November 17, 2019

November is “National Family Caregivers Month.” Upwards of 41 million Americans provide care to someone else (beyond normal childrearing responsibilities), and in the vast majority of cases that someone is an older adult, typically a parent or a spouse. Just exactly what do these caregivers do and how much time do they spend doing it? Two reports published in the last few months and supported in part by AARP shed light on both these questions.

The most recent report is “Valuing the Invaluable: Charting a Path Forward.” Released this month (November, 2019), it is an update of the 2015 report of the same name. Based on the latest available data, it assesses the economic value of caregiving at $470 billion, a calculation that estimates the average amount of time spent at 16 hours per week and values that time at $13.81/hour. Now this may be the average wage for a home health aide, so perhaps it’s the relevant way to compute the “value” to the economy. But it’s surely not typical of what the average adult could earn if she (it’s usually although not always a she) were not serving as a caregiver and were engaged in her usual occupation—perhaps being a lawyer or a teacher—instead. Taking the $470 billion figure as a floor, we see that even this low-ball figure is more than the total amount Americans spend out of pocket on health care ($366 billion in 2017) and it’s three times as much as Medicaid spent on what it calls long term services and supports, which includes nursing home care as well as home health aides, adult day care, and other programs.

As to what unpaid caregivers actually do, the job encompasses a variety of activities, ranging from dealing with insurance claims to providing transportation to medical appointments, to providing hands on medical and nursing tasks. The latter is what the second report, "Home Alone Revisited," addresses.

"Home Alone Revisited: Family Caregivers Providing Complex Care" was published in April, 2019 and, like Valuing the Invaluable, it’s an update of an earlier report, this one from 2012. The study finds that just under half of all family caregivers provide “complex care:” medical or nursing services ("M/N tasks") that until recently were primarily if not exclusively in the domain of health professionals. These tasks range from managing medications to using sophisticated technology such as a respirator or dialysis.



Not only are many caregivers delivering complicated medical treatment, treatment that often allows older people to stay out of nursing homes, but they are finding their responsibilities burdensome. They often report the activities are also rewarding, but they worry about making mistakes and suffer from minimal guidance from nurses and doctors.



The report observes that while we have made some progress in helping caregivers do their critically important work—for example, the CARE Act, which requires hospitals to ask older patients to name a caregiver and then include that caregiver in discharge planning, has been enacted in 41 states—much remains to be done. The authors conclude that health care systems and professionals must offer “instruction and support” to caregivers providing complex care.

All this is well and good, but I think we need to emphasize not just the concrete actions that caregivers take—preparing special diets, providing wound care, and operating durable medical equipment—but also the medical decisions they are expected to make. A key component of what caregivers do that is scarcely touched on in either report involves day to day management of chronic disease (the exception is the emphasis in the new report on managing pain, which is identified as a particularly challenging area for caregivers), deciding whether to adjust the medication dose or the flow of oxygen, determining whether to take the older person to the doctor’s office or the hospital emergency department. These crucial decisions that caregivers make all the time affect whether the patient gets care at home or in the hospital, gets invasive care or supportive care, takes expensive, newly developed medication or cheap, tried and true drugs. Such decisions have the potential to shape the older individual’s quality of life—and the national expenditure on health care. 

Caregivers should not engage in medical decision-making in isolation. They need the guidance of a health care professional. They need to spend time talking with the older adult and the physician about what overall goal of care makes sense at a particular point in time, given the patient’s general health and any limitations in daily functioning. If we want to support caregivers, and at the same time conceivably limit spiraling health care costs, we need to work with medical practices to teach them to partner with caregivers. Now that's a good activity for National Caregivers Month.

October 27, 2019

Rescinding the DNR order--for anti-amyloid drugs


The pharmaceutical firm Biogen issued a stunning press release this week: it would seek FDA approval for its anti-Alzheimer’s drug, Aducanumab—the very same drug the company had pronounced a failure just last March, after preliminary analyses indicated the drug was very unlikely to achieve its objectives. Dennis Selkoe, a prominent Alzheimer’s researcher at the Brigham and Women’s Hospital in Boston, wrote in STAT (a health-oriented news website owned by the Boston Globe) that he believed that “aducanumab is the breakthrough we have been waiting for.” But is it?

Aducanumab is by no means the first drug studied that targets beta amyloid, a protein widely believed to play an important role in the development of Alzheimer’s disease. An article in Nature Reviews (Drug Discovery), published shortly after the first analysis of the Aducanumab data, put the drug in perspective: a monoclonal antibody that binds to beta amyloid, it is the fourth such drug to make it to a Stage III clinical trial. And all three of its predecessors, as well as another five anti-amyloid drugs that have a different mechanism of action, were abysmal failures leading Nature Reviews to proclaim "Anti-Amyloid Failures Stack Up as Alzheimer's Antibody Flops." Maybe what this new analysis of the Aducanumab data has done is to reverse the Do-Not-Resuscitate label previously attached to monoclonal antibodies and instead put them on life support. So, what, exactly, does the new data analysis show? 

The details will be released to the FDA when Biogen files with the FDA to approve the drug. Thus far what we know is what Biogen has included in its press release. Biogen conducted two randomized, double blind, controlled studies, giving the monoclonal antibody (presumably by injection, like other monoclonal antibodies) or placebo to a total of 3285 patients and following them, some for 78 weeks. One study, sporting the acronym ENGAGE, produced negative results even upon re-analysis, although a subset of ENGAGE patients who received a high dose of the drug appeared to respond. The other study, named EMERGE, showed a reduction in the rate of clinical decline in treated patients compared to those receiving placebo. In other words, the study patients did not improve nor did they plateau; rather, they got worse more slowly. Unfortunately, the press release doesn’t report the absolute magnitude of the change, opting instead to say that the scores on the Mini-Mental State Examination (MMSE), a commonly used measure of cognition, fell 15 percent less with treatment than with placebo. Similarly, the rating on the ADAS-Cog13, another measure of cognitive function, declined 27 percent less in those on the drug. Finally, and perhaps most encouragingly, the decline in the ability to perform basic daily tasks (as measured by the Alzheimer’s Disease Cooperative Study Activities of Daily Living Inventory) was 40 percent lower in those receiving Aducanumab than in their counterparts who received placebo. 

These are not spectacularly impressive results—the patients continued to worsen and the difference between treated individuals and untreated individuals, at least on measures such as the MMSE, was very small. But what we don’t know is whether the slowed rate of decline will persist over time or whether, as with drugs that are currently on the market such as donepezil (Aricept), there is a one-time effect. We don’t know whether the effect would be greater if the medication were used earlier in the progression of Alzheimer’s disease, perhaps in people with mild cognitive impairment. We don’t know whether the drug will prove to be more effective in those with “pure” Alzheimer’s disease, that is, without concurrent vascular changes. 

What we can predict is that if the drug is approved by the FDA, Biogen, whose stock price soared after the press release, will aggressively market the drug. An estimated 5.8 million Americans have Alzheimer’s disease, according to Alzheimer’s Association statistics released in 2019: since the time from diagnosis to death is 5-7 years, roughly one-fifth of the affected individuals or over a million people likely have early Alzheimer’s and are potential Aducanumab consumers. This could be a dream come true for the pharmaceutical company--a blockbuster specialty drug. (Blockbuster drugs are prescribed to at least one million people a year and specialty drugs are very expensive biologicals such as monoclonal antibodies). And if the sales price for the drug is anything like that of other newly marketed monoclonal antibodies, it may be upwards of $1000 per month (Dupilumab, brand name Dupixent, a new monoclonal antibody used in the treatment of asthma and/or nasal polyps, has a list price of $37,000 per year). 

Biogen stockholders will benefit enormously; how much people with Alzheimer’s disease will benefit is less clear. But on a more positive note, as Dennis Selkoe commented in STAT, for the first time we have evidence that it is possible both to design molecules that target amyloid and to administer them to real people with minimal toxicity and some evidence of benefit. That truly is good news.

October 07, 2019

Clearing the Air

I’ve been reading “The Uninhabitable Earth: Life After Warming,” an extensively researched account of where we are headed that begins with the warning: “It is much, much worse than you think.” When I got to the chapter depressingly entitled “Unbreathable Air,” I encountered the following shocking sentence: “Pollution has been linked with increased mental illness in children and the likelihood of dementia in adults.” Now I’ve seen all kinds of things associated with dementia: head trauma, assorted medications (anticholinergic drugs, anti-anxiety drugs, and anti-ulcer drugs), aluminum. Some of those links have become well-established over time, such as head trauma. Some of have been totally debunked, such as aluminum. Others are questionable and I’ve written about them on this blog (drugs). But air pollution? This was a new one to me. 

Most likely, I figured, it would prove to be another spurious association. Probably, I thought, there was some other factor that was associated with both air pollution and dementia. The alleged connection would be like the link between washing machines and colon cancer—a favorite example of a “confounder” from my medical school epidemiology class. People who own washing machines, it turns out, do have a higher rate of colon cancer than people who don’t. But they also vary in where they live and what they eat, which is far more important than their possessing a washing machine. Surely air pollution was likewise a marker for something that did matter. But then, as I read on in Wallace’s book, I came to an even more dramatic statement: “An enormous study in Taiwan found that, for every single unit of additional air pollution, the relative risk of Alzheimer’s doubled.” This I had to look into.

The “enormous study in Taiwan” was published in a minor but respectable journal, the Journal of Alzheimer’s Disease in 2015. It was large: it was a cohort study of 95,690 adults aged 65 and older followed prospectively for 10 years beginning in 2001. Not only was it large, but it was a random sample drawn from Taiwan’s National Insurance Research Database comprised of 23 million people, or 99 percent of the entire Taiwanese population. Moreover, Taiwan has 70 EPA monitoring stations distributed over the island, allowing it to have reasonably accurate measures of both ozone exposure and small (less than 2.5 micrometers) particulate measure. Finally, the population is fairly stable over time, allowing for fairly good estimates of exposure based on home address. The conclusion? The risk of newly diagnosed Alzheimer’s disease (adjusting relevant co-morbidities such as stroke, hypertension, and diabetes) rose steadily with the rate of exposure to ozone or small particulate matter—going up, for example by 211 percent for each 10.91 ppb increase in ozone.

Taiwan isn’t the only place where a relationship between air pollution and dementia has been discovered. In 2017, a similar study entitled “Exposure to Ambient Air Pollution and the Incidence of Dementia: A Cohort Study,” appeared in Environmental International. Carried out in Ontario, Canada and involving a cohort of just over two million adults, this analysis attributed just over six percent of all dementia cases to air pollution. 

Neither study is conclusive, but they’re awfully suggestive. I wondered if there had been any further work on this subject since Wallace wrote his book. Lo and behold, a systematic review was just published by Peters et al from Australia, also in the Journal of Alzheimer’s Disease. These authors found thirteen reasonably well-conducted studies bearing on the question. They concluded that small particulate matter (containing nitrogen) and carbon monoxide are both associated with an increased risk of dementia. 

These reports are very disturbing in light of the Trump administration’s systematic assault on air pollution regulation. According to an article just published in the New York Times, 85 environmental rules are being rolled back, including 24 in the arena of air pollution. Of these 24, 10 have already been undone and another 14 are “in process.” 

We already know that climate change will have an enormous impact on health, principally through its multitudinous indirect effects—for example, by causing drought, which in turn affects agricultural productivity, which in turn results in death. Now there may be another health risk to add to the list of adverse effects of environmental harm. Dementia is such an enormous public health problem that even measures that only slightly affect the risk of developing this devastating condition may be worthwhile. But the good news is that air pollution is an area where we can intervene. We even know how to. The last thing we should be doing is unraveling the progress we have made. So, speak up, tell your senators and representatives to act, and vote wisely to decrease the pollution that threatens us all.


August 28, 2019

Good and Old

            The solution to my dilemma was staring me in the face: if I didn’t find the new 

developments in medicine of sufficient interest to blog about, and if I didn’t think my readers

—a motley collection of people interested in aging—would find those developments of great 

interest either, I should write about great books. I would re-read the books that influenced 

my thinking twenty or more years ago. After all, just because the ideas in those books have 

become integrated into my world view, just because I take them for granted, doesn’t mean 

they are trite or passé. Nor should I assume that most people, particularly the younger 

generations, are familiar with those seminal ideas.

            I first realized that not everyone who cares about old people—not even everyone 

trained as a specialist in caring for older people—has read what I consider the great works 

of geriatrics, whether books or essays. Several years ago, I was giving a talk to a group of 

well-educated, exceptionally smart and ambitious young doctors and I mentioned the 

longstanding disconnect between the kind of care patients say they want near the end of life 

and the kind of care they actually get. I traced the history of the recognition that such a gap 

existed and reviewed the early strategies for overcoming it, so of course I referred to the 

SUPPORT study. The faces of the well-educated, exceptionally smart and ambitious young 

doctors looked blank. Hesitant to go over well-trod ground, but not wanting to make any 

unwarranted assumptions about what my audience knew and what they didn’t, I asked how 

many of them were familiar with SUPPORT. Not a single hand was raised.


            The SUPPORT (The Study to Understand Prognoses andPreferences for Outcomes 

and Risks of Treatments). The study was a large, randomized trial conducted at 5 U.S. 

hospitals and involving over 5000 very sick patients, people who had one of a handful of 

conditions and a high likelihood of dying within the next year. Phase I of the study 

established that a majority of these patients, provided they were informed of their prognosis 

(which few had been) favored certain limitations of treatment but that only a minority 

received treatment that accorded with their wishes. Phase II of the study showed that when 

specially trained nurses told patients their prognosis, elicited their preferences, and 

transmitted those preferences to the attending physician, the lack of concordance persisted. 

As an intervention trial, this multimillion dollar, Robert Wood Johnson Foundation supported 

study was a resounding failure. But as a descriptive study showing, for example, the 

proportion of seriously ill people who died in pain or despite invasive technology, it was a 

landmark work. And the failure of the particularly remedy was also illuminating. 


            SUPPORT is now 25 years old but it was crucial to all subsequent work in the area 

of advance care planning, It defined many of the norms by which “good” end of life care 

would be measured. It launched the careers of numerous researchers who struggled to 

understand why SUPPORT flopped, on the one hand, and how to achieve its aims in the 

future, on the other. The truth is, we are still today trying to figure out how best to explain to 

patients the way their diseases are likely to unfold, what their options are, and to help them 

translate their personal values into a viable treatment plan.

            Ignorance about SUPPORT is no anomaly. Last month, Daniel Callahan died, one of 

the giants of American biomedical ethics. I am old enough to remember reading his 

controversial book, Setting Limits, when it first came out in 1987. At last, I recall thinking, a 

philosopher who is not floating in some abstract universe of ethical principles, but who is 

grounded in clinical reality. I also remember browsing in my local bookstore, which 

somewhat bizarrely shelved its books according to publisher, regularly seeking out the 

Simon and Schuster section, eagerly awaiting Dan Callahan’s next book. I read them all and 

eventually I got to know Dan Callahan himself, as kind, generous, and modest as he was 

insightful and path-breaking. So, I was shocked and dismayed to realize that young 

physicians today, even those with a background and interest in ethics, typically know that 

Daniel Callahan co-founded the Hastings Center, the foremost American biomedical ethics 

think tank but have never read Setting Limits.


            So we come to the new plan: I will write about the classics. Not the Iliadand the 

Odyssey. Not IL Nascher’s book, Geriatrics: The Diseases of Old Age and Their Treatment

which laid the groundwork for a new field but which is now hopelessly out of date. Instead, I 

will peruse my own bookcases and write about those books that deserve to be read and re-

read. I will get to Setting Limits soon. But the first book I’d like to blog about was not written 

by a geriatrician or a philosopher nor a historian, but by a novelist. It’s Patrimony by Philip 

Roth and it’s one of the finest depictions I have ever encountered of frailty, on the one hand, 

and of the perils of medical decision-making on the other. It is one of Roth’s only forays into 

non-fiction and in it he tells the story of the final year in the life of his father, Herman Roth. 

Reading this fine book now is particularly poignant because Roth Senior was 86 in the 

narrative and Philip Roth, the son, died a year ago at age 85.


            WhatPatrimony is really about is the relationship between a father and a son, which 

may not seem like a geriatric issue. But from my perspective, relationships are the 

quintessential geriatric issue. One of old age’s principal challenges is to find meaning in life, 

often in the face of loss, illness, and disability. One of the principal sources of meaning is 

relationships, and what relationship is more profound than that between a parent and child. 

What makes Patrimony  so special is that Philip Roth, who sounds as though he had for 

years found his father endlessly annoying: he was not an intellectual, he had a habit of 

constantly correcting and cajoling those he cared about, and he simply wasn’t interested in 

the same things as Roth Junior. But over the year that Philip shepherded his father from his 

brain tumor diagnosis to his eventual death, he came to accept his father’s foibles and to 

appreciate his strengths. It is with affection and understanding that he reports his father’s 

penultimate question to the neurosurgeon he saw in consultation about the tumor: “What do 

you use to go in there? Do you use General Electric or Black and Decker?”


            The book shows us how painful loss is—and why we are so reluctant to let go. When 

driving from New York City to Elizabeth, New Jersey, where his father lives, a route he has 

taken countless times, Philip Roth makes a wrong turn and ends up at the cemetery where 

his mother is buried. He visits his mother’s grave and we see that though he is a famous 

author, financially successful and, at least during the writing of the memoir, enjoying a 

fulfilling romantic relationship, his mother is still “Mommy.”


            Roth the novelist is known for raw and explicit details, usually in the sexual arena. In 

Patrimony, he is raw and explicit in his description of his father’s difficulty chewing and 

swallowing and of a bout of incontinence. He shows the devastating loss of dignity that 

makes frailty so difficult to endure—and how acceptance of his father, despite his difficulties, 

is the way to transcend frailty.


            Finally, Roth’s book shows how the medical profession pushes patients and families 

toward aggressive treatment. Surgery to remove Herman Roth’s tumor is variously 

described as requiring an 8- or even 10-hour operation or two multi-hour procedures, either 

way, an unequivocally major ordeal. But surgery, from the medical professional’s 

perspective, offers the only path to improvement, though the likelihood of achieving 

improvements is not great and the chance of surgery making things worse is considerable. 

As the story unfolds, the Roth family gradually come to see that the best course of action for 

the 86-year-old Herman is supportive.  There’s even a poignant acknowledgment that 

advance care planning is often harder for the family than for the patient: Philip Roth 

struggles for days to discuss a living will with his father. He says it was harder for him to 

broach limiting treatment than it had been to talk about the brain tumor diagnosis. With the 

tumor, he could behind terms such as “benign,” ignoring the reality that even non-malignant 

growths can cause plenty of mischief and conveniently neglected to mention that the tumor 

was enormous and had already encircled a major blood vessel in the brain. When Roth 

finally does raise the subject of advance planning, he finds his father is matter of fact about 

the process and quite comfortable with setting limits. Herman had sold life insurance for a l

iving; he had “spent his life time talking to people about the thing they least wanted to think 

about.” So, even though Herman Roth can’t resist hoping for “another couple of years” and 

then, by the time he goes for a second opinion, for “3 or 4 years,” he’s a realist and knows 

that the end is coming. As he says, once he’s dead, he won’t have anything to worry about. 

It is his son who will suffer afterwards, who will continue to feel love, affection, respect—and 

loss.


            Patrimony is a geriatric masterpiece. First published 28 years ago, it is not in the 

least bit dated. Father/son relationships, frailty, advance care planning, and death are all still 

around and always will be.

August 19, 2019

Loss

There will be no more email messages with requests for data about the median age of legislators in Western European countries. No emails with provocative observations about the association between the rise in the overall suicide rate and the growing legalization of physician assisted suicide. They all began with “Dear Muriel,” never with “Hi Muriel,” never without a salutation. He is gone, I learned in July. Died just before his 88thbirthday. It was the emphysema that got him in the end.

I realized last night that I haven’t written a single blog post since then. For some time, I’ve been finding it difficult to identify new findings in medicine worth writing about, that is, sufficiently interesting to me to write about them. Vitamin D is the panacea for aging; Vitamin D is out—useless, or worse. Calcium prevents osteoporosis; calcium doesn’t prevent osteoporosis. At long last, Congress passes legislation supporting caregivers; the new legislation won’t achieve much of anything. There’s a new, promising test to identify pre-clinical Alzheimer’s disease; there’s no point taking the test unless you want to enter a research study—or if you want to make yourself miserable sooner than necessary. None of this seemed to matter enough for me to write something about it. And now it matters even less because there is a hole in the fabric of the universe.

For years, I’ve been writing about meaning in old age: the importance of figuring out ways to remain engaged with the world despite age-associated limitations, despite encroaching frailty. I’ve consistently seen the role of geriatrics as facilitating a good old age, where 'good' implies a time to cultivate relationships and contributing to the net goodness in the world. Geriatrics is the means to an end, not the end itself. Sure, preventing or reversing frailty would be nice, but what is even more critical is adapting to whatever life has in store for us, and that's the domain where geriatrics, like palliative care, can make contributions. I’ve also written about accepting mortality, which applies both to people who themselves are facing the end of life and to those who care about them. But I don’t think I’ve said anything about how to cope with loss after death.

I suppose that as a physician, I’ve seen my role as ending when life ends. Dealing with what comes next, whether for the person who has died or for everyone else, that’s someone else’s domain. That’s for religion or psychology or social work. But now I’m facing a hole. Yes, I recognize that life is finite. Yes, birth and death, growth and loss are all natural, normal. But we humans, we are meaning-makers. We need to make meaning out of life even where there isn’t any. We do this with rituals, with ceremonies, with reminiscences. We immortalize the mortal through our memories. So, I will do what I usually do when confronted with something that I see as important: I will write. My writing will not patch the hole, but perhaps it will serve as a sort of ornamental curtain.

Rest in peace, my friend.


Daniel Callahan, pre-eminent bioethicist and a true mensch, died on July 16, 2019.

July 23, 2019

Home Sweet Nursing Home

Every year, about one-quarter of the 1.4 million American nursing home residents are hospitalized. Most of them survive the experience and go back to the same nursing home from whence they came. But like their community-dwelling counterparts, they often suffer from one or more adverse events after discharge, despite the documentation that is supposed to travel with them from the hospital to the nursing home, and despite the nursing staff that cares for them on their return and the physicians who attend to them shortly after their arrival. How often do they experience such adverse events? How serious are they? And can they be prevented? A new study in JAMA Internal Medicine attempts to provide the answers.

To analyze what happens when nursing home residents travel from the hospital back to their nursing home of origin, the authors of the study sampled 32 nursing homes from the 762-member New England Nursing Home Quality Collaborative. They identified all residents who made the nursing home-to-hospital-and back-journey over a nearly two-year period ending on December 31, 2017. They hired and trained nurse reviewers to study the records of these patients and, after further physician review, came up with 379 adverse events.

Classifying these episodes on a four-part scale ranging from not serious to fatal, they found that fully 38 percent were serious, another 7 percent were life-threatening, and 2 percent proved fatal. In terms of the type of episode, over half (52 percent) were related to “resident care,” i.e. involved a pressure ulcer, skin tear, or fall. The biggest chunk were due to heath care acquired infections (29 percent), with medication-related episodes accounting for 17 percent. In the judgment of the physician reviewers, fully 70 percent were either preventable or ameliorable.

What’s going on here? Why did so many long-term care residents suffer an adverse event after hospitalization? Clearly, this is a very vulnerable population. The patients tend to be very old and very frail, otherwise they wouldn’t live in a nursing home. That means they are particularly susceptible to common health care acquired infections such as c. difficile. Often weak before their hospitalization, they are typically weaker—and at greater risk of falling and of skin tears—after being ill, with associated immobility and poor nutrition. Is there a fix? Are many of these events truly preventable or at least ameliorable?

Most likely, improving this sad situation will require additional effort by both hospital and nursing home personnel. At the hospital level, early mobilization is essential, as is adequate attention to nutrition. Avoiding high risk medications, whether those predisposing to c diff or those apt to trigger delirium, is of utmost importance. At the nursing home level, assuming that whatever-worked-before-will-work again is probably the major impediment to change. Simply re-instituting the previous regimen—the same diet and the same degree of independent ambulation—or mindlessly accepting the new medication list sent over from the hospital predisposes to problems. 

As is so common in geriatrics, we may know what to do but don't make the effort to do it. To incentivize the relevant staff to do what’s necessary, we may need to design a system in which facilities are paid extra to go the extra mile. Maybe nursing homes that take their residents back from the hospital without an intervening skilled nursing facility (“rehab”) stay should be paid extra for the days they should be functioning more like a short stay SNF. Maybe Medicare payments to hospitals should be adjusted to account for frailty, with hospitals whose nursing home patients do well after discharge getting a bonus for outstanding care. Perhaps hospitals and nursing homes need to take shared responsibility for the welfare of long-term care residents, using a shared electronic medical record system, “warm” hand-offs, and even shared staff. If we really want to improve a manifestly improvable system, maybe we should do all the above.

July 01, 2019

The Dirt on Drugs

Several months ago, in writing about Katy Butler’s generally admirable new book, The Art of Dying Well,I questioned her uncritical acceptance of claims that certain drugs, the anticholinergics, caused dementia. That drugs such as antihistamines and some antidepressants cause delirium, or acute confusion, is well-established. But dementia? A large, well-conceived study just published in JAMA Internal Medicine provides additional evidence that they may well result in dementia. Previous studies were tainted because they tended to be small, observational studies that lumped many different anticholinergic drugs together, some of which are known to be far more potent than others. So how does the new study fare by comparison?
The recent analysis is still an observational study—it is impossible to randomize patients into those who receive anticholinergics and those who do not and then follow them for years—but it is very large, it analyzes different classes of anticholinergics separately, and it focuses on the cumulative anticholinergic exposure over a period of many years. While not perfect, it is probably the best we are going to get and it provides strong, although not definitive, evidence that anticholinergics are a risk factor for dementia.
This “nested case control study” allowed the authors to identify just under 59,000 people over age 55 with dementia from a British data base of 30 million. For each case, they found 5 controls matched along four discrete dimensions. The main variable of interest was the total, cumulative anticholinergic exposure which they calculated according to a well-established protocol that allows standardization across drugs with different dosage regimens. The authors also decided in advance to study the association between the total standardized daily dose (TSDD) for each type of anticholinergic: antihistamines, antidepressants, antipsychotics, antiparkinsonian drugs were considered both separately and collectively. Finally, the study repeated the analysis for patients diagnosed with Alzheimer’s disease, those diagnosed with vascular dementia, and those with some other form of dementia. So what did they find?
The main finding was that the adjusted odds ratio associated with low anticholinergic exposure was 1.06, while the ratio associated with the highest degree of anticholinergic exposure was 1.49, a highly significant difference. Also interesting was the observation that only certain groups of anticholinergics increased the risk of developing dementia. In particular, antidepressants, antipsychotics, antiepileptics, and drugs used to treat Parkinson’s and incontinence were the main offenders (and antihistamines, which geriatric physicians inveigh against as potential causes of delirium, had no effect). Curiously, the effects were more dramatic in patients with vascular dementia than in those with Alzheimer’s disease, a novel finding. Finally, the strongest association was found in people diagnosed before age 80.
As the authors are quick to point out, associations do not demonstrate causality. They can’t. Researchers simply cannot exclude the possibility that some of the drug use in fact reflected early, preclinical effects of as yet undiagnosed dementia. For example, many people with dementia are depressed; it is entirely possible that the depression manifests itself before a formal diagnosis is made, at a time when patients are beginning to detect subtle but disturbing changes in their memory and problem-solving ability. But if anticholinergics are causative, then they may well be responsible for as much as 10 percent of all dementia. The evidence is sufficiently suggestive and the magnitude of the danger sufficiently great that it’s time to be very wary of these drugs, especially in people under age 80. 

June 25, 2019

Elderhood

I particularly like the title of geriatrician Louise Aronson’s new book, Elderhood. I appreciate that she does not shy away from calling old people “old.” She cringes at euphemisms like “seniors” and seems to find "older adults," the formulation that the American Geriatrics Society deems politically correct, a bit affected (or so I infer from her conspicuous failure to use the phrase). Dr. Aronson also declines to talk about “successful aging” (a phrase that suggests that anyone who isn’t aging successfully is a failure) and scoffs at the term currently in vogue, “flourishing.” Not that she thinks old people can’t flourish, but after 30 years of practicing medicine she’s a realist. That means accepting that aging comes with a good deal of loss and deterioration. The challenge is not to halt that process—though prevention, when feasible, is a good thing—but rather to find ways to enable older people to derive meaning and satisfaction from their lives despite those losses. Old age is simply a phase of life with its unique challenges and opportunities, like childhood or adulthood. Hence, elderhood.
The book is a wonderfully readable and accessible introduction to geriatric medicine. Through clinical anecdotes and accompanying commentary, Aronson teaches the reader all the basics: she discusses falls, polypharmacy, delirium, dementia, and depression. She also touches on the perils and potentials of the institutions where today’s old people receive medical services such as hospitals, rehab facilities and the office, with special attention to the merits of house calls. And she discusses the backdrop against which all this medical care takes place—the ageism of the surrounding society, the misconceived (or so she argues), expensive, and distracting effort to extend the lifespan, and the poor design of the environments in which most old people live.
The organization of “Elderhood” is somewhat opaque. It is divided into sections: birth, childhood, adulthood, elderhood, and death, which seem to reflect the author’s early life, adulthood, and incipient elderhood. But the structure breaks down because the sections on elderhood and death clearly refer to the author’s patients and not to herself, though she reflects on how she experiences their life stories. After a while I gave up trying to make sense of the book’s structure and just followed the author wherever she led me, from one story to the next, with thoughtful meditations on each vignette. It’s a wonderful ride.
No single volume can possibly capture all aspects of aging. If there’s one thing missing from this rich and satisfying book, it’s a deeper understanding of the forces that both create and sustain the maladaptive system Aronson so eloquently describes. She is well aware of the social dimension of her tale and in fact explains early on that she had been “an unlikely medical student,” regularly substituting literature, psychology, and anthropology college courses for math and science courses whenever she could. She spends a good deal of time talking about medications but not so much on the pharmaceutical industry; likewise, she discusses the baleful effects of hospitals on the physical functioning of old patients but not on prospective payment or the device manufacturing industry that led to the the prevailing system. One consequence of this omission is that Aronson cannot quite succeed in fulfilling the ambitious mission of her subtitle, “redefining aging, transforming medicine, reimagining life.” She hasn't yet come up with ways to change the powerful institutions that shape contemporary reality--maybe in her next book. 
But that’s all right. The book is a treasure. Perhaps its most fundamental lesson is that what matters most in medicine is the relationship between patients and physicians. And through her engaging style, her allusions to her personal life (hence, presumably, the birth-childhood-adulthood-elderhood-death structure of the book), and her emotional reaction to what she observed in her patients, we come to know and respect Louise Aronson. We trust her. The secret to the care of the patient, George Peabody famously said and Aronson quotes, is caring for the patient. Maybe the secret to improving geriatric care is designing an educational system that will produce more physicians like Louise Aronson.

June 10, 2019

Caveat Emptor!

Quite by accident, I stumbled upon Kurt Eichenwald’s memoir in the new book section of my local library. I remembered the author from his work as an investigative reporter who uncovered massive white collar crime. His book, The Informant, about just such a scandal, became a best seller and a movie starring Matt Damon. When I realized the new work had a medical theme, I was intrigued; when I discovered that much of the story unfolded at Swarthmore College, where Eichenwald had been a student, and where I had been a student some years earlier, I decided I had to read it.


At first glance, you might think that A Mind Unraveled has no relevance for geriatrics. The diagnosis and misdiagnosis of Eichenwald’s temporal lobe epilepsy as well as the shockingly misguided treatment by ostensibly reputable physicians all took place in the early 1980s, when the author was a teenager or in his early twenties. Unfortunately, the book’s messages are all too relevant for older patients today. Distilled to their essence, those messages are first, that not all doctors are created equal and second, that communication is key. The long, complicated, and riveting story of lying, arrogance, and sheer incompetence that led to those conclusions is worth reading. I read the entire 380-page book in a single weekend, devouring it much as I would a spy thriller.

The not-all-doctors-are-created-equal conclusion is particularly relevant to older individuals because even physicians who are competent within their sphere of expertise often have little knowledge or understanding of geriatric issues. In my last post, commenting on recent data indicating that despite all we have learned about preventing falls, older people are falling—and injuring themselves—at higher rates than ever before,  I suggested that a critical weakness of prevailing fall-prevention systems is that they hinge on the knowledge and interest of physicians, both of which are often absent. Identifying a physician who is a good diagnostician, a kind person, and who actually knows about falls, confusion, polypharmacy, cognitive impairment, incontinence, and other common geriatric syndromes is imperative, particularly for frail older people. Finding such a person can be challenging, and being confident s/he has the requisite expertise is also challenging. Board certification in geriatrics is one indicator; working with a multidisciplinary team including a nurse practitioner is another; word of mouth is a third. Trial and error may prove the only way to be certain you have found the right person: come to your first appointment with a checklist of topics the physician should be sure to address such as functional status and advance care planning. If the physician doesn’t address those issues during an annual physical exam, absent a compelling need to focus on an acute medical problem, it’s probably time to find someone else.

The communication-is-key conclusion is relevant to all physician/patient interactions, but is especially important for older people, many of whom have hearing problems or cognitive impairment. It took multiple tries before Eichenwald found a neurologist who understood that given that all the medications used in the treatment of epilepsy have potential side effects, choice of which drug to use involves balancing risks and benefits. The patient’s preferences, which side effects s/he finds tolerable in exchange for how much benefit, are essential in making a choice of drugs. For geriatric patients, the role of preferences is often paramount in medical decision-making. The assumption that the goal of treatment is cure may simply not apply to an 88-year-old with multiple medical problems; maintaining or bolstering his ability to remain independent may, for example, outweigh the benefits of disease eradication. Or cure may be irrelevant, as with some cases of prostate cancer, if the odds are that the patient will die of some unrelated problem long before his prostate cancer metastasizes, but the risk of surgical treatment causing incontinence or impotence now is great. 

Regrettably, the dismissive attitude of Eichenwald’s physicians to him as a person are all too familiar to many older individuals. Just as many of the neurologists in A Mind Unraveled failed to take their patient seriously as a person with anxieties, concerns, and understanding, so too do physicians often neglect to treat their older patients with respect and sensitivity. To find a physician who listens you cannot rely on board certification. Word of mouth can help (if the mouths belong to people you trust, preferably people whose personalities and medical problems are similar). But once again, trial and error may be the best path. Don’t hesitate to use yourself as a barometer. Only you can gauge whether you “clicked” with the physician. Just as you should be reluctant to listen to the shoe salesman who assures you that those very uncomfortable shoes will improve with time, you should ignore at your peril the internal voice that tells you to stay away from a particular physician.

I would like to believe that Eichenwald’s experience was highly unusual. Most physicians who treat epilepsy know that a negative EEG doesn’t mean there’s no seizure disorder (but the presence of characteristic electrical changes indicates there is). Most physicians would monitor blood counts when prescribing a medication that has a “black box warning” from the FDA stating that the drug can cause life-threatening bone marrow depression and that regular blood tests are required. No competent clinician would offer a diagnosis of a brain tumor based solely on a few of the patient's behavioral quirks. And I haven’t even touched on the arrogance and prejudice that animated members of the Swarthmore administration, leading to their expelling young Eichenwald—and then readmitting him when faced with the prospect of what for them was an unwinnable suit charging civil rights violations (in particular, violation of Section504 of the Rehabilitation Act of 1973 requiring educational institutions to meet the needs of students with disabilities). 

We can only hope that the behavior described in this memoir is extraordinarily rare in colleges and universities today. But we do know that just as systematic racism persists today, so too does systematic ageism. Caveat emptor! 

June 06, 2019

Our Downfall

Falls have long been known to be a major problem among older people. Even when they don’t cause chronic disability or death, a single fall can lead to paralyzing anxiety. The medical costs alone, for hospital care, rehab, and post-acute care, are enormous: one estimate is that they reached $50 billion in 2015. But despite significant advances in knowledge about fall prevention, new data indicate that the problem is getting worse. In fact, a short “research letter” in JAMA indicates that age-adjusted mortality from falls among people aged 75 and older roughly doubled between 2000 and 2016. 

The data are shocking. The age-adjusted mortality rate from falls for men over 75 went from 60.7/100,000 in 2000 to 116.4/100,000 in 2016. For women, the numbers are even more dramatic, with age-adjusted mortality for those over 75 going from 46.3/100,000 in 2000 to 105.9/100,000 in 2016. 

To understand just how bad things are, it helps to break down the statistics by both age and gender. The overall crude mortality rate for individuals over 75 (2016 data) was 122.2/100,000. For the youngest cohort, those ages 75 to 79, the age-adjusted rate is 42.1/100,000 (52.3 for men). For the 80 to 84-year-old set, the age-adjusted rate doubles to 88.9/100,000 (105.8 for men). For the oldest old, the numbers are extraordinary: going from 171.2/100,000 for those 85 to 89 to 362.5/100,000 for the 90 to 94-year-olds to 630.8/100,000 for those age 95 or older. And the corresponding age-adjusted rates for men are even worse, ranging from 205.2/100,000 to 762.8/100,000.

With statistics like these, you might think no one has a clue as to how to prevent falls. You would be mistaken. Entering “fall prevention in the elderly” as a search term in Google Scholar for the period 2000-2016 yields 18,000 hits. The articles have titles such as “randomized controlled trial of falls prevention” and “falls and their prevention in elderly people: what does the evidence show?” The American Geriatrics Society and the British Geriatrics Society issued a joint clinical practice guideline for the assessment of fall risk and preventive strategies in 2010. Two years later, the CDC decreed falls in older people a major public health problem issue and released a variety of evidence-based materials to help physicians, patients, and families address the problem. Calling their program STEADI (Stopping Elderly Accidents, Deaths, and Injuries), they offered, at no charge, a provider tool kit, a detailed algorithm and a handy pocket guide for clinicians, and a patient information sheet. 

Strategies to diminish falling in older people continue to proliferate. The American Hospital Association along with two other organizations came out with recommendations for addressing the problem in hospitals, where falls are also a major problem: between 700,000 and one million people fall in US hospitals each year and about one-third suffer injuries from their falls. As many as 11,000 people die as a result of the fall.  

The Centers for Medicare and Medicaid Services concluded that falls are preventable—and decided to penalize hospitals if a patient falls and either dies or sustains a serious injury as a result. Medicare considers such falls to be “never events” and will not reimburse hospitals for any additional costs associated with falls.

And yet, despite the research, the policies, and the programs, fall rates are rising, not falling. The burning question is, why?

Analyses of the obstacles—and successes—encountered when health systems tried to implement STEADI are revealing. When Oregon Health Sciences University introduced the program in their primary care clinics, they found the single most important factor conducive to adoption was the presence of clinical champions at each site. These clinicians spearheaded a team effort to develop a clinical workflow, customized for their site. They were also empowered to commission the development of electronic health record tools to document screening and assessment of falls. Other programs similarly reported that without strong endorsement by clinical leadership and the resources to implement and document fall-related activities, the initiatives were dead on arrival.

But if we examine the STEADI algorithm for fall risk screening, assessment, and intervention, we can identify other barriers. 



Falls often have multiple interacting causes and the most successful interventions tend to be correspondingly multidisciplinary. But medicine is much better at dealing with isolated problems than with messy, multifactorial ones: high blood pressure? Take a pill. Pneumonia? Use an antibiotic. 

Now look at the screening that the clinician is supposed to carry out. If a patient answers yes to any of a few key questions, the clinician is supposed to evaluate gait, strength and balance. That means performing a “timed up and go” test and possibly a 30-second chair stand or 4-stage balance test. How many internists or family physicians know what these tests are, let alone routinely perform them.

Then consider the kinds of interventions that STEADI suggests. For high risk patients, the recommendation is to refer to enhance mobility and improve balance, optimize vision, optimize home safety, and address foot problems. For all practical purposes, that means referring the patient to physical therapy, to ophthalmology, to occupational therapy, and to podiatry. Only rarely will a physician be equipped to do any of these things themselves. What’s left? Educate patients—another activity that physicians often delegate to others. Prescribe vitamin D and calcium—controversial these days. Manage and monitor hypotension and medications—the only activities that fall within the orbit of the typical internist or family physician.

What we see here is a profound educational deficit. What’s worse, few of these deficits are skills that physicians are likely to find interesting to acquire. I would argue that what most physicians are excited about is learning about prescribing new medications and using nifty new technology. As a whole—and of course there are exceptions—physicians are less enamored of low tech, low complexity interventions, especially when they deem them to lie outside the bounds of medicine. Advance care planning, which rests on communication skills, has similarly been an area that physicians have been reluctant to engage in. So, if the problem is largely cultural, then strong leadership and a supportive electronic health record, while necessary, are not going to suffice to fix it.

What is the way out? I think two strategies could make an enormous difference. First, nurse practitioners and physician assistants should educate themselves in fall risk screening, assessment and intervention and medical practices should gratefully turn to them for help. Second, patients and families need to clamor for falls assessment. In this era of consumer pressure, what the customer wants may be the key to change.