Bioidentical hormone replacement therapy (BHRT) is currently a topic of great interest among women. Bioidentical hormones have the exact molecular structure as those made in the human body, and produce the same physiological responses as those of endogenous hormones. The Food and Drug Administration (FDA) considers bioidentical hormones to be natural regardless of their source, and as a result they cannot be patented. Every day millions of women confront uncomfortable and sometimes painful health problems related to menopause and hormone imbalances; individualized treatment including the use of BHRT is proving to be a beneficial treatment approach for many of those women. Certainly, not all women require hormone therapy, and many successfully manage their menopausal symptoms through other approaches such as nutrition and exercise. However, the interest in and use of bioidentical hormones – by women and health care providers – has been increasing. We know this is largely due to women experiencing benefits from this individualized treatment approach including a reduction in menopausal symptoms, and improvements in sleep, mood, energy and overall functioning – often with fewer side effects than with non-bioidentical hormone options. On October 6, 2005 Wyeth filed a Citizen Petition with the FDA that undermines the health care provider-patient relationship and could greatly limit women in their access to bioidentical hormones. With bioidentical hormones long-approved by the FDA, why is Wyeth raising an issue now? A 2002 study by the National Institutes of Health linked Premarin and Prempro®, synthetic hormone drugs manufactured by Wyeth, to increased risk of stroke, breast cancer, heart attacks and circulatory disease. Wyeth took a hit financially as a result of the study, and sales of the drugs plummeted from $1.3 billion in 2002, to $880 million in 2004. Therein lies the timing, and motive, for Wyeth's latest attempt at burying BHRT. It has nothing to do with concerns for women's health or the safety and effectiveness of bioidentical hormones. It has everything to do with revenue and profit. If the FDA acts on Wyeth's Citizen Petition where would that leave the millions of American women who rely on this safe, proven and effective healthcare option? The FDA would better utilize its time, energy and resources by standardizing bioidentical hormones, and rather than restricting them, making them more available and accessible.
