Lilly lengthens drug withdrawal <----IMPORTANT

[Guest guest]

In a message dated 3/5/04 11:48:39 AM US Eastern Standard Time,

mofunnow@... writes:

>

>

> Lilly lengthens drug withdrawal

> Change is one of several made to trial after participant committed suicide.

>

>

> By J.K. Wall

> jk.wall@...

>

In following this girls death and the media surrounding it,

the translation to this then is that the drug

did play a role?

I have a couple media projects to address suicide and

anti-depressants. The public must be given the truth of such

serious side effects. After all these are not isolated cases.

Marhoefer

Miracles Of Hope Network®

New York City Chicago

<A HREF= " www.miracles-of-hope.com " >www.miracles-of-hope.com</A>

The Defense Foundation for children USA

Obstruction-Of-Injustice Media and Production

Touch the Thunder Publishing & Recording Company

::justice in media::

" Sometimes instead of leveling the playing field, you just have to buy the

field " DM2004®

[Guest guest]

In a message dated 3/5/04 11:48:39 AM US Eastern Standard Time,

mofunnow@... writes:

>

>

> Lilly lengthens drug withdrawal

> Change is one of several made to trial after participant committed suicide.

>

>

> By J.K. Wall

> jk.wall@...

>

In following this girls death and the media surrounding it,

the translation to this then is that the drug

did play a role?

I have a couple media projects to address suicide and

anti-depressants. The public must be given the truth of such

serious side effects. After all these are not isolated cases.

Marhoefer

Miracles Of Hope Network®

New York City Chicago

<A HREF= " www.miracles-of-hope.com " >www.miracles-of-hope.com</A>

The Defense Foundation for children USA

Obstruction-Of-Injustice Media and Production

Touch the Thunder Publishing & Recording Company

::justice in media::

" Sometimes instead of leveling the playing field, you just have to buy the

field " DM2004®

[Guest guest]

Lilly lengthens drug withdrawal

Change is one of several made to trial after participant committed suicide.

By J.K. Wall

jk.wall@...

March 5, 2004

Eli Lilly and Co. said it has doubled the amount of time used to wean people

from an experimental drug because of feedback from study participants after a

19-year-old woman killed herself.

Lilly made the change after some participants complained in mental health

evaluations required after Traci 's death that they were sleepless,

anxious or nervous during their withdrawal from duloxetine. No symptoms in other

participants showed a chance of suicide, says a new consent form that Lilly

issued Feb. 24.

" I don't want to have that interpreted as being I was afraid that the drug was a

problem. If I thought it had been, I would have stopped the study, " said

, a clinical psychiatrist who leads Lilly's development team for

duloxetine.

The change in protocol comes amid some experts' worries that the risk of

suicidal thinking is heightened when coming off an anti-depressant, as

was. After taking duloxetine for 20 days, she took a placebo for four days

before her death.

Police say hanged herself with a scarf Feb. 7 at the Lilly Laboratory

for Clinical Research on the campus of Indiana University-Purdue University

Indianapolis. Lilly said she was a healthy volunteer testing duloxetine, a drug

designed to treat both depression and incontinence.

The study had participants taking duloxetine beginning at 120 mg -- 1.5 times

the expected normal daily dose -- according to trial consent forms obtained by

The Indianapolis Star. Over 16 days, those dosages were stepped up to a peak of

five times normal, or 400 mg. Then participants scaled back to the 120-mg

starting level over four days, then went off the drug.

After 's death and some new safeguards required by an institutional

review board, the four days were extended to eight.

Lilly has said did not have depression, and it concluded, based

primarily on an analysis of its data about duloxetine, that the drug did not

cause her death.

Several changes to the trial after 's death reflect a concern for

withdrawal symptoms. Lilly decided to question subjects about their mental

health daily for two weeks after their last dose of duloxetine or placebo and to

have a psychiatrist evaluate each participant after his or her last dosage.

(Lilly spokesman Shaffer said participants have taken their last dose at

all six test clinics, and the trial will end by late March.)

said the changes were precautions taken for the patients. " We just wanted

to make sure they were OK. "

Dr. Joe Glenmullen, a psychiatrist at Harvard Medical School, thinks Lilly's

weaning schedule was too quick.

When a person suddenly stops taking other anti-depressants, suicidal thoughts

can increase, particularly within 10 days after the last dose, said Glenmullen,

who wrote " Prozac Backlash, " attacking anti-depressants and advocating

alternative treatments.

Withdrawal has been an issue with anti-depressants that leave the blood quickly,

like duloxetine.

Wyeth, which makes a similar drug, Effexor, advocates tapering the drug after it

has been taken for at least a week because of potential ill effects from

withdrawal.

In a warning last summer to physicians, Wyeth suggested that Effexor should not

be given to minors. Soon after, British and U.S. drug regulators began examining

whether anti-depressants cause some people to commit suicide. In December,

Britain's drug regulatory agency told physicians to stop writing prescriptions

for most anti-depressants for anyone under 18. The Food and Drug Administration

conducted hearings on the issue in February.

said that in duloxetine testing on 8,500 people, Lilly has not seen

evidence of suicide as a withdrawal symptom.

" We don't have reasons to believe at this time that duloxetine is dangerous to

people in terms of precipitating some suicidal event, either in its taking or

its discontinuation, " said.

Lilly's change in protocol is not uncommon, said Dr. Fred Cohen, who has run

clinical trials for Lilly and & .

" It happens a lot, " said Cohen, now president of Crownstone, a pharmaceutical

investment research firm in Pennsylvania. He said a drug company may alter its

trial procedures to loosen eligibility requirements, to increase dosage to more

effective levels or after an adverse event.

Traci 's suicide, in pharmaceutical industry parlance, is a " serious

adverse event. "

She was the sixth person to commit suicide during Lilly's study of duloxetine.

On the new consent forms, prepared after 's death, only her suicide was

noted. Lilly did not mention on those forms, or the original ones, that four of

4,124 depressed patients taking duloxetine killed themselves during trials. Or

that one in 777 depressed participants on placebos committed suicide.

Also, the consent form does not list suicide as one of the " very uncommon " side

effects -- occurring in fewer than 1 percent of those taking duloxetine for

depression.

There is no mention of suicide, said, because its occurrence is not

completely unexpected when testing depressed patients. The consent form does

mention one person who experienced jaundice because that was unexpected, he

said.

The suicide rate for duloxetine is much lower than for other antidepressants,

such as Paxil, Effexor and Prozac, Lilly said.

" In this case, the statistics would say it's not a risk, " said.

But those explanations didn't satisfy some participants in the duloxetine trial

in a California clinic. Several complained of violent nightmares while taking

it.

Participant Carmellia , 38, said, " Suicide is not (just) a side effect. .

.. . I want them to mention these things. "

Call Star reporter J.K. Wall at (317) 444-6287.

[Guest guest]

Lilly lengthens drug withdrawal

Change is one of several made to trial after participant committed suicide.

By J.K. Wall

jk.wall@...

March 5, 2004

Eli Lilly and Co. said it has doubled the amount of time used to wean people

from an experimental drug because of feedback from study participants after a

19-year-old woman killed herself.

Lilly made the change after some participants complained in mental health

evaluations required after Traci 's death that they were sleepless,

anxious or nervous during their withdrawal from duloxetine. No symptoms in other

participants showed a chance of suicide, says a new consent form that Lilly

issued Feb. 24.

" I don't want to have that interpreted as being I was afraid that the drug was a

problem. If I thought it had been, I would have stopped the study, " said

, a clinical psychiatrist who leads Lilly's development team for

duloxetine.

The change in protocol comes amid some experts' worries that the risk of

suicidal thinking is heightened when coming off an anti-depressant, as

was. After taking duloxetine for 20 days, she took a placebo for four days

before her death.

Police say hanged herself with a scarf Feb. 7 at the Lilly Laboratory

for Clinical Research on the campus of Indiana University-Purdue University

Indianapolis. Lilly said she was a healthy volunteer testing duloxetine, a drug

designed to treat both depression and incontinence.

The study had participants taking duloxetine beginning at 120 mg -- 1.5 times

the expected normal daily dose -- according to trial consent forms obtained by

The Indianapolis Star. Over 16 days, those dosages were stepped up to a peak of

five times normal, or 400 mg. Then participants scaled back to the 120-mg

starting level over four days, then went off the drug.

After 's death and some new safeguards required by an institutional

review board, the four days were extended to eight.

Lilly has said did not have depression, and it concluded, based

primarily on an analysis of its data about duloxetine, that the drug did not

cause her death.

Several changes to the trial after 's death reflect a concern for

withdrawal symptoms. Lilly decided to question subjects about their mental

health daily for two weeks after their last dose of duloxetine or placebo and to

have a psychiatrist evaluate each participant after his or her last dosage.

(Lilly spokesman Shaffer said participants have taken their last dose at

all six test clinics, and the trial will end by late March.)

said the changes were precautions taken for the patients. " We just wanted

to make sure they were OK. "

Dr. Joe Glenmullen, a psychiatrist at Harvard Medical School, thinks Lilly's

weaning schedule was too quick.

When a person suddenly stops taking other anti-depressants, suicidal thoughts

can increase, particularly within 10 days after the last dose, said Glenmullen,

who wrote " Prozac Backlash, " attacking anti-depressants and advocating

alternative treatments.

Withdrawal has been an issue with anti-depressants that leave the blood quickly,

like duloxetine.

Wyeth, which makes a similar drug, Effexor, advocates tapering the drug after it

has been taken for at least a week because of potential ill effects from

withdrawal.

In a warning last summer to physicians, Wyeth suggested that Effexor should not

be given to minors. Soon after, British and U.S. drug regulators began examining

whether anti-depressants cause some people to commit suicide. In December,

Britain's drug regulatory agency told physicians to stop writing prescriptions

for most anti-depressants for anyone under 18. The Food and Drug Administration

conducted hearings on the issue in February.

said that in duloxetine testing on 8,500 people, Lilly has not seen

evidence of suicide as a withdrawal symptom.

" We don't have reasons to believe at this time that duloxetine is dangerous to

people in terms of precipitating some suicidal event, either in its taking or

its discontinuation, " said.

Lilly's change in protocol is not uncommon, said Dr. Fred Cohen, who has run

clinical trials for Lilly and & .

" It happens a lot, " said Cohen, now president of Crownstone, a pharmaceutical

investment research firm in Pennsylvania. He said a drug company may alter its

trial procedures to loosen eligibility requirements, to increase dosage to more

effective levels or after an adverse event.

Traci 's suicide, in pharmaceutical industry parlance, is a " serious

adverse event. "

She was the sixth person to commit suicide during Lilly's study of duloxetine.

On the new consent forms, prepared after 's death, only her suicide was

noted. Lilly did not mention on those forms, or the original ones, that four of

4,124 depressed patients taking duloxetine killed themselves during trials. Or

that one in 777 depressed participants on placebos committed suicide.

Also, the consent form does not list suicide as one of the " very uncommon " side

effects -- occurring in fewer than 1 percent of those taking duloxetine for

depression.

There is no mention of suicide, said, because its occurrence is not

completely unexpected when testing depressed patients. The consent form does

mention one person who experienced jaundice because that was unexpected, he

said.

The suicide rate for duloxetine is much lower than for other antidepressants,

such as Paxil, Effexor and Prozac, Lilly said.

" In this case, the statistics would say it's not a risk, " said.

But those explanations didn't satisfy some participants in the duloxetine trial

in a California clinic. Several complained of violent nightmares while taking

it.

Participant Carmellia , 38, said, " Suicide is not (just) a side effect. .

.. . I want them to mention these things. "

Call Star reporter J.K. Wall at (317) 444-6287.