INDIANAPOLIS — Traci Johnson believed it was God's plan for her to leave home to attend a tiny Bible college here — and she prayed every day for the Lord to provide for her tuition.
Then an unusual
opportunity presented itself.
Eli Lilly & Co., the
pharmaceutical giant headquartered a few miles from Indiana Bible College,
was seeking healthy subjects for a live-in clinical drug trial. The
19-year-old freshman told her friends back home in Pennsylvania that the
study was her best hope to stay in school.
"Trace, that don't sound
right," her friend Colleen Jacoby told her. "I never heard of a human
But the students at the Bible college knew all about
the trials. They made perfect subjects for studies requiring healthy
people — and they were used often, receiving hundreds, even thousands of
dollars for a few weeks work.
If accepted into the study, she could
make $150 a day for 49 days — more than a year's worth of her school
expenses — for taking a drug known as duloxetine, an antidepressant that
had already been given to thousands of people and was on the verge of
approval by the Food and Drug Administration.
She had faith that
God would find a way. "It was in his hands," she wrote in her
Just before the new semester, a Lilly representative called.
Her prayers were answered.
A month later, she was dead.
Indiana Bible College is on the outskirts of Indianapolis, in a
former hospital. With 260 students, it is a tight-knit community of
Pentecostals. TV is banned and girls are required to wear long skirts.
It's not unusual to see students drop their knapsacks and form an
impromptu circle, praying for a sick aunt or alcoholic cousin.
Johnson it was a sanctuary.
She grew up in blue-collar Bensalem,
Pa., but the center of her childhood was a Pentacostal church in a rough
Philadelphia neighborhood. Every Wednesday morning, she walked with the
pastor past bars and discount stores canopied by train tracks. They
huddled around prostitutes and drug addicts. She prayed so hard for them
that tears rolled down her cheeks.
Then last summer, she announced
that the Lord had told her to attend Bible school.
"She just went
wherever the Lord was leading her," said Kathy DePalma, who ran the
Christian day-care center where Johnson had worked.
came to visit in Indianapolis, Johnson chattered about the college's
football team, her new church and the young men who had caught her
"I think my highest want right now is the person who Jesus
wants me with," she noted in her diary soon after starting school,
"someone I can pray with."
In a school essay, she envisioned
herself as a preacher's wife, raising her children and sitting in the
first pew of church.
All she needed was $3,470 a semester. She had
arrived with little money, and her father had recently lost his job as a
"I REALLY REALLY REALLY need you to open a way for me to
pay my bill," she wrote to God in her diary. "Please provide a
One Final Trial
A few miles from the Bible
college, the neon logo of Eli Lilly glows atop the company's headquarters
in south Indianapolis.
In 1972, a Lilly biochemist discovered that
a patented chemical, fluoxetine, enhanced the action of the brain chemical
serotonin, which affects mood. More testing showed the chemical could
dissolve feelings of despair and sadness.
The FDA approved the
drug, Prozac, in 1987 and since then, sales have totaled more than $21
billion. But by the late 1990s, the patent on Prozac was about to expire,
and the company needed a sequel. Lilly began looking at duloxetine, a
patented agent that not only affects serotonin, like Prozac, but also
norepinephrine, another brain chemical.
Duloxetine had been shelved
in the early 1990s, in part because low doses had no effect on depression.
But higher doses, Lilly scientists discovered, relieved depression at
least as well as Prozac. Subsequent testing proved the drug also curbed
stress-related urinary incontinence.
By 2003 Lilly had a trade
name, Cymbalta, and industry analysts were projecting sales of $2.5
billion a year for depression alone, a figure rivaling the high-water mark
The drug already had been tested in 8,500 people, but
the FDA wanted one last clinical trial to measure its effect on heart
rhythm. It would use doses as much as up to five times that recommended
for incontinence, and six times the dose for depression.
needed 100 healthy females between 18 and 75 (women are more prone to
incontinence) for seven weeks.
The inventors of Prozac had their
sequel. They just had to complete one last trial.
Lilly's human test clinic, located at the University
of Indiana Medical Center, is a resort-like facility with a library,
rooftop sundeck and a panoramic view of downtown. "I felt I was on a
mini-vacation," reads one testimonial on the clinic's website.
site touts the drug trials as a great way for schools, churches and
community organizations to raise money.
There are hundreds of
similar test centers around the country, many of them near college
campuses because of the ready supply of students looking for part-time
Healthy subjects, free of the ailment for which the drug is
designed, are typically used to measure a drug's side effects and health
risks. By the time a drug has reached this stage, it has been extensively
tested in animals, and the risk of death is considered minimal.
test was for a medicine for schizophrenia," said Nasri Ashkar, a
21-year-old senior at Indiana Bible College.
The medicine made him
itchy, but "it wasn't a bad experience at all," he said.
classmate, 22-year-old Gary Parks, said he had applied to nearly two dozen
studies at the clinic and participated in nine. Ticking them off, he
quickly lost track: "Something to prevent the spread of cancer … a
Parks made $2,600 in the diabetes study for a week
of work, although he recalled that "everybody was throwing
Nausea, Parks concluded, was just part of the
Before every trial, a Lilly official explained the risks and
asked him to sign a consent form, a legal document which protects both the
subject and the company. It entitles participants to medical care for
health problems arising from the trial, allows them to leave the study at
any time and warns of the danger of withholding information from
Parks said the worst risk he ever heard of during a
drug trial was the possibility of fainting from low blood sugar. He wasn't
worried. "They have I.V.'s," Parks said, referring to intravenous fluids.
"They can bring you back."
Enough students joined the Lilly trials
over the years that they became a routine way of making money, like
delivering pizzas or parking cars. That worried some members of the
Cavalry Tabernacle Church, which all the students attended.
dinner with students, one woman told them that "your body is the temple of
the Holy Ghost."
The Rev. Paul Mooney, who heads the college and
the church, said participating in a Lilly trial was just for "raising
pocket money." He said he neither encouraged nor discouraged students from
taking part in such trials.
"We're not talking about illegal
drugs," Mooney said. "And these programs are very well monitored by the
government and so forth, and they have all kinds of
An Overdose at 15
Johnson seemed like a
good candidate for the duloxetine trial. At 5-foot-4 and 130 pounds, she
was physically fit and, by all accounts, reliable and upbeat.
during her interview, she told screeners that when she was 15, she had
landed in the emergency room after overdosing on Tylenol pills and had to
have her stomach cleared, according to a psychiatrist studying duloxetine
who has read a report on Johnson's case. The doctor spoke on condition of
anonymity because the information was considered confidential.
family friend said the overdose occurred after Johnson's first boyfriend
broke up with her, and involved a cholesterol-lowering medication used by
her father, not Tylenol.
Johnson denied to screeners she was
suicidal then or depressed now, the psychiatrist said.
researchers accepted her in the study, which was conducted at several
sites across the country.
Then they presented her with a consent
form that listed side effects common in previous duloxetine trials,
including insomnia, nervousness and anxiety. It also noted rarer effects,
such as fainting and an occasional feeling of indifference.
signed the form.
At the time, a controversy was brewing over
antidepressants that affect serotonin.
Six months before the trial
began, drug maker GlaxoSmithKline sent a letter to doctors in England
warning that its drug Seroxat (known as Paxil in the United States) should
not be prescribed to people under 18. It reported that in its own
pediatric trial, subjects reported side effects including "crying, mood
fluctuations, self-harm, suicidal thoughts and attempted suicide" when
they stopped taking the drug.
Two months later, drug maker Wyeth
cautioned U.S. doctors that its drug Effexor — the FDA-approved
antidepressant most similar to duloxetine — increased the risk in
teenagers of "suicide-related adverse events such as suicidal thoughts and
In December, British health officials effectively
banned the use of most antidepressants in children and
Lilly's chief medical officer, Dr. Alan Breier, said in an
interview that the company was confident that duloxetine was safe.
Previous trials did not reveal a statistically significant number of
suicides, Breier said.
The trial's overseers agreed. Dr. Rafat
Abonour, head of the University of Indiana board that approved the
duloxetine protocol, said he did not recall that suicide was ever
mentioned during the review process.
Five suicides had occurred
among 4,124 depressed subjects in studies of the drug. One subject had
taken only a placebo. In a recent study of about 1,000 depressed people
taking duloxetine for up to a year, seven people attempted suicide and
seven others reported that they'd thought seriously about
Breier said that was less than would be expected in a group of
depressed patients. The annual suicide rate in the general population is
about one in 10,000. The risk in people diagnosed with depression can be
10 to 30 times higher.
Lilly spokesman David Shaffer said that
because data did not link duloxetine to suicide, a history of depression —
even a past suicide attempt — would not necessarily disqualify somebody
from the trial.
Several people in the trial had struggled with
moodiness and despair.
Yullan Valor, a freelance product
consultant, was among about two dozen subjects who took part in the
duloxetine trial at California Clinical Trials in Glendale. She said
screeners seemed interested only in depression suffered during the last
seven years. She said they did not ask for details about the depression
she said she suffered two decades ago — and so never learned that she had
once called a suicide hotline for counseling.
another participant, didn't tell screeners that five years ago she cut her
wrists and took some pills in an attempt to kill herself.
said was that she had a history of depression.
"I really needed to
be in the study," said Sikic, who was out of work at the time. "And I felt
A Host of Odd Reactions
On Jan. 10, Johnson,
along with the Bible college's secretary and another student, entered the
enclosed world of Lilly's clinical drug trial.
blends dorm living and medical quarantine. Subjects share meals and TV
time, opinions and life stories, forming a makeshift community.
this study, subjects took duloxetine twice a day. At regular intervals,
the medical staff took blood samples and checked heart
Each participant took the drug for 20 days: 16 days
working up to a dose of 400 milligrams of duloxetine, followed by a
four-day weaning period in which the dosage dropped to zero. For the rest
of the study, they were given a placebo.
Almost everyone had some
odd reaction to the drug. Some could not sleep. Others could not get out
of bed. There was constant bickering.
One woman at the Glendale
site said she was stunned when she felt an overwhelming urge to run over
her husband with the family car as he walked past. Some subjects cut in
front of Alzheimer's patients for use of coveted VCRs.
turning into a madhouse," said 38-year-old Carmellia Wright, an actress.
"Every minute someone was breaking down crying or laughing."
weeks into the experiment, Johnson dropped out of school. Even though she
could leave the clinic, she was missing classes and skipped the funeral of
Still, she found time to socialize. And there was
a young man, a sophomore, a Christian. "I LOVE his love for you," she
wrote to God about the boy in her diary. "God, please work it
They quarreled, but on Jan. 28 — a day when she took the
maximum 400-milligram dose of duloxetine — they went on a date and parted
with a kiss. "So yeah talking about DRAMA!!" she wrote in her
She took 240 milligrams the next day, beginning a withdrawal
period when brain chemicals can swing wildly. On Feb. 3, Johnson took 120
milligrams of duloxetine before starting on the placebo.
fine and baby-sat three nights later, telling one mother she couldn't wait
to get back to school. She talked with friends back home and was anxious
to be there for the delivery of her sister's baby.
At 3 p.m. the
next day she spoke by phone with John Crompton, a church friend from
Philadelphia, and told him she felt sick and needed to
Sometime in the next few hours, the young woman took the
multicolored scarf that she wore around her waist and looped it around her
neck. She tied the other end to a shower rod.
And there she hung,
feet dangling close to the floor, until a nurse found her body shortly
after 8:30 p.m.
The Rev. Joel
Barnaby, Johnson's pastor back home in Pennsylvania, broke the news to her
parents in their living room.
Reporters barraged Lilly with
At one of the trial sites, in Evansville, Ind.,
directors shut down the study, sending home all 16 subjects, according to
a Lilly spokesman. But enough people remained in the study to ensure the
trial was still scientifically valid, the spokesman said.
assured stockholders that the suicide would not delay the drug's release
later this year. The company also reported Johnson's earlier
pill-swallowing episode to the FDA and the scientists who were studying
duloxetine for Lilly.
While company officials declined to comment
in detail on Johnson's death, they said they did not believe the
duloxetine contributed to it — and that the reasons behind her suicide
were a mystery. She left no note.
At the Glendale test site, clinic
staffers tried to ease worries by telling subjects that Johnson had tried
to commit suicide before, and that problems with money and other matters
had pushed her over the brink, several subjects said.
psychiatrist told me that she had a history of depression and that she had
just broken up with her boyfriend," Wright said.
Lilly asked test
subjects to sign new consent forms and started daily psychological
evaluations. It also doubled the weaning period from the drug to eight
days. The new forms disclosed the suicide, saying that "at this point the
sponsor believes that this event was not caused by duloxetine or the
Most of the Glendale subjects stayed in the trial, but they
were infuriated to discover in an online news article that they were being
paid less than their counterparts in Indiana.
To quell revolt, the
clinic raised their pay to match the $150 a day in
Convergence of Beliefs
Those closest to
Traci Johnson blame her death on the drug — and the lure of
"This is a terrible spiritual breach of Christian ethics,"
Barnaby said. "Christians should never have to experiment with
psychotropic medicine as a means to make money."
that faith would protect her — faith that God had led her down a path to
$7,000, that other people at the Bible college wouldn't participate in an
unsafe study, that a company as huge as Eli Lilly would not let anything
happen to her.
Lilly officials believed that their data ruled out a
link between duloxetine and suicide, and that it wasn't necessary to tell
subjects about the suicide controversy.
Even after studies of
antidepressants involving thousands of people, the debate over their risk
Most psychiatrists say antidepressants are more likely
to prevent suicide than trigger it. "Looking at the analysis the British
regulators did, I see no significant difference between the drugs and
placebo when it comes to suicide risk," said Dr. David Brent, a psychia-
trist at the University of Pittsburgh who studies suicide
But some researchers point out that suicide is
inherently difficult to study. It occurs too rarely to provide reliable
data, and too many factors, often deeply personal, can spark a plunge into
They say Lilly would have to conduct a thorough
investigation of each suicide during the duloxetine trials to determine
whether the drug was involved. Company officials, who knew few details
about the previous suicides, said they now plan to study all six
The concerns over antidepressants were already serious
enough that on March 22 the FDA warned that some patients could become
suicidal when they first started antidepressants or during withdrawal. The
agency urged the makers of 10 drugs currently on the market to include
labels alerting doctors and consumers to danger signs such as anxiety,
hostility and agitation in patients of all ages.
The FDA is still
reviewing duloxetine. If the drug wins approval, regulators will likely
advise that it, too, carry the warning.
On a blustery day in February, 17 students rode a bus
from Indiana to Pennsylvania with Pastor Mooney for Johnson's
Among them was the young man from the Bible college who
Johnson had been dating. He has refused to talk about her death. The night
she died, he had been scheduled to join an unrelated study at the Lilly
He never showed up.
More than 300 mourners gathered
at her old church. "Traci Johnson died last Saturday night, by no fault of
her own," Barnaby said from the pulpit.
The worshipers could not
reconcile their memories of Johnson with her suicide. "I was surprised
because she had the Holy Spirit," said Ernest Copple, 79, an official at
the Indiana church Sunday school.
To fathom the possibility that
Johnson freely chose suicide would be to challenge the very foundations of
her faith. She would never forsake God's most precious gift.
know if you take your own life, you don't go to heaven," said Jacoby, her
friend from home. "We wouldn't do that."
The day after the suicide,
Pastor Mooney invited Dr. Michael Turek, the top Lilly investigator in the
Indianapolis duloxetine trial, to church. Students who attended said Turek
expressed Lilly's sympathy and answered questions.
asked if they should still participate in trials.
replied, was up to them.