Despite 5,000 lawsuits, Wyeth and US endocrinologist group hope for HRT comeback
By Martha Rosenberg
Online Journal Contributing Writer
Feb 27, 2008, 00:47
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, NJ-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, Nev., brought by three women with breast cancer.
Wyeth had asked Washoe District Judge Robert Perry for a
Selling a product that's proven to cause cancer isn't easy
In January, it announced it was selling the one million
square-foot Rouses Point, NY, plant, where it made its horse-urine derived
drugs and employed 900, and was cutting a full 10 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
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 percent reduction for estrogen-receptor positive breast
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!)
Of course some doctors have noted the creeping HRT
Enthusiasm for the Yes But studies "far exceeds the
science" and does not "alter current recommendations that hormone
therapy should never be used to prevent heart disease," says Dr. Helen
Roberts, senior lecturer in women's health at Auckland University. For one
thing, "the risk of stroke was elevated regardless of how many years had
elapsed since menopause," she says of the new studies.
But others like the American Association of Clinical
Endocrinologists (AACE) have jumped on the HRT bandwagon.
"This is an important and meaningful analysis for women
who can benefit from Hormone Replacement Therapy," said Richard Hellman,
AACE President, about a study which indicated HRT did not elevate
cardiovascular disease risk in some women.
And a position paper on the AACE site says, "Given the
powerful effects of estrogen therapy in relieving menopausal symptoms, we
believe that physicians may safely counsel women to use estrogen for the relief
of menopausal symptoms."
Some suggest Wyeth money is behind the AACE position.
After all, Hellman also came out for controversial diabetes
drug Avandia when the FDA questioned the drug's safety. "There is still
not a good scientific basis for assessing the drug's safety in all patients.
But, we can say, if there is an increased risk for a heart attack, it appears
to be a relatively small risk," he wrote on the AACE site.
And even though he added the organization has "no
financial ties to the company, GlaxoSmithKline, that manufactures
Avandia," AACE's annual report for 2006-2007 thanks GlaxoSmithKline four
times for its financial support.
Wyeth money could help for future court cases.
Martha Rosenberg is a Staff Cartoonist at the Evanston
Roundtable. Her work has appeared in the Chicago Tribune, LA Times, San
Francisco Chronicle, Boston Globe, Providence Journal. Arizona Republic, New
Orleans Times-Picayune and other newspapers. She can be reached at: firstname.lastname@example.org.
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