[HSF] Aprotinin...again

[Tea Acuff]

Since most of my cases are without CPB, I may use it less than you. But thanks for the reminder.
tea


----- Original Message ----
From: "hgrmd at aol.com" <hgrmd at aol.com>
To: OpenHeart-L at lists.hsforum.com
Sent: Thursday, February 8, 2007 5:30:06 AM
Subject: Re: [HSF] Aprotinin...again


Tomas,
  Like Ani, my office got 3 calls regarding aprotinin from concerned patients.  I hate to tell Ani, Tea, Ben, and others "I told you so", but I told you so.  My use has and will be limited to thoracic aortic grafts and patients already on dialysis.
Hal


-----Original Message-----
From: TSalerno at med.miami.edu
To: OpenHeart-L at lists.hsforum.com; OpenHeart-L at lists.hsforum.com
Sent: Thu, 8 Feb 2007 1:46 AM
Subject: RE: [HSF] Aprotinin...again


My patients, even done in 2003, are now calling in panic and I am sure will be 
part of a class action lawsuit for the use of aprotinin. The use of this drug in 
the USA is in jeopardy and I personally will not use it outside the guidelines 
given by FDA. We now have to make legal decisions...


Tomas

________________________________

From: openheart-l-bounces at lists.hsforum.com on behalf of Ben Bidstrup
Sent: Wed 2/7/2007 10:45 PM
To: OpenHeart-L at lists.hsforum.com
Subject: Re: [HSF] Aprotinin...again



>I was wondering if anyone has read the new Mangano paper? It appears
>that regardless of veracity or scientific accuracy it will inflict a
>major, if not irreversible blow on the use of this agent. We have
>had 3 patients calling today wanting to know if they received the
>drug and I am sure there will be numerous more. Although I have been
>a strong believer in aprotinin for years, I have a sad feeling that
>its end may be nigh except in the complex high risk case.
>
>I suspect that this paper has all the flaws of the first, I will
>read it myself and find out, but the suggestion that patients are at
>increased risk of dying up to five years later is one few patients
>will ignore.
>
>Ani
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If Mangano analysed his data with risk stratification (say Euroscore)
and it came out with the conclusion that mortality risk adjusted was
higher, then it would be far more persuasive than this most recent
attempt. As he has in the past scored patients with Euroscore, he
probably has the correct elements to do this. Hopefully properly
defined as well. But given the attitude he presented at the FDA
hearing, his unwillingness to let anyone look at the raw data I agree
that this is as flawed as the earlier reports. High risk patients
will die sooner than low risk. I believe we already know that.

I am an unashamed supporter of my early research on aprotinin and
much of it has been funded by industry (Bayer). I have received other
support from Bayer in terms of Speaker Bureau and consultancy fees. I
also have done work for many other companies.
I might add that much research these days is supported by industry as
other funds are few and far between.

--
Ben Bidstrup FRACS FRCSEd FEBCTS
Consultant Cardiothoracic Surgeon
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