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How FDA drug safety costs lives

According to a doctor quoted in the New York Times, in Italy, it is considered "malpractice" to let a heart attack survivor go home without a prescription for omega-3 fatty acids, which are shown in studies to reduce deaths from heart disease by as much as 20%. In America, however, only 17% of doctors recommend the substance to patients. Why? Because the FDA has not yet caught up with international guidelines; pharmaceutical companies cannot advertise the benefits of the supplement to American doctors or patients; and physicians can only make an off-label prescription to heart patients. (Elisabeth Rosenthal, "In Europe It�s Fish Oil After Heart Attacks, but Not in U.S.", New York Times, Oct. 3).

Here's what's missing from the New York Times report: if that 20% figure is correct, or even half-correct, FDA reluctance costs far more lives than Vioxx allegedly caused throughout its entire existence. The FDA, criticized with 20/20 hindsight over Vioxx, has slowed down drug approvals to a crawl. But heart-attack victims won't be able to sue Public Citizen or the plaintiffs' bar for their culpability in the deaths of thousands of Americans. The demand for no false negatives in drug safety, and the attempt to steal billions of dollars from a pharmaceutical company because it had a minor false negative in hindsight, is costing far more lives because of the increase in Type-II errors.



Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.