Drug trial stopped after link to suicide - Australia

February 13, 2004

http://www.smh.com.au/articles/2004/02/13/1076548225189.html

Drug trial stopped after link to suicide

By Ben Wyld

February 14, 2004

Safety concerns have been raised over an incontinence and anti-depressant drug

taken by about 40 women in a Sydney trial after a woman participating in a US

study committed suicide.

The drug manufacturer, Eli Lilly and Co, has been ordered not to accept new

participants in the US trial of the compound duloxetine after the 19-year-old

was found hanged in a room at a company research laboratory in Indianapolis this

week.

The Sydney women were part of a separate, four-continent trial of the drug

involving 458 women, and an Australian researcher involved in that study has

dismissed a direct link between the drug and suicide.

The woman who died in the US, a student, was psychologically screened before the

test and found not to have depression. She was one of 25 volunteers in the trial

of the drug compound, which the company hopes to use as the main ingredient in

an anti-depressant, and as a treatment for stress urinary incontinence.

There have been four other suicides of participants in clinical trials of

duloxetine, out of about 9000 participants.

The compound belongs to a class of drugs known as selective serotonin and

norepinephrine reuptake inhibitors (SNRIs), similar to selective serotonin

re-uptake inhibitors (SSRIs), which include anti-depressants such as Paxil and

Zoloft.

The British Medicines and Healthcare Products Regulatory Agency and the US Food

and Drug Administration have issued recommendations against the use of SSRIs in

the treatment of depressed children. There is evidence suggesting a link between

some of the drugs and suicidal thoughts in children.

But Kate , an associate professor of obstetrics and gynaecology at the

University of NSW, dismissed suggestions the drug could be directly linked to

suicide as " illogical " .

Professor , who was involved in clinical trials of duloxetine at Sydney's

Prince of Wales and St hospitals, said the compound was revolutionary and

offered the first effective drug treatment for stress incontinence - estimated

to affect at least 78 million women over the age of 20 worldwide.

" Because the drug has an anti-depressant effect, any relationship with suicide

with this drug would be surprising, " Professor said.

In the study involving the Sydney women, Professor and her co-researchers

found that duloxetine halved the number of incontinence episodes.

" The safety and efficacy data from this study provide evidence for the value of

duloxetine as potentially the first widely approved pharmacological treatment

for women with bothersome stress urinary incontinence, " the researchers wrote in

last month's British Journal of Urology.

Professor said the main side-effect of the drug was nausea, and added that

the prescribed dosage of the drug for urinary incontinence would not have an

anti-depressant effect.

However participants in the US trial were given higher than normal doses of the

drug.

A coroner's toxicology report is yet to confirm the drug company's finding that

duloxetine did not cause the death.

But Jon Jureidini, head of the department of psychological medicine at

Adelaide's Women's and Children's Hospital, said suspicions that the similar

SSRI class of drugs may be dangerous and cause suicidal thoughts should not be

dismissed.

" We should be attending to the possibility that suicidal thinking might emerge

in otherwise normal people, " Dr Jureidini said.

The company, yet to receive final approval for the compound from the US FDA, has

lodged a submission to the Therapeutic Goods Administration for its use here, a

spokeswoman for Eli Lilly in Australia said.

February 13, 2004

>From: " Jim- Norman " <mofunnow@...>

>Reply-SSRI medications

><SSRI medications >, <wildestcolts >

>Subject: Drug trial stopped after link to suicide -

>Australia

>Date: Fri, 13 Feb 2004 15:00:04 -0600

>

Here's another asinine comment from an 'expert'...

But Kate , an associate professor of obstetrics and gynaecology at the

University of NSW, dismissed suggestions the drug could be directly linked

to suicide as " illogical " .

Professor , who was involved in clinical trials of duloxetine at

Sydney's Prince of Wales and St hospitals, said the compound was

revolutionary and offered the first effective drug treatment for stress

incontinence - estimated to affect at least 78 million women over the age of

20 worldwide.

" Because the drug has an anti-depressant effect, any relationship with

suicide with this drug would be surprising, " Professor said.

In the study involving the Sydney women, Professor and her

co-researchers found that duloxetine halved the number of incontinence

episodes.

" The safety and efficacy data from this study provide evidence for the value

of duloxetine as potentially the first widely approved pharmacological

treatment for women with bothersome stress urinary incontinence, " the

researchers wrote in last month's British Journal of Urology.

Professor said the main side-effect of the drug was nausea, and added

that the prescribed dosage of the drug for urinary incontinence would not

have an anti-depressant effect.

(I don't have time at the moment, but will be writing this woman and

explaining how stupid her 'illogical' comments are...I'm actually quite

insulted by her statements, can you imagine this woman being an ob/gyn?

Illogical? She sounds like Spock from Star Trek...maybe she IS Spock from

Star Trek...)

_________________________________________________________________

Choose now from 4 levels of MSN Hotmail Extra Storage - no more account

overload! http://click.atdmt.com/AVE/go/onm00200362ave/direct/01/

February 13, 2004

I've heard parents make the comment that Imipramine (a tricyclic)

isn't an antidepressant when it is given for bed wetting. Huh? Like

the brain knows what the doctor's intent is for the medication? Don't

mess with the brain just the urinary part? The ignorance of doctors

is frightening. And we actually pay them for their " expertise " .

Perhaps you should refer the good doctor to the prescribing

information for some of the popular antidepressants which list

suicidal ideation as adverse reactions. Or the Effexor " Dear Doctor "

letter.

> >From: " Jim- Norman " <mofunnow@s...>

> >Reply-SSRI medications

> ><SSRI medications >, <wildestcoltsgroups (DOT)

com>

> >Subject: Drug trial stopped after link to suicide

-

> >Australia

> >Date: Fri, 13 Feb 2004 15:00:04 -0600

> >

> Here's another asinine comment from an 'expert'...

>

> But Kate , an associate professor of obstetrics and gynaecology

at the

> University of NSW, dismissed suggestions the drug could be directly

linked

> to suicide as " illogical " .

>

> Professor , who was involved in clinical trials of duloxetine

at

> Sydney's Prince of Wales and St hospitals, said the compound

was

> revolutionary and offered the first effective drug treatment for

stress

> incontinence - estimated to affect at least 78 million women over

the age of

> 20 worldwide.

>

> " Because the drug has an anti-depressant effect, any relationship

with

> suicide with this drug would be surprising, " Professor said.

>

> In the study involving the Sydney women, Professor and her

> co-researchers found that duloxetine halved the number of

incontinence

> episodes.

>

> " The safety and efficacy data from this study provide evidence for

the value

> of duloxetine as potentially the first widely approved

pharmacological

> treatment for women with bothersome stress urinary incontinence, "

the

> researchers wrote in last month's British Journal of Urology.

>

> Professor said the main side-effect of the drug was nausea,

and added

> that the prescribed dosage of the drug for urinary incontinence

would not

> have an anti-depressant effect.

>

> (I don't have time at the moment, but will be writing this woman and

> explaining how stupid her 'illogical' comments are...I'm actually

quite

> insulted by her statements, can you imagine this woman being an

ob/gyn?

> Illogical? She sounds like Spock from Star Trek...maybe she IS

Spock from

> Star Trek...)

>

> _________________________________________________________________

> Choose now from 4 levels of MSN Hotmail Extra Storage - no more

account

> overload! http://click.atdmt.com/AVE/go/onm00200362ave/direct/01/

>

February 14, 2004

,

This made me laugh so. I've just had my dog at the vet and I've been

gripping since. For $225, I listened to the vet freak out when I told her

what I fed my dog. There were two phases - first when I said I gave her

meat. That resulted in bizarre expression on her face. Second when I told

her the meat was raw. I thought she was going to throw up. She started to

lecture me on how bad that was for the dog. Of course it should be

commercially produced junk food, preferrably the stuff sold by the vet

clinic. I answered her back that it was God (or mother nature take your

pick) that made the animal a carnivore, not me. And it hardly seemed within

the plan that the food be cooked as canines didn't have the hands to do

such - rather nature gave them teeth for fresh live kill. She couldn't come

up with an answer. So she dropped that and proceeded on about vitamins

telling me how there was just a study that showed you could not trust

vitamin companies because they were not regulated. I responded back asking

her if she was going to tell me that you could " trust " the pharmaceutical

companies and tell me that they were regulated? She couldn't think of a

good answer for that either.

I think going to med/science schools these days means surrendering your

brain at the door.

Drug trial stopped after link to suicide

> -

> > >Australia

> > >Date: Fri, 13 Feb 2004 15:00:04 -0600

> > >

> > Here's another asinine comment from an 'expert'...

> >

> > But Kate , an associate professor of obstetrics and gynaecology

> at the

> > University of NSW, dismissed suggestions the drug could be directly

> linked

> > to suicide as " illogical " .

> >

> > Professor , who was involved in clinical trials of duloxetine

> at

> > Sydney's Prince of Wales and St hospitals, said the compound

> was

> > revolutionary and offered the first effective drug treatment for

> stress

> > incontinence - estimated to affect at least 78 million women over

> the age of

> > 20 worldwide.

> >

> > " Because the drug has an anti-depressant effect, any relationship

> with

> > suicide with this drug would be surprising, " Professor said.

> >

> > In the study involving the Sydney women, Professor and her

> > co-researchers found that duloxetine halved the number of

> incontinence

> > episodes.

> >

> > " The safety and efficacy data from this study provide evidence for

> the value

> > of duloxetine as potentially the first widely approved

> pharmacological

> > treatment for women with bothersome stress urinary incontinence, "

> the

> > researchers wrote in last month's British Journal of Urology.

> >

> > Professor said the main side-effect of the drug was nausea,

> and added

> > that the prescribed dosage of the drug for urinary incontinence

> would not

> > have an anti-depressant effect.

> >

> > (I don't have time at the moment, but will be writing this woman and

> > explaining how stupid her 'illogical' comments are...I'm actually

> quite

> > insulted by her statements, can you imagine this woman being an

> ob/gyn?

> > Illogical? She sounds like Spock from Star Trek...maybe she IS

> Spock from

> > Star Trek...)

> >

> > _________________________________________________________________

> > Choose now from 4 levels of MSN Hotmail Extra Storage - no more

> account

> > overload! http://click.atdmt.com/AVE/go/onm00200362ave/direct/01/

> >

February 14, 2004