Is Nesiritide Safe? A Prestigious Journal Wants That Question Asked
I have written about a concern that nesiritide (Natrecor TM) may not be a safe medicine. When asked, I will certainly acknowledge the benefits of the drug. These include improving symptoms and lower the pressure in the heart very quickly (both good things if you have bad heart failure). But these advantages don't exist much longer than 3-6 hours. By 24 hours of treatment, the medicine is not different than the established options.
The reason that I expressed my concern initially (early 2002) was that it seemed to me that there could be a risk associated with use of nesiritide. I spoke at a national meeting in the spring of 2003 to present data that suggested this risk to me and was given the "freeze." The data from our analysis suggesting risk associated with nesiritide leaked to the Wall Street Journal in advance of the publication, but perhaps because I did not speak with the reporter, the lay press paid little further attention (according to the policy of the meeting where I was scheduled to present the data, I was not permitted to discuss the results in advance).
Discussion amongst my peers, focusing on the scientific and medical implications, was also fairly absent. I was told (this is hearsay, I have no proof it happened) that Scios (manufacturer of nesiritide) devoted a significant part of a teleconference with key cardiology opinion leaders to try to figure out what my agenda was. It was as simple then as it is now, drugs used in clinical medicine should undergo rigorous safety analyses in formal studies wheneven feasible.
Besides that "discussion," I was treated more as a pariah than did the analyses lead to meaningful discussions about how to learn whether there was a risk associated with nesiritide. For the most part, a huge database was analyzed (ADHERE registry) to see if there were any associations of concern. This kind of analysis is even less meaningful than the pooled analyses I have performed with my colleagues.
I gave apresentation at another national meeting (fall 2004), and was greeted by both outright attacks and quiet encouragement. Finally, more practicing physicians are realizing how important it is to look cautiously at the rationale for using nesiritide, hopefully as a first step towards carefully considering the rationale for any test or treatment. Ideally, doctors will go even one step further, and look at the data.
This is what the cardiology journal Circulation has done. This spring, they will be publishing our analysis that shows an association between nesiritide use and worsening kidney function. As a colleague said to me recently abou this association, "that is not good."
My goal; to continue to push for rationale, data-driven medical care.
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