Analysis of articles published on the outcomes of clinical trials of psychiatric drugs found that many unfavorable results never appeared in the professional journals doctors rely on to make informed decisions for their patients.
A new report published in PLoS Medicine found that drug companies seeking FDA approval for eight newer, so-called atypical antipsychotic drugs performed a total of 24 studies. But four of the studies were never published in professional journals – and all four of those studies had negative results for the drugs in question.
Three of those unpublished studies showed that the new drugs were no better than sugar pills.
Lead author Erick Turner, M.D., a former drug reviewer for the FDA and now at Oregon Health & Science University and the Portland VA Medical Center, called the results of the analysis “unsettling” and called on the FDA for greater disclosure of drug trial results.
Doctors subjected to aggressive marketing by pharmaceutical companies, but not getting full disclosure of negative clinical trial results, are fueling the skyrocketing use of these expensive antipsychotic drugs, increasingly using them for purposes for which the drugs have not been approved. A study published last year found that off-label antipsychotic prescriptions doubled between 1995 and 2008, from 4.4 million to 9 million. Sales of the drugs exceeded $16 billion in 2010, according to IMS Health, a data tracking firm for the health-care industry.
And antipsychotic drugs were not the only psych drugs for which negative clinical trials were squelched. In 2008, Dr. Turner and his colleagues found an even greater publication bias for antidepressants. Nearly one of every three clinical trials of antidepressants by drug companies produced troubling results that were never revealed in professional publications.
Without access to this negative information, doctors do not get the complete picture of the dangers and ineffectiveness of the psych drugs they may be prescribing to their patients – and both doctors and their patients need to know this.
WARNING: Anyone wishing to discontinue psychiatric drugs is cautioned to do so only under the supervision of a competent medical doctor because of potentially dangerous withdrawal symptoms.
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