Juries and Medical Journals Making HRT mongering More Difficult for Wyeth
Premarin, the once popular hormone replacement therapy (HRT) drug can never be a blockbuster again writes an anonymous
pharmaceutical salesman in the chat room, Cafepharma, because in defending recent cancer lawsuits Wyeth lawyers, "blamed
the woman for not reading the warning label and you can't sell the stuff once they do. "
Nor can it win back physician acceptance, continues the salesman, because, "Wyeth left the prescribing doctors hanging
out to twist slowly in the wind by blaming the patients for not knowing what they were doing when they were just
following their doctor’s advice. Bad move."
February saw two major legal defeats for the Madison, NJ-based hormone maker Wyeth.
In Reno, NV, Washoe County District Judge Robert Perry awarded $58 million to three Nevada women who say its products
gave them cancer. And in Little Rock, AK, $2.75 million was awarded to Donna Scroggin, 66, who had a double mastectomy
after taking Wyeth drugs for 10 years.
Wyeth lawyers claimed Scroggin had a history of breast cancer on both sides of her family and would have gotten the
disease anyway. But Scroggin’s attorney, James Morris, argued her cancer was hormone-receptor positive not genetic and
jurors agreed, finding Wyeth and Pfizer's Pharmacia & Upjohn, another drug company, showed ''reckless disregard'' for their products’ risks.
Wyeth has now lost four of seven Premarin and Prempro cases since hormone replacement therapy (HRT) trials began in
2006.
In 2002, the federal 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 and journal articles regularly confirm and expand the dangers.
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.
In February, an article appeared in the Archives of Internal Medicine that found HRT, in addition to increased breast
cancer risk, caused abnormal mammograms in one out of ten woman and abnormal breast biopsies in one 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.
Also in March, the influential 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.
Worse, two and a half year after stopping HRT, invasive breast cancer risks did not diminish, say the researchers,
though stroke, pulmonary emboli and deep vein thrombosis did.
The new 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.
Wyeth has been hoping its new menopause drug, Pristiq, would, "help it rebound from a huge drop in sales of its Premarin
and Prempro," according to the International Herald Tribune.
But both the US Food and Drug Administration and the European Medicines Agency say they won’t approve the drug for use
in menopause until Wyeth answers important questions about heart and liver safety.
Still, an undaunted Philip Ninan, a Wyeth vice president for Neuroscience, Global Medical Affairs told the Wall Street
Journal, "We would want to bring medicines to the market that have value to society. The financial benefits are a result
of that value that we would bring."
So are the jury awards.
*************
Martha Rosenberg, Staff Cartoonist, Evanston Roundtable.