New York State Department of Health (NYSDOH) Stops a World First U.S. Egyptian Collaborative Study on Hepatitis C and Blood Ozonation
by Gérard V. Sunnen, M.D.
© March 2007
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Hepatitis C (HCV) is a chronic affliction caused by a lipid-enveloped virus with a high mutation rate. HCV's wide genetic spectrum and mutational thrust are responsible for its expanding prevalence base and its growing worldwide distribution.
Hepatitis C preferentially invades the liver, but it can also affect other organ systems, including the bone marrow and the kidneys. Progressive liver destruction may lead to cirrhosis and liver cancer. Indeed, after 20 years, about 25% of hepatitis C patients develop cirrhosis and another 5% manifest liver cancer. Up to 15% of patients, however, conquer the disease, presumably due to the adaptability and creativity of their immune systems.
The hepatitis C virus is spread by body fluid transmission. Like many other viruses, its life cycle shows fluctuations of relative dormancy alternating with viremic episodes when blood is virally flooded. It is estimated that in any one viremic hepatitis C episode, up to 10 billion viral particles may be generated daily.
Clinically, in the first few years, hepatitis C is often manifested by vague symptoms of fatigue, headache, and gastrointestinal malaise. Later on, the extent of organ damage determines the severity of its symptom profile.
Medications for hepatitis C include interferons, which are natural cellular products that activate neutrophils, macrophages, and natural killer (NK) cells, and drugs that inhibit enzymes responsible for viral replication (e.g., ribavirin). Success rate is variable and relapses are common. Frequently, these drug cocktails are poorly tolerated leading to discontinuation.
Ozone, administered as an oxygen/ozone mixture, has long been known to be safely interfaced with blood in minuscule doses. Calibrated exposure respects the integrity of cellular elements such as white and red blood cells, and platelets. On a molecular level, ozone exposure induces complex blood biochemical changes that have yet to be comprehensively described. There is solid evidence from the world medical literature, however, that blood exposure to ozone enhances endogenous interferon and cytokine production (Bocci V. Ozone: A New Medical Drug. Springer, The Netherlands, 2005).
The prevalence of hepatitis C is variable in different regions of the world. In the U.S., about 1% of the population is affected, an estimated 4 million carriers. Certain groups, for a variety of reasons, are preferentially afflicted. Veterans, for example, have a prevalence rate five times that of the general population.
In Egypt, the prevalence rate is the highest in the world. Fully 20% of the population is afflicted by hepatitis C, or approximately 12 million individuals. This phenomenon is partially explained by a vaccination program gone awry. Regardless of its causation, this huge hepatitis infection rate represents a national public health emergency.
The National Research Centre (NRC) in Cairo contacted me after seeing my articles (Sunnen G. Ozone in medicine: Overview and future directions. Journal of Advancement in Medicine 1988 Fall; 1(3): 159-174). In view of the Egyptian hepatitis C emergency, health authorities were interested in new therapeutic approaches for hepatitis C, namely novel technologies of oxygen/ozone administration. Indeed, contemporary conventional drug therapies were and are prohibitively onerous for a target population of 12 million. In addition, they are inordinately prone to failure and to serious side effects.
NRC representatives came to New York where a meeting was held with Medizone International, Inc., (of which I was President and Director of Research) on Aug 7, 2000. Research protocols were agreed upon and a contractual agreement was signed by all parties. The study was officially named:
"SAFETY AND EFFICACY OF OZONE IN THE TREATMENT OF PATIENTS WITH CHRONIC HEPATITIS C."
The study was to involve 66 patients. The main objectives of the study were to measure and evaluate:
- Hepatitis C viral load reduction with blood ozonation
- Liver enzyme recovery
- Clinical improvement, as measured by scales of health and well-being
Officially, the investigators for this study were:
||Professor Dr. M.Y. Estefan, M.D., MRCP
Prof. Dr. Mouchira A-Salam, M.D.
Prof. Dr. Said Shalaby, M.D.
Dr. Hala Zaki Raslan, M.D.
Dr. Seif W. Morcos, MRCP
Dr. Ibrahim M. Kamal, M.S.
Dr. Yasser A. El-Houssary, M.S.
Prof. Shadia A. Ragab, M.D.
Prof. Mostafa El-Awadi, Ph.D.
Dr. Azza A. Ali, M.D.
Dr, Hanaa R. Mohamed, M.D.
|Chemical Engineering Team:
||Prof. Gizeen El-Diwany, Ph.D.
Dr. Maaly Khedr, Ph.D.
||Dr. Emad El Din Samala, M.D.
|| Prof. Dr. Maher Y. Estefan, M.D., MRCP
|Study Progress Monitor:
||The Egyptian and Foreign Committees
||Egyptian Ministry of Health and Population
The study was well under way as regard the selection of participating patients and the readying of NRC supporting personnel and laboratory facilities.
In 2001 and into 2002, however, through various actions, and for reasons that can, as of now, only be speculated, the New York State Department of Health (NYSDOH) stopped this world-first U.S. Egyptian collaborative medical study. Medizone International, Inc., as a result, floundered and is now nearly defunct. Millions of patients thus lost a unique opportunity for better health care.
Lamentably, this destructive action continues to send a very negative message, not only to the Egyptian medical research community and to Egyptian patients hopeful for treatment breakthroughs for hepatitis C, but also, by way of extension, to the medical community in the greater Middle East. It also embodies a transgression against essential research that was envisioned to benefit our own citizens. Indeed, hepatitis C is an important determinant for death via liver failure and liver cancer, and is the leading cause for liver transplants.
Furthermore, the fruits of this research would have extrapolated far beyond the treatment of hepatitis C. Immune function enhancement is a bonus for a host of diseases. In addition, it appears that lipid-enveloped viruses have increased vulnerability to ozone exposure. Ozone-based therapeutics, administered via innovative technologies, could thus well complement current treatment options for viruses such as hepatitis B, HIV, and influenza, among others.
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Gérard V. Sunnen M.D.
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New York, NY 10016