Although some of the studies presented in this section are the result of double-blind research (in which neither the patient nor the investigator knows what treatment the patient is receiving), most are objective and subjective clinical findings based on empirical knowledge or practical experience.

Double-blind trials have become the “gold standard” of scientific research, especially in the United States. The main advantage of this type of research is that complete objectivity is achieved and measurable results are easier to obtain and evaluate. It also prevents the physician from giving any preferential treatment to the patient. Much of the newer scientific research presented in this section is based on double-blind studies. Ozone researchers like Dr. Bocci believe that randomized, double-blind studies will open the door to greater acceptance of these therapies by the scientific community. He writes: “We must perform RCTs [randomized clinical trials] in selected diseases, for which we have good evidence of ozone’s activity. In order to convince skeptics, the results must be more than adequate and be published in peer-reviewed journals.”¹

The primary drawback to double-blind trials is that people who may be in need of a valuable treatment do not receive it. In some cases, patients are not permitted to take any other experimental medications (some of which may be lifesaving) during the trials because the findings of the study might be compromised.

Most German physicians who have done research with medical ozone therapy believe that double-blind studies are immoral. They maintain that ozone is not an experimental drug; it has been used since World War I and has been proven to be safe and effective on millions of patients. They believe that to deny a sick patient a treatment that is likely to relieve suffering or save his or her life is a violation of the Hippocratic oath and an affront to the people who go to them for care. Dr. Joachim Varro, a physician from Dusseldorf, Germany, who worked primarily with cancer patients, shared his views on double-blind studies at the 1983 World Ozone Conference in Washington, D.C.:

For ethical reasons, and as a practicing physician facing the threat of life in advanced cases, I cannot do a so-called random study or double-blind study. I leave that to science and research with responsibility for such methods. Largely, I adhere to research findings and clinical experiences, and I try to adapt these so that they can be practically applied in my range of activities. As a result, I am able to constructively bring my empirical long-term observations into the medical discussion.²

Another problem with double-blind studies is that although they may be a good idea in theory, they do not always work in actual practice. Participants in double-blind trials are known to cheat, especially when their lives are on the line. Several such cases were reported by Paul A. Sergios in One Boy at War: My Life in the AIDS Underground. In one instance, he spoke of a double-blind trial for a promising AIDS drug. Some participants received an inert sugar pill while others were given the experimental drug. He wrote, “Numerous patients who were admitted to the trial between February and April 1986 opened their capsules to taste the contents. If the powder tasted bitter, they continued the treatment. If it tasted sweet, they threw the bottle away and rushed to catch a plane to try their luck at getting an actual drug at another site.”³

Sergios also wrote of his own experience as a participant in another trial for a promising AIDS drug in which he shared half of his pills with another participant in order to increase their chances of survival in the event that one of them was receiving the experimental medication. When first offered the option of sharing the pills, he said that he felt it was immoral because it could disrupt the trial. His friend replied: “Immoral? . . . What about their twisted morality in giving half of us a sugar pill for a year or two in order to see how fast we go to our deaths while others get a drug that could potentially save their lives? Not only that—this study prohibits us from taking certain drugs to prevent opportunistic infections. The odds are stacked against us.”⁴

An unlikely mainstream criticism of double-blind studies was reported on the front page of the September 18, 1997, edition of the New York Times. The article highlighted objection by U.S. government scientists and others over sponsorship by the National Institutes of Health and Centers for Disease Control and Prevention of overseas AIDS studies where half of 11,211 pregnant women in seven third-world countries were given AZT to determine minimal doses of the drug to prevent HIV infection, while the other half were given dummy pills. It is believed that as a result of this study, more than one thousand infants would contract HIV. The article quotes Dr. Peter Lurie of Public Citizen, an advocacy group, as saying, “We have turned our backs on these mothers and their babies,” and cited the government’s own scientists as questioning whether these double-blind studies are ethical.⁵

The decision to use double-blind or random clinical trials involves a number of difficult moral issues that will likely be debated among scientists, physicians, and their patients for years to come. One of my primary goals in this book is to present the evidence, whether it be preliminary, empirical, or the result of double-blind studies. After readers see the evidence, it is their task to either come to their own conclusions or do additional research on their own.