Attorney for family of drug trial suicide victim questions FDA probe
Sep. 04, 2004
INDIANAPOLIS - An attorney for the parents of a woman who committed suicide during a clinical trial of a new Eli Lilly and Co. antidepressant is questioning whether her death was thoroughly investigated before the drug was approved for sale.
According to Lilly, the Food and Drug Administration concluded last month that 19-year-old Traci Johnson's death wasn't caused by duloxetine, the antidepressant she was testing as part of a Lilly clinical trial.
John Cordisco, a Philadelphia attorney who is representing Johnson's parents in a possible lawsuit against Lilly, said the FDA investigation was done without contacting him, Johnson's parents or physician. He said Johnson's fellow volunteers in the drug-testing trial also were not contacted.
"I find it very difficult (to believe) the FDA would take a general position the drug was not related to her death when I don't believe they had sufficient information to determine that," Cordisco told The Indianapolis Star on Friday.
The FDA approved duloxetine for sale as an antidepressant with the brand name Cymbalta.
FDA spokeswoman Kao would not comment on how the investigation was conducted.
She said the agency's suicide investigation report is being edited and will likely not be released for several weeks. She said it routinely takes the FDA up to 10 weeks after a drug is approved to release materials associated with the approval.
The edited report will eventually be posted on an FDA Web site, she said.
Lilly spokesman Rob Smith said the Indianapolis-based drugmaker has not seen the report but has been told by the FDA that the investigation found that duloxetine did not play a role in Johnson's suicide.
"It certainly will not contradict anything that's already been reported about the connection between duloxetine and the suicide," Smith said.
He hinted that Lilly is open to a settlement to avoid a lawsuit - a suggestion the company seldom has made in public comments about other such liability cases.
"Given the facts of the situation, we think an equitable settlement, if one could be worked out, would be beneficial to both parties," Smith said.
Johnson's February suicide was the first of a volunteer in the 78-year history of Lilly's main lab for testing experimental drugs on humans.
Cordisco would not say if Johnson's parents, Mike and Peggy Johnson, who live in the Philadelphia area, intend to sue Lilly. But he said he and the three other members of his legal team have "assembled the case and ... we are preparing to move forward."
He said one possible charge against Lilly is medical malpractice "relative to the operation of the (Lilly) clinic and in conjunction with the drug" given to Johnson while she was in the drug test.
"There may be some issues surrounding the screening process as well as monitoring" of Johnson by medical personnel while she was in the clinic, he said.
Johnson entered the clinical trial, which asked for healthy volunteers to test the safety of the drug, to get money to help pay tuition at Indiana Bible College in Indianapolis, where she had been a student, Cordisco has said.