The government sure loves running smear campaigns when it wants its people to believe a certain way, which sometimes seems to be to promote the sale of one product or service over another. These campaigns run rampant in the cannabis and psychedelics industries where Big Pharma is scrambling to gain control from black or gray markets. In just another showing of this, the government released yet another fear tactic smear campaign because it only wants patients to use its ketamine. Take a look.
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The government approved one kind of ketamine, called esketamine, and it only wants you to use that one! Problem is, there’s a big wide gray market for ketamine that seems way more inviting, and comes with less restrictions. Why does the government care so much then, when both seem perfectly safe? We cover everything important in the emerging psychedelics industry, and work hard to bring you the best stories out there. Subscribe to The Psychedelics Weekly Newsletter to keep up with everything going on. And make sure you’re up-to-snuff on all the important psychedelics talking points of today.
What is ketamine?
Ketamine has been very much in the spotlight recently, with a strange push-and-pull now going on between the legal market and the gray market. Ketamine (C13H16ClNO) is a dissociative psychedelic that sits in Schedule III of the Controlled Substances list because of its approval as an anesthetic. This makes it different then nearly every other psychedelic compound, which are Schedule I, meaning the federal government decided they are dangerous and with no medical value.
Ketamine was formulated by scientists at Parke-Davis pharmaceutical company in 1962, for use as a strong anesthetic. It is said to have cataleptic, analgesic, and sedative properties, but not hypnotic properties. It is considered dissociative because it can make users feel that different parts of their brains are disassociating from each other. It was written as “electrophysiological and functional dissociation between thalamocortical and limbic systems.”
It was approved for use as an anesthetic in 1970. But it was never approved for anything else, and this despite prisoner studies from the 1960’s showing that not only did ketamine have effects on psychological issues (which were not completely flushed out at the time, but which were later more elucidated), but that it was also a good treatment for pain issues. It became a staple recreational drug in the 1980’s club scene.
Since ketamine is Schedule III, and therefore legal, it can be prescribed by any doctor for off-label use. This refers to using it for something that’s not what it’s approved for, but which can be legally done if the doctor feels that the drug can still be useful for a patient. This is cleared by the FDA, so there’s nothing illegal about the practice, and the practice has led to a large and quickly growing ketamine gray market, where the drug is offered in clinics to help with psychological issues, and pain.
Though ketamine must be prescribed by a doctor, it has no regulation attached for its uses for pain and psychological disorders outside of major depression, meaning there is no added tax structure by the federal or local governments. This is because if a drug isn’t approved for what its being used for, it can’t have a tax regulation structure set for it. To give an idea how the government must feel about that, consider how many taxes are levied on the legal cannabis industry, often to the point of raising prices so far above black market prices, that legal markets, though they can bring in money, realistically have not shown the ability to fully compete.
And then came esketamine
Usually when a new drug is up for approval, especially when that drug comes from a controversial class of drugs like psychedelics or cannabis, it generally is the subject of intense debate. All conversations related to different states legalizing either of these drug classes, are riddled with debaters trying to prove points on both sides.
So it’s a little shocking that in 2019, the US federal government legalized a psychedelic medication, without any conversation, or public knowledge of it at all. Under cover of night decisions and legislation are usually a tactic to get something through expressly without the public knowing, for fear of negative opinions causing issues.
Esketamine shares the same chemical formula, but was discovered much more recently in 1997. It was discovered by German scientists, who were in the search for a better anesthesia, and this was its initial purpose as well. While it was being used in this way, it was noticed that it provides strong anti-depressant effects. It was released in the US on March 5th, 2019 as the Johnson & Johnson drug Spravato. Whereas regular ketamine is generally given by IV, Spravato has only been cleared as a nasal spray.
But the government didn’t approve the ketamine being used in the gray market, it legalized a nearly identical, but mildly different version, called ‘S-enantiomer’ ketamine. The kind being used in the gray market, is ‘racemic’ ketamine. In general, “Ketamine is a racemic mixture containing 2 mirror image molecules, R- and S-ketamine.”
A racemic mixture is a compound that has “equal quantities of two enantiomers, or substances that have dissymmetric molecular structures that are mirror images of one another.” Enantiomers are a “pair of objects related to each other as the right hand is to the left—that is, as mirror images that cannot be reoriented so as to appear identical.”
This means that ‘racemic ketamine’ is ketamine with both enantiomers, and ‘S-enantiomer ketamine’ (approved as esketamine) is only the S-enantiomer of ketamine. How much difference is there? Well, in one study from 2009 called Comparison of racemic ketamine and S-ketamine in treatment-resistant major depression: report of two cases, it was found that S-ketamine use was “reported to be less prone to psychomimetic side effects, such as derealisation and hallucinations.” The conclusion was that “S-ketamine might exert similar antidepressant effects as ketamine in drug-resistant depression but may be better tolerated by the patients.” It should be remembered that psychedelic therapy tends to rely on some of the effects mentioned. No one complains that psilocybin causes hallucinations in therapy.
Another one from 2021, Compounded intranasal racemic ketamine for major depressive disorder: A case report, which is a case study of one patient, found that racemic ketamine treatment of a patient with major depression was successful after three doses. As per study investigators “Intranasal ketamine was not associated with significant adverse drug effects and facilitated a relatively short hospital admission. The case report provides support for the use of intranasal racemic ketamine as adjunctive treatment for MDD.”
Why the debate?
The ketamine loophole has allowed for a very large gray market to grow in the US, and which is spreading around the world. Back in 2015 there were about 60 operational clinics giving ketamine therapy in the US. By 2018, that number was up to about 300. With the boom in psychedelics felt all around, that number has surely increased greatly, and this can be seen by simply pulling up an app like Google Maps, going to a location, and looking for ketamine clinics. You might be surprised by how many there are. Most are independent locations, while some like Delic and Field Trip Health run chains with multiple locations across the US and beyond.
Obviously, the US government doesn’t want an industry it can’t control, and as Big Pharma pumps tons of money into the government, it suffices to say that the government will do its bidding. Except that it seems to have messed up with esketamine. Or maybe it wasn’t a mess-up at all. Esketamine prescriptions require use of a standard anti-depressant, which is a major detraction for those who do not want them. And more importantly, despite being well-researched for its ability to help with pain without causing an addiction, it was never cleared for this. Even though the opioid death rate increases every year.
Since esketamine has not seemed to make much chink in the ketamine market, the government has resorted to what it does best: smear campaigns. And this time, its geared toward compounded ketamine nasal sprays, which are in competition with the government-cleared esketamine nasal spray. A compounded drug is a drug formulation made specially for an individual patient, so in this case, it would be a ketamine formulation that involves something else as well, but which is based on racemic ketamine.
In a February 17th, 2022 fear article called FDA: Safety Concerns With Compounded Ketamine Nasal Spray, its states that “In animal studies, the use of racemic ketamine has been shown to cause brain lesions in rodents, whereas this association was not observed with esketamine.” Except this doesn’t get mentioned much, not even in this 2016 review called Ketamine enantiomers in the rapid and sustained antidepressant effects, which sources from tons of research out on ketamine. In fact, of R-ketamine, it concludes, “R ketamine appears to be a potent and safe antidepressant relative to S ketamine.”
The FDA points out that: “In recent years, the FDA has received a number of reports of pharmacies compounding nasal spray formulations of ketamine either alone or in combination other ingredients.” If a patient is given ketamine, its by a doctor’s prescription and guidelines. Most ketamine therapy does take place in clinics, but this doesn’t mean a pharmacy can’t fill a valid doctor’s prescription. If this was illegal, the FDA wouldn’t complain about it, it would shut pharmacies down. Since it can’t, it’s trying to make them sound dangerous. Compounded medications may not be FDA-approved, but neither is ketamine for pain, and that doesn’t mean using it that way is illegal, because its not. And it also doesn’t seem to be dangerous.
And then the article continued with this fear tactic: “A search of the FDA Adverse Event Reporting System (FAERS) database and the medical literature revealed 5 cases that were associated with psychiatric events, as well as abuse and misuse between 2016 and 2021.” Five whole cases? Which didn’t end in death, and realistically might have been cleared up within a short period of time? And over five whole years? Kind of makes it sound pretty safe. In fact, with all those clinics in operation, and no stories of issues whatsoever besides this one, it kind of seems like this is the government trying to scare users into only using the legally approved and government taxed version of ketamine.
How this mirrors Quaaludes
Weirdly, the ketamine industry of today mirrors the Quaaludes industry of the 60’s and 70’s. Use of Quaaludes (or methaqualone) was so widespread, that in 1981 the DEA claimed that Quaaludes were second only to cannabis in popularity, and that 90% of production was exclusively for the black market. In 1980, the government announced there were more than 20 million Quaaludes on the street and that that number would likely double in a year. It was even being prescribed in ‘stress clinics’ whereby patients didn’t need to go to a primary care physician, much like the ketamine clinics of today.
So what happened? A bunch of smear campaigns about the danger of the drug that comically included complaints of about 117 deaths in a year (1980) from legally prescribed Quaaludes, which when compared to 70,000+ deaths a year from opioid overdoses, really puts the safety of Quaaludes in perspective. A statistic from Dade Country Florida backs this up (there are very few death statistics out there for Quaaludes), where it was reported there were 246 methaqualone deaths in an 11-year period from start of 1971 to the close of 1981. Considering that same county had 300 overdose deaths in 2019 alone, it speaks volumes to the actual safety of Quaaludes.
So the drug worked well, and for a sedative, had a pretty low death rate (so long as you don’t buy the government hype). But it was also nearly only existent on the black market, meaning no profit for government or Big Pharma. So the US went around the world and shut down almost all production of it, which essentially eradicated it entirely. It still exists in black markets in India (where it was made), and Africa (where it was first used as an anti-malaria medication), but is absent from the streets of America. Methaqualone was replaced by benzodiazepines which boast a higher kill rate, but which don’t exist so widely in a black or gray market. So, maybe it makes sense that the government is trying so hard to dissuade people from the ketamine gray market, which way overshadows the legal one. It would be harder these days to shut down production of ketamine all around the world.
It’s not my job to tell you if you should be hesitant to use a compounded ketamine nasal spray, racemic ketamine, or the government sanctioned version. But one thing is for sure, if you don’t want to take an antidepressant with your ketamine treatments, or want them for pain, you only have the choice of the gray market anyway. With no statistics showing a real concern – let alone a grave enough one for warnings from the FDA, it seems this is just another tactic of the US government to get you to take their drug, over the one you can also legally get in a ketamine clinic, but which the government doesn’t make extra money from.
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