The Sunday Times 26 January 2014
RESEARCH suggesting that as many as 800,000 people could have died unnecessarily across Europe over the past five years after being prescribed beta-blockers has sparked a row between doctors.
As well as combating high blood pressure, the drugs have also been recommended for use since 2009 to reduce stress on the heart during non-cardiac surgery.
Don Poldermans, former professor of cardiology at the Erasmus Medical Centre in Rotterdam, Holland, and former chairman of the European Society of Cardiology’s (ESC) guideline committee, was exposed in 2011 for fabricating data that had influenced this non-cardiac surgical decision.
Now a controversial study by Darrel Francis, professor of cardiology at Imperial College London, and his colleague Graham Cole, a clinical research fellow in cardiology, claims those taking beta- blockers in the short term for non-cardiac surgery have a 27% higher risk of dying due to an increased risk of stroke and the lowering of blood pressure to dangerously low levels.
“It was lovely to recommend beta-blockers because we thought we would reduce mortality,” said Francis when his study was published last summer in the medical journal Heart.
“Unfortunately it looks as though we may have been killing them [patients].”
Francis and Cole subsequently calculated that up to 800,000 people across Europe, including at least 10,000 Britons, may have died unnecessarily. Those findings were published earlier this month in the ESC’s own European Heart Journal but within hours were removed from the ESC website.
Thomas Lüscher, professor of cardiology at University Hospital Zurich in Switzerland and the journal’s editor, said publication of the findings had been a mistake because the data had not been properly checked.
“This issue is complex and should not be handled like that. Such statements are not scientifically valid and create panic among patients and physicians and in this form are not only completely inappropriate but ethically questionable,” Lüscher said.
Francis said he was unable to comment because he had been informed the findings were being reviewed and could be republished.
The Medicines and Healthcare Products Regulatory Agency, which oversees drug safety, said it would consider any new evidence about beta-blockers.
Medical experts emphasised that long-term use of beta-blockers by those with heart problems, including an estimated 2m Britons, was entirely safe.
The following letter was received in response to this article:
An article published in the Sunday Times on January 26, 2014 (“800,000 ‘killed’ by beta-blockers”, News, January 26) raised concerns about the use of beta-blocker medications. We would like to assure patients that beta-blockers are safe and effective. In fact, one of the major advances in medicine over the past 50 years is the use of beta-blockers in patients with hypertension, heart attacks, heart failure and heart rhythm problems – numerous well conducted studies show that these medications save lives, reduce symptoms and improve quality of life. The study published in Heart authored by Dr. Bouri and colleagues1, which is available to anyone online at http://heart.bmj.com/ , addressed the special situation of adults who are undergoing major surgery who are not already taking heart medicines but who are at higher risk of heart problems with the stress of surgery. Regrettably, the evidence base for current recommendations has been called into question because of allegations of research fraud in some of the main studies. Research fraud is a serious issue that can result in harm to patients and undermines public trust. Academic institutions, research funding agencies, professional societies and medical journals are all committed to preventing research fraud and to remediating its effects in the few unfortunate instances when it does occur. The paper by Bouri and colleagues re-analyzed pooled data from clinical trials that started beta-blocker treatment before major surgery, after excluding the questionable studies. This analysis suggests that, rather than being protective, these medications may be harmful. However, the final answer is not in yet – another analysis of the published data indicates that beta blockers may be beneficial. 2 In addition, this pooled analysis does not apply to patients who are already taking beta-blockers for other reasons and then are scheduled for major surgery. It also does not apply to patients who are found to have significant heart disease during the pre-operative evaluation. Experts agree that beta-blockers at appropriate doses usually should be continued in these patients. We need more well-designed honest studies on how to decrease the risk of surgery, particularly in older patients who have a high risk of undiagnosed heart disease. In the meanwhile, patients should continue to take their beta-blockers and not stop them without professional advice. Physicians should carefully consider whether additional therapy is appropriate in an individual patient undergoing major surgery.
Catherine M. Otto, MD, Editor-in-Chief, Heart
Iain A. Simpson, MD, President, British Cardiovascular Society