My passion for personalized medicine led me to recognize that it is incongruent with centralization of medicine. Centralized regulatory bodies are prone to regulatory capture. The extent of this problem was likely underestimated pre-pandemic but has ever haunted those of us in the cannabinoid space for decades.
Deregulation of medicine can lead to snake oil salesmen and witchcraft. How do we decentralize medicine and build markets that still encourage safety testing and legitimacy?
The default and somewhat naive answer to this age old question was to have the state involved as they have the power to imprison/fine bad actors and certify the trusted ones.
What many of us may have failed to appreciate is that the state also has the power to engorge bad actors if those actors can facilitate an expansion of state power. The war on drugs is one example of the State demanding pharmaceuticals only move through their anointed Federal regulatory channels.
For this racket to operate, they need to make a few changes to blackmarket drugs. Add a few methyl groups, declare it novel, patent it and get it FDA approved… then wage a war on the generic plant/fungi based medicine. Opiates, Cannabinoids, Tryptamines (Psilocybin), these are all illegal but derivatives of them are carried through the IP→FDA pipeline. In fact 80% of the pharmaceuticals are derived from plants and microbes.
This wanton vilification of certain drugs during the pandemic was notable. HCQ, IVM, Z-paks and even OTC nutraceuticals like NAC were not safe from their ban hammer.
In this arrangement, the pharmaceutical partner enjoys a patented monopoly for a novel drug they know next to nothing about compared to the time tested, heavily used generics. Their partner in this racket, enjoys an enforcement budget that allows the ransacking of peoples homes under the guise of a war on drugs. Asset forfeiture laws from the drug war are the states way of assuming you’re guilty until proven innocent and taking your property. Reversing these unconstitutional asset seizures can take years and cost an innocent citizen a fortune.
Another polymorphism of this scheme is for the influential public health institutions like the NIH to have $400 Million in mRNA vaccine royalty while declaring to the world that no ambulatory or early treatment exists for COViD.
While the vilification of IVM and HCQ was devastating, wait until they prop up an institution (ahem.. NIDA) to study the abuse potential of generic or blackmarket drugs and you can watch the peer reviewed literature cement a false narrative of abuse over benefit.
What we want is an impartial umpire to referee these products. What we get is a fascistic Pharma-State enterprise that trades your freedom for poorly tested and expensive drugs. They do it with your tax money while declaring you too stupid to decipher information from misinformation. Censorship is required for the spells longevity.
How do we decentralize safety and quality control for pharmaceuticals?
We have modern tools for connectivity that offer consumer feedback that we never had in the thalidomide era. Yelp, E-Bay, AirBNB, Uber, and Bitcoin all enabled new markets where trade between untrusted third parties could be consumer rated and trusted…or at least better trusted than the state offered solutions of bad business bureaus and Taxi cab medallions.
A common bromide against using such tools for medicine goes something like this-
“While you may entrust your life with an Uber driver, you can never leave the internet to opine on the complicated topic of medicine. You need government to ensure only anointed experts can practice medicine or you’ll have charlatans and snake oil everywhere.”
If this doesn’t sing of “I am The Science” Fauci, I don’t know what does.
The problem with this line of thinking is that governments pay no price for being wrong and as a result debacles like Vioxx are not reversed for 5 years despite the market understanding its failure long in advance of government action.
The market understands the risk of opiates long in advance of governments placing fines on the Purdue family. Incumbent businesses write the laws and pay the regulators through the PDUFA act of 1992 and in return receive benefit in the form of liability waivers for vaccines. Government prohibition of drugs that actually work like cannabinoids and psilocybin only force those markets into black markets that also offer limited liability for bad actors in those fields.
The solution lies in building rating agencies and quality testing markets for medicines that are becoming deregulated to more over the counter markets.
We can see this in the medical cannabis markets. Cannabis is a medicinal treasure trove with over 151 documented cannabinoids. At least a dozen of these have strong publications showcasing medicinal properties (THC, THCA, THCV, THCVA, CBD, CBDA, CBDV, CBDVA, CGB, CBGA, CBGV,CBGVA CBN etc). A few of these are now published as being active against C19.
Dr. Bonni Goldstein, MD gave us a tour through a few of these cannabinoids at CannMed 2023. These are just a few slides from a major cannabinoid (CBG) that has recently been bred to 20% in some cultivars. There are known genetic markers for CBG dominant cultivars and seed providers have engineered triploid varieties.
What you can witness at CannMed is the confluence of analytic chemists who know how to precisely quantitate the cannabinoids, terpenoids, heavy metals, pesticides and residual solvents of any cannabis extraction. In addition you have the breeders, and microbiologists/genomics minded folks in the industry in the same room as the physicians pioneering treatments. This synergy of diverse talent has attracted investors and IP attorneys to participate.
Each compound discovered in the plant is put through the paces of the chemists to understand isolation artifacts and physicians to understand their potential utility. If any promise is shown the breeders and genomic sleuths put their heads together on how to synthesize or breed for this trait most productively.
This patient centered approach delivers open debate and decentralized solutions as opposed to “brought to you by Pfizer” narratives. This community has been navigating these government intrusions into medicine for decades and knows a thing or two about how to change prohibitions through voter initiatives and sound safety testing policies.
The medical freedom movement that has emerged out of the C19 pandemic can learn a few tactics from this audience.
As a community, we are not perfect. We have loop holes in a patch work of state to state heterogenous regulation that afford some CBD derived cannabinoids to go untested onto gas station shelves (Delta8 THC etc) that needs addressing.
The consumer in this environment needs to become more self reliant and aware of which products are high quality and tested and which ones are bypassing these safety standards to make a quick buck. You can no longer outsource your trust to untrustworthy agencies.
We are also ending up in a similar place as post pandemic medicine. State sovereignty is being tested. The 10th amendment is being recognized. While many people complain about the cannabis laws being different in every state, I find that quite reassuring as the laboratory of democracy ensures different regulations are tested in different places and its far harder to capture 50 different state agencies than a single group of people at the FDA or CDC.
Having states experiment with different COViD policies was critical. It allowed Sweden, Florida, Texas to emerge and be compared to states that took more authoritarian approaches. Regardless of which state you believe performed best, it is hard to argue against having these control groups. Without such a control group, your freedom is just one uncontrolled political suggestion away from being abolished entirely.
Laura Sands, PhD gave a great presentation on the “Analysis of hormonal regulation of promoter activities of Cannabis sativa prenyltransferase 1 and 4”.
Debra Kimless M.D. presented a “Novel water-soluabilized CBD-based sublingual tablets to treat diabetic neuropathic pain.”
Ethan Russo MD delivered the key note address about the challenges in developing cannabis therapeutics.
Jeffrey Raber, PhD delivered a stunning talk about the diversity of unregulated hemp derived THC-like compounds (THCP, THC-O, HHC, delta8 THC). “New Cannabinoids on the Rise, Delta8-THC and others impacting the entourage.”
Dustin Sulak, M.D. “Low and ultra-Low doses of cannabinoids: Are we missing the sweet spot?”
Zamir Punja, PhD.
“Understanding and managing hop latent viroid in cannabis”
I also presented on RNAi , RNA-Seq and Hop Latent viroid.
Akeem Gardner gave a very interesting talk on CannFlavinA and B. These are flavonoids unique to cannabis. “Targeting Glioblastoma Invasion and Survival with Cannabis-Derived Flavonoids”.
Stay tuned. In the next coming weeks many of these presentations will be made live to help educate the field.
The bulk of this substack should form part of any Uni pharma/medical course. Well written and well reasoned. People's dependence on the state to think for them has become a massive problem. I would like to think that young students reading this would at least be prompted to realise there can be more than one way to develop drugs and source data on them. And not just for CBDs and psilocybin's or the others mentioned. 🙏
It is good to see so much serious work being done in this arena. As a college student back in the 70s, my involvement with NORML was for less noble reasons! Your point about plants as starting points for various medications as well as comments about the varying legal standards brings me to this basic point:
Morality applies to actions, not objects. Physical objects are amoral, and people in this nation used to understand the difference. That is why it took a Constitutional Amendment to outlaw alcohol! We can also take note of what happened - organized crime (non-governmental) grew massively during Prohibition. Once this was undone by another amendment, there were all of those soon-to-be-unemployed federal ‘revenuers’. Well, we can NEVER shrink the size of the Fed.gov, so at the same time they passed the National Firearms Act, making laws about another group of physical objects, firearms. Thus began the ‘ATF’ and an explosion of federal agencies to control “things.”