There is a mad dash among pharmaceutical companies worldwide to find a drug that safely treats the symptoms of menopause. Premarin, after all, was the best selling HRT in the U.S. before the Women’s Health Initiative (WHI) in 2002 linked HRT to higher incidences of breast cancer, heart attacks and strokes. Since then, the use of HRT has drastically reduced, and similarly, so has the incidence of breast cancer among menopausal women.

Despite the urgency in finding a safer alternative to HRT, experts say it will take at least four years for the synthetic hormones to become available. And it would expensive. Drugs for human use typically cost about $1 billion to develop. The next step would be finding an effective way to communicate to women that the synthetic hormones are actually safe, a tough job considering the bad rap HRT has received since WHI.

SOURCE: Hormone Replacement Therapy › Researchers working on safer synthetic HRT for menopause

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

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

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