Warning on Unapproved Use of Natrecor

The first steps are being taken by Scios Inc. to restrain the prescription of the drug Natrecor, produced by the company, for uses that are not FDA approved.

Although physicians can legally prescribe off-label, FDA regulations forbid drug companies from promoting off-label uses. The company, a unit of Johnson & Johnson, denies having promoted such uses of Natrecor.

The drug had been approved in 2001 for a type of acute congestive heart failure, but a Cleveland Clinic heart disease expert, Dr. Eric Topol, brought to public attention the fact that Scios was aggressively marketing Natrecor in the form of weekly "tune-ups" on an outpatient basis. Dr. Topol's article, published in the July 14 issue of the "New

England Journal of Medicine", signaled that the drug was found to cause kidney dysfunction and to increase mortality rate and demonstrated that much of the company's sales for 2005, projected to be double as compared to last year, comes from the off-label "tune-up" application.

The company says it received a subpoena from the U.S. attorney's office in Boston on July 20, in which documents related to the sales and marketing of Natrecor were requested.

The Scios telephone hotline established to explain to doctors how to bill Medicare for the off-label treatments now presents a recorded disclaimer advising that due to a "lack of clinical trial data", Natrecor is not recommended in the form of infusions in outpatient clinics.

Mark Wolfe, the company's spokesman, explains that the recorded message is only the first of a series of measures Scios will take at the recommendation of a panel of experts it had commissioned. The expert panel recommended that Natrecor should be used only for patients suffering from acutely decompensated congestive heart failure and labored breathing while at rest, and not for repeated administration in outpatient settings. The panel urged that these guidelines should be conveyed to doctors through an educational campaign, and that further clinical trials on the impact of Natrecor on kidney function and death rates should be conducted.

Meanwhile, Johnson & Johnson shares lost 61 cents (0.95%), to close at $63.54 on Friday.

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