Good science or good marketing? - Editorial - hormone therapy

Alternative Medicine Review, August, 2002 by Kathi Head

Has medical practice gotten ahead of medical science? It often seems so. The latest example involves the publication of a major study on hormone replacement therapy (HRT) and its risks in the July 17, 2002 issue of the Journal of the American Medical Association (JAMA). The Women's Health Initiative study examined the effects of Prempro versus placebo on 16,608 women between the ages of 50 and 79. It was halted three years early because the potential risks to the participants began to surpass the anticipated benefits. It is estimated that as many as 6 million American women take this combination hormone replacement--Prempro, produced by Wyeth Ayerst, being the most common HRT drug used in the United States. It is a combination of equine conjugated estrogen (0.625 mg; aka Premarin) and medroxyprogesterone acetate (2.5 mg; aka Provera). During the clinical trial (the average time women were enrolled was 5.2 years), it was determined that Prempro compared to placebo resulted in a 29-percent increased risk for coronary heart disease, 41-percent increased risk for stroke, 26-percent increased risk for invasive breast cancer (there was no increased risk for breast cancer in situ), and double the risk for blood clots (deep vein thrombosis, thromboembolism, and pulmonary embolism). On the positive side, colorectal cancer risk was decreased by 37 percent and total fracture rate by 24 percent. Another study, published in the same issue of JAMA, reported on an increased risk for ovarian cancer in women who used estrogen replacement for more than 10 years.

Although observational studies had noted such things as decreases of blood lipids, colon cancer, and bone fractures with hormone replacement, this study of HRT was the first large-scale, placebo-controlled trial to be conducted on healthy women, despite the fact that Prempro or Premarin (just the estrogen) have been among the most widely prescribed drugs for women (Premarin since 1966; in 1975 when it was determined that estrogen alone increased the risk for uterine cancer, progestin was added to the regimen for women who still had their uterus). A chorus of network newscasters said that the study's results had turned the medical profession on its ear. In an article published in The New York Times on July 10th (the day the results were announced), Dr. Wulf Utian, executive director of the North American Menopause Society, commented, "This is the biggest bombshell that ever hit in my 30-something years in the menopause area."

But really, why was the news such a shock? The medical community has known for years that the combination of estrogen and progestin increases the risk of breast cancer, and that estrogen also increases the risk of blood clots, endometrial cancer, and liver and gall bladder disease. As a naturopathic physician, approximately one-third of my practice over the course of 11 years was helping women find alternatives to conventional hormone replacement therapy. And I'm not alone. For years, health-conscious practitioners have been offering alternatives to Premarin and Provera in the form of things like soy isoflavones, phytoestrogenic herbs, and bio-identical hormones (estrogen and progesterone synthesized from soy or wild yam that are exactly like the hormones produced in the body and prescribed in a cyclic manner, rather than every day). While more research on these alternatives remains to be conducted, it is unlikely they will be found to be associated with the same risks as the drugs, since phytoestrogenic herbs, despite the fact that they can relieve hot flashes and other symptoms of menopause, are only about 1/400th the potency of Premarin.

In recent years, women have become the targets--and, it now appears, the victims--of the clever marketing strategies by drug companies that have made menopause a disease rather than a normal part of life. The companies have promised women that hormone replacement will help to keep them "feminine forever." In fact, a best-selling book by that title (Feminine Forever) was written in 1966 by Robert Wilson, MD. It included a large promotional campaign to hype the book and the concept that taking estrogen would keep women young, attractive, and healthy. Although Dr. Wilson died in 1981, his son, in an interview with The New York Times, disclosed that the drug company, Wyeth Ayerst, had not only paid for the writing of the book but had also funded his father's trips around the country to lecture on the wonders of estrogen. The recent JAMA study is simply the latest example of conventional medicine finally coming to the same conclusions, after a tedious, double-blind study, that many health practitioners have already observed, based on their considerable clinical evidence. This latest research hopefully will make it easier for women to make better, more informed decisions about menopausal interventions and for open-minded physicians to guide their female patients toward more responsible approaches, including using diet, exercise, nutrients, botanicals, and safer hormonal interventions to prevent hot flashes and other acute symptoms of menopause and to provide long-term prevention of heart disease and osteoporosis.