CYMBALTA: 18 suicides: 41 Deaths: Freedom of Information: Counterpunch

Paragraph 9 reads: "Safety data for Cymbalta obtained by reporter
Jeanne Lenzer under a Freedom of Information request for an
Independent on Sunday article disclosed 41 deaths and 13 suicides
which did not include Johnson's or the four cited by Hayes, says
Lenzer."

Paragraph 13 reads: "And an article in the January 2007 issue of
Diabetes Care found Cymbalta actually raises fasting blood glucose
which can worsen the diabetic peripheral neuropathy it is supposed to
treat. (see: depression; causes and effects)

http://www.counterp unch.org/ rosenberg0414200 8.html

Apri1 14, 2008

Eli Lilly Markets Its Dangerous New Drug as If a Pipeline Depended On
It

Suicide and Cymbalta
By MARTHA ROSENBERG

A sk about published reports of 470 completed suicides of people on
antidepressants since Prozac debuted in 1988 and the drug industry
will say that's depression for you. Without our drugs, it would be
worse.

But how does Eli Lilly and Co. explain the mounting suicides of people
given Cymbalta (duloxetine) for urinary incontinence or peripheral
neuropathy?

The planned debut of Cymbalta, now Lilly's number two drug, was even
delayed by the suicide of a non-depressed person in 2004.

Traci Johnson, a healthy 19-year-old college student volunteer
enrolled in a Cymbalta trial hung herself by a scarf from a shower rod
in Lilly's Indianapolis, IN laboratory while withdrawing from the
drug.

Johnson showed no outward signs of depression and Lilly said she had
been screened for mental problems, but staff conducting a concurrent
Cymbalta trial made comments about her "mental history" to at least
four participants- -perhaps to keep them from dropping out of the
trials as a fifth of volunteers did after the suicide.

After Johnson's death, Lilly was ordered to stop accepting new
volunteers for the study and to have continuing participants evaluated
by an independent psychiatrist and sign new consent forms. But in
another Cymbalta trial of 4,124 depressed patients just weeks later,
four more participants took their lives according to a Lilly clinical
psychiatrist, Dr. John R. Hayes.

Meanwhile reports from abroad where duloxetine was already in use as a
stress urinary incontinence treatment called Yentreve were just as
grave.

Twice the expected number of suicide attempts among middle aged women
were seen with the drug-- 400 per 100,000 person-years versus a
baseline of 160 per 100,000 person-years- -said the FDA on its Web
site in June, 2005, leading Lilly to precipitously withdraw its
application to sell Yentreve in the US.

Safety data for Cymbalta and Yentreve obtained by reporter Jeanne
Lenzer under a Freedom of Information request for a Independent on
Sunday article disclosed 41 deaths and 13 suicides which did not
include Johnson's or the four cited by Hayes, says Lenzer.

In fact in an article titled," Duloxetine: new drug. For stress
urinary incontinence: too much risk, too little benefit," in the
December 2005 issue of French medical journal Prescire International,
the authors conclude that the drug should not even be in use.

More than 40 different types of adverse effects have been reported,
including suicide attempts and potentially severe hepatic disorders.
(7) Duloxetine is metabolised by the cytochrome P450 isoenzymes CYP
1A2 and CYP 2D6, creating a risk of interactions with other drugs that
follow these metabolic pathways. (8) In practice, purely symptomatic
treatments that have no documented efficacy but many adverse effects
should not be used, especially when there is an alternative treatment
with a positive risk-benefit balance.

The FDA approved Cymbalta for depression and diabetic peripheral
neuropathy in 2004 and generalized anxiety disorder in 2007. But last
fall it ordered Lilly to stop downplaying liver toxicity in its
promotional materials.

And an article in the January 2007 issue of Diabetes Care found
Cymbalta actually raises fasting blood glucose which can worsen the
diabetic peripheral neuropathy it is supposed to treat. (see:
depression; causes and effects)

Cymbalta has other side effects too, say users in email messages to a
reporter.

In Jim Ellsworth, 52 of Houlton, Maine it caused a "hypertensive
crisis" that did not fully subside until a month after quitting the
drug he says.

It caused "involuntary twitching and jerking motions" that persist
three years after being off Cymbalta for fibromyalgia says Lonna.

And for Amy, who had no history of depression but was "given Cymbalta
for Attention Deficit Disorder, (which I haven't been able to find
anywhere that it is even approved for that)" it caused a withdrawal in
which she "went on rampages and cried over everything and felt so sick
and awful that I didn't think I wanted to live anymore."

But worst are the out of character, almost matter of fact suicides
like a man described by his family as, "NOT depressed, he was a
fun-loving guy with all sorts of plans in place for the future," who
was prescribed Cymbalta for foot pain.

He "had a normal day at work, drove home, said he was going to grab a
sandwich to his wife, and went and shot himself."

With its number one drug, Zyprexa on the ropes--Alaska and Louisiana
sued Lilly for the Medicaid costs of treating Zyprexa-caused diabetes
and CEO John C Lechleiter was caught promoting it off label by the New
York Times--Lilly is marketing Cymbalta like its pipeline depends on
it.

It used 500 sales reps from slick contract sales organization
Quintiles International to launch Cymbalta as well an unspecified
number of its own reps and hopes to get approval for fibromyalgia
while doctors are still writing the drug.

But bad press for Cymbalta might start sooner than Lilly expects--in a
wrongful death suit of Carol Gotbaum who strangled herself with
handcuffs while in police custody at the Sky Harbor International
Airport in Phoenix, AZ in September.

Press reports say the 45-year-old daughter-in- law of a New York City
elected official and prominent labor leader was under the influence of
Cymbalta.

Martha Rosenberg is staff cartoonist on the Evanston Roundtable. She
can be reached at mrosenberg@evmark. org