The Business of Menopause

If triple estrogen is so much better than Premarin, why have so few people heard about it? The answer to this question can be summed up in one word: patentability. Premarin is patentable, and hence, can be sold exclusively only by its manufacturer and licensees, whereas triple estrogen is a natural product, like vitamin C, and can be sold by anyone. Patentability has made Premarin a huge moneymaker for its manufacturer, Wyeth-Ayerst Pharmaceuticals. For nearly 30 years, it has been at or near the top of the drug bestseller list. In just the first half of 1997, pharmacists filled 22.1 million prescriptions for Premarin, amounting to revenues of $388.2 million in the United States alone. Add in the rest of the world's women, and you get a sense of the high stakes involved in the business of menopause.

These enormous financial resources have provided Wyeth-Ayerst the muscle to practically corner the estrogen market. Through advertising, sponsorship of clinical trials, and conferences, free samples, and other common marketing techniques, they have created an atmosphere in which physicians virtually equate estrogen replacement with Premarin.

Most physicians, who have little enough time to keep up with the world of double-blind, placebo-controlled drug trials reported in medical journals — which are supported largely by pharmaceutical advertising — are completely in the dark about the use of Triple estrogen and other natural hormones. Their use is not taught in medical schools, nor is it promoted by any large pharmaceutical companies. With no money available to pay the enormous costs, the large, definitive studies that might demonstrate the efficacy and safety of these natural hormone regimens will likely never be done.

What Makes a Hormone Natural?

The word "natural" gets thrown around a lot in discussions of hormone replacement therapy. Premarin, for example, is widely considered to be a "natural" hormone. So is the estradiol in the estrogen "patch" and "cream" products. Triple estrogen is also considered to be a "natural" estrogen product. Are they all natural? Does it really matter? The answers depend on how you define "natural."

Triple estrogen consists of three separate estrogens — estriol, estrone, and estradiol — all of which are derived from a plant, the wild yam (Diascorea composita). How can a hormone that got its start in a vegetable be considered "natural" in the human body? The wild yam is rich in "precursor" molecules that can be easily converted by biochemists into estrogens and other steroid hormones. The molecular structure of these hormones is indistinguishable from that of the "natural" hormones produced in the human body, and as a result, they function exactly like those the body produces, especially when used in their natural proportions. Thus, the crucial variable defining "natural" is not the origin of the hormone or how it is produced, but whether its chemical structure matches that of the hormone it is intended to replace.

Premarin is Natural for Horses But Not for Humans

Premarin is widely considered by physicians to be a "natural" hormone product, because it is derived from horse urine and is not synthesized in a laboratory. But is it really natural? Certainly, it's natural in horses. But when placed in the human body, the hormones in Premarin are as foreign as any synthetic drug, because the body lacks the enzymes and cofactors to metabolize them safely.

What about estrogen "patch" and "cream" products?

These are composed of 100% estradiol, the most potent — and most carcinogenic — of the estrogens. The estradiol is derived from the same source as the estradiol in Triple estrogen, the wild yam, so in that sense, these products can be considered "natural." However, because they are 100% estradiol, with no estrone, and most importantly, no estriol, these products must be considered unnatural once inside the human body. The human physiology is designed to work with three forms of estrogen — estriol, estrone, and estradiol — in a ratio of about 90:7:3. Exposing the body to 100% estradiol creates an unbalanced, and therefore, unnatural and potentially dangerous situation.

Natural Progesterone Protects Against Cancer, Heart Disease, and Osteoporosis

Women who replace estrogen also need to replace progesterone. This may seem obvious to anyone who has studied human reproductive physiology, because estrogen and progesterone are closely linked in the normal menstrual cycle. Each month, as estrogen levels rise, progesterone levels fall, and vice versa. Unfortunately, it wasn't always so obvious to physicians and pharmaceutical companies. In the early days of ERT, tens of thousands of women developed endometrial cancer as a result of taking Premarin in the absence of progesterone. In the absence of progesterone, the estrogens in Premarin can cause excessive proliferation of endometrial tissue, which, in an alarming number of instances, can turn malignant. Progesterone largely prevents this excessive growth.

But conventional medicine being what it is, most physicians do not prescribe natural progesterone for their menopausal patients. Instead, they prescribe a synthetic progesterone-like drug, or "progestin," called Provera® (medroxyprogesterone), or one of its clones. Synthetic progestins are not the same thing as progesterone. Thanks to the pharmaceutical industry's superior promotional abilities, few physicians ever make that distinction.

Women who take Provera pay a high price for the protection it affords against Premarin-induced endometrial cancer. That price includes an increased risk of cardiovascular disease (CVD), because progestins strip away most of the protection against CVD that they gain from estrogen replacement. Since this protection is one of the main reasons they take Premarin in the first place, and since Provera causes a long list of unpleasant side effects, including breast tenderness, weight gain, depression, and breakthrough bleeding, to name just a few, you have to wonder whether they wouldn't be better off not taking anything.

Natural progesterone — which comes from the same source as the natural estrogens in triple estrogen — is a completely different story. Because it is structurally and functionally identical to the progesterone the body produces, replacing missing progesterone with natural progesterone puts back the same hormone the body is accustomed to. As a result, when used properly, natural progesterone affords the same protection against endometrial cancer as synthetic progestins, but does not interfere with estrogen's ability to protect against CVD. This was most clearly demonstrated in a large federal government-sponsored clinical trial known as PEPI (Postmenopausal Estrogen/Progestin Interventions).¹²

In the PEPI trial, 875 postmenopausal women were randomly placed in one of four treatment groups: 1) Placebo, 2) Estrogen (ie, Premarin) only, 3) Premarin + Provera, or 4) Premarin + natural progesterone (oral). The relevant measure was the level of HDL-cholesterol, which is known as the "good" cholesterol, since it protects against CVD. The results (Fig. 3) clearly demonstrated that when Provera was added to Premarin, HDL levels dropped nearly to baseline. By contrast, when natural progesterone was added to Premarin, there was no significant loss of HDL-based CVD protection.

If this weren't enough to recommend natural progesterone, there's also the protection it provides against osteoporosis. This ability has been most clearly shown by the work of John R. Lee, MD.¹³¹⁴ Osteoporosis is the bone-thinning disease that commonly occurs following menopause. It appears to be due to a loss of both estrogen and progesterone. Replacing estrogen will usually help slow or even halt the thinning process, but it does nothing to restore bone that has already been lost.

Dr. Lee took regular bone mineral density measurements of 62 postmenopausal women who were taking either Premarin + progesterone (in a cream base) or progesterone alone for a period of at least 3 years. The women also took calcium supplements and maintained a diet and lifestyle designed to minimize bone loss. He found that natural progesterone replacement resulted in a remarkable increase in bone mineral density. Some of Dr. Lee's patients increased the density of their lumbar vertebrae by 20 to 25% in the first year! Over the 3 years of the study, the mean increase in bone mineral density was 15.4%. According to other studies, including PEPI, a 4 to 5% decrease in bone density would have been expected in women not using natural progesterone. Not surprisingly, Provera appears to provide no protection against osteoporosis and definitely does not enhance bone growth (Fig. 4).

Natural progesterone creams are widely available over-the-counter, usually at health food stores as well as mail order sources. 

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References

Articles of Interest from Smart Publications Health & Wellness Update

• Natural Progesterone … Bringing Your Life (and Hormones) Into Balance
• Soy Isoflavones are Safe and Effective for Preventing Breast Cancer
• Natural Ways to Balance Your Hormones