Thursday, March 6, 200

Session 1: The American Health Care Predicament

David Mechanic, Ph.D .
Institute for Health, Health Care Policy, and Aging Research Rutgers University

Good morning officially. The first act of all of the meetings of the Council is to recognize the presence of our official government representative, our Executive Director, whom all of you know by this time, Dr. Daniel Davis . His presence makes our meeting an official governmental activity.

Thank you, Paul , for joining us. Good to have you with us.

DR. McHUGH : It's good to be here.

CHAIRMAN PELLEGRINO : This morning's session will be devoted to a topic, one of three which will make up the agenda for the next day and a half. The first topic we will address is the topic we've visited before and will be visiting this time from a different perspective, and that is the topic of health and medical care and its status in the United States and particularly from the point of view of whatever ethical issues may be involved which is consistent with the charge and charter of the Council.

We will also have tomorrow a brief bringing us up-to-date on one of the projects we're involved in but have not yet completed, and that is newborn screening. And then the final session will be a colloquium on the recently issued volume on human dignity.

Before I introduce the speakers, let me say that they are all distinguished scholars, persons, in their own disciplines and in other ways as well. Were we to read the curriculum of each and every one of them, it would consume most of the time, and I suspect the speakers themselves would rather have a little more time for their own conversation, and I think we would appreciate that ourselves as well. So I hope they will understand and the audience will understand why we do not give lengthy introductions.

Our first speaker is Dr. David Mechanic , and in very slight violation of what I just have said, I've known David for many years. He has distinguished himself in many ways and certainly has worried about, thought about, and been critical in his thinking about the health care system in the United States . He's an eminent scholar in his field.

David , without saying much further, lest I cut into your time, we welcome you and look forward to your remarks.

PROF. MECHANIC: Thank you. I have a lot of sympathy with many of my friends in medicine and in health policy who are very concerned with the growing corporation of medical care, the growth of very, very large for-profit corporations that now play such a pervasive part and which have, we think, I would say, a rather major share in creating some of the problems we now face as well as eroding the professionalization of medicine, and I see that as sort of a major background problem.

Unlike some of my friends who write about this and worry about this a lot, I personally don't see that there is much attraction in trying to fight against the for-profit nature of American medicine. I find it difficult to believe that that's going to change, just as I think it's very difficult to fight against the globalization of economies. And so my approach is to try and seek solutions within the context of some of these forces which I may not see as particularly valuable in the development of medicine, but, in fact, I see as persisting well into the future and not going away.

Let me first start with some of the broader questions that define the way in which we think about health care. And, clearly, one of my strong assumptions and beliefs is that our system is very much conditioned by our value system, our ideas, our beliefs and so on. And it's not a failure of understanding how to provide health care reform or to provide a decent health care system that serves everyone.

Most developed countries around the world have found a way. There's no one way. There are many different ways to accomplish that task. But basically the barriers to reform come, not from a lack of intelligence or a lack of know-how, but rather from a clash in values and beliefs which result in gridlock in trying to produce necessary and valuable reforms.

Underlying that is, of course, a very strong difference among peoples and governments and populations between those, the value in individualism, which, of course, is very strong in this country, and a sense of social solidarity and cohesiveness of society. And people are much less likely in our context when they discuss policy to ask the question, "What do we owe to each other?"

I've spent some time participating in policy discussions in European countries. I've spent a couple of years working in the National Health Service in England, and it's very unusual to hear, to participate, in a health discussion in those countries and not have one of the considerations that come up in talking about changes and reforms as to what that will contribute or take away from the idea of social solidarity in that country. I can't say that I've ever heard a discussion of that kind in American policy forums that I've participated in, and I think that makes us in many ways different from many other populations.

A second very big question, and one which I think we're increasingly beginning to think about and address, is the difference between treating sick people when they're sick and seeking interventions at a population level to prevent illness on a larger scale. We obviously do spend vast resources in trying to treat people when they're sick, but we give much less emphasis to the idea of finding ways of promoting population health in the larger sense. Now there is a dilemma here because when people are sick they feel very strong about health care and they want health care and the best health care when they're sick. But when you talk about population health, the probability that any individual person will benefit is relatively small compared with the benefit that's provided when one is sick. So there's much less political demand for population health change as compared with individual improvements in treatment, improvements in medical technology, and things of that sort.

Third, we are in a situation in our country abetted by many claims by individuals, which I think are faulty, that we can have it all, that everything possible can be made available to people when they have the need for medical care. And we do a bad job, I think, of reconciling what are reasonable investments in medical resources with medical demand. We find it very difficult to talk about what fair limits might be and how to set fair limits.

In other countries, if you go to the Scandinavian countries or you go to other European countries, people are quite willing to talk quite seriously about rationing. As you know in our context, "rationing" is a dirty word. And if a politician, god forbid, would mention rationing, that politician would be very much burdened politically by taking the position on that particular point of view.

We obviously have an ideological divide between the market and planned care. We have very strong market advocates who believe that we could treat medicine very much like any other market product. And through having a more competitive market, we can solve some of our problems. I happen to believe that that's an illusion. But in any case, there are intelligent people and people who feel very strongly that that is the way we could go.

We are a country in which we very much value choice, and I share that value of choice. But the issue is, how much choice? We are learning increasingly that too much choice basically is very difficult for people. People who have too many choices, in a sense, will withdraw and not make choices because they are puzzled and don't really understand how to choose among too many choices. So perhaps we have to have conditioned choice and can do much better by conditioning choice than by making every possibility open to people who find it very impossible to evaluate those different possibilities against one another.

We also live in a context where we increasingly medicalize almost every social problem, every sense of distress, and so on. There's a lot of money to be made by medicalizing social problems. The pharmaceutical companies would like to see more and more indications for use of their drugs. So there's a lot of momentum to encourage this. But it seems to me that one has to set some boundaries as to what medical care is as compared with the vicissitudes of everyday life and what kinds of things are reasonable to pay for and what kinds of things might be less reasonable to pay for.

And all this takes place in a context where there is an erosion of trust, erosion of trust in all of our institutions. There's an erosion of trust in medical leaders in particular and medical institutions, much less than in individual doctors. People still have a lot of trust in individual doctors, but they don't trust the health system and they don't trust the leaders of the health system.

At a lower level, we have various cultural influences which contribute to the great demand for medical care in this country. Americans repeatedly demonstrate a very, very strong belief in technological progress, a belief that we can solve most problems through technological advances. And, indeed, we are a very innovative country. I mean, we are technologically very, very impressive. In medicine we do some very, very impressive things. And when used properly, they contribute a great deal to the value of life and health.

Secondly, Americans are very active. They believe that, if there is a problem, there's an answer to a problem and one should vigorously seek that answer. In the case of medical care, that means that people want things done and insist on things done even if the evidence is lacking that those things are efficacious.

And it's quite interesting. In all the studies I've ever done, as many others have found, that when you talk to people about provision of services, people have much greater distrust about something being kept from them that may potentially be useful or valuable or something they want and much less distrust about over-provision of services which may be of little value and may harm them and so on. So we have a real bias toward doing something, whatever the case might be, and perhaps not enough skepticism about doing things which offer little value.

We are individualistic, as I said, and we want lots of choices, as I noted, and we live in an environment where consumerism and marketing, entrepreneurial marketing, exacerbate that increasingly with the direct-to-consumer advertising of pharmaceuticals and medical devices. That tends to get more and more exaggerated, get more and more — mobilize more and more patients to demand things they may or may not need. And as a consequence we have a situation where physicians feel terribly burdened by patients demanding things which the physicians don't believe they need or would benefit from but where the pressures are such that they accede to these demands.

I won't dwell on these things because you all really have heard about these over and over again, I'm sure. We have growing health care costs. We've never been able to quite rein them in given the nature of the health care system. The growth and costs in Medicare and Medicaid are persistent and will get worse over time. And this is not driven by people demanding more and more services, but really driven by technological innovation using more and more expensive kinds of innovations, by using more and more expensive drugs, drugs which may cost $80,000 or $100,000 a year to advance life by a month or something for a patient with, let's say, end-stage cancer. So there are these uncontrollable costs, and we really haven't figured out any reasonable way of dealing with that. So costs continue to grow far beyond the economy as a whole.

We've had a large erosion of our health insurance coverage with 47 million people uninsured. Study after study shows that the quality of care, despite our saying that we have the best care in the world, is rather poor and rather poor relative to many other European countries. So that — and I'll say a little bit more about that as I go on, but generally we do not do a very good job. And by any indicator of health that one measures across nationally, we do rather badly: infant mortality, adult mortality, various disease indices, and so on.

We have large race and class disparities in access and quality of care, which have been a growing concern. It's a very difficult problem. It's not easily addressed, but it is a problem that one would ideally like to deal with better than we do.

Of most disease, the most expensive disease is chronic disease. Generally, the studies show very poor management of chronic disease. We still are very much imbedded in an acute-care model and have difficulty developing the kinds of continuity and teams which make for a strong chronic disease care.

And unfortunately compared to countries that are a lot less wealthy and a lot less prepared than we are, we have been very slow in adapting and using the information technology, particularly the electronic health record and the various advantages it provides, which makes it much more difficult to deal with some of the problems we have to deal with in the future.

This is in great contrast, for example, to the Veterans Administration which has done a beautiful job in putting in a very sophisticated and very effective IT system; Kaiser-Permanente, which spent billions of dollars to put in a very sophisticated system; and other places like UK General Practice, which is a much less well-financed form of practice than we have in this country but where the typical general practitioner is wired and has access to many of the tools that American primary care doctors don't have access to.

There are lots of stresses. And, once again, I don't want to elaborate on these because I'm sure you're familiar with them. But it's worth just noting them in passing for our discussion.

Our system is set up in a way in terms of its incentives so there's very little incentive for strong preventive and early care approaches. We've had a very large erosion of primary care. Young physicians do not seek to be primary care doctors. They see that the hassles have increased and the remunerations are so much lower than for specialists and subspecialists. If you do invasive cardiology, you can make three times or four times what a good primary care doctor makes. And so our organizational arrangements and professional incentives are poorly aligned with our quality of care goals, the view that you really do need a strong primary care sector if you're going to adequately manage chronic disease and other kinds of problems on a longitudinal basis.

We have very unrealistic population expectations which are encouraged by the kind of entrepreneurial promotion I've talked about by direct-to-consumer advertising and the hype from the media. And many Americans, when they are sick or family members are sick, are not willing to accept limits. There is a real notion that when one is sick or when one's loved one is sick, nothing — there should be no barriers to any kind of care regardless of how little value it has relative to cost.

And ideally — and I think this is, I think, a very important point that deserves the Council's consideration and thought. Ideally, if we are going to sort of deal with these issues, we need a credible and legitimate agency to help on a neutral basis assess effectiveness and cost-effectiveness. We have lots of people doing it. There are lots of people writing practice guidelines and setting standards — professional societies, drug companies, many people who have a stake in the game — but what we need is a neutral source to provide really good scientific, valid assessments.

There are such organizations in other countries. There's a National Institute for Clinical Excellence in Britain . They've just changed their name. I think it's the National Institute for Health and Clinical Effectiveness. But we need an agency that is protected from political interference. We've had agencies in the past like the Agency for Healthcare Research and Quality which, when they tried to set standards for the treatment of back pain and so on, were attacked by the spine surgeons and almost eliminated as an agency. They lost much of their budget during that particular situation after they had studied and put out very good guidelines on the treatment of back pain. We had a technological — we had an institution in the government that evaluated new technologies. They, too, were attacked by various interested sources who didn't want an agency doing that.

And so the usual federal structure doesn't work for these kinds of agencies that will be subjected to great political attack and influence and we need a way in insulating such an agency. People have suggested that it be somewhat on the order of the Federal Reserve or something along those lines. That whole area needs a lot of thought and a lot of attention.

One of our large problems — and I understand you're going to be talking to Dr. Fisher . You'll hear more about this. But one of our large problems is that our technologies exceed our understanding of how one intervenes meaningfully, or, as Black and Welch have said, "We have a slippery slope of new technologies where, despite clinicians' best intentions, many patients have been labeled with diseases they do not really have. They may have been given therapy they do not really need."

We now have substantial empirical evidence that excessive care can lead to worse health rather than better health, and, on average, higher spending regions in the United States have lower quality of care, greater patient dissatisfaction, and higher mortality. And this is one of the arguments, one of the areas of research, that Dr. Fisher has been involved in with the Wennberg Group more generally and they have produced lots of data over time that support this basic argument.

One has to think of this, I think, theoretically in terms of where one intervenes most effectively and gets the most value for one's dollars. And if you think of this, on the left side of this curve, you have those activities, those medical activities, which are effective and cost-effective; that is, they provide lots of value for expenditure.

And then you have an area of uncertainty where, for some, physicians believe on the basis of clinical studies, not randomized-control studies, that there was medical worth. Other people are skeptical. But there is an open argument that — let me get some water, excuse me — there's an open argument that those things may have medical worth, although they might not be fully cost-effective. And you can argue that in a country as rich as ours we could afford some investment in those areas.

And then you have other areas which are wasteful and potentially counterproductive in that they do more harm than good. Economists of late have been talking about flat-of-the-curve expending, meaning that the spending yields no value for the added increments of input. However, it can also add negative value in that too much care of the wrong kind can do harm to people. And yet that kind of care many, in fact, be remunerative, be basically pushed through the advocates who have a stake in maximizing the use of such care.

Now it makes it particularly difficult, as very often the modalities, the technical modalities, that provide good important care when misused or overused provide some of this bad care. So it's not a clear case where you say, "This technology is not right or not good or not cost-effective." It's a case where you basically weigh, where you have to weigh the technology when it is properly used, when it is improperly used. And we see a lot of improper use of some of these technologies because of the economic incentives involved.

There's a gigantic growth of the use of CAT scans, for example. CAT scans could be a wonderful modality, life-saving in many instances. But when used inappropriately for every patient who walks in for every complaint, it obviously has little value and produces radiation which, when people have repeated CAT scans, don't need, and that radiation problem is also a large problem which has not been fully talked about.

This just gives you some examples from the two RAND studies. There are many, many studies of this kind where you had physicians setting standards for quality of care for people with different conditions. This is a very, very small sample. There are two papers in The New England Journal of Medicine that will give you many more examples, and you can see that the performance as measured by the standard set by these physician groups is very low. In all of these cases, both in the case of adults and children, less than half of the children were receiving indicated care for the particular problem involved.

So the problem is not only stopping — going back, it's not only stopping and doing all those things that provide no value on the right side of the curve, but doing much more on the left side of the curve that we're not doing now because there are very few incentives and rewards for health people to do those things. We do a bad job. We don't organize well to do it, and we miss doing many of the things that are highly effective in providing health care.

Now one of our problems is — I mean, it isn't all the profession or the company's responsibility. It also is part of our public's understanding and our public's demand. There are a couple of examples here which I think illustrate this issue about the difficulty of setting limits in any meaningful way.

This comes from an NORC survey, and let me just read you the question so you'll see the context. It's a long question. It's a very unusual survey question.

It says, "Imagine you're experiencing headaches. You visit your doctor and talk to him about your symptoms. You also tell the doctor you've been feeling a lot of stress lately. And after doing a complete examination, the doctor decides that the headaches are probably due to stress. You want to have an MRI to make sure everything is okay. An MRI is a special and expensive type of X ray that allows doctors to take detailed pictures of parts of the body such as the heart, spinal cord, or head. Remember that after your complete examination the doctor thinks you don't need the MRI. Then imagine you have the following conversation with a doctor about the MRI and financial incentives. And then the patient speaks first. 'I'd feel better if I had an MRI. I'm worried that you won't order it because it's too expensive.' The doctor then says, 'I can understand that you're worried about whether everything is okay. It also sounds like you're worried that I'm not ordering the test because it's too expensive. These days with managed care lots of people share your worries about this. I want to set your mind at rest because I truly do not think the test is needed at this point.'"

And the question is, "How much would you trust the doctor to put your health above costs? Would you say completely, mostly, somewhat, a little, or not at all." And you can see the distribution. And you can see why it's so difficult for physicians in working in a time-pressured environment to deal with patients who basically don't trust them not to provide something that the doctor professionally thinks is not necessary.

And in a recent survey just published in The New England Journal of Medicine of a national survey of physicians, 36 percent of physicians reported they would do an MRI scan for a patient with two days of low-back pain in a comparable situation. Let me read you that question because it's important to know what the question is to understand the answer, and here's the scenario given to the physician.

"An otherwise healthy, long-term patient presents with his first episode of low-back pain lasting two days with onset following some work around the house. He has no neuromuscular signs or symptoms. You explain to him that the symptoms will likely resolve with rest and analgesia and that you don't think any further investigation is warranted at this stage. However, the patient is convinced that he has a herniated disk and is quite insistent that he should have an MRI scan. Would you order the MRI? Order the MRI scan but say that you're doing so reluctantly? Refuse to order the MRI scan at this time," and that's the question. As you can see, 36 percent of the doctors said that they would order the MRI scan.

As you know, it's an expensive venture. Somebody has to pay for it; typically, the insurance policy. But in a sense, when insurance ends up paying for things that really aren't necessary, everyone's health care premiums go up and more people are forced out of the insurance market, so that's the dilemma, and we really haven't — we not only haven't come to terms with this, we don't seem to have the guts in a way to address the issue. As soon as someone tries to address the issue, they get attacked for rationing and thinking about socialism and stuff of that sort.

So what are the areas, the key areas, of needed reform? And I'll go through these once again rather quickly because I'm sure you're familiar with them. I'm sure you've seen them in many other contexts.

We have to improve health care access for many of the people who are uninsured by improving insurance coverage and access to services, and we have to figure out a way of allocating care fairly and consistent with the evidence, and that's simply providing whatever anyone demands at any time.

In the quality area, we have to reduce medical and hospital error which you know are big problems. We have to do much more to build effective care management. We have to redesign our incentives to promote better performance. There are lots of what are called "pay-for-performance" programs. I am rather critical of some of them. It's not — you can't do it on a small basis here and there. It has to be part of the way the whole system functions. But in any case, there is interest growing in trying to figure out, can we pay for the end product, which is better health care and better health outcomes, and what are the ways of doing that?

If we're ever going to deal with the growth of knowledge and technology and the complexity of what we're doing, we have to have better IT. We have to develop electronic health records. We have to have intercommunication. We have to do those things and those organizations that have done it have demonstrated great improvements in quality compared with the American health care system. And yet we are very, very slow in adopting any kind of comprehensive information technology. More and more doctors are using it for billing and things of that sort, but they are not using it for the kinds of things that really will add to the substance and quality of health care.

On a larger scale, we have to think of how do we, sort of , develop an evidence-based culture. We don't want people telling doctors you must do this. I'm a big advocate of protecting physician discretion. I don't believe that physicians must be held accountable for doing exactly what the guidelines say.

There's a great diversity in patients' differences in comorbidities, differences in life situations. Ultimately, we want the professional's professional judgment about what makes sense in a particular instance. However, those professionals have to be accountable, have to be accountable in terms of having a reasonable rationale for doing what they do.

I happen to like very much — I know you've met in an earlier period with Norman Daniels. I like very much his kind of thinking about how do you set limits by providing rational reasons which are then amenable to change with further information and so on. And I think we have to think much more along the lines that he and his colleagues have presented.

We, as I said earlier, need an instrument. We need an agency which improves technology assessment and drug and device evaluation and regulation. But, however, as we found in the past, we have to find a way of having an agency that is more insulated from the political pressures that we've seen in the context of the agencies that we've used in the past.

And I happen to believe that improved and increased transparency, providing information to people so they can make better choices — I think it's pretty impossible now. The information is not there. Although there is a lot of rhetoric about giving people information to make choices, if you actually try, because I tried — I follow these algorithms and see where they lead and so on. You just can't. You just can't get the information that allows you to make a reasonable choice in our current health care system.

Now generally most people want reform. The latest data just published by a Blendon survey published in The New England Journal found that in 2007, 22 percent of Republicans and 7 percent of Democrats thought the system worked well. The vast majority of people from both parties thought the system didn't work well. Twenty-eight percent of Republicans and 46 percent of Democrats felt the system had to be completely rebuilt.

So generally there's a dissatisfaction across the political spectrum, and it occurs in a context where generally there is low trust in government, there's very low trust in the Congress, low trust in medical leaders, the insurance companies, and in the media. So the issue is , how do we build the kind of trust environment in which we can compromise meaningfully among our different values and predispositions?

Now, and that's exacerbated even in medicine by the kind of breakdown in sort of views within medicine. So you have tremendous competition among specialties and sub-specialties. You get skimming. So, for example, the effort for specialty hospitals to take the more remunerative cases and organize around the remunerative cases leaving community hospitals with many more difficulties, the Congress has now temporarily banned that. You have in primary care boutique medical practices which provide more time to patients and more attention to patients, but at the cost of creating inequalities in the care available in primary care of patients.

So there are lots of divisions here, and how you begin to bring people together around those divisions and come out with some rational solution is, I think, a very, very difficult challenge for future years.

Obviously there's big money in medicine. It's now, what, $2.2 trillion and it is a source of income for many powerful interests and millions of other people. Each of these groups lobby to protect their turf through political contributions, grass-roots mobilization, and using the media.

Everyone — well, a very large majority — believe that we need reform. But when they feel their interests are at stake, they prefer to stay where we are than to accept a reform which is different than the one they particularly support. So there's little consensus on any single pathway to reform. And with the uncertainty and low trust we have in this area, for many people, for many policymakers, the status quo remains a preferable option.

Let me stop here. These are just some — I have a couple of slides which you have, I believe, which just talk about different options, different ways in which one can begin to address some of the problems we have in terms of covering more people, providing more equal access. And, once again, I'm pretty sure you're familiar with these. You've heard these advocated in various ways, and I think we might do better by having the time for discussion. So let me just stop here and see where this leads.

(Applause)

CHAIRMAN PELLEGRINO : Thank you very much, Dr. Mechanic . Dr. Rebecca Dresser , one of the members of the Council, has graciously accepted our invitation to open the discussion. Rebecca ?

PROF. DRESSER : Well, thank you. That was really a comprehensive and helpful overview for us. I appreciate that. So I have three questions. One is general and a couple are specific.

One is based on your article about muddling and rationing. I wasn't quite convinced of your defense of implicit rationing as better. Do you still think that? You just said something about more transparency. And you say that it shouldn't involve not informing people of an option that's available in order to save money, that that's not appropriate.

I guess maybe I'm one of the mistrusting people. I think that that probably does happen, say, with older people or people who are uninsured where a particular option doesn't get brought up. So I wondered how transparent can an implicit rationing system be and what your current thoughts are on that?

A second specific question that I had based on the presentation was , you mentioned medicalization. And distinguishing between the vicissitudes of ordinary life versus medical care — and I'm very interested in that area — I wondered if you had some further thoughts about that?

And then the final question is asking you for help. I really appreciated how you started out with values and gave us some general concepts. But here we are, a group of people whose expertise supposedly is bioethics, and so we're trying to frame an analysis about moral issues and moral positions, and I wondered if you had advice for us on how we might frame that in a useful way given that we're not the policy expert that you are?

So is that enough?

PROF. MECHANIC: I've been involved for many years actually in the rationing debate. I got very interested in this when I was working in the National Health Service in the Medical Research Council, and then got involved in these discussions with people in a variety of European countries.

And at the time, there was this notion that we could make all of these things highly explicit. You know, we set these explicit rules and we follow these rules in treating patients. And I've always been impressed in my observations that life is far more complicated. Patients are extraordinarily diverse in their life situations and in their preferences that people's illness situations vary greatly. We set up guidelines: How do you treat asthma, how do you treat depression, how do you treat this and that? But, in fact, the average person has many comorbidities . They tend to be taking a lot of different drugs, quite typically, and therefore it becomes very, very difficult to write meaningful rules that apply across the great diversity of patients. And as a consequence, I still very much believe that physician discretion, physician judgment, is the key. It's what intervenes between sort of all these technologies and understanding of a patient. And I believe very firmly that physicians have to be given some discretion to make judgments within the context of people's lives and so on. And I recognize that the weakness of that is that the physicians can exercise bias in this situation.

My view is for the big questions — you know, is a certain new technology going to be made available? I believe that that can be made in a very explicit way, that you can evaluate that technology, you could evaluate its benefits, and you can make a decision as to whether it's reasonable to pay for it. There might be differences of opinion, but you have a decision-making process to arrive at some conclusions about that on the best basis you can. And so you don't leave those to each individual's discretion, each individual physician's discretion. However, in many, many kinds of cases you have very, very complicated situations where what you do depends so much upon the individual circumstances as a patient. And so I have argued quite strongly that basically implicit rationing makes much more sense; that is, there should be some sort of general understanding that one should not waste resources, one should use resources meaningfully and prudently, but that physicians have to have some discretion to make decisions which are perhaps different than the sort of overall view if they feel the facts and the circumstances of the patient warrant it.

And I must say I admire — Kaiser Permanente has some understanding of what the guidelines are, but they also have a principle that any physician can override the guidelines if they feel in the case of a particular patient that overriding those guidelines has merit and is accountable to colleagues and management for explaining why they did not follow the guidelines and so on. And I believe that's the way we should go. I believe we should hold people who don't conform to the principles, the guidelines, that are set accountable for their deviations, but allow those deviations because I think they make sense. I think health care, as you know, is extraordinarily complex and people's situations are extremely complex, and I think it's very, very difficult to write meaningful rules that fit everyone, and that's why we have professionals who intervene between, sort of, rules and patients and try to make prudent decisions about how to care for them. But I've written a lot about that. That was just one example of an article I pulled out.

In the case of medicalization, I think much of that is being — I mean, I think there is a tendency to call more and more things illnesses, and I don't — I think that sort of medicalization emphasis is not warranted. Part of it comes from the promotion of products. The pharmaceutical companies are very strong in trying to push pharmaceuticals for what I would think of as normal problems of living, as a way of building their markets. And I think there is a tendency in many of these areas to over-diagnose and be far more inclusive about what is really illness versus what is unhappiness or the ordinary distresses of living.

Two of my colleagues just recently wrote a book — I think Dr. McHugh actually reviewed it in The New England Journal of Medicine , I believe — where they show, I think very systematically, that the DSM and the way it's applied tends to over — it's over-inclusive in defining depression to include many conditions which are normal responses to life's vicissitudes. And while the DSM makes an exception for bereavement, it makes no other exception, but a lot of terrible things happen to people. They lose their employment, their families break up, their loved ones become sick, they get jilted in romantic relationships that lead to sadness, but that isn't necessarily a clinical condition. That's a normal response to terrible things that happen to us. So they argue that there's a real problem in the over-exclusion of conditions, and I think that happens throughout. I mean, you know, people are now trying to sell drugs for a range of things that we have typically thought of as a normal variation in everyday life. And I think as we think about — and to the extent that it's providing, you know, very inexpensive care, I think it's humane to do it. But when one gets into sort of very expensive modalities and the use of expensive modalities, I think we have to be very careful about how we address those problems and whether we allow diagnoses to be so expanded that they include all kinds of human distress, unhappiness, and so on.

When you asked — I'm sure that — the last question was on frame of?

PROF. DRESSER : Do you have any ideas about how we might put the brakes on some of this over-medicalization in terms of if we were trying to, you know, reform and improve?

PROF. MECHANIC: Well, I mean, I think there are lots of little ways, and I think it's rather difficult because it becomes part — what happens is, you have very large amounts of money being dispensed by the pharmaceutical industry, in particular, but other industries as well, promoting treatment of things that we ordinarily would not think of as sort of medical care. And to the extent that that treatment is basically a very simple kind of counseling, I have no objection. But to the extent that it involves getting people involved in heavily sponsored technological care, I think one can think of the way in which we regulate the promotion of drugs for particular indications as now there's some question as to whether we should sort of loosen up on the ability of the pharmaceutical companies to sponsor drugs for off-label indications. They've been limited up to now.

I think that we have to basically think about what is appropriate in terms of technology. For example, when I drive home from work, I hear advertisements for total lung screening to make sure you don't have lung cancer, CAT scans of lungs. I think we have to have some standards for, you know, what — I have some concerns.

I haven't thought this through in detail, but I think we have to think about ways in which we can perhaps decide if certain kinds of advertising is misleading and restrict it in some fashion. But, once again, I really haven't thought it through and I would hate to give you an answer that's just off the top of my head.

CHAIRMAN PELLEGRINO : I have three Council members waiting to question: Dr. Eberstadt , Dr. Carson , and then Dr. Meilaender . Dr. Eberstadt ?

DR. EBERSTADT : Thank you. First of all, Prof. Mechanic , thank you for a very comprehensive and thoughtful presentation for us all. I think we much appreciated that.

I have a question about a particular suggestion that you made in the course of your presentation. You said we need a neutral and credible agency to assess effectiveness and cost-effectiveness of health care interventions. And if I understood the drift of your argument, you would see that sort of an institution possibly as being a key towards a more rational utilization of health care services in the United States .

I wanted to ask you in particular, where and with whom? And by that, I mean, where would you envision such an agency as being located in the spectrum of American society? "Agency" sounds like a government institution, but that may not be what you meant there. And credible with whom? Do you envision this as being an organization that would be credible with the life sciences and health sciences research community, with practicing physicians, with other sorts of health care professionals, with ordinary Americans who might want treatment?

The idea sounds very plausible when you describe it. I'm wondering if you could describe it more? Is this a modest proposal or how would this work?

PROF. MECHANIC: Well, I mean, basically getting back to the sort of rationing notion, there are many, many different levels on which rationing takes place. Rationing takes place when one decides what the benefit package of an insurance plan is. It takes place when one organizes services and decides where to put one's resources which then rations the man because of the availability or lack of availability of resources. One rations at the service level which is what the earlier question was referring to.

Basically, we are introducing technologies, technologies often that are not evaluated or not evaluated in any sort of serious scientific way. And then basically, patients demand them and threaten litigation if they don't have them because they learned through the media that that might conceivably be helpful in an end-of-life sort of situation.

I guess bone marrow transplants for patients with breast cancer, until the definitive control trial was done, was an example where there was lots of reason to think that this was not a valuable thing to do. When insurance companies refused it, they got sued, they got bad publicity, and they were basically sort of forced simply by the bad publicity to often relent and provide the procedure. That's less of a problem now in that case because it's pretty definitive that it was not a useful procedure.

I think people are thinking about this in terms of a protected agency which exists at a fairly prestigious level and has lots of representation from different organizations through its membership, but which is run by — which has its scientific sort of evaluative component. It has a public advisory group that provides input and so on. It's worth looking at NICE because NICE has gone through this process over several years and basically has its advisory groups, it has its negotiations with the professions. NICE, as you know, provides advice on the effectiveness and cost-effectiveness of various modalities as advice to the National Health Service.

Interestingly enough, I mean, NICE has had some perhaps unexpectable results in that in some cases NICE decisions have increased the cost of medical care because they have in some cases indicated the things that aren't being done should be done because they are cost-effective and worth doing, things that would be on the left side of my diagram; that is, many of the things where we do very poorly in providing health care which are cost-effective and valuable and we don't do because of incentives or for other reasons.

The model people generally have talked about — and I have to say right up front I haven't given a lot of attention myself to thinking specifically of what the model would be. What the model people have in mind in terms of its integrity is the Federal Reserve System where you have commissioners who are appointed through the federal process who assess in this case the health of the economy or the health technology who try to look at the best evidence as to the state of where things are going and what's valuable and what isn't and make recommendations about whether insurance programs should be encouraged to fund such modalities and so on and under what circumstances.

So we have models to look at, and I think those models are worth looking at. Whether they pertain specifically to the US , I think, is something I haven't studied, but is, I think, worthy of some study.

We've done it within federal agencies, and it hasn't worked. I mean, the best example which I alluded to was the agency for — it was called something else earlier, but it's now the Agency for Healthcare Research and Quality, which almost disappeared. They set up organizations in various universities to study the effectiveness of care in different areas. Back pain was one of the ones, and the organization they funded was at the University of Washington-Seattle to study different modalities for the treatment of back pain and develop practice guidelines. They had similar things for cardiovascular disease, for many other areas. They were called "ports" and were funded pretty substantially to do these very careful studies of the existing evidence.

And the back pain group did a lot of research and produced some wonderful, I think, publications on what we knew and what we didn't know and what seemed reasonable in the terms of treatment of the back pain. They found among other things that much of the surgery was unnecessary and did not contribute to improving function. I had chaired, co-chaired, a panel of the Institute of Medicine some years earlier on the treatment of pain for the Social Security Administration, and we, too, when we looked at all that evidence came to a very similar conclusion. So they put out these guidelines which infuriated the people who did this kind of surgery, and they organized. They organized a new organization and they lobbied the Congress very aggressively to eliminate the Agency, and they almost succeeded. I think Sen. Frist in the end interceded and the Agency was saved. It changed its name. It had a very much reduced budget as a consequence. So these are the powers out there who have something to gain and obviously are not going to sit quietly while decisions are made which they see are not in their economic interest.

We have to have an agency that has the credibility with the public and with policymakers that has the sort of power to withstand those kind of attacks. And I think if one could put it together in an appropriate way, such an agency could play a rather important role in our health care system.

CHAIRMAN PELLEGRINO : Thank you.

DR. EBERSTADT : If I could just ask one followup question? You mentioned the analogy with the Federal Reserve Board which is, I think, an appropriate analogy. When one thinks about the indicators of credibility, something like the Fed looks at the soundness of the US currency, the inflation rate, one gets a pretty good indication of whether the Fed policy is credible or not from those sorts of indications. In fact, within our lifetime there was one Fed chairman who was seen as being not terribly credible, was yanked and replaced by Paul Volcker.

What sorts of indications do you think we should look at to determine whether such an agency, if it were ever to exist, were credible in making these sorts of assessments?

PROF. MECHANIC: I think that's actually easier than in the case of the Federal Reserve perhaps. I mean, there are many, many interests out there that have a very great stake in what these judgments are, and, you know, medical-device companies, pharmaceutical companies, physician specialties, there are many, many groups that have a large stake.

And one can anticipate that they will watch these decisions very, very closely and critique those decisions very, very strongly. And you see this actually — you see this in NICE. I mean, NICE doesn't operate in a vacuum. NICE is constantly under criticism by the pharmaceutical companies and others and they negotiate these things with these groups and discuss what data these groups have. So I think obviously one has to build credibility over time. It isn't established simply by establishing an agency. But I think we have examples to look at and processes to look at by which these decisions get made and get implemented and how they get changed.

And, you know, once again, I made a reference earlier to the work of Norman Daniels . I like the idea of any organization being held accountable for its decisions and being open to a process that allows revision of decisions when new information becomes available. And I think whatever the process is it obviously has to be open to criticism and new information that becomes available.

But I think we have to have a way of providing some credible judgment as to what kinds of very expensive things we should pay for and not pay for and obviously they're not going to be the only player in the game. There will be many others. I mean, this is an area with many people who have very strong stakes and are very vigorous in protecting their stakes.

So I would see such an agency as being under much, much surveillance and a lot of criticism and presumably there would be some give and take, but I think it has to be protected from the kind of political onslaught that we've seen with the Technology Assessment agency and with the Agency for Healthcare Research and Quality.

CHAIRMAN PELLEGRINO : Dr. Carson ?

DR. CARSON : Thank you for that thorough and thoughtful review.

I'm delighted that you're an advocate of physician discretion based upon, you know, education and analysis. But I know last year a good friend of mine, a very well-known pediatric neurologist, spent a large part of the year in court because a child with a brain tumor who he had examined — he didn't recommend an MRI until 11 days later. The tumor was taken out. The child did fine. But nevertheless he was sued for not having ordered the MRI 11 days earlier. And as a pediatric neurosurgeon, I've been involved in multiple such cases defending pediatricians and others who perhaps have not had the crystal-ball ability to determine the exact timing of a study.

How can we really have a system that relies upon the discretion of practitioners when we have a rampant litigation system that penalizes them? Even if they're correct, they still have to spend an inordinate amount of time and money, and that obviously is going to affect people's judgment and make them much more likely to be bullied by patients.

PROF. MECHANIC: I think, you know, many physicians obviously worry a great deal about litigation and very often the costs are not simply the monetary costs, but the hassle and the feelings of humiliation and so on which come through that process. And lots of people are trying to think about alternative ways of dealing with error and negligence and allegations of those.

As I see it, it's a two-step process. I mean, basically there would be guidelines which indicate when something should appropriately be done, which are based on the best knowledge at the time, and to the extent that these guidelines — right now, we have many, many guidelines on everything, so there's no chief guideline. But if you had guidelines which were then seen as credible and had some authority in the minds of the various actors, the guideline itself would provide some protection in these circumstances.

The discretion comes, you know, at the point at which — when I was talking about the discretion, it's the point at which there are sort of indications that something should be done and the physician on the basis of his or her judgment decides that it is not appropriate given the particular facts of that particular case, and my argument was that that kind of discretion, you know, must be protected. That is, these guidelines are written generically. They don't apply to everyone.

People vary a great deal on many, many dimensions including the nature of their illness and their comorbidities and their age and so on and so on and that when guidelines are written they may or may not be applicable to a particular patient in a particular set of circumstances, and that's the judgment, that's the good judgment, we really want from physicians so that when physicians deviate they should be able to explain meaningfully in a credible way why they're deviating, and it seems to me that, too, would be a form of protection. But the basic guideline itself is a form of protection if the guideline is credible and widely-respected.

Now, the problem now is there are people who basically do CAT scans for everything. I mean, basically we have — the growth and the use of CAT scans is enormous and, you know, the interpretation is that the motivation is the economic motivation and not a medical motivation. But in any case, we know that the number of CAT scans being done and the overall aggregate costs are increasing quite dramatically.

There was a very interesting paper in The New England Journal of Medicine a few years ago, I believe, in which they looked at the radiation resulting from CAT scans and found that basically, you know, a few of these CAT scans begin to approximate the radiation in people that were exposed after the bombings in Japan, the nuclear, the atomic bombings in Japan, and then looked at the — you know, that's our best source of understanding the results, the cancer results, coming from exposure to radiation.

And so there's a cost. I mean, you know, there's not only a money cost, but there's a cost for people who are subjected to procedures they don't really need or that good judgment would suggest they don't really need and the dangers to them, and that's part of, I think, Dr. Fisher's argument which you'll hear later today and that is that care is not only wasteful often, but care is damaging and that one has to sort of protect both the public purse but also one has to protect patients from care which is iatrogenic, that does them more harm than good.

But the malpractice issue will continue on. I mean, there is — it's a very contentious issue. There are claims, all sorts of claims. I happen to run — I happen to be the director of a national policy program where we finance investigators to study various issues, and we just — one of our investigators just completed a book, a person who has spent a lot of time studying malpractice, Frank Sloan at Duke University, where he tries to analyze a lot of issues surrounding the malpractice issue and indicating that the data aren't quite what some of the contentions might suggest.

CHAIRMAN PELLEGRINO : Dr. Meilaender ?

PROF. MEILAENDER: I'd like to just push a little bit on two questions and hear what you have to say.

The first really, in a sense, piggybacks on Nick Eberstadt 's question. I just have a little different angle on this, your notion that we need a credible, legitimate agency to make these cost-effectiveness evaluations. I just noticed that we may be on the cusp of circumstances in which people's judgments about the credibility of the Federal Reserve may begin to waiver a bit.

(Laughter)

But you started us off with, you know, a couple of slides about the value, differing values and cultural influences that are — sort of this area is permeated by, and I think in some ways the physician-patient interaction is value-laden from the outset. And I'm just wondering sort of where the neutral place is on which this agency is supposed to stand in making cost-effectiveness judgments about sort of what we're getting. On the one hand, you see the sphere of medical care is shot through with these various values. And on the other hand, you seem to think that there is a place to stand that sort of transcends that. I have some doubts about that, but I would just like to hear you say more about that. So that's the one thing.

The other then has to do with the issue of trust in one's physicians. I mean, it doesn't seem to me to be irrational for people to at least to qualify their trust in various ways, I mean, except for the physicians on this Council, all of whom I would trust completely.

(Laughter)

But it always seemed to me that if you would just think back to your high school graduating class and the people from it who went into medicine (laughter), you know, you have some warrant for concern and your very next slide after the survey results about trusting doctors talked about medical error as an enormous problem. I mean, and it's not that I want to make a case for obsessive distrust, but it doesn't seem to me irrational for people to approach the encounter with a certain amount of hesitance or reservation. And I just wondered if you think that's wrong or what you'd say about that?

PROF. MECHANIC: I'm talking very largely about trust in medical leaders and representatives of medicine who speak for medicine in the public arena. Actually, I've done a lot of work on trust in patient care, per se, and certainly many patients enter their relationships with doctors with some skepticism and try to test their doctors to determine to what degree their physicians should be trusted. And over time, that trust builds if the relationship continues. If the patient becomes distrustful, they go elsewhere.

But patients are not experts. I mean, patients don't have the technical competence to really judge the effectiveness of a physician from a technical-medical point of view, but they do. I mean, they make assessments about competence using all sorts of cues and basically what patients say when you ask them about trust and when they talk about — and I've studied cancer patients and patients with mental illness and other conditions — basically they want competence. I mean, competence is first. But they typically have a notion that most physicians are competent, that the training and accreditation process results in most physicians being competent. But they look for cues that their physician is exercising competence.

They want what I have called "interpersonal trust." They want someone who is responsive, who listens to them, who communicates a caring for them, who indicates some awareness of their, sort of, what the patient has told the doctor in the past, and they use all sorts of cues to assess whether, in fact, the physician is a person who really cares about them, who is really interested in them, who really listens to them, and that's very important in their assessments. And, finally, they want some indication the doctor is really on their side, cares about them, will fight for them when they need it. And I think doctors sense that, too, because, I mean, studies typically show that doctors will sort of agree to give patients things the doctors don't feel they really need or necessarily will be good for them.

There are a number of studies on how doctors deal with patients who have drugs they've seen in direct-to-consumer advertising. And many, many doctors say that they give patients these drugs, particularly if they think the drugs won't do any harm, even though they think the drugs might not do any good. And, in part, they're doing it because they, in a sense, are trying to communicate that they are — there are other reasons, but they are trying to communicate that they are on the patient's side. And when you say no to patients who really feel strongly they ought to have a drug, then you get into a very difficult kind of social interaction.

But so basically I was sort of — I was talking more about the way in which medical leaders are seen, and largely they've been seen over time as self-interested and not necessarily committed to the public welfare and organizations are —

PROF. MEILAENDER: Could I just ask?

PROF. MECHANIC: Yes.

PROF. MEILAENDER: If what you just said is true, then that may be good medical care, that it elicits trust from the patient even if the physician is prescribing something that the physician isn't sure is really needed, but it might be good medical care?

PROF. MECHANIC: Well, there usually are alternatives, and actually a couple of studies now indicate that some physicians use the opportunities to provide an alternative treatment that makes more sense, and that would be good medical care from my point of view. That's simply not simply providing Vioxx because the patient saw an ad on television for Vioxx.

So I think when you talk about — I'm sorry. I think I've lost your first point. But you were talking about the credibility of?

PROF. MEILAENDER: It was just a question about whether there is some neutral place from which these credible, legitimate judgments are supposed to be made when we're judging — making cost-effectiveness judgments in the health care field.

PROF. MECHANIC: Well, once again, I think the question is to try and create an agency that has enough, sort of, built-in course currents and has enough respect to elicit credibility but we're in a domain that there will be many voices. So such an agency will certainly not exist in a vacuum. It will have to be responsive to many, many other groups that are pushing agendas which are different from their agenda to make up the best assessment.

And my view is that ultimately that won't be the only voice. I mean, we live in a pretty diverse and pluralistic and, sort of, free society, and basically their role will largely be to try and provide guidance to federal programs and to what insurance companies are willing to accept. They would provide some, I think, backbone to insurance companies that in many cases would like to have higher standards about the use of certain modalities. So I see it as being both informative, but, in the case of federal programs, perhaps having greater weight in influencing what things get covered and what things don't in part of the general benefit design.

It's not an easy issue, I mean, no matter how you look at it. It's a difficult issue, and, you know, there's a lot at stake. It's a very, very big sector and lots of people have a stake in the game. But I think we need a way of having this spokesperson for what is sensible and reasonable and provide guidance.

That would not mean, given the realities of America, that people can't buy whatever they want using their own resources to the extent that they have them, but I'm not saying that, you know, that everyone sort of has to fall in line between these standards set up by such an organization, but it would provide guidance for what organized programs decide to cover within their insurance programs or within federal programs like Medicare.

CHAIRMAN PELLEGRINO : I have two questions, one from Dr. McHugh and one from Dr. Hurlbut . The time is short. I merely mention that in passing.

DR. McHUGH : I wonder why.

(Laughter)

Well, you know, everybody here is so grateful to you for coming, David, and we all and certainly I know you as America's greatest medical sociologist and in my mind perhaps America's greatest sociologist, and so therefore I want to ask another level of question beyond the technological issues and issues that you've illuminated here today.

I want to ask a more sociological question that relates to the conclusion or at least part of the conclusion you came to being America 's second choice being the acceptance of gridlock. And there's usually a reason sociologists, and, by the way, psychiatrists, would talk about why people come to a stop, and it's because they have so much good that they've got that they're unready to risk the loss of that good in the process even of expanding the access and things of that sort which we see as needed.

And so when I think about that question in a sociological point of view, I want to know whether there is not an appreciation on our part, our American part, of something that — of the good that came from organizations or groups that the great old sociologist, Charles Horton Cooley, used to refer to as the "primary group" from which we worked first in family but often as well in certain kinds of occupational enterprises where everybody in the group saw that the goal of the group was so good that individual advantage was put aside for the good of the group and out of that contribution came, not only great advantages and progress, but great happiness in the process. Okay? And so we can see that in the family, but we also see that in certain medical situations. By the way, you see it sometimes in certain medical situations and you see it not in other similar medical situations.

For example, I've worked in a number of medical services and some of them were the most wonderfully happy places. We were paid a pittance, but we all worked for the benefit of the group and worked for the care of the patients and we took care of the sick poor in most of these places and we stayed up late at night and we did without and yet everybody was quite committed to it. Then I worked in a government agency in a hospital-like government agency and everybody was 9:00 to 5:00 and was a fuss — the patients weren't getting really good care and we wanted — we were clamoring for more resources, but it didn't really work.

Is, in other words — and here's my little question that I've come to. Is the problem how to preserve the qualities of the primary group in the face of wanting to expand and increase the supplies that are available the thing that is essentially producing this gridlock? Have we failed to remember that what we need to preserve can be hard to do in the face of wanting more and more in some way to come to us?

PROF. MECHANIC: I guess I'm not sure of your last, sort of, notion when you say —

DR. McHUGH : Let me see if I can make it clearer. As I say, I'm muddling along here, too. This is my concern.

Is the kinds of things which we agree are the trusts that is shown in certain places for medicine — you see, we trust our doctors. I can tell you I trusted the group I was working with as an intern. I trusted certain laboratories that I worked in. Certain laboratories really work in this kind of family way, you know, the progress of things. But then there are other places that don't work that way at all, and, yet, are often modeled as places where we should have more resources for these people, more things should come, they should get bigger grants, they should — I don't know what it is. But no one looks at the fact that the social quality of the primary group is what's making everybody wish they could have more of that, but you can't have more of that without being for, kind of, primary. You go out for more resources, but you don't emphasize that which is giving the quality itself. Is that —

PROF. MECHANIC: Yeah.

DR. McHUGH : As I say, I'm muddling along here, but I just wonder whether the gridlock isn't the sense that, "Hey, look!" We're not building on the very kinds of things that make things good when we're turning to say we've just got to be sure that more people have access to insurance and things of that sort. Maybe we should be emphasizing how to replicate the primary groups that do so well. How's that?

PROF. MECHANIC: Well, I mean, the real difficulty is that increasingly the kinds of things we identify with primary groups have disappeared in medicine. It's basically sort of the basic notion of the traditional primary care doctor who has a close relationship with the patient and the family, that kind of medicine is increasingly not available to people, and part of — I think part of what people are struggling with is, how do you kind of create a new community around medical professionalism that responds more meaningfully to the wide range of needs that patients have?

I got involved with the Foundation for General Internal Medicine working on the, sort of, medical professionalism. And, certainly, there are lots of people with very high ideals about what we should do and how we should do it and how we can enhance what we do with patients in a fashion that would be to everyone's welfare, including the professions.

And, you know, there is a need to sort of build a new culture in medicine. The old culture seems to no longer work. And how you build that culture, particularly in the context where you have, you know, all of these other forces operating, a very strong sort of focus on profit. I don't — you know, several of my friends who write about these medical issues of professionalism — I'm sure you know them all, you know, people like Bud Relman and others — are actually convinced that sort of the corporation and profitization of medicine has ruined it and has ruined medical professionalism and we have to go back to something else.

The trouble is, as I said at the very beginning, I just don't think it's practical to think about taking profit out of medicine in America . It's just not — it's not a reasonable sort of expectation, and so we have to think of new ways of organizing medical groups and physicians in ways that provide many of the same sort of good values of medicine without necessarily trying to change the whole world.

And there are people that are struggling to do that. There are physician groups that are struggling to do that. But I think at the cultural level — I mean, it's very hard for people who are worried about, you know, their future health care to want to give up what they feel secure with for something that they feel more insecure with. And I think that's part of the sort of major dilemma we face.

They don't mind add-ons, per se, but they're very worried about anything which will affect their kind of situation to the extent that they believe their situation is a good situation.

And this is why I think the candidates have all tried to sort of skirt that. You know, you can keep what you have if you want it, but we'll talk about the rest because they know that there is this sort of big constituency out there that the system does work well for and who are afraid of losing what they have for something which remains uncertain.

CHAIRMAN PELLEGRINO : Dr. Hurlbut ?

DR. HURLBUT : Do we actually have time for my question? Probably not, huh? We do?

CHAIRMAN PELLEGRINO : We will extend the time.

DR. HURLBUT : So, first of all, I want to say that your paper on muddling through, I really found it very interesting, and I think as a physician very true to the reality of this extremely complicated realm of human existence.

It's evident in the current political campaign that medical care is going to be a major public discussion now for at least for the next eight months, and that's good and bad. But one of the things that's troubling about it is it's so easy in speaking about medical realities especially when using anecdotal cases to inflame natural moral sentiments. Suffering is a very hard thing for a community to deal with in a collective dialogue and especially when it's brought down to the complexities of the individual cases and the relationship between doctor and physician.

So what I want to ask you about is something that's a very broad question, and the reason I bring this up is because obviously our Council isn't going to take this issue on in the broadest sense of deciding our culture's policy, our nation's policy, but we want to add ethical — a comment about ethical dimensions.

So this is a very hard question to ask or to frame properly. But in your paper, the one I'm referring to, "Muddling Through," you make two statements that strike me as quite interesting in their relationship to one another. At one point further in the paper, you say, "Rationing of health care has always been present in all systems of care," and that seems obvious because values float through. But then earlier you say, "The goal of any rationing process is to constrain expenditures in a way that provides a reasonable level of care, is equitable, and is cost-effective."

And there it strikes me that there might be other reasons for rationing or reasons not to — let me reframe that. There might be other factors going into the rationing process and that those factors could be very different if we're muddling through with an imperfect system or we try to establish a more uniform system that has a stronger authority and constraint within it.

And this is most specifically what I'm getting at: Yes, cost containment and reasonable levels of care are crucial and probably the main body of medicine is uncontroversial. But rationing could also do a lot of other things besides meet those more obvious financial goals. It could serve, for example, to encourage responsibility. It could shape the character of our culture. It could more or less send an announcement that medicine is for certain things but not other things. It could even go so far as to more or less tell people that their lives are about some things but not other things. You mentioned antidepressants and their misuse for what you were calling the vicissitudes of natural life processes.

When I look out at the future of medicine, it looks like the main body of medicine will always probably be about very serious and uncontroversial treatments and issues, but it also looks like we're going to get more and more into areas that are controversial. We did a whole report called "Beyond Therapy." And I just wanted to get your overview and ask you how you think our Council might contribute to this larger dialogue, most specifically the issue I'm referring to here, how medicine's implicit rationing shapes our culture's character.

PROF. MECHANIC: Well, that's a tough question. I think that — I mean, there's been this continuing debate, and I've been part of it both here and in Europe , between those people that think somehow, if you write all the rules upfront, you then have greater transparency and greater fairness. And my position is, first of all, you can't write the rules that well, that life is too complex and there are too many contingencies, and that bureaucracies get pretty bad at rigidly implementing rules that don't work in particular instances and that judgment has to prevail at some level.

And so my conclusion is you write the rules at the higher levels; that is, the rules are framework rules. But you have to leave room at the, sort of, intermediate level, what I call the service level, for people with good judgment to adjust those rules consistent with the contingencies of the particular situation that is being dealt with.

And there's been a lot of back and forth. There's been a lot of discussion between those who think that explicit rationing is the only way to go and other people who don't like explicit rationing. This, of course, was very salient during Oregon 's effort to develop its rationing rules and its various categories of what would be included above the line and below the line.

Interestingly enough, if you actually look at the studies of what really happened in Oregon , the lists really weren't that important in reality. There were a lot of other things that really drove the system quite independent of these lists and there are all sorts of ways of getting around the list if you really wanted to so that — yet, a lot of good things happened through that discussion.

So my feeling about — I think it's very difficult. I mean, obviously rationing, however it occurs, sends signals as to, sort of, what the frame is, and I think it's quite correct that how we talk about rationing and how we go about trying to do it can impact other areas that you mentioned, such as, what is the appropriate domain for medicine versus other areas? I mean, increasingly people talk about medicine as if it's everything. It's education. It's everything else. And at some level, we have to really, sort of, be very clear about, you know, what the boundaries are and what things, while worth doing, are not necessarily medicine, they're something else.

In the context of the individual patient care, I mean, it's quite proper and appropriate that physicians try and do whatever they can to help their patient over whatever the difficult circumstances are. But they obviously can't insure for their old age. They can't change their economic circumstances if they're dire. I mean, I think we have to be realistic about what the limits of medicine are as well as what the opportunities are. There are great opportunities, but there are also great limits.

And by having an intelligent discussion about this — and I think this is where a council of this sort contributes — one can, I think, help the public understand, you know, what these dilemmas are and what the different levels of responsibility are with different parties to health care.

There is a lot of glib discussion about patient responsibility and that kind of always annoys me in the sense that, while it's true people have to be responsible and that the people share responsibility and we should try and minimize free riders, that a lot of the assertions about responsibility and we're going to save costs through people exercising responsibility doesn't take account of the fact that many of the things we're talking about are not within the capacity or individuals or people to change.

I mean, people have all sorts of problems which are behavioral. The assumption somehow is that they simply stem from the will of the person and if the person would just be a better person and be more responsible these things wouldn't happen. But I don't think that's the way that life really goes, and that's the difficulty. But I do think it is valuable to talk about, you know, patients' responsibility as well as other responsibilities of physicians and policymakers and so on.

I don't know if I've answered your question or not.

DR. HURLBUT : Yes, that was good. It was a pretty hard question.

Do you have any specific suggestions for what our Council should comment on?

PROF. MECHANIC: Well, I mean, this is — you've obviously taken on a very big topic, but I think there are many, many aspects of the — I mean, I think the basic question I started with is the kind of question the Council can properly take on and contribute a great deal to, and that is, you know, in a society like ours, what do we owe to each other?

It sounds like a, you know, very vague, general question. But it seems to me that that is really very basic to much of what is going on. And while it doesn't lead to a very precise sort of policy recommendation, it does kind of open up the whole issue as to, you know, what our values are about the future, you know, of the country.

I happen to feel very strongly, for example, in certain principles. I mean, I always start with children. I think children . are the future resources of the country and that we have a responsibility to children to ensure to the extent that we can appropriate social development, appropriate education, appropriate health which allows them to take advantage of future opportunities.

So as I think about this — actually, in other contexts when we've talked about staging, of how we might stage some expansion of coverage, it struck me that the appropriate way and other people— and it's hardly a unique idea. The appropriate way is to start with children for both moral reasons and also pragmatic reasons. The moral reasons are that they are the resources. They are the resources of the future. You know, it's to our advantage and to their advantage to give them the capacity to make good of the opportunities our country provides. But it also is, from a financial point of view, not a terribly demanding thing; that is, children for the most part are reasonably healthy. The costs of taking care of them compared to the elderly are very modest. And so from a cost point of view, extending coverage and dealing with the problems of children is a far more manageable task than many other tasks we see as equally important and worthwhile.

But it seems to me sort of taking on some of those issues, and I think when we say, "What do we owe to each other," I think we particularly owe the children because in a sense children are largely defenseless and dependent upon what their milieu provides, and we could do a great deal to enhance their life chances through medicine as well as other means.

CHAIRMAN PELLEGRINO : Thank you very much, David , for your very extensive discussion and response to questions.

We have overrun our time a bit, so I will exert the chairman's prerogative and we'll have break now, and if you would be good enough to return at 10 after 11:00 , I would appreciate it.

PROF. MECHANIC: Thank you.

(Recess 10:45 a.m. - 11:10 a.m.)