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Suicide brings changes to Lilly drug trials
February 11, 2004
Eli Lilly and Co. has been ordered not to accept new participants for local clinical trials of an anti-depressant and incontinence drug after the weekend suicide of a teenage test subject.
The Institutional Review Board that oversees all Lilly trials on the Indiana University medical school campus also decided Tuesday that the company must bring in an independent psychiatrist to evaluate participants. The company also must ask them to sign a new consent form to continue with the trials.
Lilly reported to the board Monday that Traci Johnson, 19, a former student at Indiana Bible College, hanged herself Saturday in the bathroom of her room at the hotel-like Lilly Laboratory for Clinical Research.
The Rev. Paul Mooney, president of the college, said many students at his school and other nearby universities take part in the clinical trials as a way to earn money and pay tuition.
Shelley Bizila, administrator in charge of the five institutional review boards that oversee research at IUPUI, expressed dismay at the death of the young woman.
"We're all people, and many of us have children, and we would be distressed by that happening to any of us," she said.
Lilly spokesman Rob Smith said the board's ruling was "perfectly reasonable" and noted that an independent psychiatrist had already visited participants Tuesday. He said enrollment in the trials had been staggered over several weeks but was already closed before the board's ruling.
Johnson's suicide occurred while she was participating in one of three local trials Lilly is conducting on its drug duloxetine.
The compound has been moving toward final approval by the U.S. Food and Drug Administration to treat both depression and stress urinary incontinence. Data from the clinical trials would be relevant for both uses.
Lilly officials have told Wall Street analysts they expect to launch the depression drug this summer and the incontinence medication later this year. Analysts have predicted that sales of the incontinence drug could exceed $1 billion and that the depression drug, called Cymbalta, could top $2 billion.
Johnson, a native of Bensalem, Pa., was one of about 25 "healthy volunteers" serving as test subjects for duloxetine at higher-than-normal doses. She had been physically and psychologically screened before the test and did not have depression, Smith said.
The FDA had requested that Lilly conduct the safety tests, which typically examine side effects.
Lilly still has several days to submit a report of the incident to the FDA, which will then look into the matter. FDA spokesman Jason Brodsky said the agency could not comment specifically on the duloxetine studies.
But, he said, "We take a report of a suicide very seriously." The FDA will scrutinize Lilly's reports and perhaps ask for more information, such as patient records and past trial data, he said.
"It definitely requires some investigation," said Scott Henry, a stock analyst covering Lilly at Oppenheimer & Co. in Boston. But he said investors are willing to overlook the situation as long as duloxetine -- or the withdrawal from it -- is not specifically linked to Johnson's death.
Shares of Lilly's stock hit a 52-week high Tuesday, rising $1.32 to close at $74.54.
The Marion County coroner's office has ordered a toxicology test to determine whether drugs played a role in Johnson's suicide.
Lilly, in its preliminary review, concluded that duloxetine did not cause her death.
Johnson joined the trial in early January. She initially had been given duloxetine but, at the time of her death, had been taking a placebo for four days.
"As it relates it specifically to duloxetine, we have not seen anything at all from the data that either being on the drug or being withdrawn would pose a suicide risk," Smith said.
Johnson's pastor and relatives, however, have hotly countered that contention. They noted Johnson's active participation in her church, Greater Church of Philadelphia, where she led a Friday-night youth group and some singing during worship services. Her suicide, they said, was totally out of character.
"Traci Johnson was one of the star young people of our youth group. Her death has taken the heart out of our church family," said her pastor, Joel Barnaby.
Vera Sharav, president of the Alliance for Human Research Protection, said people of Johnson's age often are not mature enough to grasp the risks of a drug trial.
"She just finished (high) school," Sharav said. "Where is the cutoff?"
Smith said Lilly's cutoff is the legal age of 18. "They're certainly considered adults," he said.
Mooney said his college neither endorses nor discourages student participation in the studies.
"We have nothing to do with Lilly whatsoever," Mooney said. "We don't recruit for them, and we don't advertise. They don't pay us anything. This is something the students pursue on their own."
He said students have developed a pipeline to Lilly. Most work to pay their tuition, about $5,000 a year.
Indiana Bible College is a four-year college sponsored by Calvary Tabernacle at 902 S. Fletcher Ave. The church is an Apostolic/Pentecostal church affiliated with United Pentecostal, International.
About 70 percent of the college's 260 students are from out of state. They attend to prepare for a career as ministers.
Mooney said he did not know Johnson well but described her as an average student. She dropped out of school in January to take part in the Lilly trials so she could earn enough money to return to college, family and friends said.
Because the school is small, most students know one another. Many students are taking Johnson's death hard, Mooney said.
Sunday morning, Dr. Michael Turek, from Lilly, spoke to the students at the Calvary Tabernacle chapel.
Mooney said he has spoken with Johnson's family and will attend the funeral Thursday in Pennsylvania.
Freshman Eric Ashcraft, 19, said the students are not ready to blame Johnson's suicide on the clinical study.
"We all have an open mind about this, especially since there are so many people here who do the studies," he said.
Call Star reporter J.K. Wall at (317) 444-6287
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