CBBS: The efficacy of aprotinin and the ethics of further Randomized Clinical Trials to assess that efficacy

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The efficacy of aprotinin and the ethics of further Randomized Clinical Trials to assess that efficacy

On September 19, 2005, an internet link was posted on the CBBS website for a news article describing a study of the efficacy of Aprotinin compared to placebo.

Dr. Morris Blajchman (attribution used with permission) has expressed concerns about this link because it was to a news story about a recent Randomized Clinical Trial, which in Dr. Blajchman's opinion was unnecessary, since he believes that the efficacy of aprotinin has been established. Dr. Blajchman suggests that colleagues should review a cumulative meta-analysis of 64 studies done between 1987 and 2002 by Fergusson D et al, published in Clinical Trials (2005; volume 2; pp 218-232) [Full Text PDF] in which the authors conclude that their study "demonstrates that investigators evaluating aprotinin were not adequately citing previous research, resulting in a large number of Randomized Controlled Trials being conducted to address efficacy questions that prior trials had already definitively answered", and that "Institutional review boards and journals could reduce the number of redundant trials by requiring investigators to conduct adequate searches for prior evidence and conducting systematic reviews."

In addition, on page 229 of the Fergusson publication is a discussion of the Fergusson article by lain Chalmers in which Chalmers refers to "The scandalous failure of science to cumulate evidence scientifically" resulting in a "litany of unnecessary and therefore unethical research", subjecting study subjects inappropriately to placebo rather than an established treatment. In the opinion of Dr. Blajchman "This was the case for the study cited by the CBBS FAST BREAKING NEWS in the above internet link".

Editor's note: Attributed comments regarding Dr. Blajchman's concerns are encouraged.

ADDENDA Nov. 29, 2005

1. Editor's Note: Colleagues might find the articles:

Smith GC, Pell JP. Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials. BMJ. 2003 Dec 20; 327(7429): 1459-61
and
Editorial from Journal of the International Association of Physicians in AIDS Care (JIAPAC), Vol. 3, No. 4, 108-109 (2004)

to be of interest, in relation to the present discussion.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator

Posted: September 23, 2005

Addenda: Nov. 29, 2005

Link Updated: Jan. 2 & Mar. 17, 2007

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