Dollars For Heart Docs: 2015 Edition

–Cardiologists received more than $200 million from industry in 2015. In 2015 cardiologists and other cardiovascular specialists received more than $200 million dollars from industry, according to new data released by Medicare. More than 30,000 physicians in cardiovascular medicine received industry payments in 2015, though many of these payments were relatively small amounts. But more…

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Anticipated Heart Failure Trial Delayed Until November

–The results of TRUE-AHF won’t be presented at the ESC. The results of a highly anticipated and already-delayed clinical trial won’t be presented until November at the American Heart Association meeting in New Orleans. Presentation of the trial was originally scheduled earlier his year as a late-breaking presentation at the American College of Cardiology meeting…

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FDA Delays Approval Of First Agent To Reverse Effect Of New Anticoagulants

  Portola Pharmaceuticals announced late on Wednesday evening that it had received a complete response letter (CRL) from the FDA regarding its Biologics License Application (BLA) for AndexXa (andexanet alfa). Approval for the drug had been widely expected earlier in the day, which was the drug’s PDUFA date. The drug had been on an accelerated…

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Imprecise Medicine: Genetic Tests Lead To Misdiagnosis

–Some black Americans were wrongly told they had a high risk for hypertrophic cardiomyopathy. Precision medicine offers the promise of an accurate assessment of individual risk for serious conditions like hypertrophic cardiomyopathy (HCM). But a new report published in the New England Journal of Medicine,” which the authors describe as “a cautionary tale of broad…

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Can 50 Million Blood Pressure Prescriptions Each Year Be Wrong?

–For decades physicians may have been prescribing the wrong diuretic. Now an innovative new trial will settle the question. A radically innovative large new VA trial will finally shed light on a decades-old unresolved question that could have important public health implications. According to guidelines thiazide diuretics are the first-line treatment for hypertension. Hydrochlorothiazide accounts…

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Major Shift As Deaths From Cancer Overtake CV Disease In Western Europe

–In 12 high-income countries cancer is now a bigger cause of death than cardiovascular disease. In Europe as in the rest of the world cardiovascular (CV) disease remains the number one cause of death. But in 12 western European countries cancer now kills more people than CV disease. The finding, which likely presages a major…

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The Twitter Debate Over Cholesterol Screening In Kids

–Cardiologists discuss the screening controversy in 140 characters or less. My recent post on the debate over cholesterol screening in children provoked a fascinating discussion on Twitter, including comments from several highly knowledgeable experts and clinicians. The discussion started when James Stein, a preventive cardiologist at the University of Wisconsin), tweeted: Lipid screening in kids….

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Experts Disagree About Cholesterol Screening In Kids

(Updated) –Lack of evidence leads to major disagreement over guidelines. Once again the US Preventive Services Task Force (USPSTF) has performed an invaluable— and almost certainly thankless— service. In a series of papers published in JAMA and Annals of Internal Medicine the USPSTF states unequivocally that there is no good high quality evidence to evaluate…

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Clinical Trialists Dig In And Vote For Status Quo

–Doctors who got famous for doing clinical trials resist changes to the clinical trial system. It should probably come as no surprise that hundreds of clinical trial investigators whose positions and livelihoods depend largely on the existing clinical trial system have expressed great reluctance and annoyance at a proposal that could radically shake up that system. As…

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Top Clinical Investigators Seek To Dampen Impact Of Data Sharing

Despite earlier concerns by its editors about “data parasites,” the New England Journal of Medicine has now published 4 articles offering support in some form for data sharing. But two of the articles— written by many of the most prominent clinical trial researchers in the United States and Canada— express grave concerns about data sharing…

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The Big Dirty Secret Every Doctor Knows

–Eminence-based medicine is not the exception. It’s the rule.    Lately I’ve been writing about eminence-based medicine (here, here, and here). In response to these posts Saurabh Jha, a well-known radiologist and health-policy critic, asked me on Twitter: “How do you find these utter gems?!” I was surprised by Jha’s question. At first I thought…

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Pioneering Interventional Cardiologist Defends Unorthodox Practices

–Bernhard Meier explains why he seals plaques and thinks PFO closure is ‘the best procedure in interventional cardiology’ (Updated) Recently I wrote about an article by Bernhard Meier, a top interventional cardiologist, in which he rejected the idea that evidence based on randomized controlled trials should be the basis for the practice of interventional cardiology….

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Changes In Eskimo Diet Linked To Increase In Heart Disease

New paper explores the fascinating history of research into the Eskimo diet. The Eskimo diet and its effect on the heart has been a source of confusion and contention for decades. The observation that Eskimos, who traditionally consumed large amounts of saturated fat and small amounts of carbohydrates, had low rates of heart disease appeared…

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Eminence Based Medicine And Cardiac Surgery

Did a top surgeon perform a nonrandomized, semi-prospective, historically controlled clinical trial without IRB approval or patient consent? I don’t want to only pick on interventional cardiologists. Last week I wrote about a breathtaking case of interventional cardiology hubris. In response a prominent interventional cardiologist shared with me a fascinating anecdote about cardiac surgery. Here’s…

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Interventional Cardiology And The Rejection Of Science

–Prominent interventional cardiologist says clinical trials are slowing progress In their eagerness to embrace a glorious future of ever more spectacular technology-based advances, interventional cardiology— a subspecialty never exactly known for caution, patience, or self reflection— is poised to reject science, evidence-based medicine, and randomized controlled trials. “Generating and publishing evidence is a tedious job,”…

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The Billion Dollar Lab Scandal

If you think Theranos is a big story then I have some news for you. There’s another medical laboratory scandal  that dwarfs the Theranos story by almost any standard except for hype. The Theranos story is an important sexy Silicon Valley story. It’s more about an imagined  shimmering future than about the greasy present we actually…

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Alere Withdraws Anticoagulation Monitoring System At Heart Of ROCKET AF Controversy

–FDA says the manufacturer has not demonstrated that it has fixed the problem. The  Alere INRatio® and INRatio®2 PT/INR Monitoring System are being pulled from the market. Alere, the manufacturer of the devices, which are used by people taking warfarin to monitor their INR, said that the action follows a “collaborative process” with the FDA. The…

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Reality Check On The ‘Noninferior’ Abbott Bioresorbable Stent

–The slippery slope of noninferiority. Last week the big news in interventional cardiology was the approval of Abbott’s bioresorbable stent, Absorb. There’s no doubt that this represents a remarkable technical achievement, propping open a clogged artery and then gradually disappearing. There are all sorts of theoretical reasons why this might represent an important advance over traditional stents that…

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Repatha Approved for Single Monthly Injection

–New hands-free system replaces three sequential shots The FDA has approved a device that can deliver a single monthly injection of evolocumab (Repatha), the cholesterol-lowering PCSK9 inhibitor manufactured by Amgen. Repatha is currently administered by subcutaneous injection in a 140-mg dose every 2 weeks or as a 420 mg monthly dose. Until now, the monthly…

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The Wild West Of New Laboratory Scams

It’s like the wild west. With no sheriff acting to impose law and order, many laboratory companies are now deploying a wide variety of new scams to gain new business. The new scams have emerged in the wake of the collapse and bankruptcy of Health Diagnostics Laboratory (see the bottom of this story for links to previous coverage)…

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ROCKET AF Investigators Say New Analysis Supports Original Trial Results

–Test of stored blood may help answer troubling questions about the trial. A new analysis of stored blood by the ROCKET AF trial investigators may help resolve lingering questions about the trial. The questions about ROCKET AF, which compared rivaroxaban (Xarelto, Johnson & Johnson) to warfarin in patients with atrial fibrillation, emerged last November, when…

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Prominent Cardiologists Decry Tepid Support For Empagliflozin By Endocrinologists

At the FDA advisory panel empagliflozin enjoyed strong support from the cardiologists and statisticians but not from the endocrinologists.    An FDA advisory panel last week turned out to be a much more contentious and divided than many had expected. Based on the FDA’s own analysis of last year’s Empa-Reg Outcome trial I had predicted that the…

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FDA Places Roadblock On Approval Path Of Novel Cholesterol Drug

Could this be the end of LDL as a surrogate? A possible shift in policy at the FDA means that a much heralded novel new cholesterol drug won’t reach the US market until 2022 at the earliest. Esperion Therapeutics’ bempedoic acid (formerly known as ETC-1002) had previously been thought to be eligible for approval within…

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Bad News Bears: After Scary Headlines Some Patients Stopped Taking Statins

Study provokes discussion about the responsibilities of medical journals and the general media. A new study and surrounding discussion raises important questions about the role and responsibility of researchers, editors, and journalists when tackling topics with potentially life-affecting consequences. The new study, published in the BMJ, found that many people stopped taking statins in the…

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Empagliflozin May Be Poised To Gain CV Indication

–FDA reviewers have raised no major questions ahead of Tuesday’s advisory panel meeting. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will likely lend its support to an important new expanded indication for empagliflozin (Jardiance, Boehringer Ingelheim). The new indication is to reduce the risk of all-cause mortality by reducing the incidence of cardiovascular death,…

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