Guest guest Posted September 7, 2004 Report Share Posted September 7, 2004 > 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. > > > > [Non-text portions of this message have been > removed] Quote Link to comment Share on other sites More sharing options...
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