Tuesday, September 29, 2020

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. 

Tuesday, September 15, 2020

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. 

Friday, September 11, 2020

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.

Tuesday, September 08, 2020

$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."

Monday, September 07, 2020

"‘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.

Saturday, September 05, 2020

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:

Links to all previous articles in this series are here.

Thursday, August 27, 2020

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.

Tuesday, August 25, 2020

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:

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).

Monday, August 24, 2020

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.

 

Monday, August 17, 2020

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. 

Thursday, August 13, 2020

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.

Tuesday, August 11, 2020

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.

Monday, August 10, 2020

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. 

Friday, August 07, 2020

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.