It's kind of ironic (bordering on unconscionable) that hormones continue to be prescribed, even though evidence of harm just keeps piling up. Is it that no one wants to mess with menopausal women whose hormones are raging? Or are doctors unmoved by new evidence, and know of little else to offer their patients who are suffering? For whatever reason, many doctors and patients still underestimate the serious risks of these drugs.
Almost 20 years ago the Women's Health Initiative (WHI) was established by the National Institute of Health (at an initial cost to taxpayers of $140 million) to investigate the most pressing health issues for women: This massive longitudinal study contained a major component, the Hormone Trials,which looked at the incidence of cardiovascular disease, cancer and osteoporosis in post-menopausal women taking hormone replacement drugs (Prempro and Premarin) compared to women not taking them. Since then more than 16,000 women have participated in the drug investigations, and although the Hormone Trials are now defunct (cancelled early for exposing women to serious health risks), they continue to turn up disturbing data, while the drugs remain on the market with an ever-growing list of side-effects detailed in the fine print of the package inserts.
The first bomb fell eight years ago when WHI investigators found hormone replacement with the drug Prempro (estrogen made from the urine of pregnant horses plus synthetic progesterone) was associated with breast and uterine cancer, heart disease, stroke, dementia and blood clots in the lungs. As a result, the segment of the Hormone Trials pitting Prempro against a placebo was halted 3 years before its scheduled finish (the Premarin study was halted prematurely shortly thereafter with increase stroke risk being a primary concern.) And the NIH clearly stated, "The risks of the combination hormone therapy outweighed the benefits." Many people stopped taking Prempro, followed by a decline in breast cancer.
Still, the drugs were left on the market. And women were told to consult their doctors. As usual, some doctors took their cue from the drug manufacturers, which were busy putting their own spin on the story. A further look at the data softened the heart disease warning (though not the stroke warnings) for younger women (50-59) taking the hormones, but not for older women. But urinary incontinence was quietly added to the list of side effects (women on Premarin were 52% more likely to develop incontinence, and those on Prempro were 39% more likely to do so.) The big triumph was that fewer women experienced bone fractures while on the drugs.
Also a factor in the continued prescribing: many women struggling with menopause really want the pills. There seems to be a pervasive "It won't happen to me attitude about the side effects." The perception of a fountain of youth in these pills has been successfully created. But urinary incontinence, stroke, dementia and breast cancer certainly tarnish that image. And in another bit of irony, when the Hormone Trials measured "Quality of LIfe," hormone therapies did not beat the placebo based on women's own assesments.
Now, yet another Hormone Trial follow-up--published this week in the Journal of the American Medical Association (JAMA)--links Prempro (estrogen plus progestron) to breast cancer. It's now 11 years after the trial finished, and significantly more women who were given Prempro have developed breast cancer, their cancers are more frequently node-positive (meaning it has spread) and more of the Prempro recipients have died from breast cancer. According to the NIH, a woman continuing estrogen plus progesterone hormone therapy after about 5 years doubles her annual risk of breast cancer.
What is so hard about making this call: Cancer and stroke vs symptoms of menopause? Seems pretty straightforward to me. And yet researchers and public health officials continue to hem and haw. "The data suggest [the risk] is [in] cumulative long-term use. Women should avoid long-term use. I think that's the bottom line," one of the study's lead authors told The New York Times. But there's no firm data on whether short-term use of the drugs (for less than 5 years) is any safer.
A voice of reason did come through in the JAMA editorial accompanying the research. Peter Bach of Memorial Sloan-Kettering Cancer Center in New York questioned the advice being given to women to consult their doctors. And he told The New York Times, "If you care about preventing [cancer] and keeping women from suffering and dying from it, then it's hard to look at these drugs and not have serious concerns about them being used, even for what are intended to be relatively short periods of time." Any sane person should ask, how much more information do we need before we take hormones off the market?
A final irony: that youthful glow Hormone Therapy imparts may be partly responsible for its lethal side-effects. One probable mechanism of Prempro's cancer risk is that it stimulates growth of blood vessels, and thus increases blood supply and nutrients to tumors. It's possible the slowdown in some metabolic processes as a result of aging is protective. Interfering with that natural process by artificial means is not without consequence.
Yes we need better treatments for menopause, but the current hormone drug therapies are not the answer.
