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Pfizer Loses Prempro Ruling Must Pay 10 Million

Pfizer (PFE) (PFE) Inc. must pay $10.4 million in damages to a woman who blamed the company’s Prempro menopause drug for her breast cancer, an appeals court said.

Jurors properly awarded Audrey Singleton, who sued Pfizer’s Wyeth unit over Prempro, compensatory and punitive damages for the company’s marketing of the drug, the Pennsylvania Superior Court ruled yesterday. Singleton’s lawyers alleged that Wyeth hid the drug’s health risks and a jury awarded her damages on those claims in 2010.

“Wyeth’s concerted effort to misdirect physicians from the dangers of Prempro illustrates the consciousness that its conduct was not at all reasonable,” the three-judge panel said in upholding the jury’s findings.

The ruling comes as Pfizer officials are working to settle lawsuits over the menopause drugs. The drugmaker has settled about 60 percent of cases over the medicines and paid out $896 million, executives said in a May filing with the U.S. Securities and Exchange Commission. The company has set aside an additional $330 million to resolve the remaining cases.

More than 6 million women took Prempro and related menopause drugs to treat symptoms including hot flashes and mood swings before a 2002 study highlighted their links to cancer. At one point, Pfizer and its units faced more than 10,000 lawsuits over the medications.

Many Patients
Until 1995, many patients combined Premarin, Wyeth’s estrogen-based drug, with progestin-laden Provera, made by Pfizer’s Pharmacia & Upjohn unit. Wyeth combined the two hormones in Prempro. The drugs are still on the market.

Chris Loder, a spokesman for the company, said “the evidence in this case does not support the plaintiff’s claims,” and that the company is “evaluating its next steps.”

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Moderate Drinking May Help Older Women’s Bones

July 11, 2012 — Women who drink alcohol moderately may be doing their bones a favor, new research suggests.

“Moderate alcohol as a component of a healthy lifestyle that includes a balanced diet and physical activity may lower the risk of osteoporosis,” researcher Urszula Iwaniec, PhD, associate professor at Oregon State University, tells WebMD.

The study is small, with only 40 women, she cautions, and the research needs to be repeated in larger groups to see if the findings hold up.

The women in the study averaged 1.4 drinks a day. More than 90% were wine drinkers, Iwaniec tells WebMD.

The study is published in the journal Menopause: The Journal of the North American Menopause Society.

Drinking and Bone Health: Study Details

In the past, other research has found a link between moderate drinking and bone health, as measured by bone density, Iwaniec says. However, it has not been shown definitely that alcohol itself helps the bones or that the benefit is due to other factors.

Her team evaluated healthy women who were in early menopause, not on hormone therapy, and drank only moderately. Their average age was 56 and they had no history of fractures related to osteoporosis.

Bones are constantly remodeling, with old bone being removed and replaced. Estrogen helps keep this bone remodeling process in good balance.

As women go through menopause and estrogen declines, they are at risk of decreased bone density and getting osteoporosis.

The researchers took blood samples at the study start and computed the levels of indicators of bone turnover.

Next, the researchers asked the women to abstain from all alcohol for two weeks and took blood samples again.

After two weeks, the rate of bone removal and replacement increased. “That means that bone turnover is increased, and increased bone turnover is an independent risk factor for fractures [in older women],” Iwaniec says.

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Low Fat Diet May Ease Hot Flashes

In addition to its other benefits, a low-fat diet may also reduce menopausal hot flashes and night sweats, new research has found.

Scientists studied 17,473 menopausal women who were not on hormone therapy. Forty percent were assigned to a low-fat dietary plan with increased intake of fruits, vegetables and whole grains. They met periodically with nutritionists to assure compliance. The rest ate their customary diets. All participants recorded night sweats and hot flashes with details about their severity.

Over all, women in the diet group were 14 percent more likely to eliminate these symptoms in the first year than those not on the diet, a difference that persisted after controlling for initial weight, smoking, ethnicity and other factors.

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Menopause and Marketing, Do Women Need Freshening?

Menopause should mean fewer trips to the feminine hygiene aisle, right?

Not if Kimberly-Clark has its way. The company is about to extend its Poise line of products for women of a certain age. Included: a lubricant for vaginal dryness, cooling towelettes and a roll-on gel for hot flashes, and panty “fresheners” and a “vaginal wash” for vaginal odor — all addressing what the company says are common problems in over-40 women. The line already includes panty liners for women with “light bladder leakage.”

The theme of the marketing campaign: “The Second Talk” — meaning a talk about menopause equivalent to the one young girls get about their periods.

“There’s not a lot of conversation happening about menopause,” a company official tells the Associated Press.

Never mind “Menopause the Musical” or the decade-long debate about hormone therapy for hot flashes. It’s probably true that women don’t do a lot of chatting about vaginal dryness (though lubricants, moisturizers and estrogen products have long been available for that problem). And those cooling towels sound harmless enough (though not as nice as having fewer hot flashes in the first place — something an encouraging new study suggests many women might do by losing weight).

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Ovary transplant could put menopause ‘on ice’

Women will be able to give birth in old age following an ovary transplant breakthrough that means they can postpone menopause until well after their 50s.

The technique to remove parts of an ovary, store them for decades and then transplant them, could effectively put menopause “on ice”, doctors have said. Only physical ability to carry a baby would prevent women from becoming mothers, meaning they would no longer have to think about the “biological clock”.

A conference in Istanbul was told that 28 babies had been born to infertile women who had ovary tissue transplants, and that most of the children were conceived naturally without the need for IVF or drugs.

Dr Sherman Silber, an American surgeon who has been involved in transplants for 11 women at a hospital in St Louis, Missouri, said: “A woman born today has a 50 per cent chance of living to 100. That means they are going to be spending half of their lives post-menopause.

“You could have grafts removed as a young woman and then have the first replaced as you approach menopausal age. You could then put a slice back every decade.

“Some women might want to go through the menopause, but others might not.”

Scientists said the treatment could also have health benefits, by avoiding the increased risk of osteoporosis and heart disease linked to menopause. They admitted, however, it may raise the risk of breast and womb cancer.

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15 Top Medical Organizations Agree on Hormone Therapy Use; 10 Years Have Passed Since Women’s Health Initiative Raised Questions

After 10 years of debate regarding the risks and benefits of hormone therapy, 15 top medical organizations have come together to issue a statement of agreement regarding the benefits of hormone therapy for symptomatic menopausal women.

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Hormone Therapy Undergoes 10-Year Review

A systematic review of nine randomized, placebo-controlled trials published to assess the effectiveness of menopausal hormone therapy in the prevention of chronic conditions revealed: estrogen plus progestin and estrogen alone decreased risk for fractures but increased risk for stroke, thromboembolic events, gallbladder disease, and urinary incontinence; estrogen plus progestin increased risk for breast cancer and probable dementia; and estrogen alone decreased risk for breast cancer.

At one time, menopausal hormone therapy was routinely used by postmenopausal women to prevent cardiovascular disease, dementia, osteoporosis and other chronic conditions. However, once initial results of the Women’s Health Initiative (WHI) trials emerged in 2002 indicating important adverse health effects of this treatment, the U.S. Preventive Services Task Force (USPSTF) issued recommendations against using hormone therapy to prevent chronic conditions for estrogen plus progestin in 2002, and for estrogen only in 2005.

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How to Find Reliable Menopause Information Online

Seventy-two percent of women have not received any treatment for menopausal symptoms, according to recent study conducted by Lake Research Partners for the Endocrine Society.

Of those polled, 45 percent said they thought current available information was confusing and 41 percent weren’t sure what to trust.

There are over 10 million menopause websites, many with misinformation about menopause, treatment options, tests, and strategies.

How do we find reliable menopause information online so we can have a productive conversation with our health care providers?

Different types of information are provided by a variety of websites: unbiased sites from scientific organizations, commercial sites with medically reviewed content, hospital sites, online health news, blogs and communities.

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Menopausal women could ‘work out’ their hot flashes

Menopausal women who exercise may experience fewer hot flashes in the 24 hours following physical activity, according to health researchers.

In general, women who are relatively inactive or are overweight or obese tend to have a risk of increased symptoms of perceived hot flashes, noted Steriani Elavsky, assistant professor of kinesiology at Penn State.

Perceived hot flashes do not always correspond to actual hot flashes. Most previous research analyzed only self-reported hot flashes. This is the first study known to the researchers to look at objective versus subjective hot flashes.

Elavsky and colleagues studied 92 menopausal women for 15 days. The women recruited for this study were different from many earlier menopause studies, said Elavsky. In the past, women in menopause studies were experiencing severe symptoms and seeking help. They were probably not representative of the general population.

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