Promotion and prescribing of hormone therapy after report of harm by the Women's Health Initiative.

CONTEXT

Little is known about how the pharmaceutical industry responds to evidence of harm associated with its products, such as the publication in July 2002 of the Women's Health Initiative Estrogen Plus Progestin Trial (WHI E+P) report demonstrating that standard-dose Prempro produced significant harm and lacked net benefits.

OBJECTIVE

To examine pharmaceutical industry response to the WHI E+P results by analyzing promotional expenditures for hormone therapy before and after July 2002.

DESIGN AND SETTING

Nationally representative and prospectively collected longitudinal data (January 2001 through December 2003) on prescribing and promotion of hormone therapies were obtained from IMS Health and Consumer Media Reports.

MAIN OUTCOME MEASURES

Trends in quarterly prescriptions for hormone therapy and expenditures on 5 modes of drug promotion: samples, office-based detailing, hospital-based promotion, journal advertisements, and direct-to-consumer advertising.

RESULTS

Prior to the WHI E+P report, prescribing rates and promotional spending for hormone therapy were stable. In the quarter before the WHI E+P report (April-June 2002), 22.4 million prescriptions for hormone therapy were dispensed and 71 million dollars was spent on promotion (in annual terms, 350 dollars per year per US physician). Within 9 months of the report's publication (quarter 1 of 2003), there was a 32% decrease in hormone therapy prescriptions, and a nadir had been reached for promotional spending (37% decrease compared with pre-WHI E+P levels). Spending decreased for all promotional activities and most hormone therapies. Overall, the greatest declines were for samples (36% decrease as of quarter 1 of 2003) and direct-to-consumer advertising (100% decrease). The greatest declines in promotion occurred for standard-dose Prempro (61% decrease as of quarter 1 of 2003), the agent implicated by the WHI E+P report. More recently, promotional efforts have increased, particularly for lower-dose Prempro, a resurgence associated with modestly increased prescriptions for this newer agent.

CONCLUSIONS

Concordant with its widespread use, hormone therapy was among the most heavily promoted medications prior to the WHI E+P report. Following reporting of the evidence of harm from this trial, there was a substantial decline in promotional spending for hormone therapy, particularly for the agents most directly implicated in the trial. Interrelated with the impact of the trial results themselves and the ensuing media coverage, reduced promotion may have contributed to a substantial decline in hormone therapy prescriptions.