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Natrecor a Drag on Johnson & Johnson since Reports of Kidney Failure, Deaths

Dec 6, 2007 | Parker Waichman LLP

Natrecor side effect reports have taken a toll on the finances of Johnson & Johnson.  Natrecor was considered a potential hit in 2001 when the Food and Drug Administration (FDA) approved it for treating severe heart failure.  So great was this potential, that in 2003, Johnson & Johnson paid $2.4 billion for Natrecor's developer, biologics company Scios.  However, a lot has changed since then, and last night, Johnson & Johnson reported it would record a $440 million write-down to account for Natrecor's declining revenue.  Although Natrecor sales reached about $400 million in 2004, the company said sales declined significantly since outside medical researchers raised questions in 2005 about the possible risk of kidney problems and death associated with Natrecor.  In a regulatory filing with the Securities and Exchange Commission, Johnson & Johnson maintained that Natrecor was an important clinical option for heart failure treatment and is safe when used correctly.

When Natrecor was originally reported to increase kidney problems and death rates among patients, Johnson & Johnson announced it had agreed with the FDA to revise labeling for the drug to include the data underlying those reports.

Natrecor is FDA approved to intravenously treat severe cases of acute heart failure, which typically require hospitalization; however, it has been widely used "off-label" in outpatient clinics where patients arrive for regular infusions, although the drug has not been tested for that use.  Some cardiologists have raised questions about whether the drug is safe enough to be used so frequently while others claim regular treatments help.  While legal, regular treatments are not a federally approved use of the drug

Physicians' off-label prescribing of powerful drugs approved for specified limited conditions is posing serious life-safety risks.  Given that physicians are so intimately under the influence of drug sales reps, perhaps it is time to reconsider the freedom U.S. physicians enjoy based on assumptions that their judgment is always in the best interest of the patient.  Natrecor's use beyond emergency treatment to weekly maintenance is, in the view of some doctors, another example of the pharmaceutical industry's ongoing search for broader markets for drugs with FDA approval for specific and narrow usage.  Speaking in terms of dollars, Natrecor has been used by over 600,000 patients in the U.S. since the FDA approved it in 2001.  Infusions-without physician examination fees-run about $600 a session.  Most of the cost is billed to Medicare, thus taxpayers are being bilked.  Operating a Natrecor infusion clinic can be lucrative.  About 80 percent of patients who receive the drug are 65 or over, and therefore eligible for Medicare-which fully covers Natrecor in many states because it is an infusion therapy.

Several states' insurers that provide Medicare coverage have refused to pay for the outpatient use.  In May 2005, a group of cardiologists recommended the use of Natrecor be banned or severely limited recommending Natrecor be prescribed by cardiologists, or top intensive care doctors, and only in its recommended dosage on congestive heart failure patients admitted to the hospital whose medical condition had rapidly deteriorated.

Many doctors contend that much cheaper alternatives to Natrecor-such as nitroglycerin and Lasix and its generics-can work just as well as an emergency treatment for heart failure.


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