After Yet Another Failure, Stem Cell Leaders Double Down

–Could repeated doses of stem cells turn the tide of negative trials? Despite an unrelieved history of negative trials, stem cell leaders continue to defend their field. In response to the failure of yet another cardiac stem clinical trial, Roberto Bolli, a prominent leader in the field, argued that it’s time for a “paradigm shift” in…

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International Experts Call Salt Guidelines Far Too Restrictive

A broad group of international experts are recommending a far more modest and less draconian approach to sodium restriction than current U.S. and international guidelines. In a new paper, published online in the European Heart Journal, they also focused on the broad gaps of knowledge in the field and drew attention to the paucity of…

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Enormous Rivaroxaban Study Stopped Early For ‘Overwhelming Efficacy’

(Updated) –Oral anticoagulant reduced CV events in patients with coronary and peripheral disease. The very large COMPASS study has been stopped early for “overwhelming efficacy,” according to a press release issued by Bayer AG and Janssen, manufacturers of rivaroxaban (Xarelto). The phase 3 trial randomized 27,402 patients with coronary artery disease (CAD) and peripheral artery…

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New Questions Raised About SPRINT

More questions are being raised about SPRINT, the enormous NIH-funded blood pressure lowering trial. Two recent developments will likely add more obstacles to the already difficult task of applying the results of the trial in the real world. Even before the full results of the trial were first made public the NIH and the SPRINT…

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27,000 Patient PCSK9 Inhibitor Trial Meets Main Endpoints

(Updated) –Cardiovascular outcomes finally available for PCSK9 inhibitors. Amgen announced on Thursday afternoon that the FOURIER trial had met both its primary composite endpoint (cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or coronary revascularization) and the even more rigorous key secondary composite endpoint (cardiovascular death, non-fatal MI or non-fatal stroke). The company…

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In Which I Go Under The Knife And Learn About Medicine In The Real World

I’m not a doctor but I thought I knew something about anticoagulation. Over the course of a career covering cardiology I’ve written countless stories about heparin, warfarin, the low molecular weight heparins, and the new oral anticoagulants. So when I had bilateral total knee replacement a few weeks ago I thought I knew what to…

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Long Unsuccessful Heart Failure Drug Once Again At Center Of Controversy

–The long, strange 30-year journey of BiDil. It’s been buried in the avalanche of related news but there’s an interesting and somewhat bizarre cardiology angle to the debate over Trump’s nomination of Tom Price to be the next HHS Secretary. ProPublica reported on Friday that last summer Price went to bat for the makers of…

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Screen-And-Treat to Prevent Diabetes Doomed to Fail

Screening must be supplemented by broader public health approaches. Screen and treat strategies to prevent type 2 diabetes are doomed to failure, according to a large new systematic review and meta-analysis published in The BMJ.  Instead, the authors said and outside experts agreed, any effort to combat the already enormous and still growing problem of type 2…

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2016: Great Year Or Greatest Year Ever?

Editor’s note: Once again Larry was too depressed to write the 2016 yearly review. (Actually, he’s hiding under his bed.) Veteran healthcare journalist and eternal optimist Candide Corn has again kindly agreed to take over the task this year. Candide’s motto is “all is for the best in the best of all possible worlds.” What a great year!…

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More Shots Fired in ‘Sugar War’

–Industry-sponsored study questions current guidelines on dietary sugar. Dietary guidelines relating to sugar— all of which recommend significant reductions in sugar intake— are based on weak evidence and are not trustworthy, according to a systematic review published in Annals of Internal Medicine. But an accompanying editorial points out that the systematic review is itself not…

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Novartis Withdraws Support For Controversial Entresto Contest

(Updated) Novartis will no longer sponsor a contest designed to support the publication of peer review articles about Entresto, the company’s important new heart failure drug. The contest is taking place on Cureus, an open access journal, publishing platform, and vehicle for industry-sponsored content. The contest offered $10,000 in rewards for articles supporting a recent…

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Novartis Contest Rewards Positive Peer Review Articles About Entresto

(See the bottom of the story for updates. Since the original publication of the story the cardiologists on the “peer review panel” have resigned and Novartis has withdrawn its support for the contest.) Despite the fact that it had one of the biggest clinical trial successes in recent years, the Novartis heart failure drug Entresto has…

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Seeking Profit and Investors, Rogue Lab Moves Into Small Hospitals

A controversial new laboratory company specializing in “advanced cardiovascular risk testing” is developing an innovative, highly profitable– and legally dubious– new business model. Details of the scheme are spelled out in a “Management Presentation” slide presentation sent to me by a confidential source. The slide presentation, according to my source, is  being shown by executives at True Health…

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The GiveAway Act

The 21st Century Cures Act should be called the 21st Century GiveAway Act. The Act may not even deliver on its main attraction– the funding of new research– but will instantly definitely give a regulatory boost to a host of special interests, including drug and device makers. As Michael Hiltzik writes in the LA Times,…

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Telling People What They Want To Hear: Alt-Med And Donald Trump

Donald Trump won* the election because he told people what they wanted to hear. Alternative medicine is growing in popularity because it tells people what they want to hear. Of course, there’s a big difference between telling people what they want to hear and actually delivering on those promises. He can say it as often as he…

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Genetic Studies Offer Hint Of Clinical Benefits-And Risks- of PCSK9 Inhibitors

–Both cardiovascular benefits and increase in diabetes seem likely. There is no more eagerly awaited question in cardiovascular medicine than the clinical role of the PCSK9 inhibitors. The first reports from a series of outcomes trials are not due until next year. But two large genetic studies published this week deliver strong indirect evidence that…

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Prenatal Genetic Test Billing Practices Questioned

–Sequenom billed insurance companies $2,760 but let patients pay only $200? Patients who order an expensive prenatal genetic test from Sequenom are being told that they will not be held responsible for the vast majority of the bill if it is denied by insurance. This policy may appear to benefit patients but may be considered a…

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Saturated Fats Linked To Heart Disease Once Again

–But critics say that observational studies can’t establish causal relationship. A prominent group of nutrition researchers have once again linked saturated fats to increased coronary heart disease. The new paper, published in BMJ, is the third paper in the past year to decry saturated fats. Along with the previous two papers, published in JACC and JAMA Internal…

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Guest Post: Two Nations Separated by 5.3 mm

Editor’s note: This guest post is by Saurabh Jha, MBBS, a radiologist at the University of Pennsylvania. This post will also be published on The Health Care Blog, where Jha is the associate editor. A popular meme is that the US spends more on healthcare than other developed nations but has nothing to show for…

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Mixed Results For ApoA-1 Therapies

–It’s still not time to write the obituary for all HDL therapies. There was good news and bad news for a category of experimental drugs that attempt to mimic the putative beneficial effect of HDL at the American Heart Association meeting in New Orleans. Thirteen years after setting the field on fire with a promising…

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Lunchroom Scandal At The AHA: Day Two Of Buttergate

–After a CardioBrief investigation the American Heart Association changes the lunchroom menu There is no better proof that journalism can change the world– both for the good and the bad– than Buttergate. Yesterday your intrepid reporter exposed the ongoing scandal of Buttergate taking place within the press lunchroom at the American Heart Association meeting in New…

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Is The American Heart Association Trying To Kill Health Reporters?

The answer is no. The AHA is not trying to kill us. But its dietary advice is consistently confusing and occasionally wrong, and health reporters in New Orleans may end up as collateral damage. Just take a look at what’s being served in the press room at the big American Heart Association meeting going on now…

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Statin Nation ‘Census’ Highlights Major Disparities

–Women, minorities treated at significantly lower rates Anyone reading this is almost certainly aware of the enormous importance of statins in the current health scene. But until now they may have had a hard time to bring precise numbers and statistics to this all important story. Now data from a large federal survey confirm that…

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No Cognitive Benefit from Heart Drugs in HOPE-3

–Substudy finds mental function unimproved by BP, cholesterol treatments NEW ORLEANS — A large substudy of the HOPE-3 trial found no benefit relating to cognitive function in patients who took cholesterol or blood pressure-lowering drugs. In recent years cognitive decline and dementia have emerged as a concern equal if not even greater than cardiovascular disease…

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Debate Ensues As USPSTF Finalizes Statin Primary Prevention Guideline

–Broad disagreement about how, when, and if to use statins. The U.S. Preventive Services Task Force (USPSTF) has issued final recommendations regarding the use of statins for primary prevention of cardiovascular disease in adults. The recommendations, first proposed last December, are broadly consistent with the 2013 American College of Cardiology/American Heart Association guidelines. But accompanying the…

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