One patient’s story. Action Alert!
We’ve been telling you for a while now about the FDA’s attack on individualized bioidentical hormone replacement therapy, particularly the threat to estriol.
To recap where we are: estriol and other bioidentical hormones have been nominated to the FDA’s Demonstrably Difficult to Compound List; items that appear on the list when it is final will no longer be able to be made at compounding pharmacies. The FDA convened a National Academies of Science, Engineering, and Medicine (NASEM) committee to study the clinical utility of treating patients with compounded bioidentical hormone replacement therapy (cBHRT); the findings of this committee will be used by the FDA to make a final decision on the fate of estriol and other compounded hormones.
What is often lost in the discussion of the data is the human impact a ban could have. An ANH member, who we will keep anonymous, shared her experience with hormone replacement therapy, highlighting the importance of preserving consumer access to compounded bioidentical hormone replacement therapy.
At age 52, the patient was diagnosed with stage 3 uterine cancer following the rupture of her cancerous ovary. She was forced to have a total hysterectomy and thrown into menopause, with her body no longer making estrogen.
The patient then had six rounds of chemotherapy, leading to severe fatigue and cognitive dysfunction, as well as severe menopausal symptoms, including sleep disruption and hot flashes. She also suffers from Hashimotos and adrenal insufficiency. Her immune function plummeted, allowing several viral infections to reemerge, making her very ill.
The patient’s doctors wanted to “normalize” her function as much as possible, so that they could work on the more serious immune problems. They were particularly interested in her cognitive function and were knowledgeable of the research showing that estrogen can help patients with chronic fatigue, as well as menopausal patients. Her doctors adjusted her thyroid dosage, put her on small amounts of hydrocortisone, and prescribed estriol and progesterone.
At first, her oncologist was concerned about her taking any estrogen, but they reviewed all of the studies and found that estriol, in cream form, is the only estrogen not found to promote endometrial, ovarian, or breast cancer. They found that estradiol, in all of the FDA-approved drugs, would not be safe, and could put her at risk for further cancer. Remember there are no FDA-approved drugs available that offer estriol, so if the FDA decides to ban compounded estriol, patients will completely lose access to this hormone.
As a safety, the patient’s doctor also put her on progesterone to reduce her cancer risk. She currently takes 200-300mg generic Prometrium, which is an FDA-approved drug—but this product contains peanut oil, which is an allergen. The patient has mast cell activation syndrome, which can cause her to have new reactions to substances. If she starts to react to peanuts, as many people do, having access to compounded progesterone, which pharmacists can prepare without unwanted allergens, would be critical.
As a result of her compounded estriol treatment, the awful hot flashes the patient had for four months after her surgically induced menopause immediately went away and have not returned. Over time, her fatigue and cognitive function, including short-term memory, word finding, organization, and executive function have improved.
Now five years out, the patient’s oncologist is extremely impressed with the quality of her vaginal tissue. He has shared that all of his other patients who have not taken estriol experience dry, shriveled tissue, with painful intercourse. The patient’s primary care doctor wants her to continue on estriol to also help her bones, since she has osteopenia after carboplatin/paclitaxel chemotherapy. Additionally, the patient’s doctors think her skin looks younger and unwrinkled due to the estriol treatment – she’s now 58 and people consistently guess her age to be in the mid-40s. With all of this, her estradiol and estrone levels have been close to zero, and remain so.
The patient let us know that if estriol were taken off the US market, it would leave her with a very difficult choice—to either have all of the awful symptoms again, including decreased cognitive function, or to go out of the US to buy a personal supply. She cannot take the risk of using the FDA-approved estradiol.
This is just one story from the 2.5 million American women who currently rely on compounded bioidentical hormones and who will lose access if the FDA continues on its current path.
Action Alert! Write to Congress and the FDA, telling them to protect access to compounded bioidentical hormones. Please send your message immediately.
