Testing for the coronavirus and the CDC

On August 24 the CDC announced new recommendations for testing for the coronavirus. They said that there is no need for testing if someone is asymptomatic, even if that person has come into contact with someone who has the infection. 

Of course, this change serves the political goals of President Trump perfectly, since he has repeatedly asserted that with fewer tests the U.S. would have fewer cases. I have a granddaughter who loved playing a game where, if she closed her eyes, I would disappear. By the time she was four or five, though, she knew it was just a game and that I really didn't disappear. That lesson seems to have been lost on the president.

But back to the CDC. Adm. Brett Giroir (an old friend whose integrity I've never had reason to question) says there was no political pressure: "We all signed off on it, the docs, before it ever got to a place where the political leadership would have, you know, even seen it, and this document was approved by the task force by consensus." The medical community outside the CDC, however, has been pretty close to unanimous in rejecting this latest guidance. The former head of the CDC, Dr. Tom Frieden summed up the response from outside the Washington Beltway: the guidance change is "unexplained, inexplicable, probably indefensible.”

There are two competing narratives out there, and there is no reason both couldn't be be true. 

1. This is a politically driven change pushed by the White House, HHS, and political actors on the coronavirus task force to make the president look good. Brett Giroir denies this, though he has confirmed that once "the docs" signed off the change made its way into the political process. Sheryl Gay Stolberg of the NY Times reports that "[t]wo federal health officials said the shift came as a directive to the Atlanta-based C.D.C. from higher-ups in Washington at the White House and the Department of Health and Human Services." That still allow for the possibility that the politicos "directed" the CDC to make a change after it was presented to them by "the docs."
2. This new guidance is an attempt to ration tests, which are still drastically and acutely in short supply, to those who are most likely to be contagious. As has been reported throughout the summer, it can take days to get tested and weeks to get test results back due to the backlog in properly equipped testing facilities. 

But to say that asymptomatic individuals don't need to be tested masks the rationing effort with a veneer of pseudoscience that is being widely criticized. Asymptomatic individuals can still be infected and can spread the virus without knowing they are infected. Testing addresses that real risk. What we need is honesty about what's really going on.

Especially against a backdrop of on-again, off-again advice from the White House task force and CDC, this couldn't have been handled more ineptly. But it's not just the messaging that's off. Behind the altered guidance is the reality that our testing program, by any measure, has been a disaster.

The COVID Storm: three more Wall Street Journal articles

The Wall Street Journal continues to excel with its in-depth study of how we got to where we are today, what went right and what went wrong:

• What Derailed America’s Covid Testing: Three Lost Weeks (Aug. 18, 2020)
• Why Are There Still Not Enough Paper Towels? (Aug. 21, 2020)
• New Thinking on Covid Lockdowns: They’re Overly Blunt and Costly (Aug. 24, 2020) - by the inimitable Greg Ip

Previous articles in the series are here and here. 

". . . it illustrates that we are all connected "

From the Boston Globe (possible paywall protection): When Biogen held its meeting of the firm's international leaders in a Boston hotel in February, they apparently had no idea it would be a super-spreader event. Attendees congregated in meeting rooms, on escalators and in elevators, at cocktail receptions and meals. Masks and social distancing weren't much of a thing back then. Current estimates of the number of coronavirus infections in four easter Massachusetts counties that are traceable to that two-day event: 20,000. And that number could be too conservative an estimate.

The "connected" quote is in reference to the spread from the tony Marriott Long Wharf hotel to at least "122 people living in Boston-area homeless shelters and employees who work there, the study says. It’s unclear what path the virus took to get there."

Lesson learned? Not necessarily, as illustrated by last week's decision by a number of universities to cancel the return to on-campus classes after clusters of infections broke out among undergraduates (Inside Higher Ed, 8/25/20).

Declining life expectancy in the U.S. and legal determinants of health

It is well known that average life expectancy in this country declined from 2014-2017, followed by a slight (~1 month) increase in 2018 (CDC, Jan 2020), leaving the average still below its high in 2014. An important new article in JAMA (on-line and free) by Larry Gostin and co-authors James Hodge and Donna Levin consider "Legal Interventions to Address US Reductions in Life Expectancy." Here, in brief, is their case:

Age-based, geographic, and socioeconomic status disparities collectively diminish average life expectancy. Midlife “diseases of despair” (eg, suicides, drug overdoses, and alcohol-related conditions), firearm violence, and obesity also are contributing factors for reduced life expectancy, especially in rural counties, the industrial Midwest, and Appalachia. Life expectancy gaps among the richest and poorest 1% of the population are estimated to exceed 10 years for women and 14 years for men. Stated simply, poorer, less-educated individuals in the US live considerably shorter lives. This pattern of inequality has been highlighted further during the COVID-19 pandemic.

Among multiple causes, weak laws at all levels (federal, state/tribal, local) contribute to regional differences in life expectancy, suggesting a need for responsive legal reforms. Universal health coverage is vital, but “upstream” prevention aimed at known risk factors undergirded by law also contribute to increased life expectancy. Post–COVID-19 public health laws can address specific social determinants beyond the health sector—such as by focusing on connectedness, education, environment, housing, food, income, and transportation—and potentially narrow vast health equity gaps among underserved at-risk populations.

 

The COVID Storm: Part 2 of The Wall Street Journal Series on What Went Wrong

 

The second installment in the WSJ's series -- "China’s CDC, Built to Stop Pandemics Like Covid, Stumbled When It Mattered Most" -- focuses on the breakdown, primarily in surveillance, which didn't discover the outbreak in Wuhan until it had already started to spread to the rest of the world. The story in China is distressingly similar to the story in the U.S.: Public-health infrastructure was underfunded, understaffed, and degraded to the point that it couldn't do the job it was designed to do.

As expected, the writing is superb. Also as expected, the series is still behind a paywall. It's too bad. A lot of other news outlets are putting their COVID-19 coverage on-line for free as a public service. 

New Wall Street Journal Series: The COVID Storm

The first installment was in today's paper: "A Deadly Coronavirus Was Inevitable. Why Was No One Ready?" The series is off to a pretty strong start, with some useful historical data and trends, good stuff on SARS, lessons learned from EBOLA (not caused by a coronavirus, but a highly infectious disease), and a straightforward narrative describing the international response. 

Unfortunately, there are only a few paragraphs on the developments, historical and present-day, that produced a public-health disaster in the U.S. Maybe there will be more in subsequent articles. 

And the articles are behind a paywall. (Really, WSJ? Many papers and journals are making their COVID-related articles available for free because, you know, they are in the public interest). 

For now, I still highly recommend two articles by Ed Young in The Atlantic that I've mentioned previously (here and here). Yong is somewhat less diplomatic than the WSJ when it comes to describing the failures in policy and in practice during the first half of 2020, and I for one am grateful for his forthrightness.

Cruzan and the Right to Die -- SMU Law Review Symposium (Vol. 73, No. 1)

 I'm happy to report the publication of the SMU Law Review's Symposium, "Cruzan and the 'Right to Die'" in Vol. 73, No, 1 (2020). The authors who wrote for the Symposium are the thought leaders around the country. I want to thank them for their wonderful scholarship and urge everyone reading this to check out their articles.  (All are available in PDF from the link above.)

The motivating idea behind the Symposium was "where are we now, 30 years after the U.S. Supreme Court's decision in Cruzan? Here are our authors and their topics:

• Foreword: Cruzan and the “Right to Die”
  Thomas Wm. Mayo
  
  
• First Man and Second Woman: Reflections on the Anniversaries of Apollo 11 and Cruzan
  George J. Annas
  
  
• Cruzan’s Legacy in Autonomy
  Kathy L. Cerminara
  
  
• Remaking the “Right to Die”: Give Me Liberty but Do Not Give Me Death
  Janet L. Dolgin
  
  
• Beyond Cruzan: Dementia and the Best Interests Standard
  Rebecca Susan Dresser
  
  
• Cruzan and the Other Evidentiary Standard: A Reconsideration of a Landmark Case Given Advances in the Classification of Disorders of Consciousness and the Evolution of Disability Law
  Joseph J. Fins
  
  
• A History of the Law of Assisted Dying in the United States
  Alan Meisel
  
  
• Cruzan and Surrogate Decision-Making
  David Orentlicher
  
  
• Video Advance Directives: Growth and Benefits of Audiovisual Recording
  Thaddeus Mason Pope
  
  
• The Legacy of Cruzan: Balancing the Moral Agency of Surrogates and the State
  Margie Hodges Shaw, Timothy E. Quill, and Bernard L. Sussman

Can we finally put to rest the certifiably false assertions by Trump and Cornyn that children are immune to or not affected by the coronavirus? Positive cases in children (under the age of 19) increased by 97,000 in the last two weeks of July alone (WaPo, 8/10/20). It really doesn't matter whether increased testing or increased numbers of infections (or, most likely, some combination of the two) are behind this number. (A) The number disproves claims that kids are, by virtue of being kids, safe from infection. (B) The true number of positive cases is probably quite a bit larger than the reported number (which is true of all reported numbers).

Ed Yong (Atlantic writer) on KERA-FM's "Think"

Ed Yong, whose article in the September issue of The Atlantic I previewed in an earlier post, was recently interviewed by Krys Boyd on KERA-FM (8/11/20). Krys is a fabulous interviewer, and her one-hour session with Yong is a good example of her work. 

Yong's current piece focuses on the inadequacy of our response to the coronavirus. He and Krys mentioned his two-year-old article, also in The Atlantic, that predicted our inability to respond to a pandemic: "The Next Plague is Coming. Is America Ready?" (July/August 2018).The article pretty well nailed what came to pass, with the added factor -- now all too apparent -- of the total lack of coherent leadership from our president, which Yong details in the current article.

Both articles are indispensable reading (if you can get past the paywall). Also, Yong is a prolific writer and his Atlantic articles since January are worth checking out.

Long-term Health Care Costs for COVID-19

 

Even after the critical-care hurricane passes, we are looking at COVID-19-related thunderstorms for the years ahead.

 We are used to thinking about the impact of COVID-19 in light of short-term effects: hospital beds, ventilators, staffing, schools and businesses, local and national economy, etc. It makes perfect sense. These are the places and concerns where the pandemic first hits us. But researchers are starting to look at the longer-term effects, beginning with the health care needs of individuals with long-term and even permanent health problems as a result of their exposure to the novel coronavirus. 

Even after (that is, when and if) Reuters ran this story last week:

With mounting evidence that some COVID-19 survivors face months, or possibly years, of debilitating complications, healthcare experts are beginning to study possible long-term costs.

Bruce Lee of the City University of New York (CUNY) Public School of Health estimated that if 20% of the U.S. population contracts the virus, the one-year post-hospitalization costs would be at least $50 billion, before factoring in longer-term care for lingering health problems. Without a vaccine, if 80% of the population became infected, that cost would balloon to $204 billion.

This of course is on top of the year-in, year-out bill for health care B.C. (Before COVID-19). According to the Centers for Medicare and Medicaid Services, "U.S. health care spending grew 4.6 percent in 2018, reaching $3.6 trillion or $11,172 per person.  As a share of the nation's Gross Domestic Product, health spending accounted for 17.7 percent." 

If we're aiming for herd immunity without a vaccine available, 80% is a good number, but in terms of the human misery, economic dislocation, and impact on health care providers (institutional and individual), getting to 80% is a disaster. And $204 billion represents a 5.67% bump on top of the underlying 4.6% growth rate that is pretty much baked into our national health care costs. 

We may get a vaccine that will be at least partially effective, and we may get out the required hundreds of millions of doses (in this country along, let alone the billions needed worldwide). The infection rate, therefore, may be less than 80%. But a 20% infection rate still puts an enormous burden on the system, especially primary-care physicians and specialists including cardiologists, pulmonologists, endocrinologists, neurologists, and gastroenterologists. 

And that burden will not be shared equally by states and regions. Massachusetts has more physicians per capita than any other state. There may be shortages in the years ahead, but they are unlikely to be as severe as in states that already have physician and other health-provider shortages. Many of those states are in the South (including the the Southeast and Southwest), where restrictions have been lifted too broadly and too soon and where COVID-19 spikes have been the most pronounced since July. 

Determination of Brain Death/Death by Neurologic Criteria: The World Brain Death Project

Brain death/death by neurologic criteria (BD/DNC) is described in every jurisdiction in the U.S. as the irreversible cessation of all brain function, including that of the brain stem. The universal acceptance of this seemingly straightforward criterion masks an unsettling reality: "There are inconsistencies in concept, criteria, practice, and documentation of brain death/death by neurologic criteria (BD/DNC) both internationally and within countries." That's the opening salvo by an international, multidisciplinary group that has published its findings and recommendations in an important new paper in JAMA. 

As summarized by the panel: "This report provides recommendations for the minimum clinical standards for determination of brain death/death by neurologic criteria in adults and children with clear guidance for various clinical circumstances. The recommendations have widespread international society endorsement and can serve to guide professional societies and countries in the revision or development of protocols and procedures for determination of brain death/death by neurologic criteria, leading to greater consistency within and between countries."

In the same issue, Dr. Robert Truog at Harvard Medical School and Boston Children's provides a useful editorial on the report. His bottom line: loss of consciousness, loss of spontaneous respiratory drive, and the irreversibility of both conditions are the source of inconsistency and confusion. Research as to all three factors is desperately needed and devilishly difficulty to carry out. And even if that research is performed and is successful in establishing clinical criteria for their determination, much work will remain to be done, e.g.:

Bringing these recommendations to the entire international community will require a 2-pronged approach. First, evidence to support the existing tests needs to be bolstered, and this may require greater use of advanced neurodiagnostic techniques. A key question will be whether the whole-brain biological standard for defining BC/DNC will remain tenable, or whether this concept should be replaced by the values-based brainstem standard. Second, since much of the world does not have access to advanced technologies, the World Brain Death Project will need to focus on development and validation of tests that rely on the clinical examination and widely available diagnostic tools. This will be essential if the capacity for accurately diagnosing BD/DNC is to become accessible to all clinicians around the world.

Trump and Cornyn Apparently Listen to the Same Morons

This was posted to Facebook and Twitter by President Trump's campaign: a clip of an interview Trump did Wednesday with Fox News in which he said children were “virtually immune” from the Covid-19 coronavirus. “[Children] don’t have a problem, they just don’t have a problem,” Trump said in the video as part of an argument for why schools should reopen. “It doesn’t have an impact on them. I’ve watched some doctors say they’re totally immune.” To their credit, both Facebook and Twitter took the posts down pursuant to their policy against pandemic-related misinformation. (For the record, non-pandemic misinformation is still okay.) And Twitter briefly suspended the campaign's access to Twitter.

Last month John Cornyn questioned whether children can get COVID-19 or even transmit the virus. Who are the experts these people are talking to? A call to a pediatric hospital ER would bring them up to speed. 

Or Google "children + COVID." The first link is to the CDC's page with the title "Help Stop Spread of COVID-19 in Children." Here's the first sentence on that page: "Based on available evidence, children do not appear to be at higher risk for COVID-19 than adults." It doesn't take a Ph.D. in epidemiology to parse this sentence. It doesn't say children are at no risk. It doesn't say they are at lower risk. It says that as far as we know they are at the same risk as adults. See also "Characteristics of COVID-19 in febrile infants 2 months of age and younger" in 2MinuteMedicine.com.

Misleading the public about the risk of COVID-19 is no small thing. It is a violation of a fundamental obligation our leaders have to BE USEFUL, especially during a damned pandemic. Misrepresentations are not useful. At a time when school districts across Texas and around the country are trying to figure out how to open safely, or if they can open at all, dismissing the risk to school children with phrases like "no impact" and "totally immune" is reckless and dangerous.

COVID-19 Evictions and Health

Health Affairs has posted an excellent blog piece: "When Storms Collide: Evictions, COVID-19, And Health Equity" (08/04/2020). 

The good news: Forty-three states and D.C. enacted COVID-era moratoriums on foreclosures and evictions. The federal government enacted its own moratorium.

The really bad news: The federal moratorium expired on Friday, July 31. All but nine states' moratoriums will expire by the end of October.

If the connection between having a home and health seems a little fuzzy, these four paragraphs are key (emphasis added):

"Just as the economic fallout of COVID-19 has increased the likelihood of evictions, evictions might also increase the risk of COVID-19 transmission in the short term. Households may be rendered homeless by eviction or will need to double up in shared space, resulting in diminished ability to socially distance and increased risk of COVID-19 transmission.

"However, the immediate health effects of eviction extend far beyond COVID-19 risk. For individuals and families who become homeless, especially those who become chronically homeless, the health risks have long been recognized. Mounting evidence suggests that psychosocial stress and material scarcity following an eviction may carry profound and lasting health consequences. Among adults, evictions have been associated with several interrelated conditions, including all-cause mortality, emergency department utilization, sexually transmitted infections, HIV-related treatment outcomes, drug use, exposure to violence, mental health hospitalization, suicides, and depression. Health conditions and high levels of health care costs also increase vulnerability to evictions in a manner that can perpetuate a longstanding cyclical pattern of economic and housing instability and poor health.  

"For children, experiencing evictions during the COVID-19 pandemic may cast a long shadow, impacting their health and well-being as adults. Children whose mothers experience evictions during pregnancy are more likely to be born with low birthweight or preterm than are children whose mothers are not evicted. In early childhood, evictions are associated with food insecurity and lead poisoning, which over time can compound and cause lasting deficiencies in children’s physical, mental, and emotional development.

"Evictions during COVID-19 are also likely to perpetuate and worsen racial health inequities at both individual and community levels. Structural racism drives inequities in labor and housing markets, resulting in increased risk of both COVID-19 and eviction for Black and Latinx individuals. Black and Latinx individuals are also more likely to live in communities characterized by high levels of eviction with important spillover effects on health."

 

Devastating Report on the U.S. Response to the Novel Coronavirus

Ed Yong has written the definitive story on the federal (non)response to the pandemic in The Atlantic: "How the Pandemic Defeated America" (Sept. 2020 issue; updated 8/4/2020). Yong's reporting is thorough, well-sourced, and fair and balanced, including this paragraph:

No one should be shocked that a liar who has made almost 20,000 false or misleading claims during his presidency would lie about whether the U.S. had the pandemic under control; that a racist who gave birth to birtherism would do little to stop a virus that was disproportionately killing Black people; that a xenophobe who presided over the creation of new immigrant-detention centers would order meatpacking plants with a substantial immigrant workforce to remain open; that a cruel man devoid of empathy would fail to calm fearful citizens; that a narcissist who cannot stand to be upstaged would refuse to tap the deep well of experts at his disposal; that a scion of nepotism would hand control of a shadow coronavirus task force to his unqualified son-in-law; that an armchair polymath would claim to have a “natural ability” at medicine and display it by wondering out loud about the curative potential of injecting disinfectant; that an egotist incapable of admitting failure would try to distract from his greatest one by blaming China, defunding the WHO, and promoting miracle drugs; or that a president who has been shielded by his party from any shred of accountability would say, when asked about the lack of testing, “I don’t take any responsibility at all.”

Yong's conclusion: What's unfolding before our eyes at this very moment was entirely "predictable and preventable." 

Repeal and Replace (Redux and Redux and . . . )

The Washington Post has done a good job of summarizing the litany of promises made and then-candidate and now President Trump to replace the Affordable Care Act with the new and better national health plan. By my count, he has claimed on at least four occasions that a comprehensive plan was imminent. The time frames vary ("in two weeks," "maybe this Friday," etc.) but the brazenness of each claim does not. It's pretty clear there is no such a plan, there never was such a plan, and -- with three months left before the election -- there won't be such a plan. 

Instead, the administration nibbles away at this and that provision of the ACA, often with pushback from the federal courts. One last attempt to do away with the ACA is now in front of the Supreme Court (California v. Texas, No. 19-840), and Trump's DOJ has filed a brief in that case that argues for doing away with the ACA lock, stock, and barrel. The brief attempts to defend the indefensible -- a Fifth Circuit opinion that declared that Congress's intent when it repealed the penalty for the individual mandate was to repeal the entire ACA, although that is precisely what Congress neither did nor said.

Have IRBs Become Compliance Bureaucracies?

Professor Sarah Babb (Sociology Professor, Boston College) has a new book -- Regulating Human Research: IRBs from Peer Review to Compliance Bureaucracy (Standford Univ. P. 2020). It is reviewed well by Edward Dove (Lecturer in Health Law and Regulation, University of Edinburgh Law School) in Jotwell -- Health Law (6/9/2020). Dove's bottom line: "In sum, Babb’s book is a welcome addition to the scholarship on research ethics governance. For those interested in this area of health law, it is a must-read."

Dove's restatement of Professor Babb's thesis, based upon her experience on the B.C. IRB and extensive interviews, is this: 

IRBs have transformed since the late 1990s from committees of peer reviewers – fellow academics making ethical judgements on the basis of scholarly expertise, but paying little attention to the letter of the regulations—to “compliance bureaucracies,” wherein full-time IRB administrators do much of the heavy lifting, often behind the scenes. Babb defines compliance bureaucracy as “a nongovernmental office that uses skilled staff—compliance professionals—to interpret, apply, and oversee adherence to government rules” (P. 5.) In this transformed governance environment, faculty board members still participate in terms of voting on whether to approve a project or expedited research protocols, but their work is simply not possible without IRB staff. This transformation, Babb argues, was due primarily to the growth in IRB scrutiny in the late 1990s by the Office for Human Research Protections (OHRP), which is situated in the federal Department of Health and Human Services. In turn, there was consequential growth in funding from research institutions to invest in IRB administration to better manage the risk associated with OHRP audits and enforcement actions. IRBs today are led not by peer reviewers, then, but rather a professionalized service of research administrators who know the nuances of IRB management. 

Based upon my experience as a member of four IRBs over the past 35 years, Professor Dove 's thesis may be based upon a false dichotomy. While The Common Rule, which is based upon the Belmont Report, is indeed a thick (in all senses of the word) document that reflects the bureaucratic mind at work, much of this bureaucratese emanates from ethical concerns that are central to the IRB's mission. When are a research program's risks sufficiently low that the IRB can pass on the proposal without any review? Or with a mere "expedited review"? Protection of research subjects depends upon the answers to these questions, as well as others: 

• Does the research protocol focus on minors? Prisoners? Other "vulnerable" subjects? 
• If so, what additional safeguards need to be built into the review process to help ensure the subjects are treated ethically? 
• Is there some human research that just shouldn't be done? 
• Are the fundamental human rights of research subjects sufficiently protected by the design of the research and the disclosure of risks?

The bureaucratic Common Rule, and the professional staff that guides IRB members through the compliance process, is intended to provide consistent answers to questions such as these. Our experience in the United States during much of the 20th century gives little reason to believe researchers should be left to decide these questions for themselves. 

Dartmouth Atlas Project

This is a great source of data on all manner of health care topics: 

• COVID-19 data -- maps! (some of them time-lapsed) -- up-to-date within a few days
  
  
• Data through 2018 (I guess 2019 is still being processed)
• Medicare reimbursement, mortality, primary care access and quality measures, etc.
• Neonatal intensive care