Premarin and Premplus are made by Wyeth, which was later bought out by Pfizer. In a statement issued by Pfizer, the drug company said it would fight the charges and argued there was no way to prove HRT causes breast cancer: “It is widely accepted that science cannot determine what caused or contributed to any individual woman’s breast cancer except in rare circumstances where genetics play a role. Wyeth acted responsibly by conducting or supporting more than 180 studies on hormone therapy’s benefits and risks, and including science-based information in Premarin and Premplus’ labels that accurately communicate these benefits and risks to doctors and patients alike.”

Wyeth strongly promoted HRT as a cure-all for symptoms of menopause that not only treated hot flashes and vaginal dryness, but also offered added benefits such as protection from osteoporosis and heart disease. Any negative press about the drugs was quickly overshadowed by articles promoting the benefits of HRT in medical journals written by ghostwriters paid by Wyeth.

Despite the cover up, the public became aware of the dangers of HRT in 2002, when the Women’s Health Initiative (WHI) published a five-year study of menopausal and postmenopausal women that demonstrated that HRT increases the risk for cardiovascular disease and breast cancer.

“I never would have taken Premarin if I had been told of the risks,” said the main plaintiff in the class-action lawsuit, Dianna Stanway of Sechelt, B.C., in a statement issued by her law firm. “I want my lawsuit to help all Canadian women, and their families, who have been harmed by this drug.”

Source: Toronto Sun

SOURCE: Hormone Replacement Therapy › British Columbia certifies HRT class action lawsuit

Wyeth had heavily promoted its HRT drugs Premarin and Prempro as safe and effective treatments for bothersome symptoms of menopause. The pharmaceutical company even promoted the pills for their added benefit of protecting women against heart disease and dementia. But evidence was beginning to surface that the drugs were actually far more dangerous than the public or doctors ever perceived.

The Women’s Health Initiative (WHI), a research project on the morbidity and mortality of menopausal and post-menopausal women, abruptly halted its study on HRT in 2002 when data showed a significant risk for breast cancer in women who used HRT.

In Singleton v. Wyeth, the jury had awarded $3.45 million in compensatory damages, which the court raised to $4.4 million for delay, and $6 million in punitive damages, according to The American Association for Justice. Judge Mark Bernstein based the punitive award on Wyeth’s deceptive public relations campaign designed to “dismiss and distract” doctors away from concerns about HRT and breast cancer.

The drug company went so far as to fund continuing medical education programs in an attempt to convince physicians that there was no increased risk for breast cancer, and used training materials to imply that the drugs would, in fact, protect women from developing the disease.

There are 15,000 hormone replacement therapy cases pending in lower courts.

Source: The American Association for Justice

SOURCE: Hormone Replacement Therapy › Compensatory and punitive damages awarded in HRT lawsuit

Wyeth Pharmaceuticals

Each plaintiff in the consolidated lawsuits had filed suit against Wyeth more than two years after being diagnosed with breast cancer, which was outside the statute of limitations, but within two years of the Women’s Health Initiative (WHI) study’s publication date in 2002. The study had established the link between HRT use and breast cancer, and the fact that doctors were not even aware of the dangers until WHI results were published.

In fact, in the years leading up to the WHI announcement, sales representatives were instructed by Wyeth to promote HRT as a safe treatment for menopausal symptoms and that the drugs helped protect women against cardiovascular disease and dementia. Wyeth even funded continuing medical education programs intended to convince physicians that there was no increased risk for breast cancer with HRT. Wyeth also provided training materials implying that the drugs would protect women from developing the disease.

Some Wyeth reps were compelled to write letters to the company’s ethics board expressing their concerns about misleading physicians and putting the public in danger.

“Given those facts,” plaintiffs argued in their brief to the state supreme court, “reasonable jurors applying the discovery rule could find that plaintiffs used reasonable diligence to discover that defendants caused plaintiffs’ cancer and file suit.”

The high court of Pennsylvania responded by denying Wyeth’s appeal, which trial lawyers say will likely impact thousands of pending HRT and breast cancer cases.

Source: The American Association for Justice

SOURCE: Hormone Replacement Therapy › Denial of Wyeth appeal in high court likely to affect pending HRT cases

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 pill, known as TU-025, combines cinnamon bark, peach pits and several other botanicals, and is regulated as a prescription drug in Japan. It is commonly used by Japanese gynecologists to treat hot flashes in menopausal women. The drug’s maker, Tokyo-based Tsumura & Company, helped fund a study to see if the benefits would also be seen in American women. The consensus was that if it proved beneficial, the herb could offer a safer alternative to traditional hormone replacement therapy (HRT).

For years, it was widely publicized that HRT not only curbed menopausal symptoms but also helped protect women against heart disease and osteoporosis. A study conducted in 2002 found that instead of improving the quality of women’s lives, it was actually putting them at great risk for developing breast cancer. As more and more women are looking for safer alternatives to HRT, the herb-based TU-025 became an attractive notion.

To determine the effectiveness of TU-025, researchers randomly assigned 178 postmenopausal women to take either the herbal pills or a placebo every day for three months. At the end of the study, researchers found that women who took the herb experienced fewer hot flashes, sleep problems and other symptoms associated with menopause.

However, women who took the placebo reported similar improvements. Thus, the “miracle drug” TU-025 will not be marketed in the United States.

Source: Reuters

SOURCE: Hormone Replacement Therapy › Herbal alternative to HRT denied FDA approval

PAD, which is also referred to peripheral vascular disease, is a condition of the blood vessels that leads to narrowing and hardening of the arteries that supply the legs and feet. People with PAD have an exceptionally elevated risk for cardiovascular events and the majority will eventually die of a heart attack or stroke.

The study involved 847,982 postmenopausal women, 51.1 percent of whom reported having used HRT. Those who used hormone therapy were slightly older than patients who had not used the drugs, and significantly more likely to be Caucasian. However, they were less likely to have diabetes.

Data found that women on HRT did in fact have a decreased risk for developing PAD. When risk factors – such as smoking history, hypertension, high cholesterol or diabetes – were looked at separately, there was still a 20 percent chance for the reduction of PAD in women who used HRT.

The study provides at least one benefit for highly controversial hormone replacement therapy. The pills were widely used and touted by the manufacturer as a cure-all for menopausal symptoms from hot flashes to moodiness with the added benefit of reducing the risk of heart attacks and dementia. However, a huge study as part of the Women’s Health Initiative revealed that the drugs instead had little cardiovascular benefits for women and put them at risk for breast cancer.

Source: Med Page Today

SOURCE: Hormone Replacement Therapy › Breast cancer risk outweighs HRT PAD benefit

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

Charles H. Payne

In a letter dated July 18, 2000, Payne wrote that he had been given written presentations from company management to promote the drugs for conditions such as the prevention of Alzheimer’s disease and of cardiovascular disease. The drugs are only approved for the treatment of menopausal symptoms such as hot flashes and vaginal dryness.

Payne said he was concerned about Wyeth-Ayerst’s liability, “since many recent studies have shown increased incidences of breast cancer, heart attack, and little effect on Alzheimer’s disease, and many physicians may have been influenced by representatives when detailing out of labeling to prescribe Premarin or Prempro.”

Payne’s letter and similar letters written by other Wyeth sales representatives were classified information for more than a decade and have only just come to light. The letters express serious concerns that the drug manufacturer was encouraging its drug sales to reps to minimize any risk of breast cancer, and to promote dangerous off-label use of its hormone replacement therapy (HRT) drugs Premarin and Prempro.

Just two years after the letters were written, the Women’s Health Initiative uncovered alarming evidence that the drug company was evidentially already privy to – that HRT was causing women to become gravely ill with diseases such as breast cancer.

“My sales, monetary incentives, and health have been impaired by this matter, but I feel very strongly about this issue,” Payne wrote. “This is a potentially life threatening situation for the women in Alabama and Georgia and I will not be intimidated or coerced to retreat in my actions to correct this problem.”

Source: Charles H. Payne’s letter

SOURCE: Hormone Replacement Therapy › Wyeth salesman warned ethics board about dangers of HRT

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

The popular HRT drugs, including Premarin and Prempro, were marketed by Wyeth Pharmaceuticals as a cure-all for bothersome symptoms of menopause with added benefits such as protecting women against osteoporosis and heart disease. In 2002, a long-term study on women’s health instead found the drugs put women at greater risk for breast cancer and other deadly diseases and conditions including ovarian cancer, non-Hodgkin’s lymphoma, heart attack, stroke and blood clots.

Thousands of women or their family members filed suit against the drug company alleging that Wyeth was aware of the dangers its HRT but continued to market it to doctors.

Two years ago, Pfizer purchased Wyeth for $67 billion, and inherited its liability. In a recent filing with the Securities and Exchange Commission, Pfizer booked a charge of $300 million for the minimum expected costs to resolve all of the remaining cases against the company. The company said with the uncertainties involved with product liability litigation, Pfizer may be required to pay even more.

Pfizer won’t say how many cases are left to settle, though some estimates put the number at more than 3,000.

Sources:
Wall Street Journal
The Day

SOURCE: Hormone Replacement Therapy › Pfizer to pay out at least $300 million to settle remaining HRT lawsuits

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

The landmark government research studied 24,000 postmenopausal women taking either HRT or placebo, and found that women on HRT were 21 percent more likely to develop kidney stones over a five-year period. The risks were equal among women taking Prempro, pills containing estrogen plus progestin, and Premarin, estrogen-only pills. Comparatively, studies show that overall about 6 percent of postmenopausal women develop kidney stones.

It is yet more bad news for women who for years had been fooled by false advertising from pharmaceutical companies that promised the pills not only relieved annoying symptoms of menopause, including hot flashes and mood swings, but also protected them against cancer, heart disease and osteoporosis. However, a major study into the mortality and morbidity of postmenopausal women was abruptly halted in 2002 when data indicated that women who used HRT were at substantially greater risk of developing breast cancer.

As the data was more closely studied, evidence surfaced that HRT also didn’t protect women against heart disease, and in fact, put them at greater risk or heart attacks and strokes. It was also found to increase a women’s risk for dementia and increase the death rate among women with lung cancer.

Kidney stones are hard crystals of calcium or other substances that separate from liquid in urine. The stones usually pass without treatment, but even the smallest stones can cause excruciating pain until they break up or exit the body. Stones too large to pass are often treated with noninvasive shock wave therapy or surgery.

Researchers say are uncertain why HRT increases a woman’s risk though one explanation may be that the pills can cause an increase in uric acid which may contribute to the formation of kidney stones.

SOURCE: Hormone Replacement Therapy › New study finds HRT increases women’s risk for kidney stones

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 study was based on data from the Women’s Health Initiative (WHI), a research project into the mortality and morbidity of menopausal and post-menopausal women. One aspect of WHI looked into the benefits of HRT, but was halted in its early phases in 2002 when researchers found women on hormone therapy were at substantially higher risk of developing breast cancer than women who did not take HRT. The study also showed women were at greater risk for heart attacks, strokes and blood clots, which contradicted popular HRT-maker Wyeth’s claims that the therapy actually improved a woman’s risk for those and other conditions.

The new study on the connection between HRT use, breast tenderness and breast cancer involved 16,000 women, half of which were given estrogen-plus-progestin and the other half were given a placebo. The women who took the HRT who did not experience breast tenderness prior to therapy were three times more likely to report breast tenderness one year after beginning therapy, than women taking the placebo. Women on HRT who reported breast tenderness one year after beginning hormone therapy had a 48 percent high risk of developing invasive breast cancer than women also taking HRT who did not report new-onset breast tenderness at the one-year mark.

Researchers say more research needs to be done to understand the relationship between new-onset breast tenderness in women on HRT and breast cancer.

Source: Oncology Nursing News

SOURCE: Hormone Replacement Therapy › Women on HRT who experience breast tenderness at greater risk of cancer

Powerful drug companies, like Wyeth, promoted their HRT meds Premarin and Prempro to doctors and heavily targeted older women with their commercials. They hired respectable figures, like actress Lauren Hutton, to announce her support. “There’s nothing more important than protecting your health,” she said. “Believe me, the time to protect your future is now.”

Another ad showed an actress playing the role of a doctor: “When considering menopause, consider the entire body of evidence,” she said.

An ironic statement, really, when you consider the evidence that was beginning to mount against HRT in the years those ads were running, data that Wyeth kept under wraps to protects its billion-dollar empire. It wasn’t until the Women’s Health Initiative (WHI) began to uncover shocking evidence about HRT that the world became privvy to it.

WHI, which was studying the causes of mortality and morbidity in menopausal and post-menopausal women, quickly halted its study on hormone therapy in 2002 when it found that women who took the drugs were at much greater risk of developing breast cancer. It also showed that women who took HRT were at an increased risk of heart attack, stroke and blood clots, and that there was no evidence to support HRT manufacturers’ claim that HRT protected women against dementia.

Now victims are finally having their day in court. Two recent lawsuits filed against Wyeth by two women who were diagnosed with breast cancer following use of HRT, have resulted in a combined $110 million judgment against the Wyeth. More victims will likely see justice soon, as another 10,000-plus other product liability suits have been filed over the HRT drugs across the country.

Source: New York Times

SOURCE: Hormone Replacement Therapy › HRT ads built trust, but breast cancer diagnoses changed opinions

Attorneys for the research center argued that the data, which is the most recent information collected in a follow up of the Women’s Health Initiative (WHI), had not yet been analyzed, peer-reviewed or published and that allowing Wyeth to sort through the raw data was simply “preposterous.” The Cancer Research Center had been resisting Wyeth’s requests for the information through subpoenas but will now have to surrender the data.

WHI, conducted by the Department of Health and Human Services, National Institutes of Health, and the National Heart, Lung and Blood Institute, was launched in 1991 and consisted of a set of clinical trials and an observational study that involved more than 160,000 generally healthy postmenopausal women. The major 15-year research program was designed to address the most common causes of death, disability and poor quality of life in postmenopausal women – cardiovascular disease, cancer and osteoporosis.

Preliminary results of the 2002 WHI showed that women who took HRT to relieve symptoms of menopause were at an even greater risk for serious diseases and conditions such as breast cancer, ovarian cancer, cardiovascular disease, stroke and blood clots.

As a result of the study, numerous lawsuits have been filed against makers of HRT, including Wyeth. To date, there are about 8,000 plaintiffs with cases pending against Wyeth, of which 7,000 plaintiffs are part of the multidistrict litigation that falls under Wilson’s pretrial oversight.

Source: NWAnews.com

SOURCE: Hormone Replacement Therapy › Judge orders WHI follow-up data be released to Wyeth

There is a mad dash among pharmaceutical companies worldwide to find a drug that safely treats the symptoms of menopause. Premarin, after all, was the best selling HRT in the U.S. before the Women’s Health Initiative (WHI) in 2002 linked HRT to higher incidences of breast cancer, heart attacks and strokes. Since then, the use of HRT has drastically reduced, and similarly, so has the incidence of breast cancer among menopausal women.

Despite the urgency in finding a safer alternative to HRT, experts say it will take at least four years for the synthetic hormones to become available. And it would expensive. Drugs for human use typically cost about $1 billion to develop. The next step would be finding an effective way to communicate to women that the synthetic hormones are actually safe, a tough job considering the bad rap HRT has received since WHI.

SOURCE: Hormone Replacement Therapy › Researchers working on safer synthetic HRT for menopause

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

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

Prior to the initiative in 2002, more than 200,000 American women were diagnosed with breast cancer each year. After 2002, that rate dropped below 190,000 each year since. Statistics from other countries show similar results.

Despite the findings, some researchers aren’t convinced the drop is due to a decrease in hormone use. For one, mammography was increasing in the late 1990s, enabling physicians to detect breast cancer earlier than before. This is an argument favored by Joseph Camardo, senior vice president of global medical affairs for Wyeth, the maker of hormone replacement drug Prempro. Wyeth is facing lawsuits from more than 11,000 women who took Prempro. Other critics of the campaign against HRT say that the drop was far too sudden to be linked to to the WHI findings.

The new study is a response by doctors involved in WHI who stand firm on their belief that HRT lead to serious health risks for women.

“These are non-conventional analyses, but I think this is the best data we have,” Rowan Chlebowski, a University of California, Los Angeles doctor who led the new study, was quoted in the news story. “This really suggests there’s a great benefit to women for stopping, because the risk goes down almost immediately.”

SOURCE: Hormone Replacement Therapy › Drop in breast cancer rates linked to reduction of HRT use

Iowa Sen. Charles E. Grassley, a member of the Senate Finance Committee, is leading the investigation into the drug industry’s influence on doctors. As part of the investigation, Sen. Grassley has sent letters to Wyeth and DesignWrite, a medical writing company, asking for details on scientific reports that were prepared by DesignWrite for Wyeth and to describe the authors’ extent of involvement and any fees paid.

“Any attempt to manipulate the scientific literature, that can in turn mislead doctors to prescribe drugs that may not work and/or cause harm to their patients, is very troubling,” Sen. Grassley wrote to Wyeth’s chairman and chief executive, Bernard J. Poussot, according to the New York Times story.

Prempro was one of the more widely used hormone replacement therapies prescribed for women to combat symptoms of menopause, such as hot flashes, night sweats, mood swings and decreased sexual desire. It was thought that hormones had an added benefit – that taking HRT reduced a woman’s chance of breast cancer and heart disease. However, the Women’s Health Initiative in 2002 found that taking HRT measurably increased a woman’s risk for serious conditions including breast cancer, ovarian cancer and heart disease. Since then, Wyeth has faced numerous lawsuits claiming the drug company misled the public about the safety of its hormone therapy.

SOURCE: Hormone Replacement Therapy › Study finds Wyeth paid ghostwriters to promote Prempro

Most doctors prescribed HRT for women experiencing bothersome symptoms of menopause such as hot flashes and night sweats, mood swings and decreased sexual desire. Just a few years ago it was believed that long-term use of HRT was safe and offered other benefits, such as protecting against osteoporosis and heart disease.

However, preliminary results of the 2002 Women’s Health Initiative (WHI) showed that the complications of HRT far outweighed the benefits. WHI researchers found that women on hormones were at an even higher risk for serious diseases and conditions such as breast cancer, ovarian cancer, cardiovascular disease, stroke and blood clots.

The new study is the first follow up to the landmark WHI. The analysis focused on women’s health three years after stopping HRT. Researchers have found that women who stopped HRT still had an increased risk of cancer – especially breast and lung cancers. The report also found a decreased risk of heart disease.

During the second and third years after the end of WHI, researchers noticed that women who took hormones but stopped were 24 percent more likely to develop cancer than women who had taken placebos during WHI.

Researchers say the analysis results show that women who have stopped taking hormones need to be vigilant about getting cancer screenings and mammograms.

SOURCE: Hormone Replacement Therapy › Cancer risk still elevated even years after stopping HRT

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

The usual symptoms of a heart attack are what he describes as a “crushing chest pain radiating to the arm and/or jaw.” The symptoms often are associated with shortness of breath and sweating. However, he warns, those “typical” symptoms are not so common in women, with as many as 40 percent of women reporting that they never even experienced chest pain during a heart attack, also known as a myocardial infraction, or MI.

Dr. Hersh explains that women most often have “prodromal symptoms,” or symptoms for up to a month before having a heart attack. The warning symptoms include unusual fatigue, sleep disturbances, shortness of breath, a feeling of indigestion, and anxiety. During an MI, women often experience symptoms such as a hot or burning sensation in their back (above the waist), shoulders, arms or lower jaw that is often sensitive to the touch. Other unusual symptoms include shortness of breath; overwhelming fatigue; severe nausea or vomiting; dizziness or fainting; weakness in the arms; a sudden feeling of anxiety, panic or impending doom; and occasionally chest pain and other “typical” symptoms.

Menopause, on the other hand, carries symptoms such as hot flashes that typically start in the face and chest and then become generalized; sleep disturbances, which are often due to the hot flashes; and fatigue and depression. The common symptoms, Dr. Hersh points out, often are played out differently. For example, hot flashes that start all over the face and become generalized may be more likely to be due to menopause as opposed to a hot sensation in the lower jaw.

Heart disease is the No. 1 cause of death in women, so women with any concerning symptoms should address them with their doctor. And if you experience symptoms of an MI, call 911 or go directly to the emergency room. Early treatment can save your life.

SOURCE: Hormone Replacement Therapy › Menopause, heart attack symptoms sometimes can be similar

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

According to the story, attorney General Catherine Cortez Masto said in a news release, “When drug companies purposefully misrepresent the safety and efficacy of their drugs, or promote their drugs in a deceptive way, everybody loses. We’re confident we have the facts necessary to prove this case, and we hope this lawsuit and its outcome will deter improper drug company practices in Nevada.”

The suit claims that the drug company misled Nevada patients and their doctors about the safety and the effectiveness of the drugs Premarin, Prempro and Premphase, sold by Wyeth; and Provera, sold by Pfizer. That, the suit contends, resulted in the over-prescribing and drastic increase in hormone-positive cancers in women who had taken the drugs. The suit seeks $5,000 to $12,000 in damages for each violation.

Weyth’s HRT drugs Premarin and Prempro dominated the market for menopausal symptoms. However, since the Women’s Health Initiative of 2002, which found HRT increased a woman’s risk for breast cancer and other serious diseases and conditions, Wyeth has been faced with numerous lawsuits over its drugs Premarin and Prempro.

Last year, three Navada women won $58 million in compensatory and punitive damages after claiming Prempro caused their breast cancer. Wyeth also was ordered to pay $1.6 million in attorney fees. The drug maker has appealed the verdict to the Nevada Supreme Court.

SOURCE: Hormone Replacement Therapy › Nevada AG sues companies for misleading about HRT safety

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

Researchers from the University of Queensland’s School of Population Health in Brisbane studied data from the Australian Longitudinal Study on Women’s Health, which compiled information beginning in 1996. From that, the researchers pulled data collected from nearly 1,000 women born between 1946 and 1951, both before and after hysterectomies. What they found was that hysterectomies performed on women older than 45 to 50 years of age did not lead to greater weight gain. However, the study did show that overweight women with a body mass index between 25 and 30, were more likely to have hysterectomies.

The study supports the concern of health care providers that obesity leads to more chronic health concerns.

Where and how a woman lives also may affect hysterectomy rate, according to the report. Women from rural communities or lower socioeconomic backgrounds had a higher rate of hysterectomy compared to women from urban communities or higher socioeconomic upbringings. Researchers theorize that hysterectomies were more often considered “quick fixes” for various health problems in rural environments and in communities where there are more barriers to access to regular care.

Research also has found that women from those backgrounds are more likely to have children at younger ages and thus more likely to accept hysterectomies than women who choose to have children later in life.

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

SOURCE: Hormone Replacement Therapy › Australian study finds hysterectomies do not cause weight gain

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

If only there was some way of knowing when our reproductive cycles will end.

Last week, Australian news.com.au reported that researchers at the University of Michigan have developed a new test that can tell women how many years they are away from menopause, offering, as they put it, “a road map to their reproductive life.”

The research, which followed 600 women over 14 years, looked at changes in the hormones FSH and inhibin B, which stimulate eggs. Researchers found that the two hormones dropped significantly five years prior to menopause.

Researchers also tracked another 50 women for changes in the hormone AMH, a hormone that helps predict fertility. They found that AMH also fell to a very low or non-measurable level five years before final menstruation.

The University of Michigan research team says the findings can help women who choose to have babies later in life make important decisions about their future. However, Australian experts say it offers false hope.

According to the news story, Australian researchers dismiss the findings, arguing that similar studies have been done in Australia but have yet to produce conclusive results. “I do not believe it’s possible at this time to accurately predict (menopause),” says Australian Menopausal Society endocrinologist Henry Burger.

SOURCE: Hormone Replacement Therapy › Test may help women know when menopause is approaching

The changes, which go into effect immediately, are part of “Project Impact,” a restructuring plan announced by Wyeth in January that cuts 10 percent – or about 5,000 – of its workforce. As part of Project Impact, the company will narrow its focus to find more successful new drugs especially those for which no good treatments are available. Thus, it will scale back from research on 55 diseases to only 27.

Wyeth’s new focus will be on vaccines; cancer; inflammatory disorders such as rheumatoid arthritis, severe asthma and lupus; metabolic conditions such as diabetes and obesity; musculoskeletal disorders such as arthritis and spinal fracture; and neuroscience such as Alzheimer’s and Parkinson’s disease, depression, schizophrenia and chronic pain, according to the report.

Since the Women’s Health Initiative, which found hormone replacement therapy increased a woman’s risk for breast cancer and other serious diseases and conditions, Wyeth has been faced with numerous lawsuits over its hormone replacement drugs Premarin and Prempro, which dominated the market for menopause symptom treatments for years.

According to the report, Wyeth will continue with late-stage testing on experimental menopause drugs Aprela and Pristiq. (Currently, the FDA has demanded additional research data on Pristiq.) A study of 3,400 women indicated no evidence of increased breast cancer rates. Wyeth plans to submit Aprela for FDA approval in the second half of 2009.

SOURCE: Hormone Replacement Therapy › Wyeth to stop making HRT, focus on cancer research

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

Those who practice acupuncture say that the therapy can remedy a host of women’s health issues, particularly fertility, pregnancy support and menopause. While the holistic healthcare discovered in Asia more than 3,500 years ago is gaining popularity in the Western world, getting the world out has been challenging. In an effort to raise awareness, the National Certification Commission of Acupuncture and Oriental Medicine has deemed today and every October 24th National Acupuncture & Oriental Medicine Day.

The National Center for Complementary and Alternative Medicine, an outreach of the National Institutes of Health, one-third of adults in the United States uses some form of alternative medicine, according to the Ventura County (California) Star. The most common practices are acupuncture, acupressure, herbal medicine, tai chi and gi gong.

For Myerson, acupuncture was a godsend. After a few visits of targeted pin pushing, she felt like a new woman. And her night sweats stopped. But hard evidence that the practice actually does work is still inconclusive. The American Medical Association says there is little evidence for it to confirm the safety or efficacy of most alternative therapies. But some doctors and patients claim, if acupuncture helps relieve chronic symptoms, like uncomfortable and disruptive night sweats from menopause, then it is worth consideration.

SOURCE: Hormone Replacement Therapy › Acupuncture an alternative therapy for menopause

According to the report, Kings College London researchers tracked 442 female breast cancer survivors for more than four years, half of which had been given HRT. The women who were taking HRT had a 14 percent higher recurrence rate than those who did not take HRT.

All women tracked participated in the 2002 U.S. government-sponsored Women’s Health Initiative, which studied the effects of HRT on women. That study was halted after researchers found that HRT led to an increased risk of dangerous medical conditions such as breast cancer, heart attack, stroke and blood clots.

In a related commentary in the Journal of the National Cancer Institute, Dr. Kathy Prichard of Canada’s Sunnybrook Odette Cancer Center, indicated that the data is convincing. “It seems that the harmful side effects of HRT (in breast cancer survivors) have finally been clearly demonstrated in what is, by today’s standards, a small randomized trial, carried out in a few relatively small countries,” Dr. Pritchard wrote.

SOURCE: Hormone Replacement Therapy › HRT linked to recurrence of breast cancer

In 1997, two women – one in Kansas and the other in New York – were becoming frustrated with the lack of beneficial and comprehensive health care information available to them, especially on the topic of menopause. So they teamed together and formed ProjectAWARE.

The mission of this nonprofit organization is to provide “menopausal and pre-menopausal women with complete and comprehensive information regarding all resources, therapies, and research data currently available, so that armed with this knowledge, women can make informed decisions regarding every healthcare option.”

ProjectAWARE, also known as the Association of Women for the Advancement of Research & Education, has since built to a team of eight and, through its website, gives detailed information about hormone replacement therapy (HRT), including synthetic HRT, natural (bio-identical) HRT, and alternatives to hormones, such as herbal remedies.

The site also touches on the possible link between HRT and breast cancer and other serious illnesses, and gives background on studies and trials that have made HRT a controversial subject over the past few years.

One of the best resources I’ve found on the site are the personal, heartfelt stories of women detailing their journey through menopause and beyond. As women, we find strength in numbers. Just knowing that someone else is experiencing the same symptoms or fears as she approaches “the change,” gives us added confidence to tackle the rough road ahead.

SOURCE: Hormone Replacement Therapy › ProjectAWARE answers questions about menopause

Prempro and Premarin , along with Provera, which is made by Pfizer, have come under attack in recent years as mounting evidence revealed that the drugs can increase the risk of developing breast cancer. Plaintiffs lodging claims against the drug makers argue that the manufacturers failed to voice sufficient warning about the increased risk of developing breast cancer that the drugs present. Approximately 5,000 women have filed lawsuits against Wyeth, contending that the company’s HRTs (hormone replacement therapies) caused them to develop breast cancer.

A study monitoring 3,400 recipients of Aprela indicated no evidence of increased breast cancer rates, compared with women who received Evista or placebo. Aprela recipients also showed the same relatively lower rates of breast tenderness and pain as Evista and placebo recipients – a significant benefit considering that breast discomfort is the main reason why stop using menopause drugs

Other studies revealed that Aprela recipients experienced better sleep and diminished hot flashes compared to women who were treated with placebo. Increased bone density, improved sexual function, and less vaginal dryness were also evident in late-stage tests of Aprela.

Wyeth will submit Aprela to the FDA for approved use in the second half of 2009. If approved, the drug may provide a better line of treatment for postmenopausal women. Its marketing would also help the company offset continual losses resulting from its Prempro suits.

SOURCE: Hormone Replacement Therapy › Wyeth developing another HRT for menopause

Scharlotte Fitzgerald says she began taking hormone replacement drugs in 1994. In 2001 she was diagnosed with breast cancer.

Fitzgerald and her husband Larry filed a personal injury suit against the drug companies in the Beaumont Division of the Eastern District of Texas on Nov. 2. They are seeking in excess of $75,000 in damages.

“This lawsuit asserts claims for negligence; strict product liability for failure to warn, strict product liability for design defect; and breach of implied warranty against the defendants responsible for the design, manufacture, production, testing, study, inspection, mixture, labeling, marketing, advertising, sales, promotion and/or distribution of those hormone therapy products that caused her breast cancer,” the plaintiffs’ original complaint states.

The plaintiffs’ claim that the defendants had an obligation to provide warnings about risks and side effects of their hormone therapy drugs as soon as it was aware of them. The suit alleges that the drug companies failed to disclose “an increased incidence and risk of strokes, blood clots, heart attacks, breast cancers and ovarian cancer from these drugs.”

Plaintiffs also assert that the defendants made claims regarding health benefits of the drugs and should have known “that these claims were false and misleading.”

The defendants also gave a false impression that adequate pre-marketing clinical testing and research and post-marketing surveillance had been done, the plaintiffs claim.

“Plaintiff would not have ingested the hormone therapy drugs … or would have discontinued their use, or would have used safer alternative methods, had defendants disclosed the true health consequences, risks, and adverse effects, including the increased incidence and risk of breast cancer and other illnesses, caused by their hormone drugs,” the complaint states.

In the first claim against defendants, the plaintiff alleges that the companies were negligent by failing to exercise reasonable care in designing, manufacturing, testing and distributing the hormone replacement drugs.

“Defendants knew or should have known that their hormone therapy drugs caused unreasonable harm and dangerous side effects that many users would be unable to remedy by any means,” the petition states. “Despite this, defendants continued to promote and market their hormone therapy drugs for use by consumers, including plaintiff, when safer and more effective methods of countering the negative health effects of menopause were available.”

The petition also includes claims for strict liability through failure to warn and design defect.

“These hormone therapy drugs were each dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchased them,” the suit says. “They were more dangerous than plaintiff contemplated. The risk of each of these hormone therapy drugs outweighs its utility.”

The companies also breached implied warranty, the suit said, because the sold the drugs as being of “merchantable quality and safe and fit for their intended use.”

Scharlette Fitzgerald is seeking damages to exceed $75,000, attorney fees, costs of suit and other relief that the court may deem just and proper.

Her husband, Larry Fitzgerald is also seeking monetary damages for his loss of spousal services, society and companionship.

SOURCE: Hormone Replacement Therapy › Lawsuit filed over HRT drugs blamed for breast cancer

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

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