Ten years after it was approved to help heart failure patients breathe, the Johnson & Johnson drug Natrecor is proving ineffective, if not as risky to the kidneys as feared, a New England Journal of Medicine study finds. The drug had no significant effect on breathing difficulties or other problems related to congestive heart failure, the researchers found, and while it didn't hurt kidney function or increase the number of deaths, it was associated with cases of dangerously low blood pressure.
Dr. Eric Topol of the Scripps Research Institute, who wrote an accompanying NEJM editorial, goes so far as to say that the study "doesn't show any use for [Natrecor], that's for sure." But the real question raised by the research is more fundamental. Why has it taken 10 years to discover that Natrecor doesn't work? "It shouldn't take this long to find out the truth about a drug," Topol told HealthDay.
According to the study, 44.5% of patients said their breathing improved 6 hours after a Natrecor infusion, and 68.2% reported improved breathing after 24 hours. But 42.1% and 66.1% of placebo patients reported the same improvement, a difference of just over two percentage points. The difference in rehospitalization rates was also insignificant, at 9.4% for Natrecor patients and 10.1% for placebo patients.
Topol also mentioned Zetia, the Merck cholesterol drug that's also part of the combination product Vytorin. Questions have been raised about Zetia's safety and its efficacy at improving cardiovascular outcomes, he noted. "For new drugs, we don't have an adequate plan to have enough data," he said. "We need a rebooting of the whole process." Plus, spending on less-than-effective drugs is "an example of profound waste," he said. "Billions of dollars were spent on nesiritide when we could have just used Lasix or intravenous nitroglycerin, which costs pennies a dose."
Thank You Fiercepharma and Ms. Staton