Madison Area Lyme Support Group

Some two centuries ago, Ignaz Semmelweis observed that hand washing with a chlorinated lime solution (an oxidizing agent) would curb infection mortality related to the maternity ward. He was scorned and castigated by his peers for daring to suggest hand washing between dissecting cadavers and delivering babies. Medicine should have learned from this debacle. Has it?

Today we face unprecedented crises in infectious diseases. Pharmaceutical antibiotic drugs that ushered in the medical era are being neutralized by innovative pathogens acquiring resistance or collectively organizing in impossible to treat biofilms. According to the CDC, “more than 2.8 million antibiotic-resistant (“superbug”) infections occur in the U.S. each year, and more than 35,000 people die as a result. In addition, 223,900 cases of Clostridioides difficile occurred in 2017 and at least 12,800 people died” [1].

Despite witnessing the growth of resistance to antibiotics (which are patented for profit), there has been no interest in promoting the defensive innate processes in the human body, which creates innate oxidizing germicides (H2O2, singlet oxygen, ozone, hypochlorite, etc.) to hurl at invaders. In fact, just the opposite occurs, in large part due to the reflex rejection of highly efficacious therapies [2]. Hence, few in the medical field are aware of any alternative to chemical medicine, and fewer will consider “unapproved” therapy, even to save lives [3].

I provide the following first-hand knowledge and will elaborate.

1. In 2018, this practitioner was begged to come and minister ozone therapy to a man (husband, father and airline pilot) dying of a superbug infection in a Texas hospital. Despite the promise of a liability waiver, the hospital denied me access stating: “Policy”. The helpless man died in front of his grieving family. Several years before, a hospitalized beloved Northern California integrative physician died of lethal infection after the institution denied the requests of family and physician friends to administer high dose intravenous ascorbate.

2. One erudite layman, who is a prominent trustee of a major mid-west teaching hospital, asked the infectious disease chairman (ID) if he would permit the use of ultraviolet blood irradiation (UBI) in the hospital to save an otherwise unsalvageable patient. ID responded, “Is it FDA approved?”

Answer, “No”.

ID response, “Then I would not permit it”.

Trustee’s reply, “Then you would let the patient die rather than even tell the patient’s family about UBI?”

ID answer: “Yes”.

The trustee was aghast. “That death could be me!”

3. This practitioner took an associate to, and, led a group in Sierra Leone to use ozone therapy to rapidly cure 100% of 5 cases of the most lethal virus the world has ever known – Ebola (mortality rate – 60%). The report was submitted to major journals which summarily rejected the novel report, one stating: “we don’t think this will be of interest to our general practicing readers.” While ignoring a major potential breakthrough in acute actual viral disease management, the journal was concurrently publishing articles on vaccines for Ebola. A vaccine was of more interest to its European readers than a possible penny costing cure? The ozone breakthrough was later published in the African Journal of Infectious Diseases [4].

4. A south Florida hospital applied for an IND for ozone use in COVID. (2020) The FDA demanded expensive animal studies, despite thousands of publications on ozone and a virtually 100% safety record over many decades. Even “compassionate use” was not considered.

5. Two reporters, one for a small-time news outlet, and the other, a famous reporter for a huge NYC daily, attempted to publish articles on ozone therapy early in the COVID-19 outbreak. Their higher-ups canned publication. Both were shocked.

The world is in deadly “Catch-22” considering non-patentable therapies which might save lives. Therapies that have been studied and reported successful with complete safety for scores of years are called “anecdotal” by the FDA because clinical trials that incur huge unrecoverable costs have not been done. Millions of successful treatments are “anecdotal”. What utter nonsense. These therapies are shunned, even to the tune of watching a patient die.

Condemned to Die with No Right to Try

This seemingly corrupt paradigm has been coined: “Condemned to Die with No Right to Try” [5]. Promising but not “approved” therapies are dead on arrival. Currently, institutional (and individual) “policy” (not law) prevents hospitals (and most conventional physicians) from any consideration of non-FDA approved therapies.

The government/industrial complex has been inserted between the doctor and his patient’s needs/welfare.

This begs the question of the morality of a system that proactively denies a dying patient a chance. What has medicine (and society) become if we chose or permit sacrifice of lives for profit, policy, personal, and corporate interests?

Closer to the practicing physicians lie the state medical boards. Many have attacked doctors’ therapies not “approved” by the FDA. This also leads to death. Medical errors, most often using FDA approved treatments, are the third leading cause of American deaths [6]. FDA approved drugs are the fourth leading cause of American deaths [7]. Approved antibiotics, particularly the newer ones, even when properly administered, can lead to very severe injury.

This journal published the first article on the use of ozone therapy for coronavirus [8]. Since then, several articles have emerged echoing the wisdom of using ozone therapy [9,10], and articles have been published on its success [11–13]. Yet there has been no move by authorities to investigate this reportedly virtually 100% safe treatment, whilst governments expend trillions on novel vaccine research, development and distribution.

CDC reports half a million COVID deaths in the USA alone. Many doctors, including me, reached out to officials with ozone information, only to be shunned. Other oxidation therapies (intravenous hydrogen peroxide [14], ultraviolet blood irradiation (UBI) [15–17], intravenous ascorbate [18]) were reported in the last century to cure or mitigate untreatable serious viral (pneumonia, polio) and bacterial infections, with 100% safety and high efficacy, yet few if any infectious disease experts are so aware. Of course, none of these are patentable for profit (Figure 1).

Oxidation therapies harness and augment the body’s own innate pro-oxidant (germicidal) primal defenses against invaders. Ozone is actually produced in the body, and hydrogen peroxide is one of its mediators of action. High dose ascorbate is a pro-drug for hydrogen peroxide. UBI is another oxidant. These therapies have several commonalities. They have been reported: 1) Absolutely safe when properly administered, 2) Highly effective, and, 3) Because they are a “natural cure” in the public domain for many decades, they cannot be patented for profit, remaining unstudied to the degree needed for regulatory agency “approval”. Consequently, they suffer instant rejection. The medical annihilation style of Ignaz Semmelweis remains, morphing from proscribing promising sanitation to proscribing and condemning promising therapies by medical practitioners.

Solutions to the Dilemma

There are solutions to the dilemma. Current hospital practices are based on policy and not law. Change must begin at the lowest level rather than expect an agency (FDA), highly influenced by a revolving door of Pharma interests within the agency, to begin change. Leaving the FDA board should immediately disqualify one from Pharma employment for five years. Having any financial interest in Big Pharma should disqualify one from FDA employment or office.

After all, despite thousands of international articles on ozone therapy, the official stance of the FDA remains:

“Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. In order for ozone to be effective as a germicide, it must be present in a concentration far greater than that which can be safely tolerated by man and animals” [19].

This statement, while actually a regulation, is blatantly false. Its continuing presence has certainly condemned patients to death. Physicians and hospitals will not look past it. Water is also toxic, as is ozone, if inhaled. It also ignores the myriad of positive published papers and clinical trials readily available for half a century on PubMed.gov, our National Library of medicine, and other databases.

Change can and must begin with physicians caring more about the welfare of their patients than the prevailing dogma/paradigm and interests of the medical and pharmaceutical industry. Hospitals, like government, must recognize the human “unalienable” Right to Life, Liberty and Pursuit of Happiness, which includes health, wellness and recovery, unhindered by “policy”. Clinical success will bring these therapies into the accepted mainstream, regardless of lack of multibillion-dollar studies effectively bypassing regulatory agency obstruction. Considering the crisis we face, mainstream journals should welcome reports on solutions for these times. But to date, prestigious infectious disease journals have failed to publish manuscripts on these therapies.

Courts must also be made to take cognizance of these fundamental human rights. The New Jersey Supreme Court has recently recognized that the informed consent by patients requires doctors to include disclosure of management that the doctor might not even believe in, and let the patient make his/her own choice [20].

If the profession fails to do this on its own (after obtaining an institutional waiver of liability for offering/providing “unapproved” therapy), sooner or later a savvy attorney may bring down the doctor or institution that fails to place the needs of the patient before “policy”. The institutionalized practice of “condemning to die with no right to try” will then come to a “violent” end. Can medicine rise to avoid this? Can medicine (and science) ever put an end to Semmelweis like sagas?

References

1. https://www.cdc.gov/drugresistance/biggest-threats.html.
2. Goodwin JS, Goodwin JM (1984) The tomato effect. Rejection of highly efficacious therapies. JAMA 251: 2387-2390.
3. Clinical Research Support Center, Office of Regulatory Compliance, University of Colorado (2019) The clinical use of non-FDA-approved drugs and devices.
4. Rowen R, Robins H, Carew K, Kamara M, Jalloh M (2016) Rapid resolution of hemorrhagic fever (Ebola) in Sierra Leone with ozone therapy. Afr J Infect Dis 10: 49-54.
5. Rowen RJ (2019) Ozone and oxidation therapies as a solution to the emerging crisis in infectious disease management: A review of current knowledge and experience. Med Gas Res 9: 232-237.
6. https://www.hopkinsmedicine.org/news/media/releases/study_suggests_medical_ errors_now_third_leading_cause_of_death_in_the_us.
7. https://ethics.harvard.edu/blog/new-prescription-drugs-major-health-risk-few-offsetting-advantages.
8. Rowen RJ, Robins H (2020) A plausible “Penny” costing effective treatment for corona virus – Ozone therapy. J Infect Dis Epidemiol 6: 113.
9. Menendez-Cepero S, Marques-Magallanes-Regojo JA, Hernandez-Martinez A, Hidalgo Tallón FJ, Baeza-Noci J (2020) Therapeutic effects of ozone therapy that justifies its use for the treatment of COVID-19. Journal of Neurology and Critical Care 3: 1-6.
10. Izadi M, Cegolon L, Javanbakht M, Sarafzadeh A, Abolghasemi H, et al. (2020) Ozone therapy for the treatment of COVID-19 pneumonia: A scoping review. Int Immunopharmacol 92: 107307.
11. Franzini M, Valdenassi L, Ricevuti G, Chirumbolo S, Depfenhart M, et al. (2020) Oxygen-ozone (O2-O3) immunoceutical therapy for patients with COVID-19. Preliminary evidence reported. Int Immunopharmacol 88: 106879.
12. Wu J, Tan CS, Yu H, Wang Y, Tian Y, et al. (2020) Recovery of four COVID-19 patients via ozonated autohemotherapy. Innovation (N Y) 1: 100060.
13. Brownstein D (2020) A novel approach to treating COVID-19 using nutritional and oxidative therapies. Science, public health policy, and the law. Clinical and Translational Research 2: 4-22.
14. Oliver T, Murphy D (1920) Influenzal pneumonia: The intravenous injection of hydrogen peroxide. The Lancet 195: 432-433.
15. Miley GP, Christensen J (1948) Ultraviolet blood irradiation therapy in acute virus and virus-like infections. Rev Gastroenterol 15: 271-283.
16. Miley G (1942) X-ray evidence of complete clearing of the lungs within 24-96 hours after a single treatment. American Journal of Bacteriology 45: 303.
17. Miley G, Christensen JA (1947) Ultraviolet blood irradiation therapy; Further studies in acute infections. Am J Surg 73: 486-493.
18. Klenner F (1971) Observations on the dose and administration of ascorbic acid when employed beyond the range of a vitamin in human pathology. Journal of Applied Nutrition, 23.
19. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=801.415.
20. https://law.justia.com/cases/new-jersey/supreme-court/1999/a-9-98-opn.html.