FDA Regulation “Hurts” for Depression Drug Maker Eli Lilly
by Martha Rosenberg / October 17th, 2007
It was supposed to replace Prozac profits when the patent expired in 2001 and cash in on the national love affair with antidepressants.
But Eli Lilly & Co.’s Cymbalta (duloxetine) seemed cursed from the start.
The first antidepressant to be introduced since FDA investigations into suicide/antidepressant links, Cymbalta itself was marred with suicides before it was approved.
Five occurred during Cymbalta clinical trials including previously healthy volunteer Traci Johnson who hung herself in Lilly’s Indiana University Medical School lab in 2004.
“Their posturing was offensive,” said the Rev. Joel Barnaby, spokesman for Traci Johnson’s family upon hearing Lilly would not delay the drug’s planned introduction. “They were saying that this little death certainly should not defame our study or, God forbid, make us miss a deadline for FDA approval.”
Nor was Traci, “in a depressed state of mind or had a spirit wounded so much that she gave up on life,” Mr. Barnaby said.
Despite $208 million in sales in its first eight months of marketing thanks to auto suggestive “Depression Hurts” television ads and do-you-have-this-disease? symptom checklists on its web site, Cymbalta’s bad buzz didn’t go away.
A year after Cymbalta hit drug store shelves it was indicted for causing more than twice the rate of suicide attempts in women prescribed the drug for stress urinary incontinence–a use not approved in the US–according to the FDA.
Last May, the FDA ordered Lilly to add a black box to Cymbalta warning about suicides and antidepressants in young adults.
And in October Lilly was told to “immediately cease” its Cymbalta campaign for diabetic nerve pain–an approved use–which promises “significantly less pain interference with overall functioning.” In a letter, the FDA says the claim “has not been demonstrated by substantial evidence or … clinical experience” nor do the Cymbalta marketing pieces give precautions about liver toxicity or reveal risks for patients with certain conditions.
(Lilly spokesman Charlie McAtee said Lilly will take action once it has “more clarity” on FDA objections. Which part of “immediately cease” does he not understand?)
Even Lilly’s own reps are trashing the drug on the pharma chat room cafepharma.com.
“My territory includes a high percent of blue collar beer guzzlers that drive home from work with a six pack on their lap,” wrote one anonymous poster. “The Docs around here won’t touch Cymbalta.”
“This prohttp://www.dissidentvoice.org
by Martha Rosenberg / October 17th, 2007
It was supposed to replace Prozac profits when the patent expired in 2001 and cash in on the national love affair with antidepressants.
But Eli Lilly & Co.’s Cymbalta (duloxetine) seemed cursed from the start.
The first antidepressant to be introduced since FDA investigations into suicide/antidepressant links, Cymbalta itself was marred with suicides before it was approved.
Five occurred during Cymbalta clinical trials including previously healthy volunteer Traci Johnson who hung herself in Lilly’s Indiana University Medical School lab in 2004.
“Their posturing was offensive,” said the Rev. Joel Barnaby, spokesman for Traci Johnson’s family upon hearing Lilly would not delay the drug’s planned introduction. “They were saying that this little death certainly should not defame our study or, God forbid, make us miss a deadline for FDA approval.”
Nor was Traci, “in a depressed state of mind or had a spirit wounded so much that she gave up on life,” Mr. Barnaby said.
Despite $208 million in sales in its first eight months of marketing thanks to auto suggestive “Depression Hurts” television ads and do-you-have-this-disease? symptom checklists on its web site, Cymbalta’s bad buzz didn’t go away.
A year after Cymbalta hit drug store shelves it was indicted for causing more than twice the rate of suicide attempts in women prescribed the drug for stress urinary incontinence–a use not approved in the US–according to the FDA.
Last May, the FDA ordered Lilly to add a black box to Cymbalta warning about suicides and antidepressants in young adults.
And in October Lilly was told to “immediately cease” its Cymbalta campaign for diabetic nerve pain–an approved use–which promises “significantly less pain interference with overall functioning.” In a letter, the FDA says the claim “has not been demonstrated by substantial evidence or … clinical experience” nor do the Cymbalta marketing pieces give precautions about liver toxicity or reveal risks for patients with certain conditions.
(Lilly spokesman Charlie McAtee said Lilly will take action once it has “more clarity” on FDA objections. Which part of “immediately cease” does he not understand?)
Even Lilly’s own reps are trashing the drug on the pharma chat room cafepharma.com.
“My territory includes a high percent of blue collar beer guzzlers that drive home from work with a six pack on their lap,” wrote one anonymous poster. “The Docs around here won’t touch Cymbalta.”
“This prohttp://www.dissidentvoice.org
