[HSF] Aprotinin

[hgrmd at aol.com]

Ben,
  Thanks for your response, which I've always highly respected.  See you in a couple of months.
Hal 
 
 
-----Original Message-----
From: benjamin.bidstrup at bigpond.com
To: OpenHeart-L at lists.hsforum.com
Sent: Tue, 21 Nov 2006 10:53 AM
Subject: Re: [HSF] Aprotinin


>Ben, 
> I'm starting to get a little thin skinned about those cracks regarding me 
>using articles in the WSJ and NYT as a frame of reference. Let me tell you, 
>those are the articles that will fire up the public and the lawyers, not some 
>paper stuck keep in the bowels of a peer reviewed journal. As for me, I 
>keep up with both sides of the fence. As an admitted paid >consultant for Bayer 
>for many years, I'm starting to get the impression that you "doth protest too 
>much." I've yet to hear you say that there is anything possibly harmful 
>with aprotinin. Do you honestly think that this side effect of ATN is just a 
>"vast right wing conspiracy" that has no basis whatsoever? Really, I think 
>your credibility suffers somewhat if you don't at least acknowledge >that there 
>might be some possibility that some of these aprotinin side effects >are real. >Shortly after the infamous Mangano article came out, I was cornered by a 
>couple of Bayer reps in the surgeon's lounge who whipped out a laptop and 
>fervently tried to convince me that all of these aprotinin allegations were 
>statistical poppycock. Quite frankly, your postings kind of remind >me of them. Hope 
>you're not offended, but I really felt the need to clear the air. 
>Hal 
When you have done the work, you tend to believe in your own research. If you read the FDA transcripts, you will see how Mangano defends his research. Is ATN associated with aprotinin use? I do not believe so. Does it have issues? Yes. The one we all need to be aware of is related to previous exposure. It is a foreign protein and can cause hypersensitivity and anaphylaxis. This is a reason why 'routine' use in some groups of patients needs to be deprecated. For example, use of a tissue valve in a younger patient. This is a group where many on this Forum have advocated non use of it and I agree with that. Bear in mind that not a lot of patients will undergo a redo in the future, so one must balance the current risks vs future risks. 
It has an effect on ACT. Now reasonably well know, but does need to be considered in managing heparin. 
Do I consider the ATN issue a conspiracy? No. There is a spectrum of renal change that can and does occur after cardiac surgery. We all know that. Many drugs can influence these changes. Aminoglycosides, NSAIDs use of FFP and other blood products to name but a few. What does a rise in creatinine portend? Especially if it returns to normal after a few days. Not all ATN needs dialysis, and not all creatinine rises = ATN. That is a specific pathological condition. It is an interesting point, as the renal people have trouble truly defining renal impairment after cardiac surgery. 
Patients receive many drugs during the course of a cardiac case. What is the impact of this cocktail? We are all taught about poly-pharmacy at medical school. In the majority of our patients, it does not seem to matter as they tend to get well. However, it is puzzling to see patients with persisting nausea after an OPCAB or a lung resection, or other non cardiac symptoms with which we have to deal. 
So it is all a balance. 
I have discussed the issues of propensity analysis with many people. There are ways to use it, and ways not. 
So where does truth lie? How do we determine truth in science ? We have a belief and we assess evidence to make that determination. It is the size and shape of that evidence base that that often differs for each of us. I do not take issue with your support for MV repair. I concur, although my base is possibly smaller than yours. 
 
The one beauty of this Forum is the ability to raise issues and concerns and have them discussed without the editorial constraints we see say in the NEJM. Well Mark does occasionally step in if he sees it straying too far from the track. It is also timely and done in the vein of improving patient care. 
Am I offended - no way. I respect your views and I hope I have in some small way added to your evidence base on not just drugs for stopping bleeding. 
I do hope to be in San Diego as well. 
-- Ben Bidstrup FRACS FRCSEd FEBCTS 
Consultant Cardiothoracic Surgeon 
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