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There's Still Money in Huckstering HRT for Wyeth 2-25-08
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!)
Of course some doctors have noted the creeping HRT revisionism.
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.