SELECTIVE ESTROGEN RECEPTOR MODULATORS AND BREAST CANCER
Dr Steven R. Goldstein is a leading HRT Specialist NYC who uses hormone replacement therapy to help women in the Menopause stage of life. A past President of the International Menopause Society and a Certified Menopause Practitioner in private practice on the East Side of Manhattan for over 30 years, Dr Goldstein is at the forefront of using and testing SERMs (Selective Estrogen Receptor Modulators) to help women with hormone imbalances in general and Menopause in particular.
This is part 2 of a series on SERMs. Dr Goldstein, a Menopause Specialist in NYC shares the below on SERMs (a form of hormone replacement therapy) regarding hormone replacement therapy and breast cancer.
Virtually every study has shown that when you add progestogen to estrogen, regardless of the dose or the method of prescribing, there is approximately a tripling of the risk of breast cancer above estrogen alone! Estradiol, sometimes referred to as bioidentical estrogen, has never been shown to reduce breast cancer. In the large study of 2002 that got all the negative press, the use of Premarin by itself in women who had had a previous hysterectomy and, therefore, did not need progesterone, actually had a reduction in breast cancer which, when followed through 20 years, resulted in less breast cancer deaths than the placebo group.
This combination in Duavee uses that particular estrogen (Premarin) which has been shown to reduce breast cancer, with the SERM bazedoxifene. I have seen unpublished experimental animal data where a breast tumor in a mouse who was given tamoxifen diminished in size, a similar mouse given raloxifene/Evista caused a tumor to diminish in size. In a similar mouse given Duavee, the tumor also shrunk.
The nine key opinion leaders in the room asked why the company (Pfizer) was not doing a breast cancer prevention trial with this combination currently marketed as Duavee. The answer was, “not enough ROI” (return on investment). Admittedly, it was a 40,000 person, 5-year study with another year and a half to get it into the labeling for the FDA. It would have cost two billion dollars in 2013 dollars. And the company made a business decision that it was not worth it.
In retrospect, in 2013, menopause was a dirty word associated with aging that women wanted to avoid. As you well know (you would have to be living under a rock not to) menopause is having a moment. It is
very much front and center. I truly believe if Pfizer realized how important menopause would be in 2025, it would have spent the money in 2013. If they had done the proper study and had shown the obvious reduction in breast cancer that would have resulted from such a study and then could have marketed this, it could and should have revolutionized the whole field of menopausal hormone therapy.
Sadly, it never will because of the constraints of the FDA labeling process. Only a handful of key opinion leaders are aware of this information. And I’ve often told many of you that if a drug rep said to a physician what I have just said to you, they would be fired and fined because it is considered off-label promotion.
Thus, not all SERMs are the same and there is no class labeling for SERMs. They are under-utilized across the board.
Dr Steven R. Goldstein MD is a past President of the International Menopause Society, a past President of The Menopause Society, and a Certified Menopause Practitioner. In private practice for over 35 years as a Menopause Specialist in NYC, Dr Goldstein has helped thousands of patients combat the symptoms of Menopause and Perimenopause. If you are a woman between the mid thirties to late forties and are suffering from irregular periods, mood swings, irritability, high floating anxiety and other psychosomatic symptoms, then you may be suffering from Perimenopause. In this case, hormone replacement therapy is not the best choice to address your symptoms. There are other options to address your symptoms until you reach full menopause.
Dr Steven R. Goldstein is co author of the book “Could it be…Perimenopause?” and a Perimenopause Specialist NYC.