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Tug-of-War Over Heart Drug

May 23, 2005 | Newsday A year ago, Michael Chiarello was in a wheelchair, dependent and depressed, helpless as his life was being slowly stolen by heart failure.

The 74-year-old Riverhead man was told that only 25 percent of his heart function remained. Without options and within a whisper of death, Chiarello had run technology's gamut. Then last summer, doctors suggested a new approach: a drug to be infused four hours a day, three days a week. He took the chance.

"I'm 100 percent better," Chiarello said. "I can do anything I want to do; I even feel like I can go and hang wallpaper again," his career of 30 years.

But Natrecor, the drug that transformed Chiarello's life, is at the center of a growing storm, the result of research that uncovered life-threatening dangers linked to its use. Approved as a therapy for hospitalized patients or those rushed to emergency rooms in acute heart failure, the drug increasingly is being administered to outpatients, treatments that critics say may be dangerous and driven by the drug's high-flying price tag. Clinics charge about $500 per infusion, often several times per week.

Natrecor mimics a hormone-like molecule that dilates vessels to prevent blood from pooling in the heart and lungs, easing breathing. More than 600,000 patients have taken the drug since its approval.

'A last resort'

Yet some doctors say the medication should be used with caution. Not only does it cause problems in hospitalized patients, they contend, it may prove even more problematic over the long haul in vast numbers of people receiving it frequently. The drug wasn't approved, they say, to be administered to outpatients multiple times per week.

"We're not saying that it should be pulled from the market," said Dr. Jonathan Sackner-Bernstein, director of clinical research at North Shore University Hospital in Manhasset and chief investigator of two studies that found problems. "We're saying it should be a drug that is used as a last resort."

In one analysis, Sackner-Bernstein found Natrecor increased the likelihood of kidney failure by up to 50 percent. In the other he discovered an elevated risk of dying within 30 days of leaving the hospital for some patients who were administered the drug. Although he could not explain the biochemistry of how the drug might increase mortality, he said the findings should alarm the manufacturer and government regulators. He's calling for a large, randomized placebo-controlled clinical trial to assess the drug's safety.

Natrecor's maker, Scios Inc., a division of Johnson & Johnson, and the Food and Drug Administration say the medication is safe and effective when used according to its label. As for Natrecor's use in outpatient clinics, Johnson & Johnson spokesman Mark Wolfe said even though the drug was not originally tested in outpatients to be administered intermittently, the product label does not say that it should not be.

Moreover, he added, the company can't control how doctors prescribe the drug. And the FDA underscores that doctors are free to prescribe any approved medication "off-label."

"We promote the product based on its FDA-approved indication," Wolfe said. "Decisions regarding how it's used are made by practicing physicians based on their professional medical judgment." Medicare and insurers cover the drug.

Sackner-Bernstein's analysis of kidney problems was reported in March in the journal Circulation. The finding was produced by pooling all available scientific data on the drug.

His second and more startling analysis last month in the Journal of the American Medical Association revealed the 30-day mortality risk. Sackner-Bernstein and colleagues found patients were 80 percent more likely to die in the month after treatment than patients who got standard therapy. The FDA approved Natrecor, also known as nesiritide, in 2001.

Dr. Steven Nissen, vice chairman of cardiology at the Cleveland Clinic, was the lone dissenter on the FDA panel that approved Natrecor. He said he wasn't convinced it was safe.

More patient warnings

An FDA official told Newsday the agency had been aware of Natrecor's potential to increase kidney dysfunction and raise the risk of mortality years ago when Natrecor was first reviewed. Warnings were added to its package insert then. Last month additional death-risk information was added. Earlier this month, Scios sent a "Dear Doctor" letter to health heart specialists nationwide, underlining mortality risks associated with the drug. The FDA did not call for a black-box warning, however, its most potent caution.

"This drug has been a lightning rod for controversy ever since it was introduced," said Dr. Robert Hobbs, a cardiologist and researcher at the Cleveland Clinic and a strong proponent of the drug. He added that Sackner-Bernstein's research was based on older data involving higher Natrecor doses that are no longer used.

"There are physicians who love it and those who hate it," he said. "Most of the people who love it are treating heart-failure patients in the hospital or in the emergency department, and the reason we love it is because it makes people feel better faster."

Hobbs said Natrecor, a genetically engineered drug, is more effective than infused nitroglycerin, a standard medication used for decades.

Another proponent of Natrecor is Dr. Clyde Yancy, director of the heart-failure program at the University of Texas Southwestern Medical Center in Dallas. Yancy and a team of doctors are examining Natrecor in a Scios-sponsored study of nearly 1,000 outpatients to answer questions about frequent use.

Yancy said he has no financial ties to the manufacturer and is interested only in answering medical and scientific questions. He added that the population originally defined for Natrecor might be too narrow. Acute heart failure, also known as decompensated heart failure, the form of the disease for which the drug was approved, may be evident even when patients are not in crisis. The problem is typified by acute shortness of breath.

"There are many patients who remain symptomatic despite being on all the right medications," Yancy said. "In my judgment they may not have acute decompensated heart failure, but chronic decompensated heart failure," he said.

While some heart-failure patients benefit from nitroglycerin, diuretics, pacemakers and other implantable devices, transplantation remains another option. Heart transplants, however, are usually out of the question for people older than 60 because these patients are considered too old and often too sick. Yancy believes Natrecor offers a life-sustaining option.

William Morrisey, 72, of Brooklyn, said Natrecor has renewed his strength. He has a history of heart disease and underwent quintuple bypass surgery more than a decade ago. "Before this [drug] I couldn't make more than two steps at a time," the retired machine-parts salesman said about ascending the stairs to his home. "Now I can go up the whole flight of 15 steps. I wouldn't call it a miracle drug, it doesn't cure anything it just helps."

Doctors opposed to outpatient Natrecor infusions say no one has established how often the drug should be administered or when patients should be weaned. Chiarello, a patient in Stony Brook University Hospital's heart-failure program, has been weaned from three weekly infusions to one. He hopes to soon be free of the drug.

Millions affected

Heart failure is a growing public health issue, said Dr. Norbert Moskovits of Maimonides Medical Center in Brooklyn. He calls heart failure the No.1 cardiac affliction among people 65 and older. In the disease, an enlarged heart no longer pumps efficiently. An estimated 5 million people are affected nationwide.

Dr. Robert Phillips, chairman of medicine at Lenox Hill Hospital in Manhattan, said Sackner-Bernstein's analyses suggest the need for more research on Natrecor's safety.

"At this point in time the ethical position that any physician or researcher should take is that the drug should be tested in a randomized placebo-controlled clinical study," Phillips said. "Even though this study [Sackner-Bernstein's] raises concerns, if the drug is useful, we need to know this and how to use it most effectively."

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