Medtronic tells physicians about rare software issue with its ICDs

Medtronic has informed physicians about a rare software issue with its ICDs.  News of the problem was first reported by the Hong Kong Department of Health and picked up by electrophysiologist and blogger Westby Fisher. Medtronic said that it had received 5 reports of the problem out of approximately 144,000 devices implanted worldwide. According to…

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Vioxx, Avandia, Vytorin: absolute risk versus relative risk

There’s a fascinating discussion about Vioxx echoing around the blogosphere. (William Heisel has a nice summary here.) A few weeks ago Catherine DeAngelis, the editor of JAMA, spoke at the recent meeting of the Association of Health Care Journalists and said: I believe Vioxx should not have been taken off the market. At least a…

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Hong Kong authorities issue warning about Medtronic ICDs

As far as I can tell, electrophysiologist and blogger Westby Fisher is the first person in the western hemisphere to publicly report a new, potentially life-threatening software problem with Medtronic ICDs. Fisher found a warning issued by the Hong Kong Department of Health. As of April 19, Medtronic said it had received five confirmed reports…

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Stentapalooza Wednesday: SPIRIT IV and MAIN-COMPARE

With the publication of SPIRIT IV in NEJM and the 5 years results for left main stenting in the  MAIN-COMPARE trial in JACC, I guess today is Stentapalooza Wednesday. Of course, for many interventional cardiologists every day is stentapalooza, so maybe today really isn’t anything special for them….

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The wealth gap: are cardiologists’ high salaries standing in the way of primary care?

High salaries for cardiologists and other specialists lead to an overwhelming lifetime advantage in wealth accumulation, according to a new study appearing in Health Affairs. That advantage may play a decisive role in the choice of medical careers, say Kevin Schulman and his colleagues in their article, “Can We Close The Income And Wealth Gap…

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EHJ editors rebuffed GSK efforts to suppress Nissen editorial on rosiglitazone

The editors of the European Heart Journal rejected a request by a senior GSK executive to suppress an editorial written by Steve Nissen about rosiglitazone (Avandia). The incident is recounted in a separate editorial written by the EHJ editor-in-chief, Thomas Lüscher, and two deputy editors, Ulf Landmesser, and Frank Ruschitzka, and published online on April…

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The survey says: uphill battle for Effient, Plavix remains strong, anticipation grows for Brillinta

Sales of prasugrel (Effient) are slowly growing, but the road to blockbuster status appears blocked by continued strong current usage of clopidogrel (Plavix) and, in the future, widespread anticipation and excitement over ticagrelor (Brillinta). In its last financial statement Lilly reported worldwide sales of Effient of $8.8 million in the first quarter, $4.5 million in…

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TMI or the future of medicine? Complete human genome used in patient assessment

Three extraordinary papers in the Lancet provide a fascinating first glimpse at issues that will be the topic of discussion and debate for the next generation at least. For the first time, investigators at Stanford and Massachusetts General Hospital used a complete human genome of an individual patient to provide a clinical assessment of the…

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Roche announces more positive results for taspoglutide

Once again Roche has announced positive phase III results for taspoglutide, a once-weekly GLP-1 analog under development. The drug is being tested in a series of phase 3 studies that compose the T-emerge clinical trial program. In today’s announcement, Roche said the T-emerge 3 study showed that taspoglutide was superior to placebo for the primary…

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Vitamin B and steroids: monuments to human folly

Walk into any Vitamin Shoppe or GNC and you can see them: people looking to fight a cold, reduce “stress”, sleep better, or build bigger muscles. They’re all looking for a quick fix with no downside. They’re all deluded. Two new clinical trials testing the effects of vitamin B and steroids serve to demonstrate the…

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US Judge rejects $296 million plea agreement for Guidant

A US federal judge rejected a proposed $296 million plea agreement which would have allowed Guidant to settle the investigation into the company’s handling of defective ICDs. As reported here last week, cardiologists Barry Maron and Robert Hauser, who originally brought the case to public attention, wrote a letter to the judge urging him to…

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Calcium screening: another positive study, another critical editorial

Once again a study has turned up results that appear to favor widespread application of calcium screening. And once again an editorial has pointed out that the technique is still not ready for prime time. (And we predict that once again the proponents of calcium scans will trumpet the study as absolute justification for widespread…

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PPIs and Clopidogrel: new study finds evidence that pantoprazole may also be a problem

Over the past few years physicians have grown increasingly concerned about possible negative consequences when clopidogrel is given to people taking PPIs. Last November the FDA added a warning to the clopidogrel label and issued a public health advisory on the interaction between clopidogrel and omeprazole. Now a new study lends fresh support to concerns,…

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Guest Post: Medical Societies’ New Ethics Code: Secret Q&A Document Revealed

Editor’s Note: A transforming moment in the current discussion about conflict of interest in medicine occurred on November 25, 2007, when the New York Times Magazine published a lengthy article by Dr. Daniel Carlat, a psychiatrist affiliated with Tufts University. In the article, Carlat wrote at length about his experience as a paid speaker to…

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Guest Post: the long afterlife of Joshua Oukrop

Editor’s Note: In response to a plea agreement in which Boston Scientific would pay $296 million to resolve the well-known case involving defective Guidant ICDs that the company failed to disclose, the New York Times and the Minneapolis Star Tribune report that the two cardiologists who first brought the issue to public attention have sent…

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IOM report heralds new FDA initiative to gradually cut salt in processed foods

Update: In response to the Washington Post article discussed below, the FDA issued a statement saying the article “leaves a mistaken impression that the FDA has begun the process of regulating the amount of sodium in foods. The FDA is not currently working on regulations nor have they made a decision to regulate sodium content…

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Small steps lead to big reduction in risk for overweight Mayo Clinic cardiologist

Moderate changes in lifestyle can lead to big reductions in risk, as reported in a feature story in the Wall Street Journal by Ron Winslow. The story opens with an anecdote from Mayo Clinic cardiologist Stephen Kopecky, who describes the case of a 240 pound, 49-year-old  man with a scary lipid profile. “He may not…

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Residual Risk Reduction Initiative: promotion or education?

Cardiologists and other physicians have reported receiving an email lately from an organization called the Residual Risk Reduction Initiative. Here’s how the organization describes itself: The Residual Risk Reduction initiative (R3i) is a worldwide, academic, multidisciplinary, non-profit, Swiss-law Foundation established by international researchers and clinicians who recognize the importance of the high risk of fatal…

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Boston Scientific resumes sales of Cognis and Teligen ICDs

Boston Scientific announced today that it had received approval from the FDA to resume sales of most of its ICDs and CRT-Ds following a 30 day suspension. Sales of Cognis CRT-Ds and Teligen ICDs will resume immediately. The company said it had “found a few additional instances where the Company did not submit the appropriate…

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Even more questions about Multaq and Prystowsky, alas

I’m feeling a bit like Al Pacino in Godfather III: every time I think I’m out of the Multaq story I get pulled back in. A sharp observer forwarded an article posted online in the Journal of Cardiovascular Electrophysiology: “The Impact of New and Emerging Clinical Data on Treatment Strategies for Atrial Fibrillation.” First author:…

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Final results of ARBITER 6-HALTS confirm CIMT benefit with niacin and no benefit with ezetimibe

Last November the initial presentation at the AHA and simultaneous publication in the New England Journal of Medicine of the ARBITER 6-HALTS trial resulted in a storm of confusion and controversy. Now the final results of the trial have been published in the Journal of the American College of Cardiology. The data appear to provide…

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Promising early results for “valve-in-valve” approach to failing bioprosthetic valves

Fixing a failing porcine or bovine heart valve with the percutaneous implantation of a mechanical valve inside the previous valve appears promising, according to a new report by  John Webb and colleagues in Circulation. But an accompanying editorial warns that the new technology needs to be carefully assimilated. “Generally the transcatheter valves work very well…

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Guest Post: Running on empty

Editor’s Note: The following post was written by Westby G. Fisher, an electrophysiologist  practicing at NorthShore University HealthSystem in Evanston, IL and  a Clinical Associate Professor of Medicine at the University of Chicago’s Pritzker School of Medicine. He is  the author of Dr Wes, a widely known and highly admired blog about cardiology, the internet,…

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NEJM: trials find few long term benefits for endovascular AAA repair

The short-term benefits of endovascular abdominal aortic aneurysm repair seen in previous trials appear to evaporate with long-term followup, according to results of two large trials published online in the New England Journal of Medicine. In EVAR 1 (United Kingdom Endovascular Aneurysm Repair 1), between 1999 and 2004, 1,252 patients with large abdominal aortic aneurysms…

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More pieces of the Multaq puzzle

I don’t want to keep harping on Multaq (see the bottom of this post for links to recent stories), but then I keep running across promotions for so-called educational programs that practically beg to be scrutinized. Earlier today I received an email from theheart.org CME Center. At the top of the message was this featured…

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