Andtidepressants and Children...

[Guest guest]

Gotham Gazette - http://www.gothamgazette.com/article/health/20040611/9/1004

Andtidepressants and Children

by Sue Young

June 06, 2004

As this month began, a landmark research study and an unusual lawsuit by the

state of New York added to the current controversy about whether children

and adolescents with depression should be treated with the popular

antidepressant medications known as selective serotonin reuptake inhibitors

(SSRIs), a class of drugs which includes the best-selling Prozac and Paxil.

On June 1, researchers carrying out a federally funded study at Duke

University announced preliminary findings that Prozac works significantly

better than talk therapy to combat depression in adolescents, although a

combination of the two treatments is the optimum. The early data also

suggest that Prozac does not, in fact, raise the risk of suicide in

adolescents, and that the benefits of taking it far outweigh the risks if a

teen is battling moderate to severe depression.

On June 2, New York State Attorney General Eliot Spitzer filed a

consumer-fraud lawsuit against the manufacturer of the antidepressant Paxil,

charging that international pharmaceutical giant GlaxoKline

deliberately suppressed negative data about Paxil's safety and efficacy when

prescribed for depression in children and adolescents.

Specifically, Spitzer's lawsuit alleges that the company suppressed the

results of four studies it conducted that failed to demonstrate Paxil's

effectiveness against depression in children, and suggested possible

increased risk of suicidal thinking and acts. Out of the five studies it

conducted, Glaxo released the results only of the one that showed mixed

results on efficacy in children and teens, the suit alleges.

As the New York Times story on the lawsuit notes, the suit highlights two

particular issues about antidepressants that have recently made headlines

and captured medical and public attention. One is the previously mentioned

question of whether some antidepressants, specifically some SSRIs, can

actually increase suicidal tendencies, especially in children and

adolescents. The other is whether, and to what extent, drug companies pick

and choose among the data they present to the U.S. Food and Drug

Administration when seeking FDA approval for a drug, presenting only those

studies that support the drug's efficacy and safety and suppressing any that

reach the " wrong " conclusions.

" Doctors should have access to all scientifically sound information so that

they can prescribe appropriate medication for their patients, " Spitzer said

of his lawsuit. " By concealing critically important scientific studies on

Paxil, Glaxo impaired doctors' ability to make the appropriate prescribing

decision for their patients and may have jeopardized their health and

safety. "

The suit, filed in New York State Supreme Court, also stated that an

internal Glaxo document from 1998 shows that the company intended to " manage

the dissemination of [the] data in order to minimize any potential negative

commercial impact. "

It alleges that Glaxo misrepresented the drug to its sales representatives

who promote Paxil to physicians, as having " remarkable efficacy and safety

in the treatment of adolescent depression, " despite the company's studies

that suggested differently.

Glaxo issued a statement the same day asserting that the company " has acted

responsibly in conducting clinical studies in pediatric patients and

disseminating data from those studies.... All pediatric studies have been

made available to the FDA and regulatory agencies worldwide. "

" As for the 1998 memo, it is inconsistent with the facts and does not

reflect the company position, " the statement continues.

Paxil has been approved by the FDA for the treatment of depression in adults

but not in children. The only antidepressant that has been approved to treat

depression in children is Prozac, which is made by Eli Lilly & Co.

It is, however, legal for doctors to use their discretion to prescribe

medications for uses other than the approved ones, if clinical practice has

shown them to be useful. They are especially likely to do so if the

medications are similar to ones that are approved for those uses. This

widespread practice is called " off-label " prescribing.

U.S. sales of Paxil to treat mood disorders in children and adolescents

totaled $55 million in 2002, the lawsuit states. The suit seeks the return

of all profits Glaxo has earned as a result of the alleged misconduct.

Meanwhile, according to a New York Times report, the researchers for the

Duke University study announced at a psychiatric meeting in Phoenix that the

12-week data showed that a combination of Prozac plus " talk " therapy worked

best for depressed teenagers, with 71 percent of these patients responding

well to treatment. Prozac alone worked next best, improving depression in 61

percent of the young patients. Talk therapy alone (specifically,

cognitive-behavioral therapy, which previous studies have shown to be the

most effective type of talk therapy at combating depression) worked only

slightly better than a placebo. Only 43 percent of the patients treated with

cognitive-behavioral therapy, versus 35 percent of those taking a placebo

pill, showed significant improvement. None of the 378 teens aged 12 to 17

committed suicide, although there were six attempts.

The Duke team, whose research is being funded solely by the federal National

Institutes of Mental Health with no drug-company involvement, is currently

analyzing the data from the rest of the year-long study.

Sue is a journalist who writes frequently on health and science

topics for such outlets as the New York Times, WNET, and UNICEF

[Guest guest]

Gotham Gazette - http://www.gothamgazette.com/article/health/20040611/9/1004

Andtidepressants and Children

by Sue Young

June 06, 2004

As this month began, a landmark research study and an unusual lawsuit by the

state of New York added to the current controversy about whether children

and adolescents with depression should be treated with the popular

antidepressant medications known as selective serotonin reuptake inhibitors

(SSRIs), a class of drugs which includes the best-selling Prozac and Paxil.

On June 1, researchers carrying out a federally funded study at Duke

University announced preliminary findings that Prozac works significantly

better than talk therapy to combat depression in adolescents, although a

combination of the two treatments is the optimum. The early data also

suggest that Prozac does not, in fact, raise the risk of suicide in

adolescents, and that the benefits of taking it far outweigh the risks if a

teen is battling moderate to severe depression.

On June 2, New York State Attorney General Eliot Spitzer filed a

consumer-fraud lawsuit against the manufacturer of the antidepressant Paxil,

charging that international pharmaceutical giant GlaxoKline

deliberately suppressed negative data about Paxil's safety and efficacy when

prescribed for depression in children and adolescents.

Specifically, Spitzer's lawsuit alleges that the company suppressed the

results of four studies it conducted that failed to demonstrate Paxil's

effectiveness against depression in children, and suggested possible

increased risk of suicidal thinking and acts. Out of the five studies it

conducted, Glaxo released the results only of the one that showed mixed

results on efficacy in children and teens, the suit alleges.

As the New York Times story on the lawsuit notes, the suit highlights two

particular issues about antidepressants that have recently made headlines

and captured medical and public attention. One is the previously mentioned

question of whether some antidepressants, specifically some SSRIs, can

actually increase suicidal tendencies, especially in children and

adolescents. The other is whether, and to what extent, drug companies pick

and choose among the data they present to the U.S. Food and Drug

Administration when seeking FDA approval for a drug, presenting only those

studies that support the drug's efficacy and safety and suppressing any that

reach the " wrong " conclusions.

" Doctors should have access to all scientifically sound information so that

they can prescribe appropriate medication for their patients, " Spitzer said

of his lawsuit. " By concealing critically important scientific studies on

Paxil, Glaxo impaired doctors' ability to make the appropriate prescribing

decision for their patients and may have jeopardized their health and

safety. "

The suit, filed in New York State Supreme Court, also stated that an

internal Glaxo document from 1998 shows that the company intended to " manage

the dissemination of [the] data in order to minimize any potential negative

commercial impact. "

It alleges that Glaxo misrepresented the drug to its sales representatives

who promote Paxil to physicians, as having " remarkable efficacy and safety

in the treatment of adolescent depression, " despite the company's studies

that suggested differently.

Glaxo issued a statement the same day asserting that the company " has acted

responsibly in conducting clinical studies in pediatric patients and

disseminating data from those studies.... All pediatric studies have been

made available to the FDA and regulatory agencies worldwide. "

" As for the 1998 memo, it is inconsistent with the facts and does not

reflect the company position, " the statement continues.

Paxil has been approved by the FDA for the treatment of depression in adults

but not in children. The only antidepressant that has been approved to treat

depression in children is Prozac, which is made by Eli Lilly & Co.

It is, however, legal for doctors to use their discretion to prescribe

medications for uses other than the approved ones, if clinical practice has

shown them to be useful. They are especially likely to do so if the

medications are similar to ones that are approved for those uses. This

widespread practice is called " off-label " prescribing.

U.S. sales of Paxil to treat mood disorders in children and adolescents

totaled $55 million in 2002, the lawsuit states. The suit seeks the return

of all profits Glaxo has earned as a result of the alleged misconduct.

Meanwhile, according to a New York Times report, the researchers for the

Duke University study announced at a psychiatric meeting in Phoenix that the

12-week data showed that a combination of Prozac plus " talk " therapy worked

best for depressed teenagers, with 71 percent of these patients responding

well to treatment. Prozac alone worked next best, improving depression in 61

percent of the young patients. Talk therapy alone (specifically,

cognitive-behavioral therapy, which previous studies have shown to be the

most effective type of talk therapy at combating depression) worked only

slightly better than a placebo. Only 43 percent of the patients treated with

cognitive-behavioral therapy, versus 35 percent of those taking a placebo

pill, showed significant improvement. None of the 378 teens aged 12 to 17

committed suicide, although there were six attempts.

The Duke team, whose research is being funded solely by the federal National

Institutes of Mental Health with no drug-company involvement, is currently

analyzing the data from the rest of the year-long study.

Sue is a journalist who writes frequently on health and science

topics for such outlets as the New York Times, WNET, and UNICEF

[Guest guest]

Gotham Gazette - http://www.gothamgazette.com/article/health/20040611/9/1004

Andtidepressants and Children

by Sue Young

June 06, 2004

As this month began, a landmark research study and an unusual lawsuit by the

state of New York added to the current controversy about whether children

and adolescents with depression should be treated with the popular

antidepressant medications known as selective serotonin reuptake inhibitors

(SSRIs), a class of drugs which includes the best-selling Prozac and Paxil.

On June 1, researchers carrying out a federally funded study at Duke

University announced preliminary findings that Prozac works significantly

better than talk therapy to combat depression in adolescents, although a

combination of the two treatments is the optimum. The early data also

suggest that Prozac does not, in fact, raise the risk of suicide in

adolescents, and that the benefits of taking it far outweigh the risks if a

teen is battling moderate to severe depression.

On June 2, New York State Attorney General Eliot Spitzer filed a

consumer-fraud lawsuit against the manufacturer of the antidepressant Paxil,

charging that international pharmaceutical giant GlaxoKline

deliberately suppressed negative data about Paxil's safety and efficacy when

prescribed for depression in children and adolescents.

Specifically, Spitzer's lawsuit alleges that the company suppressed the

results of four studies it conducted that failed to demonstrate Paxil's

effectiveness against depression in children, and suggested possible

increased risk of suicidal thinking and acts. Out of the five studies it

conducted, Glaxo released the results only of the one that showed mixed

results on efficacy in children and teens, the suit alleges.

As the New York Times story on the lawsuit notes, the suit highlights two

particular issues about antidepressants that have recently made headlines

and captured medical and public attention. One is the previously mentioned

question of whether some antidepressants, specifically some SSRIs, can

actually increase suicidal tendencies, especially in children and

adolescents. The other is whether, and to what extent, drug companies pick

and choose among the data they present to the U.S. Food and Drug

Administration when seeking FDA approval for a drug, presenting only those

studies that support the drug's efficacy and safety and suppressing any that

reach the " wrong " conclusions.

" Doctors should have access to all scientifically sound information so that

they can prescribe appropriate medication for their patients, " Spitzer said

of his lawsuit. " By concealing critically important scientific studies on

Paxil, Glaxo impaired doctors' ability to make the appropriate prescribing

decision for their patients and may have jeopardized their health and

safety. "

The suit, filed in New York State Supreme Court, also stated that an

internal Glaxo document from 1998 shows that the company intended to " manage

the dissemination of [the] data in order to minimize any potential negative

commercial impact. "

It alleges that Glaxo misrepresented the drug to its sales representatives

who promote Paxil to physicians, as having " remarkable efficacy and safety

in the treatment of adolescent depression, " despite the company's studies

that suggested differently.

Glaxo issued a statement the same day asserting that the company " has acted

responsibly in conducting clinical studies in pediatric patients and

disseminating data from those studies.... All pediatric studies have been

made available to the FDA and regulatory agencies worldwide. "

" As for the 1998 memo, it is inconsistent with the facts and does not

reflect the company position, " the statement continues.

Paxil has been approved by the FDA for the treatment of depression in adults

but not in children. The only antidepressant that has been approved to treat

depression in children is Prozac, which is made by Eli Lilly & Co.

It is, however, legal for doctors to use their discretion to prescribe

medications for uses other than the approved ones, if clinical practice has

shown them to be useful. They are especially likely to do so if the

medications are similar to ones that are approved for those uses. This

widespread practice is called " off-label " prescribing.

U.S. sales of Paxil to treat mood disorders in children and adolescents

totaled $55 million in 2002, the lawsuit states. The suit seeks the return

of all profits Glaxo has earned as a result of the alleged misconduct.

Meanwhile, according to a New York Times report, the researchers for the

Duke University study announced at a psychiatric meeting in Phoenix that the

12-week data showed that a combination of Prozac plus " talk " therapy worked

best for depressed teenagers, with 71 percent of these patients responding

well to treatment. Prozac alone worked next best, improving depression in 61

percent of the young patients. Talk therapy alone (specifically,

cognitive-behavioral therapy, which previous studies have shown to be the

most effective type of talk therapy at combating depression) worked only

slightly better than a placebo. Only 43 percent of the patients treated with

cognitive-behavioral therapy, versus 35 percent of those taking a placebo

pill, showed significant improvement. None of the 378 teens aged 12 to 17

committed suicide, although there were six attempts.

The Duke team, whose research is being funded solely by the federal National

Institutes of Mental Health with no drug-company involvement, is currently

analyzing the data from the rest of the year-long study.

Sue is a journalist who writes frequently on health and science

topics for such outlets as the New York Times, WNET, and UNICEF

[Guest guest]

Gotham Gazette - http://www.gothamgazette.com/article/health/20040611/9/1004

Andtidepressants and Children

by Sue Young

June 06, 2004

As this month began, a landmark research study and an unusual lawsuit by the

state of New York added to the current controversy about whether children

and adolescents with depression should be treated with the popular

antidepressant medications known as selective serotonin reuptake inhibitors

(SSRIs), a class of drugs which includes the best-selling Prozac and Paxil.

On June 1, researchers carrying out a federally funded study at Duke

University announced preliminary findings that Prozac works significantly

better than talk therapy to combat depression in adolescents, although a

combination of the two treatments is the optimum. The early data also

suggest that Prozac does not, in fact, raise the risk of suicide in

adolescents, and that the benefits of taking it far outweigh the risks if a

teen is battling moderate to severe depression.

On June 2, New York State Attorney General Eliot Spitzer filed a

consumer-fraud lawsuit against the manufacturer of the antidepressant Paxil,

charging that international pharmaceutical giant GlaxoKline

deliberately suppressed negative data about Paxil's safety and efficacy when

prescribed for depression in children and adolescents.

Specifically, Spitzer's lawsuit alleges that the company suppressed the

results of four studies it conducted that failed to demonstrate Paxil's

effectiveness against depression in children, and suggested possible

increased risk of suicidal thinking and acts. Out of the five studies it

conducted, Glaxo released the results only of the one that showed mixed

results on efficacy in children and teens, the suit alleges.

As the New York Times story on the lawsuit notes, the suit highlights two

particular issues about antidepressants that have recently made headlines

and captured medical and public attention. One is the previously mentioned

question of whether some antidepressants, specifically some SSRIs, can

actually increase suicidal tendencies, especially in children and

adolescents. The other is whether, and to what extent, drug companies pick

and choose among the data they present to the U.S. Food and Drug

Administration when seeking FDA approval for a drug, presenting only those

studies that support the drug's efficacy and safety and suppressing any that

reach the " wrong " conclusions.

" Doctors should have access to all scientifically sound information so that

they can prescribe appropriate medication for their patients, " Spitzer said

of his lawsuit. " By concealing critically important scientific studies on

Paxil, Glaxo impaired doctors' ability to make the appropriate prescribing

decision for their patients and may have jeopardized their health and

safety. "

The suit, filed in New York State Supreme Court, also stated that an

internal Glaxo document from 1998 shows that the company intended to " manage

the dissemination of [the] data in order to minimize any potential negative

commercial impact. "

It alleges that Glaxo misrepresented the drug to its sales representatives

who promote Paxil to physicians, as having " remarkable efficacy and safety

in the treatment of adolescent depression, " despite the company's studies

that suggested differently.

Glaxo issued a statement the same day asserting that the company " has acted

responsibly in conducting clinical studies in pediatric patients and

disseminating data from those studies.... All pediatric studies have been

made available to the FDA and regulatory agencies worldwide. "

" As for the 1998 memo, it is inconsistent with the facts and does not

reflect the company position, " the statement continues.

Paxil has been approved by the FDA for the treatment of depression in adults

but not in children. The only antidepressant that has been approved to treat

depression in children is Prozac, which is made by Eli Lilly & Co.

It is, however, legal for doctors to use their discretion to prescribe

medications for uses other than the approved ones, if clinical practice has

shown them to be useful. They are especially likely to do so if the

medications are similar to ones that are approved for those uses. This

widespread practice is called " off-label " prescribing.

U.S. sales of Paxil to treat mood disorders in children and adolescents

totaled $55 million in 2002, the lawsuit states. The suit seeks the return

of all profits Glaxo has earned as a result of the alleged misconduct.

Meanwhile, according to a New York Times report, the researchers for the

Duke University study announced at a psychiatric meeting in Phoenix that the

12-week data showed that a combination of Prozac plus " talk " therapy worked

best for depressed teenagers, with 71 percent of these patients responding

well to treatment. Prozac alone worked next best, improving depression in 61

percent of the young patients. Talk therapy alone (specifically,

cognitive-behavioral therapy, which previous studies have shown to be the

most effective type of talk therapy at combating depression) worked only

slightly better than a placebo. Only 43 percent of the patients treated with

cognitive-behavioral therapy, versus 35 percent of those taking a placebo

pill, showed significant improvement. None of the 378 teens aged 12 to 17

committed suicide, although there were six attempts.

The Duke team, whose research is being funded solely by the federal National

Institutes of Mental Health with no drug-company involvement, is currently

analyzing the data from the rest of the year-long study.

Sue is a journalist who writes frequently on health and science

topics for such outlets as the New York Times, WNET, and UNICEF