In connection with the New York Times’ recent coverage of hormone therapy1, Pfizer Inc. today released important facts and context to respond to the newspaper’s account. Pfizer believes the coverage is based on a misleading and selective reading of both the science and history of hormone therapy (HT) medicines.
Premarin (conjugated estrogens tablets USP) and Prempro (conjugated estrogens/medroxyprogesterone acetate tablets), which are approved by the Food and Drug Administration (FDA), have brought relief to tens of millions of women for decades. The FDA has stated that HT has a well-established safety profile and is among the most studied classes of medicines. In addition, the FDA states that HT “is the most effective FDA approved medicine for relief of hot flashes, night sweats or vaginal dryness.”
A full, fair and accurate report on HT would show:
1. FDA-approved hormone therapy is an important treatment option for certain post-menopausal women.
First and most importantly, doctors have been prescribing HT medicines for the treatment of menopausal symptoms (e.g., hot flashes and night sweats), as well as for the prevention of post-menopausal osteoporosis, for decades. As FDA itself wrote in a news release following the Women’s Health Initiative study (WHI): "Because there are few alternatives for the relief of severe vasomotor symptoms and severe symptoms of vulvar vaginal atrophy, estrogens and estrogens with progestins have an important role in women's health." The FDA has regularly and thoroughly reviewed the benefits and risks of these medicines, and has consistently determined that the benefits outweigh the risks for the appropriate woman.
2. Wyeth has acted responsibly by studying its hormone therapy medicines closely, including the risk of breast cancer, for decades.
HT medicines are among the most thoroughly studied drugs. Wyeth conducted or supported more than 180 studies covering 180,000 women that examined the risks and benefits of hormone therapy (including the WHI), 19 of which expressly examined hormone therapy and breast cancer risk. The first such study was published in 1959, and these studies were published in peer-reviewed medical journals and were consistent with the then-current medical science.
The most definitive study on hormone therapy and breast cancer, the WHI, reaffirmed the increased relative risk of breast cancer that was already in the labeling for Premarin and Prempro.
3. The labels for Premarin and Prempro, which are the official, FDA-approved description of their benefits and risks relied upon by doctors, are and have been accurate and science-based, and have warned of the risk of breast cancer for many years.
Guidance to use Premarin and Prempro at the lowest dose and for the shortest duration needed to meet treatment goals has been included in the labels of these medicines for decades.