Vivian Torres-Suarez, 54, a healthcare executive from Queens, New York, was one of millions of women suspicious of hormone therapy in the wake of the WHI findings. But her symptoms were getting to her—not only hot flashes but also a hot temper that had prompted her to lash out at a colleague during a staff meeting. "I don't remember exactly what he said, but I must have turned into a wicked witch," Torres-Suarez recalls. "Then he said, 'Are we having a bad menopausal day?' And I just blasted him."
Torres-Suarez's gynecologist recommended the estrogen pill Premarin, which contains the same type of estrogen used in the WHI study. "I don't feel comfortable with that, I really don't," Torres-Suarez told her doctor. And there are experts who would agree with that choice, arguing that Premarin and Prempro are not ideal products because they're derived from the urine of pregnant horses. Instead, these doctors prefer a synthetic estrogen, estradiol (found in Estrace, Climara, Estring); it's chemically identical to the kind made by women's ovaries, which is why it is described as "bioidentical." Between 2003 and 2008, prescriptions for bioidentical estradiol-based products rose from 22 to 35 percent of the supplemental estrogen market while those for Premarin tablets fell from 53 to 35 percent, according to IMS Health, a healthcare information and consulting company.
Manhattan internist Erika Schwartz, MD, prescribes estradiol made by pharmaceutical companies or orders a transdermal cream from a compounding lab, which customizes it for individual patients. When Torres-Suarez visited Schwartz for a second opinion, the bioidentical hormones made sense to her, and she liked the idea of a cream (hers includes bioidentical progesterone), which she applies to her chest twice a day. "My hot flashes haven't disappeared, but they're much better," she says. "And I'm no longer like the girl in The Exorcist. I felt like I was losing my mind, and I'm not like that—I'm really a nice person. This has absolutely made me better."
Yet, whether bioidentical estrogen and progesterone are safer or superior is unproved. It's entirely possible that they have the same risks that Prempro does. "There was a flight from reason when the WHI results were published," says Santoro, referring to the illogical assumption that if a hormone product wasn't used in the study it must therefore be safe. She adds: "To prescribe something more physiologic may make sense, but what's really physiologic for a 55-year-old woman is to have less hormone, period."
Kirtly Parker Jones, MD, a professor of reproductive endocrinology at the University of Utah, in Salt Lake City, points out another important fact of biology. The body often takes the estrogen it's given and changes its form so that a woman may use estradiol only to have her body turn it into estrone sulfate, the main ingredient in Premarin and Prempro. "Some well-meaning practitioners probably don't know the endocrinology," Jones says. One trial in the works called the Kronos Early Estrogen Prevention Study (KEEPS) is giving some subjects estradiol patches and others Premarin pills, with the goal of determining whether the patch is as effective as, and potentially safer than, the pill. But the results aren't expected until 2012.
In the meantime, a number of practitioners who are deeper into the bioidentical movement are stirring up controversy by measuring the hormone levels in women's saliva, a method unproven by mainstream science, in order to concoct products that may contain mixtures of various kinds of bioidentical hormones, as well as ingredients that have not been approved by the Food and Drug Administration. Last January the FDA took action, sending warning letters to seven compounding pharmacies stating that their claims of producing drugs that are safer, more natural, and superior to FDA-approved HT drugs are "false and misleading" and unsupported by medical evidence. In particular, estriol, one form of estrogen used by these pharmacies, has never been approved by the FDA, and its safety and effectiveness are unknown.
Official statement from the FDA on bioidentical hormones
We Hear You!