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

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

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

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

Source: Toronto Sun

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

Wyeth 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

The largest drop in HRT use occurred between 2002 and 2004, when usage fell from 12.7 percent to 4.9 percent. During the same years, breast cancer rates dropped nearly 10 percent.

Breast cancer rates among postmenopausal women in Canada began to rise again starting in 2005, which researchers say is likely still linked to HRT use. “Such a rebound might be expected if (previously undetected) hormone-sensitive tumors were merely slowed by the withdrawal of hormone replacement therapy rather than prevented by it,” researchers wrote.

HRT was widely used among women to treat symptoms of menopause including hot flashes and vaginal dryness. It was also touted for added benefits of the prevention of cardiovascular disease and dementia, and became widely prescribed in several countries including the United States and Canada. But a large study as part of the Women’s Health Initiative was abruptly halted in 2002 when data showed that the medication put women at greater risk for breast cancer. Since then, prescriptions for HRT have dropped considerably.

Source: ThirdAge.com

SOURCE: Hormone Replacement Therapy › Drop in breast cancer rates coincides with drop in HRT use

Charles H. Payne

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

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

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

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

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

Source: Charles H. Payne’s letter

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

“Instruction from my management for promotion of products … has included information outside of labeling. In other words, core presentations for promotion contain information that the FDA has not granted approval for use with these drugs. Specifically, the use of Premarin for the prevention/treatment of cardiovascular disease, Alzheimer’s disease, and colorectal cancer. Additionally, the issue of potential side effects has been minimized, such as the risk of breast cancer,” she wrote.

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

Just two years after the letters were written, massive research involving women of menopausal and post-menopausal age, known as the Women’s Health Initiative, uncovered alarming evidence that HRT put women at risk for breast cancer and other serious health conditions. Epidemiologists estimate that as many as 200,000 women have been diagnosed with cancer as a result of HRT.

“My most critical concern is the lives of the women in Alabama and Georgia that may be at risk due to these promotions,” Whatley wrote. “Many physicians have been persuaded to use these products for uses that have not been proven on the masses of postmenopausal women in Alabama and Georgia. I fear that their lives may be placed in serious potential danger. It is this matter that forces me to address this issue with appropriate personnel.

“Somewhere along the way, the goal of providing the most credible information for physicians and the best pharmaceuticals to them and the women of Alabama and Georgia became a mute point. It appears the only thing that matters now is increasing market share. I can no longer stand by silently and allow this to continue, for I one day will be faced with the decision for choosing to take hormones and I want to know my physician has been provided with facts, not fabrications or maybes.”

Read more about HRT litigation.

SOURCE: Hormone Replacement Therapy › Wyeth sales rep expresses concern in letter to conduct board

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

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

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

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

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

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

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

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

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

The 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