Hormone therapy findings suggest a complex relationship between marketing, scientific evidence and prescribing patterns

Pharmaceutical companies slashed their promotional spending for hormone therapies by more than a third following reports in July 2002 of health risks associated with the drugs, but within the year they beefed up their marketing efforts to promote lower-dose forms of the medications, according to researchers at the Stanford University School of Medicine.

Although pharmaceutical marketing has grown widely, few studies have examined the industry’s response to evidence of harm caused by a drug. The researchers say their study, which appears in the Oct. 27 issue of the Journal of the American Medical Association, found that promotional spending for postmenopausal hormone therapies dropped by 37 percent, correlating with previous Stanford research that found prescriptions for the drugs decreased by 38 percent during a similar time span.

“Our findings suggest a complex relationship between marketing, scientific evidence and prescribing patterns,” said Randall Stafford, MD, PhD, assistant professor of medicine at the Stanford Prevention Research Center and senior author of the study. “Physicians should recognize that the promotion of pharmaceuticals might have a bigger impact on their practice than they often acknowledge, particularly when evidence is lacking.”

Stafford and his colleagues felt the hormone therapy episode offered a unique opportunity to examine the reaction of the pharmaceutical industry to evidence that a drug did more harm than good. The researchers wanted to know whether the companies would increase marketing efforts to counter the bad publicity, maintain existing spending levels or reduce spending. Unlike other, more extreme examples in which observed harms resulted in a drug’s removal from the market (i.e., the recent case of the pain reliever Vioxx), hormone therapies remain available but with additional warnings mandated by the Food and Drug Administration.

For the study, Stafford’s team used data from two independent market research companies to estimate promotional spending for postmenopausal therapies that contained estrogen. In July 2002, researchers from the federally funded Women’s Health Initiative reported a higher incidence of heart attacks, breast cancer, stroke and blood clots among older women who took a combination of estrogen and progestin. The findings dashed long-held beliefs that hormone therapy offered protection against heart disease in addition to its intended use of relieving postmenopausal symptoms.

Stafford noted that prior to July 2002, hormone therapies were the 10th most heavily promoted class of medications and accounted for promotional expenditures of more than $300 million per year. The researchers found that in the quarter before the WHI results were reported, promotional spending was estimated at $71 million or the annual equivalent of about $350 per practicing physician in the United States. Following the reports of the WHI results, promotional spending dropped dramatically, reaching a low in the first quarter of 2003 of $45 million or about $220 per physician annually.

The spending decreases occurred in all promotional categories Stafford’s team examined, including free samples, office-based “detailing” visits to physicians, advertising in medical journals and direct-to-consumer marketing. In the case of the medication known as Prempro, the company abandoned all direct-to-consumer advertising of the standard-dose form of the drug, Stafford said.

A resurgence in promotional spending began in the second quarter of 2003 with the availability of lower-dose versions of estrogen/progestin. In the wake of the WHI findings, organizations such as the North American Menopause Society initially recommended that women needing relief from postmenopausal symptoms take the lowest possible dose of the medication for the shortest possible length of time. However, the paper’s first author, Sumit Majumdar, MD, of the University of Alberta in Edmonton, pointed out that there have been no clinical studies of the low-dose approach. “It’s a common-sense viewpoint but there is no current evidence that the balance of harms and benefits would be different from the higher-dose form of Prempro studied in WHI,” Majumdar said.

By the fourth quarter of 2003, promotional expenditures had climbed to an estimated $55 million, of which $13.5 million went toward marketing lower-dose forms. Despite the effort to promote the low-dose drugs, Stafford noted there was only a modest increase in prescriptions for those drugs by the end of 2003.

The mixed response by the pharmaceutical companies intrigues Stafford. “The early response reflects that the companies were cautious about heavily promoting a product where harms appeared to exceed benefits. On the other hand, the later resurgence in spending, particularly for a product with unknown risks and benefits, suggests that industry envisioned a continuing and viable market for hormone therapy.”

Stafford, who also led the previous study of prescribing patterns for hormone therapy, said the two studies demonstrate the variety of forces that affect physician practice. “The simplistic view is that physicians respond directly to the results of clinical trials; the reality is much more complex. Prescribing patterns are also shaped by such factors as the publicity surrounding scientific findings, patient involvement in prescribing decisions and the extent of pharmaceutical industry marketing.”

The paper’s other author is Elizabeth Almasi, an undergraduate at Stanford.

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