What are we willing to accept as limits on access to very expensive marginally beneficial healthcare in our society?

Center Professor Leonard M. Fleck’s latest book, Precision Medicine and Distributive Justice: Wicked Problems for Democratic Deliberation, is now available from Oxford University Press. Fleck’s work as a philosopher and medical ethicist has focused on health care policy, and the role of community dialogue in addressing controversial issues of ethics and public policy related to emerging genetic technologies.

In an interview about this book, Fleck spoke of beginning democratic deliberation work around 1980 as part of a research project regarding changes to the Medicare program. He described the importance of involving members of the community in conversations about what values and considerations should shape the kinds of limits they would be willing to live with in terms of accessing needed healthcare. That project, centered in an Indiana community, shaped his work moving forward. The interview that follows explores the importance of democratic deliberation regarding the use of targeted cancer therapies.

Registration is open for a webinar on November 16 where Fleck will present on this topic.

The following interview has been edited for length and clarity.

Who is the ideal audience of this book?

The ideal audience would be a broad segment of the public that needs to be aware of the kinds of challenges, the ethical and public policy challenges, that are associated with precision medicine. Its high cost and its marginal benefit.

How would you broadly define precision medicine?

Typically, precision medicine is defined as providing the right drug at the right time and the right dose for the right medical problem. Right now, mostly what we’re talking about is cancer, that is, metastatic cancer. What we’re talking about are the molecular features of a metastatic cancer that a particular individual has. The drugs that are used to attack that cancer are drugs that are designed for the very, very, very specific molecular features of a particular cancer. Some of those features get to be defined in really sharp terms. Researchers and physicians no longer talk about a stomach cancer or a lung cancer—I mean they they’ll use those terms, but the recognition is that the nature of the cancer, in terms of what we’re going to try to do about it from a therapeutic perspective, that’s going to be determined by the molecular signature of that cancer.

What is democratic deliberation, and why is it important? How does it apply to this topic of precision medicine and healthcare justice?

I always start off with what I call the “Just Caring” problem. What does it mean to be a just and caring society when we have only limited resources—money—to meet virtually unlimited healthcare needs? And that’s a very, very broad problem that applies to all of healthcare, certainly in the United States today. With regard to cancer, the issue is that these targeted cancer therapies, and the so-called immunotherapies which are among the targeted cancer therapies, are extraordinarily costly. They typically apply to relatively small groups of patients, measurable in a few thousand rather than one hundred thousand. For the vast majority of these patients, receiving one of these very expensive drugs is only going to yield extra months of life, if that, as opposed to a lot of extra years.

I’ve spent 50 years of my life thinking about this issue. And it’s only grown and become more complex over those 50 years, because of all the emerging life prolonging medical technologies that have come to be.

Leonard M. Fleck, PhD

So, if we had a $100,000 drug and this was going to give somebody three extra years of life, my guess is that most of us, democratic deliberators charged with determining how to spend our money on a whole range of healthcare interventions, including, of course, cancer, would say it’s a lot of money, but if we’re giving somebody three extra years, we ought to do that. And we ought to do that, we might say, because we think about, what are we spending now for purposes of giving a patient with HIV an extra year of life? A patient on a four-drug combination? The answer there would be $35,000 a year. And if we spend a $100,000 to give somebody three extra years of life, then that’s $33,000 a year. So it seems like if we’re spending money for the HIV positive patient at that level, we ought to be willing to spend that same amount of money to help cancer patients.

However, things are a lot more complicated than that simple example would suggest. So, in the case of cancer, one of the basic problems that I didn’t make perfectly clear in my earlier remarks is that even though I talked about a molecular feature of a cancer that is usually described as the driver of that metastatic cancer, and that is the target one of the targeted therapies, the fact of the matter is that in metastatic cancer there are going to typically be multiple drivers of a cancer. Most of them will be suppressed by the dominant driver. What happens in practice is that we’ve identified the dominant driver of the cancer, we give the individual a drug to kill that dominant driver, which it successfully does. And then another new driver emerges within that tumor, and then the tumor continues to grow, the cancer progresses. Now we may have another drug for that new driver, which will have roughly the same effect. It’ll kill that new driver and make room for yet another driver. But now, then, we’re providing to individuals several drugs in a row that have costs of $100,000 or $200,000 each. So, we’re spending a lot more money for a lot less good for these cancer patients. And so, the question for democratic deliberation is, what do we owe, under what particular circumstances, as a matter of what a just and caring society ought to be, to patients with metastatic cancer for whom there are these very expensive drugs that are only going to yield, for most patients, marginal benefit?

What I would ask an audience to imagine, when I’m working with an audience of individuals from the community, is that everybody in that room is probably very healthy. They have no idea what their future health vulnerabilities might be. Some people might say, well, we’ve got heart disease in the family, or some family history suggests cancer, but there’s still lots and lots of other health problems that you could have that could be deadly. The question is, if you don’t want to spend all your money on healthcare, and you don’t want to spend everybody else’s money on healthcare, then, collectively, what would you see as being reasonable investments of limited healthcare resources for addressing healthcare needs? Cancer needs, heart needs, Alzheimer’s disease needs, diabetic needs, psychiatric needs, needs associated with various kinds of disability. When you, in a thoughtful and objective way, try to consider the whole range of healthcare needs, where should we invest the limited dollars that we’re willing to provide? Right now, it’s 18% of our gross domestic product, roughly $4.1 trillion. Where are we willing to invest those dollars?

What led you to work that focuses on precision medicine? Was it natural from the other health policy work you have done, specifically work on allocating resources?

It was related both to allocating resources, because the cost of these drugs just leapt out at me, starting roughly in around 2010 or so. But the other thing was that I had been looking at a whole range of ethics and policy issues related to emerging genetic technologies. This was one of the newer elements associated with these emerging genetic technologies. This was a product of the Human Genome Project. Plus, the research that had been going on with regard to cancer, as researchers began to understand the extent to which cancer is this extraordinarily complex disease, that there’s not just sort of one or two or three drivers of these cancers. That there are different biological features of the cancer that are responsible for the cancer being so vigorous in multiplying. In brief, there’s that combination of the cost of these drugs and what that would do to distort the just allocation of health resources in our society, and the genetic features of these cancers that turned out to be so extraordinary genetically complex.

Something that strikes me, discussing these very expensive targeted therapies, is where does palliative care fit into the discussion of precision medicine?

For oncologists who are treating patients, for patients who have read something about precision medicine, for patients who have looked at some of the ads that are associated with precision medicine that have been on television, it’s very difficult to convince any of those patients that palliative care is something that they needed to give serious consideration to. Because it looked like these drugs could give them some very significant extensions of their life. And, of course, the fact of the matter is that there’s some percentage of patients who will get one or two or three extra years of life. There’s a teeny tiny percentage of patients who we call super responders, who might get seven, eight, ten extra years of life or more. At the moment we have no way of identifying before the fact how particular patients are going to respond to these drugs.

What happens is that patients imagine to themselves, I could be that person. Somebody is going to be a super responder, just like somebody ultimately wins that half a billion dollar lottery prize. How do I know it’s not me if I don’t buy a lottery ticket? How do I know it’s not me if I don’t take on this targeted cancer therapy? And if the first therapy doesn’t work, I heard that there’s a second and a third. And so as long as they seem to be doing something by way of controlling my cancer, of course I want that. I don’t want palliative care. So that’s sort of the psychological logic behind the reluctance of both patients and oncologists to recommend palliative care before it is just absolutely clear that nothing else is going to work.

What is one overall takeaway someone should get from this book? What is the question you want folks to continue thinking about?

What are we willing to accept as limits on access to very expensive marginally beneficial healthcare in our society? I want readers to think about the just caring problem, which is an extraordinarily complex problem. I’ve spent 50 years of my life thinking about this issue. And it’s only grown and become more complex over those 50 years, because of all the emerging life prolonging medical technologies that have come to be. Not just with regard to cancer, but with regard to heart disease, liver disease, lung disease, diabetes, and every other area of medicine that we care to name.

I’d like to add that ideally, ethically, I think we’re inclined to say, if we have a somewhat costly life prolonging care that’s effective, then everybody with the relevant need ought to have access to that if we are a just and caring society. If somebody has an inflamed appendix that is life threatening if they don’t receive the necessary surgery, then they ought to receive that surgery, whether they’re rich or poor, insured or uninsured. They ought not to be allowed to die. You will get, I think, very broad agreement in our society that that’s a just and reasonable kind of moral commitment we ought to make. It gets more difficult, though, to make that commitment when it comes to these extraordinarily expensive cancer drugs. And part of the problem is that in the United States probably no more than half of us are employed at places where we’re provided with very comprehensive health insurance, and where we’re not responsible for paying very much of the cost of our healthcare. But for the other half of the population who typically are working in lower wage jobs, who may be provided with some health insurance but it’s very marginal, it’s bare bones insurance. It’s the sort of insurance that requires that individuals pay 30 or 40% of the cost of these cancer drugs. And, of course, that’s impossible for individuals making $15, $20, $25, even $30 an hour. For a $150,000 drug, they cannot pay $30,000, and so they don’t get it. Nevertheless, they are paying through taxes, and through their insurance premiums, for others who would have access to these drugs. So that’s one of the fundamental inequities in our society, and the targeted cancer therapies make that inequity, I think, more visible. It doesn’t seem as if, as a society, we’re willing to address that challenge. However, that is one of the preeminent ethical challenges that must be addressed if we are to be a just and caring society.