October 16, 2020

Lock 'em up!

            A provocative, contrarian position paper (somewhat ostentatiously and bizarrely entitled by its authors a “declaration”) is creating a stir by advocating “focused protection” as a means of dealing with the Covid-19 pandemic. The strategy of “focused protection” as defined by the 3 principal architects of the “declaration” recommends 3 different approaches for 3 different segments of the population: for those at highest risk of death from Covid-19, individuals over 85, they recommend a lockdown; for those at moderately elevated risk, including those who are “retired” (aka people over age 65), they advocate a “safer at home” policy—delivery of groceries and other essentials, and staying home  except for socially distanced outdoor visits with friends or family; for those under 65, they suggest a resumption of normal activities. This algorithm, they argue, would allow the development of herd immunity in the general population by assuring that roughly 70 percent of them be allowed to contract the virus, leading to the end of the pandemic.

            Scathing critiques of this proposal are appearing daily. They discuss issues such as the failure to take into account the burdens of Covid-19 short of death (for example, the long-term sequelae that have increasingly  been reported) and the ethical and practical problems of effectively locking up all older people who live in congregate housing of any kind, not to mention the ethical and practical problems of vastly restricting the activities of everyone over age 65 who doesn’t live in congregate housing. These are legitimate concerns. I’m going to add to the growing list of critics by focusing on two others: the ageism of the proposal and, what is more surprising, the failure to recognize that a rare event that afflicts a large number of people produces a commensurately large number of casualties.

            First, ageism.  The authors of the proposal never explicitly acknowledge that the total population over age 65 in the US is now over 53 million people. This number doesn’t include the millions of people who are in the high-risk category, who would also be locked down, who are under age 65 but have important underlying health conditions. The authors seem to imagine that the most vulnerable individuals, those over age 85, account for most of the excess deaths and that all of them live in nursing homes. In fact, only 4 percent of the elderly population live in nursing homes, or about 1.3 million people. The authors also seem to assume that limiting contact by older individuals with the rest of the world will prevent them from becoming infected; they have apparently forgotten that the effectiveness of sequestration depends on the prevalence of the disease in the surrounding community: if all the nursing assistants and grocery delivery people are allowed to get sick, then their chance of transmitting the virus, even with relatively limited contact, will go up.

             Perhaps the lead authors of the paper, all of whom are under age 60, assume that everyone age 65 or older is superannuated. They should be reminded that fully half of the members of the US Senate are over age 65, as of course is the current president and his challenger. Not only do many older people work (16.4 percent, or 8.69 million), but the 65+ set account for a disproportionate share of consumer spending. How will the rest of society be able to “go about their business” without older people to come to their restaurants, stores, and performance venues? And parenthetically, if the 8.69 million people over age 65 who are still working are exhorted to behave just like their younger counterparts, i.e. to “go about their business,” and even assuming that most of these individuals are 65-74 (though this is not strictly true—14 percent of senators, for example, are over age 75), then the projection is that about 152,000 of this group would also die of Covid-19).

            Second, a small number multiplied by a very large number can be a large number. Let’s look at the segment of the population among whom the “declaration” suggests the virus should run rampant. Americans aged 55-64, like their younger counterparts, are advised to go about  unfettered by regulations. As of 2019, this group included 42.44 million people. If herd immunity is to be achieved, an estimated 70 percent of them would have to contract Covid-19, or 32.68 million people. Now here’s the tricky part. We need to know what fraction of people in a given age group are likely to die from Covid-19. The number that is commonly cited is the case fatality rate, or the fraction of people with documented infections who die. But what we really want to know is the infection fatality rate (IFR), or the fraction of people who have contracted Covid-19, whether they know it or not, whether they are symptomatic or not, who actually die from the disease. Computing that rate depends on accurately determining the prevalence of Covid infection in a particular population and the death rate in that group. The best measure I have seen for the IFR for people age 65-74 is 2.5; the IFR for the 75-84-year-old group is 8.5; and the IFR for the 85+-year-olds is 28.3.

            But what about those who are 55-64? Their IFR is .75, so the authors of the “declaration” deem them safe. But if 32.68 million people in this age group contract Covid-19, and .75 percent of them die, then that means, by simple multiplication, that there will be 222,810 deaths in this group alone. A small number (.0075) times a large number (32.68 million) is a pretty big number when we’re talking about human lives. 

             For that matter, why stop with the 55-64-year-olds? Why not consider the 45-54-year-olds? They make up 40.88 million people. If 70 percent contract the virus (after which there should be herd immunity and the virus will vanish), that’s 28.16 million people. The IFR for this group is .068, which translates to 29,708 deaths. Is that acceptable?

            To determine what number of deaths is too many, some commentators have compared the numbers to flu deaths; others have compared them to automobile deaths. The fallacy is to assume that either you open society completely (to selected age cohorts) or you have a complete shut-down. That’s no more accurate than assuming that either people are allowed to drive cars and die in automobile accidents or they aren’t allowed to drive and no one dies. The reality for driving is that there are some mitigating steps we can take, such as seatbelt laws and speed limits on roads, which will significantly decrease the risk of death. In the case of Covid-19, mitigation means exactly what the majority of public health experts currently advocate: masks, social distancing, limiting the size of indoor gatherings, and substituting work at home for work in the office whenever possible. 

            When scientists band together to make an argument that is intended to influence public policy, they write a “position paper” or a “white paper” or an “open letter.” The “Great Barrington Declaration” reveals in its very name that it is something different. It is an ethical perspective masquerading as a technical brief. The authors claim their case for what to do in the setting of the pandemic arises logically from the data. In fact, their strategy, like all strategies for dealing with the outbreak, requires balancing personal freedom and the social good. The “declaration” implicitly assumes that the quality of life of older people is of no consequence and that a society has no special responsibility to its most vulnerable members. It dismisses the anticipated huge amount of death and disability among people under 65 by sleight of hand. Even if this policy could effectively be implemented—if allowing the virus to multiply unchecked would not overwhelm the health care system, causing people suffering from non-Covid conditions to suffer, if older people sheltering in place would remain uncontaminated as the disease becomes rampant in the workers who bring them their food and other services—this is not a policy that most Americans can endorse. The moral fiber of the American people may have been frayed in recent years, but it has not broken entirely.

October 05, 2020

Should Your Doctor Lie to You?


            The nation is riveted by President Trump's illness: whether we hate Trump or love him, we want to know how he is faring with Covid-19. We want to understand what this disease looks like in an elderly man with at least one chronic health condition. Unfortunately, what we have been told by the physicians involved in Trump's care has been marred by commissions, distortions, and downright lies.

            There is a long history of presidents wishing to mislead the public about their health and of their physicians colluding in the deception—Woodrow Wilson’s stroke was concealed, Franklin Roosevelt’s high blood pressure and heart problems were downplayed, and John F. Kennedy’s Addison’s disease and chronic back pain were not fully disclosed. But however objectionable we may find this public lack of transparency, President Trump’s personal physician has claimed a different reason for being less than forthcoming. He asserted that he had understated the seriousness of his patient’s condition because he “didn’t want to give any information that might steer the illness in another direction.” That is, Dr. Sean Conley didn’t want his patient to know that his low oxygen levels and high fever were worrisome, so he lied about his condition. Telling the truth, he was asserting, could harm his patient. But is that true?

            Truth-telling in medicine has been the subject of extensive ethical analysis and of clinical study. The bottom line is that while doctors used to routinely lie to their patients in the belief that they were protecting them, for the last 50 years the standard of care has been to keep patients informed to whatever extent they wish and, based on their accurate understanding of their situation, to engage them in decision-making about treatment.

            The change in practice occurred in the sixties and seventies: in 1961, when a questionnaire was administered to oncologists asking them if they told their patients that they had cancer, fully 90 percent of them said they did not. When the study was repeated in 1979, 97 percent of them said they would tell patients their diagnosis. The earlier view was based on the paternalistic belief that physicians always knew what was best for their patients and on the conviction that if patients knew they were seriously ill they would become depressed and possibly even suicidal. Between 1961, when the first study was conducted, and 1979, when the second study was carried out, western biomedical ethics came into its own as a field.

            Physicians and medical ethicists increasingly recognized that there was often no single optimal course of treatment: several different possible approaches might be possible, each with its own likelihood of benefit and each with its own risks; which approach was “right” for a given patient depended on that person’s preferences and values. One person with a particular type of cancer might wish to undergo treatment with chemotherapy that had a high probability of resulting in serious side effects in exchange for a small chance of life-prolongation; another individual with the same disease might opt for a different treatment that was less likely to cause severe side effects but that offered a smaller chance of life-prolongation. Whenever the choice of treatment depended on values as well as technical expertise, the patient had to be included in the decision-making along with the physician. The principle of beneficence, or doing good, and the principle of non-maleficence, or not doing harm, co-existed with the principle of autonomy, or the right of patient self-determination. 

            Choosing the right treatment for a particular patient, in many cases, required that the patient know the truth about his diagnosis. Without knowing the facts, he couldn’t possibly participate in a conversation with his physician about treatment options. Moreover, growing evidence indicated that when patients are engaged in their own health care, they do not become morbidly depressed or overtly suicidal; on the contrary, health outcomes improve. 

            The regrettable example set by the president’s personal physician notwithstanding, you should expect honesty from your doctor. Yes, you should expect that your doctor will have the communications skills necessary to impart bad news sensitively. Trust is at the core of the doctor-patient relationship, and trust cannot be built on a lie.

October 04, 2020

Why Trump is Bad for Your Health


            For years, older people have been more likely to vote than have their younger counterparts: in the 2016 election, 71 percent of Americans age 65 and older voted, compared to only 46 percent of those ages 18-29. They are likely to exert a major effect on the election again in 2020, especially in those swing states with large older populations such as Florida, Pennsylvania, Michigan, and Wisconsin. 

            Four years ago, 53 percent of voters over age 65 voted for Donald Trump, compared to 44 percent for Hilary Clinton. Whatever these voters thought in 2016, older individuals today should know that Trump is bad for the elderly. He's especially bad for their health.

            Among the most explicit and egregious ways that Trump has adversely affected the health and health care of older Americans is his failure to lead the country effectively in the coronavirus era. His unwillingness to develop and implement a coherent national strategy and his refusal to accept the science underlying public health recommendations have contributed to the high incidence of COVID-19 and the correspondingly high death rate from the disease—and people over the age of 65 account for 80 percent of all COVID-19 deaths in the U.S. 

            In addition, the Trump administration has pursued a vigorous policy of seeking to privatize Medicare, the popular and successful source of health care insurance for the vast majority of older people. For example, Trump issued an executive order in October, 2019 entitled “Protecting and Improving Medicare for Our Nation’s Seniors” which, far from either protecting or improving Medicare, aims to bolster private Medicare Advantage plans (a popular choice for some well elderly) to the detriment of fee-for-service Medicare (the long-preferred option for frail older people) while dismantling safeguards on access and shifting costs to beneficiaries. 

            Then there are the more indirect effects of Trump’s policies on the health of our oldest citizens: dramatically curtailing immigration means cutting off the major source of personal care attendants and nursing aides. These are the people who take care of older individuals who need help bathing, dressing, feeding themselves, walking, and going to the bathroom—both in nursing homes and in their own homes. Deregulation is translating into more polluted air and water, worsening existing conditions such as emphysema and asthma. Rolling back steps to control climate change is contributing to relentless global warming, which is not some abstract future problem but a reality today—and it is frail older people who have suffered disproportionately from hyperthermia and death during the recent heat waves and from the fires that have been ravaging the western US.

            The future under Trump would bring new threats to the health of older Americans. The budget that Trump has proposed for 2021 would significantly cut Medicaid, the federal/state program that is the main funder of nursing homes, where 1.4 million dependent older people live. The budget would also cut SNAP (Supplemental Nutritional Assistance Program) benefits—the food stamps nd other nutritional support for millions of older adults. 

            Purely in terms of self-interest, older Americans should be terrified of four more years of Trump. And, as the NY Times argued two years ago, “senior power is the sleeping giant of American politics.” With the latest estimates from the US Department of the Census indicating that the 52 million Americans over age 65 comprise 16.5 percent of the population, gray power is here; it’s time to exercise it.

September 23, 2020

What We Got Wrong


            To date, 68,000 residents and staff of nursing homes and other long-term care facilities have died from COVID-19, accounting for a significant proportion of U.S. pandemic deaths. According to the editorial board of the NY Times, “…many, if not most of those 68,000 lives could have been spared with careful planning and effective leadership.” There is little doubt that poor management and unwise decision-making, sometimes driven by cost considerations, exacerbated what was already a highly flammable situation. Putting a large number of very old people with multiple underlying health conditions together and then sending in caregivers who live in communities with high rates of coronavirus is asking for trouble. But to blame for-profit chains for the devastation wrought by COVID-19 in nursing homes, as the NY Times does, is missing the forest for the trees. It is like blaming the forest fires raging throughout the western U.S. on gas companies that had not cleaned up the dry brush near their power lines while ignoring the role of climate change and of urbanization that have brought hotter, dryer conditions and dense human habitation in close proximity to forested areas, respectively. A recent article in the New England Journal of Medicine gets it right, suggesting that “the coronavirus has exposed and amplified a longstanding and larger problem: our failure to value and invest in a safe and effective long-term care system.” 

            The problem began, as Rachel Werner and colleagues from the University of Pennsylvania argue, with the Medicare and Medicaid legislation of 1965, which effectively medicalized long-term care. Long-term care refers to services that help people get by when they cannot perform everyday activities independently; it encompasses housing, personal care, and medical care. By placing almost all government support for the social and daily care needs of frail older individuals under a medical umbrella, the non-medical needs were given short shrift and the medical needs were under-funded. 

            I’m talking about frailty because it’s frail older people who are the main users of long-term care. Frailty refers to a syndrome of age-associated loss of independent functioning that puts people at risk of illness, decline, and death. Frail people constitute about 15 percent of the elderly population or 8 million people. Most frail elders continue to live in their own homes and get help from caregivers; about one million live in an assisted living facility, where they have their own apartment but eat meals communally, receive a small amount of personal care each day, and can participate in on-site social activities; another 1.3 million live long-term in a nursing home. How does the prevailing long-term care system in the U.S. operate and how do Medicare and Medicaid determine its contours?

            In terms of housing, because Medicare and Medicaid are medical programs, they were not designed to cover housing. Medicare does not pay for housing at all: it will pay for short-term “post-acute care” after a hospitalization, either in a rehabilitation facility or a skilled nursing facility because that is viewed as hospital care. Medicare does not pay for long-term residential nursing home care or residential hospice care—it will cover medical care received by an individual who lives in a nursing home or a hospice, just as it covers doctor’s visits and laboratory tests for a person who lives independently in his own home. Medicaid pays for nursing home care for individuals who have “spent down” all their assets and are sufficiently physically impaired to require nursing home in a rare acknowledgement that the line between housing, personal care, and medical care is blurred for frail older individuals.

            With respect to personal care, Medicare provides only those home care services that are deemed necessary because of an acute illness. Patients who are hospitalized for pneumonia or a stroke or a heart attack can have personal care services at home (a homemaker or health aide) while recovering from their acute medical problem as long as they are also receiving some type of skilled care at home such as a visiting nurse or a physical therapist. Medicaid is more generous in its coverage of home-based personal care services by not tying them exclusively to a single episode of illness, perhaps recognizing that it is cheaper to pay for a personal care attendant at home on a long-term basis than to pay for the alternative, which is residential nursing home care. Nonetheless, the number of hours of personal care available per person per week is very limited: two hours a day, several times per week, is a typical benefit; four hours a day, seven days a week is a rare extensive benefit. 

            Lastly is medical care. Because Medicare was initially crafted as an acute medical benefit, intended to address short-term medical care, it provides good coverage for hospitalization and brief post-hospital care in a skilled nursing facility or similar site. It also has comprehensive out-patient coverage, but it was never intended to promote medical care at home—even when “home” is a nursing home.  Long-term care, by definition, is chronic. Only recently has Medicare added a chronic disease management benefit in recognition of the reality that fully 68 percent of Medicare beneficiaries have at least two chronic conditions—and another 37 percent have four or more chronic conditions. More recently still, the CMS Innovation Center (authorized by the Affordable Care Act) launched the “Independence at Home” demonstration project, which provides for home-based primary care, but this initiative is capped at 10,000 enrollees. 

            What are the consequences of a system that sees itself as providing a medical rather than a long-term care benefit? Because coverage of supportive services is modest—whether for home health aides or homemakers or transportation—the system tends to favor institutional care over home care. Services that might enable frail older people to continue to live at home are insufficient, driving them into nursing homes; services that would facilitate treatment of acute medical problems at home are lacking, promoting the use of hospitals. For nursing homes, there are additional consequences. Nursing home regulations, promulgated by CMS but monitored by local health departments, focus on safety and adherence to selected public health measures, such as annual flu shots, rather than on quality of life. Paradoxically, physicians are paid separately by Medicare and are not included in per capita Medicaid payments, a system that promotes highly individualized medical care rather than a focus on the community.

            The failure to recognize the importance of long-term is unique to the United States in the developed world. European countries provide a comprehensive long-term care benefit for older and disabled individuals. The structure of the benefit and the mix of private and public services available using the benefit are highly variable from country to country. 

            Most European countries offer universal coverage, with nursing and personal care available to all eligible individuals (based on an assessment of their level of dependency in basic daily activities). Co-payments and deductibles are common, typically subject to income thresholds. In a number of countries, frail older people can choose whether to receive that personal care in their own home, in the home of a family member, or in an institutional environment. In some models, they can opt to receive a cash benefit rather than an in-kind benefit, and can use the cash to maintain their independence, whether by remodeling their home to make it more accessible or to pay for private aides.

            In Denmark, for example, priority is given to community over residential care. A frail older person living in his own home or in a special dwelling for the elderly is entitled to home health services (generally nursing and rehabilitative care) and practical help (assistance with shopping, cleaning, meal preparation and personal care). Both health care and long-term care are public responsibilities. LTC financing and provision are the responsibilities of the local municipality and health services are planned and operated on a regional level. A case management system serves to coordinate the health and long-term care components of care. The system is financed through both local and national taxation.

            The existence of a long-term care benefit would not, by itself, have prevented COVID-19 from sweeping through American nursing homes. But it would likely have decreased the number of frail older people who live in nursing homes and assisted living facilities in the first place. For those individuals who nonetheless required an institutional environment, a long-term care orientation would have meant attention to quality of life, which would have resulted in private rooms and single bathrooms. This sort of living arrangement is far more conducive to limiting the spread of an infection than are the old-fashioned double or even four-bed rooms. 

            Once we reconceptualize nursing homes as primarily places where people live and only secondarily as sites for the delivery of health care services, we can move on to our next challenge: designing a branch of medicine that addresses both the individual geriatric needs of residents (advance care planning, incontinence treatment, fall prevention, avoidance of polypharmacy, etc.) and community health needs (flu shots, sanitation, good nutrition, etc). If we minimize the number of frail elders requiring institutional care by supplying community services, and we then modify the nature of the medical care provided within those institutions, we can anticipate a lesser toll from the next epidemic—and an improved quality of life for society’s frailest and oldest members.

August 28, 2020

After the Deluge

Nursing homes are at a crossroads. Unpopular before the pandemic, Covid-19 has brought them to a new low. There was the epidemic itself, which swept through nursing homes and assisted living facilities, causing an estimated 40 percent of all thevirus-related deaths in the U.S. Then there was the response to the epidemic: the draconian measures taken to control the outbreak caused social isolation, depression, and sometimes confusion in residents.  Next were the institutional consequences: the deaths that inevitably result when vulnerable people became ill (with a mean age of about 85 and multiple underlying health conditions, nursing home residents are at the highest risk of contracting and then dying from Covid-19) led to empty beds but the quarantine made it difficult to fill them. Empty beds meant less revenue, this at a time when costs were rising due to the need for frequent deep cleaning, personal protective equipment, and supplementary staff. 

The future looks grim as nursing homes face a loss of confidence in their ability to provide good care and as state budgets, which determine the level of nursing home reimbursement through Medicaid (the homes' major source of revenue), are strained by the recession. What, then, will become of nursing homes after the deluge? 

In a provocative essay, Charles Sabatino of the American Bar Association argues that “it’s time to defund nursing homes.” Institutional care as defined by the average American nursing home, he suggests, is simply not what old people or their families want. It’s demeaning, disrespectful, and disgraceful. Moreover, to those who claim the institutional environment is necessary to keep the oldest, frailest members of society safe, the monumental failure of nursing homes to prevent sickness and death during the COVID-19 pandemic provides ample evidence that even in this arena, the nursing home is a failure. Medicare and Medicaid, which together fund a large proportion of skilled nursing home care (Medicare pays for short term rehabilitative care while Medicaid pays for long-term residential care) hold the key. They should pay for care only, Sabatino says, if the nursing homes are small and homey, provide all their residents with private rooms and bathrooms, and embody a culture focused on the goals, interests, and preferences of their residents—not the nurses, nursing assistants, administrators, and others who run the institution. 

Geriatrician, palliative care specialist, and health care policy expert Joanne Lynn distinguishes among the various populations found in nursing homes and suggests different strategies for each group. People recently discharged from a hospital who need short-term rehabilitation or further medical care that they cannot receive at home—the “post-acute” patients who stay in skilled nursing facilities for a few days or at most a few weeks and whose care is paid for by Medicare—can continue to receive this type of treatment in a hospital-lite environment. People with severe brain damage, whether from dementia, stroke, or prolonged lack of oxygen, and who are unaware of their surroundings and do not recognize their family members can likewise remain in a hospital-style institution. People who are dying and who need more assistance than can be provided through home-hospice should not have to go to a skilled nursing facility under the guise that they need rehabilitation in order to have 24-hour, residential care. Instead, they should be eligible for inpatient hospice. That leaves the large fraction of the current nursing home population who are dependent on others for many of their basic daily needs—bathing, dressing, walking—due to multiple physical problems and/or moderate dementia. For those individuals, Lynn argues, the best environment is a model very much like what Sabatino advocates. This type of facility already exists: it is called the Green House Project. What is the Green House Project and how did homes built along this model fare during the pandemic? 

Green Houses are the brain child of Bill Thomas, a pioneering geriatrician who has been designing progressively better nursing homes since he introduced the Eden Alternative—bringing pets and plants into nursing homes—in the early 1990s. He then went on to mastermind what would become the culture change movement, or bringing resident-centered care to nursing homes. The model was fleshed out by the consortium of nursing homes that banded together to form the Pioneer Network, which advocated breaking large, hospital-style nursing homes into multiple discrete households, eliminating the centrally-located nurses’ station to promote integrating nursing care into daily life, and decreasing the differentiation of labor which compartmentalized care. But while many facilities endorse culture change, few have implemented its principles on a wide scale. Enter the Green House. Green Houses are built along the lines envisaged by the culture change movement—they make use of “universal workers” rather than siloing staff members into discrete categories and they are built around honoring the preferences of residents. But the critical difference is that they are small. Instead of breaking a large institution into multiple households, the Green House is a single, freestanding household with 10-12 residents. Its guiding principle is that to be homey, it needs to be built like a home and function like a home. 
The first such home was built in Tupelo, Mississippi in 2003. 

Today, there are 300 Green House sites across the country. The big question is whether these facilities in fact improved the quality of life for their residents. Have they been able to meet the health and safety requirements imposed upon conventional nursing homes? Have their costs been higher than those of standard nursing homes? And how did they fare during the Covid-19 pandemic? The most comprehensive attempt to answer the questions about quality of life and health and safety requirements is from the THRIVE Research Collaborative (The Research Initiative Valuing Eldercare), published in 2016. While the model was seldom fully implemented, the version that was utilized did not lead to a decline in the “quality indicators” established by the Centers for Medicare and Medicaid to evaluate nursing home care; it did lead to lower rates of hospitalization and greater use of hospice care than conventional facilities. Staff turnover, normally alarmingly high, was lower in Green House facilities. 

Measures of resident and family satisfaction have been harder to come by as studies tend to be very small and qualitative in nature, but enthusiastic articles have appeared in the popular press—and I cannot remember encountering any similar level of excitement, however anecdotal, about standard nursing homes. Based on the limited data available, I have been guardedly optimistic. But the Covid-19 experience has tipped the scale for me: with 95 percent of nursing homes and 92 percent of assisted living facilities reporting no cases, the Green Houses have been remarkably successful. 

Here is what we know—256 out of the existing 298 facilities supplied data for the period March-May, 2020. In the 229 nursing homes, which served 2384 elders, there were 32 positive cases among residents and only one death. In the 24 assisted living facilities serving 224 elders, there were 15 positive cases and 3 deaths. Compare this to all nursing homes in the US, as reported by CMS: as of mid-August, there have been just under 50,000 deaths in 1.5 million residents, with slightly below 200,000 confirmed cases and another 120,000 suspected cases. I



In summary, Green House nursing home residents were far less likely than their conventional nursing home counterparts to contract Covid-19, and if they did get sick, they were far less likely to die. Small really is better. 

My suspicion is that after the deluge, when the pandemic finally fizzles, legislators and healthy policy mavens will look to new regulations to try to prevent or at least diminish the ferocity of future outbreaks. Requiring nursing homes to have infectious disease consultants—a rule that was instituted by the Obama administration and undone by Trump—makes sense. Demanding regular testing for nursing assistants if there is another viral epidemic with similar characteristics makes sense—as was recently mandated by CMS for nursing homes during Covid-19. Systematically engaging residents and families in discussions of their preferences regarding end of life care before they are faced with a crisis is good generally a good policy, because nursing home residents are always at high risk of death, not just during a pandemic. 

But more effective change will not come from regulations. It will require a wholesale rethinking of institutional long-term care. The Green House project is a good place to start.

July 30, 2020

Have We Been Barking Up the Wrong Tree?

More of my blog posts deal with dementia than with any other subject and the news about Alzheimer’s disease over the years has been largely dispiriting, so who would have thought that I would leap at the opportunity to write about a new diagnostic test. But with so much of the medical literature relentlessly focused on COVID-19, it’s reassuring to realize that research on other subjects is continuing. The new study does not report a treatment, let alone a cure for Alzheimer’s disease. Furthermore, the prospect of screening healthy individuals to determine their future risk of developing progressive cognitive impairment is ethically fraught. Nonetheless, in the current climate, this report is good news.

It’s good news, and not just because it indicates that not all medical scientists have retooled as corona virus researchers, though it does that. It’s good news, and not just because it means it will be possible to target intervention studies to high risk individuals will permit studies to be carried out on smaller numbers of people and over a shorter period of time, though it means that. It’s good news because it shines a bright light on a long-neglected character in the Alzheimer’s story, the tau protein. 

Back in 1906, when Alois Alzheimer peered into his microscope at tissue from the brain of a patient who had died of the disorder of cognition that would one day bear his name, he identified two unusual substances that he described as plaques and tangles. The plaques, which were located between neurons, would ultimately be found to be composed of a protein known as amyloid. The neurofibrillary tangles, which were located inside the nerve cell bodies, would eventually be identified as a protein called tau. These two substances have been recognized as the hallmarks of Alzheimer’s disease for over a century.

For years, the roles of amyloid and tau were hotly debated. Some researchers felt that amyloid was the result of Alzheimer’s; others were confident it was the cause. Some scientists were more interested in studying amyloid; others directed their efforts towards tau. But over the course of the last 25 years, amyloid has gained the upper hand. Study after study has sought to improve cognition in Alzheimer’s disease by ridding the brain of amyloid-laden plaques—and each time, the approach failed. 

A great deal of excitement was engendered by immunotherapy back in 2001: the idea was to stimulate the body to create antibodies against amyloid with what was essentially a vaccine—but the study had to be stopped because a subset of patients developed meningitis. Then there was enthusiasm about the use of monoclonal antibodies. Several such antibodies have made it to phase 3 trials in which their efficacy was compared to placebo. In 2014, two studies of Bapineuzumab showed no benefit. In 2018, Solznezumab was tried for individuals with mild Alzheimer’s and it was unsuccessful. In the same year, additional negative results were reported for Verubecestat in people with mild to moderate Alzheimer’s. 

All these negative studies don’t exonerate amyloid. Maybe the trials are initiated too late in the course of these disease’s development. Maybe the dose is too low. But with anti-amyloid strategies repeatedly striking out, I can’t help but wonder, as have others who know much more about the science than I do, that we’re looking at the wrong target.

Which is why the new study that focuses on tau is exciting. The authors found that their tau antibody test was able to diagnose Alzheimer’s disease as well as or better than more invasive existing tests—when they used the test in patients all of whom had some kind of neurodegenerative disease. That is, the test did well in answering the question: is this person being tested more likely to have Alzheimer’s or, say, Parkinson’s? That’s a very different question from: is this person normal or does he have Alzheimer’s? Not only was the population in which the test was studied composed exclusively of patients with some neurologic condition, not only did the population include a much larger proportion of people with Alzheimer’s than would be found in the general population, but the subjects were far from ethnically or racially diverse. So, it’s a long way from the article in JAMA to a widely useful diagnostic test.

Despite the test’s preliminary nature, it is a compelling piece of evidence that tau should get more attention. Two weeks before the on-line publication of the JAMA study, a small Swiss pharmaceutical company, AC Immune, announced that together with Johnson & Johnson, it was launching a trial of a vaccine designed to stimulate the body to produce antibodies against tau—leading its stock price to soar by 18.9 percent. Just a few weeks earlier, the giant Swiss pharmaceutical company, Roche, announced it, too, was investing in the development of an anti-tau vaccine. 

It’s too early to say whether the attack on tau will fizzle, much like the previous attacks on amyloid. But maybe, just maybe, it will be a rousing success.







July 17, 2020

What's the Risk?

Nearly six months into the pandemic, we ought to know the important risk factors for serious illness or death from Covid-19. Whether because of poor record-keeping, lack of international cooperation, or sloppy statistical analysis, the information until now has been limited. 

Not just limited; the claims about risk factors to date have been quite misleading. I complained in my blog post in early May that the rates of certain conditions in patients dying of Covid-19 were actually no different from the rates of those same conditions in older people in general. For example, I noted that one study reported that the rate of high blood pressure in patients with severe cases of Covid-19 was 56.6 percent—but failed to comment that the rate of high blood pressure in the elderly population is 60 percent. Far from indicating that high blood pressure increases the likelihood of severe Covid-19 in older adults, this finding suggests that high blood pressure confers no extra risk or maybe is even protective. 

The only consistently observed risk factor for both severe illness and death has been older age, with age greater than 80 representing very high risk. Now, thanks to the existence of widespread, compatible electronic medical records in the British National Health Service (NHS), we have some useful data.

The study, published early on line in Nature Reviews, compares British patients who died of Covid-19 with all other British patients who are cared for in a group practice that used the necessary software (approximately one-third of the population). By using “a secure analytics platform inside the data centre of major electronic health records vendors, running across the full live linked pseudonymised electronic health records,” and after excluding people under age 18 and those with less than a year's worth of data, the investigators were able to collect health information on over 17 million individuals, including just under 11,000 with Covid-19 related deaths. The results confirm age as the single most potent risk factor, with a small number of other major risks.

To capture the most striking findings, I extracted data from the chart listing the hazard ratios (HRs) and 95% confidence intervals (CI) for Covid-19 death (Table 2) and present 3 separate tables: one highlighting very high-risk characteristics, one highlighting high-risk characteristics, and one showing characteristics associated with no or minimally increased risk. For added emphasis, I highlighted hazard ratios of greater than 3 in red and hazard ratios between 2 and 3 in blue.

Characteristics Associated with Covid-19 Deaths


The important difference between these charts and previous attempts at quantifying risk is that the hazard ratios reported have been age and sex-adjusted and have been further adjusted for other potential confounders along with age and sex.  

The conclusion from this analysis is that when we consider the age- and sex-adjusted hazard ratios, there are only four very high-risk conditions: old age, a hematologic malignancy diagnosed within the previous year, severe kidney impairment, and organ transplantation. Within the old age categorization, the hazard ratio goes from 8.62 to 38.29 as the age increases from 70-79 to 80 and older (the reference group is people aged 50-60). The only medical condition that comes close to this magnitude is organ transplantation, with a hazard ratio of 6. 

Another handful of conditions are in what I have classified as high-risk: obesity with a BMI of 40 or greater, poorly controlled diabetes, stroke or dementia, a hematologic malignancy diagnosed between 1 and 5 years earlier, liver disease, and other forms of immunosuppression. Incidentally, four out of six of these conditions drop out if we look at the “fully adjusted” column.

It’s worth noting some of the chronic conditions that were not associated with increased risk. High blood pressure, as I had previously suggested by comparing the rate in the very ill Covid-19 patients with the rate in the general older population, does not appear to be a risk factor. Mild to moderate asthma, defined in this study as someone with asthma who did not use oral steroids within the previous year, is also not a risk factor.

It’s also worth noting that the CDC has issued its own guidance about risk factors for Covid-19. Their conclusions, while overlapping with the NHS data, differ in important ways. Most important, their methodology differs. The CDC, lacking a domestic large, comprehensive data base, is forced to draw on evidence from small case series, cohort studies, and some meta-analyses, as well as a much earlier preliminary report from the NHS. The new NHS data, rigorously obtained and meticulously analyzed, should be seen as the gold standard.

July 14, 2020

When Will We Ever Learn?

Residents of long-term care facilities in the US have been hit harder by the COVID-19 pandemic than have any other group. They have almost all the known risk factors for becoming seriously ill with the disease: they are unambiguously old, with fully 41 percent over age 85, and almost all have one or more chronic diseases, generally multiple conditions that result in their needing personal care. To top it all off, they live in close proximity to one another, typically eating together in a common dining room and often sharing a room with another resident. As a result, nursing home residents account for at least one-third of U.S. COVID-19 deaths. In some states, such as Massachusetts, estimates by early May were that nursing home residents accounted for 60 percent of COVID-19 deaths. 

We learned from the devastating early experience with COVID-19 how to keep the corona virus from causing havoc in nursing homes. In particular, we came to understand the importance of protecting nursing home residents from staff members who might bring it into the facility. By testing staff regularly and mandating head to toe personal protective equipment, together with other draconian measures such as banning family visitors and restricting resident-to-resident interaction, the rate of illness, hospitalization and death among nursing homes residents plummeted. Now that the virus is again surging in the Sunbelt, with Florida, Arizona, and Texas reporting skyrocketing infection rates, how are nursing home residents faring in those areas?

The answer, in a word, is not well. The Florida Department of Health reported 3072 active cases in nursing homes and assisted living facilities as of July 13, up from 1408 on June 23. The rate had nearly doubled in two weeks.  Houston saw an 800 percent increase in cumulative new cases among nursing home residents between the end of May and the end of June—and Texas has more nursing homes than any other American state. 

Why is this happening? Only in mid-July did Florida announce it would test nursing home staff regularly. The government defined regularly as every other week—not likely to be often enough—but many facilities report no testing has taken place as yet. Phoenix nursing homes report a shortage of personal protective equipment, with 25 percent of facilities acknowledging they have only one week’s worth of masks, gowns, and gloves on hand for nursing assistants and other direct care personnel. 

So far, death rates have not soared the way they did in New York during the height of its outbreak, but they are beginning to rise. As epidemiologists point out, death is a “lagging indicator:” people first get sick, then some of them become sick enough to require hospitalization; next, some are admitted to the ICU, and then, over a period of weeks, the deaths start coming. The outbreaks began with younger people who ignored public health recommendations to wear masks, limit group gatherings (especially indoors), and maintain physical distance from others. Florida, Texas, Arizona, and other hot spots did not engage in a vigorous campaign to test people with symptoms, to isolate anyone with an infection, and to quarantine exposed individuals. The result was community spread. At that point, the outcome for nursing home residents is entirely predictable. Once COVID-19 is widespread in the community, it is going to make its way into nursing homes, carried by asymptomatic or minimally symptomatic staff members who do not wear adequate protective gear. And vulnerable older people who are dependent on staff members to go to the bathroom, to eat, to dress, and to bathe will themselves become ill. More and more of them will become very sick and many will die. 

States that experienced a major outbreak early in the course of the pandemic—in late March and much of April—learned through experience that in the absence of a vaccine or effective treatment, old-fashioned public health methods are the only scientifically sound and morally defensible way to act. The invasion of nursing homes has no doubt already begun in the states with soaring case rates; every hour of delay in instituting the only measures that we have just demonstrated can succeed will result in more viral transmission, more suffering, and more death.

June 19, 2020

Telemedicine Tips



For years, Medicare has defined a visit with the doctor, what it calls an "encounter" as comprising the history, physical exam, and lab tests.  Without the face to face component, from Medicare's perspective, there can be no visit. Telemedicine has changed this perspective. For some time, Medicare has allowed telemedicine visits in rural communities and for consultation between physicians. The pandemic has forced Medicare to adopt a new standard for a visit. But just because Medicare now pays physicians for these new encounters and just because software is now available  to facilitate patient/doctor interactions in a secure way doesn't mean it's obvious how best to use the technology. Older patients, some of whom do not use the internet, are often uncomfortable with such a system. To benefit from telemedicine--and no group is more in need of being able to interact with the medical profession remotely than older individuals--they will need help from caregivers.
Here's a video for family caregivers to give them some ideas about  making optimal use of telemedicine.



May 22, 2020

Doctor, Meet Family Caregiver

Here's a short video pitched to physicians, extolling family caregivers and explaining how partnering with caregivers can help both physicians and patients.