In order for a drug to pass the "effectiveness" test, the FDA requires substantial evidence not that it saves lives but only that it is effective for its intended uses. "Substantial evidence" is defined as "adequate and well-controlled investigations . . . on the basis of which it could fairly and responsibly be concluded . . . that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof."[1]

Cancer drugs are considered "effective" if they merely shrink tumors. But medical research indicates that radiation and chemotherapy, while shrinking tumors, do NOT necessarily increase survival. In 1990, German biostatistician Dr. Ulrich Abel reached that conclusion. He found that reduction of tumor mass does not prolong expected survival and can cause the cancer to return more aggressively, since killing off most of the cancer mass allows drug-resistant cell lines to grow.[2] An article in the British Medical Journal concurred. It observed that while tumor shrinkage is the usual way to measure the efficacy of chemotherapy, "radiological shrinkage of solid tumors . . . often has little or no survival benefit . . . Unfortunately, few studies have compared chemotherapy with supportive care alone."[3]

One of the few studies that had made this comparison was conducted by Dr. Hardin Jones, professor of medical physics and physiology at the University of California, Berkeley. He told an ACS (American Cancer Society) panel, "My studies have proven conclusively that untreated cancer victims actually live up to four times longer than treated individuals. For a typical type of cancer, people who refused treatment lived for an average of 12-1/2 years. Those who accepted surgery and other kinds of treatment lived an average of only three years . . . I attribute this to the traumatic effect of surgery on the body's natural defense mechanism. The body has a natural defense against every type of cancer."[4]
 

Notes
1. 21 United States Code Sec. 355(d).
2. U. Abel, Chemotherapy of Advanced Epithelial Cancer (Stuttgart: Hippokrates Verlag GmbH, 1990), summarized by R. Moss in "Chemo's 'Berlin Wall' Crumbles," Cancer Chronicles (December 1990), page 4. Dr. Abel observed that for breast cancer, there is no direct evidence that chemotherapy prolongs survival, making its use "ethically questionable." His work was reviewed in the popular German magazine Der Spiegel in 1990.
3. G. Mead, "Chemotherapy for solid tumors: Routine treatment not yet justified," British Medical Journal 310:246 (1995).
4. G. Borell, The Peroxide Story (Delano, Minnesota: ECHO, 1988), page 30.