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Pharmaceutical Research

Marketing and prescribing of hormone replacement therapy declined substantially following reports of harm

By the end of the 1990s, almost half of postmenopausal women in the United States were being treated with long-term hormone therapy, which was also among the most heavily promoted medications. In July 2002, the Women's Health Initiative Estrogen Plus Progestin Trial (WHI E+P) report demonstrated that standard-dose Prempro produced significant harm (for example, increased risk for cardiovascular disease and breast cancer) and lacked net benefits.

U.S. prescriptions for postmenopausal hormone therapy declined 43 percent during the 18 months after these results were published. Promotional spending for hormone therapy, particularly for the agents most directly implicated in the trial, also declined substantially, according to a study conducted by researchers at the University of Alberta and Stanford University School of Medicine. The study was supported in part by the Agency for Healthcare Research and Quality (HS13405).

Interrelated with the trial results themselves and the ensuing media coverage, reduced promotion may have contributed to a substantial decline in hormone therapy prescriptions, according to the researchers. They examined nationally representative data on hormone prescribing and promotion from January 2001 through December 2003 from IMS Health and Consumer Media Reports. In addition, they analyzed promotional expenditures for hormone therapy before and after July 2002.

In the quarter before release of the trial results (April-June 2002), 22.4 million prescriptions for hormone therapy were dispensed, and $71 million was spent on promotion ($350 per year per U.S. physician). Within 9 months of the report's publication (first quarter of 2003), there was a 32 percent decrease in hormone therapy prescriptions and a 37 percent decline in promotional spending from pre-trial result levels. The greatest declines in promotion occurred for standard-dose Prempro (61 percent decrease), the agent implicated by the WHI E+P report.

See "Promotion and prescribing of hormone therapy after report of harm by the Women's Health Initiative," by Sumit R. Majumdar, M.D., M.P.H., Elizabeth A. Almasi, and Randsall S. Stafford, M.D., Ph.D., in the October 27, 2004, Journal of the American Medical Association 292(16), pp. 1983-1988.

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