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

The rejected appeal comes on the heels of a Pfizer report that it had put aside $772 million to settle lawsuits from women who claimed the pills caused them to develop breast cancer.

Prempro is a medication containing estrogen plus progestin. It is often prescribed to treat symptoms of menopause, such as hot flashes, vaginal dryness, mood swings, difficulty sleeping, and decreased sexual desire. Wyeth, which was later bought by Pfizer, had promoted the drugs as safe and claimed they offered women added benefits such as protection against heart disease and dementia.

However, a study as part of the Women’s Health Initiative (WHI) that looked at the effects of HRT in menopausal and post-menopausal women, was abruptly halted after early data showed HRT put women at risk for breast cancer. Since then, about 10,000 Prempro breast cancer lawsuits have been filed.

A large number of the Prempro trials have resulted in multi-million dollar awards against the drug maker after juries found that the drug company knew that the dangers associated with HRT but actively tried to cover up the risks.

SOURCE: Hormone Replacement Therapy › Supreme Court rejects Prempro breast cancer lawsuit appeal

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

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

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 the story, attorney General Catherine Cortez Masto said in a news release, “When drug companies purposefully misrepresent the safety and efficacy of their drugs, or promote their drugs in a deceptive way, everybody loses. We’re confident we have the facts necessary to prove this case, and we hope this lawsuit and its outcome will deter improper drug company practices in Nevada.”

The suit claims that the drug company misled Nevada patients and their doctors about the safety and the effectiveness of the drugs Premarin, Prempro and Premphase, sold by Wyeth; and Provera, sold by Pfizer. That, the suit contends, resulted in the over-prescribing and drastic increase in hormone-positive cancers in women who had taken the drugs. The suit seeks $5,000 to $12,000 in damages for each violation.

Weyth’s HRT drugs Premarin and Prempro dominated the market for menopausal symptoms. However, since the Women’s Health Initiative of 2002, which found HRT increased a woman’s risk for breast cancer and other serious diseases and conditions, Wyeth has been faced with numerous lawsuits over its drugs Premarin and Prempro.

Last year, three Navada women won $58 million in compensatory and punitive damages after claiming Prempro caused their breast cancer. Wyeth also was ordered to pay $1.6 million in attorney fees. The drug maker has appealed the verdict to the Nevada Supreme Court.

SOURCE: Hormone Replacement Therapy › Nevada AG sues companies for misleading about HRT safety

Prempro and Premarin , along with Provera, which is made by Pfizer, have come under attack in recent years as mounting evidence revealed that the drugs can increase the risk of developing breast cancer. Plaintiffs lodging claims against the drug makers argue that the manufacturers failed to voice sufficient warning about the increased risk of developing breast cancer that the drugs present. Approximately 5,000 women have filed lawsuits against Wyeth, contending that the company’s HRTs (hormone replacement therapies) caused them to develop breast cancer.

A study monitoring 3,400 recipients of Aprela indicated no evidence of increased breast cancer rates, compared with women who received Evista or placebo. Aprela recipients also showed the same relatively lower rates of breast tenderness and pain as Evista and placebo recipients – a significant benefit considering that breast discomfort is the main reason why stop using menopause drugs

Other studies revealed that Aprela recipients experienced better sleep and diminished hot flashes compared to women who were treated with placebo. Increased bone density, improved sexual function, and less vaginal dryness were also evident in late-stage tests of Aprela.

Wyeth will submit Aprela to the FDA for approved use in the second half of 2009. If approved, the drug may provide a better line of treatment for postmenopausal women. Its marketing would also help the company offset continual losses resulting from its Prempro suits.

SOURCE: Hormone Replacement Therapy › Wyeth developing another HRT for menopause

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

Earlier this month a jury in Nevada awarded $134 million in a similar case against Wyeth, which is appealing the verdict. Wyeth spokesman Doug Petkus would not comment specifically about the Hesch case, but said it”s the first lawsuit he”s heard about since the Nevada judgment.

Sharon Hesch was first prescribed the hormone therapy medication Provera and Premarin in May 1998, her lawsuit says. She switched to only Premarin in January 2001. She was diagnosed with breast cancer in January 2002.

Sharon Hesch alleges the drug companies acted recklessly and without regard to public safety.

“The defendants misled both the medical community and the public at large, including the plaintiff Sharon Hesch, by falsely representing the safety of their products,” her lawsuit says.

In the Nevada case, a jury awarded three women $35 million for expenses, pain and suffering, and added $99 million in punitive damages. Wyeth spokesman Lawrence Stein said it was a flawed verdict in a trial “riddled with errors.”

Petkus said 20 other hormone therapy cases have gone to trial or were otherwise resolved. He said three went in Wyeth”s favor, two were plaintiff awards that were thrown out by courts, three were dismissed, and 12 were withdrawn by plaintiffs.

October 25th, 2007

SOURCE: Hormone Replacement Therapy › Hormone therapy led to 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