text_1: Amarin fish oil capsule shows dramatic benefit for cardiovascular patients, potentially upending market
text_2: A 25% reduction in cardiovascular events, including death, heart attack or stroke sounds like a big deal… and maybe it is. But this story about the results of a trial of a prescription drug derived from fish oil (brand name Vascepa) relies on a news release and company statements that don’t provide basic information about the precise number or type of cardiovascular events observed by researchers. Without absolute numbers, it is impossible to judge the importance of these results. It is also premature to claim that the results represent “heart-medicine history,” especially given that the findings haven’t been peer-reviewed and are at odds with numerous previous studies. The story takes a cheerleading tone and fails to supply key context. For example, it highlights a dramatic quote from a researcher without noting that he was paid over $120,000 by the drug company, including payments for speeches and other appearances on its behalf, in 2017. The story headline and text do make clear that only patients with cardiovascular disease and high levels of triglycerides or diabetes were in the trial, so it should be clear to readers that this drug was not shown to prevent disease in healthy people. The story does not give any details about potential harms of the drug. It reports key details of the trial, but without access to the full trial report, it is impossible to judge the quality of the evidence or its real significance. This story is based on the news release claim of a 25% reduction in the risk of major cardiovascular events. But what does that mean? It’s difficult to say, because that outcome consists of a combination of cardiovascular disease death, heart attack, stroke, coronary revascularization procedures (placing a stent in a blocked artery) and hospitalization for unstable angina (chest pain). Based on what little we know, it is possible that the 25% reduction was driven mainly by a lower rate of hospitalizations for chest pain — an outcome that’s less important and also more subject to bias on the part of investigators who decide which patients get hospitalized and which ones don’t. It’s possible there was little or no reduction in deaths, heart attacks or strokes. Until the full trial results are released, we simply don’t know.