19 quit Lilly drug
trial after a death
Nineteen of 99 people in a clinical trial of an antidepressant
have left after a Bensalem woman in the study hanged herself
Saturday, Eli Lilly & Co. said yesterday.
Traci Johnson, 19, a 2002 graduate of Bensalem High School, was
found hanging by a scarf from a bathroom shower rod at the Lilly
Laboratory for Clinical Research in Indianapolis.
Johnson was buried yesterday in Resurrection Cemetery in Bensalem
after a funeral at the Greater Church of Philadelphia in Kensington,
where she was a youth leader.
Johnson had been a first-year student at the Indiana Bible
College, but she left in January to become a subject in the Lilly
study of duloxetine.
The chemical is intended to treat depression and urinary
incontinence caused by stress.
David Shaffer, a Lilly spokesman, said three of Johnson's 25
fellow subjects at the Indianapolis site had left the study.
Shaffer said 16 people at a trial site in Evansville, Ind., also
had left the program when "the site management decided to pull out
from the study."
Shaffer declined to identify the management or the specific
"No other participants in any of the other sites have chosen to
withdraw" from the clinical trials of duloxetine, he said.
On Wednesday, Shaffer 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
Yesterday, Shaffer said he had misspoken and that "more than
8,500" was the total number of trial subjects, both depressed and
He was uncertain how many took part in each study and how long
the studies had been under way.
Lilly has said it believes duloxetine was not associated with
Before it can be marketed, he said, the Lilly drug needs to be
approved by the U.S. Food and Drug Administration.
Yesterday, FDA spokeswoman Susan Cruzan said the agency "couldn't
really address the [Lilly] drug trials specifically" in light of
Johnson's death. "But FDA does have a process for reviewing reports
of death associated with use of a drug in a clinical trial. We'll
review all the information and evaluate its implications."