“Ariel Sharon dies after 8 years in a coma,” proclaimed one headline. “Brain dead pregnant woman kept alive” said another. Neither headline can possibly be accurate. The former prime minister of Israel was not in a coma. The pregnant woman in Texas is either not brain dead or, if she is dead, no medical technology can “keep her alive.” From simple fainting to death, with coma, vegetative state, minimally conscious state, and persistent vegetative state in between, unconsciousness is a messy business. But it’s time we—the general public, the media, lawyers—got it straight. The distinctions matter.
Once upon a time, if your heart stopped beating and you weren’t breathing, you were dead. Anyone could identify a dead body. But then modern medical science made a few radical discoveries. Medicine showed that some people who looked like they were dead were actually in a kind of state of suspended animation. It turned out that if your heart and your breathing stopped because of profound cold (hypothermia) or certain drugs, you had a decent chance of waking up if you were re-warmed or if the drugs were removed from your system. Medical science led to new technologies such as ventilators that take over for the lungs and pacemakers that stimulate the heart to pump. Dependence on the new technologies was not the same as death. All these developments challenged the traditional notion of death. And then in 1968, a new concept of brain death was born. Articulated by a Harvard Ad Hoc committee, the new way of looking at death emergend from the recognition that the brain is our central processing unit, the organ that organizes and integrates all the functions necessary for human life.
It’s perhaps unfortunate that brain death was originally defined by a committee. It’s regrettable that it was an ad hoc committee and one with the name of a single university attached. But the basic view of this group, that death exists when the entire brain irreversibly ceases to function, has become established as the legally recognized definition of death in all 50 states and the District of Columbia. The American Academy of Neurology has issued guidelines detailing how, in practice, brain death should be determined. Any neurologist, neurosurgeon, or intensive care unit specialist should be able to make the assessment. And it doesn’t require any fancy technology: diagnosing death is basically a clinical determination, though in hospitals today, physicians often use tests such as EEGs or MRIs as “confirmatory evidence.” A person is dead if his brain is dead.
Since the introduction of the modern concept of brain death less than 50 years ago, physicians have learned a great deal about the various forms of unconsciousness. There’s fainting or “passing out,” characterized by transient loss of blood flow to the brain, a reversible condition that is familiar to most people and which can be brought about by marked anxiety or by extremely low blood pressure. Then there’s coma, in which a person is in a deeper state of unconsciousness and doesn’t respond at all to his environment. The eyes are closed. Coma results from conditions such as trauma or stroke and typically lasts no more than a few weeks. People in coma either wake up or move into a vegetative state.
A vegetative state is much like coma except the eyes are open and it can last much longer. The person looks as though he is awake, but he’s not. His eyes wander randomly; he does not respond to words or to physical stimuli. Someone in a vegetative state often has a working brainstem, the part of the brain responsible for automatic functions such as breathing. But he has no cognitive function—no awareness, no ability to think or hear or speak.
From a vegetative state, a person can progress to either a minimally conscious state or a persistent vegetative state. The minimally conscious state is a recently described state in which a person has a very limited amount of higher level brain function: sophisticated tests such as a functional MRI show some kind of neurological response when the person is shown familiar photographs or words. The persistent vegetative state—the other possible next step after a vegetative state—is basically the same as a vegetative state but one that has lasted a long time (months) and is now irreversible.
It should be evident from even this brief description of the varieties of unconsciousness that Ariel Sharon was not in a coma for eight years. Exactly what state he was in is not entirely clear from the public record, but it was most likely PVS. He was sustained by artificial nutrition and hydration. Acute illnesses such as infection were treated with antibiotics. Apparently his death was precipitated by kidney failure: his kidneys shut down and the decision was made not to start dialysis but rather to allow him to die. Whether Marisa Munoz is brain dead or is in a vegetative state is also not clear from the public record. If she’s in a vegetative state then, according to Texas law, medical interventions to sustain her and allow her pregnancy to continue are required, even if she would not have wanted such interventions. If she is brain dead, then she is dead, period. There is no such thing as “life sustaining treatment” for a dead person. We cannot revive the dead. And the state cannot decide to use a dead body as an incubator for a fetus, any more than it can decide to remove organs from a dead body to save the lives of people awaiting transplants.
These in-between states are hard to accept because the people languishing in such a condition—and there are somewhere between 15,000 and 40,000 people in the US in a PVS—do not look dead. They are not cold. Their hearts are beating. Their eyes are open. Common sense tells us they must be alive. But science is often at odds with common sense. Common sense rejected the notion that micro-organisms (tiny single celled organisms that are invisible to the naked eyes) could cause disease. Common sense dismissed the connection between cigarettes and cancer. Common sense holds that pneumonia results from going out into the cold without a hat and that cancer results from repressing emotions. The essence of the science is that it reveals truths that are not self-evident.
Difficult as the distinctions among the different states of unconsciousness may be to accept—and it hasn’t helped that the terminology has evolved over time—we have to get them right. Only then will we be able to spell out in an advance directive how we wish to be treated if we are ever in one of these conditions or to tell our families and physicians. Only then will we be able to make a decision based on our moral understanding, not on magical thinking that allows us to believe that an irreversible condition can be “cured.” People may disagree about the morally correct way to treat someone who is in limbo between life and death. The Catholic Church holds that reverence for the sanctity of life requires that people in PVS be treated with artificial nutrition and hydration.
I think that the best way to show respect for human life is not to confuse it with a mere collection of cells, cells that do not and will never be able to function as a thinking, feeling human being. Accordingly, I think that it is wrong to inflict invasive medical treatment on someone in a persistent vegetative state. I have written a living will in the form of a letter to my husband, my formally designated health care proxy, telling him what approach to medical care I would want if I lost the functions that make me who I am. I encourage everyone to learn about unconsciousness states, to think about what their goals would be for themselves if they developed such a condition, and to share their views with the person who would make decisions for them if they lost the ability to make their own decisions.
The NY Times didn’t cover it; neither did the Washington Post or the Wall Street Journal. But the BBC made a big deal of the G8 “dementia summit,” hosted by the UK just a couple of weeks ago. Representatives from the research world, the pharmaceutical industry, and the Organization of Economic Development, along with government health leaders, met to discuss what to do about Alzheimer’s disease and other dementias.
Seven members of the G8 took the conference seriously: the UK, Canada, France, Germany, Italy, Japan, and Russia each sent their top health representative. The US didn’t send the Secretary of Health and Human Services. We didn’t even send the assistant secretary. We sent the "acting assistant secretary for planning and evaluation" in the Department of Health and Human Services. The title says it all: the US didn’t regard this conference as a priority.
Granted, President Obama already announced his domestic analog, the “National Plan to Address Alzheimer’s Disease,” which looks a lot like the G8 agreement in its ambitious, some would say outlandish, promise to cure Alzheimer’s disease. Granted, the principal American governmental health agency is currently bogged down trying to roll out the Affordable Care Act, which would finally bring the US in line with the rest of the developed world in providing health insurance to its citizens. And granted that the G8’s solemn commitment to “develop a cure or treatment for dementia by 2025” is no more likely to succeed than was Nixon’s 1971 National Cancer Act, aka the War on Cancer. But dementia represents a public health challenge of staggering proportions. Globally there are 44 million people with dementia. Their care costs $604 billion a year. By 2050, barring any substantial progress in preventing or treating the disease, there will be 135 million people with dementia.
What’s interesting about the Summit on Dementia is not the rhetoric about cure; it’s the pledge of eight of the scientifically most advanced countries to cooperate to solve a problem that concerns the entire world. Maybe the promise to share data and to work collaboratively on research is a lot of hype. Maybe the Dementia Summit will prove to be as disappointing as the international conferences on climate change have been. But within the US, there is a movement to break down the barriers between specialties and to promote genuinely interdisciplinary research. There is a growing sense that cooperation may be more powerful than competition in science. Working together with other nations to improve the care and treatment of people with dementia seems like a great way to break down barriers. How’s that for a New Year’s resolution?
From both an individual and a public health perspective, frailty is one of the most important conditions affecting older people. Along with dementia, which is really just cognitive as opposed to physical frailty, it is a devastating syndrome. Frailty predisposes to recurrent hospitalizations and leads to the dreaded cascade of iatrogenic complications once someone is in the hospital. Frailty leads to nursing home placement and to disability and death. So a recent consensus statement discussing how to approach frailty is one of the most exciting and significant papers to appear in the recent geriatric literature. Published in a third tier medical journal, it’s only by chance that I stumbled on the article at all.
The consensus paper, authored by 20 geriatricians and including some of the most distinguished figures in the field, is based on a conference convened a year ago for the sole purpose of arriving at a shared perspective on frailty. It offers a definition of frailty, a few validated simple screening tests, several possible medical interventions, and the recommendation that physicians routinely screen for the disorder in people over age 70. The definition the authors came up with is “a medical syndrome with multiple causes and contributions that is characterized by diminished strength, endurance, and reduced physiologic function that increases an individual’s vulnerability for developing increased dependency and death.” Sounds like something written by a committee, but it hits all the high points. One of the screening tools the authors favor is the FRAIL questionnaire. Ask 5 simple questions: are you tired (Fatigue); are you unable to walk up 1 flight of stairs (Resistance); are you unable to walk 1 block (Aerobic); do you have more than 5 illnesses (Illness); and have you lost more than 5% of your weight in the past 6 months (Loss of weight). A score of 3 or greater (a yes answer counts as 1 point) indicates frailty. A score of 1 or 2 implies pre-frailty.
Frailty can seldom be cured and is often progressive, but in some cases it can be ameliorated. Exercise, nutrition, and medications can all help. In particular, the authors cite a review article indicating that 45-60 minutes of exercise done 3 times a week is beneficial. Calorie supplements can promote weight gain and reduced mortality in those frail old people who are undernourished. In people with a low vitamin D blood level , vitamin D supplements can reduce falls, hip fractures, and mortality. Reviewing all prescription medications and getting rid of selected drugs can also be useful. Finally, the conference concluded that primary care physicians as well as other clinicians should routinely screen for frailty in the geriatric population.
No one wants to be labeled “frail.” It’s up there along with “elderly” or “old” as a term everyone seems to want to avoid. But far better to prevent or treat the condition than to pretend it doesn’t exist. It’s time for doctors to pay attention to frailty—to recognize when it’s present and to intervene when possible. How’s that for a New Year’s Resolution!
How often does anyone come up with an idea for improving medical care that does good and saves money at the same time? Not very often. Even inventions that ought to save money often don’t—for instance, a number of years ago, surgeons figured out how to take out a person’s gallbladder using a fiberoptic device called a laparoscope. Instead of a five-inch incision, patients have a one-inch incision; instead of a 5-day hospitalization, they spend a single night in the hospital; instead of a 6-8 week recuperation period, patients are up and about within days. Good idea? Absolutely. Money-saving? Not so clear. What happened is that the rates hospitals charged for the procedure were based on the “equivalent” alternative procedure that insurers were used to paying for, so the per procedure charge wasn’t much less than standard gallbladder surgery that involves cutting open the abdomen. Not only that, but the total number of people getting gallbladder surgery went up dramatically after the simpler procedure was introduced. Net result? No decrease in overall spending on taking out people’s gallbladders. So when something comes along that both improves outcomes and saves money, it’s worth taking note and celebrating. Palliative care, as a recent article in the New England Journal of Medicine points out, is exactly that kind of remarkable invention.
Palliative care is not synonymous with hospice care. It is not the same as end-of-life care. And it is not a court-of-last-resort, what you get when you’ve exhausted all possible other treatments. Palliative care, as the Center for the Advancement of Palliative Care defines it, is “an extra layer of support,” something that is appropriate at “any stage in a serious illness.” Patients can have palliative care and life-prolonging treatments; they can, for instance, have chemotherapy or radiation therapy as treatment of cancer along with palliative care. What palliative care adds to conventional treatment is a whole team of clinicians (typically a doctor, nurse, and social worker, though it can include a chaplain or music therapist or other professional) whose focus is on managing symptoms (problems such as pain or nausea or depression), on advance care planning (on preparing for future medical care), and on providing psychosocial support to the patient with a life-limiting illness and his or her family.
Several studies have now shown that early palliative care improves quality of life and may even lengthen life. In advanced lung cancer, in which patients typically have a prognosis of at most a year, patients who received outpatient palliative care along with conventional cancer care were less depressed, had fewer physical symptoms, and actually lived longer than those who did not get palliative care. Similar findings have been reported for people with severe heart failure, severe chronic lung disease, and for people with multiple sclerosis. My clinical work suggests the same is true for older people with physical frailty or with cognitive frailty (dementia).
What’s remarkable is that palliative care also saves money. It leads to shorter hospital stays, fewer days spent in an intensive care unit, and fewer expensive tests, all without shortening life. But most patients with life-threatening illnesses do not receive palliative care services? Why not? The New England Journal article suggests that the way to improve the situation, and implicitly the reason for the current limitations, is by changing the payment system so that insurers would pay physicians for counseling about end of life care, by reforming the medical education system to increase palliative care training, and by improving access to palliative care by making consultation available at all hospitals. These are all reasonable strategies, but I don’t think they get to the heart of the problem.
The main barrier to extending the benefits of palliative care more widely is not economic—palliative care physicians have been successfully billing Medicare and other insurers for their services for years by transforming a “family meeting” into a “history and physical examination” through the inclusion of a few comments about the patient’s medical problem (the “history”) and appearance (“physical examination”) into the medical record. The main barrier to more widespread use of palliative care is psychological. Even though patients and their families who do avail themselves of palliative care generally like what they get, many patients refuse palliative care services because they do not want to face their mortality. At the same time, physicians do not want to propose palliative care because they think they are conceding defeat in the “fight against death.” And Congress does not want to legislate changes in Medicare and Medicaid that mandate broader use of palliative care because of the "death panel" legacy. The truth is that we are all mortal. The question is not whether we will die but what our journey will look like. Maybe it’s time to face this reality.
Physicians are not known for their communication skills. Despite sessions in medical school and during residency addressing topics such as “breaking bad news” and “discussing prognosis,” clinicians still do not perform well. A new program for both doctors-in-training and nurse practitioner students sought to improve the poor track record.
Participating students attended eight 4-hour workshop sessions addressing communication in end-of-life care. Each session included a short lecture, a demonstration by a faculty member of good communication, a practice session for the trainees using a simulated patient, and a discussion. A total of 184 students completed the workshops; another 222 completed “usual education.” (The vast majority were physicians- in-training and only a few were NP students, so I will restrict my comments to doctors). The students were evaluated for their proficiency in communication and their skill in providing end-of-life care after the educational intervention, with physicians, patients, and family members all contributing to the evaluation process. The bottom line: the workshops did not appear to accomplish anything. Students who participated in the workshops performed at almost exactly the same level as those who received the “usual education,” both in their communication skills and in their delivery of end-of-life care. In fact, the only measurable difference between the two groups was that patients whose physician had taken the training were more likely to end up being depressed than those whose physician did not. What are we to make of these findings?
The authors offer several interesting possible interpretations. They point out that an earlier study showed that patients who understood they had a very poor prognosis were more likely to rate their physicians’ communication skills as poor than those who incorrectly believed their prognosis was pretty good. So it is entirely possible that what palliative care physicians mean by “good communication skills” is not what patients and families mean. Palliative care doctors think that good communicators give patients a realistic understanding of their clinical situation and elicit their patients’ preferences for future medical care, all in a compassionate and caring way. Maybe patients and families equate “good communication” with encouragement, or instilling hope, or holding out the prospect of cure, however implausible cure may be. Maybe objective assessments by trained faculty are a better way of evaluating success than are patient and family reports; it turns out that when faculty did the evaluating, they found that students did improve after the workshop. Maybe expecting that the students would do a better job providing end-of- life care after a workshop on communication was naïve; after all, excellent end-of-life care includes expert pain management, good diagnostic skills, and appropriate referral to other clinicians, not just good communication.
I’d like to suggest a different conclusion. Perhaps it’s time to stop investing so much effort in trying to change physicians. We should turn instead to a radically different way of educating patients and helping them make the difficult decisions they face near the end of life. One of my colleagues has taken just such a tack. He designs short videos to show patients and their families the medical conditions they have and the interventions they might be offered. Multiple studies have now demonstrated that patients who watch these videos have a much clearer idea of what is at stake and express different preferences from patients who hear a verbal description of their disease and the options for treatment. The videos do not replace clinicians; rather, they give patients a strong foundation on which to build when they talk with their physician. They allow doctors to go beyond explaining the basics and they allow patients to apply the information they have learned to their specific situation.
Most of my career has been devoted to trying to be the best possible communicator with my patients, on the one hand, and to writing books and articles to help clinicians and patients make better decisions, on the other. So it pains me to think that this intensely verbal approach may just not be as effective as carefully constructed videos that show the realities of advanced illness and contemporary treatment. I will continue to write (this blog included) because that’s what I do. But I will also partner with my young colleague to create scientifically accurate videos, reviewed by experts, that complement all those words.
Perhaps Eliza Doolittle put it best, in My Fair Lady:
Words, words, words
I’m so sick of words…
Sing me no song, read me no rhyme,
Don’t waste my time, show me!
Please don’t implore, beg or beseech,
Don’t make a speech, show me!
My mother will turn 88 in a few weeks. According to the definition of successful aging put forward by Rowe and Kahn nearly 16 years ago, she is aging quite well. Her kidneys, lungs, and heart work fine. She is still very active—she teaches a French class once a week at the local senior center, she tutors English to foreigners, she plays scrabble with friends, and she drives daily to visit my father at the nursing home where he lives. My mother does have her share of medical problems: she has painful arthritis affecting her knees and her back and she is very weak, finding it difficult to turn a door knob or to lift a container of milk. Until about a year ago, she walked at least a mile every day, but now she can only take short walks and has to sit down frequently. Her memory isn’t what it once was, though it’s still pretty good. My mother will say that “old age is no picnic” and that “people live too long” today. When her physician told her she was aging gracefully, she told him he was full of it. Her doctor has one perspective on successful aging; she has another one. How are we to put the two views together? Are we using the right definition of “successful aging?”
A new study in The Gerontologist tries to answer this question. The authors carried out in-depth interviews with 56 elders who have significant disabilities and are enrolled in the On Lok program, the original PACE program (Program of All Inclusive Care for the Elderly) in San Francisco. Members of PACE all have enough disabilities to qualify for entry into a nursing home and for Medicaid enrollment, so they are both frail and poor. In fact, the group studied had an average age of 78; 64% were women; the average number of ADL dependencies (problems in areas such as bathing or dressing) was 2.2 and the average number of IADL dependencies (areas such as food shopping or cooking) was 6.6. It was a diverse group, with 23% African American, 32% Asian American, 20% white, and 20% Latino.
By and large, the group held the view that aging is an unavoidable process that entails disability. The key to successful aging, they said, was to accept your limitations and to adapt. If you have trouble walking, use a walker. If a walker isn’t enough, use a wheelchair. They also tended to focus on relative disability rather than absolute disability—as long as there were others who were worse off, then they felt they were doing well. The minority who said they hadn’t aged successfully commented that they had not found ways to adapt to their disabilities and they felt were a burden to their families.
So the PACE elders and my mother don't have quite the same perspective. My mother would agree that it’s critical to accept your limitations and to adapt, and she's done that. She doesn’t want to be a burden on anyone, and she isn't. But I doubt she would say she is “aging well." She is aging better than my father, who has dementia and Parkinson's and lives in a nursing home because he needs help with just about everything, but she wouldn't call herself a phenomenal success.
Perhaps the whole idea of “successful aging” or “aging well” is the wrong way to think about this phase of life. For no other stage of development do we assign grades: we don’t say someone had a “successful childhood” or a “failed adolescence.” We might refer to their emotional state during a particular stage: someone might have a “happy childhood” or a “troubled adolescence.” We might use the label “successful” for a career or a marriage, but not for a part of the life cycle. So why do we insist on evaluating aging in this way?
Instead of grading aging, government and professionals should do work to assure that people are satisfied with their lives and are contributors to their community. After all, this is arguably the goal for the entire population, regardless of age. Our challenge is to figure out how to achieve this for people who are old and frail, whether because of physical impairments, cognitive impairments, or both.
Just as we cannot eradicate inequality among people—they have different genetic endowments, they are born into different families and different cultures—but we can aspire to provide equal opportunity, perhaps our goal for older people should similarly be to promote equality of opportunity. We cannot eliminate differences in disease burden or disability, but we can seek to assure that everyone has a fair chance to make the most of themselves, whatever their situation. It’s time to switch from talking about “successful aging” to coming up with a successful aging policy.
The remembrances of JFK this week focused, understandably, on his great promise and how an assassin’s bullet burst the bubble of optimism and exhilaration generated by his election. Implicit in this perspective, however, is the suggestion that all that came after Kennedy was pessimism and gloom, epitomized by the Vietnam War. What is ignored by claims that it-was-all-downhill-after-JFK is that for all Kennedy’s youth, his oratory skills, and his brilliance, he was in many ways not a terribly effective president. Left largely unsaid is that it was under LBJ, the consummate politician, that progress was made on the liberal agenda. It was LBJ who pushed the Civil Rights Act, Head Start, the Food Stamp program—and Medicare and Medicaid--through Congress.
For 50 years, America had resisted national health insurance. Theodore Roosevelt (yes, the Republican Roosevelt) supported national health insurance in the election campaign of 1912, arguing that no society could be strong whose people were sick and poor. But he lost the election and the issue largely faded from the national agenda until a different Roosevelt became president in 1932. While enthusiasm for national health insurance grew within FDR’s administration, the president himself never championed it as he faced relentless opposition from the AMA and state medical societies.
Truman picked up the baton after WWII, but again confronted insurmountable opposition from the AMA as well as other powerful health care organizations such as the American Hospital Association. Thus, despite continued public support—polls every couple of years between 1936 and 1945 showed a large majority of Americans supported government health insurance—Congress balked. The passage of legislation providing comprehensive national health insurance for the poor (Medicaid) and the elderly (Medicare) during the Johnson Administration in 1965 was an extraordinary achievement, launching a very popular program from which older people continue to benefit today.
Just how important Medicare is to the health and well-being of the 47 million people (8 million disabled Americans and 41 million older individuals) now covered by the program was brought home recently by the publication of an article reminding us that access, affordability, and insurance complexity are generally worse in the US than in 10 other developed countries.
American's poor access and affordability arise largely because of the enormous uninsured population in the US—a situation that does not affect older people, thanks to Medicare, and that will be less of a problem if the Affordable Care Act is allowed to go into effect. Even among insured adults in the US, however, high out-of-pocket spending was a problem, chiefly because of the high deductibles and cost-sharing in many US insurance plans. This problem is less likely to affect older people in light of Medicare’s comparatively modest cost-sharing.
Access to primary care was less good in the US than in many other developed nations, a problem that was particularly severe for the uninsured. This is one domain that also affected the insured, including those with Medicare, because of a relatively poorly developed primary care infrastructure in the US.
In the area of administrative costs and complexity, the US was an outlier, with US health insurers spending $606 per person on administrative costs, more than twice as much as the number 2 spender, Switzerland, and 17 times as much as the number 11 spender, Norway. While there is considerable debate about just how to compute administrative costs of a health insurer, some of the best estimates indicate that Medicare spends less than 2% of its operating expenditures on administrative costs, compared to 11% for Medicare Advantage Plans (the private Medicare spinoffs) and 12% or higher for other private insurers.
Let us celebrate what Medicare has achieved—reasonably good access to comprehensive care at an affordable price for consumers—and make sure that we do not sacrifice these accomplishments as we improve Medicare to make it more responsive to contemporary medical problems and to slow the rate of rise of health care costs. And as we pay tribute to Medicare, with all its imperfections, let us also recognize that the Affordable Care Act, with all its imperfections, aims to do for the rest of the population what Medicare has done for the elderly and the disabled. Obamacare is not national health insurance--it is as its core a plan designed by Republicans, supported by big business, and relying on private rather than government insurers--but its intent is to extend the indubitable benefits of health insurance to another 30 million Americans.
The 1.4 million people who live in nursing homes are among the most vulnerable, powerless individuals in American society. They are old (mean age 79.2), they are physically frail (60% are unable to do 4 or more of the most basic daily activities), and most of them are cognitively impaired, many of them severely (39%). Nursing homes have come a long way since the bad old days when residents were tied up, neglected, and abused, and one of the stratagems for improving care has been the “care planning meeting.” A plan of care must be developed by the facility staff for all new admissions to nursing homes that are Medicare or Medicaid certified, addressing physical, emotional, and medical needs. These plans are reviewed on a quarterly basis—more often if there is a major change in status, such as a hospitalization. And one of the innovations of the last decade is to invite family members to participate in care planning meetings. This gives families information about their loved one and an opportunity to make suggestions and raise concerns. But one issue that neither staff nor families routinely raise and that the many websites that advise families about how to negotiate the unfamiliar nursing home terrain is medications. And that, specially in light of recent revelations, is an essential question.
The recent revelation is that Johnson & Johnson, the world’s largest drug company, just settled a variety of civil and criminal complaints about its sales of the psychiatric drug Risperidone (Risperdal) for $2.2 billion (yes, that’s billion) J&J “accepted accountability” for misbranding Risperdal as useful for treating elderly patients with dementia, for marketing Risperdal for the elderly, and for paying kickbacks to both physicians and to Omnicare, the largest pharmacy supplying nursing homes, for using the drug.
It’s been known for quite some time that drugs like risperidone, an “atypical” neuroleptic used in the treatment of schizophrenia, come with considerable side effects. Though less likely to cause Parkinsonian symptoms than earlier “typical” neuroleptics such as chlorpromazine (Thorazine) or haloperidol (Haldol), it can cause sedation, low blood pressure, and dry mouth, among other symptoms. Then it was shown to increase the risk of diabetes and weight gain. And a meta-analysis in 2005 found it increased the risk of sudden death by death by 60-79%, which led to the FDA issuing a “black box” warning—a warning on the risperidone label highlighting its hazards. Families and physicians might have been willing to accept the risk of side effects and even of death when the drug was used in people who were already very old and very sick if it had been effective. Unfortunately, a series of studies looking at whether risperidone and other “atypical neuroleptics” (similar drugs in the same class) were effective in controlling the behavioral symptoms of dementia—problems such as agitation or paranoia—found only limited evidence that it achieves these goals.
Since behavioral symptoms are often very difficult to control and create problems both for the patient and for nursing homes, physicians have continued to use neuroleptics including risperidone “off label,” that is for uses other than those for which the FDA approved them. This is an entirely legitimate practice. What is not legal is for drug companies to advertise their drugs for use in these conditions or to bribe physicians or pharmacies to use the drugs.
The Justice Department is hoping that the new settlement (in which, by the way, J&J does not admit any wrongdoing) will stop the prevailing practice and serve as a deterrent to this kind of behavior in the future. Given that GlaxoSmithKline settled with the government last year for $3 billion over similar behavior with respect to two antidepressants (Paxil and Wellbutrin), along with a diabetes drug, and that Pfizer made a payment of $2.3 billion in 2009 over inappropriate marketing of several other drugs, it’s not so clear that ithe deal will deter outrageous behavior. It is entirely possible that settlements of this kind are seen by Pharma as the cost of doing business. Everybody misbehaves all the time; occasionally a company is caught; on balance, a periodic payoff may be worth the tremendous benefits. After all, at its peak in 2007, J&J sold $4.5 billion worth of Risperdal. The company has now signed a 5-year “corporate integrity agreement” in addition to paying the fine, but analogous agreements signed by medical device manufacturers in the past led to no substantive changes in behavior.
So in those care planning meetings in the nursing home, if they ask nothing else, family members should ask “what drugs is mom on?” And that should be followed by “why is she on them?” and “are they helping?” And if there is no good reason for giving the medication, ask that it be stopped, especially neuroleptics. It will save mom a lot of misery—and save money for all of us.
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Teeth matter. Not just to chew food, although that is critically important to older people, who are at greater risk of undernourishment than of obesity. Not just for esthetic reasons, although appearance is an important part of self-esteem and teeth are an important part of appearance. Oral health is a significant ingredient in the overall health of older people. For years, geriatricians have recognized poor dentition as a risk factor for pneumonia--the bacteria that build up in dental plaque can get into the lungs and cause infection. The Journal of the American Geriatrics Society, the leading professional journal dealing with medical issues in older individuals, has a special section each month called “Dental and Oral Health,” much as it has a section on”Ethics, Public Policy, and Economics” and one on “Educating and Training.” In October, the article in the “Dental and Oral Health Section” was on oral health in old people with diabetes (it’s poor). So if teeth are so important, why isn’t dental care covered by Medicare?
It turns out that lots of arguably important services are not covered by Medicare. In large part, what is covered and what isn’t is still governed by the original 1965 legislation enacting Medicare (Title XVIII of the Social Security Act). Medicare excluded then, and still excludes today, eye exams, refractions, and eyeglasses, as well as auditory exams and hearing aids. It excludes “services that are not medically reasonable and necessary,” although nobody knows what exactly is reasonable and necessary and Congress has assiduously avoided defining the term, resulting in the exclusion of cost from consideration in determining Medicare coverage. Some of the services excluded from the original legislation have since been added in: for example, prescription drug coverage is available thanks to the Medicare Modernization Act of 2003, and certain preventive care such as colorectal cancer screening, Pap smears, and prostate cancer screening have been added. But dental care remains an exclusion: “Items and services that are furnished in connection with the care, treatment, filling, removal or replacement of teeth” are off the table.
Older individuals can have private dental insurance, just as younger people can. But this raises another problem. Dental insurance itself isn’t really insurance at all. It covers routine preventive and maintenance care but specifically excludes the costliest treatment. Typical policies have a $2000 per person annual maximum. All it takes is one or two root canal treatments and the bills start to mount up. So dental insurance has it backwards—it covers the small stuff and leaves you vulnerable to the big bills. The essence of insurance is supposed to be that it protects against extreme loss: as Wikipedia puts it, an individual assumes a guaranteed and known relatively small loss (the premium paid to the insurance company) in exchange for a promise to compensate the insured in case of a far greater loss.
Medicare includes neither reasonable dental insurance (payment for costly care such as dentures or root canals or extractions) nor conventional dental insurance (payment for routine preventive care and filling simple cavities but minimal coverage for anything else). The reason that Medicare doesn’t cover teeth or a whole host of other services that older people need is that Medicare was designed as insurance for hospital care. While it has gradually expanded—originally, it wasn’t even going to pay doctors—it is only slowly adapting to contemporary reality. What Medicare is still best at is providing comprehensive coverage for acute illness: all the high tech diagnostic procedures and treatments, from PET scans and cardiac catheterizations to surgery and intravenous chemotherapy. What Medicare is not so good at is addressing chronic disease. And most older people suffer from chronic disease. Over two-thirds of people on Medicare have more than one chronic condition; 21% have four to five chronic conditions and 14% have six or more.
Good geriatric care has to be coordinated, integrated, and patient-centered, but Medicare does little to foster any of these features. Medicare still does not pay for case managers to facilitate integration; it is largely fee-for-service, undermining any realistic possibility of integrating physicians, hospitals, and nursing homes; and it does nothing to encourage patients to discuss their goals of care with their physicians. A few experimental programs are underway to remedy these deficits, such as Accountable Care Organizations (to promote integration) and disease management programs (to promote coordination and self-care). But we’re a long way from having a truly modern Medicare program that serves the needs of frail elders and near-frail elders along with those of their more robust counterparts.
So the critics are right that we need to do something about Medicare. But what we need to do is not to privatize the program or cut benefits. If we want to put teeth into Medicare, we should add true dental coverage— and overhaul the program so that it focuses more on chronic care rather than acute care, more on home care than on hospital care, and more on human care than on technological care.
Since the 1990s, physicians and patients have been fighting over futility. The doctors look at a patient who is dying and say that further tests and treatment cannot possibly work and shouldn’t be done. The patients, or more commonly their families, look at those same patients and say that they want “everything done” to try to prolong life.
As often happens in the US, the futility battle ended up in the court room. In the case of Helga Wanglie, an 86-year-old woman in a vegetative state after hip surgery, the doctors went to court over whether the patient's husband had the right to insist that she remain on a ventilator. The court, as also often happens, didn’t address the issue of whether the ventilator was or was not appropriate treatment for Mrs. Wanglie; it simply ruled that her husband, as her surrogate, had the right to make the decision. After that case, many physicians concluded that the fight over futility was itself futile. For the last 15 years, physicians have tried to focus on determining a patient’s goals of care and then suggesting what treatments are most consistent with those goals. When they still cannot agree with family members about the right course of action, they resort to mediation, sometimes provided by a hospital ethics committee. But simmering below the surface, conflicts over perceived futility rage bubble vigorously.
A short article in the New England Journal of Medicine, “The Debt of Life—Thai Lessons on a Process-Oriented Ethical Logic,” offers a refreshing way of looking at futility. Based on his experiences doing ethnographic field work in Thailand while a graduate student in Anthropology, physician Scott Stonington shines a new light on the typical ICU dilemma. The physicians, he reports, are loathe to perform various possible tests and treatments because they think in terms of outcomes. They argue that their interventions won’t work in the sense that they won’t overcome the existing medical problems and that they are burdensome to the patient and, parenthetically, expensive. The patient’s family, he observes, think in terms of the process of care. He comments on one Thai family who said that their father had given them “flesh, blood, and breath” so they had a “debt of life” to pay. The ICU, they reasoned, allowed them to repay their debt: it gave their father flesh (tube feedings for nutrition), blood (intravenous medications and dialysis to cleanse the blood), and breath (a ventilator for breathing). The family was not so much interested in the outcome of treatment as in the treatment itself. In this scenario, the conflict was ultimately resolved when the family came to the conclusion that they had paid their debt and further aggressive care could be discontinued.
I made a very similar argument in my essay, “The Standard of Caring: Why Do We Still Use Feeding Tubes in Patients with Advanced Dementia?” I noted that it had been over 10 years since a series of studies in the medical literature reported that feeding tubes (a tube inserted into the stomach to provide nutrition) did not prolong life in patients with advanced dementia who had eating difficulties. These patients are nearing the end of their lives and no matter what procedures they have, their prognosis remains pretty much the same. Not only don’t the tubes prolong life, but they don’t accomplish a variety of other goals that doctors had hoped they might: preventing pressure ulcers (skin breakdown that is often related to malnutrition) or preventing pneumonia (caused by food going into the lungs instead of the stomach). As a result of these studies, the rate of tube feeding people with advanced dementia has declined, but it is still far from zero. I suggest that the reason some families want a feeding tube is to show that they care. It’s not that they expect to improve some quantifiable outcome—living longer or avoiding pneumonia. It’s that they want to have a way to demonstrate caring. For the same reason, we keep people with advanced dementia clean and dressed. We don’t require a study that shows that they will be less likely to develop an infection if they are kept clean. We don’t demand proof that they will live longer if they are clothed. We assume that being clean and clothed contribute to well-being because they are among the only ways we as caregivers have of showing respect for the human being who happens to have dementia. Tube feeding, from this perspective, is a means of proving that we care.
There’s an important conclusion to draw from the tube feeding example, a conclusion that applies to the ICU situation as well. If we want to dissuade families from advocating feeding tubes for their relatives with advanced dementia, we need to offer a viable alternative way to demonstrate caring. I suggested using special popsicles made by freezing high protein liquid supplements for patients who have trouble chewing and swallowing but can still suck. Hand feeding, laboriously spoon feeding someone who has trouble feeding himself, is an alternative for people who can still process food in this way. But simply telling families that we won’t feed their relative at all and trying to assure them that the person with advanced dementia will not experience hunger or thirst fails to offer any means of caring. In the ICU setting, perhaps what we need to do is not continue burdensome treatment until families feel their “debt is paid.” Perhaps instead what we need to do is to find genuine alternatives to painful or uncomfortable or undignified treatment. But unless we offer something rather than what families perceive as nothing, we will be stuck with providing what physicians regard as futile treatment. Hospice care is intended to serve this role, but may not offer enough active interventions to satisfy family members. Our challenge is to identify ways to truly show we care.
