Adriane Fugh-Berman M.D.

The Truth about Hormone Replacement Therapy

The publication last July of clinical-trial evidence that long-term use of hormone replacement therapy (HRT) does women more harm than good (1) stunned many menopause experts, but the authors of this book were not among them. While organizations such as the Society of Obstetricians and Gynaecologists of Canada (SOGC) and the North American Medical Society regrouped to "figure out what findings from the Women's Health Initiative trial actually mean," (2) the Washington-based National Women's Health Network issued a blistering press release that left no doubt about its leadership's reaction. "This is a story of the corruption of the medical and scientific community," declared the Network's executive director, Cynthia Pearson. "Women, and their physicians, were duped. Women [who took HRT] were placed in the way of harm by their physicians, who acted as unsuspecting patsies for pharmaceutical companies."(3)

Fighting words, which more timid souls might mince. The authors of The Truth About Hormone Replacement Therapy, however, are outspoken, well-versed on the HRT dossier, credentialed - and mad as hell about the overselling of hormones to women. They include two MDs, three PhDs and two seasoned health policy advocates. All are members of the National Women's Health Network, a feisty organization whose publications are to women's health what Consumer Reports is to the skeptical shopper.

This is the sixth edition of The Truth About Hormone Replacement Therapy, first published in 1989. It blends practical advice and political analysis, making a convincing case that, when it comes to HRT, the two are inseparable. The main portion of the book critically reviews the medical literature on the benefits and risks of HRT, holding the scientific evidence up against popular claims. The authors then examine alternatives in the same strong light. The introductory and concluding sections explain why women need an independently produced guide to hormone use: physicians have let them down.

The opening chapters address this failure, posing the question, "How does a doctor trained in the most advanced medical system in the world stay so ignorant?" The authors point to the pharmaceutical industry's control over medical education. Most physicians recognize that drug companies exert an unhealthy influence on their profession through detailing, free conferences, research sponsorship and the like; the authors argue, however, that health care practitioners grasp neither the extent nor the artfulness of the tricks used to manipulate their "education" about menopause. The inventive strategies to camouflage corporate strings, combined with clinicians' lack of time to read and analyze all the available research, conspire to make industry propaganda seem credible while insulating physicians from contrary views.

The book's discussion of HRT and heart disease most clearly illustrates this "duped docs" thesis. Judging from the surprise among gynecologists over the Women's Health Initiative announcement, the news that HRT promotes rather than protects against heart disease was a bolt from the blue. It should not have been. Chapter 11 underlines three telling points: estrogen had never been shown to prevent heart disease in women; evidence to suggest that estrogen might actually cause heart attacks in some women had appeared in the literature over several years; yet clinicians prescribed the drug for heart health anyway. Indeed, during the 1990s unquestioning faith in hormone use became part of the professional culture. Respected medical journals ran articles with titles like "Hormone replacement therapy for all? Universal prescription is desirable,"(4) while clinical practice guidelines recommended that every menopausal woman take HRT for at least 10 years.

Even more revealing of a system in the grip of dogma, the book documents ways that physicians' professional organizations opposed challenges to this perspective. The Network has been a policy watchdog on women's health issues for over 25 years, and its critique of industry influence has sometimes placed it in direct opposition to both the gynecology establishment and to the pharmaceutical industry. In the mid-1970s, after a clinical trial showed that unopposed estrogen causes endometrial cancer, the Network fought successfully for patient package inserts in all estrogen products. The American College of Obstetricians and Gynecologists sued the FDA to block the inserts - and lost. The Network mobilized again in 1990, when Wyeth-Ayerst asked the FDA to approve Premarin for heart disease prevention in women who have had a hysterectomy. Every heart disease prevention drug used by men has been tested in a large randomized trial, the Network argued at a public hearing; by contrast, claims that estrogen replacement promoted heart health in women had never been rigorously tested. Leading researchers, sponsored by Wyeth-Ayerst, countered that a trial of estrogen replacement would not be feasible. The FDA turned down the company's application.

The Woman's Health Initiative clinical trials, funded under Bernadine Healy's leadership at the US National Institutes of Health, grew out of this ruling. The Network lobbied hard to make sure the trial went ahead. The trial's opponents included leading gynecologists, who argued that "the heart disease benefit is so well proven that it would be unethical to ask women to accept the possibility that they might be randomized to a placebo." The rest is history. The Women's Health Initiative study was launched in 1993, and the HRT component was halted three years early when it was found that the combined increased risk of heart disease and breast cancer overwhelmed lesser benefits to bone and colon.

The authors of The Truth About Hormone Replacement Therapy could not have foreseen the trial's early end, but in many other respects their perspective is prescient.

Clinicians can confidently recommend this book to patients as a science-based resource written in lay language on all aspects of hormone therapy, from short-term use for menopausal symptoms to a thorough evaluation of alternatives like phytoestrogens, herbs and "natural" hormones. Its cautionary approach to these preparations, and to the risks of long-term hormone use, addresses many questions women have been asking since July. For busy physicians, the book could be the answer for all those unread studies (with a few exceptions, journal references are provided).

Since the release of the Women's Health Initiative findings, Network members have had one message for physicians: get drug companies out of medical education. Easier said than done - but the alternative, this book implies, is to slide into an Illichian abyss in which the risks of seeing a physician outweigh the benefits."

--Canadian Medical Association Journal, February 4, 2003; 168 (3) (Sharon Batt, Elizabeth May Chair in Women's Health and the Environment Atlantic Centre of Excellence for Women's Health Dalhousie University Halifax, NS).


References

1. Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. Principal results from the Women's Health Initiative randomized control trial.JAMA 2002;288(3):321-33.

2. Sibbald B. Fallout from JAMA's HRT study continuing to land in MDs' offices. CMAJ 2002; 167(4):387.

3. Pearson C. Response to the announcement that health risks outweigh benefits for combined estrogen plus progestin. National Women's Health Network, July 2002. Available: www.womenshealthnetwork.org/​hrtupdate.htm(accessed 2003 Jan. 13).

4. Toozs-Hobson P, Cardozo L. Hormone replacement therapy for all? Universal prescription is desirable. BMJ 1996;313: 350-1.

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