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Healthy Skepticism Library item: 14686

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

Procopio M.
The multiple outcomes bias in antidepressants research
Medical Hypotheses 2005 Apr 27; 65:(2):395-399
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WN2-4G1V67S-3&_user=10&_coverDate=12%2F31%2F2005&_rdoc=34&_fmt=high&_orig=browse&_srch=doc-info(%23toc%236950%232005%23999349997%23596828%23FLA%23display%23Volume)&_cdi=6950&_sort=d&_docanchor=&_ct=44&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=37fe41b4681d8d3bc5e4b145a9cd6e12


Abstract:

Despite the widespread use of antidepressant medication, there are no signs that the burden of depression and suicide is decreasing in the industrialised world. This is generating mounting scepticism on the effectiveness of this class of drugs as an approach for the treatment of mood disorders. These doubts are also fuelled by the increasing awareness that the literature on antidepressants is fundamentally flawed and under the control of the pharmaceutical companies. This article describes systematically for the first time what is probably the most insidious and misleading of the biases that affect this area of research: the “multiple outcomes bias”. Most trials on the effectiveness of antidepressants, instead of first establishing a hypothesis and then trying to demonstrate it, following the scientific method, start instead “data mining”, without a clear hypothesis, and then select for publication, amongst a multitude of outcomes, only the ones that favour the antidepressant drug, ignoring the others. This method has obviously no scientific validity and is very misleading, allowing the manipulation of the data without any overt fraudulent action. There is the need to generate new research, independently funded and with clear hypotheses established “a priori ”. What is at stake is not only the appraisal of the balance between benefits and potential damage to the patients when using this class of medications, after the realisation that they are not as harmless as believed. It is also to establish whether the research on antidepressant medication has gone on a “wild goose chase” over the last half century, concentrating almost exclusively on molecules that modify the monoaminergic transmission at synaptic level and virtually ignoring any other avenue.

 

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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