This was published more than 10 years ago (5/15/2013) and reproduced here to show how our state of confused science with traditional medicines has NOT changed: –

An Appeal to Fellow Scientists and ColleaguesTrue Alternatives to Conventional Drugs are Needed!

You receive this document because of one or more of the following:

  1. You hold a key position in government, industry or academia who can make a difference if you want to;
  2. You are an authority on matters relating to herbs and science;
  3. You subscribed to, or received, my newsletter (Leung’s Chinese Herb News; ISSN# 1523-5017) while it was being published between 1996 and 2004; or
  4. You are my colleague, associate, or friend whom I respect.

The next page consists of my comments on a New York Times article on ‘gingko biloba’ research. I have decided to send them to you because I believe there is a better chance you can help rectify the issues regarding herbal product identity and quality than others. These comments also apply to most other herbs in the ‘alternative’ field. 

Also attached is an article I had been invited to write, slated to be published in February by one of those new online journals by the OMICS group, but has not yet been published.  Instead, it has been giving me one excuse or another, because I refused to pay a $900 publication fee that it had promised to waive when it solicited my manuscript.  I have given the publisher the date of withdrawal of my paper as May 1, 2013.  So, here it is.  I believe my article is relevant to what I have been saying during the past 10 plus years about our failure to provide consumers with a true alternative to conventional modern drugs in the form of herbal supplements/medicines.  Instead, what we are providing them are not true herbal products as traditionally used and documented.  These so-called ‘alternative’ supplements or medicines are mostly chemical entities that are not much different than conventional pharmaceuticals or nutritional chemicals (e.g., vitamins & amino acids) except that they also contain unknown chemicals with no long-term safe-use tradition as the herbs from which they are derived.   Their only connection to true alternative herbal medicines is that these herbs are used as raw materials for their isolation.  Once these chemicals are identified or isolated, they are afforded the full treatment of modern drug protocol.  Thus, without any historical connection to the traditional herbs from which these ‘alternative’ supplements/medicines are derived, how alternative can they be?

The problem is not just research on ginkgo biloba, ginseng, or a common item like coffee.  It is a fundamental flaw in our research approach to natural products.  So far, there is only one basic approach that applies to conventional drugs (single-chemical entities) without problems.  But it has failed miserably when applied to complex multicomponent botanicals (especially traditional herbs), unless you only use the latter as raw materials from which to extract pure chemicals and develop them into drugs.  Then the vicious cycle repeats and none of the alternative options is utilized.  This is exactly what has been happening over the past several decades, with the alternative options being increasing pushed aside.  

Despite many of you are aware of the issues, not much has been done on the R&D end, except that NCCAM several years back started to restrict funding of herb research projects to those that had sufficiently clear definition of their proposed test materials to meet the criteria and approval of expert reviewers who had the training and knowledge to make such decisions. [I don’t remember the exact wording.] Yet most of these experts are trained in pharmaceutical research technology as many of us, not paying attention to the fact that herbal materials cannot be treated as pure chemicals by simply assigning specific chemical(s) to a complex material and analyzing for them.  Such a selected chemical often does not have the effects traditionally known and documented for its parent herb.  For example, “caffeine” or “chlorogenic acid” is not coffee the bean, nor are ginsenosides equivalent to American ginseng or Asian ginseng with the latter’s effects.

On the commercial product end, my compliments to colleagues at the FDA for finally moving in the right direction to enforce clearer and more meaningful identification and definition of herbal materials, using an approach suitable for multicomponent materials, especially requiring companies to show more than the usual marker compounds with more practical and comprehensive techniques such as HPTLC.  This technique can readily detect adulterants (both drugs & phytochemicals) or missing components as long as at least 2 solvent systems are used to separate nonpolar to polar compounds.  After all, with current GMP regulations being promulgated, how good are they if the multicomponent herbal material is not at least defined to the point that it can reasonably be reproduced with consistency.

Al

Albert Y. Leung, Ph.D.                                                                                                                                        

05152013

“New Doubts about Ginkgo Biloba” by Roni Caryn Rabin (NYTimes 4/29/2013)

Comments by Albert Y. Leung, Ph.D.

Most of my esteemed fellow scientists and colleagues seem to have missed the point.  The issue here (as with all other herbal supplements) is not humans versus animals or the dosage but rather, the fundamental basics of good scientific practice.  It is a basic issue of single-chemical drugs versus multicomponent natural products.  If we are using the wrong (or ambiguous) test material, nothing else matters, because the results generated cannot be reproduced anyway.  Drs. Varro (Tip) Tyler and Christine Swanson as well as I had written about these 10 to 12 years ago. 

For the identification and quality control of single-chemical drugs, there are already well established analytical protocols.  Not so for herbal supplements!  Yet so far we still have barely started to deal with it, largely due to complacency, inertia and/or marketing pressure.   Without clearly identifying a test material such as ginkgo extract (e.g., 1, 2, 3, or more of the ginkgolides, flavonoids & ginkgolic acids along with numerous others also potentially present but not analyzed), how can we expect to get any meaningful or reproducible results? 

“Ginkgo Biloba” is not a single-chemical entity.  We cannot apply current analytical protocols meant for pharmaceuticals to multi-component herbal products and expect to get consistent results.  At present, the only appropriate and practical means to reasonably define a multi-component herbal supplement is to use multiple techniques that can give us a better picture of the material other than some arbitrary or irrelevant marker compound(s), disregarding other components (good or bad) that may also be present.  These combination techniques (Phyto-True™ that includes TLC/HPTLC) are now available, which are practical, relatively inexpensive, and have the capability and versatility of showing better profiles (fingerprints) of broader spectra of phytochemicals than any other more expensive and advanced techniques; and they have already been routinely used for over 10 years.  They not only can show what is claimed to be present in commercial herbal supplements but also other components that are (and should also be) naturally present or absent (adulterations), encompassing a broad profile of compounds (nonpolar to polar), including the ones not currently being routinely analyzed in the quality control of herbal supplements whether or not specified by official compendia.   

This issue is not unique to ginkgo biloba because its identity is not clearly defined to the point of reasonable reproducibility.  For example, its active chemicals responsible for its total effects (good or bad) are not clearly known, as it contains different groups of chemicals, some of which contribute to its alleged effects.  These groups include flavonoids and terpenoids, in roughly 24% and 6%, respectively.  At present, there is no legal requirements for producers and manufacturers to identify (or at least show most of) the flavonoids and terpenoids present in the 24% and 6%, or what else is present in the remaining 70% of the extract(s) used in ginkgo products.  Nor has there been any published comparison between these extracts and the original one on which early studies in Europe showed the desired pharmacologic effects that led to ginkgo biloba’s commercialization.  In short, the ‘gingko biloba’ supplements on the market can differ widely, not just in strength, but also in identity as opposed tosingle-chemical drugs like aspirin that can be easily identified and quantified, as aspirin is aspirin in aspirin products – same identity, only different strengths.  And since there is no one uniform extraction process used by all producers, the commercial ginkgo extracts used can be very different indeed in their chemical composition with numerous (to many) active chemicals not routinely being analyzed in their quality control, leaving a big gap in our knowledge of the identity, quality, efficacy and safety of these products. 

Unless there is a basic change in the understanding and research approach among experts in industry, government and academia relating to multicomponent herbs/supplements (ginkgo biloba, ginseng or coffee) versus single-chemical drugs (quercetin, gingkolides, ginsenosides, or caffeine), these inconsistent, erratic results and hence controversy will continue, needlessly continuing to waste much of our country’s human and financial resources.  Other comments and critiques of research results on ginkgo are premature without first more clearly and reasonably defining what constitutes the entity ‘ginkgo biloba’ extract – not just as currently specified (24%/6%), but what else is also present in the remaining 70%.

05/10/2013

My Thoughts on Synthetic Chemicals and their Impact on our Health and Environment

by Albert Y. Leung, PhD

For 150 years since the synthetic era began, we have been making countless chemicals from toxic petroleum, most of which are useless or unused and discarded to pollute our environment.  Some of them eventually find their way into our body to do additional harm besides that from the drugs, additives, and supplements we have been brainwashed to routinely take indiscriminately.  Over measly decades, these toxic chemicals have been ruining our environment and causing us our current state of poor health that not even millennia, or millions of years, of human existence and interaction with our surroundings have been able to do.  Yet few of us have sounded the alarm!  

Is it because most of us have to work so hard to make a living and have no time to protect ourselves or our environment, letting a handful of sociopaths grab most of our resources, hence wealth, ending up exploiting/enslaving the vast majority of our world population?  Or can it be that we have learned to be nice to others and are too reluctant or complicit to disturb the status quo?

These exploiters of our less fortunate are driven by greed and have no compassion or conscience.  They specialize in twisting the truth to suit their agenda, in politics and in science.  Yet, because of their wealth, there is no lack of fortune seekers and businessmen who adore them, waiting for a chance to follow their path.

Here, I am only concentrating on the science of drug-therapy and the accompanying vicious cycle it has created.   The latter has allowed our current confused state of faux science to exist, flourish, and perpetuate, ending up in the rapid deterioration of our environment and health, causing our fellow world citizens much pain and suffering.   I’m going to try to summarize what I have written often on healthcare issues with drugs, herbs, and additives over the past 50 years.  Unfortunately, most of the deleterious effects of these toxic chemicals are not readily visible (except obesity, puffy face, & unsteady gait, to name a few), making it more difficult to explain these effects to the general public.

1.     The confusion of science in health care and its resultant vicious cycle.  Health science does not have a uniform meaning.  It all depends on the therapeutics used.  The differences between using synthetic chemicals and natural ones in our health care vary greatly, from toxic to beneficial.  The former, being largely made from toxic chemicals derived from petroleum, are brand-new to this planet and innately toxic.  Because of this, when used in treating illnesses, they cause side effects and generate new diseases that require more new drugs to treat, in a vicious cycle.    461

Once in the vicious cycle, these synthetic chemicals overwhelmingly benefit the exploiters of human health, who are the ones with the resources and money, hence power, to steer the world to wherever they so desire.  All the drug testing in vitro, in vivo, in animals, followed by clinical trials in humans are a sham, the reason being, after clinical trials (gold standards of modern drug therapy), the approved drugs still have to undergo the real trial-and-error process our ancestors started umpteen years ago to test our foods and  traditional (herbal) medicines,  and then passed their knowledge on to us.  This is the ultimate process (human-testing) to prove our medicines are truly effective and safe in humans after centuries or millennia of use, not just safe in some cells (in vitro & in vivo) and animals for measly decades, tops.   [See my paper, Manmade Evolution in Reverse – Where Drug Therapy Using Synthetic Psychedelics is Heading (www.ayslcorp.com/blog)]. 

Furthermore, in our healthcare sciences, we routinely mix up synthetic drugs, additives, and chemical supplements with natural healing herbs and foods.  However, we concentrate instead mainly on the chemicals that are promptly synthesized, thus introducing the brand-new unknown and inherently toxic element not present in natural therapeutics.   The impurities (usually 2%-5% approved by official Pharmacopoeias like the USP, BP & ChP) vary greatly among synthetics vs naturals.  Those in the former, like approved drugs, are brand-new to us and require centuries or millennia before they can be proven safe, while naturals have been here with us since our human species first appeared on our planet eons ago.  This simple fact has been ignored by my science colleagues since modern drug therapy, based on synthetics, began around 150 years ago.  Because of this vicious cycle, created by greed, we have chosen to ignore its scourge in human health and continuously allow it to be a fountain of gold for makers of drugs or chemicals and their associates.  At the same time, the toxicities of new drugs, along with their toxic impurities, are conveniently ignored.

2.   Importance of purity or impurities in synthetic chemicals.  If we neglect or ignore it, I don’t see how we can resolve any problems arising from our use of synthetics, including their side effects, new diseases, and pain and suffering endured by most people who ingest these chemicals, often unknowingly in their foods and drinks.  Regardless, once we no longer confuse synthetics with naturals, we still have to heed the purity (or impurities) of the synthetics.  Hence, a 1% of a highly toxic chemical present in the impurities of an approved synthetic drug, can definitely pose not just a health problem, but also raise a scientific/technical dilemma, especially even many of my well-known colleagues still insist health sciences meet standards of precision.  Yet, for decades, I have observed this dilemma in our scientific endeavors whenever they involve our complex body and sometimes complex traditional medicines (herbs).  Synthetic drugs are rarely absolutely pure (say, 100.000,000%), but usually around 98%.  Hence, all synthetic chemicals by nature have an unknown or fuzzy element in them, which by nature is toxic or most likely so.  How can we have precision in our science of drug therapy with this fuzzy test material (aka drug) that we have only encountered at most 150 years out of our human existence and experience of millions of years?  Really?  Don’t we want some of our top scientists to do some explaining?    Statistics will not resolve this, nor measly weeks, months, or decades enough time to show our new synthetic drugs safe for us.  The only solution is to add traditional medicines (herbs) embedded with millennia of human experience and wisdom to our new therapeutics (aka synthetic drugs).  However, these cannot be added casually or nonchalantly.  They have to be done with serious consideration and timing, not just continuing to misapply some human ingenuity that lacks common sense, as we have been doing for many decades!

      I know I am right on this, because I have been on both sides of the synthetics/naturals (herbs) divide all my career and have experienced the good and the bad of both fields for at least 50 years and am still writing about them.  I am very proud of this, because unlike some of my fellow herbalists or scientists (incl. surgeons turned herbal-supplement peddlers on TV), I have not sold out to either party, or compromised by sleazy financial interests to lie to promote my own products.  Nevertheless, I feel sorry for them, especially their ignorance or innocence of being bamboozled by ‘herbs’ or ‘science’ that they don’t understand, ending up making well-known fools of themselves in the eyes of their peers.

      Regardless, we can avoid or bypass synthetics, as we are now trying to do with our PBN Naturals (aka PBN Pearls) Worldwide Consortium.  [https://www.buymeacoffee.com/ayleung852].  I can’t do this myself.  So, please join us if you are a true herbalist, scientist, or simply agree with what I am doing.  

3.  Why impurities in synthetic chemicals can pose major health problems?  Closely associated with the use of synthetic chemicals is the assumption that they are pure, with nothing else besides the titled or named chemical to account for its activities.  However, a strong synthetic psychedelic like LSD (up to 200X stronger than psilocybin) may be present in any psychedelic to skew research and clinical results.  How about other equally strong but highly toxic chemical(s)?  Have there been any uniform standards for any synthetic psychedelics used in all recent research or clinical practice, as those reported in “Psychedelic Spotlight’s Week of October 23rd Roundup” for depression, obsessive-compulsive disorder (OCD), or others?  I strongly suspect that in supplement research and clinical practice of synthetic psychedelics, there are no uniform standards for these synthetics, nor for mushrooms, apart from guessing.   [See my article on my blog, www.ayslcorp.com/blogSome Basic Requirements for the Identity and Quality of 3 Types of Psilocybin Products]. In the same week’s news highlight, DEA calls for the dramatic increases of psilocybin, psilocin, and ibogaine.  Regardless, does DEA itself produce these chemicals or farm them out to the greed-based industry?  But what are the uniform standards for these synthetic chemicals, the usual 98% pure, or 100.000% and higher?  In the former, does anyone routinely analyze the 2% impurities for highly toxic chemicals?  If not, don’t bring up the word “precision” or “precise” whenever we deal with health sciences!  Also remember, we know a lot about our human body.  But we still don’t know enough to keep acting as if we were the Creator, making decisions for our body as if it were a robot that we had built and could correct anything that went wrong with it.   

The above are just a couple of my questions.  Now that the goldrush for psychedelics is on, we can’t continue to go the way of synthetics, especially if our tax dollars are going to support such ‘fuzzy’ or faux research that is based on pseudoscience!  Wake up, my young friends and colleagues!  You are the ones inheriting this mess from us.  But few of you seem to care.   I do.  Hence, I will continue to speak out!

Manmade Evolution in Reverse –

Where Drug Therapy Using Synthetic Psychedelics is Heading

By

Albert Y. Leung, PhD

PBN (Psilocybin Baeocystin Norbaeocystin)

Introduction

Let’s not be too carried away when following the ‘goldrush era’ of psychedelics, especially if you are after the synthetic versions.  There are some serious hazards.  They are made from inherently toxic chemicals derived from petroleum which are brand-new to our planet, with which no living organisms, especially our complex body, have any long-term experience.  They enter our body with no divine guidance – only our modern ‘scientific’ misguidance.   As scientists, we should be careful in making decisions, not based on for whom we work or to whom we are indebted.

Aesop’s Fable of 6 Blind Men and the Elephant

First, to show our current state of confusion and misinformation in the drug-therapy field with psychedelics (natural & synthetic), this parable illustrates my point.  Through their touch, each blind man had a very different idea of what the elephant was (wall, pillar, spear, snake, tree, or brush?).  This is not different from the current understanding of health science and its variations.  Hence, the ramifications are far reaching.

Hole-Digging

Second, I like to describe our modern science of drug therapy with synthetic chemicals as hole-digging (more and more, deeper and deeper) into the ground, without surfacing even once aboveground to see how these holes (specializations) affect our scenery (total health).  After some time, others (non-diggers) might see some of these holes collapse into sink holes (drug-caused diseases), that eventually lead to a ruined environment (death)!

The Vicious Cycle

The above 2 scenarios describe the more obvious features of our drug-therapy system with toxic synthetic chemicals and its adverse effects on our complex but well-functioning body.  As this practice was based on the premise of faux science over the past many decades, it has resulted in the vicious cycle – the more toxic the drugs, the more side effects (or new diseases) are generated which require more new drugs to treat.   This ONLY benefits the drug- and chemical-makers, irrespective of whether or not the drugs actually work.  However, for patients and consumers, it brings mostly pain and suffering, often accompanied by financial ruin because of our national health policies favoring the few outrageously rich who control our country’s wealth, and thus also own much of Congress that makes our laws.

A Slight Oversight

There is a simple criterion among us chemists to consider 2 pure chemicals (a synthetic & a natural) with the same chemical structure to be identical.      The question (how pure?), never came up, at least for me, until probably half way through my career, around 30 years ago.   Not being a synthetic chemist, I never had to ask that question earlier in my natural-product career.  While 5%-10% ‘impurities’ in the foods and herbs we ingest may raise no alarm because whatever chemicals therein have already been always with us since time immemorial.  And most, if not all, of our foods and herbs have well-documented records.  We already know what is safe and what kills.  [See my article:  A.Y. Leung, Traditional Toxicity Documentation of Chinese Materia Medica – An Overview, (Invited Review), Toxicologic Pathology 34: 319-326 (2006)  http://tpx.sagepub.com/cgi/reprint/34/4/319 ]

Not so with synthetics.   Even a 1% or 2% there can spell trouble.  Imagine an equivalence of a 1% of LSD (lysergic acid diethylamide) that is up to 200x stronger than psilocybin, present in it.  It would double or triple the psilocybin’s effects.  What if, instead of LSD, the chemical present is as strong as LSD but toxic, and its effects show up only decades later as one of the most dreaded new drug-caused diseases that continue to spring up decade after decade (e.g., tardive dyskinesia, Parkinson’s disease & Crohn’s disease)?

Expedient Science – Can it be real?

Yes, when taken over by greed and politics, so obvious during the Covid-19 pandemic that no one involved even bothered to hide it.  So, the modern ‘scientific’ drug-therapy process, designed by our scientist forebears only decades ago and has since been followed by 3 or 4 generations of health science professionals, including mine.  It seemed to be going well until the bureaucrat scientists in charge found it expedient to change some established scientific rules during the Pandemic.  For example, vaccines no longer needed to be tested in humans for years, only months or weeks would suffice.  It seems that human experience is deemed no longer necessary for modern vaccines by the new vaccine researchers; just computer programming with detailed information on nucleic acids (DNA & mRNA) in their nano/pico environment.  This is the hole-digging science I mentioned earlier.  The bright young folks who are digging these holes need to broaden their horizon, as we are far from being omniscient, if ever.   Detailed information within our deep holes, for decades now, has only brought us to our current state of expedient science.  We already have too many specializations that lead to nowhere, only more specialists in things that don’t matter to the health of most Americans.  Thus, we still have too many toxic drugs, new diseases caused by these drugs making us a nation of drug takers or addicts (legal or illegal), not because we have weak will, but because the vicious cycle of drug therapy gives the powerful drug makers and their indebted associates the money and resources to continue to brainwash our bright young generations to ignore our deteriorating environment and health.

The way our modern health sciences now operate seems to be largely dictated by greed, not true or appropriate science.  If you don’t agree, ask why so many multimillionaires were created during the Pandemic and simultaneously new vaccines were made in months, if not weeks, like video games, built on the computer?  Do you really trust these specialists’ money-clouded mind and intellect?  Also, ask why some vaccine makers continue to get funding from NIH (or other American agencies) to develop new drugs/vaccines and then turn around and charge us taxpayers whatever outrageous prices they want and apparently getting away with it.   What bureaucrat(s) approved them?

One more thing, despite our country being the most advanced in health sciences, why did we have the highest deaths from this pandemic, and there is no easily accessible information on how many of our fellow Americans died from the new vaccines, or related drug-caused diseases. I am just puzzled.  Aren’t you?

Besides the long-term uncertain effects of  the fast DNA/mRNA vaccines developed for us on the computer as if they were video games, we also have to take the widely touted meticulous hand washing, sanitizing, and disinfecting with a grain of salt.  Because we have no clue which microbes are good and which are bad.  So, we simply kill them all.    This practice will further cause major unknown problems to our general health, just as our indiscriminate use of oral antibiotics over decades has caused new diseased conditions like Crohn’s disease or irritable bowel syndrome, due to the antibiotics killing of bad bacteria along with the good.  This indiscriminate killing of our microbiota (microbes on our body), if continued, will only benefit those who take the slightest evidence to invent ‘microbiome’ supplements and promote them to guileless consumers.  Not to mention that this will continue to perpetually benefit drug makers.

Keep Your Natural Immunity

If you still have a healthy natural immune system, don’t lose it to junk foods, sugary colored waters (e.g., sodas), or nonessential use of synthetic drugs.  If you can afford to choose your own doctor, go to an MD with knowledge of nutrition and/or alternative medicines.  Don’t take drugs advertised on TV because their misinformation or disinformation are the cause of many of our health problems.  Regardless, Big Pharma & Associates are the only ones benefiting from our health mess, aka the vicious cycle.   Also, be sure to be active, at least take walks regularly, if you can. 

I had my 85th birthday a few months ago, but I feel maybe 60 or 65.  I am still very active, though I don’t run or jog.   I just fast walk a mile or 2 every day and 5 to 6 miles 2 or 3 days weekly, at 15 to 18 minutes a mile.  So, I keep myself in shape.  And I don’t specifically try to kill all the germs around me.    I don’t use disinfectants or sanitizers, only a nonfragrant liquid soap or a bar of Ivory soap.   Here are my reasons.  I grew up as a child during World War II.  I had experienced trauma and famine.  Then, we lost our family business in Cuba due to the Cuban revolution while I was in high school.  I had to pawn my parents’ jewelry to buy food.  The last time I had to depend on others for food a couple of times was during the first year of my independent entrepreneurial career 50 years ago.  My wife had to get food from a local food bank.   Hence, even as an ADHD person, I couldn’t sweep those memories under the rug.  So, I am known as ‘garbage can’ at home because of those experiences; and I don’t waste or throw away food!  

Anyhow, my mind is still sharp.   I want to bypass the synthetic psychedelics with natural PBN products, because I don’t want to see the inherently toxic synthetics to continue to damage our environment and our health   But, if it takes me more than 10 months to accomplish my Phase I goals (Education & Information Dissemination), so be it.  I’ll simply continue until they are done.   [See our buymeacoffee (BMC) Page for my Phase II and Phase III goals:   https://www.buymeacoffee.com/ayleung852

    

My main goal is, in 2 to 3 years, along with my likeminded fellow members in our worldwide consortium, we will start producing clean natural PBN (Psilocybin Baeocystin Norbaeocystin) mycelia, with no toxic synthetics, to test in humans.   I have my personal reasons too:  I was the first scientist to isolate and name baeocystin and norbaeocystin, along with psilocybin, over 55 years ago in graduate school.   Since then, no one has isolated them in enough quantities to test their roles in our mental process and mental healthcare, despite some having secured funding but promptly wasted it in publicity and fantasy promotions.     Since PBN are the closest sister compounds simultaneously to serotonin and psilocybin, with norbaeocystin a practical nonidentical twin to serotonin (5-hydroxytryptamine) after it crosses the blood-brain barrier and gets dephosphorylated in the brain to its twin, 4-hydroxytryptamine.  Serotonin is an important neurotransmitter and hormone, present throughout our body.  It is toxic if too much is present.  However, if it is needed in the brain for whatever functions, our brain, at its discretion (not the lung or kidney) certainly would know when, and how much N to convert to serotonin’s twin, in order to meet the best interests necessary for our survival and wellbeing.

What to do with our Drug Therapy using Synthetics

Incidentally, the drug development and practice of drug therapy with the inherently toxic synthetics are obsolete, due to their illogical premise and design right from the start.    Most of our scientist colleagues are ignorant or confused on this.  They have gotten things mixed up and tangled in a jumble mess, especially after generations of intensive brainwashing by Big Pharma:  natural vs. synthetic, purity vs impurities, appropriate science vs misapplied science, precision vs chaos inside our complex body, modern drugs (synthetics) vs traditional herbal medicines, among others.

You should ask our more empathetic/compassionate synthetic chemist colleagues (not the sociopathic ones) some questions to which I have no answers:

  1. Where have all the useless and extra chemicals from the synthetic process of making a single useful chemical gone (e.g., drug, food additive or supplement), over the past, say only 40 years?  Bearing in mind, for every useful chemical, there must be 5 to 10 extra chemicals (byproducts, intermediates, side products, reagents, solvents, catalysts, etc.) generated or used in the process but discarded.
  2. Do you test the usually 2% of a drug’s impurities to be sure they don’t have some highly active (but toxic) chemical present to come back to haunt us 30 or 40 years from now?  Remember, a 20mg dose of synthetic psilocybin containing only 1% of LSD would add 200mcg of LSD to that dose of psilocybin!  How are we sure the psilocybin we use in clinical trials is not just this tiny active dose of LSD?  Has there been proof, or simply evidence, to show all the synthetic psilocybin used in psychiatric research over the past 30 years in all the research centers (Johns Hopkins, NYU, Harvard, Princeton, and numerous others) to contain no LSD?  If out of thousands of research projects involving psilocybin, only 1 is shown to have doubtful purity of the psilocybin used, no matter how much statistics was used in trying to bring the results back to ‘norm’, it simply won’t work.   I want to remind my scientist colleagues and friends who demand scientific precision in life sciences, like drug therapy with synthetics (or herbs), involving our extremely complex and well-functioning body, to ponder this.  It is the most common misconception in the science we have been dealing with for 3 generations.   Guess what it has brought us, after being hijacked by one of our human elements – greed!  The result is the vicious cycle that I have so often written about.  It is not what our drug and healthcare professional colleagues define it, blaming the victims’ weak will, repeatedly succumbing to drugs, hence addiction.  Please read my posts or blogs and see if you can come up with a better version of the vicious cycle than mine.

What to do Next with our Evolution in Reverse?

So far, most of the research on drug development and drug therapy is based on synthetic chemicals, which, in turn, is based on a process counter to that of human evolution, and also to what Mother Nature has intended for us.  However, it will be ideally suited for training and fixing humanoid robots in the near future when we’ll need them more and more to perform routine chores.  Unlike our human body, we build them and we know everything about them, hence we can fix anything wrong with them or at least continually improve them.

For human health problems, we have already seriously tried many approaches with different processes, including drug therapy using synthetic chemicals.  The last one has mostly failed after 70 to 80 years of intensive efforts, causing not only health deterioration in most humans, but also increasingly damaging our environment by more and more brand-new, intrinsically toxic but useless chemicals, generated by the synthetic process.  We should wake up to these continuous and untenable processes of drug development and therapy, and start seeking better options.

After 3 generations of intensive efforts of trying with modern synthetic drug therapy, we have basically failed.  The apparently ingenious process of trying to turn brand-new by-nature toxic chemicals made from petroleum into therapeutics to rid us of diseases or pain and suffering, has also not worked!   Instead, we now have tens, hundreds of thousands, or countless, of these useless and unused chemicals throughout our environment and in most of our bodies, like time bombs.  After all these decades of modern visible (evidence-based) research from molecules to cells, to tissues, to slightly more complex creatures, and then to us extremely well-functioning and complex humans (with countless chemicals, cells, living organisms, among others), most of us technical professionals still don’t know what to do with them, other than to concentrate on our own hole-digging (specializations), and minding our own business.  This evidence-based ‘scientific’ drug-therapy with synthetics is evolution in reverse!  After all these decades, we finally find out that our success (especially getting drug approval after clinical trial) is nothing but a chance to follow the nonscientific practice of trial and error our ancestors had started umpteen years ago since we became a living species on our planet.  And we are still learning and documenting this trial-and-error process, after we have invented brand-new intrinsically toxic chemicals from our most polluting natural resource on earth – inedible toxic and deadly petroleum, along with its ramifications, that are damaging broadly to our environment and specifically to our health! 

Isn’t it time for us to rethink and reboot the whole drug-therapy system?  Instead of creating and synthesizing chemicals with the weirdest compositions and structures we find interesting and challenging, but which do nothing to help our rapidly declining environment and health, why not, for a change, think empathetically of our health and environment first?  If we have to deal with chemicals, look towards those already coexisting with us since life began on earth.  Better still, relook at thousands of traditional healing herbal formulas in age-old healing systems like TCM or Ayurveda.  I can’t speak for the latter because I have no experience with it.   But with TCM, I have grown up using it and am still using some of the well-known, tried-and-true formulas for common ailments such as colds, flus, canker sores, cough, sore throat, joint pain, and others.  Or taking tonics (herbs doubling as food and medicine) like jujube, watercress, walnuts, mung beans, goji berries, turmeric, and Job’s tears (‘Chinese pearl barley’) as preventive measures before diseases show up and take over.  Now that you know the modern ‘scientific’ drug-therapy process is not our answer because it is nothing but good old trial-and-error after meticulous, successful scientific testing to pass our final criterion (aka clinical trial) of a particular ‘effective’ drug.   It’s time to act!!

Concluding Remarks

I have pointed out our Evolution in Reverse (aka drug therapy with synthetics) that has occupied our scientific and financial thoughts for 3 generations, in addition to wasting much of our resources, to the point of no return, unless something is done to rectify the false premise of our drug-therapy process.   It is not precise or straightforward as we have described it or wanted it.   Our synthetic drug era started around 150 years ago.  These drugs being made from brand-new chemicals derived from toxic, inedible petroleum, have within decades proven to be all toxic, creating the vicious cycle.  Despite our smart realization of their potentially toxic nature and started to test them with the best technologies we had, such as those used in vitro, in vivo, small animals, and, finally, in humans which we call clinical trials.  But all these tests cannot eliminate the trial-and-error step because we are still dealing with our complex and extremely well-functioning body, now with a realistic perspective, that it contains billions and trillions of chemicals, microbes, cells, tissues, and others.  The usual sciences can’t handle them, only experience over time can.  Hence, no more fast ‘evidence-based’ science as we know it.   Only its successful clinical trial that leads us naturally back to our age-old trial-and-error process that our ancestors had initiated eons ago in their search for cures that still exist.  Yet, for decades, we have blocked them from entering our modern ‘scientific’ healthcare because of ignorance and/or arrogance along with greed!    

Our body and health are not just an entity of our wishful thinking which can easily be taken care of by synthetic drugs made from toxic petroleum chemicals.  Our health involves our genetics, how we keep ourselves healthy (e.g., with our natural immunity intact), and more recently learned, a balanced microbiome, among others.  Since the synthetic era began, we have not been doing anything significant except making new drugs and taking them in a self-perpetuating manner to financially benefit only drug makers.  Compared to drug development and drug therapy, practically no efforts and money have been spent in preventive medicine or in traditional medicines.  Now, our population at large have been brain-washed to routinely take drugs without being warned of the problems of new diseases generated by its vicious cycle, which require more new drugs to treat, thus perpetually benefiting drug makers and their associates.

Even though there are many smaller practitioners of traditional medicines that understand the problems modern drugs have been causing, they are only minding their own business and, as far as I know, haven’t spoken out.  A few of them had either sold out to Big Pharma or so intimidated by their ‘scientific’ technology that they follow them without understanding the implications, ending up basically betraying the profession they had started.  Hence, together, they have built an herbal (supplement) industry imitating chemical drugs, making it easy for the larger leaders to sell a lot of products and make tons of money.  Unfortunately, many of these products called ‘herbal supplements’ have practically nothing herbal in them.  These have happened within the past 25-30 years and I have recently posted some examples of such products on my LinkedIn profile, maybe also on my blog:  www.ayslcorp.com/blog

Although I have not abandoned my herbal profession, I can only take one important issue at a time.  The current one for me is natural psychedelics, specifically natural PBN mycelial and mushroom products to bypass the synthetics.  I don’t want it to go the way of herbal supplements, where synthetic chemicals are slowly but surely taking over.  [See Some basic requirements for the identity and quality of three types of psilocybin products in my blog.]

Food therapy – Job’s tears (Coix seed or Chinese pearl barley) for joint pain…

I

I may be wrong.  But I don’t see food therapy practiced in America.   Most of us simply take herbal supplements.  Yet we have no idea what they contain, because our understanding of drugs, herbs, and foods is confused and convoluted. 

While pharmacopoeial requirements for drug chemicals can easily be applied to the finished drug products, because chemicals can readily be analyzed.   But not herbs; they are complex entities, not just 1 or 2 chemicals in each herb,  which cannot arbitrarily be held responsible for the herbs’ actions.   All the elaborate pharmacopoeial tests required for a raw herb or plant are fine, and impressive, but they cannot be applied to finished herbal products, because these raw materials have gone through processing and manufacture and are no longer herbs.    All the pharmacopoeias in the world can  do nothing about the identity and quality of the  finished herbal supplements or medicines, because all they describe are raw materials (herbs/plants) in painful details mostly irrelevant for finished product, except powdered botanicals in capsules.  

Which is why our ‘modern scientific’ drug-therapy system, no matter how ‘precise’ or ‘evidence-based’ we claim, with in vitro, in vivo, animal testing, and finally the gold standard of tests (clinical trials in humans) that gives us our drug ‘scientific’ approval for us to ingest.  Still, we end up with something that needs to go through the same trial-and-error step (some of us scientists call it voodoo) used by our ancestors umpteen years ago when they first discovered their medicines, some of which are now ours.  What we have done with our clinical trials is but a grain of sand on a beach when compared to our tried-and-true time-tested traditional medicines, not just curing some cancer in rats.  

After the passage of #DSHEA in 1994, besides prescription and OTC drugs, most Americans now also take supplemtnets some of which are untested synthetic chemicals  while others are ‘herbal’ supplements, (some without herbs).

Now, back to stiff or painful joints. They can be due to toxic side-effects of the drugs we take or the wrong foods (e.g., junk food) we have eaten over time, weakening our immune system.  Increasingly, it can also be due to our taking too many new chemical supplements (some are lieterally new drugs) that have not even been tested on humans (e.g., clinical trials).  All thanks to DSHEA.  

So, friends and colleagues, please think long term (at least for your geat grandchildren’s sake), because many of the inherently toxic effects of synthetics don’t show up in our lifetime.   So, before you continue to take drugs or some new highly-hyped chemical supplements to ease your joint pain or other problems, due to whatevev cause(s), why not try Job’s tears first. 

This food has no traces of potentially toxic synthetics.  The latter’s inherently toxic nature will continue to degrade our health. 

To cook Job’s tears, just boil it in water for an hour or more, then drink the liquid and eat the seeds. 

I seldom, if ever, follow receipes.  But recently, when some of my friends wanted to know how to cook it, I actually did some measuring and recording.  Here is how I usually cook and eat Job’s tears:

1/3 cup Job’s tears

1/3 cup oatmeal (steel cut, not instant)

2 heaping tablespoons of goji berries

3 or 4 strips (~3 x 1 inch) of dried mango

Put all except oatmeal in a 3- or 4-qt pot

Cover with water up to ½ full,

Bring to a boil and lower heat.  Watch the boiling/simmering.

After cooking for 30 to 40 minutes, add the oatmeal 

Put it in low simmer until it is slightly thickened. 

Add boiling water if too thick.  Cook for another 30 minutes.

That’s it!

It’s enough breakfast for 3-4 people; when refrigerated, I have 3 or 4 days of breakfast.

Most of the time, I eat grapes and mixed nuts (esp. walnut) with it because both are well-known in TCM as ‘life-prolonging’ tonics, like goji, they have been used in China for around 2,000 years, or more. 

For more information, search “Job’s tears” in My Life & Rollercoaster Career (CreateSpace, 2018, pp. 211-212), Encyclopedia of Common Natural Ingredients used in Food, Drugs, and Cosmetics, 2nd Ed. (Wiley 1996, pp. 320-322) and its 3rd Ed., renamed Leung’s Encyclopedia of Common Natural Ingredients…(Wiley, 2010, pp. 384-385).  It is also one of the several dozen common Chinese tonics (foods doubling as medicines) described in my Better Health with (Mostly) Chinese Herbs & Food (AYSL Corp., 1955, pp. 49-50), the last now out of print, but I think it is still available in the Czech and Japanese translated versions; among others. 

Have fun discovering safe Chinese tonics.

What Exactly is an Herbal Supplement?

     

By Albert Y. Leung, Ph.D.

The recent action by the New York Attorney General has drawn much criticism from different experts on the analytical method it used – DNA barcode testing. Yet the important issue is not a testing method, because no one single method, no matter how sophisticated, can do the job by itself anyway, especially when we are dealing with complex herbs and not a pure chemical like aspirin.  The point is that the NY AG has unwittingly revealed one of the key defects surrounding herbal supplements, which has caused so many of the problems and controversies over decades.  It is the use of inappropriate sciences (even wrong paradigms) to identify and characterize herbs. 

Herbal supplements are an extremely complicated subject.  They contain many chemicals, most unknown but working together to produce the effects we seek in traditional herbs as alternatives to conventional drugs.  These effects cannot be arbitrarily assigned to a few marker compounds, and designate them as the ones responsible.  But this is exactly what has been practiced for decades, while all along, traditional herbal products have been made from herbs, starting with the raw herbs or their total extracts from which nothing herbal is removed. There are still small companies making true herbal supplements this way, from raw herbs to finished products.  This type of herbal supplements is what the consumers had in mind before the Dietary Supplement Health and Education Act of 1994 was passed.  I believe they still want them.  However, unbeknownst to them, what they are getting now are no longer true herbal supplements that come with the traditional benefits known for the herbs through centuries or millennia of human experience.  Instead, some ‘herbal’ supplements nowadays can simply be chemicals from herbs/plants (toxic or not) formulated into a matrix of inert fillers, excipients, carriers, or whatever is needed to fill up a capsule or the bulk of a tablet.  This type of product is now in the news because of the NY AG’s recent action. It has raised a simple question:  why herbal supplements contain no herbs?  The answer may lie in Big Pharma’s influence all these years after direct-to-consumer drug advertising were first permitted on TV in the mid-1980’s under President Ronald Reagan’s tenure.

          Apparently, these herbal supplements without herbs are legal and can be marketed and sold as ‘herbal’ supplements as long as they satisfy some marker chemical requirements.  These non-traditional herbal supplements, more appropriately called “chemical supplements” or plain “unapproved new drugs” are made mostly by, or for, the large chains which have little herbal expertise, but plenty of know-how in formulating and manufacturing drug and vitamin products.  They produce huge volumes of these ‘chemical’ supplements which have drawn all kinds of extracts suppliers, especially from China and India, offering ‘high-purity’ extracts at prices often below the raw material costs.  By ‘high-purity’ they don’t mean the extract; they mean the chemicals.  For example, Chinese or American ginseng root usually contains only 1%-3% total ginsenosides.  A good traditional high-quality water extract may contain 5%-6% ginsenosides, along with the rest of ginseng’s complement of active ingredients some may be more important than the marker ginsenosides.  If you use it to make a ginseng supplement, say, using 10g of this 5%-ginsenosides extract per 100g of finished bulk product, your finished product would have 10g of this real ginseng extract of which 0.5g is analyzable ginsenosides and 9.5g consists of the other ginseng components (polysaccharides, short-chain peptides, steroids, ginseng pectin, choline, flavonoids, volatile oil, and many others).  The balance of the formulation (90g) would be carriers, including rice powder, hydrolyzed starch, etc. or anything legally allowed.  This would be what I consider a real herbal product/supplement. 

In contrast, if you want to formulate an ‘equivalent’ herbal ginseng supplement using a so-called ‘high-purity’ ginseng ‘extract,’ standardized to 98% ginsenosides (basically 100% pure), all you need is mix 0.5g of this ‘extract’ with 99.5g of inert fillers like those used in the above herbal supplement.  The resulting product would meet the criteria of required chemical markers and thus would be legal to be marketed and sold as an ‘herbal’ supplement.  This product would obviously contain no herbal (botanical, plant) elements, only targeted chemicals, hence the DNA barcode test would not find any herb in such a product.  Incidentally, highly purified chemicals (‘extracts’) from herbs are now readily available, including tea catechins, milk thistle silymarin, ginsenosides, resveratrol from the Chinese herb huzhang, and many others.  Nowadays, dietary supplements seem to be a mixed-up bunch of herbs and chemicals (aka vitamins, amino acids, nutraceuticals, phytochemicals, phytonutrients, etc.).  The ‘scientific’ support for most of the new herbal supplements are market driven and the methodology used basically follows the drug paradigm that is well established for drugs but not appropriate for anything involving herbs.  If a chemical is isolated and totally separate from its parent herb, then it should be treated as a new chemical because it has no more connection to the herb; and it should not be called an herbal supplement.  This should be only for consumers who don’t mind taking in another new chemical daily in their diet and are willing to bear the long-term consequences.  However, for millions of educated Americans like me who have grown up with traditional herbs and know how toxic drugs are, taking these modern drugs is our last resort;  we want to have the option of getting herbal supplements we know to have prior human safe- and beneficial-use history behind them.    

            All the above has led me to ask this question:  “What exactly is an herbal supplement – is it an herb or a drug?”  And this is the tentative title of a book I have been working on for almost 6 months, after having earlier lost my herbal-supplement business due to my 2 major customers’ having switched to cheaper imitation (adulterated) products.  It will document my experiences with herbs and commercial herbal products, inappropriate herb research, product development, manufacture, politics, cronyism, academic empire building, marketing, adulteration, confusion and a myriad of associated unresolved issues that have resulted in wasting billions yearly of our tax dollars and producing ongoing controversies.  Most of these still-ongoing issues have been discussed in my newsletter, Leung’s Chinese Herb News (ISSN# 1523 5017), published between 1996 and 2004.  Although many improvements in herbal supplements have been made over the past 2 decades, many other problems remain, along with the alarming trend of true herbal supplements heading more and more towards chemical drugs marketed as herbal supplements but without herbal elements.  All these are possible because, for over 2 decades, our experts in government, industry, and academia have stuck to using the drug approach with drug technology in identifying and characterizing herbs and herbal supplements for numerous reasons, including complacency, peer pressure, and financial indebtedness, among others.  However, the drug technology, although developed and well-established for pure-chemical drugs, is totally inadequate for herbs that are made up of multiple active chemicals unique to each herb.  By not clearly differentiating between single-chemical drugs and multicomponent herbs in our research, we have generated enormous amounts of ambiguous and/or useless biological, medical and related data sitting in our databases ready to be tapped and disseminated to perpetuate the status quo.  I only realized this maybe 15 years ago that I had been a guilty party in spreading wrong information and/or misinformation after the Second Edition of my Encyclopedia of Common Natural Ingredients used in Food, Drugs, and Cosmetic (Wiley, 1996) was already published.  I tried to rectify this for its Third Edition, but found it a close-to-impossible task, because it would entail checking the herb material(s) used in every single test in the papers reporting the research results, not just relying on the judgment of their authors or the prestige of the journals, because sometimes they were the worst offenders.  So I did not participate in its revision despite its revised title: “Leung’s Encyclopedia of Common Natural…” which I assume was for marketing purposes. 

Now, back to the present.  Herbal supplements would soon reach the point of no-return if this is allowed to continue – fewer and fewer true herbal supplements versus a steady increase of more and more potentially toxic chemical drugs.  At present, the so-called alternative is nothing but more of the same chemical drugs from an alternative source – herbs.  For decades, I had been outspoken on this and had seen progress, especially in the FDA’s recent mandate of requiring HPTLC fingerprinting for testing herbal supplements besides the usual marker chemicals.  This is the same fingerprinting technique we had used for testing our products for years before FDA mandated it.  However, this progress is just cosmetic.  It is unlikely to change the general thinking of the experts involved in this field.  I had been observing the trending of herbal supplements towards purer and purer chemicals and I didn’t like what I saw, especially after the Dietary Supplement Health and Education Act was passed in 1994, because this would mean the end of alternatives to modern drugs.  Hence, I decided to write a nontechnical book that would tell the whole story about herbal supplements so that the American public would at least be aware of what has been going on without their knowledge.  Then, about 2 months ago, when the NY AG came out with his action that had generated the ensuing controversy, with various experts weighing in, I realized that the testing method was not the real issue and I needed to speak out sooner.  As mentioned earlier, the real and most important issue is the lack of an appropriate alternative technology to deal with multi-chemical herbs, as the current drug technology is incapable of handling them.  Since my scientific colleagues don’t seem to get it or are simply towing the company line in continuing to use the wrong technology on herbs, I want to let the intelligent American public know the other side of the story which they usually don’t get from the usual experts.  The above is only a glimpse of the way how some simple and complex traditional herbal medicines (especially Chinese tonics), handed down by our ancestors over centuries or millennia, and made popular by the hippie generation 50 years ago, evolved into their current often-unrecognizable herbal supplements devoid of herbs.  

[Sent to NYTImes & Marty.Mack@ag.ny.gov on 3/29/2015]

Time’s a-wasting with Natural PBN Mycelial Products – in 5 parts.

Time’s a-wasting with #Natural #PBN (#psilocybin #baeocystin #norbaeocystin) #mycelial #products!  Part 1 of 5. (Uploaded on LinkedIn on 3/29/2023 ~ 10:56 pm)

I am talking about doing what should have been done in early 2022 – to produce clean natural PBN mycelium at least in experimental quantities. 

Instead, some companies wasted their initial #funding, without anything to show except #fancy #ads to promote their #fantasy #product(s) that didn’t exist.  

 After obtaining my PhD in 1967, I left the psilocybin space to pursue a successful #entrepreneurial / #consulting career in #natural #products (#food, #drugs, #cosmetics and finally, #herbs), ending up owning a plant to formulate and produce #herbal #supplements for other companies. 

My first book, #Encyclopedia of #Common #Natural #Ingredients Used in #Food, #Drugs, and #Cosmetics was published by Wiley in 1980.  It soon became one of Wiley’s best sellers and revised in 1996 (2nd Ed.), and again in 2010 (3rd Ed.).   Despite being well known in different industries for several decades, because of my ADHD, easily distracted, and sometimes mentally slow, nature, I am usually quiet, and was never the #self-#promoting type, until after I self-published my second major book, #My #Life & #Rollercoaster #Career (CreateSpace, 2018).  When my Encyclopedia was published in 1980, Wiley did all the marketing.  But with my newest book, I realized I had to promote it myself.  As I never liked the other social networks (e.g., Face Book & Twitter), I picked the more professional one, #LinkedIn.  So, I reactivated my account and started to post on it in late 2019.  Within weeks, I noticed the #chatter in #psilocybin, so I rejoined the PBN space, promptly forgetting to promote my new book.

 Quickly, I noticed #greed was the #prime #incentive leading my psychedelic colleagues and friends towards the same path taken by #herbal #supplements.  In less than 3 decades after the passage of #DSHEA) in 1994, #misinformation, #disinformation, scientific #ignorance or #oversight, led by #greed, have made massive #confusion of our herbs with drugs, naturals with synthetics, resulting in our current plight.  Many herbal supplements have no herbs in them; and 2 herbal products with the same labeled herbs can be different as night and day.

See my post on “#HPTLC #fingerprints of #herbal #products” uploaded on LinkedIn 2-3 weeks ago, where my #herbal #drinks (PC & ITo) were compared to #imitation / #adulterated ones (ITn & AV) supplied by my clients’ new suppliers.  It’s pitiful this could happen: even though 5X more sample of the imitation drink, ITn (lane 3), was used, it shows less than 1/10as strong as our original drink, ITo (lane 2), or basically > 50X WEAKER!

I don’t want these to happen to our PBN products.  So, I’m going to continue to speak out, trying to #educate the public and my colleagues on these confusing issues, highlighting the benefits of natural PBN over synthetic psychedelics.

Time’s a-wasting with #Natural #PBN #mycelial #products! Part 2 of 5. (3/30/2023 ~11:00 pm)

Synthetic chemicals made from toxic petroleum are inherently toxic – either the drugs themselves, or some highly toxic chemical(s) in their usually 2% impurities. 

They have created the #vicious #cycle that has been causing us much pain and suffering (physical, mental & financial) for over 3 generations. We are now hopelessly entangled in the following areas:      

  • #Confusing #herbs vs. #drugs, naturals vs. synthetics; 
  • #Toxic #chemicals in the drugs’ usually 2% #impurities are seldom tested; hence we don’t know the #effects and #toxicities are due to the drugs themselves or to some highly toxic chemical(s) in their impurities.

Unless these issues are resolved, our now-established #drug-#therapy with #synthetics will never yield reproducible or useful results. 

Being a successful entrepreneurial scientist for decades, I can provide #guidance to the #bright #younger #scientists to stay on course.   Here are a few projects to show my innovative thinking to assure you of the success of our current and future endeavors:  

  1. During my 6-decade long career, I have only responded to two requests for proposals / applications (#RFP / #RFA) from the National Institutes of Health (#NIH) and both times I won.

The first was in the mid- to late-1980s from the #National #Cancer #Institute to build a #database on #anticancer #natural #products.  My one-person company, teamed up with a young database company, #Ketron, won one of the two 1st phase awards ($50,000).  The other winner was closely connected with #NAPRALERT (the world-famous database of natural products).  That was a Small Business Innovation Research (#SBIR) program with, I believe, 13 companies having submitted bids. 

We finished our contract with me as #Principal #Investigator (PI), and my company, #AYSL #Corporation, as the prime contractor.   Both companies were invited to submit a 2nd-Phase proposal.  We did, and #our #proposal #won again.  But NCI allegedly had no money to fund it.   It is described in “Chapter 8: David vs. Goliath…” of My Life & Rollercoaster Career (pp.121-125).  I was so turned off by #government #cronyism that for 15 years, I didn’t want to deal with any government contracts or grants. 

Then around 2000, persuaded by a friend and colleague, we responded to 1 of 4 requests for application (#RFA) issued by the National Center for Complementary and Alternative Medicine (#NCCAM) to study some major herbs (echinacea, milk thistle, #feverfew & valerian).  Again, with me as the PI and my other company, #Phyto-#Technologies (manufacturing & lab) as the applicant, we won the combined Phases I & II grant to investigate feverfew, and successfully finished it in 5 years, costing NIH $1.4 million.  A major byproduct of that research is our #Representative #Botanical #Reference #Materials (#RBRM) (part of our #Phyto-#True #System) that received a #patent from the #European #Patent #Office   

Time’s a-wasting with #Natural #PBN #mycelial #products! Part 3 of 5. (3/31/2023 ~9:35 pm)

2. Another couple of accomplishments of which I am proud were made during the five years I worked for two companies.  The first one was around 1969-1971 when there was a petroleum glut.   My first job after my postdoc years was with a small research company in San Francisco as a #microbiologist doing research on petroleum – #growing #bacteria on #petroleum and harvesting them as #single-#cell #protein.  I had total charge of the microbial research and in less than 18 months, mostly funded by #Gulf & #Western, we developed a process ready for pilot plant.  This is described in “Chapter 5: My first big business intrigue…” of #My #Life & #Rollercoaster #Career, pp.99-104. 

3. Then, during the mid-1970s I was working as Director of R&D for Dr. Madis Laboratories, a botanical extraction company.   I developed a simple process of extracting #natural #levodopa from #velvet #beans, which has been used in treating #Parkinson’s #disease (PD) with fewer toxic side effects than synthetic levodopa, according to #Dr. #George #Cotzias, a pioneer in using levodopa for PD.  While there were a few patents describing the separation of levodopa from basically a #bean #soup with complicated steps, my process involved the key step of only cracking the beans (no powdering) and wetting the chunks with dilute acetic acid to fix the #protein and trapping the other large molecules in the beans. Then, when we extracted the beans with warm water, filtered and concentrated the extract, crystals were formed and the levodopa was already over 90% purity.  It is just that simple!   [My Life & Rollercoaster Career, pp.94-96.]

The above examples are just to show my innovative thinking and my #research #management skills that can be applied successfully to our process for growing mycelia containing PBN, as its technical details have already been published in 5 papers during 1965 to 1969.  Yet so far, this has not been produced NATURALLY by anyone, in sufficient quantities for testing, even with $millions in funding already spent.

Regardless, sometimes innovative thinking and specialization in your own field is not enough.  You have to have another set of knowledge not taught in scientific disciplines.  In my case, I grew up with Chinese medicines, because my maternal great grandfather was the village doctor.  My grandma must have learned the art from him, her father-in-law, because she married into the Ng (Wu) family young, in her mid-teens.  So, Grandma was basically our family physician when we were growing up.   And I know the basics of herbs. 

Time’s a-wasting with #Natural #PBN #mycelial #products!  Part 4 of 5. (4/1/2023 ~9:09am)

4. So, when Avon, one of my numerous #cosmetic #clients, had problem with its best-selling facial cream containing #retinoids, causing #rashes, I knew where to look for solutions, because I could interpret the esoteric Chinese language used in describing herb actions – cooling, heating, removing evil wind, etc.  At the time, Avon was interviewing the top expert in the cosmetic field, and another in the natural products field (the #dermatologist, #Dr. #Kligman & the #pharmacognosist, #Dr. #Norman #Farnsworth, respectively).  I think my reputation was known mostly to fellow scientists I had worked with, as I had no wealth and ‘empire’ or fame attached to my name.  I think one of my colleagues must have told #Avon to also take a look at me.  So, I was one of the three experts interviewed by Avon.  I told them I could make them five #extracts from #Chinese #herbs and one of them should work.  Then, only weeks after Avon gave me a 3-year consulting contract, I provided them with the extracts.  They tested them quickly and found one extract that met their needs.  Since I was not an approved vender, and Avon wanted the extracts ASAP, we had to arrange to have them delivered to an Avon-approved vendor near me.  So, everyone involved was happy.  I don’t remember what we did with the remaining two-and-a-half years of my contract.  

Now, on reminiscing about my encounters with Dr. Farnsworth over my long career, he never talked down to me as a couple of his #self-#aggrandizing #underlings in his ‘empire’ had.  Could it be due to the fact that his group’s being the top dog in the #database game, and they didn’t know my capabilities, except Norm?    But after I had beaten them in the contract with NCI in their own database game (#NAPRALERT), and also with Avon in the #natural #products field (one of my specialties), I didn’t get any more disrespect from them since.   Incidentally, in one of the Society of Pharmacognosy annual meetings during the mid-1970s, I happened to be playing poker with Norm, #Dr. #Gordon #Svoboda (the one who introduced the #vinca #alkaloids for leukemia treatment while at Lilly) and another scientist I can’t remember; I cleaned them out, and earned the nickname of ‘cardsharp’ from them.  Yet I was a novice in poker, because unlike most Chinese, I don’t gamble!   This may be another example of my #luck throughout my life, which often decides success or failure in our life undertakings, not just in gambling, as here.        

Time’s a-wasting with #Natural #PBN #mycelial #products! Part 5 of 5. (4/1/2023 ~ 5:45 pm)

Now that I have abandoned our original plans of seeking funding and doing the whole process ourselves, there is no longer any need to spend time and efforts to build another company from scratch (securing $2 million, hiring staff, setting up lab and production facilities & all).  Instead, after wasting almost 3 years in failed ventures with others, I have finally decided to form a #worldwide #organization to #connect #likeminded people (#colleagues, #peers & #friends) who have interest in #natural #psychedelics (#NOT #SYNTHETIC) for whatever reason, including those who use and/or dispense them, #professionals, #laymen, #producers with full or minimal #facilities, #analytical #labs, and #research #institutes, among others.  My goals basically come down to two –

i. Provide natural PBN mycelial products, with defined amounts of PBN as HPTLC #fingerprints, to those who need them the most, at #affordable prices, #BYPASSING the #toxic #synthetics.

ii. Continue to try to make others (technical and lay) aware of the damages done by the #vicious #cycle of toxic synthetic drugs caused by our continued #mixing-up of naturals and synthetics, herbs and drugs, as explained earlier.

I’ll announce soon to start inviting potential members to join our #PBN #Pearls group, as soon as I have the #basics and #logistics worked out, hopefully in another week.    

          Please bear with me in the meantime.  I am a very slow worker, especially I am supposed to be retired, hence I no longer have competent assistants in different locations.  This is going to be a long process, maybe a year or two.  But I have to get the organization #started #first for disseminating information regarding the misinformation and confusion of drugs and herbs, natural and synthetic, that have caused the vicious cycle in drug therapy which, in turn, has led us to the current mess – a #fountain of #gold for #drug #makers and their associates (#promoters, #insurers, #crooked #politicians, etc.) but #pain and #suffering for the vast majority of #Americans with #financial #ruin for a sizable number.  Then, when #psychedelics become #legal, we can promptly produce natural PBN mycelial products with defined amounts of PBN fingerprinted by #HPTLC, so that we’ll no longer have to guess on their dosages.                  


 

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.   

#Colorado has just #legalized #psilocybin, with various stipulations.

I want to #caution my fellow Coloradoans not to mix up the #science of synthetics with that of naturals, ending up treating them as equals, making a mess of our #drugs and #natural #medicines. 

Unlike our #foods and #herbs, all synthetic drugs and additives are #brand-#new to our #planet, never been human-tested to be #safe.  Yet, so far, over the past many decades, the drugs especially, have all turned out to have #toxic #side #effects, some of which have become #new #diseases, like #tardive #dyskinesia.  Why haven’t we seriously tested their 1% to 2% of #impurities legally allowed in them?

As an example, remember the strong action of #LSD.   It is over 100x stronger than psilocybin.   A 1% of it present in psilocybin would double the latter’s #psychedelic effects.   What if LSD’s effects were not psychedelic but, say, liver-damaging or harmful to our immune system?  How are we sure if these impurities will not continue to be present to do us harm?   

For example, how often do we have synthetic psilocybin capsules with no psilocybin, but a tiny dose of LSD mixed in with an inert carrier of plant starch or fiber?   

I have questions on the current synthetic psilocybin (‘crystalline’ included) so widely used in #research and #clinical #trials.  Shouldn’t they be tested for their impurities and #adulterants?  My colleagues and friends, technical or lay, don’t let the advanced sciences, say, #crystallography, bamboozle or distract you from the main goal of our psychedelics used in #mental #healthcare – to repair our body and mind to make us whole again.  We don’t want to take drugs, #prescription or #OTC, to just cope and barely survive.  We don’t want to be sucked into the #vicious #cycle and just take any drugs being thrown at us.  In my long independent career of more than 50 years, I have seen both synthetic and natural #therapeutics at work.  I don’t want us to fall into the vicious cycle of synthetic #psychedelics (e.g., PBN & others).  Hence, I have decided to NOT let natural #shrooms (and the #PBN within them) be replaced by #synthetic #chemicals and go the way many #natural #medicines / #supplements have been heading. 

Therefore, a few of my young colleagues and I are forming a #worldwide #organization to use natural PBN #mycelium to #BYPASS the synthetics (psilocybin, #baeocystin, #norbaeocystin & others) to avoid the toxic effects due to their impurities present in their usually 1% to 2% legally allowed.  We will help our members produce totally clean and natural mycelia containing natural PBN and define their contents so that we will no longer have to guess the amounts of psilocybin’s dosage (along with baeocystin and norbaeocystin, among other #tryptamines) as so commonly practiced in this space. 

It’s good to know that #Congress has noticed the #potential of #psychedelics in #mental #healthcare.

However, based on what I have observed during the past 4 decades using #synthetic drugs vs. #herbs in treating diseases, we have no clear #scientific #evidence that the toxic effects of drugs are NOT due to these #unknown #brand-#new synthetic chemicals or to those in their #impurities.  If we are not even sure about the very nature and/or #purity of the modern medicines/drugs we use, how good is our scientific process of which we are so proud for so many decades?

Some respectable scientists, like #Dr. #Harald H.H.W. #Schmidt, have insisted on looking at the #causes of our #diseases before treating them, and I agree.  However, if the diseases are then treated with the same synthetic drugs without knowing exactly what these are, we would be back to square one, because, as I have explained elsewhere, we have NOT effectively dealt with the #side #effects of these drugs and the #new #diseases they cause.  Whatever causing them have created and perpetuated the #vicious #cycle – because the more toxic the drugs, the more side effects, and subsequently, more #new #diseases. This process only enriches drug makers by temporarily eliminating some symptoms, but adding more side effects that need other #new #drugs to treat.  Consumers are thus stuck with the #pain and #suffering.   In the USA, many are financially ruined by these new drugs.   

#Politics should not be the first important action we take concerning psychedelics, unless we have a government truly owned by the people (our citizens) who in turn also own the drugs that truly benefit them and not only #drug #makers and #pushers, financially.  That way, there would be fewer, if any, of #bureaucratic #government #scientists who are involved in #cronyism of #government #research, preserving the status quo of #incompetence and #profitmaking.  I personally experienced this almost 40 years ago, after I won my first #government #contract as a budding #entrepreneur and scientist.  It is described in “Chapter 8:  David vs. Goliath:  #NCI #SBIR #Database Phase II #Contract.  What if…?” in #My #Life & #Rollercoaster #Career, published in 2018 (pp. 121-125).  I am sure this cronyism is still happening in our healthcare monolith, the National Institutes of Health (#NIH).   I suggest the first step is to require all mangers above the departmental level make public their #tax #returns.

Regardless, we should seriously look into 3 major #healthcare #modalities – #nutrition, true #prevention, and #traditional #medicines – that have been eclipsed for far too long by #greed, #ignorance and #arrogance of many scientists and their managers.   If actively employed, these might have prevented some of the following #drugs and #diseases –  #thalidomide, #antibiotics, #Fentanyl, #heroin, #cocaine, #Xanax, #Ingrezza, #Austedo, #amphetamines, #Crohn disease, #Parkinson’s disease, and #Tardive #Dyskinesia, to name a few.

Criteria for evaluating research on herbs and other natural products

[First published in Leung’s Chinese Herb News (LCHN-19), Mar/Apr, 1999; reprinted in My Life & Rollercoaster Career (MLRC), 2018, pp. 330-334]

Too many scientists and researchers investigating botanical medicines frequently treat herbal materials as if they were pure single-component drugs. This has resulted in countless numbers of publications that are meaningless (Issue 18), which in turn has wasted considerable amount of our precious resources and mental energy in disseminating and/or debunking.  To help scientists and writers/editors who are not familiar with the intricacies and complexities of natural product research, the following are some guidelines for evaluating and accepting natural products for study or manuscripts for publication. They also will serve as basic information for abstractors to include in their abstracts of published papers. I have divided them into 2 standard levels. The higher-level criteria should be ones whose attainment is our ultimate goal. With this higher standard, results of investigations in this field are more likely to be consistently duplicated. On the other hand, the minimal-level criteria are ones that should constitute the basic requirements for accepting a natural product for research or a manuscript for publication as well as minimal information to be included in abstracts. This lower standard is necessary for now because, at present, there are not too many publications that meet the ideal criteria.  However, as researchers not trained in the comprehensive aspects of natural products research get acclimated to this field, the ideal criteria naturally will then be adopted.

1. Commercial products without disclosure of formulas. Frequently, researchers publish reports based on a commercial or proprietary product, without revealing what the product is. In the Chinese herbal/medical literature, there are many publications of this type. The information in them is meaningless and useless, except to manufacturers and marketers of the investigated products.

Minimal (to allow traceability):

• Name and address of manufacturer

• Concentration(s) used in the study

• Method(s) of administration

• Source of financial support if other than manufacturer/marketer

Ideal:

• Reject the material or manuscript

2. Pure natural compounds. They should be treated as any pure natural

chemicals (e.g., caffeine, ephedrine, huperzine A, synephrine), with indication of whether they are isolated from plants or chemically synthesized.

Minimal:

• Chemical name

• Purity

• Concentration(s) used in study

• Method(s) of administration

Ideal (all above, plus):

• Plant source (Latin binomial), with authenticating authority

• Plant part (s), with authenticating authority

3. Purified extracts containing artificially high concentrations of specific chemical compounds or groups of chemicals. They include extracts of green tea with high amounts (e.g., 90%) of certain polyphenols (catechin, epigallocatechin, epigallocatechin gallate, etc.), of Asian ginseng with high total ginsenoside content (e.g., 80-90%), of grape seed or pine bark with high proanthocyanidin content (e.g., >80%), and of milk thistle with silymarin. Since the contained chemicals are present in such artificially high levels, they no longer bear resemblance to the botanicals from which they are extracted. These extracts are the ones that can cause the most problems. Unless the whole extraction process (including solvents) is revealed, there is no easy way to ascertain, besides the named chemicals (markers or actives), what else is present in the extract. For example, does the remaining part of the extract contain other even more active components from the botanical drug, or is it made up of only excipients? What is the chemical profile of the extract? Is this chemical profile consistent and how comparable is it to ones previously reported? Variations among these factors can greatly affect the biological activities of these extracts.  The more precisely we identify these parameters, the more likely can the results be duplicated by future studies. To perform scientific studies on these natural materials without addressing these issues would not yield consistent and meaningful results.

Minimal:

• Plant source(s) (Latin binomials), with authenticating authority

• Plant part(s), with authenticating authority

• Percent purity of marker(s)/active(s) in extract

• Chemical profile of marker(s)/active(s) (minimum 2 of: HPLC,

TLC, GC, etc.)

• Concentrations used in study

• Method(s) of administration

Ideal (all above, plus):

• Nature of extract (solvents used and ratios)

• Total chemical profile of extract (minimum 2 of: HPLC, TLC, GC, etc.)

• Excipients used in extract

4. Standardized extracts. These are extracts with a standardized amount of one or more marker or active compounds. There are 2 major types: total extracts containing specified amounts of markers or actives plus other compounds also naturally present; and partial extracts containing specified amounts of markers and actives, but lacking other components present in total extracts. As with purified extracts containing high concentrations of specific markers or active compounds, the same types of issues relating to solvents used and consistency of chemical profile apply.

Minimal:

• Plant source(s) (Latin binomials), with authenticating authority

• Plant part(s), with authenticating authority

• Percent purity of marker(s)/active(s) in extract

• Total chemical profile of extract (minimum 1 of: HPLC, TLC, GC, etc.)

• Concentrations used in study

• Method(s) of administration

Ideal (all above, plus):

• Nature of extract (solvents used and ratios)

• Chemical profile of marker(s)/active(s) (minimum 2 of: HPLC,

TLC, GC, etc.)

• Total chemical profile of extract (1 more of: HPLC, TLC, GC, etc.)

• Excipients used in extract

5. Regular extracts. These are extracts with no standardized amounts of marker or active compounds. Their strength may be expressed in ratios between raw herbs and extracts (e.g., 4:1, meaning 1 kg of extract is derived from 4 kg of raw herb) or as percent of herb material in a specific solvent (e.g., 20% extract in 70% ethyl alcohol, meaning 100 g or mL of the hydroalcoholic extract is derived from 20 g of crude herb). However, these strengths are meaningless unless solvents used in their extraction are given. For example, a strength of 10:1 to describe extracts of astragalus root or Asian ginseng root is meaningless, unless the solvent(s) are clearly stated, because a normal exhaustive extraction of either herb with water will result in extracts of no more than a 3.5:1 strength. On the other hand, an extraction with 1-butanol would yield very little extractives and thus would result in extracts of high strength (e.g., 10:1). However, these extracts do not represent these botanicals in traditional properties or in chemical profiles.

Minimal:

• Plant source(s) (Latin binomials), with authenticating authority

• Plant part(s), with authenticating authority

• Type of extract (tincture, fluid extract, solid extract, powdered

extract, etc.)

• Solvent(s) used and ratios

• Strength (ratio of crude herb to extract)

• Concentration(s) used in study

• Method(s) of administration

Ideal (all above, plus):

• Total chemical profile of extract (minimum 2 of: HPLC, TLC, GC, etc.)

• Dosage form used (tablets, capsule, syrup, drink, etc.)

6. Crude botanicals. Sometimes powdered herbs and fresh herbs or juices are used in studies. It is important to be sure the following minimum information is provided.

• Plant name(s) (Latin binomials), with authenticating authority

• Plant part(s), with authenticating authority

• Form used (fresh, juice, dried, dried after processing, etc.)

• Dosage form used (capsule, tablet, drink, etc.)

• Method of administration or application (oral, topical, etc.)

• Amount(s) used in study

The above guidelines I have provided are by no means complete. But at least they can serve as a start. I am sure some of my esteemed colleagues who are well versed in this field will provide further suggestions and comments. However, there are several caveats. Thus, despite all these criteria, an uninformed investigator could always provide a plant name (Latin binomial) even though he/she may have no idea of its authenticity. Consequently, it is imperative that the authority who authenticated the plant material be identified in the publication. Also, fundamental problems relating to the influences of growing location, time of harvest, and age of plant at harvest, as well as other geographical and climatic factors, need to be addressed on an ongoing basis until resolution is achieved.  I am not the only scientist who sees as a major threat to natural product research, the use of dubious plant materials, which leads to the proliferation of published information that is biased, dubious, and often plain wrong. As the few examples described in the last issue of this newsletter [Issue 18] demonstrate, we, as responsible scientists, must take the challenge and responsibility to stop this “cancer” that is growing out of control. We need to have relevant organizations such as the American Society of Pharmacognosy (ASP) take the lead in refining these guidelines and promoting their adoption by fellow scientists. ASP should itself encourage its own members to follow them as well as enforcing them in its own publication and publications of its sister organizations. If we, as a small group of scientists who understand the complexities of natural product research, do not take the lead, the scientific and medical fields would be drowned in quasi-scientific herbal gibberish in 10 years. Just look at the sudden proliferation of books, journals, magazines, and newsletters on this subject over the past 5 years! Too much damage has already been done!