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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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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How The Internet Brought Us Donald Trump

Does the internet expand our world? Does it lead us to a broader and richer view of our world and ourselves? It seemed like a simple question. The year was 1994 and the internet was still new. I was sitting in a classroom full of MIT students as a guest during my year as a…

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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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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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Novel Cholesterol Therapy Flops And Company Ends Development

–13 years after ApoA-1 Milano sparked excitement the novel HDL therapy appears to be dead. After 13 years and despite the efforts of 3 separate companies, the novel cholesterol therapy known as ApoA-1 Milano appears to be dead. On Monday afternoon the Medicines Company announced that it had discontinued development of the drug and would…

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Cardiac Devices Could Become a Big Problem For Califf And The FDA

–Approvals with no strong evidence of efficacy: What could go wrong?  The FDA has a big problem. It likes to approve new drugs and devices. Approvals look good politically and allow the FDA to boast each year about their large number of approvals. But when the FDA approves a drug or device that doesn’t work…

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Early Watchman Experience Reassuring, But Many Questions Remain

In the year and a half after its approval the Watchman left atrial appendage closure device was successfully implanted 95.6% of the time, or more than 3,600 times out of a total of 3,822 consecutive cases. The finding comes from procedural data collected by Boston Scientific and presented at TCT by Vivek Reddy (Mt. Sinai)…

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The Impact Of ABSORB II: Down The Slippery Slope

When it was approved earlier this year in July the Absorb (Abbott) bioresorbable stent provoked a fair amount of discussion about the “slippery slope of noninferiority.” Although the stent met the FDA criteria for approval, the available trial results went in the wrong direction and there was a particularly concerning warning sign of a higher…

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Pfizer Ends Development Of Its PCSK9 Inhibitor

–Immune issues and diminishing efficacy doomed the new drug. Pfizer announced on Tuesday that it was discontinuing development of bococizumab, its cholesterol-lowering PCSK9 inhibitor under development. “The totality of clinical information now available for bococizumab, taken together with the evolving treatment and market landscape for lipid-lowering agents, indicates that bococizumab is not likely to provide…

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Debaters At Interventional Cardiology Meeting Literally Put The Gloves On

The world’s premiere interventional cardiology meeting now features cardiologists wearing boxing shorts and gloves. The Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington, DC kicked off  with a “Saturday Night Fights” theme for its debate session, and the participants– nearly all greying, eminent male interventional cardiologists– adopted the theme whole-heartedly. All lovey-dovey at the start of #TCT2016 fights pic.twitter.com/upGprIcxkQ…

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Impella No Better Than IABP in Cardiogenic Shock

–Underpowered IMPRESS trial shows no mortality benefit A rare randomized trial and a new meta-analysis both failed to find any evidence that Impella mechanical circulatory support devices are any better than intra-aortic balloon pumps (IABPs) for patients with cardiogenic shock. For many years, the intra-aortic balloon pump has been the standard device to increase circulation…

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Universal Child FH Screening Proposed

–Novel strategy would identify both children and adults at high risk for CV events. Doctors in the U.K. are proposing a novel strategy to identify very young children with familial hypercholesterolemia (FH). The strategy would also identify and help prevent events in the parents who also have FH. The new approach begins with a heel-stick…

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Eliquis Nipping At The Heels of NOAC Market Leader Xarelto

–But the overall market for the new oral anticoagulants continues to expand. The new oral anticoagulant (NOAC) market is growing larger and is becoming increasingly competitive. The latest market data shows that apixaban (Eliquis, Pfizer and BristolMyers Squibb) is challenging the established leader in the field, rivaroxaban (Xarelto, Johnson & Johnson). According to recent data…

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FDA Reaffirms Safety And Efficacy Of Rivaroxaban

–FDA says no changes needed to the rivaroxaban label. Following a year of controversy and uncertainty relating to the anticoagulant drug rivaroxaban (Xarelto, Johnson & Johnson), the FDA has reaffirmed the drug’s safety and efficacy. Rivaroxaban is approved for stroke reduction in patients with atrial fibrillation. The indication is based on results of the ROCKET-AF…

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No, $75 Million Won’t Cure Heart Disease Or Reinvent Science

–Silicon Valley hype and hubris come to cardiology. We may be close to peak hype and hubris in cardiology. This week some of the smartest people on the planet said that $75 million can help find new ways to prevent heart disease AND, as if that’s not enough, completely reinvent the way we do science….

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Trump’s Risk For A Cardiac Event Is Seven Times Hilary Clinton’s Risk

Editor’s note: The following guest post is reprinted with permission from Dr. Anthony Pearson, a cardiologist who is the medical director of the Echocardiography Laboratory and Anticoagulation Clinic at St. Lukes Hospital, Chesterfield, Missouri. Dr. Pearson writes The Skeptical Cardiologist blog, where this post originally appeared. Donald Trump recently appeared on the Dr. Oz show and handed a letter to the…

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More Bleeding Linked To Rivaroxaban In Observational Study

–Compared to dabigatran, rivaroxaban was associated with more intracranial and other serious bleeds. A new observational study finds that patients who take rivaroxaban (Xarelto, Johnson & Johnson) may be more likely to have serious bleeding events than patients who take dabigatran (Pradaxa, Boehringer Ingelheim). In a paper published in JAMA Internal Medicine, David Graham and…

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Ticagrelor No Better Than Clopidogrel In Peripheral Artery Disease

AstraZeneca announces top-line results from EUCLID trial ahead of the AHA. Ticagrelor is no better than clopidogrel in patients who have peripheral artery disease, a large new study will show. On Tuesday morning AstraZeneca announced the top line results of the EUCLID (Examining Use of Ticagrelor in PAD) trial. The full results will be presented…

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More Blasts Of Concern Over ROCKET-AF

The controversy over the big Xarelto trial does not appear to be going away. A new investigation published in the BMJ raises more troubling questions about the ROCKET-AF trial, which compared the novel oral anticoagulant rivaroxaban (Xarelto, Johnson & Johnson) to warfarin in patients with atrial fibrillation. The controversy about the trial first unfolded last…

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