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Click HERE for original (PDF), pp. 52 and 53.
BACK TO HOME Arab Health World magazine interviews Dr. Gérard V. Sunnnen, President of Ozonics International, LLC to discuss the issue of the US-Egyptian collaborative study on Hepatitis C and blood ozonation which was stopped in 2002 by the New York State Department of Health (NYSDOH). The study “Safety and Efficacy of Ozone in the Treatment of Patients with Chronic Hepatitis C” was a collaboration between Cairo’s National Research Centre and Medizone International, Inc. of which Dr. Sunnen was President and Director of Research. What is Hepatitis C? How variable is its prevalence around the world? Hepatitis C (HCV) is a lipid-enveloped virus with a high mutation rate. All pathogenic viruses with high mutation rates are major threats to humanity. Leading viruses in this category include HIV, hepatitis C, and influenza. High mutation rates allow viruses to start behaving as they never had before. HCV preferentially attacks the liver, but may also involve the bone marrow and the kidneys. Liver cells become challenged. Liver failure and liver cancer may then result after years of infection. HCV is the leading cause for liver transplantation. Hepatitis C is growing worldwide and by some estimates will reach a quarter billion people in a few years. Egypt, unfortunately, holds the record for prevalence. A well-meaning public health effort undertaken in the last few decades against schistosomiasis unwittingly spread the hepatitis C virus. Several studies show fully 20% of the Egyptian population challenged by hepatitis C. With a current Egyptian population of 80 million people or so, a best guess estimate of hepatitis C prevalence in Egypt reaches 12 million. In the USA, it is estimated that 1% to 2% of the population is hepatitis C-afflicted, or about 5 million people. Clearly, in the light of this morphing pandemic, more dedicated demographic research needs to be pursued. Where did the idea of a collaborative study with Egypt’s NRC arise from? The Egyptian public health authorities were understandably concerned about this national calamity. The National Research Centre (NRC) in Cairo started to explore all credible avenues for hepatitis C control. They came upon my articles on blood ozonation. After reviewing the world medical literature on the subject, they contacted me. NRC representatives came to New York where a meeting was held with Medizone International, Inc., a leader in innovvative ozone-based medical technologies. A world’s first humman study was then designed. Clinical protocols were agreed upon and ratified by all parties. Why a human study at this point? Because of the excellent safety profile of blood ozonation reported in the world medical literature, combined with the poignancy of Egypt’s hepatitis C public health emergency. The list of the superlative NRC researchers chosen for this study can be found on the following website: What was the aim of the study and why was it stopped? This unique study sought to measure the benefits of blood ozonation in hepatitis C, namely: (1) Viral load reduction (2) The improvement in metabolic parameters (e.g., liver enzymes) and (3) Subjective changes in energy and well-being. The New York State Department of Health (NYSDOH), via various unsavory tactics, eventually stopped the study. In the process, Medizone was severely crippled. Millions missed an opportunity for improved medical care. Why the study was stopped continues to be a point of speculation, but I am sure it will be elucidated some day. The consensus for explaining this disturbing eventuality invokes an unhealthy confluence of pharmaceutical economics, and politics. To what extent is the human need for hepatitis C therapeutics crucial? Demographic analyses talk about numbers. Beyond huge numbers are human beings who endure symptoms that chronically stress their quality of life. Fatigue and malaise are the most frequent symptoms at first. Later on, the extent of organ damage determines the severity of the symptom profile. Contemporary treatment is based on the prescription of interferons, which are cellular products bolstering immune functions, and drugs that block viral replication (e.g., ribavirin). This combination therapy has limited success, frequent relapse, and a high expression of side effects, medical and psycchiatric. HCV is increasingly seen coexisting with HIV infection, another unfurling pandemic. Such coinfections bring on new sets of clinical problems. What is blood ozonation and how effective is it? Blood ozonation initially sounds like a toxic process. It is not. Decades ago, German clinicians thought that ozonation could clear blood of pathogens, much as it does water. They devised methods of interfacing ozone with blood so that its cellular elements (e.g., red and white blood cells, platelets) retained their integrity. Immune models have surpassed this early notion of ozone’s direct viral clearance. In the miniscule doses in which ozone is administered to blood, it is now firmly documented that blood ozonation stimulates immune system components to produce natural interferons and cytokines cappable of initiating viral kill. In addition, it appears that blood ozonation has special effectiveness against lipid-enveloped viruses (e.g., hepatitis B and C, HIV, influenza), due to lipids’ susceptibilities to oxidation. On a related note, it may appear surprising – or even preposterous - to suggest that our bodies rely on endogenously generated reactive oxygen molecules, one of which is ozone, to oxidize constantly invading pathogens. A greatly underappreciated study from the Scripps Institute, California, in 2002, found that ozone is indeed created by our own neutrophils and macrophages to serve as a natural viruccidal agent! Give us a glimpse of Ozonics’ history and field of activities. I resigned from my position at Medizone International to found Ozonics International, LLC. Ozonics owns intellectual properties related to ozone-based therapeutics. Obviously, as this article describes, the medical establishment is not yet ready to investigate the internal uses of ozone/oxygen mixtures for antiviral and other purposes. Ozonics is therefore currently only focusing on ozone’s external applications. As a pan-antipathogen, capable of inactivating all bacterial, viral, and fungal species, ozone is ideally suited to heal extternal afflictions such as diabetic skin ulcers, poorly healing lesions, and infected traumatic injuries such as those found in war wounds. In the future, I expect a process of extracorporeal blood ozonnation to take a central place in ozone-based therapeutics. Much like dialysis techniques, this embryonic technology expposes the entire blood volume to calibrated ozone/oxygen mixtures, primarily for purposes of viral clearing. How do economics and politics affect drug research? It must be remembered that blood ozonation is dramatically less expensive than conventional treatments. In addition, ozone itself, as a natural molecule, cannot be patented; only its delivery process can. If serious research validates the vast clinical experience cumulated so far, ozone-based therapeutics will become an important player in hepatitis C management. In view of these facts, one can easily imagine, with billions of dollars in the balance, how special interests could work to inhibit the progress of parallel therapies. What suggestion would you have for the Egyptian Minister of Health regarding blood ozonation? My suggestion to the Egyptian Minister of Health and Population would be to give priority to a comprehensive clinical (human) study on hepatitis C and blood ozonation, much as was envisioned in 2002. There is a public health emergency at hand. I would design the study a bit differently, this time with more attention paid to the immunological dimensions of ozone administration. I would also do studies determining blood ozonation’s role in hepatitis C treatment: can it be a stand-alone treatment? Or, alternatively, a complementary add-on treatment to the standard interferon/ribavirin cocktail? With so many millions affected, I would envision (as the NRC did in 2002) a system of regional clinics throughout Egypt inccorporating this treatment within the context of comprehensive clinical care for hepatitis C. On another note, a saying of recent fame (Colin Powell) goes something like this: "You break it, you own it." This, to me, applies to the NYSDOH, which, I feel, is fully responsible for the demise of this U.S.- Egyptian study. The conclusion is evident: the NYSDOH should, at this time, fully support the repair of damages and ensure the revival of this research to its rightful completion, preferably in Egypt, the country where the study was scheduled to take place, and the country currently with the most need for new hepatitis C therapies. Final word to our readers? What is true for a hepatitis C sufferer holds true for all of us: we must constantly educate ourselves to evaluate all therapies in progress, and this not only regarding “accepted” treatments that enjoy the medical establishment’s blessings, but also credible approaches that have solid scientific foundations. One of these is blood ozonation, among several other ozone-based therapies, which, I have no doubt, will increasingly be incorporated into the mainstream medicine of the future. BACK TO HOMEGérard V. Sunnen M.D. 200 East 33rd St. New York, NY 10016 212/679-0679 (voice) 212-679-8008 (fax) |