In the O-Zone

In the O-Zone
In the o-zone is an article from the November 2013 edition of WDDTY.

It conflates legitimate science, exaggeration of early findings, fringe claims and unproven claims to present a novel synthesis that is significantly different from the consensus view. The stated authorities for the more extravagant claims have evident conflicts of interest and red flags for fringe practitioners such as claiming unrecognised certification. Outright quacks are quoted alongside qualified doctors, albeit with practices that push the boundaries of what is ethically and evidentially supportable.

Ozone therapy occupies an interesting niche at the fringes, and WDDTY’s coverage of it is usefully indicative of its approach to fringe subjects generally. While it is not a quack therapy as such, fringe claims made by true believers go well beyond the current state of evidence. The most dangerous words in medicine are said to be: “in my experience”. The cited authorities are trusting their instinct and not listening to the cautious voice of scientific inquiry; as a result they are promoting a “miracle cure” which may well be legitimate in some cancers and from which useful therapeutic results may come, but without going through the process of checks and balances that is being applied by their more cautious colleagues. 

These sciencey-looking pods are used by quacks to perform "ozone therapy" on the credulous and/or desperate. They have pretty much nothing to do with the contents of the article.
These sciencey-looking pods are used by quacks to perform “ozone therapy” on the credulous and/or desperate.  They have pretty much nothing to do with the contents of the article.

In the o-zone

Ozone therapy is being used to treat a wide spectrum of diseases

It makes the sky blue, provides our planet with a protective layer from the sun’s UV rays and, for almost a hundred years, has been used medicinally to treat a wide variety of diseases. The German army used ozone extensively during World War I to treat battle wounds and anaerobic infections. Prior to that, ozone gas was used to disinfect operating rooms in Switzerland.7

Reference 7: Altman N. The Oxygen Prescription: The Miracle of Oxidative Therapies. Rochester, VT: Healing Arts Press, 2007

Interesting fact: a substantial proportion of the miracle cures promoted in WDDTY are formed around inflated claims for anti-oxidants; vitamin C megadoses are founded on the idea that antioxidants cure cancer, ozone therapy on the idea that massive oxidisation cures cancer. One of the cited sources uses both at once.

“Why, sometimes I’ve believed as many as six impossible things before breakfast” – The White Queen

You have to be kidding. Using a “miracle cure” book as a source? A “miracle cure” book by a palmistry believer?

And no, ozone does not make the sky blue. Rayleigh scattering occurs throughout the atmosphere. The benefit of the ozone layer is primarily in reducing ultraviolet radiation.

Not a good start: a schoolboy error and a citation to a worthless source.

Today, physicians around the world are using ozone to treat a wide spectrum of diseases, including AIDS, asthma, cystitis, herpes, rheumatoid arthritis and cancer, and it was part of my mum Gemma’s treatment.

That’s one view. Another is:

Ozone
Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. In order for ozone to be effective as a germicide, it must be present in a concentration far greater than that which can be safely tolerated by man and animals. – FDA

On the face of it, “physicians all around the world” appears to be code for quacks.

“Oxidative therapies induce your white blood cells to make tumourkilling properties,” explains California-based physician Dr Robert Jay Rowen. “When introduced into the bloodstream, ozone triggers an avalanche of beneficial changes: it boosts circulation, activates the immune system and improves the exchange of oxygen in the blood.”

What actually happens when ozone hits the blood is that (unsurprisingly) it generates free radicals which cause significant tissue damage. Inhaled, it is even worse: projectionists exposed to ozone as a result of the burning arc lamps suffered damage to the lungs, and this is also seen when ozone is inhaled “therapeutically”.

Dr. Robert Rowen is undoubtedly popular with the likes of Mercola, having “[pioneered] the nation’s first statutory protection for alternative medicine in 1990” (source: Robert Rowen). He is a real doctor. He is also an ozone quack and a peddler of supplements. He also claims to be “board certified in clinical metal toxicology” – this is a fake certification awarded by unrecognised “boards” set up by chelation quacks.

For over 80 years, it’s been known that low oxygen levels are associated with cancer. Dr Otto Warburg, a Nobel Prize-winning physician working in Germany, made this discovery in the 1930s and presented his findings at a Nobel Laureates’ meeting at Lake Constance, Germany, in 1966. “Cancer cells meet their energy needs by fermentation, not oxidation. Thus, they are dependent on glucose, and a high
oxygen environment is toxic to them,” he said.

Warburg’s research was confirmed in 1980, when scientists reported laboratory evidence showing that ozone selectively inhibits the growth of cancer cells.8

Reference 8: Science, 1980; 209: 931–2 Ozone selectively inhibits growth of human cancer cells. Sweet F, Kao MS, Lee SC, Hagar WL, Sweet WE.

An in-vitro study. Given the toxicity of ozone, this is hardly surprising, the problem is clinical applicability. As it says, “evidently, the mechanisms for defense against ozone damage are impaired in human cancer cells.” Ozone damage.

Meanwhile, back on planet Earth:

Available scientific evidence does not support claims that increasing oxygen levels in the body will harm or kill cancer cells. It is difficult to raise the oxygen level around the cancer cells in the middle of a tumor because the blood supply tends to be poor. But there are differences in the way cancer cells use oxygen that may allow new treatments to better target cancer cells. (American Cancer Society)

This suggests the standard SCAM trope of taking an early result, inventing a treatment from it, and then castigating medicine for failing to accept this naive treatment as the One True Cure for Cancer. Medicine, meanwhile, has to deal with tiresome details like the well documented toxicity of ozone, the difficulty of delivering it to the actual tumour and so on.

Dr Joachim Varro offered one of the first reports of successful treatment of cancer with ozone at the Sixth World Ozone Conference in 1983,9 reporting that his patients were free of metastases and tumour relapses for remarkably long periods of time, with improved quality of life. Italian researchers at the University of Siena theorized the supposed anticancer effects of ozone may due in part to its ability to induce the release of tumour necrosis factor (TNF), after measuring ozonated blood and discovering that most of the TNF was released immediately after ozonation took place.10

Reference 9: Medical Applications of Ozone, LaRaus J, ed, International Ozone Association, 1983: 94–5, not PubMed indexed

Evidence of the medical or any other credentials of Julius LaRaus is lacking. This might be a good time for a word from Dr. Kimball Atwood:

Practitioners of pseudomedicine band together to create pseudomedical pseudoprofessional organizations, complete with pseudo-legitimate names, pseudo-legitimate conferences, pseudo-legitimate appearing websites, pseudo-“board certifications,” protocols for pseudo-therapies, patient brochures hyping pseudo-therapies, pseudo-consent forms for pseudo-therapies, pseudo-Institutional Review Boards to approve pseudo-research, pseudo-journals to publish reports of pseudo-research, very real contributions from pseudoscientific corporations to help pay for very real advertising, very real lobbying, very real legal representation, and more – The Pseudomedical Professional Organisation, Kimball Atwood, Science Based Medicine

Reference 10: Lymphokine Cytokine Res, 1991; 10: 409–12. Studies on the biological effects of ozone: 2. Induction of tumor necrosis factor (TNF-alpha) on human leucocytes. Paulesu L, Luzzi E, Bocci V.

Another in-vitro study.

In the medical literature, the few scientific trials conducted on ozone to date to assess whether it helps overall survival have had problems with study design, but numerous studies on patients with cancer show a variety of benefits, such has treating osteonecrosis of the jaw in patients with bone metastases or ulcers in those with colon cancer.11

Reference 11: Haematologica. 2007 Sep;92(9):1289-90. Role of ozone therapy in the treatment of osteonecrosis of the jaws in multiple myeloma patients. Petrucci MT, Gallucci C, Agrillo A, Mustazza MC, Foà R.

Reference 11: Oral Oncol. 2011 Mar;47(3):185-90. Efficacy and safety of medical ozone (O(3)) delivered in oil suspension applications for the treatment of osteonecrosis of the jaw in patients with bone metastases treated with bisphosphonates: Preliminary results of a phase I-II study. Ripamonti CI, Cislaghi E, Mariani L, Maniezzo M.

The jaw is one area where ozone would plausibly be useful: the problems of delivering ozone to the cancer without collateral damage are probably reasonably good. However, there is substantial risk from inhalation, and these are preliminary studies.

Animal studies also show promise; in one, 86 per cent survived lethal squamous cell cancer, with complete tumour regression.12

Reference 12: Int J Cancer. 2008 May 15;122(10):2360-7. Treatment with ozone/oxygen-pneumoperitoneum results in complete remission of rabbit squamous cell carcinomas. Schulz S, Häussler U, Mandic R, Heverhagen JT, Neubauer A, Dünne AA, Werner JA, Weihe E, Bette M.

Promising animal study, but still does not properly address the issue of toxicity (therapeutic side effects may be missed in animal models).

Furthermore, the clinical evidence from the many doctors using ozone worldwide is compelling. Dr Rowen, who has educated hundreds of doctors worldwide about the use of ozone for many illnesses, says he witnesses his most profound effects with cancer. One patient, a 76- year-old-man with endstage colon cancer and two metastatic tumours in his liver (11 cm and 9 cm) was diagnosed as having at most a few weeks to live. Within four months of starting Rowen’s treatment with ozone and ultraviolet blood irradiation, another treatment often used with ozone, the patient’s liver tumours had shrunk by 85 per cent. After 16 months, his liver tumours disappeared, and he had his colon tumour removed surgically. Today he has no trace of cancer.

Bait and switch alert: we have moved from the scientific definition of evidence to the SCAM definition, where the best outlier is presented as the representative example.

Also note blood UV irradiation, another treatment at the fringes:

Ultraviolet blood irradiation treatment is approved by the U.S. Food and Drug Administration (FDA) for treating T-cell lymphoma involving the skin. Photopheresis is sometimes used conventionally when organ transplant rejection or graft-versus-host disease (a complication related to bone marrow or stem cell transplants) does not respond to usual conventional treatments. Some clinical trial results look promising for the treatment of immune system diseases such as multiple sclerosis, systemic sclerosis, rheumatoid arthritis, lupus, and type 1 diabetes. Available scientific evidence does not support claims for alternative uses of UV blood irradiation.

Medicine is not “suppressing” this “miracle cure”, but the conclusions of medicine are neither bold enough nor fast enough for those who have Belief.

So what does ozone therapy involve?

“The patient sits in a chair and has from six to 12 ounces of blood removed into a sterilized bottle,” says Dr Dan Cullum, a holistic practitioner based in Oklahoma. “Then ozone is injected into the bottle and the bottle is gently shaken, allowing the red and white blood cells to take up the ozone. The ozonated blood is then returned to the body. The entire procedure takes about 30 to 40 minutes.”

“Dr” Dan Cullum is a chiropractor, homeopath and practitioner of multiple forms of mutually contradictory quackery.

Other versions of the treatment exist, as is normal for treatments that have not been developed through clinical trial and peer review.  The effects of blood ozonation are not quantified, the evidence for delivery of ozone to the tumour site is scant other than in very specific regimens (as noted above).

Most centres, like Oasis of Hope in Mexico, offer ozone therapy as just one part of a holistic program. Vitamin C infusions, potent supplements and conventional treatments including chemotherapy may also form part of the patient’s package. Breast cancer survival rates at Oasis are two to three times higher than the US national average, and in the case of stage IV lung cancer, the survival rate at Oasis is five times the national average. Doctors claim ozone limits the damaging effect of chemotherapy to healthy tissues; a 2004 animal study from Cuba found that ozone reversed the toxicity caused by chemotherapy (cisplatin) and reduced kidney damage.13

The problem is that there is little or no evidence to support the claims of these treatments and some of them are potentially harmful, the Tijuana clinics are essentially set up to deceive and it’s a disgrace. – Richard Sullivan, head of clinical programmes, Cancer Research UK.

Reference 13: Mediators Inflamm, 2004; 13: 307–12 Protection by ozone preconditioning is mediated by the antioxidant system in cisplatin-induced nephrotoxicity in rats. Aluet Borrego, Zullyt B Zamora, Ricardo González, Cheyla Romay, Silvia Menéndez, Frank Hernández, Teresita Montero, and Enys Rojas

There is probably no bigger red flag for quackery than being offered by the Oasis of Hype, a marble and mirror glass edifice located in Tijuana, just beyond the reach of the FDA but convenient for a lucrative trade treating desperate American cancer victims. Quack therapies on offer include amygdalin (laetrile), detox, megavitamin therapy, shark cartilage, the Issels treatment and others.

The source describes an experiment in a rat model which is interesting but its clinical relevance is unclear in the context of the toxicity of ozone; it would be interesting to see subsequent work on this line of inquiry, but a nine-year-old study is cited as the last word. There are two citations of this work from 2010, one is not directly relevant and the other discusses renal lipid peroxidation, which is linked but not really a development of the idea.

Interestingly, Cuba is the only country in the world that offers ozone therapy on national insurance and is leading the research.

If Cuba is leading the research, then why is only one published peer-reviewed Cuban source cited?

Other resources:

What Doctors Don't Tell You
Why don’t doctors tell you that ozone therapy reverses cancer?

Because at this stage the evidence does not support it.

 

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2 thoughts on “In the O-Zone”

  1. Pingback: Daily Overload – News in short (15-11-2013) « The Skeptical Bear
  2. The only time I have been aware of ozone therapy was via a machine developed by German firm KaVo which attempted to use a stream of ozone to kill the bacteria in areas of tooth-decay, thus arresting the lesion and obviating the need for fillings. The technique involved a lot of chairside time and the patient fannying about with high-strength fluoride gels. The cost to treat one lesion was approximately five times that of placing an equivalent filling. It was utterly impractical.

    And it also didn’t work.

    http://www.ncbi.nlm.nih.gov/pubmed/15266519

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