Aaron E. Carroll's Blog, page 57

Update on COVID-19 Sources

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.

Having finished our fifth week in isolation, we are encouraged that the nation may have passed its peak date for the number of new cases and new deaths. We update you on efforts to identify treatments for the coronavirus, as well as policymakers’ discussions on when to reopen the economy, what that might look like, and where government funding should be directed. Previous issues are posted here.

Epidemiology and Treatment

Health experts warn us not to expect a single peak day in terms of new cases, deaths, or otherwise. Daily reports of new cases and deaths can fluctuate depending upon the availability of tests and delays in reporting. The New York Times’ juxtaposes a bar graph of the number of new cases by day with a line calculating the 7-day average of these numbers, indicating that the number of new cases has fallen to less than 30,000 per day. The 7-day average of new deaths also has begun to fall, to roughly 2,000 per day.

On Friday Worldometers estimated that 58,000 people in the U.S. have recovered from the coronavirus. Mark Lipsitch, an epidemiologist at Harvard University, provides a compelling case that most individuals who contracted the virus will have an immune response, some better than others. He suggests that the immune response will offer some protection over the medium term — at least a year — and then its effectiveness might decline. This view that contracting the virus yields only temporary immunity, is shared by other experts. Thus, treatments and a vaccine for COVID-19 are crucial in ultimately conquering this pandemic.

To date, researchers and drug companies have launched over 100 human experiments to identify treatments for the coronavirus. However, an article in the Washington Post warns that the lack of coordination across investigations could generate numerous small-scale trials with conflicting answers. For example, there are more than two dozen separate U.S. trials listed for the anti-malarial drug hydroxychloroquine. Some use the drug as a preventive, others as a treatment; some in combination with other drugs, and some with no comparison group. Information from multiple investigations is often better, but coordination across these studies could have yielded larger sample sizes and cleaner study designs, so that results could be used to prioritize treatments. Francis Collins, director of the National Institutes of Health has been working behind the scenes to launch an unprecedented public-private partnership to achieve better coordination.

In the scientific journal Immunity, researchers review the COVID-19/SARS-CoV-2 vaccine development and its challenges  In addition, the WHO cataloged a long list of potential candidates, and an article from “The Scientist” describes frontrunners that hoped to be tested this year, providing details on each vaccine’s approach to target the virus as well as preliminary evidence. Meanwhile, fake news regarding causes of and treatment for coronavirus are circulating through social media. The World Health Organization (WHO) has posted a series mythbuster infographics to dispel rumors such as one that 5G mobile networks spread COVID-19.

Policy Response

Public health experts continue to emphasize that passing the peak number of cases or deaths does not mean that the pandemic is over, and that we will need to maintain social distancing in one form or the other for months to come. More than a dozen states have extended stay-home orders past the White House deadline of April 30th. In the meantime, governors on the east and west coasts were reported last Monday to have formed pacts to decide when they would reopen their economies. Governors of Midwest states followed suit soon afterwards. These pacts will draw on facts and science to create plans to re-open each state in a way that limits new outbreaks of coronavirus. Among the steps are contact tracing, treatment and social distancing measures.

For example, last week we highlighted the recommendation for A National COVID-19 Surveillance System which included capacity to conduct 750,000 coronavirus tests per week. Unfortunately, most parts of the country report test supply shortages that remain “crippling.” Experts emphasize the need for contact tracers, to identify those who could have contracted the virus by coming into contact with someone who has tested positive for the virus. Policy makers are acting on that recommendation, with the C.D.C. planning to hire hundreds of contacts tracers and, it is in discussions to divert 25,000 Census Bureau workers to do contact tracing in the coming weeks and months. Experts suggest that employers can do their part to reduce the spread of coronavirus by offering screening at their place of business. Employers can help workers to safely self-isolate at home and work with local health authorities to improve contact tracing.

As TIME magazine stated, “Public health experts have savaged President Donald Trump’s decision to cut U.S. funding to the WHO.” Critics include U.N. Secretary General António Guterres and the editor-in-chief of the Lancet medical journal, who called the decision “a crime against humanity.” The administration is reportedly withholding funds, because the WHO failed to adequately investigate early information about the virus’s ability to spread between humans and for not criticizing China for its lack of transparency over the virus. This view is echoed in an article in The Atlantic, which points to structural problems at the WHO that make the organization vulnerable to misinformation and political influence, in this case by China. Nevertheless, the U.S. pays for about 22% of the WHO’s budget. Cutting funding for international public health initiatives in the midst of a crisis could have dire consequences for Americans in the future.

Health and Human Services is distributing the first $30 billion in emergency grants to hospitals and doctors from the CARES Act according to their historical share of revenue from the Medicare program for seniors — not according to their coronavirus burden. States lightly hit by the coronavirus, such as Minnesota, are getting more than $300,000 per COVID-19 case, while New York is receiving $12,000 per case. The HHS decision raises the prospects that hospitals in hard-hit areas will be weighing their financial health more heavily than patient well-being for each additional COVID-19 case that comes through their doors.

On the Medical Frontlines

Evidence of strain on the healthcare workforce continues to mount.  The Centers for Disease Control (CDC) published a estimating at least 9,282 United States health care workers have been sickened by COVID-19, and at least 27 died.  This is likely an underestimate because of how local or state authorities report cases. The CDC concluded that approximately half of these providers were exposed in their workplace.  The worse outcomes were in the over 65 workforce, although death and critical illness occurred at all ages. The first installment of a bi-weekly survey of medical staff across the country was performed by MedPage Today.  The responses suggest that regional variation in the share of the healthcare workforce that is temporarily out, critically ill or dead because of COVID-19 lies between 1% and 20%.  The proportions are much higher in concentrated areas like New York.  For an in-depth account of healthcare workers who died from COVID-19, we applaud the stories found in Lost on the Frontline.

Healthcare workers are particularly at risk when performing nasal swabbing to test for the coronavirus, which requires the provider to stand directly in front of the person being tested. The swabbing generates a natural reflex to cough or sneeze, sending droplets into the air. To that end the first COVID-19 test of saliva was approved by the FDA this week.  This new test will allow patients to spit into a vial and hand it back to the health care worker. The test is not yet available in most health care organizations, and questions remain about its accuracy. But as these hurdles are overcome, this safer, simpler testing would also circumvent the shortage of nasal swabs that is hindering test availability across the country.

In the coming we week, hopefully new cases of the coronavirus and daily death toll continue to decline. We are most concerned about the continuing short supply of coronavirus tests. We hope that federal, state, and local governments aggressively pursue efforts to hire and train contact tracers throughout the country. Debate has begun on what role smartphone apps by Apple and Google could play in contact tracing, and we will follow that discussion closely. We also look forward to reviewing state governors’ developing plans to reopen their economies.

What should be in our post-pandemic prediction survey?

We (Rob Stevens and Austin Frakt) are putting together a survey of people’s predictions about post-pandemic behavior and key trends. We wonder what people think some aspects of life will be like in, say, 2025. Below are the kinds of questions we’ve thought of so far. What are we missing? Tweet at us to let us know. Rob is at @robgstevens and Austin is at @afrakt. You are also free to email Austin.

All questions are “agree/disagree” as of 2025. For items that pertain to changes (e.g., “doubles,” “drops by more than 50%,” etc.), those are relative to the state of the world before the pandemic (December 2019 or so).

Number of people working from home on a regular basis more than doubles
Number of home-schooled students doubles


The number and size of conventions/tradeshows drop by more than 50%
Attendance at movies/performances/sporting events (any large gatherings) drops more than 50%
Business travel decreases by more than 50%
Spending on cruises decreases by more than 50%
Handshaking decreases by more than 50%
Restaurant spending drops by more than 50%


Use of public transportation decreases by more than 50%


More than 50% of people wear a face mask when they are ill
More than 50% of people get health insurance from somewhere other than through their employer
More than 50% of population is covered by mandatory paid sick leave
More than 50% of people use telemedicine for a doctors visit in a year
Unemployment is above 10%

Healthcare Triage: COVID-19 Q&A 4/15/20

Can I buy stuff from China? Should I be worried about excess screen time for my kids? We’re answering your questions about COVID-19 again. Click on the time code in the video description to go straight to a question.

 

@DrTiff_PhD

Lesson From Singapore: Why We May Need to Think Bigger

The following originally appeared on The Upshot (copyright 2020, The New York Times Company)

Many experts are beginning to coalesce around a set of benchmarks that could help determine when it might be safe to reopen parts of the country. But even though most areas of the United States are nowhere near achieving the goals necessary to do so, there has been a push to relax social distancing soon.

Even more alarming, some experts say even those still-not-yet-achieved goals aren’t close to enough. It appears that it may be time to think bigger.

“These are unprecedented times, and so we need to think on a scale that would previously be considered unimaginable,” said Natalie Dean, an assistant professor of biostatistics at the University of Florida.

The cautionary tale at the moment is Singapore. For weeks, public health officials have been enviously lauding its response to Covid-19.

Singapore officials have been screening and quarantining all travelers from outside the country since the beginning of the pandemic. Their contact tracing is second to none. Every time they identify an infection, they commit to determining its origin in two hours. They post online where identified infected people work, live and have spent time so that potential contacts can be identified. They enforce quarantines and isolation of such contacts, with criminal charges for those who violate orders.

And yet, in the last week, they’ve put the entire country into lockdown. All migrant workers are confined to their compounds for at least two weeks. Citizens may leave their homes, but only to buy food or medicine, or to exercise. Anyone who breaks the rules, including spending time with anyone not in their household, can be imprisoned, fined the equivalent of $7,000 U.S., or both.

What Singapore was doing (more on that below) dwarfs what most are discussing in the United States. Its present circumstances bode poorly for our ability to remain open for a long time.

“There’s just no way that we’re going to be able to keep most of the country open through the year,” said Ezekiel Emanuel, vice provost of Global Initiatives at the University of Pennsylvania. “If Singapore can’t do it, I don’t imagine how we think we can. As I have said, this is going to be a roller coaster with multiple waves of opening and partial re-closings necessary.”

Plans that aim higher

Given the U.S. government’s limited and lagging response to date, the idea of a hugely ambitious project may seem implausible. But the cost of another future shutdown is so high that previously unfathomable ideas may be worth considering. Here are a few:

The Romer plan of maximum testing.

Paul Romer, a Nobel-winning economist and N.Y.U. professor, proposes that 7 percent of the population be tested each day. If put on a rotating schedule, that would mean everyone would be tested roughly once every two weeks.

He argues that even if there are plenty of false negatives, if we committed to isolating everyone with a positive test, we could keep the vast majority of Americans out and about in normal life. All told, that would mean 150 million tests a week.

Critics will argue that’s impossible. We cannot even seem to manage a million a day. They say we lack the materials, as well as the reagents for chemical analysis, the delivery infrastructure and the machines to run so many tests.

Mr. Romer is not dissuaded. “I’ve been focused on a single idea my whole career, that just because something is unfamiliar doesn’t mean it’s impossible,” he said. “Building interstate highways, scanning every book, going to the moon — these were all outrageous ideas at one time. But if we put enough resources and our minds behind it, we are able to make the impossible possible.”

His plan would rely less on contact tracing and isolation, since everyone would be tested regularly, and this might make infection control easier in many parts of the country. Contact tracing requires significant infrastructure and is hard to do well.

“We spend something like $700 billion a year to protect us against military threats,” he said. “We are at greater risk from a biological threat at the moment than any military threat. We should be prepared to spend at least a hundred billion a year not only to protect us against this virus, but any potential new viruses that could threaten us in the future.”

The Center for American Progress plan that leans on monitoring via your phone.

Other ambitious ideas can be found in a plan from the Center for American Progress, written by Dr. Emanuel and colleagues. Part of the proposal is an enormous information technology monitoring system. It would call for all Americans to download apps to their phones that would monitor where they go and whom they get near, which would allow contact tracing to be done instantaneously. Everyone could sign in electronically before using public transportation, entering large buildings or schools or gathering in groups above a certain number. They even propose requiring the app to be downloaded in order to receive test results. In an ideal situation, it would run in the background, regardless of whether users signed in.

“If we could do real-time contact tracing based on a person’s phone and GPS signals, and alert people that they have been exposed to a Covid-19 positive person,” that would greatly ease the containment strategy, he said.

Of course, such a system would be considered a large intrusion on privacy, and it’s not clear it is politically feasible — or even legal. Additionally, not every American has a smartphone.

The PolicyLab focus on universal community-level surveillance.

Meredith Matone, scientific director of PolicyLab and an assistant professor of pediatrics at the University of Pennsylvania School of Medicine, says we may need to get away from testing to more grass-roots approaches.

“A more realistic and useful approach would focus much more on surveillance, monitoring communities more than individuals,” she said.

As detailed in a PolicyLab Policy Review, such surveillance could relax our need for active testing. It would be more reliant on passive systems, like monitoring electronic medical records or traditional infection monitoring systems to pick up signals for outbreaks, like increased visits to doctors or emergency rooms for respiratory illnesses. Surveillance could also involve a “participatory approach,” like asking patients to be tested before clinic visits, or to enter symptoms on web-based tracking platforms, or to regularly check their temperatures at home. Thermometers would be ubiquitous, and could even be linked to the internet for reminders and reporting.

If such systems work well, we don’t need to capture an entire population to detect a signal. We could identify hot spots, telling us where to do more focused testing.

Such testing could even be done by pooled samples. In such an approach, areas would have their individual samples combined together for testing, which saves resources. If it’s clear, everyone is safe. If an infection is found, then — again — more focused testing could be done on the individuals in the pool.

The PolicyLab review also highlights the benefits of improving workplace safety, especially in high-risk areas like child care, school and health care environments, to make infection control more robust and surveillance easier to accomplish.

Revisiting Singapore’s strengths.

Not everyone thinks we need to aim quite that high. Caitlin Rivers, an author of a recent American Enterprise Institute report on reopening the nation and an epidemiologist at the Johns Hopkins Center for Health Security, said: “While Singapore is adding in some community mitigation measures, they’ve been able to successfully keep levels of infection under control for months, and they’re still only seeing one to two hundred infections a day, which is far fewer than we are. A case-based approach is still the best way to move forward, and while it’s possible that some areas may have to revert to staying home, I don’t think that’s inevitable. Of course, we should still prepare for that with economic aid that can quickly snap into place if that needs to happen so that there’s much less disruption than this time.”

In a city-state of 5.7 million people in an area the size of Indianapolis, Singapore has had 140 people dedicated to contact tracing, working in conjunction with the police. A month ago, it could test 2,000 people each day. That’s the equivalent of testing about 115,000 people in the U.S. We were testing barely a tenth of that amount then.

Singapore has always provided free testing and medical care for all citizens; more recently, it distributed reusable face masks to everyone.

Officials were careful. While stores and restaurants were open, people were told to keep at a distance from one another, and gatherings of more than 10 people were considered inadvisable.

All of this is to say that people in Singapore have been operating in an environment that looks like what we might hope to create as we reopen — with safeguards beyond what we are probably going to achieve. And yet Singapore is in lockdown now.

It’s not clear how tolerant the United States would be of another national pause. If Americans failed to comply, the results could be disastrous. Preventing a second lockdown could even be considered a long-term investment.

“Our trajectory right now does not give me hope,” said Gregg Gonsalves, a professor of epidemiology and law at Yale. “Social distancing is happening in only a patchwork across the United States. The next phase needs a massive national mobilization not seen since World War II, with dramatic scale-up of the production of tests for the virus and its antibodies, the commodities we need to do these tests, from long-stemmed swabs to RNA extraction kits and the personal protective equipment to keep those conducting the tests safe. We also need a huge new cadre of people to do these tests, trained and deployed across the country.”

“And that’s the first step,” he added.

All this sounds expensive. But consider that the cost of a shutdown is trillions of dollars. We clearly don’t want to do this again. As Mr. Romer says, if it costs a couple of hundred billion to avoid it, that may still be a relatively low price to pay.

@aaronecarroll

 

Automated Coronavirus Contact Tracing: the Apple|Google Plan

The logo of the Apple | Google project.

How do we exit from our COVID-19 lockdown and revive our social and economic lives? Every current proposal involves extensive testing for coronavirus and tracing of the social contacts of infected persons. There are, however, many logistical and ethical challenges to doing the amount of testing that the pandemic will require. In this post, I discuss a proposal from cooperating engineering teams from Google and Apple that has attractive features in terms of efficiency, user autonomy, and privacy. In this post, I will offer the case for the Apple|Google (A|G) plan, and it’s the most attractive scheme that I have seen so far. But it still scares me, which I’ll discuss in a later post.

What’s the problem we are trying to solve? The problem with epidemics is that if each infected case transmits the infection to more than one other person — in the jargon, if (the transmission rate) R0 > 1 — then the number of cases explodes.* The coronavirus appears to spread primarily through person-to-person contact. The developed world is in a collective partial lockdown as a brute force means of reducing these contacts, thereby lowering R0. This has been partially successful but at a ruinous economic cost. Sooner or later, we will go back to work. However, when we go back to work the rate of interpersonal contacts will rise, and with it R0. So, how do we return to work without reviving the spread of the virus?

The standard public health answer is that instead of isolating everyone in lockdown, we test everyone with symptoms. Then, when we find a positive case, we isolate that person, stopping further transmission from him. Also, we identify everyone he has recently contacted and test all of them. We apply this procedure recursively to each new positive case we discover. If we do this quickly and thoroughly, we can reach and isolate enough infected people to drive R0 below 0. This will, eventually, extinguish the epidemic.

Unfortunately, COVID-19 will be difficult to control this way. First, the virus appears to be highly transmissible. A recent paper from the CDC found that in data from Wuhan, R0 > 5. Besides, because many infected people experience few if any symptoms, they do not come to the attention of public health workers, so their contacts can’t be traced. Finally, the virus is already widely diffused in the community. Testing and contact tracing is a labour-intensive process, so you need a lot of public health workers if you want to move fast enough not to be overwhelmed by the transmission of the virus to uninfected people

This is why Aaron argued recently that we need to do something bigger and more radical than traditional contact tracing. One proposal is from Paul Romer, who argues that we should test everyone every 7 days. If we could test that much, we’d suppress the COVID-19 pandemic. Moreover, if you tested everyone that frequently, you wouldn’t need to do much contact tracing.

But to do that we would need to be able to manufacture and distribute ~40 million tests a day, train many 100s of thousands of people to administer those tests, and get those testers deployed in every corner of the land. Even then, we’d need to get the people to the test. Would people show up at an office once a week for an invasive and unpleasant procedure? If they didn’t, would we send testers to their houses? And what would we do if they wouldn’t open the door?

A second proposal comes from the Center for American Progress (CAP). One of their ideas is to use technology to automate contact tracing.

[M]anual contact tracing is not nearly fast enough to slow transmission. However, technology can be used to conduct instantaneous contact tracing, eliminating the delay between the confirmation of a case and notification of contacts… [The idea is to] use mobile phone apps or mobile telecommunications infrastructure to notify individuals on their mobile phone through notifications or text messages if they have been in close proximity to an individual who has tested positive for COVID-19. These methods use GPS, Bluetooth, cell tower, and Wi-Fi network data to identify whether the user’s phone pinged the same signals as the phone of a COVID-19-positive individual during the same time period.

Please imagine that you have tested positive. Would you be able to remember everyone you had been in contact with in the past week? Yes, if you have been alone with your partner all week. No, if you have ridden a subway to work each day. The CAP plan would do a better job than an interview at identifying people who are likely unknown to a COVID+ person but may have been in contact with her. It also does this contact tracing far more cheaply and quickly. Hence, if the app works as designed, and if people who are informed that they have been near a COVID+ person proceed to get themselves tested, then this could be more effective than traditional contact tracing.

You will have noticed, however, that in the CAP plan the entity administering this system knows which cell phones belong to COVID-19 positive persons. Moreover, that entity will be tracking the whereabouts of everyone’s phones in real-time. The CAP authors recognize that this raises serious civil liberties concerns, and they describe a series of rules about how the data will be used that are designed to mitigate these threats. This means that the data are safe. That is, until a President decides that the government needs the data and a court accedes to his wishes. Or until the system gets hacked. The CAP authors sense that many people would be reluctant to download this app. To remedy that, they propose that

As a condition of receiving a COVID-19 test in the future, individuals may be required to download the app, which would include their test result.

This means that the CAP proposal would have the additional feature of discouraging people from seeking tests.

Here is where the A|G proposal comes in. Apple and Google engineers are working jointly on a phone app for both Android and iOS phones that automates contact tracing. Compared to the CAP plan, the A|G plan keeps far less information about people’s COVID-19 status and places more control over the use of the information in the hands of the user. There’s little detail about the project available yet. I’m just working from a post on a Google blog.† Therefore, read my words with caution. With that in mind, here’s how the app would work.

Suppose Alice and Bob are strangers who happen to sit near each other on a subway. Alice carries an iPhone, Bob carries Android, but each phone has the A|G app. Using Bluetooth, the phones sense each other’s presence. The phones — not Alice and Bob — exchange ID tokens. The tokens are long random numbers that uniquely identify the phones. Alice’s phone sends Bob’s phone her phone’s token, which Bob’s phone stores in a list, call it the ‘tokens that have been near me’ list. This list never leaves Bob’s phone. Moreover, it just stores Alice’s phone’s token and a timestamp. It doesn’t store the location of the contact. At the same time, Bob’s phone sends its token to Alice’s phone, which Alice’s phone stores in its own ‘tokens that have been near me’ list. Alice and Bob don’t have to do anything. They aren’t even aware that the exchange has occurred.

Suppose that a week later, Bob gets tested and turns out to be COVID-19 +. Bob enters this fact in the app. With Bob’s explicit permission, his phone uploads its ID token to a public health agency app. Bob’s phone uploads just Bob’s phone’s ID token, and not anything else about Bob or even the phone. (Or anything about Alice or her phone.) The public health app adds Bob’s phone’s ID token to its list of ID tokens for phones belonging to COVID-19 positive people (call it the ‘COVID+ token list’).

Independently of what Bob’s phone and the public health app does, we should assume that public health workers will interview Bob about the contacts Bob knows about. They will find out that he has a partner named Charlie, a co-worker Denise in the next cubicle, and that he recently visited his nephew Eric. Public health workers will contact and, if possible, test all those folks. But they learn nothing about Alice because, after all, Bob doesn’t know anything about her.

Now, back to Alice’s phone. Once a day, Alice’s phone (and every other phone with the app) downloads an encrypted copy of the COVID+ token list from the public health app. Alice’s phone decrypts the COVID+ list and compares it against its ‘tokens that have been near me’ list. “Hey,” sez Alice’s phone to itself, “There’s a token on both lists!” Alice’s phone sends a notification to Alice, and no one else, “You’ve been near someone who tested positive. Here’s a place you could get tested.” Now it’s up to Alice to decide what to do about that.

Of course, a government could have A|G build the app so that it also notifies the public health agency to send someone to test Alice. Doing that, however, would probably just mean that few people would put the A|G app on their phone. A government could require that every citizen install the app. Then the A|G plan becomes just a more secure version of the CAP plan. These choices are possible, but in my view, they’d radically diminish the acceptance of the app. The option of interest is the one that keeps Alice in control of what to do about her proximity to a COVID+ person.

I see at least three immediate questions about the A|G plan. First, is it as secure as it sounds? Well, how the hell would I know? What I can do is broadcast my “Avengers assemble!” call to all security engineers to start attacking this. Second, would people download the A|G app? Silicon Valley history proves that no one knows the answer to that until they try. All I do know is that I would be more likely to install it than a CAP app.

Third, would people who’ve gotten notified of a possible contact actually go seek testing? Surely, some would not. However, the notifications that successfully prompt people to get tested will often be contacts who would not have been identified using traditional contact tracing. This is the win that the A|G app could deliver: it multiplies the effectiveness of our contact tracing effort at low cost.

My view is that this option deserves consideration, starting right away. But the immediate concerns about security and feasibility aren’t the only things we should discuss. I’ll raise some longer-term worries in the next post.

*Literally, explodes. It’s the same math as nuclear fission.

†h/t to Benedict Evans and his superb tech newsletter.

@Bill_Gardner

Damage From OxyContin Continues to Be Revealed

The following originally appeared on The Upshot (copyright 2020, The New York Times Company). It also appeared on page B3 of the April 14, 2020 print edition.

OxyContin, and the aggressive, misleading way that Purdue Pharma marketed it, might have been even more damaging than was previously understood.

Recent research shows how the company focused its marketing in states with lighter prescription regulation — to devastating effect.

Also, a new version of OxyContin introduced a decade ago — which was meant to reduce harm — had unintended consequences. Besides contributing to heroin overdoses, it led to hepatitis C and other infections. Careful studies are only now starting to reveal the extent of the damage.

OxyContin is an opioid painkiller that Purdue Pharma first brought to the U.S. market in 1996. Its chief innovation was its 12-hour timed release of oxycodone. This made it ripe for abuse, since by crushing or dissolving OxyContin pills, abusers of the drug could ingest the entire dose at once.

Several studies have pointed to Purdue’s aggressive marketing of OxyContin as a significant contributor to the opioid epidemic. The marketing took various forms, including calling and visiting doctors; paying them for meals and travel; providing gifts; and funding pain treatment groups that urged liberalization of opioid prescribing.

Some of the company’s marketing messages minimized the potential for OxyContin to lead to addiction, for which it paid over $600 million in fines in 2007.

A National Bureau of Economic Research working paper published last fall sheds light on Purdue’s role. The researchers, economists from the University of Pennsylvania, the University of Notre Dame and the RAND Corporation, looked at variations in prescribing regulations that led Purdue to market OxyContin more aggressively in some states than in others.

The study found that OxyContin distribution was nearly twice as high in states where regulations made it easier to market. Misuse of the drug was also higher in the more marketed states, both immediately after OxyContin’s introduction in 1996 and many years later.

The study relied on unsealed documents from settled lawsuits and investigations involving Purdue Pharma in Florida, West Virginia and Washington State. The documents, obtained through Freedom of Information Act requests, included the company’s official OxyContin launch plan, focus group research and budgets from 1996-2002.

The documents showed that the company largely avoided marketing OxyContin in states with “triplicate prescription programs.” Prescribers of Schedule II opioids like OxyContin in those states were required to produce three copies of each prescription: one to be retained by them, one by the pharmacy, and one forwarded to a state agency. In addition to the extra paperwork and record keeping, the mandated reporting in triplicate programs raised concerns among prescribers about law enforcement scrutiny.

Consistent with other research, Purdue’s own focus groups of prescribers revealed that these programs had a chilling effect on opioid prescribing. One study of a Texas hospital found that its state triplicate program reduced prescribing of drugs it targeted by 60 percent in the early 1980s. Another study of New York’s program found a comparable decline in the late 1980s.

The N.B.E.R. study compared changes over time in OxyContin prescribing and related overdose deaths in states with triplicate programs — California, Idaho, Illinois, New York and Texas — with that of other states, controlling for demographic and other differences across states. It found that in 2000 alone, OxyContin use per person was 250 percent higher in states with less regulation as reflected by the absence of triplicate programs. OxyContin misuse was also much higher in those more lightly regulated states, with deadly consequences.

Over 1996-2017, opioid overdose deaths would have been 44 percent lower in states had they used triplicate programs, the study estimated. And 65 percent of the growth in overdose death rates between 1996 and 2017 could be attributed to the introduction and marketing of OxyContin.

In 2010, Purdue discontinued the original formulation of OxyContin and released one that reduced abuse of the drug, potentially slowing the growth in opioid addiction. When crushed, the new formulation would not turn into a powder, so it could not as easily be snorted or injected. This did not avoid all harms, however. As studies show, many misusers of OxyContin turned to heroin, which brought a new set of risks.

The heroin overdose rate more than tripled in several years after the start of the new version of OxyContin. The extent to which the new formulation of the drug inadvertently caused harms from heroin depended in part on how frequently original OxyContin was being abused, which varied substantially across states.

Several studies leveraged this state variation to assess the new formulation’s impact. An analysis by three economists in the American Economic Journal: Economic Policy found that states with the highest rates of original OxyContin misuse had the largest increases in heroin deaths after reformulation. They found that as much as 80 percent of the threefold increase in heroin mortality between 2010 and 2013 could be attributed to the introduction of abuse-deterrent OxyContin. Over all, the study and others have found that the new version of the drug did not reduce total mortality, but shifted the cause of it from one drug to another.

Injecting heroin comes with other risks as well. By one estimate, less than 2 percent of heroin users fatally overdose, but one-third to two-thirds of injection drug users contract hepatitis C. Others may contract hepatitis B or H.I.V. These diseases kill tens of thousands of people annually.

One study in Health Economics estimated that had OxyContin not been reformulated, there would have been 76 percent fewer cases of hepatitis C and 53 percent fewer cases of hepatitis B between 2011 and 2015. Another study in Health Affairs found that in states with above-median rates of OxyContin misuse before the new formulation, there was a 222 percent increase in hepatitis C infections after reformulation. But in states with below-median misuse rates, the increase was 75 percent.

A six-month stay in opioid litigation against Purdue Pharma, the maker of OxyContin, ends this month. Nearly every state and thousands of cities, towns, counties and Native American tribes have brought suits against the company. As Purdue Pharma tries to reach final agreements on settlements, the recent studies add further evidence implicating the company in the opioid crisis and its consequences.

@afrakt

Healthcare Triage Coronavirus Q&A: April 8, 2020

Aaron’s back answering your submitted questions about all things COVID-19. Time stamps for each question are in the video description, and if you’d like to submit a question for a future episode you can do so at healthcaretriage.info

 

 

@DrTiff_PhD

What policymakers can do to defeat COVID-19

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 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 much of the nation completes its fourth week of isolation at home, sources suggest that we are gaining a better of idea of when we can relax social distancing and what needs to be accomplished before we ease restrictions. We continue our commentary on sources we read this week that shape our thoughts on how the nation is coping with the pandemic and what actions policy makers can take to address the crisis.

Epidemiology and Treatment

Last week the Institute for Health Metrics and Evaluation’s (IHME) model predicted that the U.S. pandemic would peak on April 15th, with 2,644 deaths on April 16. Fortunately, the April 10th update predicts that the pandemic peaks on this day, with fewer deaths (1,983) nationwide. The modelers assume that social distancing stays in place until the point when daily deaths fall below 0.3 per million people. Their latest projections suggest that this point will be reached at the end of May.

As the lack of sufficient supplies of test kits remains a signature failure of the battle against the coronavirus in the U.S., Californians have adopted an alternative strategy to measure the prevalence of COVID-19 in the community. The Los Angeles Times reported that Los Angeles County officials will begin testing the blood of 1,000 randomly selected residents, including those with no symptoms, to see if they have or had COVID-19. The serological testing looks for antibodies to the virus in the blood. The article reports that a similar study recruiting 3,000 individuals began in Santa Clara County last week. However, because these antibody tests are so new, an expert in a New York Times piece commented that “serological tests are plagued with issues.” There are cases where the tests yield too many false negatives (not picking up antibodies when they’re present) and other times yield too many false positives (indicating antibodies when there are none). We consulted with infectious disease experts, and one suspects that the tests which are widely available now in the U.S. can only detect whether you have had any type of coronavirus (including a common cold), but not which one.

Much uncertainty remains regarding best approaches to treating severely ill COVID-19 patients. An AP article reports that some doctors are moving away from ventilators for hospitalized patients after 80% or more of coronavirus patients placed on the machines in New York City have died. Some health professionals are concerned that ventilators may ignite or worsen a harmful immune system reaction in patients.

On a more positive note, a study published this week in Proceedings of the National Academy of Sciences showed that convalescent plasma, which is drawn from the blood of recently recovered COVID-19 patients, was effective in improving the clinical outcomes of 10 severely ill patients in China. More extensive clinical trials of this treatment approach are underway in the U.S.

Policy Response

Many public health experts worry that the federal government is responding to the pandemic in a slow and disorganized manner, with the lack of sufficient test kits being just the tip of the iceberg. An article in Kaiser Health News outlines multiple actions that the federal government could be taking to curb the virus. Most importantly, the Trump Administration has undercut the Federal Emergency Management Administration’s power. The article reports that states and hospitals are leveraging White House contacts to bypass FEMA’s approval process — diluting the effectiveness of national efforts to coordinate and distribute supplies where they’re most needed. In addition, the administration has not designated FEMA or any other federal authority to be the sole agency purchasing equipment, forcing states and localities to bid on the same supplies, driving up costs.

This week Drs. Gottlieb and McClellan, both former FDA commissioners, partnered with other experts to publish detailed recommendations for a national COVID-19 surveillance system that would enable us to safely reopen the economy without fear of a recurring pandemic. The steps they recommend are extensive and costly, but they are comprehensive and worth paying careful attention to. The authors recommend a national capacity of at least 750,000 tests per week to allow for isolation and contact tracing to contain disease spread. Contact tracing is labor intensive. For example, Massachusetts recently announced a new program to hire and train 1,000 people to support contact tracing. The report also recommends sentinel surveillance programs, e.g., in select populations or in settings where people congregate with high risk of transmission. To make the best use of testing information, the report lays out guidelines for electronic data sharing of testing results across insurers, healthcare providers, and public health experts in the private and public sectors.

This week Scott Gottlieb also penned an op-ed in the Wall Street Journal describing two types of coronavirus treatments that policy makers should be doing everything possible to encourage drug manufacturers to move forward with as quickly as possible. One approach involves antiviral drugs that target the virus and block its replication. Antivirals already exist for influenza, HIV and cold sores. The other approach involves antibody drugs, which can be used to fight an infection and to reduce the risk of contracting Covid-19. Antibody drugs function on the same scientific principles as convalescent plasma, but because they are synthesized, they could be manufactured in large quantities using recombinant technology.

On the Medical Frontlines

In locations with patient volume exceeding healthcare system capacity, medical providers are under physical and emotional strain, with some falling ill. New York Health + Hospitals has a disaster volunteer recruitment system, and California has a request for emergency personnel via healthcorps.ca.gov. Practicing requirements are at the state level, and some states are implementing emergency licensing processes to allow providers to get to the front lines faster. For example Texas is temporarily allowing medical providers – including physician assistants, perfusionists, and respiratory therapists – who have completed all other steps towards their license to undergo a name-based background check instead of a more lengthy fingerprint background check. Other states are allowing retired providers to return to work.

Meanwhile pay cuts, layoffs, and temporary furloughs are occurring across the nation. Hospitals have cancelled elective procedures.  Outpatient clinics and dental offices have cancelled non-urgent visits or increased the use of telehealth. Outpatient primary care visits have decreased by 75% according to a report from National Public Radio. With less revenue, practices find it difficult to pay the salaries of their staff. There does not appear to be a consistent plan or extent of cut backs across healthcare systems, except that they are focused on personnel without patient care duties.  Cuts at the Boston Medical Center affect approximately 10% of its workforce.  Envision Healthcare Corporation has cut salaries of senior leadership by 50%. If the COVID crisis continues, HealthLandscape predicts nearly 60,000 family medicine physicians will lose their jobs or practices by the end of June 2020.

The Occupational Safety and Health Administration (OSHA) should be playing a major role in protecting workers and slowing the epidemic, but it has been limited to putting out recommendations. CDC and most states aren’t tracking cases by occupation, but Ohio reports 20% of cases are health care workers. There are more than 2200 workers at 2 Detroit hospital systems who are infected. Workers are being fired for raising concerns about inadequate protection. Employers, even ones who want to protect workers, are not being told what they need to do. This Politico piece describes what OSHA could and should be doing. Secretary Gene Scalia finally appeared at last Friday afternoon’s press briefings with the President telling employers to protect workers and not retaliate against them. OSHA should issue an emergency standard for health care workers and start inspecting and quickly issuing general duty clause citations in situations where workers are egregiously exposed.

Even as we have reached a point where the country is suffering massive loss of life from COVID-19, we are encouraged by the fact that social distancing is proving effective at slowing the spread of disease. Predictive models suggest there is a light at the end of the tunnel, and the country could begin a return to normality in late May or early June. However, that normality will be short-lived unless the country is able to implement a rigorous COVID-19 surveillance system as recommended by Drs. Gottlieb and McClellan. We have seen much in the news about federal efforts to secure more ventilators, but nothing about efforts to aggressively ramp up availability of coronavirus tests. We hope there is better news on the testing front next week.

Express Lane Eligibility, so why haven’t states used it?

Paul Shafer is an assistant professor of health law, policy, and management at the Boston University School of Public Health. He tweets at @shaferpr.

A few weeks ago, I wrote about an often ignored pathway for streamlining enrollment into Medicaid and the Children’s Health Insurance Program (CHIP) called Express Lane Eligibility (ELE). ELE allows states to use information collected by other agencies to determine eligibility for Medicaid and CHIP. This follow-up post explores the why, why ELE is underutilized and what capabilities we are missing as a result that could be game-changing in the midst of this pandemic.

States didn’t have the authority to do this sort of information sharing before, so granting it should lead to all sorts of excitement at the prospect of administrative efficiency and better reach at serving those targeted by these programs, right? Not exactly.

Less than a third of states (14) are currently using it. Why?

A 2016 report from the Department of Health and Human Services (HHS) highlighted several barriers to states implementing and continuing use of ELE. Eleven of 14 states surveyed noted difficulties related to collaboration with relevant agencies and information sharing. These were often overcome but the short-term nature of these partnership agreements led to several states discontinuing ELE after a few years.

Very few states implementing ELE were able to partner with their state tax agency because information sharing would have required new legislation and other changes. Other states noted that ELE was a short-term plan to boost enrollment and/or upgrades to enrollment and eligibility determination systems as part of the Affordable Care Act coverage expansions had “reduced the need for ELE.”

Another concern could be less than perfect information sharing resulting in eligibility errors. A pair of 2016 reports from HHS estimated that over 95% and 88% of eligibility determinations for CHIP and Medicaid through ELE were correct, respectively, based on very small audit samples. Even with little guidance, states were implementing ELE in a way that yielded generally accurate eligibility determinations.

But perhaps the elephant in the room is simply the cost to states of having more people enrolled. A 2012 letter on ELE from the Government Accountability Office (GAO) to Senator Baucus, then chair of the Senate Finance Committee, noted

significant budget pressures that states are facing, which might make them reluctant to undertake options that would increase Medicaid or CHIP enrollment and costs, including costs for the services additional enrollees would receive.

Making government operate more efficiently could have a real cost in this case, fiscally and politically, if Medicaid and CHIP rolls grow.

In the same letter, GAO added that allowing ELE for adults makes it a much more attractive option for states. As currently legislated, it can only be used for children. 1115 waiver authority can be used to extend ELE to adults, but has been rarely used despite promising evidence (e.g., Massachusetts). Still, numerous states have embraced ELE, and we have an idea of what makes it work well (e.g., automated processes, permanent information sharing authority).

Even if a state could get past those barriers, the transient nature of ELE makes states reticent to invest the political capital and dollars to set it up. ELE has been historically tied to CHIP reauthorization, which was most recently extended through fiscal year 2027 in the Bipartisan Budget Act of 2018. The Medicaid and CHIP Payment Advisory Commission (MACPAC) has recommended “permanently extending the authority” for ELE but Congress has yet to do so.

States are experimenting with other mechanisms for streamlining enrollment. The Maryland Easy Enrollment Health Insurance Program allows anyone to check on box on their state tax return to get more information from the state exchange and approval for a special enrollment period, which more than 18,000 Marylanders had taken advantage of as of early March. An opt-in system isn’t nearly as powerful as an opt-out, as demonstrated by the Louisiana experience discussed in my first post, but it is nonetheless a step.

A crisis is not the time to overload social service agencies and the American people with paperwork and documentation requirements. We should consider robust ELE-like information sharing across state agencies as part of our disaster preparedness strategy, allowing us to pair short-term stimulus, like checks and expanded unemployment benefits, with the capability to efficiently get those affected covered by Medicaid when they qualify.

Sources for COVID-19 information

The following post by Vivian Ho originally appeared on the Baker Institute Blog. Dr. Ho is the James A. Baker III Institute Chair in Health Economics and Director, Center for Health and Biosciences at Rice University. She tweets @healthecontx. (If you find this post useful, see also this and this.)

Like many of you, we completed our third full week in self-quarantine. We have gotten used to the routine of videoconferencing for meetings near and far. Our families, along with many we have spoken to, have had a mix of good and bad experiences with online instruction and keeping our kids occupied. We continue our commentary on sources we read this week that shape our thoughts on how long the pandemic will last and what policy actions seem most promising.

Epidemiology

Everyone is wondering when the pandemic will end in the U.S. so that life can return to normal. Scientists from around the world have created multiple predictive models to estimate how the pandemic will play out. The coordinator of Trump’s coronavirus task force, Deborah Birx, said the White House’s projections were based on results of five or six modelers. One model that appears to figure prominently in the White House’s projections is the Institute for Health Metrics and Evaluation’s (IHME) model, which projects the U.S. pandemic to peak on April 15. This model predicts 2,644 deaths on April 16, when the nation will have a shortage of 87,674 beds. The builders of this model predict that the first wave of the pandemic will end by early June, when the country is predicted to suffer fewer than 200 deaths per day. The modelers took into account the social distancing measures ordered in every state, but multiple different factors for which we lack data could make their predictions inaccurate. Therefore, the results are presented along with “confidence bounds” which delineate lower and higher bounds to their estimate.

One can download an Excel spreadsheet from the IHME website to examine predictions of the pandemic’s spread in each state. The IHME predicts that the pandemic will peak later in Texas on May 6. On this data the model predicts that Texas will have 17,221 hospital beds filled with Covid-19 patients and 160 deaths. By mid-June, the state is expected to have just under five new deaths per day and roughly 500 patients hospitalized with Covid-19, which would be manageable for our health care system.

Factors that contribute to the difficulty in predicting the consequences of the pandemic are the lack of sufficient tests for the disease, as well as differences across countries in counting deaths attributable to the pandemic. This article reports that France only records Covid-19 fatalities in hospitals, Spain does not include unconfirmed cases in senior homes, and the Netherlands only tests hospitalized patients.

Two articles highlight the devastating effects of crowds in allowing the coronavirus to spread. The Los Angeles Times describes a choir practice in Washington state in early March, where 60 members gathered for 2.5 hours. Three weeks later, 45 of them tested positive for the disease, and two were dead. The Wall Street Journal describes how an unusually popular soccer match attracting 40,000 fans was a catalyst in turning the Lombardy region in Italy into one of the worst-hit areas on the planet. The crowded public transportation to and from the game, as well as fans gathering in venues to eat and drink, along with the crowded stadium led the reporter to label the event a “perfect amplifier” of the virus.

Policy Response

The ability of the country to re-open for business depends critically on when there will be sufficient supplies to test both symptomatic and asymptomatic people for the coronavirus. Multiple articles have explained why the country currently lacks sufficient test kits, but we have not seen reliable information on when this deficiency will be addressed. A plentiful supply of tests will facilitate the identification of asymptomatic individuals carrying the virus, so that they can self-isolate rather than spreading the disease to others.

This week the FDA approved the first antibody test in the U.S. to detect the coronavirus. We still do not know when this test will become widely available. The test can identify people who have effectively recovered from the disease, with antibodies that fight off the virus circulating in their blood. It is believed that there are many people, including health care providers, who contracted the coronavirus but only had mild symptoms and never were tested when they were infected. Health care providers with antibodies may be able to treat Covid-19 patients with fewer concerns of falling ill again. Scientists have not been able to confirm that recovering from Covid-19 confers immunity, but if so, recovered workers would not need to self-quarantine and could serve many effective roles until the nationwide lockdown ends.

Many policymakers and experts have questioned whether the health benefits of closing large sectors of the economy are worth the economic losses imposed on many Americans. The New York Times reported on an analysis by Anna Scherbina that attempts to answer this question. Her cost-benefit analysis concludes that the optimal health policy would involve closure measures similar to ongoing policies for seven weeks, but likely longer. The benefits of shuttering the economy to fight the pandemic include the avoided medical costs of treating Covid-19 patients, productivity losses due to worker illnesses, and the value of lives saved due to social distancing. The costs of the economic closure to fight the pandemic are estimated by summing the losses to sectors such as entertainment, hotels, restaurants, retail, and transportation, which are estimated to amount to $35.7 billion per week. The marginal benefits of closure gradually decrease by week, assuming that closure successfully reduces the number of newly infected workers. Scherbina warns that her calculations assume that the economy moves to a less aggressive mitigation strategy after the shutdown ends, where actions such as social isolation of the elderly and home isolation of suspected cases continues.

Meanwhile the significant health care costs of treating Covid-19 are becoming more evident. We wrote a blog last week noting that the $100 billion included in the federal CARES Act to compensate health care providers for the expenses associated with the pandemic and lost revenues is likely woefully inadequate. Hospitals are estimated to lose $2,800 per Covid-19 patient admitted, and providers have been forced to cancel all elective procedures and treatments to reduce the spread of the virus. On the patient side, a news article reports that the costs of Covid-19 treatment for an uninsured patient is estimated to be $73,000. On the bright side, many insurers have announced that they will waive copayments, deductibles and other costs associated with treatment of Covid-19 for beneficiaries, although the details on what will and won’t be covered are unclear.

Much attention has been paid to President Trump invoking the Defense Production Act to require GM to make ventilators. However, other sources note that GM may not be able to begin producing ventilators until May at the earliest, which is well past the estimated peak of the crisis. An opinion piece in The Dispatch notes that firms like Medtronic and GE Healthcare are our best bet for ramping up supply to meet the current shortage. Nevertheless, experts argue that the actions of a mass-production firm such as GM are important, because the company could help build a stockpile of equipment for future outbreaks.

As 6.6 million Americans filed for unemployment benefits this week, states that expanded Medicaid to low-income adults under the Affordable Care Act will be better positioned financially to meet the health care needs of their residents. Workers who have lost their jobs due to the economic shutdown have also lost heavily subsidized employer-provided insurance. These individuals will be seeking health care coverage through Medicaid if they quality. Some states objected to the Medicaid expansion, because they were concerned that states would be required to pay 10% of the costs, which they could not afford. However, a piece in last week’s New England Journal of Medicine notes that states that have expanded Medicaid did not experience an increase in Medicaid expenditures. We will spare you the details, but a combination of health care spending and taxes at the state level leads to this outcome.

In the coming week, we will be closely watching the number of deaths at the national and state level for Texas to see whether the IHME predictive model is painting an accurate picture of where the pandemic is headed. We do not value the number of reported cases of coronavirus as a helpful statistic, because the number of tests is in such short supply. Like you, we will be wondering when the nation will have enough tests to allow us consider other options besides a complete lockdown of the economy.