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Comment & Response
December 15, 2015

Pioglitazone Use and Risk of Bladder Cancer—Reply

Author Affiliations
  • 1Division of Research, Kaiser Permanente Northern California, Oakland, California
  • 2Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia
JAMA. 2015;314(23):2568-2569. doi:10.1001/jama.2015.13915

In Reply Drs Singh and Suchard suggest that we deviated from the prespecified protocol submitted to the US Food and Drug Administration by adjusting for calendar year and that this could explain differences between our interim results1 and the results recently published. They may not have known that this protocol change was requested by the Food and Drug Administration.