Just over one year ago, two leading medical journals published analyses of the Johnson & Johnson drug Natrecor, administered intravenously to heart patients whose hearts are pumping too weakly for them to breathe properly. The analyses estimated that Natrecor may increase the risk of kidney failure in heart patients by 50% and of death within 30 days by 74% or more, prompting a rash of calls for further study of the drug.

At the time, Johnson & Johnson asked renowned Harvard cardiologist Eugene Braunwald to call an advisory panel to examine the findings. The panels recommendation was to immediately begin a follow-up clinical trial of Natrecor to assess kidney risk, which was called an endorsement of plans the company already had underway. In the year since the panels recommendation, Johnson & Johnson has failed to take action, but doctors have become more wary of using Natrecor. Natrecors sales have fallen to $100 million this year from an estimated $375 million in 2004 according to J.P. Morgan estimates.

Milton Packer, professor at the University of Texas Southwestern Medical School and a member of the advisory panel, called the delay an unacceptably long period of time. The delay also concerns Dr. Steven Nissen of the Cleveland Clinic, a leading heart research facility. Instead of designing a clinical trial as promised, Johnson & Johnson had continued to aggressively market Natrecor without performing additional safety research, when there isnt sufficient evidence to support its use.

The company says it is still putting together a large-scale study and that it has taken so long because of the complexities involved. One of the doctors on the advisory panel disputes the companys claim, though, saying it should have taken no more than two to four months to decide on the approach and assemble the team of doctors for the study; yet, none of this has happened.

Source: Scott Hensley, Critics assail J&J for delaying a safety study, Wall Street Journal, May 30, 2006.