- Drugs' risks too great
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Posted 6/20/2004 9:04 PM     Updated 6/20/2004 9:07 PM
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Drugs' risks too great
Sharav 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.