Arlyn G. Riskind
Director, Media Relations
Phone: (301) 941-0240
Email:ariskind@endo-society.org

Aaron Lohr
Manager, Media Relations
Phone: (240) 482-1380
Email: alohr@endo-society.org

In response to recent media attention and what appears to be the public’s ongoing confusion surrounding the benefits and risks of hormone therapy, The Endocrine Society is re-issuing its 2006 position statement  that there is no scientific evidence supporting the safety or effectiveness of compounded bioidentical hormones.

Since issued, the Society’s statement has become policy of The American Medical
Association (AMA) with widespread support of the medical community, calling
for increased regulatory oversight of all bioidentical hormones.  Just last year, the
U.S. Food and Drug Administration (FDA) ruled the term “bioidentical” to be a
marketing term and not one of scientific or medical merit.  FDA officials stated
that the claims being made about safety and efficacy of compounded “bioidentical
hormones” are false and misleading with no credible scientific evidence to support
them.

“The Society is concerned about the continued propagation of misleading information about so-called bioidentical hormones,” stated Society President Robert M. Carey, M.D., M.A.C.P.  “The term has been used by some to describe non-standardized hormone therapies that are formulated by compounding pharmacies.  The formulations created by compounding pharmacies are often based on unreliable tests in an attempt to customize for an individual’s own hormone levels.”

A bioidentical hormone is in fact one that is identical in structure to that which is produced in the human body.  Considering this factual definition, patients can obtain bioidentical hormones as FDA-approved preparations formulated with strict oversight and dispensed by retail pharmacies. 

Studies have shown both benefits and risks of hormone therapy.  Risk accompanies therapy regardless of the chemical structure of the hormone.  However, medications from compounding pharmacies—including bioidentical hormones—are not always subject to FDA monitoring for dose, purity, safety or efficacy.  Inconsistency of dose and purity presents additional risk to patients.
 

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Founded in 1916, The Endocrine Society is the world's oldest, largest, and most active organization devoted to research on hormones and the clinical practice of endocrinology. Today, The Endocrine Society's membership consists of over 14,000 scientists, physicians, educators, nurses and students in more than 80 countries. Together, these members represent all basic, applied, and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Md. To learn more about the Society, and the field of endocrinology, visit our web site at www.endo-society.org.