Wyeth had heavily promoted its HRT drugs Premarin and Prempro as safe and effective treatments for bothersome symptoms of menopause. The pharmaceutical company even promoted the pills for their added benefit of protecting women against heart disease and dementia. But evidence was beginning to surface that the drugs were actually far more dangerous than the public or doctors ever perceived.

The Women’s Health Initiative (WHI), a research project on the morbidity and mortality of menopausal and post-menopausal women, abruptly halted its study on HRT in 2002 when data showed a significant risk for breast cancer in women who used HRT.

In Singleton v. Wyeth, the jury had awarded $3.45 million in compensatory damages, which the court raised to $4.4 million for delay, and $6 million in punitive damages, according to The American Association for Justice. Judge Mark Bernstein based the punitive award on Wyeth’s deceptive public relations campaign designed to “dismiss and distract” doctors away from concerns about HRT and breast cancer.

The drug company went so far as to fund continuing medical education programs in an attempt to convince physicians that there was no increased risk for breast cancer, and used training materials to imply that the drugs would, in fact, protect women from developing the disease.

There are 15,000 hormone replacement therapy cases pending in lower courts.

Source: The American Association for Justice

SOURCE: Hormone Replacement Therapy › Compensatory and punitive damages awarded in HRT 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

Whatley was one of three Wyeth sales representatives who in July 2000 wrote letters to the company’s Office of Ethics and Business Conduct expressing serious concerns that the drug manufacturer was encouraging its sales team to downplay the risks of breast cancer associated with its hormone replacement therapies (HRT) Premarin and Prempro, and to promote uses that were not approved by the Food and Drug Administration (FDA), such as for the prevention of Alzheimer’s disease.

“One of my biggest concerns however is that such off-label promotion could conceivably lead to Premarin (being) prescribed in good faith by a physician who was influenced by the Alzheimer’s disease data and, in a worse case scenario, the patient develops breast cancer, a thrombosis, or any other medical problem.”

Two years after Whatley’s letter, the Women’s Health Initiative (WHI) canceled a massive study on the effects of HRT on menopausal and post-menopausal women after data showed a significant increase in the risk of breast cancer. It also showed the drug had no effect on Alzheimer’s disease.

Since the WHI data became public, thousands of women have filed lawsuits against Wyeth, alleging the drug company was fully aware of the dangers of its hormone replacement therapies but continued to vigorously promote the drug to doctors and their patients. Concerns from the drug company’s sales representatives confirm that Wyeth was well aware its HRT was dangerous.

Unfortunately, Whatley’s message and those of his co-workers fell on deaf ears. “I believe this issue has become too large to further ignore and is a matter that must be resolved,” he wrote.

Source: Carl Whatley Jr.’s letter

SOURCE: Hormone Replacement Therapy › Salesman agonized over off-label promotion of HRT

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

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

“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

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

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

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 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

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

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

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

Premarin is a low-dose mixture of estrogen hormones and is already available in pill form to treat symptoms of menopause such as hot flashes and vaginal dryness, burning and itching. Premarin and another Wyeth drug prescribed for menopausal symptoms, Prempro, dominated the hormone replacement therapy market until the Women’s Health Initiative of 2002 linked long-term use of HRT to an increased risk of breast cancer and other serious health problems. Wyeth has since been faced with numerous lawsuits concerning the drugs.

Dyspareunia is a disorder that follows the atrophy or thinning of the vagina and vulva, a condition that can occur in menopause.

The .5-gram cream has two dosing regiments – 21 days on followed by 7 days off, or twice weekly. FDA approval of the cream and its dosing regime was granted based on results from a multi-center clinical study that included a 12-week, randomized, double blind placebo phase followed by a 40-week open-label phase, according to the story.

Wyeth advises women considering the cream to review possible side effects with their physician, and to avoid the product if they fall into a high-risk category.

SOURCE: Hormone Replacement Therapy › FDA approves Premarin cream to treat dyspareunia

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

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

The U.S. Supreme Court will hear arguments today in the first of two cases this term that consumer advocates fear could shut courthouse doors to patients injured by FDA-approved drugs or medical devices.

Legal experts say the cases could also affect lawsuits already filed by tens of thousands of Americans challenging the safety of blockbuster drugs such as Celebrex and Prempro and a host of medical devices.

The case before the court today was brought by the family of a New York man who suffered severe medical complications when a balloon catheter burst during a procedure to clear his arteries. The second case, involving claims for injuries allegedly caused by Rezulin, a now-withdrawn drug used to treat diabetes, will be heard in February.

Pharmaceutical manufacturers have long complained that the expense of defending injury claims has slowed research into new medications and driven up costs for patients. Because Congress granted the Food and Drug Administration the authority to determine whether products are safe and effective, manufacturers argue that state judges and juries should not be allowed to second-guess the FDA once a product is approved for use.

State damage claims put pharmaceutical makers in a “Catch-22 between complying with FDA regulations on the one hand and still being subject to state liability on the other,” said Rob Clark, a government affairs director for Medtronic Inc., which made the cardiac catheter.

But plaintiffs’ lawyers and consumer groups say that the FDA has approved some drugs and devices based on sloppy or falsified test data, adding that lawsuits are the only way evidence of drug risks or drug maker fraud has come to light.

A report issued Friday by three members of the FDA’s own Science Boardfound that the agency was so poorly organized and short of funds that it could not adequately protect the public from dangerous drugs.

A ruling for Medtronic would “take away the last possible safety net against unfettered corporate misbehavior and negligence,” said Karen Barth Menzies, a Newport Beach lawyer who has represented plaintiffs in cases against drug makers.

Menzies sees these “preemption” cases as a new battlefront in the tort-reform wars in the wake of limits imposed by Congress and state legislatures in recent years on class actions and medical malpractice claims.

Charles Riegel sued Medtronic, claiming his injuries were caused by the catheter’s negligent design, manufacture and labeling, despite the fact the device had won FDA approval. Riegel died in 2004 of causes unrelated to the angioplasty, and his widow took over his claim. Her case was thrown out by a U.S. District Court judge and then by the U.S. Court of Appeals.

The prospect that the high court may bar injury claims for FDA-approved pharmaceuticals helped precipitate the $4.85-billion settlement of Vioxx claims last month, according to lawyers involved in the negotiations.

Lawyers representing plaintiffs who took the popular painkiller insisted on language that would allow the settlement to close and compensation be paid even if the high court sides with Medtronic. Vioxx maker Merck & Co. took the drug off the market in 2004 after a study showed it doubled the risk of heart attack and stroke in patients taking it for more than 18 months.

The question in the catheter case is whether Congress intended to bar state common law claims when it gave the FDA authority to regulate medical devices in 1976. Widespread injuries reported by women who used the Dalkon Shield intrauterine device and other products had earlier prompted California and a few other states to impose some labeling and design requirements in the absence of federal standards.

The 1976 federal statute specifically said that states couldn’t maintain requirements that were different from federal standards. But Congress didn’t specify that those federal standards preempted state common law claims, and device manufacturers didn’t argue that they did until recently, said Allison Zieve, a lawyer with Washington-based Public Citizen Litigation Group who will be arguing for Donna Riegel before the court.

In rejecting the Riegel suit, the lower courts reasoned that if the plaintiffs reached trial and won, the damages would amount to a state “requirement” different from FDA requirements because the complaint depended on state law.

Glenn Lammi, chief counsel with the Washington Legal Foundation, said continuing to allow injury claims under state law could create “a patchwork of rules” governing product design and use that “creates confusion among consumers” and raises costs. The foundation, a group that advocates restrictions on lawsuits, submitted an amicus brief on behalf of the company.

Beyond the issue of whether patients have the right to sue under state law, Medtronic’s Clark insisted the company was not responsible for Riegel’s injuries because his doctor used the catheter improperly, inflating the balloon beyond the pressure specified on the FDA-approved instructions.

Zieve disagrees that the label was adequate, calling the instructions “confusing and misleading.” However, she said the preemption argument was more central to the case, calling it “essentially a get out of jail free card.”

If the court upholds Medtronic’s position, Zieve said, it means that “no matter who messed up, you can’t sue the company.”

December 4th, 2007 by Molly Selvin with Los Angeles Times

SOURCE: Hormone Replacement Therapy › High court may bar claims for FDA-approved drugs

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

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

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

The company won 15 of the 18 lawsuits that have been tried, according to company information. Two others were settled, and one was in the plaintiff’s favor.

Lawyers for the three women who were awarded more than $120 million in jury awards in Reno have disputed Wyeth’s claims.

Nevada residents Jeraldine Scofield, Arlene Rowatt and Pamela Forrester testified that they developed breast cancer after taking Premarin, an estrogen replacement, and Prempro, a combination estrogen, and progestin to offset the symptoms of menopause.

They claimed in their lawsuit that Wyeth produced a dangerous product, failed to adequately test the drugs and failed to provide warnings about the drugs’ risks.

After two days of deliberations, the jury agreed with the women’s claims and ordered Wyeth to pay $43.5 million each to Scofield and Rowatt, and $47.5 million to Forrester.

The jury will deliberate at 10 a.m. today about punitive damages.

October 12th, 2007

SOURCE: Hormone Replacement Therapy › Wyeth fights more than 5,000 hrt lawsuits nationwide

It was the largest award to date against Wyeth, of Madison, N.J., which faces more than 5,000 similar lawsuits across the country in state and federal courts.

The panel deliberated for two days before announcing its verdict late Wednesday in favor of Jeraldine Scofield, 75, of Fallon; Arlene Rowatt, 67, of Incline Village; and Pamela Forrester, 64, of Yerington.

A Wyeth spokesman, Douglas Petkus, said Thursday that the company would have no comment. But in an e-mail message to The Associated Press, he noted that 20 similar cases had gone to trial or been otherwise resolved. Of those, he said, three were resolved in favor of the company, two plaintiff verdicts were set aside by the courts and three cases were dismissed on summary judgment. Twelve other cases were dropped by the plaintiffs before trial, he said.

During the trial concluded here, the women testified that they had started taking Premarin, an estrogen replacement, and Prempro, a combination of estrogen and progestin, to help offset menopausal symptoms, but were taken off the therapy when they developed breast cancer.

Wyeth lawyers said the company sponsored or participated in studies on the risks of breast cancer, and detailed the risks on warning labels included with each bottle of the drug.

Last October, Wyeth reached an undisclosed settlement with a fourth woman who had been part of the lawsuit. That woman, Carol McCreary, was found to have breast cancer in 2001 after taking Prempro for about 33 months. She died in April at 59.

To learn more about the link between hormone replacement therapy and breast cancer, visit www.hrt-legal.com.

October 12th, 2007

SOURCE: Hormone Replacement Therapy › Jury awards 3 women $134.5 million in hormone therapy lawsuit

The jury also must decide whether Wyeth failed to adequately test their drugs Premarin, an estrogen replacement, and Prempro, a combination estrogen and progestin, before putting them on the market and whether it failed to warn doctors about the drugs’ risks.

“Wyeth didn’t do (breast cancer) studies because the results could be embarrassing and could be costly,” Zoe Littlepage, a lawyer for Jeraldine Scofield of Fallon, Arlene Rowatt of Incline Village and Pamela Forrester of Yerington, told the jury.

The company’s decision to produce, market and sell a dangerous product affected thousands of women, and the company should be held responsible, Littlepage said during her closing argument in Washoe District Court.

Wyeth lawyer Heidi Hubbard said microscopic analysis showed the cancers each of the three women suffered are different, and no one can say why they developed. But each woman had a list of risk factors that could have contributed to their diseases.

“So many women get breast cancer, and we don’t know to this day what causes it; and researchers are trying to find the cause so they can find the cure,” Hubbard said.

“This case is about a medication that’s an appropriate treatment option for many women,” she said. “To this day, (the drugs) are the most effective available for menopausal symptoms.”

Scofield, 75, Rowart, 67, and Forrester, 64, began taking hormone replacement drugs years ago to offset hot flashes and other discomforts associated with menopause. But when each developed breast cancer, they stopped the drugs and underwent treatment.

The lawyers for the three women, who have sat in the front row of the courtroom every day of the trial, said Wyeth knew there were links between their drugs and the cancers but ignored the dangers in favor of skyrocketing sales.

The warning labels the company put on the drugs sounded more like reassurances than alarms, Littlepage said. Doctors testified if they knew then what they know now about the breast cancer risks, they never would have prescribed the drugs long-term as the company promoted them, she said.

Dan Webb, another Wyeth lawyer, challenged those claims.

Wyeth helped sponsor or participated in 63 studies to look at whether hormone replacement drugs increased the risk of breast cancer, he said. When the results came in, the company followed a directive from the U.S. Food and Drug Administration and created warning labels that detailed the risks, he said.

“The FDA knows more about research on drugs than the plaintiffs,” Webb said. “When (the women) say we didn’t properly test, it’s not true. Wyeth clearly understood the breast cancer risk and put it on the label.”

The women’s civil lawsuit seeks unspecified damages, but Littlepage told the jurors that they should look at how the company spent its money to promote the drugs when considering an appropriate amount. Those totals were in the millions of dollars.

October 10th, 2007

SOURCE: Hormone Replacement Therapy › Prempro lawsuit goes to the jury

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