Author Affiliations: Georgetown University Law Center (Mr Gostin) and the Board on Global Health, Institute of Medicine (Drs Buckley and Kelley), Washington, DC.
When Hippocrates advised physicians to never give a deadly drug, he assumed they would know for sure that the medicines they prescribed were safe. Today, criminals and unscrupulous manufacturers have permeated the global pharmaceutical market, calling into question this basic assumption of clinical practice. Between November 2012 and March 2013, an injectable drug compounded under unhygienic conditions at the New England Compounding Pharmacy was linked to more than 700 illnesses and 50 deaths.1 In poor countries, where drug regulatory oversight is weaker, the problem is worse, but blends with the background noise of high mortality and strained health systems. Only in rare cases, as when 120 Pakistanis died after taking a carelessly made batch of isosorbide mononitrate, do people in low- and middle-income countries learn of their vulnerability.2
Gostin LO, Buckley GJ, Kelley PW. Stemming the Global Trade in Falsified and Substandard Medicines. JAMA. 2013;309(16):1693-1694. doi:10.1001/jama.2013.3048