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
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.
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
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
She had been attending nearby Indiana Bible College but left
school to participate in the study because it paid $150 a day plus
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.