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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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.

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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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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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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“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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(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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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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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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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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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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