J&J unit facing Natrecor inquiry
Officials seek data on marketing of heart treatment
WASHINGTON -- The US attorney's office in Boston has served a subpoena seeking documents that detail how Scios Inc. marketed its heart failure drug, Natrecor, the Fremont, Calif., company said yesterday.
The federal investigation comes one week after a New England Journal of Medicine article by Dr. Eric Topol, a prominent cardiologist, criticized the company's aggressive marketing of Natrecor. Questions have swirled around the drug's increase in popularity as a regularly administered outpatient heart treatment, a use not approved by the Food and Drug Administration.
The drug had been on track to double sales this year to $700 million, Topol wrote, despite growing concerns that it increases death rates and causes kidney damage even when used sparingly.
Samantha Martin, a spokeswoman for the US attorney, would not comment on whether an investigation was underway.
In a one-paragraph news release Scios, a Johnson & Johnson subsidiary, said it ''is cooperating in responding to the subpoena."
Johnson & Johnson told investors during its second-quarter earnings call on Tuesday, that Natrecor sales had recently dropped by 20 percent. Shares of Johnson & Johnson closed yesterday at $64.96, down 0.09 percent.
The FDA approved Natrecor for hospitalized patients whose hearts were so weak they gasped for breath at rest or during minimal activity. But doctors said Scios sales representatives provided sample brochures explaining how to open lucrative outpatient clinics that would administer the drug to patients regularly. More recently, the company directed doctors seeking Medicare reimbursement for outpatient use of the drug to a toll-free hotline to obtain billing codes and forms. Contractors that handle Medicare reimbursements for states, alarmed at increasing spending for the drug, asked the federal government for national guidelines that would stop most of those payments.
An investigation led by the US attorney's office in Boston resulted in Pfizer Inc. agreeing to pay $430 million in May 2004 to resolve charges of illegal marketing of the epilepsy drug Neurontin.
Diedtra Henderson can be reached at dhenderson@globe.com. 
