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 in 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 cardiologist 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 towards 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.
Interesting post, Larry. But let’s not take aim at those “medical Luddites” who are sounding alarm bells about medically unnecessary procedures. Such cautionary warnings are after all unlikely to come from those who stand to gain by continuing these procedures, and to dismiss critics as Luddites is facile and – more importantly – it misses the point.
The frightening reality is that cardiology is not alone in reporting cases of such questionable procedures.The stent-happy Mark Mideis of the world are joined by neurosurgeons like Oregon’s Dr. Vishal James Makker, whose rates of repeat spine surgeries (up to seven spinal operations on the same patient) came under fire because his rates were TEN TIMES higher than the national average for spine surgeons. ( More on this at http://ethicalnag.org/2011/06/28/makker-conflict-of-interest/ )
We also have the Joseph Biedermans of the psychiatric world, on the take for millions of dollars from Big Pharma (and finally after two years of “investigating” Dr. B’s undisclosed profits, Harvard has issued its disciplinary ruling for a man who’s considered the poster boy for industry conflict-of-interest financial gain).
And we have Merck’s wholly owned made-up front called The Bone Density Institute, a brilliant marketing strategy designed to increase sales of its Fosamax osteoporosis drug by promoting osteopenia from a health informatics term up to a full-fledged disease that requires daily doses of Fosamax if enough physicians and ‘Ask Your Doctor’- educated patients can be convinced to embrace it.
The list is endless. As merely a dull-witted heart attack survivor (and coincidentally, also a “stentee” – is there such a word?) I for one applaud the “medical Luddites” who dare to suggest that the way things are need to change.
Carolyn, I don’t think the cases you mention should be ignored or downplayed, but they also should not be used to justify a Luddite perspective. It’s important to see all sides of an issue and not get trapped by partisanship into a narrow and limited view of the world.
A friend who is a noninvasive cardiologist sent the following email to me, which he gave me permission to repost here as a comment:
As a noninvasive cardiology dude and a fairly keen observer, I think that your estimates are correct (and your math impeccable). But there’s a process to be thought out. Most of the inappropriate procedures are elective. Many of these patients are referred by cardiologists like me (but not me, for the most part) or by internists or FPs. These procedures will never cease unless there is regulation, as interventionalists are reluctant to turn away such patients for fear or cutting off their referrals. Then there’s the malpractice issue, which probably accounts for 75% of the referrals in the first place and 75% of the interventionalists’ actions. When faced with this, the guidelines tend to fall apart, as a small (but soon-to-be-angry) group will have an event in the next year or two. One is in a much better place legally with the tact that “I did everything I could” rather than “the guidelines said that he should have done well without a procedure”. One can easily find an expert to contradict the guidelines, and it boils down to credibility. It’s the same argument that drives up costs when grandma’s in the ICU with little time left either way, just the stakes are way higher when it’s a 60 year old. If you want to cut unnecessary procedures, provide malpractice protection for following established standards of care.
I had a problem when I stood up from sitting down I would get light headed. I couldn’t do nothing because I had no energy. I went to family doctor and she sent me to the cardiologists. He took my blood pressure sitting down and then had me stand up and my blood pressure would drop about 30 points. I sat down and he left the room.A short time he came back and told me I need to go to the General Hospital which is the heart hospital, the doctors will be waiting for me. I arrived,they took me in for I don’t know what is going on yet. Finally they told me they were checking my heart artery’s and if there is any problems they would correct them while they are there. The RCA was blocked and it took three stents to fix it. I stayed over nite. Two weeks have gone by and I have a pain in my left side and the doctors tell me I must of strained my self. It doesn’t feel like a muscle hurting. I’m hoping it is something left over from surgery and it will heal.