Madison, N.J.-based hormone maker Wyeth has lost four of seven Premarin and Prempro cases since hormone replacement therapy (HRT) trials began in 2006.
But it's not backing down
It's appealing the February award of $58 million to three Nevada women who say its products gave them cancer. Washoe County District Judge Robert Perry originally awarded Jeraldine Scoffed, 74, of Fallon; Arlene Rowatt, 68, of Incline Village; and Pamela Forrester, 65, of Yerington $134 million, but later reduced the amount.Wyeth is also appealing $2.75 million awarded to Donna Scraggy, 66, of Little Rock, Ark., in February; she had a double mastectomy after taking Wyeth drugs for 10 years.
Wyeth lawyers claimed Scraggy had a history of breast cancer on both sides of her family and would have gotten the disease anyway. But Scroggin's cancer was hormone-receptor positive—activated by external hormones invading surrounding tissue—not genetic, argued her attorney, James Morris, during the trial.
Little Rock jurors agreed with Morris and found Wyeth and Pfizer's Pharmacia & Upjohn showed ''reckless disregard'' for their products' risks.
"This verdict should make the Wyeth folks ask whether they really want to try the more than 5,000 cases they face over these drugs," observed Ken Rothweiler, another lawyer trying HRT cases.
Since the Women's Health Initiative (WHI) study found HRT caused a 26 percent increased risk of breast cancer, 29 percent increased risk of heart attack, 41 percent increased risk of stroke, and 100 percent increased risk of blood clots in 2002, new dangers are described in medical journals regularly. And they're not as easy to appeal.
A study in the January issue of Cancer Epidemiology Biomarkers and Prevention found women who took hormone replacement therapy for just three years had four times the usual risk of lobular breast cancer, a cancer which accounts for about 10 percent of invasive breast cancers.
The next month, an article appeared in the Archives of Internal Medicine that found HRT, in addition to increased breast cancer risk, caused abnormal mammograms in 1 out of 10 woman and abnormal breast biopsies in 1 out of 25 women after just five years of use. A year after HRT termination, compromised "diagnostic performance" was still seen in the studied women.
"This adverse effect on breast cancer detection should be incorporated into risk-benefit discussions with women considering even short-term combined hormone therapy," wrote the authors.
And in March, another study appeared in Cancer Epidemiology Biomarkers & Prevention, this time finding that estrogen levels were almost twice as high in the blood of breast cancer patients with recurring cancer as in those who were cancer free.
"Women who have already been treated for breast cancer should do as much as they can do to reduce estrogen in their blood, such as exercising frequently and keeping weight down," said lead author, Cheryl L. Rock of the University of California, San Diego.
The same week the Journal of the American Medical Association (JAMA) ran a new analysis of WHI data and found that three years after stopping HRT, WHI participants had more lung cancer and greater mortality than non-hormone users.
"Estrogen receptors occur in non-small-cell lung cancer, and although results are mixed, post menopausal hormone therapy use has been found to be associated with significantly decreased survival in women with lung cancer in one recent report," wrote the authors.
And there was more bad news
Two and a half year years after stopping HRT, stroke, pulmonary emboli, and deep vein thrombosis risks diminished, say the authors, but invasive breast cancer did not.The analysis even quashed the one "benefit" thought to belong to HRT—a possible decreased risk of colorectal cancer. The decrease disappeared when hormone therapy was stopped.
Even the journal Military Medicine had a discouraging word for Wyeth and HRT.
In January, it found that 66 percent of female veterans who used hormone therapy in 2001 had discontinued by 2004, and that "clinical diagnoses such as heart disease and mastectomy were significantly associated with discontinuation."
Wyeth might even see them in court.
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