BOX 4-2Fatal Falsified Iron

When a drug that had been on the market for 40 years killed a young, generally healthy woman in 2004 despite her six previous doses with no side effects, the technical director of the AstraZeneca subsidiary in Río Negra, Argentina, was alarmed and suspected impropriety. The drug was Yectafer, an injectable iron supplement given to the patient for her anemia. She died of liver failure within weeks of receiving the fatal injection, unable to undergo transplant surgery quickly enough to save her life (Loewy, 2007). A sample of the drug was sent for testing at the plant and was immediately identified as a fake: the package labels were applied incorrectly, the name of the drug written in a different font, and the color of the liquid significantly altered. Chemical analysis confirmed that the bottle did not contain iron sorbitol, the active ingredient in Yectafer, but a different form of iron at three times the stated dosage (Loewy, 2007). Despite an attempted recall, one more woman died in the ensuing months, and at least eight women undergoing the same treatment were hospitalized for liver damage, including a 22-year-old pregnant woman whose condition caused her to deliver her baby prematurely at 26 weeks (Loewy, 2007; WHO, 2006b).

Although some of the people involved in distributing the dangerous fake were charged for their crimes, lack of an effective paper trail prevented Argentine authorities from tracking down the manufacturer. The victims' youth lent an emotional appeal to this incident, making it the public face of drug regulation agenda, but Argentina was no stranger to tragedy of this sort. Fake drugs for treating Parkinson's disease circulated in 1997 and exacerbated the symptoms they were taken to prevent (Loewy, 2007). Weak regulation and the legal confusion made Argentina's drug supply vulnerable and hampered efforts to prosecute those involved (WHO, 2006b).