Scios Inc., the division of Johnson & Johnson responsible for the intravenous drug Natrecor that has been linked to kidney failure and breathing problems in heart patients, announced on June 1, 2006 that it has set aside a $100 million budget for a new safety and effectiveness study of the drug. The study was called for more than a year ago by a panel of cardiac experts. Since that time, the company has faced strong criticism for its delay in commenting on the panel’s recommendations.

Scios is under federal investigation for the controversial marketing of Natrecor. The drug was approved by the FDA for use in hospitalized heart patients whose heartbeat is weakened to the extent that the patient cannot breathe normally or becomes breathless with minimal activity. Doctors said that they received sample brochures from Scios explaining how to open for-profit outpatient clinics to administer Natrecor to patients on a regular basis, a use that would not be covered under the existing approval. The company allegedly directed doctors seeking reimbursement for Medicare for this type of outpatient use of Natrecor to a toll-free Scios hotline to obtain billing codes and forms for this purpose. Contractors who handle Medicare reimbursements on behalf of many state governments complained to the federal government after claims for the drug appeared to rise as a result of this type of aggressive marketing.

The U.S. attorney’s office in Boston, MA, issued a subpoena to Scios in July of 2005 for documents related to their marketing of Natrecor. In 2004, a similar investigation into marketing practices for the epilepsy drug Neurontin led to an agreement by pharmaceutical maker Pfizer Inc. to pay $430 million to resolve federal charges.

Sources: “Diedtra Henderson, “J&J unit facing Natrecor inquiry,” Boston Globe, July 21, 2005, accessed June 14, 2006; Theresa Agovino, “Scios to Conduct Safety Study of Natrecor,” Associated Press, June 1, 2006, accessed June 14, 2006.