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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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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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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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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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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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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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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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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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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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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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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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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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 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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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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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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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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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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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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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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“We were surprised that consistently and pervasively, through every way of looking at the data, it turns out this isn’t about skin color or gender. It’s about being poor.” So said Colleen Koch, in a press release from the AHA, about her study in Circulation: Cardiovascular Quality and Outcomes. Along with her colleagues, Koch followed [...]
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The billion dollar question is this: when to use Multaq (dronedarone)? A new viewpoint and commentary in JACC from Sanjay Kaul’s group (Singh et al) offers a highly conservative answer to the question. An accompanying editorial by Christian Torp-Pedersen, Ole Dyg Pedersen, and Lars Køber provides a much more liberal view of the drug. It [...]
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Editor’s Note: This post originally appeared on Dr. John Halamka’s Life as a Healthcare CIO blog. It is written by Dr. Larry Nathanson, who leads the Emergency Medicine Informatics efforts at Beth Israel Deaconess Medical Center. (Note that the photo contains only fictitious patient names.) One further note: I believe that it is a distinct [...]
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Last week the IMPROVE-IT investigators, led by Rob Califf, provided an update on the trial’s progress in the American Heart Journal. Remember: this is the trial that everyone hopes will finally resolve the question of ezetimibe’s clinical value. (Earlier this year, as we reported, Merck announced several of the details contained in this paper.) According [...]
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