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HRT Promotions Plummet After Negative Study
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By Amanda Gardner, HealthDay Reporter

TUESDAY, Oct. 26 (HealthDayNews) -- Drug companies drastically curtailed their promotional spending on hormone replacement therapy products after a watershed U.S. government study found they could harm the health of women.

A new report on the impact of the 2002 Women's Health Initiative (WHI) study also found that direct-to-consumer advertising vanished.

This cutback may have contributed to a subsequent decline in prescriptions, said the authors of the article, which appears in the Oct. 27 issue of the Journal of the American Medical Association. The article offers a rare look into how a large, trusted study can change the clinical impact of the rich and mighty marketing arm of the pharmaceutical industry.

Other experts said the paper is less about the link between promotion and prescriptions and more about just the sheer magnitude of investment on the part of industry -- topping out at $300 million a year in the case of hormone replacement therapy (HRT).

"It's not surprising that they pulled back, but the degree of pullback is like withdrawing all American troops deployed in Europe. This is one massive pullback," said Arthur Caplan, chairman of the department medical ethics and director of the Center for Bioethics at the University of Pennsylvania in Philadelphia. "This gives a hint of how important and powerful those promotional activities are."

In July 2002, the estrogen-plus-progestin segment of the WHI was unexpectedly halted after results showed that standard-dose Prempro increased the risk of heart attack, stroke, blood clots and breast cancer, with no overall benefit.

While originally formulated to ease symptoms of menopause such as hot flashes, these hormone products became widely prescribed to help protect against heart disease and other aspects of aging, despite the absence of any hard evidence to support these contentions.

Prior to the WHI announcement, hormone therapy was among the most heavily promoted medications, according to the study authors, and prescriptions were correspondingly high. By the mid-1990s, the authors stated, almost half of all postmenopausal women in the United States were being prescribed long-term HRT. In 1998, hormone therapies accounted for more than $300 million in annual promotional expenditures, making them the tenth most heavily promoted class of medications.

There have been few studies on how pharmaceutical companies respond to negative studies such as this one. Their responses, however, could be important because marketing often has a bearing on how physicians prescribe.

The study authors looked at nationally representative data from January 2001 through December 2003 on both prescribing and promoting of hormone therapies.

Prior to the release of the WHI results, prescribing rates and promotional spending for hormone therapy were stable, the authors reported. In the first three months before the WHI results, 22.4 million prescriptions for hormone therapy were written, and $71 million was spent on promotion.

This translated to $350 per year per U.S. physician, as opposed to $220 annually per physician after the WHI results were released.

Within nine months of the results, there had been a 32 percent decrease in prescriptions and a 37 percent decrease in promotional results, representing its lowest level.

A year and a half after the WHI results were published, data showed a 43 percent decrease in prescriptions for hormone therapy in the United States.

More recently, promotion for certain products has started to creep up again.

"There was sort of a two-stage process that went on," said study author Dr. Randall S. Stafford, an assistant professor of medicine at the Stanford Prevention Research Center. "In the period immediately following the study and pretty much for the next year, there was a reduction in promotion and, more recently, there has been some resurgence. That resurgence has been largely focused on the promotion of the low-dose version of Premarin and Prempro."

Women may have also have played a role in the dramatic decline and slight upturn. "The first two or three months after the WHI came out, a lot of women were very concerned. Some actually went cold turkey off of hormones," said Dr. Anthony Grieco, a staff physician in obstetrics and gynecology at the Ochsner Clinic Foundation in New Orleans. "Then they came back later."

For Caplan, the whole cycle signals something far bigger than just hormone therapy.

"Can we really expect the zealous pursuit of adverse events on the part of those making money and having an investment? That system is never going to protect the public health. The only reason we're getting some information is that companies are trying to get new indications to broaden the market," he said. "We are way overdue to create some sort of independent, federally sponsored agency that [conducts] more follow-up safety and comparative studies. If you're making money from these things and pouring promotional money into these things, how could you ever think you could ever hang around looking for adverse events?"

The study noted that one potential strategy by the drugmakers was to spend additional money on promotion despite the results. However, "they pulled out as fast as they could," Caplan said.

More information

For more on the Women's Health Initiative, visit the National Heart, Lung, and Blood Institute (www.nhlbi.nih.gov ).

SOURCES: Randall S. Stafford, M.D., Ph.D., assistant professor, medicine, Stanford Prevention Research Center, Stanford University School of Medicine, Palo Alto, Calif.; Arthur Caplan, Ph.D., professor, bioethics, and chairman, medical ethics, University of Pennsylvania, Philadelphia; Anthony Grieco, M.D., staff physician in obstetrics and gynecology, Ochsner Clinic Foundation, New Orleans; Oct. 27, 2004, Journal of the American Medical Association

Copyright � 2004 ScoutNews, LLC. All rights reserved.

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