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Women participating in lilly drug trial hangs self { February 9 2004 }

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Woman participating in Lilly trial hangs self
Coroner will examine whether experimental drug played possible part in 19-year-old's suicide.

By J.K. Wall and John Tuohy
February 9, 2004

A toxicology test will determine whether narcotics played a role in the suicide of a 19-year-old woman who was participating in clinical trials for a new drug that Eli Lilly and Co. hopes to launch this year.

Traci Johnson, Bensalem, Pa., hanged herself Saturday night in the Lilly Laboratory for Clinical Research by tying a scarf to a bathroom shower rod, according to the Indianapolis Police Department.

While the toxicology test is standard procedure in the investigation of suicides by the Marion County coroner, it could have huge implications for Lilly if it is determined that the trial drug -- or removal from it -- played a role in the woman's suicide.

Lilly said Monday it does not believe the drug, duloxetine, was related to the death of Johnson, who was a former student at Indiana Bible College. Toxicology test results are expected in about a month.

Duloxetine is key to future business prospects of Lilly. It is the main ingredient in Cymbalta, an anti-depressant drug, and in a stress urinary incontinence treatment, both of which are moving toward final approval by the U.S. Food and Drug Administration.

However, incidents such as the suicide of a clinical trial participant often draw questions from the FDA and can delay the federal approval needed to bring a drug to market.

In earlier statements, Lilly has said it expects the FDA to approve duloxetine to treat both depression and incontinence in 2004. Analysts have predicted sales of each could near $200 million this year. They bill Cymbalta as a potential blockbuster that could top $2 billion in sales by 2008.

Lilly spokesman Rob Smith would not say which use of the drug was the subject of Johnson's trials. However, the trial cycled the participants between doses of duloxetine and a placebo. At the time of her death, Smith said, Johnson was taking placebo.

"Based upon our initial review, we do not believe at this time that the design or conduct of the study is related to the death," Smith said. He said Lilly would continue looking into the matter, but added that "there's nothing to suggest that this is anything but an isolated incident."

Todd Lappin, the Indianapolis police detective who investigated Johnson's death, said she did not leave a note, making her motive undetermined. "I talked to her friends. They all said, 'She was chipper,' " Lappin said.

A nurse found Johnson's body around 8:20 p.m. Saturday at the Lilly Lab, which occupies the fifth and sixth floors of an outpatient center on the campus of the Indiana University Medical School.

Lilly's clinical trial is one that tests "healthy volunteers," who do not have depression or incontinence, in order to evaluate how the human body metabolizes the drug and to examine proper dosages and side effects.

The FDA had requested Lilly to conduct this latest safety test, even though duloxetine has been tested on more than 9,000 people to date, Smith said. He added that the FDA had not asked for the study for any suicide risk.

Johnson joined the trial in early January, staying overnight at the clinic, but with the freedom to come and go. She received $150 a day plus meals, Smith said. She was one of about 25 local volunteers, and one of about 100 nationally.

Johnson's parents could not be reached Monday by phone. Smith said that Lilly had told them of Johnson's death over the weekend.

"It's a real tragedy. We really feel sorry," Smith said. "We extend our deepest condolences to her family."

Lilly will not halt its clinical trial of duloxetine, Smith said, because the company does not believe the drug is putting participants in danger. But Lilly did conduct additional monitoring of the other participants after Johnson's death.

Smith said Lilly would make a formal report to the FDA and similar international regulatory agencies later this week.

Similar incidents have sparked lawsuits against some companies, according to two clinical trial experts at the University of Southern California. And those lawsuits sometimes have led companies to suspend their clinical trials, said Peter Pressman, clinical physician at the Keck School of Medicine, and Roger Clemens, a professor of molecular toxicology at School of Pharmacy.

But both Pressman and Clemens noted the regulatory protocol for the safety tests in which Johnson was involved requires an abundance of safeguards standardized by an international organization.

Lilly screens participants at the Lilly Labs with physical and mental exams. In safety tests, the company also must make sure that participants do not have the disease or condition that is treated by the drug being tested. Participants must sign consent forms after receiving explanations of a drug's potential side effects and risks in both technical and layman's terms.

"It's more careful, it's more thoughtful -- almost to a fault -- than most people realize," Pressman said.

Clemens, who worked on clinical trials for more than 20 years, primarily in the food industry, said he had never seen a death related specifically to a drug.

"It's rare," he said. "There may be a lot that you could criticize about the pharmacological industry, but this is one area where it's very difficult."

Star reporter Tom Spalding contributed to this story.

Call Star reporter J.K. Wall at (317) 444-6287.

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Women participating in lilly drug trial hangs self { February 9 2004 }

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