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Attorney questions FDA probe of Lilly
Family of drug trial suicide victim says it wasn't consulted; details of investigation still unreleased.

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September 4, 2004

An attorney for the parents of Traci Johnson, the 19-year-old who hanged herself while helping test a drug at the Lilly Clinic in Indianapolis, said he is skeptical the Food and Drug Administration thoroughly investigated her death before approving the drug for sale last month.

John Cordisco, a Philadelphia attorney who is representing Johnson's parents in a possible lawsuit against drugmaker Eli Lilly and Co., said the FDA investigation was done without contacting him, Johnson's parents or physician, or Johnson's fellow volunteers in the drug-testing trial.

The FDA concluded that Johnson's death wasn't caused by duloxetine, the antidepressant she was testing, according to Lilly.

"I find it very difficult (to believe) the FDA would take a general position the drug was not related to her death when I don't believe they had sufficient information to determine that," Cordisco said Friday.

The FDA likely won't release a copy of the suicide investigation for several weeks, spokeswoman Victoria Kao said. The report is being edited to make it suitable for public release, said Kao, who wouldn't comment on how the investigation was conducted.

Lilly has been told by the FDA that the investigation found that duloxetine didn't play a role in the death, said company spokesman Rob Smith.

"We haven't seen it, and we don't know the contents," he said about the report from the FDA investigation. But, he said, "It certainly will not contradict anything that's already been reported about the connection between duloxetine and the suicide."

Smith also hinted that Lilly is open to a settlement to avoid a lawsuit -- a suggestion that Lilly seldom has made in public comments about other such liability cases.

"Given the facts of the situation, we think an equitable settlement, if one could be worked out, would be beneficial to both parties," Smith said.

Johnson's suicide in February was the first of a volunteer in the 78-year history of Lilly's main lab for testing experimental drugs on humans.

The FDA approved duloxetine for sale as an antidepressant with the brand name Cymbalta. Most of the nation's pharmacies now have supplies in stock, Lilly has reported, and it is being actively marketed by Lilly and prescribed by physicians.

The information the FDA gathered to investigate Johnson's suicide appears to him to have come primarily from Lilly, Cordisco said.

"It's difficult to believe . . . the information provided to the FDA was objective and not self-serving," he said.

Cordisco has asked Rep. Joseph M. Hoeffel, D-Pa., to help him get a copy of the report with the results of the FDA investigation.

"We've been in contact with the FDA and have not received definitive answers from them," said Frank X. Custer, press secretary for Hoeffel. He called the FDA's response "spotty."

FDA spokeswoman Kao said it's common for the FDA to take up to 10 weeks after a drug is approved to release materials associated with the approval, such as the report on the suicide.

The report, when edited by the FDA, will be posted on an agency Web site and available to everyone at once, she said.

Cordisco would not say if Johnson's parents, Mike and Peggy Johnson, who live in the Philadelphia area, intend to file suit against Lilly. But he noted that he and the three other members of his legal team have "assembled the case and . . . we are preparing to move forward."

He said one possible charge against Lilly is medical malpractice "relative to the operation of the (Lilly) clinic and in conjunction with the drug" given to Johnson while she was in the drug test.

"There may be some issues surrounding the screening process as well as monitoring" of Johnson by medical personnel while she was in the clinic, he said.

Johnson entered the clinical trial, which asked for healthy volunteers to test the safety of the drug, to get money to help pay tuition at Indiana Bible College in Indianapolis, where she had been a student, Cordisco has said.

Cordisco's legal team includes two partners at his Philadelphia law firm and Houston trial lawyer Andy Vickery, who was asked to join the team several months ago.

Vickery specializes in suing antidepressant makers on behalf of clients who allege the drugs harmed users or provoked them to try to kill themselves or others. He has settled out of court more than a dozen such cases against Lilly involving its antidepressant Prozac. Settlement terms have remained confidential.

Vickery said the facts surrounding Johnson's suicide could form "an incredibly strong case" against Lilly. "It's twice as strong as all the Prozac cases" he has filed, Vickery said.

Lilly spokesman Smith said the Indianapolis drugmaker has "worked diligently (with the Johnsons and their attorneys) to share with them what we know to try to find out what happened in this tragic situation."

"If the case does go to trial, it might be extremely painful for the Johnson family, and we are hoping that can be avoided," Smith said.

He said Lilly officials "haven't given much thought" to the impact that a lawsuit and trial over Johnson's suicide could have on sales of Cymbalta, a potential blockbuster drug for Lilly that could top sales of $1 billion a year.

Call Star reporter Jeff Swiatek at (317)444-6483.

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