Healthy Skepticism Library item: 116

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Naedele , W.f
19 quit Lilly drug trial after a death
Philadelphia Inquirer 2004 Feb 13

Full text:

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.