FDA Review Raises Safety Concerns About Mipomersen

An FDA review raises a number of potentially significant safety concerns about the cholesterol-lowering drug mipomersen. The review appears ahead of a Thursday meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to evaluate Genzyme’s new drug application (NDA) for use of the drug as an adjunct to maximally tolerated lipid-lowering medications and diet to reduce…

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Don Poldermans And The Dutch Research Scandal

The publication last week of the final report from the Erasmus Medical Center on the Don Poldermans research scandal in the Netherlands ends the first and most explosive chapter of an ugly episode of scientific misconduct. But there are still many important questions regarding scientific integrity and the culture of medical research raised by the case. And…

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FDA Reviewers Raise No New Red Flags Over Lomitapide

FDA reviewers have raised no new concerns about lomitapide ahead of a Wednesday meeting of the Endocrinologic and Metabolic Drugs Advisory Committee.  The FDA today released briefing documents that evaluate the new drug application (NDA) for lomitapide capsules, the microsomal triglyceride transfer protein (MTP) inhibitor from  Aegerion Pharmaceuticals for use as an adjunct to a low-fat diet and…

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Free Cardiac And Spine Surgery For Walmart Employees At Six Hospitals

Starting next year 1.1 million US Walmart employees and their dependents will be eligible for free heart, spine, and transplant surgery at 6 highly regarded health care organizations. Walmart employees will have no out-of-pocket costs, including travel, lodging and food for the patient and a caregiver. On Thursday the company announced that its “Centers of Excellence”…

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Erasmus Medical Center Releases Final Report On Cardiovascular Research Scandal

After an extensive investigation, a large medical center in the Netherlands has confirmed earlier charges of research misconduct against a prominent cardiovascular researcher. On Tuesday, Erasmus MC in Rotterdam released a final report on the scientific integrity of trials conducted by Don Poldermans, a well-known and highly prolific Dutch cardiovascular researcher. The final report contains…

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Walking With the American Heart Association: Valerie Bertinelli and Chester Cheetah

A few weeks ago Chester Cheetah, the official mascot for Frito Lay’s Cheetos, played an official part in  the American Heart Association’s Dallas Heart Walk. Yoni Freedhoff, on his Weighty Matters blog, pretty much says what needs to be said about this disgraceful association between Frito Lay and the AHA. This weekend I received a press kit…

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Another One Bites the Dust: Diovan Patent Expires But Generic Valsartan Is MIA

Although the patent on valsartan (Diovan, Novartis) expired last Friday, a generic version of the popular antihypertensive drug has yet to make it to market. By contrast, a generic version of Diovan HCT, the combination of valsartan and hydrochlorothiazide, was recently launched by generic drugmaker Mylan. As reported on Pharmalot, Ranbaxy, the embattled generic drugmaker, holds…

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Apixaban (Eliquis) For Atrial Fibrillation Gets Positive European Recommendation

The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval for apixaban (Eliquis, Pfizer and BristolMyers Squibb) for atrial fibrillation (AF). The drug is already approved in Europe for the prevention of venous thromboembolic events (VTE) following hip or knee replacement surgery. The drug has not yet been approved in the United States. Here…

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Screening For AAA Comes Under Renewed Scrutiny And Criticism

A 2007 Medicare initiative to increase AAA (abdominal aortic aneurysm) screening in appropriate patients failed to prevent AAA rupture or reduce all-cause mortality, according to a new study published in Archives of Internal Medicine. The larger implications of the study are unclear, but two accompanying papers, an invited commentary and a perspective, emphasize the darker side of…

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A Manhattan Project To End The Obesity Epidemic

A newly launched nonprofit organization, the Nutrition Science Initiative, will try to find an answer to the question,  “What should we eat to be healthy?” NuSI is nothing if not ambitious: its goal is to seek “the end of fad diets and high obesity rates.” The founders of the organization, called NuSI (pronounced “new see”) for short, are Gary Taubes…

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Plagiarism Of Hypertension Article In Korean Journal Results In Retraction

In response to evidence of plagiarism in a review article in the Korean Circulation Journal, the article has now been retracted by the journal. Here is the notice: On July 31, 2011, Korean Circulation Journal (KCJ) published a review article by Park et al.1)regarding the J-curve in hypertension and coronary artery diseases. However, a possibility of plagiarism has…

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ESC Trials: The Best And The Worst

Two trials presented at the ESC this year– WOEST and IABP-SHOCK II— are great examples of the way medicine is supposed to work. Another trial, FAME 2, is an example of so many of the things that can go wrong. WOEST and IABP-SHOCK II are remarkably similar. Both trials tested conventional wisdom and found it lacking. WOEST…

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ICD Investigation: DOJ Sends Resolution Model To Hospitals

Hospitals across the country received emails from the US Department of Justice on Thursday containing a proposed “Resolution Model” that will allow the hospitals to begin to settle the long-standing and much-feared DOJ investigation into improper Medicare billing for ICDs. The action appears to confirm an article, published earlier in August in Report on Medicare…

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New Universal Definition Of MI Unveiled At ESC 2012

A new universal definition of myocardial infarction (MI) was unveiled today at the European Society of Cardiology meeting in Munich. The document was developed jointly by the European Society of Cardiology (ESC), the American College of Cardiology (ACC), the American Heart Association (AHA) and the World Heart Federation (WHF) and will be published in five journals:…

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Guest Post: New Questions Raised About Latest Generation St. Jude ICD Leads

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH.  New Questions About Latest Generation ICD Leads From St. Jude by Edward J. Schloss A highly anticipated study analyzing failures of St. Jude Durata…

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Guest Post: Why Is The National Library Of Medicine Still Indexing Reviews In Cardiovascular Medicine?

The following guest post by Kevin Lomangino was originally published on HealthNewsReview.org. Lomangino is an independent medical journalist and editor who is currently Editor-in-Chief of Clinical Nutrition Insight, a monthly evidence-based newsletter which reviews the scientific literature on nutrition for physicians and dietitians. He tweets [email protected] Why Is the National Library of Medicine Still Indexing Reviews in Cardiovascular…

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Guest Post: FDA Calls For X-Ray Screening Of Riata Leads And Additional Followup Studies

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. St. Jude’s troubled implantable defibrillator leads came under a fresh layer of scrutiny today with new FDA imaging recommendations and post-market study requirements. …

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Guest Post: Children Should Have Their Cholesterol Checked

Editor’s Note: CardioBrief is pleased to publish this guest post written by Samuel Gidding, the head of the cardiology division at the Nemours Cardiac Center at A. I. DuPont Hospital for Children and a professor of pediatrics at Jefferson Medical College. CardioBrief invited Gidding, a member of the NHLBI panel that recommended universal lipid screening at ages 9-11…

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Guest Post: Is It The Right Time To Introduce Real Supervision Into Medical Practice?

Editor’s Note: Dr. Schloss, the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH, originally submitted the following post as a comment on my previous post in which I compared HCA to Barclays and JP Morgan. I’d be very eager to hear responses from other physicians about this subject. Is It The Right Time To…

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Why HCA Is Like Barclays And JP Morgan

Earlier this week the New York Times reported on a pattern of seriously deficient cardiac care at a number of hospitals owned by HCA. Understandably, the most common reaction is simple disgust over more bad cardiology behavior. After the Mark Midei case, after subsequent and even worse cases in Maryland, Pennsylvania, and elsewhere, the easy thing is to…

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Guest Post: Feds Turn Corner in ICD Investigation; Hospital Liability Divided into Categories

Editor’s Note: The following article is reprinted with permission from Report on Medicare Compliance, an independent publication not affiliated with hospitals, government agencies, consultants or associations and published by Atlantic Information Services, Inc.  The Department of Justice is apparently about to take a big step forward in its national false claims investigation of Medicare billing for implantable…

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NY Times: HCA Concealed Significant Problems At Lucrative Cardiac Centers

Despite numerous internal reviews that turned up a widespread pattern of unnecessary cardiology procedures being performed at many of its hospitals, the giant HCA corporation did little to rein in the problem or to inform regulators, payers, or patients about the problem, according to an investigative report in the New York Times by Reed Abelson and…

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Industry PR Efforts Influence Debate On Cholesterol Screening Guidelines For Children

Note: This post is accompanied by a separate guest post by James Stein. What role should industry play in discussions about guidelines, especially when the debate about those guidelines includes allegations that industry may have influenced the final product of the guidelines? Should a public relations agency that represents a company with a product that…

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Guest Post– Universal Screening for Dyslipidemia In Children: A Debate With Equipoise, But Tarnished By Industry Influence

Editor’s Note: CardioBrief is pleased to publish this guest post written by James Stein, a professor of medicine at the University of Wisconsin and the director of preventive cardiology at the University of Wisconsin Hospital and Clinics. This post is accompanied by a separate post by Larry Husten. Universal Screening for Dyslipidemia in Children:  A Debate with…

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TAVI: Belgian Researchers Slam Evidence Base And Overuse In Europe

The growing and enthusiastic adoption of transcatheter aortic valve implantation (TAVI) in Europe has no justification, according to three researchers who performed a health technology assessment for the Belgian government. In a paper published in BMJ, the authors from the Belgian Health Care Knowledge Centre conclude that TAVI should only be used in patients “who are…

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