November 07, 2006

Alzheimer’s Centennial

On November 6, 1906, Alois Alzheimer presented a paper to his medical colleagues describing a patient, Auguste D, who had a progressive, ultimately fatal form of dementia. He studied her brain tissue under the microscope after she died, describing the tangles and plaques that would become the hallmarks of the disease. Her illness, which he distinguished from the “senility” found so often in elderly patients—Auguste D was only 51—would become known as Alzheimer’s disease.

It would take more than half a century until we recognized that “senile dementia” and “Alzheimer’s disease” were one and the same. Most people who develop this dread condition, marked by cognitive changes (memory loss being the earliest and most striking example), behavioral changes (agitation and often paranoia), and ultimately, total dependence on others for the most basic functions of daily life, are in their seventies or eighties. Less commonly, they develop the same symptoms at a much younger age. Often these individuals have a hereditary form of the disease—but it is fundamentally exactly the same disorder.

How much progress have we made in understanding and treating Alzheimer’s disease in the past 100 years? An article in the British periodical, The Lancet, (Konrad Maurer, Ian McKeith, Jeffrey Cummings et al, “Has the Management of Alzheimer’s Disease Changed Over the Past 100 Years?” Lancet 2006; 368: 1619-1621) argues that many of the basic approaches to care remain unchanged, though the number of available medications has increased enormously. The authors indicate that already a century ago, Alzheimer understood that a key element of care was the environment. Patients with dementia need calm and compassionate caregivers and an atmosphere that is distracting but not excessively stimulating.

But what about all those medications we use today—Donezpezil (Aricept) and Memantine (Namenda) and drugs such as Risperidone (Risperdal) and Olanzapine (Zyprexa)? Just how much better are they than the small doses of alcohol and sedatives such as chloral hydrate and paraldehyde that were used in Alois Alzheimer’s day? Today’s pharmacologic agents may have fewer side effects than their predecessors, certainly an important consideration, but they are far from benign—the antipsychotics, for example, have been associated with an increased risk of stroke.

What concerns me is that the effectiveness of the medications we routinely and liberally use in Alzheimer’s disease is regrettably only modest. The cholinesterase inhibitors (such as Aricept) result in a statistically significant improvement in measures of global function—but it’s far from clear that they make a real difference in the daily lives of most patients and their caregivers. A review of all studies on these drugs by the British National Institute for Health and Clinical Excellence concluded the evidence for real benefit was so questionable that they should not be considered the standard of care (see my blog posting, “Americans, Alzheimer’s, and Aricept..”) The antipsychotic drug that are commonly used for agitation, restlessness, paranoia and other major behavioral features of Alzheimer’s have just been examined at in the most sophisticated and careful study to date. Unfortunately, the conclusion of this study is that these medicines are usually no more effective than placebo (See Lois Schneider, Pierre Tariot, Karen Dagerman et al, “Effectiveness of Atypical Antipsychotic Drugs in Patients with Alzheimer’s Disease,” New England Journal of Medicine 2006; 355:1525-1538). And the glutamatergic antagonists (ie Memantine) have been shown to slow the progression of disease in patients whose dementia is already advanced—an effect which some might regard as tantamount to leaving patients suspended in a condition worse than death. (See Barry Reisenberg, Rachelle Doody, Albrecht Stoffler et al, “Memantine in Moderate-to-Severe Alzheimer’s Disease,” New England Journal of Medicine 2003; 343:1333-41).

Scientists have made remarkable strides in understanding the genetic and biochemical underpinnings of Alzheimer’s disease. Several promising avenues of research into treatment are being vigorously pursued—a vaccine, tested in mice, has led to dramatic regression of plaques in the brain. But bran diseases are extraordinarily complicated and those affecting thinking are particularly recalcitrant to treatment. Perhaps we should spend as much effort on designing more humane environments in which to care for people with dementia as we do searching for a pharmacologic fix.

September 18, 2006

A Time to Be Born, A Time to Die

On September 6, the Food and Drug Administration (FDA) approved the use of the artificial heart. The AbioCor heart, the device that was approved, has been used in 14 people. Their experience formed the basis of the FDA decision. All 14 had very advanced heart failure at the time of the surgery, so advanced they were not expected to live for more than a month. They could scarcely walk without getting short of breath and they were not candidates for a heart transplant (typically because of their age or other medical conditions). All 14 have died: 2 died during surgery, and 6 of the survivors suffered strokes. They lived an average of 5.2 months with the surgery, including one subject who lived for 17 months. However, only one was discharged home. Ten left the hospital only with short passes, and 1 moved to a hotel near the hospital. The cost of the device has been set at $250,000 by AbioMed, its manufacturer. The hospital charge for the insertion (not counting the cost of the prolonged hospital stays that have been required to date) is estimated at $100,000.

A little over a year ago, the scientific advisory panel to the FDA recommended against approving the device. FDA approval is contingent on a device being “safe and effective.” The artificial heart was deemed “effective,” since it prolonged life from an expected one month to an average of 5.2 months. The advisory panel, by a 7:6 vote, concluded they could not consider a device which led to major strokes in 50% of the recipients and which kept almost all patients hospitalized until their deaths “safe.” Usually, the FDA heeds the recommendation of its advisory panel. In this instance, without any engineering modifications since the advisory panel met in June, 2005, the FDA nonetheless approved the device. What happened?

The story of just who put pressure on whom to win approval of the device has yet to be researched. Interestingly, back in 1976, the director of the National Heart, Lung and Blood Institute tried to pull its contracts with 4 firms for designing and manufacturing the total artificial heart on the grounds that the technology was too flawed and too expensive. He didn’t expect anticipate the response from 2 powerful senators, Orrin Hatch of Utah and Edward Kennedy of Massachusetts, in whose states several of the firms were based. At their insistence, the contracts were reinstated—including the one to Abiomed, the Danvers, Massachusetts firm that produces today’s AbioCor heart. (For further insights on the history of the AbioCor heart, see the article by Renee Fox and Judith Swazey, “He Knows That Machine is His Mortality: Old and New Social and Cultural Patterns in the Clinical Trial of the AbioCor Artificial Heart,” Perspectives in Biology and Medicine 2004; 47:74-93).

What we know today is that the FDA decided not to grant full approval, but to allow use of the device under its “humanitarian exception” provision.” The standard in these cases is that the device be “safe and probably beneficial” and that the condition for which it is used afflicts fewer than 4000 individuals per year. The FDA, to be fair, has a tough job. It has to weigh the risks and the benefits of a new device. It has no clear calculus for doing this. In clinical practice, we typically offer treatments that “work” and expect patients to figure out, using their own personal values, whether the potential advantages of the treatment outweigh the disadvantages. When the treatment (whether drug or device) simply doesn’t do what it’s supposed to do, the job is fairly easy. When it does what it’s alleged to do, but there’s a safer alternative, the job of deciding on approval is also fairly straightforward. In the case of the artificial heart, it seems to “work,” if we define working as, on average, prolonging life. But the cost to the individual is enormous. Tom Christenson, the one subject who lived for 18 months after the implant, developed a fever to 107, kidney and liver failure and respiratory problems. He actually made it home for a few months, only to be readmitted to the hospital at which point the decision was made to disconnect the power source of the device and allow him to die.

Just because the FDA has approved use of the device doesn’t mean that it will automatically be paid for by the major health insurers. Medicare, for instance, has a process for making coverage decisions for controversial technologies such as the artificial heart. Medicare is required by law to make available to enrollees in the Medicare program any medical intervention that is “reasonable and necessary,” a phrase even less well-defined than the FDA’s “safe and effective.” Officially, Medicare is not supposed to take cost into consideration. This has become increasingly problematic as more and more expensive and only marginally useful procedures have entered medical practice, such as lung volume reduction surgery (an operation in which parts of the lung are cut out of patients with emphysema), the implantable defibrillator (a device that automatically shocks the heart if it detects a potentially dangerous heart rhythm), and the left ventricular assist device (another device used for patients suffering from very advanced heart failure, one that boosts the function of the heart rather than replacing the heart entirely). As a result, the Centers for Medicare and Medicaid Services has begun setting the price it will pay for certain procedures far below their actual cost—the left ventricular assist device was initially reimbursed at $70,000 even though the device alone cost $65,000 and the surgery to insert it typically cost over $200,000. With the AbioCor Heart, if Medicare does agree to cover the device, it will no doubt employ a similar strategy: it will choose to permit use of the device but pay something like $150,000—roughly what it pays for a heart transplant but less than half the cost of the new procedure—a strategy that will no doubt put a crimp on actual use of the procedure. (See my article, “Medicare Coverage for Technological Intervention: Time for New Criteria? Published in the New England Journal of Medicine 2004; 350: 199-203).

Replacing the human heart has been the American dream since the National Institutes of Health established an Artificial Heart Program in 1965. Originally granted $600,000 and 5 years to achieve its goal, the project has continued for over 40 years. Along the way, it has been critically reviewed multiple times, sometimes with the recommendation that the work continue only if the technology is expected to be cost-effective, or a good “value for the money.” At $350,000 to implant the AbioCor heart—and this figure does not take into account the full cost of hospitalization for these patients (all but 2 of the initial 14 cases spent the rest of their lives in the hospital)—it is surely not a good value. Heart disease is a critically important problem in America, afflicting some 5 million people. Perhaps it’s time to focus on preventing this disease—which we can do, if we do a better job on the prevention of high blood pressure, diabetes, and cigarette smoking. For those patients who do develop heart failure and who are dying of their heart failure, palliative care is an excellent means of addressing their symptoms and supporting them and their families in their final days.

July 12, 2006

Dutch Treat

The Framingham Study is probably the most famous long-term medical study ever designed. Founded in 1948 to identify risk factors for heart disease, it began by following 5209 people from the city of Framingham, Massachusetts. It was so successful, definitively showing the importance of smoking, high blood pressure, cholesterol, diabetes, and inactivity in causing coronary heart disease, that a second group of about 5000 people were added in 1971—the children of the first group, along with their spouses. Less well-known, but also teeming with useful insights is another epidemiological study, this one conducted in a suburb of Rotterdam, Holland (A. Hofman, P. deJong, C. van Duijn et al, “Epidemiology of Neurologic Diseases in Elderly People: What Did We Learn from the Rotterdam Study?” Lancet Neurology 2006; 5: 545-50).

The Rotterdam Study has been following a group of men and women since 1990 and is concerned with finding potentially modifiable factors that put older people at risk of debilitating chronic disease. It recruited just under 8000 people over the age of 55, with the oldest participant age 106. Each study member was put through a 2-hour interview at home and a 5-hour battery of tests. On average the examinations were repeated every 3 years, focusing on the heart, the blood vessels, eyes, skeleton, and brain.

Just as the Framingham Study was particularly concerned with heart disease, the Rotterdam Study was especially interested in understanding more about neurologic disease (such as dementia and Parkinson’s disease), visual problems (mainly macular degeneration), and problems with mobility (arising principally from osteoporosis and fractures). The investigators found that by age 85, about 20% of the study group had dementia, and by age 95, the percentage had risen to over 40%. But they also found that the same factors that are associated with heart disease—high blood pressure, cholesterol, and cigarette smoking, along with diabetes—are associated with dementia. And those factors appeared to be important not just for the development of “vascular dementia,” or the dementia arising from multiple strokes, but also for producing Alzheimer’s disease.

The good news from Rotterdam, confirming earlier findings from smaller studies, is that we may be able to prevent dementia in the elderly, or at least delay its clinical manifestations, by treating high blood pressure, lowering cholesterol, avoiding smoking, and preventing or treating diabetes. It remains to be demonstrated that actually doing all these things will in fact make a difference, but it seems well worth a try.

June 28, 2006

Thinking About Long-Term Care Insurance

I’ve always dreaded when people ask me whether they should buy long term care insurance. They assume that as a physician specializing in the care of geriatric patients, I should know the answer, or at least have an opinion. There are so many different policies and people’s circumstances vary so much that I’ve never known what to say. Now the AARP (American Association of Retired Persons) Public Policy Institute has commissioned a report that sheds considerable light on the subject: “Comparing Long-Term Care Insurance Policies: Bewildering Choices for Consumers” (May, 2006). I still don’t have an answer, but at least I understand the issues better.

By way of background, we should all recognize that we face a substantial risk of needing nursing home care. Nearly 50% of people who recently turned 65 can expect to spend some time in a nursing home before they die. For many this will be the last place they live in; for some, it will be a facility where they stay for rehabilitation after hospitalization. The majority of people over age 80 need some form of long term care—fully 68% of men and 77% of women who live at home need assistance with everyday activities (see Wan He, Manisha Sengupta, Victoria Velkoff, and Kimberly DeBarros: US Census Bureau, Current Population Reports, P23-209, 65+ in the United States: 2005. US GPO, Washington, DC, 2005.

We should also be aware that Medicare pays for only a small fraction of our long- term care needs. Medicare covers up to 100 days of skilled nursing home care each “benefit period,” (where a benefit period typically starts at the time of hospitalization). But this kind of “skilled nursing home” care involves short-term rehab after a hospital stay only. Medicare may also pay for a home health aide or homemaker for a limited time after an acute illness. It does not pay for the kind of ongoing care than an older person with one or more chronic diseases may need. Medicaid, the insurance program for the poor and the disabled, does pay for nursing home care or services in the home for those who have used up most of their resources. The actual Medicaid eligibility criteria vary considerably from state to state since Medicaid is a joint federal-state program.

If you think you want to get long term care insurance, you typically need to choose among policies that only cover care in institutional settings, policies that only cover care at home, and comprehensive policies that provide both. While some people figure that the point of a policy is to be able to pay for home care so as to avoid going into a nursing home and therefore are interested only in a home-care policy, the coverage provided is likely to be inadequate to pay for full time help. Many people decide that if they’re going to get long-term care insurance, they may as well guard against all eventualities.

Finally, consumers should be aware that their premiums can increase. Insurance companies cannot single out particular individuals for increases based on their particular circumstances, such as their health. They can, however, raise premiums to entire groups of people, for example those over age 75. Here are some of the specific questions you need to ask if you are looking at a LTC policy:

Does it cover assisted living?

State laws often require that those LTC policies that cover “facility care” provide coverage for assisted living facilities. However, there is no standard definition of assisted living, so insurers can claim that a particular assisted living facility does not qualify.

What level of disability is needed to qualify?

LTC policies only kick in if the insured meets a specified level of disability. Most (but not all) policies accept the standard of impairment in at least 2 activities of daily living (such as dressing, bathing, or going to the bathroom). However, insurance companies can choose how they will determine if you are dependent in these areas.

What is the daily benefit?

The daily benefit amount provided can be as low as $50 a day or over $300 per day. In some cases, if your benefit ceiling is $150/day and your costs are $100/day, you effectively forfeit the difference, even if the following year you enter a nursing home and your costs go up. Another approach is to use a “pool of money.” The total benefit is then the daily benefit times the number of days of coverage (ie the duration of the policy). The pool can be spent for any combination of services: it might be spent slowly (if your only needs are modest home care) or more quickly (in a nursing home).

How long is the waiting period?

Once a person has met the policy’s “disability trigger,” the waiting period is the time before the benefit actually begins. If you have a 100-day waiting period, and nursing home care costs $150/day, you will have to pay $15,000 before the insurance company starts to pay.

What is the duration of the benefit?

Once you start using the LTC benefit, you may have anywhere between 1 year’s worth of coverage and a lifetime’s worth. Most people who need long-term care need it for several years.

Does it have inflation protection?

Unless you have inflation protection, the daily benefit will lose in value relative to the cost of care. This is an especially severe problem for younger purchasers whose benefit may be inadequate to cover the costs of care years later.

Summary

As the AARP report suggests, it would be very helpful if the government mandated standard policy benefits and provisions, just as is the case for supplemental Medicare policies. In addition, it would be desirable to require companies to offer to pay family caregivers. Finally, LTC policies that pay benefits for multiple types of care should make the total value of all benefits available in any covered setting.

Until such regulations are passed, consumers are faced with a confusing array of possibilities. If you decide you want to buy LTC insurance, you should generally choose a comprehensive policy. You should make sure that by “comprehensive” it in fact does cover assisted living facilities. You probably will want a policy that specifies the maximum total amount it will pay out and that allows you to allocate that amount between home care, assisted living, and nursing home care, as you see fit. You should be sure that the benefit will go into effect once you are dependent in 2 activities of daily living, that the waiting period if no more than 100 days, and that the duration of coverage is at least 3 years. The cost of the premium for such a policy may be very high. Once the insurance agent quotes you a premium, you will need to consider whether you would be better off setting aside money regularly as a special LTC fund for yourself.

May 31, 2006

Washington Post Review

The following review appeared in the Washington Post on Sunday. It's perhaps a bit overstated, but positive nonetheless.

In The Denial of Aging: Perpetual Youth, Eternal Life, and Other Dangerous Fantasies (Harvard Univ., $25.95), Muriel R. Gillick whacks all the major players orchestrating the Last Dance of America's senior citizens. Medicare is misguided, she argues. Nursing homes are like prisons. Assisted living facilities are too often motivated by greed. Doctors (Gillick is a physician, by the way) are too willing to extend life at any cost. Relatives often have lousy judgment about what's best for a loved one. Even those facing their own finality are too focused on themselves.

In assessing the nation's retirement and health care institutions, Gillick is not the first to see flaws that are ruinous both for the seniors receiving aid and for those of us receiving huge bills for that aid. For example, she notes that while most people want to spend their last days at home, only a quarter of people over age 65 do so. Twice as many die in hospitals, which are so focused on keeping patients alive that they haven't mastered the art of respectfully allowing those near death to leave this world.

For those who need medical care, Gillick would deliver more of it at home, via phone calls, visits from practitioners and other simple measures that have proved effective and efficient. But don't mistake Gillick for a heartless advocate of rationed care. She wants to keep old people alive and well for however long each person can thrive. But she views many efforts to protect nursing-home residents as more of a problem than a solution. By focusing on statistics and standards aimed at ensuring quality of care for these people, she contends, the government is actually prompting these institutions to ignore quality of life.

Gillick challenges Baby Boomers to reengineer nursing homes, first into true homes where elders can thrive and, when necessary, into places providing the care they need to either recover or spend their final days in comfort. More broadly, she challenges her generation to embrace the inevitability of aging and to make the most of it. That would be quite a legacy for the Baby Boomers to leave their children.

--Tom Graham

May 23, 2006

When More is Less

Last week, Dartmouth’s Center for the Evaluative Clinical Sciences released the latest version of its “atlas” of medical care in the U.S. Since 1993, the Dartmouth Atlas Project has produced a fascinating series of studies examining the geographic variability in health care resources and their utilization. A consistent theme throughout the life of the project has been that the availability of resources drives their use: surgical rates—even for elective surgery—are higher in communities with more surgeons; hospitalization rates are higher in areas with more hospital beds. The newest report, called “The Care of Patients with Severe Chronic Illness: A Report on the Medicare Program by the Dartmouth Atlas Project” draws the same conclusions about the care for people with chronic disease (available in entirety online here)

Chronic disease—conditions such as diabetes, cancer, and heart disease—is the major health problem among Americans today, afflicting some 90 million people and accounting for 7 out of 10 deaths. The care of people with chronic illness accounts for over 75% of all U.S. health care expenditures. And most of the people with chronic conditions are elderly.

The principal finding of the Dartmouth study is that Medicare spends much more per enrollee in some states than in others. Spending for patients with severe chronic illness during their last 2 years of life ranges from almost $40,000/person in New Jersey, Washington, D.C., California, New York and Maryland, to under $25,000 in states including Idaho, Iowa, West Virginia and North Dakota. The variability is not due to higher rates of sickness in some regions. In fact, differences in illness levels are “virtually unrelated to differences in spending.” The other disturbing finding of the study is that the extra spending does not buy longer life or better quality of life. On the contrary, those with chronic illness in high spending regions have shorter life expectancies and less satisfaction with their care.

Spending on chronic illness varies by state, with those states that have greater reliance on primary care than on specialists spending less money and depending less on intensive care units. In Florida, for instance, Medicare patients who died spend an average of 4.7 days in the ICU during the last 6 months of life (a marker of the aggressiveness of care), whereas patients in North Dakota spend only 1.5 days. Academic medical centers also vary in the way they manage chronic illness: during the last 6 months of life, for example, patients who use New York University Hospital have an average of 76 physician visits, compared to 24 visits for patients who use the Mayo Clinic. In general, acute hospitals are dramatically over-used (in Hawaii, patients spend an average of 16.4 days in the hospital during their last 6 months of life, compared to 7.3 days in Utah) and hospice care is under-utilized (while in Arizona, 44.7% of dying patients are enrolled in hospice, in Alaska it is only 6.7% and the national average is 27.2%).

The authors conclude that what we need is “a population-based, community wide integrated system for managing severe chronic illness.” I agree. Specialists have no incentive to refer patients to hospice care; they do have incentives to order diagnostic tests and to use ICU care. Hospitals likewise, unless they are part of a network of care, have no incentive to enable patients to die at home; they benefit if their beds are filled. If we had a comprehensive system—and the closest that any segment of the U.S. comes to such an approach is the Veterans Administration system—Medicare would reduce its costs on patients with chronic disease by 30%, while simultaneously improving care.

May 03, 2006

Aricept Redux

Three months ago I wrote a column arguing that in the U.S. we over-use donepezil (Aricept), a drug widely touted as helpful in early Alzheimer’s disease (“Americans, Alzheimer’s, and Aricept,” February 1, 2006). In Britain, by contrast, careful review of all the available studies led to the recommendation by NICE (the independent National Institute for Health and Clinical Excellence) against routine use of this medication. Now a new study suggests that donepezil may help patients with advanced Alzheimer’s disease, people who need help with basic tasks such as bathing and dressing and who have profound cognitive impairment (see B. Winblad, L. Kilanter, S. Erikkson et al, “Donepezil in Patients with Severe Alzheimer’s Disease: Double-Blind, Parallel Group, Placebo-Controlled Study,” Lancet 2006; 367:1057-65). How can this be? Are we seeing an attempt to find some use, any use, for this drug, which does not appear to be tremendously useful in early Alzheimer’s patients, the group in whom it was initially targeted?

The new study was carried out in Swedish nursing homes. Subjects were randomized to receive either donepezil or placebo and they were treated for 6 months. The treated group showed slight improvement in tests of mental function and a lower rate of deterioration in basic activities of daily living compared to controls. But before families rush to request donepezil for their relatives, we should consider the intriguing possibility raised by the study’s authors: perhaps what the donezpezil did was to counteract the negative effects of the many other medications these individuals were taking. Virtually all the people in the study (99%) were taking other medications, and 80% were on psychoactive medications intended to control their behavior. We know that the brains of individuals with dementia are very sensitive to chemicals that affect the nervous system—they are very prone to developing delirium, or an acute confusional state. Before concluding that all patients with severe dementia should be given donepezil, we need to study its effectiveness in demented persons who are on no other medications. Only then can we figure out whether we should dole out more donepezil (assuming that the “statistically significant” benefits are in fact clinically meaningful)—or give patients a drug holiday, discontinuing the many potentially toxic medicines they are currently taking.

April 18, 2006

The Skinny on Longevity

It’s been known for some time that skinny rats live longer than fat rats. They have to be extremely svelte for this effect to kick in: laboratory rats that consume 60% of the usual rat diet live 30% longer than the average rat. Studies are underway in primates, but because monkeys live for many years, the results of “caloric restriction,” as the intervention is called, on their longevity is not yet know. But a new study in the Journal of the American Medical Association suggests that a comparable phenomenon is at work in people.

A team of researchers from Louisiana State University in Baton Rouge and the Garvan Institute for Medical Research in Darlinghurst, Australia reported on a randomized study involving 48 people (see Leonie Heilbron, Lilian de Jonge, Madlyn Frisard et al, “Effect of 6-Month Calorie Restriction in Biomarkers of Longevity, Metabolic Adaptation, and Oxidative Stress in Overweight Individuals,” Journal of the American Medical Association 2006; 295:1539-48). The 48 people included men under 50 and women under 45 who were healthy but sedentary and overweight but not obese. It was hard to find people to participate: of 599 people who were screened for participation, 460 failed to meet the criteria. Another 91 people decided as they were being screened that they weren’t interested in participating. For the 48 people who did enroll, 12 served as controls and were kept on a weight-maintenance diet; 12 were assigned to a calorie restricted diet (25% restriction of their baseline energy requirements); 12 were assigned to a combination of calorie restriction and exercise (12.5% calorie restriction and 12.5% increase in energy expenditure through exercise); and 12 were assigned to a very low calorie group (890 kcal/day). Midway through the study and then at the end of the 6-month study period, all sorts of measurements were performed, including tests reflecting metabolism, tests of DNA damage, and of course weight.

What the authors found was that after six months of the prescribed regime, insulin levels and core body temperature were decreased in the intervention groups, both of which are “biomarkers of longevity.” They also found evidence of “metabolic adaptations,” i.e. lower energy expenditure in the groups on the special diets. While they could not conclude anything about whether these changes would persist if the subjects continued on their diets indefinitely and they certainly could not conclude that the subjects would live longer if they kept up the diet, they found the results “suggestive.”

The interesting aspect of this work is the possibility not that we could live longer if we starved ourselves, but rather that the aging process might be slowed down if we could find ways to emulate the effects of caloric restriction. Nobody seriously believes that large numbers of people are going to go on an 890 calorie diet indefinitely in a society where we cannot even find ways to prevent obesity or to help markedly overweight individuals lose weight. Most people aren’t really interested in living to be 100, particularly not if it means a long period of physical frailty and cognitive impairment. But if scientists could design chemicals that mimic the effects of calorie restriction and if these chemicals are able to delay aging, then conceivably all the major disorders of old age—heart disease, cancer, dementia—would have a later age of onset.

Of course it’s far from clear from a study of 48 people conducted over a mere 6 months that caloric restriction will have the desired age-delaying effect. And even if caloric restriction does prove effective, it will be a long way to finding a pill that produces the desirable consequences of caloric restriction without any significant side effects.

Before any older individuals cut down on food in the hope of preventing disability, it’s critically important to note that among older people today, malnutrition rather than obesity is a major problem. In the National Health and Nutrition Examination Survey, a study conducted periodically by the federal government, the incidence of malnutrition is reported to range between 12 and 50% among hospitalized older people and from 23-60% among institutionalized older adults. In the community, where malnutrition rates are lower, it remains a problem among people with low income, difficulty digesting or chewing food, and people who have trouble shopping or cooking (See Carol Evans, “Malnutrition in the Elderly: A Multifactorial Failure to Thrive,” Permanente Journal 2005; 9:3).

Facing our mortality is not easy. But phantasmagorical dreams of perpetual life are not the answer. What I argue in my book, The Denial of Aging: Perpetual Youth, Eternal Life, and Other Dangerous Fantasies is that immortality projects are better ways to cope with knowledge of our finitude than are searches for the elixir of life. Immortality projects—whether a book we write, a company we found, or the children we nurture—help us transform our painful awareness of our own limits into enduring memories. They are the way we leave a mark on the world, even after we ourselves have departed.

March 29, 2006

Adding Life to Years

The latest statistics on life expectancy were released by the National Center for Health Statistics in January, 2006 and they show continued improvement in the prospects for old age (DL Hoyert, M. Heron, SL Murphy, and HJ Kung, “Deaths: Final Data for 2003,” National Vital Statistics Reports. National Center for Health Statistics, Hyattsville, MD, released January 19, 2006). Life-expectancy at birth is 77.5 years, as of 2003, the year on which the results are based, surpassing the previous record, from 2002, by 0.2 years. The age-adjusted death rate (that is, the death rate taking into consideration the distribution of ages in the population) is also at a record low, down 1.5% from 2002.

If we examine the statistics more closely, we discover several interesting observations. First, let’s look at life expectancy at age 65. Life-expectancy at birth reflects the risk of dying of congenital abnormalities or of the dangers that affect young adults, such as AIDS and homicide. For older people, what is of concern is how much time they are likely to have left if they have made it through middle age. The answer is that life-expectancy at age 65 is an impressive 18.4 years. It is even higher for white women (19.8 years) and a little lower for white men (16.9 years). What is disturbing, however, is how much lower life-expectancy at age 65 is for black men (14.9 years). Black women, by contrast, are just about exactly at the national average (18.5 years).

Since age 65 really is not considered “old” any more, what is of even greater interest is the data on life-expectancy at age 75. The 2003 data indicate that 75-year olds can expect, on average, to live for another 11.8 years. Again, the situation is a little better for white women (12.6 years) and a little worse for white men (10.5 years). And again, the life-expectancy for black men is unfortunately only 9.7 years, although black women are almost as well off as white women, in terms of years of life left (12.4 years compared to 12.6 years).

Another important result reported by the government is that while the age-adjusted death rate is down for several of the leading causes of death, including heart disease, cancer, and stroke, the rate of Alzheimer’s disease continues to rise. Regrettably, this means that as we make strides in the treatment of many of the diseases afflicting the elderly, the net result is often that people live long enough to develop and ultimately die of dementia.

What is not discussed in the government statistics is the rate of chronic disability in old age. While we all aspire to live longer, for many of us it is critical that those additional years be good ones. We want to live longer but we want to be as independent as possible. We don’t want to require the help of others for our most basic activities—dressing, bathing, eating, walking. It turns out that the studies that have been done analyzing disability rates show that from 1982 to 1999 (no more recent figures are available for the U.S.) disability declined: one report calculates that the decline from 1982 to 1989 was 0.26% per year, the decline from 1989 to 1994 was 0.38% per year, and the decline from 1994 to 1999 was 0.56% per year (Kenneth Manton and XiLiang Gu, “Changes in the Prevalence of Chronic Disability in the United States Black and Nonblack Population Above Age 65 from 1982 to 1999,” Proceedings of the National Academy of Science (2001); 98: 6354-6359). A second report, summarizing the results of various other studies, suggests that the rate of decline in disability among the elderly has been 1% per year for several decades (David Cutler, “Declining Disability Among the Elderly,” Health Affairs (2001); 20: 11-27).

But if we examine the data on chronic disability carefully, what we find is that the improvements are most pronounced for domains such as the ability to cook or shop or clean house. The fraction of the elderly population with severe disability remains virtually unchanged. Moreover, historical research indicates that it is hazardous to predict future rates of decline based on recent trends: in the past, sharp declines in disability rates have often been followed by stability or increases in disability. (See: Donald Redfoot and Sheel Pandya, “Before the Boom: Trends in Long-Term Supportive Services for Older Americans with Disabilities,” AARP Policy Institute, October, 2002.) Recent work on the potential long term outcome of the obesity epidemic, for example, predicts that even the gains in life expectancy may be reversed (see S. Jay Olshansky, Douglas Passaro, Ronald Hershow et al, “A Potential Decline in Life Expectancy in the United states in the 21st Century,” New England Journal of Medicine; 2005; 352: 1188-95).

What should we conclude from all of this? We can conclude that most of us who reach retirement age will live past 80. During much of our old age, we will be quite vigorous. But we are still at considerable risk for developing frailty (severe physical disability) and dementia (cognitive disability). Preventing these conditions, treating these conditions, and developing supportive care that will enable us to make the most of our old age despite these conditions, are the challenges that lie ahead.

March 14, 2006

Break a Leg?

Sometimes I wonder what disease will get me in the end: statistically speaking, it’s a toss up between cancer and heart disease. But I worry even more about breaking a hip. For many older people, a hip fracture is the beginning of the end. After sustaining a hip fracture, only 50-60% of people walk as well as they did previously. About 20% never walk again and 40% end up in a nursing home. Within a year, 37% of elderly Americans who break a hip are dead.

Not only are your odds of returning to your baseline level of functioning poor, but the chance of breaking a hip is substantial: 350,000 Americans break a hip each year. Older people are at risk of fractures because they fall and because they have thin (osteoporotic) bones. So articles in two major medical journals in the last month that call into question the efficacy of two leading preventive strategies—calcium and vitamin D on the one hand and hip protector pads on the other—are worrisome. Should all older people give up their calcium supplements and forget about wearing hip pads?

The study of calcium and vitamin D appeared in the New England Journal of Medicine (R. Jackson, A. Lacroix, M. Gass et al, “Calcium Plus Vitamin D Supplements and the Risk of Fractures,” NEJM 2006; 354:669-83). The authors had the opportunity to randomize over 36,000 women who had previously enrolled in a Women’s Health Initiative trial to receive either 1000 mg of calcium carbonate and 400 units of vitamin D or placebo. They were monitored for fractures for the next 7 years and their bone density was measured. The results? There was a small but not statistically significant decrease in the risk of hip fracture, a small improvement in bone density, and a small increased risk of kidney stones.

Before throwing away those calcium and vitamin D pills, it’s important to realize that only 59% of the women were actually taking the recommended dose at the end of the study. When the authors evaluated the outcomes in women who really took the medicine, there was a 29% statistically significant decrease in the likelihood of hip fracture. For scientific reasons, the analysis should be done the way the authors did it—using an “intent to treat” approach. This allows them to conclude that from a public health or policy perspective, they cannot recommend the use of calcium and vitamin D because prescribing those supplements is not likely to produce the desired outcome. But that’s different from concluding that taking the medication will not result in lowering your chance of hip fracture. It’s also important to realize that the 36,000 women in the study were healthy, community-dwelling post-menopausal women with an average age of 62. Inferring from this study that calcium and vitamin D do not prevent hip fractures in older women with other medical problems is not warranted. And in fact there was some suggestion that women over 60 did in fact benefit.

The second study on a related subject was a meta-analysis or pooled analysis of previous studies that was published in the British Medical Journal. (M. Parker, W. Gillespie and R. Gillespie, “Effectiveness of Hip Protection for Preventing Hip Fractures in Elderly People: Systematic Review,” BMJ 2006; 332: 571-4). It asked whether hip pads achieved their initial promise: earlier studies of nursing home patients had found that hip protectors could halve the rate of hip fractures. After combining the information from 14 studies, 11 of which involved nursing home patients and 3 of which were conducted in community-dwellers, the authors were unimpressed. They concluded that the pads were ineffective in the home setting and conferred only a small (but statistically significant) benefit in institutionalized individuals. But very much like the work on calcium, it turns out that many of the people who were supposed to wear the hip pads didn’t do so for much of the time. They found them inconvenient or awkward or uncomfortable, despite efforts to streamline the pads. Once again, it’s reasonable to conclude that hip pads should not at this point be the “standard of care.” We shouldn’t routinely expect insurance companies to pay for them or nursing homes to provide them. But there may well be a benefit for the person who is at high risk of falls and fractures and who is motivated to use them.

The data aren’t all in yet—we may find that calcium and vitamin D are effective, but higher doses are required, or it may turn out they are principally useful in an as yet undefined subgroup of the population. We may discover that certain types of hip protectors work and others, made of different materials, do not. In the meantime, these two interventions may make a lot of sense for people who want to do everything they can to avoid a hip fracture. And that’s not such a bad idea.

March 09, 2006

How Much will Medical Care Cost After Retirement?

Fidelity Investments just released a report estimating what the average 65-year old couple can expect to pay in medical expenses during their retirement (Reuters: “US Retirees’ Health Care to Cost $200,000-Fidelity”) Fidelity’s prediction is that a couple can anticipate spending $200,000 over the next 20 years. This is up from $190,000 in 2005 and $175,000 in 2004.

This figure—and clearly it’s just an estimate—is based on the expected cost of premiums for Medicare Part B and Medicare Part D, plus the cost of co-payments, deductibles, and out-of-pocket prescription drug costs. It does not include dental care, over-the-counter prescriptions, or long term care (ie nursing home costs).

It’s important to realize that this figure is based on the fact that the average life expectancy for a man at age 65 is 15 years and for a woman is 20 years. Actually, a 65-year old white man will, on average, live another 16.6 years; a 65 year old white woman will live 19.5 years; a 65 year old black man can expect to live another 14.6 years; and at age 65, a black woman will, on average, live for 18.3 years (see Health United States, 2005). Since these are averages, some people will live less long, and others a good deal longer.

Fidelity’s estimate assumes the couple will enroll in Medicare but have no supplementary employee health insurance coverage. Increasingly, corporations are discontinuing their medical care coverage for retirees in order to save money, so couples should not count on having such benefits. Out-of-pocket medical costs are the single largest expense for most retired couples, so start saving now!

February 22, 2006

The New Presidential Ethics Commission Report

You may never have heard of a national bioethics commission. At best, such commissions can perform a valuable synthetic function, summarizing the best current thinking on a controversial ethical topic. The 2 reports of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, one on defining death and one on decisions to forgo life-sustaining treatment, did exactly that. As Alexander Morgan Capron comments in his article, “Governmental Bioethics Commissions: the Nature of the Beast,” (Lahey Clinic, Fall, 2002) these reports were successful because they “built a bridge connecting the legislative and executive branches, experts and academics in science, philosophy and law, and the general public,” resulting in the adoption of better policies. Regrettably, the current “President’s Council on Bioethics,” appointed by President George W. Bush and chaired by Dr. Leon Kass, has not served as a forum for public discussion of controversial issues, but rather as support for the president’s political agenda (for a discussion of how this problem could be remedied, see Arthur Caplan’s article, “Free the National Bioethics Commission”.)

The newest report, “Taking Care: Ethical Caregiving in Our Aging Society,” (September, 2005) has unfortunately adopted the ideological coloring of the executive branch. Taking Care is important in recognizing that one of the major challenges our society faces is how best to deal with the growing elderly population, many of whom will develop dementia. It makes the critical point that dementia in particular and frailty in general are unlikely to disappear any time soon. But the ideological driving force behind the report is the belief that euthanasia and assisted suicide are “antithetical to ethical caregiving” and “should always be opposed.” The report devotes one of its four chapters to a tirade against advance directives. The authors seem to think that the purpose of advance directives is to enable patients to decide, at the first sign of incipient frailty, to end their lives by forgoing life sustaining treatment. They envisage long lines of patients clamoring for physician assisted suicide. In fact, in Oregon, the one state where PAS is legal, a total of 33 people availed themselves of it in 2004, accounting for less than one-eighth of one percent of the deaths in that state. And advance directives, for all their flaws and limitations, have as their goal to enable prospective patients to avoid unwanted, burdensome, and often near-futile treatment near the end of life.

The report is also disturbing in its excessive focus on family caregivers. Having attacked individual autonomy as inadequate, Taking Care endorses family responsibility for the frail elderly. The relentless emphasis on individual responsibility that characterizes much of modern biomedical ethics may indeed be inadequate to address the situation of impaired elders. But surely a more communitarian vision warrants consideration—a society in which we build nursing homes and assisted living facilities that are truly resident-centered, rather than “total institutions,” a society in which we develop a system of health insurance that includes long term care and that provides excellent treatment for chronic as well as acute conditions, and in which we find ways to enable people to remain engaged and contributing citizens, even if they have problems with their hearing, their vision, their memory, or their walking. Taking Care seems to echo the party line that “family values” are paramount. Let us hope that this report receives the disregard it deserves.

February 14, 2006

The Medicare Cuts

Last week, President Bush released his proposed budget for 2007, which included $36 billion cuts in Medicare spending over 5 years. The response has been anxiety on the part of older people who worry their benefits will be slashed, as well as by hospitals and physicians who depend heavily on the Medicare population for their business. But are the cuts—if they go through, and in an election year, many will not—such a bad idea?

Medicare spending is growing at a phenomenal rate. If we don’t put the brakes on it, according to some projections, Medicare will consume 24% of all federal income tax revenue by 2019 and 51% by 2042 (quoted in “Medicare: A Ticking Time Bomb for Tax Increases” by Daniel Mitchell of the Heritage Foundation). We won’t have much left for education, housing, and other social programs (leaving aside the issue of national security). The Medicare prescription drug benefit alone, crucial as it is for the millions of elderly people who rely on medicines to treat chronic illnesses and who previously had no drug coverage, is expected to cost at least $700 billion over the next 10 years. It won’t do to protest every attempt to control Medicare spending. The question is not whether Medicare should be trimmed back, but how.

The suggested approaches in the President’s budget largely reflect the recommendations of the Medicare Payment Advisory Commissions (MedPac), an independent, bipartisan panel that has a reputation for thoughtful, careful proposals. And it’s important to realize that the budget proposal isn’t calling for lower reimbursement rates than currently prevail; it’s calling for a smaller increase than previously planned (eg payments to hospitals would increase by 2.9% rather than 3.3%). Moreover, to complement moderately increased reimbursement rates, Medicare would introduce a quality incentive payment policy for hospitals. While this has to be done carefully to make sure hospitals are not penalized for taking care of the sickest patients (if quality is defined in part by mortality rates, for example, adjustments must be made to take into consideration just how complex and elderly a hospital’s patients are), it is potentially a means of stimulating improved quality of care.

One piece of the budget that is worrisome is the freeze on prospective payment rates to home care agencies and skilled nursing facilities. Home health care has been one of the fastest growing components of the Medicare budget and is thus a logical target for cost-cutting. But a large fraction of the cost of home health care and of nursing home care is labor. And most of this labor is provided by aides, who are among the lowest paid, least appreciated workers in the US economy. The average hourly wage for a nursing home aide, as reported in 2002, was $8.29, less than what she would earn working in a fast food chain. Only 68% of home health aides receive health insurance from their employers. To make matters worse, home health aides and certified nursing assistants experience higher injury rates than workers in any other industry, including the construction industry. Lifting and turning sometimes resistant older people is literally backbreaking work. (Statistics are from Nora Super, “Who Will Be There to Care? The Growing Gap between Caregiver Supply and Demand,” a National Health Policy Forum Background Paper, issued January, 2002). To freeze payments to home health agencies and nursing homes will prevent wages from rising for their workers. As it is, we are facing an imminent shortage of long term care workers. The number of people who will need personal care (whether in a nursing home, assistant living facility, or at home) is going to soar from 8 million today to 19 million in 2050, at the same time that the working population is growing slowly. If we want to have aides to care for older people, we need to make the work more attractive—and freezing salaries at their current low rate is exactly the wrong way to proceed.

What’s striking about the proposed Medicare spending cuts is what measures aren’t included that should be. Right now, Medicare will reimburse for any medical treatment that it accepts as “reasonable and necessary.” Costs don’t figure into reimbursement decisions at all: the Centers for Medicaid and Medicare Services (CMS), which runs the Medicare program, pays for technology and now medications even if their added benefit is miniscule and their cost is enormous. As an example, Medicare will pay for the left ventricular assist device, a kind of partial artificial heart. This device is implanted in people with extremely severe heart failure who are too sick or too old to qualify for a heart transplant, at a cost of roughly $250,000. Even with the device, about half such patients are dead within a year and only a quarter are alive at the end of 2 years. People who have the device are at high risk of developing severe infections, bleeding, or device failure (which necessitates a second open heart operation). One way to rein in Medicare spending is for CMS to consider costs in its decisions about which treatments to reimburse. A well-established way of doing this is with cost-effectiveness analysis, a means of comparing the costs of alternative strategies for treating the same condition relative to their efficacy. For the left ventricular assist device, a cost-effectiveness analysis by Blue Cross/Blue Shield shows that the cost/quality-adjusted-life-year, the standard unit of measurement, is about $500,000, compared to the benchmark of $100,000/quality-adjusted-life-year for widely accepted procedures such as kidney dialysis (see the report by the Technology Evaluation Center of BC/BS, “Special Report. Cost-Effectiveness of Left-Ventricular Assist Devices as Destination Therapy for End-Stage Heart Failure,” released in April, 2004).

The Bush budget proposal starts the critically important process of controlling Medicare spending. It includes a number of reasonable strategies, and several short-sighted ones. But it misses a major opportunity, the chance to systematically build considerations of cost into the process of deciding what Medicare will cover and what it won’t.

February 01, 2006

Americans, Alzheimer’s, and Aricept

According to the drug company giant Pfizer, 2.4 million Americans have taken donepezil (Aricept) since it was approved by the Food and Drug Administration in 1996 for use in mild to moderate Alzheimer’s disease. The British think tank, NICE (National Institute for Health and Clinical Excellence), which evaluates the effectiveness of drugs and devices, reported last month that the drug’s usefulness is very limited. If it’s helpful to anyone, it’s mainly those with somewhat more advanced Alzheimer’s who stand to benefit. By contrast, the American Academy of Neurology says that “considering” Aricept is the “standard” approach for mild to moderate disease (RS Doody et al, “Practice Parameter: Management of dementia: An Evidence Based Review. Report of the Quality Standards Subcommittee of the American Academy of Neurology,” Neurology 2001; 56: 1154-66.) And the Alzheimer’s Association, the leading non-profit advocacy group in the field, while falling short of endorsing the use of Aricept and related drugs, recommends their use “if clinically indicated, to treat cognitive decline.” (California Workgroup in Guidelines for Alzheimer’s Disease Management: Alzheimer’s Association of Los Angeles, Riverside and San Bernardino Counties, 2002).

The latest dispute over anti-Alzheimer’s drugs began last March when, after performing an exhaustive review of every study published on the effect of the drugs on cognition, on daily functioning, or on behavioral symptoms, NICE issued a report concluding that neither Aricept nor its newer cousins, Rivastigmine and Galantamine, were worth the money the National Health Service (NHS) spent on them. They clearly did something—they produced a statistically significant improvement in various test scores, but the real life benefit was miniscule. When NICE released its report, family members of Alzheimer’s patients, physicians, and of course the drug manufacturers, were outraged. They were convinced, based in many cases on anecdotal experience, that the drugs worked. NICE responded by asking the drug companies to produce evidence that there were in fact subgroups of people who benefited substantially from this entire class of drugs, known as cholinesterase inhibitors.

Last month (January, 2006) NICE released a new report in which it once again asserted the drugs are of no meaningful use in people with mild Alzheimer’s. They concede there may be enough benefit in people with moderate Alzheimer’s to warrant trying them. In other words, even after bending over backwards to find some justification for recommending the use of Aricept and similar drugs in people with early Alzheimer’s, NICE just couldn’t find any.

The view that Aricept, with US sales in 2004 of just under a billion dollars, probably shouldn’t be used in most of the patients for whom it’s prescribed, has so far been largely ignored in the U.S. It hasn’t been picked by the New York Times or the Washington Post or by the news section of leading American medical journals such as the Journal of the American Medical Association. And this isn’t the first time we in America have chosen to pay little attention to fairly compelling evidence that Aricept doesn’t work well. In 2004, another British study, this one a randomized controlled clinical trial, tested whether Aricept could delay nursing home placement, a claim made in many advertisements for the drug. The study, which compared 283 patients who got Donepezil with an equal number who did not, found the two groups had exactly the same chance of admission to a nursing home (AD2000 Collaborative Group, “Long-Term Donepezil Treatment in 565 Patients with Alzheimer’s Disease: Randomised Double-Blind Trial,” Lancet 2004; 363:2105-10.) It was published in a leading journal, the Lancet, and did generate a response by the Alzheimer’s Association, journals such as the Journal of the American Geriatrics Society, and also by the New York Times, but many practicing physicians remained unaware of its existence. The study has been criticized on a variety of technical grounds. But why accept the results of earlier, small, non-randomized studies and reject the results of a much better, although less than perfect, randomized study? Only a fervent desire to believe the conclusions of the study that professed to show Aricept keeps people out of nursing homes can explain this phenomenon.

The irony is that when the cholinesterase inhibitor Tacrine was first alleged to help in Alzheimer’s disease, back in 1986, the American neurologic community was extremely skeptical. How could a drug that worked by preventing the destruction of a neurotransmitter in the brain (acetylcholine) be useful in a disease in which the nerve cells that used that neurotransmitter had already been destroyed? And the skeptics seemed justified when the experiments behind the first enthusiastic reports were found to be if not fraudulent, at least questionable. After years of further study, rigorous tests established that the drug did have a statistically significant effect. Whether it had a clinically meaningful effect was another matter.

Even when Tacrine was approved by the FDA in 1994, and then, in record time, its successor, Aricept, was also approved, many Alzheimer’s researchers were dubious that the drugs was actually helpful. John Growdon, a prominent researcher at the Massachusetts General Hospital in Boston, wrote diplomatically in an editorial in the New England Journal of Medicine that “the expectation of benefit…exceeds reality.” Yet use of cholinesterase inhibitors in the US has become more and more widespread. In 2004, Aricept was ranked #52 in the top 200 drugs by sales in the US ($.92 billion, up from a rank of 62 and sales of $0.7 billion in 2003). Why?

Alzheimer’s is perhaps the most feared disease of old age. Called “the gray plague,” it makes once vibrant people debilitated and dependent (see my book, Tangled Minds: Understanding Alzheimer’s Disease and Other Dementias; NY: Dutton, 1998). It’s not surprising that family members of those afflicted are desperate for a treatment. It’s not surprising that physicians are eager to have something to offer—and one after another, the various proposed remedies have proved worthless or even harmful, including estrogen and Rofecoxib (Vioxx). But should we be spending nearly a billion dollars a year to indulge our wishful thinking? Or would we all be better off spending the billion dollars on research for other drugs which might actually be effective? Or perhaps we could invest the billion dollars in improving the quality of nursing homes and assisted living facilities that claim to specialize in the care of people with Alzheimer’s so as to find ways to promote dignity and well-being in some of our most vulnerable and most demeaned citizens. The British seem to recognize that an unchecked appetite for drugs that might be beneficial has consequences when our resources are unlimited. Americans are loath to accept this view. Maybe we have something to learn from our English cousins.

January 24, 2006

Does Exercise Prevent Dementia?

We would all like to believe that if only we eat well and exercise regularly, we will remain vigorous well into our eighties and perhaps our nineties. But is it true? A new study published this week argues that exercise can help fend off dementia, one of the major plagues of old age.

Writing in the Annals of Internal Medicine, a leading medical journal, Dr. Eric Larson and his colleagues in Seattle, Washington, describe a study in which they monitored a group of 1740 people over age 65 for an average of 6 years to see whether they developed dementia. To be part of the study, you had to be free of any evidence of dementia. You were asked questions about your medical conditions, whether you smoked, whether you used alcohol, and whether you rated your health as excellent, very good, fair, or poor. You were also asked one question about exercise: over the past year, how many times per week did you spend at least 15 minutes on an activity such as walking, hiking, bicycling, aerobics, or swimming. All the people who agreed to be in the study were then tested for dementia twice a year. By the end of 6 years, 1185 of them were still free of dementia, 158 had been diagnosed with dementia, and another 397 either died or withdrew from the study. The authors then compared the risk of developing dementia among those who had said they exercised at least 3 times a week with the risk of developing dementia among those who said they exercised less than 3 times a week. What they found was that when they made adjustments to account for factors such as age and gender, the exercise group was 32% less likely than the low-exercise group to be diagnosed with dementia. (See Eric Larson, Li Wang, James Brown et al, “Exercise is Associated with Reduced Risk for Incident Dementia among Persons 65 Years of Age and Older,” Annals of Internal Medicine 2006; 144: 73-81).

Physical activity in both middle age and old age is a good idea for a variety of reasons. In addition to its well-known effects on preventing heart disease, the leading cause of death in older adults, exercise can prevent or at least delay the onset of frailty, a syndrome in which people typically have multiple medical problems which together cause impairments in their ability to function in their daily lives (see my book, Lifelines: Living Longer, Growing Frail, Taking Heart, NY: Norton, 2001.) Exercise can help prevent obesity, which is currently epidemic in the U.S. But it’s important to remember that while exercise can decrease the risk of a variety of conditions that afflict older people, it does not prevent them. In the study of exercise and dementia, for instance, fully two-thirds of the people who developed dementia had exercised at least 3 times a week. Among those who did not get dementia, there were more regular exercisers (77% instead of 67%), but it was hardly the case that the couch potatoes got dementia and the exercisers did not. In fact, in this study of relatively young, educated, middle class people, dementia didn’t develop very often either in exercisers (10.38%) or non-exercisers (16.4%). Among the general population over age 85, by contrast, nearly 50% have dementia.

It’s also important to realize that the new study doesn’t definitively show a causal connection between lack of exercise and dementia. Because it is an observational study and not a randomized trial—the people in the study were watched and tested rather than being assigned to either an exercise group or a sedentary group—we don’t know for sure whether it was exercise that was responsible for the difference in outcomes. The authors did their best to make statistical corrections to account for factors such as age, cigarette smoking, and alcohol use that might affect the likelihood of getting dementia. But it’s possible that people who exercised (or more precisely who said they exercised) were also more socially active or intellectually engaged and it was those behaviors that helped protect them from dementia. It’s even possible that the people who didn’t exercise were already in the early stages of dementia—so early they still did well on the tests of cognitive function they were given—and that it was the dementia that prevented them from exercising rather than the other way around.

The answer to whether you should exercise, whether you are 60, 70, or 80, is a resounding yes. But will exercise save you from dementia? Maybe, but don’t count on it.

January 18, 2006

The Supreme Court and Physician-Assisted Suicide

The good news is that the Supreme Court just ruled 6-3 that the U.S. Attorney General has no business trying to prevent Oregon from implementing its physician-assisted suicide law (Linda Greenhouse, “Justices Reject U.S. Bid to Block Assisted Suicide,” NY Times, 1/18/062006;). Regardless of what you think about the appropriateness of physician-assisted suicide—and I think there are better ways to address end-of-life suffering—you should be glad that the Court has upheld Oregon’s law. The Supreme Court already concluded 8 years ago that there is no constitutional right to physician-assisted suicide, but neither is there any constitutional prohibition of the practice. States were held to be free to pass legislation legalizing physician-assisted suicide if they wished.

State legislatures haven’t exactly jumped at the opportunity to pass such legislation. To date, only Oregon has a “death with dignity” law. And very few individuals have taken the steps outlined by the law to obtain prescriptions for medication they could use to end their lives (only 326 people between 1997 and 2004). Even fewer actually took the medication (only 208)—most died of their underlying disease and just wanted the medication as an insurance policy. There are even some suggestions that the availability of physician assisted suicide in Oregon led to improved palliative care and more referrals to hospice as physicians developed a heightened awareness of the inadequacies of end-of-life care. Instead of choosing to end their lives as a response to their physical or psychic distress, patients have enhanced access to programs that ameliorate symptoms and provide support to both patients and families.

Former Attorney General Ashcroft did not approve of physician assisted suicide and tried various strategies to declare Oregon’s law unconstitutional. The most recent was the argument that physicians who prescribed medication that could enable a patient to end his life violated the Controlled Substances Act of 1970. These physicians, he believed, should have their federal prescribing privileges revoked and be prosecuted. Such measures would potentially have dire effects on physician prescribing sufficient pain medication for dying patients (see T. Quill and D. Meier, “The Big Chill: Inserting the DEA into End-of-Life care,” New England Journal of Medicine 2006;354: 1-3;). The Controlled Substances Act was intended to prevent the use of addictive medication as recreational drugs. Invoking it to prevent dying patients from exercising control over their deaths is sheer trickery, attempted sleight-of-hand to interfere with a medical practice of which the Administration disapproved. Fortunately, the trick failed and physicians can continue to prescribe opioids (which, parenthetically, are not typically the medications prescribed to aid in suicide) and other controlled substances to treat pain, shortness of breath, and additional symptoms near the end of life without fear they will be punished.

The bad news is that Chief Justice Roberts joined the predictable duo of Scalia and Thomas in dissenting from the majority opinion. We can anticipate that Judge Alito, when he is confirmed as the next member of the Supreme Court, which appears almost certain, will join with his ideologically motivated colleagues in interpreting the law so as to support his moral and political views. That still leaves a majority of justices, some of whom are considered liberal and others of whom are considered conservative, without these unfortunate biases. But it’s a tenuous majority, composed of Justice John Paul Stevens (age 85), Ruth Bader Ginsburg (age 72), Anthony Kennedy (age 69), David Souter (66) and Stephen Breyer (67). On the other hand, we have Justice Antonin Scalia (69), Clarence Thomas (57), John Roberts (50), and probably soon will have Samuel Alito (55). My geriatric word of the day is the fervent hope that Justice Stevens remains healthy for at least the next 2 years.

Congress Slashes Geriatric Education Funding

Within a 2-week period, we witnessed 3 seminal events in the development of U.S. policy toward older people. First, in mid-December, the White House held a Conference on Aging. This is an event that takes place every 10 years and is attended by delegates from all over the country who pass resolutions designed to give guidance to Congress on how best to improve the quality of life of older Americans. This year’s theme was “The Booming Dynamics of Aging.” The top 10 resolutions passed included 2 that focused on educating health care providers: “Support geriatric education for all health care professionals” was one. The other was “Attain adequate numbers of healthcare personnel in all professions who are skilled, culturally competent, and specialized in geriatrics.” Interestingly, President Bush did not set foot in the meeting, the only sitting president to miss the event in 50 years, according to Ruth Garrett, writing in the Tennessean.com (“Frist gives care for the elderly a congressional kick in the gut,” December 29, 2005.)

The second milestone was the trashing of 3 major government programs that have been funding geriatric education for years. Reportedly, Senate Majority Leader Bill Frist knew that the senators wanted to deal with the budget and did not want to have to come back after the holidays, so he rushed through a voice vote on the measure. The vote was tied 50-50, with Vice President Cheney casting the tie-breaking vote. The 3 programs that were consigned to the dustbin collectively cost $31.5 million in 2005. The total estimated federal spending over the next 5 years will be $14.3 trillion.

One of the victims is the Geriatric Training Program for Physicians, Dentists, and Mental Health Professionals which offered 1- or 2-year programs to train geriatric academicians. I was Director of the Harvard Geriatrics Fellowship Program for years and we relied heavily on government support to provide stipends to young doctors and dentists who wanted to specialize in geriatrics. We were able to offer our fellows a broad exposure to hospital care, outpatient care, rehabilitative care, and nursing home care, as well as a year to begin developing expertise in research. Our fellows went on to become prominent researchers, teachers, and practitioners. The government funded 13 such programs in 2005 and will fund 0 in 2006.

The second program that was axed is the Geriatric Academic Career Award initiative, which provided stipends to junior faculty members who were committed to teaching geriatrics. There are very few opportunities for physicians to develop expertise and experience in teaching. This was one way to be launched on a teaching career. In 2005, awards were given to 102 promising young professionals. In 2006, there will be none.

Finally, funding for the nation’s Geriatric Educational Centers was eliminated. These Centers offered educational programs to health care professionals to train them in issues of importance to the health of older individuals. Since the Centers were introduced 20 years ago, they have touched the lives of over 425,000 professionals in 27 disciplines, according to the National Association of Geriatric Education Centers. All 50 states had such Centers. They will all disappear. (See the article in the Boston Globe on January 13, 2006 by Sue Levkoff, “Assault on the Elderly.”)

The third landmark is that on January 1, 2006, the first of the 76 million baby boomers turned age 60. There was a fair amount of hoopla about this in the media. Congress and the President do not seem to have noticed.

January 13, 2006

On Medicare Part D

As of January 1, 2006, if you are elderly, disabled, or both you are eligible to receive a prescription drug benefit through Medicare. If you are one of the millions of Americans who had no coverage for prescription drugs, this is welcome news. If you are one of the millions of other Americans who already had coverage for prescription drugs through a private plan, this means confusion as you try to decide whether to switch to a new plan, and if so, to which one. If you are one of the approximately 7 million people who are enrolled in both Medicare and in Medicaid, the new law means an obligatory change to the Medicare prescription drug plan, which in turn may result in some degree of confusion during the transition period.

Medicare is providing information on the web to help you decide what to do (go to www.medicare.gov); many local pharmacies are offering advice; and the Medicare Advantage programs (which used to be known as Medicare plus Choice or Medicare Part C) have their own hotlines. While the decisions you make should depend on your individual circumstances and your own preferences, a few general observations may help:

To Enroll or Not to Enroll

  1. Medicare enrollees who are taking many medications and who previously had no health insurance coverage for drugs will almost undoubtedly benefit by enrolling in Medicare Part D. The part D plans will not pay for everything: in addition to a monthly premium charge, there is a $250 deductible for most plans, patients typically have to pay 25% of the next $2000 of drug costs, and generally you will have to pay the entire cost of the next $2850. Only after you have purchased $5100 worth of medicines will most plans start paying at a rate of approximately 95%. Nonetheless, for patients with high expenditures, such a plan is far superior to no plan at all.
  2. Medicare enrollees who are taking few medications and previously had no health insurance coverage for drugs will not benefit from enrolling in Medicare Part D over the short run. However, you should recognize that there is a penalty for enrolling after May 15, 2006: the rates will be higher for people who join after this date. Moreover, the majority of older people eventually will take quite a few medications. Thus, you may find it advantageous to enroll in Medicare Part D now. If you are willing to gamble that you will remain very healthy, if you have ample savings, or if you are already extremely elderly (perhaps over age 90), you may prefer to take your chances and not enroll in Medicare part D.
  3. Medicare enrollees who are already enrolled in a plan that covers prescription medicines will probably find that it makes sense to switch to a Medicare plan because the Medicare plans are typically more comprehensive. Doing so sooner rather than later (ie by May 15, 2006), allows you to get the best rate. However, some plans in which older people are currently enrolled may offer better coverage than the Medicare part D plans. It’s crucial to compare plans carefully. Also keep in mind that the companies that currently provide health care plans for retirees may decide to drop the coverage in the future—this has been happening with great regularity.
  4. The “dually eligible,” those who are on both Medicaid and Medicare, were automatically switched to a Medicare Part D plan as of January 1, 2006. You can opt for a different Medicare plan from the one you were assigned to, but you cannot continue coverage under Medicaid. Your new plan is likely to be different from your old plan in a number of ways: there may be copays for medications of $5, whereas previously you may have paid only $1-2 or nothing at all. Certain medications are explicitly excluded from coverage under Medicare Part D that were covered under Medicaid, such as benzodiazepines and drugs for weight loss or weight gain, although provisions may be made to remedy this problem.

Which Plan to Choose

  1. Choosing based on price: the cheaper plans offer less comprehensive coverage, although all plans provide at least 2 drugs within each “class,” for example 2 drugs to lower blood sugar. Each plan’s formulary, or list of covered medicines, includes “all or substantially all” antidepressant medications, antipsychotic medications, cancer medicines, and anti-seizure medicines. There are plans with no deductible, plans that cover the “gap” or “doughnut hole” (between $2250 and $5100 where the basic plan offers no coverage), and plans that charge different co-payments depending on the brand (ie $5 for a generic medication, $10 for a relatively inexpensive brand name medication, and $25 for a more expensive brand name medication). Plans that provide broader coverage will have higher premiums.
  2. Choosing based on specific medicines: if you are taking several medications currently and if it is important to continue taking exactly the same version of those medications, you should look for a plan that includes those medicines. In general, substituting one medicine of a particular class for another one in the same class may be confusing initially but it rarely makes a difference in terms of your health. Sometimes patients respond better to one drug rather than another, or have side-effects from one drug and not another similar drug. If you know that you are best off with precisely the medicines you are taking, because you have already been on other versions and have had problems, then you should seek a plan that covers your current medicines.
  3. Choosing based on convenience: you should check which plans your local pharmacy accepts. You should also consider whether a given plan offers a mail order service. If you take medications on a regular basis and are on a fairly stable regimen, it may be very useful to be able to send away for your medications. You will then get a 90-day supply in the mail.


For more details on what Medicare Part D means for the dually eligible, see RA Elliott, SR Majumdar, MR Gillick and SB Soumerai, “Medicare Drug Benefit: Benefits and Consequences for the Poor and the Disabled,” New England Journal of Medicine 2005; 353: 2739-41.

January 12, 2006

An Introduction

The “Perspectives on Aging” website has been set up to communicate with the general public about controversial issues affecting older people through commentaries on topics of timely interest. I am a physician specializing in the care of the elderly, with particular interests in making decisions about medical treatment and in ethical issues that arise near the end of life. While I will address on this site that are of potential concern to all older individuals and their families, I am particularly interested in providing information and guidance to the sickest, frailest, and oldest of the old.

My background is in internal medicine, with specialty certification in both geriatrics (medical care of older patients) and palliative medicine (care of people facing life-threatening illness). I have practiced medicine in a neighborhood health center, a community hospital, in a number of nursing homes, and in several tertiary care teaching hospitals. Throughout my career, I have been affiliated with Harvard Medical School, where I am an Associate Professor. Stimulated by my clinical experiences, I have written extensively about issues in geriatric care. While much of my work has been published in medical journals including the New England Journal of Medicine, the Annals of Internal Medicine, and the Journal of the American Geriatric Society, I have also written for a general audience. In particular, I have published 3 books, one on dementia (Tangled Minds: Understanding Alzheimer’s Disease and Other Dementias), one on frailty (Lifelines: Living Longer, Getting Frail, Taking Heart), and one on medical decision-making in old age (Choosing Medical Care in Old Age: What Kind, How Much, When to Stop). My newest book will be published in March of 2006 and will be called The Denial of Aging: Perpetual Youth, Eternal Life, and Other Dangerous Fantasies.

It takes years to write a book and have it published and much is happening all the time that affects older people: Medicare has just rolled out a new prescription drug benefit; the Centers for Medicare and Medicaid Services (which runs the Medicare program) has agreed to pay for eligible patients to receive sophisticated technological interventions such as an implantable defibrillator (like what Vice President Cheney has); new initiatives have been introduced that have the potential to radically transform nursing homes. I want to be able to talk to older patients and their children about these issues as they arise; to that end, this website has been created.