Mental Health Self Care – A Key to Positive Mental Health
September 2, 2019Fasting Gets Easier
September 9, 2019Drink HRW Beginnings: Invention of Open Cup Hydrogen Tablets
Part IIII
It’s funny how emotions work. Something that I was so deeply against to the core of my being just a few weeks before, that I tentatively and hesitantly agreed to explore became my absolute obsession when it became possible that it may no longer be an option. It’s a concept I was well aware of, “cat string theory” and “we want what we can’t have.” Despite being fully aware of the psychological phenomena, when blindsided with it in practice, I became fully susceptible to its enchantment.
My tablets, while a “success” in many ways and arguably a dramatic improvement on the competitor’s version, had a few drawbacks and were considerably worse than the prototypes. Perhaps it was a miscalculation sending the hand-pressed prototypes and successful prototypes from the scale-up. If I had simply waited until production finished, I could have sold the benefits. Instead, I was stuck with the devastating blow of a product being dramatically worse than first advertised.
The hydrogen concentration, while still significantly higher than MK’s tablets, was about half of the prototypes. Likewise, while the taste was significantly more palatable than MKs tablets, there was a taste. My prototypes had an almost indiscernible taste, just a hint of mineral to a refined palate. On top of this, there was some residue and sediment. An incredibly small alteration to our process had resulted in dramatic differences in the end product.
This created confusion and uncertainty. Could I be trusted as a manufacturer? How would my next run turn out? Distribution options that had passed on MK’s tablet and been enthralled by the possibility of my prototypes started passing until a better option was available. Others that had reconciled with the need to dump the inventory of MK’s tablet as they couldn’t compete and couldn’t justify the sale of such an inferior product, rationalized that the improvement wasn’t that substantial, and they could wait until they ran out.
My new reality set in. I had agreed to an exit plan with my other business, I had two mortgages, and now I was faced with having no income and no idea of how to resolve my dilemmas. My former partner was luckily incredibly understanding and we agreed to a longer phase-out where I would be involved in lesser capacity for a longer period. This only mitigated my stress as I had emotionally resolved to leave my last business. I do not do well with continuing with something after I have decided to leave or stop that pursuit. When I decided to take a position and move from Vancouver to Toronto, I left days after giving my current partner and VP of Operations Terrell, who was my roommate at the time, day’s notice, and the following month’s rent. I am not sure I even told all my friends I was leaving, I barely told my family. When I returned a few years later, I made the decision one evening and was packed and gone in two weeks. I found someone to take over my lease, packed my life, severed ties with my career, and hit the road. I’ve never done particularly well with being told I am required to do something or reconciling doing something just because I need to for some artificial or superficial purpose.
That fun old habit of dry heaving from stress until I began vomiting resurfaced and I was incapable of extended sleep. While emotionally crippled with stress and anxiety and going into autopilot in other areas of my life, I obsessed over solutions to my problem with the hydrogen tablets. I quickly realized that Dr. Holland had no knowledge of either manufacturing or excipient formulation issues, his expertise was strictly in chemistry. My manufacturer, while open to trying any solutions I had, had no input and had never seen anything like this. I was later told by a formulator specializing in effervescent CO2 tablets, which are known as difficult in the trade, that the tablet I ended up developing and is widely available on the market was by a factor of 100x the most complicated and difficult tablet he had ever seen.
I conferred with Robert, who by that time I knew had tried to develop his own tablet, and he let me know many things that had failed and why they had failed. Since no one had ever actually succeeded yet, he couldn’t help me with that part. I realized that there was no one that could give me the answers, no single person that I could turn to for assistance. This was an issue that was very unique, very specialized, and very esoteric, so much so that the number of people who had ever considered the problem could be counted on my hands.
I developed what I will attribute and name a “Kurzweil-ian strategy.” Ray Kurzweil noted the need for a general science Ph.D.’s in one of his books, for the life of me I cannot remember which as I’ve read most of them. Ray mused that our collective knowledge is far vaster than we realize, but due to the specialized nature of research various fields, lack the ability to communicate with each other. He posited that if we had individuals with general science Ph.D.’s, tasked with communicating in laymen’s terms with experts in each field to ascertain what they had discovered, they could effectively put puzzles together by linking various fields of knowledge. This reasoning had always resonated with me and I decided to utilize it.
I had a Ph.D. chemist, engineers retained, a physicist I was bouncing ideas off of periodically, and a competent and motivated manufacturing partner. I didn’t have a formulator, however, which I learned was the most imperative part. I quickly tasked myself with this role, spending all free hours reading study after study, textbook after textbook, anything I could find online about the complicated art of excipient usage to not have a deleterious effect on active ingredients(APIs), or in my case delicate reactive ingredients. As one would expect, no literature existed on my exact dilemma, so I was stuck on postulating the causations of the effects and reasoning on solutions based on incomplete data.
My manufacturer was rather new in their existence and as I have mentioned, was eager to help. As I would come up with a new idea, I would bounce it off each of my respected experts in the aspect pertaining only to their field of expertise. A phenomenon exists where experts are sometimes more confident in areas they have only a base level of understanding than in their own field and may run the risk of conflating very different issues or giving too much or too little credence to an area outside of that where they’re familiar. Conversely, they may realize that there are variables in which they cannot account for and do not understand and hesitate in their advice or position. This perverts their perception of their own field, leading to worse advice than would typically be expected. For this reason, I systematically deconstructed the issues into each pertinent category and presented only the problem and my proposed solution to what mattered to that individual and their expertise. No one could see the “whole picture” except me.
My first production run took place in early July 2016, and by the end of August, my manufacturer had stopped numbering my proposed formulas. We adopted the rule of only adopting #s for those formulas which were an improvement. By October, this had reached 37, the actual # of adjustments exceeding another 1,000, and we stopped numbering the formulas in our conversations and only on paper. Improvement became an obsession. My partners, manufacturers, and everyone involved would routinely ask me, “isn’t it good enough?”, but I wasn’t satisfied. I wanted it perfect or at least as close to perfect as I could get. If I was capable of getting it this far, in that amount of time, surely someone else would outpace me and make my discoveries obsolete.
Not only was our manufacturing arm delayed, but Drink HRW was delayed. Due to how we were setting up the business, I was being forced to put one of my houses up as collateral to get a merchant account, and the application process took months. Without a merchant account, we couldn’t beta test any of our systems or work out any kinks before launching. While we had intended to launch in July when our inventory was ready, in actuality, we launched in the first week of October with no internal testing of our site, software, and payment system as we couldn’t wait any longer.
Launching our site succeeded in my goals. The feedback on the product was positive, better than I expected at this point from months of my own self-criticism. Sales were brisk, better than I anticipated. My outreach campaign to contact other companies involved in H2 was met with astonishing levels of response, overwhelming even. That said, the issues with our software (that had never been tested) were numerous, retarding any growth. I didn’t have the staffing or time to deal with both pursuing overall growth and ensuring our own small brand was operating. Luckily, I chose to deal with the larger issues, pursuing the industry while continuing to try to perfect the tablets. I started soliciting hydrogen water brands the day my site launched, within two weeks I had my first deposit for a private label. The timing was critical as I was quickly burning through not only the couple hundred thousand I had put aside personal but the money I had pulled in through investments. R&D was taking up far more in costs than I had ever imagined.
My phase-out at my previous business had taken effect in October. While I was still assisting with the business, it was only via phone and e-mail. I no longer needed to travel, and therefore could do all of the R&D myself. Through the summer and into September, I continued to correspond with my friend who was assisting in R&D (mentioned in Part III) and would send formulations to my facility, delivered by any friend or family member I could find to help me, but now I could fully focus. I could also guarantee I was at scale-up runs in-person to visualize issues in real-time and troubleshoot with the knowledge I had accumulated.
I cannot overstate how many times I read and re-read every study, paper, review, or volume on pharmaceutical formulation I could find. It was all I read. Over and over again. I tried everything, every combination I could think of. I dug out old patents, and new, from pharmaceutical companies and created systems in utilizing their logic. Many things worked, but nothing worked exactly how I wanted it.
The biggest challenge, and accompanying discovery, while created by my formulation work was a complete accident. I was reaching, based on psi, what should have been 4-5 mg/L or hydrogen water levels of 4 or 5 PPM in 500 ml of water, in under 5 minutes. In reality, I was reaching this level in a frothy white solution seconds after opening the container and it would quickly fall down to ~1.6 mg/L, the saturation point. This was quite befuddling, and no matter what I did to solve the challenges I was tackling, it kept happening.
To quote Isaac Asimov, “The most exciting phrase to hear in science, the one that heralds new discoveries, is not ‘Eureka!’ but ‘That’s funny…’”
In my case, it was a bit of both. It was literally months of “that’s funny” and then “this is mind-numbingly infuriating,” finally followed by a eureka moment in December 2016. I had been sealing about 10 L of hydrogen water in 2 L jugs, and then slowly releasing them into my bathtub for topical H2. I was feeling “lazy” one day and decided to just bring the pills into the bathtub and add them close to my tender muscles. I noticed this same “white cloud” was forming that formed when I opened the sealed bottles. I leaped out of the bath and ran to get testing supplies, hopping back in the bath and dropping in some fresh tablets. I tested the white water and was astonished, the levels were above saturation.
I couldn’t believe what I was seeing. I tested tablets in triplicates, in 5 different volumes of water, and then did it again. And again. And again. I was getting the same results, or at least close to, every time. The results were different at different volumes of water. I started texting with Dr. Holland, culminating in a call, which lasted at least a couple of hours. While there were many hypotheses, we certainly didn’t leave the call confident in some breakthrough. It really didn’t make much sense.
I did what may seem counterintuitive to someone in business, but was absolutely the right and necessary thing to do for intellectual honesty and the pursuit of understanding. I immediately reached out to both Tyler W. LeBaron and Randy Sharpe, the maker of the test reagent. The level of skepticism I received back from both of them was as close to absolute as it can get. I spent days letting them know what I was seeing, sending accompanying videos of me conducting the testing, and my own attempt to falsify, which was sealing the cloud under pressure at the height of the cloud which corroborated the readings- the pressurized “cloud water” would build up expected psi, then test for similar levels of H2, saturated and “clear”, after allowing to hit an equilibrium. After all of this, they started entertaining the thought.
As discussed in my interview with him here, Tyler watched my videos of attempts to falsify and still didn’t really believe me. He asked that I send him some tablets and he did the tests himself, coming to similar findings. Randy also wasn’t keen on trusting my word and asked for samples as well, conducting numerous of his own tests over the following months, including a gas evolved report he took the initiative of doing, further corroborating what was going on. Tyler ended up taking tablets to other facilities throughout Asia during his academic travels to test with other methods, and each time it kept pointing to this phenomenon being real.
I hadn’t wasted time waiting for their confirmations, I was moving faster than I have ever moved in R&D. My house was an absolute disaster, there was powder everywhere. I was barely sleeping, and I had scrap pieces of paper and a pen on every surface in my house in case I quickly needed to jot down thoughts, in the day or in the middle of the night as I awoke. I completely deconstructed my entire formulations and started from scratch. I had to throw out every conclusion I already had. I began incrementally altering key components at the smallest adjustable levels while graphing results. I remember Randy Sharpe joking with me that the 10 ml H2Blue test kits weren’t sufficient for me and asking if he should make a special order drum. It wasn’t far off, while I don’t know exactly how many bottles of H2Blue I went through, it was enough to have a financial reviewer from the Canadian Government inquire about it.
Between December 2016 and March 2017 I ran well over 1,000 formula adjustments. I tested different formulas and tested them with different alterations to each particle in each formula. I figured out what was possible in theory, and now I needed to make it a reality. Just as getting everything to work “in practice” and “in pilot runs” was much easier than successful manufacturing in the early days, it was the same case yet again. I had to take all of my data and then tear it down and reapply it to the effects of the reaction in the presence of excipients. Our first “go-to” open cup tablet was titled the “F6”, but it was dramatically different in the process than the “F6” originally created. Now the word was really buzzing. We were getting ~9 mg/L in 500 ml of water in under 2 minutes.
Yet again this timing was fortunate. I was completely out of money. R&D had almost bankrupted us, despite having two good customers for manufacturing at this point and brisk sales of Rejuvenation (even with the software and processing issues never being fixed). A new rush of sales March-June with our new breakthroughs and we were able to put funds back into our regulatory pursuits. With a sigh of relief, I was able to spare a couple of hours a day to begin my “researcher outreach program,” which basically meant e-mailing every research team that had published a paper on H2 (most never responded) and e-mailing anyone I knew may have connections in this area.
In the two years since this transition happened, we’ve received no objection from the FDA on NDI 1104, have 4 finished clinical trials (3 published, 1 is written and 5 others underway), and have continued to pursue perfection in formulations. Manufacturing to scale is a difficult task and while we are getting closer every day, we now have a full production press and mixing/processing set up in our own R&D facility to save the trouble for our manufacturing partners, perfection remains elusive.
As we spread our technology for creating hydrogen water across the world, supply products for clinical trials, and witness the exciting results, my partners and I cannot help but laugh about our humble, stressful, and rocky beginnings.
Due to the limitations in R&D work I have for this project – ideas come much slower on the pursuit of perfection – I’ve now turned some attention elsewhere. I’m writing, a lot, as anyone following my articles can see. Other health-related topics, ones that I would use to “take a break” from this work have become very much encompassing. This is a strategy I intend to detail in another article, I’ve used it to great success. As a takeaway, when reading, I will always have two, preferably three, volumes in completely unrelated fields I will oscillate between.
I hope this reaches anyone interested in hydrogen water, and specifically hydrogen tablet beginnings. While my partners are nervous about how much I have divulged here, as a message to my competitors: I am not nervous at all. Very little in what I relayed lends to completing any of these feats in practice.