Tamoxifen, as well as all cancer chemotherapy drugs, is listed as experimental by the FDA. It is so dangerous that treatment was originally limited to terminal cancer patients. It works by interfering with the activity of the hormone estrogen, which (according to theory) promotes the growth of breast cancer cells. Many alternative practitioners believe that it's not the estrogen but a fairly easily corrected estrogen imbalance that contributes to breast cancer.
The drug is said to be "modestly effective" for advanced breast cancer and was recently approved by the FDA for use in healthy women at risk for breast cancer. Many women's groups oppose this new use of the drug contending that the purported benefits are limited and Tamoxifen may be dangerous in healthy women. Tamoxifen increases the chances that healthy women will develop endometrial cancer, blood clots in the lungs, or cataracts and if used too early or for too long the body may become resistant to it.
The basis of the FDA approval was a five-year Tamoxifen study involving 13,000 women began in June, 1992. It was terminated early and declared a huge success. The data indicated that less than 3 women in 100 on the placebo developed breast cancer. Less than 2 women in 100 on Tamoxifen developed the disease. This was touted as a 45% risk reduction.
British and Italian doctors recently reported in the Lancet that they did not find any benefit from Tamoxifen for healthy women. The FDA panel that examined the benefits and risks made it clear that there is no proof Tamoxifen prevents breast cancer. There is already evidence that taking Tamoxifen for more than 5 years reduces its benefit. Why, then, did they halt the study early? Surely not because the results were beginning to deteriorate. One can only speculate what increasing the size of the market by over 30 million women would mean. Could something like this really happen in America?
New Information has come to light in the Tamoxifen controversy
The costs of the latest cancer "miracle" (2002)Richard D. Gelber, a biostatistician at the Dana-Farber Cancer Institute in Boston, and numerous co-authors have concluded that "chemotherapy may offer no benefit" for post-menopausal women with breast cancer that is made worse by the presence of estrogen. Instead, they recommend a five-year course of Tamoxifen after surgery, since Tamoxifen blocks estrogen.
According to Dr. Gelber, "There is a quality of life burden associated with chemotherapy. It is not a free ride. It should not be given frivolously." But is Tamoxifen any better? Tamoxifen isn't technically called chemotherapy, because it's an anti-hormone agent that blocks the effect of estrogen, whereas a "chemotherapeutic" drug is one that attacks cancer cells. The rationale is that chemotherapy will kill the bad cells before it kills enough good cells to kill the patient.
But if you ever take Tamoxifen, you may not be able to tell the difference. It will seem like chemotherapy because of the side effects. There is a legion of support from concerned medical experts from all over the world on this issue. One wonders when the traditional medical establishment will realize that the same quality of life issues can be raised for all chemotherapies? But that is not the point of this article.