This week's article

[bunrab]

As I've mentioned before, I get a weekly summary of articles from Medscape Pharmacy. This article is from this week's; I've reprinted the abstract here, but not the whole article.

From Pharmacotherapy

Controversy and Conflict in the Treatment of Acute Decompensated Heart Failure: Limited Role for Nesiritide

John A. Noviasky, Pharm.D.
Abstract

The use of nesiritide for acute decompensated heart failure (ADHF) has been clouded with controversy since its approval in 2001. Extensive marketing and many review articles have established this drug as a safe and superior product to current standards. However, its safety has been called into question by the results of a meta-analysis, and its superiority of important outcomes (length of stay, mortality, decreased readmission rate) has never been proved by a randomized trial against agents with similar vasodilator properties (e.g., nitroglycerin). A review of the available literature on nesiritide in the areas of mortality, renal effects, retrospective studies, use in off-label indications, length of stay, and mortality is presented and illustrates why its use should be limited or even eliminated. After review of this article, the reader should be able to answer the question—if nesiritide had never been approved for use in patients with ADHF, would we have missed it?—with a negative reply.

The gist of the whole article is, neseritide appears to increase mortality, rather than decrease it. This includes results from a study done *by the manufacturer* of the drug.

What I wonder is, if all the preliminary studies showed that it was safe and effective, how does it happen now that all the after-approval studies show either no statistically significant effect whatsoever compared to other drugs used for the same purpose (that is, it's no better than older treatments), or else a slight negative effect? Thaat's a rhetorical question, by the way, as we already know that there are a lot of problems with the pharmaceutical approval process in the USA, and that our government agencies are far too heavily influenced by Big Pharma money. The article itself answers the question, pointing out the manufacturer's aggressive marketing campaign, which included a "guide" for hospitals on how billing Medicare for this drug could be more profitable for the hospital than other drugs. 

The EU has not approved this drug, and probably won't, according to the article.