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.

 

AstraZeneca And Oxford Surge To The Lead

July 20th, 2020 by Tom Lynch

Lord knows, good news is hard to come by these days, but, H’Alleluia, we got some this morning.

Researchers from pharmaceutical giant AstraZeneca* and Oxford University’s Edward Jenner Institute for Vaccine Research announced promising results from a Phase 1/2 study of their COVID-19 vaccine candidate, known as AZD1222.

Researchers gave AZD1222 to about 500 volunteers and compared the results to those from around the same number getting a meningococcal vaccine.

For the AZD1222 vaccine, antibodies against the SARS-CoV-2 spike protein peaked by day 28 and remained elevated to day 56, the end of the study, indicating an immune response against the virus. Much has recently also been made of T cells, a type of white blood cell: Here, the vaccine levels of T cells peaked 14 days after vaccination and were still present two months later.

Ages in the study group ran from 18 to 55; the median was 35. This is much younger than the median age of the group that will need it the most: the elderly. Also, nobody in the study group had co-morbidities associated with heightened risk of bad outcomes.

There were side effects, but they were relatively minor: fevers, aches, headaches and fatigue, but acetaminophen, the active ingredient in Tylenol, alleviated these.

Phase 3 trials are now underway in the U.K., Brazil and South Africa and are due to start in the U.S.

The UK has already ordered 100 million doses of the unproven vaccine, which scientists from Oxford’s Jenner Institute have said could be ready for approval in September.

A word or two about the light speed of this vaccine’s development, as well as the roughly 100 others being developed around the world.

First, Oxford has been working toward developing a novel coronavirus vaccine for two or three years. After the 2014 Ebola epidemic, the British government invested  £120 million (about $149 million at the time) to create vaccines aimed at protecting against the 10 or 11 health threats deemed to be the most likely to threaten the country. Coronaviruses were on that list, and the government gave the Jenner Institute some of the money.

Once that happened, Oxford doctors Sarah Gilbert and Adrian Hill pioneered a way to put a bit of a novel coronavirus in a vaccine, but without the part that makes it replicate in humans. At that point it would be safe to inject in people. What Gilbert and Hill created was a platform that theoretically should work for many viruses and has been proven to be safe in vaccines for other diseases. And that methodology, called recombinant adenovirus vector, is what AstraZeneca and Oxford are making the foundation of their COVID-19 vaccine candidate.

So, because of the work of Gilbert, Hill and their Oxford team, Oxford and AstraZeneca had a head start on the COVID-19 vaccine derby. But still, AZD1222 entered its Phase 1 clinical trial the last week in March, 2020. If they succeed and have a vaccine ready for humanity by September, that will be six months from start to finish. This is way beyond unheard of!

Don’t believe me? Typically, and this is anything but, clinical trials go through four phases according to the FDA:

Phase 1: 

Study Participants: 20 to 100 healthy volunteers

Length of Study: Several months (For this example, let’s say 4)

Purpose: Safety and dosage

Result: Approximately 70% of drugs move to the next phase

Phase 2: (AZD1222’s Phase 1 and 2 were done in two months)

Study Participants: Up to several hundred people

Length of Study: Several months to 2 years (Let’s say 4 months to two years)

Purpose: Efficacy and side effects

Result: Approximately 33% of drugs move to the next phase

Phase 3: (This is what AZD1222 is beginning now)

Study Participants: 300 to 3,000 volunteers

Length of Study: 1 to 4 years

Purpose: Efficacy and monitoring of adverse reactions

Result: Approximately 25-30% of drugs move to the next phase

There is a Phase 4 with several thousand volunteers, but it appears the government may be combining Phase 3 and 4 as it did Phase 1 and 2.

If there is one thing Donald Trump and I can agree about it is that this is being done at Warp speed. If you do the math from above, you’ll see the fastest a drug typically makes it through the first three trials is 20 months, not six. Also, by rapid calculus, you’ll note that if we start with 100 drugs going into trials, five make it through Phase 3. We’re dealing with long odds here.

A couple of other things to think about.

First, drug discovery and development involves pre-clinical work that begins with mice, moves on to rats, guinea pigs, rabbits, pigs and non-human primates. Yes, monkeys. After all that, scientists apply for what’s called an Investigational New Drug Award, an NDI. If the FDA approves that, one can move into a Phase 1 trial. None of that has happened here, at least it hasn’t been reported as happening.

Second, even if good results happen from AZD1222’s Phase 3 trial, or one of the other vaccines under development, with such little longitudinal study how certain will we be that long-term immunity will result?

Finally, there are the old folks. One presumes they represent a cohort in the Phase 3 study. What happens if the vaccine succeeds beautifully in young people, but fails miserably in the elderly?

John Milton famously wrote, “Hope springs eternal.” But, frankly, I prefer the advice of my old commanding general in the mountains of Vietnam: “Hope for the best; prepare for the worst.”

 

* AstraZeneca is a British/Swedish company formed from the merger of Astra Pharmaceuticals, a British firm, and Zeneca, a Swedish one, in 1999. It’s headquarters are in Cambridge, England.

 

 

The “K” Factor and EU and USA Cases

June 26th, 2020 by Tom Lynch

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.

 

It Bears Repeating: We Have Been Here Before

June 19th, 2020 by Tom Lynch

In the summer of 1918, during the first wave of the Spanish Flu pandemic, American troops were at war in Europe’s killing fields. That was when Philadelphia officials decided they would hold a massive parade for the ages to promote Liberty Loans – government bonds issued to pay for the war. The City Of Brotherly Love organized an extraordinary spectacle: marching bands, women’s auxiliaries, Boy Scouts, soldiers and floats showcasing the latest innovation in warfare – floating biplanes built in Philadelphia’s Navy Yard.

That Philadelphia’s medical community thought this a very bad idea didn’t matter. That the nation was awash with flu had to be put aside in order to support the war effort. The flu could wait.

When two miles of parade marchers took their first steps on the morning of 28 September, some 200,000 people jammed Broad Street, cheering wildly.

The Spanish Flu had been circulating in America for six months at the time of the parade, and the flu, like COVID-19, loved a crowd. The flu couldn’t, and wouldn’t, wait.

Within 72 hours of the parade, every bed in Philadelphia’s 31 hospitals was filled. In the week ending 5 October, nearly 2,600 people in Philadelphia had died from the flu or its complications. A week later, that number rose to more than 4,500, with 200,000 more sick. With many of the city’s health professionals pressed into military service, Philadelphia was unprepared for this deluge of death.

City leaders closed Philadelphia, locked it down. But it was too late. Morgues and undertakers could not keep pace. Grieving families had to bury their own dead. Casket prices skyrocketed. And a rumor started to spread – The Germans did it.

History continually repeats itself. Tomorrow night we have a potential case in point when 19,000 followers of the Cult of Donald Trump will gather in the BOK Center in Tulsa Oklahoma. That the city’s medical officials have unanimously declared this a very bad idea doesn’t seem to matter. That the nation is awash with COVID-19 has to be put aside in order to support the election effort. COVID-19 can wait.

Campaign officials say they’ll take peoples’ temperatures as they enter and pass out face masks and hand sanitizer. But they won’t insist any be used and they won’t enforce social distancing. Can you, in your most far out imagination, visualize the camera shot of Donald  Trump at his podium with his amped-up ardent followers behind him, each six feet apart and all wearing masks?

Since 17 June, two days ago, Tulsa’s COVID-19 cases have risen 42%, going from 259 to 450. At one time, New York City had 450 cases.

As we have seen, this is not the first time in the midst of a pandemic people have been irresponsible and downright wacky.

Both President Trump and Vice President Pence have lately taken to declaring victory over the virus. You’d be hard pressed to find a single medical expert who agrees. We can only hope that somehow Trump’s medical experiment tomorrow night will not turn a very bad idea into a tragic one.

Today’s Class: Impeccable Timing 101

June 15th, 2020 by Tom Lynch

No one will ever accuse the Republican Party of being overburdened with sensitivity. In two stick-in-the-eye moves just oozing with impeccable timing, the Grand Old Party is telling the world just what it can do with its Black Lives Matter folderol.

First, the GOP’s unquestioned leader, President Donald Trump, like a too long cooped up horse, has decided to resume his rallies, which for him seem to be better than crack cocaine. This week in Tulsa Oklahoma he and as many of his followers as campaign officials can cram into the 19,000-seat BOK Center will gather for a couple of hours of The Best Of Trump as if the COVID-19 pandemic had never happened, neither masks nor social distancing required. Reminds me of Ebenezer Scrooge discussing innovative methods to “decrease the surplus population.”

In the first of his two impeccable timing decisions, Mr. Trump announced he would hold his Tulsa rally on 19 June, known as Juneteenth, the date on which in 1865, the last of the South’s slaves were notified of their freedom under the Emancipation Proclamation. It would take until the following December and the 13th Amendment to officially abolish slavery in America.

Juneteenth is recognized as a state holiday or ceremonial holiday in 47 states and the District of Columbia (what are you waiting for Hawaii, North Dakota, and South Dakota?) and is the oldest celebration marking the end of slavery, dating from 1866.

According to the Associated Press, Trump was unaware of Juneteenth, let alone the significance of it to the Black community, when he announced his rally’s date. Consequently, he did not anticipate the blowback he would get. But get it he did. Even from his own supporters.  In a rare instance of backing down, he moved the rally to the next day, the 20th, still in Tulsa at the BOK Center.

But in America’s Black consciousness, Tulsa is known for a lot more than Juneteenth, as significant as that is. On another day in June, the 1st June day of 1921, Tulsa was the site of the worst race massacre in American history.

The day before, police had arrested a young black man by the name of Dick Rowland for allegedly attacking a white woman in a Tulsa elevator. Soon after Rowland’s arrest, rumors began to spread about a group of whites planning a lynching party. To protect Rowland, African American World War 1 veterans surrounded the jail holding him. There was a standoff with a mob of whites. Somebody fired a shot, and a firefight ensued. The much larger white mob pushed the black vets all the way to Greenwood, Tulsa’s black section.

Greenwood was the wealthiest black neighborhood in the country. Oil had made it rich. Racism was about to destroy it. Over the course of the day, 6,000 homes and businesses and 36 square city blocks were turned to ash. Pilots of two airplanes dropped turpentine bombs on buildings, instantly igniting them. Three hundred African Americans were slaughtered, most thrown into mass graves. Not a soul was ever prosecuted for anything. Then Tulsa, population 100,000, swept it all under the rug. Two generations later nobody knew a thing about it. It was never taught in schools, no books were written, no oral history passed down. It was as if it never happened.

Tulsa’s current mayor, G. T. Bynum, wants to take the rug up to see what’s hiding under it. He’s committed to investigating what happened and determining accountability. He thinks he’s found a couple of the mass graves and is having them excavated. The goal is to at least identify as many victims as possible through DNA analysis.

For the people of Tulsa, especially the black people of Tulsa, this is a deep, open, festering wound, and next Saturday Donald Trump will come riding into town on his big, very white horse to preach the gospel of Trump to 19,000 of his followers. It’ll be an interesting day.

There is one more incident of impeccable timing.

The Republican National Covention had been scheduled for North Carolina, but because North Carolina’s Democratic Governor Roy Cooper, concerned about the spread of COVID-19, would not guarantee a full house for the late August event, the Republican party has moved most of the convention to Jacksonville, Florida. The Coronation of Mr. Trump is set for the night of 27 August.

And, you guessed it, there is a black history story about 27 August and Jacksonville. It is known as Ax Handle Saturday.

The year is 1960 and the Jacksonville Youth Council of the National Association for the Advancement of Colored People (NAACP) is holding peaceful lunch counter sit-ins. Peaceful demonstrations. A group of outraged whites taking exception to this level of daring, begin spitting on the demonstrators and calling them names no one should ever be called. Then ax handles, mercifully without ax heads, suddenly appear along with baseball bats, and the demonstrators begin to get hit. Things go downhill from there. When it is all over dozens of young African Americans would be wounded in various ways. On a brighter note, nobody died, but that was probably blind luck.

To give you an idea of racial relations in Jacksonville at the time, a year earlier, in 1959, the year before Ax Handle Saturday, Nathan Bedford Forrest High School opened in Jacksonville, celebrating the memory of a Confederate General and the first Grand Dragon of the Ku Klux Klan.

The 60th anniversary of Ax Handle Saturday will be celebrated on 27 August in a park about a mile away from the convention at about the same time the balloons come down. Impeccable timing.

 

 

Racial Justice: If Not Now, When?

June 8th, 2020 by Tom Lynch

Since the nonchalant murder of George Floyd our nation has galvanized behind the cause of equal justice for all. We have moved past the chaos of the first day or two to a too-loud-to-be-ignored-any-longer chorus peacefully demanding systemic changes in race relations. Now, the question of the moment is: What will come of this? After all, we’ve had demonstrations and protests when abominations like this have happened before. And afterwards, after the thoughts and prayers stuff, life goes on. Is this going to be any different? Personally, I think it will be.

Why? Let me tell you a story.

It is 31 January 1968. In Vietnam, it’s the most important holiday of the year, the Tet Lunar New Year. In years past, this seven to nine day holiday has been the occasion for an informal cease fire between North and South warring forces. But not this year. Since the previous autumn, the North Vietnamese military commander General Vo Nguyen Giap has been secretly caching weapons, ammunition and Viet Cong troops throughout the country. In late autumn 1967, in a brilliant move of military misdirection, Giap has North Vietnamese regular army regiments attack U.S. strategically placed Firebases in the highlands of central Vietnam. The ferocious  battle of Khe Sang is an example. As U.S. commanders concentrate on repulsing these attacks, Giap prepares to spring the Tet trap.

And in the early morning hours of 31 January, 70,000 Viet Cong troops attack all over the country.

The Tet Offensive takes South Vietnamese and American commanders and politicians completely by surprise, shocks the U.S. public and begins the slow erosion of public support for the war. The fiercest fighting happens in the city of Hue, the ancient capital of Vietnam. The Viet Cong capture Hue and hold it until they are finally driven out on 24 February by American forces. During the time they hold the city, the Viet Cong exact a terrible price. They go house to house arresting all people thought to be South Vietnamese sympathizers, including a convent full of Catholic Nuns. They massacre them all and throw them into mass graves. Five thousand people.

In three to four weeks, Giap’s forces are resoundingly defeated. He has spread them too thin. The Tet Offensive will prove to be a military disaster for the North, but, more important, it will become its biggest strategic victory. American and South Vietnamese politicians now realize the contest will be longer and much more deadly than they have anticipated, the mood of the American people begins to shift, and U.S. army Killed In Action increases to 500 per week.

And then, twenty days after the recapture of Hue, comes the most horrific and gruesome stain on America’s character during the entire war: The My Lai Massacre.

It is 16 March, and at the village of My Lai an American nerve-frayed platoon of the Americal Division under the command of 1st Lieutenant William Calley massacres hundreds of innocent civilians – men, women and children – as they run from their huts. Then they round up the rest of the village, line them up along a large ditch and shoot them all. According to Vietnamese records, they slaughter 547 people that day (the U.S. admits to only 304).

Calley had been ordered by his Company Commander, Captain Ernest Medina, to enter My Lai and kill the Viet Cong that Army Intelligence thought were hiding there among the civilian population. But there are no Viet Cong at My Lai that day. The Platoon troops don’t care. They kill everyone. And Calley, their commanding officer, stands by and watches. He does nothing to stop it.

Afterwards, Calley’s commanders in the Americal’s 11th Infantry Brigade will cover up the massacre by simply saying there wasn’t one. But the truth eventually comes out when American reporter Seymour Hersh breaks the story a year later (for which he will win a Pulitzer Prize). Calley is court-martialled, found guilty and sentenced to life in prison. President Nixon will reduce the sentence to three years and allow Calley to serve it by house arrest at Fort Benning, Georgia. The army also charges fourteen other people up and down the chain of command. All either have their charges dismissed or are acquitted at trial. Everyone seems to live happily ever after, even Calley, who doesn’t publicly admit any regret until 41 years later.

Why am I writing this? For two reasons. First, because the quality of leadership matters. All the leadership, top to bottom,  surrounding the My Lai massacre was horridly bad leadership, and, in the eyes of the public, leadership in many of America’s police departments is of a similar calibre. It is seen as suspect, at best, and despotic, at worst. Second, because the Tet Offensive and the My Lai massacre galvanized the American public into creating a movement that eventually became too powerful for politicians to resist and led to the end of the Vietnam war, a war that killed more than 50,000 Americans and millions of Vietnamese.

Today, we are in a similar situation of urgent morality. For hundreds of years, black children have been raised to fear whites, especially white police. “Don’t talk back, keep your hands on the steering wheel at all times, and never ever reach for anything.” Driving While Black is not fake news. The selection and training of police recruits continues to perpetuate this fundamental character flaw in the soul of America.

At the very least, what will reduce the worst in policing and increase the best is a thoroughly reimagined system of selecting and training new police officers. “Protect and serve” begins with empathy, actually seeing the people one is sworn to serve; actually listening to better understand them and their needs.

After My Lai, the army rebuilt its officer training programs. The Code of Military Justice and the Geneva Convention were given more attention. As we moved to an All-Volunteer Army, the selection criteria were rethought and enhanced. We have seen the benefit of that in our military’s improved conduct in Iraq and Afganistan. That kind of retooled selection and training has not happened in police academies. What has happened is more training in crowd control, more buying of military quality weaponry and a perpetuation of an us versus them mentality. These have been on stark display since the killing of George Floyd.

To change this will require sustained, dedicated and empathic leadership, which I’m guessing will not be coming from 1600 Pennsylvania Avenue, at least not in the immediate future. But the growing and forceful muilticultural demands for equal justice as vividly  demonstrated recently on the streets of America is a start, a start that urgently needs a finish.

More About The Moderna Vaccine Results

May 22nd, 2020 by Tom Lynch

Scientists and Wall Street analysts are now beginning to peal the onion of Moderna’s announcement about its Phase One Trial results in which it reported its vaccine candidate had produced antibodies in eight of the study’s 45 participants. Following the announcement, Moderna’s shares rose nearly 30%. A profitable day, indeed.

On Tuesday, I wrote it was way too early to get excited based on this teeny tiny study. Since then, it’s nice to see that Evercore ISI’s Umer Raffat, an analyist Institutional Investor called a Rising Star of Wall Street Research, has added context and perspective. Early Tuesday, Raffat sent a 78-page slide deck to his clients explaining why, while possibly encouraging, Moderna’s announcement  and Monday conference call should not give anyone a serious sense of hope until a lot more work is done and a lot more is known about this particular Phase One Trial.

Getting into the science weeds, Raffat focused his analysis on antibodies and T-Cells.

First, the antibodies. Raffat thinks the most impressive thing about Moderna’s data release concerns “binding” antibodies. These are antibodies that attach to SARS-CoV-2, the virus that causes COVID-19. The concern with Moderna’s announcement is that what’s really important for an effective vaccine is its ability to generate “neutralizing” antibodies that actually prevent the virus from infecting healthy cells, and Moderna provided no information about neutralizing antibodies except to say its neutralizing antibodies “were at or above convalescent serum” collected from people who recovered from COVID-19. Studies have shown that people who have recovered from COVID-19 can generate a wide range of neutralizing-antibodies in their convalescent serum. So, it is unclear just how comparable Moderna’s convalescent serum samples were to samples taken from the trial participants.

The FDA will have to determine what level of neutralizing antibodies are required for an approved vaccine. The Agency has already said that when convalescent serum is used to treat COVID-19 patients the neutralizing antibodies should be high, whatever that means.

Another issue with Moderna’s mRNA-1273 vaccine rests with T-Cells. The level of T-Cell generation is an indicator of the degree to which the immune system is attacking COVID-19. Moderna’s announcement and subsequent call did not address this. Some researchers have shown that a high level of T-Cell generation, even without high levels of neutralizing antibodies, have been found in people who have recovered from COVID-19, leading to speculation that T-Cell generation may be very important for any successful vaccine. However, when asked about this during the conference call, Moderna’s Chief Medical Officer, Tal Zaks, M.D., Ph.D., said  “You would expect that based on the fundamental scientific principles of how an mRNA vaccine works because it teaches the body’s own cells to make the protein from within the cell.”

One last point – The study participants numbered 45. Eight produced binding antibodies. Only four were sampled for neutralizing antibodies. Four.

As I wrote earlier this week, Moderna has made it to the one yard line. Ninety-nine to go.

 

 

The Continuing Saga Of COVID-19 In Long Term Care Facilities And New Research

May 21st, 2020 by Tom Lynch

We have written about the ongoing death spiral in LTCFs four times – herehere, here, and here.

We’ve done this, because for three months authorities have known that LTCF’s were lethal hot spots, the most lethal in the country, actually. And to this day the federal government has devoted nothing more than lip service to it. Don’t believe me? Read on.

Last Thursday, OSHA issued COVID-19 Guidelines, not Requirements, for nursing homes. The Guidelines recommend screening residents and staff for symptoms, keeping everyone six feet apart and creating alternatives to group activities. I challenge anyone to read the Guidelines and find the word, “must.” OSHA has become the quintessential paper tiger. Remember, it only took three months to produce these groundbreaking recommendations.

And it is now exactly one month since CMS Administrator Seema Verma, to much ballyhoo, announced new COVID-19 reporting requirements for nursing homes. Specifically, CMS was requiring:

…nursing homes to inform residents, their families and representatives of COVID-19 cases in their facilities. In addition, as part of President Trump’s Opening Up America, CMS will now require nursing homes to report cases of COVID-19 directly to the Centers for Disease Control and Prevention (CDC).  This information must be reported in accordance with existing privacy regulations and statute. This measure augments longstanding requirements for reporting infectious disease to State and local health departments. Finally, CMS will also require nursing homes to fully cooperate with CDC surveillance efforts around COVID-19 spread.

So, how has that worked out? Keep in mind that, as reported by the New York Times, “While just 11 percent of the country’s cases have occurred in long-term care facilities, deaths related to Covid-19 in these facilities account for more than a third of the country’s pandemic fatalities.” As of 9 May, the Times reported the death toll in Long Term Care Facilitites (LTCF) was 28,100. Those are the ones we know of.

Unfortunately, that number is probably low, because we are still waiting for the CMS reporting requirement to produce anything. And now, it appears CMS’s plan has changed. On 14 May, one week ago, Administrator Verma said data from LTCFs would not be posted on the CDC website. Rather, it will be reported by the end of this month somewhere on Medicare’s website Nursing Home Compare.

Nursing Home Compare is exactly what the name suggests. It is a site where, by inputting a zip code, one can compare what Medicare calls Health Deficiencies in specific nursing homes within the relative geography chosen. It includes a humongously large database containing a number of datasets devoted to health deficiencies. This may be the place one would search for nursing home data regarding COVID-19. But we won’t know that until “the end of this month.” Maybe.

We shall see.

By the way, Verma’s announcement of one month ago began with this:

Today, under the leadership of President Trump, the Centers for Medicare & Medicaid Services (CMS) announced new regulatory requirements that will require nursing homes to inform residents, their families and representatives of COVID-19 cases in their facilities.

“Leadership.” Really?

Research on what is most effective to stop COVID-19 transmission

Two new research papers look into the effectiveness of the measures governments have either required or recommended for slowing the spread of the virus.

The first, Strong Social Distancing Measures In The United States Reduced The COVID-19 Growth Rate, published in Health Affairs on 14 May, investigated the efficacy of four social distancing policies taken by most state and local governments: Shelter-in-place orders (SIPOs), public school closures, bans on large social gatherings, and closures of entertainment-related businesses. Specifically, the researchers were trying to estimate the relationship between social distancing policies and the exponential growth rate of confirmed COVID-19 cases using an event-study regression with multiple treatments.

There were surprising results.

First, from the Paper:

Adoption of government-imposed social distancing measures reduced the daily growth rate by 5.4 percentage points after 1–5 days, 6.8 after 6–10 days, 8.2 after 11–15 days, and 9.1 after 16–20 days. Holding the amount of voluntary social distancing constant, these results imply 10 times greater spread by April 27 without SIPOs (10 million cases) and more than 35 times greater spread without any of the four measures (35 million). Our paper illustrates the potential danger of exponential spread in the absence of interventions,…

Second, only two of the policies produced statistically significant impacts on the growth rate at the 95% confidence level: SIPOs and the closures of entertainment-related businesses.

In contrast, the researchers found no evidence that bans on large social gatherings or school closures influenced the growth rate. That is not to say there was no influence on the growth rate due to these measures, just that whatever influence was there, it was not statistically significant.

The school closure finding is important as school boards and college trustees ponder whether to reopen in the fall. Yesterday, Boston College, where I spent some of my youth, announced that the campus would be open for classes for the fall semester.

The second PaperFace Masks Against COVID-19: An Evidence Review, “synthesized the relevant literature to inform multiple areas: 1) transmission characteristics of COVID-19, 2) filtering characteristics and efficacy of masks, 3) estimated population impacts of widespread community mask use, and 4) sociological considerations for policies concerning mask-wearing.”

The verdict of the researchers: “The preponderance of evidence indicates that mask wearing reduces the transmissibility per contact by reducing transmission of infected droplets in both laboratory and clinical contexts. Public mask wearing is most effective at stopping spread of the virus when compliance is high. The decreased transmissibility could substantially reduce the death toll and economic impact while the cost of the intervention is low.” In otherwords, masks work.

This paper carried the following supplemental tidbit:

While the focus of this article is on preventing the spread of COVID-19 disease through public mask wearing, many countries face concurrent epidemics of contagious respiratory diseases like tuberculosis and influenza. Tuberculosis kills 1.5 million people globally per year, and in 2018, 10 million people fell ill. Face covering has been shown to also reduce the transmission of tuberculosis. Similarly, influenza transmission in the community declined by 44% in Hong Kong after the implementation of changes in population behaviors, including social distancing and increased mask wearing, enforced in most stores, during the COVID-19 outbreak.
This could be important when one considers that an effective vaccine for tuberculosis exists: the Bacillus Calmette-Guérin vaccine. It isn’t usually given to infants in the U.S., because the disease isn’t a widespread problem here. However, when we eventually have a vaccine for COVID-19, we’re going to have to face the fact that getting it to people around the world is not going to be easy.
And, God help us, we’ll also have to deal with the anti-vax cult living among us here at home.

 

COVID-19: Two Updates

May 19th, 2020 by Tom Lynch

Who pays?

The last question asked in our question-filled Post of 13 May was the same as the first question asked, namely: Who’s the guy at the end of the line left holding the bill for COVID-19 workers’ compensation claim costs?

Right now, as we have written here, each state is addressing this in its own way; fifty different plans for one national crisis.Thus far, workers’ compensation is the pot out of which, in one way or another, claims are addressed. Employers do not like this.

Employers of essential workers haven’t wanted to scream too loudly about being the last in line guy, what with so many of their  workers falling ill, even dying, every day. That kind of crass insensitivity would be bad for business. But inwardly, they have to be nervous about getting stuck with the check, the cost of which, as we have documented here, could be enormous.

Employers have already taken a high hard one to the side of the head with the complete and utter devastation COVID-19 has done to their economic well being, and the requirement to pay the workers’ compensation claims which are going to avalanche over the top of them is something with which they strongly disagree. For what it’s worth, I think they have a point.

Back at the state capitals, I would venture, governors don’t really care where the money comes from, just as long as it’s not coming out of their state treasuries.

And throughout history, insurers have resisted paying for occupational disease claims. Witness the 20-year fight to avoid paying the costs of pneumoconiosis, which resulted in the Federal Coal Mine Health and Safety Act of 1969, amended four years later by the Black Lung benefits Act, which created the Black Lung Disability Trust Fund.

So, if the states don’t pay and if insurers don’t pay and if employers don’t pay, who is left?

Brothers and sisters, the federal government is left, which is another way of saying we are left. We will all share the risk and share the costs. If you cannot bring yourself to believe that, you haven’t been paying attention.

In fact, a model exists: The September 11th Victim Compensation Fund, which:

…provides compensation to individuals (or a personal representative of a deceased individual) who were present at the World Trade Center or the surrounding New York City exposure zone; the Pentagon crash site; and the Shanksville, Pennsylvania crash site, at some point between September 11, 2001, and May 30, 2002, and who have since been diagnosed with a 9/11-related illness.  The VCF is not limited to first responders.  Compensation is also available to those who worked or volunteered in construction, clean-up, and debris removal; as well as people who lived, worked, or went to school in the exposure zone.

The wheels are already in motion. Last week, a bipartisan group in the House unveiled the Pandemic Heroes Compensation Act, a plan to compensate essential workers who fall sick or die from COVID-19. The Act is modeled on the September 11th Victim Compensation Act.

Senate democrats are also proposing legislation. Like everything else in D.C. these days, the road from here to eventual victim compensation will be tortuous, but I cannot see any other way of paying for this national catastrophe other than with a national program. Can you?

The Moderna results

For a number of years, I chaired the Board of a BIOTECH pre-clinical Contract Research Organization (CRO). We took compounds, whose makers hoped would become the next blockbuster drugs, and tested them in mice, rats, guinea pigs, rabbits, pigs and non-human primates (that’s right, monkeys). In the biotech business, everyone knows everyone else, and we certainly knew a lot of scientists trying to develop vaccines.

Yesterday, the Boston pharmaceutical company Moderna reported a vaccine it was developing for COVID-19 produced antibodies in humans. In vaccine development, this is the beginning of a Phase One trial, and its purpose is to confirm the vaccine is not toxic. Moderna’s Phase One trial is composed of 45 participants, eight of whom  Moderna says produced the antibodies. We know nothing of the other 37.

While encouraging, you won’t find respected scientists getting too excited yet. They know what Moderna has done is to take the ball out of the end zone and reach the one yard line. Nintey-nine to go.

Two things are exciting, however. First, Moderna was able to get to this point at light speed. What Moderna did in about 70 days usually takes three to four years. That is over the moon fast, but the other ninety-nine yards are going to be increasingly more arduous. Second, there are more than 100 other groups around the world, both pharmaceutical and academic, who are also going hell bent for leather to develop the vaccine that will eradicate COVID-19. Although I have every confidence one of these groups, maybe Moderna,  will cross the goal line at the other end of the field, it will take a miracle on the order of the Raising of Lazarus for this to happen before mid to late 2021.

Until then: Constant vigilance. Complacency will kill you. Really. Please keep this in mind as all the beaches and parks open this coming Memorial Day weekend. It will be highly tempting to revert to former form.