New unpublished study may help tighten the noose around Avandia’s neck

A new unpublished study utilizing data from 227,571 Medicare patients is raising new questions about rosiglitazone (Avandia), which will be the subject of an extraordinary 2-day FDA advisory panel meeting in July. The study found that among elderly people taking a thiazolidinedione (TZD), the risk of stroke, heart failure, and death, as well as of composite…

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Cardiobriefs: MIs Decline Over Past Decade, Smoke-Free Legislation Reduces MI Admissions in England

The following news briefs are republished with permission from CardioExchange, a new website for cardiovascular healthcare professionals from the New England Journal of Medicine. CardioBrief readers who are healthcare professionals are invited to register at the site. Decline in MIs Observed Over Past Decade: Yeh and colleagues reviewed data from 46,000 hospitalizations for MI among…

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Atrial fibrillation: a big messy problem

Atrial fibrillation is a big messy problem. It’s a complex disease that’s poorly understood, and as the population ages the problem will only grow larger. Although there are a variety of competing therapies to treat AF, none is completely safe and effective, and many  are quite expensive. Today’s Kaiser Health News contains a very nice…

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Investigators in Maryland expand investigation of unnecessary stenting

The investigation of interventional cardiologist Mark Midei has now turned up similar suspicious practices by other Maryland physicians, the Baltimore Sun reports. “Several cardiologists in the state have performed a suspiciously high number of the same invasive cardiac stent procedures that Dr. Mark G. Midei is accused of over-performing at St. Joseph Medical Center,” writes…

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FDA schedules Avandia advisory panel for July 13-14

The FDA has definitely scheduled the much-anticipated Avandia (rosiglitazone) advisory panel for July 13-14 in Gaithersburg, MD. The notification appears in the Federal Register. [Update: click here for the meeting announcement on the FDA website.] As previously speculated in the In Vivo blog, the FDA will also present a meta-analysis of trials of pioglitazone before the…

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Up the Avandia creek without a paddle: CANOE

It’s hurricane season. By that I mean of course that the storm of controversy over Avandia will continue at least until the July FDA advisory panel and the subsequent final (?) decision by the FDA on the drug’s ultimate fate. Now, into the middle of this storm, comes CANOE, which lacks both a paddle and…

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Listening to industry: what’s the ROI of medical education?

In the ongoing debate over industry influence in medicine, who should you believe, the critics or the defenders of industry? The answer is easy: the industry defenders. Just listen to what the defenders say when they’re talking among themselves. For example, listen to Bill Cooney, President & CEO of Medpoint Communications, which is, in its…

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FDA schedules July advisory panel for Brilinta (ticagrelor)

The FDA has announced a July 28 Cardiovascular and Renal Drugs Advisory Committee meeting to review the NDA for ticagrelor (Brilinta, AstraZeneca). The proposed indication is “for use in acute coronary syndrome (including heart attacks and any of a group of signs and symptoms, such as chest pain or shortness of breath, that are consistent…

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Handicapping the July FDA panel on Avandia

The In Vivo Blog posted a very thoughtful preview of the FDA’s upcoming advisory panel on Avandia in July. It’s even possible that they’re not exaggerating when they call it “the most important single event for FDA’s drug review in 2010 and possibly beyond.” Among other tidbits of information, the blog reveals that “Nissen recently…

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Can we trust ATHENA?

I’ve written extensively on CardioBrief about Sanofi’s promotion of Multaq (dronedarone). John Fauber, a reporter for the Journal Sentinel in Milwaukee, tackles the topic from an important perspective that often gets ignored or neglected. He focuses on ATHENA, the drug’s pivotal trial, and notes that all the trial authors had financial ties to Sanofi. Further,…

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At least 200 patients with unread echocardiograms have died

At least 200 patients whose echocardiograms went unread by a cardiologist for as long as three years have died, according to a new article in the New York Times by Anemona Hartocollis. Equally troubling, a cardiologist reading some of the tests says that he has found “life-threatening diagnoses” on some of the tests. (See our…

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Think about it: 4,000 echocardiograms were not only unread, but unmissed

As we reported a few hours ago, there’s a scandal now underway here in New York City involving 4,000 unread echocardiograms at Harlem Hospital Center. (The story was first reported by Anemona Hartocollis in the New York Times here and here.) But the story may be far bigger than has so far been reported. A…

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Over 3 years 4000 echocardiograms went unread at NYC’s Harlem Hospital

Nearly 4,000 echocardiograms were never read by a cardiologist until recently, according to a report in the New York Times by Anemona Hartocollis. The tests were performed over the past 3 years at Harlem Hospital Center. After passing an initial review by technicians the tests were stored on a hospital computer and forgotten. “While the…

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Even more people may have received unnecessary stents at St Joseph’s

There may be more people who received unnecessary stents at Maryland’s St Joseph’s Medical Center than previously thought, according to a front page story in the Baltimore Sun by Robert Little. As previously reported, St Joseph Medical Center in Towson, MD had previously informed hundreds of patients who received stents implanted by Mark Midei that they may…

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Eplerenone trial stopped early after reaching its primary endpoint, Pfizer announces

Pfizer announced today that recruitment in the EMPHASIS-HF trial has been halted after the Data Safety Monitoring Committee found that the study had reached its primary efficacy endpoint. According to information posted on Clinicaltrials.gov, the trial was designed to test eplerenone (Inspra) when compared to placebo plus standard therapy in patients with established mild-to-moderate heart…

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Guest Post: Steve Nissen and Jack Lewin debate interactions with industry

Editor’s Note: The following guest post was written by Marilyn Mann, a lawyer with a keen interest in health policy. Members of her family have familial hypercholesterolemia (and have been treated by Steve Nissen), which may account for her particular interest in cardiology and this debate. Last week I attended the American Heart Association Quality…

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Guest Post: Do hundreds of left atrial burns reduce dementia risk?

(The following guest post is reprinted with permission from the blog of Dr John Mandola, an electrophysiologist in Louisville, KY.) “No data is better than bad data…If you can’t see it, don’t call it,” Dr Feigenbaum often admonished us young fellows during the old Thursday Echo conference at IU. Calling more than is actually there seems…

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Francis Collins proposes new conflict of interest rules for NIH-funded researchers and institutions

In an online JAMA commentary, NIH Director Francis Collins has proposed a new set of rules to govern conflicts of interest (COI) by researchers and institutions who receive NIH funding. The new rules go further than earlier efforts by the Institute to curb COI concerns, but not all critics are likely to be satisfied. In…

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Is time starting to run out for TIDE and Avandia?

The embattled TIDE trial, which is evaluating the cardiovascular safety of rosiglitazone (Avandia), is having trouble enrolling participants in the United States, according to a story in the Wall Street Journal by Alicia Mundy. Two sites in the US have withdrawn from the trial. One, Wake Forest University Baptist Medical Center, had been unable to recruit…

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Why we shouldn’t kill all the lawyers just yet

“Let’s kill all the lawyers.” It’s every doctor’s favorite Shakespeare quote.  And if you’re giving a talk to doctors there’s no better way to get the audience on your side than by starting with a  lawyer joke. But perhaps we shouldn’t be too hasty about killing all those lawyers. As recent commentary about the Mark…

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Good Morning America segment lands some hard punches on the AHA

Why don’t they just duke it out on Wii boxing? Today Good Morning America pummeled the American Heart Association for its new “strategic relationship” with Nintendo. Later in the day, in an effort to contain the damage, the AHA issued a press release (see below) clarifying its position. Dr. Richard Besser, in a segment titled…

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Guest post: Badness in Baltimore: can peer review catch rogue doctors?

(The following post was written by Robert Wachter, who is the Associate Chairman of the Department of Medicine at UCSF and the Chief of the Division of Hospital Medicine at the UCSF Medical Center. Among his many other accomplishments, he coined the term “hospitalist” in a 1996 New England Journal of Medicine article. This post originally appeared…

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Guest Post: Shocking revelations at the HRS…

(The following guest post is reprinted with permission from the blog of Dr John Mandola, an electrophysiologist in Louisville, KY.) Defibrillators (ICDs) are in the news today. Few medical treatments are more misunderstood, both by doctors and patients, than the ICD. It was a huge observational study presented today in Denver at the annual HRS (Heart…

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Topol vs Gurbel: experts split on routine genotyping for DAPT

Routine genotyping to guide dual-antiplatelet therapy (DAPT) seems like a great idea. After all, argue Damani and Topol in a Viewpoint in JACC, the arguments are overwhelming, and the consequences of not rushing to adopt the new technique are dire. They write that loss-of-function and gain-of-function variants of CYP2c19 are extremely common, and are “the root…

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Gust Bardy Answers Questions About the Entirely Subcutaneous ICD

Editor’s note: This item, in a slightly altered form, is republished with permission from CardioExchange, a new website for cardiovascular healthcare professionals from the New England Journal of Medicine. CardioBrief readers who are healthcare professionals are invited to register at the site. Earlier today, at the annual meeting of the Heart Rhythm Society in Denver,…

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