Natural hormones: Safety, effectiveness and regulation of alternatives to conventional hormone therapy

As more women learned about the health risks of conventional hormone therapy drugs, many have started looking for natural alternatives. One kind of alternative -- natural hormones, or bio-identical hormones -- has attracted a lot of new interest, driven in large part by claims by the companies and pharmacies that make and distribute them that their products are safer than conventional hormone therapy drugs. Most natural hormones are prescribed by health care providers and sold at special pharmacies, called compounding pharmacies, which mix the hormones into forms that women can use – usually pills or topical creams. Some (including topical progesterone creams) may be found over-the-counter. Many of the claims made about these products are unproven, but most women don't know that. They assume that natural products must be safer, but products are not necessarily safe just because they're natural. Women also think because natural hormones are prescribed and sold in a pharmacy that the Food and Drug Administration (FDA) requires them to be tested and proven safe and effective just like conventional drugs, but that's not true either. Women need, and have for years been calling on, the FDA to exercise better oversight of natural hormones. Last year the agency finally took action, telling the pharmacies that sell them that the safety and effectiveness claims they were making "are unsupported by medical evidence, and are considered false and misleading." The agency also warned that selling products containing the estrogen estriol is a violation of federal law because it has never been approved by the FDA. Groups that promote natural hormones responded with an ad campaign that repeated the unproven claims. This presentation will provide an overview of what's known and not known about the safety and effectiveness of the natural hormones that are commonly recommended to women at menopause. These include estriol, Tri-Est and natural progesterone. It will also review the unproven and misleading claims that are commonly made about these products and discuss the need for further oversight of manufacturing and marketing of natural hormones by the FDA and the Federal Trade Commission to protect women's health.