Women’s Health Initiative Study – 2002 – A 2009 Supplemental Report

Brenda Fulmer

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A long-awaited supplemental report was published in early February of 2009, from the authors of the heralded Women’s Health Initiative (WHI) Study. The WHI Study, published in July of 2002, was suspended after noting that the risks of combination hormone replacement therapy appeared to outweigh the benefits, finding that continuing to give the drugs to study participants would be improper and unethical. In particular, the WHI Study noted an increased risk of heart attacks, strokes, and hormone related breast cancers in patients who ingested popular HRT products.

Following publication of this study, women who were long-time users of Prempro, Premarin + Provera, and other popular combination HRT products were understandably alarmed. The phones of treating gynecologists rang off the hook and understandably worried women crowded waiting rooms, looking for answers. For the first time, women and their physicians had finally received accurate information concerning the very substantial risks of the drugs and their limited utility. As a consequence, many female patients chose to discontinue use of the medications. The resulting steep decline in the sales of Prempro in 2002 and 2003 is closely associated with the decline in the diagnosis of the types of breast cancers known to be associated with these drugs. This relationship between declining sales and breast cancer rates was also noted in other countries and by other scientists. However, some, including manufacturers of the drugs, such as Wyeth, maintained that this statistical relationship did not necessarily prove anything and took the position that it was related to other causes such as increased use of mammography.

This latest study published by Dr. Rowan Chlebowski and others discounts these other potential causes for the striking decline in breast cancer rates, in post-menopausal women, following publication of the original WHI Study. The authors concluded that mammography rates had remained fairly stable during this time period and they could not explain away the decline. The authors of this latest report concluded:

“[T]ne increased risk of breast cancer associated with estrogen-plus-progestin therapy declined markedly soon after discontinuation of the therapy and was unrelated to a change in the use of mammography. This finding supports the hypothesis that the recent reduction in the incidence of breast cancer among women in certain age groups in the United States is predominantly related to a decrease in the use of combined estrogen plus progestin.”

This conclusion was supported by analysis of two different sets of data from the WHI Study as well as analysis of the Surveillance, Epidemiology, and End Results (SEER) database and other collections of data regarding regional breast cancer rates. With so much solid science showing that combination HRT drugs promote the growth of breast cancers, limited utility of such drugs, and a number of safer alternatives, all of us should wonder why the FDA would permit Prempro to remain on the market for all of these years? And perhaps a better question is whether the new FDA, the administrative agency that has vowed to put patient safety above corporate interests, will permit this cancer-causing drug to remain on the market for much longer?