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Oxygenation Therapy: Unproven Treatments for Cancer and AIDS, 6/1/2008
They claim that toxins that adulterate processed foods, the environment, and medications damage the oxidative metabolism of normal cells which then regress into anaerobic metabolism in which an inferior energy is produced, resulting in cancer. Normal functions such as digestion, elimination, and immune function are also claimed to benefit from treatment with pure, all-natural, poison-free nutrients, vitamin and mineral supplements, and oxygen-yielding substances that restore and replenish the oxygen needed by tissues for burning off toxins. Hydrogen peroxide and ozone are the substances recommended .

Ozone

Ozone was discovered and named by Schonbein in l839. It is formed when an electric spark or ultra-violet (UV) light splits an oxygen molecule into two highly reactive oxygen atoms. Each of these combines with intact oxygen to form the tri-atomic ozone, O3. Ozone is one of the most powerful natural oxidizing agents known because of the highly reactive free radicals it generates on decomposition. These free radicals can destroy many natural biological substances . The discovery of inert plastics made ozones medical applications possible. In the late 1930's, German doctors began to use it in experiments on patients who had a variety of infections and wounds . Ozone gas might be bubbled directly into the patients blood, it might be bubbled into blood taken from the patient after which the blood would be re-infused, it might be bubbled into a solution to be used in an enema, colonic irrigation, or douche, or it might be pumped directly into the rectum. Except for situations in which ozone was used topically, the determination of effectiveness was depicted by patient testimonials.

When ozone is introduced into blood, it reacts with water in red cells producing hydrogen peroxide. This aqueous decomposition of ozone also produces bactericidal and membrane-damaging free radicals . Ozone used for treatment is prepared by creating an electric spark in a chamber of pure oxygen. The final mixture contains between 0.l and 5.0% ozone, concentrations that are equivalent to from l.0 ppm to 50 ppm ozone in pure oxygen.

Ozone generated this way has a half life of 45 minutes at room temperature, and under ideal conditions of sterility, dryness, and cleanliness, it must be prepared on site each time it is used.

A two-hour exposure to 1200 ppm ozone is needed to kill microorganisms on open surfaces and in water . Concentrations of ozone recommended are: for topical treatment of superficial wounds, 70 to 100 ppm; for slow-healing ulcers, between 40 and 70 ppm; and when oxygenating effects are needed to treat diseases associated with hypoxia, from l to 40 ppm .

Ozone has been proposed as a treatment for AIDS .

"Results of experiments indicate that medical ozone has the ability to inactivate extra-cellular HIV-l in serum-supplemented tissue culture fluids and to inhibit the growth of HIV-l at concentrations that are benign to cells in tissue culture." However, HIV is susceptible to inactivation by many relatively innocuous compounds, and claims for benefiting AIDS patients are unconfirmed .

In 1993 testimony before Senator Harkin's Subcommittee of the Senate Appropriations Committee, Ed McCabe, a promoter of ozone, stated, "644 German ozone therapists successfully treated 384,775 patients with 5,579,238 doses of ozone with no ill effects.

Thousands of published medical papers contain proof of ozones effectiveness in vivo. Numerous US physicians have converted hundreds of AIDS patients from HIV sero-positive to HIV sero-negative status using ozone. Help is available to AIDS patients right now but the medical establishment is ignoring it." No evidence for the claims exist in reliable scientific literature.

Is ozone effective against HIV?

In 1991, Wells et al reported that gaseous ozone inactivated cell-free HIV-l in cell-free culture medium. Using escalating concentrations of ozone, they showed that a l200 ppm dose delivered into the solution for two hours, reduced the number of infectious viruses by about l011 and reduced detectable virions about 85%.

However, there was also a significant reduction in infectivity after virus exposure to nitrogen. Other factors influencing the rate and degree of inactivation of HIV-I by ozone were protein and plasma components in the culture medium. (HIV is known to be inactivated by a host of relatively inactive substances.) While ozone might be useful in rendering commercial blood products free of infectious organisms, more extensive analyses of the HIV-I life cycle was needed before ozone's usefulness as an in vivo anti-retroviral agent could be defined. Poiesz, Wells' co-author, wrote, " No further in vitro work has been done and to my knowledge no in vivo work has been done."

Carpendale and Freeberg studied the effect of 4 ppm ozone on HIV-l suspensions in vitro. Ozone was rapidly degraded by serum components in the culture medium. They theorized that the virus inactivation must have been caused by unknown ozone reaction products.

Reaction products of ozone and fatty acids called ozonides have been studied, and some are known to mimic the cellular effects of ozone . But Carpendale et al did not report on the effects of ozonides on HIV in suspension.

Ozone has been used to treat infections for nearly 50 years.

For the most part the treatments were based on impressions from uncontrolled anecdotal clinical experiences reported in German newspapers, magazines, and proponent newsletters. With the coming of the AIDS pandemic in the 1980s, some physicians offered ozone treatment. Organizations began promoting the medical use of ozone at international meetings. The majority of the papers presented at these meetings referred to the germicidal activity of high concentrations of ozone in vitro, but no convincing evidence was presented that autohemotherapy with ozone at concentrations ranging from 0.l to 5.0 ppm had an effect against HIV in AIDS patients.

In 1991, Garber et al carried out the first well controlled clinical study of auto-hemotherapy for AIDS. These investigators first tested for safety in a Phase I trial and found no toxicity after 12 weeks of treatment. In the Phase II trial which followed, AIDS patients were entered into a randomized, placebo-controlled, double-blinded program designed to compare the effects of unprocessed or ozone-enriched blood infused intermittently over a period of 8 weeks. All patients had CD-4 T-cell counts between 200-400 cells/ul.

In May 1995, the 12th World Congress of the International Ozone Association convened in Lille, France. Of the 42 papers presented, none addressed the effectiveness of autohemotherapy in the treatment of AIDS . In August, 1995, Prof. V. Bocci, one of the organizers of that meeting, wrote:

My positon is based on theoretical grounds that ozone autohemotherapy may be useful only because there is no valid alternative. From a practical point of view I have great difficulty organizing clinical trials. I have frequently expressed my deep concern over the irresponsible, uncontrolled, and unscrupulous information that is being spread around. You must understand that I am not responsible for what is being done or said by people in the U.S.


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Ozone Generators: Criminal Prosecution, 7/11/1999
Ozone Generators: Criminal Prosecution

Marketing Ozone Generators

Kenneth R. Thiefault and his wife, Mardel Barber, formerly of Jupiter, Florida, were sentenced in the U.S. District Court for the Southern District of Florida in March to prison terms that together total more than eight years and fines that add up to more than $100,000. They illegally distributed ozone generators, devices that turn oxygen into ozone, by claiming that the devices could cure a variety of diseases, including cancer and AIDS.

FDA has never approved ozone generators or ozone gas for treating any medical conditions. .

Proponents of medical ozone generators believe ozone can kill viruses and bacteria in the body. While ozone is used as a germicide in the cleaning of manufacturing equipment, FDA is not aware of any scientific data that supports the safety or effectiveness of ozone generators for treating medical conditions. In fact, the agency believes that at the levels needed to work effectively as a germicide, ozone could be detrimental to human health.

FDA's knowledge of Thiefault's involvement in ozone generators dates to at least 1990, when Thiefault was interviewed during an FDA criminal investigation of one of Thiefault's associates. This associate was later prosecuted and imprisoned for, among other things, manufacturing and selling ozone generators for treating medical conditions. After release from prison, he returned to making and distributing ozone generators for treating medical conditions but fled the country before he could be prosecuted again.

In April 1990 and January 1991, Thiefault acknowledged in an FDA-obtained written affidavit that medical ozone generators needed to be approved by FDA before they could be marketed. He also- wrote that his interest in ozone generators was limited to ozone's "antiviral and antibacterial capabilities in relationship to water for dairy cows, swimming pools and spas."

Since 1988, Thiefault had been buying components and making ozone generators, selling them for about $4,800 each to customers across the country.

Each ozone generator, contained in a silver metal case, included a medical grade humidifier and a medical-grade oxygen cylinder with a label that said the cylinder had been converted from medical to industrial grade.

Thiefault did not have any bank, credit or charge accounts. Instead he funneled proceeds from the ozone generators estimated to be $1 million-through his wife and other individuals' financial accounts. Thiefault and his wife touted ozone as a treatment for many diseases, ranging from AIDS and cancer to herpes, hepatitis and gangrene. In the videotape, Thiefault says, "Ozone will cure almost any disease."

Product literature recommended several ways to administer the ozone: by catheter into the rectum, vagina or ear; by breathing in through the nose or mouth; or by absorption through the skin, accomplished by standing naked in a body bag into which ozone is blown.

As he, did with the ozone generators, Thiefault touted K Z Enzyme and Kanzyme as cures for many diseases. According to promotional literature and Thiefault, the products were plant extracts. FDA laboratory analysis showed that each product contained about 10% dissolved substances, such as sugars, amino acids, acetic acid, chloride, phosphate, sulfate, and nitrate.

Kanzyme II was colloidal silver, also an unapproved drug. Thiefault promoted and sold it as an accompaniment to ozone therapy for treating cancer. Product literature claimed the product replaced the body's store of silver, a substance lacking in cancer patients. However, FDA is not aware of any scientific studies that support this claim.

OCI's investigation, complemented by a multi-year IRS investigation, led in 1998 to a seven-count indictment against Thiefault and Barber. FDA-related charges focused on the couple's involvement with ozone generators and not the unapproved drugs because the devices appeared to be their main business thrust-and source of income, according to OCI.

Following a two-week trial, in November 1998, a federal jury found Thiefault and Barber guilty of mail fraud, wire fraud, and distribution of an ozone generator. They also were found guilty on one count of impeding the IRS.

For illegally selling ozone generators, Thiefault was sentenced to six and a half years in prison, fined $100,000, and ordered to pay $14,400 in restitution.

OTA Report: Pharmacologic and Biologic Treatments, 13/1/2006
Examples of pharmacologic approaches offered at a number of places, either singly or in combination, include laetrile, megavitamins, dimethylsulfoxide (DMSO), cell treatment, digestive enzymes, hydrogen peroxide, ozone, and a variety of other agents. When used in various combinations and with special diets, enemas, and instructions about avoiding substances thought to be harmful, these treatments become part of a general approach often referred to as "metabolic therapy," a non-specific term used by many unconventional practitioners to refer to a combination of unconventional approaches aimed at improving the physical and mental condition of cancer patients (96). Many of the best known "metabolic clinics" are located in or near Tijuana, Mexico, not far from the US border, e.g., Centro Medico del Mar, American Biologics, the Manner clinic, St. Judes International, and Hospital Santa Monica. Practitioners associated with these clinics include Ernesto Contreras, Robert Bradford, Jimmy Keller, and Kurt Donsbach.

Some of the major components of the "metabolic" treatments (vitamin C, laetrile, DMSO, cellular treatment, hydrogen peroxide, and ozone) are also discussed in this chapter. The treatments are presented in alphabetical order according to the name of the main practitioner or the substance used.

Various types of oxidizing agents are discussed in the popular literature on unconventional cancer treatments and at meetings sponsored by advocacy and information groups such as the Cancer Control Society (162). Although not apparently widespread in the United States, the use of oxidizing agents has been reported at clinics in Mexico and West Germany where U.S. cancer patients are treated (289,588). The most commonly mentioned treatments of this type are ozone (a gas), hydrogen peroxide (a liquid), antioxidant enzymes, and related products (853). Oxidizing agents such as ozone and hydrogen peroxide are commonly available and have a variety of mainstream uses: as antiseptic, disinfectant, and cleansing agents, as laboratory chemical reagents, and in the food packaging industry. In addition to their use in unconventional cancer treatments, oxidizing agents are also proposed as components of unconventional treatments for AIDS, cardiovascular disease, multiple sclerosis, arthritis, and a variety of other conditions (96,297).

Ozone can be administered by direct infusion of the gaseous mixture into the rectum or into muscle, but it is usually given by unconventional practitioners in blood infusion, a process whereby blood is removed, treated with oxygen, and returned to the body, as explained in a recent review by an unconventional medicine advocate:

The ozone is produced by forcing oxygen through a metal tube carrying a 300-volt charge. A pint of blood is drawn from the patient and placed in an infusion bottle. The ozone is then forced into the bottle and mixed in by shaking gently, whereupon the blood turns bright cardinal red. As the ozone molecules dissolve into the blood they give up their third oxygen atom, releasing considerable energy which destroys all lipid-envelope virus, and apparently most other disease organisms as well, while leaving blood cells unharmed (297).

Medizone International, a company that manufactures a device used to deliver ozone by infusion in the blood system, has filed an investigational new drug application with FDA to study the possible use of ozone as an antiviral agent. Before phase I studies in humans can proceed under the IND, however, the company is required to submit data, probably involving tests in animals using a range of doses, showing that ozone can be administered safely. Little information in the published, peer-reviewed literature is available on the use of ozone in general in the treatment of cancer, or on the recommended doses and regimen for treatment. Claims for the efficacy of ozone are based on a number of papers and case reports of its use on cancer patients (926,929), in animal studies (52,586), and in cell culture (940). One paper by Sweet and colleagues, published in Science, presents indirect evidence that atmospheric ozone selectively inhibits the growth of human tumor cells in cell culture (in vitro) (846).

Hydrogen peroxide is given in dilute form by various routes -- oral, rectal, intravenous, vaginal, and in bathing. Proponents state that hydrogen peroxide oxidizes toxins, kills bacteria and viruses, and stimulates immunity (364). One unconventional practitioner, Kurt Donsbach, who treats cancer patients in Tijuana, formulated a line of products using hydrogen peroxide, including ear drops, nasal spray, and tooth gel. Donsbach states that every cancer patient at his clinic in Tijuana receives dilute "infusions of the 35% food grade hydrogen peroxide throughout their entire stay" (262). In 1988, the U.S. Postal Service issued Donsbach a cease and desist order to stop him from claiming that the hydrogen peroxide used orally or intravenously is effective against cancer or arthritis, or that it is fit for human consumption (69). Another clinic, the Gerson clinic in Tijuana, has recently added ozone therapy to their regimen, partly on the basis of the laboratory study by Sweet and colleagues referred to above (401). Patients at the Gerson clinic are commonly given ozone enemas, consisting of 500 to 1000 cc of ozone given rectally in less than one minute (318).

Oxidizing agents, such as ozone and hydrogen peroxide, can destroy cells, including those of the blood-forming organs, and at some doses, can be seriously damaging or even lethal (860).

The doses at which these agents can be administered safely have not yet been determined. Although advocates of ozone and hydrogen peroxide maintain that these substances can be used safely, other unconventional practitioners have noted possible adverse effects (98).

License Revocation of James E. Johnson, M.D, 27/11/2004
Johnson then recommended intravenous hydrogen peroxide treatments as well as ozone therapy. E.H. declined the ozone therapy but agreed to the hydrogen peroxide treatments.

The Board issued an Order of Summary Suspension, in which it found that in October 1999, E.H. began seeing Johnson. The Order recited that Johnson diagnosed her as having polysystemic candidiasis; that Johnson told her that he could cure the illness using intravenous hydrogen peroxide treatments; that Johnson injected high doses of vitamin C into inappropriate injection sites that resulted in a large abscess that had to be surgically removed; that Johnson accepted barter payments from E.H.; and that Johnson advertised hydrogen peroxide therapy and ozone treatments on his internet web site. The Order of Summary Suspension concluded that, "as a result of the medical treatment received by from , the patient was misdiagnosed, treated outside the standard of care, and suffered injury as a result." The Order of Summary Suspension also stated:

Dr. Roth also testified about the ozone treatment that Johnson advertised and recommended to E.H. but which E.H. declined. Dr.

Roth testified that it is not legal to sell ozone generators in the United States, that ozone is a poisonous gas, and that he had not found "anyplace where the use of ozone therapy is efficacious in the treatment for any disease process, via inhalation or injection route of any form."

In its written Order revoking Johnson's medical license, the Board found that Johnson diagnosed E.H. as having polysystemic candidiasis; that Johnson recommended that he treat her illness with intravenous hydrogen peroxide treatments and also recommended ozone treatments; that Johnson administered vitamin C injections into E.H's hip and buttock area in inappropriate injection sites; that there was "no medical substantiation of the diagnosis reached by "; that Johnson "violated the standard of care in the community through his use of hydrogen peroxide treatments for the treatment of candidiasis"; and also that "the patient suffered an injury as a result of said treatment." The Board concluded that Johnson engaged in unethical and unprofessional conduct as contemplated in section 63-6-214(b)(1) of the Tennessee Code Annotated, and that his treatment of E.H. "constituted gross malpractice, a pattern of continued or repeated malpractice, and incompetence and ignorance in the course of medical practice pursuant to T.C.A. § 63-6-214(b)(4)." The Board, for the welfare and benefit of the citizens of Tennessee, ordered that Johnson's license be revoked, and that he be assessed $11,000 in civil penalties.

In this case, the chancery court found that the Board's decision to revoke Johnson's medical license was prompted by a desire to prevent him from practicing "alternative medicine." In the proceedings before the Board, however, there was ample evidence that, regardless of whether it is considered "alternative medicine," Johnson's treatment of E.H. went well beyond unorthodox, that it was below the standard of care, and was in fact dangerous. The Board heard expert testimony that the treatment methods recommended and utilized, indeed advertised by Johnson, were not simply ineffective to treat E.H.'s maladies, but could have resulted in more serious consequences, even her death. The evidence showed that Johnson recommended ozone treatment, a poison, administered hydrogen peroxide intravenously, a dangerous treatment, injected vitamin C near E.H.'s rectum, resulting in a potentially life-threatening abscess, and then treated the abscess with a charcoal poultice mixed in a coffee can. For this Johnson charged E.H. in excess of $4,500, and nevertheless maintained in his testimony before the Board that his treatment of E.H. was within the standard of care in the Nashville medical community. Based on this record, the Board's decision was not arbitrary or capricious, was not an abuse of discretion, and was clearly supported by substantial and material, indeed compelling, evidence. Consequently, we must reverse the decision of the chancery court, and uphold the Board's decision to revoke Johnson's medical license. The chancery court's decision upholding the civil penalties assessed against Johnson was not appealed, and is therefore affirmed.

"Bio-Oxidative Medicine" Practitioner Disciplined, 27/11/2004
In September 2002, John C. Pittman, M.D., signed a consent order (shown below) under which the North Carolina Medical Board suspended his license for 60 days with the stipulation that he "would not use IV ozone or hydrogen peroxide until the board explicitly orders otherwise." Documents from the board indicate that the case involved a woman he treated who had nearly died from a precipitous drop in hemoglobin caused by intravenous infusions of ozone and hydrogen peroxide, which destroyed many of her red blood cells.

Several proponent Web sites state that in 1992, the board had pressured Pittman to stop treating AIDS patients with ozone. He subsequently practiced in Haiti until passage of an Alternative Medical Practices Act

encouraged him to open the Carolina Center for Alternative and Nutritional Medicine in Raleigh in 1994, where he offered "supplemental nutrition therapy," intravenous ozone and hydrogen peroxide, EDTA chelation therapy, lymphatic massage, and colon hydrotherapy and "detoxification." In 1998 and 1999, his treatment typically cost about $3,800 for the first week and $1,600 for each additional week. During this period, patients were asked to sign a "Request for Admission" form which stated that "the Carolina Center has a goal of collecting laboratory and clinical data for research purposes." However, I am not aware of any research report that Pittman has published.

In an article posted to the Internet in 1998, Pittman claimed that "chronic oxygen deprivation" is a major cause of disease and that "bio-oxidative therapy" with ozone or hydrogen peroxide can "(1) increase metabolic efficiency of all cells; (2) stimulate cellular immunity (protects against infections) and suppress humoral immunity (allergic reactions); (3) regulate cytokines which control the action of all immune system cells; (4) regulate hormone production; (5) increase energy production; (6) exert a direct killing effect of bacteria, viruses, yeasts, and cancer cells; and (7) stimulate the production of more natural antioxidant enzymes." However, these notions are unsubstantiated and lack a scientifically plausible rationale.

Whereas after attempting other forms of treatment, Dr. Pittman decided to treat the above conditions with ozone and a diluted form of hydrogen peroxide, administered intravenously (IV), and

Whereas by instituting IV ozone and hydrogen peroxide treatment on a patient who indicated on her initial intake form she was a member of Jehovah's Witnesses without being more attentive to her hemoglobin and hematocrit, the possibility that she might require a blood transfusion but might refuse it, and documentation of these matters, Dr. Pittman departed from, or failed conform to, the standards of acceptable and prevailing medical practice, within the meaning of 90-14(a) (6) which is grounds under that section of the North Carolina General Statutes for the board to annul, suspend, revoke, condition, or limit Dr. Pittman's license to practice medicine and surgery issued by the Board, and

2. Dr. Pittman will not use IV ozone or hydrogen peroxide therapy in his practice until the Board explicitly orders otherwise.

NutraScan : Another "Test" to Avoid, 21/8/2007
In 2002, a young woman from Iowa completed the questionnaire and sent urine and saliva samples for testing. She was told that her test results showed an accumulation of toxins and was advised to visit Martin's clinc to undergo "plate zapping" and ozone treatments. ("Zappers" are quack devices that emit low-voltage electric currents. Their use is based on Hulda Clark's notion that all living things broadcast a characteristic range of radio frequencies and that zappers can issue counter-frequencies that kill unwanted organisms .) The young woman sent me a copy of her clinic records and described her experience this way:

Each day I zapped from 9-11:00 a.m. and from 1:00 or 2:00 until 4:00 p.m. At 11:00 and 4:00 each day I was scheduled for an ozone treatment. For the ozone treatments, I sat in . . . an old-fashioned white sweat box with my head sticking out a hole at the top. The compartment got very steamy inside. Inside the compartment was a hose with a funnel-shaped cone connected to it. The hose was connected to an ozone-producing machine. I was told to direct the cone at my liver for half the session and my thyroid the other half of the session. I was told that toxins would be excreted through my open pores as the temperature inside the compartment heated and my body began to perspire. Each session lasted about 30 minutes. Following each session, I was given a glass of ozone water to drink while ozone was directed into my ears (via a tube connected to what looked like a stethoscope). The hose was connected to an ozone-producing machine. . . .

OTA Report: References, 13/1/2006
52. Arnan, M., and DeVries, L.E., "Effect of Ozone/Oxygen Gas Mixture Directly Injected Into the Mammary Carcinoma of the Female C3H/HEJ Mice," J. Holistic Med. 7(1):31-37, 1985.

86. Blue Cross and Blue Shield Association, "TEC Evaluation: Ozone Therapy for Cancer," unpublished mimeograph, Chicago, IL, November 1987.

586. Mayer, R.A., "Ozone: A Chemotherapeutic Agent for the Treatment of Acute Monocytic Leukemia in Rats and Mammary Adenocarcinoma in Mice," typescript, undated.

846. Sweet, F., Kao, M.-S., Lee, S.-C.D., et al., "Ozone Selectively Inhibits Growth of Human Cancer Cells," Science 209(4459):931-933, 1980.

926. Varro, J., "Ozone Application in Cancer Cases," typescript of presentation at the 6th World Congress on Ozone, Washington, DC, May 22-26, 1983.

929. Viebahn, R., "Twenty Five Years of Practicable Ozone Therapy," typescript, Hansler, West Germany, undated.

WaterOz Founder David Hinkson Receives 43-Year Prison Sentence, 11/6/2005
Hinkson owned and operated business in Grangeville called WaterOz, which markets products via the Internet and a "buyer's club." Its Web site claims that its products are effective against a wide variety of human ailments. In the summer of 2000, the IRS launched a criminal investigation based on evidence that Hickson had willfully failed to file income tax returns or pay employment taxes for his workers. That investigation ultimately produced a 43-count indictment charging him with failure to file income taxes, failure to pay employment taxes, mislabeling his water products to overstate their mineral content, marketing adulterated drugs, selling misbranded and adulterated ozone generators, and structuring financial transactions to avoid bank currency reporting requirements. The indictment stated that from 1997 through 2001, WaterOz grossed $11.9 million, netted $7.4 million, and paid

In May 2004, Hinkson pleaded guilty to two of the product-violation charges and a jury found him guilty on 26 counts of failing to file income tax returns, failing to collect federal taxes, and structuring transactions to avoid reporting requirements . In his plea, Hinkson admitted not labeling his lithium water a drug, as required by law, as well as operating a facility not licensed to manufacture drugs. WaterOz also sold ozone generators and body suits which the company claimed had health benefits. In his plea, Hinkson admitted that the generators were not labeled as medical devices, and that he had not applied for approval to market them as such. Testimony at this trial also indicated that Hinkson did not file tax returns and routinely paid his employees in silver dollars or other cash, without withholding federal taxes. Other testimony indicated that the company regularly obtained its payroll cash in multiple withdrawals, keeping each withdrawal under the $10,000 limit that triggers federal reporting requirements.

Archived versions of the WaterOz Web site show the extraordinary extent to which Hinkson violated federal law. Before his prosecution took place, the site contained For about two years between 2000 and 2002, versions of the site contained "recommended protocols" for using 22 mineral products to treat about 70 or 100 "specific health issues" including AIDS, appendicitis, cancers, Down's syndrome, epilepsy, multiple sclerosis, and parasites. The site also offered an ozone generator and "ozone body suit" with claims such as:

The medical benefits of using an ozone suits with the ozone generator have been seen in cases of simple muscle fatigue to severs infections such as limb threatening gangrene. Sitting in the body suit (with or without clothing, it is a personal choice) cleans the skin, helps remove odor, oxygenates the skin, helps increase circulation and helps remove viruses from the body and attacks cancer cells.

Suit against Dr. Stephen Edelson, 17/12/2003
This stated that the boy had numerous different diagnoses, including neurotoxicity, chemical toxicity, heavy metal toxicity, among many others. Defendants represented that these diagnoses needed to be treated with biodetoxification, chelation, nutritional therapies, and intravenous ozone therapy.

27. Upon arrival at the Edelson Center, Defendants began administering the detoxification, chelation, ozone and nutritional therapies they recommended. These treatments involved daily injections (sometimes multiple injections per day) of chelating agents, ozonated blood, and liquid nutrients.

28. Contrary to the representations made by Defendants in their promotional materials, these therapies subjected the boy to substantial risks. Ozone treatments can result in embollic phenomena, or dangerous air or clots in the blood stream. Any I.V. treatment can result in sepsis (blood poisoning). Chelation therapy can result in renal failure and blood dyscrasias. By undergoing these therapies, The boy was subjected to risks of death and disablement.

29. The boy began to undergo the detoxification, ozone, chelation and I.V. vitamin treatment recommended by Defendants. The treatments were administered by unsupervised workers that, on information and belief, did not have formal nursing training or professional licenses of any kind.

He had adverse physical and behavioral reactions to the ozone and sauna detoxification therapy. The nutritional supplement regimen prescribed by Defendants required the boy to ingest approximately seventy pills and capsules per day. He frequently would vomit after having to ingest large quantities of supplements, yet Edelson refused to alter the supplement regimen when requested by the Parents. The treatment caused the boy to suffer significant emotional distress and physical pain, and subjected the Parents to considerable stress and anxiety as their son suffered under Defendants' care.

43. Further, even if environmental or chemical agents had been proven to be a factor in causing autism, Defendants knew or should have known that there is no reliable medical or scientific evidence supporting the idea that autism could be cured or reversed using chelation, ozone, detoxification or nutritional supplement programs.

Edelson Center Closed after Three Suits alleging Fraud and Malpractice, 5/9/2006
The treatment involved "detoxification," ozone, chelation and I.V. vitamins administered by unsupervised workers who apparently have no formal nursing training or professional license of any kind.

The boy also had adverse physical and behavioral reactions to the ozone and sauna detoxification therapy.

The ozone generators that Edelson used to administer ozone treatments lacked FDA approval and were imported illegally. In September 2004, federal officials raided Edelson's and seized two such devices .

Ozone devices promoted as cure for autism. FDA Office of Criminal Investigations Fiscal Year 2005 report.

"The Missing Link" Debunked, 27/11/2004
One cannot get oxygen, negative ions or ozone from essential oils. Nothing can live in ozone (it is an extremely powerful oxidant \ not antioxidant), and "negative ion environment' is a scientifically meaningless description. Some essential oils contain antioxidants, but the best antioxidants (vitamin C, vitamin E, some flavonoids) are not found in essential oils. The essential oils are indeed very diverse in structure, function and properties."

Young says: "So diffusing puts the oils into the atmosphere in your home. You're getting increased oxygen because it releases the oxygenating molecules, you're getting increased ozone and negative ions because that's where it comes from in nature, from the plant oils. You're getting antiviral, antibacterial, antifungal, germicidal properties and the immuno-stimulating"

Reality: If only this were true! But as described above, essential oils are not oxygenating, and they do not supply ozone or negative ions. And while some preliminary research indicates that perhaps a few essential oils may have antibacterial properties, there is no data supporting their use in humans in any form to treat infectious disease. And there is no evidence that essential oils help the immune system. In fact the vast majority of people have normal immune systems that do not need stimulation. Some diseases are even caused by overactivity of parts of the immune system.

The Toadstool Millionaires: Chapter 11, 23/5/2002
Not only complicated formulas of the chemist's compounding, but also simplified essences of his analysis, have poured into patent medicine bottles. The basic elements of the universe itself have gone to the aid of suffering humanity. Dr. Judge's Oxy-Hydrogenated Air cured catarrh, deafness, and consumption when sucked or sniffed through a tube from the bottle in which it was confined. The National Ozone Company prepared twenty-four different remedies ranging from an ozone specific for cholera to an ozone tonic for the uterus .

Dr. Cullen's Vegetable Remedy poster, Rare Book Div., Library of Con-gress; Judge pamphlet (Boston, 1878), in Ntl. Library of Med.; Oxydonor ad, Frank Leslie's Popular Monthly, 43 (1897), 630; Ozone Era, and Family Physician (Chicago, 1885), in Chicago Hist. Soc.

Cancer: "Miraculous Recoveries", 27/3/2001
Lucas Boeve, proprietor of a clinic in the Dominican Republic, claimed that ozone gas administered at his facility had cured cancer, AIDS, Alzheimer's disease, Parkinson's disease, arthritis and many other diseases, and that he provided an ozone machine that had cured "Magic" Johnson of AIDS. In 1994, the staff of NBC's "Dateline" took a responsible look at Boeve's activities by investigating all the cancer and AIDS patients on a list of success stories provided by Boeve. Of thirteen cancer patients: two had died; three could not be found; two refused to be interviewed; three were alive but still had cancer; and three said they had been helped, but their doctors said they were probably cancer-free before ozone therapy. Of two AIDS patients, one said he felt well but still was HIV positive, and the other had not been retested for HIV. "In all," a commentator concluded, "not one documented cure on Boeve's own list." In addition, Johnson's representatives said that he had had nothing to do with Boeve (or ozone therapy) and was still infected with the virus.

OTA Report: Index, 14/1/2006
Antineoplastons, 95 biologically guided chemotherapy, 118 Essiac, 73 Immuno-Augmentative Therapy (IAT) 133-135 laetrile, 103-104 ozone infusion, 114 vitamin C, 121

Antineoplastons, 92, 219 dimethyl sulfoxide, 99 herbal treatments, 69, 75 hydrazine sulfate, 100 Immuno-Augmentative Therapy, 131, 142, 143, 145, 147, 148, 192 information dissemination, general, 154, 162, 163-164, 166, 167 insurance reimbursement, 186-192 (passim), 195 laetrile, 21, 22, 192, 201-202 Nieper, Hans, 112, 173 ozone infusion, 114

Antineoplastons, 95 biologically guided chemotherapy, 118 Essiac, 73, 74-75 Immuno-Augmentative Therapy, 133-136, 137, 139 laetrile, 103-104 ozone infusion, 114 vitamin C, 121 see also Animal research

Court Dismisses Sharper Image Lawsuit against Consumers Union, 20/4/2005
In previous reports, CR has criticized the claims made for ozone-generating "air purification devices" of the type marketed by Living Air, Alpine Industries, and EcoQuest .

In May 2005, Consumer Reports reported new finings that the Ionic Breeze Quadra S1737 SNX and four competing devices emitted excessive amounts of ozone that could cause respiratory difficulty when operated close to the user .

Barrett S. Alpine Industries ordered to stop unsubstantiated claims for ozone generators.

Questionable Cancer Therapies, 12/3/2005
Gerson therapy is still actively promoted by his daughter, Charlotte Gerson, through lectures, talk show appearances, and publications of the Gerson Institute in Bonita, California. Gerson protocols have included liver extract injections, ozone enemas, "live cell therapy," thyroid tablets, royal jelly capsules, linseed oil, castor oil enemas, clay packs, laetrile, and vaccines made from influenza virus and killed Staphylococcus aureus

"Hyperoxygenation" therapy -- also called "bio-oxidative therapy" and "oxidative therapy" -- is based on the erroneous concept that cancer is caused by oxygen deficiency and can be cured by exposing cancer cells to more oxygen than they can tolerate. The most touted agents are hydrogen peroxide, germanium sesquioxide, and ozone. Although these compounds have been the subject of legitimate research, there is little or no evidence that they are effective for the treatment of any serious disease, and each has demonstrated potential for harm . Germanium products have caused irreversible kidney damage and death .

"Detoxification" Schemes and Scams, 15/5/2009
Colonic irrigation (also called colon hydrotherapy) is intended to flush the entire length of the colon. It is done both at home and in commercial offices. The fluid may be plain water or contain enzymes, coffee, probiotics, ozone, and/or herbs. Various web sites indicate that the amounts used range from a few gallons up to as much as 30 gallons, a few pints at a time. The fluid is delivered through a tube or speculum inserted into the rectum. Most devices depend on gravity to deliver the water and peristalsis to expel the fluid and debris. Home kits (colonic boards) enable the user to flush gradually from a 5-gallon tank. Closed-system colonic machines have one tube for delivering the fluid and another for its removal. Open-system devices use a smaller tube connected to a water tank and a built-in basin to receive the waste. Sessions generally last between 25 and 50 minutes and may include abdominal massage. Some systems have disposable specula and tubing. Reusable components are sterilized after each patient. Colon irrigation has a few legitimate medical uses, such as preparation for surgery or radiological endoscopy and for treating fecal incontinence, but its use for “detoxification” is irrational .

Questionable Device Index, 22/1/2009
Ozone generators (air cleaners)

More Oxygen Hype: OxCgen, 18/6/2008
"OxCgen Advanced Activated Oxygen for Colonic Cleansing & Health" is said to contain 500 mg of magnesium oxide, 75 mg of vitamin C, 25 mg of bioflavonoids packaged in a vegetable-based capsule. It claimed to "release activated oxygen—a unique and powerful mixture of oxygen and ozone - initially into the digestive tract." According to a site that promotes it:

http://www.quackwatch.org/11Ind/kadile.html, 18/4/2007
performed "oxidative therapy" which involves administering ozone to a patient intravenously which is of no medical value;

Genetics and 'Predictive Medicine': Selling Pills, Ignoring Causes, 17/8/2006
McConnell, R, Berhane, K, Gilliland, F, London, SJ, Islam, T, Gauderman, WJ, Avol, E, Margolis, HG, Peters, JM (2002), Asthma in Children Exposed to Ozone: A Cohort Study. The Lancet, 359, 386-391.

OTA Report: Dietary Treatments, 13/1/2006
ozone treatment (328) (given by enema (318) or via infusion in autologous, heparinized blood or directly into patients' blood vessels (401))

OTA Report: Financial Access to Unconventional Treatment, 13/1/2006
Few unconventional cancer treatments meet these criteria, largely because of a lack of clinical evidence and lack of publications in scientific peer-reviewed journals. TEC has evaluated only one unconventional cancer treatment so far, ozone treatment, which it labeled investigational (86). If FDA has not given a drug or biologic final marketing approval for the indication for which it was used, BCBSA usually recommends against reimbursement. Few drugs or biologics used in unconventional cancer treatments would meet this criterion. In the past, BCBSA has chosen not to evaluate or issue coverage recommendations for drugs and biologics that do not have FDA final marketing approval or are not used for the indication(s) approved by FDA. BCBSA is, however, now in the process of reevaluating their role in assessing drug coverage (56,343).

OTA Report: Summary and Policy Options, 13/1/2006
Chapter 5 also describes a number of other pharmacologic and biologic agents that are used as unconventional cancer treatments, some singly and some in combination. Examples include laetrile, a substance widely popular in the 1970's and currently offered in several clinics in Mexico; vitamin C, whose most prominent advocate for use in cancer treatment is the biochemist Linus Pauling, Ph.D.; dimethylsulfoxide (DMSO), an industrial solvent often used in combination with laetrile and vitamin C; cellular treatment, processed tissue obtained from animal embryos or fetuses given orally or by injection; and various substances containing oxygen, including hydrogen peroxide and ozone taken orally, rectally, or via blood infusion. Hydrazine sulfate, a substance that, from 1975 to 1982, was on the American Cancer Society's Unproven Methods List, was taken off when clinical trials under an investigational new drug exemption (IND) were started. The trials were controversial, however, and it is still considered in the context of unconventional cancer treatments.

The Medical Messiahs: Chapter 11, 20/11/2004
Device quackery preyed on the same widespread credulity, fear, and desperation which permitted all other forms of quackery to flourish. Gadgets could possess certain kinds of persuasiveness denied to drugs. One was the power to shock. A New York "clinic" early in this century treated young men who were led to believe they might be suffering from syphilis or the dire consequences of self-abuse. The patient sat naked upon a sort of toilet throne, his bare back resting against a metal plate, his scrotum suspended in a whirling pool. The plate and pool were linked by wire to a battery. No frightened sufferer could question the rigor of this therapy. Further, gadgets could appeal to several of the senses. The Violetta, vended as useful in 86 ailments, ranging alphabetically from abscess to writer's cramp, impressed itself simultaneously upon the hearing, seeing, smelling, and feeling of its user. A small, high-voltage generator, ionizing the air in a hollow glass head, the Violetta buzzed and crackled, produced a bluish glow, exuded ozone, and with its sparks tingled and warmed the skin .


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