Emotional or evidence based medicine - is there a moral tragedy in haemostatic therapy?

We strongly recommend that critical evaluation of medical practice is based on evidence rather than emotional reaction. Surprisingly, Stanworth and Hunt [1] seem to resort to the latter in response to our review [2]. Their questioning of ethics and morals appears unjustified, since we fully acknowledged multiple, serious limitations of the current evidence and methodologies within our review. They claim 'the danger of this review is that the message supports a move toward greater use of fibrinogen concentrate without proper evaluation' [1], ignoring our final statement that 'more high-quality, prospective studies are required before any definitive conclusions can be drawn' [2].

Proposing cryoprecipitate as an alternative source of fibrinogen is irrelevant in most European countries, where cryoprecipitate is not used due to safety concerns [3]. Cryoprecipitate is no longer regarded as appropriate therapy for hereditary bleeding disorders in Europe, the United States or the United Kingdom, and hence its administration for acquired coagulopathies represents a double standard [4].

Fibrinogen concentrate was first licensed in Brazil in 1963. Over 3 million grams have been used since 1985, mainly in countries where fibrinogen concentrate has approval for acquired bleeding. In Germany, Austria and Switzerland, fibrinogen concentrate represents the standard of care in most hospitals; it is typically used as the first-line haemostatic intervention. Restricting use of fibrinogen concentrate to clinical trials as suggested by Stanworth and Hunt seems absurd - consistent application of this principle would abolish the use of all blood-bank products.

If there is a moral tragedy, it is the acceptance of fresh frozen plasma and cryoprecipitate in practice despite the absence of evidence to confirm efficacy [3, 5].