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Inching Back to Hormone Therapy

By Amy Tsao July 9, 2002, wasn't a good day for menopausal women. The Women's Health Initiative, which was the largest study ever of hormone replacement therapy in menopausal women, was stopped because the data showed that the treatment increased the risk of certain cancers and cardiovascular problems. The market for hormone therapy, until then considered one of the pharmaceutical industry's fastest-growth areas, has contracted sharply since. According to market researcher IMS Health, drugmakers sold $2.7 billion in hormone treatments in 2001. By 2003, that number had declined to $1.9 billion, and it's likely to shrink further by the end of 2004.

In the initial aftermath of the WHI results, patients and doctors were outright fearful. But as time has passed -- and analysis of the data deepened -- the medical community and patients have tiptoed back to using hormone therapy to treat the difficult symptoms of menopause -- hot flashes, night sweats, and vaginal dryness.

As America's population ages, it means a huge swath of women will be in the market for such remedies: Each day, 1 in 4,000 women reaches menopause -- when menstruation ceases and female hormone levels plummet. Some 50 million women are now age 50 or older, and the median age for menopause is 47.5. To date, hormone replacement therapy is still the most effective treatment for the symptoms of menopause.

NEW APPROACHES. These demographics haven't been lost on the drug industry, which would clearly like to resurrect hormone therapy's cash-cow status. All companies in the business say their sales declines have started to bottom out. Says Marie Feogh, vice-president of medical affairs for female health care at Berlex, which is a division of Germany's Schering: "The market had flattened, but it's increasing again."

Also working in the industry's favor, the Food & Drug Administration and major professional societies continue to support the use of the lowest dose of hormones possible for the shortest duration necessary to treat symptoms. Companies including Novartis (NVS), Berlex, and Wyeth (WYE) are all in the process of trying to revive their hormone treatment revenues with low- and even micro-dose hormones.

Marketing dollars for hormone therapy have been rising since the second quarter of 2003, when Wyeth received FDA approval to market its low-dose Prempro (estrogen and progesterone combined) for treatment of severe menopause symptoms and to prevent osteoporosis, says Randy Stafford, assistant professor of medicine at Stanford Medical School and a former WHI researcher. "The industry has resumed relatively heavy marketing," he says, figuring companies are back to spending just 20% less than they did when the WHI headlines came out. "The resurgence of spending reflects that this is still a viable market for pharmaceuticals," Stafford says.

BONE BUILDERS. Over the years, the recommended level of hormones had already been moving down, but interest in low-dose treatments really took off after the WHI study's results came out. "In the past, many doctors used a one-size-fits-all approach," says June LaValleur, associate professor at University of Minnesota and a former WHI researcher. Now they tend to tell women with symptoms of menopause to start on lower doses and increase the level if necessary. "There has been a resurgence of interest in lower doses," LaValleur says.

The new low-dose hormones are approved for maintaining bone density (which tends to diminish as hormone levels fall) and for controlling symptoms like hot flashes and vaginal dryness. Berlex makes a line of transdermal estrogen patches called Climara, which is available in a variety of doses, says Marie Foegh, vice-president for medical affairs for female health care. Climara Pro, which comprises estrogen and progesterone, was approved earlier this year for menopausal symptoms.

Berlex also received approval for an ultra-low-dose hormone patch called Menostar. A two-year study showed that it helped prevent osteoporosis better than a placebo. The company is continuing to investigate Menostar's effectiveness in alleviating menopause symptoms such as hot flashes. Foegh anticipates data on that use in 2006.

HARD HIT. This fall, Berlex received conditional approval letter from the FDA for a low-dose, oral estrogen-progesterone combination product called Angeliq to treat menopausal symptoms. "We anticipate approval some time next year," says Foegh.

Wyeth, the world's biggest maker of hormone therapy with some $1 billion in anticipated sales this year, has also been active. The company, which helped sponsor WHI, was hit worst by the study's results because its drugs were featured. Wyeth, however, is redoubling its efforts, winning FDA approvals to treat osteoporosis and menopause with low-dose versions of Premarin (estrogen alone) and Prempro last year.

As of the second quarter of 2004, sales of Wyeth's hormone products steadied amid strong demand for low-dose versions. "New products tend to energize the franchise," says Joseph Camardo, Wyeth's senior vice-president for medical affairs. Wyeth is in the late stages of developing an estrogen product for treating bone-density problems. It's also testing that product combined with Premarin.

MORE CLARITY COMING. Hormone therapies labeled "organic" or "natural" are also turning up in advertisements saying they can alleviate menopause symptoms, but experts caution that little is known about them. "Very few studies have been done," says LaValleur. "We have no safety data, no long-term data." Patients come to her asking for natural estrogens, she says, thinking they'll be safer, but she steers them away.

Is the revival of hormone therapy advisable? It isn't necessarily a bad thing "but we need to be careful about how estrogen and progesterone are used in the future," Stafford says. "We want to make sure we don't go back to a situation where women continue on hormones indefinitely."

More clarity on the issue may finally be on the horizon. In October, the North American Menopause Society gathered a panel of experts to discuss hormone therapy. The resulting consensus backed away from the WHI study as the last word on how to treat menopausal women. "I would say it's a better-reasoned look and actually looks at the evidence," says LaValleur. "There's so much more that we don't know, and it's an area so ripe for research."

If that research leads to new understanding and wiser use by doctors and patients, menopausal women will surely be thankful. Tsao is a writer for BusinessWeek Online in New York

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