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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FDA Ends Niacin and Fenofibric Acid Combinations With Statins

–“In the absence of benefits, there remain only harms.” The FDA is putting an end to the combined use of statins with two once-popular lipid drugs, niacin and fenofibric acid. On Monday the FDA will announce in the Federal Register that it is withdrawing its approval for indications for coadministration of these drugs with statins…

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Orexigen Terminates Another Cardiovascular Outcomes Trial

Updated–In a further sign of the chaos surrounding its weight loss drug Contrave, Orexigen has again terminated an FDA-mandated cardiovascular outcomes trial with the drug. Following a year of controversy (see below) Orexigen last month assumed sole control of Contrave (the combination of naltrexone and bupropion) from its former partner, Takeda. The company has now terminated enrollment…

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New Analysis Of Old Study Delivers Another Blow To Traditional Diet Advice

–Replacing saturated fat with vegetable oils lowered cholesterol but didn’t improve outcomes A new analysis from a long-forgotten study dating to the 1960s adds to mounting doubts over a cornerstone of dietary advice for more than 50 years: the demonization of saturated fat in the diet. Although in recent years the nutritional establishment has retreated…

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USPSTF Updates Aspirin for Primary Prevention Recommendation

–But many experts think the evidence base is slim at best. The U.S. Preventive Services Task Force (USPSTF) finalized the update to its guidelines regarding the use of aspirin for the primary prevention of cardiovascular disease and colorectal cancer. The USPSTF is now recommending that people between the ages of 50 and 59 who are at increased…

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FDA Expands Metformin Label

— The diabetes drug can now be used in more patients with reduced kidney function The FDA on Friday greatly expanded the indication for the type 2 diabetes drug metformin. Until now use of metformin in patients with reduced kidney function had not been recommended. The new label states that metformin “can be used safely…

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PNAS Paper By Prominent Cardiologist And Dean Retracted

A 2002 PNAS paper has been retracted by its authors, including senior author Pascal Goldschmidt, a prominent cardiologist and Dean of the University of Miami School of Medicine. News of the retraction was reported by Retraction Watch on Tuesday. The paper, “Deficient Smad7 expression: A putative molecular defect in scleroderma,”has been cited 198 times, Retraction Watch reported. Here is…

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ATMOSPHERE: Heart Failure Trial Poisoned By Controversy

–Aliskiren raised regulatory pandemonium as it crashed in trials When it comes to interrupting the renin-angiotensin system, the third time was definitely not the charm. Following the enormous success of the ACE inhibitors and angiotensin-receptor blockers, there were early high expectations for a third class of drugs, the direct renin inhibitors. Those hopes were dashed…

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After a Decade, CABG Pulls Ahead of Meds for HF

–Life-saving benefit of CABG now clear in long-term trial follow-up Finally, after 10 years of follow-up, the life-saving benefits of coronary artery bypass graft (CABG) surgery in heart failure patients with coronary artery disease are clear. More than 15 years ago, the NIH funded the original STICH trial to answer a question that was already…

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Not So Rare, FH Is Truly Risky Lipid Disorder

–Not all elevated is LDL is equally dangerous CHICAGO — Familial hypercholesterolemia (FH), a condition that has long been overshadowed by more common cardiovascular diagnoses, has now found the spotlight in the big tent as a hot and even controversial topic. The new interest is driven by important advances in understanding the genetics of the…

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ACCELERATE Puts the Brake on CETP Inhibition

–No benefit with evacetrapib despite increase in HDL and decrease in LDL The fat lady hasn’t sung, the referee hasn’t counted up to 10, but it’s sure not looking good for the once highly promising class of drugs known as the CETP inhibitors. Bang the Drum Slowly, and Play the Fife Lowly Following the crash…

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US DOJ Expands Investigation Into Phony Novartis Speaking Events

— The government wants Novartis to turn over documents on 80,000 separate speaking events. The US Department of Justice is seeking to greatly expand its investigation of Novartis “for engaging in a nationwide kickback scheme, spanning 10 years, to induce doctors to write prescriptions for certain of its cardiovascular (‘CV’) drugs.” Last week the DOJ…

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Top HF Expert Decries ‘Unbelievable Folly’ of Clinical Trials and Guidelines

–Milton Packer, MD, calls the system to test and evaluate heart failure drugs dysfunctional The system is completely broken, writes heart failure specialist Milton Packer, MD, in an editorial in Circulation: Heart Failure. The results of important clinical trials are not being incorporated into guidelines quickly, intelligently, or consistently, Packer argued. The most important reason…

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Court Decision In Patent Battle Threatens PCSK9 Drug

—-One analyst thinks the decision might take Praluent off the market. A jury’s decision last week in a patent case might possibly lead to the removal of one of the new PCSK9 inhibitor cholesterol lowering drugs from the US market, according to a Wall Street analyst who has been closely following the case. Amgen, which…

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New Evidence Fitness Trackers Don’t Actually Track Fitness

–Little agreement found when 12 wearable devices were compared to gold standards Fitness trackers have not been found to help people improve the way they exercise, an article in the Sunday New York Times noted in a summary of the case against wearable fitness trackers, pointing up technical and even philosophical limitations of the devices….

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The Door Opens Wider For Drug Companies To Make Off-Label Claims

The FDA has finally reached a settlement in its long dispute with Amarin Corporation, manufacturer of the prescription fish oil product Vascepa. Last year a US judge ruled against the FDA.  The settlement brings an end to the litigation and will permit Amarin to promote off-label usage of Vascepa as long as its statements are…

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Theranos Ignored Red Flags On Its Blood Clot Tests

Beleaguered laboratory company Theranos sent out unreliable blood clot tests on at least 81 patients, according to an article by John Carreyrou and Christopher Weaver in the Wall Street Journal. Theranos, a former darling of Wall Street, Silicon Valley, and high technology medicine enthusiasts, has been the subject of a series of embarrassing revelations in…

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Controversial, Ill-Fated Obesity Drug Trial Published In JAMA

The final– but now largely useless– results of the cardiovascular safety trial of the obesity drug Contrave have now been published in JAMA, one year after the trial’s dramatic and scandalous crash and burn. By way of background: Contrave is a combination of naltrexone and bupropion marketed as a weight loss drug by Orexigen and…

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Top Line Results Favor Victoza In Large Cardiovascular Outcomes Trial

Novo Nordisk today announced top-line positive results of the LEADERS trial, the cardiovascular outcomes trial testing its diabetes drug Victoza (liraglutide). Liraglutide is a GLP-1 inhibitor used to help achieve glucose control in patients with type 2 diabetes. 9,340 people with type 2 diabetes were randomized to liraglutide or placebo in LEADERS for 3.5 –…

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