Hunted a dark romance, p.6
Hot Flash, page 6
Nevertheless, prescriptions for MHT rebounded over the following decade and a half, around the time that Donna Kendall and Connie Barton, whose stories introduce this chapter, began taking MHT. Like millions of women, Kendall and Barton sought effective hormone treatments for menopausal symptoms like hot flashes.75 Around this time, as more researchers studied MHT, they began to uncover its further potential benefits beyond the treatment of the symptoms of menopause.76 Scientific studies suggested, for example, that hormone treatment played a positive role in preventing hip fractures and coronary heart disease.77 As a result, in 1984, the FDA’s advisory committee on fertility and maternal health drugs voted to recommend estrogen to prevent the development of, and to treat, osteoporosis.78 The FDA did not, however, recommend MHT for reducing the risk of heart disease; indeed, the research on this issue has consistently been mixed, as discussed below.79
Drug manufacturers were quick to critique any negative studies and capitalize on any positive ones to spread the message that MHT was effective as more than just a treatment for menopausal symptoms. They actively claimed that it had broad benefits for women’s postmenopausal health.80 For example, Wyeth developed extensive campaigns to market Premarin in the 1980s and 1990s, even hiring ghostwriters to prepare materials that touted the benefits of MHT while minimizing its risks.81 Its “educational” campaigns claimed that using Premarin could reduce the risks of osteoporosis and heart disease without increasing those of stroke or cancer.82 By 1992, Premarin was the most frequently prescribed drug in the United States.83 Estrogen replacement therapy, as a prescription to prevent heart disease, is an example of what two scholars have called “technology adoption catalyzed by industry promotional efforts, absent good scientific evidence.”84 Another glaring absence was, of course, significant government oversight regarding drug companies’ activities in this area.
Wyeth’s commitment to marketing its drugs was so strong that it even began using celebrities in its campaigns to drum up interest in MHT among physicians and members of the public.85 For example, Patti Labelle “was an official Prempro spokesperson, promoting the drug in television advertisements in which she sang of her ‘new attitude.’”86 The company also actively courted women who were hesitant to use MHT, and particularly sought to increase the rate of uptake among Black women, a population that had lower rates of utilization of MHT than members of other racial groups.87 It is difficult to know whether this aggressive marketing played any role in the FDA’s 1995 approval of the Wyeth drug Prempro, a pill that combined estrogen with progestin (synthetic progesterone).88 But by the late 1990s, a survey of gynecologists, family physicians, and internists found strongly favorable attitudes toward the use of long-term hormonal therapy for aging women.89 By 2002, doctors were writing 90 million MHT prescriptions a year.90
CONTINUED CONCERNS
The scientific evidence for this widespread use of MHT, however, remained mixed. In 1998, the findings of a large-scale randomized, placebo-controlled and double-blind study known as the Heart and Estrogen/progestin Replacement Study (HERS) were released.91 The HERS study, coordinated by researchers at the University of California, San Francisco, and funded by Wyeth, showed that not only did MHT fail to protect against heart disease, but women who had received the experimental drug had almost three times the risk of a blood clot as the placebo group.92
By the time the HERS study’s results were released, the National Heart, Lung, and Blood Institute had already initiated a long-term national study of postmenopausal women that focused on strategies to prevent various diseases, ranging from breast cancer to heart disease. The launch of this study, known as the Women’s Health Initiative (WHI),93 was announced by Bernadine Healy, the first woman to head the National Institutes of Health, at a congressional hearing in 1991.94 Investigators recruited more than 161,000 women for the WHI study, with 68,000 in the clinical trial and more than 93,000 in the control group.95 The study also sought to include people from different racial and ethnic groups, and, although it enrolled women between the ages of 50 and 79, the mean age was 63.96 Its clinical trial placed women into three groups. One group, which included women with a uterus, took a combination of estrogen and progestin; the second group, which included women without a uterus, took estrogen alone; and the third group received a placebo.97
The WHI study, which began recruiting participants in 1993, was supposed to be a fifteen-year clinical trial.98 However, the arm of the study in which women received an estrogen/progesterone combination was stopped prematurely in 2002, due to concerning evidence that the risks to the women participating in the study exceeded the benefits.99 Those taking the popular combination of estrogen and progestin for menopausal symptoms, the WHI study found, “had an increased risk for breast cancer, heart disease, stroke, blood clots, and urinary incontinence.”100 (The portion of the study involving women taking solely estrogen also ended prematurely, in 2004, because of concerns about an increased risk of stroke.101)
Reaction to the WHI study’s early conclusions about the combined therapy was swift and negative for MHT.102 It “blew apart the widely-held belief that hormone replacement therapy protected women from heart disease and other chronic ills.”103 For the executive director of the North American Menopause Society, Dr. Wulf Utian, the 2002 announcement was “the biggest bombshell that ever hit in my 30-something years in the menopause area.”104 A clinical professor of obstetrics and gynecology at Yale, Dr. Mary Jane Minkin, similarly describes the moment when she learned about the study as one of the most memorable of her life; indeed, she groups it with remembering where she was when she learned that John F. Kennedy had been shot and when she heard about the terrorist attacks of 9/11.105
The news that the study had been halted—and the reasons for its sudden cessation—caused the number of women who used MHT for relief of menopausal symptoms to drop quickly by almost 50 percent.106 An editorial in the Cleveland Clinic’s Journal of Medicine, issued shortly after the study’s halt, proclaimed that the “ground rules” for prescribing MHT had changed, while also noting that some types of hormone therapy might still be useful for managing symptoms of menopause.107 And an American College of Obstetricians and Gynecologists task force, chaired by Harvard’s Isaac Schiff, carefully summarized the risks and benefits.108 That was in accord with the WHI study itself, which was not intended to evaluate MHT’s usefulness in managing symptoms of menopause, but rather to investigate the role of hormonal therapies in reducing fractures, breast and colorectal cancer, and heart disease.109 The FDA issued new indications for prescribing hormone therapy and other warnings, emphasizing that hormonal therapy had not been approved for the prevention of heart disease.110
No doubt spurred by the halting of the WHI study, approximately 10,000 lawsuits—including those of Connie Barton and Donna Kendall—were filed in the United States and in Canada against the drug manufacturers of MHT.111 These lawsuits asserted claims of negligence, strict liability, breach of warranty, fraud, and more; there were also some specific claims under states’ consumer protection laws.112 For the most part, as was true for Kendall and Barton, the cases focused on MHT’s possible connection to breast cancer, although there were other claims as well.113 By mid-2012, the pharmaceutical company Pfizer had settled (or was in the process of settling) 60 percent of the lawsuits (or approximately 6,000 of them). Pfizer had already been found responsible for $896 million, and it had earmarked $330 million for future settlement costs.114
CONTEMPORARY PERSPECTIVES ON MHT
Subsequent scientific analysis of the WHI data indicates that the early publicity in connection with the study’s sudden halting overstated the risks of MHT, particularly for women in their 50s. As noted earlier, the WHI enrolled postmenopausal women, with an average study participant age of 63. Its goal was not to focus on how to relieve menopausal symptoms, but on the effect of MHT on heart disease, bone fractures, and cancer.115 Dr. Jennifer Gunter, the gynecologist author of The Menopause Manifesto, has counseled: “The WHI data shouldn’t have been extrapolated to all women.” She explains, for instance, that “[c]ardiovascular disease increases significantly with age, so two-thirds of the women in the WHI who were 60 years or older were already at higher risk for estrogen-related heart complications. The risk of estrogen on the heart may not be the same for women who start MHT at a younger age.”116
This failure to segment the risk, and the resulting “one-size-fits-all” message, unfortunately overshadowed the benefits that MHT can have in treating menopausal symptoms. Subsequent clinical trials have shown that MHT is of relatively low risk for younger, recently menopausal women, but that clinicians are reluctant to prescribe it.117 That is still true, even though, as one of the WHI researchers wrote in 2023, MHT “is the most efficacious treatment for reducing menopausal vasomotor symptoms,” such as hot flashes and night sweats.118 For vaginal dryness, low-dose estrogen in the form of vaginal inserts or rings is also effective and safe when prescribed correctly, the authors noted. This vaginal estrogen can also be used to treat urinary symptoms; systemic estrogen, which contains higher levels of estrogen, can be used for hot flashes and other symptoms. Both require a prescription in the United States, although vaginal estrogen is considered safe enough in the United Kingdom to be available without one.119
In a 27-page position statement on hormonal therapy, issued in 2022, the North American Menopause Society (which changed its name to The Menopause Society in 2023) notes the importance of analyzing the risks and benefits of each type of therapy for the various symptoms of menopause.120 The recommendations differ depending on whether women are under the age of 60 or within ten years of the onset of menopause. For such women, MHT can be particularly helpful in terms of reducing bone loss and vasomotor symptoms (hot flashes and night sweats).121 Moreover, MHT has other health benefits, including preventing osteoporosis and reducing the risk of onset of type 2 diabetes.122
Further, for those experiencing early menopause, MHT can also be a recommended treatment to help with the impact of lost hormones, including the risk of developing osteoporosis.123 Under a heading on its web page entitled “The Experts Do Agree About Hormone Therapy,” The Menopause Society states that “most” people who have recently experienced menopause and are healthy can use MHT, although it also notes the risks of MHT, particularly with long-term use. It concludes that “[h]ormone therapy is an acceptable option for the relatively young (up to age 59 or within 10 years of menopause) and healthy women who are bothered by moderate to severe menopausal symptoms,” concluding that “individualization is key in the decision.”124 In a widely read 2023 article for the New York Times Magazine, Susan Dominus reached a similar conclusion, contextualizing the risks of MHT as follows: “A woman’s risk of having breast cancer between the ages of 50 and 60 is around 2.33 percent. Increasing that risk by 26 percent [the estimated risk of MHT] would mean elevating it to 2.94 percent. (Smoking, by contrast, increases cancer risk by 2,600 percent.)”125
These conclusions echo a 2019 editorial in the Canadian Journal of Obstetrics and Gynecology, which observed that “the pendulum has swung back in favour of hormonal replacement therapy for most symptomatic newly menopausal women.”126 In fact, Gunter herself—who has been hailed as an important social champion for “normalizing menopause”—uses an estrogen patch for relief of her menopausal symptoms. As is true for half of women, she has found that it cures vaginal dryness and helps with other symptoms.127
Like Gunter, approximately 4 percent of women in the United States take some form of MHT each year.128 Compare that to the almost one-half of postmenopausal women who reported ever using some type of MHT, with 22 percent reporting “current” usage in a study from 1988 to 1994.129 Indeed, there is certainly an argument that MHT is currently under-prescribed—and, at the very least, it seems clear that there is insufficient information for people to make the type of individualized cost-benefit assessment that is called for here. There are several reasons for this. In addition to the widespread fear prompted by the early WHI results, many physicians may simply not have the knowledge—or the time—for the detailed discussions necessary to prescribe MHT.130
The abrupt halt of the WHI study in the early 2000s meant that, in the years that followed, there was scant discussion of MHT in medical education. Less than 15 percent of medical residents specializing in obstetrics and gynecology reported that they felt either very well prepared, or even adequately prepared, to manage a patient experiencing menopause, according to a study published in 2019.131 There also continues to be a lack of clarity about the appropriate length of time for taking MHT, given that “MHT allows women to bypass [ . . . ] extreme hormone fluctuations and step back in, as it were, after they have passed.”132 Research suggests that half of those who discontinue MHT may experience the reappearance of menopausal symptoms and that low and ongoing doses may help prevent osteoporosis, but that there remain risks of long-term use.133 The recommendation, again, is individualized determinations.
There is a societal expectation that neither one’s menopausal symptoms, nor the care one receives, should be discussed among friends or family, let alone in public. That silence and stigma have contributed to not only a lack of knowledge about menopause and its potential treatments, but also inadequate scientific funding for research into the safety and efficacy of various menopause treatments. That said, medical schools and hospitals are now recognizing and responding to the need for better menopause care. Among other initiatives, Harvard’s teaching hospital, Brigham and Women’s, opened its Menopause and Midlife Clinic, a department in the Fish Center for Women’s Health, in 2020. UCLA Health opened its Comprehensive Menopause Care program in 2023. And Johns Hopkins provides its residents with detailed menopause training.134 Congress has also been considering legislation to identify gaps in existing menopause studies and to promote further research.135
Because drug companies have a financial interest in defining menopause as a medical problem to be solved, the focus on profitable (patentable) forms of estrogen and progesterone therapies likely will continue. Yet, as this chapter has explained, there is a developing consensus on MHT’s safety, so long as MHT is prescribed within certain guardrails, including careful monitoring, starting with the lowest possible dose, using MHT for a limited duration, and paying close attention to the age at which treatment begins. It also important to recognize the growing menu of treatment options. For some, bioidentical, or plant-based, hormone treatments provide some relief from menopause symptoms, although they are under-studied. Other approaches, ranging from cognitive behavioral therapy to antidepressants, can also be helpful, and are especially critical for those for whom MHT may be contraindicated.136 Indeed, the antidepressant paroxetine has been approved since 2013 to treat VMS. New treatments are also appearing, ranging from alternative forms of estrogen to nonhormonal drugs, an example of which is fezolinetant (brand name Veozah), which works on brain cells to reduce the severity of hot flashes.137 Because it is nonhormonal, fezolinetant is also helpful for those in older age groups who face increased risk when starting hormonal therapy. When fezolinetant was approved in May 2023, it was hailed as “groundbreaking and long overdue.”138 But it was also very expensive, as is often true when new drugs first appear. With more attention on menopause, even more treatments are likely to emerge and to become more accessible.
Ultimately, while this chapter has focused on the history of treatment for menopausal symptoms—thus foregrounding the medical model of menopause—it is important to contextualize the preceding discussion with the broader themes of this book. Menopause is an inevitable part of the aging process for half of the population, and it is experienced differently by each person, in connection with a wide variety of factors. Some people experience no negative physical effects at all from menopause.139 Some may never need or want to consider any type of hormonal therapy. These varied experiences point toward the need for greater scientific research into menopause—which can benefit everyone—and the equally important imperative to emphasize individual agency, multiple perspectives, and self-determination.140
CHAPTER FOUR
MENOPAUSE AT WORK
On July 29, 2009, Georgia Sipple quit her job. It was not the outcome that she had wanted. She loved her work as a food product demonstrator in a retail store.1 But Sipple had begun to experience intense menopausal hot flashes that were exacerbated by her employer’s required dress code: a long-sleeve shirt, long pants, closed-toe shoes, an apron or lab coat, and a baseball cap. She sought an accommodation, submitting a doctor’s note that explained that she was experiencing “menopausal hot flashes.”2 The doctor put it plainly: “Please allow her to modify the dress code with short sleeves, knee high skirt or pants and a hairnet with or without a visor. . . . These changes would minimize her symptoms allowing her to keep working.” Her employer, however, said no. It concluded that menopause was not covered by the Americans with Disabilities Act, and that the dress code stemmed from health concerns, safety concerns, and the contract with the retail store to which Sipple was assigned.3 When the HR manager told Sipple that her request was being denied, Sipple responded in surprise: “I’m not resigning but I can’t do what you’re asking.”4 Nine days later, Sipple emailed her supervisor, saying that she perceived that she was being forced out: “I wore the full dress code uniform last Friday and Sunday, and I came home sick both days from too much heat. I will no longer be able to come back to work.”5
Shortly thereafter, Sipple sued her employer, claiming disability discrimination. But her case was dismissed, largely because the court agreed that her employer was not legally required to accommodate her. “This Court is not willing to recognize menopause as a disability per se. Menopause is a natural progression over time, like gradually losing one’s keen sense of vision or hearing,” the court wrote in its 2011 opinion. “It is an inevitable part of the human condition for women.”6
