Quoted from http://blogs.forbes.com/robertlangreth/2010/11/14/surprise-jnj-heart-drug-doesnt-kill-people-or-do-much-of-anything/
Surprise: JNJ Heart Drug Doesn’t Kill People. Or Do Much Of Anything.
Nov. 14 2010
By ROBERT LANGRETH
A giant new study out today shows that a controversial Johnson & Johnson heart failure drug doesn’t kill people or cause serious kidney problems, as previous studies have suggested. But the study showed that the drug doesn’t seem to do all that much to help improve symptoms of acute heart failure, either.
The results should provide an end to the long and strange story of the J&J drug Natrecor. It rose to fame after it was approved based on a small study showing it appeared to help symptoms of patients reporting to the hospital with acute heart failure symptoms. Sales rose meteorically after some doctors started using it also in outpatient clinics in non-hospitalized patients. This was very profitable for both the doctors and for Johnson & Johnson.
But then sales dropped just as quickly after studies combed together the results of previous studies and showed that Natecor seemed to boost the risk of death. This led to a huge controversy over the widespread unproven “off-label” use in these outpatients.
The new 7000 patient showed the drug did not kill people, nor did it help very much in preventing symptoms either, when compared to patients that were treated aggressively with standard therapy. The modest symptom improvement was not statistically significant. “The drug does not have a long-term effect on clinical outcomes one way or another,” says Robert Califf of Duke University, who presented the big new study of 7000 patients at a news conference here at a meeting of the American Heart Association in Chicago.
The earlier study in 2005 showing a death risk “was wrong in its conclusion” that the drug killed people, admitted University of Michigan’s Keith Aaronson, who was involved in the earlier work showing a risk. This was not due to a technical flaw in the previous study, but just because the data available at the time was not rigorous enough to reach a definitive conclusion.