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

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

The landmark government research studied 24,000 postmenopausal women taking either HRT or placebo, and found that women on HRT were 21 percent more likely to develop kidney stones over a five-year period. The risks were equal among women taking Prempro, pills containing estrogen plus progestin, and Premarin, estrogen-only pills. Comparatively, studies show that overall about 6 percent of postmenopausal women develop kidney stones.

It is yet more bad news for women who for years had been fooled by false advertising from pharmaceutical companies that promised the pills not only relieved annoying symptoms of menopause, including hot flashes and mood swings, but also protected them against cancer, heart disease and osteoporosis. However, a major study into the mortality and morbidity of postmenopausal women was abruptly halted in 2002 when data indicated that women who used HRT were at substantially greater risk of developing breast cancer.

As the data was more closely studied, evidence surfaced that HRT also didn’t protect women against heart disease, and in fact, put them at greater risk or heart attacks and strokes. It was also found to increase a women’s risk for dementia and increase the death rate among women with lung cancer.

Kidney stones are hard crystals of calcium or other substances that separate from liquid in urine. The stones usually pass without treatment, but even the smallest stones can cause excruciating pain until they break up or exit the body. Stones too large to pass are often treated with noninvasive shock wave therapy or surgery.

Researchers say are uncertain why HRT increases a woman’s risk though one explanation may be that the pills can cause an increase in uric acid which may contribute to the formation of kidney stones.

SOURCE: Hormone Replacement Therapy › New study finds HRT increases women’s risk for kidney stones

“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

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

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 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

To further complicate matters, ovarian cancer is hard to diagnose in its early stage. Only about 20 percent of ovarian cancer is found at the early stage. When found early, the survival rate is 95 percent over five years. Approximately 75 percent of ovarian cancer cases are diagnosed at an advanced stage after the cancer has spread beyond the ovary.

But a new method devised by researchers at the Fred Hutchinson Cancer Research Center in Seattle, Wash., has been found to increase the diagnosis of the disease by one third, according to FoodConsumer.org. The process used both a questionnaire on symptoms and blood tests. Using the questionnaire alone led to the discovery of early stage ovarian cancer in 60 percent of the cases. The blood test alone reported to same percentage of results. However, both the questionnaire and the blood test combined resulted in an early stage diagnosis in 80 percent of the cases.

Symptoms include bloating, pelvic and abdominal pain, difficulty eating or feeling full quickly, and urinary urgency or frequency. Additional symptoms may include fatigue, indigestion, back pain, pain with intercourse, constipation and menstrual irregularities. Blood tests to diagnose ovarian cancer include the CA-125. Other diagnostic tests include physical exam, pelvic exam, ultrasound and biopsy.

SOURCE: Hormone Replacement Therapy › New method found to detect early stage ovarian cancer

According to the lawsuit filed in St. Clair County Circuit Court, Gray used Prempro from Jan. 19, 1998, through Oct. 15, 2005. She was diagnosed with left breast cancer on Nov. 14, 2005.

They claim the drug was defectively designed and that the defendants failed to warn users of its danger.

“…Defendants failed to perform adequate testing and study HRT (hormone replacement therapy) drugs prior to marketing it or properly analyze and warn based upon studies and testing,” the complaint states.

The defendants failed to warn the plaintiff that use of HRT drugs carried a risk of ovarian cancer.

In a claim for loss of consortium, the lawsuit alleges the marital association of the Grays has been altered causing great mental anguish.

November 26th, 2007

SOURCE: Hormone Replacement Therapy › Prempro user claims drug caused breast cancer

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

Minnie Louise Gray and her husband John E. Gray filed an 11-count suit against Wyeth, Inc. over its drug Prempro, which is used by post-menopausal women. The suit also names Walgreen as a defendant for having sold the drug to Gray.

According to the lawsuit filed in St. Clair County Circuit Court, Gray used Prempro from Jan. 19, 1998, through Oct. 15, 2005. She was diagnosed with left breast cancer on Nov. 14, 2005.

The lawsuit claims the drug was defectively designed and that the defendants failed to warn users of its danger.

“…Defendants failed to perform adequate testing and study HRT (hormone replacement therapy) drugs prior to marketing it or properly analyze and warn based upon studies and testing,” the complaint states.

The lawsuit claims the defendants failed to warn the plaintiff that use of HRT drugs carried a risk of ovarian cancer.

In a claim for loss of consortium, the lawsuit alleges the marital association of the Grays has been altered causing great mental anguish.

October 23rd, 2007

SOURCE: Hormone Replacement Therapy › Prempro user claims drug caused breast cancer

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