Johnson & Johnson has come under heavy criticism recently for failing to test its cardiac drug Natrecor. The drug, approved in 2001 for intravenous use in hospitalized patients whose hearts pump so weakly that they have trouble breathing, has yet to be tested for safety.

Just over a year ago, however, two leading medical journals published analyses that raised new safety questions. The analyses pooled data from selected tests of Natrecor and estimated the drug may increase the risk of compromised kidney failure by 50%, and of death within 30 days by 74% or more, compared with other therapies.