Political Interference with FDA and COVID-19 Vaccine

The New York Times reports that the White House chief of staff and other "[t]op White House officials are blocking strict new federal guidelines for the emergency release of a coronavirus vaccine, objecting to a provision that would almost certainly guarantee that no vaccine could be authorized before the election on Nov. 3, according to people familiar with the approval process."

This is part and parcel of this administration's on-going politicization of public-health processes designed to promote the greatest good for the greatest number while minimizing harms to others. Put otherwise, the FDA's mandate is to regulate medical devices, drugs, and biologics (including vaccines) to promote their safety and efficacy. It's a balancing act, to be sure, but it's one that needs to be guided by evidence, not electoral politics. Shouldn't that be clear? Why isn't that clear to the White House's "top officials"? And where's the outrage? Are we (and by "we," I mean not only our political class but the rest of us as well) so inured to the utter predictability of this sort of dangerousness that we simply accept it as par for the course?

If they are successful, these "top officials" are going to expose the nation to the unnecessary risk of a vaccine that is not ready for prime time. And, sadly, it also negates the efforts of the tens of thousands of volunteers who have voluntarily taken on the risks of participation in clinical trials.

POSTSCRIPT: 6:00PM CDT

FROM THE NEW YORK TIMES:

BREAKING NEWS

The F.D.A. released stricter coronavirus vaccine guidelines that the White House had blocked. They make a vaccine by Election Day highly unlikely.

The new guidelines recommend gathering extra data about the safety of vaccines in the final stage of clinical trials, a step that would take time and make it highly unlikely that a vaccine could be authorized before Election Day, Nov. 3.

Common sense and decency prevail! 

Senate Report on Health Inequities and COVID-19

It's a report from the Democratic staff of the Senate Health, Education, Labor, and Pensions Committee: "COVID-19 & ACHIEVING HEAL TH EQUITY: Congressional Action Is Necessary To Address Racism And Inequality In The U.S. Health Care System" (Sept. 2020).

From the summary:

COVID-19 has had a disproportionate impact on Black people across urban, suburban, and rural communities. As of September 2020, Black people were nearly 3.5 times as likely to die from COVID-19 as white people when age is accounted for.

Latinx people have experienced some of the highest rates of infection from COVID-19 in the country. As of June 2020, counties where more than a quarter of the population is Latino saw infection rates increasing at higher rates than in counties with smaller Latino populations, and as of July 2020, the infection rate among Hispanic patients was more than three times the rate among white patients. Over the same time period, Hispanic patients were hospitalized at a rate that was more than four times higher than white patients, and COVID-19 accounted for approximately one in five deaths among Hispanic people.

Data are not consistently available from states for other minority groups, but what is known supports similar conclusions about the risk of serious COVID-related complications and death among Asians, Native Americans, and LGBTQIA+ individuals.

Contributing factors include underlying health conditions, a lack of adequate insurance, increased likelihood of exposure to COVID-19 at work, mistrust of the health care system based upon a history of racial bias and exploitation, present-day explicit and implicit bias in the health care system, underrepresentation of physicians of color, bias in medical research and pharmaceutical clinical trials, limited access of patients of color to high-quality medical care, and a long list of social determinants of health that have disproportionately disadvantaged persons of color.

This is an important report, and not only for the fifteen pages of endnotes. The report ends with thirty recommendations for congressional action. Ask your representative or senator if they've read the report. We all should. 

Leave it to Trump to Say the Exact Wrong Thing

  

President Trump announced his intention to leave Walter Reed at 6:30 this evening. Okay, it is not the standard of care, but it's common for VIPs to get inferior care because no one wants to tell them "no." But did he have to tweet this utterly inappropriate message?

"Don't be afraid of Covid"? Mr. President, 209,000 of your fellow citizens have died of this disease since January. And, according to an infectious-disease doctor at NYU who is quoted in the NY Times, there's a very real chance the president's medications have induced a false sense of euphoria and well-being:

“I think it would be disastrous to be in a situation where he gets really sick at the White House, and you’re having to emergency transfer him,” said Dr. Céline Gounder, a clinical assistant professor of medicine and infectious diseases at the N.Y.U. Grossman School of Medicine, who has been caring for Covid-19 patients. “To me, it’s not safe.”

Dr. Gounder also noted that dexamethasone can cause a sense of euphoria. Mr. Trump said in his tweet that he feels better than he has in 20 years.

“A lot of people will just feel really great. If you had any aches and pains, they will disappear. If you had a fever, that will disappear,” she said. “People can become somewhat manic, grandiose.” 

The Opposite of How Public Health is Supposed to Work

The staff of the Congressional Select Committee on the Coronavirus Crisis has issued a report on The Trump Administration's Pattern of Political Interference in the Nation's Coronavirus Response (10/2/2020). Coming from a committee with a majority of members of the Democratic caucus one month before the national election -- and with a title like that -- the political implications (and motivation) are hard to avoid. But . . . 

The public-health lesson should be clear to all. The administration -- at least within the White House -- has treated the pandemic like a political problem to be managed. And the political interference with public-health authorities has made COVID-19 far worse that it needed to be. 

Public health is a fragile enterprise. It always involves some interference in the lives and liberty of individuals, whether by encouragement or legal mandate. Widespread compliance requires understanding and trust. Mixed messages and blatant political manipulation of public-health authorities and the information they must convey undermine both public understanding and trust. It's as simple as that.

NY Times Op-Ed: Maybe Roe v. Wade Isn't Worth Fighting For Anymore

UC-Hastings law professor Joan Williams writes in today's NY Times ("The Case for Accepting Defeat on Roe," 9/29/2020) one of the best summaries of where the current abortion jurisprudence stands in 2020 and argues that reproductive-rights advocates may fare better with state legislatures than they have in the courts:

It’s true that abortion access is already abysmal. . . . Nearly 60 percent [of women seeking abortions] have already had one child and nearly half live below the poverty level; some fear they’ll be fired if they take time off, particularly if they need to make two trips, as they must in the 26 states with mandatory waiting periods.

The argument that the left has already lost the abortion fight reflects the fact that there’s no abortion clinic in 90 percent of American counties. This is the result of the highly successful death-by-a-thousand-cuts anti-abortion strategy, which has piled on restriction after restriction to make abortion inaccessible to as many American women as possible.

Prof. Williams isn't ready to give up on the fight to preserve Roe, though every year it seems to protect less and less of a woman's right to choose. She cites Justice Ginsburg's critique of Roe as support for a legislative strategy going forward:

So what should we do now? Often forgotten is that R.B.G. herself had decided that Roe was a mistake. In 1992, she gave a lecture musing that the country might be better off if the Supreme Court had written a narrower decision and opened up a “dialogue” with state legislatures, which were trending “toward liberalization of abortion statutes” (to quote the Roe court). Roe “halted a political process that was moving in a reform direction and thereby, I believe, prolonged divisiveness and deferred stable settlement of the issue,” Justice Ginsburg argued. In the process, “a well-organized and vocal right-to-life movement rallied and succeeded, for a considerable time, in turning the legislative tide in the opposite direction.” 

There's more to read and learn from Prof. Williams's insightful op-ed. I recommend it. 

KFF Report on Trump's Health Care Record

We can expect health care (and HC reform) to be a major policy focus of the fall presidential campaign. The president's record is long and complex, including (quoting a press blurb from the nonpartisan Kaiser Family Foundation):

his response to the COVID-19 pandemic, his early and ongoing efforts to repeal and replace the Affordable Care Act (ACA), his annual budget proposals to curb spending on Medicare and Medicaid, his executive orders and other proposals to lower prescription drug prices, and his initiative on hospital price transparency.

This is from an issue brief published by KFF  -- "President Trump's Record on Health Care" -- with all the details. It is the fairest and most comprehensive summary I've seen. 

The Case for the Saliva-Based Antibody Test, Rather than PCR Test, to Reopen Society Safely

Co-authors A. David Paltiel & Rochelle P. Walensky write in today's Health Affairs blog that we shouldn't be put off by the 30% false-negative rate of antigen testing (as compared to the PCR test, which is great at identifying the virus (sensitivity) but has a relatively high rate of specificity (it can be fooled into giving a positive result long after the virus has left the individual, and therefore long after the individual has ceased to be infectious). The key distinction pressed by the authors is "infection" vs. "infectiousness." Their claim is that the antigen test is pretty lousy as a test for the presence of the virus but actually quite good as a test for infectiousness. It's a pretty persuasive case for the rapid-return, inexpensive test, which has been touted by some, as well criticized by others. 

The authors state that the FDA has been slow to approve these tests. As far as I can tell from the FDA's "COVID-19 Emergency Use Authorization" page, that's true. The authors argue that the time has come to ask the FDA why it isn't moving faster on an EUA for this technology.

The Latest from The Atlantic's Ed Yong on Where We Are Headed with COVID-19

Yong is quite possibly the best journalist covering the pandemic beat -- knowledgeable about the science, perceptive in spotting trends. His latest article in The Atlantic (9/8/20) is a good example. It's also borderline apocalyptic: "America Is Trapped in a Pandemic Spiral." Did I say "borderline"? I meant "downright apocalyptic." Here's the article's subtitle: "As the U.S. heads toward the winter, the country is going round in circles, making the same conceptual errors that have plagued it since spring." 

If you want to read all of Yong's reporting (and by others on its staff) on the pandemic, The Atlantic has made all of its articles free at this link.

A Look at the Top-Down Management of the Coronavirus by Gov. Cuomo: WSJ's Series

The latest in the Wall Street Journal's series, "The COVID Storm," is critical of Governor Cuomo's insistence on controlling the shut-down and reopening of New York City, one of the hardest-hit cities in the United States. The article argues that the death toll didn't need to be as high as it was, if local authorities had been left to manage the crisis on their own.

$10,984 for a COVID-19 Antibody Test? Yes.

This is like one of those kid's puzzles -- Can You Spot the Errors in This Picture? -- with upside-down swings hanging up from tree branches and a man wearing unmatched socks. As reported by ProPublica, a part-time ER medical director walks into his employer's stand-along emergicare center to get a COVID-19 antibody test. There's no serious attempt to take a history and no physical exam, just a blood draw and results 30 minutes later.

The charge (100% of which was paid by the doctor's insurance company, a subsidiary of health insurance behemoth UnitedHealthcare): $10,984: $2,100 for the physician portion and $8,884 for the facility fee.

1. The facility advertises the price of an antibody test on its website: $75.

2. The insurer never blinked before paying the charges in full. 

3. The parent company of the insurer cleared $6.6 billion in net earnings in the second quarter of 2020. An $11,000 bill -- whether sent in error or because of a policy of price gouging -- may amount to a rounding error for the insurer's first hour of operations at the beginning of each quarter and just not worth the hassle to question the provider.

4. It's not as if UnitedHealthcare or its sub ends up footing the bill for these charges. They are paid by all of UHC's policyholders.

I am partial to Medicare opt-in for all in the hope that it will provide a reality check for providers and private insurers, whose business model is making lots of people rich off the most expensive system of health care in the world. According to the ProPublica article: "Medicare lists its payment at $42.13 for COVID-19 antibody tests." That's a reality check!

The ER doctor/patient responded to this episode with a letter of resignation: "I have decided I can no longer ethically provide Medical directorship services to the company . . . . If not outright fraudulent, these charges are at least exorbitant and seek to take advantage of payers in the midst of the COVID19 pandemic."

"‘Really Diabolical’: Inside the Coronavirus That Outsmarted Science": Latest in WSJ Series

Another good installment in the WSJ series, "The COVID Storm" (9/7/20). Here are the opening few paragraphs:

The new coronavirus is a killer with a crowbar, breaking and entering human cells with impunity. It hitchhikes across continents carried on coughs and careless hands, driven by its own urgent necessity to survive.

It has a gregarious side that makes it hard to resist. It loves a party. The persistent social climber claims its victims around the world by riding on moments of the most innocent of human interactions—a shared laugh, a conversation, an embrace. And it is a liar. SARS-CoV-2, which causes Covid-19, often misleads the body’s immune systems.

Taken on its own terms, SARS-CoV-2 is the infectious disease success of the past 100 years.

Sen. Cruz (+ 20) Makes a Move on Women's Health

Kudos to The Dallas Morning News for this article on the senator's letter urging the head of the FDA to pull Mifeprex (a/k/a mifepristone, RU-486, or "the abortion pill") from the market. The DMN story quotes the senator as saying "Pregnancy is not a life-threatening illness, and the abortion pill does not cure or prevent any disease. Make no mistake, Mifeprex is a dangerous pill." The story explains the background: 

As the COVID-19 pandemic limited access to in-person doctor appointments, abortion-rights advocates called for the FDA to alter its risk evaluation strategy for the pill, arguing that the policy, which required a woman be prescribed the pill in person, made it more difficult for a woman to acquire it. A federal judge suspended the rule in July.

The article offers this lesson in basic reproductive biology: 

Pregnancy can be especially deadly to Black and American Indian women. From 2011 to 2016, there were 42.4 deaths per 100,000 live births for Black non-Hispanic women and 30.4 deaths per 100,000 live births for American Indian and Alaskan Native non-Hispanic women.

The CDC reported in [2019] that since Mifeprex’s approval in 2000, there were 24 recorded maternal deaths associated with the drug.

The article ends with this great Twitter quote from Democratic congressional candidate (TX-4) Russell Foster: "If you dont have a uterus, you shouldn't have a say in a womans healthcare. You lack basic knowledge. Viagra doesnt prevent any disease but I'm sure you have a full bottle at home. Please stay out of women's healthcare decisions unless you want them to start legislating mens."

Wall Street Journal's Latest in "The COVID Storm" Series

The Wall Street Journal continues its excellent series with two new installments:

• "How Trump Sowed Covid Supply Chaos. 'Try Getting It Yourselves.’" (8/31/20)
• "How Coronavirus Overpowered the World Health Organization" ((8/28/20)

Links to all previous articles in this series are here.

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

In Texas, More People Are Losing Their Health Insurance as COVID Cases Climb

From a story by Ashley Lopez of Public Radio station KUT in Austin (and picked up by Kaiser Health Network):

Texas’ uninsured rate has been climbing along with its unemployment rate as COVID cases also surge in the state. Before the pandemic, Texas already had the highest rate and largest number of people without insurance among all states. And 20% of all uninsured children in the U.S. live in Texas.

The uninsurance problem has only gotten worse in Texas in 2020. According to recent data from Families USA, a consumer health advocacy group that supported the Affordable Care Act, 29% of Texas adults under 65 don’t have health insurance so far this year.

The group found that about 659,000 people in the state became uninsured between February and May as job losses soared. Texas is one of 13 states that has not expanded Medicaid under the ACA.

Thirty-seven states and D.C. have expanded Medicaid eligibility in response to a generous federal match under the ACA -- and that doesn't include Missouri, where voters are voting on Tuesday on Medicaid expansion. Texas is one of the holdouts, for reason that defy logic. We'll see if it continues to defy politics in November. In recent decades we've been a resolutely red state in statewide and presidential elections. Is this the year the politicians who have turned their backs on the poor and disabled individuals in this state are held to account for their heedless, heartless actions?

Starr County, TX implements "crisis standard of care"

It's been reported that the only hospital in Starr County (on the southern border) will deny access to critical-care facilities based upon a patient's likelihood of survival. You can hear the desperation in this quote from the Starr County Judge (the highest executive official in the county), Eloy Vera:

“It is important that we all know the situation that we’re facing in the county, not only the community but the hospital is overwhelmed right now,” Vera said. “Our backs are to the wall.”

And from the County Health Authority, Dr. Jose Vazquez:

“We are not gods or anybody to make a decision for who should live or who should die. However, when you have a mass-casualty situation there are guidelines that makes you work in a more efficient manner and to help save the maximum number of people,” said Vazquez, who added in his entire career as a physician he has never experienced such a desperate mass medical situation. 

According to the Border Report:

Starr County has an eight-bed COVID-19 unit at its hospital, but currently there are 28 patients with three on ventilators and life support, including one in the emergency room. Vazquez said physicians will be using a mass-casualty treatment plan devised by physicians in North Texas to determine who gets treatment and who does not.

“The number of cases we see in the ER are growing every day; 50% of cases in the ER are COVID. The situation is desperate. We cannot continue functioning at Starr County Memorial Hospital the way things are going. The numbers are staggering,” Vazquez said. 

Haynes and Boone "Health Law Vitals": Almost All COVID-19 Almost All the Time

New issue of the firm's health-law newsletter includes the following:

• COVID-19-Related Healthcare Fraud and Anti-Kickback Enforcement Focuses on Laboratory Testing
• While the U.S. Department of Justice (DOJ) has identified and pursued a variety of fraud schemes and activities related to COVID-19 (such as sales of fake testing kits and PPE, price gouging, and fraudulent offers for free COVID-19 testing in order to obtain Medicare beneficiary information that is used to submit false medical claims), several recent cases involving laboratory testing demonstrate that this is a key area of healthcare fraud and anti-kickback enforcement during the pandemic
• HIPAA Updates
• OCR's HIPAA guidance for healthcare providers during the COVID-19 pandemic
• HHS's extension of its Public Health Emergency
• Detailed reporting instructions for recipients of Provider Relief Funds (PRF) will be released on August 17, 2020
• Substance Abuse and Mental Health Services Administration (SAMHSA) announced the adoption of the revised Confidentiality of Substance Use Disorder Patient Records regulation, 42 CFR Part 2
• Department of Justice updated its guidance regarding evaluation of corporate compliance programs
• OCR resolved two religious freedom complaints related to COVID-19

After taking a week off from misleading the public about the coronavirus, Pres. Trump is at it again.

Public health law promotes public health, including public-health measures to combat threats to the health of the public. But what happens when the top federal executive-branch official -- someone whose public-health executive-branch agencies include the FDA, the CDC, the National Institute of Allergy and Infectious Disease, the Indian Health Service, and the Public Health Service, among many others -- is himself a threat to public health?

That's right, President Trump, I am talking about you.

After a week of acting and speaking fairly sensibly about the coronavirus and COVID-19, he's back at it again, today retweeting that hydroxychloroquine is an effective treatment for COVID-19. And, according to the Associated Press, "Trump also shared a post from the Twitter account for a podcast hosted by Steve Bannon, a former top White House adviser to Trump, accusing Fauci of misleading the public over hydroxychloroquine." This is the same nonsense that today got Twitter to limit Donald Trump Jr.'s Twitter access for 12 hours as a sanction for misleading the public about COVID-19.

One of my earlier posts analogized Trump to Nero, fiddling while Rome burned. A better analogy is  poring gasoline on the fire to make it worse.

Somnolescent state medical boards bear large responsibility for epidemic of opioid death and destruction

400,000 deaths (and counting. Many multiples of that number of lives ruined. A big part of the problem is a regulatory regime that seems not to be up to the task of policing prescription abuses by doctors (and other health care professionals working under their supervision and control). A recent article in the New York Review of Books -- "Licensed to Pill" by Rebecca Haw Allensworth -- starts with the story of a completely ineffectual Tennessee licensing board that allowed a physician involved in a criminal enterprise to push pills. It is a harrowing tale.

Granted, not all medical boards are created equal. Some have been more active than others in disciplining physicians who overprescribe. But the opioid crisis could not have reached the level it has without many boards failing in their responsibility to protect the public from unscrupulous physicians. This is occurring against a background of overregulating physicians who practiced evidence-based medicine to treat patients with medical problems other than addiction to opioids. Many doctors began avoiding pain management altogether because the regulatory environment was too hostile and the legal risk too great. Over time, state legislatures began enacting "intractable pain" laws that were intended to protect legitimate pain-control practices. Somehow, over the past two decades, the regulatory pendulum seems to have swung very farin the opposite direction.

Artificial Intelligence-Assisted Conversational Agents in Health Care

"Clinical, Legal, and Ethical Aspects of Artificial Intelligence-Assisted Conversational Agents in Health Care": That's the title of a new, free Viewpoint article in JAMA (online only at this point).

If you've called the DMV, your cellphone service or cable tv provider, the complaint line of an on-line vendor, or other automated, disembodied telephone "presence," you know the drill:

1. You are asked a question. 
2. You respond. 
3. You hear funny "sorting" noises. 
4. You are asked another question. 
5. Rinse and repeat. And repeat. And repeat.

Now imagine doing this when you call your doctor's office or local medical clinic.

Are there going to be problems with AI-assisted conversational agents (CA) in the health care setting? Oh, yeah. The authors of this paper list "considerations," and it's an impressive list:

• Patient Safety
• Who monitors the interactions between patients and CAs? Does monitoring occur 24 hours/day and 7 days/week or on another schedule?
• Is there a rigorously tested escalation pathway to a human clinician? What scenarios have been configured to initiate the escalation pathway?
• How well do CAs detect subtleties of language, tone, and context that may signal a risk for patient harm?
• Scope
• What kinds of clinical tasks should be augmented or automated by CAs and which should not? How much guidance is appropriate for CAs to provide to patients?
• Trust and Transparency
• Do clinicians trust CAs? Do patients? Should they?
• To what degree do clinicians and patients need to understand the workings of CAs to use them effectively, intelligently, and ensure the appropriate amount of trust?
• Content Decisions
• What are the content sources for CAs that provide recommendations or guidance? 
• Do the CArecommendations align with content sources and with supervising clinician recommendations?
• Data Use, Privacy, and Integration
• Who can access exchanges between patients and CAs? 
• Who owns or controls the data? 
• Will the data be stored or purged? 
• If stored, for what purposes (eg, research, commercial use)?
• Are conversations integrated into patients’ electronic health records (EHRs) or do they remain in each device? 
• Can EHR data be integrated into CAs to better contextualize interactions?
• Bias and Health Equity
• Which patient groups are used to train algorithms? 
• How representative are they? 
• How do CAs evolve over time to reflect new user populations?
• How do CAs handle accents and speakers of other languages? 
• What about various health literacy levels and compliance with the Americans with Disabilities Act?
• Third-Party Involvement
• CAs should be protected against commercially motivated data sharing or marketing, while permitting referencing of evidence-based products and therapies. 
• A balance is needed among commercial, technology leadership, and other incentives for CA developers and health care organizations
• Cybersecurity
• What if data, devices, or apps are hacked or monitored covertly and cause harm? 
• Will CA conversation data be encrypted?
• Are there restrictions on CA access? 
• Is 2-factor authentication required? 
• What are the trade-offs between sufficient security and convenient access?
• Legal and Licensing
• Who is accountable if CAs fail? The sponsoring health care organizations or clinicians? The CA vendors? All of the above?
• What is the role of insurance in CA services?
• Will there be required licenses or credentials for CAs similar to those required for clinicians?
• Research and Development Questions
• What approach or tone works best for patients? Human vs robotic, empathetic vs stoic, terse vs engaging, female vs male vs gender-neutral?
• What are the most common questions or needs posed to CAs?
• What do patients find most and least useful? What motivates patients to use CAs? What are differential discontinuation rates? Why do some patients stop using CAs? What other functions are requested, are viable, and are needed most? What are patient outcomes with CAs?
• Governance, Testing, and Evaluation
• How will decisions about CA selection, deployment, and use be governed? How will performance be tested and evaluated with actual patients before deployment?
• What types of standard performance metrics and evaluations will be developed and implemented? How will desired outcomes and unanticipated or undesirable outcomes, including biases, be captured and assessed on an ongoing basis? How will these assessments be used to continue, suspend, or modify use of CAs?
• How will hazards or anomalies be detected and addressed?
• Supporting Innovation
• How can development, testing, and introduction of promising boundary-pushing technologies be balanced with the need to protect patients and address the other issues listed here?

This is all pretty new stuff. The oldest source cited by the authors came out in 2014, and only a handful are specifically about CA in healthcare. This article is a good starting place for anyone who wants to catch up with what will be a fascinating innovative process.