Listen to Dr. Heward explain why menopause hormone therapy is so controversial.
There’s such a controversy about menopausal hormone therapy these days is because of the Women’s Health Initiative. The Women’s Health Initiative, also called the WHI, was a big study that was designed years ago to give us a definitive answer to the question, "Is hormone replacement therapy, is estrogen replacement therapy or estrogen and progesterone replacement, specifically beneficial, really, as we think it is?"
We’ve been giving women hormone replacement therapy, estrogen and progesterone, for 30 plus years when they present clinically with the symptoms of menopause, and we’ve describe in the literature the benefits that these women seem to be experiencing as a result of this hormone replacement, but the gnawing question in the back of the mind of scientists like myself is this fear that there’s a healthy user bias.
That idea is that maybe the women who present for hormone replacement therapy and ultimately end up going on hormones are, as a group, just healthier already than the women who don’t go on hormones, and so when we see longer terms that these women do better, maybe they’re really just doing better not because of the hormones, but because they’re just healthier.
So there is a lot of discussion in literature and concern about this healthy user bias, and so, in order to answer the question definitively, we needed prospective placebo-controlled clinical trial where we randomized people in advance into two groups and then we gave some people the hormone and some people a placebo and followed them for long enough to see events, and that’s what the WHI did.
The problem is that the WHI had to be terminated because there’s rules about the ethics of doing clinical studies that require studies to be terminated when you’re giving a compound that you know to be harmful, and there’s no compensatory benefit. Well we know and we’ve known for many, many years, decades, that estrogen is associated with increased risk of breast cancer, and that’s very true, but we expected there to be a cardio-protective benefit that we see in the epidemiological studies, and that didn’t show up in the WHI.
As soon as we got the increased risk of breast cancer without the compensatory cardio-protective benefit, they were required by ethical constraints to terminate the study, and when they terminated the study, which was a giant study, cost the government half a billion dollars involving 16,000 women, I mean this was a giant study, everybody was watching it, they had to terminate it. The publicity associated with that scared millions of women away from using hormone replacement therapy because the primary benefit of hormone replacement, cardio-protection, didn’t seem to show up, and that was disaster.
About Dr. Heward, Ph.D:
Dr. Christopher B. Heward is past-President of Kronos Science Laboratory. His primary responsibility was providing scientific and technical leadership for all laboratory activities. He oversaw the development and implementation of the clinical laboratory testing program; assisted in designing and refining both internally and externally sponsored clinical studies; directed and coordinated diagnostic product research and development; administered laboratory and patient databases; was principal investigator for the Kronos Longitudinal Aging Study (KLAS); and communicated Kronos’ discoveries and advances to lay and scientific audiences via presentations and publications. Dr. Heward’s research interests included healthy aging, endocrinology, oxidative stress, Alzheimer’s disease, prion disease (TSE) and menopause. Dr. Heward attended the University of Arizona and received a Bachelor of Arts degrees from both the Department of Psychology and the Department of Chemistry, as well as a Bachelor of Science degree from the Department of Biology. He earned his PhD from the Department of Biology in 1981.
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