But that's just common sense. Materialists need to prove that laughing gas works by looking under a microscope and studying brain chemistry!
Spoiler alert: Materialists have never bothered to find out if laughing gas could help, and so it is being criminalized by the US and Britain: laughing gas, the very substance that William James used in researching the nature of religion and human consciousness.16 James told us that such psychoactive substances must be studied to see what their use might tell us about the nature of ultimate reality, but the Drug War is all about censorship and will not allow such studies.17
When the FDA works to criminalize psychoactive substances, they are infringing on religious liberty, because many people believe in the primacy of peace, compassion and the inspirational power of higher states of consciousness. If the FDA wants to go after psilocybin next, let them understand that they're picking a war with religion. There are already churches that use psilocybin as a sacrament. But then the Drug War itself is a sort of negative religion: it is Christian Science on steroids, Christian Science being the drug-hating religion of Mary Baker Eddy.
It's telling that people now call MAPS a cult, as if it's somehow weird to work with medicines that elate and inspire. This would have come as news to indigenous people, but then that's what the materialistic Drug War is all about: normalizing the jaundiced views of Francisco Pizarro and company with respect to non-western healing practices.
Author's Follow-up: August 10, 2024
The Drug War is the cult!
Author's Follow-up: August 11, 2024
This absurd search for 100% safety for psychoactive drugs is a feature of the materialist outlook. I recently shared my ideas about psilocybin microdosing with the Surviving Antidepressants website18. Mistake. The moderator was unfamiliar with that practice or that drug (or even that kind of drug, namely, a psychedelic), but she did not stint in expressing an endless list of concerns. Just like the FDA, she refused to be impressed by the OBVIOUS prima facie value of my plan. The benefits of psilocybin read like a "wish list" for folks wishing to endure the withdrawal process for other drugs. Yet materialist orthodoxy tells us to get off the first drug completely unaided since the effects are easier to document and quantify -- in other words, it's easier for the doctors and researchers. And after all, how are our deterministic doctors going to pretend to a perfect knowledge of the world if we factor in too many messy variables?
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? Why the FDA is not qualified to judge psychoactive medicine
Scientists are not the experts on psychoactive medicines. The experts are painters and artists and spiritualists -- and anyone else who simply wants to be all they can be in life. Scientists understand nothing of such goals and aspirations.
Prohibitionists are also responsible for the 100,000-plus killed in the US-inspired Mexican drug war
ECT is like euthanasia. Neither make sense in the age of prohibition.
Just saw a People's magazine article with the headline: "JUSTICE FOR MATTHEW PERRY."
If there was true justice, their editorial staff would be in jail for promoting user ignorance and a contaminated drug supply.
It's the prohibition, stupid!!!
"When two men who have been in an aggressive mood toward each other take part in the ritual, one is able to say to the other, 'Come, let us drink, for there is something between us.' " re: the Mayan use of the balche drink in Encyc of Psych Plants, by Ratsch & Hofmann
Had we really wanted to "help" users, we would have used the endless godsends of Mother Nature and related synthetics to provide spirit-lifting alternatives to problem use. But no one wanted to treat users as normal humans. They wanted to pathologize and moralize their use.
The worst form of government is not communism, socialism or even unbridled capitalism. The worst form of government is a Christian Science Theocracy, in which the government controls how much you are allowed to think and feel in life.
Well, today's Oregon vote scuttles any ideas I might have entertained about retiring in Oregon.
Psychiatrists keep flipping the script. When it became clear that SSRIs caused dependence, instead of apologizing, they told us we need to keep taking our meds. Now they even claim that criticizing SSRIs is wrong. This is anti-intellectual madness.
"I can take this drug that inspires me and makes me compassionate and teaches me to love nature in its byzantine complexity, or I can take Prozac which makes me unable to cry at my parents' funeral. Hmm. Which shall it be?" Only a mad person in a mad world would choose SSRIs.
Buy the Drug War Comic Book by the Drug War Philosopher Brian Quass, featuring 150 hilarious op-ed pics about America's disgraceful war on Americans
You have been reading an article entitled, Why the FDA is a joke: when it comes to approving psychoactive substances, published on August 10, 2024 on AbolishTheDEA.com. For more information about America's disgraceful drug war, which is anti-patient, anti-minority, anti-scientific, anti-mother nature, imperialistic, the establishment of the Christian Science religion, a violation of the natural law upon which America was founded, and a childish and counterproductive way of looking at the world, one which causes all of the problems that it purports to solve, and then some, visit the drug war philosopher, at abolishTheDEA.com. (philosopher's bio; go to top of this page)
received a bulk email last night from Rick Doblin announcing that the FDA had raised technical objections to the approval of MDMA. The email confused me at first because the first paragraph did not make it clear whether this new development represented a huge problem for MDMA approval or whether it was just a bump in the road, something that MAPS and company were expecting all along and which was no real threat to the ultimate re-legalization of the substance. I kept reading, trying to determine whether Rick's message was good news, bad news or even indifferent news. Not until I came to the first sentence of paragraph seven did the answer become clear to me:
You have been reading an article entitled, Why the FDA is a joke: when it comes to approving psychoactive substances, published on August 10, 2024 on AbolishTheDEA.com. For more information about America's disgraceful drug war, which is anti-patient, anti-minority, anti-scientific, anti-mother nature, imperialistic, the establishment of the Christian Science religion, a violation of the natural law upon which America was founded, and a childish and counterproductive way of looking at the world, one which causes all of the problems that it purports to solve, and then some, visit the drug war philosopher, at abolishTheDEA.com. (philosopher's bio; go to top of this page)