Hormone replacement therapy – commonly referred to as HRT or HT – is the use of supplemental birth hormones (estrogen and progestin) by women to replace the production of hormones naturally lost as a woman ages, and during menopause. HRT can effectively reduce symptoms of menopause such as hot flashes, night sweats, and mood swings. However, manufacturers of HRT drugs for decades made questionable claims that these drugs could additionally prevent heart disease and confer other health benefits with few or no side effects. These questionable claims of health benefits were based on questionable scientific research. And in most cases, such as claiming prevention of heart disease, these supposed health benefit were simply untrue.
Moreover, HRT clearly causes breast cancer, ovarian cancer, and actually increases the risk of heart disease, despite the claims that HRT was “heart healthy.” Publication of a Women’s Health Initiative (WHI) study in 2002 revealed publically to many women, for the first time, that the HRT they were taking did not improve their health. On the contrary, HRT was shown by the WHI to actually increase a woman’s risk of blood clots, heart disease, stroke, breast cancer and other illnesses. As a result, thousands of lawsuits were filed against Pfizer’s subsidiary, Wyeth, maker of Prempro, Premarin, and Premphase.
Bubalo Goode has been at the forefront of protecting the legal rights of women injured by the negligence of HRT manufacturers. For instance, in April 2012, Gregory J. Bubalo and Paula Bliss lead a team of lawyers in New Haven, Connecticut and obtained a $4 million on behalf of a Connecticut woman who developed breast cancer caused by her use of the HRT drug, Prempro. On August 8, 2013, the Honorable Janet Bond Arterton, Judge for the United States District Court for Connecticut in New Haven, added an additional $1,769,832.04 assessing attorneys’ fees and costs against Wyeth as punitive damages.
At this point, Bubalo Goode has resolved all of its HRT claims for their clients.
Menopause certainly isn’t a modern phenomenon, but the identification of medical menopause and the use of hormone therapy treatment by menopausal women are relatively new developments.
In 1938 diethylstilbestrol (DES), a synthetic estrogen, was first synthesized. DES was approved by the FDA in 1941 as a treatment for menopausal symptoms as well as vaginitis and postpartum lactation suppression. DES was also commonly prescribed to prevent miscarriages as an off-label use during the 1940s and in 1947 the FDA added miscarriage prevention as an approved DES indication.
By 1960, however, the incidence of DES daughters and DES sons (that is, children born to women who took DES) began to call into question the safety of DES. DES daughters were found to have immune system disorders, bone loss, and abnormal sex organs, while DES sons often had testicular dysfunction and were sterile. The FDA in 1971 ordered that DES stop being prescribed to pregnant women and that prevention of miscarriage be removed from the drug’s labeling. DES stopped being marketed in 1997.
The first brand of HRT marketed in America was Wyeth’s Premarin, which was approved for sale in 1942 as a remedy for depleted estrogen. Premarin is made from mare’s urine (pregnant mares’ urine).
Sales of Premarin skyrocketed in the late 1960’s with the publication of Feminine Forever, a book authored by gynecologist Robert Wilson. In Feminine Forever Wilson argued that menopause causes women to lose their youth and femininity, and that synthetic estrogen was an effective remedy against the onset of menopause. “Every woman alive today has the option to remain feminine forever,” wrote Wilson. It was later revealed that he was indirectly on the payroll of Wyeth.
Far from remaining “feminine forever,” women taking Premarin were developing uterine cancer at increasing rates. Concern for this trend began in the 1950s and came to a head in 1975 with the publication of research in the New England Journal of Medicine (NEJM). Two hormone studies showed that women who took menopausal estrogen were four times more likely to develop endometrial cancer (a type of uterine cancer). For women who used the drugs longer than seven years, the incidence of cancer was 14 times greater than normal.
Sales of estrogen replacement drugs slowed following the revelation of estrogen’s link to endometrial cancer. The drug industry responded by introducing so-called “combined therapy,” or the pairing of estrogen with progesterone (progestin). Combined therapy was shown to reduce the risk of uterine cancer and it helped drug companies to recapture lost HRT sales. Combination therapy, however, never underwent clinical trials for safety and efficacy before being marketed. Then, Wyeth release its new combination HRT drug in a single pill, called Prempro. This drug gained FDA approval in 1995, and sales skyrocketed increasing exposing more women to the dangers of HRT.
In the years that followed Prempro’s release, various HRT drug makers promoted, through observational studies and marketing campaigns, the use of HRT for a wider range of uses including wrinkles, aches and pains, Alzheimer’s disease, depression, heart attacks, and bone loss. The FDA found in 1986 that HRT was an effective treatment for osteoporosis, although the agency declined to approve the drugs for the prevention of heart disease. Despite this, doctors are allowed to prescribe drugs for off-label uses, and many continued to encourage their patients to take HRT for their purported range of health benefits. Dr. Isaac Schiff of Mass. General Hospital, speaking to Time magazine in 2002 said, “Ten years ago, it was almost malpractice not to endorse estrogen.”
The statistics on HRT sales bear this out. By 1990, Premarin became the most frequently prescribed drug in the country. Seven years later, it became Wyeth’s first brand to reach $1 billion in sales. In the year 2000 alone, forty-six million prescriptions were written for Wyeth’s HRT drug, Premarin, and 22.3 million prescriptions were written for Wyeth’s Prempro.
The strong sales of Premarin and Prempro would not continue, however, as years of suspicion over HRT’s negative health effects gained traction. In spite of HRT industry claims that the drugs prevented heart disease, in the late 1970s evidence began to emerge that hormone therapy could actually cause heart attacks and strokes in addition to breast cancer. The strongest evidence yet on the link between cardiovascular health and hormone therapy was published in 1998. The Heart and Estrogen-Progestin Replacement Study (HERS) concluded that women with heart disease who took HRT could face increased risk of heart attack and stroke.
Shockingly, HERS was the first major placebo controlled trial of HRT. Equally shocking was the fact that combination HRT still had not been subjected to clinical trials, the “gold standard” of modern pharmaceuticals.
In 2002, the results of the Women’s Health Initiative (“WHI”) were released. This was the first long term, double blind controlled clinical trial large enough and long enough to truly evaluate the risks and health benefits of HRT. When this standard was finally applied to combination hormone therapy, it was found that women who took both estrogen and progestin faced an increased risk of heart disease (up 29%), blood clots in the veins (up 107%), blood clots in the lungs (up 113%), stroke (up 41%), and breast cancer (up 26%).
The WHI findings definitively put to rest drug manufacturer claims that combination HRT reduced a woman’s risk of age related diseases, such as heart disease. The release of the WHI finding resulted in a steep decline in the number of HRT prescriptions and set the stage for massive litigation against Pfizer and its subsidiaries. Trials began in 2006.