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Many rush to take menopause drug's place


In the eight weeks since the federal government announced that it had halted a study of a popular hormone therapy used by postmenopausal women, doctors say they have been deluged by an ever-growing tide of promotional material for anything and everything that could substitute for Prempro, the drug used in the study.

The alternatives run the gamut: prescription drugs that consist of slightly different hormone formulations, nutritional supplements made of herbs and vitamins, soy products said to be natural sources of estrogen and even what might be termed menopause accessories, such as one company's "cooling comfort towelettes" to wipe the sweat from hot flashes.

But many doctors and scientists say they are alarmed by the profusion of Prempro substitutes. The trouble, they say, is that these drugs and supplements have been studied less than Prempro has and their benefits and risks are unknown.

That is especially true for nutritional supplements. Their advertising receives far less government scrutiny than claims for prescription drugs, which are closely regulated by the Food and Drug Administration.

They are also sold without a doctor's guidance. "Everything you've ever heard of is being marketed," said Dr. Wulf Utian, executive director of the North American Menopause Society, "and it's being marketed to a confused and vulnerable population."

Prempro, a combination of estrogens and progestin made by Wyeth, has long dominated the menopause market. Until this summer it was used by 6 million American women, many of whom assumed they would be taking it for a lifetime to protect against some effects of aging, like brittle bones.

But when the federal study, the Women's Health Initiative, found that Prempro carried slight risks of heart attack, stroke and breast cancer that outweighed its benefits (a slightly lower risk of colon cancer and hip fracture), the part of the study in which women were taking Prempro was ended. A study in which women take estrogen alone continues.

A Wyeth spokesman, Doug Petkus, said sales of Prempro had declined 25 percent to 30 percent.

Many companies appear to have rushed into the opening. "The Women's Health Initiative Study wasn't out of my fingers before the mailings started coming in," said Dr. Nanette Santoro, a professor of obstetrics and gynecology at Albert Einstein College of Medicine and the Montefiore Medical Center in New York. "It's what you expect in a capitalist economy. You have people with products to sell."

Prempro, like other estrogen replacements, is clearly effective against some symptoms of menopause, including hot flashes and vaginal dryness. Dr. Isaac Schiff, chief of obstetrics and gynecology at the Massachusetts General Hospital, said the government's findings touched off "a mild to severe panic" and left some women desperate for alternatives.

"Now we are seeing the fallout," Schiff said. "They are saying, 'The hot flashes are killing me,' or 'I don't feel well.'"

Schiff said some of his patients tell him they have lost energy or a sense of well-being.

"They are trying to go back on estrogen," he said. "They do not want to go on Prempro."

While the level of marketing for alternative drugs and supplements is impossible to quantify in the short time since the findings about Prempro were reported, Schiff and others say they have been bombarded with fliers, e-mail promotions and visits from drug salespeople. A similar barrage is going out to patients, in the form of advertisements in newspapers and magazines, in the mail and on the Internet.

The American College of Obstetricians and Gynecologists has warned its members that it is not necessarily safe to switch women from Prempro to other prescription hormones, adding, "Caution is warranted for different preparations, and their safety should not be assumed in the absence of conclusive data."

But prescription hormones are only part of the picture. Doctors say they are particularly concerned about the promotion of nutritional supplements.

The college of obstetricians, for example, cautions, "The number and sophistication of most studies on alternative therapies, including botanicals, do not meet the current standards of evidence-based recommendations." It adds that "'natural' does not mean safe or effective," and that "potentially dangerous or lethal drug-herb interactions can occur."

The National Institutes of Health's National Center for Complementary and Alternative Medicine also cautions women on its Web site, http://nccam.nih. gov/health/alerts/menopause/, about the claims being made for vitamins, herbs and products like soy that contain plant estrogens.

"At this time, there is not enough scientific evidence to determine whether these therapies are beneficial," the Web site says.

Makers of the supplements assert that they are safe and effective. Gayle Engles, education director for the Botanical Council, a nonprofit group that disseminates information on herbal medicines, says that many of the products have been in use for hundreds of years and that some have been tested in scientific studies.

Still, Utian, of the menopause society, said that too many companies were sending a message he paraphrased this way: "The Women's Health Initiative has shown the other stuff is garbage, but we have the answer."

He noted an e-mail promotion with the headline: "Women Search for a Safe Alternative to Hormonal Replacement Therapy. Scientific Research Already Has the Answer." The company, SuperNutrition, says its vitamin and herb combination called Menopause Multiple Blend prevents hot flashes, strengthens bone, protects against heart disease, prevents memory problems and, best of all, is "safe and natural."

Makers of other products also advertise benefits that groups such as the National Institutes of Health say are not demonstrated.

Other companies offer custom blends of actual estrogens and progestins. These products do not require explicit FDA approval because they are simply mixtures of approved drugs.

Schiff, at Massachusetts General, pointed to a flier from one such company, the Women's International Pharmacy, advertising "bio-identical hormones" and "customized prescriptions" and claiming that its product is safer than hormones sold by drug companies. "They have no evidence for that," Schiff said.

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