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J&J Drug Raises Safety Concerns

Apr 20, 2005 | The Star Ledger Patients given a Johnson & Johnson drug for congestive heart failure may face an 80 percent higher risk of dying within a month of treatment, according to an article in this week's issue of the Journal of the American Medical Association.

As a result, the authors recommended a long-term safety study of Natrecor, an expensive medication that was touted as a breakthrough when it became available four years ago and is now a widely used treatment in hospital emergency rooms.

"The data suggests the best approach is to reserve Natrecor as a drug of last resort and not to use it as freely as it is currently used," Jonathan Sackner-Bernstein, one of the journal authors and a cardiologist at North Shore University Hospital in Manhasset, N.Y., said.

The findings are the latest controversy surrounding Natrecor, which prompted safety concerns in 2001 when regulators were deciding whether to approve the drug. Last month, a separate study indicated Natrecor may pose a 50 percent greater risk of worsening kidney function.

The back-to-back journal articles have also drawn Johnson & Johnson into the harsh spotlight focused on the safety of prescription medicines, which erupted over the hazards posed by antidepressants and painkillers, notably Merck's Vioxx.

The latest article was actually not a new clinical trial. Instead, the authors reviewed three older clinical studies, which dated back to 2002 and involved 862 patients who were given Natrecor or older therapies, such as diuretics.

Although Natrecor has not been proven to cause excessive harm, Sackner-Bernstein, who also was a co-author of the article showing greater kidney risk, said Johnson & Johnson should have investigated the risk of death sooner, given earlier safety concerns.

Mark Wolfe, a spokesman for Johnson & Johnson, the health- care giant based in New Brunswick, disagreed with the latest study and insisted the benefits offered by Natrecor outweigh the risks. He added 600,000 people have been treated with the medication.

"A review of the full data set does not show a statistically significant difference in mortality," he said. "With patient safety as our top priority, an external review of our existing data and our clinical development program is underway."

Johnson & Johnson, which is perhaps best-known for Band-Aids and baby shampoo, inherited Natrecor as part of its $2.4 billion purchase two years ago of Scios, a high-flying biotechnology company based in Fremont, Calif.

Natrecor, which is administered intravenously, helps people suffering from acute heart failure to breathe easier. One doctor yesterday said he has used Natrecor successfully many times and is concerned its benefits are being overlooked.

"I've used this medication and had favorable outcomes," Robert Takla, an emergency room physician in Detroit who had been a member of the Scios speakers' bureau, said. "I'd use it on my own father, who was recently diagnosed with congestive heart failure."

Last year, the medication generated $375 million in revenue, a fraction of Johnson & Johnson's 2004 sales of $47.3 billion. But Natrecor has moved the company into a lucrative market there are about 550,000 cases of congestive heart failure each year in the United States.

Moreover, the medication costs up to $500 a day, according to Steve Nissen, a cardiologist at the Cleveland Clinic, who added that Johnson & Johnson's Scios unit has been very aggressively marketing Natrecor, but has been slow to respond to safety concerns.

"The safety concerns are all happening just when the use of the drug is exploding. There are clinics popping up all over the place offering outpatient therapy," Nissen, who sat on the 2001 regulatory panel and argued in favor of a long- term safety study, said.

Johnson & Johnson's Wolfe maintained Natrecor marketing doesn't violate any regulatory guidelines. And he noted the company last week named Eugene Braunwald, a Harvard Medical School cardiologist, to convene a panel to assess clinical-trial data.

However, Nissen dismissed the effort as "damage control. It's an attempt to recover from a public relations disaster," he said. "Right now, we have a gap in our knowledge because the company never did a mortality trial. It's a serious omission."

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