–Surprising success after 3 previous drugs in the class failed. Merck announced on Tuesday that the REVEAL trial with anacetrapib had met its primary endpoint, significantly reducing the rate of coronary death, MI, and coronary revascularization in high risk patients already taking statins. Full results of REVEAL will be presented on August 29 at the European…
Does Whole Genome Sequencing Have A Role in Primary Care?
June 26, 2017 by 2 Comments
–Pilot study confirms feasibility, but clinical value for healthy-seeming people is not obvious Whole genome sequencing (WGS)may one day play an important role in routine medical practice. But the results of a small study suggest that WGS, though perhaps promising, is certainly not ready for prime time. The price of WGS has dropped spectacularly in…
My Beef With The AHA’s Saturated Fat Recommendations
June 21, 2017 by 22 Comments
–We shouldn’t forget the unintended consequences of dietary recommendations. The American Heart Association’s position on saturated fat pretends to be science-based but is not, writes Gary Taubes, in a brilliant and wildly popular guest post published here on CardioBrief late last week. The AHA’s statement, which recommends that saturated fats be replaced with polyunsaturated…
Guest Post: Vegetable Oils, (Francis) Bacon, Bing Crosby, And The American Heart Association
June 16, 2017 by 26 Comments
–Gary Taubes responds to the AHA presidential advisory on dietary fats. Editor’s note: I was planning to write about the American Heart Association’s new statement about dietary fats so I asked Gary Taubes for a brief quote. Taubes, of course, is an investigative science and health journalist who has written three major books (Good Calories,…
Trustee For Zombie Lab Sues Thousands Of Doctors And Dozens Of Nonprofits
June 12, 2017 by 4 Comments
–The suits unveil the scope and sordid details of the massive kickback scheme. Thousands of doctors are being sued by the trustee representing the creditors of Health Diagnostic Laboratory (HDL), the bankrupt laboratory company. The trustee is demanding that the doctors repay thousands of dollars in illegal processing and handling (P&H) fees, a key part…
New Stroke Prevention Device May Not Prevent Strokes
June 7, 2017 by Leave a Comment
–There’s no hard evidence the Sentinel Cerebral Protection System reduces stroke in TAVR. Here’s how to get a second generation medical product or add-on product approved: show that the original device isn’t nearly as safe and effective as believed back in, you know, the dark ages before the new product showed up. Until now proponents…
The Unintended Consequences Of Bicycle Helmets
June 5, 2017 by 11 Comments
(UPDATED) –We should encourage people to cycle, not scare them away. From personal experience I can attest that it is almost impossible, in the US at least, to have an intelligent conversation about bicycle helmets. The universal view is that you have to be crazy not to wear a helmet. Since I almost never wear…
Study Finds Alarming Increase In US Bicycle Accidents
June 1, 2017 by 1 Comment
–But doesn’t consider the public health benefits of cycling The problem: bicycle accidents in adults in the U.S. now cost more than $24 billion a year. The solution: more, not fewer, bikes! A new paper published in the journal Injury Prevention finds that the number and costs of bicycle accidents in the U.S. have risen…
Last Beats of the Failing Heart — Two Views
May 30, 2017 by 1 Comment
–Milton Packer and Richard Lehman compare perspectives, Part 3 Editor’s note: This is the third installment of an ongoing discussion about heart failure (HF) between Milton PackerMD, who has been leading major heart failure clinical trials for decades, and Richard Lehman, MA, BM, BCh, MRCGP, a retired U.K. GP who writes a blog for the…
Two NEJM Papers Spotlight Promising But Early New Cardio Drugs
May 24, 2017 by 2 Comments
Now that cardiologists and other doctors are comfortable talking about PCSK9 inhibitors they can start preparing to add a new mouthful of a therapeutic target to their vocabulary: angiopoietin-like-3 (ANGPTL3). Two papers published in the New England Journal of Medicine by industry researchers provide a snapshot of promising but still early research on two new drugs that target…
Should Everyone With Heart Failure Get Aggressive Treatment?
May 23, 2017 by 1 Comment
–A Conversation About Heart Failure With Milton Packer And Richard Lehman (Part 2) This is the second installment of an ongoing discussion about heart failure between Milton Packer, who has been leading major heart failure clinical trials for decades, and Richard Lehman, a retired UK GP who writes a blog for the BMJ website. (Click…
Dissecting The Press Release For A Failed Stem Cell Trial
May 18, 2017 by 5 Comments
–Stem cell therapy supporters can’t acknowledge that it might not work. Stem cells have never been shown to have any clinical benefit in patients with heart disease. But there is mounting anecdotal evidence that they may have serious adverse effects on the reasoning and objectivity of the medical researchers, biotechnology executives and investors who get…
End of the Road for CETP Inhibitors?
May 17, 2017 by 1 Comment
With the publication of the ACCELERATE trial in the New England Journal of Medicine the long train of bad and disappointing news for the once-promising approach of CETP inhibition remains unbroken. More than 12,000 high-risk patients were randomized in ACCELERATE to evacetrapib or placebo. In 2015 the trial was prematurely terminated for futility; the main…
A Conversation About Heart Failure With Milton Packer And Richard Lehman
May 17, 2017 by 2 Comments
Milton Packer and Richard Lehman are both 66 years of age. Packer has been leading major heart failure clinical trials for decades. Lehman is a retired UK GP who writes a blog for the BMJ website. The two have agreed to answer questions and participate in a discussion about their different ideas and perspectives about…
Recent Blow Ups Spark Call For Overhaul Of Clinical Trials
May 11, 2017 by 2 Comments
[Updated] –Trial leaders say they need to get down into the weeds of trial details. Large international trials are under fire. In recent weeks, as I’ve reported, serious questions have been raised about three major heart failure trials. There is no reason to believe these are the only trials about which questions will be raised…
Another Acute Heart Failure Drug Fails In Large Clinical Trial
May 5, 2017 by 2 Comments
–In RELAX-AHF-2 serelaxin didn’t improve clinical outcomes. Yet another promising drug for acute heart failure has failed to improve long-term outcomes. In the RELAX-AHF-2 trial 6,600 patients hospitalized for acute heart failure were randomized to a 48-hour infusion of serelaxin or placebo. There was no significant difference between the two groups in either of the…
As Another Trial Goes Bust Investigators Call For Major Changes In International Trials
April 29, 2017 by 2 Comments
–Why were so many ineligible patients in Eastern Europe enrolled in TRUE-AHF? A new analysis of the recent TRUE-AHF trial offers strong evidence that large numbers of patients from Eastern Europe were ineligible for the trial and should not have been enrolled. The analysis doesn’t change the main finding of the trial, but it does…
Serious Questions Raised About Integrity Of International Trials
April 26, 2017 by 4 Comments
–TOPCAT analysis is the ‘smoking gun’ for trouble from ‘offshoring’ trials. Large international randomized controlled trials, the cornerstone of modern medicine, are in big trouble. As clinical trials have become a global enterprise, many observers have become increasingly worried about the integrity of data from certain geographic areas, in particular from Russia and other countries…
Principal Investigator Defends SPRINT Against Critics
April 20, 2017 by 1 Comment
–Blood pressure experts disagree about the NIH ‘Landmark’ Trial. Since the first announcement of its preliminary results the SPRINT trial has been the focus of intense controversy. One major focus of contention revolves around the precise technique used to measure blood pressure in the trial. As in all recent large outcome trials in hypertension, blood…
Concerns Over New Cardiac Blood Test Spark Intense Twitter Discussion
April 18, 2017 by 3 Comments
–Cardiologists fear the new high sensitivity troponin test will lead to lots of unnecessary testing. Along with many other cardiologists, Sek Kathiresan (Massachusetts General Hospital and Broad Institute) is worried that a new and improved diagnostic test will have disastrous unintended effects. Kathiresan expressed his concern on Twitter yesterday in response to my summary of a…
Ularitide Still a Bust After TRUE-AHF Peer Review
April 12, 2017 by Leave a Comment
–As reported at AHA, novel vasodilator failed to improve outcomes in heart failure Short-term treatment with the novel vasodilator ularitide did not lead to improved clinical outcomes in the long term. Results of the TRUE-AHF trial, first presented in preliminary form last November at the American Heart Association annual meeting, have now been published in…
Can SPRINT Be Used To Inform Hypertension Treatment?
April 9, 2017 by 3 Comments
–The landmark trial results are not easy to apply to clinical practice. Since the first breathless announcement of its preliminary results, SPRINT trial has been viewed as a landmark trial serving to establish a more aggressive approach to blood pressure management. It is now becoming increasingly clear, however, that the application of SPRINT in the…
Abbott Pulls Troubled Absorb Stent From European Market
April 6, 2017 by Leave a Comment
(Updated) Abbott Laboratories has sent a letter to European physicians informing them that the Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS “will only be available for use in clinical registry setting at select sites/institutions.” The company’s action comes in response to an avalanche of bad news for the controversial device. Last fall 3-year results from…
More Bad News For The Once Promising Bioresorbable Stent
March 31, 2017 by Leave a Comment
(Updated) –Problems for the Absorb BVS stent just won’t disappear Bad news for the Absorb BVS stent continues to accumulate, though defenders of the device keep looking for a silver lining. When it was approved in the US last summer the novel device appeared to have a bright future, with many prominent interventional cardiologists predicting…
Interventional Cardiologists Face Major Obstruction In Treatment Of Total Blockages
March 29, 2017 by 1 Comment
–Deep divisions over how CTO patients should be treated. In recent years ambitious interventional cardiologists have started to perform PCI on chronic total occlusions (CTOs), though these lesions have long been recognized as among the most difficult to successfully treat. Many other physicians, including some prominent interventional cardiologists, have expressed grave concerns about this expansion…
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