J&J's Heart Drug: Jolted Again

A new study finds higher mortality for patients who get Natrecor. J&J now says it will further investigate the potential blockbuster's risks

Another blow for Johnson & Johnson's heart-treatment drug Natrecor: On Apr. 19 a paper published in the most recent issue of the Journal of the American Medical Association details a possible link between taking the drug and a higher death rate, even though it's designed to treat heart failure.

The paper analyzed three studies involving 862 heart disease patients. The findings: Those taking Natrecor were 80% more likely to die within a month than patients taking other drugs such as diuretics. While the finding wasn't statistically significant -- meaning the studies weren't large enough to definitively prove that a problem exists -- the results raised new questions about the drug's efficacy.

"I don't think this drug should be pulled," says Dr. Jonathan Sackner-Bernstein, director of clinical research at the Heart Failure & Cardiomyopathy Center at North Shore University Hospital in Manhasset, N.Y., and co-author of the paper. "But this is an important signal that there is potential harm with the drug."

BETTER QUARTER. In a statement, J&J noted that a review of all the data doesn't establish a statistically significant difference in mortality. But it has been stepping up its response to growing concerns about the drug. On Apr. 12, J&J announced it was convening a panel led by respected cardiologist and Harvard Medical School professor Eugene Braunwald to evaluate all the data on Natrecor and to assess whether the company's clinical-trial program was sufficient. That move came after a paper by the same authors was published in March in the journal Circulation that raised questions about whether Natrecor hurt kidney function.

J&J's stock was up slightly on Apr. 19 after the company issued an upbeat earnings report. Sales for the first quarter were up 11%, to $12.8 billion, while net income soared 17.4%, to $2.9 billion. J&J certainly isn't dependent on Natrecor, which last year racked up sales of $343 million. But the drug has been growing rapidly -- some on Wall Street expect its sales this year to approach $700 million. And safety concerns could dampen growth prospects of a product that's expected to become a blockbuster.

Questions about Natrecor have been mounting (see BW, 4/11/05, "A Prescription for Trouble at J&J?"). And while the drug was approved by the Food & Drug Administration in 2001 for short-term use, longer-term use has been growing (see BW, 4/25/05, "Off Label Drugs: J&J Is Pushing the Envelope").

Some experts wonder why Johnson & Johnson has yet to do a large study that definitively answers questions about the mortality rate. "The fact that the drug was marketed aggressively without [such] a study is very undesirable," says Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who was on the FDA panel that recommended approval of the drug. "Frankly they should have done it four years ago." The JAMA paper will only raise the pressure on J&J to do such a study.

Barrett is BusinessWeek's Philadelphia bureau chief

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