August 5th, 2011
USA Today Finds Disparity Between Hospital Performance and Public Perception
Larry Husten, PHD
Patients may think they’re going to a high-quality hospital when in fact they’re not, according to an analysis of Medicare data appearing in USA Today, by reporters Steve Sternberg and Christopher Schnaars. The USA Today website also contains an interactive graphic with a user-friendly interface, to help readers compare hospital death rates and readmission rates for MI, HF, and pneumonia.
A pointed example of the gap between perception and performance is Maimonides Medical Center in Brooklyn, New York. Although it gets low rankings from patients, who think it’s dirty and noisy, the article notes:
Medicare data released today shows that Maimonides is one of 13 of more than 4,700 hospitals nationwide with below-average death rates for all three conditions: 11.2% for heart attacks, compared with a national average of 15.9%; 7.3% for heart failure, compared with 11.3%; and 6.8% for pneumonia, compared with 11.9%.
By contrast, the USA Today writers also identified more than 120 hospitals with outcomes significantly below the national average for MI, HF, and pneumonia that nevertheless received high praise from patients.

August 4th, 2011
Yale Receives $2.5 Million from Medtronic for Independent Evaluation of rhBMP-2
Larry Husten, PHD
Responding to intense criticism from the government, the press, and the academic community, Medtronic announced that it was giving $2.5 million to Yale researchers to oversee independent reviews of the safety and effectiveness of rhBMP-2 (Infuse). Criticism of the spinal growth product was the sole topic of the June issue of the Spine Journal. Yale’s Harlan Krumholz (editor-in-chief of CardioExchange) will assemble a steering committee of 12 to 15 advisers and will commission two independent clinical research organizations to conduct the analyses.
Furthermore, Medtronic said it would place rhBMP-2’s clinical trial data on the ClinicalTrials.Gov website, including data from trials completed before September 2007, when publication on the site became mandatory. In addition, Krumholz will spearhead a novel initiative that will provide researchers with access to the complete patient-level data from clinical trials of the drug.
You can read more about the announcement in the Wall Street Journal, the New York Times, and the Milwaukee Journal Sentinel.
August 4th, 2011
Easy Come, Easy Go? ESC to Review Dronedarone’s Role in AF Guidelines
Larry Husten, PHD
Less than a year after speeding into the European Society of Cardiology’s atrial fibrillation guidelines with a class 1 recommendation, the role of dronedarone (Multaq, Sanofi) in the treatment of AF will be reconsidered.
“The ESC will produce a focused update of the AF Guidelines when the full results of PALLAS have been published and regulatory authorities have revised the labelling for dronedarone,” the ESC announced today.
Since the publication of the ESC guidelines last September, dronedarone has sparked concerns related to several cases of severe liver injury. Then the PALLAS trial was terminated early due to an increase in cardiovascular events in patients with permanent AF treated with dronedarone.
August 4th, 2011
Pfizer Wants to Market OTC Atorvastatin (Lipitor)
Larry Husten, PHD
Pfizer will attempt to gain FDA approval to sell atorvastatin (Lipitor) over-the-counter, according to a report by Peter Loftus in the Wall Street Journal. In the past, the FDA has turned down requests to market other statins over-the-counter. Lipitor is scheduled to go off patent in November, well before an OTC version of the drug could become available.
Many believe Pfizer faces a long upward climb with no assurance of success. But Loftus quotes an FDA spokesperson who states that “the agency is open to discussing OTC statins, as long as companies are ready to demonstrate that consumers will make the right decisions.”
The chair of an FDA advisory panel in 2008 that rejected OTC lovastatin explained that panel’s reasoning in an article in the New England Journal of Medicine.
August 3rd, 2011
Recommended Reading: A Critical (and Funny) View of Antioxidants
Larry Husten, PHD
“Antioxidants don’t work, but no one wants to hear it,” writes Kent Sepkowitz, an infectious diseases specialist at Memorial Sloan-Kettering, in Slate. Sepkowitz reviews the sparse scientific knowledge about antioxidants and then discusses the difficulties faced by physicians who “were slow to jump onto the antioxidant bandwagon and are slower still to jump off.”
“Few medical remedies have a more sterling reputation” than antioxidants, he writes, but
there is a wee small problem in our ongoing anti-oxidize-athon: As it turns out, we have no evidence that antioxidants are beneficial in humans. (Though if you’re a Sprague-Dawley rat, there’s hope.)
Sepkowitz explains to Slate readers that a free radical isn’t “a fiery Berkeley politico” and observes that if physicians try to warn their patients about the lack of evidence “it’s like we’re denying the benefits of sunshine and fresh air.” Citing evidence is fruitless, he says:
…double-blinded medical studies are counterbalanced, in America, by a parallel system of peer review in the form of a nonstop confab of health-themed talk shows, print magazines, and blogs.
August 1st, 2011
A Set of Calculators for Estimating Readmission Risk
Harlan M. Krumholz, MD, SM
If you are interested in a tool that estimates the readmission risk of a patient who has been hospitalized for acute myocardial infarction, heart failure, or pneumonia, you can find one at www.readmissionscore.org.
Readmission rates are increasingly a focus of quality-of-care efforts in the U.S., including those initiated by the Centers for Medicare and Medicaid Services, such as the work my colleagues and I do at the Yale-New Haven Hospital Center for Outcomes Research and Evaluation. To validate models that had been based on administrative codes, we developed models using medical records information. These models do a good job of predicting readmission risk, but they were not developed for the specific purpose of creating the tool you’ll find at readmissionscore.org.
So here are a few things to bear in mind as you use our risk calculators to help a patient make the transition from the hospital to home:
1. The calculators provide an estimate of risk, not a pinpointed assessment of it.
2. The calculators assume that the performance of the treating hospital is average in terms of readmission rates. Hospitals that perform better or worse than average may have readmission rates that differ accordingly.
3. When we developed our models, we did not seek to limit the number of variables (as the calculators do) or to include information about in-hospital adverse events. The models were intended to calculate risk using all of the information about the patient’s condition upon presentation to the hospital — that’s because they were assessing hospital quality, and we did not want to adjust for complications. Therefore, you should consider factors that may be important but are not included in the tool. I am hopeful that future calculators may improve over time.
4. The calculators do not say how to use the estimates. That’s up to you. It may be that high-risk patients (e.g., >30% chance of readmission within 30 days) would merit additional services to support the transition to home. Whether — and how — this information will improve care are questions that remain to be answered. Our hope is that we can work together with clinicians and other health care professionals who try this tool to ultimately determine how best to use it in practice.
5. We eventually want to turn these calculators into a mobile app. Because, unfortunately, the programming is expensive, we may decide to charge a modest amount to offset the costs. On the web, though, you can use the calculators for free. All the information we used to create them is in the public domain. We will be deciding about the mobile apps in the next couple of weeks. If you have an opinion, be sure to make a comment below.
Please make use of these free calculators as we all work to reduce readmission rates. And tell me: Is the tool helpful? How can it best be used to benefit patients?
August 1st, 2011
Moderate Exercise Delivers the Biggest Bang for the Buck
Larry Husten, PHD
Although the beneficial effects of physical activity in lowering risk for coronary heart disease (CHD) have been long recognized, the relative benefits of different levels of activity are not well understood. Now, a meta-analysis published in Circulation helps fill this significant gap.
Jacob Sattelmair and colleagues identified nine studies that provided quantitative data about the effects of leisure-time physical activity. They found, when compared to people who did not exercise:
- a 14% lower risk for CHD ( (RR 0.86; CI 0.77-0.96) among people who exercised 150 min/wk.
- a 20% lower risk for CHD ( (RR 0.80; CI 0.74-0.88) among people who exercised 300 min/wk.
People who exercised more than 300 min/wk enjoyed only a modest further decrease in risk. Women appeared to benefit more than men (p=0.03 for interaction by sex).
These results, write the authors, suggest “that the biggest bang for the buck for coronary heart disease risk
reduction occurs at the lower end of the activity spectrum: very modest, achievable levels of physical activity.”
“The overall findings of the study corroborate federal guidelines – even a little bit of exercise is good, but more is better – 150 minutes of exercise per week is beneficial, 300 minutes per week will give even more benefits,” said Sattelmair, in a press release issued by the AHA.
August 1st, 2011
Going Beyond COURAGE: NHLBI Funds the ISCHEMIA Study
Larry Husten, PHD
The NHLBI has awarded an $84 million grant to fund the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA). The trial will randomize 8,000 patients with stable ischemic heart disease and moderate-to-severe ischemia. Two different treatment strategies will be compared:
- An invasive strategy, consisting of early routine cardiac catheterization followed by revascularization plus optimal medical therapy (OMT) and lifestyle changes.
- A conservative strategy of OMT and lifestyle changes in which invasive procedures will be performed only after failure of OMT.
In addition, ISCHEMIA will assess whether the invasive strategy is better able to improve angina-related quality of life.
NYU’s Judith Hochman is the study chair.
July 29th, 2011
Controversial IOM Report Highly Critical of 510(k) Process
Larry Husten, PHD
The Institute of Medicine (IOM) has released a report highly critical of the FDA’s 510(k) medical device clearance process and called on the FDA to develop “a new framework that used both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices.” The IOM said the current process is unable to provide “a reliable premarket screen of the safety and effectiveness” of these devices.
The FDA’s director of the Center for Devices and Radiological Health said in a press release that “the 510(k) process should not be eliminated” but also said that the FDA was “open to additional proposals and approaches for continued improvement of our device review programs.” The IOM report had originally been commissioned by the FDA.
As reported earlier this week in the New York Times, the IOM report was the subject of a preemptive attack by the medical device industry before the report was even released. AdvaMed, the medical device industry association, released a statement rejecting the conclusions of the report, saying they “do not deserve serious consideration.”
Additional Resources:
July 29th, 2011
Less May Be More, But Stents Are Neither Good Nor Bad
Larry Husten, PHD
A few days ago, the distinguished healthcare writer Shannon Brownlee wrote a provocative blog post about the overuse of stents. A key piece of evidence that she used was a paper co-authored by Grace Lin and Rita Redberg, in which focus groups of cardiologists cheerfully admitted that they would give stents to hypothetical patients who were, according to the current guidelines, not eligible for stents. Here’s a paragraph from her post:
The really unsettling part of Lin and Redberg’s paper? The conversation they quote among the cardiologists from one of the focus groups that suggests that once a patient is in their clutches, he or she is going to get a procedure. One cardiologist says, “There’s no chance of escaping.” Another responds, “That’s the end of it. He [the patient] is not going to get out […] without a stent.”
But when I looked at the original Archives paper, I saw that it had been published in 2007. I follow cardiology fairly closely, and it’s my impression that much, but certainly not everything, has changed since 2007, which happened to be a very important year for cardiology: several months before the Archives paper was published, the groundbreaking COURAGE trial was published in the New England Journal of Medicine.
COURAGE provoked a long and complex debate in the cardiology world. This debate is by no means over, but it is fair to say that almost no one doubts the main conclusion of the trial today, which is that stents are no better than optimal medical therapy (drugs and lifestyle changes) in people with stable chronic angina for delivering important long-term health benefits, like reducing death, heart attacks, or other adverse cardiovascular events.
COURAGE provided the intellectual basis for a less aggressive approach to interventions. One Wall Street analyst who follows the stent market told me that PCI volume dropped about 10% in the year after COURAGE. Now that may not sound like a lot, but since non-urgent PCI for stable angina composes about 40% of the market, the 10% overall drop likely translates to a 25% reduction in non-urgent, elective procedures, which is where the overuse was most likely to occur.
And then the Mark Midei case came along.
As the magnitude and implications of the case filtered through the cardiology community (and as other similar cases appeared, along with numerous lawsuits and government investigations), the culture of cardiology began to change even more. I don’t know what the numbers are now, but it’s clear that interventional cardiologists as a group are aware that they are subject to far more scrutiny than they were in the past. I would imagine that the voices coming out of a focus group today would sound very different than those cynical voices in 2007.
I certainly don’t want to leave the impression that I believe there are no remaining serious problems in interventional cardiology. A recent study in JAMA provided perhaps our best look yet at this issue. A nuanced view of this study in context suggests that overuse of stents remains a problem, but that much progress has been made. No doubt the overwhelming influence of industry on physicians, journals, and medical culture in general remains a serious problem, and no doubt interventional cardiologists, like everyone else (except journalists), will find ways to justify behaviors that align so neatly with financial rewards. But it is a mistake to say that the situation in 2011 is the same as the situation in 2007.
Less Is More
One more point about Brownlee’s post. She defends the “Less Is More” series in Archives of Internal Medicine, which, it turns out, is supported by a $50,000 grant from a small nonprofit organization, the Parsemus Foundation. The president of the foundation is Elaine Lissner, who became interested in the topic when she consulted Redberg, a cardiologist who is now the editor of Archives, after her father was scheduled to receive an angiogram. (He skipped the angiogram and is doing well today.) Writes Brownlee:
Apparently, this donation is not sitting well with some cardiologists. Lissner’s experience and the donation from the Parsemus Foundation appeared in a story in TheHeart.org, an online source of information for cardiologists published by WebMD. The story quotes Arjay Kirtane, a cardiologist at Columbia University, in New York, who takes offense at the idea of a medical journal taking money from a foundation that has the gall to suggest that there’s a lot of unnecessary cardiology procedures being done, that maybe cardiologists are doing things to patients they shouldn’t.
Brownlee dismisses Kirtane’s response:
C’mon. According to two recent papers, about 1 in 8 angioplasties and stents done in the U.S. are performed on inappropriate patients – patients who by cardiologists’ own studies and by their own guidelines don’t stand a ghost of a chance of benefiting from the procedure, but who are nevertheless exposed to its risks. Those risks aren’t high, but they’re serious, including heart attack, stroke and death. Not to mention the fact that we’re spending more than $3 billion a year (that’s billion with a B) on those unnecessary procedures.
I think Brownlee oversteps here, at least a bit. Given the tidal shift in recent years toward full disclosure of conflicts of interest, it only seems fair to insist that Archives play by the same rules. Perhaps it didn’t want to publicize the fact that, as reported in the story on TheHeart.Org,
the wording about the angioplasty initiative on the Parsemus Foundation website changed in the last year: while they now support ending “inappropriate angioplasty use,” the former title of this effort was known as the “antiangioplasty project.”
So here’s the danger: It’s one thing to raise concerns about “inappropriate angioplasty use,” it’s another thing entirely to become aligned with medical Luddites who stand against one of the most important advances in modern medicine, even with all its real faults. I’m a big fan of “less is more,” both the concept and the Archives series, but the ideal of “less is more” is betrayed by the lack of disclosure of financial support and the crude partisan tone of the term “antiangioplasty project.”
By itself, angioplasty isn’t “good” or “bad.” A well-performed procedure in a properly selected and educated patient is one of the miracles of modern medicine, and should be celebrated as such. In contrast are procedures performed in poorly selected and educated patients, either out of pure greed or out of the overweening self-delusion of the physician who thinks he can heal the world. A balanced view of the picture needs to encompass both perspectives.