Natrecor Maker Scios Gets Subpoena

Boston US Attorney's Office Requesting Documents Related to the Sales and Marketing of Natrecor

Johnson & Johnson's aggressive marketing of its heart-failure treatment Natrecor has become the subject of an inquiry by the Justice Department. Johnson & Johnson subsidiary Scios received a subpoena from Michael Sullivan of the U.S. Attorney's Office in Massachusetts on July 21, 2005 over its marketing of Natrecor. The subpoena followed allegations from some doctors that Scios has been promoting off-label uses of the drug.

The FDA approved Natrecor only for cardiac patients who suffer from dyspnea, or shortness of breath, during rest or minimal activity following heart failure. Natrecor was intended to be administered intravenously to hospitalized patients. Criticizing 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 Natrecor. Further, Johnson & Johnson is said to have enlisted doctors and nurses who had experience treating outpatients with Natrecor to deliver presentations at medical symposiums and meetings. Doctors seeking Medicare reimbursements after outpatient use were directed to a toll-free hotline and provided with billing codes and forms.

Johnson & Johnson has disputed claims that it violated any rules in its marketing of Natrecor. Natrecor sales reached $400 million in 2004, but have decreased following two studies linking Natrecor to kidney problems and higher death rates among patients.

Natrecor has become so widely used in outpatient clinics where patients arrive for regular infusions, that in May 2005, cardiologists at the Cleveland Clinic recommended that the use of Natrecor be banned or severely limited at its facilities. Cleveland Clinic drug-policy decisions are significant because those decisions often set precedent for the nation's other hospitals, or get the attention of the FDA, such as when in December 2004 the Cleveland Clinic took the lead in banning the painkiller Bextra; this was several months before the FDA asked Pfizer to withdraw Bextra from the U.S. market.

• Read Tom Lamb's further commentary on Drug-Injury.com
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