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

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

The level of risk seemed to increase with the duration of therapy. Women who took combined therapy for 10 years or more were at the greatest risk for lung cancer. The study also indicated that the risk was limited to the combined therapy as opposed to the estrogen-only HRT. Smoking also didn’t affect the influence of HRT on lung cancer risk.

“Although HRT use has declined and is not recommended except for short-term treatment of menopausal symptoms, our results indicate millions of women remain at risk of developing lung cancer,” Christopher G. Slatore, MD, of Oregon Health and Sciences University in Portland, and colleagues wrote.

The study involved data from a prospective cohort of 36,588 peri- and postmenopausal women ages 50 to 76 who had participated in the Vitamins and Lifestyles (VITAL) study that examined associations between use of supplements and cancer risk. Two-thirds of the study’s participants either took or had taken HRT. A similar number had a family history of lung cancer, and another two-thirds smoked.

During the six years of follow-up in the study, 344 women, including some from both the HRT and the non-HRT group, developed lung cancer. The study showed that women who took combined HRT for nine years or less had a 1.27 risk for lung caner, something not considered statistically significant. However, women who took the combined therapy for 10 years or longer had a 1.48 hazard ratio for lung cancer, considered a much more notable increase.

“These findings may be helpful for informing women of their risk of developing lung cancer and delineating important pathways involved in hormone metabolism and lung cancer,” the authors wrote in conclusion.

Source: MedPage Today

SOURCE: Hormone Replacement Therapy › Study: HRT puts women at greater risk for lung cancer

Yet, Wyeth kept providing to medical journals more ghostwritten articles by doctors on topics that supported the benefits of HRT. It wasn’t until a study as part of the massive Women’s Health Initiative (WHI) showed that the drugs to treat menopause symptoms were actually putting women at higher risk for breast cancer and heart disease that the public took notice.

By then, Wyeth had made billions on its HRT drugs Premarin and Prempro. Thousands of women have taken Wyeth to court demanding justice. But what about the articles in archived medical journals? Martha Rosenberg, a columnist featured in OpEdNews says the articles should be retracted. “Plagiarism, ‘unethical research’ and unreliable findings from ‘fabricated data’ are grounds for retraction of medical journal articles according to the Committee on Publication Ethics (COPE),” she writes. “But one look at the US National Library of Medicine database reveals that bogus, ghostwritten papers Wyeth planted in medical journals in a scandal which reached the U.S. Congress last year still stand, unretracted.

“Hormone therapy represents one of the largest swaths of preventable injuries to healthy citizens in recent history with thousands of women developing cancer and other deadly side effects. Yet Wyeth/Pfizer maintains it doesn’t know how the idea that hormone therapy could prevent heart disease and dementia and provide other ‘benefits’ ever got started.”

SOURCE: Hormone Replacement Therapy › Ghostwritten medical journal articles about HRT should be retracted

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

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

Source: Southeast Texas Record

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

The 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

This week, Pfizer, which recently acquired Wyeth, the makers of the hormone replacement therapies (HRT) Prempro and Premarin, were hit with more than $100 million in two punitive-damage awards from Philadelphia juries. The two plaintiffs, Connie Barton and Donna Kendall, claimed the drugs caused their breast cancer.

The evidence was startling. Plaintiffs attorneys proved that Wyeth launched a massive campaign to push the benefits of its HRT drugs to doctors and the general public while knowingly dismissing or downplaying other institutes’ data that revealed an increased risk of breast cancer with the use of combination hormone therapy. The company went to such lengths as to hire ghostwriters to write articles for reputable medical journals that minimized the breast cancer risk and exaggerated the benefits of HRT.

It wasn’t until the government-initiated Women’s Health Initiative (WHI) that everything changed. WHI was a 15-year study launched in 1991 that aimed to address the most common causes of death, disability and poor quality of life in postmenopausal women, including cardiovascular disease, cancer and osteoporosis. In 2002, WHI halted the estrogen-plus-progestin trial after investigators found that the associated health risks of the combined hormone therapy out weighted the benefits. The 2002 report showed there was a 24 percent increase in the risk for breast cancer due to estrogen-plus-progestin HRT.

Since then, more than 10,000 other product liability suits have been filed over the HRT drugs in across the country, 1,500 of which have been filed in the Philadelphia court. Many of the cases are filed in Philadelphia because Wyeth’s headquarters were located there.

“Wyeth had no concern whatsoever for the health of the patients. They were only concerned about their profits,” says Michael Richmond, a jury foreperson in a Prempro trial.

Sales of Prempro and Premarin exceeded $2 billion a year before 2002. Last year, $1.4 billion in estrogen drugs and $400 million in estrogen-progestin combination drugs were sold in the United States.

More Information
HRT Jury Verdict Chart

Sources:
Beasley Allen Law Firm
New York Times

SOURCE: Hormone Replacement Therapy › Two breast cancer survivors awarded $100 million in HRT lawsuits

According to court documents, ghostwriters for Wyeth wrote 26 articles that appeared in 18 different medical journals between 1998 and 2005 emphasizing that hormones protect against osteoporosis, heart disease and dementia and down-playing the risks. In 2001, Wyeth benefited by reaping nearly $2 billion in sales of its HRT drugs Premarin and Prempro, making them among of the most prescribed drugs in the U.S.

But at what cost did Wyeth benefit?

In 2002, the Women’s Health Initiative (WHI), a research initiative initiated by the National Institutes of Health to look into some of the major health problems of older women, was abruptly halted after researchers found that menopausal women who took certain hormones had an increased risk of invasive breast cancer, heart disease and stroke. One of the thousands of victims is Geraldyne Frambs of Sacramento, Calif.

In the mid-1980s, Frambs was prescribed and began taking HRT. In 2003, she was diagnosed with breast cancer. Now she wants justice. This week, attorney Ted G. Meadows with Beasley Allen Law Firm filed a lawsuit on behalf of Frambs against Wyeth Inc., Weyth Pharmaceuticals Inc., Pharmacia & Upjohn Company LLC, Pharmacia Corporation, Pharmacia & UpJohn LLC, Greenstone Ltd, Barr Laboratories Inc., Barr Pharmaceuticals and ESO Lederle Inc.

The lawsuit alleges that the cancer, subsequent surgery, treatment, injury and damage to Frambs were caused by her use of HRT. The complaint alleges that the defendants were negligent by not assuring that their products did not cause users to suffer from foreseeable unreasonably dangerous side effects and serious health problems, and that they should have known the serious risks women were put under by using drugs that were defective at the time of production. Furthermore, the complaint alleges that the defendants willfully deceived the plaintiff by concealing the true facts concerning the hormone therapy drugs, which the defendants, as manufacturers, marketers and distributors of the products, had a duty to disclose to the plaintiff.

The lawsuit seeks recovery of all monies the plaintiff paid for the products; to be compensated for the cost of medical care as a result of the use of the products including past medical expenses, wage loss, pain, suffering, disability and emotional distress.

Read Frambs’ complaint: Frambs v Wyeth (HRT Lawsuit)

Sources:
New York Times
Beasley Allen

SOURCE: Hormone Replacement Therapy › Wyeth paid ghostwriters to sway doctors to prescribe HRT

“Even though this share seems low, ovarian cancer remains highly fatal, so accordingly this risk warrants consideration,” the researchers, led by Lina Steinrud Morch of Copenhagen University, wrote.

The risk of ovarian cancer from hormone replacement therapy remained steady among variables such as duration of use, formulation of hormones, estrogen dosage, or how it was administered. Earlier studies, however, suggested cancer risk diminished about two years after therapy was stopped.

The findings add fuel to the Women’s Health Initiative (WHI) study that was halted in 2002 after data suggested the use of HRT put women at a much greater risk for breast cancer, ovarian cancer, strokes and cardiovascular disease. Those findings contradicted the claims of HRT makers, who told physicians the hormones actually warded off such conditions.

Since the WHI findings became public, use of HRT has dropped considerably. Since 2001, drug maker Wyeth has experienced a 50 percent drop in sales of its HRT Prempro, and has been faced with numerous lawsuits from women harmed by the drug.

Sources:
Reuters
New York Times

SOURCE: Hormone Replacement Therapy › Study: HRT puts women at greater risk for ovarian cancer

The study, conducted by researchers at Northern California Cancer Center in Fremont, tracked overall incidence of invasive breast cancer from 2001 to 2004, and noted that the rate of breast cancer fell by 13.8 percent in urban areas but by only 7.5 percent in rural areas. Neighborhoods in high-income areas also reported 13 percent fewer incidence of breast cancer compared to a 9.6 percent decline in poor counties.

Breast cancer reports in rural counties peaked in 1999 and then steadily declined while breast cancer reports in urban counties didn’t reflect significant decline until after 2002. In 2002, the Women’s Health Initiative abruptly halted its trail on postmenopausal women and HRT after data indicated women on HRT were at greater risk for serious health concerns, in particular breast cancer.

Authors of the Cancer Center study say that the pattern of decline in the rate of breast cancer in rural versus urban counties is “consistent with the changing pattern of (HRT) prevalence and cessation or noninitiation.”

The study also indicated that breast cancer was most likely diagnosed in urban areas versus suburban or rural communities. While HRT appears to be the primary cause, the authors caution that some changes could be explained by “saturation or decreases in mammographic screening.”

Source: MedPage Today

SOURCE: Hormone Replacement Therapy › Greater reduction in HRT/breast cancer rates in urban, affluent towns

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

SOURCE: Hormone Replacement Therapy › Hormone therapy update

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

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