In 1994, the pharmaceutical company Wyeth got FDA approval for Prempro, which is a combination hormone therapy in a single pill and began to market, distribute, and sell the product. Soon after the introduction of Prempro, Wyeth agreed to fund a four-year heart disease prevention trial: Heart and Estrogen/Progestin Replacement Study. Wyeth hoped the study would show that Prempro prevented heart disease in women — Wyeth was seeking the approval of the FDA of the use of Prempro to prevent or reduce the risk of heart disease. But in 1998, this study’s investigators reported that Prempro did not reduce the rate of coronary heart disease events in women and in fact radically increased the risk, especially in the first year.
Other studies have also proven the extreme risk Prempro and Premarin pose to women. In the early 1990s the Women’s Health Initiative study was begun to examine the effects of Prempro and Premarin on the prevention of heart disease and hip fracture, and any associated change in risk for breast cancer and colon cancer. This comprehensive study enrolled 161,809 post-menopausal women volunteers in the age range of 50 to 79 years. On July 9, 2002, the National Heart, Lung and Blood Institute halted the Women’s Health Initiative Study because the investigators concluded that, under the circumstances, the risks of taking the drugs outweighed its benefits.
For over nine years, Wyeth represented that hormone therapy was safe for long-term use. Due to the studies proving Prempro and Premarin’s increased health risk to its users, on January 6, 2003, Wyeth abandoned its long-standing marketing strategy and cautioned doctors that hormone replacement therapy should be prescribed for the shortest duration consistent with treatment goals. Following this recommendation, Wyeth experienced a significant decline in sales of Premarin and Prempro, from over $2 billion in 2002 to just over $1 billion in 2006.