Woman participating in Lilly trial hangs self

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.

Lilly Claims that "there's nothing to suggest that this is anything but an isolated incident."

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