More Bad News for Natrecor

Two researchers have published data supporting the conclusions reached in their study last year that the heart drug Natrecor (generic name nesiritide) poses an increased risk of death. The study showed that 7.8 percent of patients taking Natrecor died within 30 days of using it; but only 3.9 percent of patients taking other drugs died within the same 30 day period. The study, which was conducted by Dr. Keith Aaronson of the University of Michigan and Dr. Jonathan Sackner-Bernstein of the NY research firm Clinilabs, included 400 patients taking Natrecor and 335 patients who took other heart drugs. The study was initially criticized for including patients who didn’t get the recommended dose of Natrecor, so the researchers re-analyzed the data, focusing only on patients who got the correct dose. But it also included two patients whose deaths hadn’t been reported at the time of the initial study. “There appears to be a very strong association between the use of nesiritide and the risk of death within 30 days,” says Dr. Sackner-Bernstein.

Natrecor is made by Scios, owned by Johnson & Johnson, and was approved by the FDA in 2001 for treatment of congestive heart failure. Scios defends Natrecor’s safety, and cites its own studies which report only a slightly increased death rate among those taking Natrecor after 30 days.

Nevertheless, Scios has announced that it will perform a two-year study of up to 7,000 people to determine whether the drug is safe. In the meantime, parent company Johnson & Johnson appointed a renowned Harvard heart specialist, Dr. Eugene Braunwald, to review the drug’s safety. The result wasn’t what Johnson & Johnson expected–Dr. Braunwald’s committee concluded that it was inappropriate to use Natrecor, except in acutely ill hospitalized patients.

That’s bad news for the drugmaker, since according to Merrill Goozner (author of “The $800 Million Pill”), 90 percent of the drug’s 2004 sales came from weekly outpatient “tune-ups,” most of which are paid for by Medicare. One researcher says that Scios company documents instructed doctors to bill Medicare $408 for eight hours of observation during the infusion, above and beyond the actual cost of the drug, which can approach $500 per vial. Compare that to other heart-failure drugs that many doctors believe are just as effective, but cost less than $10 per dose, and we can well understand why Johnson & Johnson’s marketing practices became the subject of inquiry by the Justice Department in July, 2005.