On January 9th of this year, the FDA warned seven compounding pharmacies about false and misleading advertising over the safety and efficacy of their compounded hormone products. The FDA further stated that the term bioidentical is not a truly defined term, and represented the pharmacies use of the term as entrepreneurial and misleading to patients by implying benefits which may not be scientifically proven.

 

Local gynecologist and menopause expert Dr. Henry Hess says that the FDA's message adds another layer of confusion and frustration for menopausal women seeking real answers about effective and safe remedies for their menopause symptoms.

 

Dr. Hess notes that while the FDA made meaningful allegations to certain offending pharmacies that do effectively distort the facts, the FDA did not make it clear that there are only a few compounding pharmacies among the many who are making these false and misleading statements.

 

Dr. Hess comments that the FDA’s actions against the 7 cited compounding pharmacies were necessary and important, but the broadly written statement may confuse patients even more, and may make all compounding pharmacies look bad in the eyes of traditional health-care providers when they advise their patients. In fact, most compounding pharmacies are reliable, accurate, and precise. They fulfill an important aspect of individualized healthcare when medicines in general, and hormones in particular, require specific tailoring to an individual's needs. Many healthcare providers consider compounded hormones and pharmaceutical hormones as two distinct resources, both of which are helpful to our patients.

 

He expressed the same concerns about the FDA’s condemnation of the term “bioidentical.” Dr. Hess doesn't agree with the FDA that this is only a marketing term, and adds that the word bioidentical is actually used by healthcare professionals and national societies such as the Endocrine Society, and the American College of OB/GYN as a way to define therapeutic hormones that are specifically identical in chemical structure to those produced by the body, such as estradiol, progesterone, testosterone, DHEA, cortisol, and others. This term requires specific definition, not condemnation, as it is helpful for women to understand and differentiate when making thoughtful decisions about their therapies. The compounding pharmacies that were warned by the FDA made broad statements about the safety and efficacy of bioidentical hormones, where there are not specific scientific data to back them up. 

 

Dr. Hess advises patients and healthcare professionals alike to take the FDA’s warning for exactly what it is, a warning against 7 compounding pharmacies who overstepped their bounds by marketing their hormone preparations as safer, risk-free, natural products exclusively available through compounding. The poor judgment of a few compounding pharmacies should not stop the use of the term “bioidentical” by those who are appropriately differentiating a product. The term “bioidentical hormones” is an extremely useful concept for menopausal women to use, and it should be properly defined and understood.

 

These important concepts are discussed by Dr. Hess in his new book, "The Perfect Menopause : 7 Steps to the Best Time of Your Life".

 

In his book, which is due out in late February, Dr. Hess thoroughly defines the term bioidentical hormones, and discusses their use, both in pharmaceutical as well as in compounded products. Dr. Hess supports the use of bioidentical hormones from both pharmaceutical companies as well as compounding pharmacies, where and when appropriate.

 

Dr. Henry Hess is a well-known local gynecologist, chemist, and natural therapist who writes and lectures nationally on the areas of menopause, perimenopause, and hormone imbalance.

 

"The Perfect Menopause : 7 Steps to the Best Time of Your Life"was written to end women's confusion and frustration over menopause therapies. In this book he outlines complete, up-to-date, safe and effective solutions for many symptoms and issues associated with menopause. Dr. Hess believes in the integrative approach—a blend of traditional and natural medicine—and presents a complete plan for the perfect menopause, using all the best from natural therapies, medical therapies, and bioidentical hormones.