Despite a 2-year-old scandal discrediting key evidence, current guidelines relying on this evidence have not been revised. As a result of physicians following these guidelines, some researchers say, it is possible that thousands of patients may have died each year in the UK alone. It is unlikely that a true understanding of the damage will ever be known.
- Current European Society of Cardiology guidelines recommend that beta-blockers be given to many patients having surgery for noncardiac reasons to protect the heart during surgery. (US guidelines are somewhat less aggressive in their endorsement of perioperative beta-blockade.) The guidelines, which were published in 2009, were based on analyses of the available trials. The strongest evidence came from the DECREASE family of trials, which appeared to strongly support perioperative beta-blockade, and one other large trial, POISE, which raised concerns that beta-blockers might lead to an increase in deaths. When the ESC committee combined all the data they found a neutral effect on mortality but a strong benefit due to significant reductions in non-fatal MI and stroke with beta blocker use. This was the basis for the strong recommendation in the ESC guidelines.
In 2011, however, faith in the reliability of the DECREASE trials was shattered as a result of a scientific misconduct scandal centering on the principal investigator of the studies, the now disgraced Dutch researcher Don Poldermans. The issue was further complicated because, in addition to his key role in the trials, Poldermans was the chairman of the committee that drafted the guidelines.
Now, a group of UK researchers, led by Darrel Francis, have published in the journal Heart the results of a meta-analysis of the remaining non-DECREASE trials that tested perioperative beta-blockade. With the removal of the DECREASE trials the findings were strikingly different from the earlier analyses. In a combined population of 10,529 patients taken from 9 trials there was a statistically significant increase in the risk of death in the group of patients randomized to beta-blockers…
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Click here to read the full story on Forbes.
- Don Poldermans
- Darrel Francis
Thanks for bringing forward this important issue Larry. Preoperative assessment of patients undergoing non-cardiac surgery is a common task among cardiologists. However, this is a difficult area and the literature is scarce. Therefore we rely heavily on clinical guidelines. We believe them to be the holy grail when it comes to these issues. If our recommendations are based on current clinical guidelines, we cant really be wrong, can we?
However, although guidelines may be helpful, their weakness is becoming increasingly apparent. The above is good example of this problem. Was it premature to recommend the use of beta blockers based on the DECREASE trials? It certainly appears so. What are the consequences? How is it going to be dealt with? How long is it going to take?
Of course the whole story also raises the issue of scientific misconduct in medicine. We have had another recent example of that:
http://www.docsopinion.com/2013/07/29/you-know-nothing-jon-snow-scientific-misconduct-in-medicine/
It is scary to realize that our medical knowledge and current clinical practice may partly be based on falsified or manipulated data.