Time Magazine: Prescription for Suicide?

[Guest guest]

In a message dated 2/6/04 1:44:20 AM US Eastern Standard Time,

leah_ida@... writes:

>

> apologies if this was already posted--there's so much press right now on

> this issue, I'm losing track. & amp;nbsp;

Hi there;

It might be dismal but it is great that it is getting coverage.

This is a voice that has been silenced for too long!!!!

I am so glad. & amp;nbsp; & amp;nbsp;For all the kids who died because of this it

is a

victory for them.

Thanks for posting this

Marhoefer

Miracles Of Hope Network

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

Touch the Thunder Publishing & amp;amp; Recording Company

Obstruction-Of-Injustice Radio and Promotions

[Guest guest]

In a message dated 2/6/04 1:44:20 AM US Eastern Standard Time,

leah_ida@... writes:

>

> apologies if this was already posted--there's so much press right now on

> this issue, I'm losing track. & amp;nbsp;

Hi there;

It might be dismal but it is great that it is getting coverage.

This is a voice that has been silenced for too long!!!!

I am so glad. & amp;nbsp; & amp;nbsp;For all the kids who died because of this it

is a

victory for them.

Thanks for posting this

Marhoefer

Miracles Of Hope Network

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

Touch the Thunder Publishing & amp;amp; Recording Company

Obstruction-Of-Injustice Radio and Promotions

[Guest guest]

apologies if this was already posted--there's so much press right now on

this issue, I'm losing track. this is pretty dismal.

http://www.time.com/time/magazine/printout/0,8816,1101040209-586237,00.html

Monday, Feb. 09, 2004

Prescription For Suicide?

British authorities say some antidepressants can be deadly for kids. Now the

FDA is investigating

By MICHAEL D. LEMONICK

Kara Jaye-Anne Otter, 12, had been on the antidepressant Paxil for seven

months when she committed suicide. " I was told the worst side effects would

be flulike symptoms, " recalls her mother, Baker. " But after three

weeks she had begun to cop an attitude. Her grades started falling. Then she

didn't care what she looked like, and she was fighting with everybody. "

Baker says her daughter developed rashes and dark circles under her eyes and

had trouble sleeping. Then, on June 7, 2001, Kara pinned a note to her chest

reading, " By the time you find me I'll be dead. I love you with all my

heart. Don't worry, Jesus is with me. " She hooked a bungee cord onto a plate

hanger on the wall, wrapped the cord around her neck and pulled against it

until she passed out. Within minutes she was dead.

Baker is convinced Paxil is what killed her daughter, and that's what she'll

tell a U.S. Food and Drug Administration panel meeting this week in

Bethesda, Md. For years a small but vocal group of patients and doctors have

insisted that certain antidepressants, including Paxil, Zoloft, Prozac and

other medications known as selective serotonin reuptake inhibitors (SSRIs),

carry an unacceptable risk of antisocial behavior and suicide in kids who

take them. Many clinicians and most pharmaceutical companies disagree. Major

depression is a dangerous illness that in itself can lead to suicide, and

they insist that the benefits of these drugs outweigh the risks. But drug

firms also refuse to release all their research - some of which tends to

undercut their claims. " It's a real shell game here, " says Vera Sharav,

president of the Alliance for Human Research Protection, an advocacy group.

The issue is coming to a head. By last December, the British Medicines and

Healthcare Products Regulatory Agency, the equivalent of the FDA, had

declared Celexa, Effexor, Lexapro, Luvox, Paxil and Zoloft (but not Prozac)

too risky for kids under 18. Two weeks ago, a task force of the American

College of Neuropsychopharmacology fired back, saying that despite the risk

of potentially serious side effects, it's riskier to withhold the drugs.

Now comes the FDA probe, which began with an investigation of Paxil launched

in the fall of 2002. Last June the FDA cautioned doctors against prescribing

the drug to young people because of a possible increase in suicidal

thinking. In October the FDA issued a broader public-health advisory

alerting physicians that in clinical trials, Paxil, along with about half a

dozen other antidepressants, wasn't any more effective than a placebo at

treating depression in kids. Indeed, no antidepressant other than Prozac has

been formally approved for young people. But that's not the same as a ban.

Once a drug is legal, doctors can prescribe it at will.

The British, on the other hand, actually banned the use of Paxil (under the

drug's British trade name, Seroxat) for kids last June, and went on to ban

the others in the following six months. Why the difference, when British

authorities were looking at the same data as the FDA? One reason is that

most studies on effectiveness aren't really definitive. They don't prove one

way or the other whether the drugs work significantly better than placebos -

and the Brits went with the more conservative interpretation. That, argues

Dr. Graham Emslie, co-chair of the American panel and the author of several

studies on SSRIs, is shortsighted. " A failure to show effectiveness is not

the same as proving ineffectiveness. "

Moreover, he argues, the evidence linking SSRIs to suicide is very weak.

Autopsies on people who have taken their lives show that most victims hadn't

taken an antidepressant, or had taken an overdose, in the hours before their

death. The British cited " suicide-related events, " not actual suicide, as

the reason for the ban - and there's obviously a big difference. " About 2

million teens in the U.S. have clinical depression, " says Dr. Harold

Koplewicz, a psychiatrist and director of the NYU Child Study Center. " But 3

million kids have suicidal thoughts. They seem to be part and parcel of the

adolescent experience. " And, he points out, only a fraction of either group

actually attempts suicide.

Finally, say critics, the British medical authorities looked at the evidence

in an unsophisticated way. Many of the unpublished studies they reviewed

came from the drug companies themselves, and at least some of those had been

carried out for a very specific purpose. Under FDA rules, any company that

tests its medications on young people at the FDA's request wins an extra six

months' worth of patent protection, whether or not the results are positive.

Since these studies were done for financial gain and weren't reviewed by

independent scientists, they probably shouldn't be given full weight. Making

them public, as activists demand, might muddy the waters rather than help

families make informed decisions.

Nonsense, say scientists who favor sharing such data. The reason some

studies remain unpublished is that the drug companies don't like to admit

negative results. According to Dr. Teicher, a researcher at McLean

Hospital outside Boston who has published case reports linking suicide and

Prozac use, an internal Eli Lilly study of adults taking the drug showed " a

substantially greater incidence of suicide attempts in people in the study

receiving Prozac than in people receiving placebo or other antidepressants. "

But that study wasn't published, he says, while research showing no increase

in suicide attempts was. Says Dr. Harrington, an expert in child and

adolescent psychiatry at England's University of Manchester: " It's very

important that things get peer reviewed. There is no question about that.

But if you have to make decisions about giving drugs to children, you might

sometimes have to go on unpublished reports. "

Starting this week, the FDA will try to make sense of it all: the studies,

published and unpublished; expert testimony from both sides; and the

personal stories of ordinary people like Mark , 19, wounded in the

Columbine school shootings by , 18, who was taking the

antidepressant Luvox at the time.

The agency could come to a decision by next summer, but it might not be as

well informed as some would like. The truth, suspect many psychiatrists, is

complicated: SSRIs help some people and hurt others. Says Teicher: " To

figure out what impact [sSRIs] have on a side effect like suicidal thoughts

that might only affect a couple of percent - or even less than 1%--of people

in a study, you need a much, much larger study. " And, says Teicher, nobody

is doing those studies yet. Besides, argues Koplewicz, SSRIs are most often

prescribed for kids by pediatricians or family practitioners, not by experts

in child psychiatry. " We need to train these physicians properly, " he says,

" not ban drugs that are clearly effective. "

Reported by August/Washington, Helen Gibson/ London,

Hylton/Austin and Sora Song/New York

[Guest guest]

apologies if this was already posted--there's so much press right now on

this issue, I'm losing track. this is pretty dismal.

http://www.time.com/time/magazine/printout/0,8816,1101040209-586237,00.html

Monday, Feb. 09, 2004

Prescription For Suicide?

British authorities say some antidepressants can be deadly for kids. Now the

FDA is investigating

By MICHAEL D. LEMONICK

Kara Jaye-Anne Otter, 12, had been on the antidepressant Paxil for seven

months when she committed suicide. " I was told the worst side effects would

be flulike symptoms, " recalls her mother, Baker. " But after three

weeks she had begun to cop an attitude. Her grades started falling. Then she

didn't care what she looked like, and she was fighting with everybody. "

Baker says her daughter developed rashes and dark circles under her eyes and

had trouble sleeping. Then, on June 7, 2001, Kara pinned a note to her chest

reading, " By the time you find me I'll be dead. I love you with all my

heart. Don't worry, Jesus is with me. " She hooked a bungee cord onto a plate

hanger on the wall, wrapped the cord around her neck and pulled against it

until she passed out. Within minutes she was dead.

Baker is convinced Paxil is what killed her daughter, and that's what she'll

tell a U.S. Food and Drug Administration panel meeting this week in

Bethesda, Md. For years a small but vocal group of patients and doctors have

insisted that certain antidepressants, including Paxil, Zoloft, Prozac and

other medications known as selective serotonin reuptake inhibitors (SSRIs),

carry an unacceptable risk of antisocial behavior and suicide in kids who

take them. Many clinicians and most pharmaceutical companies disagree. Major

depression is a dangerous illness that in itself can lead to suicide, and

they insist that the benefits of these drugs outweigh the risks. But drug

firms also refuse to release all their research - some of which tends to

undercut their claims. " It's a real shell game here, " says Vera Sharav,

president of the Alliance for Human Research Protection, an advocacy group.

The issue is coming to a head. By last December, the British Medicines and

Healthcare Products Regulatory Agency, the equivalent of the FDA, had

declared Celexa, Effexor, Lexapro, Luvox, Paxil and Zoloft (but not Prozac)

too risky for kids under 18. Two weeks ago, a task force of the American

College of Neuropsychopharmacology fired back, saying that despite the risk

of potentially serious side effects, it's riskier to withhold the drugs.

Now comes the FDA probe, which began with an investigation of Paxil launched

in the fall of 2002. Last June the FDA cautioned doctors against prescribing

the drug to young people because of a possible increase in suicidal

thinking. In October the FDA issued a broader public-health advisory

alerting physicians that in clinical trials, Paxil, along with about half a

dozen other antidepressants, wasn't any more effective than a placebo at

treating depression in kids. Indeed, no antidepressant other than Prozac has

been formally approved for young people. But that's not the same as a ban.

Once a drug is legal, doctors can prescribe it at will.

The British, on the other hand, actually banned the use of Paxil (under the

drug's British trade name, Seroxat) for kids last June, and went on to ban

the others in the following six months. Why the difference, when British

authorities were looking at the same data as the FDA? One reason is that

most studies on effectiveness aren't really definitive. They don't prove one

way or the other whether the drugs work significantly better than placebos -

and the Brits went with the more conservative interpretation. That, argues

Dr. Graham Emslie, co-chair of the American panel and the author of several

studies on SSRIs, is shortsighted. " A failure to show effectiveness is not

the same as proving ineffectiveness. "

Moreover, he argues, the evidence linking SSRIs to suicide is very weak.

Autopsies on people who have taken their lives show that most victims hadn't

taken an antidepressant, or had taken an overdose, in the hours before their

death. The British cited " suicide-related events, " not actual suicide, as

the reason for the ban - and there's obviously a big difference. " About 2

million teens in the U.S. have clinical depression, " says Dr. Harold

Koplewicz, a psychiatrist and director of the NYU Child Study Center. " But 3

million kids have suicidal thoughts. They seem to be part and parcel of the

adolescent experience. " And, he points out, only a fraction of either group

actually attempts suicide.

Finally, say critics, the British medical authorities looked at the evidence

in an unsophisticated way. Many of the unpublished studies they reviewed

came from the drug companies themselves, and at least some of those had been

carried out for a very specific purpose. Under FDA rules, any company that

tests its medications on young people at the FDA's request wins an extra six

months' worth of patent protection, whether or not the results are positive.

Since these studies were done for financial gain and weren't reviewed by

independent scientists, they probably shouldn't be given full weight. Making

them public, as activists demand, might muddy the waters rather than help

families make informed decisions.

Nonsense, say scientists who favor sharing such data. The reason some

studies remain unpublished is that the drug companies don't like to admit

negative results. According to Dr. Teicher, a researcher at McLean

Hospital outside Boston who has published case reports linking suicide and

Prozac use, an internal Eli Lilly study of adults taking the drug showed " a

substantially greater incidence of suicide attempts in people in the study

receiving Prozac than in people receiving placebo or other antidepressants. "

But that study wasn't published, he says, while research showing no increase

in suicide attempts was. Says Dr. Harrington, an expert in child and

adolescent psychiatry at England's University of Manchester: " It's very

important that things get peer reviewed. There is no question about that.

But if you have to make decisions about giving drugs to children, you might

sometimes have to go on unpublished reports. "

Starting this week, the FDA will try to make sense of it all: the studies,

published and unpublished; expert testimony from both sides; and the

personal stories of ordinary people like Mark , 19, wounded in the

Columbine school shootings by , 18, who was taking the

antidepressant Luvox at the time.

The agency could come to a decision by next summer, but it might not be as

well informed as some would like. The truth, suspect many psychiatrists, is

complicated: SSRIs help some people and hurt others. Says Teicher: " To

figure out what impact [sSRIs] have on a side effect like suicidal thoughts

that might only affect a couple of percent - or even less than 1%--of people

in a study, you need a much, much larger study. " And, says Teicher, nobody

is doing those studies yet. Besides, argues Koplewicz, SSRIs are most often

prescribed for kids by pediatricians or family practitioners, not by experts

in child psychiatry. " We need to train these physicians properly, " he says,

" not ban drugs that are clearly effective. "

Reported by August/Washington, Helen Gibson/ London,

Hylton/Austin and Sora Song/New York