Posted by JLM on February 12, 2004, at 19:16:13
In reply to Cymbalta/Duloxetine--Something's Up, posted by Jack Smith on March 11, 2003, at 12:55:39
> There has got to be something going on with duloxetine that we just don't know about. I mean they got an approvable letter almost six months ago and knowing Lily's eagerness to get the stuff out, you think it would be here by now. I CANNOT believe that their manufacturing problems are that great. I mean Straterra is here which is also manufactured by Lily. Something is going on. Moreover, apparently Lily is asking for more volunteers to do more clinical trials for depression with cymbalta. I think this drug won't be out for a while, unfortunately. I hope I am wrong.
>
> So many times people get their hopes up. If you look through the archives, you will see posts saying that reboxetine would be out by the end of 1999! Now, we know it's never coming out. Also, you will see posts in 2000 saying that the selegiline patch will be out by the end of that year. Last I heard, someone here talked to Dr. Bodkin who said that he would bet it would be out by this time next year. I would take that bet in a heartbeat. . . . . I have high hopes for cymbalta but looks like I am going to just go with effexor--which seems to be a little less potent than duloxetine and because of its shorter half life almost postively has worse withdrawls.
>
> Just my two cents. Thanks for listening.
>
> JACK
Yes, 'something' is up indeed:"February 12, 2004
Student, 19, in Trial of New Antidepressant Commits Suicide
By GARDINER HARRIS
19-year-old college student who had shown no outward signs of depression killed herself over the weekend at an Eli Lilly & Company laboratory in Indianapolis where she had been participating in a company drug trial for an experimental antidepressant.The student, Traci Johnson, was one of 25 healthy patients at an Eli Lilly clinic who were being given larger than therapeutic doses of duloxetine, which will be known as Cymbalta if it is introduced as an antidepressant. Four days before her death, Ms. Johnson was taken off Cymbalta and given a placebo.
While Eli Lilly asserted that it had properly screened Ms. Johnson before the study started to ensure that she was healthy and had no mental problems, her death is being used by critics of a popular class of antidepressants to bolster their case that the widely used drugs carry the risk of suicidal tendencies for a small number of people, particularly young people.
Four other patients who were given the drug during earlier trials also committed suicide, the company said. The drug is being tested not only as an antidepressant but also as a possible treatment for stress urinary incontinence.
Ms. Johnson's death came less than a week after a federal advisory panel concluded that the Food and Drug Administration should issue stronger warnings to doctors that this class of antidepressants may be linked to suicide and violent behavior in children and teenagers.
A review board has told Eli Lilly to stop entering new patients into the trial, and to have all the current participants evaluated by an independent psychiatrist.
Robert Smith, a Lilly spokesman, said the company did not believe that duloxetine, the drug's generic name, caused the suicide.
"This drug has been studied in 9,000 patients, in depressed and nondepressed healthy people, and we have not been able to discern any signal between duloxetine and suicide or suicidal ideation," Mr. Smith said.
Ms. Johnson had not shown signs of depression, distress or mood swings throughout about a month in the trial, said Dr. Alan Breier, Lilly's chief medical officer.
Patients who abruptly stop therapy with some antidepressants often experience withdrawal symptoms that can include severe agitation, unusual dreams and night sweats. This is especially true of antidepressants like Paxil, made by GlaxoSmithKline, that leave the bloodstream quickly. Cymbalta also leaves the blood stream quickly.
Dr. Breier said Ms. Johnson did not appear to be suffering any withdrawal symptoms. He said the company might never be able to answer why Ms. Johnson killed herself.
"Most people who commit suicide in the general population leave people asking these kinds of questions," Dr. Breier said. "And just because this happens while someone is taking a drug doesn't mean the drug caused it."
Ms. Johnson did not leave a suicide note. She hanged herself in a shower stall Saturday night in the bathroom of Lilly's dormlike laboratory on the top two floors of the Indiana University Medical Center.
She had been attending nearby Indiana Bible College but left school to participate in the study because it paid $150 a day plus meals.
Whether antidepressants cause some people to commit suicide was an issue that flared briefly in the early 1990's but had been largely dismissed by mainstream researchers until last summer. That is when GlaxoSmithKline warned that a series of studies had found that children and teenagers given Paxil were more likely to attempt or think about suicide than those given a placebo.
Wyeth soon followed with a warning suggesting that its antidepressant, Effexor, should not be given to children. British and American drug regulators set to work studying the problem. The British soon concluded that most antidepressants in this class should not be used in children and teenagers since they have not proved effective in that population and could be linked to suicide.
The F.D.A. continues to study the issue, said Susan Cruzan, an agency spokeswoman. The agency is aware of Ms. Johnson's death and will evaluate its implications once the agency receives all of the needed information about it, Ms. Cruzan said."
She was a HEALTHY volunteer in a HEALTHY volunteer study. Hence, they can't use their standard 'it was the illness' arugment this time.
Folks, Lilly shelved this drug a long time ago as a possible AD. It only got brought back to life when r-fluoxetine blew up in their face, and they needed a successor to Prozac to maintain their market share.
poster:JLM
thread:208072
URL: http://www.dr-bob.org/babble/20040210/msgs/312580.html