New studies on Rx drugs: clinical trials reporting; off-label marketing; and use of antipsychotics

US federal rules and regulations related to transparency of prescription drug studies and prohibitions on off-label marketing are the focus of papers in the December 2011 issue of Health Affairs. In addition, a separate study examines the effect of prior authorization restrictions on the use of antipsychotic drugs.

A brief summary of each of the three papers follows:

Despite a 2007 law requiring that certain prescription drug clinical trials be registered on the public database ClinicalTrials.gov, fewer than one in eight studies are reported within one year of being completed, write Michael Law and colleagues from the University of British Columbia. Surprisingly, clinical trials funded by the pharmaceutical industry are three times more likely than trials funded by the National Institute of Health to disclose results on the site. An incomplete record of trial results could skew the information that trials provide, the authors state. They call for additional enforcement of reporting requirements to enable more comprehensive and less biased studies and meta-analyses of the clinical efficacy, off-label use, and safety of prescription drugs