Johnson & Johnson Receives Subpoena Related to Marketing Practices for Heart Failure Drug Natrecor

Main Category: Pharma Industry / Biotech Industry
Article Date: 22 Jul 2005 - 17:00 PST

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New Jersey-based Johnson & Johnson subsidiary... Scios on Wednesday said it has received a subpoena from Michael Sullivan of the U.S. Attorney's Office in Massachusetts over its marketing of the heart-failure treatment Natrecor, following criticism from some doctors that the company has been illegally promoting off-label uses of the drug, the New York Times reports (Saul, New York Times, 7/21). FDA approved Natrecor only for cardiac patients who are so weak that they are short of breath during rest or minimal activity. Doctors have said that Scios sales representatives provided them with sample brochures explaining how they could open outpatient clinics that would offer regular treatments of the drug (Henderson, Boston Globe, 7/21). J&J enlisted doctors and nurses who had experience treating outpatients with Natrecor to deliver presentations at medical symposiums and meetings (New York Times, 7/21). The company also directed doctors seeking Medicare reimbursements for outpatient use of the drug to a toll-free hotline that provided them with billing codes and forms (Boston Globe, 7/21). J&J has disputed claims that it violated any rules in its marketing of the drug. A committee requested by J&J to determine the safety of Natrecor in April concluded that the drug should only be used in acutely ill hospital patients. Natrecor sales reached $400 million in 2004, but J&J on Tuesday said sales have decreased by 20% since two studies linked the drug to kidney problems and higher death rates among patients.

JAMA Editorial
Eric Topol, chair of cardiovascular medicine at the Cleveland Clinic, last week in a New England Journal of Medicine editorial alleged that Scios encouraged physicians to open infusion centers to bill Medicare for the drug and added that Scios documents instructed doctors to charge Medicare $408 for eight hours of observation during the infusion. Topol noted that other heart-failure drugs considered by many physicians to be as effective as Natrecor cost less than $10 per dose. Topol also wrote that FDA approved Natrecor despite little proof about its safety or effectiveness (New York Times, 7/21).

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