After my earlier article on hormone therapy, I received numerous emails with follow-up questions, which prompted me to write a second piece to address these concerns in more detail. First, I want to clarify my background. I am not an oncologist or gynecologist. I am a public health researcher specializing in maternal and child health, with a focus on pregnant women, those who have recently given birth, and their newborn babies. This topic is not within my research scope, nor will it be part of my PhD studies. However, the recent FDA decision has been portrayed on social media with an excitement that oversimplifies the complexity of the situation.
The FDA recently removed the black box warning from hormone replacement therapy. That warning originally came from the Women’s Health Initiative Study more than twenty years ago. It was a strong study for its time, but most of the women enrolled were over sixty, and genetic testing for breast cancer risk was not common back then.
In the years that have followed, research has shown that initiating hormone therapy earlier, specifically before the age of sixty or within ten years of menopause, is associated with a more favorable balance of benefits and risks. We also now make a clear distinction between systemic hormone therapy, which circulates throughout the entire body, and local hormone therapy, such as low-dose vaginal estrogen, which provides targeted relief for symptoms like vaginal dryness and has minimal absorption into the bloodstream.
It is important to make that distinction. For most women without a personal or family history of breast cancer, low-dose vaginal estrogen is generally considered safe. However, patients with BRCA1 or BRCA2 mutations, as well as those with a history of hormone receptor-positive breast cancer, should approach systemic hormone therapy with caution. BRCA carriers who have never had breast cancer may still be able to use hormone therapy in certain situations, but the risks and benefits need to be discussed thoroughly with their providers. Women who have had hormone receptor positive breast cancer are generally advised to avoid systemic hormone therapy.
Systemic hormone therapy refers to any form of estrogen, with or without progesterone, that enters the bloodstream and affects the body as a whole. This includes estrogen taken orally, estrogen delivered through skin patches, gels, or sprays, as well as combined estrogen and progesterone therapies. These treatments differ from local vaginal estrogen in that they expose breast tissue to circulating hormones, which may influence breast cancer risk or recurrence. So, while the FDA’s decision reflects a better understanding of newer data, hormone therapy remains far from a one-size-fits-all. It is about using the correct type of therapy at an appropriate dose, according to the unique circumstances of each case.
Two things are especially relevant to me here. First, the risk of breast cancer, particularly for those with a genetic predisposition or hormone receptor-positive cancer, must always be central to the decision-making process. Moreover, since I spoke at a public health conference last year about earlier controversial FDA rulings, albeit in an entirely different context, I feel that even if this current move is well-supported, it is still important to approach all FDA decisions with a healthy level of skepticism.
Ultimately, therapeutic interventions should be individualized, taking into account the patient’s unique medical and family history, and made through careful consultation between the patient and their healthcare provider in the privacy and sanctity of the clinical setting.
