FDA Targets Bioidentical Hormone Providers

Wednesday, January 30, 2008 by: Adam Miller
Tags: bioidentical hormones, health news, Natural News

(NewsTarget) Early January, the U.S. Food and Drug Administration sent warnings to seven compounding pharmacies
distributing the hormone estriol - a weak estrogen found in the human body - to patients whose doctors have deemed it safer and more appropriate than FDA-approved synthetic versions of the hormone. Compounding is a process in which a pharmacist responds to a doctor's prescription by tailoring a drug to meet the patient's unique needs. In some cases a patient might be allergic to a specific dye or other additive, where in this case a patient would not be expected to respond well to a synthetic version of estrogen.

Starting earlier this decade, research began to reveal that hormone replacement therapy (HRT) using synthetic drugs was not effective in the prevention of disease, and in fact increased the risk of certain diseases. Lasting 15 years, the Women's Health Initiative study found that hormone replacement therapy using pharmaceutical drugs designed to mimic estrogenic activity in the human body caused an increased risk of heart attack, breast cancer, blood clots, and stroke. In response, an alternative therapy known as bioidentical hormone replacement rose in popularity led by advocates like Suzanne Somers. Bioidentical hormones are molecules produced in a lab to have the exact same molecular structure as estriol, a weak estrogen found in the human body.

In response to this new competition HRT drug manufacturer Wyeth, maker of the FDA-approved Prempro and Premarin, which is derived from horse urine under conditions that animal rights activists call inhumane, petitioned the FDA to crack down on bioidentical hormone replacement therapy in 2005. Because the therapy uses a natural hormone identical to that found in the human body, it cannot be patented and is thus unlikely to become approved by the FDA.

In their warnings to the pharmacies offering the bioidentical alternative, the FDA states that claims over the safety and effectiveness of bioidentical hormones were false, misleading, and not supported by medical evidence. The FDA ordered the companies to stop making claims that the hormone was effective in treating disease such as Alzheimer's, stroke, and cancer, and that the natural hormone was more effective than synthetic, FDA approved versions.

Bioidentical hormone replacement therapy is one of the few instances where integrative, naturopathic, and other alternative practitioners largely maintain that a molecule manufactured in a lab is superior to similar versions which are sometimes derived from nature, such as Premarin which comes from hormones found in pregnant mare urine. This is because synthesizing the hormone in the lab is the only reasonable way to attain a molecule whose structure is identical to that of hormones found in the human body. Marcelle Pick, OB/GYN NP of the Women to Women Clinic says that "the great majority of women can rebalance their hormones without the use of drugs. We have found that about 85% can find relief through an approach that combines medical-grade nutritional supplements, gentle endocrine support, and dietary and lifestyle changes." For the remaining percentage, though, bioidentical hormone replacement is widely perceived as the preferred natural approach.

About the author

Adam Miller is a student of life who has dedicated literally thousands of hours of personal research on top of formal institutional training in Dietetics to learn the secrets of achieving vibrant health and extended lifespan. His passion and dedication is in bringing the best ideas for self-empowerment through nutrition and nutraceuticals as well as alternative therapies, technology, and information to the public through various means.