Shifting the paradigm: Vikas Saini

Below is Dr. Vikas Saini’s speech from the Avoiding Avoidable Care conference.

What a pleasure to see you all here today. Welcome!

I think it is fair to say that there is near unanimity across society and across the political spectrum that American healthcare is seriously broken. We have a system that undertreats large numbers of people who need more and better care, and overtreats equally large numbers of people with ill-considered, wasteful, unnecessary care. These are really two sides of the same coin.

Now, for the first time that I am aware of, we will be devoting most of our attention in the next two days to the second side of that coin.

It’s been quite some time getting to this point. I reached out to Shannon over a year and half ago after reading Overtreated, a remarkable book that was congruent with what I had come to believe. After a series of conversations we began working on this conference. We were aiming for 40 to 50 people at most, but were resigned to the possibility of having 10 or 20 show up. We thought we would have relatively frank conversations about serious matters in health care that don’t often get an airing either in public or in medical meetings. Critically, we were fortunate to get the initial unhesitating moral support from Harvey Feinberg at the Institute of Medicine. With the IOM’s willingness to co-host the meeting, we started putting this together.

Since then the topic has rocketed into visibility around the country and it seems clear that something is brewing. The question is what?

Now I’m not an idiot. For many powerful people, solving the health care crisis is about the money. But for doctors it has to be about how we can take care of our patients as we seek a system that’s also affordable. As we conducted our preparatory conference calls, a lot of important ideas emerged.

We also did a survey of attendees, and those results are also interesting. As soon as we can figure out the best way to get them to you, we will.

Let me share some of the questions that emerged.

The first question to emerge was should we be spending all this time outlining the problem? Isn’t it obvious?

Isn’t it more important to get more people on board and plan for something concrete?

Isn’t the main issue the need for doctors to become activists in their own institutions?

What are we going to say about the issue of malpractice, because that is the topic that generates the most pushback from our colleagues.

Why should we focus on the role of clinicians when the biggest forces distorting the system and promoting overtreatment are drug and device companies and the profit oriented sectors of health care?

In the rush to global payments how do we avoid the opposite risk of undertreatment? Can any payment system really fix these twin problems?

Are we a movement or do we need to become a movement?

These are just a few.

And from the survey it seems clear that most of you believe that payment systems matter and that these are drivers of physician habits and culture. Hence the majority here support the concept of Primary Care driven ACO’s.

We are always told by management gurus that successful meetings need to have clear goals and clear measures of success.

So how will we measure success here? What do we do the day after? More meetings of the newly persuaded? A new professional society? A new journal? New laws?

Well, I have bad news for you: Shannon and I have met our goals and measured our success. You are all here.

So see ya at the cocktail hour.

We are asking you to consider what, if anything, you want to accomplish here and what your goals are after you leave this meeting. It will be necessarily provisional. We can’t tell you what comes next.

We knew we needed these 2 days of discussion and debate to be able to see the next part of the road. And we do believe that we will see enough ahead, and gain enough consensus that we’ll want to move forward together.

I’d like to fast forward for a minute to the most important session we are having, the last one, about the role of patients and purchasers. It’s really why we are here. I had a long conversation with Gerry Shea of the AFL-CIO ahead of this meeting who said that over the last year his membership has been hammered by the loss of healthcare benefits, along with rising costs, increasing copayments and deductibles. Many unions are finding themselves in the unfamiliar role of purchasers of health care services. You’ll hear some very interesting experiences from Betsy Gilbertson in her role as a benefits manager of the Hotel and Restaurant Worker’s Union in Las Vegas, which does self insurance. Their work in utilization review had a direct material impact in supporting the wages of low income workers who were struggling to get by. But beyond the economics, you’ll hear from Patty Skolnik about the serious issue of harms generated by unnecessary care. A sober reminder that this issue is about quality and about our duty of care to our patients.

At this point I really need to disclose a serious conflict of interest of mine:

I’m Canadian. I went to medical school in Canada where about a third of the faculty was British, a third was Canadian and a third was American. It was a remarkably sane combination.

As you know, Canada is a country that could have had French culture, British government, and American technology but instead has French government, American culture and British technology. It’s sad, really.

When I arrived in the United States for residency training I was dazzled by American doctors. They had all read and could cite endless amounts of the literature – moreover, the literature was always wrong and they were always right. I thought I’d arrived in a Mecca of medical genius. No, really – that was my first impression – doctors here seemed like data entrepreneurs, with a sense that the data is always contestable, that there really is no sense of ground reality for what’s known and what’s not known until we decide for ourselves. In the ivory towers of Harvard and Hopkins, that’s an exhilarating, potent brew, especially for a young person. In Canada, by contrast, there was a greater sense of what is firmly settled and what is not, and the difference between the two.

So there you have it, in a simple snapshot, one central issue, culture.

And I’d like to suggest that the culture of overtreatment is spreading far and wide — in McAllen, Texas and across the entire globe.

Our goals today are to focus intensely on the multiple dimensions that constitute this problem we’re calling overtreatment or avoidable care or unnecessary care. We can debate the term, and the definition. We certainly want to discuss the drivers. But most importantly of all I would ask you to check our own assumptions and presuppositions and to challenge them as much as possible. I think this is incredibly important if we are going to move forward in our understanding. I say this not for some moralistic impulse for self-improvement – but for a very practical reason.

I believe we have entered a period of a major paradigm shift in medicine, and that this period will be full of seeming contradictions. And our own thinking will necessarily be an oscillating mixture of competing paradigms, old and new.

And that will likely generate many puzzling riddles that are not easy to solve.

If I’m right, then mere logic won’t get us there, because any frame shift will require reference to principles external our particular system of logic (that’s my cheap version of Godel’s theorem). But we’ll skip an exegesis of Thomas Kuhn and the structure of scientific revolutions.

For us in medicine, I’d like to suggest that after the last hundred years, the Flexnerian worship of a reductionist science is getting mighty old. We’ve deconstructed the human being into a billion parts – and now hope that computers can put Humpty Dumpty back together again for us. And we keep looking for the silver bullets of drugs or devices to solve the core problem that we are mortal and suffer. And we want to imagine we can cure or prevent our way out of our cost problem. But for us as human beings isn’t the logical unit of analysis the whole human being? To be sure, that human being is enmeshed in interacting networks of families, communities and societies, as well as networks of physiology, cellular and subcellular processes.

A simple recent example: A study proclaimed last week that a thousand genes are turned on and off as the social status of rhesus monkeys changes. Certainly fascinating. But then the lead scientist was quoted as saying “the genes had an 80% accuracy in predicting social status”. And I found myself asking: doesn’t that mean that by ignoring the genes and simply observing the whole animal we would be 100% accurate?

In thinking about paradigm shifts, we can easily encounter many contradictions. These can be worth exploring.

I’d like to offer three riddles:

When is Evidence-based medicine useless?

Evidence based medicine – we espouse it, and want it, but operate in an environment where it is scant. The experience of the Lown group may be instructive here.

When is Patient centered care not a good thing?

We similarly espouse patient centered care, but patients are as much a part of the culture of overtreatment as are doctors, though in my view they’ve been trained to be so by a system short on time to talk and long on product to sell

And how can real reform happen in the practice of medicine when reform is not in the interests of the practitioners themselves? Many of us advocate for maintaining the integrity and autonomy of the medical profession in the midst of health care delivery reform – but many physicians are seriously conflicted. Putting it another way, the health system can’t change without MDs but do enough MD’s have any interest in change?

And a final riddle: seemingly immutable systems do change, and sometimes quite quickly. How?

How do paradigms shift, and is it possible for individuals or groups to accelerate that?

So we have some issues to grapple with.

Now let me tell you some stories. I trained with Bernard Lown here in Boston, at the Brigham. Before I came, as an intern at Hopkins on the City Hospital service I swapped into 6 months of every other night call in the CCU because I loved the drama and because the technology was cool and because I was 26. I remember getting chewed out by my attending one morning on rounds for not putting in a Swan-Ganz catheter in somebody with an MI and heart failure who I managed medically quite successfully simply by staying up and listening to his lungs every hour through the night. And I felt kind of sheepish and a little guilty thinking I had been lazy and done the patient a disservice. Meeting Bernard Lown was therefore a revelation – a quantum leap which offered a new frame of reference for my inner laziness by showing me how much thought and energy it takes not to do things to patients.

What I discovered, like most Lown fellows did, was that I really found myself as a doctor for the first time. What a delight to find you needed to be reading novels, and history and philosophy to participate effectively on rounds.

There was and is a unique culture here that made all the difference. On his blog, Dr. Lown has a recent post in which he outlines the origin of his approach to coronary disease in the late 1970’s. It’s well worth a look. Maybe he’s going to talk about it tomorrow.

But here is the riddle about evidence:

He and others around the country came to certain conclusions about the utility of coronary bypass surgery well before the randomized trials such as CASS and others. Similarly with stents, where we also had a clear view. Yet that view emerged when we didn’t really have any randomized trials, and our approach seemed positively medieval to some. Here we were (and are) being just like those American doctors I encountered on arrival, arrogantly doubting what seemed settled for everyone else. Were we wrong before and then retroactively become right after the randomized trial? Or is there another frame for thinking about evidence besides the randomized trial?

I can tell you that when the first study from Lown on the medical management of coronary disease was published in the New England Journal of Medicine showing remarkably good outcomes in patients with clear-cut multivessel CAD, the reaction was skeptical disbelief – you know – “they weren’t all catheterized” or “they’re a highly selected special subpopulation” or this or that criticism; criticisms which were all very true. The same was true when our second opinion studies were first published, in which we found that remarkably high numbers of people did not need bypass surgery and were managed without it in our hands. How high? Over 80% — so astonishingly high that serous emotional reactions erupted or just plain denial ensued. Again, the criticism of selection bias was impossible to refute.

But boy, did it miss the obvious forest for the trees: we showed that such results were in fact biologically possible. (and possible in a fee for service world, I might add, for those who think that culture only grows from payment mechanisms).

We are currently looking at our very long-term outcomes – more than a decade of follow-up. And what we’re finding is that rates of revascularization, nonfatal MI and long-term mortality are not much different from what was seen in the recent large randomized trials, the COURAGE study, and BARI 2-D trial, both of which showed that aggressive medical management of stable CAD yields similar results to those we’ve been reporting for 20 years. So actually it turns out that we at Lown are really not that special, we didn’t have some magical shaman’s potion, we just had a different culture and a different frame of reference.

So what really is required for meaningful evidence? If large RCT’s are the gold standard for evidence based medicine, but RCT’s are done 20 years after the technology is deployed, do we remain silent waiting for perfection?

What do we do about the dark matter of evidence-based medicine? Are we condemned like the drunk in the old joke? He lost his keys elsewhere but is looking under the lamppost because that’s where the light is? What questions never get asked or answered or funded because there’s no strong vested interest pushing hard to ask, or to answer or to get funded? And in the midst of a paradigm shift where peer review is not stable is the public interest served? Isn’t it a complete multi-billion dollar scandal that it took 30 years to get large randomized trials of the Swan-Ganz catheter, or bypass surgery, or stenting?

Equally important is that when the trials are done who frames the results? Something I hope we will talk about with our panel from the medical journals.

In our survey of your opinions, not one person had faith in professional guidelines as the sole solution to avoidable care. So I truly am preaching to the converted when I tell you that the Lown Foundation is now looking at appropriate use criteria to see how they would have affected the patients we managed over the past 2 decades and how they might help us refine our approach. We’re finding that at least half, if not two thirds of our patients, patients we’ve successfully managed medically, would be considered, even today, to be perfectly appropriate for surgery or stenting.

But when we examine those criteria closely, they fit within the paradigm of a prior system of thinking. They import a lot of the same problems and flaws – the view of arteries as passive plumbing, built-in presumptions that are unsupported, or sometimes actually contradicted by more recent evidence.

The paradox is that I think all of us — I hope all of us — would agree that we want the practice of medicine to be based on evidence, to be based on science. But to me evidence-based medicine seems to be like What Gandhi said when asked what he thought about Western Civilization: “I think it would be a good idea”

Part of our challenge today is to grapple with these issues. Most importantly for our purposes, when paradigms are shifting, we should be aware that the interpretation of the evidence will always be seriously contested.

The second riddle is around the phrase patient-centered care. I think many of us in the room believe that the patient is, or should be, at the center of our gravitational system. But what does that mean concretely? Putting the patient first has too often become a meaningless, empty phrase – like putting vitamins into sugar-sweetened beverages and calling them healthy. As we all know, quite often the patient is the last person to be in the loop. That is in many ways as deep a systemic problem as the problem of avoidable care. In fact one could argue, as I suspect many of you might, that the solution to the problem of avoidable care is impossible without firmly putting the patient really at the center of things. But that’s not a statement about evidence-based science – that’s a statement of a first principle, grounded in something besides scientific logic. But maybe that’s more important than payment reform. But what do we do for all the many grey areas where the patient wants to chase an outcome which is low probability, for the sake of his or her own peace of mind

We won’t always have all the evidence, but we will still need to forge ahead; we’ll sometimes be tripped up by the old way of thinking, for example waiting for the right comparative effectiveness research to get funded and get done and get analyzed and get disseminated instead of moving forward with simple common sense using what we already know.

At some point we have to recognize rearguard actions for what they are: running out the clock while conducting business as usual. When professional reputations and academic prestige and billions and billions of dollars are on the line, everything will be contested, usually with more noise than light. At those points we have to ask ourselves even tougher questions: who gets to declare when evidence is enough; who gets to decide that something labeled as patient-centered care is not in fact patient friendly; because fundamentally that is going to be the question that emerges as we continue this dialogue and deepen it and take it to our colleagues.

So our charge to you is to answer these riddles and help us all grow a new culture and a new way of looking at patients. And when we do, we must acknoweldge the significant, multiple layers of conflicts of interest within the healthcare system — regardless of the payment method. This applies to big hospitals and integrated delivery systems, large medical groups, high volume procedure oriented specialties like cardiology, the structures of organized medicine and our medical journals.

We’ve been ecumenical in our invitations: this is not a meeting about ACO’s; this is not a meeting about pay-for-performance or single-payer; this is not a meeting about the ethics of rationing; it’s really not even a meeting about overtreatment or avoidable care as much as it is about the forces and biases and cognitive frames that lead to the staggering, absolutely staggering amount of unnecessary care in the US today.

But I also know that that we human beings are remarkable, and we have a remarkable group of them here in the room today, all of you. Margaret Mead famously said:

“Never doubt that a small group of thoughtful, committed, citizens can change the world. Indeed, it is the only thing that ever has.”

So we have a lot to talk about. I certainly am quite humbled by the assembly of talent here. I can’t tell you how much satisfaction and pleasure I’ve had in listening to our moderators and panelists as we’ve been preparing for this meeting. All of them bring a passion, an intelligence and a serious moral commitment to taking care of people the right way. What I’ve witnessed so far leads me to be very optimistic that this problem can be solved.

On these questions I believe doctors should unite to focus on what really needs to be talked about: what’s best for patients, what’s best for our communities, and what’s best for our calling as a profession.

Thank you all for being here.

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