Comments on: Natrecor – an interesting controversy

By: DB’s Medical Rants » The nesiritide story

DB’s Medical Rants » The nesiritide story — Fri, 15 Jul 2005 13:21:28 +0000

[...] ndustry — rcentor @ 7:20 am I wrote about this drug a couple of months ago – Natrecor – an interesting controversy. One of the main parties to t [...]

By: louis the great

louis the great — Mon, 13 Jun 2005 20:43:48 +0000

the cleveland clinic is good heart hospital, however, what was their public relations dept thinking? Ouch

By: DB’s Medical Rants » Thanks to an author

DB’s Medical Rants » Thanks to an author — Mon, 16 May 2005 18:41:33 +0000

[...] thor of the Natrecor meta-analysis, took time to comment today. Please read his remarks. Responses to â€œNatrecor – an interesting controversyâ€ [...]

By: jonathan sackner-bernstein

jonathan sackner-bernstein — Mon, 16 May 2005 02:40:01 +0000

As authors of the two manuscripts that precipitated the current controversy, we are pleased that you commented on your blog.

While some may criticize our studies as inconclusive because they are meta-analyses, it shouldn’t require advanced statistical training to realize the relevance of the analyses. No, a meta-analyis is not definitive, but a review of the literature will show that they are either on target or pretty close to truth. Therefore, if the precedent in the literature holds, a meta-analysis that points to this degree of risk will not turn out to be diametically opposed to truth. The drug will either be risky or neutral.

More importantly, J&J and even Jim Young at the Cleveland Clinic can’t point to any double-blind controlled trials that suggest beneficial or neutral outcomes. Only three such studies were performed and they all point to increased risk (these are the three in the meta-analysis).

Medical decision making is a balance, risks vs. benefits, one study vs. another. Nesiritide barely beats a placebo on dyspnea scores (after three hours of therapy) but is no better on a global well being questionnaire. It’s no better clinically than nitroglycerin. Balance these “benefits” against an estimated 80% higher risk of death within 30 days and how many would volunteer to receive the medicine?

Further, a meta-analysis suggests risk while no other controlled double-blind study suggests benefit.

Weigh all the data, and the conclusions are obvious. Anyone still imitating an ostrich? Not looking for evidence of harm does not mean there isn’t any. With nesiritide, it looks as though there is some, but without J&J stepping up and doing the responsible thing, starting a mortality trial, nesiritide should remain a drug of last resort.

Jonathan Sackner-Bernstein, MD

By: Marcy

Marcy — Thu, 05 May 2005 18:08:33 +0000

Wow…Wasn’t Topol involved in raising the issue about Vioxx too?

By: QuietStorm

QuietStorm — Thu, 05 May 2005 16:46:08 +0000

You seem to be leaning in favor of continuing the use of nesiritide and I can’t understand why. The drug is incredibly expensive, never has been shown to be better than furosemide and may be very harmful. Now, you highlighted the words may be and rightly so. The term is ambiguous enough that everyone can see what they want in it but the fact is that the metaanalysis suggested substantial risk of death and almost no possibility of mortality benefit which should be required if we are going to spend thousands of dollars a day giving it. I spend alot of time in ICUs as I assume you do and I can’t recall a single case of a patient who was given nesiritide and could not have achieved diuresis with intravenous furosemide. Bumetanide is another overhyped drug but I’ll save that rant for some other time.