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 since the presentation of the JUPITER results. (For just one example, see this earlier CardioBrief story.)

Wilson focuses on the issue surrounding primary prevention: “But for healthy people who would take statins largely as prevention — which would be the case for the new category of Crestor patients — other experts suggest the benefits may not outweigh any side effects.” He quotes Mark Hlatky: “It’s a good thing to be skeptical about whether there may be long-term harm from healthy people taking a drug like this.”
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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 the recall in which the company confirmed details about the cause of the recall, which Wall Street analysts had already largely figured out. The company has filed a request for approval within 30 days for the manufacturing changes that sparked the recall, but it is possible that the FDA will take as much as 135 days for its review before giving Boston Scientific the green light to resume ICD sales.

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) used Archimedes to evaluate the value of 8 screening strategies for type 2 diabetes. The authors reported that screening strategies would result in reductions in MI  and microvascular events (for each, 3-9 events would be prevented per 1000 people screened) and would increase the number of quality-adjusted life-years over 50 years. There was little or no effect on stroke incidence.
Click to continue reading, including an interview with Richard Kahn…

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 steps to address the issue that has been raised.” (By way of background, the off-label, off-guideline Prystowsky lecture was the only original content on the site, and there had been no disclosure that Prystowsky had received compensation for Sanofi.)

Update, Wednesday, March 31– An alert reader has pointed out that the Prystowsky lecture has now reappeared on the site, this time accompanied by conflict of interest disclosures.

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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 billion, have been drastically reduced, with at least one analyst stating it will never sell more than €300 million a year for its maker, Sanofi-Aventis.

Puzzle Piece 2: The ACC and the Heart Rhythm Society (HRS) have jointly launched AFibProfessional.org, which they define as “a unique collaboration to address atrial fibrillation for the cardiology community.” The Sanofi logo appears in the lower right hand corner under “site sponsors” (no other companies are listed). There is no mention of sponsorship, or the role of the sponsor, anywhere else in the site that I can find.

Puzzle Piece 3: As far as I can tell, with one exception all the educational content on the site is drawn from material previously available on the HRS site and the ACC’s CardioSource. Here’s the exception:
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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 debate was widely covered by the Associated Press, Forbes, the Wall Street Journal Health Blog, and MedPage Today (where you can also find a link to listen to the initial presentations of the debaters).

The debate was combative but thoughtful and even nuanced– among other things, Harrington conceded that there have been many egregious cases of conflict of interest and Nissen acknowledged that academics need to work with industry. But after the debate almost the only thing reporters and others who were in the audience focused on was a Nissen blooper, which happened when Nissen criticized the AHA for issuing a statement some time ago that pointed out the limitations of a study linking soda consumption to metabolic syndrome. Nissen said the AHA had compromised itself by accepting money from Coca-Cola. To illustrate his point he showed images of Diet Coke cans with red dresses and hearts.

Turns out Nissen made a mistake. The AHA does not have a deal with Coke. But here’s where it gets weird: the NHLBI has its own Women’s Heart Health red dress program, and it does have some kind of deal with Coke. Who knew there were two such programs? And who would ever have thought Coke could buy a partnership with the NHLBI?
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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 with the device.
Click for links to news reports and a Medtronic press release…

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 company should be required to design a postmarketing study in consultation with the FDA.

Click for links to media coverage and a press release from Boston Scientific…

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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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 Pacing System, the first pacing system that would permit patients with the device to have MRI scans.

Meeting materials for the panels are available on the FDA website.

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 at the ESC last year with the presentation of the main results of PLATO, and continuing with subsequent presentations of the PLATO Invasive substudy at TCT and the PLATO STEMI results at the AHA.
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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 statin drugs and fenofibrate.” The FDA noted that the labeling for Trilipix “currently states that no incremental benefit of Trilipix on cardiovascular morbidity and mortality over and above that demonstrated for statin use alone had been established.”
Click here to read the complete FDA statement to healthcare professionals…