SSRI Use in Children - An Industry Biased Record

[Guest guest]

" Oh, I see... " said the Avenging Angel. " Well, it's time to tell the world

how Prozac became the only positively 'safe' drug for use in children " .

And, she contemplated a little longer... " There are many cunning men upon

the Earth these days; it is time for the angels of Heaven to descend down

lest we lose more of these precious children... "

(grin...!!! - couldn't help myself!!!)

http://www.cspinet.org/new/200402011.html

Center for Science in the Public Interest

Industry Funding Skews Kids and Drugs Research, Says Report

CSPI Identifies Bias in Medical Literature on Pediatric Antidepressants

A new study of medical journal reports on the effectiveness of

antidepressants in children shows that drug industry-funded research is much

more likely to be positive than independently-funded research, and both are

far more positive than the Food and Drug Administration’s (FDA) assessment

of the drugs’ tests.

The Center for Science in the Public Interest found that 96 percent of the

industry-funded efficacy studies of drugs like Prozac, Zoloft, and Paxil in

children were positive. That compares to just 63 percent of independently

funded studies published in medical journals.

If one looks at just published clinical trials that contained a

placebo-controlled arm, industry-funded clinicians reported the drugs were

effective in 9 out of 10 cases. But among researchers not funded by

industry, only 5 out of 9 reported positive results, which is surprisingly

low given that other studies have shown that medical journals are biased

toward publishing positive reports. By comparison, just 3 of 15 FDA reviews

of pediatric antidepressant trials, many of which have not been published,

were positive.

" Regrettably, drug companies see medical journals as just another cog in

their public relations machine, " said Merrill Goozner, director of the CSPI

Integrity in Science Project. " Industry funding has skewed the published

literature and through that medical opinion on the use of these drugs in

kids. "

Prozac, Zoloft, and Paxil are among a class of antidepressants known as

selective seratonin reuptake inhibitors (SSRIs). A joint meeting of the

FDA’s Psychopharmacologic and Pediatric Advisory Committees is meeting on

Monday to discuss the possible connection between this class of drugs and

suicide in youths. As the FDA reviewer pointed out in his review before

today’s meeting, " Ultimately, this is a risk benefit assessment, so it is

important to know where we stand on the benefit side of the issue. "

While most researchers believe their funding source does not influence their

results, this study echoes numerous previous studies finding that published

research that is industry-funded is much more likely to show results

favorable to the sponsor than independent research funded by either

government or academic institutions.

" The pharmaceutical industry’s domination of this field of research has

biased the published record, " Goozner said. " That fact should be taken into

account when evaluating the alleged benefits of these drugs versus their

potential risks. "

ALSO, READ THIS! A MOST IMPORTANT AND REVEALING REPORT !!!

http://cspinet.org/new/pdf/ssri_paper.pdf

In the third paragraph:

The FDA’s approval of fluoxetine (PROZAC) for children was based on two

studies whose outcomes were controversial, even to the FDA reviewers.

According to the report issued by the Center for Drug Evaluation and

Research at FDA, the treatment effect of fluoxetine compared to placebo was

“non-significant” but trended in the direction of favoring the drug in one

trial of 96 patients. Even that trend was based on what the reviewer

considered a low threshold for measuring relief from the symptoms of

depression. A second trial involving 210 youths “did not win on the

protocol specified endpoint.” However, other measures of psychic wellbeing

indicated that about 70 percent of patients improved compared to 60 percent

on placebo. “The sponsor appeared to achieve nominal significance on other

secondary endpoints,” the reviewer noted.

_________________________________________________________________

Let the advanced features & services of MSN Internet Software maximize your

online time. http://click.atdmt.com/AVE/go/onm00200363ave/direct/01/

[Guest guest]

" Oh, I see... " said the Avenging Angel. " Well, it's time to tell the world

how Prozac became the only positively 'safe' drug for use in children " .

And, she contemplated a little longer... " There are many cunning men upon

the Earth these days; it is time for the angels of Heaven to descend down

lest we lose more of these precious children... "

(grin...!!! - couldn't help myself!!!)

http://www.cspinet.org/new/200402011.html

Center for Science in the Public Interest

Industry Funding Skews Kids and Drugs Research, Says Report

CSPI Identifies Bias in Medical Literature on Pediatric Antidepressants

A new study of medical journal reports on the effectiveness of

antidepressants in children shows that drug industry-funded research is much

more likely to be positive than independently-funded research, and both are

far more positive than the Food and Drug Administration’s (FDA) assessment

of the drugs’ tests.

The Center for Science in the Public Interest found that 96 percent of the

industry-funded efficacy studies of drugs like Prozac, Zoloft, and Paxil in

children were positive. That compares to just 63 percent of independently

funded studies published in medical journals.

If one looks at just published clinical trials that contained a

placebo-controlled arm, industry-funded clinicians reported the drugs were

effective in 9 out of 10 cases. But among researchers not funded by

industry, only 5 out of 9 reported positive results, which is surprisingly

low given that other studies have shown that medical journals are biased

toward publishing positive reports. By comparison, just 3 of 15 FDA reviews

of pediatric antidepressant trials, many of which have not been published,

were positive.

" Regrettably, drug companies see medical journals as just another cog in

their public relations machine, " said Merrill Goozner, director of the CSPI

Integrity in Science Project. " Industry funding has skewed the published

literature and through that medical opinion on the use of these drugs in

kids. "

Prozac, Zoloft, and Paxil are among a class of antidepressants known as

selective seratonin reuptake inhibitors (SSRIs). A joint meeting of the

FDA’s Psychopharmacologic and Pediatric Advisory Committees is meeting on

Monday to discuss the possible connection between this class of drugs and

suicide in youths. As the FDA reviewer pointed out in his review before

today’s meeting, " Ultimately, this is a risk benefit assessment, so it is

important to know where we stand on the benefit side of the issue. "

While most researchers believe their funding source does not influence their

results, this study echoes numerous previous studies finding that published

research that is industry-funded is much more likely to show results

favorable to the sponsor than independent research funded by either

government or academic institutions.

" The pharmaceutical industry’s domination of this field of research has

biased the published record, " Goozner said. " That fact should be taken into

account when evaluating the alleged benefits of these drugs versus their

potential risks. "

ALSO, READ THIS! A MOST IMPORTANT AND REVEALING REPORT !!!

http://cspinet.org/new/pdf/ssri_paper.pdf

In the third paragraph:

The FDA’s approval of fluoxetine (PROZAC) for children was based on two

studies whose outcomes were controversial, even to the FDA reviewers.

According to the report issued by the Center for Drug Evaluation and

Research at FDA, the treatment effect of fluoxetine compared to placebo was

“non-significant” but trended in the direction of favoring the drug in one

trial of 96 patients. Even that trend was based on what the reviewer

considered a low threshold for measuring relief from the symptoms of

depression. A second trial involving 210 youths “did not win on the

protocol specified endpoint.” However, other measures of psychic wellbeing

indicated that about 70 percent of patients improved compared to 60 percent

on placebo. “The sponsor appeared to achieve nominal significance on other

secondary endpoints,” the reviewer noted.

_________________________________________________________________

Let the advanced features & services of MSN Internet Software maximize your

online time. http://click.atdmt.com/AVE/go/onm00200363ave/direct/01/

[Guest guest]

" Oh, I see... " said the Avenging Angel. " Well, it's time to tell the world

how Prozac became the only positively 'safe' drug for use in children " .

And, she contemplated a little longer... " There are many cunning men upon

the Earth these days; it is time for the angels of Heaven to descend down

lest we lose more of these precious children... "

(grin...!!! - couldn't help myself!!!)

http://www.cspinet.org/new/200402011.html

Center for Science in the Public Interest

Industry Funding Skews Kids and Drugs Research, Says Report

CSPI Identifies Bias in Medical Literature on Pediatric Antidepressants

A new study of medical journal reports on the effectiveness of

antidepressants in children shows that drug industry-funded research is much

more likely to be positive than independently-funded research, and both are

far more positive than the Food and Drug Administration’s (FDA) assessment

of the drugs’ tests.

The Center for Science in the Public Interest found that 96 percent of the

industry-funded efficacy studies of drugs like Prozac, Zoloft, and Paxil in

children were positive. That compares to just 63 percent of independently

funded studies published in medical journals.

If one looks at just published clinical trials that contained a

placebo-controlled arm, industry-funded clinicians reported the drugs were

effective in 9 out of 10 cases. But among researchers not funded by

industry, only 5 out of 9 reported positive results, which is surprisingly

low given that other studies have shown that medical journals are biased

toward publishing positive reports. By comparison, just 3 of 15 FDA reviews

of pediatric antidepressant trials, many of which have not been published,

were positive.

" Regrettably, drug companies see medical journals as just another cog in

their public relations machine, " said Merrill Goozner, director of the CSPI

Integrity in Science Project. " Industry funding has skewed the published

literature and through that medical opinion on the use of these drugs in

kids. "

Prozac, Zoloft, and Paxil are among a class of antidepressants known as

selective seratonin reuptake inhibitors (SSRIs). A joint meeting of the

FDA’s Psychopharmacologic and Pediatric Advisory Committees is meeting on

Monday to discuss the possible connection between this class of drugs and

suicide in youths. As the FDA reviewer pointed out in his review before

today’s meeting, " Ultimately, this is a risk benefit assessment, so it is

important to know where we stand on the benefit side of the issue. "

While most researchers believe their funding source does not influence their

results, this study echoes numerous previous studies finding that published

research that is industry-funded is much more likely to show results

favorable to the sponsor than independent research funded by either

government or academic institutions.

" The pharmaceutical industry’s domination of this field of research has

biased the published record, " Goozner said. " That fact should be taken into

account when evaluating the alleged benefits of these drugs versus their

potential risks. "

ALSO, READ THIS! A MOST IMPORTANT AND REVEALING REPORT !!!

http://cspinet.org/new/pdf/ssri_paper.pdf

In the third paragraph:

The FDA’s approval of fluoxetine (PROZAC) for children was based on two

studies whose outcomes were controversial, even to the FDA reviewers.

According to the report issued by the Center for Drug Evaluation and

Research at FDA, the treatment effect of fluoxetine compared to placebo was

“non-significant” but trended in the direction of favoring the drug in one

trial of 96 patients. Even that trend was based on what the reviewer

considered a low threshold for measuring relief from the symptoms of

depression. A second trial involving 210 youths “did not win on the

protocol specified endpoint.” However, other measures of psychic wellbeing

indicated that about 70 percent of patients improved compared to 60 percent

on placebo. “The sponsor appeared to achieve nominal significance on other

secondary endpoints,” the reviewer noted.

_________________________________________________________________

Let the advanced features & services of MSN Internet Software maximize your

online time. http://click.atdmt.com/AVE/go/onm00200363ave/direct/01/

[Guest guest]

" Oh, I see... " said the Avenging Angel. " Well, it's time to tell the world

how Prozac became the only positively 'safe' drug for use in children " .

And, she contemplated a little longer... " There are many cunning men upon

the Earth these days; it is time for the angels of Heaven to descend down

lest we lose more of these precious children... "

(grin...!!! - couldn't help myself!!!)

http://www.cspinet.org/new/200402011.html

Center for Science in the Public Interest

Industry Funding Skews Kids and Drugs Research, Says Report

CSPI Identifies Bias in Medical Literature on Pediatric Antidepressants

A new study of medical journal reports on the effectiveness of

antidepressants in children shows that drug industry-funded research is much

more likely to be positive than independently-funded research, and both are

far more positive than the Food and Drug Administration’s (FDA) assessment

of the drugs’ tests.

The Center for Science in the Public Interest found that 96 percent of the

industry-funded efficacy studies of drugs like Prozac, Zoloft, and Paxil in

children were positive. That compares to just 63 percent of independently

funded studies published in medical journals.

If one looks at just published clinical trials that contained a

placebo-controlled arm, industry-funded clinicians reported the drugs were

effective in 9 out of 10 cases. But among researchers not funded by

industry, only 5 out of 9 reported positive results, which is surprisingly

low given that other studies have shown that medical journals are biased

toward publishing positive reports. By comparison, just 3 of 15 FDA reviews

of pediatric antidepressant trials, many of which have not been published,

were positive.

" Regrettably, drug companies see medical journals as just another cog in

their public relations machine, " said Merrill Goozner, director of the CSPI

Integrity in Science Project. " Industry funding has skewed the published

literature and through that medical opinion on the use of these drugs in

kids. "

Prozac, Zoloft, and Paxil are among a class of antidepressants known as

selective seratonin reuptake inhibitors (SSRIs). A joint meeting of the

FDA’s Psychopharmacologic and Pediatric Advisory Committees is meeting on

Monday to discuss the possible connection between this class of drugs and

suicide in youths. As the FDA reviewer pointed out in his review before

today’s meeting, " Ultimately, this is a risk benefit assessment, so it is

important to know where we stand on the benefit side of the issue. "

While most researchers believe their funding source does not influence their

results, this study echoes numerous previous studies finding that published

research that is industry-funded is much more likely to show results

favorable to the sponsor than independent research funded by either

government or academic institutions.

" The pharmaceutical industry’s domination of this field of research has

biased the published record, " Goozner said. " That fact should be taken into

account when evaluating the alleged benefits of these drugs versus their

potential risks. "

ALSO, READ THIS! A MOST IMPORTANT AND REVEALING REPORT !!!

http://cspinet.org/new/pdf/ssri_paper.pdf

In the third paragraph:

The FDA’s approval of fluoxetine (PROZAC) for children was based on two

studies whose outcomes were controversial, even to the FDA reviewers.

According to the report issued by the Center for Drug Evaluation and

Research at FDA, the treatment effect of fluoxetine compared to placebo was

“non-significant” but trended in the direction of favoring the drug in one

trial of 96 patients. Even that trend was based on what the reviewer

considered a low threshold for measuring relief from the symptoms of

depression. A second trial involving 210 youths “did not win on the

protocol specified endpoint.” However, other measures of psychic wellbeing

indicated that about 70 percent of patients improved compared to 60 percent

on placebo. “The sponsor appeared to achieve nominal significance on other

secondary endpoints,” the reviewer noted.

_________________________________________________________________

Let the advanced features & services of MSN Internet Software maximize your

online time. http://click.atdmt.com/AVE/go/onm00200363ave/direct/01/