Pfizer Settled About Half of Prempro Cases | Bloomberg
Pfizer Inc. (PFE), the world’s largest drugmaker, has settled almost half of the lawsuits over its menopause drugs and increased the funds set aside to resolve the cases, the company said in a regulatory filing.
Pfizer and its Wyeth and Pharmacia & Upjohn units have resolved about 46 percent of suits that claimed the companies’ hormone-replacement medicines, including Prempro and Premarin, caused breast cancer, according to the Securities and Exchange Commission filing. Pfizer said it added $68 million to the $772 million it already reserved for the cases.
“We have recorded a charge of $260 million in the first nine months of 2011 that provides for the minimum expected costs to resolve all the remaining hormone-replacement actions,” Pfizer officials said in the Nov. 10 filing.
More than 6 million women took Prempro and related menopause drugs to treat symptoms including hot flashes and mood swings before a 2002 study highlighted their links to cancer. Wyeth’s sales of the medicines, which are still on the market, exceeded $2 billion before the release of the Women’s Health Initiative study sponsored by the National Institutes of Health.
Until 1995, many menopausal women combined Wyeth’s Premarin, an estrogen-based drug, with progestin-laden Provera, made by Pfizer’s Upjohn unit, to relieve their symptoms. Wyeth combined the two hormones in its Prempro pill.
At the height of the litigation, Pfizer faced more than 10,000 claims that its menopause drugs caused breast cancer, according to lawyers for former users. Those lawsuits included more than 8,000 cases consolidated in federal court in Arkansas and suits in state courts in Pennsylvania, Nevada and Minnesota.
Pfizer in May disclosed the $772 million reserve and said it had resolved a third of the cases, or about 3,300. The November filing indicates Pfizer officials have now settled almost 5,000 of the suits.
“Pfizer continues to have a strong record of success in defending these cases,” Chris Loder, a company spokesman, said in an e-mailed statement. “While we will continue to look for opportunities to enter into favorable settlements where appropriate, we will also continue to vigorously defend these medicines in litigation.”
Prempro Drug Trial In Second Day of Deliberations
No verdict after a second full day of jury deliberations Wednesday in a Benton woman’s lawsuit alleging that Wyeth Pharmaceuticals’ hormone drugs caused her breast cancer.
U. S. District Judge Bill Wilson Jr. ordered jurors to return at 9 a. m. today to the federal courts building in Little Rock to resume deliberations.
Jurors are asked do decide if the hormone drugs Premarin and Prempro were safely made and adequately labeled at the time Linda Reeves took them from 1992 to 2000 to prevent osteoporosis and alleviate vaginal dryness.
Reeves’ case is the first of several bellwether cases across the country to go to a jury. There are roughly 5,000 similar cases pending against Wyeth across the country.
Prempro Trial Getting Under Way
Merck has been the drugmaker in the news the past couple of months. It's fighting off thousands of Vioxx lawsuits one by one. But another company is set to steal that unwelcome spotlight. Wyeth is defending about 4,500 suits over its hormone replacement, Prempro. Six million menopausal women in this country have taken it. But the drug has been linked to breast cancer. Jury selection in the first case to go to trial began in late August.
Premarin, Prempro, Provera - Hormone Pills
Over the last three years, some 3,600 cases have been filed against Wyeth, Upjohn, Pfizer Inc. and other companies over estrogen drugs women took to ease menopausal symptoms.
This controversy departed from the usual script: The hormone medication — unlike other drugs that have inspired waves of litigation, such as Wyeth's "fen-phen" and Merck & Co.'s Vioxx — is still on the market. It's still approved by the Food and Drug Administration as safe and effective.
And although sales have declined dramatically since 2002, doctors wrote more than 40 million prescriptions for the pills last year alone. Many women consider them a godsend.
This creates a challenge for the plaintiffs' lawyers.
The fact that the hormone medication is still on the market "implies that it must be pretty safe," and this probably will help drug-company lawyers appeal to jurors, said Robert MacCoun, a professor at UC Berkeley's law school.
For half a century, hormone pills were fixtures in medicine cabinets of women of a certain age. Tens of millions of American women have taken some form of the estrogen-progestin mix to temper the drenching night sweats, insomnia, heavy bleeding and other bedeviling symptoms of menopause.
Women often stayed on the regimen for years, convinced by their doctors — and a steady barrage of ads — that the pills also would ward off wrinkles, brittle bones, heart disease and other ravages of age.
Marketed as Premarin, Prempro and Provera, hormone-therapy drugs were so widely prescribed that they long ranked among the top-selling pharmaceuticals — until the 2002 study.
Drug makers contend that the study was flawed because so many of the women were in their 60s or 70s, or they were smokers or had high blood pressure or other risk factors for cancer and vascular disease.
Wyeth's senior corporate counsel, Mark Lynch, also said that doctors and patients had been warned about the breast cancer link. "That information had been on the Prempro label since 1995," he said.
Santa Monica plaintiffs' lawyer Gary M. Paul disagrees. "No one had ever indicated either to the doctors or to the women how much of an increase there was for breast cancer from using this medication," he said.
By Molly Selvin Times Staff Writer
Prempro and Premarin Background
Hormone Replace Therapy (HRT)
Under the guidance of the federal government, the National Heart, Lung and Blood Institute (NHLBI) launched a study to determine the long term effects of Prempro, a hormone replacement therapy drug. The study, originally planned to last eight years, was abruptly halted after five years when researchers determined the side effects were so severe they could not continue to give patients the drug.According to the NHLBI, women who were given Prempro were more likely to develop serious problems compared to those in the placebo group.
26% increase in breast cancer
41% increase in strokes
100% increase in blood clots
22% increase in incidents of cardiovascular disease
Additional side effects associated with Prempro include ovarian cancer, lupus and gall bladder cancer. A study released in May 2003 by the AMA also noted increased risk of Alzheimer's disease and other forms of dementia.
Hormone Replacement Therapy (HRT) Linked with Elevated Risk
Between 20 percent and 50 percent of women in the Western world who are between the ages of 45 and 70 have taken or are now taking Hormone Replacement Therapy drugs like Prempro. In the past they were prescribed to every woman who experienced unpleasant symptoms of menopause. They were even expected to decrease certain health risks. Chances are if you took HRT medications, you assumed that drug companies like Wyeth had tested the safety of the medications. You are not alone – thousands of women were led to believe that these drugs were not only safe, but that they provided health benefits.
On July 9, 2002, the National Institutes of Health (NIH) revealed that it was abruptly halting the use of Wyeth’s Prempro in the Women’s Health Initiative (WHI) study because of unacceptable risks associated with taking Prempro. Letters were sent to study participants urging them to stop taking the drugs because they led to increased risk of breast cancer, heart disease and stroke.
The Women’s Health Initiative was a $700 million, eight year publicly funded study of Hormone Replacement Therapy. It was intended to study the BENEFITS of hormone replacement and hoped to find that drugs like Prempro and Premarin helped in the prevention of heart disease, breast and colon cancer, and osteoporosis. Instead, the risks associated with these drugs outweighed any benefits found and led to the immediate halting of the study. The findings were so shocking that the study was stopped with almost three years left to go.
Summary of WHI Study Findings
• The risk for invasive breast cancer was 26% higher in the group on Hormone Therapy than in the placebo group.
• Doctors for years have actually prescribed Prempro to prevent heart disease. Instead, the risk for heart disease was 24% higher for the group taking Combined Hormone Therapy than for the group on placebo.
• There was a 31% increased risk of stroke for the group on Hormone Therapy.
• The group on HRT had two-fold greater rates of blood clots than the group on placebo.
Prempro Alternative under Development
Dutch drug company, Organon, has initiated further studies to develop a specific class of non-hormonal drugs to treat the hot flushes associated with menopause. The new drug, currently in development, is set to be amongst the first of its kind on the market.
The drive by Organon in developing a non-hormonal approach to the vasomotor symptoms associated with the menopause could be seen as a direct response to the widely publicized studies, which appeared to alter the HRT risk benefit ratio. One of those hardest hit was US pharmaceutical company Wyeth and its combination hormone replacement therapy, Prempro (oestrogen/progestin), which was linked to breast cancer and cardiovascular disease.
A study by the Women's Health Initiative, released in early October, showed that estrogen-progestin pills double post-menopausal women's chances of developing dangerous blood clots. The results came from the same government study that was halted two years ago after Prempro estrogen-progestin pills appeared to raise the risk of heart attack, stroke and breast cancer.
Reichert and her attorney say Wyeth was negligent in warning of the dangers, made false representations about the safety of the product and offered a product that was neither safe nor effective and had serious side effects.
Since the studies, Wyeth officials have been promoting lower doses of estrogen be used in treating menopause for a shorter period of time than was prescribed in the past.
Richert's lawsuit was part of a class-action filing in Arkansas earlier this year, but the judge ordered that the cases be separated.