STAR Trial

Ann's NOTE: This section contains MANY articles and arguments against the use of Tamoxifen for healthy women. The STAR trial has two arms, one for healthy women at risk who will receive Tamoxifen and one for healthy women at risk who will receive Raloxifene. I think this is a badly conceived trial. My reservations against Tamoxifen use in this context combined with my belief in the value of natural, nontoxic therapies makes me VERY unhappy over the trial. Here is a article about this.

The Late Fall 2000 issue of The Ribbon, the newsletter produced by Cornell University Program on Breast Cancer and Environmental Risk Factors in New York State contained an article entitled:

Activist Perspective: The Dark Side of the STAR Trial by Andrea R. Martin, Founder and Executive Director, The Breast Cancer Fund.

Here are some quotes from that article:

"The Breast Cancer Fund, The National Breast Cancer Coalition and other leading breast cancer and women's health organizations are strongly opposed to the STAR trial not only because of its lack of ethics in failing to have a placebo arm, but also because its predecessor trial (BCPT)*left too many unresolved issues. Most importantly, during the BCPT approximately 96% of the women taking placebo did not get breast cancer and 98% of the women taking tamoxifen did not get breast cancer. This means there was only a 2% absolute reduction in risk..." *BCPT=Breast Cancer Prevention Trial 1 compared Tamoxfien to placebo.

"The reported risks of Evista (Raloxifene) are similar to Tamoxifen's risk but, according to a professor of environmental medicine at the University of Illinois School of Public Health, one unreported risk- ovarian cancer - could prove more deadly. Writing in the Chicago Tribune (April 19, 1998), Dr. Samuel Epstein says: "Lilly's pre-market clearance study clearlyshows that Evista induces ovarian cancer in both mice and dosages well below the recommended therapeutic level." While effects in rodents are not proof of human risk, there is strong scientific consensus that carcinogenic effects in two rodent species constitutues significant evidence of human risk."

"Eli Lilly also claims that Evista poses no risk of breast and uterine cancers. However the pre-market trials of Evista lasted less than four years, too short a time to measure such risks. Epstein called Lilly's suppression of its own evidence about ovarian cancer risk "reckless and threatening to women's health and life." He also termed the FDA's marketing approval of the drug without the ovarian cancer warning "equally reckless". The Breast Cancer Fund agrees."

"The STAR trial could have been used to address many of the unanswered questions from the BCPT Tamoxifen study. It could have tested each drug against a placebo to properly evaluate the risk/benefit ratio compared to nothing or to a vegetarian diet or to a diet containing soy products or to other factors. But instead of advancing research in the direction of breast cancer prevention, STAR is exposing healthy women to toxic drugs in a way that willultimately provide no new information."

Ann's NOTE: One of the researchers who spoke at the 1999 National Breast Cancer Coalition's Annual Advocacy Conference, discussed the danger of finding ovarian cancer risk in two species. She did not work in the breast cancer field and strongly warned advocates against this drug.

The Breast Cancer Fund

Link to their website

Breast Cancer & Env Risk Factors

Link to their website

National Breast Cancer Coalition

Link to their website

Cancer Prevention Coalition

Link to Dr. Samuel Epstein's organization

Effect of Raloxifene on Bca Cell Ki67 and Apoptosis

Cancer Epidemiology, Biomarkers and Prevention, 9/01

Tam, Raloxifene Show Preclinical Cross-resistance

Dr. H. Liu, MD,PhD presentation 12/01

Not Beneficial to Follow Tam with Raloxifene

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