We want a balanced and evidence-informed approach

With our friends at NCPA, APC has submitted formal comments to FDA on the risks and benefits of menopause hormone therapy. Our biggest ask is that the agency take “a balanced and evidence-informed approach” to any hormone-therapy regulation — one “that reflects both the evolving science and the practical realities of patient care.”

[F]or too long, the risks, particularly those suggested by the early findings of the Women’s Health Initiative, have been overstated, while the benefits to bone health, cognitive function, cardiovascular outcomes, and overall quality of life have been under-recognized.

We of course pointed out that in many cases compounded hormone therapy “is not merely a preference — it is, for many women, the only viable option.” And yes, we absolutely brought up that flawed NASEM study that lurks in the background like a misplaced Stephen King character. (Find the Berkeley Group’s independent analysis — that points to the NASEM report’s flaws — here.)

We can’t predict what FDA will do on a given issue — especially when it comes to hormones — but we have hopes that the experts there will take the time to understand our concerns, and more importantly follow the science when it comes to decisions that affect so many lives.