Hormone replacement therapy

Bioidentical hormones for menopause symptoms stirs up needless fear — Women to Women responds

If safety’s in question, where’s the science to back up the claims?

November 2, 2009; Yarmouth, Maine — Women to Women, one of the nation’s leading experts on managing menopause symptoms, explained why the recent media coverage of an article questioning the safety of bioidentical hormones is misleading for women. This article, entitled “'Bioidenticals' Not FDA-Approved, Contain Estrogen,” posted October 25, 2009 by the Associated Press does much to confuse rather than to help women seeking relief from menopausal symptoms. The article stirs up needless fear about women’s alternatives by failing to create accurate distinctions between bioidentical hormones and compounded bioidentical hormones.

“The press coverage claims that bioidentical hormones may be unsafe for menopause symptoms relief, when we know that they have been used for decades and have powerful effects on a range of symptoms, including hot flashes, mood swings, vaginal dryness, and insomnia, just to name a few,” says Marcelle Pick, OB/GYN, co-founder and director of the Women to Women clinic. “Further, compounded bioidentical hormones have been used safely by tens of thousands of women under the supervision of their healthcare providers.”

The article contains the following points that require clarification or correction:

• The title of the article is misleading: it suggests that the hormones marketed as “bioidentical” are not FDA-approved, when in fact there are numerous natural, FDA-approved bioidentical estrogens prescribed by doctors every day. These include: Divigel, Evamist, EstroGel, Estrasorb, and Climara.
• The term “bioidentical” was coined by a physician to describe hormones derived from non-human sources but identical in molecular structure to human hormones, not by a team of marketers as the article implies.
• “Traditional menopause therapies” have for decades included either synthetic or equine hormones which are not identical in molecular structure to human hormones. Drug companies seek such differences not for medical but for profit motives, because usually bioidentical substances can’t be patented. It is only recently that estradiol, a bioidentical hormone derived from plant sources, was patentable to its unique delivery methods, giving women a bioidentical therapy that can be obtained by prescription from conventional pharmacies.
• Top compounding pharmacies are accredited by a board that includes eight of the nation’s leading pharmacy organizations. To become accredited, a pharmacy must demonstrate manufacturing procedures and quality assurance inspections comparable to those used by pharmaceutical companies. Women can check the Pharmacy Compounding Accreditation Board (PCAB) website to locate an accredited compounding pharmacy near them.
• Women can request a Certificate of Analysis from their compounding pharmacist to validate the dosage and form of the hormones included in any compound they are recommended.

At Women to Women, we believe that women will benefit by having scientifically accurate, up-to-date information that offers them the risks and benefits of any approach. “Our approach is to start by educating women to the wide range of alternatives available to them, and to encourage them to begin with the safest, most natural methods possible,” concluded Pick.

About Women to Women

Women to Women is America’s leading medical practice devoted to health care for women, by women. Founded over 25 years ago, it has always advocated an approach to women’s health that combines the best of alternative and conventional medicine. Through its practice, website, and publications, Women to Women supports over a million women a year in their efforts to create health and well-being in their lives.

 

Last Modified Date: 05/25/2011