[April 2, 2004 Eli Lilly drug trial death] A Godsend, Till a Life Unravels

disclosure http://www.ahrp.org

"Traci Johnson joined a clinical trial of an antidepressant to pay for
college. The devout woman ended up taking her own life."

The Los Angeles Times examines the tragic story of this 19 year old bible
college student who committed suicide while she was a paid volunteer in an
Eli Lilly trial testing the cardiac effects of an experimental drug at 5 and
6 times the normal dose. The report reveals the hidden hazards of current
drug research under FDA oversight.

* Drug trials are not designed to protect the well-being of human subjects.
* Students are mostly unaware of the potential hazards when they volunteer
as paid drug testing subjects.
* The FDA does little to protect the vulnerable and unwary, nor does the FDA
ensure that the risks are fully disclosed.
* Institutional review boards (IRBs) cannot be relied upon to protect the
subjects; their loyalty is to the institution that employs them.

The LA Times report notes, "The [Lilly] 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 work."

It seems to us that schools that open their doors to drug companies for the
purpose of recruiting students for experimental drug trials-an activity
involving known and unknown risks--bear some responsibility for the
consequences. One wonders whether rules exist to prevent schools from
accepting cash in return for recruiting privileges?
The LA Times article raises several troubling issues:

* Were parents consulted about their teenage children's exposure to
experimental drugs for pay?
* Did the informed consent documents that students signed disclose that
there were 5 suicides in previous tests of duloxetine?
* What was the FDA's justification for approving an experiment that exposed
student subjects to the increased risk of suicide and cardiac stress by
ingesting 6 times the normal dose?
*Was the institutional review board (IRB) informed that the dose would be 5
to 6 times the normal dose? What was their justification for its approval?

Had Traci Johnson taken the advice of her best friend who cautioned against
becoming a human guinea pig, she would likely be alive.

Contact: Vera Hassner Sharav
Tel: 212-595-8974
e-mail: veracare@ahrp.org

April 2, 2004
A Godsend, Till a Life Unravels
By Alan Zarembo and Benedict Carey

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 guinea pig."

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 diary.

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.

For 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

"She just went wherever the Lord was leading her," said Kathy DePalma, who
ran the Christian day-care center where Johnson had worked.

When friends 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

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 machinist.

"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 way."

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

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 for Prozac.

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.

Lilly 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

A Great Fundraiser
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.

The 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 work.

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.

"My 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

Another 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 diabetes

Parks made $2,600 in the diabetes study for a week of work, although he
recalled that "everybody was throwing up."
Nausea, Parks concluded, was just part of the job.

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 researchers.

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

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.

At a 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

"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 guidelines."

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

But 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.

A family friend said the overdose occurred after Johnson's first boyfriend
broke up with her, and involve a cholesterol-lowering medication used by her
father, not Tylenol.

Johnson denied to screeners she was suicidal then or depressed now, the
psychiatrist said.
The 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

She signed the form.
At the time, a controversy was brewing over antidepressants that affect

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