Lilly's new antidepressant: Attorney questions FDA probe of Lilly

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> SSRI-Research

> Mon, 6 Sep 2004 11:16:35 -0400

> [sSRI-Research] Lilly's new antidepressant:

> Attorney questions FDA probe of Lilly

>

>

http://www.indystar.com/articles/1/176037-4311-223.html

>

> Attorney questions FDA probe of Lilly

> Family of drug trial suicide victim says it wasn't

> consulted; details of investigation still

> unreleased.

>

> By Jeff Swiatek

> jeff.swiatek

> 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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