The Great Hormone Therapy Debate, Ten Years After the Women's Health Initiative Said,

Dr. Wulf Utian, NAMS Founder

Just days before the ten year anniversary of the Women’s Health Initiative‘s (WHI) groundbreaking findings that hormone replacement therapy can cause serious health problems in otherwise healthy women (including an increased risk of breast cancer), MedPage Today reports that Dr. Wulf Utian, founder of the North American Menopause Society isn’t so sure. Claiming that the WHI’s findings have done more harm than good, Utian argues that the WHI’s conclusions are not supported by the evidence. Utian is calling for an independent panel to review WHI’s publications “to confirm whether there was irresponsibility that needs to be identified and admitted.”

Source: http://www.nih.gov/PHTindex.htm/

The National Institutes of Health established the Women’s Health Initiative (WHI) in 1991 to address the most common causes of death, disability and impaired quality of life in postmenopausal women–namely heart disease, cancer, and osteoporosis. Budgeted at about $700 million, the unprecedented 15-year study is one of the largest preventive women’s health studies ever done in the United States. It has three major components: (1) a randomized controlled trial (RCT) of promising but unproven approaches to prevention; (2) an observational study to identify predictors of disease; and (3) a study of community approaches to developing healthful behaviors. In all the Initiative enrolled more than 160 thousand generally healthy postmenopausal women. At issue for Utian is the Initiative’s hormone trial.

The hormone trial involved two separate studies and aimed at clarifying the risks and benefits of hormone therapy, particularly its use in the prevention of cardiovascular diseases. The estrogen-plus-progestin study gave progestin in combination with estrogen to more than 16 thousand women between the ages of 50 and 79 who had an intact uterus. The estrogen-alone study gave only estrogen to 11,000 healthy postmenopausal women who did not have a uterus, and who had had a hysterectomy prior to the study. In both studies, participants were randomly assigned to one of two groups, either the group receiving the drug being studied, or the group receiving the placebo.

The estrogen-plus-progestin study was scheduled to run for eight years, but it was stopped early and abruptly (after only 5 years) because the risks outweighed the benefits. Compared to the placebo, the hormone group saw a reduction in hip fractures and colon cancer, but it also saw an increase in heart disease, stroke, pulmonary embolism, and breast cancer. The study’s Data Safety Monitoring Board (which is an independent advisory committee that regularly reviews study data and oversees participant’s safety) recommended that the trial be stopped. The findings confirmed earlier studies that found an increased risk of breast cancer among hormone replacement users with duration of use. This is important since it is the body of research rather than single studies that are necessary for developing protocols and health policy.

The estrogen-alone study continued until 2004 when the monitoring board concluded that after nearly seven years of follow-up estrogen alone appeared to decrease hip fracture, but it had no health benefit for heart disease or colon cancer. At the same time, it increased the risk of strokes and blood clots. Unlike the estrogen-plus-progestin combination, the risk of breast cancer did not appear to go up for the estrogen-only group. Some studies have even found that some estrogen-only drugs could lower breast cancer risk in some women for a period of time. However, the long-term risks of estrogen-only therapy are still in question. Research presented recently at the American Association for Cancer Research found that the longer the use of estrogen-only therapy, the greater the risk.

Clearly, there is a relationship between the use of synthetic hormone therapies and breast cancer even if the mechanisms are not fully understood. In 2002, when the findings from the Women’s Health Initiative estrogen-plus-progestin study came out, about 38 percent of postmenopausal women in the U.S. were using some type of hormone therapy drug. When the WHI findings hit the news, sales plummeted and breast cancer incidence rates also dropped. An article published in the New England Journal of Medicine attributed the sharp decline (6.7 percent) in breast cancer incidence in 2003 to be “temporally related to the first report of the Women’s Health Initiative and the ensuing drop in the use of hormone-replacement therapy among postmenopausal women in the United States.”

Graphic from the National Women’s Health Network (www.nwhn.org)

Given the body of research linking synthetic hormone therapy drugs and breast cancer, I’m confused by Dr. Utian’s statement that the WHI’s conclusions are somehow out of proportion or fail to be supported by evidence. He has himself acknowledged both that the “long term use of hormone therapy drugs may increase incidence of breast cancer” and that “HRT is not the only treatment against menopause.” A position statement from the organization he founded, the North American Menopause Society, also acknowledges an increased risk of breast cancer incidence and mortality with increased duration of hormone therapy drugs as well as a lack of safety data supporting the use of estrogen therapy in women who have already been diagnosed with breast cancer.

I hope Dr. Utian will join the National Women’s Health Network for two briefings on the Women’s Health Initiative to be held on Monday, July 9th in Washington, DC to get a deeper understanding of the Initiative’s findings and implications. The two panels will include  leaders in clinical research, women’s health, evidence-based health care, and consumer advocacy:

If you’re in Washington DC, you might also want to drop by to hear them “set the record straight on the Women’s Health Initiative.” Click here to RSVP.

For more information on the politicization of menopause, check out Liz Scherer’s analyses on Flashfree: Not Your Mama’s Menopause.

Dr. Utian Photo Credit: Chris Stephens/The Plain Dealer

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7 comments to The Great Hormone Therapy Debate, Ten Years After the Women’s Health Initiative Said, “STOP.”

  • Wow, I hadn’t heard about this latest controversy. Ten years after the pronouncement I’m surprised it’s even an issue. I remember a co-worker telling me after the news came out in 2002 that she was stopping hormone therapy immediately. I’m sure she’s smart enough not to reconsider her decision at this stage of her life. But how many other women might be fooled? Thanks for bringing this latest development on hormone therapy to our attention.

  • It is interesting, Jan, that some controversies seem to hang on so long despite the existence of evidence that would seem to put them to rest. The pharmaceutical industry, particularly Wyeth, has been working to medicalize menopause since it developed its first synthetic hormone from horse urine. By 1975, Wyeth’s product, Premarin (from PREgnant MAR’es urINE), had become the fifth leading prescription drug in the United States. In the past, Dr. Utian also got grant money from Wyeth — a conflict of interest that could contribute to bias.

  • Mary

    Many “survivors” will disagree with me but, I do think there has been a generalized demonization of all forms of estrogen where breast cancer is concerned. For years the use of soy products has been highly discouraged in women who have had BC. The judicious use of whole soy products is becoming more accepted by the medical community and is even seen as a preventative against BC and recurrence. I, personally, would prefer a weak plant estrogen attaching to estrogen positive receptors as opposed to the estrogen like substances from pesticides etc., that are so prevalent in our environment. Also, the AIs, now commonly used in er/pr/+ post menopausal cancer, wreak havoc on the entire female system as they deprive the body of all estrogen. There is a reason that the body produces some estrogen after menopause. Joints suffer, bone thinning can become worse and vaginal drying and urinary issues can make life miserable. I do not think that we should go back to the status quo, where estrogen replacement is concerned. However, quality of life issues, regarding the total lack of estrogen encouraged in so many BC treatments, needs to be revisited and modified with reasonable low dose estrogen alternatives such as topical estrogen (estrace) which is absorbed minimally if at all into the general system. It, generally, only acts on the area being treated. We who have been “slashed, burned and poisoned” deserve better treatment that will preserve what quality of life we have left! My current thoughts on BC treatments are that they can be worse than the disease itself. It is only in having refused many of the adjuvant therapies that I have been able to preserve a semblance of quality in my current situation.

  • Excellent points, Mary.

  • Thorough piece. Thank you! If women start speaking out more about the medicalization of menopause, we might actually gain some traction in changing things. My goal on Flashfree is to introduce evidence for alternative strategies into the overall conversation so that women are better equipped to make informed decision for themselves. As Mary suggests, there has been a demonization of certain plant compounds with estrogenic properties that have ultimately proven safe for breast cancer survivors. It is unfortunate the Western practitioners have not taken the time to thoroughly engage with practitioners who are well versed in other modalities. I am hoping with the evolving interest in mind-body therapies and acupuncture, that this will start to change.

  • Thanks for stopping by, Liz. Your work on Flashfree is great! I agree that speaking out about medicalization is vital. Onwards and Upwards!

  • Maureen Mendohlson

    Can’t believe this has been around for ten years. I guess even women are still divided regarding the issue, if not, society itself.

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