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

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

Hormone replacement therapy was designed to boost hormone levels in menopausal and post-menopausal women and help them deal with symptoms such as irritability, night sweats, hot flashes, vaginal dryness and sleeplessness.

If you asked drug companies – especially 20 years ago when HRT was widely prescribed – they would rattle off a laundry list of extra benefits ranging from prevention of osteoporosis, heart disease, and dementia. But the reality is, HRT can be deadly.

A large study on the effects of HRT on menopausal and post-menopausal women as part of the Women’s Health Initiative was halted in 2001 after data showed that combination HRT put women at risk for breast cancer and other dangerous conditions including heart attacks and strokes.

Now that the serious risks associated HRT have been made public, prescriptions have gone down considerably. Dr. Oz asks Rosemarie if she is having any symptoms, and she says her only problem is trouble sleeping at night. He suggests if she is not experiencing any major problems, that she stay drug free.

For women who feel they cannot cope with their symptoms, Dr. Oz suggests they talk to their doctors about bio-identical hormones. The important thing, he said, is to “take them smartly” because while there are “theoretical advantages” to HRT, there are also serious disadvantages to consider.

Source: Dr. Oz/Fox 11

SOURCE: Hormone Replacement Therapy › Dr. Oz warns post-menopausal guest to stay away from 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

Given the risks associated with hormone replacement therapy (HRT), women should seriously weigh whether the benefits of therapy are worth the potential harm it may cause. Luckily, women today are armed with information to make informed decisions about HRT. This wasn’t always the case.

When HRT was first introduced, the hormones were heavily marketed to doctors and women as a miracle drug that not only tamed menopausal symptoms, but also helped protect women against heart disease and osteoporosis. As a result, Wyeth, makers of the popular HRT drugs Premarin and Prempro, raked in billions of dollars in sales.

But what Wyeth was not telling doctors and their patients is that women who used HRT were putting themselves at greater risk for breast cancer and other serious illnesses. It wasn’t until the Women’s Health Initiative (WHI) began to uncover this shocking evidence that the rest of the world became privy to it.

The study, which focused on the causes of mortality and morbidity in menopausal and post-menopausal women, quickly halted an investigation of hormone therapy in 2002 when it found that women who took the drugs were at much greater risk of developing breast cancer. They were also at an increased risk of heart attacks, strokes and blood clots.

Wyeth has settled or has agreed to settle more than 10,000 lawsuits against it from women or their family members who say they were needlessly injured by HRT. The settlements are expected to cost the pharmaceutical company at least $772 million – a far cry from the billions the company earned in sales from the dangerous drug.

Source: MyHealthNewsDaily

SOURCE: Hormone Replacement Therapy › HRT ‘miracle drug’ not good idea for most women

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

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 link was discovered during the Women’s Health Initiative (WHI), a major 15-year research program launched in 1991 to address the most common causes of death, disability and poor quality of life in postmenopausal women – cardiovascular disease, cancer and osteoporosis. The study was halted prematurely because participants on HRT exceeded the boundary for breast cancer risk that was established at the beginning of the study. There also was an increased risk for heart disease for patients on HRT compared to those who were not.

But a new report published online Tuesday in the Journal of the National Cancer Institute found that cases of breast cancer had fallen 2.2 percent between 1999 and 2002, several years before hormone replacement therapy became an issue, meaning other factors may be involved, according to the Houston Chronicle.

Overall, the report pointed to a first-time drop in the cancer rates among both men and women, according to the story. It also showed a dramatic drop in the 15-year decline in cancer death rates, meaning people diagnosed with cancer are living longer. Researchers credit aggressive cancer prevention and treatment efforts for the successes in the fight against the country’s No. 2 killer.

SOURCE: Hormone Replacement Therapy › Report cites drop in cancer rates among men and women

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 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

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

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