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Big Johnson gets the shaft from NICE

Commonly referred to as “horse tranquilizer” ketamine has been part of analgesic cocktails for decades. Recently the practice of ketamine assisted therapy for depression has become a growing niche in psychiatry.

Perhaps anticipating a turn towards psychedelic and dissociatives for such uses, the pharma giant Johnson & Johnson developed Sparvato (esketamine) delivered nasally for Treatment-Resistant Depression.

Unfortunately, they got too giddy in their pricing and have been shot down by various third-party payers a few times, most recently by the wise guys at England’s NICE:

The National Institute for Health and Care Excellence (NICE), which determines if a drug is included in Britain’s National Healthcare System (NHS), said there was a lack of evidence on how the treatment, chemically called esketamine, fared over rivals, and that it could raise costs.

A stumbling block for esketamine is that “the trip”, what many would argue is the mechanism of action, is deemed as a side-effect by regulatory agencies.

“Due to its side-effect profile, the therapy is designed to be administered in the presence of a healthcare practitioner, a limitation that seemingly played a role in NICE’s math on Spravato’s overall cost.”

I was under the impression the nasal delivery method reduced the duration of dissociation since it was a direct shot to neural tissues and in conjunction with the intellectual property associated with the delivery method lead Big Johnson to this method.

bloody hell that’s expensive!

“NICE acknowledged that while the drug may be more effective at relieving the symptoms of depression than placebo and oral antidepressants — Spravato’s current list price exceeds a common cost-effectiveness threshold considered acceptable, the agency said, noting that according to the company’s economic model, an average course costs £10,554.25.”

It appears that neither the NHS or the Veterans Administration seem to think much of Sparvato at this point.

How this should be interpreted in light of forthcoming MDMA, Psilocybin and other psychedelics with similar or more extensive “side-effect profiles” is not worthy of speculation, two different beasts entirely.

But, ATAI with their version of ketamine, arketamine, will have certainly taken note, even if they believe they’re developing the superior isomer.

Perhaps it’s unfair to poke fun at Big Johnson, even if they are a whale in the industry. They are testing the regulatory waters that many deem to be future challenges for rolling out psychedelic medicine and could be paving the way.

But alas, all is not lost, this decision can be challenged as the NICE guys will be taking feedback from stakeholders (J&J lawyers) for another 30 days before the decision is final.

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Larry David for Oakland Plant Medicine Czar

OK, here we go.

Roll up your sleeves, grab a stiff drink, lets dive into the heart of the heart of the heart of the matter.

Marijuana Moment reported that Decriminalize Nature unveiled a plan for tax and regulation of entheogenic plants and fungi.

I was pumped to see what such a plan would look like. However, it turned out that the plan is to make a plan.

“So our approach with these sacred plants is to decriminalize throughout the U.S., and then in areas that have achieved this basic standard of equitable access for all people through decriminalization, to then pursue a regulatory framework emerging from compassion, with the clear intention of prioritizing healing above profits… …measures will be taken to avoid creating another profit-driven, commercialized market similar to how the marijuana industry is rolling out in many legalized jurisdictions. Psychedelics legalization will be “community-driven, bottom-up, and focused on compassion and healing, first and foremost,”

Intentions are wonderful first steps and guiding principles, but what are the incentive structures to guide this?

How do you avoid “another profit-driven, commercialized market?”

Why not simply decriminalize and call it a day?

It would appear that if the goal is to avoid the excesses, profit motive, and commercialization as with marijuana, or any other speculative commodity, the movement should restrain itself to the ‘grow-gather-give’ on the one hand and FDA approved, clinically administered therapeutics on the other.

This seems to be the main squabble point - why even create a regulated market?

Just let people grow their own—this is, after all the fundamental relationship between humans and nature, and the movement is named Decriminalize Nature, not "Seek consensus to institutionalize a framework for the cultivation, sale, tax, and regulation of nature.”

It doesn't roll off the tongue as well.

I imagine the 'grow and give framework' ship sailed as soon as the city council got involved. Let's not forgot governments need revenue and the proverbial “deal with the treasurer of the local city council” has obstructed many a well-intentioned movement.

But I could be wrong.

But in addition to the fundamental relationship between humans and nature, there are fundamental relationships between humans, and one of the primary relationships is trade.

Let’s not be so hasty to judge commerce as a corrosive agent because not everyone has a spare closet in which to grow mushrooms, not everyone will have a friend with a spare closet from whom they can procure. Not everyone has a local shaman.

So what might a tax and regulate framework look like?

I have a couple of ideas.

If the goal is to avoid profit motive and commercialization and the principal aim is the healing and spiritual growth potentials of entheogens why not make spiritual and religious leaders the conduit to entheogenic commerce?

Afterall religious and spiritual leaders have no concern for wealth, material possessions or power over their followers, they are simply agents carrying out God’s plan.

They are notoriously generous, benevolent, and kind and would never leverage their position of power and authority as charismatic actors to act inappropriately.

Why not put them in charge?

Seems logical.

Or maybe Oakland should follow the medical marijuana model in which upstanding and credible physicians perform thorough evaluations in order to grant patients ‘a card’ and the legal ability to procure medical mushrooms?

Insomnia? Try some shrooms.

Stress? How bout some shrooms?

Ingrown hair? Got shrooms?

Tummy ache? You need shrooms.

Ok, so now we have two viable ideas in which incentives are aligned so as to ensure the sanctity of plant medicine.

You're welcome.

What’s Wrong with the Weed Industry?

When organizers say:

"measures will be taken to avoid creating another profit-driven, commercialized market similar to how the marijuana industry is rolling out… [it] will be community-driven, bottom-up, and focused on compassion and healing, first and foremost"

What does this mean in practice?

Should entrants be required to be non-profit, Bcorp or Public benefit corporations?

Will some portion of profit/revenue be redistributed in some way?

Should limitations be placed on investment, sales, growth, purchases?

Furthermore, what aspects of the marijuana industry should be avoided?

Profits? What level of profits?

Certain corporate structures?

Slimy marketing/overselling the medicinal value?

The boom and bust cycle of a new market?

Do you limit the amount people can cultivate and sell?

Do you limit the amount people can earn? Limit the amount people can purchase?

I certainly have no answers but agree it’s gross.

Larry David for Oakland Plant Medicine Czar

Assuming that Oakland will have a point person, a commissioner, a Plant Medicine Czar if you will, someone overseeing the process and taking kick-backs, I mean ensuring the project rolls out in the most equitable, just and community-driven way, what might this role look like?

A layperson?

An expert in plant medicine?

Someone from a completely different field?

My assumption and I could be wrong, is that there is no clear, mutually agreed-upon way to align incentives so as to engender a community based, bottom-up, compassion driven, healing before profits framework that maintains appropriate but not draconian guard rails.

For this reason, we need someone practiced in the art of divination.

One who can peer into the souls of those who wish to form psychedelic establishments and foretell their true character, motives, and trustworthiness.

One who can act with the wisdom of King Solomon and decipher the truth with clarity and justice.

Well allow me to introduce The Trip Report's endorsement for Oakland Plant Medicine Czar: Larry David

Larry’s penetrating stare into the depths of another character’s soul to ascertain the truth is what we need in order to preserve sacred plants from the vile opportunists flocking to psychedelics.

If you didn’t go to middle school in Santa Cruz, California there are certain places that you’re not allowed to surf. This is how a ‘local’ is defined and if you’re not a local, certain surf spots are to be avoided.

I learned this the hard way.

The good news is you need not be a local to embark on a psychedelic trip in Santa Cruz:

“Following in the footsteps of Oakland and Denver, Colorado, city leaders unanimously agreed Tuesday night to decriminalize adult use, possession and cultivation of entheogenic psychoactive plants and fungi. Known in one of its more popular forms as “magic mushrooms,” the substances remain illegal on a federal level, but city law enforcement has been directed to not spend resources on its criminal enforcement locally.”

The Forrest Gump of Bitcoin turns to Psychedelics

Business Insider reported last week that the former Goldman Sachs executive turned Crypto-evangelist talked up psychedelic based therapies and COMPASS Pathways to a room full of hedge fund managers.

God help us.

At the Economics of Psychedelic Investing conference a few weeks ago, Eleusis CEO, Shlomi Raz predicted that as soon as the first institutional/traditional investors get into psychedelic investment the herd will follow.

At a recent hedge-fund conference in Miami (just imagine the douchebaggery) a well known, albeit controversial, finance guy named Michael Novogratz, the self-proclaimed “Forrest Gump of bitcoin" signaled to the herd that its time to go on Psychedelic based therapies and predicted a coming short-term bubble.

For the financially illiterate here, namely, the researchers and psychedelic therapists among us (Oh come on, it’s true!) a bubble refers to a quick rise in asset prices, like stocks in a company, or the value of your home, followed by a fast depreciation, or loss of value.

The defining characteristic of bubbles is that the price of the stock or home is decoupled from the underlying business fundamentals which means that the rising prices reflect exuberance, speculation and “everyone is doing it!” type of herd behavior and not the actual value of the company, or home. When no more investors are willing to buy at the elevated price, a massive selloff occurs, causing the bubble to deflate.

Apparently Novogratz is an investor in COMPASS Pathways, perhaps the safest investment in this emerging space.

However, as readers will be well aware there are a growing number of entrants into the space with less bona fides and less secure outlooks.

In an industry that for all intents and purposes has no legal market and therefore no revenue, this influx of capital is, let’s say, interesting.

A short-term bubble in share prices of companies that have long scientific and regulatory challenges ahead is not a primary concern as I see it. However, the same cannot be said for the entrants who are betting on legislation or measures that will create tax and regulate frameworks, aka Cannabis 2.0.

It is in this area that we’ll see the wild valuations, bogus intellectual property, pump and dumps schemes among other flavors of fuckwaddery.

Novogratz, though, thinks everyone should try mushrooms anyways — in the "right environment" of course. "It's an unbelievable experience in terms of therapy," Novogratz said to a room full of hedge fund executives and investors.

News, headlines, and other interesting stuff from the week:

Take a look at our top ten scientific papers of the last decade, selected because they provide an expansive overview of modern research on psilocybin, highlighting its multifaceted potential, both as a psychiatric treatment, and as a catalyst that can enhance the lives of healthy people in a number of ways.

Project New Day was founded in 2019 by Specialized Bicycles CEO, Mike Sinyard, and leading research scientist, Alli Feduccia, PhD. The foundation’s mission is to help people overcome addiction and actualize mental health through the legal and responsible use of psychedelics.

For those interested in becoming Psychedelic Therapists, Dr. Feduccia has a great article on that topic.

When former heavyweight boxing champion Mike Tyson first tried 5-MeO-DMT — also called “the toad” — he said it knocked him off his feet, profoundly changing his life. “I came across this thing called the toad. I smoked this medicine, drug, whatever you want to call it, and I’ve never been the same,”

“Investment into mental health technology has boomed, reaching £580 million in 2019, according to a study by early stage investor Octopus Ventures. The research, based on analysis of the latest Pitchbook data, shows an almost five-fold increase in mental health tech investment in the last six years, rising from £120 million in 2014.”

“The psychedelic experience is associated with persisting reductions in cannabis, opioid, and stimulant use, according to new research published in Frontiers in Psychiatry. The findings provide more evidence that psychedelics may hold potential in the treatment of substance use disorders”

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