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Publication bias may mislead clinicians influence decisions to prescribe antipsychotics

The apparent clinical effectiveness of second-generation antipsychotic drugs may be less than clinicians realize due to publication bias, according to study results from Erick Turner, MD, from Oregon Health & Science University in Portland, and colleagues.

The researchers reviewed 24 FDA-registered premarketing trials for eight second-generation antipsychotics. Drug trials for aripiprazole (Abilify, Otsuka), iloperidone (Fanapt), olanzapine, paliperidone (Invega, Janssen), quetiapine, risperidone, risperidone long-acting injection and ziprasidone were examined. Researchers then compared the results of the trials with the results conveyed in corresponding medical journal articles.

The study demonstrated that four of the 24 premarketing trials submitted to the FDA were not published. These four trials all had negative results: three showed the drug had no statistical advantage over placebo, one showed the drug to be statistically inferior to the active comparator drug. The researchers used meta-analysis to combine trial data and compared all eight drugs to placebo, finding that publication bias had little effect on overall apparent efficacy. The concern was that some negative data was not published, which may mislead clinicians.

“The magnitude of publication bias found for antipsychotics was less than that found previously for antidepressants, possibly because antipsychotics demonstrate superiority to placebo more consistently,” the researchers wrote.

Disclosures: Funding was received from the Stanley Medical Research Institute. From 1998 to 2001, Dr. Turner served as a medical reviewer at the FDA. Subsequently, but ending in 2005, Turner provided outside consulting to Bristol-Myers Squibb, Eli Lilly, and GlaxoSmithKline. From 2004 to 2005, Turner was on the speaker’s bureaus of Eli Lilly, AstraZeneca, and Bristol-Myers Squibb. Lee Shapley is Scorecard Director for the AMSA Pharmfree Scorecard, and a fourth year medical student at Oregon Health & Science University (OHSU). Daniel Knoepflmacher is also a fourth year medical student at OHSU and has no competing interests to report.