Some Basic Requirements for the Identity and Quality of Three Types of Psilocybin Products

by

Albert Y. Leung, PhD

(PBN = psilocybin, baeocystin, & norbaeocystin;  S = serotonin)

I have avoided the use of “psilocybin mushrooms” because I find this term confusing and misleading when used thoughtlessly.  It perpetuates the inexactness of natural medicines as perceived by our drug-trained colleagues.  Its frequent use over recent years may have been due to the lack of efforts by the more technical segment of our P space to start making our work more systematically scientific before inertia leads it to where herbal supplements are now – two such products with the exact same herbal ingredients on their labels can often be totally different.   This is because there are no uniform standards for multi-chemical herbs.  I have seen it happen with herbal supplements since the Dietary Supplement Health and Education Act (DSHEA) of 1994 was enacted, and I don’t want to see it happen with psychedelics.  If, like me, you are aware of how herbs have been treated inappropriately as chemicals all these decades, I’m sure you’ll agree with me. 

The whole issue started with the application of inappropriate (faux) science. 

(1) Synthetic psilocybin (P).  This is the most straightforward because it is a chemical, easily identifiable and measurable.  Since I am no expert in synthetic chemistry, I always have this question I can’t answer when it comes to its practice.   A synthetic chemical versus a natural chemical – are they the same? You’d say yes, as long as they are both pure.  But how pure?  

           If a synthetic chemical is 98% pure, meaning in every 100 molecules of it, there are 2 molecules of other unwanted chemical(s) of similar size also present.  This amounts to usually 2% impurities for synthetic drugs, but for naturally isolated chemicals the impurities are allowed to be present in a wider range, like 5% or higher.  I am inclined to credit my friends and colleagues at the United States Pharmacopeia (USP) for their insight, but reservedly for their foresight.  The reason is that in an institution like the USP that almost exclusively deals with synthetic drugs and answers to Big Pharma and its faithful disciples (I used to be one) based on their tenets, there are not many, if any at all, who think outside the box and also act independently.                                                                                                                                                                                                          Therefore, watch out for the impurities (byproducts, intermediates, side-products, contaminants, etc., from toxic petroleum) that are unknown and can be different from batch to batch and from process to process (patented or generic).   If these impurities contain highly active compounds like LSD (>100 X stronger than P) or Fentanyl (~100 X stronger than morphine), your ‘pure’ P would contain at least 1% or 2% of these potentially toxic but unknown, untested, and previously unexperienced, extra brand-new chemicals, allowed by the USP for synthetics.   No matter how you call your P product (‘pharmaceutical-grade,’ ‘crystalline,’ or ‘patented’) it would have the side effects that all these synthetics are known to have, which have seldom, if ever, been tested or pinpointed.   Shouldn’t we, for a change from the start, do this right with synthetic P?   Instead of being obsessed with making $millions or $billions before our patents expire and let others’ children and grandchildren suffer the messy financial, environmental, and health consequences that we leave them, let’s see how pure our best P is, meaning not just 98% or 99%.  We need to look at its unwanted chemicals co-present in the 1%-2% of its IMPURITIES.  Do you know of any manufacturer of synthetic P which has actually tested these chemicals and found them inert?   Are there any publications other than promotion literature?  Remember, so far, all synthetic drugs are toxic.  Since psilocybin is a re-discovered, potentially ‘miracle’ drug in mental healthcare, we need to be sure its effects are not due to some other extremely active chemical like LSD (but toxic) present in the impurities.   For more about toxicity of drugs, see my paper “A Disruptive Concept in Drug Therapy” posted earlier on my blog (www.ayslcorp.com/blog) and in LinkedIn.   Regardless, when in doubt, bypass the synthetic P altogether.   Stick with the mushroom or mycelium with its natural P and whatever else (BN, etc.) already present as Nature intended since time immemorial, which can be precisely analyzed and standardized.   There is no need to resort to synthetic P, involving the faux scientific testing process that ultimately still relies on testing in us humans, over time, to prove it safe and effective.    

           Do you ever wonder where all the byproducts and side products in the synthetic processes go?  Chemical synthesis is not like arithmetic:  1 + 1 = 2.  It’s more like: 1 + 1 = 3, or 4, or whatever.  Where do all these unused/useless chemicals go?  Out of sight, out of mind?  Are they toxic?  And how much are they in our meds?  Don’t rely on the people owning such profitable enterprises or their employees to tell you.   If you are of the newer generations, you have to have the guts to ask these questions openly, otherwise your grandchildren and theirs will have no place to go in their ruined earth while their health will continue to deteriorate from all these toxic drugs polluting their bodies.

(2) Magic mushroom (fruit) containing natural P.   As I understand it, the contents of P in natural mushrooms vary from one individual to the next.   Unless you are growing magic mushrooms at home for self-consumption and don’t mind its uneven ups and downs, producers for commerce should start testing their lots of 10kg, 100kg, or more, if not already.  I think if we test these fruiting bodies more than a few dozen at a time, say, a few kgs, the P contents would become normalized or evened out.  Based on the results of a few lots, we should have a good idea of how large and how many lots to combine, so as to make it our production protocol for a reasonably uniform and reproducible mushroom product, after cutting them into small pieces.          Don’t fall into the trap we have experienced with herbal supplements.   When the DSHEA was passed in 1994, right from the get go, herbs or plant medicines were treated like drugs (chemicals) by both chemists and herbalists alike, believing that that was scientific, even among those bureaucrats in charge who were supposedly trained in plant medicines as well.   Regardless, this misuse of science has created the drug-therapy’s vicious cycle, causing all these unnecessary pain and suffering, plus waste of time and money.   This is especially true for our fellow Americans who have the least, and are often destitute, in our rich country where wealth is owned by a tiny 1% or less of the filthy rich.   To avoid the ongoing scourge of the vicious cycle of synthetic drug therapy, we should emphasize the natural part of psychedelic therapy.   It can be accomplished by simply bypassing synthetic P with mushrooms containing natural P, or better still, with mycelium containing natural PBN.          

           The major criticism from afficionados of synthetic P is that the contents of P in mushrooms are too variable to meet the standards of ‘science’ in modern drug therapy.  However, the sham of using the wrong (faux) science over the past decades has created the vicious cycle of drug therapy, damaging the health of most Americans, but perpetuating a stream of undeserved huge profits for drug makers and their interdependent associates (e.g., insurers & marketers/promoters).   There appears to be no easy solutions, except to bypass these synthetic drugs whenever possible.    The fact is, mushrooms are food, they cannot be treated with drug-oriented scientific technology – the wrong science for complex natural materials (herbs, fruits & vegetables) – and expect it to yield precise results commensurate with pure chemical drugs.  The current vicious cycle of the drug-therapy system based on faux science has perpetuated serious ramifications for our health and healthcare as explained in my aforementioned article “A Disruptive Concept in Drug Therapy.”     

                Once you realize how to resolve the variability issue of mushrooms    as suggested above, you      can go ahead with producing magic mushrooms      with reasonably consistent P for those psychotherapists interested in reducing the unreasonable costs of P for their patients.  You just have      to pay attention to the contaminating elements from the soil or      substrates that may contain heavy metals, synthetic chemicals, and animal     wastes, among others.  But none is in any way worse than some unknown           and extremely strong-acting synthetics in the 1%-2% of a synthetic P, which       are present   as contaminants and/or impurities, but not removed.    

(3) Magic mushroom mycelium containing natural PBN.  This can be the start      of a separate new industry in mental healthcare.  If done right, it can serve        as a totally natural and clean source of PBN and other P analogs within the      mycelium.  No contaminants or animal wastes from the soil and no     solvent or reagent residue, or foreign biotech elements (enzymes,          nucleic-acid fragments, etc.).  Above all, no toxic synthetic chemicals      lurking in the background of a not-absolutely-pure synthetic P (‘crystalline,’      ‘pharmaceutical grade,’ or whatever it’s called). 

           It was serendipity that my growing of Psilocybe baeocystis mycelium has led to a totally natural product with PBN and other related tryptamines, but without having to treat it with solvents or chemical reagents to separate and isolate them.   I never realized this when I was working on PBN mycelium so many years ago in graduate school; I only did, after I had rejoined the P space on LinkedIn around two years ago.  Being well aware of how toxic synthetic chemicals (drugs & their unused byproducts or side products) are increasingly polluting our natural products (e.g., foods & herbs), I have been searching for truly scientific ways to make modern drugs work better and less toxic by including herbal medicines as a partner.    After I had rejoined P, I realized very quickly what I had done as a budding scientist over fifty years ago can now benefit others, especially those veterans (several of whom are my friends) who have posttraumatic stress disorder (PTSD).    The PBN mycelium that I can help produce will be totally natural, without any solvent even touching it other than clean water.  The reason is that the mycelium forms pellets in the liquid culture media which can be harvested by simply straining or centrifuging, washed with distilled or clean water, and dried.  There is your product!   Totally natural but not necessarily organic, depending on how you define “organic.”   Should it need excipients or carriers to be made into capsules or tablets, minimal amounts of natural ones can be used. 

           If funding is available from a like-minded organizationengaged in primarily true humanitarian endeavors, we only need about 2$million for the first two years to start.       After that, full production can be geared up in months.  Depending on the species cultivated, the amounts of P with or without BN can be determined by using HPTLC.  Although this could also be done with other analytical techniques (HPLC, NMR, GC, MS, FTIR, etc.), none is better than HPTLC in convenience, cost, appropriateness, visuality, and versatility.  Besides, the procedures had already been worked out for PBN and over thirty other related tryptamines.  There is no need to spend months or years to develop other analytical methods for these tryptamines.

           My career as a scientific researcher started in the spring/summer of 1963 after I arrived at the University of Michigan the previous fall as a teaching assistant.  I was assigned the research project of growing Psilocybe baeocystis mycelium for its P and psilocin, and whatever else I could find in it.  That was only five years after Dr. Albert Hofmann isolated P and psilocin from the magic mushroom that Gordon Wasson had brought back to the modern world from Mexico and published his experience in his famous article in Life Magazine in 1957.  As a graduate student, guided by my advisor and mentor, Dr. Ara G. Paul, I worked days and nights for three whole years, and made my discoveries in psychedelics (isolating 2 new sister compounds, naming them baeocystin & norbaeocystin, or B & N).  However, I didn’t pay much attention to them, because I was so concentrated on making my graduate work a success as my way of expressing gratitude to my family for raising me and to Michigan and Dr. Paul (now Dean emeritus) for offering me a teaching assistantship, sight unseen.  Otherwise, I would not have received my PhD, period.   Being brought up in a family with traditional-Chinese-medicine background, I wanted to find out how science can help herbal medicines that, in turn, benefit us all.  But it took me more than a dozen years before I actually had a chance to do research in Chinese herbs while simultaneously consulting for pharmaceutical and cosmetic companies.  My business grew quickly, starting after 1980 when the 1st edition of my Encyclopedia of Common Natural Ingredients used in Food, Drugs, and Cosmetics was published by Wiley, which promptly became one of its bestsellers.  However, I soon learned that something was not right about the science used in drug therapy AND in herbal medicines.   My scientist colleagues took the science intended specifically for synthetic chemicals and applied it indiscriminately to multichemical, complex herbs, as well as to our own body.  Most, if not all of them, still do. 

           Then, around 2000, with me as the Principal Investigator, my company (Phyto-Technologies, Inc.) received a 5-year Small Business Innovation Research (SBIR) grant (Phases I & II) from the National Center for Complementary and Alternative Medicine (NCCAM), to investigate the antimigraine components of feverfew.  Unlike other researchers, we were not concentrating on any one particular active chemical present.    We successfully finished our project, but couldn’t find a partner to do a clinical trial with the active lipid-soluble extract.  However, one of my clients (Phyto CZ, s.r.o.), insisted on applying for a patent for our technology, Phyto-True system.  Its key aspect, RBRM (Representative Botanical Reference Materials) aka PTRM (Phyto-True Reference Materials) was granted a patent by the European Patent Office.  But both the US Patent Office and the Chinese Patent Office didn’t seem to understand the concept and rejected our application outright.   Or they were so brainwashed on the misapplied science-based drug technology that no one at those patent offices had any inkling that their science was wrongly applied.

           It is sad to see decades of Big Pharma’s persistent indoctrination of the public have produced narrow-minded scientists who only see one of the many facets of science.  A few such well-known ones have actually denigrated our traditional medicines, with millennia of historical use and documentation, as anecdotal or voodoo and have advocated their abandonment.  For years, they have been openly speaking against traditional herbal medicines while being paid handsomely by Big Pharma as consultants.  They don’t seem to have any clue as to the damages their mixing up science of single chemicals and science for complex multichemical systems (like herbs and foods) can do to our body and our environment.   As I have recently posted, I want to again state this fact: SCIENCE has been too politicized and monetized to mean much anymore.  This has been fully demonstrated during the current pandemic by our government experts’ handling of vaccines and antiviral drugs.  All are talking ‘science,’ but what science?  ‘Expedited,’ ‘expedient,’ ‘keyboard,’ or wrong science?  It needs to be redefined and its premise clarified before we can truly talk about identity and quality of PBN or any other natural products used in healing.    

           Fortunately, we can always bypass the synthetic P with naturals as long as we define the ‘science’ we use.

What I think we should do for millions of sufferers of mental illness

More than a half century after my PBN work in Ann Arbor, Michigan, I finally rejoined the P movement two years ago with the hope of not wasting time to get the PBN mycelium ready for further testing, so as to benefit sufferers of PTSD, drug addiction, and treatment-resistant depression, among others.  After some false starts for over a year with various groups, some with plenty of funding while others minimal, I have found there is much talent among them, though misdirected; and most of them simply wanted free advice, even though they were not nonprofits.  However, so far, no one single group has yet come up with any natural P or PBN mycelium because their chemists are mostly hung up on modern technology (NMR, electron microscopy, GC, LC, MS, etc.) and consider TLC/HPTLC too primitive to bother with.  Without fingerprints or any visually understandable analytical technology to show their natural PBN or simply P mycelial products to contain these chemicals, most investors have gravitated towards synthetic P. There is plenty of talent among their scientists (microbiologists & biologists) to grow fungal mycelia, but not clean mycelia with specific compounds like P or PBN.  Some could make them by biotech with specific enzymes or DNA from bacteria or fungi, but not by old-fashioned fermentation that we have been using since time immemorial.  Besides, can they produce mycelial pellets you can harvest naturally by just simply scooping them up and drying them without complicated maneuvers with synthetic solvents and chemicals?  I doubt it. 

I believe in the very near future, the commercial production of P will be legal in the United States, and I am ready to help any non-profit and/or non-gouging but for-profit organizations to produce natural mycelium with P or with PBN, free of charge.   I will only take 1% or 2% of sales of the PBN mycelium down the road.  This will be for our PBN Naturals LLC to support my efforts in trying to shape up the current mess in drug therapy’s vicious cycle and the lack of identity and quality of herbal supplements, as well as to build a brand-new industry in natural PBN mycelium, starting to collaborate with a computer-savvy non-gouging organization, to form alliances with individual investors/users (including psychotherapists) so as to spread the benefits of PBN and related tryptamines worldwide, not just for a few selected rich elite.

           In addition, since I isolated BN over fifty years ago, no meaningful research has been done on their potential entourage effects (aka complementary and/or potentiating, per TCM) on those of P because there has not been natural P, B, or N available.  Any ‘entourage’ effects on synthetic P could be due to chemicals present in its impurities and those in synthetic B and N, unknown and untested.  Remember, LSD is 100x stronger than P.  If it is present in P’s 2% impurities at a 1% level, a dose of 10 mg (or 10,000mcg) of P would contain 100mcg of LSD, a full dose that can cause hallucinations.  Unless we have solid proof that the usual 2% impurities in synthetics are inert, there is no point of doing any precise research on our modern drugs.  How have we come so far during these decades with our chemical drug therapy – wrong by negligence, design, or by profit motives?  What do the smart people at the Nobel Prize Committee think?  They ought to be impartial.  I am not asking our Congress or bureaucrat scientists in charge for their opinions, as I suspect they have their own agendas.

           In the meantime, I’ll continue to write more articles on PBN to allow those of my younger colleagues not obsessed with money-chasing to engage in the true pursuit of PBN mycelia for those who genuinely need them for their mental healthcare.  And I’ll also try to finish my last book, My Psilocybin Trip.   

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