Premarin and Prempro Heyday Finally Over

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 women 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 years 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 U.S. 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.


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