Fallout from the women's health study: a short-lived vindication for feminists and the resurrection of hormone therapies.(ORIGINAL ARTICLE)

In 1993, the National Institutes of Health (NIH), under great pressure from professional, feminist, and women's groups, funded the largest ever scientific study on women's health. The Women's Health Initiative (WHI) (2004) was a randomized clinical trial to evaluate the effects of commonly prescribed hormone therapy on the incidence of heart disease (Women's Health Initiative Study Group, 1998). Arm 1 evaluated the effects of daily use of 0.625 mg. of conjugated equine estrogen (CEE) plus 2.5mg. of medroxyprogesterone acetetate (MPA), and is known as the Combination Hormone Therapy Study. Only women with intact uteri (those who had not had a hysterectomy) were enrolled in Arm 1. Between 1993 and 1998, 16,608 women were recruited by 40 clinical centers in the U.S. One-half of the participants were randomly assigned to take CEE plus MPA; whereas the other one-half took a placebo. Arm 1 was targeted to end in 2005, but it was unexpectedly halted in 2002 when investigators found that over the long-term, or more than 4 years, CEE plus MPA, when compared to placebo, increased a woman's risk of developing invasive breast cancer by 26%, of heart attack by 29%, of stroke by 41%, and of venous thromboembolism (blood clots in the lung) by 111% (Rossouw et al., 2002). In the fall of 2003, the full report on the estrogen plus progestin and the risk of coronary heart disease was published (Manson et al., 2003).

Arm 2 of the study, known as the Estrogen Hormone-only Study, was also designed to evaluate the effect of 0.625 mg. of CEE on heart disease. Arm 2 consisted of 10,739 women who met the inclusion criterion of not having a uterus. The rationale for the inclusion criterion is the estrogen-cancer of the uterus connection that has been known for decades (Smith, Prentice, Thompson, & Herrmann, 1975; Ziel & Finkle, 1975). Specifically, a woman who does not have a uterus can take unopposed estrogen safely because one cannot develop cancer of the uterus if the uterus has been removed. One-half of the women enrolled in Arm 2 of the study received CEE; the other one-half received a placebo. The estrogen arm of the study was terminated in 2004, 1 year early, when a press release from the National Heart, Lung and Blood Institute Communications Office reported that investigators concluded that estrogen did not appear to affect, that is, did not increase or decrease, a woman's risk of developing heart disease. A major negative finding of the study was an increase in the risk of stroke, which is similar to Arm 1 study findings in the group of women who took CEE plus MPA. However, unlike the findings in Arm 1 study, no increase in, and, in fact, a small decrease in breast cancer was found albeit statistically insignificant, in the estrogen only group.

The WHI findings have had a seismic effect on menopausal women's health care in the US and the rest of the Westernized world. Even so, Utian (2004), an internationally known medical practitioner and Executive Director of the North American Menopause Society (NAMS), cautioned that results of both arms of the WHI Study must be considered as 'preliminary findings,' which may change as the complete reports become available. Nevertheless, the findings from the estrogen arm have prompted Utian to comment that estrogen therapy may be relatively safe for symptomatic relief, especially for younger women who have hysterectomy and/or bilateral oophorectomy.

The theoretical underpinning of the WHI, albeit implicit rather than explicit, is embedded in a biomedical, reductionistic, path ophysiological model that defines menopause as a state of estrogen deficiency that can lead to disease. For now, at least, the long-standing, intense dogma-driven assumptions that guided the WHI, i.e., that menopause is either a disease or causes disease in women--has subsided. What has not subsided, however, is the belief (Utian, 2003, 2004) that hormone therapy is a valuable and powerful agent to treat symptoms. As such, a campaign has been launched to resurrect estrogen/hormone replacement.

Vindication for women's health advocates

Publication of the WHI study results in 2002 was exhilarating news for feminist women's health advocates, who had long opposed the use of hormones to treat a natural transition in a woman's life. The feeling of finally being vindicated for one's anti-hormone viewpoint was widespread. Conferees at the 2003 Society for Menstrual Cycle Research Conference held in Pittsburgh expressed relief and a sense of vindication. The personal feeling of vindication, however, was short-lived and self-serving. In other words, there is no vindication for the women who had had their menopause mismanaged by clinicians who had over-prescribed hormones, or by surgeons who had performed unnecessary hysterectomy, or by naturopaths who had prescribed herbs and/or botanicals when in fact medical management was necessary. Nor is there vindication in knowing that quickly following the report on the study results, hormone proponents began to strategize about how to reinstate and validate hormone therapy as the best way to treat symptomatic women. As such, it is useful at this point to review from a feminist perspective why the WHI Study was designed and funded.

A brief history of the medicalization of menopause

The disease model of menopause has driven medical practice for almost 40 years. The disease model is diametrically opposed to the normative view espoused by Northrup (2001) and Voda (1996, 1997) who view the menopausal transition as a time of personal growth and productivity, not disease. According to Northrup, the old stereotype of the postmenopausal woman as a 'withered crone' has faded. The twenty-first century image of an older woman is one with abundant energy, focus, and sexuality, all of which have a physiological basis. Northrup has referred to perimenopausal changes as seismic in nature, some not experienced since menarche and adolescence. The changes are sometimes bewildering, frustrating, and anxiety producing, but are normal and related to the hormonal fluctuations that herald the opening of menstrual life. Women are advised to think in a similar way about the changes associated with the perimenopause; the changes are also hormone-related upheavals that signal that menstrual life is coming to an end. The hormone upheavals are sending a message that it is time to 'clean out the closet of the first 50 years of life,' in other words let go of what had been stressful or anxiety producing during menstrual and/or reproductive life. A new phase of life has begun full of challenges, rewards, and freedoms previously unknown.

Voda (1997), drawing upon the voices of the hundreds of women enrolled in the TREMIN Research Program (formerly the Treloar Menstruation and Reproductive History Program), described the changes at perimenopause as a redirection of life energy. She, too, advised women to clean out the menstrual/reproductive closet, close the menstrual door for good, and not open it again. Over the past 4 decades, many women chose to reopen the door to the menstrual closet when they decided to be hormone users, unaware that the closure process is normal and that the changes that are experienced are signals that the end of cycles is near. Treloar, a pioneer in menstrual cycle research, referred to the menstrual cycle as a "life within a life," and menopause as the normal closure of menstrual life (Voda, 1997). Others, Wilson (1966) for example, described menopausal women as diseased, as physiological castrates, and proclaimed that the ovaries were dead. During the closure process a woman's ovaries do change. The cyclic production of the ovarian hormones, estrogen and progesterone, becomes episodic; hormone levels decrease dramatically; and women experience such changes as hot flashes, night sweats, mood swings and insomnia. The onset of changes does not mean that women are sick or that the ovaries are dead. Rather, it means that the body's cells are undergoing a normal physiological response to "hormone withdrawal." For some women, the time spent in perimenopause coping with changes can range from 5 to 10 years. Women who use hormones to treat the symptoms of hormone withdrawal do obtain relief, but they also alter the closure process. Hormonal manipulation of the perimenopause means that when a woman stops hormone use, whether due to the onset of a disease or the recent news about the risks associated with hormones, the symptoms associated with menopause will again be experienced. A long time hormone user will be older than the mean age at which most women experience menopause (about 51), and, theoretically, she will possess less energy to cope with the cellular stress of hormone withdrawal.

Once the menstrual door is…