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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 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