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Healthy Skepticism Library item: 3883

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Journal Article

Lenzer J.
Antidepressants double suicidality in children, says FDA
BMJ 2006 Mar 18; 2006;332:626:(doi:10.1136/bmj.332.):
http://bmj.bmjjournals.com/cgi/content/extract/332/7542/626-c


Full text:

BMJ 2006;332:626 (18 March), doi:10.1136/bmj.332.7542.626-c
Antidepressants double suicidality in children, says FDA

New York Jeanne Lenzer

Children and adolescents treated with antidepressants are nearly twice as likely to develop suicidality-suicidal thinking and behaviour-as similar children treated with placebo. This is the finding of a meta-analysis of 24 studies by the US Food and Drug Administration. The studies tested 4582 patients taking nine antidepressants versus placebo for major depressive disorder, obsessive-compulsive disorder, generalised anxiety disorder, attention deficit or hyperactivity disorder, and social anxiety disorder.

The FDA’s analysis, published in this month’s Archives of General Psychiatry is the final review of data that were previously analysed but not released by the FDA (2006;63:332-9). News of the secret data emerged in August 2004, and led to criticism of the FDA when it was learnt that Andrew Mosholder, an expert in the FDA’s office of drug safety, concluded that antidepressants doubled the risk of suicidality in children, but he was not allowed to publish his findings . . . [Full text of this article]

 

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Cases of wilful misrepresentation are a rarity in medical advertising. For every advertisement in which nonexistent doctors are called on to testify or deliberately irrelevant references are bunched up in [fine print], you will find a hundred or more whose greatest offenses are unquestioning enthusiasm and the skill to communicate it.

The best defence the physician can muster against this kind of advertising is a healthy skepticism and a willingness, not always apparent in the past, to do his homework. He must cultivate a flair for spotting the logical loophole, the invalid clinical trial, the unreliable or meaningless testimonial, the unneeded improvement and the unlikely claim. Above all, he must develop greater resistance to the lure of the fashionable and the new.
- Pierre R. Garai (advertising executive) 1963