Natrecor Criticized by Cardiologist
Cardiologist Eric Topol has written a scathing article about Natrecor (nesiritide) in The New England Journal of Medicine (NEJM). Natrecor is a heart-failure drug that has been shown to decrease shortness of breath.
In his article, Dr. Topol cites US Food and Drug Administration (FDA) data that support concerns about possible kidney damage associated with Natrecor use, going so far as to suggest that Natrecor should not be on the market.
“In my view, nesiritide [Natrecor] has not yet met the minimal criteria for safety and efficacy,” says Dr. Topol, chairman of cardiology at the Cleveland Clinic. “Until a trial definitively proves that this drug reduces the risk of death or repeated hospitalization for heart failure, there will be questions about the appropriateness of the drug’s use or even commercial availability.”
One main concern is that Natrecor, which received FDA approval only for limited use in a hospital setting, is now being prescribed by doctors for many patients, even outside the hospital. Topol also points out that prescribing Natrecor is potentially lucrative for physicians, writing:
“How can a drug that is associated with higher rates of renal dysfunction and death than placebo — and that costs 50 times as much as standard therapies and for which there are no meaningful data on relevant clinical end points — be given to more than 600,000 patients and be promoted…for serial outpatient use, an indication not listed on the label?”
In the NEJM article, Topol cites data from a 2001 study of Natrecor that show a mortality increase for Natrecor patients that may have been caused by chance, and increases in kidney chemicals that were statistically significant. A researcher on this study, Wilson S. Colucci of Boston University, says the data were collected at 5 days, and not 30, as Topol states, and their relevance remains questionable, according to a Forbes.com article published 13 July.
Natrecor is manufactured by Johnson & Johnson (J&J). Mark Wolfe, a J&J spokesman, commented in the Forbes.com article, "While we agree that survival would be the most meaningful benefit, no medicine for acute decompensated heart failure has been demonstrated to provide a survival benefit.
“Natrecor is the only approved treatment that has demonstrated proven clinical benefit." (Clinical studies show Natrecor decreases shortness of breath.)
In June 2005, J&J convened a panel of cardiologists, who recommended strict limits to prescribing Natrecor, including tighter FDA label-warnings. The panel also recommended urgently undertaking a substantial clinical trial to measure Natrecor’s ability to extend patients’ life, and to test whether it causes kidney damage.
Despite these concerns, J&J continues to market Natrecor, even providing a hotline for doctors to help them arrange reimbursement for Natrecor by insurance companies. According to the Forbes.com report, this hotline still provides information about obtaining reimbursement from Medicare or insurance companies for non–FDA-approved uses of Natrecor.
Cardiologist Calls For Limits On J&J Drug, Forbes.com, July 13, 2005
Nesiritide — Not Verified, Eric J. Topol, MD, published in the New England Journal of Medicine, Volume 353, pages 113-116, July 14, 2005.
Posted: July 2005