FDA Approves Generic Clopidogrels As Plavix Loses Patent Protection

For the second time in the past six months, a cardiology mainstay drug has lost patent protection and gone generic. Today the FDA announced that it had approved several generic versions of clopidogrel (Plavix), the antiplatelet drug that for many years was the second best-selling drug in the world. Last November the best-selling drug of all time, Lipitor…

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HRS 2012: More Clarity on DOJ ICD Investigation, “Incidental PCIs” Still Excluded

In a guest post, electrophysiologist Edward J. Schloss recounts a talk at Heart Rhythm Scientific Sessions 2012 by Suneet Mittal which provided a detailed account of his group’s experience with a Department of Justice investigation of ICD implantation outside of NCD guidelines….

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FDA Advisory Panel Recommends Approval For Weight Loss Drug Lorcaserin

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted to recommend approval of lorcaserin (Lorqess, Arena). The result signals a remarkable turnaround for the drug, which the same panel had rejected in September 2010. The vote was 18 in favor of approval, 4 against, and 1 abstention. Committee members seemed less disturbed this time around…

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Persistent Concerns About Lorcaserin (Lorqess) From FDA Reviewers

The FDA has posted briefing documents for Thursday’s meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to reconsider the new drug application for lorcaserin (Lorqess, Arena). The same panel recommended against approval of the drug in September 2010, citing weak efficacy and safety concerns. The FDA reviewers do not appear to have substantially altered…

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Politics and Transcatheter Aortic Valve Replacement

From the first early stages of its development, the prospect of transcatheter aortic valve replacement (TAVR) provoked two broad and competing fears: Regulatory safeguards would kill a promising new technology, denying its life-saving benefits to many thousands of desperately sick people. The stampede to stake a claim in a promising, highly lucrative new territory would…

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Company Fails To Disclose Details About Heart Failure Risk of Drug

Boehringer Ingelheim failed to fully disclose data suggesting that one of its drugs, pramipexole,  a dopamine agonist sold under the brand name of Mirapex, is associated with a significantly increased risk of heart failure, according to a recent news report. The drug, which was originally developed for the treatment of Parkinson’s disease, is now also used to treat…

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Heart Rhythm Editor Douglas Zipes Defends Peer Review

Rejecting an extraordinary request from industry to retract a controversial paper, Douglas Zipes, the editor-in-chief of HeartRhythm, has written a rare, highly pointed editorial defending the publication process. “If one disagrees with facts/statements in a publication,”  writes the editor, Douglas Zipes, “there is a well-defined approach that can begin with a letter to the editor or submission…

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Aliskiren (Tekturna) Gets New Warning and Contraindication From FDA

The FDA has issued new warnings about antihypertensive drugs containing the direct renin inhibitor aliskiren (including Tekturna, Amturnide, Takamio, and Valturna) when used in combination with ACE inhibitors or angiotensin receptor blockers (ARBs). The FDA now states that these drug combinations are contraindicated in patients with diabetes, and it is adding a new warning to…

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New Perspective on the Dutch Cardiovascular Research Scandal

New information and details have  emerged about the cardiovascular research scandal in the Netherlands. One prominent cardiologist with close ties to the central character in the scandal has been cleared of wrongdoing by his institution and a feature magazine article sheds new light on that central character, Don Poldermans. As previously reported here last November,…

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Million Dollar Bonuses For Five Ohio State University Electrophysiologists

Five Ohio State University electrophysiologists received 2011 bonus payments greater than $1 million, resulting in total pay for the year for each cardiologist of about $2 million. The news was first reported by the Dayton Daily News and subsequently covered by Heartwire. Five out of the 7 bonuses that topped $1 million at OSU went to the…

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Guest Post: After an Unprecedented Request for a Retraction, A Close Look at the Data

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. After an Unprecedented Request for a Retraction, A Close Look at the Data by Edward J Schloss MD Last week, St. Jude Medical took…

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Round Two: Heart Rhythm Editor Rejects St Jude Request to Retract Riata Paper

Douglas Zipes, the editor of Heart Rhythm, said the journal will not retract a controversial paper that has raised new safety concerns about St. Jude’s embattled Riata leads. On Friday (as reported here) St. Jude issued a press release alleging numerous mistakes and oversights in an article by Robert Hauser published online in Heart Rhythm linking the company’s Riata…

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Investigation Begins in the Korean Plagiarism Case

An investigation has been initiated in the case of suspected plagiarism first reported on CardioBrief. The Editor-in-Chief of Korean Circulation Journal, where the suspected article was published, wrote me to say that the article is now being investigated by the publishing committee of the Korean Society of Cardiology and that an additional investigation has been requested from the…

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Medical Societies Release Lists of Overused Tests and Procedures

The American College of Cardiology (ACC) and other medical societies have released lists of commonly overused or misused tests of procedures. The action is part of Choosing Wisely, a broad initiative from the ABIM foundation. Here are the five tests or procedures identified by the ACC: Cardiac imaging tests (particularly, stress tests or advanced non-invasive imaging)…

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And the 2012 Award For the Most Dumbass Drug Promotion Goes To…

The year 2012 is only 25% complete but it’s never too early to recognize an unprecedented and bold achievement in drug marketing. …

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What To Do When Federal Investigators Knock On The Door

For more than a year now the federal investigation of hospitals suspected of improperly implanting ICDs has been the subject of considerable rumor and speculation. Now, two cardiologists who were involved in a federal audit at one hospital have published a detailed account of their experience. Jonathan Steinberg and Suneet Mittal are Columbia University-affiliated electrophysiologists…

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A Case of Plagiarism Raises Blood Pressures

Plagiarism: it’s enough to raise your blood pressure. An article in Korean Circulation Journal appears to plagiarize from a similar article in the Journal of the American College of Cardiology (JACC). In 2009, Franz Messerli, a well-known hypertension expert at St Luke’s Roosevelt Hospital Center in New York, and Gurusher Panjrath, at Johns Hopkins Hospital, published a Viewpoint and Commentary…

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Prominent Japanese Cardiologist Accused of Scientific Misconduct

Following accusations by independent bloggers in Japan and Germany, the American Heart Association (AHA) has issued an Expression of Concern about five papers published in AHA journals co-authored by Hiroaki Matsubara, a prominent cardiologist and researcher at Kyoto Prefectural University in Japan. In addition to his many papers exploring the basic science of the renin-angiotensin system, Matsubara…

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Slow Uptake of Transcatheter Aortic Valves: Learning from History?

Transcatheter aortic valve replacement (TAVR) has been one of the most exciting new developments in cardiovascular medicine in recent years. The growing enthusiasm over TAVR led to concern and even alarm in some quarters that the introduction of TAVR would ignite a stampede of uptake, mirroring the early over-enthusiasm for similarly disruptive devices like stents…

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YouTube, NEJM, Whitney Houston, and Alpha Male Monkeys

Take a close look at this screenshot from YouTube (click to expand): Jim Ware, the legendary New England Journal of Medicine biostatistician: 8 views. Jerome Kassirer, Marcia Angell, and Arnold Relman, former NEJM editors: 36, 28, and 257 views. Whitney Elizabeth Houston Funeral Service: 994,920 views. (And how many more Whitney Houston videos do you think…

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FDA Advisory Panel Gives Green Light to Qnexa Diet Pill

Breaking a long streak of bad news for diet drugs, an FDA advisory panel on Wednesday voted 20-2 in favor of approval for Qnexa, the combination of  phentermine and topiramate under development by Vivus. Panel members strongly suggested that Vivus be required to perform a cardiovascular outcomes trial, though it was not immediately clear if this…

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Guest Post: More Lessons From the Riata ICD Lead Recall

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. This post is longer and far more technical than most of the content published on CardioBrief. Due to the extraordinary nature of the…

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Industry Supported Editorial Assistance: The Debate Continues

Editor’s Note: Here is the latest installment of a debate over industry-sponsored editorial assistance between Tom Yates, a UK-based physician critical of the role of industry in medical publishing, and Karen Wooley, who owns a medical education company and is a representative of the the Global Alliance of Publication Professionals (GAPP). (The previous installments of the…

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Japanese Researcher With Harvard Connections Retracts 3 Articles in AHA Journals

Akio Kawakami, a well published lipid researcher at Tokyo Medical and Dental University, has retracted 3 papers from AHA journals, including one article in AHA’s flagship journal Circulation. News of the retractions was first reported on Retraction Watch. Two of Kawakami’s co-authors are well known researchers affiliated with Harvard University and the Brigham and Women’s Hospital, Peter Libby and…

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Guest Post: What Are the Lessons of the Riata ICD Lead Recall?

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. What Are the Implications of the Riata ICD Recall? by Edward J. Schloss, MD This week the New England Journal of Medicine published an…

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