[HSF] Aprotinin

[Ben Bidstrup]

>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