Menopausal hormone therapy for primary prevention: why the USPSTF is wrong

Abstract

The US Preventive Services Task Force (USPSTF) Draft Recommendation statement on Menopausal Hormone Therapy: Primary Prevention for Chronic Diseases, released in May 2017, perpetuates a major disconnect between the primary population affected, women within roughly 10 years of menopause, and the data cited. Furthermore, major elements of the evidence relied upon have been misinterpreted or misstated, particularly in regard to coronary heart disease and breast cancer, for which there is no statistically significant evidence of harm. As currently drafted, the recommendations reiterate the USPSTF statements of 2012, 2005 and 2002, and will perpetuate egregious harm to the public health. In an attempt to avoid that outcome and to facilitate a return to rational discourse regarding menopausal hormone therapy, an ad hoc group of experts in menopausal health submitted this comprehensive response to the USPSTF.

Keywords:

• Menopause
• cardiovascular disease
• breast cancer
• osteoporosis
• fragility fracture
• hormone replacement therapy
• chronic disease prevention

View correction statement:

Correction to: Langer et al., Menopausal hormone therapy for primary prevention: why the USPSTF is wrong

Conflict of interest

Dr Langer has received travel support and lecture honoraria from Pfizer Inc. (New York City, NY). The sponsor had no role in determining or creating the content.

Dr Simon reports roles in advisory boards or as a consultant for: AbbVie, Inc. (North Chicago, IL), Allergan, Plc (Parsippany, NJ), AMAG Pharmaceuticals, Inc. (Waltham, MA), Ascend Therapeutics (Herndon, VA), Azure Biotech, Inc. (River Vale, NJ), Millendo Therapeutics, Inc. (Ann Arbor, MI), Radius Health, Inc. (Waltham, MA), Roivant Sciences, Inc. (New York, NY), Sanofi S.A. (Paris, France), Sebela Pharmaceuticals, Inc. (Roswell, GA), Sermonix Pharmaceuticals, Inc. (Columbus, OH), Shionogi Inc. (Florham Park, NJ), Symbiotec Pharmalab (Indore, India), TherapeuticsMD (Boca Raton, FL), Valeant Pharmaceuticals (Laval, Canada). Dr Simon has been within the past year, or is currently serving on the speakers’ bureaus of: Novo Nordisk (Bagsvrerd, Denmark), Shionogi Inc. (Florham Park, NJ), and Valeant Pharmaceuticals (Laval, Canada). Dr Simon has received within the past year, or is currently receiving grant/research support from: AbbVie, Inc. (North Chicago, IL), Allergan, Plc (Parsippany, NJ), Agile Therapeutics (Princeton, NJ), Bayer Healthcare LLC (Tarrytown, NY), New England Research Institute, Inc. (Watertown, MA), ObsEva SA (Geneva, Switzerland), Palatin Technologies (Cranbury, NJ), Symbio Research, Inc. (Port Jefferson, NY), TherapeuticsMD (Boca Raton, FL). Dr Simon is a stockholder (direct purchase) in Sermonix Pharmaceuticals (Columbus, OH).

Dr Lobo has been a consultant and participated as a principal investigator in clinical trials for TherapeuticsMD (Boca Raton, FL). He has also consulted for AMAG Pharmaceutics (Waltham, MA) and Mithra (Liege, Belgium).

Dr Pickar has received consultant fees from Wyeth/Pfizer (New York City, NY), Shionogi Inc. (Florham Park, NJ), Radius Health (Waltham, MA), and TherapeuticsMD, and has stock options in TherapeuticsMD (Boca Raton, FL).

Dr Archer reports research support from: AbbVie (formerly Abbott Laboratories, North Chicago, IL), Bayer Healthcare (Tarrytown, NY), Endoceutics (Quebec, Canada), Glenmark (Mahwah, NJ), Radius Health (Waltham, MA), Shionogi (Florham Park, NJ) and TherapeuticsMD (Boca Raton, FL). He serves as a consultant to: AbbVie (formerly Abbott Laboratories), Agile Therapeutics (Princeton, NJ), Evestra (San Antonio, TX), Exeltis (formerly CHEMO, Florham Park, NJ), InnovaGyn (Portsmouth, NH), Radius Health (Waltham, MA) and TherapeuticsMD (Boca Raton, FL). He is a member of the Board of Directors of InnovaGyn and owns stock in Agile Therapeutics and InnovaGyn.

Dr Hodis, Dr Pines, Dr Sarrel and Dr Utian report no conflicts.

Source of funding

Nil.