[HSF] Aprotinin

[Ani Anyanwu]

Hal
 
There is no mounting evidence that aprotinin is dangerous - the overwhelming evidence by far is that it is safe. What is mounting is the perception that it is unsafe. Remember that aprotinin is 20 years old. There are numerous studies in the literature, many randomized, on aprotinin the majority of which have not found any adverse effects. A metaanalysis in JTCVS few years ago confirmed patient benefit. All the present feelings on the drug are prompted not by evidence (as it overwhelmingly suggests benefit) but by the results of two studies, one of which is very questionable, the other we are awaiting. The analogy is if a paper is published today showing you are more likely to die in 5 years if you have a mitral repair and based on that we all stop repairing valves. It reminds me of the two flawed lancet papers few years ago linking the MMR vaccine to autism which received all the press and reduced uptake of the MMR to 50% sporadic outbreaks of measles. All the lay media, lawyers and many doctors caught on with this. Now the papers have all been discredited and retracted by the lancet for flaws that were very evident on the first read. All but 3 of the original authors wrote a retraction acknowledging the paper was inaccurate and misleading. The three remaining authors are facing the UK medical council for scientific fraud. The lead author, who like the aprotinin killers, had questionable motive fors lancet papers, now makes a living in the USA working with autism groups - a celebrity made by what is now accepted to be hyped up fabrication. Unfortunately like with aprotinin the damage was already done, people have suffered and people remain skeptical. My understanding is thus far the Mangano group have not allowed others independent access to their data, but it wont surprise me if that one is also withdrawrn too. I for one will await this new paper but suspect it will turn out to be no evidence on which withdrawal of a drug will be based. 
 
Mind you Hal, we ALL agree on the benefits of the drug - it is the risks we ponder about. Even yourself used it in selected patients like circulatory arrest. Why?  I do not think tranexamic acid and EACA are the solution and suspect that if given enough in a like for like dosage, it is antifibrinolysis rather than aprotinin that is potentially harmful.
 
I am afraid though that this discussion is now academic. Regardless of the truth aprotinin will likely be a historical drug. We had no problems administering aprotinin in the past but this week all patients furnished with the information that the company has stopped marketing it have refused use of the drug. If the company choses to stop marketing either they know something we don't (i.e. drug is really dangerous) or they are scared FDA will mandate a withdrawal (thus pre-empting) or they are scared of lawyers. Neither is good and I cannot see how the confidence of patients and doctors can be restored.
 
We will have a meeting next week to decide on alternatives to aprotinin - we have no choice than to accept the reality and move on. Having said that I did a sixth time reop MVR yesterday with no aprotinin and she is doing fine. So maybe it is after all a convenience drug which we can do without.
 
Ani
 
 
 



> From: Hgrmd at aol.com> Date: Wed, 7 Nov 2007 07:24:54 -0500> Subject: Re: [HSF] Aprotinin> To: OpenHeart-L at lists.hsforum.com> CC: > > Tony,> I'll be happy to wait for the "final analysis". If aprotinin is truly > vindicated and re released on the market, I will consider using it for certain > cases. However, I believe all of this breast beating bluster on HSF by some > aprotinin believers, in spite of mounting evidence of it's potential danger, > may cause some regret in the near future. I certainly hope not, but I do think > one is definitely taking a chance in persisting in using a drug with well > publicized questions about its safety. > > Hal> > > > ************************************** See what's new at http://www.aol.com> _______________________________________________> OpenHeart-L mailing list> > Send postings to:> OpenHeart-L at lists.hsforum.com> > To UNSUBSCRIBE, to CHANGE email address, or to view archives:> http://mmp.cjp.com/mailman/listinfo/openheart-l> > All messages transmitted by the OpenHeart-L are subject to the policies and > disclaimers posted at:> http://www.hsforum.com/listdisclaim> -----------------------------------------
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