In a highly critical analysis article on thebmj.com, two cardiologists call on the European Society of Cardiology (ESC) to revise its recent guidance about the use of beta blockers in patients undergoing noncardiac surgery; to make processes more transparent; and to act more swiftly upon fraudulent research—particularly when patient lives are at risk.
Since 2009, the ESC guidelines have recommended giving a short course of oral β blockers from shortly before surgery until a few days or weeks after surgery to patients with ischaemic heart disease or positive preoperative stress test results who are having high risk surgery. The aim is to reduce perioperative mortality by preventing myocardial infarction.
But Graham D Cole and Darrel P Francis from the National Heart and Lung Institute at Imperial College, London question the evidence for this. They say that the trials underpinning the recommendation were discredited in 2011 because they were “unreliable” and contained “fictitious data.”
At the end of July, the recommendation was downgraded and the discredited papers excluded from the revised guidelines. But this does not go far enough, Cole and Francis say.
They are concerned that the remaining study, which is often used to back the policy, may also be fraudulent too—it is by the same team as the other fraudulent trials.
The analysis authors published an article in the European Heart Journal outlining some of their concerns, but the article was removed from the website a few hours later.
A news story in The BMJ also raises concerns over the evidence underpinning the use of another drug. The UK Medicines and Healthcare Products Regulatory Agency has recently announced it is to review the “balance of benefits and risks” of the use of alteplase in the treatment of acute ischaemic stroke.
The MHRA’s announcement was prompted by concerns raised by Roger Shinton, a former consultant physician at Birmingham’s Heartlands Hospital, and was published as a letter in the Lancet.
Alteplase, a thrombolytic drug, is licensed in Europe for the management of acute ischaemic stroke within four and a half hours of onset of symptoms, and in the United States for use within three hours.
In his letter, Shinton highlighted several concerns with the initial trial used to obtain marketing approval for alteplase and a subsequent trial that was key to extending its window of use in Europe from three to four and a half hours. The story in The BMJ contains previously unpublished data relating to trial outcomes.
The MHRA say that the data supporting alteplase use had been “extensively discussed” and that the “benefit-risk balance is favourable.” The composition and terms of their expert committee to assess the issue will be announced in due course.
Deborah Cohen is investigations editor for The BMJ.