Posted by jrbecker on August 12, 2004, at 12:04:44
http://www.indystar.com/articles/0/169515-1780-093.html
FDA backs Lilly stance on suicide
Agency agrees that Cymbalta wasn't factor in death at clinic.
By Jeff Swiatek
jeff.swiatek@indystar.com
August 11, 2004
The Food and Drug Administration has concluded that Eli Lilly and Co.'s newly approved antidepressant Cymbalta didn't trigger Traci Johnson's suicide at the Lilly Laboratory for Clinical Research.
An FDA investigation "found (the drug) couldn't be linked to her death," an FDA spokesperson said today.
Johnson, 19, a former Indiana Bible College student, hung herself with a scarf Feb. 7 in a bathroom of the drugmaker's Indianapolis drug-testing clinic during a study to see how high doses of the drug affected healthy volunteers.
A memo about the closing of the FDA investigation of the suicide is part of the FDA's approval package, the first part of which was sent to Lilly last week, the agency spokesperson said. It gives the drugmaker permission to start selling Cymbalta.
Lilly hasn't yet received the memo, but the company was told by the FDA that it had no further questions about the suicide, Lilly spokesman David Shaffer said.
"We aren't aware of the full contents of that (memo)," Shaffer said, but "We were informed there would be no findings" contrary to what Lilly had concluded about the suicide.
Lilly has said it found its drug was not to blame.
The FDA's finding is "confirmation of our assertion there wasn't a link between her participation in the study and her death," Lilly spokesman Philip Belt said.
A lawyer for the Johnson family, John Cordisco, said the family had heard that the FDA had concluded its investigation.
"We are still exchanging information with Eli Lilly and its representatives and based on that it would be premature to give comment," said Cordisco, who practices in Philadelphia.
The Marion County coroner's office ruled Johnson's death was by hanging.
A Philadelphia native, Johnson had stopped taking the drug and was being weaned from it when she killed herself. She took doses up to six times the recommended 60 mg daily dose for depressed patients.
Lilly subsequently increased from four days to eight the weaning period in the trial.
Johnson was the first person to die in a drug-testing trial in the history of the 78-year-old clinic, located on the upper floors of Indiana University Hospital on the campus of Indiana University-Purdue University Indianapolis.
The FDA declined to immediately release any written documents related to its investigation.
FDA investigators spent about a week at the clinic earlier this year, reviewing patient records and interviewing Lilly personnel, Shaffer said.
Johnson's suicide came during a time of growing debate over the link between antidepressants and suicide in users, particularly children.
In March, the FDA told 10 drugmakers to strengthen suicide-related warnings on labels for antidepressant drugs.
Two FDA advisory committees are currently examining any links between antidepressants and suicides in children.
In addition, Congress is looking into whether drug companies have withheld information from the FDA about suicides among children taking antidepressants.
As of this spring, four suicides had occurred among 4,124 depressed patients who had taken duloxetine, which is Cymbalta's scientific name, during clinical trials, according to a Lilly clinical psychiatrist, Dr. John R. Hayes. None of those suicides were deemed to be caused by the drug, he said.
No suicides besides Johnson had occurred among more than 4,000 healthy volunteers or nondepressed patients who took the drug in trials, Hayes said.
Since spring, no further suicides have occurred in the ongoing clinical trials of duloxetine, Lilly's Shaffer said.
Lilly has said Johnson was healthy and not depressed.
But staff of a clinic in California that was testing duloxetine for Lilly reportedly told participants there that Johnson had a history of depression and had tried to commit suicide when younger.
Four participants in the California trial, which was going on at the same time as the trial that Johnson enrolled in, told The Star earlier this year that the staff commented about Johnson's mental history to participants shortly after the suicide.
Lilly officials have said they won't discuss Johnson's medical history out of patient privacy concerns.
poster:jrbecker
thread:376857
URL: http://www.dr-bob.org/babble/20040811/msgs/376857.html