FDA withheld controversial results of suicide study

[Guest guest]

Posted on Tue, Apr. 06, 2004

FDA withheld controversial results of suicide study

By Shogren

LOS ANGELES TIMES

WASHINGTON - Ten months ago, when concerns arose about a possible link between

children taking antidepressant drugs and suicide attempts, senior officials at

the Food and Drug Administration ordered their leading expert to head up an

examination of the evidence.

When the government scientist filed his report last winter, however, his bosses

decided to keep it secret, even though it found that children who took the drugs

were twice as likely to be involved in serious suicide-related behavior as those

who did not.

Instead of revealing the findings, senior FDA officials ordered more studies,

which are not expected to be completed until summer.

They squelched plans to have the author, Dr. Mosholder, present his

conclusions to an FDA advisory committee when it took up the issue in February.

And in March, when the agency issued a warning about the possibility of problems

for young patients taking the drugs, FDA officials said no conclusive scientific

evidence existed on the link between antidepressants and potentially suicidal

behavior by children.

Officials said they based their action on anecdotal complaints from physicians

and families that had been presented to the advisory committee.

They gave no hint that their own chief expert on the subject had examined the

results of more than two dozen clinical trials conducted by antidepressant

manufacturers and had found an unusually high correlation between their use by

young patients and potentially suicidal behavior.

The report still has not been made public, but news of Mosholder's conclusions

first surfaced in a CBS News report last week. His findings were detailed in an

internal FDA document obtained by the Los Angeles Times and authenticated by

government officials.

In justifying their decision to hold back Mosholder's report, his superiors

questioned the reliability of the data on which he based his conclusions.

They suggested the drug companies, which manufacture the antidepressant drugs

and conducted the clinical trials in order to market them, might have been too

quick to count some behavior as potentially related to suicide -- that is, too

quick to raise questions about their products.

Among the kinds of actions these officials said should not necessarily have been

counted as potentially suicide-related were instances of children who

deliberately cut themselves.

Some FDA officials defended the decision to sit on the report and seek more

analysis of the data, but some psychiatrists and congressional leaders who are

following FDA's handling of the issue were angered that the agency had kept

Mosholder silent.

" Evidence that they're suppressing a report like this is an outrage, given the

public health and safety issues at stake, " said Dr. ph Glenmullen, a Harvard

psychiatrist who wrote a book on the problems with the drugs known as serotonin

reuptake inhibitors, which alter brain chemistry to manage depression. " They've

been claiming that there's no evidence. Here's the evidence. "

Senate and House committees have ordered the FDA to hand over documents, such as

the ones obtained by the Los Angeles Times, that might illuminate what the

agency knew about the possible link between the drugs and suicidal behavior.

They specifically asked for any of Mosholder's reports, e-mails, correspondence

or notes on pediatric or adolescent antidepressant trials.

These members of Congress are concerned that the FDA may be keeping information

from Americans that would help them better assess the possible risks of taking

antidepressants or giving them to children.

" It would have been very wrong for the FDA to withhold any information it had

about unintended consequences that might result from the use of

anti-depressants, especially for children and adolescents, " Sen.

Grassley, R-Iowa, chairman of the Senate Finance Committee, said in a statement.

" The public deserves to know of every possible risk so that family members can

closely monitor any changes in behavior, " he said.

Suicide is the third leading cause of death in teenagers ages 15 to 19. From

1980 to 1997, the rate of suicide among this group increased by 11 percent.

Suicide is rare but growing among younger children. The suicide rate for those

10 to 14 years old increased by 109 percent between 1980 and 1997, according to

the federal Centers for Disease Control and Prevention.

Since peaking in the late 1990s, suicide rates appear to be declining among

teenagers but remain a serious problem. Experts say depression is the leading

factor in suicide.

Depression affects one in every 33 children and one in every eight adolescents,

according to the National Mental Health Association. Although only one

antidepressant, Prozac, is explicitly approved by the FDA for children, doctors

routinely prescribe others to their young patients, and the use of these drugs

by children has been steadily rising.

© 2004 Contra Costa Times and wire service sources. .

http://www.contracostatimes.com

[Guest guest]

Posted on Tue, Apr. 06, 2004

FDA withheld controversial results of suicide study

By Shogren

LOS ANGELES TIMES

WASHINGTON - Ten months ago, when concerns arose about a possible link between

children taking antidepressant drugs and suicide attempts, senior officials at

the Food and Drug Administration ordered their leading expert to head up an

examination of the evidence.

When the government scientist filed his report last winter, however, his bosses

decided to keep it secret, even though it found that children who took the drugs

were twice as likely to be involved in serious suicide-related behavior as those

who did not.

Instead of revealing the findings, senior FDA officials ordered more studies,

which are not expected to be completed until summer.

They squelched plans to have the author, Dr. Mosholder, present his

conclusions to an FDA advisory committee when it took up the issue in February.

And in March, when the agency issued a warning about the possibility of problems

for young patients taking the drugs, FDA officials said no conclusive scientific

evidence existed on the link between antidepressants and potentially suicidal

behavior by children.

Officials said they based their action on anecdotal complaints from physicians

and families that had been presented to the advisory committee.

They gave no hint that their own chief expert on the subject had examined the

results of more than two dozen clinical trials conducted by antidepressant

manufacturers and had found an unusually high correlation between their use by

young patients and potentially suicidal behavior.

The report still has not been made public, but news of Mosholder's conclusions

first surfaced in a CBS News report last week. His findings were detailed in an

internal FDA document obtained by the Los Angeles Times and authenticated by

government officials.

In justifying their decision to hold back Mosholder's report, his superiors

questioned the reliability of the data on which he based his conclusions.

They suggested the drug companies, which manufacture the antidepressant drugs

and conducted the clinical trials in order to market them, might have been too

quick to count some behavior as potentially related to suicide -- that is, too

quick to raise questions about their products.

Among the kinds of actions these officials said should not necessarily have been

counted as potentially suicide-related were instances of children who

deliberately cut themselves.

Some FDA officials defended the decision to sit on the report and seek more

analysis of the data, but some psychiatrists and congressional leaders who are

following FDA's handling of the issue were angered that the agency had kept

Mosholder silent.

" Evidence that they're suppressing a report like this is an outrage, given the

public health and safety issues at stake, " said Dr. ph Glenmullen, a Harvard

psychiatrist who wrote a book on the problems with the drugs known as serotonin

reuptake inhibitors, which alter brain chemistry to manage depression. " They've

been claiming that there's no evidence. Here's the evidence. "

Senate and House committees have ordered the FDA to hand over documents, such as

the ones obtained by the Los Angeles Times, that might illuminate what the

agency knew about the possible link between the drugs and suicidal behavior.

They specifically asked for any of Mosholder's reports, e-mails, correspondence

or notes on pediatric or adolescent antidepressant trials.

These members of Congress are concerned that the FDA may be keeping information

from Americans that would help them better assess the possible risks of taking

antidepressants or giving them to children.

" It would have been very wrong for the FDA to withhold any information it had

about unintended consequences that might result from the use of

anti-depressants, especially for children and adolescents, " Sen.

Grassley, R-Iowa, chairman of the Senate Finance Committee, said in a statement.

" The public deserves to know of every possible risk so that family members can

closely monitor any changes in behavior, " he said.

Suicide is the third leading cause of death in teenagers ages 15 to 19. From

1980 to 1997, the rate of suicide among this group increased by 11 percent.

Suicide is rare but growing among younger children. The suicide rate for those

10 to 14 years old increased by 109 percent between 1980 and 1997, according to

the federal Centers for Disease Control and Prevention.

Since peaking in the late 1990s, suicide rates appear to be declining among

teenagers but remain a serious problem. Experts say depression is the leading

factor in suicide.

Depression affects one in every 33 children and one in every eight adolescents,

according to the National Mental Health Association. Although only one

antidepressant, Prozac, is explicitly approved by the FDA for children, doctors

routinely prescribe others to their young patients, and the use of these drugs

by children has been steadily rising.

© 2004 Contra Costa Times and wire service sources. .

http://www.contracostatimes.com

[Guest guest]

Posted on Tue, Apr. 06, 2004

FDA withheld controversial results of suicide study

By Shogren

LOS ANGELES TIMES

WASHINGTON - Ten months ago, when concerns arose about a possible link between

children taking antidepressant drugs and suicide attempts, senior officials at

the Food and Drug Administration ordered their leading expert to head up an

examination of the evidence.

When the government scientist filed his report last winter, however, his bosses

decided to keep it secret, even though it found that children who took the drugs

were twice as likely to be involved in serious suicide-related behavior as those

who did not.

Instead of revealing the findings, senior FDA officials ordered more studies,

which are not expected to be completed until summer.

They squelched plans to have the author, Dr. Mosholder, present his

conclusions to an FDA advisory committee when it took up the issue in February.

And in March, when the agency issued a warning about the possibility of problems

for young patients taking the drugs, FDA officials said no conclusive scientific

evidence existed on the link between antidepressants and potentially suicidal

behavior by children.

Officials said they based their action on anecdotal complaints from physicians

and families that had been presented to the advisory committee.

They gave no hint that their own chief expert on the subject had examined the

results of more than two dozen clinical trials conducted by antidepressant

manufacturers and had found an unusually high correlation between their use by

young patients and potentially suicidal behavior.

The report still has not been made public, but news of Mosholder's conclusions

first surfaced in a CBS News report last week. His findings were detailed in an

internal FDA document obtained by the Los Angeles Times and authenticated by

government officials.

In justifying their decision to hold back Mosholder's report, his superiors

questioned the reliability of the data on which he based his conclusions.

They suggested the drug companies, which manufacture the antidepressant drugs

and conducted the clinical trials in order to market them, might have been too

quick to count some behavior as potentially related to suicide -- that is, too

quick to raise questions about their products.

Among the kinds of actions these officials said should not necessarily have been

counted as potentially suicide-related were instances of children who

deliberately cut themselves.

Some FDA officials defended the decision to sit on the report and seek more

analysis of the data, but some psychiatrists and congressional leaders who are

following FDA's handling of the issue were angered that the agency had kept

Mosholder silent.

" Evidence that they're suppressing a report like this is an outrage, given the

public health and safety issues at stake, " said Dr. ph Glenmullen, a Harvard

psychiatrist who wrote a book on the problems with the drugs known as serotonin

reuptake inhibitors, which alter brain chemistry to manage depression. " They've

been claiming that there's no evidence. Here's the evidence. "

Senate and House committees have ordered the FDA to hand over documents, such as

the ones obtained by the Los Angeles Times, that might illuminate what the

agency knew about the possible link between the drugs and suicidal behavior.

They specifically asked for any of Mosholder's reports, e-mails, correspondence

or notes on pediatric or adolescent antidepressant trials.

These members of Congress are concerned that the FDA may be keeping information

from Americans that would help them better assess the possible risks of taking

antidepressants or giving them to children.

" It would have been very wrong for the FDA to withhold any information it had

about unintended consequences that might result from the use of

anti-depressants, especially for children and adolescents, " Sen.

Grassley, R-Iowa, chairman of the Senate Finance Committee, said in a statement.

" The public deserves to know of every possible risk so that family members can

closely monitor any changes in behavior, " he said.

Suicide is the third leading cause of death in teenagers ages 15 to 19. From

1980 to 1997, the rate of suicide among this group increased by 11 percent.

Suicide is rare but growing among younger children. The suicide rate for those

10 to 14 years old increased by 109 percent between 1980 and 1997, according to

the federal Centers for Disease Control and Prevention.

Since peaking in the late 1990s, suicide rates appear to be declining among

teenagers but remain a serious problem. Experts say depression is the leading

factor in suicide.

Depression affects one in every 33 children and one in every eight adolescents,

according to the National Mental Health Association. Although only one

antidepressant, Prozac, is explicitly approved by the FDA for children, doctors

routinely prescribe others to their young patients, and the use of these drugs

by children has been steadily rising.

© 2004 Contra Costa Times and wire service sources. .

http://www.contracostatimes.com

[Guest guest]

Posted on Tue, Apr. 06, 2004

FDA withheld controversial results of suicide study

By Shogren

LOS ANGELES TIMES

WASHINGTON - Ten months ago, when concerns arose about a possible link between

children taking antidepressant drugs and suicide attempts, senior officials at

the Food and Drug Administration ordered their leading expert to head up an

examination of the evidence.

When the government scientist filed his report last winter, however, his bosses

decided to keep it secret, even though it found that children who took the drugs

were twice as likely to be involved in serious suicide-related behavior as those

who did not.

Instead of revealing the findings, senior FDA officials ordered more studies,

which are not expected to be completed until summer.

They squelched plans to have the author, Dr. Mosholder, present his

conclusions to an FDA advisory committee when it took up the issue in February.

And in March, when the agency issued a warning about the possibility of problems

for young patients taking the drugs, FDA officials said no conclusive scientific

evidence existed on the link between antidepressants and potentially suicidal

behavior by children.

Officials said they based their action on anecdotal complaints from physicians

and families that had been presented to the advisory committee.

They gave no hint that their own chief expert on the subject had examined the

results of more than two dozen clinical trials conducted by antidepressant

manufacturers and had found an unusually high correlation between their use by

young patients and potentially suicidal behavior.

The report still has not been made public, but news of Mosholder's conclusions

first surfaced in a CBS News report last week. His findings were detailed in an

internal FDA document obtained by the Los Angeles Times and authenticated by

government officials.

In justifying their decision to hold back Mosholder's report, his superiors

questioned the reliability of the data on which he based his conclusions.

They suggested the drug companies, which manufacture the antidepressant drugs

and conducted the clinical trials in order to market them, might have been too

quick to count some behavior as potentially related to suicide -- that is, too

quick to raise questions about their products.

Among the kinds of actions these officials said should not necessarily have been

counted as potentially suicide-related were instances of children who

deliberately cut themselves.

Some FDA officials defended the decision to sit on the report and seek more

analysis of the data, but some psychiatrists and congressional leaders who are

following FDA's handling of the issue were angered that the agency had kept

Mosholder silent.

" Evidence that they're suppressing a report like this is an outrage, given the

public health and safety issues at stake, " said Dr. ph Glenmullen, a Harvard

psychiatrist who wrote a book on the problems with the drugs known as serotonin

reuptake inhibitors, which alter brain chemistry to manage depression. " They've

been claiming that there's no evidence. Here's the evidence. "

Senate and House committees have ordered the FDA to hand over documents, such as

the ones obtained by the Los Angeles Times, that might illuminate what the

agency knew about the possible link between the drugs and suicidal behavior.

They specifically asked for any of Mosholder's reports, e-mails, correspondence

or notes on pediatric or adolescent antidepressant trials.

These members of Congress are concerned that the FDA may be keeping information

from Americans that would help them better assess the possible risks of taking

antidepressants or giving them to children.

" It would have been very wrong for the FDA to withhold any information it had

about unintended consequences that might result from the use of

anti-depressants, especially for children and adolescents, " Sen.

Grassley, R-Iowa, chairman of the Senate Finance Committee, said in a statement.

" The public deserves to know of every possible risk so that family members can

closely monitor any changes in behavior, " he said.

Suicide is the third leading cause of death in teenagers ages 15 to 19. From

1980 to 1997, the rate of suicide among this group increased by 11 percent.

Suicide is rare but growing among younger children. The suicide rate for those

10 to 14 years old increased by 109 percent between 1980 and 1997, according to

the federal Centers for Disease Control and Prevention.

Since peaking in the late 1990s, suicide rates appear to be declining among

teenagers but remain a serious problem. Experts say depression is the leading

factor in suicide.

Depression affects one in every 33 children and one in every eight adolescents,

according to the National Mental Health Association. Although only one

antidepressant, Prozac, is explicitly approved by the FDA for children, doctors

routinely prescribe others to their young patients, and the use of these drugs

by children has been steadily rising.

© 2004 Contra Costa Times and wire service sources. .

http://www.contracostatimes.com