The Inverse Benefit Law: How Drug Marketing Undermines Patient Safety and Public Health

Abstract

Recent highly-publicized withdrawals of drugs from the market due to safety concerns raise the question of whether these events are random failures or part of a recurring pattern. The Inverse Benefit Law, inspired by Tudor Hart’s Inverse Care Law, states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively the drugs are marketed. The Law is manifested through six basic marketing strategies: reducing thresholds for diagnosing disease; reliance on surrogate endpoints; exaggerated safety claims; exaggerated efficacy claims; creation of new “diseases”; and encouraging unapproved uses. The Inverse Benefit Law highlights the need for comparative effectiveness research and other reforms to make drugs safer and reduce costs.

Keywords: ethics, pharmaceuticals, adverse drug events