HRT was once heralded as a cure-all for problematic symptoms of menopause, including hot flashes, sleeping difficulties, mood swings and vaginal dryness. It was also given the added benefit of protecting women against heart disease and osteoporosis.

However, opinion quickly changed in 2002, after a large study of postmenopausal women found that HRT that combined the hormones estrogen and progesterone increased a woman’s risk for breast cancer by about one extra case for every 1,000 women who took the hormones for a year. It also showed no evidence of protecting women against cardiac events.

Once word got out, prescriptions for HRT plummeted by half, and cases of breast cancer soon dropped as well. Despite the decrease in HRT use, researchers continued to study women who remained on the drugs. The women in the study were an average age of 63 and remained on HRT for an average of 11 years.

Researchers found that among these women there was not only an increase in the number of breast cancer cases, but the cancers they were diagnosed with were more likely to be advanced and more deadly than previously thought. Data shows an increase of one extra death per year for every 10,000 women.

While HRT use has been drastically cut since 2002, it is still used by many women to curb menopausal symptoms. Researchers say that while the new data shows only a slight increase in breast cancer deaths compared to previous studies, it adds more fuel to the argument against the medication.

Source: CBS

SOURCE: Hormone Replacement Therapy › Study finds HRT breast cancers are more likely to be advanced, deadly

The rejected appeal comes on the heels of a Pfizer report that it had put aside $772 million to settle lawsuits from women who claimed the pills caused them to develop breast cancer.

Prempro is a medication containing estrogen plus progestin. It is often prescribed to treat symptoms of menopause, such as hot flashes, vaginal dryness, mood swings, difficulty sleeping, and decreased sexual desire. Wyeth, which was later bought by Pfizer, had promoted the drugs as safe and claimed they offered women added benefits such as protection against heart disease and dementia.

However, a study as part of the Women’s Health Initiative (WHI) that looked at the effects of HRT in menopausal and post-menopausal women, was abruptly halted after early data showed HRT put women at risk for breast cancer. Since then, about 10,000 Prempro breast cancer lawsuits have been filed.

A large number of the Prempro trials have resulted in multi-million dollar awards against the drug maker after juries found that the drug company knew that the dangers associated with HRT but actively tried to cover up the risks.

SOURCE: Hormone Replacement Therapy › Supreme Court rejects Prempro breast cancer lawsuit appeal

Mrs. Smith talked to her doctor, who recommended Prempro, a pill made by Wyeth that contains a mixture of estrogen and synthetic progestin hormones. The pills were also marketed to doctors and women as a miracle drug that tamed not only menopausal symptoms but also had the added benefit of protecting women against heart disease and osteoporosis. HRT became widely prescribed, and Wyeth racked in billions in profits.

Less than two years after starting HRT, Mrs. Smith, an otherwise hormone deficient woman, was diagnosed with a hormone-fed breast cancer. She became part of a staggering statistic that was only just beginning to emerge from the Women’s Health Initiative, research that focused on causes of mortality and morbidity in menopausal and post-menopausal women. The study that focused on HRT was abruptly halted in 2002 when data showed that women who used HRT were at greater risk for breast cancer. They were also at increased risk for ovarian cancer, non-Hodgkin’s lymphoma, heart attacks, strokes and blood clots.

Perhaps even more disturbing is evidence that suggests that Wyeth was aware of the potential for serious health risks associated with its billion-dollar drug, but failed to warn doctors and their patients. As a result, as many as 10,000 women or their family members have filed lawsuits against Wyeth. This August, Mrs. Smith is scheduled to have her day in court.

“We look forward to the trial of this case,” says attorney Ted Meadows with Beasley Allen Law Firm. “Once the jury gets to see the evidence that other juries have seen, we believe they will agree that Prempro caused (Mrs. Smith’s) breast cancer and that doctors were not adequately warned because Wyeth refused to properly test the drug.”

* client’s name has been changed

For more information about HRT litigation, visit www.beasleyallen.com.

SOURCE: Hormone Replacement Therapy › HRT breast cancer trial set for August

“I think women are confused,” Dr. Joanna Longstaffe, clinical director of Independent General Practice told Wales Online. “I have far fewer people coming in for HRT and more coming in with menopausal symptoms saying they can’t have HRT because of the risks of breast cancer. This new research may muddy the waters more.”

Dr. Longstaffe says that women shouldn’t be misled about the new information. While women are at greater risk for brain aneurysms and estrogen helps protect women from developing them, brain aneurysms are very rare, and breast cancer is far more common.

For the study, researchers asked 60 women with intact brain aneurysms about their use of birth control pills or HRT, and then compared their answers with more than 4,600 women from the general population. Women with brain aneurysms were found to be significantly less likely to have taken oral contraceptives or HRT during their lives. They also had an earlier average age of menopause.

It’s very much an individual decision about whether to take HRT based on how bad a patient’s menopausal symptoms are and balancing the risks and benefits,” says Dr. Charlotte Jones, a GP in Swansea and chair of the Morgannwg Local Committee. “But patients do have to be aware of the risks, which is why we review decisions about HRT annually with patients.”

SOURCE: Hormone Replacement Therapy › New study can leave women even more confused about HRT

Depo-Provera is an injection used to prevent pregnancy. It is also used to treat endometriosis. The drug is in a class of medications called progestins that work to prevent pregnancy by preventing ovulation and thinning the lining of the uterus. It is administered through injection into the upper arm or buttocks, and is usually given once every three months by a health care provider in an office or clinic.

The updated Warnings and Precautions section warns women who currently have or have had breast cancer to not use hormone contraceptives, such as Depo-Provera, because breast cancer may be hormonally sensitive. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care. Hormone therapy has long been a health concern for women. A massive government-funded study on menopausal and postmenopausal established in 2001 a strong connection between combined estrogen and progestin hormone replacement therapy and breast cancer risk.

The Warnings and Precautions section also includes a warning that the drug may decrease the amount of calcium stored in the bones of patients who use the drug. The longer the medication is taken, the more the amount of calcium in the bones may decrease. Even after the drug has been discontinued, the amount of calcium in the bones may not return to normal. This calcium loss in the bones may cause osteoporosis and may increase users’ risk of bone breaks, especially after menopause.

SOURCE: Hormone Replacement Therapy › Depo-Provera’s new label warns of breast cancer, bone density loss

Asthma is more common in young women after they begin having periods, and hospitalizations due to asthma is higher among women than men. The severity of asthma also varies during a woman’s menstrual cycle and when she is pregnant. But studies show that asthma generally wanes after menopause.

Estrogen-only HRT has already been linked to uterine cancer in women who still had their uteruses, but the combined therapy was deemed safer for women who had not undergone a hysterectomy. Once thought to be a cure-all for not only menopausal symptoms but also for cancer and heart disease, the estrogen-plus-progestin HRT became a billion-dollar industry in the late 20th Century. But in 2002, a large-scale federal study found that women who took the combined HRT were at greater risk of breast cancer and heart disease. Since 2002, HRT use among women has dropped significantly.

Source: Reuters

SOURCE: Hormone Replacement Therapy › Estrogen-only HRT linked to asthma after menopause

As we all know, numerous studies later showed that HRT did far from make women healthier. It increased their risk of breast cancer and heart disease. Despite the studies, some doctors continue to prescribe hormone therapy to their patients battling symptoms of menopause. Is it a wrong decision?

Dr. James Dilliard, who writes a column for the East Hampton Star, says not necessarily. Choosing to take HRT should be a thoughtful decision that women should make only after discussing their risks with their doctors.

The difference between now and 10 or 20 years ago, when HRT drugs were being heavily advertised, is that women and their doctors are now armed with the research to help them make more informed decisions.

“The right answer is that you have discussed with your doctor all the risks and benefits of hormone replacement in light of all the research and relative to your health status, risks, and family history,” Dr. Dillard says, “and that together you have agreed that it is worth the risks, for you.”

SOURCE: Hormone Replacement Therapy › Research helps women make more informed decisions about HRT

The Women’s Health Initiative bought the story to light in 2002, when a trial on the effects of HRT on menopausal and post-menopausal women revealed that women who took the combined hormone therapy were at greater risk of breast cancer. Studies also showed that the HRT elevates a woman’s risk of other conditions such as ovarian cancer, heart attacks, strokes, deep vein thromboembolism, pulmonary embolisms, gallbladder cancer and non-Hodgkin’s lymphoma.

Unfortunately, Delores died from what her family says were complications of HRT. Last month, her family filed a lawsuit in the Tyler Division of the Eastern District of Texas against HRT manufacturers Wyeth, Pifzer, Pharmacia and Upjohn Co., and Watson Pharmaceuticals claiming the drug companies covered up the risks of HRT. The Whatley family also is alleging assault and battery, as well as negligent and intentional infliction of emotional distress, against the drug manufacturers. They are seeking damages for loss of love, affection, service and support, and medical and funeral expenses, and are requesting a jury trial.

Source: Southeast Texas Record

SOURCE: Hormone Replacement Therapy › Family claims HRT killed their mother

The news is just another blow to Prempro, a combination of estrogen and progestin that was widely prescribed to women as a treatment for menopausal symptoms. Prempro and other HRTs were once thought to improve a woman’s health as she entered postmenopausal years; however, results from a Women’s Health Initiative (WHI) shook that belief when the findings of that study revealed women on HRT were at an increased risk of breast cancer and cardiovascular disease. Since 2002, when the findings were released, sales of HRT medications like Prempro have plummeted and lawsuits against companies like Wyeth have escalated.

According to the new trial, which reviewed women from WHI age 50 to 79, after five years on Prempro 67 women died from non-small cell lung cancer compared with 39 on a placebo. The study group included both current and former smokers.

“This is a new finding that tells us women who smoke shouldn’t take estrogen and progestin for menopause symptoms,” said Rowan Chlebowski, the study author and a researcher at Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center.

According to the study, among the women classified as current or former smokers, there were 56 deaths among women taking hormones and 34 deaths among women on a placebo. Among the women classified as nonsmokers, there were 9 deaths for women on HRT and 5 deaths for those taking a placebo.

Source: Bloomberg.com

SOURCE: Hormone Replacement Therapy › Prempro increases risk of dying from small cell lung cancer

Researchers at Medco Health Solutions Inc. studied an estimated 1,300 women and found that women who were taking antidepressants such as Paxil, Prozac or Zoloft along with tamoxifen for at least one year had a breast-cancer recurrence rate of 16 percent. Women who were not taking the drugs reported a 7.5 percent recurrence rate. Antidepressants such as Celexa, Lexapro and Luvox appeared not to have an increased cancer recurrence rate.

Tamoxifen is a commonly used treatment for estrogen-dependent breast cancer, one of the most common types of breast cancer and one that has been associated with the use of hormone replacement therapy, HRT.

“If we lower the effectiveness of tamoxifen, you’d get worse outcomes.” Says Dr. Julie Gralow, an associate professor in oncology at the University of Washington School. She says many doctors in the U.S. also prescribe aromatase inhibitors rather than tamoxifen to block estrogen in post-menopausal women to prevent breast cancer from returning, which also avoids the tamoxifen-antidepressant interaction.

An estimated 30 percent of the half million American women taking tamoxifen have also been prescribed antidepressants. Medco says it has found that some doctors who treat breast cancer patients are not aware of the increased recurrence risk for breast cancer patients taking tamoxifen and antidepressants.

Source: The Wall Street Journal

SOURCE: Hormone Replacement Therapy › Tamoxifen with antidepressants may raise risk of breast cancer recurrence

The study published this week in the Epidemiology journal refutes the notion that a family history contributes to the carcinogenic effects of estrogen.

“Although we know that family history is a risk factor, we don’t know yet what it is about family history that conveys the risk,” said Robert E. Gramling, M.D., D.Sc., assistant professor of Family Medicine and of Community and Preventive Medicine at URMC. “Some have proposed that it might be an increased sensitivity to estrogen, but our data did not support that notion. In fact, this study suggests the causal pathway based on family history is probably not estrogen sensitivity.”

Family history is identified as a “first-degree family history,” involving breast cancer in a mother, sister or daughter. Both family history and estrogen therapy have independently been identified as a risk factor for postmenopausal women. The Rochester study focused on whether the two risk factors together increased a woman’s risk.

Researchers used data from the Women’s Health Initiative randomized trial, which followed 16,608 premenopausal women who took HRT or a placebo pill between 1993 and 2002. The study was halted after data began to show that HRT greatly increased a woman’s risk of breast cancer, heart disease and other serious illness.

SOURCE: Hormone Replacement Therapy › HRT-breast cancer risk same regardless of family history

Last February, the New England Journal of Medicine concluded that HRT was in fact linked to a surge of breast cancer cases and that women who took a combination of progestin and estrogen for more than five years doubled their risk of breast cancer – a statistic far greater than originally thought. It also showed that a typical 50-year-old woman has less than a 1 percent chance of developing breast cancer, and if she takes HRT for less than four years, her risk of breast cancer drops back down to normal. Also, HRT now contains far less estrogen and progestin.

The new information gives women who are having a difficult time suffering through the symptoms of menopause the opportunity to make a more educated decision about whether to take HRT. Dr. Marcia Stefanick, a professor of medicine at Stanford University, says that before making a decision a woman should assess whether she is at high risk for breast cancer.

Women who are considered high risk for breast cancer include those with a family history of the disease, women who have had children after the age of 30 or have never had children, and women who started menstruating before age 11. Age is also a factor, as older women are at higher risk for the disease.

SOURCE: Hormone Replacement Therapy › More studies help women make educated decisions about HRT

Years ago, HRT was the method-of-choice for most women to combat annoying menopausal symptoms such as hot flashes, moodiness, night sweats and decreased sexual desire. The therapy also was thought to offer other benefits, such as a lowered risk of heart disease and breast cancer.

However, the Women’s Health Initiative (WHI) of 2002 changed popular opinion when it found that HRT greatly increased a woman’s risk of breast cancer, heart disease and other serious illnesses. Since then, HRT and its effects have continued to be a closely studied therapy.

University of California-Irvine senior statistician, Sarah F. Marshall, presented the findings of her study at the San Antonio (Texas) Breast Cancer Symposium. The study followed 2,800 postmenopausal women who developed breast cancer beginning in 1995 until their deaths or through the end of 2005.

It found that women who took HRT before they were diagnosed with cancer were more likely to be diagnosed with estrogen receptor-positive cancer, and that the cancer was smaller and detected at an earlier stage. Marshall says that this type of cancer – estrogen receptor-positive cancer – is easier to treat and as a result, women have a lower risk of dying.

SOURCE: Hormone Replacement Therapy › Estrogen receptor-positive cancer easier to treat, study says

Hot flashes and night sweats are a common symptom of menopause in most women. While the cause is unknown, researchers believe those symptoms are due to changing levels of estrogen on the temperature regulation centers of the brain. According to the report, when estrogen levels drop during menopause, it triggers the body to release heat, making the woman experience a hot flash. Since body fat is insulating, researchers believe that women with more body fat may have a hard time dissipating body heat when hot flashes occur. Thus, the hot flashes tend to last longer.

Overweight women also tend to have higher circulation levels of estrogen, which was initially thought to reduce the impact of hot flashes. Higher estrogen circulation can help reduce the risk of osteoporosis, but also can increase a woman’s risk of breast and uterine cancers.

Because menopausal symptoms can become bothersome, many women turn to hormone replacement therapy (HRT). HRT was a common treatment for menopausal symptoms however more women are opting to go without or seek alternatives to HRT after the Women’s Health Initiative of 2002 showed that HRT increased a women’s risk of serious health conditions such as breast cancer and heart disease.

Some studies suggest that exercise may help alleviate some symptoms of menopause, such as hot flashes and night sweats. Considering the study recently published in the American Journal of Epidemiology, perhaps reducing body fat can also reduce the duration of hot flashes.

SOURCE: Hormone Replacement Therapy › Heavier women suffer more hot flashes, study suggests

Wyeth Pharmaceuticals caught wind of the book and its author’s claims that estrogen reduced a woman’s risk for both breast and genital cancers, and began distributing the book to physicians across the country. Soon after, sales of Wyeth’s HRT drug Premarin took off, growing to more than 30 million prescriptions each year.

But the Women’s Health Initiative of 2002 showed dramatically different results, finding the use of hormone replacement therapy linked to an increased risk of breast cancer, cardiovascular disease, heart attacks and blood clots.

This is the basis of at least 22 federal lawsuits that have been filed over a period of two days against Wyeth, according to The West Virginia Record.

“The WHI and NCI studies released in July 2002 changed the way doctors and scientists viewed estrogen – not only does estrogen hormone therapy fail to prevent disease, it substantially increases the risk of causing disease,” the suit states.

The plaintiffs claim they suffered bodily injury, pain and suffering, disability, disfigurement, mental anguish and the loss of their capacity to enjoy life. The suit contends that Wyeth should be held liable because it did not perform adequate pre-clinical testing nor did it conduct post-marketing surveillance to determine the product’s safety. Wyeth also did not provide adequate warnings of long-term use of HRT, instead continuing to market its medication to physicians, according to the lawsuit.

The 13-count lawsuit seeks unspecified compensatory and punitive damages.

SOURCE: Hormone Replacement Therapy › Wyeth faces more lawsuits for promoting sales despite concerns

The research revealed that women with no existing heart conditions who took HRT experienced negative heart health effects, including inflammation which can be related to heart disease.

The study was prompted by researchers who wanted to know the validity of the so-called six-week timing hypothesis, a theory which came about following the Women’s Health Initiative which linked the use of HRT to an increased risk of heart disease and other serious diseases and conditions. The timing hypothesis suggests that if a woman begins HRT within six years of her final menstrual period, the drugs could keep heart disease from developing at the onset of menopause.

While the six-week window found HRT showed beneficial changes in HDL and LDL cholesterol levels, the risk of heart disease was still a viable threat, according to researchers. Thus, women are encouraged to discuss their options with their doctors in order to make a decision they are comfortable with.

Heart disease risk can be measured with lipid panels and by measuring inflammation markers. These tests typically are not conducted as part of an office visit for women considering hormone replacement therapy.

SOURCE: Hormone Replacement Therapy › Researchers find HRT can have negative effect on heart health

Researchers found that women who took the breast cancer drugs were 30 percent less likely to have their cancer return over the next nine years. The drugs essentially starve potential cancers of estrogen, which can cause menopause-like symptoms in the women who take them. While the side effects may be discouraging, they may also be showing how well the treatment is working.

Researchers looked at 4,000 post-menopausal women who took AstraZeneca’s Arimidex, also known as anastrozole, or tamoxifen. Arimidex can only be taken by women who already have gone through menopause. The study showed that women who reported the menopause-like side effects within three months of treatment were more likely to remain cancer free.

Breast cancer is one of the most common forms of cancer among women, and the second most common cause of cancer death among women. According to Breast Cancer: Network of Strength, female breast cancer incidence rates continuously increased for two decades, but have leveled off since 2001. The organization theorizes that one possible explanation for the decrease is that millions of women stopped taking hormone replacement therapy (HRT) following the Women’s Health Initiative of 2002, which indicates a positive link between taking HRT and developing breast cancer.

SOURCE: Hormone Replacement Therapy › Hot flashes, sweats from anti-cancer drugs may be good sign

Premarin is a low-dose mixture of estrogen hormones and is already available in pill form to treat symptoms of menopause such as hot flashes and vaginal dryness, burning and itching. Premarin and another Wyeth drug prescribed for menopausal symptoms, Prempro, dominated the hormone replacement therapy market until the Women’s Health Initiative of 2002 linked long-term use of HRT to an increased risk of breast cancer and other serious health problems. Wyeth has since been faced with numerous lawsuits concerning the drugs.

Dyspareunia is a disorder that follows the atrophy or thinning of the vagina and vulva, a condition that can occur in menopause.

The .5-gram cream has two dosing regiments – 21 days on followed by 7 days off, or twice weekly. FDA approval of the cream and its dosing regime was granted based on results from a multi-center clinical study that included a 12-week, randomized, double blind placebo phase followed by a 40-week open-label phase, according to the story.

Wyeth advises women considering the cream to review possible side effects with their physician, and to avoid the product if they fall into a high-risk category.

SOURCE: Hormone Replacement Therapy › FDA approves Premarin cream to treat dyspareunia

During menopause, sex drive can drop to very low levels, which some believe may be a result of lowered levels of estrogen, progesterone and testosterone in the body during menopause. Estrogen helps you to feel heightened sensitivity during sexual intercourse. Progesterone keeps your libido up. Testosterone boosts sexual desire and lubricates the vagina.

For relief from menopausal symptoms, women typically have been prescribed hormone replacement therapy (HRT), which is a medication containing female hormones such as estrogen. More and more women and their doctors are shying away from HRT as a result of recent studies which have found the use of HRT places women at a higher risk for breast cancer as well as other serious conditions.

The FDA has not approved the use of testosterone for low sexual function, though off-label use is allowed.

According to FoodConsumer.org, a Study by Swiss researchers titled “breast cancer risk in postmenopausal women using testosterone in combination with hormone replacement therapy” found that testosterone patches used for 24 weeks more than doubled monthly sexual episodes in women with low sexual desire and activities. However, in the one-year trail, breast cancer was diagnosed in four of the 534 women treated with the testosterone compared to none in the 277 women who were taking placebos.

Researchers concluded that “at present, there are no valid randomized or observational clinical studies that provide evidence that the addition of testosterone to conventional postmenopausal hormone therapy influences breast cancer risk.”

SOURCE: Hormone Replacement Therapy › Male hormone increases sex drive, cancer risk questionable

Perimenopause is the body’s natural transition toward menopause. This is period leading up to menopause – anywhere from two to eight years – as well as the first year after a woman’s last menstrual cycle.

Many women may not realize they can feel the symptoms of menopause long before menopause occurs. However, as many as 80 percent of women have reported experiencing menopausal symptoms years before they enter menopause.

There is no way of knowing when perimenopause starts or how long it will last. Women usually experience perimenopause in their 40s, though some experience it as early as their mid 30s.

During perimenopause, a woman’s estrogen levels rise and fall unevenly. Menstrual cycles may lengthen or shorten and women start having cycles where they don’t ovulate. They also may begin experiencing hot flashes, mood swings, sleep problems, vaginal and bladder problems, changes in sexual function and bone loss.

Therapies – such as oral contraceptives and IUDs – are available to quell the physical symptoms of perimenopause and regulate periods. AsiaOne quoted Dr Christopher Ng, a consultant obstetrician and gynecologist at GynaeMD Women’s and Rejuvenation Clinic at Camden Medical Centre, who encourages patients to focus on good nutrition and regular exercise, to adopt a low-fat, high-fiber diet rich in calcium, and to avoid alcohol and caffeine, which can trigger hot flushes.

Good nutrition is key at this point in a woman’s life as declining estrogen levels may lead to serious conditions. For example, diminishing estrogen levels may lead to an increase in low-density lipoprotein (LDL) cholesterol – also known as the “bad cholesterol” – as well as a decrease in high-density lipoprotein (HDL) cholesterol – or “good cholesterol” – both of which contribute to an increased risk of heart disease.

SOURCE: Hormone Replacement Therapy › Women can experience symptoms years before menopause

According to the study, women who have never given birth had, per child, a two percent adjusted increase in the risk of having a hip replacement and an eight percent increase of knee replacement. Current use of HRT was associated with a 38 percent increase in hip replacement and a 58 percent increase in knee replacements. There was no explanation why there was a greater risk of hip replacement over knee replacement.

The study also found that women who had their first period at or before age 11 were nine percent more likely to have a hip replacement and 15 percent more likely to have knee replacement compared to women who started their periods after age 11. Researchers also found that past use of oral contraceptives had no relationship to hip or knee replacements.

The researchers noted that estrogen is well known to prevent bone loss, however past research is divided as to whether estrogen is damaging to cartilage.

SOURCE: Hormone Replacement Therapy › Study finds HRT may increase need for hip, knee replacements

Bone scans are used to check for osteoporosis, a disease in which bones become fragile and more likely to break. Women are typically four times more likely than men to suffer from osteoporosis. Because there is a direct relationship between the lack of estrogen after menopause and the development of osteoporosis, most doctors advise older women to have bone density tests every year along with a mammogram.

The University of Arizona’s eight-year study of 10,000 post-menopausal women found that the results of a routine bone density test not only could reveal osteoporosis, it also may provide important clues in predicting breast cancer risk in older, post-menopausal women. The study, which looked at hip-bone mineral density T-score, found older women with high bone density twice as likely to develop breast cancer.

“High bone density is a marker of increased risk for breast cancer. We can use that piece of information to predict your breast cancer risk in the future,” said Zhao Chen, Ph.D, MPH, University of Arizona epidemiologist.

Bone density often means a higher production of estrogen, which researchers say may explain the correlation between high bone density and breast cancer risk.

Conversely, KABC-TV reports that some osteoporosis medications have been shown to prevent and even curtail breast cancer. For example, raloxifene (Evista) has already been FDA approved to treat both osteoporosis and prevent breast cancer in postmenopausal women at high risk of developing the disease.

SOURCE: Hormone Replacement Therapy › Strong bones in menopause may increase risk of breast cancer

For six years, Danish researchers tracked nearly 700,000 healthy Danish women aged 51 to 69. While researchers found no increased risk of a heart attack in women who were currently using HRT compared with women who had never used HRT, there was a 24 percent increased risk among women aged 51 to 54, and an increased risk in women of the same age group taking the prescribed medications for a long period of time.

The study found that older women taking HRT over the long term did not have an increased risk of heart attack; however there was an increased risk among these women with estrogen alone.

The Danish study is the largest of its kind since the 2002 U.S. government-sponsored Women’s Health Initiative (WHI), that was halted when researchers found that HRT led to an increased risk of dangerous conditions such as breast cancer, heart attack, stroke and blood clots. A woman’s risk depended on whether she was taking estrogen alone or estrogen plus progesterone. The findings disputed the prior belief that HRT could reduce a woman’s risk of heart disease.

The Danish study points out numerous factors that impact the pros and cons of HRT, including the amount of hormone taken and the timing of use.

SOURCE: Hormone Replacement Therapy › Timing, method of HRT may affect heart attack risk

Researchers analyzed data from 38 observational studies involving more than 2.7 million women to see whether taking non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin and ibuprofen, reduced risk of breast cancer. Inflammation may be a risk factor in cancer, the report says.

Earlier studies on NSAIDS in reducing breast cancer risk have shown conflicting results. Reviewers hope that by combining results they may identify trends that individual studies may miss.

NSAIDs work through the suppression of estrogen, which has researchers speculating that the use of NSAIDs may reduce the risk of hormone-positive breast cancer. Hormone-positive breast cancer, also referred to as estrogen receptor (ER)-positive breast cancer, is the most common type of breast cancer and is stimulated to grow from exposure to the female hormones estrogen and/or progesterone, according to the Daily Cancer News –CancerConsultants.com.

According to the report, women who regularly took any type of NSAIDs had a 12 percent reduction of breast cancer risk. While the news is promising, the report urges that women should first consult their healthcare provider before using any NSAIDs, as these medications can have side effects that carry risks that outweigh the benefits against breast cancer.

SOURCE: Hormone Replacement Therapy › anti-inflammatory drugs may reduce breast cancer risk

For years, HRT was considered the cure-all for menopausal symptoms that range from hot flashes and riding the emotional roller coaster to bone loss and osteoporosis. But a 2002 study by the Women’s Health Initiative (WHI) and funded by the National Institutes of Health stopped women and their doctors in their tracks when the research revealed that the risks of HRT far outweighed and outnumbered the benefits. The WHI report stated that long-term use of estrogen/progestin therapy led to a 26 percent increase in breast cancer, not to mention a laundry list of other serious side effects.

The American Cancer Society suggests women talk with their own doctors before deciding whether HRT is right for them. The organization also suggested women heed the advice of the WHI, which includes not continuing or starting HRT to prevent heart disease; to discuss their risk of heart attack, stroke, blood clots and breast cancer before taking HRT for osteoporosis prevention; and to perform regular breast self-exams and schedule annual mammograms.

Using HRT for the short-term may be a safer alternative, the report states, however, “Given these results, we recommend that clinicians stop prescribing this combination for long term use. ‘Primum non nocere’ [First, do no harm] applies especially to preventive health care.”

SOURCE: Hormone Replacement Therapy › October is breast cancer month; time to evaluate breast health

A study published in the January issue of Cancer Epidemiology, Biomarkers and Prevention found that women who used combination hormone therapy for three or more years had a higher risk of lobular cancer.

The study was led by Dr. Christopher Li of the Fred Hutchinson Cancer Research Center and was designed to evaluate the relationship between combination hormone therapy and lobular breast cancers. Previous research indicated that five or more years of combined hormone therapy use was necessary to increase overall breast cancer risk. The study led by Dr. Li found that women who took combined hormone therapy for three years or more had four times the usual risk of lobular breast cancer.

The incidence of invasive lobular cancer rose by 52% in the United States between 1987 and 1999, and cases of ductal-lobular breast cancer rose by 96% during that time. According to Dr. Li, their research “suggests that the use of post-menopausal hormone-replacement therapy, specifically the use of combined estrogen-plus-progestin preparations, may be contributing to this increase.” Following the announcement of the results of the Women’s Health Initiative in July 2002, hormone therapy use fell sharply.

The incidence of breast cancer dropped more than 8% between 2001 and 2004. Beasley Allen law firm has been involved in extensive litigation dealing with hormone therapy and breast cancer. We are convinced that there will be more litigation in this area of concern. Ted Meadows and Melissa Prickett from our firm are handling cases for clients at this time.

SOURCE: Hormone Replacement Therapy › Hormone therapy update

For some the menopause can be uncomfortable and distressing. Symptoms can include: hot flushes, night sweats, palpitations, vaginal dryness, urinary tract infections, depression, mood swings, weight gain, memory problems or sore joints. The majority of women however will only suffer hot flushes and irregular menstruation, whilst others may not experience any symptoms at all.

Throughout the last four decades the use of Hormone Replacement Therapy (HRT) has become the conventional treatment for discomfort. HRT involves taking supplements of oestrogen and progesterone or, occasionally, testosterone. The hormones used are either identical to human hormones, are extracted from horse urine or are manufactured synthetic substances.

Whilst it has been shown that long-term use of HRT may help to prevent osteoporosis and bowel cancer, studies have also indicated that the dangers of the treatment may far outweigh the benefits. The greatest concern is a much higher incidence of breast cancer cases, heart attacks, strokes and blood clots in women taking HRT.

Many are now choosing to return to natural remedies to reduce and even prevent menopausal symptoms and there are many simple alterations to your life style that can also make the experience a much more pleasant one.

For instance many plants such as soya, tofu and flax seed contain oestrogen and regular consumption of these foods appears to have the same benefits as hormone replacement therapy. In fact, in areas of the world such as China, Japan, Thailand and India these foods are part of the daily diet and the incidence of unpleasant menopausal symptoms in women is minimal.

Hot spicy foods, smoking, caffeine, stress and alcohol can all exasperate symptoms and bring on hot flushes so all should be avoided or kept to a minimum. Lack of sleep can contribute to depression and mood swings so get plenty of exercise every day and avoid working late and large meals before going to bed.

Certain vitamins and minerals can also help. For example, vitamin B12 can support the nervous system and give you energy whilst vitamin E can alleviate symptoms and is a great antioxidant.

A herbalist or naturopath will also be able to recommend plant extracts that will help your body find its own natural balance. These include wild yam cream, red clover and evening primrose.

In some people hypnosis and self-hypnosis techniques have helped relieve symptoms and tackle problems of low self esteem and body image. XF

October 17th, 2007

SOURCE: Hormone Replacement Therapy › Natural menopause

The panel ruled Oct. 12 that the company owed the women $35.1 million in compensatory damages. Jurors in state court in Reno concluded today that Wyeth, the largest maker of hormone- replacement medicines, should also pay Arlene Rowatt, Jeraldine Scofield and Pamela Forrester punitive damages for concealing the breast-cancer risks of its Prempro and Premarin drugs.

“We got the word out that a lot of women have been injured by this type of behavior by this company,” Rowatt said after the verdict. She said she was “ecstatic” with the award. Lawyers for Wyeth, the largest maker of hormone-replacement therapies, said the company will appeal the verdict.

The three women’s suits, which were combined for trial, are among about 5,300 against Madison, New Jersey-based Wyeth over its menopause drugs. As many as 6 million women took the pills to treat menopause symptoms such as hot flashes and mood swings before a 2002 study highlighted the drugs’ links to cancer.

Annual sales of Wyeth’s hormone-replacement drugs exceeded $2 billion before the 2002 Women’s Health Initiative study, sponsored by the U.S. National Institutes of Health, suggested women using the medicines had a 24 percent higher risk of breast cancer. The drugs, which are still on the market, generated more than $1 billion in sales in 2006.

Ignored Risks

Lawyers for Rowatt, Scofield and Forrester argued in the Reno case that Wyeth officials ignored Prempro’s health risks and failed to properly warn doctors and consumers about the drug’s cancer link to boost profits.

Wyeth’s lawyers insisted the company conducted extensive safety tests on the drugs and warned of the risks through prescription labels and information sheets. The Reno verdict is the company’s fourth trial loss in suits over the drugs.

“The verdict is an extreme aberration,” said Heidi Hubbard, an attorney for Wyeth. “It is inconsistent with the end result of all other hormone-therapy cases tried to date, and is inconsistent with the evidence. We are confident the Nevada Supreme Court will give the flawed verdict careful scrutiny.”

Jurors considered ordering Wyeth to pay more than $1 billion in punitive damages before settling on the lower number, said Emery Pierce, 22, a supervisor for United Parcel Service who served on the panel.

Pierce said jurors were upset that Wyeth used misleading information on its labels for the Premarin and Prempo menopause drugs.

‘Care Enough’

“There’s no way they provided an adequate warning,” the Reno resident said. “They didn’t seem to care enough that breast cancer kills people.”

Having a jury find Wyeth’s conduct warrants a punitive- damage award should be a concern for the company, said Michael Kelly, a Wilmington, Delaware-based lawyer who represents drugmakers in product-liability cases.

“The punitive award shows that the jury found there was a conscious indifference to patient safety,” Kelly said. “That’s not the kind of reputation a pharmaceutical company wants to have.”

The Reno verdict was the fourth loss for Wyeth since lawsuits over the menopause drugs began going to trial in August 2006. It’s the largest verdict so far in the hormone-replacement therapy cases and the eighth-largest verdict of any kind in the U.S. this year, according to Bloomberg data.

Prempro Trials

The company has won two federal-court suits that have come to trial over Prempro and Premarin as well one case filed in state court in Philadelphia. Three other Philadelphia juries found the medicines contributed to the development of breast cancer in women and ordered the company to pay a total of $3 million in damages. Judges later threw out those verdicts.

Until 1995, many menopausal women combined Premarin, Wyeth’s estrogen-based drug, with progestin-laden Provera to relieve their symptoms. That year, Wyeth combined the two hormones in its Prempro pill after winning the U.S. Food and Drug Administration’s approval of the treatment.

Rowatt, 67, Scofield, 74, and Forrester, 64, all used Wyeth’s hormone replacement drugs for different lengths of time, according to court records. Rowatt was awarded $31 million in punitive damages by the Reno jury, Scofield $33 million and Forrester $35 million.

Rowatt, a retired Defense Department worker, used the drugs for more than seven years. Forrester, a former administrative assistant, used them for more than nine years. Scofield, a homemaker, was on hormone-replacement therapies for 15 years.

‘Deserved This’

All three women sat through the entire five-week trial. After the initial verdict was handed down last week, the trio cried as they hugged Zoe Littlepage, one of their lawyers. “You so deserved this,” the lawyer told them.

The jury initially awarded the plaintiffs $134.5 million, or more than $43 million each. The panel had to reconsider that verdict after Judge Robert Perry learned part of the figure was intended to punish Wyeth for its mishandling of the drugs.

Jurors cut that award to a total of $35.1 million in compensatory damages for the three women after spending several hours reconsidering their verdict on Friday.

Wyeth lawyer Dan Webb today asked Perry to throw out the punitive-damage verdict because of the jury error. The judge refused.

The jury told these three women “that their lives and suffering have value,” Littlepage said. The decision shows “what a courageous Nevada jury thinks of what Wyeth has done.”

According to a company-funded study presented today in Washington, Wyeth’s drug Pristiq, the first non-hormone menopause pill, reduces symptoms such as hot flashes more effectively than placebo. Pristiq was delayed by regulators for additional safety tests.

October 16th, 2007

SOURCE: Hormone Replacement Therapy › Wyeth must pay $134.1 million in menopause drug lawsuit

The company won 15 of the 18 lawsuits that have been tried, according to company information. Two others were settled, and one was in the plaintiff’s favor.

Lawyers for the three women who were awarded more than $120 million in jury awards in Reno have disputed Wyeth’s claims.

Nevada residents Jeraldine Scofield, Arlene Rowatt and Pamela Forrester testified that they developed breast cancer after taking Premarin, an estrogen replacement, and Prempro, a combination estrogen, and progestin to offset the symptoms of menopause.

They claimed in their lawsuit that Wyeth produced a dangerous product, failed to adequately test the drugs and failed to provide warnings about the drugs’ risks.

After two days of deliberations, the jury agreed with the women’s claims and ordered Wyeth to pay $43.5 million each to Scofield and Rowatt, and $47.5 million to Forrester.

The jury will deliberate at 10 a.m. today about punitive damages.

October 12th, 2007

SOURCE: Hormone Replacement Therapy › Wyeth fights more than 5,000 hrt lawsuits nationwide

It was the largest award to date against Wyeth, of Madison, N.J., which faces more than 5,000 similar lawsuits across the country in state and federal courts.

The panel deliberated for two days before announcing its verdict late Wednesday in favor of Jeraldine Scofield, 75, of Fallon; Arlene Rowatt, 67, of Incline Village; and Pamela Forrester, 64, of Yerington.

A Wyeth spokesman, Douglas Petkus, said Thursday that the company would have no comment. But in an e-mail message to The Associated Press, he noted that 20 similar cases had gone to trial or been otherwise resolved. Of those, he said, three were resolved in favor of the company, two plaintiff verdicts were set aside by the courts and three cases were dismissed on summary judgment. Twelve other cases were dropped by the plaintiffs before trial, he said.

During the trial concluded here, the women testified that they had started taking Premarin, an estrogen replacement, and Prempro, a combination of estrogen and progestin, to help offset menopausal symptoms, but were taken off the therapy when they developed breast cancer.

Wyeth lawyers said the company sponsored or participated in studies on the risks of breast cancer, and detailed the risks on warning labels included with each bottle of the drug.

Last October, Wyeth reached an undisclosed settlement with a fourth woman who had been part of the lawsuit. That woman, Carol McCreary, was found to have breast cancer in 2001 after taking Prempro for about 33 months. She died in April at 59.

To learn more about the link between hormone replacement therapy and breast cancer, visit www.hrt-legal.com.

October 12th, 2007

SOURCE: Hormone Replacement Therapy › Jury awards 3 women $134.5 million in hormone therapy lawsuit

The jury also must decide whether Wyeth failed to adequately test their drugs Premarin, an estrogen replacement, and Prempro, a combination estrogen and progestin, before putting them on the market and whether it failed to warn doctors about the drugs’ risks.

“Wyeth didn’t do (breast cancer) studies because the results could be embarrassing and could be costly,” Zoe Littlepage, a lawyer for Jeraldine Scofield of Fallon, Arlene Rowatt of Incline Village and Pamela Forrester of Yerington, told the jury.

The company’s decision to produce, market and sell a dangerous product affected thousands of women, and the company should be held responsible, Littlepage said during her closing argument in Washoe District Court.

Wyeth lawyer Heidi Hubbard said microscopic analysis showed the cancers each of the three women suffered are different, and no one can say why they developed. But each woman had a list of risk factors that could have contributed to their diseases.

“So many women get breast cancer, and we don’t know to this day what causes it; and researchers are trying to find the cause so they can find the cure,” Hubbard said.

“This case is about a medication that’s an appropriate treatment option for many women,” she said. “To this day, (the drugs) are the most effective available for menopausal symptoms.”

Scofield, 75, Rowart, 67, and Forrester, 64, began taking hormone replacement drugs years ago to offset hot flashes and other discomforts associated with menopause. But when each developed breast cancer, they stopped the drugs and underwent treatment.

The lawyers for the three women, who have sat in the front row of the courtroom every day of the trial, said Wyeth knew there were links between their drugs and the cancers but ignored the dangers in favor of skyrocketing sales.

The warning labels the company put on the drugs sounded more like reassurances than alarms, Littlepage said. Doctors testified if they knew then what they know now about the breast cancer risks, they never would have prescribed the drugs long-term as the company promoted them, she said.

Dan Webb, another Wyeth lawyer, challenged those claims.

Wyeth helped sponsor or participated in 63 studies to look at whether hormone replacement drugs increased the risk of breast cancer, he said. When the results came in, the company followed a directive from the U.S. Food and Drug Administration and created warning labels that detailed the risks, he said.

“The FDA knows more about research on drugs than the plaintiffs,” Webb said. “When (the women) say we didn’t properly test, it’s not true. Wyeth clearly understood the breast cancer risk and put it on the label.”

The women’s civil lawsuit seeks unspecified damages, but Littlepage told the jurors that they should look at how the company spent its money to promote the drugs when considering an appropriate amount. Those totals were in the millions of dollars.

October 10th, 2007

SOURCE: Hormone Replacement Therapy › Prempro lawsuit goes to the jury

Brett Hendricks, a former sales representative for Wyeth, provided riveting testimony regarding his twenty-one year career with the largest manufacturer of hormone replacement therapy drugs that outlined the organized deception of doctors and patients that plaintiffs contend overstated the benefits of HRT therapy while concealing the risks.

“That’s how we were trained,” Hendricks said. “To offset any bad publicity, we would redirect and emphasize the benefits of the product and say the benefits far outweighed any problems that might be out there.”

On the stand, Hendricks confirmed Wyeth’s marketing strategy that had already been laid out in the millions of pages of documents produced by Wyeth and others in the HRT litigation that has been pending for more than five years. Wyeth sales representatives were encouraged to engage in aggressive, one-on-one sales tactics with prescribing physicians to supplement the manufacturer’s advertising plan which included overselling the benefits of HRT drugs, discrediting scientific studies that raised any questions about safety (especially breast cancer risks), criticizing physicians who chose safer alternative drugs or counseled their patients on the option of not taking any HRT drugs at all, and pushing menopausal women to take combination hormone product drugs from the onset of menopause (or perhaps even before) and to continue taking the drugs throughout the rest of their lives.

In July of 2002, the Women’s Health Initiative (“WHI”) study was published and confirmed what many had long suspected – that Prempro and combination hormone replacement products (including Wyeth’s Premarin taken in combination with Pfizer’s Provera or another progestin such as medroxyprogesterone) are associated with an increased risk of hormone-positive breast cancers as well as other health risks, including heart attacks, strokes, blood clots, and ovarian cancer, etc.

The WHI Study (which was funded by the United States government, after manufacturers of hormone replacement drugs failed to conduct proper studies to evaluate the risks of HRT-induced breast cancer) led to a fundamental shift in the manner in which HRT drugs were prescribed. Today, physicians and patients are being told that HRT is not right for every woman, and instead should only be considered by those for whom the symptoms of menopause are severe and interfering with their lives. In addition, patients have been encouraged to use HRT drugs for the shortest time possible and at the lowest possible doses.

In fact, the Prempro product ingested by most women prior to 2002 no longer exists, and instead was replaced by a lower dose product (although it is not yet known whether a lower dose actually equates to a lower breast cancer risk). There is also a strong movement in the medical community to investigate other drugs for menopausal symptoms and osteoporosis, including SERMs (selective estrogen receptor modulators) and natural or bioidentical hormones that more closely resemble those that are made by a woman’s body. Prempro, for example, includes an estrogen compound derived from the urine of pregnant horses and chemically synthesized progestin (which is a necessary additive since estrogen alone has long been known to cause uterine cancer, but also eliminates many of the benefits that have been shown with use of estrogen alone and increases the risks of breast cancer).

The pharmaceutical industry has long maligned alternative therapies for menopausal patients, but evidence continues to mount that the HRT-induced breast cancer epidemic noted in recent breast cancer registries might have been avoided if women had been given more information in order to make meaningful decisions regarding treatment options years ago.

The Reno HRT trial is expected to last for a few more weeks. Alley, Clark, Greiwe & Fulmer will be trying the first HRT case in Florida in Pinellas County in June of 2008. This will be the first wrongful death claim to be brought to trial in the national litigation. The case was brought on behalf of a Clearwater grandmother who was diagnosed in early 2002 at the age of 59 with hormone-positive lobular breast cancer (the type most strongly associated with use of HRT drugs), just months prior to announcement of the WHI study results. Her cancer was very aggressive and had already spread to brain and bones by that time. After fighting valiantly for several years, she lost her battle and died late last year before her case was scheduled for trial. The lawsuit is now being prosecuted by her loving husband of forty-one years on behalf of her estate and survivors.

October 5th, 2007

SOURCE: Hormone Replacement Therapy › HRT sales rep whistleblower admits improper promotion