Test subjects call Lilly screening process inadequate
Posted on Thu, Mar. 04, 2004
Original story at miami.com.

INDIANAPOLIS - Four participants in a California study of the same drug an Indiana college student was testing when she committed suicide say the process used by Eli Lilly and Co. to screen for depression was inadequate.

The women told The Indianapolis Star for a story Thursday that clinic staff told them that Traci Johnson had a history of depression and should not have been allowed to take part in the study.

But Dr. Rafat Abonour, chairman of the board that reviews all Lilly drug trials at the Indiana University Medical Center in Indianapolis, said his review of Johnson's records showed no such history.

Johnson, 19, hanged herself Feb. 7 at Eli Lilly's hotel-like research lab at the Indiana University Medical Center, where she had been participating in a study of the effects of high doses of the antidepressant duloxetine.

A coroner's report released this week did not cite the drug as a factor in her suicide. The U.S. Food and Drug Administration still is reviewing Johnson's death.

The review board said Wednesday that it was satisfied with Lilly's responses, which included hiring an independent psychiatrist to evaluate participants daily for depression and submitting a plan for dealing with those who begin to show signs of depression.

One of the participants in the California duloxetine trials described the screening interview she had undergone as "sloppy."

Michelle Hermit, 48, said researchers asked few follow-up questions after she told them that she had taken medication for depression after her mother died. She was approved for the study.

Another participant, Tatiana Sikic, said researchers had her undergo a psychiatric exam after she told them in an interview that she had been depressed when her grandmother died about eight years ago. But she did not tell doctors that she had tried to commit suicide, she said.

"I didn't tell them about that. I needed the money too bad," she told the Star.

Johnson received $150 a day plus meals and was among 25 local volunteers and 100 nationally who agreed to take part in the drug study.

Lilly officials defended their screening methods and said that applicants who acknowledge past instances of depression may be allowed to participate in a study if their current condition does not seem urgent.

"Whether their personal history would have precluded them from the study would have been a judgment call," said John Callaghan, director of U.S. exploratory medicine for the Indianapolis-based drug maker.

Researchers at the Lilly Clinic in Indianapolis classified Johnson as a "healthy volunteer" during the initial screening.

California test participants Hermit, Sikic Carmellia Wright and Nisha Patel said they were told by Dr. Mark Leibowitz, lead physician for the medical group conducting part of the trials for Lilly, that an Indianapolis trial subject had committed suicide. Other clinic staff provided more information a few days later, they told the Star.

"They said that she was already depressed and that she shouldn't have been in the study in the first place," said Wright, 38.

Lilly said company physicians gave doctors at the California clinic medically relevant data about Johnson's death without naming her.

John Hayes, a clinical psychiatrist who heads Lilly's duloxetine team, said he believed the women's statements were speculation.

Friends and family have described Johnson, an Indiana Bible College student from Pennsylvania, as an upbeat person and said depression or suicide would have been out of character.

"I've known her all her life," said the Rev. Joel Barnaby, a Philadelphia pastor and spokesman for the family. "She's a vivacious, fun-loving, spirited, uplifting person.

Shortly after Johnson's suicide, Lilly disclosed that four participants who were depressed committed suicide during previous trials of the drug, a number the company said was below the level of those who were not taking the medicine and lower than suicide rates for another class of antidepressants, which includes Paxil, Zoloft and Prozac.

Duloxetine is an ingredient in the antidepressant Cymbalta. The drug is widely expected to be a blockbuster for Lilly, with some analysts forecasting sales that could eventually top $2 billion annually.

Information from: The Indianapolis Star