Ethical problems with bioidentical hormone therapy

Abstract

The term 'bioidentical' hormone replacement therapy (BHRT) is widely misunderstood by the patient population and misrepresented in patient literature. Within the clinical community, BHRT is currently being prescribed by some as an 'innovative therapy' with no published evidence in peer-reviewed journals that it is better than the current standard of care; in at least one case, BHRT is being used as a study agent in unregulated and unethical research involving very high doses of estrogen and progesterone. Additionally, professional ethics problems abound within the prescribing population, since those claiming expertise and training in BHRT vary widely in competencies, may cross practice boundaries, and may have overt conflicts of interest if they are selling or promoting their own for-profit recipes of BHRT on commercial forums. Ultimately, BHRT presents clinical, research and professional ethics problems that are discussed in depth.

Defining bioidentical hormones for menopause-related symptoms

“…Of the remaining 178 articles, 55 contained definitions of ‘bioidentical hormones’ and were included in the analysis 2,3,5-7,12-61. The search of the internet resulted 181,000 hits and the first 10 websites were screened for definitions of ‘bioidentical hormones’ (Figure 2).…”

“…In spite of their widespread use, there is actually a great deal of confusion as to the exact meaning of the term “bioidentical hormone (BH)”. According to Rosenthal, the original use of the term “bioidentical hormones” can be traced to a book on natural hormone replacement authored by Wright and Morganthaler in 1997 2. Initially, the term was used to describe the difference between patentable and unpatentable hormones 2.…”

“…According to Rosenthal, the original use of the term “bioidentical hormones” can be traced to a book on natural hormone replacement authored by Wright and Morganthaler in 1997 2. Initially, the term was used to describe the difference between patentable and unpatentable hormones 2. The meaning of BH has evolved and there are now a variety of definitions available in the lay press as well as in the health and scientific literature including those from various health organizations that have policy or position statements published on the topic of BHs or bioidentical hormone therapy 3-5.…”

Use of Compounded Bioidentical Hormone Therapy in Menopausal Women: An Opinion Statement of the Women's Health Practice and Research Network of the American College of Clinical Pharmacy

“…Providers may also claim expert status in the field of bioidentical hormone therapy and women's health without support of academic peers, certification examinations, or other validation processes because none currently exist. The status is simply a popular press recognition, and these statements can mislead patients and fellow providers . Although continuing education is available, none of the health care professions have a standard of awareness and proficiency in these areas to hold providers accountable for a level of expertise in CBHT.…”

Bio-Identical Hormones Utilized for Treating Menopausal Symptoms

“…The use of bio-identical hormone replacement therapy (BHRT) for the alleviation of menopausal symptoms is being selected by women in the United States (US) (Watt, Hughes, Rettew, & Adams, 2003), however the research regarding BHRT is limited. Pharmaceutical treatment for menopausal symptoms is a topic of debate and has received significant attention by women, the media, the Food and Drug Administration, and the medical field (Garber, 2008; North American Menopause Society (NAMS), 2010; Rosenthal, 2008;Rossouw et al, 2007).…”