Can Wyeth win back the 40 million Premarin and Prempro users
it's lost since 2002 -- along with $1 billion a year in profits -- with a new
Or will the once-bitten women who have filed more than 5,000
lawsuits claiming the hormones gave them cancer feel fooled twice?
Pristiq, a serotonin/norepinephrine reuptake inhibitor
(SNRI), is a metabolite of Wyeth's antidepressant Effexor XR -- which netted
$3.7 billion in 2006 -- and an unabashed patent extender since Effexor XR goes
off patent in 2010.
In February, Pristiq was approved by the FDA for the
treatment of adults with major depressive disorder but its launch as the first
nonhormonal treatment for menopausal symptoms is what Wyeth hopes will fill the
Premarin/Prempro/Effexor black hole to the tune of $2 billion a year.
Unfortunately, instead of a green light to market Pristiq
for menopause last July, the FDA -- also once bitten after Vioxx, Avandia and
Vytroin -- said to Wyeth not so fast.
Why did two women in the study group taking Pristiq have
heart attacks and three need procedures to repair clogged arteries compared
with none taking a placebo it wanted to know? How can Wyeth assure long term
safety when 604 of the 2,158 test subjects took Pristiq for only six months and
318 for a year or more? And what about serious liver complications seen in the
Nor do drug industry insiders in the chatroom cafepharma sound like they're scooping up
"Pristiq is not a good drug by any standard,"
wrote one anonymous poster. "We tried to get 100 mg approved as the
standard dose. But our patients got so sick that they could care less about the
efficacy. They just couldn't tolerate the drug long enough to see any
Like longer than six months?
"No study exists showing any anti-depressant including
Pristiq works any better than a placebo for reducing hot flashes, which are
subjective anyway and only last a few minutes long at worst," wrote
another anonymous poster. "That is a heavy price to pay to take a heavy
duty drug 24/7 for a few minutes of daily relief that a sugar pill also
provides. FDA is crazy (or bought) if they allow this unproven drug travesty on
A third poster predicted women wouldn't trade, "hot
flashes for decreased libido, nausea, increased blood pressure and incredible
withdrawal issues," found with Pristiq. "Women and their physicians
are not as gullible as they were back in the Premarin days."
Even psychiatrist Daniel Carlat, who wrote an expose for the
New York Times magazine, called Dr. Drug Rep, last year about his experiences
as a Wyeth paid spokesman, is dissing Pristiq.
"Every patient who takes Effexor produces Pristiq in
their own body, at no additional charge," he writes in a blog article,
called Top 5 Reasons to Forget About Pristiq.
Moreover Wyeth's own investigator on the major Pristiq
trials, Dr. Michael Liebowitz, admits it is "not a revolutionary
drug" writes Carlat.
Of course you can't blame a one trick company,
which cut its teeth on the Feminine Forever idea that age in women is a disease
that needs treating, for churning the demographics. Especially as it lays off
1,200 US workers, closes manufacturing plants and fights for its life --
lobbying the Hill for patent and tax relief and to keep drug company gifts to
Was it Wyeth's fault that the hormone "therapy" it
pushed for decades actually increases breast cancer by 26 percent, heart
attacks by 29 percent, stroke by 41 percent and doubles the risk of blood clots
But if US women embrace a major psychiatric drug with
possible liver and heart complication side effects after the hormone hoax --
manufactured by the same company and at four times the cost of
Prempro/Premarin, $4 per day . . .
Fool me twice . . . ?
Martha Rosenberg is
staff cartoonist on the Evanston Roundtable. She can be reached at firstname.lastname@example.org.