Let there be no mistake, Johnson & Johnson, and its subsidiary Scois, knew all about the dangers associated with its heart failure drug Natrecor, but threw caution to the wind in promoting its off-label use in pursuit of profits.
Natrecor was FDA approved in August 2001 for the sole purpose of treating patients for the most acute from of congestive heart failure to be administered intravenously to patients during hospitalization under close medical supervision.
However, the company's aggressive off-label marketing campaign has allowed the drug to be administered in outpatient clinics at a much greater dose and for longer periods of time than recommended.
The off-label prescribing of drugs is wreaking havoc on unsuspecting patients. Guessing at drug dosage levels, medical conditions, and treatment duration for uses that were never approved is proving deadly. This is especially true with life-and-death drugs like heart medications. As a consequence of Natrecor's off-label use, patients have suffered serious injuries, including kidney failure, congestive heart failure, stroke, and death.
In this country, doctors are permitted to prescribe drugs to treat a condition even after the FDA has denied approval for a specific condition. Although a drug maker cannot directly promote a drug for an off-label use, a doctor can prescribe it for that use. If a company can orchestrate a doctor-backed marketing scheme, it can turn a restricted drug into a billion-dollar blockbuster.
A point has been reached, where many doctors are acting more like marketing agents than health care professionals. Doctors can spread the word of an off-label and create an exaggerated demand for a drug far and beyond its FDA approved market.
Health officials began investigating the off-label use of Natrecor in May 2005 after the New York Times published an article reporting how tens of thousands of patients were undergoing "tune-ups" at outpatient clinics by receiving weekly infusions over a period of months.
Albeit unfortunate, it is within the law for a drug company to send information to doctors about a drug's off-label uses, as long as it is for educational purposes only. In the case of Natrecor, this loophole proved to be as wide as a barn door.
Company sales representatives were actually distributing brochures to teach doctors how to set up outpatient clinics to provide regular off-label Natrecor treatments to patients. The company then recruited doctors and nurses with experience in administering outpatient infusions to deliver presentations at medical seminars and meetings.
Some outpatient clinics went so far as to establish programs to administer Natrecor to patients twice a week for up to 12 weeks with full knowledge that there had been no study conducted to determine whether long-term treatment was safe.
Operating a Natrecor clinic was very profitable. The vast majority of patients who received the drug were 65 or older, and eligible for Medicare which covered Natrecor treatment specifically because it was an infusion therapy.
An editorial in the July 14, 2005, New England Journal of Medicine by Dr. Eric Topol, the chairman of cardiovascular medicine at the Cleveland Clinic, objected to the company's encouragement of doctors to open clinics for Netracor infusions. Dr. Topol, noted that company documents instructed doctors to bill Medicare for a $172 observation fee for the first hour, and $408 for eight hours of observation during the treatment, above and beyond the actual cost of the drug.
The reimbursement guide told doctors to use Medicare codes that treat Natrecor like chemotherapy and allowed them to bill for larger reimbursement payments. As for Natrecor's $500-$700 per infusion price tag, Dr Topel explained that a dose of other equally effective medications cost less than $10.
"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."
The good Doctor is correct, there is no logical explanation for the situation. Natrecor has not only been proven to be no better than older drugs, infusion of the drug is often lethal.
A study that appeared in the April 20, 2005 issue of the Journal of the American Medical Association, found patients treated with Natrecor were 80% more likely to die in the 30 days following the treatment than patients given a placebo. And one trial found kidney problems were occurring at a rate three times that found in patients taking a placebo, according to a June 13, 2005 report by Health Day News.
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