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Total 307 results found since Jan 2013.
New York Area Cardiologist Admits $19 Million Fraud
Jose Katz, a 68-year-old cardiologist with offices in New York and New Jersey, has pleaded guilty to charges that he committed health care fraud, the US Attorney for New Jersey announced yesterday. Katz admitted that he billed Medicare Part B, Medicaid, and numerous private insurers “for unnecessary tests and unnecessary procedures based on false diagnoses and for medical services rendered by unlicensed practitioners.” Katz spent over $6 million advertising on Spanish-language advertising. For most of his patients he performed the same battery of unnecessary diagnostic tests and falsified records. He then gav...
Source: CardioBrief - April 11, 2013 Category: Cardiology Authors: Larry Husten Tags: Uncategorized Enhanced external counterpulsation fraud Medicaid Medicare Source Type: blogs
A Closer Look At A Case Of Duplicate Publication In JACC
The Journal of the American College of Cardiology has published a Notice of Duplication about a review article written by a respected European cardiology researcher who has played a central role in the development of fractional flow reserve (FFR). The brief statement from JACC provides few details and could lead to various interpretations, but a further investigation suggests that the story may be fairly simple. The notice states that a 2012 review article by Nico H.J. Pijls and Jan-Willem E.M. Sels, Functional Measurement of Coronary Stenosis, “duplicates to a considerable extent both the text and figures o...
Source: CardioBrief - April 10, 2013 Category: Cardiology Authors: Larry Husten Tags: Uncategorized journal of the american college of cardiology retractions scientific misconduct Source Type: blogs
Quinidine Unavailable In Most Of The World
Quinidine– the only drug known to be effective in preventing lethal ventricular arrhythmias in people with several rare conditions, including Brugada syndrome, idiopathic ventricular fibrillation, and early repolarization syndrome– is no longer available in much of the world. In a study published online in the Journal of the American College of Cardiology, Sami Viskin and colleagues surveyed physicians around the world about the availability of quinidine in their country and received responses from 273 physicians in 131 countries. In 76% of the countries quinidine was not available at all. In another 10% quin...
Source: CardioBrief - April 9, 2013 Category: Cardiology Authors: Larry Husten Tags: Uncategorized Antiarrhythmic agent Brugada syndrome Drug Source Type: blogs
Scientific Misconduct: From Darwin And Mendel To Poldermans And Matsubara
Responding to recent episodes of scientific misconduct in cardiovascular research involving once prominent cardiovascular researchers, the editor of the European Heart Journal, Thomas Lüscher, has written an editorial discussing the significance of the new cases and placing them in a historical context that includes allegations of scientific misconduct by Mendel and Darwin, among many others. … Poldermans was the first or the senior author in 7 papers published in EHJ. Lüscher writes that the chairman of the Poldermans investigative committee “made it clear that the vast amount of publications led by...
Source: CardioBrief - April 8, 2013 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Cardiology Don Poldermans European Heart Journal Gregor Mendel Matsubara scientific misconduct Source Type: blogs
Registry Study Offers Reassurance About Safety And Efficacy Of Dabigatran
As the first new oral anticoagulant since warfarin, dabigatran (Pradaxa, Boehringer-Ingelheim) has been subject to intense concerns over its safety and efficacy in a real-world population. Last November an FDA investigation found no indication that bleeding rates for dabigatran were any higher than bleeding rates for warfarin. A new study from Scandinavia, published in the Journal of the American College of Cardiology (see note at bottom of story), provides more real-world information that helps to confirm the safety and efficacy of the new drug. Using data from the Danish Registry of Medicinal Product Statistics, re...
Source: CardioBrief - April 4, 2013 Category: Cardiology Authors: Larry Husten Tags: Heart Rhythms Prevention, Epidemiology & Outcomes anticoagulants boehringer ingelheim dabigatran Pradaxa warfarin Source Type: blogs
79-Year-Old Cardiologist Sentenced To 6 Years In Prison For Fen-Phen Fraud
A 79-year-old Florida cardiologist has been sentenced to 7 years in prison for his participation in the Fen-Phen fraud, according to a report by John Martin on Philly.Com. The article notes that other cardiologists have been convicted for similar reasons in the Fen-Phen case, but Tai’s case is unusual because of the length of the sentence. The cardiologist, Dr. Abdur Razzak Tai, was convicted last September. Here is how the US Department of Justice summarized the case at the time: Between 1997 and 2009, Tai… reviewed the echocardiograms of more than 1,100 patients who filed claims More…
Source: CardioBrief - March 27, 2013 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Fen-Phen Fenfluramine/phentermine fraud Source Type: blogs
Embers Of Poldermans Case Still Smoldering
A prominent US cardiologist has rebuked Don Poldermans, the cardiovascular researcher at the center of a research scandal in the Netherlands. As reported here previously, Poldermans was fired for scientific misconduct by the Erasmus Medical Center in Rotterdam, where he had been a professor of medicine and the head of perioperative cardiac care. He was widely published and active in the field, serving as a member of the European Society of Cardiology committee for practice guidelines and as the chairperson of the ESC guidelines on pre-operative cardiac risk assessment and perioperative cardiac management in non-cardiac...
Source: CardioBrief - March 24, 2013 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics American Journal of Medicine Don Poldermans Erasmus MC Retraction Watch scientific misconduct Source Type: blogs
FDA Proposes Higher Regulatory Scrutiny For Automatic External Defibrillators
Automated external defibrillators (AEDs) will have a more difficult time getting on the market if a new FDA proposal is finalized. The agency today proposed a new rule that will require AED manufacturers to submit pre-market approval (PMA) applications. “Automated external defibrillators save lives,” said cardiologist William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, in an FDA press release. “However, the agency is concerned about the number of recalls and manufacturing problems that have been associated with these devices and we’re committed t...
Source: CardioBrief - March 22, 2013 Category: Cardiology Authors: Larry Husten Tags: Heart Rhythms Policy & Ethics Automated external defibrillator Center for Devices and Radiological Health Food & Drug Administration Medical Device Premarket approval Source Type: blogs
Vena Cava Filters: Little Evidence And Wide Variation In Use
Despite the absence of any evidence demonstrating benefit or showing how best to use them, vena cava filters (VCF) are used in most hospitals. Now a new study published in JAMA Internal Medicine suggests that this same lack of evidence results in an extremely broad rate of use in different hospitals. An accompanying viewpoint raises the question: “how could a medical device be so well accepted without any evidence of efficacy?” Researchers conducted a retrospective observational study that compared the frequency of VCF use in 236 California hospitals by analyzing data from 130,643 acute VTE hospitalizati...
Source: CardioBrief - March 18, 2013 Category: Cardiology Authors: Larry Husten Tags: Interventional Cardiology & Surgery Policy & Ethics FDA Inferior vena cava filter VCF VTE Source Type: blogs
The PREVAIL Fail Revisited: Spinning The Truth
The biggest story at the American College of Cardiology meeting last week was the missing story. As reported here and just about everywhere else, the PREVAIL trial, probably the most-anticipated late-breaker of the meeting, was pulled from the program at the last minute by the ACC leadership after Boston Scientific broke the embargo by issuing a press release several hours before the scheduled presentation. To understand this event we first need to know what happened in the week before the ACC. And there’s a major gap in the story that has not come out before More…
Source: CardioBrief - March 17, 2013 Category: Cardiology Authors: Larry Husten Tags: Interventional Cardiology & Surgery People, Places & Events Policy & Ethics American College of Cardiology Boston Scientific embargo food and drug administration press releases PREVAIL Source Type: blogs
Two Trials Explore On-Pump Versus Off-Pump Bypass Surgery
Two large trials presented at the American College of Cardiology meeting in San Francisco and published simultaneously in the New England Journal of Medicine provide important new information about the ongoing debate over whether CABG should be performed with or without cardiopulmonary bypass. The combined results suggest that both techniques can be effective, and that surgeons should choose the technique with which they are most familiar and comfortable. Previous 30-days results from CORONARY (CABG Off or On Pump Revascularization Study), which randomized 4,752 patients to on-pump or off-pump CABG, showed no significant ...
Source: CardioBrief - March 11, 2013 Category: Cardiology Authors: Larry Husten Tags: Interventional Cardiology & Surgery CABG cardiac surgery Coronary artery bypass surgery off-pump on-pump revascularization Source Type: blogs
Cangrelor During PCI May Reduce Ischemic Events
In the Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION PHOENIX) trial, the intravenous platelet inhibitor cangrelor was tested for its effect on ischemic events associated with PCI. Cangrelor is a potent, fast-acting and reversible agent. Results of the trial were presented at the ACC in San Francisco and published simultaneously in the New England Journal of Medicine. A total of 11,145 PCI patients were randomized to a bolus and infusion of cangrelor or to a loading dose of clopidogrel. A primary endpoint event — death, MI, ischemia-driven revascularization, or stent...
Source: CardioBrief - March 10, 2013 Category: Cardiology Authors: Larry Husten Tags: Interventional Cardiology & Surgery antiplatelet Cangrelor clopidogrel PCI Source Type: blogs
Following An Embargo Break PREVAIL Trial Won’t Be Presented At ACC
The already complicated story behind the PREVAIL trial, which was designed to confirm the safety and efficacy of the Watchman left atrial appendage closure device, just got even more complicated. This morning, after the trial’s sponsor, Boston Scientific, prematurely distributed to investors a press release summarizing the results of the trial, the ACC announced that the scheduled presentation of the results at the main opening session of the meeting would not take place. By way of background, last week the trial’s sponsor, Boston Scientific, first announced that the principal investigator of the trial, Davi...
Source: CardioBrief - March 9, 2013 Category: Cardiology Authors: Larry Husten Tags: Heart Rhythms Interventional Cardiology & Surgery People, Places & Events Policy & Ethics American College of Cardiology atrial fibrillation Boston Scientific David Holmes PREVAIL stroke Watchman Source Type: blogs
ACC Prevails Upon Boston Scientific To Present More Data At Late Breaker
In an unusual reversal of a statement it made two days ago, Boston Scientific announced this afternoon that it would present all three co-primary endpoints of the PREVAIL clinical trial this Saturday at the American College of Cardiology scientific sessions in San Francisco. The PREVAIL trial, which was designed to confirm the safety and efficacy of the Watchman left atrial appendage closure device, is one of the most highly-anticipated late-breaking clinical trials at the ACC this year. As reported here yesterday, earlier this week Boston Scientific said that the principal investigator of the trial, David Holmes...
Source: CardioBrief - March 6, 2013 Category: Cardiology Authors: Larry Husten Tags: Heart Rhythms Interventional Cardiology & Surgery People, Places & Events Policy & Ethics Source Type: blogs
FDA Issues Warning Letter To CoreValve Investigator
The FDA has issued a warning letter to an investigator in the Medtronic CoreValve US Pivotal Trial. The letter cites numerous serious violations relating to the treatment of subjects in the trial testing the experimental Medtronic TAVI (transcatheter aortic valve implantation) device. The violations were uncovered during an FDA inspection last summer. The subject of the FDA warning is Michael Ring, one of the two principal investigators of the CoreValve trial at the Providence Sacred Heart Medical Center site in Spokane, WA. Click here to read the full story on Forbes.
Source: CardioBrief - February 28, 2013 Category: Cardiology Authors: Larry Husten Tags: Interventional Cardiology & Surgery People, Places & Events Policy & Ethics CoreValve FDA FDA Warning Letter food and drug administration Medtronic TAVI TAVR Source Type: blogs
