ACNP Task Force Issues Final Report on SSRIs & Suicidal Behavior

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ACNP Task Force Issues Final Report on SSRIs & Suicidal Behavior

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

FYI

At about the same time that the Swedish government issued special

warnings and special precautions--essentially banning the use of

Prozac (Fontex)( and the other antidepressants) in children under 18

(Nov 18, 2005) in compliance with the European Commssion

requirements, the American College of Neuropsychopharmacology (ACNP)

Task Force issued its " Final Report " on suicidality and

antidepressants in children.

The ACNP shuts its eyes to reality attempting to sweep the truth

about antidepression drugs under the multi-dollar carpet.

The ACNP Task Force, whose members have long-standing substantial

financial ties to SSRI manufacturers, has once again issued a report

full of unsubstantiated declarations that serve the financial

interest of those drugs' manufacturers, the ACNP, and its membership:

" The report calculated that there was a substantial risk-benefit

ratio for the use of fluoxetine in those under 18. "

Where is the scientific evidence for that pattently false statement?

This statement flies in the face of the scientific evidence that

refutes that claim: In controlled clinical trials antidepressants

failed to demonstrate a benefit greater than placebo in depressed

children. Although the FDA approved Prozac for pediatric depression,

it is questionable whether the slight benefit is clinically

significant.

" The benefits of treating youth with depression with one

antidepressant medication outweigh the increase in risk of suicidal

thoughts and nonfatal suicidal behavior… "

Once again, ACNP declares--without substantiating evidence--

that " untreated major depression is the main cause of suicide in

children and adolescents, and that suicide is the third leading cause

of death among 15-to-24 year-olds. "

Most importantly, the implication that treatment with

antidepressants prevents suicide is totally unsubstantiated.

Indeed, no antidepressant manufacturer has ever been allowed to

claim that any antidepressant prevents suicide.

Once again, the ACNP Task Force has issued findings based on

optimistic partial data:

The report acknowledges: " the ACNP Task Force did not have access to

some unpublished data, including detailed findings held by drug

companies. "

Absent from this report is the most relevant unpublished data-- such

as is contained in company documents. An example was uncovered by New

York State Attorney General, Eliot Spitzer: See:

http://www.ahrp.org/risks/SSRI0204/GSKpaxil/pg1.html

4.4 Special warnings and Special precautions for use

Use in children and adolescents under 18 years of age

Fontex should not be used in the treatment of children and

adolescents under the age of 18 years. Suicide-related behaviours

(suicide attempt and suicidal thoughts), and hostility (predominantly

aggression, oppositional behaviour and anger) were more frequently

observed in clinical trials among children and adolescents treated

with antidepressants compared to those treated with placebo.

If, based on clinical need, a decision to treat is evertheless taken,

the patient should be carefully monitored for the appearance of

suicidal symptoms. In addition, long-term safety data in children and

adolescents concerning growth, maturation and cognitive and

behavioural development are lacking.

http://www.fass.se/LIF/produktfakta/artikel_produkt.jsp?

NplID=19970619000020 & DocTypeID=6

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

ACNP Issues Final Report on SSRIs and Suicidal Behavior in Youth

http://www.nature.com/npp/index.html

Task Force Finds Urgent Need for Effective Treatment for

Depression in Children and Adolescents

NASHVILLE, Tenn., Nov. 23 /PRNewswire/ -- The benefits of

treating youth

with depression with one antidepressant medication outweigh the

increase in

risk of suicidal thoughts and nonfatal suicidal behavior found in an

analysis

of a Food and Drug Administration (FDA) database of adverse event

reports,

according to the findings of the American College of

Neuropsychopharmacology

(ACNP) Task Force Report on SSRIs and Suicidal Behavior in Youth.

The report

was published today in the journal Neuropsychopharmacology, and

updates a

preliminary report that ACNP released in January 2004.

" Given that untreated major depression is the main cause of

suicide in

children and adolescents, and that suicide is the third leading cause

of death

among 15-to-24 year-olds, there is an urgent need for effective

antidepressant

treatments, " explained Mann, MD, Task Force Co-Chair and lead

author,

Professor of Translational Neuroscience in Psychiatry and Radiology,

and Chief

of the Department of Neuroscience, New York State Psychiatric

Institute at

Columbia University Medical Center. " Although many medications have

been

tested, only one has proven effective in testing done to date. "

The ACNP Task Force evaluated the safety and efficacy of selective

serotonin reuptake inhibitor (SSRI) antidepressant medication for

depressed

youth under 18 years of age. Antidepressant medications, including

SSRIs,

have been proven effective for treating depression in adults, and

while this

effect may also generalize to youth, it has received less study.

According to the ACNP Task Force Report, fluoxetine is the only

medication

that has been presently documented to effectively treat depression in

youth.

No other SSRI, non-SSRI new generation antidepressant, or tricyclic

antidepressant has demonstrated efficacy according to the standard of

the

report, which required two placebo-controlled clinical trials to find

such an

effect. Cognitive behavioral therapy, a form of psychotherapy, was

found to be

effective if combined with fluoxetine use, but used alone has not

been shown

to be more effective than placebo.

The Report was undertaken by the ACNP after regulatory agencies

in the

United States and United Kingdom raised concerns in 2003 about the

possibility

that treatment of depression with SSRIs in that age group might

increase the

risk of suicide. In September 2004, the FDA decided to require a

black box

warning regarding suicide risk for all antidepressants, continuing

the debate

on the efficacy and relative risk of antidepressant use in youth with

depression.

The ACNP Task Force Report urges clinicians treating depressed

youth to

ask about suicide, suicidal thinking, and plans for suicide, and

noted that

ongoing monitoring of suicidal thoughts in patients treated with

antidepressants is necessary. " Our concern is that the FDA warning

may be

misinterpreted, and clinicians may choose not to treat youth with

major

depression, " noted Mann.

The ACNP Task Force concluded that the available data from

clinical trials

of SSRIs and other new generation antidepressant medications indicate

a small

increase in the risk of adverse event reports of suicidal thinking or

suicide

attempts in youth (2% vs. 4% on average). However, no suicides have

occurred

in the FDA database of trials of antidepressants in youth.

Furthermore, the

FDA analysis of systematic ratings of suicidal ideation and behavior

in these

antidepressant studies of depressed youth did not find an increased

risk of a

worsening of those thoughts or behaviors among those taking SSRIs vs.

placebo.

" The adverse event data found no suicides among youth receiving

SSRIs in

these studies and only a small increase in suicidal thoughts and

attempts, "

explained Dr. Mann. " Other studies also systematically asked youth

about

their suicidal thoughts and behavior, and found no increase in suicide

attempts or thoughts among those taking SSRIs. " The ACNP Task Force

members

found that this inconsistency raised questions about the reliability

of

adverse event reports compared with systematic questioning.

The report calculated that there was a substantial risk-benefit

ratio for

the use of fluoxetine in those under 18. Using the FDA's meta-

analyses of

adverse event data, the ACNP Task Force members determined a " number

needed to

treat " (NNT) and a " number needed to harm, " (NNH) using a very low

threshold

that included suicidal thoughts (not just suicide attempts). The NNH

average

for all the antidepressants tested and reviewed by the FDA was 28

times that

of NNT (mean of 402 for NNH vs. 17.4 for NNT).

" Psychiatric disorders, such as depression, are the major causes

of

suicide, " said Mann. " Our Task Force concluded that the benefits of

treating

this serious illness far exceed the risk associated with the use of

fluoxetine. "

The report concluded that there is additional evidence that does

not

support the hypothesis that SSRIs increase the risk of fatal suicide

attempts.

Epidemiology studies show that the rates of suicide among youth

decrease in

nations in proportion to the increase in use of antidepressants, a

finding not

related to the national rates of drug use or firearms policy. In the

United

States, those regions prescribing the most SSRIs have experienced the

biggest

falls in youth suicide rates. Also, autopsy studies among youth who

have died

by suicide showed that few or none tested positive for SSRIs at the

time of

their death.

The ACNP Task Force Report findings are based on the full range of

publicly available data on the use of antidepressants in depressed

youth under

18 years of age, including the data used by the FDA in 2004 to review

the use

of SSRIs in depressed youth and the data reported to the United

Kingdom

Medicines and Healthcare Products Regulatory Agency (MHRA).

Additionally, the

authors reviewed new studies published since the preliminary report,

including

the 2004 findings of the Treatment for Adolescents with Depression

Study

(TADS). However, the ACNP Task Force did not have access to some

unpublished

data, including detailed findings held by drug companies.

The ACNP Task Force called for all data held by the FDA or

pharmaceutical

companies to be made rapidly available to ACNP and other research

organizations to conduct further independent evaluations of the risks

and

benefits of SSRIs. The report also noted the need for clinical

trials and

other research studies to include better measures for evaluating

suicidal

behavior, including asking study participants about suicidal thoughts

and

behavior, and not excluding patients at high risk for suicidal

behavior.

" Adverse event reports of antidepressants are a poor way to determine

suicide

risk, " explained Dr. Mann, " We need studies using other, better

systematically

collected measures. "

The full report of the article, found in the journal

Neuropsychopharmacology, is available online at

http://www.nature.com/npp/index.html.

The ACNP, a non-profit organization, receives revenues from a

variety of

sources including membership dues, publication sales, registration

fees and

pharmaceutical industry grants. The ACNP Task Force on SSRIs and

Suicidal

Behavior in Youth received no fees or industry grants. The cost of

the report

was supported solely by the ACNP.

ACNP, founded in 1961, is a professional organization of more

than 700

leading scientists, including four Nobel Laureates. The mission of

ACNP is to

further research and education in neuropsychopharmacology and related

fields

in the following ways: promoting the interaction of a broad range of

scientific disciplines of brain and behavior in order to advance the

understanding of prevention and treatment of disease of the nervous

system

including psychiatric, neurological, behavioral and addictive

disorders;

encouraging scientists to enter research careers in fields related to

these

disorders and their treatment; and ensuring the dissemination of

relevant

scientific advances.

SOURCE American College of Neuropsychopharmacology

Web Site: http://www.nature.com/npp/index.html

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