The problems encountered with guidelines  -- sent email to Ruta about the 800,000 dead 9/9/14

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1. Fiona Godlee, editor in chief, The BMJ   http://www.bmj.com/content/349/bmj.g5448?etoc=

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 serves the 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 agreement signed by the guideline authors that 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 trials that 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 guidelines that 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 [the power of bad pharma].  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 has led 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.”

Perioperative β blockade: guidelines do not reflect the problems with the evidence from the DECREASE trials

BMJ 2014; 349 doi: http://dx.doi.org/10.1136/bmj.g5210 (Published 29 August 2014) Cite this as: BMJ 2014;349:g5210

The trials underpinning initiation of perioperative β blockers in patients with ischaemic heart disease having high risk surgery have largely been discredited, and the remaining evidence points to an increased risk of death. However, changes to the European guidelines have been slow. Graham Cole and Darrel Francis call for improvements to permit guideline experts to perform rapid amendments when required

Vigorous efforts have been made across Europe to promote use of protocols to reduce perioperative deaths. Since 2009 the European Society of Cardiology (ESC) guidelines have recommended the initiation of perioperative β blockade for patients with ischaemic heart disease or positive preoperative stress test results who are having high risk surgery.1 This involves giving a short course of oral β blockers from shortly before surgery until a few days or weeks after surgery and is distinct from the long term use of β blockers in heart failure, for which safety and efficacy are well proved [not according to Cochrane Review]. The aim is to reduce perioperative mortality by preventing myocardial infarction. Until 31 July 2014, the recommendation was at the strongest level, class I, which should mean that there is “evidence and/or general agreement that a given treatment or procedure is beneficial, useful, and effective.”1

The principal support for the recommendation comes from two of the DECREASE (Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography) family of trials, which were discredited in 2011 because of misconduct.2 Our 2013 meta-analysis of the remaining 11 credible randomised controlled trials indicates that perioperative initation of β blockade increases mortality by 27% (P=0.04, 95% confidence interval 1% to 60%).3 The ESC did not alter its guidance as soon as the DECREASE trials were discredited in 2011 or after the publication of our meta-analysis reporting an increased risk of death, and in January 2014 we published …