Eli Lilly's latest curse: Cymbalta
By Martha Rosenberg
Online Journal Contributing Writer
Oct 17, 2007, 00:14
It was supposed to replace Prozac profits when the patent
expired in 2001 and cash in on the national love affair with antidepressants. But Eli Lilly & Co.'s Cymbalta (duloxetine) seemed cursed
from the start.
The first antidepressant to be introduced since FDA
investigations into suicide/antidepressant links, Cymbalta itself was marred
with suicides before it was approved.
Five occurred during Cymbalta clinical trials. including
previously healthy volunteer Traci Johnson who hanged herself in Lilly's
Indiana University Medical School lab in 2004.
"Their posturing was offensive," said the Rev.
Joel Barnaby, spokesman for Traci Johnson's family upon hearing Lilly would not
delay the drug's planned introduction. "They were saying that this little
death certainly should not defame our study or, God forbid, make us miss a
deadline for FDA approval."
Nor was Traci, "in a depressed state of mind or had a
spirit wounded so much that she gave up on life," Mr. Barnaby said.
Despite $208 million in sales in its first eight months of
marketing, thanks to auto-suggestive "Depression Hurts" television
ads and do-you-have-this-disease? symptom checklists on its web site, Cymbalta's
bad buzz didn't go away.
A year after Cymbalta hit drug store shelves it was indicted
for causing more than twice the rate of suicide attempts in women prescribed
the drug for stress urinary incontinence -- a use not approved in the US --
according to the FDA.
Last May, the FDA ordered Lilly to add a black box to
Cymbalta warning about suicides and antidepressants in young adults.
And, in October, Lilly was told to "immediately
cease" its Cymbalta campaign for diabetic nerve pain -- an approved use --
which promises "significantly less pain interference with overall
functioning." In a letter, the FDA says the claim "has not been
demonstrated by substantial evidence or . . . clinical experience" nor do
the Cymbalta marketing pieces give precautions about liver toxicity or reveal
risks for patients with certain conditions.
Lilly spokesman Charlie McAtee said Lilly will take action
once it has "more clarity" on FDA objections. Which part of
"immediately cease" does he not understand?
Even Lilly's own reps are trashing the drug on the pharma
chat room cafepharma.com.
"My territory includes a high percent of blue collar
beer guzzlers that drive home from work with a six pack on their lap,"
wrote one anonymous poster. "The Docs around here won't touch
"This product should have never been approved by the
FDA. The benefits do not outweigh the risks," wrote another. "That is
why there are very few insurance companies that will cover this product. This
is the dirtiest product in the anti-depressant class."
"Cymbalta will be pulled from the market within the
next 2 years due to its major liver damage," predicted another poster.
Things wouldn't be so bad for Lilly if its number one drug,
Zyprexa (olanzapine), wasn't also in trouble.
In the last year, doctors learned that side effects of the
atypical antipsychotic, taken by 20 million people since 1996, "include
diabetes, stroke and death," according to The New York Times.
Lilly's own published data shows morbid patient weight gain
-- 30 percent of patients taking Zyprexa gained 22 pounds or more; 16 percent,
66 pounds or more and some gained over 100 pounds -- and blood sugar levels
that keep increasing with use says the Times -- information it hid from doctors
"Olanzapine-associated weight gain and possible
hyperglycemia is a major threat to the long-term success of this critically
important molecule," wrote Lilly Chief Medical Officer Dr. Alan Breier in
an 1999 email to employees; "Unless we come clean on this, it could get much
more serious than we might anticipate," concurred a group of diabetes
doctors Lilly hired to assess the drug's safety in 2000.
Worse, Lilly was caught playing off-label roulette with
Zyprexa; marketing it for any condition that would stick to the wall instead of
the schizophrenia and bipolar disorder for which it was approved.
Its Viva Zyprexa campaign marketed unabashedly to older
patients with symptoms of dementia -- though the drug increases the risk of
death in older patients with dementia-related psychosis according to its own
label -- earning Lilly 49,000 new prescriptions valued at $300 a month after
only three months.
The elderly people might have had undiagnosed schizophrenia
offered Lilly's vice president for corporate affairs, Anne Nobles, as a weak
The campaign then evolved to Zyprexa Limitless and began
targeting the set of all people diagnosed as depressed who don't know they are
really bipolar yet.
At a 2001 sales meeting, Michael Brandick, Zyprexa brand
manager, called the new prescriptions, "a pretty sweet incentive,"
for sales representatives and olanzapine, "the molecule that keeps on
Lilly is now paying for its over the top marketing, having
spent $2 billion since 2004 to settle lawsuits from 28,500 people who blamed
diabetes or heart problems on the drug with 1,200 more lawsuits to be resolved.
No wonder Lilly "voluntarily" strengthened
Zyprexa's warning label in October with tougher language about weight gain and
elevated blood sugar after "reviewing more data from internal tests and
major outside studies."
Of course, creating diabetes with one pill and treating it
with another may look like self-dealing. But Lilly's vision isn't that narrow.
It's also marketing ADHD drugs to China's kids, Zyprexa to adolescents
and Cymbalta to fibromyalgia patients. Fibromyalgia no doubt
Martha Rosenberg is
staff cartoonist on the Evanston Roundtable. She can be reached at firstname.lastname@example.org.
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