
Canada Leads the Way in North America 1994 by Ed McCabe, Investigative Reporter, and author of the best seller, "Oxygen Therapies"
For the first time in North American history an in vivo study was completed where AIDS patients were given ozone to determine the therapeutic benefits of this modality on the plague of the 20th century.
Summary:
Various Canadian government, military and commercial representatives got together in 1989-1990 to investigate the safety and effectiveness of ozone therapy in the treatment of AIDS. Two small pilot studies were undertaken.
This resulted in the 1991 Publication:
The use of ozone-treated blood in the therapy of HIV infection and immune disease - a small pilot study was conducted consisting of two phases. Phase 1 was 10 patients, phase 2 was 14 patients. "AIDS" 5:981-984. G. Garber, D Cameron, N Hawley-Foss, D Greenway and M. Shannon.
Although the methods used were not state of the art, and there was insufficient funding to procure the type of equipment necessary to insure a controlled dose, the unofficial opinions amongst the researchers was quite favorable.
Because of the exploratory nature of this pilot study it is considered "flawed" by the exacting standards of modern medical science. According to a majority of the parties involved there was sufficient amelioration in the condition of the test group over the control group to warrant further study.
The way the findings were stated misconstrued the net result in such a way as to thwart further investigation into this form of therapy. One observer pointed out that "they demonstrated that a man can stay aloft for a period using a hang glider but along the way they learned how to build a cessna."
Modern Medical Ozone therapy consists of taking three combined very active atoms of pure oxygen (ozone) and surrounding all the anaerobic (can't live in oxygen) primitive cell bacteria, viruses, funguses and parasites with it. This active form of pure oxygen makes it impossible for the quickly oxidized microbes to live, and ozone is also harmless to normal healthy human cells when used correctly.
All the secondary infections, and possibly even the prime infection either go away, or enter a level of remission concurrent with the procedures and methods applied, including the pre-treatment health of the patient. When applied properly, meaning using correct procedures, delivery methods, concentrations, volumes, and durations, ozone is extremely safe and effective, according to published animal and human studies over the past one hundred years 2,3,4.
In an early, early for North American research, Canadian establishment attempt to see if there is any validity to the overwhelmingly positive reports on medical ozone coming out of Europe, and, to see if it was safe, an outdated and poorly executed ozone protocol was used in a "small pilot" study by researchers inexperienced in the use of ozone therapies.
Outdated because the method chosen was deemed painful and ineffective in 1938, and inexperienced, because they had never used ozone before.
Modern medical ozone application has a few significant procedures that classically trained scientists outside the field know nothing about, since the many ozone therapy procedures are not taught in North American and Canadian medical schools.
These investigators chose the delivery method of minor autohemotherapy as their starting point. This was a backwards decision when we consider that more sophisticated ozone delivery techniques have been in use by thousands of European physicians for over 50 years. Far better methods are currently being developed worldwide.
The minor autohemotherapy method (min AH) they chose involved withdrawing a small amount of blood, mixing ozone into it - to kill the viruses, and then re-injecting the dead viruses. This is the immunization theory. Minor autohemotherapy is a poor cousin to major autohemotherapy, which is itself now giving ground to even more successful modern delivery methods.
The most modern of the successful ozone therapies skip this unneeded dead virus inoculation step, and directly flood the blood, lymph, and cells with virus destroying pure medical ozone gas.
This is done in a variety of ways, IV, dialysis type recirculatory systems, ear, vaginal, penile, and rectal insufflation, sauna bags and devices, breathing ozonated air, and drinking ozonated water. Our bodies soak it right up harmlessly because we evolved in an oxygen environment.
Starting in the late 1800's up to the present, hundreds of thousands, perhaps millions use some of these methods daily.
The small pilot trial we are discussing was sponsored by the Ottawa General Hospital Infectious Disease Division, the Canadian Department of Health and Welfare, the Canadian Federal Center For AIDS, the Canadian Department Of National Defense, and The Meuller Medical Company of Canada, now Vas-O-Gen.
My analysis:
If you compare the protocols used in this study with the known to be more effective modern ozone methods, and then also compare the internal letters of the investigators reporting their documented findings against the final published version of the study, it immediately becomes apparent that the published study was not sufficiently favorable to ozone therapy to reflect the positive results that they actually generated.
How can I make such an accusation? Let's look closely at the facts.
Of prime importance is the fact that the very design of the study was so out of touch with current known worldwide private ozone medical practices that it could scarcely be labeled "ozone therapy." It is a travesty to call it anything other than a poor distant cousin to modern ozone therapy.
However, on the plus side, one factstands out on the very first page (981) of this study published in "Aids."1 The authors plainly state: "Preliminary work has suggested that ozone does inactivate HIV in vitro." Then they also state that they proved ozone does indeed kill HIV-1.
They withdrew 10cc's of blood, and interfaced 3 mcg/ml3 of ozone with it, and the ozone destroyed all the HIV-1 viruses, and didn't hurt the blood. "The resulting inoculation presents a killed virus antigen preparation." These statements alone prove ozone deserves further study.
Let's examine the materials and methods used. Here's a comparison of the outdated protocols employed in the study and modern medical ozone delivery methods:
1990 antiquated (MinAH) Canadian study Standard private medical ozone protocol
Treat outside body. Inject directly into the vein, or constant recirculation.
Withdraw 10cc's of blood. Inject/recirculate up to 500ccs, or whole blood supply.
Treat with 3 mcg/ml3 concentration. Minimum of 27 to 42 mcg/ml3 concentration.
Ozone was heated. Ozone never heated. Heat destroys ozone.
Injected into huge gluteus maximus muscle. Always infused into veins/arteries.
Injected only three times per week. Best applied once or twice per day.
Also
Ignored results. The published document ignored the results of Phase 1A wherein 3 of the few patients who had any immune system left - each with CD4 T-cells above 200 - had their counts go from 220-230 up to 500. The patients gained weight, and reported feeling great.
Instead the published document stated: "no difference was seen between placebo and ozone treated patients." Reason: I learned from a personal interview with the ozone generator manufacturer's technician that in Phase 1B, the second half of the study, the ozone generator mysteriously failed, because The ozone generator was producing very little or no ozone! and when the Meuller medical technician dutifully reported this to the investigators, he and this fact were ignored, and the study was written up without reflecting this fact.
Incorrect dosage schedules and volumes. Phase 1A and Phase 1B only treated 10cc's of patient blood on only three times a week treatment days.
Wrong procedure. It is fine to make an inoculation, but inoculations only work on people whose immune system are fully functional, certainly inoculations are not applicable to a study of AIDS patients and their compromised immune systems and only 50 to 500 T cell ranges.
Ozone is used to sterilize municipal drinking water all over the world. How are you going to clean up the microbe infested waters that the human patients are made up of, by putting only 10cc's (less than a teaspoon) of barely touched with ozone blood into a muscle - and only three times a week?
Compare this choice of minor autohemotherapy (MinAH), and its only thrice weekly injections to an obvious objective of getting rid of this disease by cleaning all the viruses, bacteria, funguses, and parasites out of the 100 POUNDS+ of water that the human body consists of.
The extra oxygen is used up when the oxygen tries to oxidize the existing and incoming pollution and microbes. This total cleansing objective is challenged daily by the added burden of 2 1/3rd days of normal daily living between treatments.
This skipping treatment days allows the environmental and dietary toxic intake load to continually tend to undo the cleaning process. There is no way you could ever "keep up" by cleaning faster than the body absorbs new toxic burdens, especially under the stress of a disease like AIDS and its constant bacterial and viral replications! 10cc's of minor autohemotherapy is only a drop in the pond of the diseased body waters.
Incorrect concentrations.
The tiny 10cc's of withdrawn patient blood was treated with an equally tiny 3 microgram per cubic millimeter (assuming a functioning ozone generator), by weight, ozone concentration. Everyone using ozone in private clinics knows that a minimum of 27 to 42 mcg/ml3 concentration of ozone is necessary to achieve maximum viral kill with a minimum of hemolysis (Standard acceptable levels of normal cell damage from any treatment.).
This study used only a fraction of the acceptable concentrations.
Wrong delivery method.
The tiny amount of blood with the (possibly intermittent or non-existent) paltry concentration of ozone was introduced into the body by injecting it into a large muscle. No-one who really knows how to use ozone employs this method since 1938, when Dr. Paul Aubourg used it in his study in two Paris hospitals, which proved that although other methods of the application of ozone, like rectal insufflation, gave excellent effectiveness, the intramuscular injection method was "painful and ineffective." 5.
The actual data does not match the published conclusions. Even more disturbing than the above errors is a detailed comparison between the actual investigators' internal inter-office correspondence, and the final published document.
Let's look at excerpts from a letter by Captain Michael Shannon, now Commodore Shannon of the Canadian Department of National Defense (the Canadian military forces) written to Dr. D.W. Boucher on January 24, 1990.
M.E. Shannon CD,MA,MSC,MD one of the principal investigators wrote the following in his final report and recommendations to the superior official representing the government funding, Dr. D.W. Boucher, of the Bureau of Biologics, Health Protection Branch, Health and Welfare, Tunney's Pasture, Ottawa, Canada, on January 24th, 1990:
"Ozone Therapy In AIDS/Project #231 Summary of Findings."
Dr. Shannon:
"This trial yielded... "encouraging results"
"There has been no clinical, biochemical or immunological evidence of adverse/toxicological effects."
"An improved sense of well being characterized the clinical responses of all patients..."
"...several patients reported a return of appetite and concomitant weight gain."
"4 patients suffering from arthralgic pain reported a significant amelioration of symptoms."
3 out of 4 "reporting complete relief of what was well documented to have been a chronic condition."
"The lack of bruising at the site of injection was somewhat surprising."
"Three patients showed a significant positive response..." in their CD4 measures."
"There were no detrimental effects on absolute CD4 counts for any of the patients."
"One patient showed a 52% reduction in the initial P24 antigen levels with a corresponding increase in absolute CD4 count."
The earlier Sept to October 1989 series of investigations by Dr. M.O. Shaughnessy at the Virology Division of the Bureau of Laboratories and Research Services "clearly support the contention that the technology has potent virucidal (virus inactivating) effects."
"It would appear that this form of therapy constitutes a potent means of inactivating HIV-1 in contaminated blood supplies, and may also provide a means for patient specific "autovaccination" in selected cases." ("Selected cases" meaning those with enough of an immune system left so that an inoculation will make the immune system respond.)
"These results are considered well beyond the error limits for the particular assays, and indicative of potential therapeutic benefits which should be further investigated."
"As reported in earlier correspondence, (1988/89 Ottawa General/NDMC) several cases of long standing sciatica and one case of severe facial pain secondary to an invasive naso-pharyngeal carcinoma responded dramatically to this form of therapy."
"As the understanding of ozone biochemistry increases and potential toxicological concerns dissipate, analgesic applications of this therapy should be pursued."
"Since a subgroup responded, consideration should be given to the need for extended follow-up, and administration of a "booster cycle" to commence as soon as possible."
DR. SHANNON'S RECOMMENDATIONS AFTER COMPILING THE TRIAL DATA
"The results of this Phase I clinical trial are sufficiently encouraging that the research team at the Ottawa General Hospital would like to pursue an extension to the subject trial as outlined..."
"The potential benefits of this inexpensive, safe, and possibly efficacious treatment for the rapidly growing HIV-1 pandemic warrants further attention. Your assistance in this regard is respectfully solicited."
THE ACTUAL WRITTEN AND PUBLISHED PAPER
These words are being quoted and passed around by government agencies as proof that ozone doesn't work.
"In summary, these small pilot studies have shown that the Meuller Ozon-O-Med ozone therapy protocol appeared to have no detectable beneficial effect."(?,!) (Emphasis mine.)
"Our work does not, therefore, support the continued use of this technique in patients with HIV associated immune disease."(?,!) (Emphasis mine.)
Even with all the problems this study had, they never did say "ozone doesn't work," only that the delivery method didn't work! So, if someone or some agency tries to use this study as proof that ozone doesn't work, they are hopelessly misguided.
Although five investigators were listed as principals on the published paper, exactly who were the actual final paper-writing authors? From Dr. Shannon's communication to The Bureau of Biologics:
"Be advised that Dr.'s Garber and Cameron (Ottawa General Hospital) have formally submitted an abstract related to this trial to the International Conference on AIDS presentation this June."
It is also extremely interesting to further note that Dr. Shannon was never given a review copy to sign off on before the paper was published. In other words, although his name appears upon the published version, he was denied any input into the final version of what was said.
What forces could promulgate this obvious convolution of the truth? One source I interviewed, an enthusiast for Canadian ozone research, stated that he understood "the word on the street" to be that Dr. Garber was looking forward to proudly announcing the positive results at a big AIDS conference, but when the second phase didn't produce as good results as the first phase, he became crestfallen that he couldn't make the announcement, and turned his back on the project.
Keep in mind that this was a double blind study and that no ozone monitoring equipment was available so it was impossible to tell that the equipment had failed. Phase one showed very promising results that could well have been favorably reported on but history shows the decision made.
There is another aspect that I attribute to no one person, but I believe it must be considered as a possible shadowy, yet powerful, influence.
That is that the ozone generator could possibly have been sabotaged. Although it is shocking to any sane person to consider this scenario, we must also ask ourselves ask who would financially loose the most if AIDS and a host of other diseases, like cancer, etc., were to actually be improved, cured, or at least treated back to a level of remission?
Hint. You wouldn't need huge AIDS specialized government oversight agencies, and their supervisors, huge sums of private or federal research funds, billions of dollars in drug sales yearly, or health care workers, or hospitals, or grassroots AIDS groups, and their directors, and their funding.
That is, of course, unless all these people and institutions were willing to clean up their lives, stop "going along", and be directed into POSITIVE life affirming employment and enterprises.
Was this influence at work when Dr.
Shannon was seeking labs to possibly continue the research, yet he was told "All the labs are booked up for years on other work." 8 Who would have enough money to tie up all the labs and lock ozone out?
Why would the investigators, and all the connected agencies, ignore, and continue today to ignore, the notification of the broken machine?
Perhaps to have spent or taken the money to do such an expensive study, and after it was over, being already known as a "respected department," or "respected investigator" with a reputation to protect, and above all a need to continue the funding, maybe it is just too hard to admit your people, or you, personally, didn't do an expensive study correctly by completing such a basic daily task as quality checking the ozone producing machine. Let us hope that more nefarious forces were not in play.
And finally, Why would the published data suddenly and mysteriously change its obviously positive data into a negative published summation?
Unfortunately, the fallout from these faulty findings now infects this country as well. The U.S. FDA uses this same study as a reference, and seriously oversteps the truth and their boundaries to make the unjustified way too broad pronouncement that based upon this Canadian report, "Ozone therapy does not enhance parameters of immune activation nor does it diminish measurable p24 antigen in HIV-infected individuals."
From an actual FDA letter to one of our elected U.S. representatives, Congressman Sherwood Boehlert. Remember, the false published paper clearly never says that ozone doesn't work, but that only the particular delivery system of minor autohemotherapy, as used, incorrectly, and with its broken generator, doesn't work. Well no wonder!
I assert wholeheartedly that the protocols, as used there, were terribly ineffectual when compared to normal medical ozone therapies as practiced daily worldwide by thousands. Especially if you try it with a faulty generator. Even with this handicap, the plain facts remain that the investigators used a comparatively ineffectual ozone delivery method, an antiquated protocol, and a possibly broken generator, to create only a killed virus antigen preparation, and then injected too little of this mixture in the wrong place. Even these inadequate methods yielded such surprisingly positive results (when given time to do their work in a few of the patients whose immune systems were still functioning) that these amazing results were overlooked in the great push to find a cure.
So, in summary, a protocol that any serious practitioner would laugh at was used, their conclusions were based upon false data if the machine was broken, and their fraudulent conclusions were written in total disregard for human suffering, not caring how far back ozone research would be set, or how many lives were at stake.
The tragedy of having such errant summations published is that this information is repeated by supposedly impartial agency officials to our elected representatives and to news reporters, while these very agencies ignore the thousands of studies that show ozone does work.
This downright intellectual dishonesty is used to politically justify barring further real research into ozone in North America that would undoubtedly prove we have something ready right now to alleviate suffering and save lives. We know this is true, because ozone has been in use for 100 years by thousands of physicians.
The perversion of facts here is so overwhelmingly evident that I don't know what more to say, but I will say this: Exactly what factors came into play in the minds of the authors, the "reputable scientists" that we have trustingly given the care of ourselves and our loved ones to, when they obfuscate the truth needed by the sick and dying, so as to further delay the introduction of ozone medical therapies in the U.S. and Canada?
Why would any sane person deny a very badly needed therapy to the sufferers of disease? May God better guide their actions, for they know not what they do when men trade their honor for convenience.
Where are the positive thinking Canadians attempting to go from here?
Quoting Commodore Shannon:
"Allister Clayton, the Director of the Federal Center for AIDS went to bat for our funding."
"The book is not closed on the efficacy of ozone therapy for the treatment of AIDS."
"We need more funding."
"There is a role for ozone in medicine."
In January of 1995 Medizone International from New York will be announcing the results of their preliminary 300 patient HIV/Hepatitis ozone trials going on in Italy under the auspices of several Universities and the Italian Medical Ozone Society.
In January/February 1995, Cornell University is expected to announce the results of their ongoing ozone blood safety and sterilization trials.
For the record Commodore M. E. Shannon Deputy Surgeon General of Canada has submitted the following statement as a rebuttle to the published findings of the 90-91 Garber study.
"Notwithstanding the negative findings of Dr. Garber's 1991 clinical trial, I firmly believe that ozone therapy has potential to play a valuable role in the medical management of AIDS. From a regulatory point of view, it is clear that not all forms of ozone therapy will be considered sufficiently safe and/or efficacious in this regard; however, there is no doubt in my mind that a protocol will eventually emerge with proven benefit.
Looking back at my past experience with minor autohemotherapy in the treatment of AIDS, there still remains a discrepancy between the Phase Ia and Ib trial results, which may, relate to the lack of sophisticated technology to control the O3 concentrations in both trials.
Given the lack of any significant therapeutic breakthroughs in the treatment of AIDS since that ill-fated trial and the growing testimonial support for it's efficacy, the need for further clinical research with Ozone is certainly indicated.
It is indeed unfortunate that the North American medical community and its funding agencies could not take a more neutral stance on this subject; tragically, professional opinion has been somewhat polarized on this issue. I believe that it is time to take the emotion out of the arguments, both pro and con, and commence a systematic examination of the evidence currently available on the merits of this therapy.
Where information gaps exist (particularly in peer-reviewed scientific studies) which might preclude any regulatory decision on the validity of certain claims, properly designed research initiatives should be encouraged with the same kind of public support normally afforded any other scientific endeavor of this import.
Although I have my doubts that ozone will ever be shown to have certain curative value on AIDS, I am certain that its well-documented analgesic effects and hence, its potential impact on patient well-being and quality of life, will some day be recognized. In this regard, I understand that both the FDA and the National Institute of Health are presently reviewing the therapeutic merits of ozone as part of their program to investigate a number of "alternative approaches" to AIDS therapy.
I have the utmost confidence that in their continued pursuit of an answer to this problem, ozone will receive the scientific attention and support it rightfully deserves."
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