Psychedelics are coming, that’s for sure, but some have already arrived! Not only has the government legalized esketamine for medical use, but there is an already existent ketamine industry for you to take advantage of. How is this possible? By accessing the ketamine loophole. Here’s more about it.
The ketamine loophole is growing everyday, and you can take advantage of it! Just find yourself a local ketamine clinic here, or search the internet for a clinic close to you. We’re dedicated to staying on top of this new industry, and providing you all the info necessary to get the help you need. For more articles on the growing industry of medical psychedelics, you can subscribe to the Psychedelics Weekly Newsletter, the #1 web source for everything important in this new and expanding market.
What is ketamine?
First and foremost, ketamine is a legal psychedelic drug in Schedule III of the DEA’s Controlled Substances list. This means it’s legal for medical use, and has been approved as an anesthetic by the US’s FDA. This legalization happened back in 1970. The compound was found by scientists at Parke-Davis pharmaceutical company in 1962, and fit the intended goal of a strong anesthetic. It’s described as having cataleptic and analgesic effects as well as anesthetic effects. It is noted to not have hypnotic properties, though it does cause sedation.
At the time ketamine was discovered, it took the place of PCP, which was already being tested for this purpose. Ultimately, after creating and testing PCP, it was thrown out, and ketamine was moved onto instead. Before being approved solely as an anesthetic (in both humans and animals), studies in the 1960’s involving prisoners found that ketamine was good at minimizing some of the more toxic behaviors of these inmates. Nevertheless, this was not factored into the approval.
Ketamine is a ‘dissociative anesthetic’ meaning it tends to make users feel like different parts of their brains are disassociating from each other. This was described as “electrophysiological and functional dissociation between thalamocortical and limbic systems.” Perhaps it’s this effect that has made it popular as a party drug, first becoming popular recreationally in the 1980’s club scene. The chemical formula for ketamine is C13H16ClNO.
What about esketamine?
While most people will be familiar with the name ketamine, many will be confused by the name of its half-brother, esketamine. However, esketamine was surprisingly legalized in 2019 for use with treatment-resistant depression. Of course, it was already known from the 1960’s that ketamine could help with the negative behaviors of prisoners, so its not shocking that a similar compound with the same chemical formula, would do similar things.
Esketamine was discovered in Germany in 1997, for use as an anesthetic as well. During testing for this purpose it was established that esketamine had anti-depressant effects, and that it worked very fast. It could be that owing to ketamine’s known abilities, that this property was actually being looked for in another compound, undercover. Either way, phase III trials for esketamine and depression ended in 2017 in the US, followed by Johnson & Johnson filing for a new drug application. This was approved by the FDA on March 5th, 2019, as the first psychedelic antidepressant drug Spravato.
The following year, because esketamine works so quickly, it was also approved for use with suicidal thoughts, a diagnosis that requires something very fast acting in order keep suicidal thoughts from leading to suicide. Esketamine has only been approved as a nasal spray, whereas ketamine is generally delivered via IV injection. Whereas esketamine has been cleared for use with depression, ketamine has not.
One negative caveat of this esketamine legalization? It actually requires patients to take a standard (monoamine) antidepressant as well – like Prozac, Wellbutrin, or Zoloft. This is not ideal for patients who are trying to get away from these non-working, and sometimes dangerous medications. In fact, the two are not related at all, making this requirement seem like a handout to big pharma, rather than a measure to help improve the wellbeing of people in need. What it also means, is that what health agencies like to constantly warn about – possible negative drug interactions, is literally being promoted by forcing patients to take two kinds of drugs, for which interactions are not fully known.
What is the ketamine loophole?
The question of why the lesser-known esketamine was legalized over the well-known ketamine – even as both showed the same properties for help with depression, is a great question. And the answer seems to lie within the ketamine loophole. So, what is this ketamine loophole, and why would it mean the legalization of a different compound?
Ketamine is not cleared for use with depression or pain, but it is cleared as an anesthetic. This means that unlike other psychedelics like MDMA, LSD, or psilocybin, all of which are in Schedule I and therefore 100% illegal, ketamine has the ability to be prescribed off-label. What does this actually mean?
Off-label use is defined as “the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.”
And yes, this is perfectly legal according to the FDA, which states: “Once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.” This means that even though ketamine has not been approved for uses with any psychiatric issues, or for pain, it can legally be prescribed for these purposes. This makes it perfectly accessible to anyone, and without government intervention, so long as they can get a prescription
As such, it also makes ketamine part of a gray market. Though medical facilities that administer it must still follow regulations for operation, this would be more about standard requirements. Things like cleaning regulations, capacity limits, and abuse reporting. But nothing to do with how ketamine is administered since the government has no regulation set for this. And neither do any individual states. Yet because of the Schedule III placing, and legality of off-label use, the ketamine loophole has been established.
I expect the federal government didn’t want to try to compete with this industry, or try to bring it above board. Think about the cannabis industry, and the difficulty legal markets have had in overtaking black markets, even getting to the point of needing a bailout. I think esketamine was legalized to create a separation in the minds of the public, in order to attempt to divert from the ketamine industry to the FDA approved esketamine one. It also likely has to do with the idea that the government and big pharma would rather have you hooked on antidepressants that don’t work, or pain meds that you’ll never get off of, than to really promote an option that will take away the necessity for further medications.
Differences in prescribing ketamine vs esketamine
Just because these drugs are similar, does not mean they can be accessed in the same way. Esketamine requires a prescription, which will generally come from a specialist, and not a primary care physician. This means a patient has to find a doctor willing to prescribe it. As psychedelics use for this purpose is very new, and runs counter to decades of smear campaigns, not everyone is on board just yet, and that might mean having issues finding a doctor who will comply.
Add onto that the requirement of needing to be taking an antidepressant, and the idea of using esketamine pales in comparison to ketamine. Though ketamine still requires a prescription, as it can only be used medicinally, that prescription can come directly from a ketamine clinic, and will never require a patient to be on another antidepressant.
If all this makes ketamine seem like the clear winner, there is one other factor to consider. Medical coverage. Since esketamine is approved by the FDA, insurance can cover it. This is not the case with ketamine therapy, where no insurance plan will cover it, as it’s not approved for these purposes. Ketamine therapy unfortunately is not cheap, so unless you can pay out hundreds of dollars per treatment session, it does propose a major issue for those with less funds. In fact, it makes it impossible for anyone living on a tight budget to access these treatments. In the cases of patients who want to try it but can’t pay, esketamine might be the best choice for now.
How big is the ketamine industry?
‘Ketamine’ seems to be quite the buzzword these days, and it makes sense. Both in helping with what seems to be an increasing number of depression cases, as well as with the growing opioid epidemic which is damning more and more people to long-standing addictions, and which comes with an overdose death rate that nearly reached 100,000 in 2020. Plus, the lack of governmental oversight might make it preferable to those who don’t want to be beholden to stringent government regulation in how they take their medicine.
In around 2015, there were approximately 60 ketamine clinics in the States, a number that increased to approximately 300 by spring of 2020. Now, two years later, that number has likely doubled again, if not grown past that. Not only do individual clinics exist, but entire chains have been established. One example is Ketamine Wellness Centers Arizona LLC, which operates 10 clinics across multiple states, and which was just bought out by Delic Holdings Corp, which expects to open 15 more. This transaction makes Delic the largest psychedelics organization currently operating in the US.
Another big player is Field Trip Health, a Canadian-based company with locations in several different US cities, as well as Canada, and Amsterdam. In fact Field Trip is doing something that might help with the issue of cost. While these clinics offer standard personal treatments, they also offer guided group treatments, at just over half the cost of a personal treatment session. This might be ideal for people who want ketamine treatment, but cannot pay higher amounts.
Clinics are also going beyond just standard depression management, to target similar issues. These include treatments for anxiety, bipolar disorder, obsessive compulsive disorder, postpartum depression, and post-traumatic stress disorder. This is exemplified by Ketamine Clinics, an LA-based ketamine therapy center, which offers treatments for all these issues.
Conclusion
As the ketamine industry grows, so do the options available to consumers. There are still plenty of questions to answer, like how to judge a clinic, and what safety measures to be aware of, but we’ll get to all that in time. For now, it’s great to know that this alternative exists through the ketamine loophole, and that people in need, might finally be able to get better treatments for their psychological problems and persistent pain issues.
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Disclaimer: Hi, I’m a researcher and writer. I’m not a doctor, lawyer, or businessperson. All information in my articles is sourced and referenced, and all opinions stated are mine. I am not giving anyone advice, and though I am more than happy to discuss topics, should someone have a further question or concern, they should seek guidance from a relevant professional.