Aaron E. Carroll's Blog, page 55

Four ways COVID-19 has exposed gaps in the US social safety net

The following was coauthored by Paul Shafer (@shaferpr), Assistant Professor, Health Law, Policy, and Management, Boston University, and Cecille Avila (@cecilleavila), a policy analyst at Boston University School of Public Health, with research support form the Laura and John Arnold Foundation. This article is republished from The Conversation under a Creative Commons license. 

The United States is experiencing its steepest economic slide in modern history. Tens of millions of Americans have filed new unemployment claims as the coronavirus shutters businesses and forces companies to lay off staff.

People need support to help them through the crisis in a few key ways – cash to meet immediate financial needs, health care to cover them should they become ill and housing even if they can’t make rent. Despite federal stimulus efforts north of US$2 trillion – so far – it is likely that some of those currently being affected will fall through the cracks.

As a scholar who studies how people enroll in public programs, I and my colleague Cecille Joan Avila, who researches social programs related to women’s health, have seen how well-intentioned policies can sometimes fail those they are supposed to help.

We took a deeper look at how difficult it might be for people to navigate their way through the U.S.‘s patchwork of social safety net measures as they try to stay afloat during the pandemic and economic downturn. Here are four gaps that we found:

1. Delays, exemptions to financial aid

Congress passed stimulus measures that are providing some Americans with a one-time check of up to $1,200 per adult and $500 per dependent child along with a temporary boost in unemployment benefits. Many received their stimulus through direct deposit, but millions of low-income Americans experienced problems and delays receiving payment. As many as 20 million may have had stimulus deposits go to tax preparers who take a fee out of refunds because clients are too poor to pay for tax prep up front. There are a variety of other reasons for delays: if individuals haven’t filed their 2019 tax returns yet, if their address has changed recently or if they don’t have a bank account.

Not everyone benefits from stimulus measures. Young adults over the age of 17 who can be claimed as a dependent will not receive checks, nor will people who jointly filed their taxes with immigrant spouses who are not citizens, even if they are here legally.

Workers in more than half of states will receive, on average, more in unemployment benefits than their normal salaries. But there are challenges to receiving unemployment benefits too, as the rules vary from state to state and labor agencies are struggling to keep up with unemployment filings. There are also thresholds for minimum earnings to qualify and limits on how long a person can collect unemployment.

2. Free testing but costly treatment?

Congress mandated that private insurance cover testing at no cost, but not treatment. Infected? Get your deductible ready. Many will count on Medicaid, which typically covers medical bills retroactively for three months prior to application if you were eligible, but people in states that have broad restrictions on retroactive coverage could be left holding the bag. And anyone in the process of getting their Medicaid coverage renewed might be concerned, to say nothing of the nearly 30 million Americans uninsured before the crisis.

A $100 billion fund will help hospitals cover the cost of treating uninsured people affected by COVID-19. But the CARES Act was unspecific about how fast and to what areas the funds will be distributed, and what they can be used for. That needs to be figured out quickly, as treatment costs may be as high as $40,000 per patient.

And none of this funding even addresses those who develop long-term complications that require ongoing care.

3. Unemployed and uninsured

Losing employment and health insurance coverage counts as a qualifying event to sign up for health insurance through HealthCare.gov or a state-based marketplace, but that assumes people know that they can. The Trump administration has avoided any broad reopening of enrollment, but several states have done so. Laid-off employees may have the option of extending their former employer’s health insurance through COBRA, but this tends to be more expensive and unsustainable.

Two recent studies project that nearly 20 million Americans may face disruptions in employer-based health insurance, with as many as 11 million becoming uninsured. For those newly uninsured, living in a Medicaid expansion state like New York or California might mean you are OK. But even before the pandemic, there were already an estimated 2.3 million people living in nonexpansion states like Texas or Florida who fell into the coverage gap – making too much money to qualify for Medicaid and yet not enough to afford coverage.

4. Safe from eviction, but for how long?

Stay-at-home orders have been seen as key in slowing the spread, but rely on the false assumption that everyone has access to safe and stable housing. Some people looking for affordable housing placements in March and April found themselves in limbo, with progress on paperwork suddenly stalled. For those with housing, unpaid rent was up 50% in April over March. Many large cities and states have temporarily halted evictions and a federal eviction ban covers about a quarter of rental housing. But this is only for nonpayment, leaving a loophole for landlords to continue pursuing eviction for other reasons. And that one-time stimulus check won’t even cover the median monthly rent in a number of states, especially in parts of California and the New York City metro area. So what happens when the check has been spent and the eviction ban is lifted?

A solution

What if these safety net programs were better integrated? Imagine if filing for unemployment triggered a next step – either presenting a series of subsidized health plan options through HealthCare.gov or auto-enrolling those eligible in Medicaid. It would potentially alleviate administrative burden and address gaps in information. States could use a mechanism like Express Lane Eligibility, which allows officials to use information provided from one state agency to make eligibility determinations for Medicaid, though there are good reasons – mostly solvable – why many states haven’t yet.

The U.S.’s social safety net is more a loose patchwork unprepared to handle a crisis like the pandemic, relying on disconnected public programs and old technology. The federal government is relying on short-term measures directed to those affected by the crisis, but we believe it does little to address the plight of those who were already economically vulnerable and those who will be long after this pandemic.

Disaster preparedness isn’t just the National Guard, personal protective equipment and bottled water anymore. This pandemic has shown that it is now also the ability to keep people economically afloat through a potentially prolonged and sudden financial crisis.

Indiana’s COVID-19 Testing Study and What it Means for Reopening

What’s the true infection rate of COVID-19? So far, we’ve had no real idea, which means most states are flying blind into reopening. But not Indiana, where a new statewide study is the first to provide the kind of data we’ll need to make safe decisions moving forward.

 

@DrTiff_PhD

Off-Label Prescribing With Limited Evidence: What We Have To Lose

President Trump told reporters on Monday that despite warnings from the Food and Drug Administration, he had been taking the prescription drug hydroxychloroquine “as a preventative” against COVID-19. As of this writing, there are no FDA-approved drugs that have been shown to treat or prevent COVID-19. But if the FDA hasn’t approved hydroxychloroquine as a preventative treatment for COVID-19, how could Mr. Trump have been prescribed the drug?

The answer, which I addressed in an article in March, is that doctors are permitted to prescribe hydroxychloroquine or any FDA-approved drug off-label, meaning to treat a different condition or indication than the condition the FDA approved it to treat, which applies to patients with COVID-19.” Off-label drug usage and prescribing are commonplace in the United States today: about one in five prescriptions is for off-label use.

Though the reasons that a physician might prescribe a drug for an off-label purpose are diverse, these uses should have a grounding in evidence that exceeds the “lot of positive calls” that Mr. Trump cited for hydroxychloroquine’s effectiveness on Monday. (Contradicting Mr. Trump’s anecdotes, a recent study published in JAMA found no association between hydroxychloroquine use and lower in-hospital mortality for a cohort of COVID-19 patients in New York City.)

When patients fill on-label prescriptions, they can be sure that the FDA has “conducted a careful evaluation of [the drug’s] benefits and risks for that use,” “the decision to use the drug is supported by strong scientific data,” and “there is approved drug labeling for healthcare providers on how to use the drug safely and effectively for that use.” The same, however, cannot be said about off-label drug use. By definition, off-label medications medication use (or use in a different patient demographic or dosage) has not been thoroughly vetted with clinical trials evaluated by the FDA.

The process of conducting clinical trials to receive FDA approval for new uses or dosages of a drug is expensive and can take years. So, some evidence-based uses of a drug may not be on-label. Partially due to the expensive nature of clinical trials, physicians are free to prescribe any FDA-approved drug for any purpose they see fit, regardless of what the drug was initially approved to treat. But simultaneously balancing a professional oath to do no harm, upholding an ethical obligation to act in the best interests of patients, and respecting the autonomy of patients is often complicated.

In the case of patients that do not have severe cases of COVID-19, however, infectious disease specialist Dr. Rachel Bystritsky warns that prescribing drugs like hydroxychloroquine that do not have an established clinical benefit is unethical and potentially dangerous. The authors of a recent research letter published in JAMA Internal Medicine agree, stating that physicians have a responsibility to prevent “unsupervised use of the products with dangerous consequences to the people who take them.”

Off-label prescribing that lacks the support of sound clinical evidence runs serious risks. As Dr. Benjamin Rome and Dr. Jerry Avorn outlined in an article in the New England Journal of Medicine in April,

benefits to patients are unknown and may be negligible… medications such as hydroxychloroquine have well-documented risks; subjecting patients to these risks would be unjustifiable in the absence of meaningful clinical benefit… widespread off-label use can limit access for patients who need them for their established use.

Though Dr. Rome and Dr. Avorn were referring to the FDA’s decision to grant emergency use authorization to hydroxychloroquine, the same reasoning holds for off-label prescribing.

When reporters have reminded President Trump that no experimental data exists to back up his claims about the effectiveness of hydroxychloroquine as a treatment or prophylactic for COVID-19, Mr. Trump has responded by asking “what do we have to lose?” The FDA recently published guidance documenting what we have to lose: “Hydroxychloroquine and chloroquine can cause abnormal heart rhythms such as QT interval prolongation and a dangerously rapid heart rate called ventricular tachycardia.”

Randomized clinical trials are the core of how government regulators prevent dangerous prescription drugs from reaching patients. That’s for good reason. Though some prescriptions can be made ethically without the backing of randomized control trials, these situations are and should remain the exception, not the rule.

It is worth noting that drugmakers often have little incentive to generate high-quality new clinical evidence for off-label uses of their FDA-approved drugs, especially in the case of generics. Incentivizing the production of better data on off-label uses of existing FDA-approved drugs is an important policy challenge that remains largely unaddressed. But doing just that is crucial because patients deserve to know that the prescription drugs they take have been tested and researched by experts. With a few notable exceptions, prescriptions should be made for indications when there is evidence that shows that the benefits of adherence clearly outweigh harms.

Throwing caution to the wind with off-label prescribing, without sound clinical evidence, means that patients will no longer be able to trust that their medicines are safe and effective. That’s something we can’t afford to risk, now or ever.

Research for this piece was supported by the Laura and John Arnold Foundation.

COVID-19 Update: May 18 Edition

The following originally appeared on the Baker Institute Blog and is coauthored by Vivian Ho, Ph.D. (@healthecontx), James A. Baker III Institute Chair in Health Economics, Kirstin Matthews, Ph.D. (@stpolicy), Baker Institute Fellow in Science and Technology Policy and Heidi Russell, M.D., Ph.D., Associate Professor, Department of Pediatrics, Baylor College of Medicine and Associate Director, Center for Medical Ethics and Health Policy, Baylor College of Medicine.

As many states begin to reopen their economies, it is too early to tell from the statistics whether they are moving too quickly. We consider the risks posed to workers not wearing masks in large offices, the risks scientists are considering for speeding the vaccine development process, and multiple policy responses to the pandemic.

Epidemiology and Treatment

As of Friday May 15th, data from the COVID Tracking Project showed that the 7-day average (smoothed) number of new daily cases continued to fall, to 22,540 from 25,895 a week earlier. This 15% decline occurred in the midst of a 27% increase in the smoothed number of tests. These 332,883 tests lie far below the target of 900,000 tests per day we discussed last week. Here in Texas, one of the earliest states to relax social distancing, the smoothed number of new cases rose 21%, from 868 to 1,048. The smoothed number of tests rose 35% to 24,125 on Friday, which is slightly below the 27,282 recommended for the state. However, news broke on Saturday that the state is combining both viral and antibody tests in its test counts, whereas states are expected to only report the former.

The New York Times used smartphone location data from the company Cuebiq to determine that 25 million more American residents ventured more than 300 feet from home last week compared to the preceding 6 weeks. The increased movement occurred both in states that did and did not lift stay-at-home orders. Normally 20.7% of Americans stay home on a given day. The rate reached a peak of 43.8% in April, and last week 36.1% stayed home. The increase in movement may not be cause for alarm if people practice social distancing.

Erin Bromage, an Associate Professor of Biology at the University of Massachusetts Dartmouth, has published a blog discussing the situations and locations where one is most likely to be infected with the coronavirus, which has received over 14 million views. He cites multiple peer-reviewed research papers that emphasize the dangers of unmasked workers sharing air space with an infected person. In one study of an 11th floor call center in South Korea, 94 of 216 (46%) workers contracted SARS-COV2 from just one employee over the course of one week. This finding raises our anxiety, as we have heard that some companies in Houston are requiring their workers to return to the office. We have not found a peer-reviewed study on the effectiveness of masks in preventing spread of the virus in large offices. However, a New Yorker piece by Atul Gawande provides detailed information on the potential benefits of masks in many situations.

Scientists face unique challenges in developing a safe and effective vaccine for the coronavirus. There is relatively limited understanding of the virus, because it is so new. Yet the urgency generated by the pandemic has spurred several vaccine candidates that employ new approaches that in theory should work but have never been used. Rigorous clinical trials are essential, to avoid vaccines which could be ineffective or accidentally give patients the virus instead of protecting them from it.

One option for speeding up the clinical trial process is a trial, where one “challenges” healthy volunteers with the virus to determine if the vaccine works. It was first proposed in March, but the idea has since gained momentum with other scholars and policymakers. However, there is no cure for COVID-19 and limited treatments. Therefore, a trial would put patients at risk of severe consequences if the vaccine does not work. Other unknowns include how to grow the virus itself without contamination from other pathogens, what is the best route/method to challenge patients, how much of the virus one needs to challenge patients, and how to effectively manage challenged patients so they do not cause localized outbreaks.

Over the past several weeks we’ve seen increasing reports of a mysterious inflammatory illness in children with links to the novel coronavirus — initially in the UK, then New York, and now across Europe and the U.S. The CDC’s May 14th health alert formally described reporting criteria for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with COVID-19. In many ways MIS-C looks like a well-described childhood illness called Kawasaki’s Disease except that the MIS-C patients are more critically ill. One small study of children with Kawasaki’s Disease in 2005 linked it with coronavirus but multiple other subsequent studies did not confirm the connection. Per the CDC’s alert, the New York State Health Department has already identified 102 children with the syndrome. The national number of cases will increase, as awareness and the number of COVID cases rises. This syndrome requires understanding and particular consideration in future models of the healthcare needs for the pandemic as it will disproportionately affect pediatric care facilities.

Policy Response

On Friday, the White House unveiled Operation Warp Speed, a massive effort to finish developing, then to manufacture and distribute a proven coronavirus vaccine as fast as possible. The chief scientist will be immunologist Dr. Moncef Slaoui, who is reported by STAT News to own $10 million in stock options for Moderna, which we noted is one of the companies in the race to develop a coronavirus vaccine. Through this program, the federal government will invest in manufacturing all of the top vaccine candidates before they are approved.

While we applaud any effort by the Administration to bolster vaccine development, it falls far short of the $70 billion Advance Market Commitment proposal we mentioned last week. The AMC for a coronavirus vaccine was proposed by a team led by 2019 Nobel prize winning economist Michael Kremer, an expert in vaccine markets. In a Zoom presentation, Dr. Kremer explains that 14 vaccine candidates are necessary for a 90% chance of having at least one vaccine available within 18 months. He derived this estimate after consulting with scientists in the vaccine industry. A large portion of the AMC funding directly finances 80% of each vaccine firms’ manufacturing capacity. As we noted last week, scientists are developing vaccines that work in multiple different ways, and each requires its own specifically designed manufacturing plant. The AMC plan lays out pricing incentives to spur faster vaccine development and a strategy for international collaboration.

On Monday a Wall Street Journal article noted that most Asian countries are not allowing mild COVID-19 cases to self-isolate at home. Instead, mildly ill patients must move to dormitories or other public facilities designated for quarantine. The concern that patients with mild cases can readily spread the disease is underlined by an Italian study, which found that more than one in five people who tested positive since April 1 were likely infected by family members. New York and Chicago have publicly funded programs to house infected patients in hotels, but we are unaware of a national program to fund this concept.

On Thursday, CNET reported that the FBI is investigating the targeting and compromise of U.S. organizations conducting COVID-19-related research by PRC-affiliated hackers. These actors have been attempting to identify and illicitly obtain valuable intellectual property (IP) and public health data related to vaccines, treatments, and testing. The CNET article also noted a fivefold increase in cyberattacks on the World Health Organization in April. Last week Reuters reported that Iran-linked hackers targeted U.S. drugmaker Gilead, which developed the coronavirus drug Remdesivir.

We learned from a technology columnist this week that contact tracing apps are being developed at the state or public-health system level. The apps are meant to be opt-in, even though estimates suggest that 60% of the population would need to be enrolled for the technology to work. The apps employ different technology and provide different levels of privacy protection. For example, Bluetooth-enabled apps could exchange anonymous codes between nearby phones throughout the day and notify you if a phone carrier you were near tested positive for the virus. A location-based app might track your whereabouts throughout the day and ask for personal information, so that a contact tracer can find you in case you visited a location where someone tested positive. The article cites former CDC head Tom Frieden as being concerned about how feasible or useful such apps would be.

We have finished a week when the White House has allotted only $10 billion towards coronavirus vaccine funding, when experts have told us that we need to spend $70 billion to achieve a 90% chance of developing a vaccine in 18 months. The House passed a $3 trillion coronavirus relief bill which will not pass the Republican-controlled Senate. The bill contains $75 billion for coronavirus testing and contact tracing, even though we mentioned last week that some economists recommend that we quickly offer $100 billion to manufacturers to produce more tests. We echo Dr. Rick Bright’s testimony before a House subcommittee this week: “Without better planning, 2020 could be the darkest winter in modern history.”

Lessons from Singapore and Reopening The United States

Singapore had one of the world’s most robust and effective responses to COVID-19. Despite that, the country still had to enter lockdown and struggled to control the spread of the disease. What can this tell us about how the US has responded, and how and when American society should reopen?

 

@DrTiff_PhD

Putting a Dollar Value on Life? Governments Already Do

The following originally appeared on The Upshot (copyright 2020, The New York Times Company). It also appeared on page A6 of the print edition on May 12, 2020. See also, this related post.

How much money is a life worth?

To many, the answer is so obvious that the question is offensive: Life is immeasurably valuable. No price is too high.

During the pandemic, some economists and health experts have said there’s not necessarily a need to weigh the balance between saving lives and saving the economy — that prioritizing fighting the coronavirus will benefit the economy.

In more ordinary times, trade-offs are common. They have arisen in policy deliberations for decades.

How the dollar value of life has changed over decades

There has always been a limit to how much we are willing to spend to protect life and health. After all, no society can spend a limitless amount.

In his book The Economists’ Hour, Binyamin Appelbaum of The New York Times documents how estimates of the economic value of life have influenced regulatory decisions since the 1970s. In 1972, a member of a Nixon administration task force on regulating the auto industry put a life’s worth at $885,000 in today’s dollars.

Two years later, using a similar figure, the Department of Transportation rejected a regulation to install bars at the rear of trucks to prevent passenger vehicles from sliding underneath them in a collision. The reasoning? It would not have been cost effective, meaning the cost would have exceeded the value of lives it would have saved. The bars became required in 1998 when the Department of Transportation’s value of a life reached $2.5 million.

The dollar value placed on life and how it is used has changed with the political tides.

In 1979, as he announced reforms in the regulatory process, President Jimmy Carter signaled support for cost-effectiveness calculations. “Society’s resources are vast, but they are not infinite,” he said. “We must ensure that regulation gives Americans their money’s worth.” A mere two years later, Al Gore, then a congressman, called cost effectiveness an “attempt to cripple” essential government functions. “What dollar figure can be assigned to the avoidance of birth deformities?” he said.

More recently, under President George W. Bush, the dollar value of life for regulatory decisions went down. Under President Barack Obama, it went up.

One of the earliest values of life used in regulation came from a 1978 calculation by the Canisius College economics professor Warren Prunella. He estimated the value of a life saved by proposed furniture fabric flammability standards at $1 million, which was later adopted by Congress for regulations made by the Consumer Product Safety Commission.

Today, the commission uses a figure of $8.7 million. Other U.S. departments’ and agencies’ values differ somewhat. The Environmental Protection Agency uses $7.4 million. The Department of Transportation (which includes the Federal Aviation Administration) uses $9.6 million.

People rarely notice these uses of cost effectiveness by the government. The gears of regulation tend to turn in obscurity. But when cost effectiveness arises in health care, it’s hard not to notice, as when Sarah Palin said an early version of the Affordable Care Act legislation included “death panels.” (The charge was based on the claim that health care would be withheld from people whose lives would be judged “not worth it,” which was not true.)

How some other nations view it

When it’s our health, or that of loved ones, we bristle at the thought of being denied coverage for care because it’s too costly.

Outside the U.S., it is not so unusual to judge some treatments as worth it and others not. The World Health Organization has a formula for governments in making these decisions, starting with dividing the annual G.D.P. of a nation per person. The W.H.O. suggests paying for treatments that cost less than three times this figure for each year of good health they provide. (A treatment that costs less than one time the national annual G.D.P. per capita is considered highly cost effective.)

So for example, if a country’s per capita G.D.P. were $65,000 (roughly the figure for the U.S.), a treatment that cost less than $195,000 for one year of good health — a so-called quality-adjusted life year — would be considered cost effective according to the W.H.O. standard.

An analysis of Australia’s pharmaceutical benefits advisory committee found that it was likely to approve a drug if its cost per quality-adjusted life year was below 1.35 times the per capita G.D.P. in 1999. Poland legislated in 2012 a cost-effectiveness threshold of three times per capita G.D.P., and Thailand has a 0.8 per capita G.D.P. threshold.

Many studies have attempted to deduce how much Americans are willing to pay for a year of life in good health. The values vary considerably, some as low as $10,000. A study published in 2008 put the figure as high as $297,000; other assessments approach $1 million.

But $100,000 to $200,000 has become the standard range, endorsed by many health economists. In addition to reflecting insights of experts, “this range draws on experience working with decision makers to manage health care’s budget impact,” said Christopher McCabe, executive director and C.E.O. of the Institute of Health Economics in Alberta, Canada.

Whatever the value, no threshold is explicitly applied to health care coverage decisions in the United States. Allowing others to decide what care is worth paying for and what isn’t strikes many as distasteful or unfair.

We tend to value treatments that assist people who are close to death, spending more for them than on treatments for others that ultimately spare more lives. This too reflects values not easily translated into math.

“All ways of deciding how to use collective resources are discriminatory to someone,” Mr. McCabe said. “The best we can hope for is to make those decisions in a transparent process. A fundamental problem in the U.S. is that there is no agreement on that process.”

Many countries and organizations that use cost effectiveness in health care recognize and take on this challenge. For example, Britain’s National Institute for Health and Care Excellence is more likely to recommend coverage of a treatment if it costs less than £20,000 to £30,000 (equivalent to $25,000 to $37,000) per additional life year it provides (adjusted for quality of life). But this is not a hard and fast rule. The body also considers other factors, including the condition and population it treats, the level of evidence of effectiveness and the availability of alternative treatments, among others.

Likewise, the Institute for Clinical and Economic Review — a private, nonprofit group in the United States that assesses the effectiveness and value of health care treatments — considers cost effectiveness alongside a range of contextual factors that such an analysis is likely to miss. To further ensure that all values are considered, both groups hold open meetings and invite comments on draft documents.

Reflecting the fact that there is no “right” price for a life, there is no single, correct way to combine all these factors and perspectives. But deliberating openly and allowing public comment help reconcile our personal sense that we want limitless health care for ourselves and the collective constraint that there are limits to what society can afford.

@afrakt

Things Fall Apart

Stay-at-Home orders are now expiring in many US states. In some places where orders remain in force, compliance is weakening. The US has not used the time in lockdown to establish effective testing and contact tracing plans. The vulnerable populations in nursing homes, factories, and prisons remain unprotected. These lapses will cause more COVID-19 deaths than would have occurred if the time had been used well. But if we aren’t using the lockdown to prepare an offensive against COVID-19, then continuing it is pointless. 

So if the lockdown is ending, where are we? The US is in a threefold crisis. 

Population health is declining. Despite being wealthier than any nation in history and despite spending 1 in every 5 dollars on health care, US life expectancy at birth was lower in 2019 than it was in 2014. And that is before the pandemic hit. To the morbidity and mortality that rose in this decade, COIVD-19 adds more than 2000 excess deaths per day, and this may persist for months.
Economic production and employment are collapsing. We are seeing job loss and the destruction of financial and human capital reminiscent of the Great Depression. The steepness of these declines is unprecedented, and we haven’t hit bottom yet. As poverty and despair grow, these calamities will further undermine population health. Release from lockdown will have economic benefits. But it is difficult to see how the economy can recover until the pandemic is extinguished.
American political institutions are failing. One of the virtues of democracy — a government of the people — is that a democracy can mobilize the population in a crisis. But despite being the world leader in biomedical science, the US has failed to mount a coherent response to the pandemic. If Clinton were president, she would have tried to implement public health measures appropriate to the crisis. That is what previous American presidents from both parties did when facing epidemics. Yet it is not clear that Clinton would have succeeded. Fighting a pandemic requires social solidarity. US citizens are highly polarized, scientists are not trusted, and conflict entrepreneurs would have exploited our fear and suffering. Many Americans would have resisted lockdown, testing, contract tracing, selective quarantine, and — when we have them — vaccinations. 

American is hemorrhaging life, wealth, and social cohesion. Now we face what will be a vicious election in the context of a pandemic and depression. Things will fall apart faster.

This is where I am supposed to reveal what we need to do to solve the problem. But I don’t have a solution. Even if I did, I’d present it another time. Right now, it is essential to see that the United States is broken. 

@Bill_Gardner

COVID-19 Update: May 11 Edition

Week 8 of CHB Coronavirus Commentary    

The following originally appeared on the Baker Institute Blog and is coauthored by Vivian Ho, Ph.D. (@healthecontx), James A. Baker III Institute Chair in Health Economics, Kirstin Matthews, Ph.D. (@stpolicy), Baker Institute Fellow in Science and Technology Policy and Heidi Russell, M.D., Ph.D., Associate Professor, Department of Pediatrics, Baylor College of Medicine and Associate Director, Center for Medical Ethics and Health Policy, Baylor College of Medicine.

Most of us have now endured two months of sheltering in place, yet the New York Times refers to our current situation regarding the spread of COVID-19 as a stubborn plateau. Still, the economic losses from lockdowns are causing many state leaders to continue relaxing restrictions on businesses and other public places. Experts from academia continue to worry that the U.S. lacks sufficient testing and contact tracing to reopen safely. Multiple reports by experts are out this week arguing that the government response regarding the amount of testing, contact tracing, and vaccine development is insufficient.

Epidemiology and Treatment

On Friday May 8th, data from the COVID Tracking Project indicated that the 7-day average number of daily new cases fell 11% to 25,895 compared to 29,119 a week earlier. Statistics for the country as a whole mask the realization that new hot spots are continually emerging. This New York Times graphic shows that daily new cases are steadily declining in the New York metro area, but new cases in the rest of the country continue to rise. The hotspots are in a mix of urban and rural areas. In Texas, one of the earliest states to relax lockdown restrictions, the 7-day average number of new cases rose 12% (from 778 to 868), although daily testing rose 15% during this time period.

The Institute for Health Metrics and Evaluation released new estimates last Monday, projecting 135,000 cumulative deaths in the U.S. by August 1st. The IHME has updated their model since we last reported their predictions, including accounting for increased accuracy of case counts as testing rises, as well as a detailed measure of social distancing based on data from multiple sources. The model is the most sophisticated that we have seen, although the IHME takes the approach of predicting cases and deaths assuming that states maintain their current lockdown policies (announced by April 28) all the way through early August.

The IHME therefore provides optimistic estimates, because it does not account for future relaxation of states’ restrictions which are likely to occur. For example, the model accounts for Texas reopening businesses to 25% capacity on May 4th, but does not account for a move to 50% capacity that the governor may allow in mid-May. And because Governor Cuomo has not formally announced any dates for easing restrictions, the model presents predictions assuming the state is on full lockdown through early August. Therefore, the model predicts 3 infections per day in New York and 865 per day in Texas on August 4th. While these scenarios are unlikely to occur, they do illustrate the significant effect that social distancing has on the spread of the virus.

Scientists are steadily increasing their understanding of the virus’ biology and pathology. This week the CDC added additional Covid-19 symptoms including gastrointestinal symptoms, chills and sore throat. In addition, researchers conducting lab experiments in the Netherlands determined that the SARS-CoV-2 virus can infect cells in the gut using the same ACE2 receptor it targets in the lung. These results suggest that the virus could also cause gastro-intestinal infections, and fecal-oral transmission could be possible. The ACE2 receptor is quite common and found on numerous cell types, so other modes of transmission could be possible. However, at this time the most severe cases seem to be linked to respiratory illnesses.

If one obtains immunity to the SARS-CoV-2 virus, we still don’t know how long it lasts. The preeminent scientific journal Nature released an excellent series of info graphics this week. The series walks the reader through how we develop immunity and the biology behind the four types of vaccines currently being developed: virus-based (using a weakened or dead virus) viral vector-based (using another virus that is engineered with SARS-CoV-2 DNA), nucleic acid (using DNA or RNA), or protein-based (using a molecule on the surface of the virus). The vaccine from Oxford University, discussed in last week’s blog, is viral vector-based, while Moderna and Inovio’s vaccines are nucleic acid based.

We mentioned previously that the FDA has been approving COVID-19 tests under the Emergency Use Authorization (EUA) in an effort to speed up test availability. However, the Wall Street Journal reported that 160 antibody tests for COVID-19 entered the U.S. without any FDA scrutiny on March 16, because the FDA felt it was most important to get them to the public quickly. Scientists subsequently determined that only 14 of these tests delivered accurate results, and only 3 delivered consistently accurate results. Now the FDA will require antibody tests to obtain an EUA. To do so, the tests must be able to correctly detect the coronavirus antibody in 90% of tests and avoid false positive results in 95% of cases.

Meanwhile, we are encouraged that pharmaceutical company Roche Holding received an EUA for its antibody test. The test is 100% accurate in identifying COVID-19 antibodies, and it yields a false positive result in only 2 of every 1,000 tests. The tests will be manufactured in Germany, and the company aims to produce in the high double-digit millions per month by June.

Policy Response

We continue to be concerned about the lack of sufficient testing and contact tracers across the country, particularly since Harvard’s Institute for Global Health concludes that the U.S. needs to be conducting 900,000 tests a day in order to control the pandemic. The Institute previously recommended 500,000 tests a day, but they found that the outbreak is worse than projected earlier. The Institute found that Georgia, which has some of the laxest restrictions in the country, is testing at 67% below its recommended rate. Texas and Florida, which have also eased more restrictions than most states, have testing rates which are roughly one-third below recommended rates.

Reporters have written that the Trump Administration held back a 17-page report prepared by the CDC that was to be released several days ago. Reporters obtained a copy of the document, which provides step-by-step advice to local authorities on how and when to reopen restaurants and other public places. For example, the report recommends that communities of faith limit gatherings to those that can maintain social distancing and consider video streaming or drive-in options for vulnerable populations. White House coronavirus adviser Dr. Deborah Birx stated that the guidelines are still being edited, and that they needed simplification. Nevertheless, a CDC official said that agency scientists were told the guidance “would never see the light of day.”

Two Yale economists recommend substantially higher reimbursement for coronavirus tests, along with robust government action to increase test availability. They reason that reduced economic activity due to the pandemic has likely reached $100 billion per week. They further note that lab tests (and PPE) yield significant positive externalities to the economy, because they are instrumental in slowing disease spread and perhaps eventually eradicating the coronavirus. That is, reimbursement for lab tests should be commensurate with the benefit they will yield in reopening the economy more quickly. The federal relief package allotting $25 billion to facilitate and expand COVID-19 tracking is therefore far too low. Potential suppliers of test kits need greater economic incentives, particularly since they are being asked to re-tool and expand production for a product that could see a rapid drop in demand when antivirals or a vaccine becomes available. The economists recommend that the federal government should set a fee schedule for COVID-19 testing that applies to all payers, and the payment should likely be double the current $100 amount paid by Medicare.

Four prominent economists are recommending that the federal government create a COVID-19 vaccine Advance Market Commitment (AMC) to promote vaccine development. Under the AMC, the government would guarantee that it would spend $70 billion on vaccine discovery and manufacturing capacity. The guarantee would include $100 per person for the first 300 million vaccinated. They seek to encourage 15 to 20 vaccine candidates. The AMC would guarantee firms partial reimbursement for production capacity built or repurposed, so that the manufacturers have “skin in the game” when building capacity.

A Washington Post article notes that state and local health departments do not publish the occupations of individuals who test positive, even though this information would be invaluable in the absence of robust contact tracing. The same article quotes an assistant medical director who found recent positive results from a grocery store worker, a day-care employee, and a housekeeper; all who had contact with a Covid-19-positive person at work. The reporter observes that the pandemic is infecting those with limited ability to social distance, who are afraid to lose their jobs. Although the Families First Coronavirus Act provides paid sick leave for many workers affected by Covid-19, it excludes companies that employ more than 500 people, as well as gig workers. The federal government should pass legislation providing paid sick leave for these lower-wage workers, which would reduce their desire to continue working if they experience Covid-19 symptoms.

In the coming week, we will be closely watching statistics on testing availability and number of new positive cases, particularly in states that have begun lifting restrictions. We are surprised that we have not heard more about the contact tracing app that is being designed by Apple and Google, although it is expected to be ready this month. We hope to hear more encouraging news about states increasing their number of contact tracers as well.

 

Upshot Extra: The Value of Life

My Upshot piece out today is about he value (price) of a year of life. Not every important angle on this issue could be included, including the following.

Whatever the value, cost-effectiveness is not an explicit criterion for health care coverage decisions in the U.S. Allowing others to decide what health care is worth paying for and what isn’t strikes many as distasteful. If insurers or public programs were to decide not to pay for a disease’s cure or care for a population (like the elderly) because it isn’t “worth it,” people identifiable in advance — those with that disease or in that population — would be harmed.

That seems more unfair and unjust than when a government agency spikes a regulation on economic grounds. Health care is deeply personal, perhaps because the care happens directly to us. Our bodies are inescapable, their most extreme degradation irreversible.

Even in the absence of cost-effectiveness, care in the U.S. is still rationed. Populations eligible for Medicaid are circumscribed precisely because it costs more money to expand the program than we are willing to spend. In this sense, the cost of what is covered by the program (including all that might be deemed not cost-effective) is borne, in part, by those who remain ineligible for it and uninsured as a consequence. Likewise, private coverage premiums are higher as more things are covered, including those of low value relative to their price. We pay for this in two ways. First, every premium dollar is one less we have for other things we value. Second, higher premiums price people out of coverage.

These opportunity costs can be quantified by cost-effective analysis and taken into consideration alongside the direct benefits and costs of a health care treatment. But those opportunity costs don’t surface in passionate appeals that health deserves boundless resources. It is easy to identify those who would be harmed by failing to cover a treatment. It is much harder to see that people are also harmed by covering it. Both are reflected in the mathematics of cost-effectiveness.

For all that, it is important to recognize the limits of cost-effectiveness analysis. To rely on it as the sole arbiter of decisions on which lives depend is akin mistaking a life insurance payout as full compensation for the loss of a loved one. Associating a dollar amount with a life does not make dollars and lives equivalent. The association is mathematically and financially convenient because money is fungible. Lives are not, but that’s true of both the lives on both sides of the equation — those that would benefit from a covered treatment and those that pay for it.

That cost effectiveness doesn’t capture everything of value underlies many its conundrums. One is whether to include productivity increases as cost offsets. A treatment for a disease that affects relatively younger people could allow them to work more than they would otherwise. That productivity gain contributes to the economy and tax collections, a cost offset. Should it be included in the accounting?

It seems reasonable to do so. But then, consider curing or alleviating some of the symptoms of a disease in populations that work less or not at all — whether due to age or severe disabilities. Though doing so would undoubtedly relieve suffering, it would yield a much smaller productivity offset. If following the math penalizes treatments for people who are older or have greater disability, is that fair? To many, the answer is “no.”

This illustrates that we value equity, which is not measurable in dollars. We also tend to value treatments that assist people close to death, spending more for them than on treatments for others that ultimately spare more lives. This too reflects values not easily translated into math.

More in my piece.

@afrakt

Paul Romer’s Coronavirus Testing Plan

Testing has been one of the most contentious aspects of the COVID-19 pandemic response in the United States. This week we’re talking to Nobel Prize-winning economist Paul Romer, who has developed a plan to roll out testing on a truly massive scale. We talk to him about what testing on this scale would look like, and what it would mean for the way we live now.

 

@DrTiff_PhD