The FDA claims there is no credible scientific evidence supporting the safety and efficacy of compounded “bio-identical” hormone replacement therapy drugs. The FDA is concerned that the term “bio-identical” which implies a substance that is natural or identical to those made by the body, will mislead patients and practitioners. It’s true that the term “natural” gets exploited and can be used as a marketing claim that denotes that something is more beneficial or safer. The hormone the FDA is ordering pharmacies to stop providing is Estriol. They claim this hormone is a new and unapproved drug and the safety and effectiveness of estriol is unknown.
Well, the FDA admitted that no side effects involving compounded bio-identical estriol has ever been reported. Can the FDA say that about drugs they’ve approved? Studies have raised questions about possible heart and cancer risks pertaining to the estrogen that comes from horse urine that was once a best seller. Now these drugs have black box warnings on them.
There actually are some scientific studies on the hormone Estriol. (The Journal of the American Medical Association, Vol. 239, No.1. Jan 2 1978). Another study by Van Haaften, M., and Donker GH, et al. Gynecol Endocrinol. 1997 Jun; 11(3):175-85 discusses the effects of Estriol on the endometrial lining of the uterus and vaginal tissue of post-menopausal women. Actually there are several links to websites including PubMed that provides access to over 10 medical and scientific citations. Of course we need more current research, which brings me to some solutions.
If the FDA claims that “bio-identical” hormones are being falsely advertised, then lets stop advertising it as all natural, and instead label it for what it is; one of three estrogens (the weakest of all) that’s made with all FDA approved ingredients. Quite frankly, I’m alittle concerned in how drug companies directly advertise to the public on TV. You can’t tell me that some of the images they portray in these commercials are not false or misleading! Take this pill (antidepressant) and all your problems go away.
Let’s also make it clear that compounding (drugs made by hand by pharmacists) was at one time how ALL drugs were made. It is not some Voo-Doo way of mixing potions or formulas. Pharmacists are trained and certified in learning how to compound medications.
Finally, instead of banning estriol, lets do more clinical research and have that scientific evidence the FDA is asking for to approve this drug or not. There are plenty of women that would volunteer for studies since so many women have benefited from its use.
If you are interested in taking action to stop The FDA from banning bio-identical hormones, go to www.homecoalition.org.