SUICIDE effect of Cymbalta/Yentreve/Xeristar/Ariclaim (duloxetine) TRAGIC OUTCOME CLINICAL TRIAL ELI LILLY

In previous trials of Cymbalta (duloxetine) there were four other individuals who had committed suicide. Traci Johnson joined the trial in early January. She initially had been given duloxetine but, at the time of her death, had been taking a placebo for four days. Another SSNRI, Effexor (Efexor, venlafaxine), which is most closely related to the Lilly SSNRI Cymbalta, has listed side-effects such as:
akathisia & mania, delirium, hallucinations and paranoid delusion, following use and/or discontinuation of the drug.

What could have happened to Traci Johnson? With the latest knowledge regarding severe withdrawal reactions that are repeatedly being observed in SSRI/SSNRI discontinuation, as reported by physicians in Effexor, it is not difficult to understand that Traci Johnson suffered from severe withdrawal reactions after discontinuation of Cymbalta.

WHY HANGING? Why such a violent method? Cymbalta is a drug that similar to Eli Lilly's Prozac (Sarafem, fluoxetine) acts on serotonin and next to it on nor-epinephrine in the brain. It is not a coincidence that violent methods of suicide have been associated with the serotonin acting drug Prozac (Sarafem, fluoxetine) before.
See: Fluoxetine and Violent Death in Maryland: violent methods in fluoxetine suicides.

Clearly, Cymbalta (duloxetine) is another very powerful mind-altering and potentially lethal new SSNRI antidepressant, stress urinary incontinence & diabetic nerve pain medication to protect yourself from and especially your children.

Dangers of Cymbalta (duloxetine) were already presented in the following study on May, 20  2002:
Duloxetine is an inhibitor & substrate of cytochrome P4502D6 in healthy volunteers -caution should be used!

FEBRUARY, 9  2004
The Indianapolis Star reports (below) that Traci Johnson, a 19 year old healthy volunteer, one of 25 local paid volunteers committed suicide by hanging while testing Lilly's drug, Duloxetine, at Lilly's Laboratory for Clinical Research. Duloxetine is the main ingredient in two new Lilly drugs: the antidepressant, Cymbalta, and an incontinence drug.

Since 1990, the suicide link to antidepressant drugs has been the source of an acrimonious debate. Eli Lilly's strategy (and that of the other SSRI manufacturers) has been to deny, deny, deny any and all reports linking Prozac to suicide.

The Star reports "Lilly said Monday it does not believe the drug, duloxetine, was related to the death of Johnson, who was a former student at Indiana Bible College. Toxicology test results are expected in about a month."

Most recently the debate shifted to evidence linking the antidepressants to a two-to-three fold increased risks of suicidal behavior in children. The British medicines authority took action to protect children from these drugs' hazards, banning all but one for use in children. Documents are posted on the AHRP website: www.ahrp.org

For unexplained reasons, the FDA has continued to drag its feet and has delayed any action to protect children. Antidepressant drugs are the blockbusters of the drug industry. Under pressure to act, FDA convened an advisory committee meeting to review the evidence--but announced that no votes or action would be taken.

On Feb. 2, 2004, 62 families testified about the hazards these drugs pose for children. Parents described the loss (or near loss) of their children to suicide after being prescribed an antidepressant.

However, the FDA refused to allow scientific experts who have vital information from presenting their analyses to the committee for consideration. The committee recommended action: warning labels to alert doctors and the public about the potential hazards of antidepressants for children. See: http://www.ahrp.org/infomail/04/02/04.html

The Alliance for Human Research Protection (AHRP) held a press briefing at which 6 scientists were given an opportunity to present publicly their documented analyses from published and unpublished sources. See: http://www.ahrp.org/risks/SSRIsuicide0204.html

See links to original, documented evidence of the actual incidence of violent and suicidal behavior in children who tested the drugs in company controlled clinical trials. See: http://www.ahrp.org/risks/SSRI0204/Healy.ppt

See also: Critical court documents re suicide risk courtesy of "Let them eat Prozac": http://www.healyprozac.com/Trials/CriticalDocs/default.htm

http://www.indystar.com/articles/7/119246-5807-092.html

UPDATE: FEBRUARY, 11  2004
Traci Johnson, a native of Bensalem, Pa., committed suicide while a subject of an Eli Lilly drug experiment. She was one of about 25 "healthy volunteers" who had been physically and psychologically screened before the test and, according to Lilly spokesperson, Rob Smith, she did not have depression.

Knight Ridder News Service reports that Eli Lilly acknowledges that 4 suicides occurred during clinical trials of the duloxetine which the company plans to market for depression and incontinence. See: http://www.kansascity.com/mld/kansascity/news/nation/7923774.htm?template=contentModules/printstory.jsp

The Rev. Paul Mooney, president of the Indiana Bible College, said many students at his school and other nearby universities take part in the clinical trials as a way to earn money and pay tuition.

The Indianapolis Star reports that test subjects were given higher-than-normal doses of duloxetine. See: http://www.indystar.com/articles/5/119765-2375-102.html

Were the subjects informed that they would be given high doses of an experimental drug whose safety has not been proven? Were school officials informed about the risks the trials posed for their students?

Traci Johnson's death "has ripped the heart out of the body of our church," said the Rev. Joel Barnaby, pastor of the Greater Church of Philadelphia in Kensington, where Johnson had been a youth leader for several years.

She dropped out of school in January to take part in the Lilly trials so she could earn enough money to return to college, family and friends said.

Reverend Barnaby told the Philadelphia Inquirer: "I am troubled to the core of my spirit that Eli Lilly has taken such a defensive posture and [has] been so quick to deny any responsibility" in Johnson's death, "throwing all the blame on this young lady... "I am shocked that they have taken such a deliberate defense to distance themselves from any responsibility."See: http://www.philly.com/mld/inquirer/news/local/7923639.htm

Indeed every family that has lost a loved one because of drug-induced hazardous effects has encountered the exact same corporate position. In part, this is because drug manufacturers are in a uniquely privileged position: their influence in government, medicine, and the health care industry knows no bounds.

UPDATE: FEBRUARY, 12  2004
The Associated Press reports that nearly a fifth of the volunteers testing Eli Lilly's antidepressant drug, duloxetine, dropped out after Traci Johnson, a 19-year old student committed suicide at a company laboratory. "Three participants in the study in Indianapolis and 16 volunteers in Evansville have quit." See: http://abcnews.go.com/wire/US/ap20040212_723.html

The Philadelphia Inquirer reports (below) that "the Institutional Review Board (IRB), a body of the Indiana University School of Medicine, which has been monitoring the clinical trial, moved to tighten the duloxetine study." And the Inquirer reports that IRB "ordered Lilly to accept no new subjects for the trial, ordered an independent psychiatrist to evaluate the current subjects, and required that they sign a new consent form."

Did the FDA approved informed consent form signed by Ms. Johnson and the other subjects disclose the fact that there had been 4 suicides in prior duloxetine clinical trials?

The New York Times finally saw fit to report the suicide of this healthy volunteer but buried the report on p. A30. The report provides Eli Lilly an opportunity to present the company's spin. For example, "the company did not believe that duloxetine ...caused the suicide." That assertion is premature, inasmuch as Lilly's chief medical officer and former senior researcher at the National Institute of Mental Health, Dr. Alan Breier, acknowledged that Ms. Johnson had been screened by Lilly before the trial and found her not to be "healthy and had no mental problem." The test did require Ms. Johnson and the other volunteers to take "larger than therapeutic doses." How then can the company exonerate the drug out of hand?

A classic example of PHARMA spin follows: When confronted with the revelation that there were not one but 5 completed suicides in duloxetine clinical trials, a Lilly spokesman, Robert Smith, is quoted stating: "The drug has been studied in 9,000 patients ....and we have not been able to discern any signal between duloxetine and suicidal ideation."

But when confronted with the revelation that there was a two-to three fold increased incidence of suicidal ideation and suicidal acts by children who tested antidepressants compared to those given a dummy pill, drug manufacturers and FDA officials claim-- "but there was no death from suicide in pediatric antidepressant trials." See: www.ahrp.org

What did the FDA know and when did it know about the suicides? What, if anything, does the FDA do to ensure that patients and volunteers are protected from harmful drug tests?

UPDATE: FEBRUARY, 13  2004
19-year old Teri Johnson's suicide occurred one week after an FDA advisory committee had urged the FDA to issue warnings about prescribing antidepressant drugs for children under 18 because of an increased risk in suicide. The FDA has yet to act upon its own advisory committee recommendations. Below are two press reports providing additional information.

* Dr. Joseph Glenmullen, a Harvard University psychiatrist, the author of Prozac Backlash, and an expert psychopharmacologists, told The Indianapolis Star that Teri Johnson's suicide, her lack of depression, her young age, and the time she had been off the drug suggests she was vulnerable to suicidal thoughts. "She's still a teenager. It does look that children or adolescents might be even more vulnerable to (suicidal thoughts while taking antidepressants)."

Today, the Ind. Star reports: "A packed inner-city church said goodbye Thursday to one of its best-loved members, a 19-year-old woman known for unstoppable optimism while working with youths in one of Philadelphia's more troubled neighborhoods. See: http://www.indystar.com/articles/8/120422-7218-009.html

The Philadelphia Inquirer reports that after the suicide, the Evansville, Ind "site management decided to pull out from the [duloxetine] study." No further explanation was given.

The Inquirer reported that on Wednesday, David Shaffer, a Lilly spokesman, said that "over the years, there had been four other suicides in trials of duloxetine, but only among the more than 8,500 subjects who already had been diagnosed with depression."

On Thursday "Shaffer said he had misspoken and that "more than 8,500" was the total number of trial subjects, both depressed and not depressed." The Ind. Star reports that 4,142 patients were depressed. This raises further questions about who the four other subjects who committed suicide during duloxetine tests were.

Schaeffer claimed he "was uncertain how many took part in each study and how long the studies had been under way." If the company is uncertain about such basic information about the trials how reliable is Lilly's claim, "duloxetine was not associated with Johnson's death"?

On Thursday, the Indianapolis Star reported: "Johnson's trial was a "high-dose" variety. From the time Johnson began the trial in early January, her dosages were increased gradually to a peak, then gradually reduced until she was given placebo."

This raises a fundamental ethical question: Why are teenagers put at increased risks of harm in "high dose" drug tests when it is no secret that most severe adverse drug reactions occur when doses are increased.

The Star further reports that "Lilly was barred Tuesday from enrolling any new participants in its duloxetine study in Indianapolis at the Lilly Laboratory for Clinical Research on the Indiana University Medical Center campus. The order was issued by the Institutional Review Board, which oversees all Lilly research on the campus."

* Dr. Gelnmullen was one of 6 scientists who presented their original analyses of evidence linking antidepression drugs to serious risks for children, at a press briefing convened by The Alliance for Human Research Protection (AHRP). See: http://www.ahrp.org/risks/SSRIsuicide0204.html

http://www.philly.com/mld/inquirer/news/local/7941952.htm?template=contentModules/printstory.jsp

http://www.indystar.com/articles/9/119961-3639-031.html

UPDATE: FEBRUARY, 15  2004
Indianapolis Star columnist, Ruth Holladay, reports (below) that Peter J. Pitts, the FDA's associate commissioner for external affairs, sounded a note of hope on Friday: "We are moving forward rapidly as to whether or not to change the warnings on these [antidepressant] drugs. The (advisory) committee strongly recommended that we do that. We, by and large, take their recommendations." However, senior FDA officials at the Center for Drug Evaluation and Research (CDER)--who have known for years about these drugs' hazards--continue to equivocate and to tinker with definitions. Their failure to issue warnings to doctors and the public puts children's lives at life-threatening risks.

Traci Johnson, a healthy 19-year old student who Eli Lilly doctors found not to be depressed, ended her life at the company's research laboratory while serving as a volunteer testing the company's drug, duloxetine. The drug had been in the company's antidepressant pipeline since the 1980s. But, according to Dr. David Healy--who had been asked to conduct a duloxetine clinical trial--the drug was shelved as an antidepressant. See, Dr. Healy's (soon to be released) book, Let Them Eat Prozac, p. 296 (Canadian edition).

Holladay points out that "Traci Johnson was not old enough to legally drink a beer; she could not even rent a car. Yet she was deemed mature enough to decide to take an experimental drug on a daily basis."

Her suicide came just a week after a dramatic FDA public advisory committee meeting at which more than 60 families testified about antidepressant drug-induced suicidal behavior in their children, teenagers, and young adults--many of whom committed suicide. See list of public speakers (Transcripts not yet online).

The advisory committee was persuaded by these testimonies and by the reasoning of the British medicines authority which took the precautionary step and banned the use of all but one SSRI antidepressants in children. FDA's advisory committee was not at all persuaded by FDA's rationale for its failure to act to protect children's lives. See documents at: www.ahrp.org

Eli Lilly has just announced that the suicide won't delay the approval of duloxetine. Clearly, Lilly executives are certain that the FDA will put the company's business interests above safety issues.

Can there be a more graphic demonstration of the collision between business ethics and children's safety? For this reason, it is critical that we identify a major threat to the health and safety of children and adults. FDA's failure to warn about hazardous drug-induced effects to protect children's lives, is directly related to the inordinate influence wielded by pharmaceutical companies on FDA officials and FDA policy.

The Alliance for Human Research Protection calls for an independent investigation of the duloxetine trials. Was Traci and her parents informed about the risks associated with the drug she was testing? Did the Informed consent document signed by the students who signed up for $150 / a day, disclose the fact that 4 test subjects had committed suicide during clinical trials? Who were the other 4 people who committed suicide and under what circumstances? Since suicidal patients are excluded from clinical trials, what, according FDA standards, is "an acceptable number of suicides" by non-suicidal patients in the course of a clinical trial? The public has a right to know.

Student's suicide cries out to FDA for drug warnings