Jul 302013
Generic Tablet, WikiCommons Images

Generic Tablet, WikiCommons Images

Unless you’ve had a hot flash — that dizzying, toxic, sitting in a sweat-lodge feeling from the neck up — you may not understand why the recent news from Yale University about the estrogen studies of 2002 makes postmenopausal women take notice.

Yale researchers believe that upwards of 50,000 women may have died unnecessarily after stopping estrogen-only hormone replacement therapy after 2002.

Eleven years ago, emerging news stories in the health universe detailed the harmful effects of non-contraceptive estrogen on postmenopausal women.

Until 2002,  millions of women took the estrogen/progesterone combination for symptoms of menopause. For more than 30 years, women with a uterus and uncomfortable menopausal symptoms were prescribed a hormone replacement therapy that combined estrogen and progestin.  Women without a uterus took estrogen only, not needing the protection of progestin for potential uterine cancer.

Popular product names included Prempro (containing progesterone) and Premarin (containing only estrogen), FemHRT and Activella, and dozens of other pills, patches, and products made at local compounding pharmacies.

The study about the progestin/estrogen Hormone Replacement Therapy (HRT) option was part of a larger Women’s Health Initiative, launched in 1990 at 40 health centers throughout the U.S. Begun in 1990 to find strategies to prevent chronic diseases in postmenopausal women, the study was a partnership between the Centers for Disease Control and the National Institutes of Health.

Back to the Daily Sauna for Hot Flashers: For the six million American women who routinely took estrogen to reduce the symptoms of hot flashes, the news was devastating. The HRT arm of the study was halted quickly after the National Heart, Lung, and Blood Institutes of the NIH noted an increased risk of breast cancer in women who took combination estrogen and progestin therapy.

According to an NIH press release, the study was intended to continue until 2005, but was halted with an average follow-up of participants at 2.5 years:

“The study also found increases in coronary heart disease, stroke, and pulmonary embolism in study participants on estrogen plus progestin compared to women taking placebo pills.”

While the estrogen/progestin combination did offer some benefits to women, researchers felt that the risk/benefit ratio fell to the toward the risk end.   The study findings in the estrogen/progestin arm found (compared to placebo) notable increases in strokes, heart attack, blood clots, total cardiovascular disease, and breast cancer.  The results for the estrogen-only arm were not as conclusive and the study continued.

Naturally, the pharmaceutical industry that promoted and sold these products suddenly found themselves engaged in multiple lawsuits, many that are still ongoing. Today, only 10% of symptomatic post-menopausal women use HRT, according to Yale; before 2009, usage was around 90%.

“Flash” Forward to Yale 2013. Not surprisingly, HRT use –of all kinds–dropped dramatically after 2002.

Women suffering from postmenopausal symptoms had a difficult choice to make.  The drugs were not pulled from the market, though labeling information was changed in January 2003 and a warning instructed women about the findings of the Women’s Health Initiative study.  (In labeling, a warning is more dire than a contraindication.)

On the Yale News site,  a headline shouted that estrogen might be a lifesaver for women without a uterus?  What?

Well, damn.  Or should I say, hot damn.  How did I  miss this?  The shocking news mentioned at the beginning notes that 50K plus women  – those who have had a surgical hysterectomy — may have suffered unnecessary deaths over the last decade because of the decline in hormone usage. Cleveland Clinic weighs in here.

According to the Yale story, researchers combed U.S. census data and hysterectomy rates and added to the mix the decline of hormone replacement therapy use in women aged 50 to 59 over a nine-year period after the WHI study.

I am lucky because I could be one of those women, one of the 50,ooo women who died because I chose not to take hormone replacement therapy.

While I understand that the study had to be stopped for the combination trial (those patients who took estrogen and progestin), for those women who have had surgical hysterectomies, there is enough scientific doubt for Yale to study this subject.

Dr. Philip Sarrel, a professor emeritus from Yale’s Obstetrics, Gynecology & Reproductive Sciences, and Psychiatry departments, led the researchers.  A quote from Yale’s news release is stunning and provides a cautionary tale:

“Sadly, the media, women, and health care providers did not appreciate the difference between the two kinds of hormones,” Sorrell said, “As a result, the use of all forms of FDA-approved menopausal hormone therapy declined precipitously.”

As women, what can we learn from this?

Professionally, I write health content and I am constantly researching studies from primary sources.  I also knew all of the studies and memorized all of the package inserts and various labeling for all estrogen and estrogen/progestin products during my pharma career (2000-2009).  My company stopped promoting these products and I moved on to something else. And frankly, what my doctor said was more important than my own studies.

But next time, I’ll dig deeper.  The lesson from this is that, as patients, we have to advocate for ourselves.  While I’m not a doctor (and I don’t play one on TV), I do think that understanding a disease state is important. You will understand what your medical provider recommends fuller if you take the time to research.

The Yale Take on Estrogen-Only Therapy:  Yale reported that the estrogen-only arm of the study, which followed women who had no uterus and who took either estrogen-only or placebo, showed different results from the estrogen/progestin study.  Papers published by the WHI since 2004 demonstrated estrogen-only therapy resulted in mostly positive health outcomes.

According to Dr. Sorrell, the study director:

“For each of the ten years the death rate among those not taking estrogen was 13 more per 10,000.  Most of these women died from heart disease while breast cancer accounted for almost all the other deaths.

“Estrogen avoidance has resulted in a real cost in women’s lives every year for the last ten years– and the deaths continue.”

So back to the doctor I go.

Disclaimer: I promoted both an estrogen-only and a combination hormone replacement therapy drug for a global pharmaceutical chain.  For the record, I do not take, nor have I ever taken, Hormone Replacement Therapy.

Published July 30, 2013 at The Broad Side. Please comment there.

%d bloggers like this: