Dear [Decisionmaker],
If the FDA isn't forced to change course, millions of patients will lose access to customized, biologically-identical hormones like estriol, estradiol, and progesterone.
These hormones have been nominated to the FDA's "Demonstrably Difficult to Compound" list, despite the fact that pharmacists say that they are not difficult to compound at all! These hormones have been used safely for decades. What really seems to be happening is that the FDA, under the guise of the "Difficult to Compound" process, is protecting the pharmaceutical industry by throttling access to the competition.
If these hormones get the axe, many patients will suffer harm. Research shows that the alternatives are linked to a much higher risk of breast cancer, blood clotting, and heart disease. A study published in the Journal of the American Medical Association showed that women who took a pharmaceutical combination of estrogen and synthetic progestin were twice as likely to die from breast cancer. Other evidence has shown that synthetic hormone replacement therapy is linked to an increased risk of stroke, with other possible side effects including osteoporosis, high blood pressure, vaginal bleeding, and weight gain.
Bioidentical estriol, on the other hand, not only appears to be safer, it has also been shown to improve bone density, promote youthful skin, and enhance urinary health. In short, limiting patient access to compounded estriol and other bioidentical, natural forms of hormones is a terrible idea. Why should women put pregnant mares' urine into their bodies instead of safe compounded estriol, which is biologically identical to the hormones in their own bodies?
Patients, in consultation with their physicians, have a right to choose the medications that are best for them. The FDA has no business restricting our access to medicines that have been used safely for decades—only to help protect the profits of the pharmaceutical industry. Please act now to protect patient access to these important hormones!
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Thank you,
[Your Name]