Mrs. Smith talked to her doctor, who recommended Prempro, a pill made by Wyeth that contains a mixture of estrogen and synthetic progestin hormones. The pills were also marketed to doctors and women as a miracle drug that tamed not only menopausal symptoms but also had the added benefit of protecting women against heart disease and osteoporosis. HRT became widely prescribed, and Wyeth racked in billions in profits.

Less than two years after starting HRT, Mrs. Smith, an otherwise hormone deficient woman, was diagnosed with a hormone-fed breast cancer. She became part of a staggering statistic that was only just beginning to emerge from the Women’s Health Initiative, research that focused on causes of mortality and morbidity in menopausal and post-menopausal women. The study that focused on HRT was abruptly halted in 2002 when data showed that women who used HRT were at greater risk for breast cancer. They were also at increased risk for ovarian cancer, non-Hodgkin’s lymphoma, heart attacks, strokes and blood clots.

Perhaps even more disturbing is evidence that suggests that Wyeth was aware of the potential for serious health risks associated with its billion-dollar drug, but failed to warn doctors and their patients. As a result, as many as 10,000 women or their family members have filed lawsuits against Wyeth. This August, Mrs. Smith is scheduled to have her day in court.

“We look forward to the trial of this case,” says attorney Ted Meadows with Beasley Allen Law Firm. “Once the jury gets to see the evidence that other juries have seen, we believe they will agree that Prempro caused (Mrs. Smith’s) breast cancer and that doctors were not adequately warned because Wyeth refused to properly test the drug.”

* client’s name has been changed

For more information about HRT litigation, visit www.beasleyallen.com.

SOURCE: Hormone Replacement Therapy › HRT breast cancer trial set for August

“I think women are confused,” Dr. Joanna Longstaffe, clinical director of Independent General Practice told Wales Online. “I have far fewer people coming in for HRT and more coming in with menopausal symptoms saying they can’t have HRT because of the risks of breast cancer. This new research may muddy the waters more.”

Dr. Longstaffe says that women shouldn’t be misled about the new information. While women are at greater risk for brain aneurysms and estrogen helps protect women from developing them, brain aneurysms are very rare, and breast cancer is far more common.

For the study, researchers asked 60 women with intact brain aneurysms about their use of birth control pills or HRT, and then compared their answers with more than 4,600 women from the general population. Women with brain aneurysms were found to be significantly less likely to have taken oral contraceptives or HRT during their lives. They also had an earlier average age of menopause.

It’s very much an individual decision about whether to take HRT based on how bad a patient’s menopausal symptoms are and balancing the risks and benefits,” says Dr. Charlotte Jones, a GP in Swansea and chair of the Morgannwg Local Committee. “But patients do have to be aware of the risks, which is why we review decisions about HRT annually with patients.”

SOURCE: Hormone Replacement Therapy › New study can leave women even more confused about HRT

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

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

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

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

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

Source: MyHealthNewsDaily

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

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

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

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

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

Sources:
Wall Street Journal
The Day

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

For some the menopause can be uncomfortable and distressing. Symptoms can include: hot flushes, night sweats, palpitations, vaginal dryness, urinary tract infections, depression, mood swings, weight gain, memory problems or sore joints. The majority of women however will only suffer hot flushes and irregular menstruation, whilst others may not experience any symptoms at all.

Throughout the last four decades the use of Hormone Replacement Therapy (HRT) has become the conventional treatment for discomfort. HRT involves taking supplements of oestrogen and progesterone or, occasionally, testosterone. The hormones used are either identical to human hormones, are extracted from horse urine or are manufactured synthetic substances.

Whilst it has been shown that long-term use of HRT may help to prevent osteoporosis and bowel cancer, studies have also indicated that the dangers of the treatment may far outweigh the benefits. The greatest concern is a much higher incidence of breast cancer cases, heart attacks, strokes and blood clots in women taking HRT.

Many are now choosing to return to natural remedies to reduce and even prevent menopausal symptoms and there are many simple alterations to your life style that can also make the experience a much more pleasant one.

For instance many plants such as soya, tofu and flax seed contain oestrogen and regular consumption of these foods appears to have the same benefits as hormone replacement therapy. In fact, in areas of the world such as China, Japan, Thailand and India these foods are part of the daily diet and the incidence of unpleasant menopausal symptoms in women is minimal.

Hot spicy foods, smoking, caffeine, stress and alcohol can all exasperate symptoms and bring on hot flushes so all should be avoided or kept to a minimum. Lack of sleep can contribute to depression and mood swings so get plenty of exercise every day and avoid working late and large meals before going to bed.

Certain vitamins and minerals can also help. For example, vitamin B12 can support the nervous system and give you energy whilst vitamin E can alleviate symptoms and is a great antioxidant.

A herbalist or naturopath will also be able to recommend plant extracts that will help your body find its own natural balance. These include wild yam cream, red clover and evening primrose.

In some people hypnosis and self-hypnosis techniques have helped relieve symptoms and tackle problems of low self esteem and body image. XF

October 17th, 2007

SOURCE: Hormone Replacement Therapy › Natural menopause

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