For Spanish Translation of this page click here
by: Axel Makaroff
Buenos Aires, Argentina
www.axel.org.ar
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See also this page about radiation
To pass the "effectiveness" test, the FDA requires substantial evidence not that drugs save lives but only that they are effective for their 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] Despite this legal requirement, the U.S. Office of Technology Assessment has reported that "Only 10%-20% of all procedures currently used in medical practice have been shown to be efficacious by controlled trial."[2]
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. One researcher reaching this conclusion was German biostatician Dr. Ulrich Abel, writing in 1990. He found that reduction of tumor mass not only does not prolong expected survival but can cause the cancer to return more aggressively, since killing off most of the cancer mass allows drug-resistant cell lines to grow.[3] 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 tumours . . . often has little or no survival benefit . . . . Unfortunately, few studies have compared chemotherapy with supportive care alone."[4]
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 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 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."[5]
Dr. Jones was speaking twenty years ago, but more recent data are lacking, because studies comparing treated and untreated patients are no longer being done. To fail to treat potentially curable patients with "proven" methods is now considered unethical. Most drug studies merely compare the effects of two treatment regimens, both more or less equally toxic, on the size of tumor growth.[6]
A 1984 review of 80 studies of chemotherapy for breast cancer found that 76 of them had looked only at tumor shrinkage, not at effects on survival or quality of life; and three of the remaining four had found no survival advantage for the drugs.[7] Other reviews reached equally disquieting conclusions.[8]
As for surgery and radiation, they were grandfathered in before the FDA's "effectiveness" requirement. For surgery, large-scale controlled trials haven't been conducted proving a survival benefit as compared to no treatment at all; and for radiation given after surgery, large-scale randomized controlled trials haven't shown a survival benefit as compared to surgery alone.[9]
Radiation is given to shrink tumors in critical situations (e.g., when the tumor is pressing on an artery, airway, vital organ, or nerve), but the long-term effect can actually be to shorten survival.[10] A 1987 review of eight trials from around the world found that the risk of death after ten years for women who had not gotten radiation after their breast surgeries was 26 percent lower than for women who had gotten.[11] "The majority of cancers," wrote Dr. John Cairns of Harvard in 1985, "cannot be cured by radiation because the dose of X rays required to kill all the cancer cells would also kill the patient."[12]
With chemotherapy, progress has been made in treating certain cancers; but the drugs haven't done much to prolong survival from the big killers -- cancers of the breast, colon and lung.[13] According to Dr. Cairns, chemotherapy prevents death in only 2 to 5 percent of cancer cases. The chance the drugs themselves will kill the patient is about the same: somewhere between 2.5 percent and 5 percent.[14] In a 1991 study in which chemotherapy was compared to no treatment in 250 women with metastatic breast cancer, the drugs not only did not improve survival but significantly decreased the quality of life.[15]
With early breast cancer, on the other hand, a modest survival benefit has been found. A 1992 British review of 31 randomized trials involving 11,000 women found a slight increase in overall survival after 10 years for patients given "polychemotherapy" (more than one drug for more than one month). The women's chances of being alive 10 years later, however, were still only 51.3 percent with the drugs, versus 45 percent without them a mere 6.3 percent survival benefit. And this grim prognosis was for women with breast cancer in the early, "treatable" stages.[16]
Despite these very modest benefits, the National Cancer Institute has recommended chemotherapy for all breast cancer patients, whether or not they have visible signs of cancer after surgery. The theory is that projected over thousands of women, a significant number of lives will be saved.[17] The problem especially for the 93.7 percent who aren't benefited is the drugs' crushing side effects. Virtually all chemotherapeutic drugs are toxic and immunosuppressive. Being unable to distinguish between cancerous and normal cells, they wind up killing both. Most also cause secondary cancers, which can show up many years after "successful" chemotherapy.[18]
-- Adapted from Forbidden Medicine by Ellen Hodgson Brown, available for $19.95 from Third Millennium Press,
1-800-891-0390.
______________________________________________________________________________
NOTES
1. 21 United States Code Sec. 355(d).
2. Office of Technology Assessment, U.S. Congress, Assessing Efficacy and Safety of Medical Technology (Washington D.C.: OTA 1978).
3. 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.
4. G. Mead, "Chemotherapy for solid tumours: Routine treatment not yet justified," British Medical Journal 310:246 (1995).
5. G. Borell, The Peroxide Story (Delano, Minnesota: ECHO, 1988), page 30.
6. See I. Tannock, "Treating the patient, not just the cancer," New England Journal of Medicine 317(24):1534-35 (1987).
7. R. Oye, et al., "Reporting results from chemotherapy trials: Does response make a difference in patient survival?", JAMA 252(19):2722-25 (1984).
8. See G. Mead, op. cit.; I. Tannock, op. cit.; U. Abel, op. cit.
9. See R. Houston, "Misinformation from OTA," op. cit., page 600; J. Weese, et al., "Do operations facilitate tumor growth?", Surgery 100(2):273-77 (1986) (surgery and anesthesia enhance the implanting of tumors and facilitate metastasis); J. Stjernsward, "Decreased survival related to irradiation postoperatively in early operable breast cancer," Lancet (November 30, 1974), pages 1285-86; R. Moss, The Cancer Industry, op. cit., pages 59-72.
10. R. Walters, in Options: The Alternative Cancer Therapy Book (Garden City Park, New York: Avery Group Publishing Co., 1993), page 13, observes that as early as 1953, Benedict Fitzgerald, special counsel for the Department of Justice, presented studies to Congress showing that patients who received no radiation lived longer than those who were irradiated.
11. J. Cuzick, et al., "Overview of randomized trials of postoperative adjuvant radiotherapy in breast cancer," Cancer Treatment Reports 71(1):15-29 (1987).
12. J. Cairns, "The treatment of diseases and the war against cancer," Scientific American 253(5):51 (1985).
13. See R. Walters, op. cit., pages 9-11.
14. B. Culliton, "The rocky road to remission," Science 244:1432 (June 23, 1989).
15. H. Muss, et al., "Interrupted versus continuous chemotherapy in patients with metastatic breast cancer," New England Journal of Medicine 325:1342-48 (1991).
16. Early Breast Cancer Trialists' Collaborative Group, "Systemic treatment of early breast cancer by hormonal, cytotoxic, or immune therapy," Lancet 339(8785):71-85 (1992).
17. The recommendation was based on a series of 1989 studies finding a "significant prolongation of disease-free survival" from drug treatment. However, the studies did not find a significant increase in actual survival. "Disease-free survival" was a term of art meaning a period of time without new tumors. See B. Fisher, et al., "A randomized clinical trial evaluating sequential methotrexate and fluorouracil in the treatment of patients with node-negative breast dancer who have estrogen-receptor-negative tumors," New England Journal of Medicine 320(8):473-78 (1989); Ludwig Breast Cancer Study Group, "Prolonged disease-free survival after one course of perioperative adjuvant chemotherapy for node-negative breast cancer," New England Journal of Medicine 320(8):491-96 (1989); E. Mansour, et al., "Efficacy of adjuvant chemotherapy in high- risk node-negative breast cancer," New England Journal of Medicine 320(8):485-90 (1989). The same year, the General Accounting Office issued a report on the effectiveness of chemotherapy in breast cancer. It focused on patients with cancers of the type thought to benefit most from the drugs. The GAO found no detectable increase in the survival of these patients, despite a threefold increase in the use of chemotherapy since 1975. See "GAO report on breast cancer," World Research Foundation News (3rd & 4th quarter 1990), page 7.
18. R. Walters, op. cit. See also H. Vorherr, "Adjuvant chemotherapy of breast cancer: Reality, hope, hazard?", Lancet (December 19/26, 1981), pages 1413-14: "Data on five- year survival [show] the benefit from adjuvant [independent] chemotherapy of breast cancer is only 4% . . Mortality due to chemotherapy may be as high as 4.4% . . In view of the many uncertainties and controversies about adjuvant chemotherapy, which itself has serious health hazards, no patient should be routinely subjected to this kind of 'treatment.'"
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