NYSDOH: Simple Malfeasance, or Transgression Against Humanity?

January 09, 2008
New York, January 9, 2008 – A landmark study aimed at Egypt’s hepatitis C pandemic recruiting the collaboration of the National Research Centre (NRC) in Egypt and Medizone International, Inc., a U.S. public company engaged in developing complementary therapies for hepatitis C, was blocked by the NYSDOH (New York State Department of Health). “When a state agency brings down a clinical study designed to help millions conquer a serious disease, is it simple malfeasance, or is it something worse?“ asks Gérard Sunnen, MD, former president and director of research for Medizone. According to Dr. Sunnen, the NYSDOH stopped the study at a time when all contracts were signed and study volunteers had already been selected. ‘‘The motives are clear, the NYSDOH has a long history of suppressing the emergence of complementary therapies, anything that is not mainstream. What is more, special interests are involved, potent economic forces fighting to keep the status quo on established pharmaceutical pipelines,“ he said. “For a state agency like the NYSDOH to actively interfere in the internal operations of a company is hardly appropriate. It is also destructive to an international goodwill mission,“ he added. In Egypt, where a hepatitis C pandemic has been developing for decades, the prevalence rate for hepatitis C is the highest in the world. Some studies show that up to 20% of the Egyptian population – currently near 70 million - has come in contact with the virus. A vaccination program gone awry provides a partial explanation for this massive infection rate which translates into a national public health crisis. The National Research Centre (NRC) in Cairo, in response, contacted Medizone seeking complementary therapeutic approaches for this pandemic. Indeed, conventional drug therapies are prohibitively costly for such a large target population. In addition, they are inordinately prone to failure and to serious side effe Protocols for this world-first study were agreed upon and signed by all parties. The study was officially named: “SAFETY AND EFFICACY OF OZONE IN THE TREATMENT OF PATIENTS WITH CHRONIC HEPATITIS C.“ The official investigators for this study were: Principal Investigator: Professor M.Y. Estefan, M.D., MRCP Clinical Team: Prof. Mouchira A-Salam, M.D. Prof. 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. Statistics: Dr. Emad El Din Samala, M.D. Research Designer: Prof. Maher Y. Estefan, M.D., MRCP Study Progress Monitor: The Egyptian and Foreign Committees Patronage: Egyptian Ministry of Health and Population The study was to involve 66 patients. Its main objectives were to measure viral load reduction, the normalization of liver enzymes, and clinical improvement using Medizone’s patented technology of blood ozonation. Dr. Sunnen stated, “predicated on the results of the study, the NRC envisioned the creation of a chain of clinics throughout Egypt, and eventually the Middle East, featuring complementary therapeutics – including education - to stem its hepatitis C problem. Lamentably, this never came to pass.“ 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 (e.g., HIV, influenza) are major threats to humanity because they are prone to behave as they never had before. HCV’s strong mutational thrust is responsible for its growing worldwide distribution. By some estimates, hepatitis C world prevalence will reach a quarter billion in a few years. Initially, hepatitis C is manifested by vague symptoms of fatigue, headache, and gastrointestinal malaise. Later on, the extent of organ damage determines the severity of its symptom profile. Hepatitis C preferentially invades the liver but it can also affect the bone marrow and the kidneys. After 20 years, about 25% of hepatitis C patients develop cirrhosis and in another 5%, liver cancer. Hepatitis C is the leading cause for liver transplantation. However, up to 20% of patients conquer the disease, presumably due to the adaptability of their immune systems. The hepatitis C virus is spread by bodily fluids. Like many other viruses, its life cycle shows fluctuations of relative dormancy alternating with episodes when blood is virally flooded. It is estimated that in any one hepatitis C viremic episode, up to 10 billion viral particles may be generated daily. The immune system in hepatitis C is thus perennially challenged. Medications for hepatitis C include interferons, 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. Discontinuation of treatment is frequent. Blood ozonation may initially sound like a toxic process. It is not. Decades ago, German clinicians reasoned that ozonation could clear the 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. Today, immune models have surpassed this early notion of ozone's direct viral clearance. In the minuscule doses in which ozone is administered to blood, it is now documented that this process stimulates immune system components to produce natural products (e.g., cytokines and interferons) capable of initiating viral kill. “Our relationship to ozone’s role in biology is undergoing major shifts. It may appear preposterous, for example, to suggest that our own bodies create ozone to inactivate invading microorganisms. Yet, an underappreciated study from the Scripps Institute in California demonstrates that reactive oxygen species, including ozone, are generated by our own white blood cells to function as natural virucidal factors,” Dr. Sunnen said. “The rewards of this (failed) 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 several others,” said Dr. Sunnen. “Ozone has many other possible medical applications,” he added. “Promising directions featuring ozone’s unique antimicrobial dynamics include external ozone applications for the healing of diabetic skin ulcers, poorly-healing surgical lesions, and war injuries.” “Special interests and other agendas, as is shown here, can all too easily kill innovative medical research,” Dr. Sunnen points out, adding, “when that happens, the public interest invariably suffers and a little humanity is removed from each one of us.” CONTACT INFORMATION: Gérard Sunnen, MD Ozonics International, LLC 200 East 33 Street, Suite 26J New York, NY 10016-4831 USA Tel. 1-212-6790679 / Fax 1-212-6798008 Ozonicsint.com This email address is being protected from spam bots, you need Javascript enabled to view it ###