Heart Clinic May End or Curtail Use of a Drug
nytimes.com
Heart doctors at the Cleveland Clinic, one of the nation's largest centers for cardiac care, have voted unanimously to severely curtail or even ban the clinic's use of the Johnson & Johnson drug Natrecor.
The final decision is in the hands of a clinic committee that is expected to review data at a meeting today. Natrecor, widely used as a treatment for heart failure, has been reported in two recent medical journal studies to increase kidney problems and death rates among patients. Last week, the company worked out a plan with federal drug regulators to cite such risks on its label.
Opposition to the drug's use among Cleveland Clinic heart physicians could be a blow to Johnson & Johnson. Last December, the clinic, a national leader in innovation and research, took the lead in banning the painkiller Bextra - several months before the Food and Drug Administration asked Pfizer to withdraw the medication from the market, because of its heart risks.
Mark Wolfe, a Johnson & Johnson spokesman, said yesterday that the company would not speculate on the outcome of the committee's review. "From our perspective, Natrecor is highly effective and has a positive risk-benefit ratio when used in patients with acutely decompensated heart failure, a life-threatening condition for which there are limited treatment options," he said.
The preliminary vote against Natrecor was unanimous among about 50 members of the department of cardiovascular medicine who attended a meeting last Thursday to review data on the drug, said Dr. Eric E. Topol, the chairman of cardiovascular medicine for the clinic. He said that today's meeting of the formulary committee - which determines which drugs are used at the clinic - was considered urgent and had been scheduled only after last Thursday's vote.
Natrecor became a Johnson & Johnson drug as a result of the company's purchase of Scios, a biotechnology company, in 2003 for $2.4 billion. The treatment is a cardiac hormone that dilates vessels so that less blood pools in the heart and lungs, reducing shortness of breath, which is often the most debilitating symptom of heart failure.
While the company does not release sales figures for Natrecor, some financial analysts had been predicting that its sales would exceed $600 million this year and could eventually reach blockbuster status. During an earnings conference last month, however, the chief of investor relations at Johnson & Johnson, Helen E. Short, said recent negative publicity about the drug had modestly diminished sales.
Natrecor is approved to treat severe cases of acute heart failure, which typically requires hospitalization. But it has also been widely used in outpatient clinics where patients arrive for regular infusions. As a result, as many as 600,000 patients have been treated with the drug since its approval in 2001.
Dr. Topol expressed concern about Natrecor yesterday, saying that he did not understand its widespread use, in light of questions about its safety and effectiveness, as well as its expense - about $500 per infusion.
"The point is, we have other medicines that cost pennies; there is a battery of drugs that are traditionally anchors in this field," he said, citing ones like nitroglycerin and furosemide, which is sold as Lasix and under other names.
"Natrecor was never shown to be superior for reducing death or reducing the need for repeat hospitalizations," Dr. Topol said. "How could this happen? All of a sudden we have 600,000 people using this drug."
He said the clinic had also suspended enrollment of patients in a Natrecor study sponsored by Johnson & Johnson. The study was designed to evaluate Natrecor's effectiveness in outpatient infusions. Nationally, a total of 276 patients had enrolled for the trial, but only 5 of them were at the Cleveland Clinic, said Dr. Randall C. Starling, a clinic cardiologist who is an investigator in the study, called Fusion II.
Dr. James B. Young, the chief of medicine at the Cleveland Clinic, was a leading researcher on Natrecor and has been a proponent of the drug. Dr. Young, who also directs the clinic's heart-failure treatment center, could not be reached for comment yesterday.
Last week, Johnson & Johnson announced that it had agreed with the Food and Drug Administration to revise labeling for Natrecor to include data showing a slightly increased risk of mortality within 30 days for Natrecor patients compared with patients taking placebo or alternative treatments.
The company said the increased death risk noted in the labeling - 5.3 percent in Natrecor patients versus 4.3 percent in others - was not statistically significant. It was based on data collected in seven studies.
The controversy over Natrecor, also known as nesiritide, has been spurred by separate studies published in two medical journals - Circulation and The Journal of the American Medical Association - raising questions about the safety of the drug. One analysis concluded that patients on Natrecor had a 40 percent to 50 percent greater chance of reduced kidney function. Another said that Natrecor patients in three studies faced a 7.2 percent risk of death in 30 days, compared with 4 percent for patients on other treatments.
Yesterday, in an e-mail message, the lead author on both of those studies, Dr. Jonathan Sackner-Bernstein of North Shore Medical Center in Manhasset, N.Y., criticized Johnson & Johnson for what he called its failure to conduct a definitive study of the drug's safety.
"Scios and J. & J. have seemed more interested in criticizing our concerns about nesiritide's safety than they have about investigating its safety," Dr. Sackner-Bernstein wrote. "We knew the data would alarm the medical community and this action by the cardiologists at Cleveland Clinic sends a strong message."
The Cleveland Clinic formulary committee will consider whether to adopt its cardiologists' recommendation that Natrecor's use be banned or severely limited. Dr. Topol said that if the formulary committee voted to severely limit the drug's use, it could then be used only on patients in the clinic's special heart-failure intensive care unit. "It would be really rare," he said. "It would be a last resort. It would be almost nil." |
