Interesting Spin by J and J
Amazing to watch "damage control" in action. In response to the publication of our study in Circulation, Scios/J&J have enlisted the help of some of the smartest people in the field (I hope). Their responses focus on the fact that we included data from doses higher than are the recommended starting doses. This is true.
We included all the data that they used to get the drug approved by the FDA. I re-read the transcript of their public meetings from 1999 and 2001. I can't find one point where a representative of Scios asked the FDA to ignore any of these studies. Scios used all the studies to support their view that the drug was safe and effective.
So now they don't want some of these studies to be included in this independent safety analysis.
The company can't have it both ways. If you want to use all the data to get your drug approved (as you should), then you can't back away from most of your data for convenience, as they are doing now.
Bottom line: the drug probably has significant risk, and until they complete an appropriate mortality trial, nesiritide should not be used until a combination of diuretics and nitroglycerin prove inadequate.
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