Archive for the ‘Coronavirus’ Category

Thoughts Of The Day

Monday, January 18th, 2021

Was Azar intentionally lying, colossally incompetent, or both?

Given the last four years, I’m guessing Door Number 3.

Because both the Pfizer and Moderna vaccines require two shots, administered 21 and 28 days apart, respectively, Operation Warp Speed’s initial plan, announced in early December, was to hold back half the supply to make sure there was enough for the second shots. At the same time, the Trump Administration was saying it would vaccinate 20 million people by the end of the year.

On Tuesday, 12 January, as it became apparent the first doses of COVID-19 vaccinations were proceeding much slower than predicted (the 20 million prediction had turned into an 11.4 million reality), U.S. Secretary of Health and Human Services (HHS) Alex Azar announced the government was making all of the coronavirus reserve vaccine supply immediately available, urged states to provide shots to anyone 65 and older and warned governors that states with lagging inoculations could see their supply shifted to other places.

You could hear the collective country-wide sigh of relief. Help was on the way.

That is, until three days later when we learned the only place the “reserve supply” existed was in Alex Azar’s imagination, because the Administration admitted to state and federal officials it stopped stockpiling the second doses at the end of last year as it attempted to hit the 20 million goal. The reserve supply no longer existed. The states were left to scramble again, as they have throughout the pandemic. Remember the PPE fiasco? States were forced to compete against each other and the Feds to get any. Remember the Administration’s leadership about masking? Neither do I. I could go on.

This latest FUBAR catastrophe led President-Elect Joe Biden to tell the world the vaccine rollout was “a dismal failure.” Seems fairly accurate to me.

“Never ruin an apology with an excuse” – Benjamin Franklin

Here’s the way it worked. After the election, which he lost, Donald Trump spewed lie after lie about how he actually won “in a landslide.” And he convinced millions of people this was so. A new Quinnipiac poll reports 73% of Republicans believe there was “widespread fraud” in the election, which allowed Joe Biden to win. Trump’s two-month assault on truth led to the 6 January armed insurrection.

It is questionable whether he would have persuaded his millions of followers to believe the lies if he had not had profound assistance from Twitter, Facebook and conservative media. Case in point: the conservative outlet American Thinker which, with no investigation,  bought the Dominion Voting Machines stole-the-election line – again and again.

Yesterday, American Thinker “screwed its courage to the sticking post” and apologized. It was not one of those, “We did a bad thing, but we did it because…” things. No, this was an apology that would have made Ben proud. Here it is in full:

We don’t know what prompted American Thinker to so abjectly fall on its sword. I choose to think optimistically, believing journalistic ethics won the day. Regardless, this is how you do an apology.

Speaking of optimism

Why not end on a lighter note?

Back in pre-pandemic times (you remember those, don’t you?), when you wouldn’t think twice about sitting in a pub with friends discussing the metaphysics of Sartre, I once did just that with two friends, one a conservative republican with whom one could actually debate policy issues with smiles all around; the other, an MIT engineering professor.

We were talking about how people so often view the same thing in different ways, which led us to a discussion about optimism. That led to further discussion about the differences between people who were naturally optimistic and those who were naturally pessimistic.

One of us brought up the old glass half full or empty screed. I, the eternal optimist, said to me the glass was always half full. My conservative friend said he couldn’t help seeing it as half empty.

My friend from MIT said, “There’s too much glass.”

Stay safe – and, if you can, optimistic.

 

 

 

 

 

Now There Are Two, And Other Thoughts

Monday, November 16th, 2020

The Moderna Vaccine

Moderna’s announcement today that its vaccine candidate, mRNA-1273, is more than 94.5% effective in early trial results is wonderful news. Pfizer’s similar announcement from last week about its vaccine, BNT162b2, (also mRNA-based) gives us great hope that by mid-2021 the U.S. may have vaccinated most of the country’s population.

One advantage Moderna has over Pfizer is that its vaccine does not require “ultra cold storage,” as in minus 103 degrees Fahrenheit. As we wrote here, Pfizer says it has developed specially designed, temperature-controlled shipping packages, using dry ice, to keep its vials at roughly minus 103 below Fahrenheit for up to 10 days. But what happens if the doses are not used in ten days? This is one of the many things that is concerning governors and health care experts who are wrestling with the logistics of large-scale vaccinations.

We won’t know if Pfizer’s and Moderna”s vaccines can really do what it seems they might be able to do until the final results of their trials are known, but there is one thing we won’t know even then: How long will they protect us from the Coronavirus? Although both companies will follow all test subjects for a couple of years, if they each file quickly for and receive Emergency Use Authorization, which is all but guaranteed, they will go to market with about four months of data.

Will this lack of certainty about long-term protection cause people to forego vaccination? Personally, I don’t think so. But there is another possibility.

As we have seen for many months, despite the lack of competent leadership from 1600 Pennsylvania avenue, there are significant segments of the population taking the virus more seriously than others: seniors, those who are health-compromised, and myriad others who have paid attention to the science. It is conceivable these groups will take the vaccine, but refuse to return to any semblance of pre-pandemic life until long-term efficacy is known, and that won’t happen until well into 2022. If this happens, it is likely that masks, remote work, telehealth, and a host of other accommodations we’ve made due to the pandemic are here for quite some time longer.

Speaking of vaccines, here comes China

Flying under the media radar was an article in Foreign Affairs (subscription required) from 5 November by Eyck Freymann and Justin Stebbing. China Is Winning The Vaccine Race: How Beijing Positioned Itself as the Savior of the Developing World is an eye-opening look at China’s herculean effort to rebound from its tragically bungled initial response to COVID-19. From the article:

As a result, the disease spread around the world, crippling economies, killing more than 1.2 million people, and badly damaging Beijing’s image. In 2021, China plans to redeem itself by vaccinating a large chunk of the global population. Although it faces stiff competition from the United States and other Western nations in the race to develop the first vaccine, Beijing is poised to dominate the distribution of vaccines to the developing world—and to reap the strategic benefits of doing so.

Four of the 11 worldwide vaccine candidates are Chinese. The most promising of these, developed by Wuhan-based Sinopharm, is already being given to frontline workers in the United Arab Emirates.

Half the world’s population lives in the developing world, and Donald Trump’s administration, with its America First mantra, has no plans to distribute vaccines to that half of humanity, leaving a wide open door through which China is already walking. Also from the article:

The United States has declined to participate in a World Health Organization (WHO) initiative to deliver two billion vaccine doses to at-risk populations in developing countries, and it has not extended financing to or signed preferential vaccine distribution deals with such countries, as China has done.

While the U.S. will supply vaccines to its own citizenry and sell them to other developed countries, the vast underbelly of humanity will go a-begging. The emerging markets of Asia, Africa, the Middle East, and Latin America can barely afford vaccines, China has seized this opportunity by announcing subsidies and striking loan deals with the eighteen countries where its vaccine candidates are now in Phase Three clinical trials. As far back as May, Chinese President Xi Jinping promised that any successful Chinese vaccine would be used for a “global public good.” Thus far, he has kept that promise.

Throughout the pandemic (and, for that matter, the entire Trump presidency), America has ignored no, stiff armed the half of humanity most in need. This is just another Everest the incoming Biden Administration will have to climb as it tries to undo four years of foreign policy misfeasance, which the Oxford English Dictionary defines as “the wrongful exercise of lawful authority.” Kind of fits, doesn’t it?

Barack Obama returns

President Obama jumped back into the political scene as a force for Joe Biden during the recent campaign. Our first Black president did his part to help rally the African American vote, which proved so consequential in Biden’s victory.

Now, President Obama has written the first book in what will be a multi-book memoir. The Promised Land goes on sale tomorrow. So, he’s begun the book interview marathon, that, in his case, will be widely covered by the media. Case in point Yesterday, he turned up twice on CBS, first with Gayle King on CBS Sunday Morning and second with Scott Pelley on Sixty Minutes.

I’m sure the book is interesting and will sell a gazillion copies, but that’s not what I want to mention here. No, I’d like to end this column with a little story Mr. Obama told at the end of his interview with Ms. King.

Having become a private citizen at 12:01 pm, 20 January 2017, the former president began to reacclimate to private life. For security reasons, he was still prohibited from driving himself. So, as he tells it, there he is in the backseat of some vehicle checking his iPad and being driven somewhere by a Secret Service Officer. Then, the car slows and stops. Since this never happens in a presidential motorcade, he wonders why they stopped. Had something happened? Was there some danger? He looks up and sees the red light. At that moment, another car drives up beside him and he sees children playing in the back seat. As he told Ms. King, “Welcome to private life, Barack.”

Sixty-five days from now, Donald Trump will begin to encounter his own red lights for which he must stop. That will be a reality show worth watching.

 

 

Seven Days

Tuesday, October 27th, 2020

A diversion

How about a break from anything having to do with COVID-19 or the election? Would you like that? Then let me tell you a story.

Long ago, in a galaxy far away, a 23-year-old, newly-minted, Infantry 2nd Lieutenant airborne ranger with my name spent two-plus years in a little country in Southeast Asia called Vietnam. I think if Donald Trump had foregone the fake bone spurs and taken his chances over there he might have learned a lot.

But that’s another story, and not the point of this one. Couldn’t help myself.

Three months before rotating home to the U.S., I had been pulled from the field, that is, taken out of the jungle, and given a staff job on Firebase Vegel in northern South Vietnam.

With two months to go, I decided to begin keeping a Short-timer’s Calendar.

My Short-timer’s Calendar consisted of the centerfold of the June, 1971, Playboy magazine. My Battalion Commander, Lt. Colonel  Bulldog Carter (that’s right, Bulldog), and my partner, Buck Kernan (who went on to become a Lieutenant General, like his father before him), marked up the luscious photo into 60 puzzle-like areas numbered from 60 down to one. The trajectory of the progression became increasingly lascivious.

Thereafter we held a nightly, candle-lit ceremony in the bunker occupied by Buck and me.

But before I describe the ceremony, I have to tell you about the Macadamia nuts.

During Vietnam  the army  allowed soldiers a ten-day R&R (Rest and Relaxation) vacation. As a two-year guy I got two of them, which I spent in Honolulu, Hawaii, with my wife, Marilyn. One day, during the second R&R, we went to the PX (Post Exchange) at Scofield Army Barracks to pick up a couple of things. While we were there we bought a large bottle of Macadamia nuts for me to take back to Vietnam. In Vietnam, little things became luxurious delicacies.

Back to the ceremony.

Our bunker had a single bunk bed. There was only one bed, because Buck and I took 12-hour shifts in the Op Center keeping the world safe for democracy. One of us would end his shift, wave to the other and crash into the bed.

Every night, at 2000 hours, 8:00 pm to you, the three of us would gather in the bunker. There was a small table to the side of the bed.  I had pinned the centerfold to the wall above the table. At the appointed hour, I would light two candles and place them on each side of the table under the pin-up. I would open the bottle of Macadamia nuts, which occupied a special spot in the center of the table, and hand each of my comrades one nut, taking one for myself. We would then have a moment of quiet reflection, after which I would, with a red marker purloined from the Op Center, X-out the next descending number on Miss June.

We would then eat the nuts.

We did that all the way down to ONE! On that night, we held a special ceremony, inviting the Battalion XO, the other six staff officers and the Battalion Sgt. Major into the bunker, which became almost as crowded as the stateroom scene in Night at the Opera. We gave everyone a Macadamia nut that night, and, in a service worthy of priestly ordination, I passed the bottle of Macadamia nuts to Buck, who, because he still had six weeks to go, later on would replace my centerfold with his centerfold and continue the tradition. We retired my centerfold to a place of prominence on the side wall of the Op Center, where Bulldog could see it every day all day. Six weeks later, Buck’s would be hung beside it.

The next day, I choppered south, boarded a chartered Pan Am plane with about three-hundred other happy guys and flew home to what we called “the world.”

OK. Break’s over

If it weren’t so stupidly tragic and delusional, one might be forgiven for viewing Donald Trump’s campaign swan song as comical. “We’ve turned the corner.” “It will go away.” “On November 4th, you won’t hear about it anymore.” And the list goes on.

But if you really want to know how we’re doing, there are, actually, reliable places to look. Johns Hopkins Coronavirus Resource Center and the New York Times COVID Tracker, for example.

And now there is this website, which tracks the Rt factor for each state, daily. Rt represents the effective reproduction rate of the virus calculated for each locale. It lets us estimate how many secondary infections are likely to occur from a single infection in a specific area. Values over 1.0 mean we should expect more cases in that area, values under 1.0 mean we should expect fewer. As of today, only one state, Mississippi, of all places, is below 1. You can see what infection rates are like today, two weeks ago, one, two and three months ago. It confirms what all of us, except the aforementioned Mr. Trump, his minions and cult-like followers, know to be true.

If we’ve “turned the corner” it is only to enter Dante’s Ninth Circle of Hell. You remember that one, don’t you? It’s the final, deepest level of hell, reserved for traitors, betrayers and oath-breakers. Up until now, it’s most famous occupant had been Judas Iscariot.

Up until now.

And finally…

Seven days to go.

The number seven comes up a lot in Roman Catholicism. There are seven Cardinal Virtues, called by the church, “Gifts of the Holy Spirit.” They are wisdom, understanding, counsel, fortitude, knowledge, piety, and fear of the Lord.

There are seven Corporal Works of Mercy. They are feed the hungry, shelter the homeless, clothe the naked, visit the sick and imprisoned, bury the dead, and give alms to the poor.

And there are seven Spiritual Works of Mercy. They are instruct, advise, console, comfort, forgive, and bear wrongs patiently.

Judge, now Justice, Amy Coney Barrett is a devout Roman Catholic. I’m sure she is also a very smart person and probably a pretty good lawyer, too.

But for a month now, I’ve been bothered by something about her, and with seven days to go, I’m bothered even more.

For the life of me I cannot get over that, at her super-spreader Rose Garden introduction and follow-on reception in the White House, she did not wear a mask to protect herself and others. I understand everyone else who attended had swallowed the Kool-Aid, but she should have known better. And last night, in the White House Blue Room and outside on its balcony, she was still unmasked.

There are only three possibilities for this behavior.

  1. She doesn’t believe masks protect us and others from the virus, which I don’t believe for a minute;
  2. She is ignorant about masks and doesn’t understand their importance, which I don’t believe for a second;
  3. She was influenced by Trump’s behavior, as well as that of everyone else’s, and just went along to get along.

I’m voting for door #3, and that is a scary thought for our future.

Seven days.

 

 

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

Saturday, October 24th, 2020

From the Department of There’s No Accounting For Stupidity

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

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

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

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

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

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

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

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

How cold is cold enough?

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

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

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

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

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

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

High Deductibles: Another nail in the rural hospital coffin

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

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

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

How to get rid of an irritating federal employee

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

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

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

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

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

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

Think about that. Please.

 

 

 

 

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.

Sisyphus Must Have Felt Like This

Wednesday, September 16th, 2020

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

Unions during COVID-19

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

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

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

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

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

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

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

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

Avoiding medical care during COVID-19

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

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

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

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

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

Enough said.

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

U. S. life expectancy

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

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

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

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

Trump’s Nevada rally

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

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

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

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

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

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

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

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

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

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

 

Why Dr. Fauci Is “Cautiously Optimistic”

Monday, August 3rd, 2020

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

Monday, July 20th, 2020

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

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.

 

Today’s Class: Impeccable Timing 101

Monday, June 15th, 2020

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.