Life's Delicate Balance
Causes and Prevention of Breast Cancer
by Janette D. Sherman, M.D.

Excerpts from Chapter 9
TAMOXIFEN
Chemical manipulation

"First do not Harm."
    -- Hippocrates

In 1995, public hearings were held in California, following which tamoxifen was designated as a carcinogen by the State of California. Substantiating the finding is a 16-page list of articles and comments, relied upon by that state's Carcinogen Identification Committee, available from the California State offices in Sacramento. How did this proven carcinogen become the drug of choice for treating breast cancer, and for the "prevention" of breast cancer?

The media hype following the National Cancer Institute announcement that tamoxifen prevents breast cancer bears some scrutiny.

It sounds good, but is it really? Tamoxifen has been promoted to two groups of women: those already diagnosed as having breast cancer and those "at risk" to develop the disease. The first option proposed for prevention of breast cancer is a drug: tamoxifen; a second "option" is prophylactic bilateral mastectomy. The latter is hardly an option, and the first is not without harm. Neither addresses the issue of causation and primary prevention.
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Between 1970 and 1987, more than 3 million women were administered tamoxifen for a cumulative time of more than 5.8 million patient years!  Unfortunately, except for specific clinical trials, few records have been kept on women given the drug
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The name tamoxifen achieved wide-spread publicity in April of 1994.  At that time, physicians across the United States received what is known as a "Dear Doctor" letter from Zeneca Corporation, concerning the development of uterine cancer in women receiving tamoxifen, as reported in a large Swedish study.  A similar study, undertaken in the Netherlands reported a statistically significant excess of uterine cancer in the women after taking tamoxifen for 2 to 5 years, correlated with both cumulative dose and duration of use

These two studies were echoed by a Danish/ British study which "detected endometrial abnormalities at various times from the first tablet of tamoxifen." At the same time as the Zeneca letter went out to physicians, a similar communique, the "Dear Patient" letter was sent to women participating in the National Surgical Adjuvant Breast and Bowel Project (NSABP), the coordinating center for the tamoxifen breast cancer prevention trial, telling them the same thing.  But women patients, taking tamoxifen for treatment of their breast malignancies, in the official NCI/ NSABP trial, received no such warning.

The Breast Cancer Prevention Trial has enrolled women as human guinea pigs to test tamoxifen as a "prevention" against breast cancer.  The trial, planned since 1990, and launched in April, 1992, enrolled 11,000 women, aiming optimally to enroll 16,000 HEALTHY women, between the ages 35 and 78.  The trial closed enrollment in September 1997, at which time, 13,388 women ages 35 and older were enrolled. Half of the women received tamoxifen and half a non-hormonal placebo.  A similar proposal to be carried out in England as of 1994 was declined by Britain's Medical Research  
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Despite the current alarming statistic that one in eight women in the United States, and one in ten in Canada, will develop breast cancer, it is necessary to understand that seven out of eight US women will not develop cancer!  Until connections to the environment AND family history AND breast cancer are fully investigated, the question remains: Is it ethical to give a carcinogenic chemical to seven women (as in seven-out-of-eight) who might develop breast cancer in the first place?  
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Given the protocol's stated risks of 62 breast cancers prevented, while causing 38 uterine cancers and 3 deaths due to blood clots in the lungs, does the arithmetic make sense?  62 minus 38 uterine cancers, minus 3 blood clot deaths, equals 21 fewer breast cancers.  According to Michael DeGregorio at the University of Texas Health Science Center in San Antonio, the official study underestimates the chances of fatal blood clot by more than two and a half times, and underestimates that of uterine cancer by fifty percent.

The estimated risks are stated above.  In actuality, the NCI results were 116 breast cancers, including 3 deaths in the tamoxifen group, and 213 breast cancers and 8 deaths in the placebo group.  For uterine cancer, there were 33 women in the tamoxifen group, versus 14 in controls; for pulmonary embolism there were 17 cases in the tamoxifen group versus 6 in the controls; and for deep vein thrombosis 30 women in the tamoxifen group versus 19 in the controls.  For the last three life-threatening illnesses, the occurrence was 80 in the tamoxifen group versus 39 in the control group.  Can this be called disease substitution?