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 

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.

Deputy Director of APARC and Director of the Asia Health Policy Program Karen Eggleston recently spoke to Bloomberg Markets about the new cases and the further spread of the COVID-19 coronavirus in the United States.

"There has been widespread international collaboration on the scientific side to try and get ready for a vaccine and for therapies, but that takes time. In the meantime, you have to rely on tried and true public health measures."

Eggleston stressed the importance of people remaining calm and avoiding both complacency and panic in response to the growing public health crisis. Instead, being proactive, science-based, and utilizing clear, organized communications channels are the keys to protecting individuals and communities and in making timely, informed, effective decisions about future steps as the outbreak continues. Typical practices for flu season such as frequent handwashing, staying away from public spaces when ill, and following recommended self-quarantine guidelines are all measures people can take to support their well-being and the health of those around them.

"It's important to remember that both the transmissibility and the fatality rate [of COVID-19] can be changed by the way we respond. The way we trace the contacts and isolate can reduce the transmissibility. And the resilience of our public health system and investment in prevention and supporting our healthcare workers — and having the right equipment in place for the severe cases — can affect the fatality rate and protect people."

Watch the full interview below to hear more recommendations on how to prepare.

A task force of national health experts recommends clinicians screen all adults 18 to 79 for the hepatitis C virus (HCV), noting that the viral infection is now associated with more deaths in the United States than the top 60 reportable infectious diseases combined.

Many people are unaware they are carrying the viral infection.

“People with hepatitis C do not always feel sick and may not know they have it,” says chair of the U.S. Preventive Services Task Force Douglas K. Owens, M.D, M.S. “Screening is key to finding this infection early, when it’s easier to treat and cure, helping reduce illnesses and deaths.”

Screening involves testing a blood sample to see whether it contains antibodies (disease-fighting proteins) that react specifically to the hepatitis C virus. This test is followed by a second test that determines the level of virus in the blood. When used together, these two tests accurately identify whether a person has hepatitis C infection, according to the Task Force.

An estimated 4.1 million people in the United States are carrying HCV antibodies; about 2.4 million are living with the virus, according to the Task Force. The HCV infection becomes chronic in 75% to 85% of cases and some of those people develop symptoms such as chronic fatigue and depression, and liver diseases that can range from cirrhosis to liver cancer.

Approximately one-third of people ages 18 to 30 who inject drugs are infected with the virus; 70% to 90% of older injection-drug users are infected.

Owens, who is the director of Stanford Health Policy and the Henry J. Kaiser, Jr., Professor of Medicine, said the opioid epidemic now plays an important role in the prevalence of HCV. There are more than three times the number of acute HCV cases than a decade ago, particularly among young, white, injection drug users who live in rural areas. Women aged 15 to 44 have also been hit hard by the virus that is spread through contaminated blood.

“The opioid epidemic has added fuel to the HCV fire, substantially increasing transmission,” said Owens. “HCV is now an enormous public health problem, affecting a much broader age range of people than before. Fortunately, we have the tools to identify people and treatment is now successful in the vast majority of patients, so screening can prevent the mortality and morbidity from HCV.”

The U.S. Preventive Services Task Force is an independent panel of national experts in prevention and evidence-based medicine whose recommendations are followed by primary care clinicians nationwide. It has recommended people who are at high risk be tested for hepatitis C, as well as “baby boomers” born between 1945 and 1965, but now recommends screening all adults age 18 to 79, and younger or older patients if they are at high risk of acquiring HCV.

Hepatitis C is primarily spread when blood from an infected person enters the body of someone who is not infected. There currently is no vaccine for hepatitis C although research in the development of a vaccine is underway. But there are effective oral direct-acting antiviral (DAA) medications that can clear the virus from the body, particularly if caught early.

“Hepatitis C affects millions of people across the country,” says Task Force member Michael J. Barry, M.D. “We recommend screening all adults regardless of their risk because new evidence shows that more people can benefit from this service than even before.”

The Task Force’s final recommendation statement and corresponding evidence summary have been published online in the Journal of the American Medical Association, as well as on the Task Force website at http://www.uspreventiveservicestaskforce.org. 

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. 

Updated January 24
Millions of residents in China are under lockdown measures as the number of reported deaths from the coronavirus outbreak rises to 26. In the United States, dozens of people are being monitored for the virus. The World Health Organization on January 23 said at a press conference the outbreak did not yet constitute a global public health emergency.

The outbreak of a novel coronavirus that began in December 2019 in Wuhan, China “is evolving and complex,” said the head of the World Health Organization (WHO) after its emergency committee convened on Wednesday, January 22, and decided that more information was needed before the WHO declares whether or not the outbreak is a public health emergency of international concern. The new virus, known as 2019-nCoV, causes respiratory illness and continues to spread across China. Chinese health authorities, reports the Washington Post, announced that at least 17 people have now died as a result of infection and confirmed cases have been reported in Japan, Thailand, South Korea, Hong Kong, and Macao, with one travel-related case detected in the United States, in the State of Washington. The WHO decision was made as the city of Wuhan shut down all air and train traffic to try to contain the spread of the virus.

With concern over and coverage of the situation rapidly developing, Karen Eggleston, APARC Deputy Director and the Asia Health Policy Program Director at the Shorenstein Asia-Pacific Research Center, offered her insights on the outbreak and its impact on both Asian and international healthcare systems.

Q: Why has this outbreak raised so much concern in China and internationally, and how worried should people be about it?

Infectious disease outbreaks can challenge any health system. Events such as SARS, Ebola, and MERS outbreaks, and even the devastating flu pandemic a century ago, remind us of the frightening power that infectious diseases with high-case fatality can have. The global burden of mortality and morbidity is mostly from non-communicable chronic diseases, but no country or society is immune to old, newly emerging, and re-emerging infectious diseases. And although health systems are generally stronger now and have more technologies to trace and contain outbreaks, there are also deep and complicated challenges that make swift, coordinated disease response difficult even in the modern era.

Any government leadership or healthcare responders who have tried to manage an outbreak situation before are hyper-aware of the need to prepare for and manage future incidents, but we are living in a moment of very complicated social dynamics surrounding public health and healthcare. Distrust in drug companies and government agencies, controversies over vaccines, and increasing skepticism in science, even if only from vocal minorities, all make it more difficult to manage a cohesive international response to an outbreak situation and protect vulnerable people.

Q: As you’ve mentioned, many people looking at this situation with the memory of outbreaks such as SARS or H1N1 in mind. How is the Chinese government addressing this crisis and how does its reaction compare with China’s history of emergency health responses?

China’s health system is much more prepared now, compared to the SARS crisis 17 years ago. More training and investment in primary health care, disease surveillance and technology systems for tracking and monitoring outbreaks, and the achievement of universal health coverage with improving catastrophic coverage even for the rural population, all suggest a health system that is much better prepared to handle a situation like this. Top-level leadership in China had already begun to publicly address the situation within days of the outbreak to assure the public that strict prevention measures will be taken and to urge local officials to take responsibility and share full information. Until more information is gained and more is understood about the nature of this virus, it’s been categorized as a “Grade B infectious disease” but will be managed as if it is a "Grade A infectious disease," which requires the strictest prevention and control measures, including mandatory quarantine of patients and medical observation for those who have had close contact with patients, according to the commission. China currently only classifies two other diseases as Grade A infection diseases—bubonic plague and cholera—and so that tells you something about how seriously this is being treated by those in leadership positions.

Q: And what about the response from the international health communities?

As with any major healthcare crisis, health systems around the globe must also respond with alacrity and integrity, including effective surveillance, monitoring, and infection control. Individuals also play a crucial role in supporting the instructions and recommendations made by established healthcare professionals. For example, the individual with the confirmed case in Washington State proactively told medical personnel about his recent visit to the Wuhan area. His medical providers then exercised appropriate levels of caution, given the unknown nature of the virus, and isolated him while his symptoms developed. He is currently combatting an infection similar in severity to that of mild pneumonia, and so far no other cases have been reported in the United States, though some may arise in the coming days and weeks.

There is always a fine balance between safeguarding public health while still respecting individual rights, civil liberties, and undertaking a prudent, scientific response. The aim is to remain clear and transparent in communications and actions without reverting to disproportionate or overly aggressive responses which lead to panic, distortion, and misinformation about the situation. Some countries, like the Democratic People’s Republic of Korea, may choose to seal their international borders until more is understood about the nature of this virus, but most nations will use tried-and-tested methods of monitoring travelers and alerting population health systems so that information about cases is widely available to health authorities and medical researchers trying to understand the cause and develop a potential cure.

Q: As this situation continues to develop, and with inevitable future disease outbreaks around the globe, what would you hope people keep in mind about the role we all play in healthcare crises and in public health?

One issue this outbreak reminds us of in a visceral and intimate way is how closely people are linked together across the world. Globalization and air travel almost instantaneously link continents, countries, and regions. The timing of this outbreak is particularly fraught, because it’s the beginning of the Lunar New Year, when there is a vast migration of people both within China, throughout greater Asia, and across the globe as massive populations go home to celebrate the holidays with family. The potential for a contagious disease to spread easily through crowds and across borders in circumstances like this is very high, and highlights the need for the international communities to share information, scientific expertise, and understanding.

We need to remember that this is not just a problem in a remote part of the world that has no impact on those of us who live in relative comfort in high-income countries. Rather, this is something that could easily impact anyone. Perhaps this latest outbreak and response will showcase how vital additional, ongoing investments in both domestic and international healthcare systems, technologies, and people are.