NEW DRUG POSES RISKS OF OVARIAN CANCER
by Samuel S. Epstein, MD
On December 10, 1997, Eli Lilly and Company announced the Food and Drug Administration’s (FDA’s) clearance to market Evista® (Raloxifene), which had been shown to be effective in preventing osteoporosis, affecting over 20 million U.S. women annually, and in reducing low density lipoprotein (LDL) or "bad cholesterol" blood levels. Lilly has submitted applications to market Evista® in more than 30 different countries. Surely, this new drug should be welcomed by women worldwide. Unfortunately, this is not the case, as Lilly, with FDA’s complicity, has suppressed critical information that this drug poses major risks of ovarian cancer.
In a study specifically designed by Lilly to prove the drug’s safety, Evista® was shown to induce ovarian cancer in both mice and rats. Moreover, carcinogenic effects were noted at dosages extending below the therapeutic. However, the study concluded: "The clinical relevance of these tumor findings is not known." Lilly reached this conclusion despite the scientific consensus that the induction of cancer in well-designed studies in two species creates the strong presumption of human risk. Nevertheless, Lilly failed to disclose this critical information in its "Warning" to women. Furthermore, no reference at all is made to these risks in the Lilly-sponsored publication on Evista® in the December 4, 1997 issue of the New England Journal of Medicine.
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Surely, this new drug should be welcomed by women worldwide. Unfortunately, this is not the case, as Lilly, with FDA’s complicity, has suppressed critical information that this drug poses major risks of ovarian cancer.
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Responding to criticisms on the January 12, 1998 Jim Lehrer Newshour program, a Lilly spokesman claimed that the carcinogenic effects of Evista® in the ovaries of sexually mature rodents are irrelevant to such risks in post-menopausal women. However, ovarian cancer is recognized as an uncommon complication of long-term hormonal replacement in the post-menopausal.
Ovarian cancer strikes about 24,000 U.S. women every year, accounting for 4% of all their cancers. About 15,000 women die from ovarian cancer annually, making it the most lethal female reproductive cancer. Lilly’s suppression of the evidence of ovarian cancer risks from Evista® is as reckless as is FDA’s marketing approval, conduct which merits congressional and legal scrutiny. This drug should be withdrawn from the world market immediately. As importantly, a "Cancer Alert" should be sent to the over 12,000 women who have participated in U.S. and international clinical trials in the absence of informed consent. These women should also be offered lifelong bi-annual surveillance for the early detection of ovarian cancer at Eli Lilly’s expense.
Article from NOHA NEWS, Vol. XXIII, No. 3, Summer 1998, page 5.
Note that the article below was published in 1991. Today, as I previously reported, the FDA has increased Vitamin C RDA to 90 mg. This amount is linked to preventing scurvy only and not addressing the needs for prevention or treatment.
VITAMIN C RECOGNIZED BY THE NATIONAL CANCER INSTITUTE
NOHA Honorary Member Linus Pauling, "the grand old man of science," 90 years old on February 28, 1991, having won the Nobel Prize both for chemistry and for peace, says now that he is "especially proud" of the recent recognition of his work on vitamin C. At the National Institutes of Health in Bethesda, Maryland, on September 10-12, 1990, experts from all parts of the world gathered to give 40 papers on "Ascorbic Acid [vitamin C]: Biological Functions and Relation to Cancer" to 130 scientists and doctors. Dr. Balz Frei, of the Division of Biochemistry and Molecular Biology at the University of California, Berkley, opened the symposium with a report of a recent experiment in which he "found that no cancer-causing chemical reactions like lipid peroxidation could be detected in the human blood plasma as long as vitamin C was present. Yet as soon as vitamin C was used up, the lipid peroxidation began again."
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". . . vitamin C had the most consistent and statistically significant inverse association with breast cancer risk," a stronger association than that with lowering saturated fat intake.
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Dr. Pauling, in his talk at the conference, pointed out that one reason he became interested in the value of large doses of vitamin C is the "extraordinary" fact that while most animals manufacture the human-body-weight-equivalent of 10,000 mg/day of vitamin C, we humans lack the enzyme needed to manufacture any. For this reason he takes 10,000 mg (10g)/day of vitamin C, almost 167 times the government recommended daily allowance (RDA) of 60 mg.
Several animal studies done by Dr. Pauling and his associates have shown that vitamin C provided significant protection against carcinogens. Other researchers have found that vitamin C enhanced the effectiveness of chemotherapeudic agents and reduced the serious side effects from both chemotherapy and radiation therapy. In addition,
In a study of human cancer patients who were taking the new cancer drug Interleukin-2 (IL-2), . . . the level of vitamin C in [their] blood dropped by 80 percent and more during this high-dose IL-2 therapy. . . . Since vitamin C is needed for immune and stress function, and IL-2 activates these two systems, it follows that vitamin C is used up because of this activation.
In other words, the body needs vitamin C to help IL-2 fight cancer.
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. . . human epidemiological studies showing that vitamin C can have a significantly protective effect at all the major cancer sites.
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Dr. Gladys Block, an epidemiologist in the Division of Cancer Prevention and Control at NCI, summarized human epidemiological studies showing that vitamin C can have a significantly protective effect at all the major cancer sites. "The data indicated that people in the top 25 percent of vitamin C intake have approximately one-half the cancer risk of those in the bottom 25 percent of vitamin C intake." A recent study published in the Journal of the National Cancer Institute concluded that "vitamin C had the most consistent and statistically significant inverse association with breast cancer risk," a stronger association than that with lowering saturated fat intake. "If all postmenopausal women in the population were to increase their fruit and vegetable intake to reach an average daily consumption on vitamin C equaling the level among women in the upper one-fifth of the population, the risk of breast cancer . . . would be reduced by 16 percent."
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"the relative paucity of vitamin C research is inexplicable, given the many vital biological functions for which it is essential."
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Epidemiological studies also show that the United States’ black population has much lower serum vitamin C levels than the white population. This may contribute to "both the higher rate of cancer among blacks as well as their lower survival rates."
Many scientists and doctors, impressed by the scientific quality of the conference, were so intrigued that they decided to increase their personal daily intake of vitamin C to 1,000 mg a day or more. Dr. Mark Levine, of the National Institute of Diabetes and Digestive and Kidney Diseases, said, with genuine consternation, that "the relative paucity of vitamin C research is inexplicable, given the many vital biological functions for which it is essential."
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"The conference ended to thunderous applause and a standing ovation. The scientists seemed thrilled and convinced that this vitamin C conference was indeed an historic occasion."
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Not only did the conference bring together researchers who had previously been working in isolation, the fact that it was held at all meant that the NCI was finally acknowledging the link between vitamin C and cancer. "The conference ended to thunderous applause and a standing ovation. The scientists seemed thrilled and convinced that this vitamin C conference was indeed an historic occasion. There was already talk of making this an annual event."
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Sources
Charles Petit, "The grand old man of science," Chicago Tribune, February 22, 1991.
Morton A. Klein, "A Major Symposium on Vitamin C Sponsored by the National Cancer Institute," Linus Pauling Institute of Science and Medicine, 1990.
Article from NOHA NEWS, Vol. XVI, No. 2, Spring 1991, pages 1-2.
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