After a firestorm of criticism on social media over his editorial comments, Jeffrey Drazen, the editor-in-chief of the New England Journal of Medicine, is trying to quiet a growing controversy by modifying his position regarding shared data. The firestorm was ignited by an editorial on data sharing in last week’s NEJM. Although highly supportive of…
NEJM Editor Flip Flops On Data Sharing After Social Media Firestorm
January 25, 2016 by Leave a Comment
Cookie Monster, Free Lunch, And The New England Journal Of Medicine
August 20, 2015 by Leave a Comment
In its efforts to defuse the conflict of interest issue the New England Journal of Medicine keeps setting off new explosions. The recent series of articles by Lisa Rosenbaum in the New England Journal of Medicine about conflict of interest issues provoked a storm of debate, including a powerful response from three former NEJM editors (and my own more eccentric response). Now NEJM itself has published…
New England Journal Of Medicine Declines To Retract Papers From Disgraced Research Group
September 26, 2014 by 2 Comments
Like the Leaning Tower of Pisa, the two New England Journal of Medicine papers by disgraced Dutch researcher Don Poldermans will never stand straight. But like the famous Tower they are also unlikely to topple anytime soon. Without attracting a lot of attention, back in August the NEJM editors decided not to retract the papers or publish an expression…
An Expert’s Perspective: Why Salt Is Not Like Tobacco And Why Guidelines Are Tricky
August 14, 2014 by Leave a Comment
Updated August 15– At the center of this week’s renewed debate on salt was Salim Yusuf, the long influential and occasionally controversial cardiology researcher and clinical trialist based at McMaster University in Hamilton, Ontario. I spoke with Yusuf before the publication of the New England Journal of Medicine papers, which include his own two papers from the PURE study….
Physicians Report Alarming Increase In LVAD Pump Thrombosis
November 27, 2013 by Leave a Comment
Physicians from three top institutions report an abrupt and highly troubling increase over the last two years in the incidence of pump thrombosis in patients who have received the HeartMate II left ventricular assist device (LVAD) manufactured by Thoractec. The current investigation, published online in the New England Journal of Medicine, was initially prompted by an observed increase in…
New Anticoagulant From Daiichi Sankyo Works Well In AF Patients
November 19, 2013 by Leave a Comment
Edoxaban, a direct oral factor Xa inhibitor under development by Daiichi Sankyo, is the latest in the series of new oral anticoagulants seeking to take over the troubled role of warfarin in clinical practice. The results of ENGAGE-AF-TIMI 48 were presented at the American Heart Association meeting in Dallas and published simultaneously in the New England Journal of Medicine. The results of the trial were…
No Value For Renal-Artery Stenting In CORAL
November 18, 2013 by Leave a Comment
Previous small studies have failed to find any benefit associated with renal-artery stenting, but the trials have been small and were not powered for clinical outcomes. Now, the CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) trial, presented at the American Heart Association meeting and published simultaneously in the New England Journal of Medicine, offers strong and persuasive evidence that renal-artery…
New Drug For Pulmonary Hypertension Approved By FDA
October 8, 2013 by Leave a Comment
The FDA today approved a new drug for pulmonary hypertension. Bayer HealthCare’s riociguat (brand name Adempas) was approved for 2 indications: The treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) (WHO* Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class The treatment of adults with pulmonary arterial hypertension…
Too Much Emphasis on Door-to-Balloon Time?
September 4, 2013 by Leave a Comment
One of the great medical advances in recent years has been the improved treatment of acute myocardial infarction. As the enormous benefits of earlier reperfusion became evident, medical systems in many parts of the world aimed to treat increasing numbers of patients in a shorter time frame. The door-to-balloon (D2B) time as a performance measure…
Cardiovascular Outcome Studies in Diabetes Drugs Finally Arrive
September 2, 2013 by Leave a Comment
For many years critics have bemoaned the absence of outcome studies for the many diabetes drugs used to lower blood glucose levels. Now, finally, two large trials with different drugs have been presented at the European Society of Cardiology meeting in Amsterdam and published simultaneously in The New England Journal of Medicine. The good news is that…
A Disruptive TASTE of the Future? Getting the Best of Randomized Trials AND Observational Studies
September 1, 2013 by Leave a Comment
A new study from Scandanavia may influence the treatment of acute myocardial infarction. But it also may end up having a much bigger impact on the entire field of medicine by pointing the way to an entirely new way of performing randomized clinical trials rapidly and inexpensively. One expert said the trial design may represent…
Disappointing Results with Dabigatran for Mechanical Valves
September 1, 2013 by 1 Comment
Despite being more durable than bioprosthetic valves, mechanical heart valves are often not chosen because of the requirement for lifelong anticoagulant therapy. It has been hoped that the newer generation of oral anticoagulants might eventually replace warfarin, making anticoagulation more tolerable and better accepted, since these agents don’t require continuous monitoring and have much fewer…
Positive Results for New Anticoagulant From Daiichi Sankyo
September 1, 2013 by Leave a Comment
A new entrant in the growing oral anticoagulant field shows promise for the treatment of venous thromboembolism (VTE) and pulmonary embolism (PE). The drug, edoxaban, is a new, once-daily Factor Xa inhibitor with a rapid onset of action that is under development by Daiichi Sankyo. Results of the Hokusai-VTE trial were presented at the European Society of…
New Actelion Drug Found Safe And Effective In Pulmonary Arterial Hypertension– But Does It Save Lives?
August 28, 2013 by Leave a Comment
Macitentan, a new drug for pulmonary arterial hypertension (PAH), appears to be safe and effective, but it is unclear whether it offers any significant advantages over currently available drugs. The drug, a dual endothelin-receptor antagonist, is under development from Actelion as an enhanced version of bosentan (Tracleer). The results of a phase 3 trial, SERAPHIN (Study with an Endothelin…
New Anticoagulant Found Safe And Effective In Acute Venous Thromboembolism
June 30, 2013 by 1 Comment
In a large clinical trial the new oral anticoagulant apixaban (Eliquis, Pfizer and Bristol-Myers Squibb) was at least as effective as standard therapy and caused fewer bleeding complications in patients with acute venous thromboembolism. The results of the AMPLIFY (Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy) trial are being presented on Monday at…
BLOCK HF: CRT Superior To Conventional Pacing In Heart Failure Patients With AV Block
April 24, 2013 by Leave a Comment
Patients with atrioventricular (AV) block generally receive right ventricular pacing; cardiac resynchronization therapy (CRT) has been restricted to patients with a low ejection fraction and a wide QRS duration. However, RV pacing may worsen LV dysfunction in AV block patients with low ejection fractions. Previous studies have raised the possibility that these patients may…
FDA Officials Calm Concerns Over Excessive Bleeding With Dabigatran
March 13, 2013 by 1 Comment
Concerns over excessive bleeding complications with dabigatran (Pradaxa, Boehringer Ingelheim) as compared with warfarin are most likely due to the heightened sensitivity and vigilance that can accompany a new drug, according to FDA officials in a perspective published online in the New England Journal of Medicine. “We believe that the large number of reported cases…
Another Negative Trial With Darbepoetin Alfa
March 10, 2013 by 1 Comment
Once again a trial testing the erythropoiesis-stimulating agent darbepoetin alfa (Aranesp, Amgen) has produced a negative result. Results of the RED-HF (Reduction of Events by Darbepoetin Alfa in Heart Failure) trial were presented at the ACC in San Francisco and published simultaneously in the New England Journal of Medicine. A total of 2278 patients with systolic heart failure…
New Studies Examine Prolonged Anticoagulation For VTE Recurrence
February 20, 2013 by Leave a Comment
Three studies published in the New England Journal of Medicine provide important new information about the risks and benefits of extended prophylaxis using two of the new oral anticoagulants in patients who have had venous thromboembolism (VTE). … In an accompanying editorial, Jean Connors writes that “deciding how to balance the risks and benefits of extended anticoagulation is…
‘Somebody has finally twigged that the heart and the lungs are joined up to each other and live in this space called the chest…’
February 12, 2013 by 1 Comment
Here are a few gems from Richard Lehman’s weekly cardiovascular literature review. Read the whole thing on CardioExchange. On a JAMA study showing that ramipril increases walking time in patients with intermittent claudication: This is the kind of trial that makes nobody millions of dollars, but which we should all be doing in our fields…
YouTube, NEJM, Whitney Houston, and Alpha Male Monkeys
February 23, 2012 by 3 Comments
Take a close look at this screenshot from YouTube (click to expand): Jim Ware, the legendary New England Journal of Medicine biostatistician: 8 views. Jerome Kassirer, Marcia Angell, and Arnold Relman, former NEJM editors: 36, 28, and 257 views. Whitney Elizabeth Houston Funeral Service: 994,920 views. (And how many more Whitney Houston videos do you think…
Guest Post: More Lessons From the Riata ICD Lead Recall
February 22, 2012 by 7 Comments
Editor’s Note: The following guest post is published with the permission of its author, Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. This post is longer and far more technical than most of the content published on CardioBrief. Due to the extraordinary nature of the…
ASSERT Sheds Light on the Role of Subclinical AF in Stroke
January 11, 2012 by Leave a Comment
A new study published in the New England Journal of Medicine sheds some much-needed light on the precise role of subclinical atrial fibrillation (AF) in the prognosis and development of ischemic stroke. ASSERT (Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial) followed 2580 patients with a newly implanted pacemaker or ICD…
No Mortality Benefit Found For Low-Molecular-Weight Heparin in Acutely Ill Patients
December 28, 2011 by Leave a Comment
Although venous thromboembolism (VTE) is a serious problem for acutely ill patients in the hospital, a new study published in the New England Journal of Medicine failed to find any improvement in mortality associated with thromboprophylaxis. Ajay Kakkar and the LIFENOX investigators randomized 8307 acutely ill patients to enoxaparin or placebo for 10 days. All…
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