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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Unforced Error: Pharma Supporter Attacks The Wrong Paper

If you’re going to attack a position you don’t like and also attempt to claim the moral and intellectual high ground it’s a good idea to get your basic facts rights. Even more– and it’s so obvious it shouldn’t need to be said– if it’s a scientific paper you are attacking you need to make sure you’re…

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The Hidden Cost Of Free Lunch

–Brand name prescribing increases when industry pays for the meals Physicians who accept free meals from a drug company are more likely to prescribe that company’s brand name drugs, according to a new study in JAMA Internal Medicine. The authors compared data from the Open Payments Database listing industry payments to physicians with Medicare prescribing…

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Cholesterol Skeptics Launch Another Attack

–But most experts say their study is highly flawed Once again, a group of cholesterol skeptics has published an inflammatory attack on the cholesterol hypothesis. But critics say that the paper is deeply flawed and should not be used to influence treatment or policy decisions. In a paper published in BMJ Open, Uffe Ravnskov, MD,…

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Clinical Trial Expert’s Deep Dive Into The Important New Liraglutide Trial

–Sanjay Kaul plunges into the LEADER data pool There will be a lot of discussion in the near future about the LEADER trial, the large new trial assessing cardiovascular outcomes with liraglutide (Victoza, Novo Nordisk). The trial is the latest in a series of large CVOTs with new diabetes drugs showing benefit— or at least…

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First PCSK9 Outcome Trial Results Pushed Back To 2017

Uptake of the new drugs likely to lag without strong outcomes data. Uptake of the new drugs likely to lag without strong outcomes data.Uptake of the new drugs likely to lag without strong outcomes data.   –Uptake of the new drugs likely to lag without strong outcomes data. There’s probably nothing more eagerly awaited in cardiovascular…

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Documents Reveal Rogue Laboratory Company’s Unorthodox Billing Practices

–Promised in writing to not bill patients, then changed its tune Records and emails newly posted on the web by a physician document the strategy used by a controversial new laboratory company to bypass laws and major safeguards designed to prevent fraud. Nearly 2 years ago, it became known that the federal government was investigating…

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Prominent Cardiologist And ESC Presidential Candidate Found Guilty Of Fraud

Updated– Karl-Heinz Kuck, a prominent German cardiologist and candidate for the presidency of the European Society of Cardiology, has been found guilty of fraud. He received a fine of 100,000 Euros and a prison sentence of one year. His prison sentence has been suspended as long as he does not commit additional fraud. According to multiple reports…

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FDA Proposes Voluntary Sodium Cuts by Food Industry

–AMA, AHA, ACC, etc voice support, but not everyone agrees. After decades of discussion and inaction, the FDA today took a first concrete step toward reducing sodium levels in the general population: It issued draft guidance for voluntary sodium reduction targets for the food industry. The FDA said that the new recommendations come from “leading…

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The American Heart Association’s Strong Stance Against Science

Once again the American Heart Association has taken a strong stance against science. Of course, that’s not how the AHA phrases it. In its own words the AHA says it “strongly refutes the findings” of a “flawed study” which “you shouldn’t use… to inform yourself about how you’re going to eat.” But in fact the…

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Entresto Gets Boost in Updated HF Guidelines

–Valsartan/sacubitril earns Class I recommendation Cardiology groups in the U.S. and Europe have updated their heart failure guidelines to include much-awaited recommendations for Entresto (the combination of valsartan and sacubitril manufactured by Novartis). The new guidelines offer broad support for the new drug. Since its approval last summer Entresto has struggled to gain a foothold…

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Novartis Announces Enormous Clinical Trial Program For Heart Failure Drug

–The company plans to perform 40 clinical trials in 5 years with Entresto. Novartis announced today an enormous clinical trial program with its promising but slow starting heart failure drug Entresto (valsartan/sacubitril). The company said it would perform 40 clinical trials with the drug in the next five years. The Fortifying Heart Failure clinical evidence and…

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Noted Skeptic Calls For More Randomized Nutrition Trials

Defying conventional wisdom Ioannidis says we need more negative trials to clear away all our misconceptions about nutrition Defying conventional wisdom Ioannidis says we need more negative trials to clear away all our misconceptions about nutritionDefying conventional wisdom Ioannidis says we need more negative trials to clear away all our misconceptions about nutritionDefying conventional wisdom…

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Increasing Support For Generic Drugs And Therapeutic Substitution

–But some physicians, perhaps influenced by industry, remain skeptical. Generic drugs and therapeutic substitution (replacing a drug without a generic equivalent with a different but closely related drug in the same general class) are two key ingredients in most recipes to hold down health care costs. Now a package of articles and commentary in JAMA…

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Pioneering Lipoprotein Researcher Richard Havel Dead

–Nobel laureates Brown and Goldstein say when they were starting out Havel taught them 90% of what they knew Richard Havel, a scientist who helped create the entire entire modern field of research in lipoprotein metabolism, died last month. In response to the news scientists in the field have poured extravagant praise on the man…

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