The July 14, issue of NEJM has an important perspective by Dr. Eic J. Topol, head of cardiology at Cleveland Clinic. Fortunately the Journal has made this free on line and should be read by anyone who has concerns about the FDA's approval record, drug company's promotional activities and the safety and efficacy of a drug that apparently is being widely used. Topol explains that Natrecor was approved by the FDA for acute treatment of decompensated heart failure. He expresses concern, however, that even in this application there are real concerns about its safety and quotes data to support that position. Further concern is expressed that the drug is being promoted for the " maintenance" therapy of chronic HF . This would consist of periodic outpatient infusions, a treatment for which there is no FDA approval nor, according to Dr. Topol, adequate evidence of its safety and efficacy in that context. There are some data from an outpatient trial reference to which can be found at this drug company website. Apparently another trial is underway. More details about the outpatient, non-acute use of nesiritide can be found in a May 17, 2000 NYT article.
With the high profile status of Dr. Topol's article in the NEJM, we are certain to hear much more about this and to the extent that Dr. Topol's characterization of the situation is correct we should. Serious questions are raised.