Douglas Mulhall

The book Discovering the Nature of Longevity chronicles how thousands of patients are benefiting when damage inflicted by hidden stress on the heart and body is targeted.¹ This ‘hidden’ stress includes hard-to-detect, low-levels of heavy metals and stealthy infections that were not considered to be heart disease risk factors, until the American Heart Association recently declared heavy metals to be exactly that.  These provoke oxidative stress that attack the body early in life, triggering a life-long vicious cycle of injury and inflammation leading to hardening and blockage of the arteries.

A new wave of therapies is emerging that targets the damage from those stresses. One is a compound known by the trade name NanobacTX. In this Companion publication to Discovering the Nature of Longevity (abbreviated here as DNOL),Idescribe the first-hand accounts by doctors and their patients of results with the compound. Much of that success is due to the tenacity of its inventor, Gary Mezo, who weathered a 20-year ordeal of regulatory, medical, and financial barriers in order to continue providing it. His story is told here.

Readers familiar with the Townsend Letter know about the struggles that practitioners have endured in bringing the therapy  known as chelation to patients. The term ‘chelation’ often triggers preconceptions, even among the chelation community.  The first is that patients must receive intravenous doses in a doctor’s office or clinic for several hours at a time. This points to the well-known drawback of inconvenience, which can mean the difference between patient compliance and non-compliance.  The second preconception is that administration via IV is necessary because oral chelation often isn’t effective due to the chelating substance EDTA being destroyed by stomach acids.  The third preconception is that chelation should follow the ingredients list and administration method recommended by the American College for Advancement in Medicine (ACAM). 

Gary Mezo challenged all of those preconceptions. In so doing, he developed a compound and administration method that deviated from the norm, to provide convenience, affordability, and added health benefits to patients. The compound is not claimed to be a ‘cure’ for anything, but it does show surprising clinical evidence of lowering calcium scores² and, for example, reducing prostate stones when no standard therapy could. Cardiologists have also reported that their heart patients improve. Many patients have testified to this improvement.

The therapy still faces the normal hurdles that other chelation-related methods do – in particular the enormous costs of doing randomized double-blinded studies to prove the point.   As with any therapy, its effectiveness and side-effects depend on the individual patient. Nonetheless, any compound that endures 20 years of intense regulatory scrutiny and survives,  warrants attention. That’s why I wrote this Companion publication. What follows is an abridged version of Chapter 1 of The Story of NanobacTX: How a medical maverick improved cardiovascular health. I chose this chapter not for its technical description of what the compound does,³ but rather to give a real-life example of the long and winding road that innovators often must endure to develop new products. It is especially relevant for those in the chelation community who might appreciate more than others the trials and tribulations described here.

Chapter One – The Inventor

If there is one word to describe Dr. Gary Mezo, it’s tenacious. In 1997, he invented the compound that, according to some patients and doctors, is life-saving. After that, he shepherded it through a gauntlet of investors, then sold his company, watched it get driven into the ground, struggled to recover his intellectual property, withstood regulatory scrutiny, modified the protocol to be more patient-friendly, survived the 2008 financial crisis, survived the pandemic, then came out the other end with a compound that, according to many physicians and patients, is reversing the damage from atherosclerotic cardiovascular disease⁴ and other chronic disorders. This was all done without surgical intervention, often alongside standard medications that had been prescribed to patients.

Gary Mezo comes from a medically streetwise background that spawned this innovative approach. His experience ranges from emergency medicine, to family practice, to studies of physiology and biochemistry. In the days when he began developing this product, it was novel to see someone without the letters “MD” (Medical Doctor) after their name who was still qualified to diagnose and treat disease. As a Physician Associate (PA), he was a pioneer in the field, working to expand medical privileges for the profession. He says he served as a board member of the Illinois Academy of Physician Assistants,⁵ and helped to grow the profession nationwide. Today, many patients in the United States, Canada and the United Kingdom are seen by a PA or Nurse Practitioner (NP) at one time or another. They diagnose, treat, prescribe medicines, deliver babies in a pinch, and do much of what MDs do. It is accepted in most jurisdictions for NPs and PAs to serve as primary care providers.^{6 6,7}

After years of family and emergency medicine practice, Mezo began to see that more patients were taking nutritional supplements—also known as “nutraceuticals”—and herbal medicines. (See Glossaries in this Companion and in DNOL.) Although these were classified as over-the-counter products, he suspected that they were having effects that he didn’t have the scientific tools to assess (hardly anybody did back then), as well as profound synergies with standard medicines. At that point, he didn’t understand the physiological and pharmacological effects. As with many PAs and most MDs during that era, his conventional medical training didn’t include naturopathic studies. This knowledge gap spurred him to dive into naturopathic medicine, to understand the biochemical synergies between herbally sourced substances and conventional synthetic drugs, and how they could be used together for better results.

It was that blend of conventional and naturopathic training—then rare, and today widely practiced in countries such as China—that gave him a new understanding of the tools. It sent him down the road to discovering why prescription drugs were failing to effectively treat the causes of calcified arteries. His frustration had been growing at the number of patients who died despite surgery and drug combinations used to treat their disease. The prescription medications were controlling symptoms but leaving the underlying causes unaffected. Then one day in the 1990s, Gary says that a patient in his forties who’d had a heart attack, came to his Tampa office in tears. Previously he’d led a vibrant, active life, but after his heart attack he’d been off work for months and his finances were in ruins. He asked why no one could help him despite billions of dollars being spent on heart disease. He wanted to try something known as intravenous, or IV, chelation (for more on chelation see DNOL), but didn’t have the money to pay for it. He said even if he had the money, he didn’t have four hours weekly to take the IV drip treatment.

Gary knew that chelation was used for lead poisoning and that alternative medicine practitioners experimented with it to remove other heavy metals. However, he saw from his own experience in providing chelation to patients that the way it was administered back then wasn’t working as well as proponents said it should. To test this, he was an early adopter of coronary artery calcification scoring (also known as a heart scan),⁸ to measure the effects of chelation on hardening of the arteries. Through a friend who owned a mobile computed tomography (CT) machine used to perform those scans, he began doing the scores on about ninety of his own patients, without charging for the service, to see if chelation was having an effect on those scores.

Based partially on those results, he perceived that published claims about chelation’s mechanism of action seemed to be missing something. For most patients who received up to twenty treatments—which was the standard for the time_⁹—calcification scores improved briefly but increased again after treatment. Also, it was time consuming at four hours per session over at least twenty sessions.¹⁰ It was inexpensive compared to the tens of thousands of dollars required for surgery or a lifetime of drugs, but it wasn’t covered by insurance. “That’s OK if you’re wealthy and retired, but impractical or impossible if you’re not,” Gary says.

From his experience administering chelation according to the then gold standard set by the American College for the Advancement of Medicine, Mezo found that calcification scores didn’t decrease.¹¹ Nonetheless, the main chelating ingredient, appeared to consistently show temporary benefits for symptoms in patients.¹² The ingredient, EDTA (ethylenediaminetetraacetic acid) is a synthesized concentrate, which mimics natural substances used to remove, or chelate, toxins like heavy metals from the body. See Appendix II in DNOL for a detailed description of EDTA.

With his desperate forty-year-old patient in mind, Gary began scrutinizing conventional and alternative therapies, and concluded that most were being administered in the wrong place at the wrong time of day and were missing key ingredients that might help to dissolve the calcified plaque in atherosclerosis.

The First Steps

Combining his background in physiology, biochemistry, medicine, and naturopathy, he developed a formula that he believed would dissolve calcified and soft plaque and could be administered at home by patients. It included a compound of amino acids, vitamins, enzyme systems (substances that promote biochemical reactions), minute vasodilators (substances that widen blood vessels) and other nutraceuticals to be taken orally (see Appendix II for details on composition).

Knowing that the amino acid EDTA is destroyed by the stomach’s acidic pH, he also developed a special rectal suppository to replace intravenous administration. The combination of the oral component and rectal suppository he surmised, would be highly effective especially if used on a nightly basis instead of during the day when metabolism was different. He then filed for a U.S. patent on the formula and process—a step that would eventually lead him to forming a pharmaceutical company, which was a basis to clinically validate and further develop the approach. He then had a compounding pharmacist prepare his formula.

The Right to Compound and the Politics of Medicine

All pharmacists are trained as chemists and are often known in Europe and other regions by the title “chemist.” Compounding pharmacists do what they’ve done for centuries—mix ingredients on a customized basis for individual patients. Gary explains:

“Prior to 1900, most all medicine was naturopathic, and chemists (pharmacists) would compound whatever the doctor wanted the patient to have. The first patent medicine companies [pharmaceutical companies] arrived in 1900. They would make mass quantities of their patent-protected medicines and sell them to the chemists. This was also the beginning of allopathic medicine, signified by the letters MD in front of a doctor’s name, and the political decline of naturopathic medicine. Soon, politics and the banding-together of the patent-medicine-companies slowed the process of chemists’ compounding.”¹³

The distinction between compounding and manufacturing starts at the point when the drug is put together. Under U.S. legislation, a compounding pharmacist is exempt from regulation as a manufacturer…

“…if the drug product is ‘compounded for an identified individual patient based on the unsolicited receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient.’”¹⁴

Compounding requires a physician to deliver a prescription to a pharmacist, who compounds it for a particular patient. Manufacturing, on the other hand, involves making prescription and non-prescription drug doses by the millions, packaging them, and reselling them to pharmacies. In this case, the pharmacist is only involved in passing on those manufactured products to patients.

Compounding had been dying out gradually since 1900 but made a comeback in some parts of the world starting in the late 1990s,¹⁵ due to new demands from alternative medicine physicians to meet patient needs. In the United States, manufacturing and advertising of compounded medications are regulated by the Food and Drug Administration (FDA). Mezo’s compounded formula could be provided to patients and physicians quickly because it wasn’t a manufactured drug, so he didn’t have to wait years and spend hundreds of millions of dollars for the FDA to approve it. Mezo adds that the ingredients in his formula (see Appendix II below) are classified by the FDA as “generally regarded as safe” (GRAS).¹⁶

Experimentation

Gary’s studying, supported by experience, suggested to him that a buffered form of EDTA would not irritate the rectum and would be absorbed into the blood in a similar way to how other drugs administered by suppository were. Stomach acidity can destroy many drugs, but rectal insertion lets them bypass the stomach and intestines, reducing the amount of drug required. He then did something that many doctors have done but often won’t admit to: He tried the compound on himself. There were no apparent ill effects, so he began working with four severely ill cardiac patients who faced bypass surgery or certain death from their illness. They had an incentive to try something new. To his delight, and as he expected, they started showing signs of recovery. Heart patients who were “cardiac cripples” were rapidly improving. He says that within a month, they began walking without chest pain (angina) and reported being able to see better and feeling better overall. “Exercise tolerance improved and their need for nitroglycerin stopped when their angina ceased,” he says. “In some men, their erectile function improved, and enlarged-prostate symptoms abated. One painlessly passed a smooth kidney stone.”

These were only early results. Mezo was worried about kidney function because EDTA had been reported in those days to cause stress on the kidneys if given too rapidly.¹⁷ Contrary to those reports, he says that his results showed kidney function beginning to improve in patients.¹⁸ Liver function was also monitored and indicated improvement. Since there appeared to be no adverse side-effects or negative effects on serum, blood and urine values, there was no apparent threat to safety.

“Darling, I’m going to solve heart disease.”

In 1998, Gary informed his astonished (now former) wife that he was leaving his medical practice to start a center to apply his formula. He had to focus on maintaining the legally required triad among pharmacist, physician, and patient. When a drug is compounded by a pharmacist, it has to be customized for each patient on the instruction of a prescriber. Mezo designed a compound prescription, using rectal suppositories and an oral component nutraceutical powder compound, all to be administered nightly at bedtime.

What followed was a series of clinical studies conducted or directed by him, with some being published and some not, as well as an extensive relationship with scientists from Finland and Turkey, principally with Dr. Olavi Kajander (as covered extensively in the earlier book, The Calcium Bomb and not repeated here).

After The Calcium Bomb was published in 2005, Gary, his company and the product went through twists and turns, including the product being licensed to a startup company that subsequently went out of business, with the result that the product ended back with him. That’s a short rendition of a ten-year journey, which included a brush with regulators who didn’t like the way the product was being portrayed on company websites. These difficulties were finally resolved when the FDA issued a letter that Mezo’s company website had addressed all of the regulators’ concerns.¹⁹

Improving Accessibility with Mass Manufacturing

In that timespan, Gary says he improved and changed the product by using patented capsules to prevent dissolving in the stomach, and dissolve and release contents into the small intestine at a set pH for efficient absorption.²⁰ This eliminated the need for a suppository and made the product far more appealing to patients (the rectal suppositories every night were not popular). Subsequently, he says, patient compliance is greatly improved. According to Gary, his formula remains pharmacokinetically (the pathway followed by chemicals into, through and out of the body) and physiologically the same as the original. He says effective levels are maintained for twelve hours post-administration at blood serum levels superior to the previous iteration (the suppository version). In total, the effort to improve accessibility to the product included changing it to an all-oral formulation, eliminating the prescription antibiotic tetracycline that had been used alongside it, and manufacturing the product instead of compounding it, which brought it under different FDA regulations. All of this made the product less expensive, and more convenient. The trade-off was complying with FDA rules about manufactured ‘dietary supplements’,²¹ which limited the company’s ability to describe what the product actually does for patients.²² This classification meant that no specific health claims could be advertised about its effects. It’s a strange contradiction that doctors and researchers can call nutraceuticals ‘treatment” for a heart condition, but the companies that sell them are forbidden by regulations from doing the same thing.

All of this might seem like technical detail, but it’s a great example of why nutraceuticals are given such a hard time by regulators when it comes to claims about benefits for patients. The alternative would have been to raise hundreds of millions of dollars to perform clinical trials in order for the therapy to be classified as a drug with specific and claimable cardiovascular effects. Most nutraceuticals manufacturers don’t have that kind of financial fire power, due to the lower profit margins of many nutraceuticals compared to patented drugs.

Gary explains why he sees his formula as a major breakthrough. According to him, using intravenous EDTA chelation alone to remove arterial plaque is “incomplete and inadequate” because it doesn’t address the underlying cause. He says that the main risk associated with chelation is “unroofing” calcifying nanoparticles (CNPs) from their dormant state, without using the synergistic ingredients required to eradicate them. [Author’s note. These and similar particles are described extensively in DNOL.] The particles cause trouble—including risk of heart attacks— when released into the bloodstream. He says the risks of unroofing them without deactivating them cannot be overstated. This might explain, he says, why some patients’ conditions seem to temporarily improve then get worse again with IV chelation, which is administered for only brief periods. The phenomenon isn’t limited to IV chelation. Mezo says he observed that patients who had kidney stones pulverized, or stents put into arteries also have relapses. He says, “Each of these phenomena share the same cause. Unroofed [particles] that then go to other parts of the body and, if not excreted, will seed new pathological calcification.”

Magic Is in the Method

Mezo’s compound is administered at a different time of day via a different route than IV chelation therapy (orally instead of by needle). When this method of administering EDTA is used in combination with other components, he says it leads to synergies and novel, fundamental differences in pharmacokinetics, excretion, and mechanisms-of-action. “NanobacTX specifically targets calcifying nanoparticles as the underlying trigger for calcification, whereas administration of EDTA in any form alone cannot possibly be as effective,” he adds. “NanobacTX is ingested at home, eliminating added medical visits that interfere with lifestyle and work, and at a small fraction of the cost of traditional chelation. “The cost (as of 2022) is $199 for a 30-day supply. IV chelation is about $200+ per session compared to one night of NanobacTX that costs less than $7.”

Challenges Scaling Up

He believes that, at least in the United States, patients as much as physicians will drive scale-up of the product, simply because patients don’t get the same benefits from drug and other therapies, and the copay portions of their insurance for those drugs and surgery are becoming ruinously expensive. He bristles at the criticism that his product is too expensive.

“Expensive compared to what? Dying? Having open heart surgery and all the drugs that come with it? Not being able to work?” He argues that “the cost for a year is far less than the co-pay provisions for surgery and drugs in many insurance policies, and besides that, those surgeries and drugs don’t work. They don’t reverse plaque or calcification effectively.” Retired from medical practice since 2000, Mezo is CEO and Chief Medical Officer of NanoBiotech Pharma, his company that oversees manufacturing and sales of NanobacTX, and its variants Urobac and RegenurEYES. He says that NanoBiotech Pharma has no debt, robust global sales, and licensed sales in the Far-East that have shown considerable promise. Mezo says he personally ensures that manufacturing of his formula meets strict FDA guidelines for certified good manufacturing practices (c-GMP), and in the United States is done at FDA-licensed facilities.

The patient population being served by these products compared to the patient population suffering from calcifying conditions is still minuscule, due largely to restrictions imposed by the FDA on claims that can be made about the product. Even though formal, published cardiology and urology clinical studies have validated results from using Mezo’s formula, according to FDA regulations, the company cannot say that it treats or cures any disease. Nonetheless, Mezo and his partner physicians continue to educate other physicians on the potential benefits of using the product in their medical practices. Because it is not a prescription compound, many ancillary health providers (chiropractic physicians, naturopathic physicians and other non-prescribing alternative health practitioners) have embraced it in their practices. Mezo remains optimistic that the time for rapid scale-up has come because enough patients are fed up with the standard approaches that don’t seem to work. Considering that this type of heart disease is the number one killer of women and men worldwide, Mezo suggests that

“a reasonable alternative to dropping dead without warning or having an expensive and painful risky bypass surgery or stent, is that you start NanobacTX. If you are 35+ with a family history of heart disease, then you get a Coronary Artery Calcification Score done. The “CAC Score” predicts accurately your risk of heart attack or stroke over the next 10 years.”

Disclaimer. This is not medical advice. Anybody wishing to use any of the methods or therapies described here should first take medical advice from a qualified healthcare provider.

Appendix II—NanobacTX Ingredients

The following list is based on the 2023 label on a bottle of NanobacTX. Citations denote the author’s search results for publications describing cardiovascular and epigenetic effects of individual ingredients. For lists of the uses, benefits, and risks of these ingredients refer to the Glossary and notes.

The sequence denotes: Ingredient name, Amount, and percentage of Recommended Daily Dose contained in 8 capsules.

• Vitamin C 2,500 mg, 4000% recommended daily dose^53,54,55
• Niacin (Vitamin B3) (as Niacinamide) 50 mg, 250% recommend- ed daily dose^56,57,58
• Pyridoxine Hcl (vitamin B6) 82 mg, 4100% recommended daily dose^59,60
• Folate (Vitamin B9) 500 mcg, 125% recommended daily dose^61,62
• Selenium 60 mcg, 9% recommended daily dose^63,64
• Proprietary Blend 3335 mg
  • Papain *
  • Grapeseed Extract * ^65,66
  • Hawthorne Berry Powder* ⁶⁷
  • Coenzyme Q10 * ^68,69,70
  • Trypsin * ⁷¹
  • Bromelain * ^72,73
  • L-Ornithine Hcl * ⁷⁴
  • L-Lysine Hcl * ⁷⁵
  • L-Arginine Hcl * ^76,77
  • Edetate Disodium Dicalcium * ⁷⁸
• Other Ingredients: Cellulose, Mg Stearate and Silicon Dioxide.

* % Daily value not established

Glossary of NanobacTX Ingredients

This glossary is for non-medical readers who want to know more about technical terms. It focuses on the ingredients in NanobacTX. For additional reference publications on each substance, see the references below. A more extensive Glossary is found in the book, Discovering the Nature of Longevity.

Bromelain—A protein-digesting enzyme, derived from pineapple, that is thought to help fight plaque. It is a natural blood thinner that lessens the risk of blood clots and reduces inflammation.

Coenzyme Q10 or CoQ₁₀—A naturally occurring nutrient that helps the body’s cells to produce energy. It is claimed to lower the incidence of angina attacks, arrhythmias, cardiomyopathy, congestive heart failure, heart valve irregularities, hypertension, mitral valve prolapse, and periodontal disease.

EDTA, ethylenediaminetetraacetic acid—A broadly used FDAapproved food preservative and a preferred treatment for lead poisoning. Once in the blood, it binds to heavy metals, and the resulting combination of EDTA, metals, and minerals is excreted during urination. It has many properties including anti-inflammatory. See Discovering the Nature of Longevity for more information.

Grape seed extract—An antioxidant used to maintain the health of small blood vessels.₇₉

Hawthorn berry—A herb claimed to lower cholesterol, normalize blood pressure, and reduce inflammation.

L-Arginine—An amino acid that helps blood vessels stay flexible to im- prove circulation. It also helps the body to fix damaged tissue and bone. It is also known to stimulate production of growth hormone which assists in healing and normal function of tissues and organs. It helps boost nitric oxide improving circulation to tissues.

L-Lysine—An essential amino acid that cannot be manufactured by the human body. The only source of L-lysine is foods, such as vegetables and grains, or supplements. It promotes absorption of calcium and production of enzymes.

L-Ornithine—An amino acid that stimulates the release of growth hormone from the pituitary gland for wound healing. It is used as a dietary supplement.

L-Trypsin—An enzyme that helps digestion in the small intestine. It also combats inflammation.

Endnotes

A note about these endnotes: If you find a broken link, try searching for the title of the referenced publication. If it’s a scientific paper, try Google Scholar. If it’s a book, try Amazon.com. Let the author know what you found by sending a message in the contact page at www.natureoflongevity.com

1. Mulhall, Douglas, “Discovering the Nature of Longevity: Restoring the heart and body by targeting hidden stress”, MolekTechs Media, 2023.
2. Mulhall, Douglas, and Katja Hansen. “The Calcium Bomb: The Nanobacteria Link to Heart Disease & Cancer.” Writers’ Collective, 2005.
3. NanobacTX is described and available at https://nanobiotechpharma.com/ nanobactx/. Accessed 14.01.2023.
4. Atherosclerotic cardiovascular disease is one of the most common forms of heart disease. The name is abbreviated variously as ASCVD or CVD.
5. The Illinois Academy of Physician Assistants serves as the primary resource on and for the PA profession in the state of Illinois, https://www.illinoispa. org/. Accessed 02.04.2023.
6. Maura Deering “How to Become a Nurse Practitioner,” Nurse Journal, Updated September 14, 2022, https://nursejournal.org/nursepractitioner/what-does-a-msn-nurse-practitioner-do/.Accessed  3.10.2022.
7. Hooker, Roderick S. PhD, MBA, PA; Cawley, James F. MPH, PA-C, DHL (Hon). Physician Associates/Assistants in Primary Care: Policy and Value. Journal of Ambulatory Care Management 45(4):p 279-288, October/December 2022. | DOI: 10.1097/JAC.0000000000000426.
8. Neves PO, Andrade J, Monção H. “Coronary artery calcium score: current status.” Radiol Bras. 2017 May-Jun;50(3):182-189, https://doi.org/10.1590/0100- 3984.2015.0235.
9. In 2022, intravenous chelation could involve up to 40 treatments to avoid the relapse problem that Gary Mezo identified. This frequency was used for example in the Trial to Assess Chelation Therapy (TACT), funded by the U..S. National Institutes of Health. Escolar, Esteban, Gervasio A. Lamas, Daniel B. Mark, Robin Boineau, Christine Goertz, Yves Rosenberg, Richard L. Nahin, et al. “The Effect of an Edta-Based Chelation Regimen on Patients with Diabetes Mellitus and Prior Myocardial Infarction in the Trial to Assess Chelation Therapy (Tact).” Circulation: Cardiovascular Quality and Outcomes 7, no. 1 (2014): 1524, https://doi.org/10.1161/CIRCOUTCOMES.113.000663.
10. The cost of intravenous chelation varies widely by state and region of the world.  A summary of estimated costs in the U.S. is found at “Chelation Therapy costs,” ThePricer.org , which cites estimates of $3,500 to in excess of $5,000. Other estimates can run higher, depending on the number of treatments. The TACT studies administered ~40 infusions, which is on the high side of many regimens. This number could run significantly higher than $5,000 in some regions, https://www.thepricer.org/chelation-therapy-cost/. Accessed 14.01.2023.
11. A later clinical trial of EDTA intravenous chelation supported by the U.S. National Institutes of Health, and known as the Trial to Access Chelation Therapy (TACT), did show sustained impacts in reducing heart attack frequency, but did not measure calcium scores. See Discovering the Nature of Longevity for more information on TACT, and on the NanobacTX regimen.
12. For years, people have used natural chelators like vitamin C and combinations of cilantro and chlorella, often without knowing that those are mild chelators. However, until 2022, no clinical trial or other measurable evidence had been done to determine if these mild chelators remove tough calcified deposits from deep in arterial tissue.
13. U.S. Food and Drug Administration, “Application of federal law to practice of pharmacy compounding,” https://www.fda.gov/drugs/human-drugcompounding/application-federal-law-practice-pharmacy-compounding. Accessed 30.03.2023.
14. U.S. Food and Drug Administration, “Application of federal law to practice of pharmacy compounding.”
15. “The compounding market supply and demand” p. 36 in National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy; Jackson LM, Parker RM, Mattison DR, editors. The Clinical Utility of Com- pounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington (DC): National Academies Press (US); 2020 Jul 1. 2, An Overview of Compounding, https://www.ncbi.nlm.nih.gov/books/NBK562881/.
16. Food and Drug Administration. Food ingredients and packaging, Generally Recognized as Safe (GRAS), https://www.fda.gov/food/foodingredients-packaging/generally-recognized-safe-gras).
17. The claim that in some cases chelation causes kidney damage has to be critically analyzed. Many regulatory approved drugs cause kidney damage if improperly administered. Citing poor administration to portray a therapy as causing kidney damage is misleading. The Government of British Columbia in Canada provides one of the more balanced descriptions when it says, “Many years ago, chelation therapy was given in high doses and may have been linked to kidney damage, irregular heartbeats, and other serious consequences.” “Chelation Therapy” Healthlink BC, https://www.healthlinkbc.ca/ healthtopics/chelation-therapy. The reference to “many years ago” is correct. In the early days when standard protocols were not established, there were reports of such damage. However, U.S. government sites often don’t make this distinction. For example, “Chelation for Coronary Heart Disease: What You Need To Know” National Center for Complementary and Integrative Medicine, National Institutes of Health, https://nccih.nih.gov/health/chelation . This website says that chelation can cause kidney damage, but gives no references. It refers to some patients having “adverse events,” but does not say they were due to kidney damage.
18. In a note to the authors May 5, 2003, Dr. Mezo indicated that he measured creatinine (a waste product from the body’s use of protein) and BUN (blood urea nitrogen from the breakdown of blood, muscle and protein). He also conducted Liver Function Studies on patients.
19. Food & Drug Administration, “Closeout letter Nanobiotech Pharma June 13, 2017,” ed. FDA (2017), https://www.fda.gov/inspections-compliance-en- forcement-and-criminal-investigations/warning-letters/nanobiotech-phar- maclose-out-letter-61317. Accessed 15.03.2022.
20. These coatings are in common use today but were developed after Mezo invented NanobacTX, which is why he had to use a suppository to start with. The suppository became redundant when new coatings allowed the ingredients to be ingested orally.
21. Correspondence from G. Mezo to the author 14.01.2023.
22. Blaze, J. “A Comparison of Current Regulatory Frameworks for Nutraceuticals in Australia, Canada, Japan, and the United States.” [In eng]. Innov Pharm 12, no. 2 (2021), https://doi.org/10.24926/iip.v12i2.3694.
23. James C. Roberts Jr., EECP Center of Northwest Ohio, “Overview,” http://www.heartfixer.com/EECP/EECP%20-%20Overview.htm. Accessed 08.11.2020.
24. James C. Roberts, “Enhanced External Counter Pulsation Chest Pain Relief without Drugs or Surgery”, EECP Center of Northwest Ohio, http:// www.heartfixer.com/IndexEECP.htm. Accessed 08.11.2020.
25. Correspondence from Dr. James C. Roberts to the author, 02.04.2003.
26. James C. Roberts, Nanobacterium sanguineum Case Studies, “Case Studies from our 1st 250 Patients,” http://www.heartfixer.com/NB%20%20Case%20 Studies.htm. Accessed 08.03.2023.
27. James C. Roberts, Nanobacterium sanguineum Case Studies, “Case Studies from our 1st 250 Patients” #2 MP: NanobacTX for Atherosclerosis Everywhere http://www.heartfixer.com:80/NB – Case Studies.htm . Accessed 08.03.2023.
28. James C. Roberts, Nanobacterium sanguineum Case Studies, “#21 JC: EECP and NanobacTX for single-vessel occlusive disease – watch the CRP fall”, and “#12 BD: CT scores may not drop in occluded or bypassed vessels-but the patient improves nonetheless” http://www.heartfixer.com:80/NB – Case Studies.htm . Accessed 08.03.2023.
29. Ibid.
30. James C. Roberts, “Atherosclerotic Oxidative Stress A Maladaptive Immune System Response to Perceived Intimal Infection”, http://www.heartfixer. com/Oxidative%20Stress.htm. Accessed 08.03.2023.
31. Stephen T Sinatra and James C Roberts, “Reverse Heart Disease Now: Stop Deadly Cardiovascular Plaque Before It’s Too Late,” (John Wiley & Sons, 2010), http://www.heartfixer.com/IndexBookPage.htm. Accessed 08.11.2020.
32. Nanobiotech Pharma “Physician testimonials,” https://nanobiotechpharma. com/physician-testimonials/. Accessed 05.03.2023.
33. “Dr. Joel Kahn – America’s Healthy Heart Doc “ Facebook page of Dr. Joel Kahn, https://www.facebook.com/pg/drjoelkahn/posts/?ref=page_internal. Accessed 15.01.2023.
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Published December 2, 2023