Friday, November 16, 2007

New York State Department of Health blocks US-Egyptian study on Hepatitis

November 17, 2007

New York State Department of Health (NYSDOH) Stops a World First U.S. - Egyptian Collaborative Study on Hepatitis C and Blood Ozonation

Recently coming to light is the involvement of the New York State Department of Health (NYSDOH) in stopping a world-first U.S. - Egyptian collaborative study on hepatitis C in Egypt. According to one of its principals, Dr. Gérard Sunnen, the study, bringing together the Egyptian National Research Centre (NRC) and Medizone International, Inc., a US - based company, sought to evaluate new therapeutic options for stimulating natural immune factors in fighting the disease. “Blood ozonation is an innovative technique of interfacing blood with minuscule amounts of ozone/oxygen mixtures that enhance natural cytokine and interferon production for purposes of viral clearing. This process, if successful, could greatly reduce the cost of current treatments for hepatitis C,” states Dr. Sunnen. In 2002, the NYSDOH stopped the study. “It is a sad day for the some estimated 5 million Egyptian patients, and some 170 million patients worldwide,” he added.

Hepatitis C (HCV) is a chronic affliction caused by a lipid-enveloped virus with a high mutation rate. All pathogenic viruses with high mutation rates are major threats to humanity because they are more likely to behave as they never had before. HCV's wide genetic spectrum and mutational thrust are responsible for its expanding prevalence base and its growing worldwide distribution. By some estimates, hepatitis C world prevalence will reach a quarter billion in a few years.

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% liver cancer. Up to 20% 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. The immune system in hepatitis C is thus perennially challenged.

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.

Blood ozonation may initially sound 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 capable of initiating viral kill.

It may appear surprising--or even preposterous--to suggest that our own bodies utilize endogenously-generated reactive oxygen molecules, one of which is ozone, to destroy constantly invading microbes. A greatly underappreciated study from the Scripps Institute in California found that ozone is indeed created by our own white blood cells to function as a natural virucidal agent.

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. In Egypt, the prevalence rate is the highest in the world. Fully 20% of the population is or has been afflicted by hepatitis C.

In view of this hepatitis C emergency, the National Research Centre (NRC) in Cairo contacted Medizone International, a leader in ozone-based therapeutics. Egyptian health authorities were interested in new therapeutic approaches for hepatitis C, one being innovative technologies of oxygen/ozone administration.

With great enthusiasm, and hope, an NRC - Medizone investigative study was designed, and 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, among other things, hepatitis C viral load reduction with blood ozonation, liver enzyme recovery, and clinical improvement, as measured by scales of health and well-being

Officially, the investigators for this study were:

Principal Investigator: Professor Dr. M.Y. Estefan, M.D., MRCP

Clinical Team:
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.

Laboratory Team:
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.

Research Designer:
Prof. Dr. Maher Y. Estefan, M.D., MRCP

Study Progress Monitor: The Egyptian and Foreign Committees

Patronage: Egyptian Ministry of Health and Population

The study was well under way as regard the selection of participating patients and the readying of NRC personnel and laboratory facilities where the study was to take place. In 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 study. As a result, millions of patients lost a unique opportunity for better health care.

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 those viruses that are lipid-enveloped 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.

Promising future directions for ozone-based therapeutics also includes external ozone applications for the enhanced healing of diabetic skin ulcers, all types of poorly healing skin lesions, and war wounds.


Gérard Sunnen, MD
200 East 33 Street, Suite 26J
New York, NY 10016-4831 USA
Tel. 1-212-6790679
Fax 1-212-6798008