December 07, 2020

Dateline: Pearl Harbor

Exactly 79 years ago today, Japanese planes bombed Pearl Harbor, an American naval base on Oahu, Hawaii, catapulting the U.S. into World War II. "A day which will live in infamy," President Franklin Roosevelt would call it--a day which lives on in the memory of the oldest Americans (though not, evidently, of the NY Times, which did not mention it in today's newspaper). The attack, which destroyed more than 300 planes and killed or wounded 3400 Americans, dealt a devastating blow to America’s sense of invulnerability and to our isolationist tendencies. It was also the last time the armed forces of a foreign nation would penetrate the American homeland. And yet, deep into the 21st century, the U.S. continues to place disproportionate weight on armed invasion as the major threat to the security of all Americans, young and old.

As the Covid-19 pandemic, the devastating wild fires on the west coast, and the unprecedented number of named storms this season demonstrate, America must address several other crucially important problems if its citizens are to remain safe and its democracy strong. Epidemics and climate change are two of the principal non-military threats; cyber-attacks and attacks on science are two additional substantial threats. 

Why do these non-traditional forms of attack constitute a threat to the national security? Epidemics have the potential to harm or kill tens of thousands, hundreds of thousands, or even millions of Americans; in addition, they can disrupt the economy (either because sick people cannot work or as society limits economic activity to protect health); and they can damage or destroy fundamental institutions such as the health care system by overwhelming its capacity. Climate change, by causing sea level rise, risks destroying coastal property or submerging entire cities; by contributing to natural disasters such as mudslides and wild fires, climate change endangers life and property. Rising maximum temperatures may make parts of the country uninhabitable or cause death from hyperthermia; they might destroy industries such as cod or lobster fishing as entire animal species migrate north in search of cooler waters. 

Cyber-attacks, whether carried out by state actors, by international terrorists, or by domestic criminals, can disrupt the financial system, the energy grid, our elections, or other fundamental institutions essential to the health and safety of Americans. Attacks on science constitute a fourth non-traditional threat, one that is just coming to be recognized as endangering both progress and our democracy: progress because a citizenry that rejects science will reject legislators who support science, resulting in diminished funding of the research essential for improvements in health and security; democracy because citizens cannot tell truth from falsehood will not have the information necessary to vote in their best interest. Undermining science will, in addition, exacerbate climate change and increase the likelihood of pandemics.

The idea that threats might not come from a foreign state actor but rather from microorganisms (in the case of a pandemic), from the anthropogenic production of greenhouse gases (in the case of climate change), from a computer hacker (in the case of cyber-attacks), or from lies and propaganda distributed via social media (in the case of the attack on science and, more generally, on truth, knowledge and expertise) represents a fundamental change in the way we need to think about national security. And just as the terrorist attacks of 9/11/2001 led to the creation of the Department of Homeland Security, so too should the current pandemic push us to reconsider the effort we devote to fending off other non-traditional types of attack. 

Consider the case of microbial threats. The idea of investing in pandemic preparedness is not new: the danger of pandemics and the importance of a coherent response strategy has been acknowledged by public health professionals since the influenza epidemic of 1918-1920. Each of the subsequent pandemics of the 20th century (Asian flu in 1957 and AIDS beginning in 1981), as well as the first pandemics of the 21st century (SARS in 2003, Swine Flu in 2009, and Ebola in 2014), brought renewed interest in both prevention and mitigation. Increased understanding of the origins of these outbreaks has led to a recognition of the importance of surveillance: we now realize that all the major pandemics have been zoonoses, they have arisen from viruses that jumped from one species, such as bats, to another species, humans, because of disruptions in the natural habitat of the original host. Furthermore, realization that global interconnectedness promotes rapid spread of the most readily transmissible organisms has resulted in an appreciation of the importance of international cooperation in combating pandemics.

Such recognition and realization emerged from thoughtful and comprehensive reports such as the workshop on "ethical and legal considerations in mitigating pandemic disease" sponsored by the Institute of Medicine. Its proceedings were published in 2007. This was followed in 2016 by a chilling report from the National Academy of Medicine, “The Neglected Dimension of Global Security: A Framework to Counter Infectious Disease Crises,” that made explicit the connection between national security and epidemics.

These documents did not just collect dust in government archives; their conclusions were, to a limited extent, translated into US public policy. Beginning with President Clinton, each presidential administration has put forward a new or revised pandemic preparedness plan. Congress authorized the establishment of a Global Emerging Infections Surveillance program within the Department of Defense in 1997, a program intended to improve surveillance, to foster prevention, and to plan for a response to potential new microbial threats. George W. Bush had his “Biodefense for the 21st Century” plan, precipitated by the anthrax scare, though this focused principally on bioterrorism, the deliberate dissemination of disease-causing organisms by state actors or individual terrorists. Obama had two: the “National Strategy for Countering Biological Threats” in 2009 and the “National Strategy for Bio-Surveillance” in 2012. Trump had his “National Biodefense Strategy” in 2018, which addressed naturally occurring, deliberate, and accidental biological threats, and theoretically centralized the federal response in the Department of Health and Human Services. 

These policies sound good on paper. But implementation, coordination, and funding have lagged. For example, the Centers for Disease Control budget allocation for prevention of zoonotic diseases in 2020 was $636 million out of a budget of $6.5 billion; Trump’s proposed 2021 budget asks for $550 million. The total Department of Defense allocation for FY 2021, by contrast, is $933 billion.

More generally, both the current (FY2020) and proposed (FY2021) federal budgets include support for combating pandemics and cyber-attacks, but do little to support combating climate change (the phrase is nowhere to be found) and nothing to defend against attacks on truth or on science. Even when the threats are acknowledged, the programs responsible for combating them are disseminated through multiple disparate agencies, are poorly coordinated, and receive only modest funding. 

Pearl Harbor Day should serve as a reminder of how threats to national security have changed in the three quarters of a century since Japanese bombers crossed the Pacific and entered American airspace. For starters, we should have a cabinet level department to take these new threats rather than embedding them into the Department of Defense, which has been structured to focus on the military. Perhaps we should simply reconfigure the Homeland Security Department, which no longer focuses on the prevention of terrorist attacks, the rationale for its establishment, but rather devotes its efforts to the enforcement of immigration policies. Immigration is not a threat to national security; but pandemics, climate change, cyber warfare, and the attacks on truth in general and on science in particular pose a real and present danger.




November 17, 2020

Now Hear This

On November 9, we learned that the preliminary data from the Pfizer/BioNTech COVID-19 vaccine trial are very promising; exactly one week later, we got similarly good news from the ModernaTX/NIH study.  What do the Moderna data show and how do they compare with the Pfizer data?

Moderna began enrolling patients last summer and has recruited 30,000 volunteers, half of whom received two doses of vaccine and half of whom got placebo, in both cases at 30-day intervals.  

The subjects, adults over the age of 18, were divided into 3 groups: people age 65 or older; people under 65 with known risk factors for coronavirus; and people under age 65 with no known risk factors. The principal outcomes that the researchers are tracking are the ability of the vaccine to safely prevent symptomatic COVID-19 infection and the capacity of the vaccine to stimulate antibody production in recipients. In addition, the researchers are looking at whether the vaccine can prevent severe COVID-19 infections and whether it can prevent asymptomatic infection (as measured by markers for COVID indicating current or previous infection despite the absence of symptoms).

The newly reported results are based on the 95 enrolled subjects who have thus far been diagnosed with COVID-19. Being diagnosed with COVID-19, according to the definition in the study, means having a positive PCR (polymerase chain reaction) nasal swab after developing symptoms consistent with the disease. What we know is that of these 95 individuals, 5 had received active vaccine and 90 had received placebo. We also know that 20 of the 95 people with the illness were over age 65 and that 11 people developed severe disease, none of whom had been vaccinated. While the specific numbers have not been reported, Moderna has asserted that the efficacy was the same among the different age groups as well as among various ethnic groups (or, more accurately, given the very small numbers of sick people, they were unable to detect any differences).

What we don’t know is the duration of the protective effect. We don’t yet know whether the vaccine prevented asymptomatic infection, although we should know something about its capacity to do so when the endpoint of the study is reached, namely when 151 enrolled individuals have been diagnosed with symptomatic disease. And we don’t know whether the vaccine is effective in children.So, how does the Moderna vaccine compare to the Pfizer vaccine 

They are both mRNA vaccines, a type of vaccine that has never been approved for human use. The efficacy rates reported thus far are extremely similar: from a statistical standpoint, the 95 percent efficacy quoted by Moderna is not any different from the 90 percent efficacy quoted by Pfizer, given the small number of sick patients.  

Both vaccines have to be kept cold to remain viable, but shipment and long-term storage of the Pfizer vaccine has to be at 70 degrees below zero Centigrade while long-term storage of the Moderna vaccine can be at 20 degrees below zero Centigrade; on arrival at your local drug store or physician’s office the Pfizer vaccine can be refrigerated at normal temperatures for up to 5 days while the Moderna vaccine can be refrigerated at normal temperatures for up to 30 days without losing potency. 

The Pfizer vaccine has been tested in children; the Moderna vaccine has not so we just don’t know whether it will work in this age group. Finally, the Pfizer vaccine is to be given as two doses separated by 3 weeks while the Moderna vaccine is given as two doses separated by 4 weeks; efficacy was tested by Pfizer beginning 1 week after the second dose and by Moderna beginning 2 weeks after the second dose. These differences may not reflect actual differences in the two vaccines, simply different protocols instituted for studying them. In sum, it looks as though the two agents are very similar except for differing refrigeration requirements. 

Quite apart from the biochemistry of these vaccine candidates and the data on their efficacy, what do we know about Pfizer and Moderna? 

Pfizer is the Goliath of pharmaceutical companies. As of March, 2020, it was the largest drug company in the world, as measured by revenue, with annual revenues of $51.75 billion. It has experience in producing vaccines and in recent times was responsible for the development of one of the major pneumonia vaccines. But Pfizer is also a leading offender among the major drug companies in unethical and illegal behavior. In 2009, it achieved notoriety for the largest settlement ever made by a drug company with the Department of Justice: It agreed to pay $2.3 billion for fraud involving the atypical antipsychotic drug Geodon and the painkillers Bextra and Lyrica. It would lose the distinction in 2012, when GlaxoSmithKline settled with the DOJ for $3 billion. 

Despite signing a “Corporate Integrity Agreement” in 2009, a quick internet search reveals that Pfizer continued to engage in bad behavior: in 2011, it paid $14.5 million for the illegal marketing of Detrol; in 2016, it paid $784.6 million to resolve a lawsuit involving Medicaid fraud; in 2018, Pfizer paid $23.85 million to resolve a suit over Medicare kickbacks. It’s worth noting that most of the big pharmaceutical companies have engaged in fraud, including such names as Johnson & Johnson, Eli Lilly, Abbott, Novartis, and Merck. They seem to regard playing fast and loose with the rules as part of doing business.

If Pfizer is the Goliath of the industry, Moderna is the David of the industry—or was until it went public in 2018, raising $604 million through the sale of its shares and gaining a valuation of $7.5 billion despite never having brought a product to market.

Moderna began as a small biotech startup in 2010 and has focused on mRNA vaccines since its inception. Questions have been raised about the integrity of the company in light of its culture of secrecy and the high-stress environment created by its CEO. 

Some have even wondered whether Moderna would be the next Theranos, the unicorn ultimately exposed as a fraud, a story detailed in the chilling account by WSJ investigative journalist John Carreyrou in “Bad Blood: Secrets and Lies in a Silicon Valley Startup.

Moderna has partnered with NIH (specifically the National Institute of Allergy and Infectious Diseases) in its COVID-19 vaccine project. Hopefully, the involvement of a highly reputable, not-for-profit, academically oriented organization has provided a layer of oversight to the drug company.

So far, the data from both the Moderna/NIH trial and the Pfizer/BioNTech trial look very auspicious (BioNTech, by the way, is a German company devoted to developing immunotherapies, principally as treatment for cancer; it has partnered with Pfizer for years in a thus far unsuccessful effort to produce an mRNA vaccine against influenza). Let’s hope that the record of American Pharma in general, and the questionable past behavior of both principal companies in particular, prove irrelevant to our health.

November 16, 2020

Vaccine Mania

Last Monday, the public woke to the news that the COVID-19 vaccine developed by Pfizer and BioNTech, which has been undergoing testing since the end of July, appears to be working. That is very good news for older people, who have been hardest hit by the coronavirus epidemic, as well as for the younger population, which is bearing the brunt of the current surge in cases. And the news is very timely, as the cumulative number of cases in the U.S. is now over 11 million, with the number of new cases every day higher than ever before. But what, exactly, do we know about how effective this vaccine is likely to be?

The statistic that is cited in the news reports is that to date, the vaccine is 90 percent effective. What that means is that among the 94 people enrolled in the Pfizer/BioNTech study who were diagnosed with symptomatic infection, only 10 percent or about 9 people had received the vaccine; the other 90 percent or about 85 people had been given placebo. This is very encouraging, since the clinical trial enrolled 44,000 volunteers, half of whom received active vaccine and half of whom received placebo: it is very unlikely that such a large differential could have happened by chance. On the other hand, there’s much we don’t know.

We don’t know, for instance, whether the 90 percent effectiveness rate will hold up in all age groups. The study population does include older individuals—the plan was to try to ensure that 40 percent of those enrolled would be over age 55, though it’s unclear what percent would be in the highest risk group, those in their 80s and older. But we don’t know anything about the age or other risk factors of the 94 people who were diagnosed with coronavirus. Since older people todare being far more risk averse on average than their younger counterparts, it’s possible that none of the 94 people with infection identified so far are older adults.

We also don’t know whether the vaccine protects people against developing asymptomatic infection. From a clinical perspective, it’s more important to know whether the vaccine prevents people from developing symptoms, but from a public health perspective, we would like to know whether the vaccine keeps the virus at bay just enough so they remain asymptomatic but not enough to prevent them from transmitting the disease to others. Since asymptomatic transmission accounts for many cases today, it would be desirable to know whether the vaccine allows people to become asymptomatic carriers. We are not going to know the answer to that question as the study protocol does not call for enrollees to be tested for COVID-19 unless they develop symptoms.

Finally, we don’t know how long immunity will last, assuming the promising early results are maintained when the study is completed, which will happen once 164 subjects have been diagnosed with COVID-19 (the pre-specified endpoint of the study). 

What does all this mean for everyone who is eagerly awaiting a vaccine to end this long period of isolation, anxiety, and loss? If the final data, when evaluated by the FDA, possibly by early December, do lead to approval and licensing of the vaccine, older people should be vaccinated as soon as possible—assuming the age-specific effectiveness holds up. 

How will life change after you have been vaccinated? First, it should be stressed that “being vaccinated” means receiving 2 injections, 3 weeks apart. The vaccine effectiveness is being measured starting one week after receipt of the second dose, so you cannot expect protection until one month after your first shot—and you should be sure to get both shots. Second, while 90 percent effectiveness is pretty good, it’s not perfect. No vaccine is perfect, so don’t wait around for a better one. While you will face a much smaller risk of becoming sick with Covid-19 if you have been vaccinated than if you have not been, how likely you are to encounter the virus will depend on how widespread it is in the surrounding community. If, to take the extreme but unfortunately not entirely improbable case in which the rate of infection in the community goes up ten-fold, then if your risk by virtue of vaccination goes down ten-fold, the net improvement is zero. Of course, if the rate in the community goes up by a factor of ten and you haven’t been vaccinated, your risk also goes up by a factor of ten. In short, you are much better off with the vaccine than without it, but how much better off you will be will be determined by what is going on around you.

So, yes, there is good news about vaccines and yes, you should get the shots as soon as they are available, assuming the early results are confirmed and apply to older people. But don’t throw out your masks and don’t expect to go to movies and concerts or other large indoor gatherings just yet.

As I prepare to publish this blog post, news is breaking about a second vaccine made by the pharmaceutical company Moderna in partnership with NIH. More to come about these results in my next post….

November 01, 2020

The Corona Century: Looking Backward, Looking Forward

For over, 50 years, epidemiologists had been expecting “the big one.” Like earthquakes in California, influenza epidemics have become an inevitable part of the landscape. From year to year, influenza mutates; every so often the strain is particularly virulent and it produces a world-wide pandemic, as happened in 1918 and, on a smaller scale, in 1957, 1968, and 2009. Every year, scientists scrutinize the prevailing type of influenza, anticipating that one day we will see the resurgence of a virus as virulent as the one that killed upwards of 50 million people in 1918-1919. Granted, we have vaccines today that prevent or attenuate many cases of the flu, we have antiviral medications with modest degree of efficacy against influenza, and we have sophisticated supportive respiratory treatments such as ventilators, none of which were available in 1918. As a result, any new influenza pandemic is unlikely to be as devastating as its counterpart 100 years ago—but nonetheless, could wreak havoc in our globalized world. So, it was very surprising when, in March, 2003, scientists in search of the causative agent of the newly described respiratory illness known as SARS (Severe Acute Respiratory Syndrome) peered through their electron microscope and discovered, not influenza, but corona virus.

Coronaviruses had first been identified in the 1960s; they were known to infect cattle, pigs, rodents and chickens; in humans, they were associated with about fifteen percent of colds, but not with any more illnesses. But there it was, with its characteristic crown-like ring of proteins—the agent responsible for the mysterious disease that had killed clusters of health care workers, families, and residents of an apartment complex, principally in China and Hong Kong.

Once the genetic identity of the virus had been established, the race was on to figure out where it came from. It was pretty clear that the virus had jumped species, making SARS a “zoonosis.” What species it came from was never definitively established, though palm civets and raccoon dogs sold in the wild meat markets of Guangdong province, China, to consumers eager for an “exotic” meal are the leading candidates. Growing evidence suggests that the true animal reservoir of the SARS virus (SARS-CoV-1) is the bat, with animals such as civets serving as an intermediary.

Due to good epidemiologic practice, the biology of SARS-CoV-1, and luck, SARS disappeared. The World Health Organization (WHO) announced the containment of the epidemic in early July, 2003, less than four months after it first issued an international alert about the dangers of the disease, and less than a year after it first appeared in China in November, 2002. A total of 8098 people developed the illness, of whom 774 died, or just under 10 percent.  All told, the virus appeared in 39 countries. Only China, Hong Kong, Singapore, and Canada had 50 or more cases each. The world breathed a sigh of relief; epidemic prevention programs were developed on paper—and shelved.

And then, in 2012, coronaviruses were back. Or rather, a new coronavirus made its debut: MERS-CoV (for Middle East Respiratory Syndrome). Originally found in Saudi Arabia, it soon travelled to the rest of the Middle East. And stayed there, with the only significant outbreak anywhere else in the world found in Korea in 2015 after the index case had travelled to the Middle East. Unlike SARS, MERS has never disappeared. It remains endemic in the Middle East, where it kills 35 percent of those it infects. Its animal reservoir is probably also a bat, but from bats it infects is camels, and from camels it reaches people. By limiting contact with camels and using case isolation and contact tracing, the total number of confirmed cases in the last eight years is only 2500. More lethal than its SARS-CoV-1 cousin, but less easily transmitted, MERS put coronavirus firmly on the map as a pathogen to be reckoned with, but a relatively minor one, compared to, say, the viruses causing Ebola or AIDS.

Until November, 2019, when yet another atypical pneumonia appeared in China, an illness that would prove to be caused by another coronavirus, this one dubbed SARS-CoV-2. The rest is history, although history that is still unfolding. As of October 30, 2020, according to WHO-COVID Dashboard, there have been a total of 44.59 million cases worldwide, with 1.18 million deaths.  In the US alone, there have been 8.83 million cases and 227,045 deaths. The pandemic is far from over, with the US reporting 81,599 new cases per day. This latest variant of the coronavirus has proved far more successful than its relatives: it seems to have found the ideal balance of transmissibility and lethality, which has enabled it to achieve far more extensive community spread than any previous coronavirus. COVID-19 (the name given to the disease caused by SARS-CoV-2) kills roughly 2.5 percent of those who are diagnosed with the condition, less than SARS (10 percent) and much less than MERS (35 percent), though in all three cases, the mortality is far higher in individuals over age 65. In addition, it ingeniously developed the ability to spread from asymptomatic hosts, allowing it to escape prompt detection and thus limiting the effectiveness of isolation to contain its spread.

Supported by governments and the WHO, several pharmaceutical companies along with university research labs are scrambling to produce a safe and effective vaccine. But with cases of COVID-19 continuing to rise in many parts of the world including the US and Europe, the prospects for an end to the pandemic any time soon are not good.  Several nations have reintroduced lockdowns: France just announced it would shut down from October 30 until December 1 and Germany declared a partial shutdown for roughly the same period. With the whole world suffering from pandemic fatigue—except, perhaps, Taiwan, which just celebrated its 200th day in a row without a single locally transmitted COVID case—it’s hard to even think about life-after-COVID except in terms of “going back to normal.” Odds are that when the disease finally goes into retreat, we will breathe a collective sigh of relief and not want to think about viruses. But that would be a grave mistake.

The current century has already seen three coronavirus epidemics, each with a different variant of this wily microorganism. Most likely, all three normally live in bats and jumped from bats to non-flying mammals and from those mammals to humans. Coronaviruses are RNA viruses, known for their extraordinarily high mutation rates—as much as a million times higher than human mutation rates, which means they will continue to develop new variants. And these new variants will now and then develop the capacity to infect people, both because humans have encroached on the territory of animals with whom we previously had little contact and because global warming drives animals out of their traditional habitats and into new arenas that are occupied by humans. The really successful ones, like COVID-19, will be transmissible from asymptomatic individuals. They will have the ability to spread to other humans quickly, without or before killing their new human host. And then they will be spread by humans from person to person, from household to household, from country to country, from continent to continent.

In short, there is no reason to believe that even if we manage to kill or contain SARS-CoV-2, we will have seen the last of the coronaviruses. However appealing it will be to resume normal life, we must not let down our guard. We have to begin now to plan for the next outbreak. We must be sure to learn from our experiences. That means, first and foremost, taking basic preparedness measures such as stocking up on personal protective equipment. It means replenishing the supply of masks and gowns, even if we go for ten years without an epidemic, just in case. 

Planning for the future, as explained by public health lawyer Lawrence Gostin, entails investing in a robust public health system. Such a system must be able to institute traditional measures such as quarantine of those exposed to disease, isolation of cases, social distancing, and mask-wearing. We have to support scientific research so that new pathogens can be identified, tests developed, and treatments tested in a timely fashion. We must restore the FDA and the CDC to their former grandeur, two organizations that, until the current pandemic, were the envy of the world because of their sophistication, wisdom, and integrity. We have to engage in surveillance, constantly monitoring bats and other species for new diseases. 

We must recognize that we live in an interconnected world, which means collaborating with other researchers and laboratories across the globe, including those of China and of the World Health Organization. And when a new, disease-causing virus appears, we need to demand transparency from our leaders and our scientists: an informed public, armed with the tools of public health and the fruits of medical science, is crucial to combatting the threats that will inevitably appear. 

October 29, 2020

Vote: Your Health Depends On It

Earlier this month, the prestigious New England Journal of Medicine took the unprecedented step of publishing a political position paper in the name of the entire editorial board. Entitled “Dying in a Leadership Vacuum,” the journal urged Americans to vote out our “current leaders.” They based their argument on the mismanagement of the Covid-19 pandemic by America’s political leaders, naming no names but asserting that “when it comes to the response to the largest public health crisis of our time, our current political leaders have demonstrated that they are dangerously incompetent. We should not abet them and enable the deaths of thousands more Americans by allowing them to keep their jobs.”

While the disastrous handling of the pandemic is the most egregious failing of President Donald Trump, Senate Majority Leader Mitch McConnell, and others who could have made a difference, it is not the only area where our leaders promoted misguided health care policy—with disastrous consequences. I argued in an earlier post that “Trump is Bad for Your Health.” Today, as we approach the end of election season, I am going to spell out why Trump, Pence, their appointees (such as Alex Azar, Secretary of Health and Human Services), their Republican supporters in the House and the Senate, and fellow travelers in state governments (both legislators and governors), will be bad for the health of all Americans, older Americans in particular. It’s not just the pandemic performance that’s the problem: it’s the limitations on access to insurance, the roll-back of regulations that protect the environment, and the attacks on Medicare and Medicaid. 

Limiting access to health insurance: One of the major “accomplishments” of the Trump administration and endorsed by Republican legislators is its relentless attacks on the Affordable Care ActThe administration eliminated the “mandate,” the tax penalty on those who do not purchase health insurance. The mandate is an important part of what allows the ACA to work without driving up the cost of insurance: the fundamental principle of insurance coverage is that it works by distributing the risk over a large population; if people can opt out, only those who are sick will remain insured, raising the cost for everyone. And indeed, with the end to the mandate, health care costs have risen—making this a leading issue for the electorate, young and old. 

Rollbacks of environmental regulations: As of October 15, according to the NY Timesthe Trump administration has rolled back or is in the process of rolling back almost 100 environmental regulations. Twenty-one involve air pollutants (plus 5 in progress); six involve water pollution (plus 3 in progress); and six involve toxic substances and safety (plus 2 in progress). Estimates are that these changes will result in thousands of extra deaths per year, affecting older people as well as those who love and care for them.

Attacks on Medicare: just this month, Trump issued an executive order designed to promote the privatization of Medicare. Ostentatiously and misleadingly titled “Protecting and Improving Medicare for Our Nation’s Seniors,” the order calls for shifting costs to beneficiaries, limiting choice of providers, and moving more and more patients into the private sector by joining Medicare Advantage Plans. 

Limiting Medicaid: among the many ways in which the Trump administration has undermined the role played by Medicaid in providing health care is a rule allowing states to cap Medicaid spending for poor adults. Through its endorsement of what are essentially block grants, the federal government is enabling states to reduce health benefits for those who gained coverage to Medicaid thanks to the ACA. In 2018, 12.2 million people were dually eligible for both Medicare and Medicaid. In addition to opting to cut back benefits under Medicaid, states have the option of refusing to allow Medicaid expansion. This is an approach authorized by the ACA that enables the near-poor to receive health insurance through Medicaid. To date, the governors and legislatures of 39 states (and the District of Columbia) have accepted Medicaid expansion; 12 states have not.

Regardless of where you stand on issues such as taxes, immigration, and reproductive rights, whatever your views on foreign policy, your health and that of your children and grandchildren is too important to allow supporters of Trumpian policies to remain in office. Whether they are found in the federal government (as senators, representatives, or in the executive branch) or state government (as legislators or governors), vote them out. Do it now. 

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.