[HSF] My! Oh, My!

[Ani Anyanwu]

Tea
 
'Convenience drug' is a term I have used in the past specifically for the use of Factor VII but can apply to other drugs too - maybe trasylol.
 
Some drugs are essential such as antibiotics in septicemia. Some drugs are of debatable essence such as digitalis in heart disease. Some drugs are non-essential and of questionable efficacy and use such as antibiotics in pharyngitis. Some drugs are to treat the physician's own anxiety or to fulfil his/her particular nuances or beliefs such as antibiotics in patients with chest tubes. Then there are those drugs are used for convenience such as hormonal therapy to suppress mensturation. An extension of the last concept is the doctors convenience.
 
Convenience therapies are not essential for the patient but make life more convenient for the physician or sometimes the patient. For example, I open majority of my redos on cardiopulmonary bypass - many could argue I do so for my convenience and that is it not necessary if I learnt to open a redo properly and safely like they do that I would not need to do so. Doctors who give every patient dobutamine or epinephrine is also an example of convenience therapy. You sleep better at night and less likely to be paged for a low output if you treat pre-emptively. Protamine given routinely when a patient returns to ICU is also an example of convenience therapy. Blood product transfusions is also a commonly used convenience therapy for surgeons who give products routinely for any operation. There is rarely an operation where use of blood products is essential in all cases as we rapidly learn when the Jehovah's witness walks in through the door. Even liver transplantation has been undertaken in these patients.
 
Factor VII unlike what others suggest is actually a prime example of a convenience drug and has been used as such several times in my institution. A surgeon does a complex arch reconstruction and has two options - pack and pack for 3 hours then go home or give Factor VII and maybe go home in 5 minutes. The drug *does* work. Many patients receive this drug in the initial operative setting and not after re-exploration for bleed and demonstration of coagulopathy. Mind you there are valid arguments for use of Factor VII as a convenience therapy which could benefit the patient.
 
1) Transfusions are associated with higher morbidity and mortality. Preventing or halting blood loss may be preferable to hours of transfusion and packing in the OR
2) Longer OR times may be associated with higher complications due to hypothermia and infection rates
3) A surgeon who is tired or who would rather not be there may be harmful to the patient
4) Re-explorations may be harmful to the patient
5) If used as an *alternative* to plasma transfusions then we have potentially less side effects to deal with
6) In patients with tenuous right heart function - notably heart transplantation and LVADs - the conventional treatment (blood product transfusion) or effect of coagulopathy (blood loss) can lead to catastrophic hemodynamic collapse. A pure pharmacological agent could treat the coagulopathy without such side effects.
 
While aprotinin is beneficial in some cases, in most cases it is a convenience drug. There is little evidence that any antifibrinolytic leads to better clinical outcomes in the majority of settings it is used. However if you want to operate on a patient on Plavix and finish the surgery in reasonable time and not be paged all night for bleeding, an antifibrinolytic might help. Alternatively if you don't have one you can take extra care with hemostasis such as Ed outlined in his strategy for Jehovah's witnesses and probably have the same effect. As I said I did a sixth time sternotomy two days ago without aprotinin and patient bled 700mls the first night.
 
Problem is that Factor VII has also side effects which to my mind are far more frequent and, if they occur, severe than those of aprotinin. It is for this reason it should not be a convenience drug. If the risk profile of the drug was low (as say aspirin), it would be a very useful convenience drug to give all our patients and while not an essential drug it would reduce the morbidity and also reduce the complications and complexity of heart surgery. The latter has been my basis for very liberal use of aprotinin till last week. I will not give up on my use of convenience therapy as I will now switch to other antifibrinolytics till they too are taken off the shelf whenever a researcher with a gripe chooses to pursue some vendetta with the manufacturing company (after all who has come up with a biologically plausible reason why aprotinin causes renal failure or death but tranexamic acid or EACA does not?).
 
I do not know though about "american medical evidence" though I think I could write some on that too - was that term from me also? Regardless of the fact that FDA has ruled, we still have to think about these issues: now Vioxx and Trasylol are gone, the FDA, the Manganos, the Lawyers etc will look for new targets...I have seen some nasty things recently on patients getting methylene blue lately, also a lot of the patients I see on Nitric Oxide seem to have renal failure and many die too...
 
Ani
 



> Date: Wed, 7 Nov 2007 19:59:31 -0800> From: tacuff at swbell.net> To: OpenHeart-L at lists.hsforum.com> CC: > Subject: [HSF] My! Oh, My!> > Listening to these threads on aprotonin, Factor VII, and hybrid ORs begs the question: why so much diversity of opinion if we are looking at that same "flat" world out there with the same universal standards of evidence that are even classified for us (eg IA, IIc , etc)? The world is flat now is it not? We all have access to the same clear and standardized evidence, right? We all look at the same problems, right?> > I have read a few novel twists in these discussions: "american medical evidence" and "convenience" drugs. As is my wont, I usually twist the question and reexamine it. What is then "unamerican evidence"? What drug exactly is an inconvenient drug, or what would be the purpose of using such a drug?> > But as to my original question, we could answer every medical and especially every American medical question with a (Chomsky type) economic answer. Does not anyone believe that there is somewhere in our medical practice some answers that do not depend on economics and fundamentally are biologic or medical in their answers, if you will, in their nature? What then would be that nature, and why might the evidence not be clear using our usual methods of asking the question? Not surprisingly I have at least a couple of ways of thinking about this that seem to me useful. What about you?> > On the other hand the FDA has decided so why bother to think about it at all?> > tea> _______________________________________________> 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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