A man in a wheelchair under the porte cochere:

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How the smoker’s supplement replacement product came into being

I was a junior year medical student in 1991 at the University of Miami School of Medicine and had just finished early for the day. Amazingly, a low work- load over for an internal medicine rotation at the Vah-Spa (a nick name for the Veterans Administration Medical Center, VAMC) versus Jackson Memorial Hospital, and I was leaving the hospital glad to feel the warmth and humidity of Miami weather.

I glanced over to see a man sitting in a wheelchair under the porte cochere, while others were standing to pick up rides he was sitting there in his PJ’s. At first glance, I saw a malnourished man with unkempt hair, scraggly beard, and bilateral AKA’s (medical speak for both legs amputated above the knees). He was just sitting there smoking through his tracheostomy tube. I surmised that he had peripheral vascular disease. I did not stop and kept walking and took a second look at a man who appeared to me to have the look of defeat. He appeared to have given up on life and was just marking time until he hopped off his mortal coil. The image of him smoking through a tracheostomy tube was just the most horrific thing to see. I said to myself, this is just very, very wrong and I was going to do something about it. I did not know what I was going to do, or how I was going to solve this riddle, but seeing him so dejected, and defeated had increased my resolve to figure out the riddle of tobacco smoking. Life was going on as usual, and no one seemed to care about this man or his plight. I continued my walk to the Metrorail station, but indelible images were seared into my mind at this point. I specifically remember that day because I was on the ramp waiting for the Metrorail train to come to take me home and I had the good fortune of sitting next to and speaking with J. Lawton Smith, MD. It’s not every day the opportunity to speak with the creator of an entire field of medicine, in this case, neuro-ophthalmology, presents itself. J Lawton had given us a lecture a few weeks ago, and I remembered him well.

In my previous medicine rotation, at Jackson Memorial Hospital, I had the good fortune of having as a mentor Dr. Mark Gelbard, an internist who took us on rounds where it appeared that one patient was sicker that the next. After rounds concluded we came back to our conference room to review what our plans would be for these patients, I did not know weather to laugh or to cry because of how sick they were. Dr. Gelbard told us that roughly 75% of the diseases that we were going to see were four common things found on dining room tables across America. We would see hypertension from ingesting too much salt. We would see Diabetes from eating too much sugar. We would see liver disease from drinking too much alcohol and smoking caused a plethora of problems, strangely enough, no one seemed concerned with treating the source, only in its effects So, most people in America would die because of the things found on their dining room table: salt, sugar, alcohol and tobacco.

In 1980 as a college student, I had been attended Werner Erhard’s, ‘Shot heard around the world’ Conference. I had seen him on a screen in downtown Miami. I remember being with my Dad and a pretty girl I had met at the University of Miami. The conference was a wake-up call for me to find and discover (really to create) what I wanted to devote my life to and to, ‘serve a purpose larger than myself’. It was from this conference, that I made up my mind that I would find a purpose larger than myself and serve it. Werner shared an Albert Schweitzer quote that stuck with me, “I don’t know what your destiny will be, but one thing I know: the only ones among you who will be really happy are those who will have sought and found how to serve.” After that conference, I was on the prowl for some worthwhile project to serve as my life’s purpose. It was roughly ten years later that I found that purpose in a man sitting in a wheelchair smoking his cigarette though his tracheostomy tube.

So, now that I have found a reason to create my purpose, my raison d’etre I started on my adventure starting from tabula rasa, but I lived inside the question of how to help tobacco smokers. From there I learned, got answers– some good, some not so good– but eventually, I was able to create something unique and the US Patent and Trademark Office (USPTO) granted me a patent.

I had then, as a medical student spent time with the acting Chairman of the Department of Pharmacology, Roger F. Palmer, MD, in his office on the island of Key Biscayne, Florida. He had a form that helped determine if the addiction to cigarettes was purely physical, psychologic, or mixed. He then had a idea for the success of his treatment if it was a purely physical addiction. He injected normal saline into acupuncture points on the nose and ear to curtail or cure their smoking. There were other curiosities over the coming years as I learned about a reacted sulfa compound that blocks nicotine sites, to other vitamins, mineral, and neurotransmitter precursors that helped attenuate the desire to smoke. More recently, my mentors, Dr. Pam Smith, and Dr. James LaValle lectured on drug-induced-nutrient-depletion and were instrumental in opening a new vista out of which I was able to create new possibilities, never seen before, which lead to a smoker’s supplement replacement product. I was able to use the knowledge to create something new for myself which lead to the issuance by the United States Patent and Trademark Office (USPTO) to grant me this US Patent. I wish to thank my patent attorneys for their wise, magnificent, and meticulous assistance: John Smith, Nelly Kaufman, and Hathaway Russell.

A smoker’s supplement replacement product can go to the market immediately. It is not a drug claim, but is a nutraceutical, ie, a dietary supplement the purpose of which is to replenish lost antioxidants, and micronutrients. This results in giving people a fighting chance of staying healthier, and allowing their biochemical pathways to operate more effectively, by reducing oxidative stress. The smokers’ supplement replacement product is a dietary supplement designed to replenish antioxidant and micro-nutrient (vitamins and minerals) losses that unwittingly occur from tobacco smoking and secondhand smoke exposure. The diseases associated with tobacco exposure have as their origins these antioxidant and micronutrient reductions. It has been shown in the peer-review medical literature that smokers unwittingly lose antioxidants and micro-nutrients from smoking. Replenishment of these losses decreases morbidity and mortality, in addition to improved numerous biomarkers as shown by the medical literature. In fact, one of the constituents of the smokers’ supplement replacement product, N-Acetylcysteine (NAC), has been shown not only to increase glutathione, the master antioxidant of the body, but also prevent recurrence of smoking once a person stops smoking. Many people have quit smoking only to relapse. This may happen three to four times on average before they are finally able to stop smoking. The NAC may reduce this average.

As of 2017, there are approximately 34 million Americans that still smoke (a number way down from prior years). Currently there are now 350 million Chinese citizens that smoke, 740 million secondhand smoke affected individuals. In China, they consume 50,000 cigarettes per second. Amazing! One out of three Chinese men will die from the adverse consequences of tobacco smoke and secondhand smoke exposure. This is a national emergency for the Chinese. The highest frequency of smoking currently is in Europe. One in three smoke tobacco. The smoker’s supplement replacement product is also for secondhand smoke affected individuals. Outside of air filtration systems there is no biological product for them. It has been shown that they too experience unwitting losses of antioxidants and micro-nutrients and that replenishment of these substances has salutory effects. Childhood smoking is still prevalent throughout the world and the smokers’ supplement replacement product would help give these kids a chance of staying healthy by balancing the oxidative stress that tobacco smoking is with the replenished antioxidants and micronutrients. Those who smoke or who have tried to stop with nicotine solutions might be willing to give this a try. It will give them a fighting chance of staying healthy.

By only giving nicotine in the form of patches or gums, is like putting a band aid over a bullet hole. It does nothing for the unwitting losses of antioxidants and micronutrients that make the biochemical pathways work properly to protect us. By replenishing these co-factors, it allows the pathways to operate more effectively to protect us from our self-induced habits of long-standing history.

Harlan Bieley, MD, MS
September 9, 2019

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