Prystowsky lecture resurfaces, this time with COI disclosures

It’s back. This time with a disclosure of conflicts of interest. The Eric Prystowsky lecture that was the only piece of original content on AFibProfessional.org, the Sanofi-sponsored website run under the auspices of the ACC and HRS, is back on the site once again after being removed last week after a critical story was published here on CardioBrief….

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New York Times: broader indication for rosuvastatin once again raises risk vs benefit in healthy population

Statins may not be as safe as many people think, and the recently granted expanded indication for rosuvastatin may create new problems while providing few benefits, according to an article in the New York Times by Duff Wilson. The Times article places before the wider public the ongoing debate that has been taking place in cardiology circles…

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UK’s NICE plays a bit nicer with Multaq (dronedarone)

The UK’s NICE (National Institute for Health and Clinical Excellence) has eased up a bit on its preliminary recommendations for dronedarone (Multaq). It had previously recommended that the drug not be used to treat atrial fibrillation. The revised draft guidance recommends use of dronedarone in people with AF uncontrolled by first-line therapy (usually including beta-blockers)…

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SEC and DOJ looking into Boston Scientific ICD recall

There’s more fallout from the Boston Scientific ICD recall. The US Department of Justice has sent a subpoena to the company and the SEC is looking into the matter as well, according to a report by Jonathan Rockoff in the Wall Street Journal. Yesterday Boston Scientific released the transcript of a conference call with physicians about…

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FDA delays approval of Certriad (rosuvastatin/fenofibric acid combo)

Abbott and AstraZeneca today announced receipt from the FDA of a complete response letter (CRL) for Certriad, their combination of Abbott’s TriLipix (fenofibric acid) and AstraZeneca’s Crestor (rosuvastatin). The companies did not provide details on the contents of the letter, but Wall Street analysts are predicting that the CRL means that Certriad’s approval will be,…

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Archimedes (the computer model, not the Greek) supports screening for diabetes

Screening for type 2 diabetes may be cost effective if it is initiated between the ages of 30 and  45 and repeated every 3-5 years, according to Archimedes, a sophisticated computer modelling program (and not the ancient Greek scientist). Richard Kahn and colleagues (including David Eddy, the subject of a recent article in Wired magazine)…

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NY Times: most nitroglycerin in the US is in regulatory limbo

Most of the nitroglycerin tablets taken in the US has never received FDA approval and exists in a kind of regulatory limbo, according to an article in Saturday’s New York Times by Natasha Singer….

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More Multaq: Prystowsky whack-a-mole, ACC responds, Sanofi overtures to EPs

In response to yesterday’s posting about several problems involving a supposedly independent ACC/HRS website (AFibProfessional.org) supported by Sanofi-Aventis, the manufacturer of Multaq (dronedarone), several new events have transpired: Prystowsky Whack-a-Mole– The Eric Prystowsky lecture has been removed from AFibProfessional.org. An ACC spokesperson told CardioBrief that the ACC, in conjunction with its partner, HRS,  was “taking some immediate…

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WTF? Now you can diagnose your own heart attack right at home

Great news for hypochondriacs: you no longer have to go to the ER or see a doctor to find out if you are having a heart attack– at least if you live in Europe. Now you can do it from the comfort of your own home. A Chinese company announced that its consumer test for…

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Pieces of a puzzle: Multaq, Sanofi, ACC, HRS, Prystowsky, AF Guidelines

CardioBrief today dispenses with its usual format. Our post today is a puzzle. Here are the various pieces of the puzzle: Puzzle Piece 1: The commercial prospects of Multaq (dronedarone) appear increasingly cloudy, according to a news report by Jim Edwards on bnet.com. Wall Street estimates for the drug, which some had thought might reach € 3…

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Avandia again: Nissen and JAMA editors spin RECORD round and round

Avandia is back in the news. After a month of relative silence, following the New York Times disclosure of FDA and Senate reports critical of rosiglitazone, the subsequent release of the Senate report, and the revelation that Steve Nissen had secretly recorded a meeting with GSK executives (though the significance of this last event is unclear), a…

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Why is there a red dress on diet Coke cans?

Diet Coke icon

I have a question for the NHLBI: why is there a red dress on diet Coke cans? But before raising the question, let’s step back for a moment. Last Tuesday at the ACC Bob Harrington and Steve Nissen debated each other (and, occasionally, the audience) over the subject of conflicts of interest in medicine. The…

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Sir James Black, Nobel laureate who invented beta blockers, dead at 85

James Black, the Nobel Laureate who followed up his invention of propranolol, the first beta blocker, with key contributions to the discovery of cimetidine, the first effective anti-ulcer drug, has died at the age of 85….

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FDA panel recommends approval of Medtronic’s MRI-safe pacemaker

The FDA Circulatory System Devices Panel unanimously voted to recommend approval of Medtronic’s  REVO MRI SureScan Pacing System, the first MRI-safe pacing system. The panel said the company should be required to perform a post-approval study. In addition, they requested that the label prominently note that the device should only be used with leads that have been tested…

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FDA warns about increased risk of myopathy with 80 mg simvastatin

The FDA said today that it was informing the public about an increased risk for myopathy and rhabdomyolysis in patients taking simvastatin 80 mg. The warning is based on an ongoing review of the SEARCH (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) trial and other data….

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FDA panel supports expanded indication for CRT-Ds

The FDA Circulatory System Devices Panel voted unanimously in favor of an expanded indication for Boston Scientific’s CRT-D devices based on the MADIT-CRT study. The panel stipulated that the expanded indication should be limited to NYHA Class I and II patients with LBBB, LVEF ≤ 30% and QRS duration ≥ 130ms. The panel also stipulated that the…

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FDA: Watchman device will need to wait a bit longer

The FDA is requiring Atritech to perform another study to confirm the safety and efficacy of the Watchman left atrial appendage closure device before it can receive full approval. Atritech said it will work closely with the FDA on the study design and that it hopes to start the study later this year….

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More details emerge about Boston Scientific’s suspension of ICD sales

Details about Boston Scientific’s suspension of ICD sales are now beginning to emerge. Wells Fargo analyst Larry Biegelsen wrote the following summary of events….

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Guest Post: Freezing in AF ablation: not so fast you all…

(Editor’s note: The following post is written by Dr. John Mandrola, an electrophysiologist in Louisville, KY. Mandrola is also the author of his own blog, Dr John M, where this post originally appeared, and which we recommended highly to our readers.) Freezing the heart is in the news.  The STOP-AF trial was presented at ACC, and…

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FDA panel set to review expanded indication for CRT-D and first MRI-safe pacing system

The FDA Circulatory System Devices Panel meets on Thursday and Friday. On Thursday the panel will consider an expanded indication for Boston Scientific’s CRT-D devices to include ischemic NYHA Class 1 and all NYHA Class II patients with LVEF ≤ 30% and QRS duration ≥ 130ms. On Friday the panel will review Medtronic’s  REVO MRI SureScan…

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AHA/ACC release thoracic aortic disease guidelines

The ACC and AHA have released new practice guidelines for the management and treatment of thoracic aortic disease….

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CABG in PLATO’s cave: is the reduction in mortality real or an illusion

Previous treatment with ticagrelor resulted in a significant reduction in death among patients who underwent CABG within 7 days of stopping drug treatment, according to the results of a PLATO substudy presented in Atlanta at the ACC on Tuesday by Claes Held. The findings are the latest in a series of promising results for the drug, beginning…

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US Attorney’s office investigating Medtronic over ties to Lahey Clinic cardiologists

Medtronic has disclosed that it is being investigated by the US Attorney’s Office in Massachusetts about its relationship with cardiologists at the Lahey Clinic. The statement appears in the company’s most recent quarterly report….

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FDA says it will review the ACCORD data

The FDA announced today that it will conduct a review of the ACCORD data. As reported here yesterday, ACCORD found that fenofibrate, when added to statins, failed to improve outcome in patients with type 2 diabetes. The FDA said it “has made no new conclusions or recommendations regarding the combination use of simvastatin or other…

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Optimal duration of dual antiplatelet therapy still unresolved

The optimal duration of dual antiplatelet therapy following DES implantation is unknown and the subject of intense interest among cardiologists. “Sadly,” writes Peter Berger in an editorial in the New England Journal of Medicine, a study from Korea that attempts to shed light on this issue will “fail to inform physicians’ practice with any degree…

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