Difficult days these are as we reel from one controversy only to be revisited by another. This past July was marked by the early termination of the Women's Health Initiative (WHI) and the publication of results showing that long-term hormone therapy in healthy postmenopausal women increases the risk of breast cancer, cardiovascular disease, and stroke. Several very recent New York Times articles[2,3,4,5] highlight the continuing confusion and upset caused by the publication of these findings. Now even Wyeth, the maker of the hormone regimen used in the WHI study, is changing the prescription information for their estrogen and estrogen/progestin products, Premarin, Prempro, and Premphase. A Reuters news story published in The New York Times on September 4, 2002, states that the package insert will "recommend that women remain on the therapies for the shortest duration possible given the individual patient's treatment goals. The drugs should also not be taken to prevent heart disease, and other treatments should be considered to prevent osteoporosis..."
A series of editorials by 4 of our Medscape Women's Health board members and authors also address the clinical implications of the WHI results.[7,8,9,10] The take-home message from these experienced clinicians is that in prescribing hormone therapy, consideration of the individual woman is critical: Each woman experiences menopause uniquely -- she may or may not be a candidate for hormone therapy -- and if she is, one should expect that she will respond uniquely to a given regimen of hormone therapy (ie, formulation, dosage, route of administration, duration). Determining whether a woman is a candidate for hormone therapy and on the basis of that information making clinical decisions may now entail more than both clinicians and patients are accustomed to.
Long before the results of WHI were published, we offered a free CME program, "Individualizing Hormone Therapy: Principles and Practice." This article by Dr. Morris Notelovitz was no doubt eye-opening for many of our readers, and if you haven't read it, I recommend it. It is well worth a review for his discussion of estrogen biology and his approach to prescribing hormone therapy.
Another field, another controversy. The results of the landmark trial, The Canadian National Breast Screening Study, reported in the September 3, 2002 issue of the Annals of Internal Medicine, add fuel to the fire of the already raging debate regarding the safety and efficacy of mammography. On the basis of an 11- to 16-year follow-up of 50,430 volunteers aged 40 to 49 years, the Canadian researchers concluded that the addition of mammography to self-examination and physician examination of women in their 40s did not reduce mortality from breast cancer, as compared with self-examination and physician examination alone.
Earlier this year, the US Preventive Services Task Force (USPSTF) published guidelines giving B-level recommendations for mammographic screening every 1 to 2 years for women in their 40s. The USPSTF meta-analysis used to support these recommendations has now been published, also in the September 3 issue of the Annals. It turns out that the evidence for these recommendations could be rated only as "fair" -- as opposed to good. (For Medscape coverage of these studies, see "Controversy Rages Over Breast Cancer Screening") Nonetheless, the USPSTF authors stand by their recommendations. In the discussion of their findings, they also make the following salient point:
The risk for false-positive results and their consequences decreases with age. Thus, although mammography at any age poses a tradeoff of benefits and harms, the balance between increasing absolute risk reduction and decreasing harms grows more favorable over time. The age at which this tradeoff becomes acceptable is a subjective judgment that cannot be answered on scientific grounds, since early evidence suggests that women will tolerate a high risk for false-positive results [my italics].
These studies come on the heels of earlier controversial Cochrane reviews by Gøtzsche and Olsen from the Nordic Cochrane Centre in Copenhagen, Denmark, published in The Lancet in 2000 and 2001.[14,15] They concluded that many of the major breast cancer trials conducted in Canada, Europe, and the United States were seriously flawed in terms of randomization. On the basis of the only 2 trials deemed adequately randomized, the Danish investigators concluded that breast cancer screening offered no benefit with regard to breast cancer mortality. They further found that treatment of breast cancer (surgery, radiation therapy) was more aggressive, and potentially unwarranted, in women who underwent mammography.
The clinical implications of the Cochrane reviews were deeply disturbing for many clinicians and women, notably in the United States. Shortly after the publication of these analyses, the American Medical Association and the American Cancer Society were among the signatories to a full-page advertisement in The New York Times urging women to go for screening. One of our board members, Dr. Anne McTiernan, a member of the Fred Hutchinson Cancer Research Center, expressed her view in response in the Medscape Editorial, "Recent Controversies in Mammography Screening for Breast Cancer" that the Cochrane analysis itself had flaws. She concluded the editorial on a powerful personal note, saying that as a 40-something woman, she would continue to get annual mammograms. I, as a 40-something woman, choose against getting annual mammograms. Two women, each unique, making a decision appropriate for herself.
Prominent breast cancer researchers in the United States are again debating the value of mammography, as pointed out in the recent New York Times article covering the publication of the 2 September Annals reports. I urge Medscape members to read the just-posted Medscape article, "Controversy Rages Over Breast Cancer Screening: A Newsmaker Interview With Michael Baum, MD," together with an article published in The New Republic on April 22, 2002, "Search and Destroy: Shannon Brownlee on Why Mammograms Are Not the Answer."
These pieces are important, and both are critical of American medical policy. Ms. Brownlee urges doctors, hospitals, scientists, and politicians " to turn their focus -- and their money -- toward the emerging technologies that could help doctors more accurately predict which tumors require aggressive treatment and which can safely be left alone. The United States needs to enter the postmammography era -- and the sooner the better." During the Medscape interview, Dr. Baum exhorts: "No one in their right mind, outside the US, would offer mammography screening to women under age 50. America has to ask herself why she is out of step with the rest of the world." When I read this, I immediately jumped up to search through a pile of as yet unpacked boxes from a recent move for my copy of the late Lynn Payer's small but seminal book, Medicine and Culture: Varieties of Treatment in the United States, England, West Germany and France, published in 1988. She introduces her chapter on the United States with the following
Even as Europeans were developing the simple mastectomy and the lumpectomy as less mutilating ways to treat breast cancer, American doctors were advocating the superradical mastectomy and prophylactic removal of both breasts to prevent breast cancer...American medicine is aggressive...An aggressive approach, of course, implies that the doctor can do something for the patients, and this "can do" attitude is as much a characteristic of American Medicine as it is of the American character in general.
The findings and the responses to the findings of these recent studies of hormone therapy and mammography emphasize the need for substantive dialogue between the clinician and the individual woman. Taking into consideration her unique physical and psychosocial constitution and other information of relevance to her case individually, the clinician and the patient together can best weigh the benefits and risks of an intervention in the light of the most recent data available to them. These studies also reinforce the responsibility we have to consider the results of these interventions in terms of the cost and benefit to society. In the context of a complex and powerfully influential medical/political/social/business environment -- our countries, our world -- these may seem daunting tasks, but we "can do" it! Let's reap benefit from controversy.
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Medscape Ob/Gyn. 2002;7(2) © 2002 Medscape
Cite this: September 2002: Harvesting Controversies for Women and Society - Medscape - Sep 01, 2002.