The Ozone Cure Part 1: Unproven machines can rob patients of crucial time

The FDA has been cracking down on companies claiming they can cure deadly diseases with unproven technologies, reminding health writers everywhere to be skeptical of the latest fads in alternative medicine.

On Friday, the FDA seized 77 ozone generators from Applied Ozone Systems in Auburn, California. This received little coverage in the press. It could be the seed for a great investigation into local medical centers or practitioners pushing ozone therapy.

The machines sound like something a mad scientist might have used to hold the world hostage in an old Fletcher Hanks comic book, but they are being marketed as cures for AIDS and cancer.

How does the ozone therapy work? The FDA explains:

Ozone administration methods suggested by the manufacturer of the AOS-1M Medical Ozone Generator and the AOS-1MD Ozone Generator include blowing ozonized air into the rectal and vaginal areas.

That alone should be reason enough for people to be skeptical, which is perhaps why the machines' salesmen use a comic-book-ready pitch: "Do not be deceived! AIDS and cancer are curable!" You can see that line fitting right in with sea monkeys and Charles Atlas muscle builders.

The machine hawkers paint the FDA as part of a medical-industrial-pharmaceutical conspiracy to keep people sick and dying so that they are forever spending money on doctor's visits, hospital stays and trips to the pharmacy. There are plenty of reasons to be doubtful of traditional medicine, not the least of which are the ongoing revelations about the extent of ghostwriting by pharmaceutical companies in the medical literature. But it's quite a leap from exposing marketing ploys to believing that all oncologists and AIDS specialists are lying to their patients. "If only these doctors would hook their patients up with some ozone, all would be well," cry the proponents of ozone therapy.

This worries the FDA. Not because the agency is part of a patient-hating conspiracy, but because ozone has never been proven to work and actually may be doing more harm than good. Here's what the FDA has to say:

The FDA advises health care professionals and consumers to discontinue use of these devices, which Applied Ozone Systems claims can treat cancer, AIDS, hepatitis, herpes, and a number of other diseases and conditions. The FDA has not determined that the seized products are safe and effective in treating the diseases or conditions, and officials at Applied Ozone Systems never responded to a Dec. 21, 2009 FDA request for a voluntary recall of these ozone generators.

In addition, the agency is concerned that patients who use these AOS ozone devices as directed by the manufacturer may believe that ozone therapy serves as an appropriate treatment and as a result delay or stop conventional or prescribed effective treatment. There is also a risk of infection from potential contamination of the applicator or catheter. Ozone is present in low levels throughout the earth's atmosphere and has many industrial and consumer applications. It also is an air pollutant that has harmful effects on the respiratory system.

To hear about some of the patients who have been fatally misled by unproven medical devices, read the excellent Seattle Times series by Michael J. Berens and Christine Willmsen called "Miracle Machines: The 21st Century Snake Oil." It should be required reading for all health writers. Here are just three of his findings from an investigation into "energy machines," which, like ozone generators, were being marketed as cures for people with cancer and other complicated illnesses.

• In Tulsa, Okla., a woman suffering from unexplained joint pain was persuaded to avoid doctors and rely on an energy device for treatment. Seven months later, her son took her to a hospital. She died within hours from undiagnosed leukemia.

• In Los Angeles, a mother pulled her 5-month-old son out of chemotherapy for cancer and took him to a clinic where a 260-pound machine pulsed electromagnetic waves through his tiny body. The baby died within months.

• In Seattle, a retiree with cancer emptied her bank account to buy an energy machine. Shortly before she died, her husband, a retired Microsoft manager, examined its software, finding that it appeared to generate results randomly - "a complete fraud," he said.

New ideas should be encouraged in medicine. People with AIDS, cancer and other debilitating illnesses have every reason to push for new approaches.

As health writers, though, we can do significant damage by giving prominent placement to stories about an unproven therapy, even if we include the usual dissenting voice from one medical expert and dress it up with a question headline. Is the cure for AIDS in the air that we breathe?

People desperate for a cure will try anything, and writers need to take the responsible path of weighing the evidence and thoroughly checking the pedigrees of the people involved in untested cures before giving them any publicity.

On Friday: Five ways to test the veracity of a medical claim.