Lilly Expects Killer Drug Cymbalta to Bring in $2 Billion Annually...

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February 13, 2004

Woman who died during drug study was trying to earn college money

Student hangs herself in Eli Lilly research lab in Indianapolis

By CAROL DRUGA

Associated Press Writer

INDIANAPOLIS -- A college student who committed suicide while testing a new

antidepressant took part in the paid drug study to earn money for another

semester of classes, a school official said.

Traci , 19, hanged herself Saturday at Eli Lilly Co.'s hotel-like

research lab at the Indiana University Medical School. She had recently

stopped taking the pill, duloxetine, after about a one-month period, the

drug company said.

Her funeral was Thursday in Philadelphia, her hometown.

Her death came the same week the Food and Drug Administration held hearings

into whether an entire list of similar antidepressants can lead to suicidal

behavior in children and teenagers. Duloxetine was not one of the drugs in

that debate.

From the time began the trial in early January, her dosages of drug

were increased gradually to a peak, then gradually reduced until she was

given a placebo.

" She was weaned off the drug, " said Rob , a Lilly spokesman.

He said was staying overnight at the medical school, but was free to

come and go. Although she received medical attention daily and was given a

place to stay, the staff would have no reason to regularly check on her

room, said.

The Rev. Talmadge French, dean of biblical studies at the Indiana Bible

College, said that enrolled in September as a freshman and was

well-liked by her classmates.

She worked part time that first semester, but decided to forgo spring

classes so she could join the study on duloxetine.

" She evidently felt that she wanted to work more and raise more money before

she returned to classes. We had hoped that she would just come and work out

some financial arrangement, but she opted to take off and work, " he said.

was getting $150 a day plus meals and was among 25 local volunteers

and 100 nationally who agreed to take part in the drug study.

Her suicide resulted in 19 of those 100 participants dropping out, according

to . But he said their departures should have no impact on the study's

results.

After her death was reported, a panel of IU doctors authorized by the FDA to

oversee medical research, ordered Lilly to tell the remaining participants

at IU about her suicide and have them evaluated by an independent

psychiatrist.

Lilly has complied with that, said Pam , an IU spokeswoman. " Everything

has been handled extremely well, " she said.

Lilly was also ordered not to accept new participants, but said the

drug study was already full by the time the board issued its orders.

He reiterated Lilly's view that duloxetine did not directly contribute to

's suicide.

French said was a vivacious young woman at the school of about 300

students.

" I think everyone was stunned, " he said.

A friend of 's told The Philadelphia Inquirer that when she spoke to

her last, the day before her reported suicide, was in good spirits.

" On the phone, she was laughing, she was happy, " said Colleen y, a

friend of 's since grammar school.

Lilly has said it expects federal regulators this year to approve

applications to market duloxetine-based drugs, which treat depression and

incontinence. The antidepressant Cymbalta is widely expected to be a

blockbuster for Lilly, with some analysts forecasting sales could eventually

top $2 billion annually.

Lilly has acknowledged that four other suicides have occurred during several

years of duloxetine testing, but those cases involved patients with

depression.

The volunteers in the current trial were screened and had no outward signs

of depression or other illnesses, said.

Lilly told this " healthy " group about the risks involved in taking the

drugs, but said there has never been any indication the drug could

induce suicidal thoughts.

He also said the rate of suicide for depressed patients taking it is lower

than for those taking a placebo. It also is lower than the rate for an older

group of antidepressants known as SSRIs, or selective serotonin reuptake

inhibitors. Drugs such as Prozac, Paxil and Zoloft are SSRIs.

The FDA opened hearings last week to determine whether such SSRIs -- deemed

safe to use by adults -- are suitable for children. An FDA advisory panel

urged that more specific warnings be given to parents and doctors until the

issue is settled.

British authorities last month declared that the drugs increase suicidal

thoughts in children and teens.

Contact the southbendtribune.com Web staff.

News coverage and editorial content provided by

the South Bend Tribune unless otherwise specified.

Copyright © 1994-2003 South Bend Tribune

_________________________________________________________________

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February 13, 2004

Woman who died during drug study was trying to earn college money

Student hangs herself in Eli Lilly research lab in Indianapolis

By CAROL DRUGA

Associated Press Writer

INDIANAPOLIS -- A college student who committed suicide while testing a new

antidepressant took part in the paid drug study to earn money for another

semester of classes, a school official said.

Traci , 19, hanged herself Saturday at Eli Lilly Co.'s hotel-like

research lab at the Indiana University Medical School. She had recently

stopped taking the pill, duloxetine, after about a one-month period, the

drug company said.

Her funeral was Thursday in Philadelphia, her hometown.

Her death came the same week the Food and Drug Administration held hearings

into whether an entire list of similar antidepressants can lead to suicidal

behavior in children and teenagers. Duloxetine was not one of the drugs in

that debate.

From the time began the trial in early January, her dosages of drug

were increased gradually to a peak, then gradually reduced until she was

given a placebo.

" She was weaned off the drug, " said Rob , a Lilly spokesman.

He said was staying overnight at the medical school, but was free to

come and go. Although she received medical attention daily and was given a

place to stay, the staff would have no reason to regularly check on her

room, said.

The Rev. Talmadge French, dean of biblical studies at the Indiana Bible

College, said that enrolled in September as a freshman and was

well-liked by her classmates.

She worked part time that first semester, but decided to forgo spring

classes so she could join the study on duloxetine.

" She evidently felt that she wanted to work more and raise more money before

she returned to classes. We had hoped that she would just come and work out

some financial arrangement, but she opted to take off and work, " he said.

was getting $150 a day plus meals and was among 25 local volunteers

and 100 nationally who agreed to take part in the drug study.

Her suicide resulted in 19 of those 100 participants dropping out, according

to . But he said their departures should have no impact on the study's

results.

After her death was reported, a panel of IU doctors authorized by the FDA to

oversee medical research, ordered Lilly to tell the remaining participants

at IU about her suicide and have them evaluated by an independent

psychiatrist.

Lilly has complied with that, said Pam , an IU spokeswoman. " Everything

has been handled extremely well, " she said.

Lilly was also ordered not to accept new participants, but said the

drug study was already full by the time the board issued its orders.

He reiterated Lilly's view that duloxetine did not directly contribute to

's suicide.

French said was a vivacious young woman at the school of about 300

students.

" I think everyone was stunned, " he said.

A friend of 's told The Philadelphia Inquirer that when she spoke to

her last, the day before her reported suicide, was in good spirits.

" On the phone, she was laughing, she was happy, " said Colleen y, a

friend of 's since grammar school.

Lilly has said it expects federal regulators this year to approve

applications to market duloxetine-based drugs, which treat depression and

incontinence. The antidepressant Cymbalta is widely expected to be a

blockbuster for Lilly, with some analysts forecasting sales could eventually

top $2 billion annually.

Lilly has acknowledged that four other suicides have occurred during several

years of duloxetine testing, but those cases involved patients with

depression.

The volunteers in the current trial were screened and had no outward signs

of depression or other illnesses, said.

Lilly told this " healthy " group about the risks involved in taking the

drugs, but said there has never been any indication the drug could

induce suicidal thoughts.

He also said the rate of suicide for depressed patients taking it is lower

than for those taking a placebo. It also is lower than the rate for an older

group of antidepressants known as SSRIs, or selective serotonin reuptake

inhibitors. Drugs such as Prozac, Paxil and Zoloft are SSRIs.

The FDA opened hearings last week to determine whether such SSRIs -- deemed

safe to use by adults -- are suitable for children. An FDA advisory panel

urged that more specific warnings be given to parents and doctors until the

issue is settled.

British authorities last month declared that the drugs increase suicidal

thoughts in children and teens.

Contact the southbendtribune.com Web staff.

News coverage and editorial content provided by

the South Bend Tribune unless otherwise specified.

Copyright © 1994-2003 South Bend Tribune

_________________________________________________________________

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February 13, 2004

Woman who died during drug study was trying to earn college money

Student hangs herself in Eli Lilly research lab in Indianapolis

By CAROL DRUGA

Associated Press Writer

INDIANAPOLIS -- A college student who committed suicide while testing a new

antidepressant took part in the paid drug study to earn money for another

semester of classes, a school official said.

Traci , 19, hanged herself Saturday at Eli Lilly Co.'s hotel-like

research lab at the Indiana University Medical School. She had recently

stopped taking the pill, duloxetine, after about a one-month period, the

drug company said.

Her funeral was Thursday in Philadelphia, her hometown.

Her death came the same week the Food and Drug Administration held hearings

into whether an entire list of similar antidepressants can lead to suicidal

behavior in children and teenagers. Duloxetine was not one of the drugs in

that debate.

From the time began the trial in early January, her dosages of drug

were increased gradually to a peak, then gradually reduced until she was

given a placebo.

" She was weaned off the drug, " said Rob , a Lilly spokesman.

He said was staying overnight at the medical school, but was free to

come and go. Although she received medical attention daily and was given a

place to stay, the staff would have no reason to regularly check on her

room, said.

The Rev. Talmadge French, dean of biblical studies at the Indiana Bible

College, said that enrolled in September as a freshman and was

well-liked by her classmates.

She worked part time that first semester, but decided to forgo spring

classes so she could join the study on duloxetine.

" She evidently felt that she wanted to work more and raise more money before

she returned to classes. We had hoped that she would just come and work out

some financial arrangement, but she opted to take off and work, " he said.

was getting $150 a day plus meals and was among 25 local volunteers

and 100 nationally who agreed to take part in the drug study.

Her suicide resulted in 19 of those 100 participants dropping out, according

to . But he said their departures should have no impact on the study's

results.

After her death was reported, a panel of IU doctors authorized by the FDA to

oversee medical research, ordered Lilly to tell the remaining participants

at IU about her suicide and have them evaluated by an independent

psychiatrist.

Lilly has complied with that, said Pam , an IU spokeswoman. " Everything

has been handled extremely well, " she said.

Lilly was also ordered not to accept new participants, but said the

drug study was already full by the time the board issued its orders.

He reiterated Lilly's view that duloxetine did not directly contribute to

's suicide.

French said was a vivacious young woman at the school of about 300

students.

" I think everyone was stunned, " he said.

A friend of 's told The Philadelphia Inquirer that when she spoke to

her last, the day before her reported suicide, was in good spirits.

" On the phone, she was laughing, she was happy, " said Colleen y, a

friend of 's since grammar school.

Lilly has said it expects federal regulators this year to approve

applications to market duloxetine-based drugs, which treat depression and

incontinence. The antidepressant Cymbalta is widely expected to be a

blockbuster for Lilly, with some analysts forecasting sales could eventually

top $2 billion annually.

Lilly has acknowledged that four other suicides have occurred during several

years of duloxetine testing, but those cases involved patients with

depression.

The volunteers in the current trial were screened and had no outward signs

of depression or other illnesses, said.

Lilly told this " healthy " group about the risks involved in taking the

drugs, but said there has never been any indication the drug could

induce suicidal thoughts.

He also said the rate of suicide for depressed patients taking it is lower

than for those taking a placebo. It also is lower than the rate for an older

group of antidepressants known as SSRIs, or selective serotonin reuptake

inhibitors. Drugs such as Prozac, Paxil and Zoloft are SSRIs.

The FDA opened hearings last week to determine whether such SSRIs -- deemed

safe to use by adults -- are suitable for children. An FDA advisory panel

urged that more specific warnings be given to parents and doctors until the

issue is settled.

British authorities last month declared that the drugs increase suicidal

thoughts in children and teens.

Contact the southbendtribune.com Web staff.

News coverage and editorial content provided by

the South Bend Tribune unless otherwise specified.

Copyright © 1994-2003 South Bend Tribune

_________________________________________________________________

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February 13, 2004

Woman who died during drug study was trying to earn college money

Student hangs herself in Eli Lilly research lab in Indianapolis

By CAROL DRUGA

Associated Press Writer

INDIANAPOLIS -- A college student who committed suicide while testing a new

antidepressant took part in the paid drug study to earn money for another

semester of classes, a school official said.

Traci , 19, hanged herself Saturday at Eli Lilly Co.'s hotel-like

research lab at the Indiana University Medical School. She had recently

stopped taking the pill, duloxetine, after about a one-month period, the

drug company said.

Her funeral was Thursday in Philadelphia, her hometown.

Her death came the same week the Food and Drug Administration held hearings

into whether an entire list of similar antidepressants can lead to suicidal

behavior in children and teenagers. Duloxetine was not one of the drugs in

that debate.

From the time began the trial in early January, her dosages of drug

were increased gradually to a peak, then gradually reduced until she was

given a placebo.

" She was weaned off the drug, " said Rob , a Lilly spokesman.

He said was staying overnight at the medical school, but was free to

come and go. Although she received medical attention daily and was given a

place to stay, the staff would have no reason to regularly check on her

room, said.

The Rev. Talmadge French, dean of biblical studies at the Indiana Bible

College, said that enrolled in September as a freshman and was

well-liked by her classmates.

She worked part time that first semester, but decided to forgo spring

classes so she could join the study on duloxetine.

" She evidently felt that she wanted to work more and raise more money before

she returned to classes. We had hoped that she would just come and work out

some financial arrangement, but she opted to take off and work, " he said.

was getting $150 a day plus meals and was among 25 local volunteers

and 100 nationally who agreed to take part in the drug study.

Her suicide resulted in 19 of those 100 participants dropping out, according

to . But he said their departures should have no impact on the study's

results.

After her death was reported, a panel of IU doctors authorized by the FDA to

oversee medical research, ordered Lilly to tell the remaining participants

at IU about her suicide and have them evaluated by an independent

psychiatrist.

Lilly has complied with that, said Pam , an IU spokeswoman. " Everything

has been handled extremely well, " she said.

Lilly was also ordered not to accept new participants, but said the

drug study was already full by the time the board issued its orders.

He reiterated Lilly's view that duloxetine did not directly contribute to

's suicide.

French said was a vivacious young woman at the school of about 300

students.

" I think everyone was stunned, " he said.

A friend of 's told The Philadelphia Inquirer that when she spoke to

her last, the day before her reported suicide, was in good spirits.

" On the phone, she was laughing, she was happy, " said Colleen y, a

friend of 's since grammar school.

Lilly has said it expects federal regulators this year to approve

applications to market duloxetine-based drugs, which treat depression and

incontinence. The antidepressant Cymbalta is widely expected to be a

blockbuster for Lilly, with some analysts forecasting sales could eventually

top $2 billion annually.

Lilly has acknowledged that four other suicides have occurred during several

years of duloxetine testing, but those cases involved patients with

depression.

The volunteers in the current trial were screened and had no outward signs

of depression or other illnesses, said.

Lilly told this " healthy " group about the risks involved in taking the

drugs, but said there has never been any indication the drug could

induce suicidal thoughts.

He also said the rate of suicide for depressed patients taking it is lower

than for those taking a placebo. It also is lower than the rate for an older

group of antidepressants known as SSRIs, or selective serotonin reuptake

inhibitors. Drugs such as Prozac, Paxil and Zoloft are SSRIs.

The FDA opened hearings last week to determine whether such SSRIs -- deemed

safe to use by adults -- are suitable for children. An FDA advisory panel

urged that more specific warnings be given to parents and doctors until the

issue is settled.

British authorities last month declared that the drugs increase suicidal

thoughts in children and teens.

Contact the southbendtribune.com Web staff.

News coverage and editorial content provided by

the South Bend Tribune unless otherwise specified.

Copyright © 1994-2003 South Bend Tribune

_________________________________________________________________

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