It’s Been Quite A Week — Here Are Some Things You Might Have Missed

October 24th, 2020 by Tom Lynch

From the Department of There’s No Accounting For Stupidity

Since 1980, the population of Idaho has grown from about one million to nearly 1.8 million, considerably outstripping the rate of growth of its neighbors Montana and Wyoming. Over the last 14 days, all three states have seen large spikes in Covid-19 cases, according to the New York Times’s Covid Map and Case Count. And they’re not alone. All the Midwest and Pacific region states are seeing similar surges. Their governors are faced with balancing increased restrictions with the personal freedom inherent in pioneering individualism.

Nowhere did this daunting task become more evident than Thursday in Idaho, a state that has seen a 55% rise in cases in the last two weeks and where, minutes after hearing local hospitals were approaching full capacity necessitating moving patients to Seattle, of all places, the regional health board voted to repeal the local mask mandate.

The regional board, composed of seven appointed members with no requirement to have any medical experience, voted 4-3 to end the mandate. Health District epidemiologist Jeff Lee had just finished describing how the state’s hospitals were becoming “overwhelmed” by the surge in cases. For example, even after doubling up patients in rooms and buying more hospital beds, the hospital in Coeur d’Alene had reached 99% capacity. But, not to worry, it’s just an eight hour, 493 mile ambulance ride from Boise to Seattle.

“We’re facing staff shortages, and we have a lot of physician fatigue. This has been going on for seven months — we’re tired,” Lee said.

He introduced several doctors who testified about the struggle COVID-19 patients face, the burden on hospitals and how masks reduce the spread of the virus. But that didn’t matter to the Board’s majority who just did not see the sense in masks, no matter what the experts said.

To put a period on the “Health” Board’s meeting, member Allen Banks got to the heart of the matter by denying the existence of Covid-19. Lecturing the medical professionals who testified, he said, “Something’s making these people sick, and I’m pretty sure that it’s not coronavirus, so the question that you should be asking is, ‘What’s making them sick?”

That penetrating question came from a gentleman with a Ph.D. in chemistry from the University of Colorado, who for 30 years has worked in medical research in biotechnology and pharmaceutical development.

Dr. Banks would make a wonderful addition to the White House Coronavirus Task Force.

How cold is cold enough?

Have you stopped to consider the logistics of delivering upwards of 200 million doses of a future Covid-19 vaccine? That’s a lot of syringes. If you laid them end to end they would stretch from the North Pole to the South Pole, about 13,000 miles.

And the vaccine would have to be kept cold, very cold. Just how cold you ask? Try minus 103 Fahrenheit. That’s nearly four times colder than your home freezer, colder even than Antarctica in the dead of winter.

This is a complex challenge. For months, manufacturers, federal and state governments, and large health care systems have been quietly planning how to navigate this ultra “cold chain” that stretches from vaccine manufacturers to hospitals, nursing homes, doctors’ offices, and many far-flung clinics. Now that Pfizer has announced it plans to apply for emergency-use authorization designation in late November for its vaccine currently in Phase 3 trials, solving the cold problem becomes more urgent.

The nation’s governors wrote the Trump Administration last Sunday expressing concerns about the supply of ultracold freezers and dry ice — already experiencing shortages. Pfizer says it has developed specially designed, temperature-controlled shipping packages, using dry ice, to keep its vials at roughly minus 103 below Fahrenheit for up to 10 days. But what happens if the doses are not used in ten days? This is what is confounding the governors.

This issue is even more difficult than it appears, because the vaccines of both Pfizer and Moderna, another leading vaccine developer in Phase 3 trials, require two shots within 21 and 28 days, respectively. The situation is eased somewhat, because Moderna’s vaccine, at around minus 4 Fahrenheit, does not require the same ultra-cold storage temperature as Pfizer’s.

Might be a good time to buy stock in a maker of dry ice.

High Deductibles: Another nail in the rural hospital coffin

Since 2010, more than 130 rural hospitals have closed, 15 thus far in 2020. One mostly overlooked reason is the health insurance deductible. Depending on the plan (employer-sponsored, ACA Marketplace, etc.) a family deductible can range from $0 (but the out-of-pockets are huge) to well over $8,000.

Families in rural communities often face deductibles in the $2,000 to $4,000 range. And when family members require hospitalization, it often happens they cannot pay the deductible. Rural hospitals are forced to eat this less than tasty bill, send it to a collections company, or set up a payment plan with the patient. They prefer the payment plan route, but this significantly delays getting the money, and the bill is often reduced because of the patient’s economic circumstances. So, the hospital goes further in the red and its patients go further in debt. The pandemic has only exacerbated this problem.

Just another example of our nation’s dysfunctional health care “system.”

How to get rid of an irritating federal employee

Despite a great swath of the public thinking otherwise, federal employees can be fired, although it is true that this happens rarely. Of the 2.1 million federal employees about 10,000 are terminated annually, according to the Merit Systems Protection Board (MSPB).

Firing a federal worker is similar to what would occur in the private sector, with one twist. In both settings, best practice recommends, and the federal system requires, the three step verbal warning, written warning, termination process. The twist comes after that. Federal employees can appeal to the MSPB, and the appeals can take a long time to adjudicate.

This past week, the Trump administration threw an interesting log on the fire when the President issued an Executive Order stripping long-held civil service protections from employees whose work involves policymaking. This will affect tens of thousands of workers, and will reduce them to being, for all practical purposes, “at will” employees, meaning they can be fired for cause or not for cause at a moment’s notice.

Under this order, federal scientists, attorneys, regulators, public health experts and many others in senior roles would lose rights to due process and in some cases, union representation, at agencies across the government.

These are not politically appointed employees who require confirmation to their positions, whom the president can terminate or have terminated by whim. Rather, they are professionals who serve as a cadre of subject-matter experts for every administration. I will let you consider the possible ramifications of this Executive Order, which to me seem profound. The Order, while not affecting a majority of the government, could upend the foundation of the career workforce by imposing political loyalty tests.

It is possible, with less than two weeks before election day, this may be more symbolic than real, because the Order requires agencies to indicate employees who would be affected by 19 January 2021, a day before the next inauguration. If Joe Biden wins the election he would be unlikely to follow through on the president’s order. But if Donald Trump is re-elected, this tectonic Order will monumentally reshape the federal service.

Think about that. Please.

 

 

 

 

The Attic Door Is Opening

October 16th, 2020 by Tom Lynch

Today is the 166th birthday of the controversial, but brilliant Irishman and playright Oscar Fingal O’Flahertie Wills Wilde. In his day, the wittiest man in Dublin, or anywhere else for that matter. And it’s the 129th anniversary of the publication of his only novel, The Picture of Dorian Gray. We’ll come back to that in a bit.

Moving to the present, we have 18 days to go, and I know you know what I mean. Eighteen unpredictable, but grueling days until 3 November, the official election day, although the election is well underway with more than 17 million votes already cast across 44 states and the District of Columbia. Democrats have voted early at four times the rate of republicans, most of whom plan on voting in person on the 3rd.

I confess for me it’s hard to focus on anything else, workers’ compensation, for instance. I’ve tried, but I keep getting sucked back into the political black hole.

Because not all states treat early balloting the same, it is highly unlikely we will know the result on the night of the 3rd, but we will certainly know at some point. To get to that point, the parties will face off in a fight to the death. Neither of them will bring a knife to that gunfight. The Supreme Court may step in à la Bush v. Gore. Given recent shenanigans, won’t that be interesting?

Last night during Joe Biden’s Town Hall in Philadelphia, George Stephanopoulos asked the former Vice President what he’d do if he lost. Biden said he’d probably go back to teaching and working at The Biden Institute within the Biden School of Public Policy and Administration at the University of Delaware (he taught constitutional law from 1991 to 2008 – bet you didn’t know that). He said he’d also continue working on the causes he’s advocating during the campaign.

Samantha Guthrie asked the same question of President Trump at his simultaneous, split screen Town Hall in Miami, but couldn’t get a similar rational response that he’d go quietly into that good night. I have the feeling that if the President loses we’re in for Hellzapoppin’.

During his presidency, Donald Trump, who, during the 2016 campaign famously said, “I could stand in the middle of Fifth Avenue and shoot somebody, and I wouldn’t lose any voters, OK?”, has been more teflon-coated than any of your expensive kitchenware. Fiascos that would annihilate Paul Bunyan just bounce off. But since mid-way through the pandemic, things seem to have changed. Recent polling from Reuters/Ipsos shows 59% of likely voters believe he has managed our healthcare horrendoma poorly. And in the last few weeks it’s been one thing after another tarnishing his image. While his followers remain religiously devoted, the rest of the nation seems to be turning on him. At last night’s Town Halls, Biden was calm, thoughtful and engaging with his questioners, going so far as to ask one young man to stay after the Town Hall so they could talk some more. Trump, on the other hand, was, well, Trump, on defense, but in fighting mode, nonetheless.

All of which brings us back to Oscar Wilde and The Picture of Dorian Gray. In the novel, Dorian Gray, a handsome and hedonistic young man, sells his soul à la Faust, but with a twist. A famous artist paints his portrait, which Dorian puts in the attic of his home. Over the years, the young man in the portrait in the attic ages in a gruesome, hideous way, but not Dorian himself, who lives a life of debauchery and cruelty. Finally, in a fit of remorse, he slashes the painting. Servants below hear agonizing cries, rush to the attic and break down the door, only to find an unrecognizable and very dead old man lying in front of the painting, restored to its original beauty.

Donald Trump’s attic door is beginning to crack open.

Like BBs In A Boxcar

October 12th, 2020 by Tom Lynch
Turning and turning in the widening gyre   
The falcon cannot hear the falconer;
Things fall apart; the centre cannot hold;
Mere anarchy is loosed upon the world….
The best lack all conviction, while the worst   
Are full of passionate intensity.
          The Second Coming, by William Butler Yeats

 

One thing COVID-19 has certainly done is to expose many of the foundational flaws in America’s healthcare house that Jack built, the house that “cannot hold.” From the Trump administration’s helter-skelter response, to the unequal treatment of Blacks and Latinos, to the near total reliance on China for PPE, to the exacerbating plight of rural hospitals, to jaw-dropping surprise bills, to something as granular as the price of insulin, and the list goes on.

To illuminate the dire situation even more, the Kaiser Family Foundation last week published its annual Employer Health Benefits Survey, which showed the average annual premium for a family of four has grown 4% over the last year, more than doubling the rate of inflation, and has now reached $21,342, with worker contributions averaging $5,588. Add in the average deductible of $4,000, along with copays of $40, and employees get their hair-raising, once-a-year healthcare sticker shock.

In 2020, the U.S. is spending 18% of GDP on healthcare, according the Office of the Actuary within the CMS. For years, I’ve been quoting Herb Stein’s Law: “If something cannot go on forever, it will stop.” And for years, I’ve been wrong. This cannot be sustainable, but so far it has been.

A distant second-most-costly-country-in-the-world is Switzerland, at 12.1% (which is what the U.S. spent 30 years ago in 1990). The Swiss, as do many other OECD countries, have a decentralized system similar to ours, a blend of public and private-pay healthcare, with two important differences: First, since 1996, government, wanting to spread the pool, has required the Swiss people to purchase healthcare insurance, similar to the Affordable Care Act’s individual mandate (which Congress eliminated when it passed the Tax Cuts and Jobs Act of 2017, effective 1 January 2019). The result is for more than 20 years the Swiss have nearly 100% participation, but not the U.S.; our rate of the uninsured is going up, not down, made worse, much worse, by job, and consequently health insurance, losses due to the pandemic. Second, government plays a large role in establishing prices, especially for pharmaceuticals.

I think we can say with total certainty that, regardless of what you hear or read, nobody knows what healthcare in America will look like a year from now. If Trump wins reelection and republicans hold the senate, the ACA, or what’s left of it, could find itself buried deep beside Davy Jones’s locker at the bottom of the ocean, and what would come after that? Back to square one. People, our fellow citizens, our friends and relatives with chronic conditions, would once again find themselves walking down the edge of an economic razor blade.

There are four possible outcomes:

  1. Trump wins and republicans hold the senate, as above;
  2. Trump wins and democrats take the senate, resulting in stalemate, but the Trump reality show continues;
  3. Biden wins and democrats take the senate, in which case big changes are coming; and,
  4. Biden wins and republicans hold the senate, resulting in stalemate, but we’re saved from Trump’s histrionics (one hopes).

Options three and four spare us the president’s governing style, which is to say, chaos. For four years we have been subjected to his whipsawing and dangerous administration. His policies, personality and pronouncements seem to bounce around like BBs in a boxcar. Never more so than in the last few weeks. Things change by the hour. Nothing is predictable, except unpredictability.

We are moving inexorably into the winter of our continuing discontent. God help us all.

COVID-19 Analysis from Jennifer Christian, M.D., M.P.H.

September 21st, 2020 by Tom Lynch

I have written before of my great admiration for Dr. Jennifer Christian and for her Work Fitness and Disability Roundtable (WFDRoundtable@groups.io). The Roundtable is a mainstay for clinicians and other health care professionals.

I thought this morning’s Roundtable post by Jennifer to be particularly thoughtful and thought-provoking, so I asked her if she would allow us to republish the post in its entirety here at the Insider. She very kindly gave permission.

I think Jennifer is one of those brilliant three or four folks I’m lucky enough to know who think around corners. Her mind makes intuitive leaps where others (like mine) plod along.

Here is Jennifer’s post:

How many people have some pre-existing immunity to COVID-19

There is growing uncertainty about what this fall and winter is going to look like with regard to the COVID-19 pandemic.  Are we going to have a second, and possibly even bigger wave of worldwide infections — or is the biggest part of this pandemic over and done with once each geographic area has had its first wave?

A new review from the British Medical Journal says researchers may have been paying too much attention to antibodies and too little attention to a second part of the human immune system that protects against and reacts to infections:  T cells.   More on this in a moment…..

But first, a reminder.  We are in the middle of the first large-scale pandemic with a new and highly contagious respiratory pathogen since the field of immunology was born!   Immunology is still quite young compared to other specialty areas in biological science and medicine.  It was only in the mid-20th century that advances in cell biology started making it possible to study the detailed processes that make up the immune response in detail.  That has led to much deeper understanding of the mechanisms by which vaccines work, to the development of the first cancer chemotherapy agents that selectively killed rapidly-proliferating immune cells, and to the development of immune-modulating drugs, which enable the transplantation of organs by muting the body’s natural rejection of foreign tissues.

The appearance of HIV/AIDS in the 1980’s again precipitated huge leaps in funding for research to increase our understanding of the immune system, which in turn highlighted the function of T cells and other previously unrecognized aspects of it.   However, in comparison to other bodily systems and organs, our knowledge of the human immune system is still primitive — it’s obvious there is much left to learn — and some of what we don’t know may seem very basic!

If you’re an immunologist, virologist, epidemiologist — or a public health officer trying to figure out how to protect and guide your local population — this is the overwhelming challenge of a lifetime.  Personally, I hope that the media and the general public will remember that this pandemic has attacked our society at the very edge of what is known.  All of those professionals are working at a feverish pace to observe carefully, assemble enough data to be confident they have enough to detect a real pattern if it’s actually there, make sense of what they are seeing, and then figure out the implications for action.  Let’s agree to be forgiving of the fact that “the facts” have not all been revealed to us yet, and “the scientists” simply don’t yet know everything we wish they did.

Back to the T cell story.   Researchers have shown that people with the most severe cases of COVID-19 (the ones in ICU and who are most likely to die) often have low T cell levels.  But some other puzzling data has appeared. For example:

  • some countries — and especially some areas within those countries that had bad initial outbreaks — have not seen widespread new infections despite having relaxed protective restrictions; and,
  • blood tests in a noticeable fraction of people with no record of exposure to SARS-CoV-2 virus show some of the T cells reacting weakly to it anyway — indicating a potentially partial immune response.

This has led scientists to start wondering whether we really know enough about the human immune system’s ability to develop partial T cell “cross-reactivity” to families of closely-related viruses and whether that might predictably and reliably reduce the severity of illness or even reduce the likelihood of getting ill at all when a new-but-related virus appears.   And, that, of course, raises some possibilities that need to be investigated:

  1. Does cross-reactivity explain why some geographic areas that had first pandemic peaks are not seeing second ones — because the people who got sick had no immunity and were more susceptible, and most of the remaining ones have some limited immunity which is protecting them?
  2. Does cross-reactivity explain some of the disparity between people who get deathly sick from COVID-19 and people who are exposed to the virus but never get infected, or, if they do, remain asymptomatic or have only mild illness?  Note that there are two  possibilities:  Cross-reactivity could be making the illness worse or it might be making it less severe — we don’t know yet.
  3. How could cross-reactivity be protective if it develops after prior exposure to coronaviruses, because children are the least likely to get a severe case of the disease and adults are the most susceptible to severe COVID-19 illness and death?  (Children have not had a lifetime of colds, and thus less opportunity to be exposed to coronavirus and develop partial-immunity to SARS-CoV-2)

In short, my best advice as of 21 September 2020 is:

  1. Stay tuned for further developments in the factual realm – both changes in case counts and new research results;
  2. Hope for the best but prepare for the worst as autumn approaches and we all retreat indoors.

COVID-19 Update

September 18th, 2020 by Tom Lynch

To close out your week we offer a few items that may have flown nap-of-the-earth under your radar.

The AstraZenica/Oxford vaccine bump in the road

On 8 September AstraZenica (AZ) halted its Phase 3 study, because one of its study participants came down with Transverse Myelitis, a neurological condition affecting the spine and caused by infection, immune system disorders or other disorders that can damage or destroy myelin, the fatty tissue that protects nerve cell fibers.

The UK has allowed AZ to restart its study there (AZ is a UK-based company), but as of this writing, the U.S. has not. In fact, in an interview with Kaiser Health News, the National Institute for Neurological Disorders and Stroke’s Avindra Nath said “the highest levels of NIH are very concerned.” According to Nath, the NIH has yet to access tissue or blood samples from the patient, who was part of the U.K. portion of AZ’s Phase 3 study. NIH believes AZ is being far too coy with its data. Nath called for the company “to be more forthcoming,” adding that “we would like to see how we can help, but the lack of information makes it difficult to do so.”

Given this halt in the U.S. study, it is not inconceivable that, if the AZ vaccine, known as AZD1222, proves efficacious and safe in the UK, regulators there could approve it for general use well before the U.S. does. This would not make our Commandeer in Chief happy.

The Mask versus Vaccine dust up

Speaking of the Commander in Chief, he recently took CDC Director Dr. Robert Redfield for a quick walk to the woodshed for suggesting during testimony to a Senate subcommittee, “Masks are more guaranteed to protect me against COVID-19 than a vaccine.”

President Trump, who is not a doctor, but repeatedly plays one on TV, took exception to this. He publicly chastised Redfield for his comments and said a vaccine could be available in weeks and go “immediately” to the general public. Diminishing the usefulness of masks, despite a wealth of scientific evidence to the contrary, he said his CDC chief was “confused.”

Well, no, he wasn’t. Redfield told subcommittee members that if everyone in the U.S. would wear masks in public the pandemic could be under control within 12 weeks. His issue with a vaccine lies in its degree of immunogenicity, which he suggested would be in the area of 70%, meaning if 100 vaccinated people are exposed to the virus, 30 of them will have insufficient protection to ward it off. Those 30 will probably be comprised of groups who are most susceptible to the vaccine now, like the elderly.

People, masks will be with us for a long time.

Health insurance losses

Before the pandemic, 49% of Americans got health insurance through employer sponsored insurance (ESI). COVID-19 has reduced that percentage, because 6.2 million of our neighbors have lost their jobs and, consequently, their health insurance. When you factor in spouses and children, the number of people who have been shoved out the door into the COVID cold becomes 12 million.

Researchers at the Economic Policy Institute (EPI) have recently documented the losses in a new study. Researchers Josh Bivens and Ben Zipperer write:

  • Extreme churn after February 2020 has led to very large losses in ESI coverage. In March and April, for example, new hiring led to 2.4 million workers gaining ESI coverage each month, but historically large layoffs led to 5.6 million workers losing coverage each month. This rate of lost coverage—over 3 million workers—dwarfs a similar calculation for the number of workers losing coverage each month during the biggest job-losing period of the Great Recession (September 2008–March 2009). Our analysis using the monthly, high-quality measure of the total number of jobs in the economy from the Current Employment Statistics (CES) program of the Bureau of Labor Statistics (BLS) is consistent with 9 million workers having lost access to ESI in March and April 2020 but 2.9 million workers having gained coverage between April and July 2020.

Bivens and Zipperer say about 85% of those who lost ESI coverage were able to gain at least some coverage either through a spouse’s plan, the Affordable Care Act or state Medicaid programs, but that still leaves about a million laid off workers and their familes with nothing. Bivens, Zipperer and others argue the job losses have only worsened the public health crisis created by COVID-19.

Of course, recognizing that millions of people losing employer sponsored health insurance is a public health crisis is not the same as fixing the system to prevent it from happening again. However, as I have written before, having exposed gross inadequacies in the nation’s health care system, COVID-19 also provides opportunities for improvement. What is needed now is the determined motivation and will to make that happen. That is a Herculean task about which I wish I were more optimistic.

Sisyphus Must Have Felt Like This

September 16th, 2020 by Tom Lynch

The COVID-19 boulder, full of facts, lies, information, misinformation, disinformation, and just plain delusional thinking keeps rolling back down the mountain. Try as we might, it’s certainly difficult to make sense of COVID-19. But we keep trying, anyway. As in:

Unions during COVID-19

I have written previously about the perplexing case of union participation in America. In 1960, about a third of hourly workers belonged to unions. In January of this year, the BLS reported that number had dropped to 10.3%. Yet, in the same press release, the BLS reports:

Nonunion workers had median weekly earnings that were 81 percent of earnings for workers who were union members ($892 versus $1,095).

Right now we won’t get into why this puzzling paradox exists, except to say we now have another log to throw on the pyre.

A new study authored by researchers at George Washington University, the University of Pennsylvania Perelman School of Medicine and the Boston University School of Medicine, published in Health Affairs, found that having a unionized workforce at a nursing home greatly reduces the likelihood that residents or staff will die from COVID-19. From the study’s Abstract:

Health care worker unions were associated with a 1.29 percentage point mortality reduction, which represents a 30% relative decrease in the COVID-19 mortality rate compared to facilities without health care worker unions.

The study analyzed data from more than 300 nursing homes in New York from March 1 through May 31. The authors conclude the unionized health care workers in the nursing homes were able to negotiate for more PPE, higher pay, and better working conditions.

During the pandemic, New York has suffered nearly 7,000 nursing home deaths, more than any other state except New Jersey.

My take on this? If you have loved ones who may be headed for a nursing home, it might be a good idea to ask if the staff is unionized.

Avoiding medical care during COVID-19

Since early in COVID-19, we’ve known that many people, fearful of the disease, have put off getting routine, or, in some cases, emergency medical care. What we have not known is what demographic groups are doing that and to what degree. Now, the CDC has put a full stop period to that issue.

In its 11 September weekly Morbidity and Mortality Report, the CDC published a comprehensive analysis concluding 40.9% of U.S. adults delayed or avoided medical care as of June 30. This includes urgent or emergency care (12%) and routine care (32%). Regarding what population segments are doing this, the study had this to say:

The estimated prevalence of urgent or emergency care avoidance was significantly higher among the following groups: unpaid caregivers for adults versus non-caregivers (adjusted prevalence ratio [aPR] = 2.9); persons with two or more selected underlying medical conditions† versus those without those conditions (aPR = 1.9); persons with health insurance versus those without health insurance (aPR = 1.8); non-Hispanic Black (Black) adults (aPR = 1.6) and Hispanic or Latino (Hispanic) adults (aPR = 1.5) versus non-Hispanic White (White) adults; young adults aged 18–24 years versus adults aged 25–44 years (aPR = 1.5); and persons with disabilities§ versus those without disabilities (aPR = 1.3).*

So, Mary, taking care of her aged mother at home, foregoes either emergency or routine care at nearly three times the rate of Sarah, her next door neighbor who is not burdened with an aged relative, because she doesn’t want to bring COVID-19 home to Mom. Even more troubling is that people with two or more co-morbidities forego care at nearly two times the rate of people without such underlying conditions.

The CDC’s paper advises that, “… urgent efforts are warranted to ensure delivery of services that, if deferred, could result in patient harm.”

Enough said.

*By way of example for the statistically challenged, an adjusted prevalence ratio of 2 means that the prevalence of cases among a study group is 2 times higher than among the control subjects. It’s calculated through a series of regression analyses. There. Now you know.

U. S. life expectancy

COVID-19 has sucked all the air out of any national attempt at healthcare reform, while revealing in sharp detail the foundational flaws in the current system. Eventually, however, America is going to have to confront this issue in a meaningful manner. Healthcare cost in America is still twice the average of all 37 member countries of the Organization for Economic Cooperation and Development (OECD), and Americans still have poorer health and lower life expectancy than the average of the member countries (78.7 versus 79.5)

In its latest Health At A Glance publication, the OECD updated its life expectancy data, as shown here:

There are many cracks in our healthcare house that Jack built. Ignoring them is not a strategically viable plan for improvement, improvement that all citizens deserve.

To quote the venerable A. E. Housman, “Terrence, this is stupid stuff.” Another example of our woebegone healthcare system.

Trump’s Nevada rally

Last night, during an ABC-TV Town Hall Meeting President Trump once again pilloried cities and states run by Democrats and blamed their leaders for any problems with the response to COVID-19.

A little contextual background is required here. On 14 April, Trump asserted “absolute authority” to control the nation’s response to the pandemic, saying, “When somebody is president of the United States, your authority is total.” He made it clear he would be in charge and the states would have to fall in line.

Two days later, he reversed himself on a call with all the governors, telling them, “I’ve gotten to know almost all of you, most of you I’ve known and some very well. You are all very capable people, I think in all cases, very capable people. And you’re going to be calling your shots.”

Since then, he has repeatedly repeated the “You’re on your own” line. The result, of course, has been that we have seen 51 different plans and approaches  with varying degrees of success.

Nevada, one of the “you’re on your own” states, is still in the midst of a tough fight against the disease with a Daily Positivity Rate of 7.1% and a Cumulative Positivity Rate of 10.2% as of 10 September.

On 24 June, Nevada Governor Steve Sisolak imposed certain restrictions, among them the requirements that all Nevada residents wear masks when in public and that no more than 50 people, socially distanced, congregate in one place.

Enter Donald Trump and his the-sky-is-the-limit indoor rally of last Sunday evening at Xtreme Manufacturing in Henderson, Nevada. Fire officials estimated the size of the crowd was 5,600 people, nearly all of whom were maskless (except for the people right behind Trump who were constantly on full TV view).

Just as we saw in Tulsa after his previous rally, we’ll probably see a spike in cases in Nevada in two to three weeks.

Beyond the nonchalant and willful endangerment to peoples’ lives, what bothers me most of all about this event is Donald Trump’s cavalier and metaphorical raising high of his two middle fingers to Nevada’s scientifically-based efforts to keep its citizens alive. After repeatedly telling the nation’s governors they should do what they think they need to do to combat COVID-19, this “law and order” president, without compunction of any kind, imperiously violates the law while telling his large crowd Nevada’s Governor Sisolak is “a hack” and “weak.”

Allow me to close with Joseph Welsh’s question to Senator Joe McCarthy on 9 June 1954: “Have you no decency, sir?”

 

The Pledge, AstraZenica’s Hiccup, An Important WCRI Study, And An Homage To Bourbon!

September 9th, 2020 by Tom Lynch

Having put The Insider on pause for a few weeks to have some fun researching pandemics in earlier times (they were awful) and to improving my tennis game (it’s pretty good), we now dive back into the blogging fray. Today, we get a running start.

The Pledge

At a press conference on 24 August, President Trump and FDA Commissioner Stephen Hahn trumpeted (pun very much intended) the FDA’s Emergency Use Authorization (EUA) of blood plasma to treat COVID-19 patients.  The Trump/Hahn announcement came less than a week after officials at the National Institutes of Health (NIH) had put a hold on releasing the EUA, saying randomized trials were needed before such an action could occur. The President disagreed, saying, “There are people in the FDA and actually in your larger department [HHS] that can see things being held up and wouldn’t mind so much — its my opinion, a very strong opinion — and that’s for political reasons. We are being very strong and we are being very forthright, and we have some incredible answers, and we’re not going to be held up.”

In yet another example of Olympian Hyperbole, a disease to which Mr. Trump seems to be terminally infected, he also called the EUA a “truly historic announcement,” which puts it alongside something like the Emancipation Proclamation.

Like most of Trump’s hyperbolic pronouncements, the blood plasma EUA created quite the controversy, especially when the FDA released the comments of one of its own scientists tasked with reviewing the appropriateness of the same blood plasma EUA. That scientist— displaying far less enthusiasm than Trump and Hahn, and whose name was redacted from a memo released by the agency — wrote that the data:

 “…support the conclusion that [convalescent plasma] to treat hospitalized patients with COVID-19 meets the ‘may be effective’ criteria for issuance of an EUA. Adequate and well-controlled randomized trials remain nonetheless necessary for a definitive demonstration of … efficacy and to determine the optimal product attributes and the appropriate patient populations for its use.”

After the 24 August press conference, it took about 1.5 nanoseconds for Joe Biden and many media pundits to accuse Trump and Hahn of politicizing the EUA to influence the coming election.

Which brings us to The Pledge.

On 8 September, wanting to get out of firing range, the CEOs of all the leading Western developers of COVID-19 vaccines vowed to only file for FDA approval after demonstrating safety and efficacy in their Phase 3 trials. Their Pledge and descriptions of all nine trials can be found here.

The Pledge also promises all the developers will share some, but not all, of their data to propel their vaccines to the finish line. However, although every CEO wants their vaccine to be the first approved, not one of them wants to get there only for the world  to discover they’ve cut corners and now endanger humanity. These are people who want to go down in history for the right reason.

Mr. Trump will push, prod and kick these vaccine developers to get one of their efforts approved before 3 November. But I have a 95% confidence level none of them will buckle under that pressure. I sure hope I’m right.

AstraZenica’s Hiccup

In an example of the caution just described, yesterday AstraZenica announced  it was putting its Phase 3 vaccine trial on hold, due to a suspected serious adverse reaction in a participant in the United Kingdom.

This is not an uncommon happening in vaccine development, but it does show how fraught with uncertainties these trials can be. It proves that AZ’s data and safety monitoring group is doing its job, and that’s what is supposed to happen. I previously wrote about all the leading COVID-19 vaccine candidates, as well as ChAdOx1, the one being tested by AstraZenica in partnership with the University of Oxford’s Jenner Institute.

It is entirely possible we will experience more bumps in the road before one of the developers wins FDA approval.

An Important, New WCRI Study Is Released

Low back pain (LBP) is something that has afflicted humanity since Homo Sapiens decided to stand straight and walk upright. And it’s been the bane of claims adjusters since Otto von Bismarck, Germany’s Iron Chancellor, created the first workers’ compensation program in the 1880s.

Back injuries are the leading cause of all musculoskeletal claims, which are the leading cause of all workers’ compensation claims, and have been since it seems forever. If you’ve ever looked at a workers’ compensation loss run for any hospital in America, you’ll know what I mean.

One of the myriad treatment modalities for these claims is physical therapy (PT). However, it’s always been a bit of a crap shoot as to when to prescribe PT for a patient beset by a work injury resulting in low back pain.

Now, the Workers’ Compensation Research Institute (WCRI) has produced a study that convincingly puts the matter to rest. The study’s conclusion: the earlier PT is begun, the better.

The study, The Timing of Physical Therapy for Low Back Pain: Does It Matter in Workers’ Compensation?, is based on a review of  nearly 26,000 LBP-only claims with more than seven days of lost time from 27 states, with injuries from 1 October 2015, through 31 March 2017, and detailed medical transactions up through 31 March 2018.

One of the many reasons this study is important is that PT can sometimes be the last resort, not the first, in many cases being recommended only after opioids and other invasive procedures have been tried.

The WCRI study found:

  • Later timing of PT initiation is associated with longer temporary disability (TD) duration. On average, the number of TD weeks per claim was 58 percent longer for those with PT initiated more than 30 days post-injury and 24 percent longer for those with PT starting 15 to 30 days post-injury, compared with claims with PT within 3 days post-injury.
  • Workers whose PT treatment started more than 30 days post-injury were 46 and 47 percent more likely to receive opioid prescriptions and MRI, respectively, compared with those who had PT treatment initiated within 3 days of injury. The differences between PT after 30 days post-injury and PT within 3 days post-injury were 29 percent for pain management injections and 89 percent for low back surgeries.
  • The average payment for all medical services received during the first year of treatment was lower for workers with early PT compared with those with late PT. For example, the average medical cost per claim for workers who had PT more than 30 days post-injury was 24 percent higher than for those who had PT within 3 days post-injury.
  • Among claims with PT treatment starting more than 30 days post-injury, the percentage with attorney involvement was considerably higher (27 percent compared with 13–15 percent among those in the early PT groups) and workers received initial medical care much later (on average 18 days compared with 2–3 days in the early PT groups).

If you’re a claims adjuster wary of incurring the cost of sending injured workers with resultant low back pain to PT, this study should make you press the “Reset” button in your mind.

And, finally, an homage to bourbon (which is also good for low back pain)

In the constant sea of terrible, divisive, set-your-hair-on-fire news, we now row to a bipartisan safe harbor: Bourbon.

In the halls of Congress, bipartisanship seems to have gone the way of the Woolly Mammoth. But, reader, that is not the case in the case of Bourbon! That’s because on 2 August 2007, Congress ratified a bill designating September as National Bourbon Heritage Month. More notable, however, is that it passed unanimously. Thus, history shows that amid the countless issues and places and opinions that divide us, nothing unites Americans like bourbon.

And that aint all. A 1964 act declared bourbon “America’s Native Spirit,” making it the only spirit distinctive to the United States, if you don’t count the “spirits” the QAnon folks are worried about.

So, although I can’t stand the stuff, on this first day after 2020’s Labor Day as we all get sucked along the giant tube of political rigarmarole, you might want to consider the nationally endorsed benefits of America’s Native Spirit. Things will still be dire, the President will continue his hyperbolic rants, many of your fellow Americans will continue to “choose liberty” over masks, but you? You’ll hardly notice any of it.

 

 

COVID-19 Update And Promising Vaccine Reports

August 10th, 2020 by Tom Lynch

An alarming and disquieting milestone

Yesterday, we passed the five million mark. Five million confirmed cases of COVID-19 in America since January. To put this in a better perspective consider this: If you took every one of those five-million people and stood them shoulder to shoulder, the line would extend from Canada to the Mexican border. About 2,200 miles.

As for deaths, we have reached 163,000, and still rising with no end in sight. That number is more than three times the number of American soldiers who died in World War 1. More than three times the number of American soldiers killed during the 16-year Vietnam War.

This continuing death spiral is happening as Congress and the Administration are, as legendary Boston sportscaster Johnny Most used to say, “fiddling and diddling.” And all this fiddling and diddling is going on while millions of our fellow citizens watch their livelihoods and their dreams of a better life for them and their children dissolve into thin air.

We deserve better than this. Fiddling and diddling with a human tragedy of this magnitude is an obscene abomination.

Vaccine update

In the pre-clinical biotech world, we call them non-human primates. To everyone else, they’re monkeys, usually rhesus monkeys.

We have reported, and I’m sure you’re aware, that a number of companies have entered Phase 3 clinical trials testing their vaccines on thousands of people. Until COVID-19, that always followed years of pre-clinical work that usually began with mice. But because regulators have compressed and redesigned the vaccine development process, companies and institutions are running their pre-clinical and clinical trials simultaneously, in parallel.

Now, four groups have reported promising results with non-human primates, those rhesus monkeys. All of the approaches are different, but they settle into two methodologies:

  • Attacking SARS-CoV-2, the virus that causes COVID-19, through Messenger RNA.
  • Using a replication-deficient chimpanzee adenovirus to deliver a SARS-CoV-2 protein to induce a protective immune response.

You don’t really need to understand the science. What is important to know is all four groups reported that their vaccines have shown promising results in monkeys. The critical thing here is this: Three or four weeks after vaccinating the monkeys, each of the groups put SARS-CoV-2 into the monkeys’ noses. Each of the vaccines offered protection for the monkeys. Three of the four groups gave the vaccine in two shots, a prime followed weeks later by a booster.

The team of Oxford University and AstraZenica injected with one shot. Their results presented some concerns. While their vaccine prevented the monkeys from developing pneumonia, it did not clear the virus, indicating the vaccinated monkeys remained infected and able to spread the disease. It should be noted that the scientists infected the monkeys with ten times the viral load that a person would experience. Still, the group said protection might have been significantly enhanced had they given two shots.

These monkey trials are tremendously important, because scientists can give the monkeys their vaccine and then infect them with SARS-Cov-2, something they cannot do with their human volunteers in their Phase 3 trials.

The four groups are:

  • Moderna, working with the Swiss company Lonza, New Jersey-based Catalent and the National Institutes of Health. Its vaccine, mRNA-1273, contains snippets of viral mRNA, a molecule with instructions for making proteins. Moderna packs the mRNA inside a slippery pod made of lipids, so it can slide easily into the cells.
  • Oxford University’s Jenner Institute, working with AstraZenica. Its vaccine, ChAdOx1, uses a replication-deficient chimpanzee adenovirus to deliver a SARS-CoV-2 protein to induce a protective immune response. Their approach has been successful before as the first Ebola vaccine.
  • Pfizer, working with BioNTech, a German biotechnology company. Their vaccine, BNT162b2, also takes the mRNA route encoding an optimized version of the whole spike protein, which we wrote about here.
  • Johnson & Johnson, working with Beth Israel Deaconess Medical Center in Boston. Its vaccine candidate, Ad26.COV2.S, delivers the SARS-CoV-2 spike protein into cells using an inactivated common cold virus as the delivery vehicle. J & J gave a single shot of Ad26.COV2.S, and that provided significant immunity to COVID-19. But previous J & J studies showed giving a second booster shot raised the antibody response by tenfold in both animals and people.

All of this is promising, indeed. It is evidence we should be optimistic that we’ll have one or more effective vaccines by early 2021. However, it is worth noting that the road to a successful vaccine is littered with the decaying carcasses of failures.

 

 

When This Is Over, We Must Do Better!

August 6th, 2020 by Tom Lynch

For decades, we have swept our health care problems under the rug for posterity to trip over.    And right now, posterity is flat on its face.

Let me ask you this: Whether you believe high quality health care is a basic human right or just a privilege to be earned (I argued the former here), what do you think about 5.4 million Americans losing health insurance in the middle of the worst health care crisis in more than 100 years, because they lost their jobs?

One of the many terrible things COVID-19 has done is to expose our health care foundational flaws for all the world to see. For example, if there is ever a time not to lose health insurance it is during a pandemic. Another deep and open wound suddenly exposed to bright light is the abominable, even obscene, way in which COVID-19 has been allowed to impact the African American, Native American and LatinX communities. Health care is neither universal nor applied equally throughout the country.

As far back as 2008, I, along with others, documented the many ways our health care system, if you can call it that, lags behind the rest of the developed world*, in some case far behind. This, despite costing twice as much as the average of the other 36 member countries in the Organization for Economic Cooperation and Development (OECD), 25 of whom are members of the European Union. Since then, except for the passage of the Affordable Care Act (ACA), things have only gotten worse, and the ACA has been flayed, gutted and nearly beaten to death more than once. It should not, but it does to many, come as any surprise that the EU countries are performing significantly better in the battle against COVID-19 than we are, despite having a total population that is 27% greater than America’s. These two charts prove the point:

First, Population – From the World Bank:

Second, COVID-19 cases – from Johns Hopkins University and Statista as of 30 July, seven days ago:

What more does one need to see to conclude America’s response to COVID-19 has been tragically woeful?

Yesterday, I was speaking with a friend, a pulmonologist who has been on COVID-19’s front lines in Massachusetts since March. He and his patients, a number of whom are no longer with us, have been through a lot. His biggest complaint? The lack of “consistent, cohesive and comprehensive leadership from the federal government.” He said, “I’m a God-fearing man, but right now my God is science.”

The rug under which we swept our problems has been pulled up, and bad things have crept out into the light of day. But COVID-19, for all its horror and misery, has presented us with an opportunity. When this is over, and someday it will be, we will have an opportunity, nay, an imperative, to build a better American health care program, less fragmented, less costly, less complicated, and universally provided to every person within the confines of our nation’s borders. If the leaders we elect have even a modicum of courage, if they have entered public service to actually serve the public – all of it – we and they may be able to take the iniquity of this virus and leverage it to the point where health care in this nation, rather than having to be earned as a privilege, available only to people who can afford it, becomes a basic human right for all of us.

* The link is to the conclusion of a 5-part series. For the first four parts, enter “The best health care in the world” in the search box on the right sidebar

 

Why Dr. Fauci Is “Cautiously Optimistic”

August 3rd, 2020 by Tom Lynch

As I’ve previously written, until now, vaccines have taken years to develop. The fastest until now? The Mumps vaccine, developed and approved in four years (1963 – 1967) by Maurice Hilleman.

In recent times we have the Ebola vaccine, approved in the U.S. in 2019. Scientists from around the world had tried to develop a vaccine for this deadly disease since the mid-1990s, but funding and, let’s face it, lack of interest in an African disease, continually stalled the work. But a large outbreak in the Democratic Republic of Congo in 2014 reignited Pharma’s interest, and last December the FDA approved Merck’s Ervebo vaccine. It took five years.

Now we have COVID-19, the disease caused by  SARS-CoV-2 (the scientific name of the new coronavirus), and immunologist Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases since 1984, is “cautiously optimistic” we’ll have a vaccine by the end of the year. This means we could have needles going into arms in less than a year since the first case was reported. How is that so?

Although Donald Trump would probably swallow his smart phone rather than acknowledge this, we owe a debt of gratitude to the Chinese for the quick start. In early January, before the disease even had a name, a team of Chinese scientists uploaded its genetic sequence to a public site. This kicked off the gold rush-like vaccine hunt. Here are some facts that contribute to the light-speed development:

  • The disease is a coronavirus. Scientists have been trying to develop vaccines for this family of diseases for decades. Coronaviruses are diseases that can leap from animals to humans, and much work had already been done. Vaccine projects currently underway were simply redirected to SARS-CoV-2.
  • Many of the vaccine teams now attacking SARS-CoV-2 had worked on the SARS virus, which in 2003 killed 800 people, and the MERS virus, which has killed 2,500 people since 2012. They were deep into coronaviruses.
  • The earlier projects had identified a part of coronaviruses called the spike protein as a potential target for a vaccine. In particular, the work on SARS had suggested strongly that the spike protein was the key. Moreover, that work had already identified the difficulties inherent in attacking the spike protein.
  • Most people recover from COVID-19. That indicates a conquering immune response that a vaccine can be targeted to induce in people.
  • The spike protein, which gives SARS-CoV-2 the crown-like appearance that’s characteristic of coronaviruses, attaches to receptors on people’s cells, allowing the virus to enter and replicate. By blocking spike proteins, then, vaccines may prevent infection.
  • Money is no object. Because COVID-19 is the biggest health crisis the world has faced in more than 100 years, governments are shoveling unheard of amounts of cash into vaccine development. If vaccine developers don’t have to worry about funding their work, they can try anything and everything without worry. And, most important, the traditional steps taken in vaccine development can be shortened and compressed, which is exactly what’s happening.
  • Government regulators learned a lot from Ebola. During the development of Ervebo, they adopted a new dexterity in streamlining decisions and a nimbleness in communication. That has continued over to COVID-19. Case in point: the FDA has let developers know that vaccines need to prevent infections or reduce the severity of Covid-19 in 50% of recipients to be approved.

Here is where we are now in vaccine development according to the New York Times Coronavirus Vaccine Tracker:

If you’re wondering about that one “Approval” on the far right, that is a vaccine developed by the Chinese company CanSino Biologics. Hong Kong-listed CanSino Biologics said in a filing to the stock exchange that data from clinical trials showed the Chinese military vaccine had a “good safety profile” and potential to prevent disease caused by the novel coronavirus. Consequently, on 25 June, China’s Central Military Commission approved the use of the vaccine for one year. The rest of the world has no idea of whether this vaccine works. One wonders what the soldiers in the Chinese Armed Forces who are being injected with it think of it.

If history is any predictor of the future, most of the vaccines currently under development will fail. However, the sheer size of the effort, as well as the mountains of work already done on SARS and MERS, suggest that Dr. Fauci’s cautious optimism may, indeed, be well founded.