A reduction in a jury award for a drug that caused cancer from $134 million to $58 million would not normally be cause to rejoice. But it has not been a normal year for hormone maker Wyeth.
The Madison, N.J. based drug company faces 5,300 Prempro and Premarin related law suits in addition to the one it just lost--but with damages reduced--in Reno, NV brought by three women with breast cancer.
Wyeth had asked Washoe District Judge Robert Perry for a mistrial.
Selling a product that's proven to cause cancer isn't easy for Wyeth.
In January, it announced it was selling the one million square-foot Rouses Point, N.Y plant where it made its horse-urine derived drugs and employed 900 and cutting a full ten percent of its work force.
Nor is the Food and Drug Administration (FDA) rubber stamping new drugs from the company which made fenfluramine/phentermine and some say has a "safety second" culture.
Last year it rejected Wyeth's osteoporosis drug, bazedoxifene, because of stroke and blood clot problems, schizophrenia drug, bifeprunox, because it was not as effective as other drugs on the market and menopause drug, Pristiq, because of serious heart or liver complications experienced by trial participants.
The FDA is "establishing monopolies" by rejecting drugs just because they're inferior to existing ones growled outgoing Wyeth CEO Bob Essner when bifeprunox was not approved. After all, the public liked Vioxx and Vytorin just fine and they weren't better than their predecessors, he might have been thinking.
No wonder Wyeth lawyers have been browbeating the FDA, successfully it turns out, to regulate pharmacy compounded bioidentical hormones that have unseated its products in many women's medicine chests.
Wyeth is not alone in hoping for an HRT comeback.
Since HRT was found by the Women's Health Initiative in 2002 to cause 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, a study in the January issue of Cancer Epidemiology, Biomarkers and Prevention found the cancers also move quickly.
Women who took combined estrogen/progestin hormone-replacement therapy for just three years had four times the usual risk of lobular breast cancer which accounts for about 10 percent of invasive breast cancer.
The effect of millions of HRT users saying, "You want us to take WHAT?" after the WHI study--75 percent quit--was also dramatic. There was an 8.6 percent reduction in overall breast cancer between 2001 and 2004 and 14.7 reduction for estrogen-receptor positive breast cancer.
But "studies" by doctors who don't want to give up the HRT gravy train appear with increasing regularity, promoting results that seek to reverse or spin the WHI findings.
HRT actually protects against heart disease and reduces calcification of the arteries--two original, disproved HRT selling points--say the authors of the new crop of "timing hypothesis/therapeutic window of opportunity" analyses, hoping the memory of the American public is as short as their practice's funds without trumped up HRT profits.
Researchers even resuscitated the discredited claim that HRT protects against dementia at a meeting of the American Academy of Neurology last year. And there are rumblings that HRT's ability to lower colon cancer could be of value. (Viz: HRT causes breast cancer, heart attack, stroke and blood clots but you might not get colon cancer!)
The article states that "Last year it [theFDA] rejected Wyeth's osteoporosis drug, bazedoxifene, because of strokeand blood clot problems..." Please note that the FDA issued an approvable letter for bazedoxifene for the prevention ofpostmenopausal osteoporosis in April 2007 and another inDecember 2007. The agency did not reject the drug, as thearticle states. I have attached the Wyeth-issued press releases reportingon the approvable letters for your reference.
HowevertheAssociated Press wrote on Dec. 26, 2007:
“Wyeth said the FDA had sent the company a second‘approvable’ letter for bazedoxifene, which stated it won't consider approvingthe drug for preventing postmenopausal osteoporosis until Wyeth explains strokeand blood clot problems.” [quotes belong to AP]
And Bloomberg News wrote in a Dec. 25, 2005 article called, “Wyeth Hit byGeneric Competition and Regulatory Setback":
“the Food and Drug Administration delayed the osteoporosis medicine Viviant fora second time because of concerns it might cause strokes and blood clots.”
If a drug that the FDA “won’t consider approving… untilWyeth explains stroke and blood clot problems”which has been “delayed…for a second time because ofconcerns it might cause strokes and blood clots,” rates an “approvable letter”there are more problems at the FDA than previously thought.
Kathryn Beeler has been invited to post her comments.
Martha Rosenberg
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Martha Rosenberg (107 articles, 0 quicklinks, 2 diaries, 1 comments)
on Tuesday, February 26, 2008 at 9:34:34 AM
