[SSRI-Research] Drugs' risks too great By Vera Hassner Sharav

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Sat, 26 Jun 2004 11:18:48 -0400

[sSRI-Research] Drugs' risks too great By Vera Hassner Sharav

 

Drugs' risks too great By Vera Hassner Sharav

http://www.usatoday.com/news/opinion/editorials/2004-06-20-oppose_x.htm

 

 

Medicine's foremost ethical principle is " First, do no

harm. " When reasonable evidence exists that some

children may be harmed from drugs prescribed for

non-life-threatening conditions, it is our duty - and

the Food and Drug Administration's (FDA)

responsibility - to protect them from preventable

harm.

 

Published trials are the basis of treatment

guidelines. But drug manufacturers and their

collaborators have published false claims about the

safety and benefit of antidepressants for children, by

excluding negative data, thereby misleading physicians

and parents. New York State Attorney General Eliot

Spitzer has charged concealment of harmful data and

fraud. That data, euphemistically labeled, " emotional

liability, " confirm case reports of aggression,

hostility and suicidal thinking and behavior in some

children prescribed an antidepressant - even for a

short time.

 

Under pressure, GlaxoSmithKline has posted previously

concealed documents on its Web site. They reveal that

in a clinical trial whose published report claimed

Paxil was " safe and effective, " 8% of children taking

Paxil became hostile compared with 0% on a placebo,

and 7% became suicidal compared with 1% on a placebo.

Furthermore, " worsening of depression, including

suicidal ideation/gestures and hostility were the most

commonly reported severe events. "

 

According to an FDA review of Prozac data, published

reports failed to disclose that at least three

children on Prozac attempted suicide vs. one on a

placebo, and others were hospitalized " for suicidal

ideation " ; some children's growth decreased within 19

weeks of taking Prozac; and " mania and hypomania

appear to be much more common in these trials than has

been the case in adult clinical studies. "

 

Had FDA officials wanted to protect children they

would have analyzed the data long ago and issued

warnings. Instead, they suppressed an FDA expert

analyst's report - which has led to a congressional

investigation. They transferred data summaries to a

Columbia University panel of questionable objectivity,

given its close ties to drugmakers. This effort to

second-guess psychiatrists who conducted the trials,

evaluated children's behavior before and after

exposure to these drugs and judged their behavior to

be suicidal is an exercise in futility.

 

Vera Hassner Sharav is president of Alliance for Human

Research Protection.

 

 

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