| 
 19 quit Lilly drug 
            trial after a death
 
 By Walter F. 
            Naedele
 Inquirer Staff 
            Writer
 
 Nineteen of 99 people in a clinical trial of an antidepressant 
            have left after a Bensalem woman in the study hanged herself 
            Saturday, Eli Lilly & Co. said yesterday. Traci Johnson, 19, a 2002 graduate of Bensalem High School, was 
            found hanging by a scarf from a bathroom shower rod at the Lilly 
            Laboratory for Clinical Research in Indianapolis. Johnson was buried yesterday in Resurrection Cemetery in Bensalem 
            after a funeral at the Greater Church of Philadelphia in Kensington, 
            where she was a youth leader. Johnson had been a first-year student at the Indiana Bible 
            College, but she left in January to become a subject in the Lilly 
            study of duloxetine. The chemical is intended to treat depression and urinary 
            incontinence caused by stress. David Shaffer, a Lilly spokesman, said three of Johnson's 25 
            fellow subjects at the Indianapolis site had left the study. Shaffer said 16 people at a trial site in Evansville, Ind., also 
            had left the program when "the site management decided to pull out 
            from the study." Shaffer declined to identify the management or the specific 
            site. "No other participants in any of the other sites have chosen to 
            withdraw" from the clinical trials of duloxetine, he said. On Wednesday, Shaffer said that over the years, there had been 
            four other suicides in trials of duloxetine, but only among the more 
            than 8,500 subjects who already had been diagnosed with 
            depression. Yesterday, Shaffer said he had misspoken and that "more than 
            8,500" was the total number of trial subjects, both depressed and 
            not depressed. He was uncertain how many took part in each study and how long 
            the studies had been under way. Lilly has said it believes duloxetine was not associated with 
            Johnson's death. Before it can be marketed, he said, the Lilly drug needs to be 
            approved by the U.S. Food and Drug Administration. Yesterday, FDA spokeswoman Susan Cruzan said the agency "couldn't 
            really address the [Lilly] drug trials specifically" in light of 
            Johnson's death. "But FDA does have a process for reviewing reports 
            of death associated with use of a drug in a clinical trial. We'll 
            review all the information and evaluate its implications." |