Can we trust ATHENA? 1

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, the authors were unable to perform an independent analysis of the data.

Fauber’s takes a local Wisconsin angle on the story and asks some hard questions about Richard Page, a well-known electrophysiologist who is the chairman of the department of medicine at the University of Wisconsin School of Medicine, a past president of the Heart Rhythm Society, and an ATHENA co-author. Writes Fauber:
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At least 200 patients with unread echocardiograms have died 1

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 stories here and here for background.)

The Times reports that as of 5 PM on Friday 2,725 of the tests had been read. Hartocollis reports that medical officials said that “none of those patients needed ‘follow-up care.” But the cardiologist, who had been recruited from another hospital to read the tests, had a different perspective, saying that “about half of them were abnormal and that 20 percent to 30 percent of the patients needed immediate medical care.”
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Think about it: 4,000 echocardiograms were not only unread, but unmissed 3

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 few hours after posting the earlier story I received an email from a cardiologist who is highly familiar with the New York City hospital scene. Here’s what he wrote:

I think that there’s a bigger story that people are missing. The problem is not just 4000 echos went unread, but think about it — 4000 echos were ordered by referring physicians, and no one asked why they didn’t get a report? Something stinks, and it’s not just the echo lab. It’s the whole hospital.

Just wondering: perhaps by the end of this story 4,000 echocardiograms might seem be just the proverbial tip of the iceberg.

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

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 process the doctors followed may have alerted cardiologists to those echocardiograms that were most likely to be abnormal, the failure to read the echocardiograms in a timely manner is inexcusable and may have placed patients at risk,” said Alan Aviles, the hospital’s corporation president, in a statement quoted by the Times. Aviles also told the Times that he had fired the clinical director of the hospital’s department of medicine, Alfred Ashford.
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Even more people may have received unnecessary stents at St Joseph’s 1

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 have undergone an unnecessary procedure. The notifications were based on a review of cases that occurred within a two-year time frame. But patients (and their lawyers) who were treated outside that time window are now claiming that they were also treated inappropriately.
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Eplerenone trial stopped early after reaching its primary endpoint, Pfizer announces Reply

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 failure who are also at risk of sudden death. The primary endpoint was the first occurrence of either cardiovascular death or heart failure hospitalization. The trial was designed to enroll 3,100 patients and had been planned to continue for 5 years until 813 primary endpoints had been reached. (A previous study, EPHESUS, had demonstrated the efficacy of eplerenone in HF patients with a recent MI.)

In its press release Pfizer said that eplerenone was well tolerated in the trial. Adverse events included hyperkalemia and renal impairment, which are known to be associated with the drug.
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Guest Post: Steve Nissen and Jack Lewin debate interactions with industry 3

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 of Care and Outcomes Research conference in Washington, DC. I’m a lawyer, and I’ve attended my share of legal conferences over the years, which tend to be on the dry side, to say the least. This conference was much livelier, and one of the highlights was a debate between American College of Cardiology CEO Jack Lewin and Steve Nissen of the Cleveland Clinic, on the topic of “Controls on the Influence of Commercial Interests.”

As background, Steve Nissen was one of the authors of a 10-point proposal set out in an editorial in JAMA last year that argued that professional medical associations (PMAs) should work toward a complete ban on pharmaceutical and medical device industry funding, except for income from journal advertising and exhibit hall fees. The JAMA editorial, among other things, also argued that PMAs should pool any industry funds for CME and not permit industry to fund specific programs. Explicit in the JAMA editorial is the view that although accepting advertising and exhibit hall fees “might possibly bias the activities of PMAs, officers and members can easily distinguish these marketing activities from educational presentations and are free to ignore them.” (You can read more on the JAMA editorial here.)
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Guest Post: Do hundreds of left atrial burns reduce dementia risk? Reply

(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 to be increasingly prevalent in this era of sensational, but often misleading medical headlines. Take the case of AF, AF ablation, and Dementia as the most recent example.

Atrial fibrillation remains one of the most common cardiac diagnosis, and dementia is one of Neurology’s most frequent diagnosis.  Recently, as background, a study from a Utah group of electrophysiologists showed that AF predisposes to all forms of dementia, especially the specifically defined Alzheimer’s disease.

The study involved 37.000 patients, and was published in the prominent and well respected Heart Rhythm Journal. Although the mechanism is speculative, it comes as little surprise to those of us who care for AF patients that it could be associated with an increased risk of dementia. Excluding the very young, “lone AF” patient, this arrhythmia is–like dementia–a disease of birthdays, a disease of wear and tear.  Associated conditions like high blood pressure, obesity, disordered sleep, sedentarism and diabetes all predispose to both dementia and AF.

However, the most recent headlines from this same group, suggesting that AF ablation may reduce the risk of dementia is troublesome. A prominent cardiac website had the AF ablation-dementia connection as its lead story most of the week.
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Francis Collins proposes new conflict of interest rules for NIH-funded researchers and institutions Reply

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 a key part of the proposed rules, investigators would now be required “to disclose to their institutions all significant financial interests, thus moving the responsibility of determining potential conflicts from the investigators to the institution.” In addition, institutions will now be required to develop a plan to manage COI concerns. Finally, every institution that received NIH funding will be required to post details on a website of all payments to researchers over $5,000.
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Is time starting to run out for TIDE and Avandia? Reply

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 a single patient into the trial, Mundy reports.

But TIDE may be in even murkier waters outside the US. According to a news article in BMJ by Janice Hopkins Tanne, consumer advocate Sidney Wolfe and David Juurlink, of Sunnybrook Health Sciences Centre in Toronto, wrote to the FDA requesting that TIDE be halted. The two were especially critical of the fact that new sites in TIDE were in developing countries. The Wall Street Journal story quotes Wolfe as saying that “it is ‘particularly troublesome’ that Glaxo had added so many sites in countries where patients may not be aware of the safety questions about Avandia.”
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Why we shouldn’t kill all the lawyers just yet 4

“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 Midei case makes clear, modern medicine doesn’t know how to police itself. And until medicine does learn to police itself and protect patients from incompetent or greedy or just plain self-deluded practitioners, we will still need the lawyers as a last safeguard, even acknowledging the many, many shortcomings of the current legal system regarding malpractice.

But of course there’s more involved here than just malpractice. At first glance it appears to be only a simple case of greed and arrogance, the story of an interventional cardiologist who made a lot of money by performing procedures on patients who didn’t need them. On further examination, however, the story runs much deeper, striking into the heart of the way medicine is practiced today. Before modern medicine learns to police itself, it will first need to change its culture.
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Good Morning America segment lands some hard punches on the AHA 5

American Heart Association versus Good Morning America

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 “Medical Fact Check,” raised some pointed questions and landed more than a few jabs: “Does it send a mixed message about healthy lifestyles?” he asked, and “why promote a product linked to obesity?”

In an interview with Besser, AHA president Clyde Yancy said it was important for the AHA to engage people “where they are.” When Besser asked him point-blank how much money the AHA was getting from Nintendo Yancy tried to bob and weave: “Certainly resources have exchanged hands because it takes quite a bit to launch a new initiative…” said Yancy.
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Guest post: Badness in Baltimore: can peer review catch rogue doctors? 4

(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 on his blog, Wachter’s World.)

A couple of months ago, a Baltimore reporter called to get my take on a scandal at St. Joseph’s Hospital in Towson, an upscale suburb. A rainmaker cardiologist there, Dr. Mark Midei, had been accused of placing more than 500 stents in patients who didn’t need them, justifying the procedures by purposely misreading cath films. In several of the cases, Midei allegedly read a 90 percent coronary stenosis when the actual blockage was trivial – more like 10 percent.

Disgusting, I thought… if the reports are true, they should lock this guy in jail and throw away the key. After all, the victims now have permanent foreign bodies in their vascular beds, and both the stent and the accompanying blood thinners confer a substantial lifetime risk of morbidity and mortality. As I felt my own blood beginning to boil, the reporter asked a question that threw me back on my heels.

“Why didn’t peer review catch this?” he asked.
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Guest Post: Shocking revelations at the HRS… Reply

(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 Rhythm Society) meeting. In 88,804 ICD patients from 2500 centers, researchers studied how ICD programming related to inappropriate shocks. They concluded: (translation to follow)

“Strategic programming of faster VT/VF detection thresholds, longer detection durations, SVT discriminators, and ATP for FVT reduced shocks. Clinical actions to reduce morbidity from shocks should include ensuring adequate rate control for pts with AF as well as programming to increase the VT/VF detection rate and duration thresholds.”

The translation goes something like this: programming an ICD skillfully, like you know something about the heart rhythm, is better than just implanting the device with its nominal factory settings. Taking the time to tailor ICD programming to the specific patient reduces the likelihood of inappropriate shocks, which are not only painful, but also portend a higher risk of future morbidity. Inappropriate shocks are horrible. Although they cannot be absolutely prevented, they can surely be minimized with sound doctoring.

That could be it–the end of the story. Just program the darn thing smartly, and let’s move on. However, if that were the case, than why would someone need to study 88,000-plus patients?
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Topol vs Gurbel: experts split on routine genotyping for DAPT 3

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 cause of adverse cardiovascular events during clopidogrel treatment.” Further, even though prasugrel and ticagrelor appear to be superior to clopidogrel, the benefit was likely caused by patients who were taking clopidogrel “who harbored resistance alleles.”

They continue: “Many experts will continue to call for results from randomized prospective trials before individualizing antiplatelet therapy on the basis of CYP2C19 carrier status, despite the overwhelming evidence presented here. This doggedness represents a false premise for a number of reasons and denies current patients state-of-the-art care. …we cannot afford to wait years for results from these trials that to date have yet to be initiated. In the interim, we should implement all potential interventions to help prevent the catastrophic outcomes of stent thrombosis and death in the tens of thousands of patients currently at risk.”
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Gust Bardy Answers Questions About the Entirely Subcutaneous ICD 1

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, Dr Gust Bardy presented the initial experience with a promising new device, an entirely subcutaneous ICD. The paper was published simultaneously online in the New England Journal of Medicine. Dr Bardy graciously agreed to answer questions about the device from the editors of CardioExchange.
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Lancet meta-analysis finds some benefits for fibrates Reply

A new meta-analysis has found evidence that fibrates may have a small beneficial effect on cardiovascular outcomes. The paper by Min Jun and colleagues is published online in the Lancet.

Combining data from 18 clinical trials including over 45,000 subjects, the investigators found that fibrates resulted in a 10% relative risk reduction for major cardiovascular events and a 13% reduction for coronary events. Fibrates had no effect on stroke, cardiovascular mortality, or sudden death.
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Medtronic tells physicians about rare software issue with its ICDs 1

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 Medtronic, a software update will be made available soon to correct the problem, which occurs in the Consulta CRT-D, Secura DR/VR, Concerto II CRT-D, Virtuoso II DR/VR, Maximo II CRT-D, and Maximo II DR/VR models. No injuries or deaths have been caused by the problem, the company said.
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Vioxx, Avandia, Vytorin: absolute risk versus relative risk 3

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 million people, if told the truth about its side effects, would accept it because their lives could be lived with a lot less pain. There are a lot of people now whose lives are miserable because they have to live with arthritic pain.

At the same meeting, the editor of Reuters Health, Ivan Oransky, was critical of the way the Vioxx issue was reported by many journalists: “There was a doubling of heart attack risk, but the doubling was from a 1% risk to a 2% risk. If you lay that all out to readers, they can make much better decisions.”

I think DeAngelis and Oransky make valid points, but I think they miss a much more important point.
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Hong Kong authorities issue warning about Medtronic ICDs Reply

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 of defects out of 144,000 devices sold worldwide. To date no patient injuries or deaths have been reported. The Hong Kong Department of Health said the software problems were “potentially life-threatening” but did not provide any details.
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The wealth gap: are cardiologists’ high salaries standing in the way of primary care? 1

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 Between Specialists And Primary Care Physicians?”

The Duke researchers compared specialists, represented by cardiologists (who have the 14th highest median practice income among 68 medical specialties), to primary care physicians, represented by general internists and family physicians, as well as other non-physicians. Here is their estimated value of career wealth from college graduation until age 65:
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