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Posted on Thu, Feb. 12, 2004

Drug test altered in wake of suicide




Inquirer Staff Writer

Colleen Jacoby last spoke to Traci Johnson on Friday, the night before Johnson is reported to have committed suicide.

"On the phone, she was laughing, she was happy," Jacoby said of her call from Northeast Philadelphia to her best friend in Indianapolis.

At 9 p.m. Saturday, a doctor at Indiana University Hospital pronounced Johnson dead, a suicide, according to an incident report from the Indianapolis Police Department.

Johnson, 19, a 2002 graduate of Bensalem High School, had been found hanging by a scarf from a bathroom shower rod in the Lilly Laboratory for Clinical Research.

Since early last month, after leaving studies at the Indiana Bible College in Indianapolis, Johnson had been categorized a "healthy subject" by Eli Lilly & Co. in a trial of the drug duloxetine, which a spokesman for the pharmaceutical company said would be used to treat depression and for urinary incontinence caused by stress.

Jacoby, 20, who lives in the Oxford Circle neighborhood of Northeast Philadelphia, said that "80 percent of [Johnson's] life, she was with me; we were her second family."

Johnson "would never hang herself," Jacoby said. "Never, ever. She was full of life."

David Shaffer, an Eli Lilly spokesman in Indianapolis, said that four of more than 8,500 people in previous trials of duloxetine had committed suicide.

But, he said in an interview yesterday, they were "studies of people who actually had depression."

"And that rate is in line with what you'd expect in a population of that size who were depressed," and who weren't taking the drug, he said.

Shaffer said Johnson's trial consisted of healthy persons "in which the patient doesn't know, the doctor doesn't know, whether they're on the medication or sugar pills." There are about 100 subjects currently.

Johnson had been given duloxetine early last month but was taking sugar pills at the time of death, Shaffer said. He called this "a high-dose study."

"It's higher than the dose we expect to be used in clinical practice, once the drug is approved and doctors are using it in the real world."

Yesterday, the Institutional Review Board, a body of the Indiana University School of Medicine, which has been monitoring the clinical trial, moved to tighten the duloxetine study.

Shaffer said the board ordered Lilly to accept no new subjects for the trial, ordered an independent psychiatrist to evaluate the current subjects, and required that they sign a new consent form.

The Lilly spokesman said that enrollment for this trial was completed before Johnson's death, that the subjects had undergone psychiatric evaluation before the trial, and that the new form asks their consent in light of the apparent suicide.

Shaffer said that "the steps that the [review board] took, we feel, are appropriate in this case."

Jacoby said she and Johnson had been friends since grammar school, and longtime members of the Greater Church of Philadelphia, a nondenominational Pentecostal church in Kensington.

The Rev. Joel Barnaby, the pastor there, said that since Johnson's death, the young woman's relatives "just walk around numb. They're just devastated."

He said they "come to me and lean on my shoulder and [ask], 'How did this happen to our little girl?' "

Barnaby said that Johnson came to him last year, asking for names of Bible schools.

"I asked why, and she said, 'Because I want to sharpen my skills and understanding of the Scriptures, so that I could be a vessel of honor that the Lord might use.' "


Contact staff writer Walter F. Naedele at 215-345-7768 or wnaedele@phillynews.com.

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