Fwd: Antidepressants and suicide_USA Today

[Guest guest]

VERACARE <veracare@...> wrote:From: " VERACARE "

To:

Subject: Antidepressants and suicide_USA Today

Date: Thu, 22 Jan 2004 14:28:38 -0500

Laughren; Katz MD; Temple; Mark McClellan MD;

Janet Woodcock

Cc: Insel MD

Subject: Antidepressants and suicide_USA Today

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

http://www.ahrp.org

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare@...

FYI

USA Today describes one family's tragedy:

Mark , believes antidepressants cost the life of his 13-year-old son,

. He'll testify at the FDA hearing. His father describes how his

13-year old son, Mathew, began to act fidgety after being prescribed an

antidepressant by a psychiatrist. " The morning after [he] took his seventh

pill,

[his] mom found him hanging by a belt from a laundry hook in his closet.

" We have no family history of depression and didn't even have a package

insert

because he gave us samples, " says. An autopsy showed his son's body

had

SSRI levels suitable for a 250-pound body, though the boy weighed less than

100 pounds, he says. "

The controversy swirling around antidepression drugs stems from the fact

that previously concealed data from clinical trials conducted in children

since the early 1990s was disclosed publicly. The evidence from those

industry-controlled trials does not support the reassuring claims made

in drug advertisements and by psychiatrists:

" SSRIs are a safe and effective treatment for depression. "

The action by British medicines authority to protect children by issuing a

ban

on all SSRIs but Prozac for children, has understandably met with resistance

by those whose careers and financial interests are built on promoting

widespread

use and increased sale of these drugs.

The American College of Neuropsychopharmacology (ACNP) convened a Task Force

and issued an executive summary of an unpublished report that it sponsored,

concluding the drugs are safe and effective for children. In 1993, an ACNP

task issued the same conclusion.

The FDA bears much responsibility for its failure to warn the public when

it had evidence--at least as early as 1996--showing that antidepressants

aren't

effective in treating depressed children. FDA had data showing that some of

the children exposed to these drugs were at increased risk of becoming

suicidal.

FDA's failure to warn has pitted families whose children suffered--

some of who committed suicide while on the drugs--against families who

claim their children were helped.

Failure to warn, however, doesn't help either families,

failure to warn results in preventable harm.

http://www.usatoday.com/news/health/2004-01-21-antidepressants-suicide-usat_

x.htm

Antidepressants and suicide

By Marilyn Elias, USA TODAY

Could antidepressants prescribed for more than 1 million U.S. children and

teenagers cause some of them to attempt suicide?

The Food and Drug Administration's first public hearing on this question

Feb. 2 is expected to draw polarized and emotional testimony. But the

evidence needed for an answer won't be in for several months, says

Katz, director of the FDA's neuropharmacological division.

The FDA is re-examining 20 studies of eight antidepressants used in

children. The studies didn't document a single drug-related suicide. But

preliminary findings suggested that suicidal thoughts and attempts, though

rare, were more common in kids taking the drugs than those on sugar pills.

Possible signs

Kids might be thinking about suicide if they:

Stop planning for the future.

Give away favorite toys, video games, music or pets.

Suddenly become cheerful, for no apparent reason, after a period of deep

depression.

Have frequent " accidents " or endanger themselves.

Seem preoccupied with death - talking about it, listening to death-oriented

music.

Source: Fassler, author of Help Me, I'm Sad: Recognizing, Treating,

and Preventing Childhood and Adolescent Depression

Now the FDA is checking to make sure that children on antidepressants

weren't more suicide-prone to start with than the placebo group and that the

suicide attempts were bona fide tries. " Right now the data are quite murky, "

Katz says.

The FDA has asked drug companies for more information. The review may find

no link between the drugs and suicidal thoughts, or a problem with some but

not all antidepressants. The analysis also may find qualities—for example

age, sex or length of illness—that put certain kids at higher risk, he says.

The newer antidepressants in question, called SSRIs or SSNIs, make " feel

good " chemicals more available in the brain and were viewed as safe.

Perils of pills

Signs of concern about children taking SSRI and SSNI antidepressants

(Celexa, Effexor, Effexor XR, Lexapro, Luvox, Paxil, Prozac, Zoloft):

June 2003: FDA advises doctors not to prescribe Paxil for kids under 18

because of possible rise in suicide risk.

August 2003: Wyeth tells doctors that studies show that hostility and

thoughts of suicide increase in children 6 to 17 taking Effexor and Effexor

XR. Advises careful monitoring and possibly reconsidering use of the drugs

in kids.

October 2003: FDA sends a " dear doctor " letter saying studies can't rule out

increased suicidal thinking and attempts in children on the antidepressants,

urges caution in prescribing.

December 2003: British drug regulators advise doctors to use none of the

eight antidepressants on children except for Prozac, saying it's the only

one whose benefits outweigh risks.

February 2004: FDA to hold public hearing to discuss the link between

antidepressants and suicide attempts.

Now the FDA and many parents are concerned. The agency has cautioned doctors

about possible risks, and in December, Britain's equivalent of the FDA

advised giving none of the SSRIs to children except for Prozac, saying it's

the only one whose benefits outweigh risks.

Prozac also is the sole SSRI approved by the FDA for treating depressed kids

7 to 17, but others, such as Zoloft and Celexa, can be prescribed legally

" off label " since they're approved for adults.

Some scientific experts think the worry is unwarranted. Research shows that

SSRI antidepressants don't increase suicidal behavior in kids, says a

preliminary report out Wednesday from the American College of

Neuropsychopharmacology. Depression, not the drugs, is probably causing

suicide attempts, the scientists say.

There's relatively little controlled research on SSRIs in school-age

children " and zippo on kids under 5, " says March, chief of child and

adolescent psychiatry at Duke University Medical Center in Durham, N.C.

But national surveys suggest soaring usage among kids, up about 60% from the

mid-90s to 2000. More than 1 million children and teens now receive SSRI

prescriptions, estimates Magno Zito, a psychiatric drug expert at the

University of land.

" The lack of supporting data, considering their widespread use, is

surprising and disturbing, " says Lawrence Diller, a behavioral pediatrician

in Walnut Creek, Calif., and author of Should I Medicate My Child?

Still, many therapists say SSRIs can help kids, and untreated depression

isn't benign. Major depression raises the risk of childhood suicide about

twelvefold, according to federal figures. Every survey finds that most

depressed kids get no treatment.

But does it have to be drugs? March, who has studied SSRIs, thinks not.

Cognitive-behavioral therapy, which teaches kids to change self-defeating

attitudes and behaviors, is about as effective as Prozac, " and that should

be tried first, " he says; drugs should be reserved for the most severely

depressed, who need therapy, too.

Children on SSRIs must be monitored closely, says Fassler, a child

psychiatrist in Burlington, Vt. Although most kids have no problems on the

medications, the SSRIs can spark agitation and impulsive acts, perhaps

leading to suicide attempts, Fassler and other experts speculate.

However, prescribing patterns and medical economics work against the

eagle-eye monitoring needed, some say. General practitioners and

pediatricians, often not experts in the field, write the majority of SSRI

prescriptions for kids. Also, HMOs may restrict access to busy specialists

and pay for pills but not therapy, Fassler says.

Even specialists may prescribe incorrect doses of poorly studied drugs or

fail to inform parents about warning signs. Mark , 54, of Overland

Park, Kan., believes antidepressants cost the life of his 13-year-old son,

. He'll testify at the FDA hearing.

After a family move in 1996, had trouble adjusting at his new

school. On the advice of school counselors, the s took him to a

psychiatrist the next summer, though he seemed happier.

The doctor gave Mark antidepressants, and he began to act fidgety,

says. The morning after Mark took his seventh pill, Mark's mom found him

hanging by a belt from a laundry hook in his closet.

" We have no family history of depression and didn't even have a package

insert because he gave us samples, " says. An autopsy showed his son's

body had SSRI levels suitable for a 250-pound body, though the boy weighed

less than 100 pounds, he says.

But other parents will tell the FDA that SSRIs saved their kids' lives.

Sherri Walton, 45, of Paradise Valley, Ariz., says major depression runs in

her family. Walton's daughters, Jordan, 14, and , 12, started Prozac in

the past 18 months after episodes of severe depression.

" They didn't even want to dance anymore, even though they're avid dancers;

they didn't want to live, and now they're normal kids, " Walton says. " I'm

going to tell the FDA, 'Don't take away what gave my kids their lives back.'

"

The agency expects to have enough evidence to answer the questions on

suicide risk by summer, the FDA's Katz says. Another hearing is likely then,

and at that time the FDA might issue a new recommendation on SSRIs and

children.

Parents who want their kids off the antidepressants now should consult

doctors on how to do it gradually because stopping abruptly can be harmful,

he adds.

For undecided parents, new interim guidance might come Feb. 2, Katz says.

" All we can say right now is, use with caution. "

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which

has not always been specifically authorized by the copyright owner. Such

material is made available to advance understanding of ecological,

political, human rights, economic, democracy, scientific, moral, ethical,

and social justice issues, etc. It is believed that this constitutes a 'fair

use' of any such copyrighted material as provided for in section 107 of the

US Copyright Law. In accordance with Title 17 U.S.C. Section 107, this

material is distributed without profit to those who have expressed a prior

general interest in receiving similar information for research and

educational purposes. For more information go to:

http://www.law.cornell.edu/uscode/17/107.shtml If you wish to use

copyrighted material for purposes of your own that go beyond 'fair use', you

must obtain permission from the copyright owner.

F. Prior jprior@... Chicago, IL 60656-1639

Calendar: http://calendar./j_prior

Cell: 773/230-5825 Fax: 781/459-8592

: 22:36-40

[Guest guest]

VERACARE <veracare@...> wrote:From: " VERACARE "

To:

Subject: Antidepressants and suicide_USA Today

Date: Thu, 22 Jan 2004 14:28:38 -0500

Laughren; Katz MD; Temple; Mark McClellan MD;

Janet Woodcock

Cc: Insel MD

Subject: Antidepressants and suicide_USA Today

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

http://www.ahrp.org

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare@...

FYI

USA Today describes one family's tragedy:

Mark , believes antidepressants cost the life of his 13-year-old son,

. He'll testify at the FDA hearing. His father describes how his

13-year old son, Mathew, began to act fidgety after being prescribed an

antidepressant by a psychiatrist. " The morning after [he] took his seventh

pill,

[his] mom found him hanging by a belt from a laundry hook in his closet.

" We have no family history of depression and didn't even have a package

insert

because he gave us samples, " says. An autopsy showed his son's body

had

SSRI levels suitable for a 250-pound body, though the boy weighed less than

100 pounds, he says. "

The controversy swirling around antidepression drugs stems from the fact

that previously concealed data from clinical trials conducted in children

since the early 1990s was disclosed publicly. The evidence from those

industry-controlled trials does not support the reassuring claims made

in drug advertisements and by psychiatrists:

" SSRIs are a safe and effective treatment for depression. "

The action by British medicines authority to protect children by issuing a

ban

on all SSRIs but Prozac for children, has understandably met with resistance

by those whose careers and financial interests are built on promoting

widespread

use and increased sale of these drugs.

The American College of Neuropsychopharmacology (ACNP) convened a Task Force

and issued an executive summary of an unpublished report that it sponsored,

concluding the drugs are safe and effective for children. In 1993, an ACNP

task issued the same conclusion.

The FDA bears much responsibility for its failure to warn the public when

it had evidence--at least as early as 1996--showing that antidepressants

aren't

effective in treating depressed children. FDA had data showing that some of

the children exposed to these drugs were at increased risk of becoming

suicidal.

FDA's failure to warn has pitted families whose children suffered--

some of who committed suicide while on the drugs--against families who

claim their children were helped.

Failure to warn, however, doesn't help either families,

failure to warn results in preventable harm.

http://www.usatoday.com/news/health/2004-01-21-antidepressants-suicide-usat_

x.htm

Antidepressants and suicide

By Marilyn Elias, USA TODAY

Could antidepressants prescribed for more than 1 million U.S. children and

teenagers cause some of them to attempt suicide?

The Food and Drug Administration's first public hearing on this question

Feb. 2 is expected to draw polarized and emotional testimony. But the

evidence needed for an answer won't be in for several months, says

Katz, director of the FDA's neuropharmacological division.

The FDA is re-examining 20 studies of eight antidepressants used in

children. The studies didn't document a single drug-related suicide. But

preliminary findings suggested that suicidal thoughts and attempts, though

rare, were more common in kids taking the drugs than those on sugar pills.

Possible signs

Kids might be thinking about suicide if they:

Stop planning for the future.

Give away favorite toys, video games, music or pets.

Suddenly become cheerful, for no apparent reason, after a period of deep

depression.

Have frequent " accidents " or endanger themselves.

Seem preoccupied with death - talking about it, listening to death-oriented

music.

Source: Fassler, author of Help Me, I'm Sad: Recognizing, Treating,

and Preventing Childhood and Adolescent Depression

Now the FDA is checking to make sure that children on antidepressants

weren't more suicide-prone to start with than the placebo group and that the

suicide attempts were bona fide tries. " Right now the data are quite murky, "

Katz says.

The FDA has asked drug companies for more information. The review may find

no link between the drugs and suicidal thoughts, or a problem with some but

not all antidepressants. The analysis also may find qualities—for example

age, sex or length of illness—that put certain kids at higher risk, he says.

The newer antidepressants in question, called SSRIs or SSNIs, make " feel

good " chemicals more available in the brain and were viewed as safe.

Perils of pills

Signs of concern about children taking SSRI and SSNI antidepressants

(Celexa, Effexor, Effexor XR, Lexapro, Luvox, Paxil, Prozac, Zoloft):

June 2003: FDA advises doctors not to prescribe Paxil for kids under 18

because of possible rise in suicide risk.

August 2003: Wyeth tells doctors that studies show that hostility and

thoughts of suicide increase in children 6 to 17 taking Effexor and Effexor

XR. Advises careful monitoring and possibly reconsidering use of the drugs

in kids.

October 2003: FDA sends a " dear doctor " letter saying studies can't rule out

increased suicidal thinking and attempts in children on the antidepressants,

urges caution in prescribing.

December 2003: British drug regulators advise doctors to use none of the

eight antidepressants on children except for Prozac, saying it's the only

one whose benefits outweigh risks.

February 2004: FDA to hold public hearing to discuss the link between

antidepressants and suicide attempts.

Now the FDA and many parents are concerned. The agency has cautioned doctors

about possible risks, and in December, Britain's equivalent of the FDA

advised giving none of the SSRIs to children except for Prozac, saying it's

the only one whose benefits outweigh risks.

Prozac also is the sole SSRI approved by the FDA for treating depressed kids

7 to 17, but others, such as Zoloft and Celexa, can be prescribed legally

" off label " since they're approved for adults.

Some scientific experts think the worry is unwarranted. Research shows that

SSRI antidepressants don't increase suicidal behavior in kids, says a

preliminary report out Wednesday from the American College of

Neuropsychopharmacology. Depression, not the drugs, is probably causing

suicide attempts, the scientists say.

There's relatively little controlled research on SSRIs in school-age

children " and zippo on kids under 5, " says March, chief of child and

adolescent psychiatry at Duke University Medical Center in Durham, N.C.

But national surveys suggest soaring usage among kids, up about 60% from the

mid-90s to 2000. More than 1 million children and teens now receive SSRI

prescriptions, estimates Magno Zito, a psychiatric drug expert at the

University of land.

" The lack of supporting data, considering their widespread use, is

surprising and disturbing, " says Lawrence Diller, a behavioral pediatrician

in Walnut Creek, Calif., and author of Should I Medicate My Child?

Still, many therapists say SSRIs can help kids, and untreated depression

isn't benign. Major depression raises the risk of childhood suicide about

twelvefold, according to federal figures. Every survey finds that most

depressed kids get no treatment.

But does it have to be drugs? March, who has studied SSRIs, thinks not.

Cognitive-behavioral therapy, which teaches kids to change self-defeating

attitudes and behaviors, is about as effective as Prozac, " and that should

be tried first, " he says; drugs should be reserved for the most severely

depressed, who need therapy, too.

Children on SSRIs must be monitored closely, says Fassler, a child

psychiatrist in Burlington, Vt. Although most kids have no problems on the

medications, the SSRIs can spark agitation and impulsive acts, perhaps

leading to suicide attempts, Fassler and other experts speculate.

However, prescribing patterns and medical economics work against the

eagle-eye monitoring needed, some say. General practitioners and

pediatricians, often not experts in the field, write the majority of SSRI

prescriptions for kids. Also, HMOs may restrict access to busy specialists

and pay for pills but not therapy, Fassler says.

Even specialists may prescribe incorrect doses of poorly studied drugs or

fail to inform parents about warning signs. Mark , 54, of Overland

Park, Kan., believes antidepressants cost the life of his 13-year-old son,

. He'll testify at the FDA hearing.

After a family move in 1996, had trouble adjusting at his new

school. On the advice of school counselors, the s took him to a

psychiatrist the next summer, though he seemed happier.

The doctor gave Mark antidepressants, and he began to act fidgety,

says. The morning after Mark took his seventh pill, Mark's mom found him

hanging by a belt from a laundry hook in his closet.

" We have no family history of depression and didn't even have a package

insert because he gave us samples, " says. An autopsy showed his son's

body had SSRI levels suitable for a 250-pound body, though the boy weighed

less than 100 pounds, he says.

But other parents will tell the FDA that SSRIs saved their kids' lives.

Sherri Walton, 45, of Paradise Valley, Ariz., says major depression runs in

her family. Walton's daughters, Jordan, 14, and , 12, started Prozac in

the past 18 months after episodes of severe depression.

" They didn't even want to dance anymore, even though they're avid dancers;

they didn't want to live, and now they're normal kids, " Walton says. " I'm

going to tell the FDA, 'Don't take away what gave my kids their lives back.'

"

The agency expects to have enough evidence to answer the questions on

suicide risk by summer, the FDA's Katz says. Another hearing is likely then,

and at that time the FDA might issue a new recommendation on SSRIs and

children.

Parents who want their kids off the antidepressants now should consult

doctors on how to do it gradually because stopping abruptly can be harmful,

he adds.

For undecided parents, new interim guidance might come Feb. 2, Katz says.

" All we can say right now is, use with caution. "

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which

has not always been specifically authorized by the copyright owner. Such

material is made available to advance understanding of ecological,

political, human rights, economic, democracy, scientific, moral, ethical,

and social justice issues, etc. It is believed that this constitutes a 'fair

use' of any such copyrighted material as provided for in section 107 of the

US Copyright Law. In accordance with Title 17 U.S.C. Section 107, this

material is distributed without profit to those who have expressed a prior

general interest in receiving similar information for research and

educational purposes. For more information go to:

http://www.law.cornell.edu/uscode/17/107.shtml If you wish to use

copyrighted material for purposes of your own that go beyond 'fair use', you

must obtain permission from the copyright owner.

F. Prior jprior@... Chicago, IL 60656-1639

Calendar: http://calendar./j_prior

Cell: 773/230-5825 Fax: 781/459-8592

: 22:36-40

[Guest guest]

VERACARE <veracare@...> wrote:From: " VERACARE "

To:

Subject: Antidepressants and suicide_USA Today

Date: Thu, 22 Jan 2004 14:28:38 -0500

Laughren; Katz MD; Temple; Mark McClellan MD;

Janet Woodcock

Cc: Insel MD

Subject: Antidepressants and suicide_USA Today

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

http://www.ahrp.org

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare@...

FYI

USA Today describes one family's tragedy:

Mark , believes antidepressants cost the life of his 13-year-old son,

. He'll testify at the FDA hearing. His father describes how his

13-year old son, Mathew, began to act fidgety after being prescribed an

antidepressant by a psychiatrist. " The morning after [he] took his seventh

pill,

[his] mom found him hanging by a belt from a laundry hook in his closet.

" We have no family history of depression and didn't even have a package

insert

because he gave us samples, " says. An autopsy showed his son's body

had

SSRI levels suitable for a 250-pound body, though the boy weighed less than

100 pounds, he says. "

The controversy swirling around antidepression drugs stems from the fact

that previously concealed data from clinical trials conducted in children

since the early 1990s was disclosed publicly. The evidence from those

industry-controlled trials does not support the reassuring claims made

in drug advertisements and by psychiatrists:

" SSRIs are a safe and effective treatment for depression. "

The action by British medicines authority to protect children by issuing a

ban

on all SSRIs but Prozac for children, has understandably met with resistance

by those whose careers and financial interests are built on promoting

widespread

use and increased sale of these drugs.

The American College of Neuropsychopharmacology (ACNP) convened a Task Force

and issued an executive summary of an unpublished report that it sponsored,

concluding the drugs are safe and effective for children. In 1993, an ACNP

task issued the same conclusion.

The FDA bears much responsibility for its failure to warn the public when

it had evidence--at least as early as 1996--showing that antidepressants

aren't

effective in treating depressed children. FDA had data showing that some of

the children exposed to these drugs were at increased risk of becoming

suicidal.

FDA's failure to warn has pitted families whose children suffered--

some of who committed suicide while on the drugs--against families who

claim their children were helped.

Failure to warn, however, doesn't help either families,

failure to warn results in preventable harm.

http://www.usatoday.com/news/health/2004-01-21-antidepressants-suicide-usat_

x.htm

Antidepressants and suicide

By Marilyn Elias, USA TODAY

Could antidepressants prescribed for more than 1 million U.S. children and

teenagers cause some of them to attempt suicide?

The Food and Drug Administration's first public hearing on this question

Feb. 2 is expected to draw polarized and emotional testimony. But the

evidence needed for an answer won't be in for several months, says

Katz, director of the FDA's neuropharmacological division.

The FDA is re-examining 20 studies of eight antidepressants used in

children. The studies didn't document a single drug-related suicide. But

preliminary findings suggested that suicidal thoughts and attempts, though

rare, were more common in kids taking the drugs than those on sugar pills.

Possible signs

Kids might be thinking about suicide if they:

Stop planning for the future.

Give away favorite toys, video games, music or pets.

Suddenly become cheerful, for no apparent reason, after a period of deep

depression.

Have frequent " accidents " or endanger themselves.

Seem preoccupied with death - talking about it, listening to death-oriented

music.

Source: Fassler, author of Help Me, I'm Sad: Recognizing, Treating,

and Preventing Childhood and Adolescent Depression

Now the FDA is checking to make sure that children on antidepressants

weren't more suicide-prone to start with than the placebo group and that the

suicide attempts were bona fide tries. " Right now the data are quite murky, "

Katz says.

The FDA has asked drug companies for more information. The review may find

no link between the drugs and suicidal thoughts, or a problem with some but

not all antidepressants. The analysis also may find qualities—for example

age, sex or length of illness—that put certain kids at higher risk, he says.

The newer antidepressants in question, called SSRIs or SSNIs, make " feel

good " chemicals more available in the brain and were viewed as safe.

Perils of pills

Signs of concern about children taking SSRI and SSNI antidepressants

(Celexa, Effexor, Effexor XR, Lexapro, Luvox, Paxil, Prozac, Zoloft):

June 2003: FDA advises doctors not to prescribe Paxil for kids under 18

because of possible rise in suicide risk.

August 2003: Wyeth tells doctors that studies show that hostility and

thoughts of suicide increase in children 6 to 17 taking Effexor and Effexor

XR. Advises careful monitoring and possibly reconsidering use of the drugs

in kids.

October 2003: FDA sends a " dear doctor " letter saying studies can't rule out

increased suicidal thinking and attempts in children on the antidepressants,

urges caution in prescribing.

December 2003: British drug regulators advise doctors to use none of the

eight antidepressants on children except for Prozac, saying it's the only

one whose benefits outweigh risks.

February 2004: FDA to hold public hearing to discuss the link between

antidepressants and suicide attempts.

Now the FDA and many parents are concerned. The agency has cautioned doctors

about possible risks, and in December, Britain's equivalent of the FDA

advised giving none of the SSRIs to children except for Prozac, saying it's

the only one whose benefits outweigh risks.

Prozac also is the sole SSRI approved by the FDA for treating depressed kids

7 to 17, but others, such as Zoloft and Celexa, can be prescribed legally

" off label " since they're approved for adults.

Some scientific experts think the worry is unwarranted. Research shows that

SSRI antidepressants don't increase suicidal behavior in kids, says a

preliminary report out Wednesday from the American College of

Neuropsychopharmacology. Depression, not the drugs, is probably causing

suicide attempts, the scientists say.

There's relatively little controlled research on SSRIs in school-age

children " and zippo on kids under 5, " says March, chief of child and

adolescent psychiatry at Duke University Medical Center in Durham, N.C.

But national surveys suggest soaring usage among kids, up about 60% from the

mid-90s to 2000. More than 1 million children and teens now receive SSRI

prescriptions, estimates Magno Zito, a psychiatric drug expert at the

University of land.

" The lack of supporting data, considering their widespread use, is

surprising and disturbing, " says Lawrence Diller, a behavioral pediatrician

in Walnut Creek, Calif., and author of Should I Medicate My Child?

Still, many therapists say SSRIs can help kids, and untreated depression

isn't benign. Major depression raises the risk of childhood suicide about

twelvefold, according to federal figures. Every survey finds that most

depressed kids get no treatment.

But does it have to be drugs? March, who has studied SSRIs, thinks not.

Cognitive-behavioral therapy, which teaches kids to change self-defeating

attitudes and behaviors, is about as effective as Prozac, " and that should

be tried first, " he says; drugs should be reserved for the most severely

depressed, who need therapy, too.

Children on SSRIs must be monitored closely, says Fassler, a child

psychiatrist in Burlington, Vt. Although most kids have no problems on the

medications, the SSRIs can spark agitation and impulsive acts, perhaps

leading to suicide attempts, Fassler and other experts speculate.

However, prescribing patterns and medical economics work against the

eagle-eye monitoring needed, some say. General practitioners and

pediatricians, often not experts in the field, write the majority of SSRI

prescriptions for kids. Also, HMOs may restrict access to busy specialists

and pay for pills but not therapy, Fassler says.

Even specialists may prescribe incorrect doses of poorly studied drugs or

fail to inform parents about warning signs. Mark , 54, of Overland

Park, Kan., believes antidepressants cost the life of his 13-year-old son,

. He'll testify at the FDA hearing.

After a family move in 1996, had trouble adjusting at his new

school. On the advice of school counselors, the s took him to a

psychiatrist the next summer, though he seemed happier.

The doctor gave Mark antidepressants, and he began to act fidgety,

says. The morning after Mark took his seventh pill, Mark's mom found him

hanging by a belt from a laundry hook in his closet.

" We have no family history of depression and didn't even have a package

insert because he gave us samples, " says. An autopsy showed his son's

body had SSRI levels suitable for a 250-pound body, though the boy weighed

less than 100 pounds, he says.

But other parents will tell the FDA that SSRIs saved their kids' lives.

Sherri Walton, 45, of Paradise Valley, Ariz., says major depression runs in

her family. Walton's daughters, Jordan, 14, and , 12, started Prozac in

the past 18 months after episodes of severe depression.

" They didn't even want to dance anymore, even though they're avid dancers;

they didn't want to live, and now they're normal kids, " Walton says. " I'm

going to tell the FDA, 'Don't take away what gave my kids their lives back.'

"

The agency expects to have enough evidence to answer the questions on

suicide risk by summer, the FDA's Katz says. Another hearing is likely then,

and at that time the FDA might issue a new recommendation on SSRIs and

children.

Parents who want their kids off the antidepressants now should consult

doctors on how to do it gradually because stopping abruptly can be harmful,

he adds.

For undecided parents, new interim guidance might come Feb. 2, Katz says.

" All we can say right now is, use with caution. "

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which

has not always been specifically authorized by the copyright owner. Such

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and social justice issues, etc. It is believed that this constitutes a 'fair

use' of any such copyrighted material as provided for in section 107 of the

US Copyright Law. In accordance with Title 17 U.S.C. Section 107, this

material is distributed without profit to those who have expressed a prior

general interest in receiving similar information for research and

educational purposes. For more information go to:

http://www.law.cornell.edu/uscode/17/107.shtml If you wish to use

copyrighted material for purposes of your own that go beyond 'fair use', you

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F. Prior jprior@... Chicago, IL 60656-1639

Calendar: http://calendar./j_prior

Cell: 773/230-5825 Fax: 781/459-8592

: 22:36-40

[Guest guest]

VERACARE <veracare@...> wrote:From: " VERACARE "

To:

Subject: Antidepressants and suicide_USA Today

Date: Thu, 22 Jan 2004 14:28:38 -0500

Laughren; Katz MD; Temple; Mark McClellan MD;

Janet Woodcock

Cc: Insel MD

Subject: Antidepressants and suicide_USA Today

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

http://www.ahrp.org

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare@...

FYI

USA Today describes one family's tragedy:

Mark , believes antidepressants cost the life of his 13-year-old son,

. He'll testify at the FDA hearing. His father describes how his

13-year old son, Mathew, began to act fidgety after being prescribed an

antidepressant by a psychiatrist. " The morning after [he] took his seventh

pill,

[his] mom found him hanging by a belt from a laundry hook in his closet.

" We have no family history of depression and didn't even have a package

insert

because he gave us samples, " says. An autopsy showed his son's body

had

SSRI levels suitable for a 250-pound body, though the boy weighed less than

100 pounds, he says. "

The controversy swirling around antidepression drugs stems from the fact

that previously concealed data from clinical trials conducted in children

since the early 1990s was disclosed publicly. The evidence from those

industry-controlled trials does not support the reassuring claims made

in drug advertisements and by psychiatrists:

" SSRIs are a safe and effective treatment for depression. "

The action by British medicines authority to protect children by issuing a

ban

on all SSRIs but Prozac for children, has understandably met with resistance

by those whose careers and financial interests are built on promoting

widespread

use and increased sale of these drugs.

The American College of Neuropsychopharmacology (ACNP) convened a Task Force

and issued an executive summary of an unpublished report that it sponsored,

concluding the drugs are safe and effective for children. In 1993, an ACNP

task issued the same conclusion.

The FDA bears much responsibility for its failure to warn the public when

it had evidence--at least as early as 1996--showing that antidepressants

aren't

effective in treating depressed children. FDA had data showing that some of

the children exposed to these drugs were at increased risk of becoming

suicidal.

FDA's failure to warn has pitted families whose children suffered--

some of who committed suicide while on the drugs--against families who

claim their children were helped.

Failure to warn, however, doesn't help either families,

failure to warn results in preventable harm.

http://www.usatoday.com/news/health/2004-01-21-antidepressants-suicide-usat_

x.htm

Antidepressants and suicide

By Marilyn Elias, USA TODAY

Could antidepressants prescribed for more than 1 million U.S. children and

teenagers cause some of them to attempt suicide?

The Food and Drug Administration's first public hearing on this question

Feb. 2 is expected to draw polarized and emotional testimony. But the

evidence needed for an answer won't be in for several months, says

Katz, director of the FDA's neuropharmacological division.

The FDA is re-examining 20 studies of eight antidepressants used in

children. The studies didn't document a single drug-related suicide. But

preliminary findings suggested that suicidal thoughts and attempts, though

rare, were more common in kids taking the drugs than those on sugar pills.

Possible signs

Kids might be thinking about suicide if they:

Stop planning for the future.

Give away favorite toys, video games, music or pets.

Suddenly become cheerful, for no apparent reason, after a period of deep

depression.

Have frequent " accidents " or endanger themselves.

Seem preoccupied with death - talking about it, listening to death-oriented

music.

Source: Fassler, author of Help Me, I'm Sad: Recognizing, Treating,

and Preventing Childhood and Adolescent Depression

Now the FDA is checking to make sure that children on antidepressants

weren't more suicide-prone to start with than the placebo group and that the

suicide attempts were bona fide tries. " Right now the data are quite murky, "

Katz says.

The FDA has asked drug companies for more information. The review may find

no link between the drugs and suicidal thoughts, or a problem with some but

not all antidepressants. The analysis also may find qualities—for example

age, sex or length of illness—that put certain kids at higher risk, he says.

The newer antidepressants in question, called SSRIs or SSNIs, make " feel

good " chemicals more available in the brain and were viewed as safe.

Perils of pills

Signs of concern about children taking SSRI and SSNI antidepressants

(Celexa, Effexor, Effexor XR, Lexapro, Luvox, Paxil, Prozac, Zoloft):

June 2003: FDA advises doctors not to prescribe Paxil for kids under 18

because of possible rise in suicide risk.

August 2003: Wyeth tells doctors that studies show that hostility and

thoughts of suicide increase in children 6 to 17 taking Effexor and Effexor

XR. Advises careful monitoring and possibly reconsidering use of the drugs

in kids.

October 2003: FDA sends a " dear doctor " letter saying studies can't rule out

increased suicidal thinking and attempts in children on the antidepressants,

urges caution in prescribing.

December 2003: British drug regulators advise doctors to use none of the

eight antidepressants on children except for Prozac, saying it's the only

one whose benefits outweigh risks.

February 2004: FDA to hold public hearing to discuss the link between

antidepressants and suicide attempts.

Now the FDA and many parents are concerned. The agency has cautioned doctors

about possible risks, and in December, Britain's equivalent of the FDA

advised giving none of the SSRIs to children except for Prozac, saying it's

the only one whose benefits outweigh risks.

Prozac also is the sole SSRI approved by the FDA for treating depressed kids

7 to 17, but others, such as Zoloft and Celexa, can be prescribed legally

" off label " since they're approved for adults.

Some scientific experts think the worry is unwarranted. Research shows that

SSRI antidepressants don't increase suicidal behavior in kids, says a

preliminary report out Wednesday from the American College of

Neuropsychopharmacology. Depression, not the drugs, is probably causing

suicide attempts, the scientists say.

There's relatively little controlled research on SSRIs in school-age

children " and zippo on kids under 5, " says March, chief of child and

adolescent psychiatry at Duke University Medical Center in Durham, N.C.

But national surveys suggest soaring usage among kids, up about 60% from the

mid-90s to 2000. More than 1 million children and teens now receive SSRI

prescriptions, estimates Magno Zito, a psychiatric drug expert at the

University of land.

" The lack of supporting data, considering their widespread use, is

surprising and disturbing, " says Lawrence Diller, a behavioral pediatrician

in Walnut Creek, Calif., and author of Should I Medicate My Child?

Still, many therapists say SSRIs can help kids, and untreated depression

isn't benign. Major depression raises the risk of childhood suicide about

twelvefold, according to federal figures. Every survey finds that most

depressed kids get no treatment.

But does it have to be drugs? March, who has studied SSRIs, thinks not.

Cognitive-behavioral therapy, which teaches kids to change self-defeating

attitudes and behaviors, is about as effective as Prozac, " and that should

be tried first, " he says; drugs should be reserved for the most severely

depressed, who need therapy, too.

Children on SSRIs must be monitored closely, says Fassler, a child

psychiatrist in Burlington, Vt. Although most kids have no problems on the

medications, the SSRIs can spark agitation and impulsive acts, perhaps

leading to suicide attempts, Fassler and other experts speculate.

However, prescribing patterns and medical economics work against the

eagle-eye monitoring needed, some say. General practitioners and

pediatricians, often not experts in the field, write the majority of SSRI

prescriptions for kids. Also, HMOs may restrict access to busy specialists

and pay for pills but not therapy, Fassler says.

Even specialists may prescribe incorrect doses of poorly studied drugs or

fail to inform parents about warning signs. Mark , 54, of Overland

Park, Kan., believes antidepressants cost the life of his 13-year-old son,

. He'll testify at the FDA hearing.

After a family move in 1996, had trouble adjusting at his new

school. On the advice of school counselors, the s took him to a

psychiatrist the next summer, though he seemed happier.

The doctor gave Mark antidepressants, and he began to act fidgety,

says. The morning after Mark took his seventh pill, Mark's mom found him

hanging by a belt from a laundry hook in his closet.

" We have no family history of depression and didn't even have a package

insert because he gave us samples, " says. An autopsy showed his son's

body had SSRI levels suitable for a 250-pound body, though the boy weighed

less than 100 pounds, he says.

But other parents will tell the FDA that SSRIs saved their kids' lives.

Sherri Walton, 45, of Paradise Valley, Ariz., says major depression runs in

her family. Walton's daughters, Jordan, 14, and , 12, started Prozac in

the past 18 months after episodes of severe depression.

" They didn't even want to dance anymore, even though they're avid dancers;

they didn't want to live, and now they're normal kids, " Walton says. " I'm

going to tell the FDA, 'Don't take away what gave my kids their lives back.'

"

The agency expects to have enough evidence to answer the questions on

suicide risk by summer, the FDA's Katz says. Another hearing is likely then,

and at that time the FDA might issue a new recommendation on SSRIs and

children.

Parents who want their kids off the antidepressants now should consult

doctors on how to do it gradually because stopping abruptly can be harmful,

he adds.

For undecided parents, new interim guidance might come Feb. 2, Katz says.

" All we can say right now is, use with caution. "

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which

has not always been specifically authorized by the copyright owner. Such

material is made available to advance understanding of ecological,

political, human rights, economic, democracy, scientific, moral, ethical,

and social justice issues, etc. It is believed that this constitutes a 'fair

use' of any such copyrighted material as provided for in section 107 of the

US Copyright Law. In accordance with Title 17 U.S.C. Section 107, this

material is distributed without profit to those who have expressed a prior

general interest in receiving similar information for research and

educational purposes. For more information go to:

http://www.law.cornell.edu/uscode/17/107.shtml If you wish to use

copyrighted material for purposes of your own that go beyond 'fair use', you

must obtain permission from the copyright owner.

F. Prior jprior@... Chicago, IL 60656-1639

Calendar: http://calendar./j_prior

Cell: 773/230-5825 Fax: 781/459-8592

: 22:36-40