About Natrecor (nesiritide)
Natrecor (nesiritide) was approved for sale in the United States for the treatment of heart failure in 2001. Heart failure, sometimes known as congestive heart failure or CHF, should not be confused with a heart attack or cardiac arrest in which the heart stops beating. Heart failure occurs when the heart is unable to pump a sufficient amount of blood through the body to support normal organ function.
Natrecor is administered intravenously and works by stimulating a chemical compound inside heart cells that compels the heart muscles to work harder. This allows the blood vessels to open wider, which reduces the amount of blood pooling in the heart and moves it out into the body, easing blood pressure and stress on the heart. The FDA approved Natrecor for use in hospital settings to help improve patients' breathing. According to Dr. Milton Packer, the chairman of the FDA advisory panel which approved the drug, Natrecor was approved for use in a very limited group of heart failure patients - specifically, those who struggled for breath even while at rest and were hospitalized at the time.
How Natrecor works
When used as the FDA approved it, Natrecor should be a short-term therapy designed to give a heart patient relief while doctors consider long-term treatment options. This relief occurs because Natrecor mimics the action of a hormone called brain natriuretic peptide, or BNP. BNP levels are usually low in a normal heart. However, if the heart has to work harder over a long period of time due to injury or disease, the level of BNP in the blood rises. BNP serves as a marker for pulmonary hypertension, or high blood pressure in the pulmonary artery. It can also serve as an indicator of further risk of heart disease in a patient (Source: "Hormone Can Predict Pulmonary Hypertension and Potential Death or Survival," Medical News Today, April 4, 2006).
Natrecor's job is to activate the cells in the heart muscle by stimulating them to pump more forcefully. Natrecor is administered via bolus, which is a large dose of medicine intended to rapidly bring the body to a therapeutic state so that it can heal. It may be considered a high-risk therapy similar to the administration of chemotherapy to a cancer patient, one in which the risk of other damage is high but the potential benefit may outweigh the danger of the drug.
Increased Risk of Death for Heart Patients on Natrecor
A meta-analysis of three clinical trials of patients with ADHF on either Natrecor or a placebo found that death occurred more often within 30 days of beginning Natrecor therapy than with a placebo. The study, completed by Drs. Jonathan Sackner-Bernstein and Keith Aaronson, heart failure specialists at North Shore University Hospital in Manhasset, NY, said Natrecor worsened the chance of dying from heart failure within 30 days by as much as 74% and should only be used when other treatment options have failed (Wall Street Journal, May 30, 2006).
Worsening Kidney Function and Renal Failure with Natrecor
Renal function is an important consideration for cardiologists and cardiac surgeons who are assessing the future course of heart failure. A JAMA analysis of five additional clinical trials, which included 1269 patients on Natrecor, showed that patients receiving Natrecor had risk of worsening renal function increased by 40 to 50 percent. Natrecor is known to increase diuresis, or the production of urine by the kidneys, placing strain on the renal system, which can lead to kidney failure.
Natrecor marketed heavily for off-label use
Due to what some prominent doctors have called an aggressive and possibly fraudulent marketing campaign by Scios Inc. and its sales organization, Innovex of Research Triangle Park, NC, Natrecor became widely used in the U.S. by thousands of heart patients in outpatient clinics around the country (Stephanie Saul, New York Times, May 17, 2005). These patients receive Natrecor infusions, sometimes called "tune-ups," once a week to help them with acutely decompensated heart failure, or ADHF, a secondary condition that affects many people with heart problems. ADHF is characterized by flare-ups in which breathing becomes difficult or nearly impossible.
As many as 19 percent of the estimated one million Americans admitted to hospitals every year who are diagnosed with ADHF may receive intravenous injections of Natrecor to treat the breathing problems that can often flare-up after experiencing heart failure (Pharmaceutical Business Review Online, April 21, 2005). In these off-label settings, the risks of using Natrecor every week may seriously outweigh the benefits to heart patients.
The federal government seems to agree. The U.S. Attorney's office in Boston, MA subpoenaed marketing documents from Scios Inc. and Johnson & Johnson last year after complaints by contractors representing state governments. Johnson & Johnson operates a reimbursement hotline for doctors to get information on how to submit claims to Medicare and other insurers. The states saw their insurance claims for Natrecor rise rapidly as a result.
Johnson & Johnson also provides a reimbursement guide to doctors suggesting that doctors code the drugs like chemotherapy treatments. This would permit doctors to bill for an hourly "observation" fee while the patient is receiving a Natrecor infusion. Such a practice came under intense criticism in a commentary written by Dr. Eric J. Topol for the New England Journal of Medicine. Dr. Topol chairs the Cleveland Clinic's department of cardiovascular medicine and is one of the country's leading cardiac drug experts.
Dr. Topol said that Natrecor has put itself into a class all its own through its marketing. "Cardiologists have never made revenue by giving a drug to a patient," he told the Boston Globe (July 14, 2005). The Cleveland Clinic voted to ban the use of Natrecor in all but the most serious cases in May of 2005.
Do Scios and Johnson & Johnson know Natrecor is unsafe?
Scios and Johnson & Johnson admitted in January 2006 that it neglected to tell the FDA about the deaths of two patients in a clinical trial of Natrecor that took place in 2001 and early 2002. The trial, the results of which were published in the Journal of Emergency Medicine in October 2005, reported 6 deaths within 30 days among 237 patients who were given Natrecor or another treatment in hospital emergency rooms. Five of the deaths were of people who were given Natrecor. The two deaths raised the known death toll in the study to seven. Neither the drug makers nor the lead investigator explained why the two deaths were omitted from the published study results.
After the analyses indicating serious renal and cardiac risks with Natrecor were published in the Journal of the American Medical Association in 2005, Johnson & Johnson convened a panel of leading U.S. cardiologists to evaluate Natrecor. The panel advised Johnson & Johnson that Natrecor "showed signs of kidney damage and that the drug seemed to increase mortality" (Forbes, June 14, 2005). The panel urged the company to convene a new safety and efficacy study with at least 5,000 patients. The panel also said that while the trial is being conducted, the FDA should limit use of Natrecor to patients who are short of breath either while sitting or after minimal exertion only.
Johnson & Johnson continues to insist that Natrecor is safe and is not being used extensively for off-label uses. Natrecor was on track to make nearly $700 million in sales in 2005. The company announced in June 2006, over one year after the panel's recommendation, that they would begin a safety study in 2007 that will test Natrecor in over 7000 patients worldwide, but has failed to name researchers to lead the study. Dr. Milton Packer calls the delay "an unacceptably long period of time" (Wall Street Journal, May 30, 2006).
Why Talk to a Personal Injury Lawyer about Natrecor?
If you or someone you love has suffered renal failure, kidney problems that led to dialysis, further complication of breathing problems, worsening heart problems, or died within 30 days of being given Natrecor, the pharmaceutical companies that manufactured and marketed Natrecor might be liable for the damages you have incurred. The Justice Department of the United States is investigating Scios Inc. and Johnson & Johnson to determine if the company acted inappropriately by aggressively marketing its drug to make up for its failure to meet sales forecasts after it was shown to be dangerous. Our law firm is investigating this matter to determine if liability exists. The Law Offices of James Scott Farrin represents injured individuals. If you believe your injury is a result of Natrecor, call or contact us today. There is never an obligation to hire our law firm, and your first conversation with us is free.
