Harmless Hormones? Bah, Humbug!

Taken from the September/October 2004 issue of the Women's Health Activist Newsletter.

After I testified at a Congressional hearing on natural hormones, a physician who promotes these drugs offered me a free exam and personalized hormone prescription. I retorted that I felt just fine, and he said, "You think you feel fine. I've had many women tell me. I thought I felt fine, until I had my hormones balanced...."

The biggest marketing push, aimed at menopausal women, has involved so-called bioidentical, or natural, estrogens. Humans make estriol, estradiol and estrone, and some compounding pharmacies (which make individualized prescriptions) and alternative medicine providers arc touting bioidentical versions of these hormones as harmless alternatives to conventional hormone therapy. Proponents may prescribe estriol, or estriol and estradiol (a combination known as Bi-Est), or estriol, estradiol and estrone (Tri-Est), sometimes combined with other hormones.

These products are promoted as natural, safe substances that are totally distinct from those nasty cancer-causing “synthetic” hormones made by pharmaceutical companies. Every claim made by these hucksters is misleading. Natural? Well, it's true that bioidentical hormones arc chemically identical to our homegrown estrogens, but all bioidentical hormones are synthesized Truth be told, compounding pharmacies purchase their hormones from major pharmaceutical companies, which use identical "natural" hormones in their own products.

Estradiol, for example, is a popular choice in branded pharmaceutical drugs; it's available in pills (including Estrace®, Gynodiol® and generics), patches (Climara®, Alora® , Estraderm® , Vivelle® and generics), vaginal creams (Estrace® and generics), vaginal rings (Estring®) and so on. Promoting estradiol-containing products as alternative therapies is like decanting supermarket jam into gingham-topped canning jars and passing them off as homemade at the county fair.

Is it true that estriol or other human estrogens are safe in terms of cancer risk? In Europe, conventional physicians commonly prescribe estriol for menopausal symptoms. Because estriol is a quite weak estrogen, physicians thought that there was no need to add a progestin, as is done with other estrogens, to protect the uterus. Whoops. Studies show that estriol, like other estrogens, increases the risk of endometrial cancer and endometrial hyperplasia (abnormal growth of uterine cells).

The claim that estriol decreases breast cancer risk is based entirely on a theory described decades ago by one Henry M. Lemon, who thought that estriol could prevent and treat breast cancer. Lemon published a review article in which he described giving estriol to 24 women with breast cancer. Two women developed endometrial hyperplasia (a precursor to endometrial cancer), and six women developed metastases. That's right: one quarter of those treated with estriol saw their cancers spread to other locations. Not exactly an argument for spiking the water supply. Lemon, by the way, did not consider his experiment positive, but he did think that estriol deserved more research. To his credit, Lemon never made specific disease prevention claims. Not so for his dim followers, who can't have actually read Lemon's work.

No risk-free hormone has ever been identified, and just because humans make a hormone doesn't mean it's good for us. In fact, studies consistently show that women who have naturally occurring higher levels of estradiol and estrone in their bodies develop breast cancer more often than women with lower levels of estrogens. Breast tissue from women with breast cancer contains higher levels of estriol, estrone and estradiol than tissue from women without breast cancer. And in breast cancer cell lines, estriol stimulates breast cancer cell growth more than other estrogens.

Claims that human estrogens will protect against cardiovascular effects are also wrong. In a randomized, placebo-controlled trial in 664 postmenopausal women after a recent stroke or transient ischemic attack ("mini-stroke"), estradiol did not protect against stroke, cardiovascular events or death. In ESPRIT (the Estrogen in the Prevention of Reinfarction Trial), 1,017 postmenopausal women with a previous heart attack were given estradiol or placebo for two years. There was no difference between groups in frequency of heart attack or death. All of these effects are consistent with what is known about commercially marketed pharmaceutical hormones.

No safety or efficacy studies have been published on bi-estrogen or triestrogen preparations, but there is no reason to believe that combining harmful hormones will be safer. Estradiol, estrone, estriol and non-human estrogens are effective treatments for hot flashes and vaginal dryness, but don't believe any health promotion claims. Trust me: your hormones are balanced just fine.

Adriane Fugh-Berman, MD, is a former NWHN Board Chair whose research presents a critical analysis of the marketing of prescription drugs. Adriane educates prescribers on pharmaceutical marketing practices as Director of the PharmedOUT program, and created the Health in the Public Interest program at Georgetown University School of Medicine where she trains a new generation of consumer advocates.

Read more from Adriane Fugh-Berman.

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