THOUGHTS on = FDA backs Lilly stance on suicide, Agency agrees that Cymbalta wasn't factor in death at clinic.

[Guest guest]

I can't help but think about the following thoughts, after reading the

below post.

-- sure she hung herself, but why, what caused this?

-- depression from years ago, but was a " healthy volunteer " for this

drug-testing study.

-- she took up to 6 times the normal 60 mg recommended daily dose - " to

see how high doses of the drug affected 'healthy volunteers' " ??? 6

times the normal recommended dose???

=====================================

http://www.indystar.com/articles/0/169515-1780-093.html

FDA backs Lilly stance on suicide

Agency agrees that Cymbalta wasn't factor in death at clinic.

By Jeff Swiatek

jeff.swiatek@...

August 11, 2004

The Food and Drug Administration has concluded that Eli Lilly and Co.'s

newly approved antidepressant Cymbalta didn't trigger Traci 's

suicide at the Lilly Laboratory for Clinical Research.

An FDA investigation " found (the drug) couldn't be linked to her death, "

an FDA spokesperson said today.

, 19, a former Indiana Bible College student, hung herself with a

scarf Feb. 7 in a bathroom of the drugmaker's Indianapolis drug-testing

clinic during a study to see how high doses of the drug affected healthy

volunteers.

A memo about the closing of the FDA investigation of the suicide is part

of the FDA's approval package, the first part of which was sent to Lilly

last week, the agency spokesperson said. It gives the drugmaker

permission to start selling Cymbalta.

Lilly hasn't yet received the memo, but the company was told by the FDA

that it had no further questions about the suicide, Lilly spokesman

Shaffer said.

" We aren't aware of the full contents of that (memo), " Shaffer said, but

" We were informed there would be no findings " contrary to what Lilly had

concluded about the suicide.

Lilly has said it found its drug was not to blame.

The FDA's finding is " confirmation of our assertion there wasn't a link

between her participation in the study and her death, " Lilly spokesman

Philip Belt said.

A lawyer for the family, Cordisco, said the family had heard

that the FDA had concluded its investigation.

" We are still exchanging information with Eli Lilly and its

representatives and based on that it would be premature to give comment, "

said Cordisco, who practices in Philadelphia.

The n County coroner's office ruled 's death was by hanging.

A Philadelphia native, had stopped taking the drug and was being

weaned from it when she killed herself. She took doses up to six times

the recommended 60 mg daily dose for depressed patients.

Lilly subsequently increased from four days to eight the weaning period

in the trial.

was the first person to die in a drug-testing trial in the

history of the 78-year-old clinic, located on the upper floors of Indiana

University Hospital on the campus of Indiana University-Purdue University

Indianapolis.

The FDA declined to immediately release any written documents related to

its investigation.

FDA investigators spent about a week at the clinic earlier this year,

reviewing patient records and interviewing Lilly personnel, Shaffer said.

's suicide came during a time of growing debate over the link

between antidepressants and suicide in users, particularly children.

In March, the FDA told 10 drugmakers to strengthen suicide-related

warnings on labels for antidepressant drugs.

Two FDA advisory committees are currently examining any links between

antidepressants and suicides in children.

In addition, Congress is looking into whether drug companies have

withheld information from the FDA about suicides among children taking

antidepressants.

As of this spring, four suicides had occurred among 4,124 depressed

patients who had taken duloxetine, which is Cymbalta's scientific name,

during clinical trials, according to a Lilly clinical psychiatrist, Dr.

R. . None of those suicides were deemed to be caused by the

drug, he said.

No suicides besides had occurred among more than 4,000 healthy

volunteers or nondepressed patients who took the drug in trials,

said.

Since spring, no further suicides have occurred in the ongoing clinical

trials of duloxetine, Lilly's Shaffer said.

Lilly has said was healthy and not depressed.

But staff of a clinic in California that was testing duloxetine for Lilly

reportedly told participants there that had a history of

depression and had tried to commit suicide when younger.

Four participants in the California trial, which was going on at the same

time as the trial that enrolled in, told The Star earlier this

year that the staff commented about 's mental history to

participants shortly after the suicide.

Lilly officials have said they won't discuss 's medical history

out of patient privacy concerns.

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

[Guest guest]

I can't help but think about the following thoughts, after reading the

below post.

-- sure she hung herself, but why, what caused this?

-- depression from years ago, but was a " healthy volunteer " for this

drug-testing study.

-- she took up to 6 times the normal 60 mg recommended daily dose - " to

see how high doses of the drug affected 'healthy volunteers' " ??? 6

times the normal recommended dose???

=====================================

http://www.indystar.com/articles/0/169515-1780-093.html

FDA backs Lilly stance on suicide

Agency agrees that Cymbalta wasn't factor in death at clinic.

By Jeff Swiatek

jeff.swiatek@...

August 11, 2004

The Food and Drug Administration has concluded that Eli Lilly and Co.'s

newly approved antidepressant Cymbalta didn't trigger Traci 's

suicide at the Lilly Laboratory for Clinical Research.

An FDA investigation " found (the drug) couldn't be linked to her death, "

an FDA spokesperson said today.

, 19, a former Indiana Bible College student, hung herself with a

scarf Feb. 7 in a bathroom of the drugmaker's Indianapolis drug-testing

clinic during a study to see how high doses of the drug affected healthy

volunteers.

A memo about the closing of the FDA investigation of the suicide is part

of the FDA's approval package, the first part of which was sent to Lilly

last week, the agency spokesperson said. It gives the drugmaker

permission to start selling Cymbalta.

Lilly hasn't yet received the memo, but the company was told by the FDA

that it had no further questions about the suicide, Lilly spokesman

Shaffer said.

" We aren't aware of the full contents of that (memo), " Shaffer said, but

" We were informed there would be no findings " contrary to what Lilly had

concluded about the suicide.

Lilly has said it found its drug was not to blame.

The FDA's finding is " confirmation of our assertion there wasn't a link

between her participation in the study and her death, " Lilly spokesman

Philip Belt said.

A lawyer for the family, Cordisco, said the family had heard

that the FDA had concluded its investigation.

" We are still exchanging information with Eli Lilly and its

representatives and based on that it would be premature to give comment, "

said Cordisco, who practices in Philadelphia.

The n County coroner's office ruled 's death was by hanging.

A Philadelphia native, had stopped taking the drug and was being

weaned from it when she killed herself. She took doses up to six times

the recommended 60 mg daily dose for depressed patients.

Lilly subsequently increased from four days to eight the weaning period

in the trial.

was the first person to die in a drug-testing trial in the

history of the 78-year-old clinic, located on the upper floors of Indiana

University Hospital on the campus of Indiana University-Purdue University

Indianapolis.

The FDA declined to immediately release any written documents related to

its investigation.

FDA investigators spent about a week at the clinic earlier this year,

reviewing patient records and interviewing Lilly personnel, Shaffer said.

's suicide came during a time of growing debate over the link

between antidepressants and suicide in users, particularly children.

In March, the FDA told 10 drugmakers to strengthen suicide-related

warnings on labels for antidepressant drugs.

Two FDA advisory committees are currently examining any links between

antidepressants and suicides in children.

In addition, Congress is looking into whether drug companies have

withheld information from the FDA about suicides among children taking

antidepressants.

As of this spring, four suicides had occurred among 4,124 depressed

patients who had taken duloxetine, which is Cymbalta's scientific name,

during clinical trials, according to a Lilly clinical psychiatrist, Dr.

R. . None of those suicides were deemed to be caused by the

drug, he said.

No suicides besides had occurred among more than 4,000 healthy

volunteers or nondepressed patients who took the drug in trials,

said.

Since spring, no further suicides have occurred in the ongoing clinical

trials of duloxetine, Lilly's Shaffer said.

Lilly has said was healthy and not depressed.

But staff of a clinic in California that was testing duloxetine for Lilly

reportedly told participants there that had a history of

depression and had tried to commit suicide when younger.

Four participants in the California trial, which was going on at the same

time as the trial that enrolled in, told The Star earlier this

year that the staff commented about 's mental history to

participants shortly after the suicide.

Lilly officials have said they won't discuss 's medical history

out of patient privacy concerns.

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

[Guest guest]

This is just so disgusting to read!! A well subject, who went through

the process of being labeled as such,is now labeled as " previously

being depressed and suicidal " to cover up the bad outcome. A there's

the FDA going right along with it!!! Clinical trials are a joke!!

I will be at the FDA hearings in September and boy do I have alot to

say!!

> I can't help but think about the following thoughts, after reading

the

> below post.

>

> -- sure she hung herself, but why, what caused this?

> -- depression from years ago, but was a " healthy volunteer " for this

> drug-testing study.

> -- she took up to 6 times the normal 60 mg recommended daily dose -

" to

> see how high doses of the drug affected 'healthy

volunteers' " ??? 6

> times the normal recommended dose???

>

> =====================================

>

> http://www.indystar.com/articles/0/169515-1780-093.html

>

> FDA backs Lilly stance on suicide

> Agency agrees that Cymbalta wasn't factor in death at clinic.

>

>

> By Jeff Swiatek

> jeff.swiatek@i...

> August 11, 2004

>

>

> The Food and Drug Administration has concluded that Eli Lilly and

Co.'s

> newly approved antidepressant Cymbalta didn't trigger Traci

's

> suicide at the Lilly Laboratory for Clinical Research.

>

> An FDA investigation " found (the drug) couldn't be linked to her

death, "

> an FDA spokesperson said today.

>

> , 19, a former Indiana Bible College student, hung herself

with a

> scarf Feb. 7 in a bathroom of the drugmaker's Indianapolis drug-

testing

> clinic during a study to see how high doses of the drug affected

healthy

> volunteers.

>

> A memo about the closing of the FDA investigation of the suicide is

part

> of the FDA's approval package, the first part of which was sent to

Lilly

> last week, the agency spokesperson said. It gives the drugmaker

> permission to start selling Cymbalta.

>

> Lilly hasn't yet received the memo, but the company was told by the

FDA

> that it had no further questions about the suicide, Lilly spokesman

> Shaffer said.

>

> " We aren't aware of the full contents of that (memo), " Shaffer

said, but

> " We were informed there would be no findings " contrary to what

Lilly had

> concluded about the suicide.

>

> Lilly has said it found its drug was not to blame.

>

> The FDA's finding is " confirmation of our assertion there wasn't a

link

> between her participation in the study and her death, " Lilly

spokesman

> Philip Belt said.

>

> A lawyer for the family, Cordisco, said the family had

heard

> that the FDA had concluded its investigation.

>

> " We are still exchanging information with Eli Lilly and its

> representatives and based on that it would be premature to give

comment, "

> said Cordisco, who practices in Philadelphia.

>

> The n County coroner's office ruled 's death was by

hanging.

>

> A Philadelphia native, had stopped taking the drug and was

being

> weaned from it when she killed herself. She took doses up to six

times

> the recommended 60 mg daily dose for depressed patients.

>

> Lilly subsequently increased from four days to eight the weaning

period

> in the trial.

>

> was the first person to die in a drug-testing trial in the

> history of the 78-year-old clinic, located on the upper floors of

Indiana

> University Hospital on the campus of Indiana University-Purdue

University

> Indianapolis.

>

> The FDA declined to immediately release any written documents

related to

> its investigation.

>

> FDA investigators spent about a week at the clinic earlier this

year,

> reviewing patient records and interviewing Lilly personnel, Shaffer

said.

>

> 's suicide came during a time of growing debate over the link

> between antidepressants and suicide in users, particularly children.

>

> In March, the FDA told 10 drugmakers to strengthen suicide-related

> warnings on labels for antidepressant drugs.

>

> Two FDA advisory committees are currently examining any links

between

> antidepressants and suicides in children.

>

> In addition, Congress is looking into whether drug companies have

> withheld information from the FDA about suicides among children

taking

> antidepressants.

>

> As of this spring, four suicides had occurred among 4,124 depressed

> patients who had taken duloxetine, which is Cymbalta's scientific

name,

> during clinical trials, according to a Lilly clinical psychiatrist,

Dr.

> R. . None of those suicides were deemed to be caused by

the

> drug, he said.

>

> No suicides besides had occurred among more than 4,000

healthy

> volunteers or nondepressed patients who took the drug in trials,

> said.

>

> Since spring, no further suicides have occurred in the ongoing

clinical

> trials of duloxetine, Lilly's Shaffer said.

>

> Lilly has said was healthy and not depressed.

>

> But staff of a clinic in California that was testing duloxetine for

Lilly

> reportedly told participants there that had a history of

> depression and had tried to commit suicide when younger.

>

> Four participants in the California trial, which was going on at

the same

> time as the trial that enrolled in, told The Star earlier

this

> year that the staff commented about 's mental history to

> participants shortly after the suicide.

>

> Lilly officials have said they won't discuss 's medical

history

> out of patient privacy concerns.

>

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

>

>

[Guest guest]

This is just so disgusting to read!! A well subject, who went through

the process of being labeled as such,is now labeled as " previously

being depressed and suicidal " to cover up the bad outcome. A there's

the FDA going right along with it!!! Clinical trials are a joke!!

I will be at the FDA hearings in September and boy do I have alot to

say!!

> I can't help but think about the following thoughts, after reading

the

> below post.

>

> -- sure she hung herself, but why, what caused this?

> -- depression from years ago, but was a " healthy volunteer " for this

> drug-testing study.

> -- she took up to 6 times the normal 60 mg recommended daily dose -

" to

> see how high doses of the drug affected 'healthy

volunteers' " ??? 6

> times the normal recommended dose???

>

> =====================================

>

> http://www.indystar.com/articles/0/169515-1780-093.html

>

> FDA backs Lilly stance on suicide

> Agency agrees that Cymbalta wasn't factor in death at clinic.

>

>

> By Jeff Swiatek

> jeff.swiatek@i...

> August 11, 2004

>

>

> The Food and Drug Administration has concluded that Eli Lilly and

Co.'s

> newly approved antidepressant Cymbalta didn't trigger Traci

's

> suicide at the Lilly Laboratory for Clinical Research.

>

> An FDA investigation " found (the drug) couldn't be linked to her

death, "

> an FDA spokesperson said today.

>

> , 19, a former Indiana Bible College student, hung herself

with a

> scarf Feb. 7 in a bathroom of the drugmaker's Indianapolis drug-

testing

> clinic during a study to see how high doses of the drug affected

healthy

> volunteers.

>

> A memo about the closing of the FDA investigation of the suicide is

part

> of the FDA's approval package, the first part of which was sent to

Lilly

> last week, the agency spokesperson said. It gives the drugmaker

> permission to start selling Cymbalta.

>

> Lilly hasn't yet received the memo, but the company was told by the

FDA

> that it had no further questions about the suicide, Lilly spokesman

> Shaffer said.

>

> " We aren't aware of the full contents of that (memo), " Shaffer

said, but

> " We were informed there would be no findings " contrary to what

Lilly had

> concluded about the suicide.

>

> Lilly has said it found its drug was not to blame.

>

> The FDA's finding is " confirmation of our assertion there wasn't a

link

> between her participation in the study and her death, " Lilly

spokesman

> Philip Belt said.

>

> A lawyer for the family, Cordisco, said the family had

heard

> that the FDA had concluded its investigation.

>

> " We are still exchanging information with Eli Lilly and its

> representatives and based on that it would be premature to give

comment, "

> said Cordisco, who practices in Philadelphia.

>

> The n County coroner's office ruled 's death was by

hanging.

>

> A Philadelphia native, had stopped taking the drug and was

being

> weaned from it when she killed herself. She took doses up to six

times

> the recommended 60 mg daily dose for depressed patients.

>

> Lilly subsequently increased from four days to eight the weaning

period

> in the trial.

>

> was the first person to die in a drug-testing trial in the

> history of the 78-year-old clinic, located on the upper floors of

Indiana

> University Hospital on the campus of Indiana University-Purdue

University

> Indianapolis.

>

> The FDA declined to immediately release any written documents

related to

> its investigation.

>

> FDA investigators spent about a week at the clinic earlier this

year,

> reviewing patient records and interviewing Lilly personnel, Shaffer

said.

>

> 's suicide came during a time of growing debate over the link

> between antidepressants and suicide in users, particularly children.

>

> In March, the FDA told 10 drugmakers to strengthen suicide-related

> warnings on labels for antidepressant drugs.

>

> Two FDA advisory committees are currently examining any links

between

> antidepressants and suicides in children.

>

> In addition, Congress is looking into whether drug companies have

> withheld information from the FDA about suicides among children

taking

> antidepressants.

>

> As of this spring, four suicides had occurred among 4,124 depressed

> patients who had taken duloxetine, which is Cymbalta's scientific

name,

> during clinical trials, according to a Lilly clinical psychiatrist,

Dr.

> R. . None of those suicides were deemed to be caused by

the

> drug, he said.

>

> No suicides besides had occurred among more than 4,000

healthy

> volunteers or nondepressed patients who took the drug in trials,

> said.

>

> Since spring, no further suicides have occurred in the ongoing

clinical

> trials of duloxetine, Lilly's Shaffer said.

>

> Lilly has said was healthy and not depressed.

>

> But staff of a clinic in California that was testing duloxetine for

Lilly

> reportedly told participants there that had a history of

> depression and had tried to commit suicide when younger.

>

> Four participants in the California trial, which was going on at

the same

> time as the trial that enrolled in, told The Star earlier

this

> year that the staff commented about 's mental history to

> participants shortly after the suicide.

>

> Lilly officials have said they won't discuss 's medical

history

> out of patient privacy concerns.

>

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

>

>