3 Nevadans take on Drugmaker
Date: September 9, 2007 12:00 AM

Jeraldine Scofield loves to quilt. The 75-year-old widow meets weekly with a quilters group in Fallon and makes special gifts for her children and grandchildren. It has been seven years since she was diagnosed with breast cancer, and she is "somewhat optimistic" about her future health.

Arlene Rowatt, 67, is one of 12 children. She moved west to work for the National Guard and came to Incline Village to hike, canoe and cross-country ski. She retired at 60, the year she found a lump in her breast, which led to a mastectomy. At present, "everything looks good."

Pamela Forrester is not as fortunate. Her condition is terminal. The 64-year-old Yerington mother of three and grandmother of seven discovered her breast cancer in 2004. She successfully underwent surgery and radiation but was diagnosed with lung cancer in 2005.

The women have shared the trauma of facing a cancer that threatened their lives. But they have another factor in common: years spent taking Hormone Replacement Therapy drugs to counter the effects of menopause.

To fend off hot flashes, restless sleep and fear of osteoporosis, their doctors prescribed Provera or Prempro, made by the Delaware-based pharmaceutical company Wyeth. When their breast cancer appeared, they were quickly taken off the drug.

After conducting research and contacting lawyers, the women now believe there's a link between their illnesses and the drug. Beginning Monday, they'll face lawyers from Wyeth in what is expected to be a six-week jury trial to determine whether Prempro and Wyeth's conduct was responsible for the cancer and, if so, whether damages should be paid.

In their lawsuit filed in Washoe District Court, the women said Wyeth failed to adequately warn women about the risk of breast cancer when taking the hormone replacement drugs, failed to adequately test the drugs and marketed dangerous products.

The Upjohn Company, maker of Provera, another hormone replacement drug used with Wyeth's estrogen pill, Premarin, was named in the lawsuit but settled with the three women for an undisclosed amount.

"Plaintiffs are eager to present their cases to a jury of their Nevada peers over the next few weeks," said Geoffry White, one of the women's lawyers. "Let the jury, not Wyeth's PR people, decide if Wyeth acted responsibly in promoting hormone therapy.

"Let that same jury decide if Wyeth hoodwinked the FDA, the Nevada medical community and tens of thousands of Nevada women about the purported safety of its hormone products, because now Wyeth and three Nevada breast cancer survivors stand toe to toe on the same, level playing field -- a court of law," he said.

Wyeth officials said FDA-approved warnings were on the drug bottles and they distributed these warnings to doctors who prescribed the drugs. The women who took Prempro, they said, knew or should have known the risks and there's no way to make a direct connection between the cancer and the drug, so other factors likely came into play.

"Wyeth has always acted responsibly when it comes to its hormone-therapy products, making sure that the warnings contained in labeling are consistent with the science at the time," company spokesman Doug Petkus said. "These medications are viewed by the FDA as safe and effective and continue to be prescribed by thousands of physicians daily."

The company is fighting 5,300 lawsuits brought by about 7,800 women in state and federal courts across the country alleging injury with the use of Prempro and Premarin, according to the company's financial report.

Of the 18 suits involving breast cancer and the hormone therapy drugs that have been set for trial and resolved, 15 were in Wyeth's favor, two were settled and one favored the plaintiff, Wyeth said.

The women's lawyers disputed the company's claims.

"As Wyeth well knows, there are verdicts going both ways," White said. "There have been at least three plaintiffs' jury verdicts against Wyeth, all in excess of $1 million for each hormone-related breast cancer victim."

Wyeth reached an undisclosed settlement last October with a fourth woman who had been a part of the Reno lawsuit. Carol McCreary was diagnosed with breast cancer in 2001 after taking Prempro for about 33 months. She died in April at age 59.

Breakthrough drug

As women age, the amount of natural hormones their bodies produce decreases. This change in hormone level can result in mood swings, hot flashes, a drop in bone density and night sweats, among other symptoms.

In 1942, Ayerst, a drug company that preceded Wyeth produced a drug called Premarin, which replaced the declining natural hormone estrogen, according to court records. By the 1980s, doctors were prescribing Premarin with the drug Provera, a progesterone replacement made by Pfizer, as the best remedy. In 1994, the U.S. Food and Drug Association approved the new drug Prempro, which combined both estrogen and progestin into one pill.

The companies actively marketed these drugs to counter the miseries of menopause and "by the mid-'70s, more than 30 million prescriptions for Premarin were being written every year," the lawsuit said.

By the 1990s, Premarin was "the most frequently dispensed prescription drug in the United States," court records said.

Around the same time, the National Institutes of Health began a large-scale study called the Women's Health Initiative Study. By 2002, the study issued a report on Prempro that said its use resulted in a 41 percent increase in strokes; 29 percent increase in heart attacks, and a 26 percent increase in breast cancer.

According to the report, the "overall health risks exceeded benefits from use of combined estrogen plus progestin for an average 5.2-year follow-up among healthy post-menopausal U.S. women."

A similar study done in the United Kingdom in 2003 found a similar link between the hormone therapy drugs and breast cancer, the lawsuit said.

"Using the Million Women Study data, it is estimated that hormone therapy has caused more than 100,000 additional and unnecessary breast cancers in the United States of America alone," the lawsuit said.

While Wyeth included a warning of such risks on its labeling and in physician information packets, the plaintiffs in this case say they were inadequate.

Petkus disagreed.

"During the time period when each of the plaintiffs were taking hormone replacement drugs, product labeling contained warnings about a possible risk of breast cancer," he said.

"These medicines are some of the most widely studied medications in existence today, with hundreds of studies and more than 3,000 citations in scholarly publications related to Premarin or Prempro since the products were introduced."

Homemakers turned patients

As the three Northern Nevada women entered menopause, their doctors joined thousands in recommending a hormone replacement.

Rowatt, for example, started taking the drugs between the age of 45 to 50 to stop heavy bleeding and hot flashes, she said in a deposition taken last year. She was not told of the risks of developing breast cancer, she said, but was told it would help with her declining bone density.

She took the drug for about 13 years, until being diagnosed with breast cancer in 2000.

Doctors began with a lumpectomy, but ended up taking the entire breast and several lymph nodes, she testified. She received chemotherapy for six months, but by the next year, a biopsy on the other breast was required.

Wyeth lawyers asked Rowatt whether there was anything that could be done for the scar across her chest.

"I'm sure there is," said Rowatt, who had a pacemaker installed in 2004 to help with arrhythmias. "But every time I have surgery, I'm a very high risk and I'm not going to risk a stroke or blood clot to my brain or anything else going through my valves just so I'll look better in the mirror,"

Scofield, whose mom is 93 and who has no breast cancer in her family, was prescribed Premarin and Provera in 1984 to help prevent osteoporosis, she said in her deposition. She's only 4 feet, 9 inches tall and has small bones, she said.

After her cancer was discovered, she had a "radical mastectomy" but no chemotherapy, she said.

When asked why she's suing Wyeth, she said: "because I'm mad and I'm upset that I have to go through the rest of my life worrying about having breast cancer."

Forrester began taking the hormone replacement drugs Premarin and Provera in 1994 to help with sleeping and missed menstrual periods, she testified.

"I knew that when you went into menopause you needed to have protection for osteoporosis and for the health of your heart," she testified.

Did her doctor discuss the health risks of taking the drugs, the lawyers asked.

"No," she replied, adding that she also was not given any written warnings.

She had her first surgery for breast cancer in January 2004, she said.

"I was immediately taken off (the hormone drugs) when they spotted the breast cancer," she said.

She underwent six weeks of daily radiation treatments after the surgery, she said, which left a scar.

"It's just a big machine that comes down and it radiates you," she said. "(It) eventually ends up in a very big nasty burn."

"Has any doctor told you that there's a link between your use of the hormone replacement drugs and your breast cancer?" the Wyeth lawyer asked.

"No," she said.

Lawsuit and trial

As the trial begins Monday with jury selection and continues Tuesday with opening statements, the women's lawyers will argue that Wyeth is liable and must be held responsible.

Their "experts in oncology, radiology and pathology will support each plaintiffs' contention that her use of Wyeth's Premarine (with Provera) or Prempro was a substantial factor in causing her breast cancer," their trial statement said.

Normally, a woman's risk of breast cancer is reduced after menopause because they lose the hormones that feed the cancer, the statement said. But the Prempro acted like a fertilizer to any breast abnormalities, causing them to quickly grow into cancer, the lawyers said.

"For these plaintiffs, Prempro provided little benefit yet was a substantial factor in plaintiffs' contraction of invasive, life-altering breast cancer," the statement said. The company produced, marketed and sold an "unreasonably dangerous drug," the statement said.

They also said Wyeth knew of the dangers, yet their warnings failed to provide meaningful information about the risks, and, in fact, downplayed the studies that suggested risks, the statement said.

Wyeth said in its trial statement their warnings were adequate.

The FDA approved the drug and "carefully reviewed, reworked, and approved Wyeth's proposed breast cancer warning line by line," the Wyeth statement said. "And this is the precise warning both plaintiffs and their prescribers received."

The women testified they commonly read patient information when using prescription drugs, and knew of the breast cancer risk when taking the hormone replacement therapy, the statement said.

Wyeth also said that the women will be unable to prove that the drugs caused their breast cancer.

"The evidence at trial will prove that the actual cause of breast cancer remains unknown," the company statement said. And the claim that the drugs acted as the "fertilizer on the seed" are bogus, Wyeth said.

"There is no way to tell in most cases whether exogenous hormones had any impact on the growth of a particular tumor," Wyeth said. Their experts will show that "each plaintiff had certain risk factors for breast cancer."


 

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