Investigative Report

Flash Back

The Troubling Revival of Hormone Therapy

It has been 8 years since the landmark Women’s Health Initiative study raised red flags about the link between hormone therapy (HT) and cancer, heart disease and stroke. Now some doctors claim that HT can be used safely beyond FDA’s narrow approval. However, these proponents are linked to Big Pharma, and their confidence is not well-founded.

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No woman looks forward to the symptoms that come with menopause, and no one disputes that hormone therapy (HT) can relieve the discomfort of hot flashes and night sweats (vasomotor symptoms) and reduce the risk of bone thinning and loss of bone density (osteoporosis). However, just about everything else about HT is in dispute.

HT is a treatment by which estrogen and progestin (synthetic progesterone) are prescribed to replace hormones that are depleted during menopause. HT medications typically cost about $50 each month; initial and follow-up doctor visits typically total about $300. Insurance typically covers the visits and the drugs.

That HT can increase the risk of breast cancer and other major health problems is well-known, but even when it comes to the positive aspects of HT, there’s a catch. For example, to derive HT’s bone-protection benefits, women must remain on HT medications indefinitely. Food and Drug Administration recommends, however, that women should undergo HT for as briefly as is possible. (FDA advises women to check with their doctor every 3 to 6 months to see if HT still is needed.)

Unfortunately, that’s just the beginning of the confusion that surrounds HT.

TIES THAT BIND. That women can develop breast cancer from HT emerged in the Women’s Health Initiative (WHI). This federally funded 15-year study of women’s health stopped its hormone trials on 16,608 women in 2002, which was 3 years before the scheduled completion date, because the trials revealed an increased risk of breast cancer, strokes, heart attacks and blood clots. Other studies link HT to many cancers. In 2009, for instance, two reports in Journal of American Medical Association linked HT to lung and ovarian cancer.

But now there is a renewed push to broaden the use of HT despite its proven dangers. You can’t turn around these days without bumping into an article that suggests that HT not only is not harmful but also might even prevent heart disease and cognitive problems in menopausal and postmenopausal women. These articles have appeared on health websites as well as in newspapers. What’s troubling is that many of the doctors who are quoted in the articles have ties to major drugmakers as paid consultants, speakers, recipients of research funding and grants, and members of advisory boards. Further, the authorship of articles has been called into question by critics who charge that pharmaceutical companies contracted outside companies to write articles to which doctors lent their names.

Ways to Cope, With Strings Attached

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Big Pharma takes its pro-HT message to doctors in the form of continuing medical education (CME) courses, which are required for doctors to keep their license. In 2009, Pfizer, which makes about 60 percent of the HT drugs that are sold in the United States, spent $2 million to fund CME courses on the importance of estrogen. The courses were held at Duke University, Penn State University and University of Oklahoma medical schools; Cleveland Clinic; and on Medscape, which is the CME site that is connected with WebMD.

Pfizer, which bought HT-maker Wyeth last year, isn’t alone among HT-makers who are patrons of CMEs that favor hormones. Bayer sponsors a hormone CME course at University of Virginia School of Medicine; Solvay sponsors a CME program through the online journal OBM Management; and Warner Chilcott funded a CME course that was offered through North American Menopause Society (NAMS). That’s a lot of education for a therapy that was thought too risky to allow a federal study to continue!

And HT medications now are pushed for uses that go well beyond the relief of symptoms of menopause, thanks to off-label marketing, which is the increasingly common practice of prescribing a drug to treat a condition despite the lack of FDA approval for that treatment. FDA approved HT for use only by otherwise healthy women who suffer from osteoporosis, hot flashes, and vulvar and vaginal atrophy. But since 2006, HT has been peddled as a way to treat just about any condition that women might encounter, including hearing loss and urinary incontinence.

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