Hormone Therapy Industry

For decades, the pharmaceutical industry has marketed and sold estrogens (both opposed and/or unopposed by progesterone or progestin), under the brand names Prempro, PremPhase, Premarin, Provera and others to women and their doctors to replace the female hormones lost during menopause. During this time, the drug companies convinced the medical community and the general public that menopause was a disease that needed to be treated with hormone replacement therapy drugs. The drug companies claimed that their hormone replacement therapy drugs could not only cure typical menopausal symptoms such as hot flashes, night sweats and irritable mood swings – they claimed that the drugs also could prevent heart disease and other long term illnesses.

The drug companies made these claims despite the absence of clinical trials to test the safety and efficacy of these drugs on a long term basis. All that changed on July 9, 2002 after the National Heart Blood and Lung Institute (NHLBI), a division of the National Institute of Health, announced that it had stopped a major clinical trial of the risks and benefits of combined hormone replacement therapy.

The NHLBI study was a 15-year clinical study conducted by the Women’s Health Initiative (WHI), which was to have continued until 2005. However, the NHLBI terminated the WHI study after data revealed that, instead of preventing heart disease, there was a marked increase in heart disease, stroke, blood clots, and hip fractures in women taking combination hormone replacement therapy after an average follow up of 5.2 years, compared with women who took placebo. Most alarming was the conclusion of the WHI study that taking combination hormone replacement therapy increased a woman’s risk of breast cancer by 26%.

The WHI study revealed the following alarming risks (which clearly outweigh the listed benefits) for women who took long-term combination therapy:

Breast cancer - 26%
Strokes - 41%
Blood Clots in the veins - 107%
Blood clots in the lungs - 113%
Heart disease - 29%
Hip fractures - 34%
Spinal fractures - 34%
Colorectal Cancer - 37%

The WHI Study also found that the combination hormone regimen should not be initiated or continued for primary prevention of coronary heart disease.

Studies subsequent to the WHI study show that the long term effects of combination hormone replacement therapy are even more severe than the WHI study revealed. The studies and findings stemming from the WHI have shown, literally, an epidemic of breast cancer likely caused by the use of combination hormone therapy. Scientific proof has shown that hormone replacement therapy is now recognized as a catalyst to increase the risk of hormone positive breast cancer, heart attacks, strokes, deep vein thrombosis, pulmonary emboli, ovarian cancer, and lupus, to list a few.

On January 6, 2003, Wyeth, the manufacturer of Premarin and Prempro, abandoned its long-standing marketing strategy of promoting the long-term use of Premarin and Prempro, and announced that it was adopting new labeling for its hormone therapy drugs in light of the WHI findings. The warnings now emphasize that Prempro and other forms of combination hormone therapy are not approved for the prevention of heart disease.