Archive for the ‘Research’ Category

Now What?

Tuesday, February 16th, 2021

The Trial of the Century —  So Far

During and after the second impeachment trial of Donald Trump, even Republicans admitted the House Managers had done a masterful job of presenting their case. Having voted the trial constitutional by a margin of 55 – 45, the Senate subsequently acquitted Trump with Republicans contending the trial was an unconstitutional abuse of power. And, as I have written earlier, that became the painted hook on the Senate wall upon which they hung their acquittal hats, all 43 of them.

The entire proceedings seemed scripted and predicable — that is, until Saturday morning, originally scheduled for closing arguments. That was when the leader of the House Managers, Representative Jamie Raskin, of Maryland’s 8th Congressional District, announced that overnight the Managers had learned of a phone conversation between House Minority Leader Keven McCarthy and President Trump at the height of the insurrection on the 6th. Representative Jaime Herrera-Beutler, Republican of Washington, had issued a statement saying McCarthy had described the conversation to her, a conversation in which McCarthy had begged Trump to forcefully call off the mob. Trump had dismissed the request cavalierly, saying, “Well, Kevin, I guess these people are more upset about the election than you are.”

Herrera-Beutler, one of the ten House Republicans who voted for impeachment, had said she was willing to testify under oath about the conversation with McCarthy, and that’s what Manager Raskin said was going to happen. Instead, Hellzapoppin happened.

Trump defense attorney Michael van der Veen, who is a personal injury lawyer, not a civil liberties lawyer, objected strenuously (to be kind about it; as I was watching I thought the Republicans were going to have to peel him off the Senate ceiling), saying if Herrera-Beutler were called to testify, he had at least a hundred witnesses he wanted to call, starting with Nancy Pelosi, and, by the way, he would depose all of them in his office in Philadelphia, because “that’s how these things are done.” At this point, the bell sounded and the fighters went to their separate corners to decide what to do next.

The House Managers, having made their point, and realizing that nothing short of something akin to the parting of the Red Sea, would persuade seventeen Republicans to vote to convict, and even that might not be enough, decided not to call Representative Herrera-Beutler as a witness. Instead, they and the defense team compromised by reading her statement into the record of the proceedings, thereby sparing us of more of Mr. van der Veen’s histrionics.

Shortly thereafter, Donald Trump was acquitted — again.

This was a show trial. With the conclusion foregone, the House Managers knew their real audience was the American public, not the 100 Senators in the chamber. It remains to be seen whether they won their case with the public. An Ipsos poll conducted Friday evening after the Defense had wrapped its case, if you could call it that, but before the Herrera-Beutler bombshell, revealed 55% of Americans believe Trump was “fully” or “largely” responsible for inciting the violence, but only 50% believe he should have been convicted. Strangely, 53% said he should be barred from holding public office again. The poll, which had a confidence level of 4%, shows in stark relief how deeply polarized this nation remains.

There will be more Trump litigation, a lot more. We may never see the end of it. Mitch McConnell, after voting to acquit, specifically mentioned this in a fiery speech (for him) putting Trump on notice that criminal and civil penalties are appropriate for what he did.

And today, it begins. This morning, Representative Bennie G. Thompson (D-Miss.), the chairman of the House Homeland Security Committee, filed a federal lawsuit accusing former president Donald Trump, attorney Rudolph W. Giuliani and two extremist groups whose members have been charged in the 6 January storming of the Capitol with illegally conspiring to intimidate and block Congress’s certification of the 2020 election. Citing an 1871, rarely used law aimed at the KKK, Thompson is suing in his personal capacity and is joined by the NAACP.

So many miles to go

With the conclusion of the world’s fastest impeachment trial, the Biden presidency can take center stage. Job #1: Defeat the pandemic and, in the words of someone who knew a thing or two about national division, “bind up the nation’s wounds.” However, right out of the gate we keep getting reminded just how delicate an undertaking that’s going to be.

Case in point: The scary growth of far right extremism in America and around the world got a boost from the Covid-19 pandemic.

Using historical data-sets from Germany, Kristian Brickle, of the Federal Reserve Bank of New York, concludes influenza mortality during the pandemic of 1918 – 1920 was directly correlated with both lower per-capita spending in the next decade, especially by the young, and the rise of extremist parties in 1932 and 1933, primarily the National Socialist Workers Party (the NAZI party). In her study, Pandemics Change Cities: Municipal Spending and Voter Extremism in Germany, 1918-1933, (May 2020, Revised June 2020), Brickle shows how Germany suffered high mortality in the pandemic, mortality that varied significantly across the country’s municipalities and regions. This variation represented tangible differences between cities and regions that reflected the beliefs and preferences of the inhabitants. In effect, the pandemic served as a means to exacerbate beliefs already held. One of these exacerbated beliefs was distrust for and hatred of minorities, predominantly Jews. Hence the significant increase of the deep-seated antisemitism of the late 1920s and 1930s.

Although Brickle’s work does not blaze a new trail — she builds on the work of many others — her research paints a clearer picture of what can be the unfortunate and unforeseen consequences of a pandemic. The United Nations and others have documented an “explosion” of antisemitism throughout the tenure of the Donald Trump presidency, but with a significant spike during 2020, the first year of the Covid-19 pandemic.

Joe Biden is going to need all the help he can find.

 

 

The Second Impeachment of Donald Trump Approaches

Wednesday, February 3rd, 2021

Next Tuesday, the 9th of February, the Senate will begin the second impeachment trial of Donald Trump. With ten Republican Representatives voting in the affirmative, the House impeached the former president for inciting insurrection on 6 January, an insurrection that has resulted in the deaths of five people.

Trump supporters in Congress and around the country have viciously attacked the ten House Republicans who voted for impeachment. Wyoming Representative Liz Cheney, the third most powerful Republican in the House, has come under particular fire. Die-hard Trump disciples have petitioned Minority Leader Kevin McCarthy to remove her from her leadership post. That group is reported to have more than 100 signatories to its petition. The entire caucus will meet about this later today. It could happen that when the dust settles tonight, Liz Cheney, who, with Leader McCarthy’s approval, gave voice to her conscience, could become the only person to this point punished for anything that happened on the 6th of January. I make this point to illustrate just how far the devolution of Congress has progressed.

On the Senate side of the building, Trump’s latest lot of lawyers yesterday filed a 15 page initial brief that bases their defense of the former president on two major points. First, Trump did nothing wrong either before or during his 6 January rally in DC; he was simply exercising his First Amendment rights. Second, they contend it is unconstitutional to impeach Trump, because he is no longer in office and therefore cannot be “removed,” a view that is shared by most Senate Republicans ( there is also a third defense position – the Bill of Attainder defense – that is altogether too wacky to go into).

With respect to the first defense, the question before the Senators is whether Trump’s oratory was advocacy or incitement. The U.S. Supreme Court explained in Brandenburg v. Ohio (1969) that “the constitutional guarantees of free speech and free press do not permit a State to forbid or proscribe advocacy of the use of force or of law violation except where such advocacy is directed to inciting or producing imminent lawless action and is likely to incite or produce such action.”  The Court’s ruling in Brandenburg meant that KKK leader Clarence Brandenburg’s statements such as “it’s possible that there might have to be some revengeance taken” did not amount to criminal syndicalism under Ohio law.

In addition to the “incitement to lawless action” charge, there is the “clear and present danger” test. In applying the clear and present danger test in Schenck v. United States (1919)Justice Oliver Wendell Holmes, Jr., observed: “The question in every case is whether the words used are used in such circumstances and are of such a nature as to create a clear and present danger that they will bring about the substantive evils that Congress has a right to prevent.” Holmes cited the example of a person who falsely shouts “Fire!” in a crowded theatre, causing a panic. The impeachment prosecutors will doubtless advocate that Trump really did, metaphorically, shout “fire” on 6 January, causing his followers to panic and storm the Capitol.

Regardless, the House Trial Managers are going to have great difficulty in convincing people who do not want to be convinced, in fact, refuse to be convinced, that Trump’s words at his rally on 6 January presented a clear and present danger to incitement to lawless action. This, despite the video and myriad recordings showing Trump egging on his followers to “fight” and “be strong,” because he “won in a landslide” and “the election was stolen” from him.

The Trump defense team’s second claim, that impeaching an out of office president is unconstitutional, will be equally difficult to counteract, even though the Congressional Research Service (the best research agency you’ve probably never heard of), at the request of House members, published a study on 15 January that showed clearly the precedence and constitutionality of such an action. The study, which is quite the civics history lesson, should be required reading for every high-school student.

In the study, Legislative Attorneys Jared P. Cole and Todd Garvey meticulously analyze this issue and write:

The Constitution does not directly address whether Congress may impeach and try a former President for actions taken while in office. Though the text is open to debate, it appears that most scholars who have closely examined the question have concluded that Congress has authority to extend the impeachment process to officials who are no longer in office. As an initial matter, a number of scholars have argued that the delegates at the Constitutional Convention appeared to accept that former officials may be impeached for conduct that occurred while in office. This understanding also tracks with certain state constitutions predating the Constitution, which allowed for impeachments of officials after they left office.

They also note:

Scholars have noted that if impeachment does not extend to officials who are no longer in office, then an important aspect of the impeachment punishment is lost. If impeachment does not apply to former officials, then Congress could never bar an official from holding office in the future as long as that individual resigns first. According to one scholar, it is “essential” for Congress to have authority to impeach and convict former officials in order to apply the punishment of disqualification; otherwise Congress’s jurisdiction would depend on the whims of the individual who engaged in misconduct. Another scholar notes that the grave nature of the disqualification punishment indicates that it should apply independently of the need for removal.

Some Trump defenders point to the Richard Nixon case. When Nixon resigned on 9 August 1974, the House of Representatives had already drawn up articles of impeachment. After his resignation, the House did not send the articles to the Senate for trial. Less than a month later, President Ford granted Nixon a full pardon, thereby ending the case. The Trump defenders claim not impeaching Nixon proves their case that a president cannot be impeached after leaving office. What they fail to mention is that Nixon had already served two terms as president and was barred from running again by the 22nd Amendment. The whole purpose of impeaching someone after leaving office is first, to set an example, and second, to disqualify them from future office. Donald Trump, if not impeached and convicted, is free to run again for President in 2024.

Let me end on a hypothetical question. Suppose a President commits an impeachable action on the 19th of January; say it is discovered a week later that he or she had been colluding with a foreign power for personal gain at the expense of our nation. If the action is committed while in office, but not discovered until after he or she flies off in Marine 1, what is to be done about it? It is almost sacred theology that a President cannot be criminally charged for actions committed while in office (See the Mueller Report). How else is the miscreant punished other than impeachment?

I have no illusions about the Senate convicting Donald Trump of “high crimes and misdemeanors,” although I think he is guilty as charged. Further, I think he is responsible more than anyone else for the deaths that happened during and after the storming of the Capitol.

It is dispiriting for me to have to conclude that, rather than suffering one day of punishment for any of it, he will just live in the lap of luxury for the rest of his horrid life, the same mass of stunted protoplasm he has always been.

 

Can We Ever Learn From History?

Tuesday, November 10th, 2020

Yesterday was the 82nd anniversary of Kristallnacht, Germany’s Night of Broken Glass.

Two days prior to Kristallnacht, Herschel Grynszpan, a 17-year-old Polish Jew, had assassinated Ernst vom Rath, a young diplomat at the German embassy in Paris, shooting him five times at close range. This gave Hitler and his Minister of Propaganda*, Joseph Goebbels, the excuse they needed to organize a pogrom against Jews in Germany and parts of Austria and Czechoslovakia.

Goebbels told an assembly of National Socialists, “The Führer has decided that … demonstrations should not be prepared or organized by the (Nazi) Party, but insofar as they erupt spontaneously, they are not to be hampered.”

And so, on 9 November 1938, thousands of Nazis and Hitler Youth erupted “spontaneously,” attacking Jewish homes, schools, synagogues and businesses, smashing windows and destroying property. They put everything Jewish to the torch. Firefighters were told to let the fires burn themselves out. Goebbels instructed police to round up as many Jewish young men as possible and cram them into jails.

As far back as 1925 when he wrote his autobiographical Mein Kampf (My Struggle) from jail, Adolph Hitler had made known his anti Semitic intentions. And by 1933 the people of the UK and America knew also, because in that year Mein Kampf was translated into English. Nobody paid attention.

Kristallnacht was Hitler’s first, large scale, organized and overt attack on Jews. Consequently, many historians consider 9 November 1938 the beginning of the Holocaust.

Immediately following the close of the Second World War, social scientists and historians began trying to figure out why so many Germans had, lemminglike, followed, even embraced, hate-filled Hitlerism. The answers are complicated.

Following the First World War, the victors had punished Germany in monumental fashion, both economically and politically. Germans resented this with seething anger. Hitler capitalized on this.

Then there was the Great Depression of the early 1930s, which plunged Germany into even more profound economic chaos. Hitler took advantage of this, also, calling on Germans to throw off the yoke of humiliation. He gave fiery speeches, observed by American and British diplomats, which should have alerted governments to what was coming, but did not.

Hitler  instilled in the German people an us-against-them world view, or Weltanshauung. They would have followed him anywhere, and they did.

A week ago today, more than 70 million Americans voted for Donald Trump. That’s four million more than voted for him in 2016. Although I’m sure perhaps half of them voted out of economic self interest – they like his policies enough to stomach his lies and boorishness – what about the other half, the cheering cult, his own lemminglike followers at his rallies and beyond? As Hitler before him, Trump has sold them the us-against-them Kool Aid, and they have swallowed without questioning and without caring if whatever comes out of their Leader’s mouth is true or not.

As far as I can see, Joe Biden won the presidency and the republican party won the election. Not a single state legislature flipped. Republicans gained seats in the House, and are on the verge of holding on to the Senate. The last time we had a democrat elected president and a republican senate was 1885, 135 years ago, with the presidency of Grover Cleveland.

Donald Trump will eventually leave the White House, but he’s not going away, and neither are his followers or Trumpism. He gets tremendous satisfaction from his Rallies. Can you see him abandoning them? No, he will continue to stoke fear and hatred, just as a certain Austrian wannabe artist did long ago.

If you think 2020 was bad politically, just wait until you get to experience 2021.

Good luck to us all.

* Originally, Goebbels opposed the word propaganda, because in the public usage of the day it connoted – wait for it – Lies!

Shameful Leaders Play Chicken With The Economy Hanging In The Balance

Monday, November 9th, 2020

Today, the Bureau of Labor Statistics announced productivity, output and earnings data for Q3, 2020. This follows its announcement three days ago that the nation’s unemployment rate in October had fallen to 6.9%, the 6th consecutive month it has dropped.

While the drop in the unemployment rate is certainly good news, the long-term unemployed (those jobless for 27 weeks or more) increased by 1.2 million to 3.6 million, accounting for 32.5 percent of the total unemployed. Further, the country has seen only half of the 22 million people who lost jobs due to the pandemic return to the workforce.

Regarding today’s announcement, while productivity and output rose 43.5% and 38.6%, respectively, real earnings, a very important number, dropped 9.1% in Q3.

Most of the relief bills passed earlier in the pandemic have expired, including the $2.2 trillion CARES Act, which provided for additional unemployment benefits of up to $600 a week for many individuals.

The Federal Reserve, led by Chairman Jerome Powell, as well as the nation’s leading economists, have been arguing for months that we need a second relief package. Powell maintains that businesses, cities and states, and the unemployed are in dire need of help. On 6 October, in a speech to the National Association for Business Economics, he said the unemployment rate would be closer to 11% were it not for misclassification of idle workers and for people leaving the workforce. He warned the group that without additional support, the economy could slip into a downward spiral “as weakness feeds on weakness.”

Powell and his colleagues at the Federal Reserve say we need a new relief package NOW, and we need it to be BIG. Personally, I am not optimistic about that. I’m no economist, but I have friends who are, and they are not optimistic, either, at least not in the short term. And, although the 74 million (and increasing) Americans who voted for Joe Biden are happy Donald Trump has been handed his walking papers, we remain a house divided now more than ever. Some of us are euphoric, some in denial, others in despair, still others angry beyond words. It will take time and a lot of compassion for healing to even begin. But time is something many of our neighbors in horrific economic difficulties through no fault of their own simply don’t have.

In the next few days and weeks we’ll discover if our elected leaders can get out of the way of their ego-driven lust for power and display enough moral fiber, presuming they have some, to help the businesses, cities, states, and millions of our fellow citizens who hang by their fingertips over the edge of an economic abyss.

 

Like BBs In A Boxcar

Monday, October 12th, 2020
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.

Monday, September 21st, 2020

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

Friday, September 18th, 2020

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.

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

Wednesday, September 9th, 2020

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

Monday, August 10th, 2020

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.

 

 

The “K” Factor and EU and USA Cases

Friday, June 26th, 2020

The K Factor

Ever heard of the “K” factor? Neither had I. But in yesterday’s Work Fitness and Disability Roundtable, Dr. Jennifer Christian’s long-running and valuable daily roundup of workers’ compensation medical news and musings, we were introduced.

Turns out the “K” factor could be tremendously important in helping leaders figure out how reopening the economy should proceed.

I thought Jennifer’s Roundtable post was so important I asked her if we could reprint it in the Insider. She gave permission, for which I’m grateful. So, here it is:

Hey, nothing like a fact-based “aha” to sharpen the mind and help point the way forward. A thought provoking article in New York Magazine (https://nymag.com/intelligencer/2020/06/coronavirus-meatpacking-plants-america-labor.html?utm_source=fb&utm_campaign=nym&utm_medium=s1&fbclid=IwAR0jnJXCeUx_zYVQuayha1XSMpMtjT-TSXIv7-RfIFNCDtlrz1hn558Da2w) on the reason for major differences between the COVID-19 experience in meatpacking industries in the USA and Europe brought up the “k” factor in the COVID-19 pandemic.  Ever heard of “k”?

Until yesterday, I hadn’t noticed (or paid attention to) any discussion about the implications for action of SARS-CoV-2’s  “k” factor. The “k” factor is an infecting organism’s observed dispersion behavior. Now is the time to start paying attention to the “k” factor because it points us straight to the main cause of the majority of COVID-19 cases: superspreading events in crowded indoor settings. We’ve all known that a lot of the cases have occurred due to spread on board ships, in prisons, hospitals, nursing homes, nightclubs and meatpacking plants – but to be truthful, I’m not sure we’d gotten the take-home message: SARS-CoV-2 is heavily dependent on crowded indoor spaces for its spread.

So, I did a bit more Googling and found a good Science Magazine article (https://www.sciencemag.org/news/2020/05/why-do-some-covid-19-patients-infect-many-others-whereas-most-don-t-spread-virus-all) that lays it all out quite clearly.  In addition to the R value (the mean number of subsequent new infections resulting from each infected individual), epidemiologists calculate how much a disease clusters. The lower k is, the more transmission is coming from a small number of people. The k value for the 1918 influenza pandemic was estimated at 1.0 – clusters weren’t too important. But during the 2003 SARS and 2012 MERS epidemics the vast majority of cases occurred in clusters, and their calculated k values were therefore low: 0.16 and 0.25 respectively.

In COVID-19, most infected people are not creating any additional cases. Adam Kurcharski from the London School of Hygiene & Tropical Medicine has conducted an analysis of COVID-19 dispersion and says, “Probably about 10% of cases lead to 80% of the spread.” A pre-print of his paper (https://wellcomeopenresearch.org/articles/5-67) has a calculated k value of COVID-19 at 0.1. Previous studies have pegged it just a tad higher than SARS or MERS.

There’s no point in trying to figure out which people are shedding the most viruses – though some of us clearly do disperse more bugs than others.  We professionals need to focus most of our attention on the places and types of events that SARS-CoV-2 needs in order to spread efficiently: loud and crowded indoor spaces, where people are cheek by jowl and raising their voices or breathing deeply: talking, singing, or shouting or aerobically exerting themselves. Ventilation and air flow in these settings also plays an important role.

Almost none of the clusters have resulted from outdoor crowded events.  Chinese studies of the early spread of COVID-19 outside Hubei province identified only one cluster among a total of 318 that originated outdoors. A Japanese study found that the risk of infection indoors is almost 19 times higher than outdoors. And here in the USA people who participated in (largely outdoor) Black Lives Matter protests have not been getting sick. (I also saw some data earlier saying that the virus is almost immediately disabled by sunlight.)

As the Science Magazine article says, the low k factor is …..”an encouraging finding, scientists say, because it suggests that restricting gatherings where superspreading is likely to occur will have a major impact on transmission, and that other restrictions—on outdoor activity, for example—might be eased.” So duh, let’s make the hierarchy of risk much more explicit. We need to make it crystal clear to the public (and patients and workers and employers) that the worst thing a person can do is participate in events in loud, crowded, and  indoor settings without rapid air turnover.

HOWEVER:  Many people are stuck. They live in crowded housing or congregate housing. The places where they live and work (ships, factories, office buildings, and medical facilities) already exist. People need to work, and winter is coming when we have to be inside.

I see this call to action: Are you, personally, confident that you are collaborating with all of the professionals whose input, cooperation, and contributions will be required? Think outside your silo. All of the various types of professionals who do event planning & commercial building design & engineering, industrial hygiene, HVAC, public health, and occupational health & safety need to join up and get deeply and rapidly involved in adapting / redesigning / re-configuring / re-engineering existing places and events to reduce the potential for superspreading.

A look at European Union and U.S. case statistics: Stunning

The following chart from the Johns Hopkins Tracker Project, printed in yesterday’s Statista Daily Alert needs no introduction or even analysis. It puts the period to Dr. Christian’s words.