Re: Lilly lengthens drug withdrawal - 03.05.04

[Guest guest]

They killed traci and they won't admit it we know they did.How nice of them to extend it to 8 days from 4 i remember day eight so excuse my french but i was so fucked up i couldn't even walk for the pain all over my body and being zapped out so bad all i wanted to do was die to make it stop.

8 days,so what are they going to put on that leaflet it's not been studied for long term effects and does not cause withdrawal, or your allowed to have withdrawal for 8 days and anything else you say is happening is not valid because we say so.Does this shit reek of paxil lies or what.Now we all know it's as evil as all the other (name the brand).If it wasn't for tracy we would never have heard about the others that died in the studies either, they were being swept under the carpet.

Ros

[Guest guest]

Digging a hole for themselves.

Looks like Lilly is coming round to our kind of thinking.

about time too.

Well done team, keep the pressure building.

" MORSE "

>

> Lilly lengthens drug withdrawal

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

suicide.

>

>

> By J.K. Wall

> jk.wall@i...

> 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 .

[Guest guest]

Bit by bit these bastards are going to come round to our way of

thinking.

I was on a short half life SNRI (Effexor) ....duloxetine is little

more than Lilly's clone of Effexor.

I know what Traci felt like, I know what it is like to be

compelled to kill ones self.

Traci is in the grave

and I am not.

Lord give me the strenght to continue to witness to our cause;

Lord rest her soul.

>

> Lilly lengthens drug withdrawal

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

suicide.

>

>

> By J.K. Wall

> jk.wall@i...

> 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 .