Patents on biological sciences – impact of synthetics vs. naturals

Unlike its synthetic counterpart, #natural #levodopa is not inherently toxic because whatever impurities in it have already been experienced by humans for millions of years or at least millennia. This issue, existent for at least several decades now, has not been resolved, making our ‘modern scientific’ drug therapy using mostly synthetics NOT scientific. The main reason is that after we have subjected our synthetic chemical to extensive scientific testing (in vitro, in vivo, small animals, & clinical trials in humans, etc.) supposedly to make sure the new drug is proven ‘safe and effective’, we then approve it and release it for general use in patients. However, from this point onward, it is nothing but going through the same process used by our ancestors in developing traditional (herbal) medicines – trial and error! All the new scientific testing is for naught. Yet few of us scientists realize it up to this day. The modus operandi (M.O.) of our scientific research seems to simply keep digging deeper and more holes (i.e., producing specializations), often losing ourselves in our highly specialized fields and forgetting our original purpose to make our body and soul (mind) healthy again. With an entity like our extremely complex body as the key part that contains millions (even billions) of unique chemicals and cells, how do we bring our research in all the parts together and normalize to make our body function well as a whole again, as our Creator has intended? I believe our future being able to do this peacefully will lie in our ability to somehow make use of cosmic elements like light, magnetic waves, and others. In Chinese medicine, we have been talking about chi/qi for millennia even though we don’t know what it exactly is. But there are signs of its being used, as in #qi gong. I am sure other cultures, like ayurveda, also have this qi counterpart. Yet advanced science is like a newborn baby in a grownup world. Why? Because most of us modern drug scientists do not think outside the box but rather hold onto some narrow-minded biase or are ignorant.

Here are my thoughts on the issue of synthetics vs. naturals. #Professionals of #modern medicine and #traditional #medicine need to be #less #critical #of #one #another, because each group is not what it seems. While modern-medicine researchers continue to demand #precision, there is no such thing when our #extremely #complex #body (containing countless chemicals, cells, and other living entities) #is #involved. I have repeatedly brought this up over recent years. Thus, with traditional medicine, it is mainly mumbo jumbo as #understood and #described #by #drug #consultants, at least during the previous 3 decades. Most of them must have #died or prematurely turned #illucid, because I don’t hear this kind of denigrative talk anymore about herbal/traditional medicine during the past 10-20 years.

I believe it’s now time to rethink our opinions against those of the other group, #ignoring their #uncorrectable #elements and start bringing the #best #of #both #therapeutic #systems to benefit our fellow humans. If not, just ingestible synthetic chemicals (e.g., drugs & additives, excluding non-ingestibles) will ruin our environment and health in no time. Without good health and a decent environment, life is not worth living. Please ponder these for the sake of your grandchildren and theirs, especially if you are in the 1% of our world population that holds the world’s money and hence power.

Briefly, the weak point in our modern drug therapy should help motivate the introduction of appropriate traditional medicines that lack modern ‘scientific’ evidence but have plenty of human trial-and-true experience and wisdom. For those few who have had the pleasure/experience of using some #traditional #Chinese #formulas for #colds and #flus or other #common #ailments (e.g., #facial #eruptions & #canker #sores), there are some safe and effective formulas commonly used in Hong Kong and nearby Asian countries that can be immediately introduced here. Some may already be here as #herbal #supplements. Unfortunately, after the DSHEA was passed in 1994, we have never handled the herbal products properly, because right from the start the industry members have been treating them as if they were drug products. Consequently, no 2 herbal supplements with the exact same labeled herbs are the same, unless they are produced by the same manufacturer. Because the technical experts in charge only see some of the chemicals in herbal or traditional medicines.

I am still confident that I will find a #computer #savvy #partner to write a program to tie the partners (producers, analyzers, researchers, users & others) in our #PBN #Naturals #Consortium together, so that we can begin #inviting #investors. Under my guidance, our #Worldwide #Consortium will be able to #greatly #improve the #mess of #current #herbal #supplements, starting with PNB naturals (#psilocybin, #baeocystin, #norbaeocystin, & others).

Here are the topics I want to address/readdress in the #next #few #posts:

#Vicious #cycle of #synthetic #drug #therapy
#Patents #on #biological #sciences – impact of #synthetics vs. #naturals
#Human #greed

#Vicious #cycle(#VC) of #synthetic #drug #therapy.
This exists only when using #synthetic #chemicals as I have often explained. Being produced mainly from #toxic #petrochemicals, they are #brand-#new #to #our #planet. Our human species have no more than #150 #years of #experience with them, a mere #grain #of #sand #on #a #sandy #beach if we want to compare #our #experience #with #synthetics #to #that #with #natural #therapeutic #remedies (#herbs & other #natural #materials). Hence, they are #inherently #toxic, not just the chemicals themselves, but their #impurities. The latter often escape our attention, as the #drug-#identity-#and-#quality ‘bibles’ (aka #Pharmacopoeias) do not deal with these impurities. They simply allow a small percentage (like 1%, 2%, or more) in the drugs and consider them pure. Even after we have made major advances during the past several decades in analyzing and detecting minute chemical materials (nano, pico, & smaller), the standards of purity among scientists (esp. analytical chemists) still go by these #pharmacopoeial #standards. And the general #axiom still holds – a #synthetic #chemical #is #the #same #as a #natural #one if they both have the #same #chemical #structure and are #pure. But how pure? No one seems to know or care.

Here is an example I have thought about for years and already described elsewhere. #Lysergic #acid #diethylamide (#LSD) is up to 200x stronger acting than #psilocybin. What if someone just mixes 1mg (1,000mcg) LSD with 99mg (99,000mcg) synthetic psilocybin. A person taking 20mg of this mixture believing it to be pure psilocybin would experience double the effects of psilocybin. Or worse, if he puts 1mg of LSD in 99mg of #corn #starch and labels it ‘psilocybin’ and some person taking a dose of 20mg of this ‘psilocybin’ would basically take in #200mcg of #LSD, a #regular #psychedelic #dose. Has this ever happened during the past 25-30 years #in #research or #practice? If so, what kind of science is that? Just the thought of this scenario happening should warn us that something is not right with our #life #sciences using #synthetic #psychedelics in therapy. This also casts doubt on the quality of our synthetic therapeutics (e.g., psilocybin) on the market, no matter how much money is spent by some companies promoting them with fancy rhetoric. So, beware of these companies; their greed accelerates the decline of our health!

The difference between synthetic drug therapy and natural traditional medicines – we can do something about them

There are obvious #problems in #modern #drug #therapy using #synthetic #chemicals. No one seems to notice the #innately #toxic #impurities present in these #brand-#new #chemicals that are mostly made from toxic petroleum. Our #pharmacopoeias allow some impurities (1%-2% or higher) to be present, assuming them to be nontoxic. Among tens or more thousands of synthetic chemicals now ingested daily by us after modern #scientific #testing (in vitro, in vivo, in small animals, then in humans via #clinical #trials) followed by approval and release for human use. This last step is the same #trial-#and-#error process used by our ancestors in developing our medicines. Isn’t it ironic we have spent over a century after our synthetic era began, trying to develop a #modern #scientific #process, but end up with the #same #one #our #ancestors #used?
During the past decades, we have developed a huge industry that recently came up with a #self-#generating and #self-#perpetuating #income-#producing #process, that #benefits #only #drug #makers and their #interdependent #associates (#promoters, #advertisers, #crooked #politicians, and others), which I call #vicious #cycle (#VC). Thus, the more toxic a chemical the more #side #effects and #new #diseases it causes that #require #more #new #drugs to treat, hence the VC ad infinitum.

In contrast, our #herbal and #traditional #medicines were developed by the #trial-#and-#error process eons ago. Some of these are #well #documented, e.g., #Chinese #herbs/ #traditional #medicines and #Ayurvedic #medicines (at least before the latter were polluted by the British Empire’s rule of India for two centuries). These medicines have thousands of years of #human #experience and #wisdom. I can only speak for #Chinese #herbs and #formulas widely used in #China and in #southeast #Asia. I have grown up with them, along with my #training and #experience #in #modern #chemical #drugs and #additives. The following is my opinion and plan for making the most of the two systems, with whatever the best of the two that is readily available.

The #major #differences #between the #two #healing #systems (#synthetic vs. #natural) are: #modern #drug #therapy tries to bring the #unknown #inherently #toxic #elements of #brand-#new #synthetics up to at most past the present. The rest will be #for #our #posterity #to #experience and #judge.

My plan is to hold off some #synthetics for now, whenever possible, and start bringing the natural therapeutics to complement those that have #natural #counterparts available. Since there are not yet any feasible ways to bring the right naturals to market because there are no #meaningful #identity and #quality #standards available yet. The simplest way is to test (by #TLC/ #HPTLC) the #suspicious #products on the market #alongside the #decent/ #genuine ones #already #present for #generations. If found obviously deficient, those #imitations would be #eliminated.
The

Alexander H. Smith – mentor for Paul Stamets & me.

In his newest book, “Psilocybin Mushrooms in Their Natural Habitats”, Paul Stamets honors A.H. Smith and his book titled “Mushrooms in Their Natural Habitats” published in 1973. Here is a section from a Chapter of my book, “My Psilocybin Trip with PBN” (still not officially published), to show Dr. Smith had mentored Paul and me at different times:

#A #tribute #to #my #magic #mushroom #colleagues.
After I received my PhD degree in 1967, my Michigan work on PBN went to the back of my mind. That was until around the end of 2019, when my PBN work was reconnected with the psilocybin work in mental health done by colleagues at #Johns #Hopkins like #Roland #Griffiths and #Bob #Jesse, among others in other #universities and #institutes. Also, I began to be aware of the important work done by #Paul #Stamets, literally in the trenches. He is the one who achieved his #current #unparalleled #status by collecting mushrooms and tripping on their psychedelics from around 1970 to 2000 when university scientists started work on magic mushrooms again, this time in earnest. He and I had one mutual connection. Both of us were at one time mentored by #Alexander (#Alex) #H. #Smith. I am much older than Paul. So, a year after I arrived at Ann Arbor, Michigan, I started working with Alex on testing potential North American magic mushrooms. He collected them and I analyzed them. As he was the curator of the #University #of #Michigan’s #Herbarium, he had access to old collections of magic mushrooms as well. That was after I had worked out the TLC analytical protocol and knew where the appropriate #tryptamines (to which PBN belong) fell on the #TLC #plate (we call it #chromatogram or #fingerprint). Since I had come from a mycophobic Cantonese culture, I had never picked a single wild mushroom and eaten it before I got to Michigan and met Alex. Even after working with him, my training in mushroom picking is still limited. I don’t know much about wild edible mushrooms, though he might have taught me to pick my first morel or chanterelle. Nor, by any means, am I an expert in recognizing psychedelic species. Out of the dozens of potential psychedelic mushrooms Alex collected in Ann Arbor and elsewhere in the United States, only one species had #psilocybin and #psilocin plus some closely related unknown compounds. That mushroom is #Psilocybe #baeocystis Singer & Smith (a new species from Oregon he and his collaborator, Rolf Singer, named). And that is the species I concentrated on for my PhD research. My first paper, published in 1965, had Alex as our co-author, “#Production of #Psilocybin in #Psilocybe #baeocystis #Saprophytic #Culture” by Albert Y. Leung, A. H. Smith, and A. G. Paul, published in J. Pharm. Sci., 54 (11): 1576-1579 (1965).
Regardless, when Alex was my mycology mentor, Paul Stamets was only a teenager. From what I have gathered, Alex must have mentored Paul when Paul was a young man at the University of Washington where Alex was probably on sabbatical or on an extended stay to investigate American Northwestern fungal species. Maybe Paul can clarify that, some day. It’s because of Paul’s continuous involvement, along with a few other psychonauts in the North American magic-mushroom scene from the early 1970s through the present, the legend of psychedelic mushrooms has been kept alive. This is especially true after their serious scientific research has been picked up by Johns Hopkins scientists and has since been continuing. For all this, I want to pay tribute to Paul Stamets, Roland Griffiths, and Robert Jesse, among other colleagues. Without their work, I would never have a chance to introduce baeocystin and norbaeocystin to the world of natural therapeutics for potential treatment of mental health problems, as they would have been buried as so many findings of obscure or suppressed research, never to be found, or are rediscovered too late to be of any timely benefits to anyone.
As long as I am alive, I’ll continue to try to make this happen – to help start a new safer industry of natural PBN for mental healthcare by bypassing the current synthetic drug therapy with its toxic vicious cycle. Even if I don’t personally have a chance to work on natural PBN mycelium now, sooner or later when the field of psychedelics, especially natural psilocybin, is more widely recognized, PBN mycelia will become legitimate and be sought after by researchers in the mental healthcare field. Scientists would then proceed to produce these mycelia without having to worry about their being banned after having spent time and money in producing them.

Chapter 1.  Beware of all Synthetic Chemicals, Ingestible and Non-Ingestible, including Drugs and Additives [To be added to my new book, “My Psilocybin Trip”]

They are all poisons, meaning innately having side effects some of which become new diseases, generating the vicious cycle (VC).  The presence of this VC begets new diseases that require more new drugs to treat.  That perpetuates the VC.  

This VC is only possible when synthetic drugs are used in therapy because they are brand-new to our planet, made mostly from toxic petroleum.   We intentionally ingest these soluble chemicals (drugs and additives) into our body, not being aware of what they may have been doing to our body while helping us in solving some short-term problems.  Unlike traditional medicines (e.g., herbs) that have been tested and used by our forebears for millennia and more, our modern medicines (synthetic drugs) have no more than around 100 years of serious use history tops, and most only a few decades. 

Not  just the ingestibles, non-ingestibles are even much worse, though their effects don’t appear until decades later.  Take plastics.  They first pollute our environment, then as they decay over  numerous decades, eventually into micro and nano particles, to enter our body via our food and water.  These are only one group of many inedible synthetics for our living comfort and convenience.  After many decades, we are now beginning to know about them as microplastics.  So, again, our born free will lets us do what we like but we have had so much fun and made so much money that we don’t think about our other fellow humans.  Even though our conscience hits us now, it may be too late.  Regardless, we must do something and NOT accept defeat.  I hope my friends and colleagues will wake up!

  1. Problems with our viewing Modern Health  Sciences based on Single Chemicals by Themselves or within Complex Media like Herbs and Living Organisms.

As scientists and/or innovators, many of us are dense and most simply follow the crowd.  Each of us keep digging our hole (a specialty or  chemical) deeper and deeper, never surface aboveground to observe what our digging has done to our scenery (health & environment). 

Since our synthetic era began 200 plus years ago, we have increasingly been making countless brand-new inherently toxic chemicals from mostly toxic petroleum.  These ingestible and non-ingestible chemicals steadily and quietly damage our environment and health, especially in recent decades.   There is no abatement but endless destruction, worsening day by day.   Furthermore, many of us who are from Europe, enticed and encouraged by capitalism, have been  invading and exploiting natives around the world for centuries now.  They continue to produce entitled descendants who seriously believe they own the world, hence filthy gazillionaires like Elon Musk, who have no shame or morals, only with a me, me, me mentality, behaving like a spoiled 9-year-old brat, recently stolen his rich parents’ treasure trough with help from his 10-year-old buddy

We cannot analyze this phenomenon without looking at the broad picture that includes the following topics that I have already published throughout my writings, otherwise we may simply continue to dig deeper holes: 

—Vicious cycle of synthetic drug therapy – synthetic vs natural – drugs vs additives & their impurities

—The modern evidence-based science vs traditional experience & wisdom (drugs & herbs), the time factor (esp. weeks/months for computer-made vaccines vs years/decades for traditional ones)

—Declining capitalism vs a form of socialism – DeepSeek vs US gazillionaires in new open-source superior AI developed in a tiny fraction of time and cost (months vs years/$6M vs >$300B)

—Should utilize more of our planet’s intangible cosmic elements (light, microwave, electromagnetic, Chinese Chi/Qi, etc.)

—Be more aware of human limits (ignorance, arrogance, etc.) often manifested as self-grandeur or narcissistic and  psychotic fantasy, playing God or the Invincible /Infallible.

2. Drug Therapy with Synthetic Chemicals is Bad for our Environmental and Health!

Drug therapy using synthetic chemicals always produces side effects and/or new diseases, no matter how scientific we always claim it to be.  It has been over 200 years now.   Because of this, we continue to have ill health and an increasingly polluted environment.  Some major corrections have to be made regarding the increasing number of synthetic chemicals (drugs & additives) being continuously churned out by the synthetic process, especially during recent decades, which few people notice. 

Since toxic drug therapy needs something else besides its synthetic chemicals to ameliorate their toxic effects to better its current  status, the most logical and safe way is to bypass synthetics with natural chemicals or traditional medicines (like herbs) that have been time-tested by our ancestors over millennia and handed down to us.  This chapter is based on the concept of complementing or bypassing modern drug therapy with natural traditional medicines (herbs) that have been time-tested to be safe and effective by our  ancestors. 

3. Synthetics (Drugs/Additives) vs Naturals (Traditional Medicines/Herbs) and the Vicious Cycle (VC). 

First, let’s take drug therapy using synthetics vs traditional medicines.  The biggest difference lies in their length of time of experience and their resulting accumulated wisdom.  The pre-therapy testing (in vitro & in vivo) is scientific; so is testing in animals to some extent.  Testing in humans, such as clinical trials in extended periods of time, is not necessarily scientific, because synthetics are innately toxic, and contain impurities whose toxicities are seldom, if ever, tested.  Hence, our modern synthetic drugs always have side effects, and we are not sure where they come from, making them carry an important unknown due to their impurities.  Thus, with such a big uncertainty, is modern drug therapy still scientific?   Furthermore, synthetics, brand-new to our planet and with unknown toxicities, are the only chemicals that create the VC – the fountain of gold for Big Pharma & Co. but doom for modern-drug consumers.

In contrast, traditional medicines, like herbs, have been tested and then used by humans since ancient times.  We know which herbs are safe to take and which ones are toxic to avoid.  Some civilizations keep detailed written records and have tens, or hundreds, of thousands of herbal formulas, like in Chinese medicines.   Many of them are still being used up to this day, despite ignorance, self-interest and/or greed had prompted some drug experts to try unsuccessfully to remove traditional medicines from modern healthcare during past decades.  They claimed these medicines were not scientific, not being aware that most modern drugs, after clinical trials and approval, are subjected to the same process of trial-and-error that our ancestors used eons ago to develop our traditional Chinese medicines that are still widely used today!  Though many of these (now as ‘supplements’), are being promoted with American exaggeration (lies) as ‘modern’ and being sold at double or several times the prices of their Chinese counterparts.  Since there are still no identity and quality standards for such commercial products after my openly advocating them for 30 plus years, any 2 such products with their labels containing the exact same herbal ingredients can be different as night and day on TLC/HPTLC fingerprinting.  This is through my personal experience with my products vs those typical on the market.  For years I have owned my production facilities, lab, and library of Chinese medicines/herbs. I have never openly advertised for clients, large and small.  They just came by word of mouth.  A few are well-known.  The products I formulated and produced for them contain Chinese tonic herbs (that double as food and medicine) and used daily over centuries/millennia by the Chinese population.  My family and I still use them, especially for cold and flu and minor aches and pains

While Pharmacopoeias like the UPS/NF, AHP, BP, and ChP all have detailed identity and quality standards for raw materials/herbs, they do not have them for the finished, commercial products.  I have never understood why, especially we are in an American marketing world that is prone to exaggerations and lies.   Hence, with drug chemicals that meet the raw chemicals’ standards of identity and quality, you can test them in the finished products.  Not so with complex herbal products, as there are no identity and quality standards for them in the finished products!  Because of this, I have lost most of my products and their trademarks.  Except for one of my multimillion-dollar clients, I don’t believe the founder of a billion-dollar client of mine was involved in switching to cheaper imitations/adulterations.   Some second- or third-level managers were responsible.  Later, when we analyzed their fake products along with our original products by HPTLC fingerprinting, they were so obviously inferior that it was like a joke.  If I were one of those who cared only about the profits (though I’ll never be one), I could have sold them fake products with token herbs and made 5 to 10 times more money.  Regardless, these former clients of mine continue to make additional millions of dollars on my name and trademarks.  Hence, I am back from retirement to form my PBN Naturals Worldwide Consortium [PBN = Psilocybin, Baeocystin, Norbaeocystin] to first afford natural PBN mycelia to interested colleagues (researchers & practitioners) by bypassing the synthetic psychedelics that have so many innately toxic unknowns, especially their impurities.  Then, I will deal with synthetics in general (drugs & additives) that may have the right raw materials but widely different finished commercial products.  Since Pharmacopoeias like the USP/NF and AHP or government agencies (FDA, ODS, etc.) don’t deal with commercial products, they all trust manufacturers to be honest to put in the correct ingredients.   Lots of luck!  I don’t have another 100 years to see that happen, if ever!  So, I want to speed up the process for the sake of our posterity.  Hence, my PBN Naturals Consortium to start.  But before doing so, I need a  coding/programming expert to write a program to tie my members/partners and their financial and technical contributions together.

Now, as to my products, the only genuine one I still have on the market is the PhytoChi, produced according to my formula and sold by a Czech company, Phyto.CZ.  Any other companies selling PhytoChi anywhere in the world don’t have the genuine product unless it is from Phyto.CZ.  So, buyers of PhytoChi beware!

4. Synthetics vs Naturals and the Time Element that can be Shortened with Innovative Thinking but not by the Usual Passage of Time.

 The recent Chinese company, DeepSeek, may be a wake-up call for America.  Our capitalism protects only rich companies top down and tend to exploit the workers and the poor, keeping them at the bottom.  These companies will do anything to maintain their monopolistic advantage, with our government’s sanction.  We have been taught to avoid or dismiss a socialistic approach, because  we are a democracy (at least trying to be) for only 250 years, 50 years after we had synthesized our first drug, chloral hydrate.  Our democracy sounded good, but our capitalism probably had started to kill it during the past 2 decades.  The few gazillionaires (can be counted on our fingers) are holding the vast majority of America’s wealth and are exploiting the majority with financial and political help from our government.  Their primary goal is profits for themselves.  Despite getting support from our taxes, they rarely pay any income taxes with an exception, Warren Buffet. 

I think DeepSeek is going to disrupt the status quo in the new artificial intelligence (AI) space, causing a new world order.  Since DeepSeek has made its product(s) open source after having developed them only in months with less than $6 million, as opposed to American tech giants having spent hundreds of $billions (ChatGPT alone >$300B?) over years.  I totally understand how this can happen because in my own fields (drugs, cosmetics, herbs & microbiology), being self-employed except for 5/6 years in industry, I have personally experienced cronyism and the lack of innovation among academic and government agencies, while consulting for, or interacting with, them. 

Despite these, I’ve endured and emerged successful in different fields.  See my story in “My Life & Rollercoaster Career (CreateSpace, 2018)”, in which there is a chapter featuring my beating a world-famous group in a database contract in natural products with the National Caner Institute (NCI) in the 1980s.  My one-person company, along with a small new computer startup as my subcontractor, won the contract but was not awarded the $1million because NCI said it did not have the money.  Sure!  Cronyism!

Regardless, the vicious cycle (VC) has been the most important element in our health and environment in recent human history.  Since the synthetic era began around 200 years ago, we have been synthesizing countless chemicals, both ingestible and non-ingestible.  This process, accompanied by the VC, continues, and is already non-stoppable, causing the deterioration of our environment and health.   If we (esp. Americans) continue to pursue just profits and leave our ill health and ruined environment to our grandchildren and theirs, there is no future for them.  The only option is to follow some narcissistic idiots to go into outer space, leaving behind a ruined earth!  Hence, lack of innovative thinking and compassion in our health scientists is dangerous to human health, especially if they are corrupted by greed and/or ignorance!

Posted 2/15/2025

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]