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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Social Media And Medical Journals: The Streetlight Effect

–Another study tests the wrong approach to social media in medical publishing    Here’s the main problem with a new study published in the Journal of the American Heart Association: they measured the wrong thing with the wrong method. In their new paper the researchers randomized new studies appearing in Circulation to receive social promotion…

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On Road To Bankruptcy A Stent Company Invested in Marty Leon’s VC Fund

More questions are being raised about the research and financial activities of Palmaz Scientific, the bankrupt medical device company founded by Julio Palmaz, the co-inventor of the stent. In the middle of severe financial troubles that eventually brought the company to  bankruptcy Palmaz Scientific found enough money to invest in a venture capital fund. The VC Fund,…

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Experts Foresee Major Role For Generic Crestor

— Finally there’s a challenger to the long reign of Lipitor The FDA approval on Friday of the first generic version of Crestor (rosuvastatin calcium) marks the end of an era and the beginning of a major shift in cardiovascular medicine. Over time, as the price of the drug drops with generic competition, it seems…

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New Cardio Drugs Off To Very Slow Start

–Heart failure experts divided over how and when to use Entresto To many long-time observers, the approval last year of two new cholesterol drugs and a heart failure drug appeared to herald a rebirth of the cardiovascular marketplace after a long period of dormancy. But so far in 2016, those new drugs have hardly made…

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Stent Pioneer’s Company In Bankruptcy And Under Investigation

–Julio Palmaz hasn’t been able to recreate his earlier success A company founded by stent pioneer Julio Palmaz has declared bankruptcy and is being investigated for misconduct, according to the San Antonio Express-News. Palmaz, along with Richard Schatz, was the inventor of the enormously successful Palmaz-Schatz stent marketed by Johnson & Johnson. In March Palmaz…

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Companies Plan To Study Diabetes Drug In Heart Failure Population

–New attention paid to the intersection of heart failure and diabetes Boehringer Ingelheim and Eli Lilly announced on Wednesday that they were planning two separate outcomes trials to test the effect of the diabetes drug empagliflozin (Jardiance) in patients with chronic heart failure. The trials herald a remarkable shift in emphasis, since there have been…

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No Evidence To Support Screening Young Athletes

–More questions raised about key study suggesting ECG screening can save lives There is no good evidence to support screening young athletes to prevent sudden cardiac arrest, concludes a new analysis published in the BMJ. The analysis also raises new and troubling questions about a key Italian study that has been the main study used…

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New Company Bets Hundreds Of Millions Of Dollars On A Genetic Strategy To Resurrect A CETP Inhibitor

–But skeptics think CETP inhibitors are a dead end A new company is betting hundreds of millions of dollars that it can snatch victory from the jaws of defeat. Over the last decade no class of drugs has undergone a reversal of fortune as dramatic as the cholesterol ester transfer protein (CETP) inhibitors, the once…

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