News

Researchers Rebut Off-Label Article in Letter to “Health Affairs”

February 10, 2012

In a letter to the editor published in Health Affairs (February 2012, vol. 31, no.2), Managing Principal Paul Greenberg and Vice Presidents Crystal Pike and Tammy Sisitsky address the shortcomings of an article by Aaron Kesselheim and coauthors on off-label drug use, published in the journal’s December issue. The Analysis Group researchers point out that the conclusion reached by Kesselheim, et al.—that prosecution under the False Claims Act does not deter such use—is based on a study that fails to include “the many possible underlying causes of off-label use, nor [does it] report the extent of off-label promotion.” The researchers note that “merely documenting trends in the extent of off-label use of [the drug] Neurontin over time, as the authors did, is an insufficient ‘analysis’ from which to draw any meaningful insight about the possible causal impact of off-label promotion on off-label use.” The researchers, who have analyzed economic and statistical issues in numerous off-label litigations, find the authors’ conclusions to be without merit.