Хочу ввернуться к вопросу, почему, в отличие от Европы, в США озонотерапия долгое время была как бы вне закона.
(Правда, в прошлом году FDA разрешило ограниченное применение).
Прошу обратить внимание, какая сумма (более двух миллионов долларов) было потрачено в Северной Америке на исследования в крупных медицинских центрах, которые продемонстрировали, в частности, очень низкий (по сравнению, с медикаментозной терапией) уровень побочных эффектов. И причины почему FDA затягивало с разрешением.
Medical Ozone has saved the lives of millions of people suffering from cancer, AIDS, Alzheimer's, herpes, hepatitis, and more. It has been used safely for over thirty years in Europe and countries throughout the world with remarkable results and the lowest level of side-effects (.000005) of any medical treatment.1 Thousands of doctors are calling it the most significant medical development in the last one hundred years, but it is not available in the U.S. The fact that it is inexpensive to produce, easily administered, and difficult to patent (ozone is a naturally occurring substance) has made it far from promising to major pharmaceutical companies. The FDA has barred it in the U.S. pending satisfaction of absurdly stringent research requirements. This has effectively created a medical blackout so thorough that most medical doctors have never heard of medical ozone. Others have ignored it, taking the FDA's lack of approval as a sign that the treatment is not worth their attention.
But perhaps the FDA is not the best judge. Pharmaceutical companies have representatives on nearly all FDA committees (and they provide a large percentage of medical school funding.2) It only makes sense that they would not be supportive of something which may be very effective and undersell the industry. And medical ozone has proven to be very, very effective. …………………………………………………………………………………………………………………………………… ………………………………………………………………………….
But for the last thirty years it has been used successfully to treat over 40 medical conditions, from gangrene to AIDS. In 1980, a German study surveyed more than one thousand therapists who had given more than five million ozone treatments. Ninety percent of the therapists reported the treatments effective. This study also revealed that ozone had one of the lowest levels of side effects (.000005) of any medical treatment.
What's more, the ozone appeared to sensitize the body to other medical treatments, allowing doctors to use up to half the amount of drugs they would usually use for treatment.8
One of the ways in which companies have tried to profit from ozone is by patenting ozone technology. Medizone is one such company. "We filed with the Food and Drug Administration (FDA) for the sale of the drug produced by the equipment and its use in the treatment of AIDS" said Terrence McGrath, former Medizone president. "The FDA required that we carry out research to demonstrate its non-toxicity and likely efficacy, and that we have done."
The FDA is responsible for regulating all the drugs and medical devices marketed in the United States. It approved the use of AZT, which had been refused as a cancer drug due to its fatal toxicity prior to the AIDS pandemic. To date, the FDA has failed to approve any ozone equipment for medical use.
Many people feel the FDA is serving a vital purpose in protecting them from dangerous treatments. But Herbert L. Ley, Jr., M.D., former commissioner of the FDA has a different view: "People think the FDA is protecting them it isn't. What the FDA is doing and what people think it is doing are as different as night and day."
Medizone has spent more than two million dollars on research at major medical centers to prove ozone's safety and effectiveness. But this has still not satisfied the FDA's requirement. Conservative medicine demands double-blind studies, which are expensive and in some cases bordering on unethical. In a double-blind study, half the patients must receive a placebo in order to determine the effect of the actual treatment. This means that in order to determine if a treatment has an effect on AIDS patients, half of them must be told they are being given a cure when they are not. With a disease like AIDS, being given false treatment for a year is more than just a minor setback.
In Germany doctors are allowed to use ozone treatments, and no one is willing to put seriously ill patients through a double-blind. As Horst Kief, M.D. puts it "Perhaps in Germany we have treated no less than ten million people in the last forty years, maybe more. Now you have the biggest test with ten million people. What do you want more?"
It takes an average of eleven years for any new drug or treatment to be approved for marketing in the U.S..10 Medizone has been unable to fund a study since 1990 using large animals as required by the FDA before approval can be granted to test ozone therapy on humans.
"It's a little bewildering for us to understand the reluctance of many of the regulatory authorities to approve a clinical trial for a drug that has been on the European market the best part of twenty-five years," said Terrance McGrath in 1990.
"In the FDA, drug companies have representatives on nearly all the committees. If there is something which may be very effective and may undersell the average drug company, of course they are not going to be very pleased if it gets developed" said Michael Carpendale, M.D. "It might be very difficult for them to compete with that and ozone is obviously inexpensive to produce, and it is very potent; if it works even half as well as the Germans claim it does, everyone should be using it now."
"If somebody wants to get well I think his or her attitude will be, 'Why should I be confined to only one approach if that approach doesn't work; why am I not allowed to do anything else?'" says Arthur Levin, Ph.D, of the Health Policy Advisory Center of New York City. "I think people want to have that freedom of choice and raise legitimate questions with the system about whether they should be told by the state in a sense that there is only one or two ways they should be treated. We have in a sense a sort of state-authorized religion of healing, which is a certain kind of medicine, and anything outside that is characterized as quackery."
Most public sector medical research is funded through the National Institutes of Health (NIH) in the U.S. This is a federal agency with an annual budget of more than two billion dollars, supporting research in more than two thousand American labs. The NIH has a mandate to investigate all promising treatments in the public interest. Since its discovery, hundreds of papers about ozone treatment have been submitted to the NIH. But to date no ozone research has been done.10
The mishandling and deliberate exclusion of research in the area of ozone treatments points to a state of conflict of interests in the U.S. health care system. While on the one hand it is important to be aware that treatments for such devastating diseases as cancer and AIDS do exist, it is equally important to address the disregard given these treatments.