The Struggle for Pharmaceutical Legitimacy

This continues the saga of one particular medication, beloranib. In 2013, writer Esha Dey had warned, “Even if all goes well, the drug is years away from hitting the market.” All did not go well. In October of 2014 a patient died of pulmonary (lung) blood clots. The Food and Drug Administration (FDA) placed a partial clinical hold on the trials, and now the manufacturer experienced trials in other senses of the word, from challenges to tribulations. The company had to step up its safety game, and choose participants unlikely to suffer adverse reactions. But in January of 2015, another patient died from the same cause as the first one — despite having been extensively screened. The FDA responded by placing a complete hold on Zafgen’s operations

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