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Women’s Health Debate

Susan Dentzer reports on the controversy over hormone replacement therapy for women.

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  • LAUREN HUTTON:

    My hot flashes and night sweats, gone. I feel great. See your doctor, and say yes to HRT .

  • SUSAN DENTZER:

    Tens of millions of women bothered by symptoms of menopause have also said yes to HRT, Hormone Replacement Therapy. But many were shocked last July when a major federal study reported sharply higher risks of breast cancer, heart attacks, and stroke from one key hormone drug. The results caused consternation among millions of women like Judith Braslow.

  • JUDITH BRASLOW:

    I thought, "I've got to get off. Why would I take this?" I'm 57 years old.

  • SUSAN DENTZER:

    Hormone drugs were long ago proven effective at relieving menopausal symptoms like hot flashes. To this day, no other drugs or supplements have been shown to produce those results. But other beliefs about the drugs eventually overtook the science, and the drugs became used for other reasons, such as prevention of heart disease. This is a story about how many of those beliefs arose, and how many have now been debunked. The hormone therapy tale begins during the early 1940s. Estrogen drugs like Premarin were introduced, and women began using them as a treatment for symptoms of menopause. That's when a woman's ovaries cease to function and she has her last menstrual period, normally between her late-40s to mid-50s. The body's natural levels of estrogen drop, leading to symptoms like hot flashes– a sudden feeling of heat spreading over the body. Premarin wasn't actually human estrogen that replaced the hormone in menopausal women; it was a so-called "conjugated estrogen," a drug made from the urine of pregnant horses. But it and similar hormone drugs did provide relief for many women. Dr. Isaac Schiff heads a task force on the drug study for the American College of Obstetricians & Gynecologists.

  • DR. ISAAC SCHIFF:

    So we began to use estrogens initially for relief of hot flashes, and then added to the indications included the relief of vaginal dryness so that it would help with sexuality.

  • SUSAN DENTZER:

    But even in those early days, an aura was growing up around hormone drugs that linked them to youth, beauty, and sexuality. A popular book appeared called "Feminine Forever." It was written by a physician, Robert Wilson, who was also a paid consultant to Premarin's manufacturer. Cynthia Pearson heads a watchdog group on women's health.

  • CYNTHIA PEARSON, National Women’s Health Network:

    So he painted this dreadful picture of older women, and held out estrogen as the cure… the prevention and the cure; that any older woman could make herself younger, more active, more vital, and actually healthier if she would start taking hormones after menopause.

  • SUSAN DENTZER:

    So persistent was the mythology that as recently as 2000, supermodel Lauren Hutton, on retainer to Premarin's manufacturer, told "Parade" Magazine that her number one beauty product was her estrogen. Marketing aside, a growing body of medical studies did suggest that hormone therapy could help women in other ways.

  • DOCTOR:

    And straight.

  • SUSAN DENTZER:

    First came convincing evidence that the drugs helped prevent the fractures and bone loss caused by osteoporosis. The Food and Drug Administration eventually approved the drugs for that indication. Dr. Schiff says that was only the beginning.

  • DR. ISAAC SCHIFF:

    In the 1980s, a whole series of studies appeared which suggested that estrogens prevent heart disease, and then we started to add prevention of Alzheimer's Disease, prevention of colon cancer. And so by the mid-'90s, it was thought that if you didn't prescribe estrogens to your patient as a physician, you were almost committing malpractice.

  • SUSAN DENTZER:

    So, many doctors treating women did prescribe hormone drugs for these purposes, even though, other than for preventing osteoporosis, there was no proof. Pearson says ads in medical journals emphasized the unproven benefits anyway.

  • CYNTHIA PEARSON:

    So this ad opened with, "If your patients are asking you questions about menopause and estrogen, consider the body of evidence." And the arrows pointed to the uterus, the breast, the brain, the skin, the bone, the teeth; and in each part of the body, there was an accompanying text that described what the connection between estrogen and healthy brains, healthy bones, healthy breasts, healthy skin. And yet the FDA had only approved an actual claim of benefit for two of those eight body parts.

  • SUSAN DENTZER:

    In 1990, drug manufacturers asked the FDA for formal approval to market the drugs for prevention of heart disease. They pointed to as many as 30 medical studies in which women taking hormones seemed to have far less heart disease than women who didn't. Some of these were well-known studies, like the famed Nurses' Health Study and the Framingham Heart Study, that carried enormous weight with physicians. But there was one big problem with these so-called "observational" studies that eventually even the drug companies acknowledged. Dr. Victoria Kusiak is Vice President of Global Medical Affairs for Premarin's manufacturer, Wyeth.

  • DR. VICTORIA KUSIAK, Wyeth Pharmaceuticals:

    In most of the observational trials, it looked at highly educated women, nurses, et cetera. These were women who were more concerned about their health, more likely to be going… undergoing regimens such as repeated visits with their physicians. They were leading a more healthy lifestyle in terms of exercise or diet, and that might have influenced the study results.

  • SUSAN DENTZER:

    In other words, the healthiest and most active women may have been the ones taking hormones, rather than hormones making women healthy. Dr. Janet Woodcock, a top FDA official, says the agency decided to hold off.

    DR. JANET WOODCOCK, Food & Drug Administration: FDA never approved any estrogen for the prevention of cardiovascular disease, even though it was widely accepted in the community that estrogens might have this effect.

  • SUSAN DENTZER:

    To get at the truth, government officials like Woodcock needed an entirely different sort of study that could sort out cause and effect: A so-called randomized placebo- controlled trial. That's one in which large groups of women are randomly assigned by computer to receive either a drug being tested or a dummy pill. Experts had argued for just such a study for years, but it didn't come about until 1990, when planning began for the so-called Women' Health Initiative, or WHI. Dr. Jacques Roussow is acting director of the WHI, a massive 15-year-long, $725 million series of studies looking at disease prevention in women.

  • DR. JACQUES ROUSSOW, Women’s Health Initiative:

    There was a growing interest in remedying what was seen as a deficit in research impacting women's health compared to research on men's health, particularly in the area of heart disease. So there was a lot of support of WHI there, from Congress and from women's health advocacy groups.

  • SUSAN DENTZER:

    The effects of two of the most popular hormone drugs, Premarin and Prempro, were examined in two separate arms of the WHI study. Unlike Premarin, the estrogen- only drug, Prempro combines both estrogen and progestin, a synthetic form of another female hormone, progesterone. Wyeth, which makes both drugs, agreed to donate the medications for the study since it was eager to prove the drugs did deter heart disease. The hormone drug studies began in 1993. Wyeth's Dr. Kusiak notes that the early results did not look good.

  • DR. VICTORIA KUSIAK:

    About one year in to the WHI study, it was seen that there was in increase in coronary heart disease events where they had potentially expected to see a decrease.

  • SUSAN DENTZER:

    By this spring, experts poring over the study results had compiled a complicated checklist of the drugs' benefits and risks. On the plus side, the drug did have some effect in reducing bone fractures from osteoporosis and in cutting the risk of colon cancer. But these benefits were small. Then came the minuses of taking Prempro: More breast cancer, heart attacks, blood clots, and strokes. The study results showed that for every 10,000 women on placebo, about 30 a year would get breast cancer. For every 10,000 women a year taking the Prempro, 38 would. That represented a 26 percent increase in breast cancer. Similarly, in the placebo group, 30 would have heart attacks. In the Prempro group, 37 would. Clearly, the absolute number of these conditions was small, and therefore the increased risks to any individual woman would be tiny. But spread across the huge population of women taking Prempro– about five million nationwide– tens of thousands of additional cases of disease could result. NIH officials decided to end the Prempro trial, and sent the 16,600 women participating in the study this letter spelling out why. Judith Braslow, age 57, wasn't part of the study, but after she read about the results, she quit taking the estrogen and progestin drugs she'd been on for 17 years.

  • JUDITH BRASLOW:

    It was the heart disease and the breast cancer, because my mother had had both of those things, and it just seemed to me that the flip side of, you know, having a few hot flashes, maybe a little less libido, it just wasn't worth the risks associated with it.

  • SUSAN DENTZER:

    As millions of other women have followed suit, Wyeth officials say sales of Prempro have dropped 40 percent in the last three months. But what about women who are still plagued by menopausal symptoms? Schiff's task force says doctors can still prescribe the drugs for short periods of time.

  • DR. ISAAC SCHIFF:

    Use the lowest dose that's effective. Although we don't have great data to say low dose is safer than high dose, intuitively it makes sense. Treat the patient, and when the patient has perfect relief, at some point, you want to stop.

  • SUSAN DENTZER:

    Meanwhile, Wyeth is revising the information it gives doctors and patients about the drugs. Pending FDA approval, it plans to say Prempro should not be used for prevention or treatment of heart disease, and that patients taking the drug to prevent osteoporosis should consider other medications approved for that purpose. In the meantime, the separate Premarin, or estrogen-only arm of the WHI study, is continuing. For now, whether Premarin produces fewer harmful side effects in patients may not be known until final results are ready in 2005. The FDA's Woodcock says women may be sorting through the conclusions of this entire episode for some time.

  • DR. JANET WOODCOCK:

    People feel somewhat betrayed, some of the women, because there was a general recommendation to just keep taking these drugs.

  • SUSAN DENTZER:

    The FDA and National Institutes of Health plan to hold public forums this month and next to help patients, doctors, and regulators digest the study results.

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