The Cartwright Law Firm is currently evaluating potential claims of women who have taken combination hormone replacement therapy (Prempro or other estrogen/progestin combination) and have subsequently been diagnosed with breast cancer. If you or a loved one have taken combination hormone therapy and have suffered from breast cancer, please call immediately for a free, confidential consultation with one of our firm’s attorneys.

Hormone Replacement Therapy (HRT) is a term that is used to describe the use of estrogen drug products or estrogen and progestin drug products in combination to alleviate the symptoms of menopause. Estrogen and progestin are both hormones that are produced naturally in a woman’s body. However, during menopause, the ovaries normally stop making estrogen, and it is this drop in estrogen levels that causes menopause or the “change of life.” Hormone replacement therapies can be used to treat symptoms of menopause, including a reduction of hot flashes, alleviation of vaginal dryness, itching and burning due to menopause, and a reduction of the chances of getting osteoporosis (thin weak bones). Also, women who do not have a uterus because of a hysterectomy or women whose ovaries do not make enough estrogen may be treated with estrogen only hormone therapies to alleviate these symptoms.

There are many different pharmaceutical companies that manufacture hormone replacement therapies. One of the largest such manufacturers is Wyeth, which has been the sole seller of Premarin, an estrogen only hormone therapy medication, since 1942. As a significant source of company revenue, Premarin brought in $841 million for Wyeth in the 12 months ending June 30, 2004. Wyeth is also the manufacturer of the leading combination hormone therapy medication, Prempro, which contains both estrogen and progestin. According to Wyeth, about 8.5 million women use some type of hormone therapy.

A decade ago, hormone replacement therapy was touted by the drug companies to be a veritable public-health elixir for post-menopausal women since it was promoted to not only alleviate the sometimes severe symptoms of menopause, but also to fight off heart disease and osteoporosis. Thus, in the early 1990’s over 15 million women were taking some form of hormone replacement therapy. Many of these HRT users did not experience severe symptoms or even minimally disruptive symptoms of menopause, but were still advised to use hormone replacement therapy because of its alleged, but unproven, preventative benefits for heart health and bone health. There was no mention by the pharmaceutical industry of potential risks or serious dangers to the vast numbers of women who used these medications.

However, within the last few years several important studies have turned prior thinking about hormone replacement therapy on its head. Perhaps the most important of these recent studies is the giant Women’s Health Initiative (WHI) study funded by the National Institutes of Health. This landmark study involved 161,000 participants and required funding upwards of $700 million. The federally funded WHI study was started in 1991, and is one of the largest health studies ever launched. Endeavoring to incorporate the experiences of “everywoman” in the study results, the WHI’s participants included postmenopausal women of every age, ethnicity, race, socioeconomic and educational level.

In July 2002, a major bombshell was dropped when the Women’s Health Initiative announced it was stopping the combined estrogen plus progestin trial-the type of treatment most commonly used by menopausal women who have not had a hysterectomy. This result came after a mountain of data revealed that women on combination hormone replacement therapy had more invasive breast cancers, heart disease, strokes and blood clots. Therefore, the study’s positive findings that HRT contributed to a reduction of hip fractures and colorectal cancers did not outweigh the added harm.

Specifically, the published data from the HRT trial stopped in July 2002 showed that there was a 24 percent increase in breast cancer in women taking combination HRT, compared with those taking a placebo. Nearly twice as many women on combination HRT had abnormal mammograms. It is thought that increased breast density caused by HRT may explain that statistical difference between normal and abnormal mammogram results. What was newly discovered was that the cancers suffered by women taking the combination HRT in the study were larger, more advanced, and more likely to involve lymph nodes, leading to speculation that combination HRT use might result not only in an increase in breast cancer risk, but more ominously in the risk of breast cancer with a less favorable prognosis.

In March 2004 another part of the WHI study was prematurely stopped, the trial of estrogen only hormone replacement therapy, which included 11,000 participants. The director of the WHI stated that this part of the study was being stopped in the interest of the safety of the study participants. The WHI believed that based upon the data it had gathered thus far, estrogen by itself did not provide the reduction of heart disease that was anticipated and hoped for. However, the study indicated that estrogen use could increase the risk for stroke.

Even though the Women’s Health Initiative study results cast a significant shadow over the safety of HRT use for menopausal women, the FDA is not considering taking estrogens or estrogen with progestin drug products off the market. However, the FDA states that it does seek to minimize the risks and maximize the benefits of HRT use by ensuring that women and health care providers fully understand these risks and benefits. The FDA has encouraged drug companies to include the information gained by the WHI studies in the physician prescribing information and patient information leaflet (i.e., labeling) for all estrogen and estrogen with progestin (combination) products.

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