I have one name for Eli-Lilly:

TRACY JOHNSON!!!!!!!!!!!!!!!

I'm too overwhelmed to comment now. You are criminals!

MURDERERS
MURDERERS
MURDERERS

You belong to JAIL

Wow. Not the first thing to see when I just woke up and turned on my puter.

I just got off Cymbalta. Finally. It was horrible, something I still don't trust myself to write about. And they are going to do this to 7 year old children? I wish there was a law against this. 7 year olds should only be testing toys!

Here in New England, A psychiatrist at the regional community health agency has prescribed Prozac to a 4 year old (at a local preschool).
Unbelievable.

How bizarre to use something not approved for use in a population as a comparator for that population. I believe "not approved for use" means YOU AREN'T SUPPOSED TO USE IT, doesn't it? Doesn't it?

Is this common practice? I really don't know. It's getting to the point where it's hard to surprise me any more but I can't see how this study ever met with approval by an IRB. I'm involved with a health study now and the IRB factor is a huge barrier to getting our work done in a timely manner. So when I see stuff like this going on as we're getting picked nearly to death it really irks me.

Prozac is approved for use for MMD in the pediatric population and Prozac, Zoloft, Luvox and Anafranil are approved for OCD in the pediatric population.

http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm161679.htm

--------------------------
However, Cymbalta is not approved for women with incontinence, get this, because it causes an increase in suicidal behaviors. Here is an article [in part] from SSRI Stories explaining the FDA's position on this.

http://www.ssristories.com/show.php?item=1840

Last paragraph reads: "In addition to the advisory, the FDA also updated its Web site with a notice about a higher-than-expected rate of suicide attempts in research with the nation's newest antidepressant, Eli Lilly's Cymbalta. Those studies were in women trying Cymbalta as an incontinence treatment; it was never approved for that use."

http://www.bdtonline.com/articles/2005/07/01/ap/headlines/d8b2lsbg1.txt

FDA Warns About Antidepressants, Suicide
Posted: Friday, Jul 01, 2005 - 02:05:16 pm EDT

WASHINGTON - The Food and Drug Administration issued a second public warning Friday that adults who use antidepressants should be closely monitored for warning signs of suicide, especially when they first start the pills or change a dose.

As Ana has mentioned, Tracy Johnson, a 19 year old student at a Bible College, committed suicide during a clinical trial for Cymbalta. She was among the healthy volunteers who were testing Cymbalta for metabolism studies.

Four other people committed suicide during Cymbalta's clinical trials.

Here is an article on the five suicides from SSRI Stories [in part].

http://www.ssristories.com/show.php?item=3573

Paragraphs five & six read: "While people say many of Cymbalta’s side effects are manageable, some users experience effects that are extremely frightening and potentially dangerous. Some patients found the drug tends to trigger heart palpitations and increase anxiety levels and elevate the severity suicidal thoughts or impulses."

"A 19-year-old college student who had shown no outward signs of depression killed herself at an Eli Lilly & Company laboratory in Indianapolis where she had been participating in a company drug trial for the experimental antidepressant. Four other patients who were given the drug during earlier trials also committed suicide."

http://www.emaxhealth.com/1357/25/33042/cymbalta-side-effects.html

Submitted by Tyler Woods Ph.D. on Aug 22nd, 2009
Posted under:

Cymbalta, generic name Duloxetine Hydrochloride, has certain side effects consumers should be aware of.

By getting a ped indication it will extend their patent. That is why.

You have got to be kidding me. While I'm not in any way anti-pharma and I take psychotropic medication daily, I whole-heartedly despise this kind of research on children.

Cymbalta is one of the worst medications I have ever tried in my life and the withdrawal effects were the worst health-related thing I've EVER had to go through. It shouldn't even be used on adults, much less children. This is horrible.

I find it hard to fathom why Lilly would want to risk testing Cymbalta in pediatric patients. The Black Box warning for suicidality in youth also covers Cymbalta, as it covers all antidepressants. Of course, Lilly could greatly expand their base for Cymbalta if the drug is approved for MMD in pediatrics by the FDA and that could reap lots of monetary rewards. I suppose, if there is a suicide, Lilly will either cover it up or get some experts, as in the Traci Johnson case, to agree that the Cymbalta had nothing to do with the suicide.

Either way, the public will never hear about the suicide or suicides among the pediatric clinical trials.

It was the same with the clinical tials for Luvox. A young man committed a murder while in the clinical trials for Luvox and nobody ever heard about it. Even though Eric Harris of Columbine was on Luvox, the story was later changed to "Harris was a psychopath" or, even according to U.S.A. Today, "Harris was not on any antidepressants."

Here is the case of the murder during the clinical trials of Luvox as it appears on SSRI Stories.

http://www.ssristories.com/show.php?item=1711

Paragraph 4 reads: "He said he was taking a drug somewhat similar to the controversial drug Prozac, and that the drug impeded his perception abilities.
__________________________________________________
Shooting reaps 17-year sentence
St. Petersburg Times
July 23, 1993
Author: LAURA GRIFFIN
Estimated printed pages: 2

A man who said an experimental psychological drug made him kill a man who had gone out with his wife was sentenced to 17 years in prison Thursday.

Rosie,
Do you have the name or any information about the four others who died?
I'm looking for them a long time.
Tracy Johnson's family has received money from Eli-Lilly.
They should have received the money and tell all the world how their daughter has been murdered.
Parents!
Dear Lord!

When we're talking about "Eli Lilly," are we talking about "Eli Lilly - purveyor of high-quality narcotics to the "intelligence" services"? I hate to harp on about this particular episode in Lilly's recent past (lie), but they are a bunch of scum-sucking criminals, with or without their political connections. But only in my opinion, for legal reasons.

Matt

"However, Cymbalta is not approved for women with incontinence, get this, because it causes an increase in suicidal behaviors."
Not to be crude, rosie, but WTF??? Gee, does it do this ONLY in incontinent women? No men? No "dry" women? How crazy is that?

I'm not sure how it is that you keep yourself from banging your head on your keyboard reading all those stories. My hat's off to you.

Sherry, I agree -- WTF!!! The reason I don't bang my head on the keyboard [only my fist] is because ocassionally a really hilarious story like the one on Cymbalta/incontinence/women and increased suicidal behavior comes along. Does Lilly think the nation is so dumbed down from Prozac that we won't notice the irony? Actually, not irony - the satire! This could be made into a wonderful spiel by a stand-up comedian.

Ana, No, I don't know the names of the four others besides Traci Johnson who committed suicide during the Cymbalta trials. Perhaps you could find this under the Freedom of Information Act.

Buenas Noches,

Rosie

Can someone please tell me what are the criteria used to diagnose major depression in children? I mean, it can't be loss of libido, right? Guilt? Nope -- that affect doesn't really emerge in true form until early adolescence. Hopelessness? Nope -- children don't really have much of a future time orientation, so how can they be hopeless about their future? Anhedonia? I mean other than sadness, what the heck is childhood depression supposed to be?

This post prompted me to look at the number of deaths in clinical trials for Cymbalta on www.clinicalstudyresults.org. I found 54 studies, none for incontinence. From what I remember, they don’t have to report trials if the drug is they don’t seek FDA approval for that purpose. So, since they decided not to ask the FDA for approval for incontinence, they didn’t have to publish the trial results (even though it’s approved in other countries for that purpose), I THINK.

I find it interesting the number of deaths attributed to the study or drug. Two people died 11 days after discontinuation. Another person died 27 days after from chocking on a piece of meat. Which tells me, just quitting, you’re not out of danger yet, deadly changes have taken place that aren’t automatically reversed. When my Cymbalta dose was doubled, I started having problems swallowing and almost died in the bathroom of a mall, chocking on a donut. The doc said I probably didn’t chew enough. I still have swallowing/chocking problems at times, after 20 months off.

Here are the deaths I found in the 54 studies listed:

6089 - One death occurred after the completion of the study. The patient was randomized to duloxetine for generalized anxiety disorder (GAD), was discontinued from the study due to the SAE of severe anxiety. 27 days after the patient discontinued, he choked on a piece of meat. He subsequently went into cardiac arrest and died. The cause of death was listed as asphyxiation. The principal investigator further stated the SAEs of asphyxiation and cardiac arrest were not related to study drug or protocol procedures.

8601 - One death was reported during the study in the duloxetine plus NPI treatment group (completed suicide). The event of suicide was considered related to protocol procedures and not related to study medication. (NPI = Non-Pharmacological Intervention in the Treatment / Hotline)

8950 - One patient (randomized to duloxetine 30 mg QD in the acute therapy phase and 120 mg QD in the extension therapy phase) died during the extension therapy phase. This death, due to asthma exacerbation and cardiac arrest secondary to asthma, was judged by the investigator to be unrelated to study drug or protocol procedures.

7108 - There were 2 deaths—1 due to cerebral hemorrhage and 1 completed suicide —reported during the open-label acute therapy phase. According to investigators, neither death was related to study drug or procedure.

4098a - There was one death (placebo). A 73-year-old male experienced the serious adverse event of accidental drowning resulting in death

4097bb - Four deaths were reported during the extension phase, none of which were considered related to the study drug by the principal investigators.
Four deaths (1 duloxetine-treated patient and 3 routine care-treated patients) were reported during the extension phase of the study. The death in the duloxetine-treated patient was caused by a myocardial infarction. The deaths in the routine care patients were caused by cardiac arrest, cerebrovascular accident (stroke), and a diabetic coma. These deaths were considered by the principal investigators to be unrelated to the study drug or protocol procedures.
There was a fifth death that occurred after the study was completed. A duloxetine-treated patient died of a possible myocardial infarction 11 days after the last dose of duloxetine. This death was also found not to be related to study drug.

10545 - There were no deaths during this study. However, 1 patient discontinued from the study, entered and completed the taper phase, and then experienced cardiopulmonary arrest 11 days after the final dose of duloxetine.

5110 - Three (3) patients died during the study. One patient (duloxetine 60 mg BID) experienced the SAE of collapse, cardiac arrest, and hypoxic brain injury, which resulted in death. One patient (duloxetine 60 mg BID) experienced the SAE of septic shock that resulted in hospitalization and eventually death. One patient (duloxetine 60 mg BID), experienced the SAE of acute myocardial infarction, which resulted in death. None of the deaths were attributed to duloxetine.

4098b - Two deaths were reported during the extension therapy phase of this study. One patient, randomized to duloxetine, experienced the serious adverse event (SAE) of sepsis and died. One patient, randomized to duloxetine, experienced the SAE of myocardial infarction and died.

4097ab - Four deaths, 2 duloxetine-treated patients and 2 routine care-treated patients, were reported during the extension phase of the HMAVa study. Three of these 4 patients (2 duloxetine-treated patients and 1 routine care-treated patient), experienced the SAE of acute myocardial infarction and died; the fourth patient (treated with routine care) experienced the SAE of pulmonary embolism and died. These deaths were considered by the principal investigators to be unrelated to the study drug or protocol procedures

10258 - One sudden death occurred during the study in the duloxetine 60 mg QD group; the death was considered related to the patient’s underlying medical condition and was not attributed to the study drug.

4092 - One death was reported during the study, which was initially reported as an accidental injury. The patient was hit by a train and the cause of death was initially listed as cardiac arrest. The 44-year-old patient (duloxetine 40 mg BID) was started on study drug the day before the injury. Upon further review by Lilly global product safety it was thought that this event may have reflected suicidal behavior, and the more conservative decision was made to consider the case a completed suicide.

4091a - One death, a patient randomly assigned to duloxetine 40 mg BID, occurred in this study. This death due to cardiopulmonary arrest was judged by the investigator to be unrelated to study drug.

4298a - Three deaths occurred during the continuation phase. Two patients committed suicide (1 patient randomized to duloxetine 60 mg BID; 1 patient randomized to placebo). The third patient (randomized to duloxetine 40 mg BID) was found barely conscious after an overdose of oxazepam and died soon after arrival at the emergency room. The cause of death was listed as pulmonary edema. These events were judged by investigators to be unrelated to study drug.

4445 - There was 1 patient death in the acute therapy phase (duloxetine 60 mg QD). This death was due to and was judged by the investigator to be unrelated to study

7978 - One death occurred in an escitalopram treated patient in the acute treatment phase of this study. The patient, a 52 year old Caucasian female, was assigned to escitalopram 10 mg/day therapy for major depressive disorder. The cause of death was reported as idiopathic cardiac dysrhythmia.

9548 - During the study 1 patient (1, 0%) suffered a SAE. The patient presented with “metastatic neoplasm” with the outcome of death after the patient was discontinued from the study. This SAE was reported by the investigator to be nonrelated to the study drug.

Thank you Rosie!

I came here to see if there was any comment advocating the use of Cymbalta.
Strangely enough whenever there is an article like this, with these comments, there is no one here to claim that these are all anecdotal.

Tracy Johnson
R.I.P.