HRT warning means heartache for Pfizer, estrogen makers

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Cautions against hormone replacement therapy continue to pile up. The US Preventive Services Task Force released preliminary recommendations Tuesday that warn post-menopausal women to avoid HRT because of its association with increased risk of coronary heart disease, stroke, dementia and certain types of cancer. The panel is made up of preventive care experts and Tuesday's recommendations apply to both estrogen-progestin combinations, such as those mimicked by Pfizer's Prempro and estrogen-only treatments, such as Pfizer's Premarin.

The guidelines make it clear that the recommendation is only for the post-menopausal set—women in their mid-sixties and up—and not for those mid-menopause.

Hormone replacement therapy has long been considered a protective measure, and in fact has been linked to positive outcomes, such as fewer bone fractures, but the task force's report moves the risk/benefit equation several notches for the worse. Experts found that, far from protecting the heart, HRT actually put women at a greater risk for heart disease, whether they were taking estrogen-only or a dual hormone treatment. Experts also found an increased risk for dementia among progestin-estrogen patients (as opposed to estrogen-only patients for whom therapy did not increase the risk).

The report is a follow-up to a landmark 2002 study by the Women's Health Initiative. This earlier study examined the impact of estrogen-progesterone therapy and was cut short because of the marked cancer risk. Post-menopausal women were encouraged to cease the two-hormone therapy. This recommendation was later extended to include estrogen-only treatments. Despite this decade-old warning, hormone treatments continue to sell. Pfizer sold $1 billion worth of estrogen-only Premarin last year, and though sales of the Wyeth legacy product were down 3% from 2010, the company's annual report hailed it as a bright spot for the primary care division.

The same Pfizer annual report also noted another HRT holdover: lawsuits. The company said it has been named in about 10,000 cases that allege personal injury or economic loss after use of “certain estrogen and progestin medications prescribed for women to treat the symptoms of menopause,” and had settled just over half of those cases by the end of 2011, with last year's settlements costing about $336 million.

Other companies that make HRT products include Warner Chilcott, Bayer and Novo Nordisk.

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