A new analysis of Vascepa, a medicine derived from fish oil and used to prevent heart attacks in a select group of patients, raises big questions about the evidence that the medicine is effective. Several experts say the questions require a new clinical trial to be conducted, and some even say the Food and Drug Administration should reconsider the product’s approval.
In a twist, the new data come from an analysis funded by Amarin itself.
The results “raise the concern that the apparent lowering of cardiovascular risk observed with icosapent ethyl may —in fact — have been an increase in cardiovascular risk with the comparator, mineral oil,” said Gregory Curfman, deputy editor at the Journal of the American Medical Association, using the generic name for Vascepa.
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