Latest Natrecor News Increases Safety Concerns About J&J Heart Failure Drug
The Scios unit of Johnson & Johnson (J&J) did not immediately report to the FDA two deaths from a clinical trial, or study, intended to determine the safety of Natrecor, its heart failure drug, according to several news reports published in early January 2006. In addition, the deaths of these two patient using Natrecor were omitted from a report of this Natrecor study that was published in the October 2005 edition Journal of Emergency Medicine.
In more detail, the October 2005 study article reported five deaths of patients within 30 days of their using Natrecor in hospital emergency rooms in 2001 and early 2002. Of the 237 patient covered by this Natrecor study, there was one additional death following the use of some other heart failure treatment. The two new deaths now divulged by Scios involved patients who had used Natrecor, which raises the total to seven deaths among Natrecor patients in the subject clinical trial.
According to a January 4, 2006 story in The New York Times (NYT):
"Neither Scios nor Dr. W. Franklin Peacock 4th of the Cleveland Clinic, the principal investigator in the study, disclosed yesterday how the deaths had been omitted from the results, but said they had learned only recently that the deaths occurred within the 30-day study period. A final analysis of the results is under way and will be submitted to the Food and Drug Administration, said Mark Wolfe, a Scios spokesman. He said he did not yet know the causes of the two additional deaths."
Meanwhile, a J&J spokesman said the drug company will look again at the results of this Natrecor study, taking into account the two "new" deaths. It seems that, by means of this study, J&J was seeking to establish support for its contention that Natrecor does not cause a higher risk of death in the first 30 days following a patient's use of the drug. As background, some earlier studies concerning Natrecor had suggested that patients using this J&J heart-failure drug had an increased incidence of kidney problems and mortality.
In addition, according to a January 3, 2006 article published online by Reuters, Scios is conducting further analysis of the Natrecor trial data in order to "evaluate all-cause mortality through 180 days following treatment with Natrecor or placebo", and a final report on this "expanded analysis" should be submitted to the FDA by the first quarter of 2006.
Returning to the January 4, 2006 NYT article, the paper's Stephanie Saul reported that "a spokeswoman for the Cleveland Clinic, Eileen Sheil, said that Dr. Peacock strongly believed that the deaths had been accidental and not related to problems with Natrecor."
Natrecor was approved in August 2001 by the FDA for isolated use in acutely ill heart-failure patients, and only in a hospital setting. Over time, however, there was increasing "off-label" use of Natrecor to treat less severely ill patients who had breathing difficulties caused by congestive heart failure, which treatment was done on a regular, i.e., repeated, basis in outpatient clinics or in cardiologists' offices.
Away from the safety issue, the U.S. Justice Department is investigating whether Scios wrongfully promoted the off-label prescribing and use of Natrecor. More recently, it was announced that Medicare and Medicaid will no longer cover the costs of outpatient Natrecor use.
(Posted by: Tom Lamb)