Blog entry by Meguid El Nahas
BMJ 2014;349:g5448 doi: 10.1136/bmj.g5448 (Published 4 September 2014)
How guidelines can fail us
Fiona Godlee editor in chief, The BMJ
Should patients be offered β blockers if they have ischaemic
heart disease and are about to undergo high risk surgery?
Guidelines from the European Society of Cardiology say that
they should, citing evidence that it prevents perioperative
myocardial infarction. Others are unconvinced and say that the
recommendation should be revoked. Initially set at class 1, the
strongest level, the recommendation was retained in 2011 even
though key randomised trials were discredited. In the most
recent update of the guidance, published last month, the
recommendation still stands, albeit at class IIb.
How does this stack up against the remaining trial evidence? A
meta-analysis published in 2013, which excluded the discredited
trials, found that perioperative β blockade in patients at risk was
harmful, associated with a statistically and clinically significant
increase in mortality. And the authors of that meta-analysis,
writing this week in The BMJ (2014;349:g5210, doi:10.1136/
bmj.g5210), tell a strange and unsettling story of subsequent
events, one that is hard to reconcile with the treasured belief
that medicine servesthe best interests of patients and the public.
Those of us who thought we had seen an end to guidelines drawn
up among vested interests behind closed doors will be
disappointed. In Graham Cole and Darrel Francis’s account, we
hear of a secrecy agreementsigned by the guideline authorsthat
is so secret that even its existence must be kept secret. Where
is the openness on which science depends? We hear of
guidelines being led by the authors of the major trials—in this
case the very trialsthat turned out to have corrupted the evidence
base. Where is the scope for critique of researchers who are in
positions of power? We hear of what I would consider to be too
close a relationship between the society and its journal. Where
is the space for dissenting voices?
I will be interested to know whether readers share the authors’
clear disquiet about distorted priorities. When the series of
randomised trials was discredited and the senior author, Don
Poldermans, dismissed from his post, the European Society of
Cardiology’s statement concluded, “We are saddened by Prof
Poldermans’ situation.” Cole and Francis in contrast saw more
to be sad about in the patients who may have died as a result of
guidelinesthat were based on falsified and fictitious data. Using
the discredited research group’s own formula, they calculated
that the number of iatrogenic deaths might have reached 800
000, with half of those occurring after the research had been
discredited. This estimate, with caveats and cautions, was
published in the society’s journal, the European Heart Journal,
but the article was almost immediately removed. A substantially
revised version, without the estimate of deaths, is apparently
due for publication, but the original article is published as an
appendix to the article in The BMJ this week.
Let me quote from it: “Professional failure in clinical research
is not uncommon. If readers are not watching carefully, journals
are not listening seriously, and guideline writers are not free to
act swiftly, future failures may again risk enduring harm with
global reach. The aviation profession hasled the way in systems
to prevent, recognize,study, and learn from professional failures.
Clinical medicine is now following the same path. We must
develop similar systems for research.”
Cite this as: BMJ 2014;349:g5448
Another sobering account of Publications, Meta-analyses, Key opinion Leaders, Guidelines, Guideline panels, and Big Pharma...
Discerning doctors, Nephrologists and readers of publications and Guidelines have to take more responsibility by critically appraise what is dished out for them...to ultimately protect themselves from malpractice...and their patients from the consquences...Claiming ignorance and blind faith in the published word...can kill!