Stanford Health Policy's Eran Bendavid and Jay Bhattacharya write in this Wall Street Journal editorial that current estimates about the COVID-19 fatality rate may be too high by orders of magnitude.

"If it’s true that the novel coronavirus would kill millions without shelter-in-place orders and quarantines, then the extraordinary measures being carried out in cities and states around the country are surely justified. But there’s little evidence to confirm that premise—and projections of the death toll could plausibly be orders of magnitude too high.

"Fear of Covid-19 is based on its high estimated case fatality rate — 2% to 4% of people with confirmed Covid-19 have died, according to the World Health Organization and others. So if 100 million Americans ultimately get the disease, 2 million to 4 million could die. We believe that estimate is deeply flawed. The true fatality rate is the portion of those infected who die, not the deaths from identified positive cases."

"The latter rate is misleading because of selection bias in testing. The degree of bias is uncertainbecause available data are limited. But it could make the difference between an epidemic that kills 20,000 and one that kills 2 million. If the number of actual infections is much larger than the number of cases—orders of magnitude larger—then the true fatality rate is much lower as well. That’s not only plausible but likely based on what we know so far."

Read the Editorial 

As the deaths and detected cases from the COVID-19 epidemic continue to rise globally, government planners and policymakers require projections of its future course and impacts. They also need to understand how potential interventions might “flatten the curve.”

“It’s important to understand these overall effects by geographic area, demographic group, and for special populations like health-care workers,” says Stanford Health Policy’s Jeremy Goldhaber-Fiebert, who will be teaching a new class in the spring on infectious disease modeling with Stanford Medicine’s Jason Andrews. “Doing this requires mathematical models that incorporate the best available clinical, epidemiological, and policy data along with their associated uncertainties — the state-of-the-art of infectious disease modeling.”

Goldhaber-Fiebert and Andrews will debut the new course, Models for Understanding and Controlling Global Infectious Diseases (HUMBIO 154D for undergrads and HRP204 for graduate students) in the upcoming spring quarter. Stanford Provost Persis Drell announced last week that all spring courses at the university will now be taught online and pushed the start of the new quarter April 6.

Andrews is an infectious disease physician and assistant professor of medicine and Goldhaber-Fiebert, an associate professor of medicine, is a decision scientist.

The class will enable students to become critical consumers of studies using infectious disease modeling and to learn the building blocks for constructing infectious disease models themselves.

Despite the course being new and listed in the middle of winter quarter, they have seen enrollment rise from eight — prior to the rise of COVID-19 in the U.S. and its direct impacts on Stanford’s operations — to nearly 30 students as of March 22.

“Together Jason and I are leading one of several efforts on COVID-19 modeling here in Stanford,” said Goldhaber-Fiebert. “And we anticipate that the course will increase the number of Stanford students with the necessary skills to contribute to Stanford’s leadership in this area.”

Controversies over the lack of diagnostic testing for the COVID-19 virus have dominated U.S headlines for weeks. Technical challenges with the first test developed by the Centers for Disease Control and Prevention (CDC) left the nation with minimal diagnostic capacity during the first few weeks of the epidemic, according to a new paper published today in the Journal of the American Medical Association by Michelle Mello, a professor of medicine at Stanford Health Policy and professor of law at Stanford Law School.

On February 29, the Food and Drug Administration (FDA) began allowing high-complexity labs across the country to use tests they developed in-house. On March 5, the Stanford Clinical Virology Lab deployed its own test for patients at Stanford Health Care and Stanford Children’s Health.

We asked Mello to answer some questions about the federal rollout of diagnostic testing.

You write that in the early stages, COVID-19 “spread beyond the nation’s ability to detect it.” Is there anything the U.S. government could or should have done weeks ago to get out ahead of the spread?

Adopting broader testing criteria and allowing use of a wider range of tests would have been helpful in identifying the first U.S. cases and containing the spread. Manufacturing problems like the one that arose with CDC’s test are always a risk, but the fact that CDC put all its eggs in that one basket made the manufacturing snafu highly consequential.

Also, the public messaging from Washington about the seriousness of the problem has been neither consistent nor accurate, and I worry it may have led Americans to take fewer steps to prevent community transmission than we should have. Containment was not “pretty close to airtight.” A vaccine was never going to be ready in “three to four months,” as the Trump administration claimed. The case fatality rate is not “way under 1 percent.” Part of the problem here is that as the stock market continues to plunge, the president and the task force he appointed appear to be more concerned about calming investors than stopping the virus.

We seem to be between a rock and a hard place: You write that remedying gaps in testing is imperative, yet “more testing is not always better.” How do we determine the happy middle ground?

First, the testing criteria have to be calibrated to our actual testing capacity. You can’t announce that any American who wants a coronavirus test can get one and then, within hours, announce that there aren’t enough test kits to make that possible. High priorities for testing include patients with serious, unexplained respiratory illness and contacts of known cases. From there, testing can be expanded, beginning with other high-risk groups, as capacity permits.

Second, we should consider unintended side effects of mass testing. The problem with this virus is that it doesn’t have signature symptoms. It looks like the common cold or the flu. If everyone with a cough or fever, or who has been around someone with a cough or fever, shows up in their doctor’s office demanding a test, it will quickly overwhelm care facilities that should be focusing on patients with a higher likelihood of being infected or and those who are infected and are seriously ill. It may also work against the social distancing measures that public health officials are trying to encourage, because crowded waiting rooms may spread the virus.

The CDC announced Monday it now has the testing capacity in 78 state and local public health labs across 50 states to test for the virus. There are now 75,000 lab kits cumulatively to test for COVID-19 with more coming on board by mid-March. But is there anything we could have done to roll this out earlier?

The alternative would have been to allow laboratories to deploy their own tests from the beginning, using the primers and protocols made publicly available by the World Health Organization. That’s what other countries have done. RT-PCR is a mature technology and high-complexity labs around the country are well-qualified to conduct this type of testing.

There is a public health argument for not going that route: perhaps those labs wouldn’t have done as good a job as CDC’s own lab and the state labs that it handpicked early in the outbreak. What if there were erroneous test results? We could miss cases, or we could put people into isolation, with huge social consequences, based on false-positive results. There is also a worry that some labs aren’t consistent about reporting positive test results to CDC, and underreporting could compromise disease surveillance efforts.

The counterargument is that high-complexity labs have that certification for a reason—they’re good at what they do. And of course, surveillance is also compromised when you miss cases because you don’t test.

You write in your paper that testing for COVID-19 “highlights a controversial area of public policy—the regulation of laboratory-developed tests—in which there has long been tension between the goals of access and quality.” Who should be in charge of regulating these tests?

Laboratory-developed tests are largely unregulated outside of emergencies. The FDA proposed draft guidance in 2014 that, if implemented, would have required labs to make certain showings to FDA about tests they developed in-house, with the particular evidence calibrated to the risks involved in having a wrong test result. Contrary to President Trump’s claim that an Obama-era policy constrained coronavirus testing, the guidance did not relate to emergency situations. During declared emergencies, another statute and set of regulations apply, and the FDA has broad discretion to allow or disallow use of novel diagnostics and therapies as emergency countermeasures.

As a general matter, it makes good sense to require labs to submit evidence that their in-house tests work. It’s odd that laboratory-developed tests are carved out of requirements that apply to other kinds of medical devices. It’s also sensible that our legal framework allows FDA’s regular rules to be relaxed during emergencies so we can tailor our response to the difficult and changing circumstances.

You write that diagnostic testing is critical to an effective response to the novel coronavirus. What sort of policies and guidelines should be put into place to prevent such a sluggish rollout during an emerging epidemic the next time one comes around?

The legal framework for an effective emergency response is in place. Because giving agency heads the discretion to act as potentially unforeseeable circumstances require is a linchpin of this legal framework, it only works if leaders make smart choices. Every emergency is different, and there is a danger of Monday-morning quarterbacking. But we should learn from every misstep we make, and I think the lesson here is to make better use of already developed networks of highly qualified labs to make sure we have adequate testing capacity to isolate cases and trace their contacts very early in an outbreak.

What are some innovative approaches we could be taking to speed up testing for those who really need it?

The South Koreans have set up drive-through testing stations in parking lots to avoid concentrating crowds of people indoors. Of course, that requires that you have plenty of test kits, which we don’t yet – but we should also be thinking about creative ways to address the epidemic. For example, how could video calls be used to monitor the health of people confined at home after being exposed to the virus? How can social media be used to connect neighbors to help one another when some are isolated at home? Hopefully we can find new ways for technology to bring us together when pathogens drive us apart.

This is the first installment in a series leading up to the publication of Fateful Decisions.

China has tremendous resources, both human and financial, but it may now be facing a perfect storm of challenges. Its future is neither inevitable nor immutable, and its further evolution will be highly contingent on the content and efficacy of complex policy choices.

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One of these challenges — how China must soon achieve economic growth as it grapples with the realities of a rapidly aging population and a shrinking workforce — is the subject of a chapter authored by Karen Eggleston, the deputy director of APARC and director of the Center’s Asia Health Policy Program. In the following interview, Eggleston shares perspectives from her chapter, “Demographic Challenges.”

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Q: What are some of the fateful decisions China is facing regarding the responsibilities of caring for a large, aging population?

A: China has achieved impressive improvements in health and longevity. It has implemented universal health coverage and is experimenting with financial support for long-term care for older adults. Yet significant gaps between the most- and least-privileged Chinese citizens persist, and in some cases are growing. As I have written elsewhere, it is not surprising that there are wide disparities in health and healthcare between different population subgroups in a country as populous, expansive, and diverse as China. How effectively and efficiently China meets these and other health- and aging-related issues will have a major impact on its ability to manage other social and economic challenges.

In the chapter I contributed to the volume Fateful Decisions, I note that China’s current population and demographic trends — including relatively rapid aging — reflect the success of earlier investments in infectious disease control, public health measures, and other contributors to mortality reduction. The lingering effects of family planning policies, historic preferences for sons, and rapid economic development are also major considerations. Together, these factors have produced a shrinking working-age population, a growing number of elderly, a gender imbalance, and hurdles for inclusive urbanization. An urgent question for China’s future is to what extent policies will ameliorate disparities in health, healthcare use, and the burden of medical spending.

The unfolding COVID-2019 outbreak is a powerful illustration of just how fateful decisions about health systems can be. Compared to the SARS outbreak almost two decades ago, China has been better prepared for this situation. SARS raised health system reform to the top of the political agenda and, many argue, played a direct role in China’s achieving universal health coverage and vastly strengthening the public health system.

But as China has become a middle-income global economic powerhouse in the years since SARS and the ensuing wave of health policy reforms, the expectations of its citizens about their health system have also risen. Has the health system, including public health and medical care, been strengthened to the same degree as other parts of the economy and public services? The impact of and lasting response to COVID-2019 may prove a litmus test.

Q: Why do these decisions about health carry such importance for China’s future development?

Through the last four decades, China has benefitted from a demographic dividend caused by the large bulge in the working-age population. But to achieve future economic growth and productivity, investments in human capital — particularly in health and education —need to be made. This higher productivity will, in turn, be the means by which a smaller workforce can support China’s large and growing cohort of retirees.

As we’ve already seen, health expenditures have increased rapidly as China has developed its system of universal health coverage. Double-digit health spending growth surpassed the rate of economic growth, and as a result, health spending absorbs an increasingly larger share of the total economy. China needs to make sure additional spending on health and elderly care is efficient and effective, while also addressing the nonmedical determinants of health and promoting healthy aging. The health system needs to be reengineered to emphasize prevention, provide coordinated health care for people with multiple chronic diseases, assure equitable access to rapidly changing medical technologies, and ensure long-term care for frail elderly, all without unsustainable increases in opportunity costs for China’s future generations.

Q: What is the Chinese government doing to improve healthcare quality and delivery, and what more could it do to affect meaningful change in its systems?

China’s current policies seek to balance individual responsibility, community support, and taxpayer redistribution through safety-net coverage funded by central and local governments. Like many countries, China would benefit from improved coordination across multiple agencies and structure incentives to avoid or mitigate unintended consequences that undermine the goals of its health system. Recent governance reforms, such as the creation of the National Healthcare Security Administration, aim to address these challenges.

China’s achievements and remaining challenges can be illustrated with the Healthcare Access and Quality Index (HAQ), which measures premature mortality from causes that should not occur if the individual had access to high-quality healthcare: among 195 countries and territories, China achieved the highest absolute increase in the HAQ Index from 2000 to 2016. However, the 43-point regional disparity in HAQ within China is the equivalent of the difference between Iceland (the highest HAQ in the world) and North Korea.

Q: The subject of your chapter, China’s demographic challenges, is one of the issues you investigate in your upcoming book, Healthy Aging in Asia. As you show in this volume, challenges at the intersection of aging, economics, demographic transition, and healthcare policy are not unique to China. How are other countries in Asia responding to them and what lessons could benefit China?

 As I note in the introduction of Healthy Aging in Asia, the demographic transition from high to low fertility and mortality has been more rapid in much of Asia than in Europe and North America. That means social institutions, such as retirement, living arrangements, and intergenerational support, have to adapt quickly. For example, extending work-lives (as is happening in Japan) will be necessary but feasible only if the added years are healthy ones and equitable only if the least advantaged also benefit from healthy aging. The blessings of longevity dim when clouded by pain, disability, and loss of dignity.

 Investment strategies in insurance and managing chronic conditions are also important considerations. Japan and Korea have adopted insurance systems for financing long-term care for frail elderly, while places like Hong Kong have good empirical research on chronic condition management.

 No country or system has a “magic pill” to address these challenges, but the empirical evidence and rich policy experience documented in Healthy Aging from health systems as diverse as those in the cities of Singapore and Hong Kong to large economies such as Japan, India, and China can certainly be instructive.

More evidence-based research is needed before the U.S. Preventive Services Task Force can recommend that clinicians screen their older patients for cognitive impairment such as dementia and Alzheimer’s disease.

Cognitive impairment is a growing public health dilemma that affects millions of Americans as they age. The Global Burden of Disease study shows that Alzheimer’s rose from the 12th most burdensome disease or injury in the United States in 1990 to the 6th in 2016.

Medical experts who were commissioned to conduct an evidence report for the Task Force projected that the burden of Alzheimer’s disease is expected to grow to 13.8 million U.S. residents by 2050 — or nearly 3.3% of the projected U.S. population by that year.

Their findings, the Task Force recommendation statement and several accompanying editorials were all published Tuesday in the Journal of the American Medical Association.

The symptoms of cognitive impairment can range from problems with memory and language, to learning new things or making decisions that affect everyday life. 

“Early identification of cognitive impairment through screening would ideally allow patients and their families to receive care at an earlier stage in the disease process, potentially facilitating discussions regarding health, financial, and legal decision-making while the patient still retains decision-making capacity,” the authors of the Task Force evidence report wrote.

But after reviewing some 287 studies including more than 285,000 older adults, the Task Force determined there wasn’t sufficient evidence about the benefits or harms of screening adults 65 and older who do not have signs or symptoms. The Task Force also did not find adequate evidence that screening for cognitive impairment improves decision-making or planning by patients, caregivers or doctors.

At the same time, there is little evidence on potential harms of screening, such as depression, anxiety or lower quality of life.

“Given the burden of dementia and the intense public interest in preventing cognitive impairment, the lack of progress is disheartening,” Carol Brayne, MD, with the Department of Public Health and Primary Care at the University of Cambridge in the UK, wrote in an accompanying JAMA editorial to the Task Force evidence report.

But, she added, “Political considerations and pressure from commercial interests and patient advocacy groups notwithstanding, public policies for dementia screening should be supported by evidence.”

The Task Force — an independent panel of national experts in prevention and evidence-based medicine — encourages clinicians to remain alert for early signs of symptoms of cognitive impairment, while calling for more research on the detection of dementia.

“Research is especially needed on whether screening and early detection of cognitive impairment helps patients, caregivers, and doctors make decisions about health care or plan for the future,” said Douglas K. Owens, chair of the Task Force and the director of Stanford Health Policy.  “We share the frustration of clinicians who want to offer something that could help patients prevent cognitive impairment. We hope that additional research will enable us to know whether that’s possible.”

The most commonly used screening tests include the Mini-Mental State Examination as well as the clock-drawing test. Screening tests involve asking patients to perform a series of tasks that asses one or more aspects of cognitive functions. The USPSTF concluded that more research is needed to know whether such screening tests can lead to interventions that help prevent or improve cognitive impairment.