Feature: Last Chance Therapies: A Question of Health Care Rationing

How far should a “just and caring” society go to prolong life?  An MSU medical ethicist analyzes one of America’s hottest dilemmas.

            Angel Diaz is 69 and in the advanced stages of Alzheimer’s disease.  A machine operator and part-time minister in Philadelphia [Wall Street Journal, Sept.12, 2003], he required emergency hospitalization in May 2002 after he choked on some food.  He emerged ventilator-dependent with a feeding tube and was discharged to a nursing home.  In February 2003 he developed pneumonia and intestinal bleeding.  Since then he has spent 140 days in the hospital at a cost of $280,000, less than half of which was covered by insurance.

            Is a just and caring hospital morally obligated to provide these resources to sustain Angel’s life in this extremely debilitated state?

            Julie was 68 and faced with terminal breast cancer.   Of the 44,000 or so women who die in the U.S. each year of breast cancer, about 30 percent can have their lives prolonged by an expensive drug (Herceptin) and related therapy.   This very costly treatment can prolong one’s life for five additional months on average. 

            Is a just and caring society morally obligated to underwrite the cost of this drug through Medicare when the cost per life-year saved is about $160,000?

            Welcome to the problem of health care rationing.  What does it mean to be a “just and caring” society or hospital when you have only limited resources to meet virtually unlimited health care needs for  “last chance” therapies—that is, treatments that promise some life prolongation but do not offer a cure.  Typically, these therapies are very costly at the individual level and extraordinarily costly at the social level.

            If human life is priceless, should we spend whatever it takes to save a human life?  In practice, we’ve been very reluctant to raise taxes to support this belief. 

            Let’s view the problem in context.  It is estimated that a benefit of “last chance” therapies would cost taxpayers $540 billion over the next 10 years (prescription drugs for the elderly would cost $2 trillion for the same period).  Last year Medicare spent $270 billion to meet less than half the health care needs of the elderly.  In 2002 we spent about $1.6 trillion on health care, 14.9 percent of our GDP, or about $5,300 for every person in the U.S.  In spite of such massive expenditures we still have 43 million uninsured in the U.S. who have no assured access to needed health care. 

            Here are some examples of “last chance” therapies.  Patients who have had serious heart attacks may develop abnormal heart rhythms, which can be fatal.  The likelihood of a fatal arrhythmia can be substantially reduced with an implantable cardiac defibrillator (ICD).  This device costs $40,000.  In 2000 we implanted 50,000 of these devices.  In 2003 we implanted 200,000.  It is estimated that in 2007 we will implant 600,000 of these devices annually at a cost of $24 billion.

            Another example:  There are 5 million individuals in the US in congestive heart failure at any point in time.  About 200,000 of those individuals will die as a result of that this year.  We can prolong their lives for 18 months on average if we provide them with a Left Ventricular Assist Device (LVAD) at a cost of $150,000 each, which works out to $30 billion per year.  Most of these would be older patients covered by Medicare, which would also be true for the ICDs. 

            Is a just and caring society morally obligated to provide access to these “last chance” therapies for all who have the relevant need? 

            If an abnormal heart rhythm were detected in Mr. Diaz, or if he went into serious congestive heart failure, would we be morally obligated to implant either an ICD or an LVAD?  Remember that Mr. Diaz is in the very advanced stages of Alzheimer’s.  Should his intestinal bleeding not have been treated either, thereby saving $280,000?

            We also have a working model of a Totally Implantable Artificial Heart (TIAH), which has been experimentally implanted in 11 people so far.  This device has costs of about $180,000 per implantation.  On average this device promises five extra years of life expectancy, which would decrease the number of Americans dying of heart disease each year but increase the number who will die of cancer, stroke or Alzheimer’s, all of which are expensive, chronic degenerative disorders.  There is an estimated need for these devices of 350,000 annually, which would add $65 billion to total health spending in the US annually.  Roughly $45 billion of that would be added to the costs of the Medicare program each year. 

            Is a just and caring society morally obligated to cover those costs through Medicare?  Or should that money be used instead to fund an expended prescription drug benefit for the elderly?  Or should it be used to reduce substantially the number of uninsured in our society?  From a moral point of view is it more important that we underwrite socially the costs of Herceptin for women with metastatic breast cancer or that we fund the costs of artificial hearts?  Is it morally relevant that the cost per life-year saved for Herceptin might be $160,000 whereas the cost per life-year saved for the artificial heart might be $35,000?  Is it morally relevant that the women whose lives would be at risk for breast cancer would generally be younger than those who needed the artificial heart?

            About 210,000 patients die of sepsis each year in the U.S.  The New England Journal of Medicine (Sept. 26, 2002) reports that when recombinant human activated protein C (Xigris made by Lilly) is given to patients with severe sepsis and greater severity of illness, there was a 6 percent increase in lives saved compared to current therapy.  This drug costs about $7,000 for a course of treatment.  If we think of this from a cost-effectiveness perspective, the cost is $47,000 per quality-adjusted life-year gained.  But that is not the hard issue.  The hard issue is that there is another very large group of patients with severe sepsis who are medically slightly better off than the prior group.  If they are given Xigris, as opposed to current inexpensive therapy, then there is a very small chance that we might save some extra lives.  But the cost per life-year saved for this latter group would be $575,000 each. 

            Is a just and caring society morally obligated to spend that much per life-year saved?  Why or why not?

            One of the general moral challenges raised by all these interventions is what Daniel Callahan calls the “ragged edge” problem.  There is no clear bright line that separates one group of patients from another; most often they are arrayed along a continuum.  Thus, if we provide Xigris to that first group of patients, the second group will demand it as well (though in reality there is no such “second group”).  If we provide an artificial heart to individuals we believe will gain five extra years of life, then are we morally obligated to provide it to patients faced with death in two months from heart failure who also have metastatic cancer almost certain to cause their death in two years?  How should a just and caring society address fairly the ragged edge problem when it comes to making rationing decisions?

            What lessons need to be drawn from these examples? 

            LESSON ONE: The moral challenges connected to these examples will only grow more frequent and more complex as we move into the future.  There are literally dozens of other examples of last chance therapies from almost any of the major areas of medicine—such as lung reduction for end-stage emphysema or the development of artificial livers or total bowel transplants for patients with short bowel syndrome or a number of other cancer interventions aimed at a metastatic disease process.  While all these interventions tend to get labeled as “medical miracles” they represent at the same time serious threats to a coherent sense of health care justice because of their potential for distorting allocation decisions.

            LESSON TWO: There is no such thing as a “Duty to Rescue” which would justify unlimited funding for all these “last chance” interventions.  The “Duty to Rescue” makes sense, morally speaking, when we have the capacity to rescue identified individuals in great distress, even if the cost of such rescue is many millions of dollars. We see this exemplified when there is a mine collapse or researchers have life-threatening medical problems in Antarctica.  The infrequency of these events permits these costly rescue efforts to be regarded as morally reasonable. But contemporary medicine promises the possibility of such last chance medical rescue efforts for literally tens of millions of us, mostly in very late stages of life, after we have already utilized considerable medical resources to cope effectively with one or more chronic degenerative illnesses.  Further, unlike morally paradigmatic rescue efforts where we save individuals intact with many good years of life to enjoy in the future, these rescue efforts for the most part save marginal quantities of life of marginal quality. 

            LESSON THREE: Neither individual physicians nor hospital ethics committees have the resources or moral authority or moral insight to address any of the justice issues that have been raised in this essay.  We need a process of rational democratic deliberation to address these sorts of rationing issues. 

            Here are the core issues:

1. We cannot escape the need for health care rationing. 
2. Health care rationing includes “last chance” therapies, since the costs there are often very high, the benefits very marginal, and the potential for distorting our social sense of justice very great. 
3. We have no reason to believe that allowing market forces (ability to pay) would result in a “just enough” allocation of “last chance” therapies.  To be sure, there will be many circumstances where ability to pay should settle the matter (since such purchases by the rich do not violate the rights of others, and a judgment has been made that the benefits are too small relative to the costs and relative to other higher priority health needs).  However, in some circumstances  ability to pay may not yield a just enough allocation.  That is, considerations of justice would justify such last-chance therapies being provided in individual circumstances at social expense.
4. Rationing decisions that are just must be public, visible, and available for critical assessment, as opposed to being hidden.  Both the decision itself and the morally relevant reasons that justify the decision must be publicly available, especially to those who might see themselves as adversely affected by these decisions.
5. Rationing decisions are most likely to be fair if they are self-imposed as opposed to being imposed by “others.” 
6. Fair rationing decisions of “last chance” therapies must be made collectively, as opposed to individually.  There could be multiple possible trade-offs, all of which might be “just enough,” that is, morally acceptable from the perspective of health care justice.  But we cannot allow that mix of trade-offs to vary arbitrarily from time to time, or place to place.  That’s why we need a public rational deliberative process to weigh these trade-offs, very specific trade-offs to which the deliberative process gives legitimacy and to which we bind our future possible selves, should we find ourselves in the relevant clinical circumstances.

            A primary virtue of that deliberative process is that we are all there as social and moral equals.  We have no right to use our social position or economic power to extract agreements from others.  Instead, we have to rely upon the force of reason, shared morally relevant considerations that the deliberative process seeks to refine and make more explicit.  Thus, if we collectively judge that patients “such as” Angel Diaz should be denied access to expensive life-prolonging medical care, then the logic of that decision is that we would also deny such care to our own future possible selves, should we be in medically similar circumstances to Mr. Diaz.  There is a ragged edge around Mr. Diaz, which is why the “such as” is in quotes.  One purpose of the deliberative process is to create bright lines and sharp boundaries where the real world presents only ragged edges. 

            There will be multiple morally legitimate places where the ragged edge might be made straight.  We can pick something like age 70 as a cutoff for access to the artificial heart at social expense, or we could pick age 75, or we could pick some degree of medical disability that would reduce too greatly the probability or quantity of medical benefit from the artificial heart—any of these choices could be morally defensible.  But some definite choice needs to be made and socially legitimated in order to protect fairness.

            In conclusion, we need to open a genuine national conversation about the problem of health care rationing.  This problem will become more complex and more intractable with each passing year, especially as the number of elderly in our society will double by 2025.  Failure to have this conversation will severely threaten our capacity to claim honestly that we are a “just and caring” society.

author’s bio: Leonard M. Fleck, Ph.D., is director of MSU’s Center for Ethics and Humanities in the Life Sciences.